ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Twinrix Paediatric, suspension for injection
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
2.
1 dose (0.5 ml) contains:
Hepatitis A virus (inactivated)
1,2
360 ELISA Units
Hepatitis B surface antigen
3,4
10 micrograms
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al
3+
3
Produced in yeast cells (
Saccharomyces
cerevisiae
) by recombinant DNA technology
4
Adsorbed on aluminium phosphate
0.2 milligrams Al
3+
For a full list of excipients, see section 6.1.
3.
Suspension for injection.
Turbid white suspension.
4.
Twinrix Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up
to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Posology
- Dosage
The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended for infants, children and
adolescents from 1 year up to and including 15 years of age.
- Primary vaccination schedule
The standard primary course of vaccination with Twinrix Paediatric consists of three doses, the first
administered at the elected date, the second one month later and the third six months after the first
dose. The recommended schedule should be adhered to. Once initiated, the primary course of
vaccination should be completed with the same vaccine.
- Booster dose
In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or
combined vaccine can be given. The safety and immunogenicity of Twinrix Paediatric administered as
a booster dose following a three dose primary course have not been evaluated.
2
The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the
combined vaccine are in the range of what is seen following vaccination with the monovalent
vaccines. General guidelines for booster vaccination can therefore be drawn from experience with the
monovalent vaccines, as follows.
Hepatitis B
The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full
primary vaccination course has not been established; however some official vaccination programmes
currently include a recommendation for a booster dose of hepatitis B vaccine and these should be
respected.
For some categories of subjects or patients exposed to HBV (e.g. haemodialysis or
immunocompromised patients) a precautionary attitude should be considered to ensure a protective
antibody level ≥ 10IU/l.
Hepatitis A
It is not yet fully established whether immunocompetent individuals who have responded to hepatitis
A vaccination will require booster doses as protection in the absence of detectable antibodies may be
ensured by immunological memory. Guidelines for boosting are based on the assumption that
antibodies are required for protection.
In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Paediatric
can be given. Alternatively, subjects primed with Twinrix Paediatric may be administered a booster
dose of either of the monovalent vaccines.
Method of administration
Twinrix Paediatric is for intramuscular injection, preferably in the deltoid region in adolescents and
children or in the anterolateral thigh in infants.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or
bleeding disorders. However, this route of administration may result in suboptimal immune response
to the vaccine (see section 4.4).
Hypersensitivity to the active substances or to any of the excipients or neomycin.
Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines.
The administration of Twinrix Paediatric should be postponed in subjects suffering from acute severe
febrile illness.
It is possible that subjects may be in the incubation period of a HA or HB infection at the time of
vaccination. It is not known whether Twinrix Paediatric will prevent HA and HB in such cases.
The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and
other pathogens known to infect the liver.
Twinrix Paediatric is not recommended for postexposure prophylaxis (e.g. needle stick injury).
The vaccine has not been tested in patients with impaired immunity. In haemodialysis patients,
patients receiving immunosuppressive treatment or patients with an impaired immune system, the
3
anticipated immune response may not be achieved after the primary immunisation course. Such
patients may require additional doses of vaccine; nevertheless immunocompromised patients may fail
to demonstrate an adequate response.
As with all injectable vaccines, appropriate medical treatment and supervision should always be
readily available in case of a rare anaphylactic event following the administration of the vaccine.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a
suboptimal response to the vaccine, these routes should be avoided. However, exceptionally Twinrix
Paediatric can be administered subcutaneously to subjects with thrombocytopenia or bleeding
disorders since bleeding may occur following an intramuscular administration to these subjects (see
section 4.2).
TWINRIX PAEDIATRIC SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED
INTRAVASCULARLY.
As with any injection procedure, vasovagal syncope can infrequently occur following administration
of Twinrix Paediatric to adolescents.
No data on concomitant administration of Twinrix Paediatric with specific hepatitis A
immunoglobulin or hepatitis B immunoglobulin have been generated. However, when the monovalent
hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins,
no influence on seroconversion was observed although it may result in lower antibody titers.
Twinrix Paediatric can be given concomitantly with Human Papillomavirus (HPV) vaccine.
Administration of Twinrix Paediatric at the same time as Cervarix (HPV vaccine) has shown no
clinically relevant interference in the antibody response to the HPV and hepatitis A antigens. Anti-
HBs geometric mean antibody concentrations were lower on co-administration, but the clinical
significance of this observation is not known since the seroprotection rates remain unaffected. The
proportion of subjects reaching anti-HBs ≥ 10 mIU/ml was 98.3% for concomitant vaccination and
100% for Twinrix alone.
Only the concomitant administration of Twinrix Paediatric with Cervarix has been specifically
studied. It is advised that vaccines other than Cervarix should not be administered at the same time as
Twinrix Paediatric.
Pregnancy
The effect of Twinrix Paediatrict on embryo-fetal, peri-natal and post-natal survival and development
has been assessed in rats. This study did not indicate direct or indirect harmful effects with respect to
fertility, pregnancy, embryonal/fetal development, parturition or post-natal development.
The effect of Twinrix Paediatric on embryo-fetal, peri-natal and post-natal survival and development
has not been prospectively evaluated in clinical trials.
Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any
adverse effects of Twinrix Paediatric on pregnancy or on the health of the fetus/newborn child. While
it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on
pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery
unless there is an urgent need to protect the mother against hepatitis B infection.
Breastfeeding
It is unknown whether Twinrix Paediatric is excreted in human breast milk. The excretion of Twinrix
Paediatric in milk has not been studied in animals. A decision on whether to continue/discontinue
4
breast-feeding or to continue/discontinue therapy with Twinrix Paediatric should be made taking into
account the benefit of breast-feeding to the child and the benefit of Twinrix Paediatric therapy to the
woman.
Twinrix Paediatric has no or negligible influence on the ability to drive and use machines.
•
Clinical trials
The safety profile presented below is based on data from approximately 800 subjects.
Frequencies are reported as:
Very common: ≥ 1/10
Common: ≥ 1/100 to < 1/10
Uncommon: ≥ 1/1,000 to < 1/100
Rare: ≥ 1/10,000 to < 1/1,000
Very rare:
< 1/10,000
* refers to adverse reactions observed in clinical trials performed with the adult formulation
Blood and lymphatic system disorders
Rare: lymphadenopathy
Common: drowsiness, headache
Rare: hypoaesthesia*, paraesthesia*, dizziness
Gastrointestinal disorders
Common: gastrointestinal symptoms, nausea
Uncommon: diarrhoea, vomiting, abdominal pain
Skin and subcutaneous tissue disorders
Rare: urticaria, pruritus*
Musculoskeletal and connective tissue disorders
Rare: arthralgia*
Metabolism and nutrition disorders
Common: appetite lost
Infections and infestations
Uncommon: upper respiratory tract infection*
Vascular disorders
Rare: hypotension*
General disorders and administration site conditions
Common: swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise,
fever (≥ 37.5°C)
Rare: influenza like illness*, chills*
5
Nervous system disorders
Uncommon: rash
Uncommon: myalgia*
Very common: pain and redness at the injection site
Psychiatric disorders
Common: irritability
•
Post-marketing surveillance
The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline
monovalent hepatitis A or B vaccines:
Blood and lymphatic system disorders
Thrombocytopenia, thrombocytopenic purpura
Nervous system disorders
Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions
Skin and subcutaneous tissue disorders
Angioneurotic oedema, lichen planus, erythema multiforme
Musculoskeletal and connective tissue disorders
Arthritis, muscular weakness
Infections and infestations
Meningitis
Vascular disorders
Vasculitis
Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness
Following widespread use of the monovalent hepatitis A and/or hepatitis B vaccines, the following
undesirable events have additionally been reported in temporal association with vaccination.
Abnormal liver function tests
Multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with
ascending paralysis), optic neuritis
Cases of overdose have been reported during post-marketing surveillance. Adverse events reported
following overdosage were similar to those reported with normal vaccine administration.
5.
5.1 Pharmacodynamic properties
Pharmaco-therapeutic group: Hepatitis vaccines, ATC code J07BC20.
Twinrix Paediatric is a combined vaccine formulated by pooling bulk preparations of the purified,
inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately
adsorbed onto aluminium hydroxide and aluminium phosphate.
The HA virus is propagated in MRC
5
human diploid cells. HBsAg is produced by culture, in a
selective medium, of genetically engineered yeast cells.
Twinrix Paediatric confers immunity against HAV and HBV infection by inducing specific anti-HA
and anti-HBs antibodies.
6
Immune system disorders
Investigations
Nervous system disorders
Protection against hepatitis A and hepatitis B develops within 2-4 weeks. In the clinical studies,
specific humoral antibodies against hepatitis A were observed in approximately 89% of the subjects
one month after the first dose and in 100% one month after the third dose (i.e. month 7). Specific
humoral antibodies against hepatitis B were observed in approximately 67% of the subjects after the
first dose and 100% after the third dose.
In two long term clinical trials, persistence of anti-HAV and anti-HBs antibodies has been
demonstrated up to 10 years in children aged 12-15 years and up to 5 years in children aged 1-11
years.
At 10 years following the initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged
12-15 years, all subjects followed up retained≥15 mIU/ml anti -HAV antibody and 85% had anti-HBs
antibody ≥10 mIU/ml.
At 5 years following initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged 1-11
years all subjects followed up retained
≥15 mIU/ml anti -HAV antibody and 97% had anti-HBs
antibody ≥10 mIU/ml.
The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the
monovalent vaccines.
5.2 Pharmacokinetic properties
Evaluation of pharmacokinetic properties is not required for vaccines.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on general safety studies (see section
4.6).
6.
6.1 List of excipients
Sodium chloride
Water for injections
For adjuvants, see section 2.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package, in order to protect from light.
6.5 Nature and contents of container
7
0.5 ml of suspension in a vial (type I glass) with a plunger stopper (rubber butyl).
Pack sizes of 1, 3 and 10.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually
inspected for any foreign particulate matter and/or variation of physical aspect prior to administration.
In the event of either being observed, discard the vaccine.
Any unused product of waste material should be disposed of in accordance with local requirements.
7.
GlaxoSmithKline Biologicals s.a.
rue de l'Institut 89
B-1330 Rixensart, Belgium
8.
EU/1/97/029/003
EU/1/97/029/004
EU/1/97/029/005
9.
Date of first authorisation: 10 February 1997
Date of latest renewal: 10 February 2007
Detailed information on this product is available on the website of the European Medicines Agency
8
1.
NAME OF MEDICINAL PRODUCT
Twinrix Paediatric, suspension for injection in prefilled syringe
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
2.
1 dose (0.5 ml) contains:
Hepatitis A virus (inactivated)
1,2
360 ELISA Units
Hepatitis B surface antigen
3,4
10 micrograms
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al
3+
3
Produced in yeast cells (
Saccharomyces
cerevisiae
) by recombinant DNA technology
4
Adsorbed on aluminium phosphate
0.2 milligrams Al
3+
For a full list of excipients, see section 6.1.
3.
Suspension for injection in prefilled syringe
Turbid white suspension.
4.
Twinrix Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up
to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Posology
- Dosage
The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended for infants, children and
adolescents from 1 year up to and including 15 years of age.
- Primary vaccination schedule
The standard primary course of vaccination with Twinrix Paediatric consists of three doses, the first
administered at the elected date, the second one month later and the third six months after the first
dose. The recommended schedule should be adhered to. Once initiated, the primary course of
vaccination should be completed with the same vaccine.
- Booster dose.
In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or
combined vaccine can be given. The safety and immunogenicity of Twinrix Paediatric administered as
a booster dose following a three dose primary course have not been evaluated.
9
The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the
combined vaccine are in the range of what is seen following vaccination with the monovalent
vaccines. General guidelines for booster vaccination can therefore be drawn from experience with the
monovalent vaccines, as follows.
Hepatitis B
The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full
primary vaccination course has not been established; however some official vaccination programmes
currently include a recommendation for a booster dose of hepatitis B vaccine and these should be
respected.
For some categories of subjects or patients exposed to HBV (e.g. haemodialysis or
immunocompromised patients) a precautionary attitude should be considered to ensure a protective
antibody level ≥ 10IU/l.
Hepatitis A
It is not yet fully established whether immunocompetent individuals who have responded to hepatitis
A vaccination will require booster doses as protection in the absence of detectable antibodies may be
insured by immunological memory. Guidelines for boosting are based on the assumption that
antibodies are required for protection.
In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Paediatric
can be given. Alternatively, subjects primed with Twinrix Paediatric may be administered a booster
dose of either of the monovalent vaccines.
Method of administration
Twinrix Paediatric is for intramuscular injection, preferably in the deltoid region in adolescents and
children or in the anterolateral thigh in infants.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or
bleeding disorders. However, this route of administration may result in suboptimal immune response
to the vaccine (see section 4.4).
Hypersensitivity to the active substances or to any of the excipients or neomycin.
Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines.
The administration of Twinrix Paediatric should be postponed in subjects suffering from acute severe
febrile illness.
It is possible that subjects may be in the incubation period of a HA or HB infection at the time of
vaccination. It is not known whether Twinrix Paediatric will prevent HA and HB in such cases.
The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and
other pathogens known to infect the liver.
Twinrix Paediatric is not recommended for postexposure prophylaxis (e.g. needle stick injury).
The vaccine has not been tested in patients with impaired immunity. In haemodialysis patients,
patients receiving immunosuppressive treatment or patients with an impaired immune system, the
10
anticipated immune response may not be achieved after the primary immunisation course. Such
patients may require additional doses of vaccine; nevertheless immunocompromised patients may fail
to demonstrate an adequate response.
As with all injectable vaccines, appropriate medical treatment and supervision should always be
readily available in case of a rare anaphylactic event following the administration of the vaccine.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a
suboptimal response to the vaccine, these routes should be avoided. However, exceptionally Twinrix
Paediatric can be administered subcutaneously to subjects with thrombocytopenia or bleeding
disorders since bleeding may occur following an intramuscular administration to these subjects (see
section 4.2).
TWINRIX PAEDIATRIC SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED
INTRAVASCULARLY.
As with any injection procedure, vasovagal syncope can infrequently occur following administration
of Twinrix Paediatric to adolescents.
No data on concomitant administration of Twinrix Paediatric with specific hepatitis A
immunoglobulin or hepatitis B immunoglobulin have been generated. However, when the monovalent
hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins,
no influence on seroconversion was observed although it may result in lower antibody titers.
Twinrix Paediatric can be given concomitantly with Human Papillomavirus (HPV) vaccine.
Administration of Twinrix Paediatric at the same time as Cervarix (HPV vaccine) has shown no
clinically relevant interference in the antibody response to the HPV and hepatitis A antigens. Anti-
HBs geometric mean antibody concentrations were lower on co-administration, but the clinical
significance of this observation is not known since the seroprotection rates remain unaffected. The
proportion of subjects reaching anti-HBs ≥ 10 mIU/ml was 98.3% for concomitant vaccination and
100% for Twinrix alone.
Only the concomitant administration of Twinrix Paediatric with Cervarix has been specifically
studied. It is advised that vaccines other than Cervarix should not be administered at the same time as
Twinrix Paediatric.
Pregnancy
The effect of Twinrix Paediatrict on embryo-fetal, peri-natal and post-natal survival and development
has been assessed in rats. This study did not indicate direct or indirect harmful effects with respect to
fertility, pregnancy, embryonal/fetal development, parturition or post-natal development.
The effect of Twinrix Paediatric on embryo-fetal, peri-natal and post-natal survival and development
has not been prospectively evaluated in clinical trials.
Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any
adverse effects of Twinrix Paediatric on pregnancy or on the health of the fetus/newborn child. While
it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on
pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery
unless there is an urgent need to protect the mother against hepatitis B infection.
Breastfeeding
It is unknown whether Twinrix Paediatric is excreted in human breast milk. The excretion of Twinrix
11
Paediatric in milk has not been studied in animals. A decision on whether to continue/discontinue
breast-feeding or to continue/discontinue therapy with Twinrix Paediatric should be made taking into
account the benefit of breast-feeding to the child and the benefit of Twinrix Paediatric therapy to the
woman.
Twinrix Paediatric has no or negligible influence on the ability to drive and use machines.
•
Clinical trials
The safety profile presented below is based on data from approximately 800 subjects.
Frequencies are reported as:
Very common: ≥ 1/10
Common: ≥ 1/100 to < 1/10
Uncommon: ≥ 1/1,000 to < 1/100
Rare: ≥ 1/10,000 to < 1/1,000
Very rare:
< 1/10,000
* refers to adverse reactions observed in clinical trials performed with the adult formulation
Blood and lymphatic system disorders
Nervous system disorders
Common: drowsiness, headache
Rare: hypoaesthesia*, paraesthesia*, dizziness
Gastrointestinal disorders
Uncommon: diarrhoea, vomiting, abdominal pain
Skin and subcutaneous tissue disorders
Rare: urticaria, pruritus*
Musculoskeletal and connective tissue disorders
Uncommon: myalgia*
Rare: arthralgia*
Metabolism and nutrition disorders
Uncommon: upper respiratory tract infection*
Rare: hypotension*
General disorders and administration site conditions
Common: swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise,
fever (≥ 37.5°C)
Rare: influenza like illness*, chills*
12
Rare: lymphadenopathy
Common: gastrointestinal symptoms, nausea
Uncommon: rash
Common: appetite lost
Infections and infestations
Vascular disorders
Very common: pain and redness at the injection site
Psychiatric disorders
•
Post-marketing surveillance
The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline
monovalent hepatitis A or B vaccines:
Blood and lymphatic system disorders
Thrombocytopenia, thrombocytopenic purpura
Nervous system disorders
Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions
Skin and subcutaneous tissue disorders
Angioneurotic oedema, lichen planus, erythema multiforme
Musculoskeletal and connective tissue disorders
Arthritis, muscular weakness
Infections and infestations
Meningitis
Vascular disorders
Vasculitis
Immune system disorders
Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness
Following widespread use of the monovalent hepatitis A and/or hepatitis B vaccines, the following
undesirable events have additionally been reported in temporal association with vaccination.
Investigations
Abnormal liver function tests
Nervous system disorders
Multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with
ascending paralysis), optic neuritis
Cases of overdose have been reported during post-marketing surveillance. Adverse events reported
following overdosage were similar to those reported with normal vaccine administration.
5.
5.1 Pharmacodynamic properties
Pharmaco-therapeutic group: Hepatitis vaccines, ATC code J07BC20.
Twinrix Paediatric is a combined vaccine formulated by pooling bulk preparations of the purified,
inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately
adsorbed onto aluminium hydroxide and aluminium phosphate.
The HA virus is propagated in MRC
5
human diploid cells. HBsAg is produced by culture, in a
selective medium, of genetically engineered yeast cells.
13
Common: irritability
Twinrix Paediatric confers immunity against HAV and HBV infection by inducing specific anti-HA
and anti-HBs antibodies.
Protection against hepatitis A and hepatitis B develops within 2-4 weeks. In the clinical studies,
specific humoral antibodies against hepatitis A were observed in approximately 89% of the subjects
one month after the first dose and in 100% one month after the third dose (i.e. month 7). Specific
humoral antibodies against hepatitis B were observed in approximately 67% of the subjects after the
first dose and 100% after the third dose.
In two long term clinical trials, persistence of anti-HAV and anti-HBs antibodies has been
demonstrated up to 10 years in children aged 12-15 years and up to 5 years in children aged 1-11
years.
At 10 years following the initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged
12-15 years, all subjects followed up retained≥15 mIU/ml anti -HAV antibody and 85% had anti-HBs
antibody ≥10 mIU/ml.
At 5 years following initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged 1-11
years all subjects followed up retained
≥15 mIU/ml anti -HAV antibody and 97% had anti-HBs
antibody ≥10 mIU/ml.
The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the
monovalent vaccines.
5.2 Pharmacokinetic properties
Evaluation of pharmacokinetic properties is not required for vaccines.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on general safety studies (see section
4.6).
6.
6.1 List of excipients
Sodium chloride
Water for injections
For adjuvants, see section 2.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package, in order to protect from light.
14
6.5 Nature and contents of container
0.5 ml of suspension in a prefilled syringe (type I glass) with a plunger stopper (rubber butyl).
Pack sizes of 1, 10 and 50 with or without needles.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually
inspected for any foreign particulate matter and/or variation of physical aspect prior to administration.
In the event of either being observed, discard the vaccine.
Any unused product of waste material should be disposed of in accordance with local requirements.
7.
GlaxoSmithKline Biologicals s.a.
rue de l'Institut 89
B-1330 Rixensart, Belgium
8.
EU/1/97/029/001
EU/1/97/029/002
EU/1/97/029/006
EU/1/97/029/007
EU/1/97/029/008
EU/1/97/029/009
EU/1/97/029/010
9.
Date of first authorisation: 10 February 1997
Date of latest renewal: 10 February 2007
Detailed information on this product is available on the website of the European Medicines Agency
15
ANNEX II
A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE
SUBSTANCES AND MANUFACTURING
AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
16
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substances
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89,
1330 Rixensart
Belgium
Name and address of the manufacturer responsible for batch release
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89,
1330 Rixensart
Belgium
B. CONDITIONS OF THE MARKETING AUTHORISATION
•
Medicinal product subject to medical prescription.
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable.
•
OTHER CONDITIONS
Official batch release: in accordance with Article 114 of Directive 2001/83/EC as amended, the
official batch release will be undertaken by a state laboratory or a laboratory designated for that
purpose.
PSUR: The Marketing Authorisation Holder will continue to submit annual PSURs.
17
ANNEX III
LABELLING AND PACKAGE LEAFLET
18
A. LABELLING
19
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
1 VIAL
3 VIALS
10 VIALS
1.
Twinrix Paediatric – Suspension for injection
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
1 dose (0.5 ml):
Hepatitis A virus (inactivated)
1,2
360 ELISA Units
Hepatitis B surface antigen
3,4
10 micrograms
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al
3+
3
Produced in yeast cells (
Saccharomyces
cerevisiae
) by recombinant DNA technology
4
Adsorbed on aluminium phosphate
0.2 milligrams Al
3+
3.
LIST OF EXCIPIENTS
Sodium chloride
Water for injections
4.
Suspension for injection
1 vial
1 dose (0.5 ml)
3 vials
3 x 1 dose (0.5 ml)
10 vials
10 x 1 dose (0.5 ml)
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
Intramuscular use
Shake before use
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
20
Keep out of the reach and sight of children
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP: MM/YYYY
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator
Do not freeze
Store in the original package in order to protect from light
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Dispose of in accordance with local regulations
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart, Belgium
EU/1/97/029/003 - 1 vial
EU/1/97/029/004 - 3 vials
EU/1/97/029/005 - 10 vials
13. BATCH NUMBER
LOT:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription
15. INSTRUCTIONS ON USE
21
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
22
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
1 SYRINGE WITHOUT NEEDLE
10 SYRINGES WITHOUT NEEDLE
50 SYRINGES WITHOUT NEEDLE
1 SYRINGE WITH 1 NEEDLE
10 SYRINGES WITH 10 NEEDLES
1 SYRINGE WITH 2 NEEDLES
10 SYRINGES WITH 20 NEEDLES
1.
Twinrix Paediatric – Suspension for injection
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
1 dose (0.5 ml):
Hepatitis A virus (inactivated)
1,2
360 ELISA Units
Hepatitis B surface antigen
3,4
10 micrograms
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al
3+
3
Produced in yeast cells (
Saccharomyces
cerevisiae
) by recombinant DNA technology
4
Adsorbed on aluminium phosphate
0.2 milligrams Al
3+
3.
LIST OF EXCIPIENTS
Sodium chloride
Water for injections
4.
Suspension for injection
1 syringe
1 dose (0.5 ml)
10 syringes
10 x 1 dose (0.5 ml)
50 syringes
50 x 1 dose (0.5 ml)
1 syringe + 1 needle
1 dose (0.5 ml)
10 syringes + 10 needles
10 x 1 dose (0.5 ml)
23
1 syringe + 2 needles
1 dose (0.5 ml)
10 syringes + 20 needles
10 x 1 dose (0.5 ml)
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use
Intramuscular use
Shake before use
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP: MM/YYYY
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator
Do not freeze
Store in the original package in order to protect from light
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Dispose of in accordance with local regulations
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart, Belgium
EU/1/97/029/001 - 1 syringe without needle
EU/1/97/029/002 - 10 syringes without needle
EU/1/97/029/008 - 50 syringes without needle
24
EU/1/97/029/006 – 1 syringe with 1 needle
EU/1/97/029/007 – 10 syringes with 10 needles
EU/1/97/029/009 – 1 syringe with 2 needles
EU/1/97/029/010 – 10 syringes with 20 needles
13. BATCH NUMBER
LOT:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
25
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Twinrix Paediatric, suspension for injection
HAB vaccine
I.M.
2.
METHOD OF ADMINISTRATION
3.
EXPIRY DATE
EXP:
4.
BATCH NUMBER
LOT:
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
1 dose (0.5 ml)
6.
OTHER
26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
Twinrix Paediatric, Suspension for injection
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Read all of this leaflet carefully before you start/ your child starts receiving this vaccine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Twinrix Paediatric is and what it is used for
2.
Before you receive/ your child receives Twinrix Paediatric
3.
How Twinrix Paediatric is given
4.
Possible side effects
5.
How to store Twinrix Paediatric
6.
Further information
1. WHAT TWINRIX PAEDIATRIC IS AND WHAT IT IS USED FOR
Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and
including 15 years to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing
the body to produce its own protection (antibodies) against these diseases.
•
Hepatitis A:
Hepatitis A is an infectious disease, which can affect the liver. This disease is
caused by the hepatitis A virus. The hepatitis A virus can be passed from person to person in
food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A
begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling
sick), fever and aches and pains. After a few days the whites of eyes and skin may become
yellowish (jaundice). The severity and type of symptoms can vary. Young children may not
develop jaundice. Most people recover completely but the illness is usually severe enough to
keep people off work for about a month.
•
Hepatitis B:
Hepatitis B is caused by the hepatitis B virus. It causes the liver to become swollen
(inflamed). The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva
(spit) of infected people.
Vaccination is the best way to protect against these diseases. None of the components in the vaccine
are infectious.
2. BEFORE YOU RECEIVE/ YOUR CHILD RECEIVES TWINRIX PAEDIATRIC
Twinrix Paediatric should not be given:
•
if you have/ your child has previously had any allergic reaction to Twinrix Paediatric, or any
ingredient contained in this vaccine. The active substances and other ingredients in Twinrix
Paediatric are listed at the end of the leaflet. Signs of an allergic reaction may include itchy skin
rash, shortness of breath and swelling of the face or tongue.
•
if you have/ your child has previously had an allergic reaction to any vaccine against hepatitis A
and hepatitis B diseases.
•
if you have/ your child has a severe infection with a high temperature (over 38°C). A minor
28
-
This vaccine has been prescribed for you/ your child. Do not pass it on to others.
infection such as a cold should not be a problem, but talk to your doctor first.
Take special care with Twinrix Paediatric:
•
if you have/ your child has experienced any health problems after previous administration of a
vaccine.
•
if you have/ your child has a bleeding problem or bruise/ bruises easily.
Using other medicines or vaccines
Twinrix Paediatric can be given with a Human Papillomavirus (HPV) vaccine at a separate injection
site (another part of your body, e.g. the other arm) during the same visit.
Please tell your doctor if you are/ your child is taking or have/ has recently taken any other medicines,
including medicines obtained without a prescription or have/ has recently received any other vaccine.
Pregnancy and breast-feeding
Take special care with Twinrix Paediatric if you are or think you may be pregnant or if you intend to
become pregnant. Your doctor will discuss with you the possible risks and benefits of having Twinrix
Paediatric during pregnancy.
It is not known if Twinrix Paediatric passes into breast milk, however the vaccine is not expected to
cause problems in breast-fed babies.
Important information about some of the ingredients of Twinrix Paediatric
Please tell your doctor if you have/ your child has had an allergic reaction to neomycin (antibiotic).
3.
HOW TWINRIX PAEDIATRIC IS GIVEN
You/ your child will receive a total of three injections over 6 months. Each injection is given on a
separate visit. The first dose will be given on an elected date. The remaining two doses will be given
one month, and six months after the first dose.
•
First dose:
at an elected date
•
Second dose:
1 month later
•
Third dose:
6 months after the first dose
Your doctor will advise on the possible need for extra doses, and future booster dosing.
If you miss/ your child misses a scheduled injection, talk to your doctor and arrange another visit.
Make sure you finish/ your child finishes the complete vaccination course of three injections. If not,
you/ your child may not be fully protected against the diseases.
The doctor will give Twinrix Paediatric as an injection into your upper arm muscle or into the thigh
muscle of your child.
The vaccine should never be given into a vein.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Twinrix Paediatric can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
29
Very common (these may occur with more than 1 in 10 doses of the vaccine)
Common (these may occur with up to 1 in 10 doses of the vaccine)
Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A
and hepatitis B vaccines or with the adult formulation of Twinrix include:
Very common
:
•
Pain and redness at the injection site
Common
:
•
Drowsiness, headache
•
Nausea
•
Loss of appetite
•
Swelling or bruising at the injection site
•
Generally feeling unwell, tiredness
•
Fever equal to or greater than 37.5°C
•
Irritability
Uncommon
:
•
Diarrhoea, vomiting, stomach pain
•
Rash
•
Aching muscles
•
Upper respiratory tract infection
Rare
:
•
Swollen glands in the neck armpit or groin (lymphadenopathy)
•
Dizziness
•
Loss of skin sensitivity to pain or touch (hypoaesthesia)
•
Feeling of pins and needles (paraesthesia)
•
Hives, itching
•
Joint pain
•
Low blood pressure
•
Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills
Very rare
:
•
Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
•
Purple or red brown spots visible through the skin (thrombocytopenic purpura)
•
Swelling or infection of the brain (encephalitis)
•
Degenerative disease of the brain (encephalopathy)
•
Inflammation of nerves (neuritis)
•
Numbness or weakness of the arms and legs (neuropathy), paralysis
•
Fits or seizures
•
Swelling of the face, mouth or throat (angioneurotic oedema)
•
Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema
multiforme)
•
Joint swelling, muscular weakness
•
Infection around the brain which may give severe headache with stiff neck and sensitivity to light
(meningitis)
•
Inflammation of some blood vessels (vasculitis)
•
Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness).
Signs of serious allergic reactions may be rashes that may be itchy or blistering, swelling of the
eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of
consciousness. Such reactions may occur before leaving the doctor’s surgery. However, if you get
any of these symptoms you should contact a doctor urgently.
•
Abnormal laboratory liver test results
•
Multiple sclerosis, swelling of the spinal cord (myelitis)
30
•
Drooping eyelid and sagging muscles on one side of the face (facial palsy)
•
A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities
and often progressing to the chest and face (Guillain-Barré syndrome)
•
A disease of the nerves of the eye (optic neuritis)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5. HOW TO STORE TWINRIX PAEDIATRIC
Keep out of the reach and sight of children.
Do not use Twinrix Paediatric after the expiry date which is stated on the carton. The expiry date
refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Store in the original package in order to protect from light.
Do not freeze. Freezing destroys the vaccine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Twinrix Paediatric contains
-
The active substances are:
Hepatitis A virus (inactivated)
1,2
360 ELISA Units
Hepatitis B surface antigen
3,4
10 micrograms
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al
3+
3
Produced in yeast cells (
Saccharomyces
cerevisiae
) by recombinant DNA technology
4
Adsorbed on aluminium phosphate
0.2 milligrams Al
3+
-
The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.
What Twinrix Paediatric looks like and contents of the pack
Suspension for injection.
Twinrix Paediatric is a white, slightly milky liquid presented in a glass vial (0.5 ml).
Twinrix Paediatric is available in packs of 1, 3 and 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
For any information about this medicine, please contact the local representative of the Marketing
31
Authorisation Holder:
België/Belgique/Belgien
GlaxoSmithKline s.a./n.v.
Tél/Tel: + 32 2 656 21 11
Luxembourg/Luxemburg
GlaxoSmithKline s.a./n.v.
Tél/Tel: + 32 2 656 21 11
България
ГлаксоСмитКлайн ЕООД
ул. Димитър Манов бл.10
София 1408
Тел.: + 359 2 953 10 34
Magyarország
GlaxoSmithKline Kft.
Tel.: + 36-1-2255300
Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 2 22 00 11 11
gsk.czmail@gsk.com
Malta
GlaxoSmithKline Malta
Tel: + 356 21 238131
Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
dk-info@gsk.com
Nederland
GlaxoSmithKline BV
Tel: + 31 (0)30 69 38 100
nlinfo@gsk.com
Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel: + 49 (0)89 360448701
produkt.info@gsk.com
Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00
firmapost@gsk.no
Eesti
GlaxoSmithKline Eesti OÜ
Tel: +372 667 6900
estonia@gsk.com
Österreich
GlaxoSmithKline Pharma GmbH.
Tel: + 43 1 970 75-0
at.info@gsk.com
Ελλάδα
GlaxoSmithKline A.E.B.E.
Tηλ: + 30 210 68 82 100
Polska
GSK Commercial Sp. z o.o.
Tel.: + 48 (22) 576 9000
España
GlaxoSmithKline, S.A.
Tel: + 34 902 202 700
es-ci@gsk.com
Portugal
Smith Kline & French Portuguesa, Produtos
Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
France
Laboratoire GlaxoSmithKline
Tél: + 33 (0) 1 39 17 84 44
diam@gsk.com
România
GlaxoSmithKline (GSK) SRL
Tel: + 40 (0)21 3028 208
Ireland
GlaxoSmithKline (Ireland) Ltd
Tel: + 353 (0)1 4955000
Slovenija
GlaxoSmithKline d.o.o.
Tel: + 386 (0) 1 280 25 00
medical.x.si@gsk.com
32
Ísland
GlaxoSmithKline ehf.
Sími: +354-530 3700
Slovenská republika
GlaxoSmithKline Slovakia s.r.o.
Tel: + 421 (0)2 48 26 11 11
recepcia.sk@gsk.com
Italia
GlaxoSmithKline S.p.A.
Tel:+ 39 04 59 21 81 11
Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 10 30 30 30
Finland.tuoteinfo@gsk.com
Κύπρος
GlaxoSmithKline (Cyprus) Ltd
Τηλ: + 357 22 39 70 00
Latvija
GlaxoSmithKline Latvia SIA
Tel: + 371 67312687
lv-epasts@gsk.com
United Kingdom
GlaxoSmithKline UK
Tel: + 44 (0)808 100 9997
customercontactuk@gsk.com
Lietuva
GlaxoSmithKline Lietuva UAB
Tel. +370 5 264 90 00
info.lt@gsk.com
This leaflet was last approved in
Detailed information on this medicine is available on the European Medicines Agency web site:
---------------------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only:
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually
inspected for any foreign particulate matter and/or variation of physical aspect prior to administration.
In the event of either being observed, discard the vaccine.
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
Twinrix Paediatric, Suspension for injection in prefilled syringe
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Read all of this leaflet carefully before you start/ your child starts receiving this vaccine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Twinrix Paediatric is and what it is used for
2.
Before you receive/ your child receives Twinrix Paediatric
3.
How Twinrix Paediatric is given
4.
Possible side effects
5.
How to store Twinrix Paediatric
6.
Further information
1.
WHAT TWINRIX PAEDIATRIC IS AND WHAT IT IS USED FOR
Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and
including 15 years to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing
the body to produce its own protection (antibodies) against these diseases.
•
Hepatitis A:
Hepatitis A is an infectious disease, which can affect the liver. This disease is
caused by the hepatitis A virus. The hepatitis A virus can be passed from person to person in
food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A
begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling
sick), fever and aches and pains. After a few days the whites of eyes and skin may become
yellowish (jaundice). The severity and type of symptoms can vary. Young children may not
develop jaundice. Most people recover completely but the illness is usually severe enough to
keep people off work for about a month.
•
Hepatitis B:
Hepatitis B is caused by the hepatitis B virus. It causes the liver to become
swollen (inflamed). The virus is found in body fluids such as blood, semen, vaginal secretions,
or saliva (spit) of infected people.
Vaccination is the best way to protect against these diseases. None of the components in the vaccine
are infectious.
2.
BEFORE YOU RECEIVE/ YOUR CHILD RECEIVES TWINRIX PAEDIATRIC
Twinrix Paediatric should not be given:
•
if you have/ your child has previously had any allergic reaction to Twinrix Paediatric, or any
ingredient contained in this vaccine. The active substances and other ingredients in Twinrix
Paediatric are listed at the end of the leaflet. Signs of an allergic reaction may include itchy skin
rash, shortness of breath and swelling of the face or tongue.
•
if you have/ your child has previously had an allergic reaction to any vaccine against hepatitis A
and hepatitis B diseases.
•
if you have/ your child has a severe infection with a high temperature (over 38°C). A minor
34
-
This vaccine has been prescribed for you/ your child. Do not pass it on to others.
infection such as a cold should not be a problem, but talk to your doctor first.
Take special care with Twinrix Paediatric:
•
if you have/ your child has experienced any health problems after previous administration of a
vaccine.
•
if you have/ your child has a bleeding problem or bruise/ bruises easily.
Using other medicines or vaccines
Twinrix Paediatric can be given with a Human Papillomavirus (HPV) vaccine at a separate injection
site (another part of your body, e.g. the other arm) during the same visit.
Please tell your doctor if you are/ your child is taking or have/ has recently taken any other medicines,
including medicines obtained without a prescription or have/ has recently received any other vaccine.
Pregnancy and breast-feeding
Take special care with Twinrix Paediatric if you are or think you may be pregnant or if you intend to
become pregnant.Your doctor will discuss with you the possible risks and benefits of having Twinrix
Paediatric during pregnancy.
It is not known if Twinrix Paediatric passes into breast milk, however the vaccine is not expected to
cause problems in breast-fed babies.
Important information about some of the ingredients of Twinrix Paediatric
Please tell your doctor if you have/ your child has had an allergic reaction to neomycin (antibiotic).
3.
HOW TWINRIX PAEDIATRIC IS GIVEN
You/ your child will receive a total of three injections over 6 months. Each injection is given on a
separate visit. The first dose will be given on an elected date. The remaining two doses will be given
one month, and six months after the first dose.
•
First dose:
at an elected date
•
Second dose:
1 month later
•
Third dose:
6 months after the first dose
Your doctor will advise on the possible need for extra doses, and future booster dosing.
If you miss/ your child misses a scheduled injection, talk to your doctor and arrange another visit.
Make sure you finish/ your child finishes the complete vaccination course of three injections. If not,
you/ your child may not be fully protected against the diseases.
The doctor will give Twinrix Paediatric as an injection into your upper arm muscle or into the thigh
muscle of your child.
The vaccine should never be given into a vein.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Twinrix Paediatric can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
Very common (these may occur with more than 1 in 10 doses of the vaccine)
35
Common (these may occur with up to 1 in 10 doses of the vaccine)
Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A
and hepatitis B vaccines or with the adult formulation of Twinrix include:
Very common
:
•
Pain and redness at the injection site
Common
:
•
Drowsiness, headache
•
Nausea
•
Loss of appetite
•
Swelling or bruising at the injection site
•
Generally feeling unwell, tiredness
•
Fever equal to or greater than 37.5°C
•
Irritability
Uncommon
:
•
Diarrhoea, vomiting, stomach pain
•
Rash
•
Aching muscles
•
Upper respiratory tract infection
Rare
:
•
Swollen glands in the neck armpit or groin (lymphadenopathy)
•
Dizziness
•
Loss of skin sensitivity to pain or touch (hypoaesthesia)
•
Feeling of pins and needles (paraesthesia)
•
Hives, itching
•
Joint pain
•
Low blood pressure
•
Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills
Very rare
:
•
Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
•
Purple or red brown spots visible through the skin (thrombocytopenic purpura)
•
Swelling or infection of the brain (encephalitis)
•
Degenerative disease of the brain (encephalopathy)
•
Inflammation of nerves (neuritis)
•
Numbness or weakness of the arms and legs (neuropathy), paralysis
•
Fits or seizures
•
Swelling of the face, mouth or throat (angioneurotic oedema)
•
Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema
multiforme)
•
Joint swelling, muscular weakness
•
Infection around the brain which may give severe headache with stiff neck and sensitivity to light
(meningitis)
•
Inflammation of some blood vessels (vasculitis)
•
Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness).
Signs of serious allergic reactions may be rashes that may be itchy or blistering, swelling of the
eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of
consciousness. Such reactions may occur before leaving the doctor’s surgery. However, if you get
any of these symptoms you should contact a doctor urgently.
•
Abnormal laboratory liver test results
•
Multiple sclerosis, swelling of the spinal cord (myelitis)
•
Drooping eyelid and sagging muscles on one side of the face (facial palsy)
36
•
A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities
and often progressing to the chest and face (Guillain-Barré syndrome)
•
A disease of the nerves of the eye (optic neuritis)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5. HOW TO STORE TWINRIX PAEDIATRIC
Keep out of the reach and sight of children.
Do not use Twinrix Paediatric after the expiry date which is stated on the carton. The expiry date
refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Store in the original package in order to protect from light.
Do not freeze. Freezing destroys the vaccine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Twinrix Paediatric contains
-
The active substances are:
Hepatitis A virus (inactivated)
1,2
Hepatitis B surface antigen
3,4
360 ELISA Units
1
Produced on human diploid (MRC-5) cells
2
Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al
3+
3
Produced in yeast cells (
Saccharomyces
cerevisiae
) by recombinant DNA technology
4
Adsorbed on aluminium phosphate
0.2 milligrams Al
3+
-
The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.
What Twinrix Paediatric looks like and contents of the pack
Suspension for injection in pre-filled syringe.
Twinrix Paediatric is a white, slightly milky liquid presented in a glass prefilled syringe (0.5 ml).
Twinrix Paediatric is available in packs of 1, 10 and 50 with or without needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
37
10 micrograms
België/Belgique/Belgien
GlaxoSmithKline s.a./n.v.
Tél/Tel: + 32 2 656 21 11
Luxembourg/Luxemburg
GlaxoSmithKline s.a./n.v.
Tél/Tel: + 32 2 656 21 11
България
ГлаксоСмитКлайн ЕООД
ул. Димитър Манов бл.10
София 1408
Тел.: + 359 2 953 10 34
Magyarország
GlaxoSmithKline Kft.
Tel.: + 36-1-2255300
Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 2 22 00 11 11
gsk.czmail@gsk.com
Malta
GlaxoSmithKline Malta
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GlaxoSmithKline Pharma GmbH.
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Slovenská republika
38
GlaxoSmithKline ehf.
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This leaflet was last approved in
Detailed information on this medicine is available on the European Medicines Agency web site:
---------------------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only:
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually
inspected for any foreign particulate matter and/or variation of physical aspect prior to administration.
In the event of either being observed, discard the vaccine.
39
Source: European Medicines Agency
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