ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Pandemrix suspension and emulsion for emulsion for injection.
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
2.
After mixing, 1 dose (0.5 ml) contains:
Split influenza virus, inactivated, containing antigen
*
equivalent to:
A/California/07/2009 (H1N1) derived strain used NYMC X-179A
3.75 micrograms
**
*
propagated in eggs
**
haemagglutinin
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and
polysorbate 80 (4.86 milligrams)
The suspension and emulsion, once mixed, form a multidose vaccine in a vial. See section 6.5 for the
number of doses per vial.
Excipients: the vaccine contains 5 micrograms thiomersal
For a full list of excipients see section 6.1.
3.
Suspension and emulsion for emulsion for injection.
The suspension is a colourless light opalescent liquid.
The emulsion is a whitish homogeneous liquid.
4.
Prophylaxis of influenza caused by A (H1N1)v 2009 virus. (see section 4.4).
Pandemrix should be used in accordance with Official Guidance.
Posology
The dose recommendations take into account the safety and immunogenicity data from clinical studies
in healthy subjects
See sections 4.4, 4.8 and 5.1 for details.
No data are available in children aged less than 6 months.
Adults aged 18 years and older:
One dose of 0.5 ml at an elected date.
2
Immunogenicity data obtained at three weeks after one dose of Pandemrix (H1N1)v suggest that a
single dose may be sufficient.
If a second dose is administered there should be an interval of at least three weeks between the first
and the second dose.
Children and adolescents aged 10-17 years
Dosing may be in accordance with the recommendations for adults.
Children aged from 6 months to 9 years
One dose of 0.25 ml at an elected date.
There is a further immune response to a second dose of 0.25 ml administered after an interval of three
weeks.
The use of a second dose should take into consideration the information provided in sections 4.4, 4.8
and 5.1.
Children aged less than 6 months
Vaccination is not currently recommended in this age group.
It is recommended that subjects who receive a first dose of Pandemrix should complete the
vaccination course with Pandemrix (see section 4.4).
Method of administration
Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or
anterolateral thigh (depending on the muscle mass).
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues
(egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of
this vaccine.
Immunisation should be postponed in subjects with a severe febrile illness or acute infection.
The vaccine can only be expected to protect against influenza caused by A/California/07/2009
(H1N1)v-like strains.
Caution is needed when administering this vaccine to persons with a known hypersensitivity (other
than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to
residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium
deoxycholate).
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.
Pandemrix should under no circumstances be administered intravascularly.
There are no data with Pandemrix using the subcutaneous route. Therefore, healthcare providers need
to assess the benefits and potential risks of administering the vaccine in individuals with
thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless
the potential benefit outweighs the risk of bleedings.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
A protective immune response may not be elicited in all vaccinees (see section 5.1).
3
There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1)v
in children aged less than 6 months. Vaccination is not recommended in this age group.
In children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose)
with an interval of 3 weeks between doses there was an increase in the rates of injection site reactions
and general symptoms after the second dose (see section 4.8). In particular rates of fever (axillary
temperature ≥38°C) increased considerably after the second dose. Therefore, monitoring of
temperature and measures to lower the fever (such as antipyretic medication as seems clinically
necessary) are recommended in young children (e.g. up to approximately 6 years of age) after each
dose of Pandemrix.
There are no safety, immunogenicity or efficacy data to support interchangeability of Pandemrix with
other (H1N1)v vaccines.
Data obtained on co-administration of Pandemrix (H1N1)v with non-adjuvanted seasonal influenza
vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any
significant interference in the immune response to Pandemrix (H1N1)v. The immune response to
Fluarix was satisfactory.
Co-administration was not associated with higher rates of local or systemic reactions compared to
administration of Pandemrix alone.
Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal
influenza vaccines (with injections made into opposite limbs).
Data obtained on the administration of a non-adjuvanted seasonal influenza vaccine (Fluarix, a split
virion vaccine) three weeks before a dose of Pandemrix (H1N1)v in healthy adults over 60 years of
age, did not suggest any significant interference in the immune response to Pandemrix (H1N1)v.
Therefore the data indicate that Pandemrix may be administered three weeks after the administration
of non-adjuvanted seasonal influenza vaccines.
There are no data on co-administration of Pandemrix with other vaccines.
If co-administration with another vaccine is considered, immunisation should be carried out on
separate limbs. It should be noted that the adverse reactions may be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant
treatment.
Following influenza vaccination, false-positive serology test results may be obtained by the ELISA
method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially,
HTLV-1. In such cases, the Western blot method is negative. These transitory false-positive results
may be due to IgM production in response to the vaccine.
Pandemrix has been administered to women in each trimester of pregnancy. Information on outcomes
from estimated more than 200,000 women who have been vaccinated during pregnancy is currently
limited. There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that
were followed in a prospective clinical study.
Animal studies with Pandemrix do not indicate reproductive toxicity (see section 5.3).
Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do
not suggest malformations or fetal or neonatal toxicity.
4
Pandemrix may be used in lactating women.
Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive
or use machines.
•
Clinical trials
Adverse reactions reported are listed according to the following frequency:
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)
Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 5,000
subjects 18 years old and above who received formulations containing A/Vietnam/1194/2004 (H5N1).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and lymphatic system disorders
Common: lymphadenopathy
Psychiatric disorders
Uncommon: insomnia
Nervous system disorders
Very common: headache
Uncommon: paraesthesia, somnolence, dizziness
Gastrointestinal disorders
Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Skin and subcutaneous tissue disorders
Common: ecchymosis at the injection site, sweating increased
Uncommon: pruritus, rash
Musculoskeletal and connective tissue disorders
Very common: arthralgia, myalgia
General disorders and administration site conditions
Very common: induration, swelling, pain and redness at the injection site, fever, fatigue
Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus)
Uncommon: malaise
Additional data on reactogenicity are available from clinical studies in healthy subjects of various age
groups from 6 months of age upwards who received Pandemrix (H1N1)v.The available data are as
follows:
Adults
5
In a clinical study that evaluated the reactogenicity of the first 0.5 ml dose of Pandemrix (H1N1)v in
healthy adults aged 18-60 (N=120) and above 60 years (N=120), the frequency of adverse reactions
was similar between age groups, except for redness (more common in subjects aged >60 years) and
shivering and sweating (more common in subjects aged 18-60 years).
In a clinical study that evaluated reactogenicity in healthy adults aged 18-60 years who received two
0.5 ml doses (21 days apart) of Pandemrix (H1N1)v, there were higher rates of most general solicited
symptoms (such as fatigue, headache, arthralgia, shivering, sweating and fever) after the second dose
compared to the first dose.
Children aged 10-17 years
In a clinical study that evaluated the reactogenicity in children 10 to 17 years of age who received two
0.5 ml doses (21 days apart) of Pandemrix (H1N1)v, there was no increase in reactogenicity after the
second dose compared to the first dose. Gastro-intestinal symptoms and shivering were reported at
higher rates compared to the rates reported above from the studies with the H5N1 vaccine formulation.
Children aged 3-9 years
In a clinical study that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received
a single half adult (i.e. 0.25 ml) dose of Pandemrix (H1N1)v, the frequency of the following adverse
reactions was as shown in the table:
Adverse reactions
3-5 years
6-9 years
Pain
60.0%
63.1%
Redness
26.7%
23.1%
Swelling
21.7%
23.1%
Shivering
13.3%
10.8%
Sweating
10.0%
6.2%
Fever >38°C
10.0%
4.6%
Fever >39°C
1.7%
0.0%
Diarrhoea
5.0%
NA
Drowsiness
23.3%
NA
Irritability
20.0%
NA
Loss of appetite
20.0%
NA
Arthralgia
NA
15.4%
Myalgia
NA
16.9%
Fatigue
NA
27.7%
Gastrointestinal
NA
13.8%
Headache
NA
21.5%
NA= not available
No data are available at present on reactogenicity after a second half adult (i.e. 0.25 ml) dose of
Pandemrix (H1N1)v in children aged 3 to 9 years. However, in another clinical study which evaluated
the reactogenicity in children 3 to 9 years who received two adult (i.e. 0.5 ml) doses (21 days apart) of
Pandemrix (H1N1)v there was an increase in injection site reactions and general symptoms after the
second dose compared to the first dose.
Children aged 6-35 months
In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received two half
adult (i.e. 0.25 ml) doses (21 days apart) of Pandemrix (H1N1)v there was an increase in injection site
reactions and general symptoms after the second dose compared to the first dose particularly in rates
of axillary fever (≥38°C). The per-dose frequency of the following adverse reactions was as shown in
the table:
6
Adverse reactions
Post dose 1
Post dose 2
Pain
31.4%
41.2%
Redness
19.6%
29.4%
Swelling
15.7%
23.5%
Fever (≥38°C) axillary
5.9%
43.1%
Fever (≥39°C) axillary
0.0%
3.9%
Drowsiness
7.8%
35.3%
Irritability
21.6%
37.3%
Loss of appetite
9.8%
39.2%
•
Post-marketing surveillance
Pandemrix (H1N1)v
In addition to the adverse reactions reported in the clinical trials, the following have been reported
during post-marketing experience with Pandemrix (H1N1)v:
Immune system disorders
Anaphylaxis, allergic reactions
Nervous system disorders
Febrile convulsions
Skin and subcutaneous tissue disorders
Angioedema, generalised skin reactions, urticaria
Trivalent seasonal influenza vaccines
From Post-marketing surveillance with trivalent seasonal influenza vaccines, the following adverse
reactions have also been reported:
Rare
:
Neuralgia, transient thrombocytopenia.
Very rare
:
Vasculitis with transient renal involvement.
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and
therefore, it is possible that sensitisation reactions may occur (see section 4.4).
No case of overdose has been reported.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
Immune response to Pandemrix (H1N1)v
Adults aged 18-60 years
7
In two clinical studies that evaluated the immunogenicity of of Pandemrix in healthy subjects aged 18-
60 years the anti-HA antibody responses were as follows:
anti-HA
antibody
Immune response to A/California/7/2009 (H1N1)v-like
D-Pan H1N1-007
D-Pan H1N1-008
21 days after 1
st
dose
21 days after 2
nd
dose
21 days after 1
st
dose
Total
enrolled
subjects
N=60
[95% CI]
Seronegative
subjects
prior to
vaccination
N=37
[95% CI]
Total
enrolled
subjects
N=59
[95% CI]
Seronegative
subjects
prior to
vaccination
N=37
[95% CI]
Total enrolled
subjects
N=120
[95% CI]
Seronegative
subjects prior
to
vaccination
N=76
[95% CI]
Seroprotection
rate
1
100%
[94.0;100]
100%
[90.5;100]
100%
[93.9;100]
100%
[90.5;100]
97.5%
[92.9;99.5]
96.1%
[88.9;99.2]
Seroconversion
rate
2
98.3%
[
91.1;100]
100%
[
90.5;100]
98.3%
[90.9;100]
100%
[90.5;100]
95.0%
[89.4;98.1]
96.1%
[88.9;99.2]
Seroconversion
factor
3
38.1
47.0
72.9
113.3
42.15
[33.43;53.16]
50.73
[37.84;68.02]
1
seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
2
seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have
a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-
fold increase in titre;
3
seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-
vaccination GMT.
Elderly (>60 years)
The anti-HA antibody responses 21 days after a first dose of Pandemrix in healthy subjects aged >60
years as follows:
anti-HA
antibody
Immune response to A/California/7/2009 (H1N1)v-like
61-70 years
71-80 years
>80 years
Total
enrolled
subjects
N=75
[95% CI]
Seronegative
subjects prior
to
vaccination
N=43
[95% CI]
Total
enrolled
subjects
N=40
[95% CI]
Seronegative
subjects prior
to
vaccination
N=23
[95% CI]
Total
enrolled
subjects
N=5
[95% CI]
Seronegative
subjects prior
to
vaccination
N=3
[95% CI]
Seroprotection
rate
1
88.0%
[78.4;94.4]
81.4%
[66.6;91.6]
87.5%
[73.2;95.8]
82.6%
[61.2;95.0]
80.0%
[28.4;99.5]
66.7%
[9.4;99.2]
Seroconversion
rate
2
80.0%
[69.2;88.4]
81.4%
[66.6;91.6]
77.5%
[61.5;89.2]
82.6%
[61.2;95.0]
80.0%
[28.4;99.5]
66.7%
[9.4;99.2]
17.95
[0.55;582.25]
1
seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
2
seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have
a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-
fold increase in titre;
3
seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-
vaccination GMT.
13.5
[10.3;17.7]
20.3
[13.94;28.78]
13.5
[8.6;21.1]
20.67
[11.58;36.88]
18.4
[4.3;78.1]
Children aged 10-17 years
8
Seroconversion
factor
3
Two clinical studies evaluated the administration of a half (0.25 ml) dose and a full (0.5 ml) adult dose
of Pandemrix in healthy children 10 to 17 years of age. The anti-HA antibody responses 21 days after
a first dose were as follows:
anti-HA antibody
Immune response to A/California/7/2009 (H1N1)v-like
Half dose
Full dose
Total enrolled
subjects
N=58
[95% CI]
Seronegative
subjects prior to
vaccination
N=38
[95% CI]
Total enrolled
subjects
N=97
[95% CI]
Seronegative
subjects prior to
vaccination
N=61
[95% CI]
Seroprotection
rate
1
98.3%
[90.8;100]
97.4%
[86.2;99.9]
100%
[96.3;100]
100%
[94.1;100]
Seroconversion
rate
2
96.6%
[88.1;99.6]
97.4%
[86.2;99.9]
96.9%
[91.2;99.4]
100%
[94.1;100]
95.8
[78.0;117.7]
1
seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
2
seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have
a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-
fold increase in titre;
3
seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-
vaccination GMT.
46.7
[34.8;62.5]
67.0
[49.1;91.3]
69.0
[52.9;68.4]
Children aged 3 to 9 years
In a clinical study in which children aged 3 to 9 years old received a half adult dose (0.25 ml) of
Pandemrix, the anti-HA antibody responses 21 days after a first dose were as follows:
anti-HA antibody
Immune response to A/California/7/2009 (H1N1)v-like
3-5 years
6-9 years
Total enrolled
subjects
N=30
[95% CI]
Seronegative
subjects prior to
vaccination
N=27
[95% CI]
Total enrolled
subjects
N=30
[95% CI]
Seronegative
subjects prior to
vaccination
N=29
[95% CI]
Seroprotection
rate
1
100%
[88.4;100]
100%
[87.2;100]
100%
[88.4;100]
100%
[88.1;100]
Seroconversion
rate
2
100%
[88.4;100]
100%
[87.2;100]
100%
[88.4;100]
100%
[88.1;100]
37.4
[28.7;48.7]
1
seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
2
seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have
a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-
fold increase in titre;
3
seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-
vaccination GMT.
32.4
[25.4;41.2]
36.4
[29.1;45.4]
36.3
[28.0;47.2]
Children aged 6-35 months
In a clinical study in healthy children 6 months to 35 months of age (stratified in ranges from 6 to 11,
12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a first and a second
half adult dose (i.e. 0.25 ml) of Pandemrix were as follows:
anti-HA antibody
Immune response to A/California/7/2009 (H1N1)v-like
9
Seroconversion
factor
3
Seroconversion
factor
3
6-11 months
12-23 months
4
24-35 months
4
Post dose
1
Post dose
2
Post dose 1 Post dose
1
Post
dose 2
Post
dose 1
Post
dose 2
Total enrolled subjects
[95% CI]
Seronegative
subjects prior
to
vaccination
[95% CI]
Total enrolled
subjects
[95% CI]
Total enrolled
subjects
[95% CI]
N=17
N = 17
N=14
N=17
N= 16 N=16
N= 17
Seroprotection
rate
1
100%
[80.5;
100]
100%
[80.5;
100]
100%
[76.8;100]
100%
[80.5;
100]
100%
[79.4;
100]
100%
[79.4;
100]
100%
[80.5;
100]
Seroconversion
rate
2
94.1%
[71.3;
99.9]
100%
[80.5;
100]
100%
[76.8;100]
100%
[80.5;
100]
100%
[79.4;
100]
100%
[79.4;
100]
100%
[80.5;
100]
Seroconversion
factor
3
44.4
[24.1;
81.5]
221.9
[102.6;
480.2]
70.67
[51.91;
96.20]
76.9
[55.7;
106.1]
378.0
[282.0;
506.7]
53.8
[40.7;
71.1]
409.1
[320.7;
521.9]
1
seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
2
seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have
a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-
fold increase in titre;
3
seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-
vaccination GMT.
4
all subjects seronegative prior to vaccination
The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Analysis of a subset of 36 subjects aged 6 months to 35 months old showed that 80.6 % had a 4 fold
increase in serum neutralising antibodies 21 days after the first dose (66.7 % in 12 subjects aged 6 to
11 months old, 91.7 % in 12 subjects aged 12 to 23 months old and 83.3 % in 12 subjects aged 24 to
35 months old).
Information from non-clinical studies:
The ability to induce protection against homologous and heterologous vaccine strains was assessed
non-clinically using ferret challenge models.
In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03
adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14). Doses of 15,
5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15,
7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment. Control
groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA)
or phosphate buffered saline solution. Ferrets were vaccinated on days 0 and 21 and challenged by the
intra-tracheal route on day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous
H5N1/A/Indonesia/5/05. Of the animals receiving adjuvanted vaccine, 87% and 96% were protected
against the lethal homologous or heterologous challenge, respectively. Viral shedding into the upper
respiratory tract was also reduced in vaccinated animals relative to controls, suggesting a reduced risk
of viral transmission. In the unadjuvanted control group, as well as in the adjuvant control group, all
animals died or had to be euthanized as they were moribund, three to four days after the start of
challenge.
10
Additional information is available from the studies conducted with a vaccine similar in composition
to Pandemrix but containing antigen derived from H5N1 viruses. Please consult the Product
Information of Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted).
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Non-clinical data obtained with the mock-up vaccine using a H5N1 vaccine strain reveal no special
hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose
toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the
lactation period).
6.
6.1 List of excipients
Suspension vial:
Polysorbate 80
Octoxynol 10
Thiomersal
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na
2
HPO
4
)
Potassium dihydrogen phosphate (KH
2
PO
4
)
Potassium chloride (KCl)
Magnesium chloride (MgCl
2
)
Water for injections
Emulsion vial:
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na
2
HPO
4
)
Potassium dihydrogen phosphate (KH
2
PO
4
)
Potassium chloride (KCl)
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
2 years.
After mixing, the vaccine should be used within 24 hours. Chemical and physical in-use stability has
been demonstrated for 24 hours at 25°C.
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.
11
6.5 Nature and contents of container
One pack containing:
-
one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
-
two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to
10 doses of vaccine (5 ml).
6.6 Special precautions for disposal and other handling
Pandemrix consists of two containers:
Suspension: multidose vial containing the antigen,
Emulsion: multidose vial containing the adjuvant.
Prior to administration, the two components should be mixed.
Instructions for mixing and administration of the vaccine:
1.
Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be
allowed to reach room temperature; each vial should be shaken and inspected visually for any
foreign particulate matter and/or abnormal physical appearance. In the event of either being
observed (including rubber particles from the stopper), discard the vaccine.
2.
The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by
means of a syringe and by adding it to the vial containing the antigen.
3.
After the addition of the adjuvant to the antigen, the mixture should be well shaken. The mixed
vaccine is a whitish emulsion. In the event of other variation being observed, discard the
vaccine.
4.
The volume of the Pandemrix vial after mixing is at least 5 ml. The vaccine should be
administered in accordance with the recommended posology (see section 4.2).
5.
The vial should be shaken prior to each administration and inspected visually for any foreign
particulate matter and/or abnormal physical appearance. In the event of either being observed
(including rubber particles from the stopper), discard the vaccine.
6.
Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a syringe for
injection and administered intramuscularly.
7.
After mixing, use the vaccine within 24 hours. The mixed vaccine can either be stored in a
refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C. If the mixed vaccine is
stored in a refrigerator, it should be allowed to reach room temperature before each withdrawal.
Any unused product or 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
EU/1/08/452/001
12
Date of first authorisation: 20/05/2008
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMA)
http://www.ema.europa.eu
/.
13
ANNEX II
A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE
SUBSTANCE AND MANUFACTURING AUTHORISATION
HOLDER RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
14
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) of the biological active substance
GlaxoSmithKline Biologicals
Branch of SmithKline Beecham Pharma GmbH & Co. KG
Zirkustraße 40, D-01069 Dresden
Germany
Name and address of the manufacturer(s) responsible for batch release
GlaxoSmithKline Biologicals S.A.
89, rue de l'Institut
B-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
•
The MAH shall agree with Member States to measures facilitating the identification and
traceability of the A/H1N1 vaccine administered to each patient, in order to minimise
medication errors and aid patients and health care professionals to report adverse reactions. This
may include the provision by the MAH of stickers with invented name and batch number with
each pack of the vaccine.
•
The MAH shall agree with Member States on mechanisms allowing patients and health care
professionals to have continuous access to updated information regarding Pandemrix.
•
The MAH shall agree with Member Sates on the provision of a targeted communication to
healthcare professionals which should address the following:
•
The correct way to prepare the vaccine prior to administration.
•
Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse
reactions, unexpected severe adverse reactions, adverse events of special interest (AESI).
•
The minimal data elements to be transmitted in individual case safety reports in order to
facilitate the evaluation and the identification of the vaccine administered to each subject,
including the invented name, the vaccine manufacturer and the batch number.
•
If a specific notification system has been put in place, how to report adverse reactions.
•
OTHER CONDITIONS
15
Official batch release
: in accordance with Article 114 Directive 2001/83/EC as amended, the official
batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, as described in version 3.6 (dated 09
November 2009) presented in Module 1.8.1 of the marketing authorisation application, is in place and
functioning before the product is placed on the market and for as long as the marketed product remains
in use.
The MAH will submit periodic safety update reports on a 6-month cycle, unless the CHMP decides
otherwise.
Risk Management Plan
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in
the Pharmacovigilance Plan, as agreed in version RMPv2 (dated September 2009) of the Risk
Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and
any subsequent updates of the RMP agreed by the CHMP.
16
ANNEX III
LABELLING AND PACKAGE LEAFLET
17
A. LABELLING
18
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS
OF EMULSION
1.
Pandemrix suspension and emulsion for emulsion for injection.
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
After mixing, 1 dose (0.5 ml) contains:
Split influenza virus inactivated, containing antigen equivalent to:
A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms
*
AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80
*
haemagglutinin
3.
LIST OF EXCIPIENTS
Polysorbate 80
Octoxynol 10
Thiomersal
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na
2
HPO
4
)
Potassium dihydrogen phosphate (KH
2
PO
4
)
Potassium chloride (KCl)
Magnesium chloride (MgCl
2
)
Water for injections
4.
Suspension and emulsion for emulsion for injection
50 vials: suspension (antigen)
50 vials: emulsion (adjuvant)
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to
10 doses
of 0.5 ml vaccine
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use
Shake before use
Read the package leaflet before use
19
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
Suspension and emulsion to be mixed before administration
8.
EXPIRY DATE
EXP
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/1/08/452/001
13. BATCH NUMBER
Lot:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
20
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
21
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PACK OF 50 VIALS OF SUSPENSION (ANTIGEN)
1.
Suspension for emulsion for injection for Pandemrix
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Split influenza virus, inactivated, containing antigen* equivalent to
3.75 micrograms
haemagglutinin/dose
*Antigen: A/California/07/2009 (H1N1) derived strain used NYMC X-179A
3.
LIST OF EXCIPIENTS
Excipients:
Polysorbate 80
Octoxynol 10
Thiomersal
Sodium chloride
Disodium hydrogen phosphate
Potassium dihydrogen phosphate
Potassium chloride
Magnesium chloride
Water for injections
4.
Antigen suspension for injection
50 vials: suspension
2.5 ml per vial.
After mixing with adjuvant emulsion:
10 doses
of 0.5 ml
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use
Shake before use
Read the package leaflet 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
22
Suspension to be exclusively mixed with adjuvant emulsion before administration
8.
EXPIRY DATE
EXP
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
GSK Biologicals, Rixensart - Belgium
EU/1/08/452/001
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
23
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PACK OF 25 VIALS OF EMULSION (ADJUVANT)
1.
Emulsion for emulsion for injection for Pandemrix
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86
milligrams) and polysorbate 80 (4.86 milligrams)
3.
LIST OF EXCIPIENTS
Excipients:
Sodium chloride
Disodium hydrogen phosphate
Potassium dihydrogen phosphate
Potassium chloride
Water for injections
4.
Adjuvant emulsion for injection
25 vials: emulsion
2.5 ml
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use
Shake before use
Read the package leaflet 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
Emulsion to be exclusively mixed with antigen suspension before administration
8.
EXPIRY DATE
EXP
24
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
GSK Biologicals, Rixensart - Belgium
EU/1/08/452/001
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
SUSPENSION VIAL
1.
Antigen suspension for Pandemrix
Influenza vaccine
A/California/07/2009 (H1N1) derived strain used NYMC X-179A
I.M.
2.
METHOD OF ADMINISTRATION
Mix with adjuvant emulsion before use
3.
EXPIRY DATE
EXP
After mixing: Use within 24 hours and do not store above 25°C.
Date and time of mixing:
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
2.5 ml
After mixing with adjuvant emulsion: 10 doses of 0.5 ml
6.
OTHER
Storage (2ºC-8ºC), do not freeze, protect from light
26
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
EMULSION VIAL
1.
Adjuvant emulsion for Pandemrix
I.M.
2.
METHOD OF ADMINISTRATION
Mix into Antigen suspension before use
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
2.5 ml
6.
OTHER
Storage (2ºC-8ºC), do not freeze, protect from light
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pandemrix suspension and emulsion for emulsion for injection
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Read all of this leaflet carefully before you receive this vaccine .
-
Keep this leaflet. You may need to read it again.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.
In this leaflet
:
1. What Pandemrix is and what it is used for
2. Before you receive Pandemrix
3. How Pandemrix is given
4. Possible side effects
5.
How to store Pandemrix
6.
Further information
1.
What Pandemrix is and what it is used for
Pandemrix is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus.
When a person is given the vaccine, the immune system (the body’s natural defence system) will
produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can
cause flu.
2.
Before you receive Pandemrix
You should not receive Pandemrix:
•
if you have previously had a sudden life-threatening allergic reaction to any ingredient of
Pandemrix (these are listed at the end of the leaflet) or to any of the substances that may be
present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde,
gentamicin sulphate (antibiotic) or sodium deoxycholate. Signs of an allergic reaction may
include itchy skin rash, shortness of breath and swelling of the face or tongue.
•
if you have a severe infection with a high temperature (over 38°C). If this applies to you then
your vaccination will usually be postponed until you are feeling better. A minor infection such
as a cold should not be a problem, but your doctor or nurse will advise whether you could still
be vaccinated with Pandemrix.
If you are not sure, talk to your doctor or nurse before having this vaccine.
Take special care with Pandemrix:
•
if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any
ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin,
formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate. (see section 6.
Further information).
•
if you are having a blood test to look for evidence of infection with certain viruses. In the first
few weeks after vaccination with Pandemrix the results of these tests may not be correct. Tell
the doctor requesting these tests that you have recently been given Pandemrix.
29
-
If you have any further questions, ask your doctor or nurse.
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended,
or may need to be delayed.
If your child receives the vaccine, you should be aware that the side effects may be more intense after
the second dose, especially temperature over 38°C. Therefore monitoring of temperature and measures
to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each
dose are recommended.
Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription or have recently been given any other vaccine.
Pandemrix can be given at the same time as seasonal influenza vaccines that do not contain an
adjuvant.
Persons who have received a seasonal influenza vaccine that does not contain an adjuvant may receive
Pandemrix after an interval of at least three weeks.
There is no information on administration of Pandemrix with other vaccines. However, if this cannot
be avoided, the vaccines should be injected into separate limbs. In such cases, you should be aware
that the side effects may be more intense.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant. You should
discuss with your doctor whether you should receive Pandemrix.
The vaccine may be used during breast-feeding.
Driving and using machines
Some effects mentioned under section 4. “Possible side effects” may affect the ability to drive or use
machines.
Important information about some of the ingredients of Pandemrix
This vaccine contains thiomersal as a preservative and it is possible that you may experience an
allergic reaction. Tell your doctor if you have any known allergies.
This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium
(39 mg) per dose, i.e. essentially sodium- and potassium-free.
3.
How Pandemrix is given
Your doctor or nurse will administer the vaccine in accordance with official recommendations.
The vaccine will be injected into a muscle (usually in the upper arm).
Adults, including the elderly and children from the age of 10 years onwards
A dose (0.5 ml) of the vaccine will be given.
Clinical data suggest that a single dose may be sufficient.
If a second dose is administered there should be an interval of at least three weeks between the first
and second dose.
Children from 6 months to 9 years of age
A dose (0.25 ml) of the vaccine will be given.
If a second dose of 0.25 ml is given this will be administered at least three weeks after the first dose.
30
Children aged less than 6 months of age
Vaccination is currently not recommended in this age group.
4. Possible side effects
Like all medicines, Pandemrix can cause side effects, although not everybody gets them.
Allergic reactions may occur following vaccination, in rare cases leading to shock. Doctors are aware
of this possibility and have emergency treatment available for use in such cases.
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
The side effects listed below have occurred with Pandemrix (H5N1) in clinical studies in adults,
including the elderly. In these clinical studies most side effects were mild in nature and short term.
The side-effects are generally similar to those related to seasonal flu vaccines.
These side effects have also been observed with similar frequencies in clinical studies in adults
including the elderly and in children aged 10 to 17 years with Pandemrix (H1N1)v, except for redness
(uncommon in the adults and common in the elderly) and fever (uncommon in the adults and elderly).
Gastro-intestinal symptoms and shivering were at a higher rate in the children 10-17 years of age. In
children aged 3-9 years who received a first half adult dose of Pandemrix (H1N1)v, the side effects
were similar compared to the side effects reported in adults, with the exception of shivering, sweating
and gastro-intestinal symptoms which were reported at a higher rate in children aged 3 to 9 years.
Additionally, in children aged 3 to 5 years of age, drowsiness, irritability and loss of appetite were
reported very commonly.
Very common:
•
Headache
•
Tiredness
•
Pain, redness, swelling or a hard lump at the injection site
•
Fever
•
Aching muscles, joint pain
Common:
•
Warmth, itching or bruising at the injection site
•
Increased sweating, shivering, flu-like symptoms
•
Swollen glands in the neck, armpit or groin
Uncommon:
•
Tingling or numbness of the hands or feet
•
Sleepiness
•
Dizziness
•
Diarrhoea, vomiting, stomach pain, feeling sick
•
Itching, rash
•
Generally feeling unwell
•
Sleeplessness
31
In children aged 6-35 months who received a half of the adult dose (0.25 ml) of Pandemrix (H1N1)v,
fever and irritability occurred more often compared to the children 3-9 years who received a half of
the adult dose (0.25 ml) of Pandemrix (H5N1).
In children aged 6-35 months who received two doses of 0.25 ml (half of the adult dose) the side
effects after the second dose were more intense, especially fever (≥38°C), which occurred very
commonly.
These side effects usually disappear within 1-2 days without treatment. If they persist, CONSULT
YOUR DOCTOR.
The side effects listed below have occurred during post-marketing experience with Pandemrix
(H1N1)v vaccine:
•
Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may
lead to shock. Doctors are aware of this possibility and have emergency treatment available for
use in such cases.
•
Generalised skin reactions including facial swelling and urticaria (hives)
•
Fits due to fever
The side effects listed below have occurred in the days or weeks after vaccination with vaccines given
routinely every year to prevent flu. These side effects may occur with Pandemrix.
Rare
•
Severe stabbing or throbbing pain along one or more nerves
•
Low blood platelet count which can result in bleeding or bruising
Very rare
•
Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney
problems)
•
Neurological disorders such as encephalomyelitis (inflammation of the central nervous system),
neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
If any of these side effects occur, please tell your doctor or nurse immediately.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor.
5.
How to store Pandemrix
Keep out of the reach and sight of children.
Before the vaccine is mixed:
Do not use the suspension and the emulsion 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.
After the vaccine is mixed:
After mixing, use the vaccine within 24 hours and do not store above 25°C.
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.
32
6. Further information
What Pandemrix contains
•
Active substance:
Split influenza virus, inactivated, containing antigen
*
equivalent to:
A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms
**
per 0.5 ml
dose
*
propagated in eggs
**
expressed in microgram haemagglutinin
•
Adjuvant:
The vaccine contains an ‘adjuvant’ AS03 to stimulate a better response. This adjuvant contains
squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86
milligrams).
•
Other ingredients:
The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium
hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium
chloride, water for injections
What Pandemrix looks like and contents of the pack
Suspension and emulsion for emulsion for injection.
The suspension is a colourless light opalescent liquid.
The emulsion is a whitish homogeneous liquid.
Prior to administration, the two components should be mixed. The mixed vaccine is a whitish
emulsion.
One pack of Pandemrix consists of:
•
one pack containing 50 vials of 2.5 ml suspension (antigen)
•
two packs containing 25 vials of 2.5 ml emulsion (adjuvant)
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:
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
Тел.: + 359 2 953 10 34
Magyarország
GlaxoSmithKline Kft.
Tel.: + 36-1-2255300
33
Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 2 22 00 11 11
gsk.czmail@gsk.com
Malta
GlaxoSmithKline Malta
Tel: + 356 21 238131
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
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
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
United Kingdom
GlaxoSmithKline UK
34
Tel: + 371 67312687
lv-epasts@gsk.com
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
{MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web
---------------------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only:
Pandemrix consists of two containers:
Suspension: multidose vial containing the antigen,
Emulsion: multidose vial containing the adjuvant.
Prior to administration, the two components should be mixed.
Instructions for mixing and administration of the vaccine
:
1.
Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be
allowed to reach room temperature; each vial should be shaken and inspected visually for any
foreign particulate matter and/or abnormal physical appearance. In the event of either being
observed (including rubber particles from the stopper), discard the vaccine.
2.
The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by
means of a syringe and by adding it to the vial containing the antigen.
3.
After the addition of the adjuvant to the antigen, the mixture should be well shaken. The mixed
vaccine is a whitish emulsion. In the event of other variation being observed, discard the
vaccine.
4.
The volume of the Pandemrix vial after mixing is at least 5 ml. The vaccine should be
administered in accordance with the recommended posology (see section 3 “How Pandemrix is
given”).
5.
The vial should be shaken prior to each administration and inspected visually for any foreign
particulate matter and/or abnormal physical appearance. In the event of either being observed
(including rubber particles from the stopper), discard the vaccine.
6.
Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a syringe for
injection and administered intramuscularly.
7.
After mixing, use the vaccine within 24 hours. The mixed vaccine can either be stored in a
refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C. If the mixed vaccine is
stored in a refrigerator, it should be allowed to reach room temperature before each withdrawal.
The vaccine should not be administered intravascularly.
Any unused product or waste material should be disposed of in accordance with local requirements.
35
Source: European Medicines Agency
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