ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Optaflu
suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
(2007/2008 season)
2.
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following
strains:
A/Solomon Islands/3/2006 (H1N1) like strain
(A/Solomon Islands/3/2006, IVR-145)
15 micrograms HA**
A/Wisconsin/67/2005 (H3N2) like strain
(A/Wisconsin/67/2005, NYMC X161B)
15 micrograms HA**
B/Malaysia/2506/2004 like strain
(B/Malaysia/2506/2004)
15 micrograms HA**
per 0.5 ml dose
……………………………………….
* propagated in Madin Darby Canine Kidney (MDCK) cells
** haemagglutinin
The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the
2007/2008 season.
For a full list of excipients, see section 6.1.
3.
Suspension for injection in pre-filled syringe
Clear to slightly opalescent.
4.
Prophylaxis of influenza for adults, especially in those who run an increased risk of associated
complications.
The use of Optaflu should be based on official recommendations.
Adults: 0.5 ml.
Immunisation should be carried out by intramuscular (into the deltoid muscle) injection.
Children and adolescents (<18 years of age):
Optaflu is not recommended for use in children and adolescents below 18 years due to the lack of data
on safety and efficacy (see section 5.1).
2
Hypersensitivity to the active substances or to any of the excipients.
Immunisation shall be postponed in patients with febrile illness or acute infection.
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.
Optaflu should under no circumstances be administered intravascularly.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Optaflu may be given at the same time as other vaccines. Immunisation should be carried out on
separate limbs. It should be noted that adverse reactions may be intensified.
The immunological response may be diminished if the patient is undergoing immunosuppressant
treatment.
Following influenza vaccination, false positive results in serology tests using the ELISA method to
detect antibodies against HIV-1, Hepatitis C and especially HTLV-1 have been observed. The Western
Blot technique disproves the results. The transient false positive reactions may be due to the IgM
response to the vaccine.
The safety of Optaflu in pregnancy and breast-feeding has not been assessed in pre-clinical studies or
in clinical trials.
In general data from influenza vaccinations in pregnant women do not indicate adverse fetal and
maternal outcomes attributable to the vaccine. The use of Optaflu may be considered from the second
trimester of pregnancy. For pregnant women with medical conditions that increase their risk of
complications from influenza, administration of the vaccine is recommended, irrespective of their
stage of pregnancy. Optaflu may be used during lactation.
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
Adverse reactions from clinical trials:
The safety of the Optaflu has been assessed in six randomized, active controlled clinical trials
performed as part of the development program. Overall 3439 single doses of Optaflu were
administered to 2366 adults aged 18 – 60 years of age and to 1073 elderly (aged 61 years or older).
Safety and reactogenicity evaluations were performed for all subjects during the first 3 weeks
following vaccination and SAEs have been collected for approximately 3100 vaccinees during six
months of follow-up.
So far there are no data from post-marketing experiences with Optaflu. In adults, the following
undesirable effects have been observed during clinical trials with Optaflu:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000
to <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data). Within
each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
3
Frequency in adults (18-60 years of age)
Organ class
Very
common
≥ 1/10
Common
≥ 1/100 to
< 1/10
Uncommon
≥ 1/1000 to
< 1/100
Rare
≥ 1/10,000 to
<1/1000
Very rare
<1/ 10,000
Blood and lymphatic
system disorders
Transient
thrombocyto
penia
Nervous system
disorders
Headache*
Neurological
disorders,
such as
encephalomy
elitis, neuritis
and Guillain
Barré
syndrome
Skin and
subcutaneous tissue
disorders
Sweating*
Generalised
skin reactions
including
pruritus,
urticaria or
non-specific
rash
Musculoskeletal and
connective tissue
disorders
Myalgia*,
arthralgia*
Vascular disorders
Vasculitis,
possibly
associated
with transient
renal
involvement
General disorders
and administration
site disorders
Erythema*,
pain*
Swelling*,
ecchymosis*,
induration*
Fever*,
shivering*
Local
lymphadeno-
pathy
Malaise*,
fatigue*
Fever greater
than 39.0°C
Gastrointesti
nal disorders
such as
abdominal
pain,
diarrhoea or
dyspepsia*
Immune system
disorders
Allergic
reactions, in
very rare
cases leading
to shock
* These reactions usually disappeared within 1-2 days without treatment.
In the elderly frequencies were similar, exept for headache and pain which were classified as
‘common’. The incidence rates for moderate and severe pain after Optaflu vaccination are similar to
those of egg-derived influenza vaccines; however a slightly increased risk for mild short-lasting
injection site pain was observed with Optaflu in the subgroup of elderly vaccinees (8% compared to
6% with egg-derived influenza vaccine).
4
With egg-derived influenza vaccines neuralgia, paraesthesia and febrile convulsions have been
observed rarely.
Overdosage is unlikely to have any untoward effect.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Influenza vaccine, ATC-Code: J07BB02
Seroprotection is generally obtained within 3 weeks, as shown by the pivotal phase III clinical study
V58P4 for the adult and elderly population.
In this comparative trial against an egg-derived influenza vaccine the seroprotection rate*,
seroconversion or significant increase rate** and the geometric mean ratio (GMR) for anti-HA
antibody (measured by HI) were assessed according to predefined criteria.
Data for adults were as follows (values in brackets show the 95% confidence intervals):
Strain specific anti-HA antibody
A/H1N1
N=650
A/H3N2
N=650
B
N=650
Seroprotection rate
86%
(83, 88)
98%
(97, 99)
83%
(80, 86)
Seroconversion/ Significant increase
rate
63%
(59, 67)
58%
(54, 62)
78%
(75, 81)
GMR
7.62
(6.86, 8.46)
4.86
(4.43, 5.33)
9.97
(9.12, 11)
* Seroprotection = HI titers ≥ 40
** Seroconversion = negative pre-vaccination HI titer and post-vaccination HI titer ≥40; Significant
increase = positive pre-vaccination HI titer and at least a 4-fold increase in post-vaccination HI titer
Data for elderly were as follows (values in brackets show the 95% confidence intervals):
Strain specific anti-HA antibody
A/H1N1
N=672
A/H3N2
N= 672
B
N=672
Seroprotection rate
76%
(72, 79)
97%
(96, 98)
84%
(81, 87)
Seroconversion/ Significant increase
rate
48%
(44, 52)
65%
(61, 68)
76%
(72, 79)
GMR
4.62
(4.2, 5.08)
5.91
(5.35, 6.53)
9.63
(8.77, 11)
* Seroprotection = HI titers ≥ 40
** Seroconversion = negative pre-vaccination HI titer and post-vaccination HI titer ≥40; significant
increase = positive pre-vaccination HI titer and at least a 4-fold increase in post-vaccination HI titer.
No differences were observed between the cell-culture and the comparator egg-derived vaccine.
Across all three influenza strains, for the egg-derived vaccine seroprotection rates ranged between
85% and 98%, seroconversion or significant increase rates ranged between 62% and 73% and GMRs
ranged between 5.52- and 8.76-fold over baseline HI titers.
The persistence of postvaccination antibodies to strains included in the vaccine is usually 6-12 months,
as shown by studies performed during the clinical development of this vaccine.
5
Optaflu has not been studied in the paediatric population and therefore, data on immune response are
not available for this age group.
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on animal studies that are appropriate for
the safety assessment of vaccines. Optaflu was well tolerated and immunogenic in mice and ferrets. In
a repeated-dose toxicity study in rabbits there was no evidence of systemic toxicity and the vaccine
was locally well tolerated. Genotoxicity, carcinogenic potential, and toxicity to reproduction were not
assessed because these studies are not appropriate for a vaccine.
6.
6.1 List of excipients
Sodium chloride,
Potassium chloride,
Magnesium chloride hexahydrate,
Disodium phosphate dihydrate,
Potassium dihydrogen phosphate,
Water for injections.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
6.3 Shelf life
1 year
6.4 Special precautions for storage
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original carton in order to protect from
light.
6.5
Nature and contents of container
0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber).
Pack sizes of 1, 10 or 20 (2 × 10), each with or without needle are available.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
The vaccine should be allowed to reach room temperature before use.
Shake before use.
Unused vaccine and other waste material should be disposed of in compliance with local rules for the
disposal of products of this nature.
6
7.
Novartis Vaccines and Diagnostics GmbH
Emil-von-Behring-Strasse 76
D-35041 Marburg
GERMANY
8.
EU/1/07/394/001 – EU/1/07/394/009
9.
01 June 2007
XX/YYYY
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA)
http://www.emea.europa.eu/
.
7
ANNEX II
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE
B. CONDITIONS OF THE MARKETING AUTHORISATION
8
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substance
Novartis Vaccines and Diagnostics GmbH
Emil-von-Behring-Strasse 76
D-35041 Marburg
Germany
Name and address of the manufacturer responsible for batch release
Novartis Vaccines and Diagnostics GmbH
Emil-von-Behring-Strasse 76
D-35041 Marburg
Germany
The printed package leaflet of the medicinal product must state the name and address of the
manufacturer responsible for the release of the concerned batch.
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 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, presented in Module 1.8.1 of the
Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Risk Management plan
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in
the Pharmacovigilance Plan.
An updated Risk management Plan should be provided as per CHMP Guideline on Risk Management
Systems for medicinal products for human use.
9
ANNEX III
LABELLING AND PACKAGE LEAFLET
10
A. LABELLING
11
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Box: syringe with needle
1.
Optaflu
suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
(2007/2008 season)
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following
strains:
A/ Solomon Islands/3/2006 (H1N1) like strain
(A/Solomon Islands/3/2006, IVR-145)
15 micrograms HA**
A/ Wisconsin/67/2005 (H3N2) like strain
(A/Wisconsin/67/2005, NYMC X161B)
15 micrograms HA**
B/ Malaysia/2506/2004 like strain
(B/ Malaysia/2506/2004)
15 micrograms HA**
per 0.5 ml dose
* propagated in Madin Darby Canine Kidney (MDCK) cells
** haemagglutinin
The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the
2007/2008 season.
3.
LIST OF EXCIPIENTS
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate
dihydrate, potassium dihydrogen phosphate and water for injections.
4.
Suspension for injection
1 x pre-filled syringe (0.5 ml) with needle
10 x pre-filled syringes (0.5 ml) with needle
2 x 10 pre-filled syringes (0.5 ml) with needle
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
For intramuscular injection
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
12
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
Do not inject intravascularly!
8.
EXPIRY DATE
Exp.:
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator. Do not freeze. Store in the original carton 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
Novartis Vaccines and Diagnostics GmbH
Emil-von-Behring-Strasse 76
D-35041 Marburg
GERMANY
EU/1/07/394/004
EU/1/07/394/005
EU/1/07/394/006
13. BATCH NUMBER
Batch:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not using Braille accepted.
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Box: syringe without needle
1.
Optaflu suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
(2007/2008 season)
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following
strains:
A/ Solomon Islands/3/2006 (H1N1) like strain
(A/Solomon Islands/3/2006, IVR-145)
15 micrograms HA**
A/ Wisconsin/67/2005 (H3N2) like strain
(A/Wisconsin/67/2005, NYMC X161B)
15 micrograms HA**
B/ Malaysia/2506/2004 like strain
(B/ Malaysia/2506/2004)
15 micrograms HA**
per 0.5 ml dose
* propagated in Madin Darby Canine Kidney (MDCK) cells
** haemagglutinin
The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the
2007/2008 season.
3.
LIST OF EXCIPIENTS
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate
dihydrate, potassium dihydrogen phosphate and water for injections.
4.
Suspension for injection
1 x pre-filled syringe (0.5 ml) without needle
10 x pre-filled syringes (0.5 ml) without needle
2 x 10 pre-filled syringes (0.5 ml) without needle
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
For intramuscular injection
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
14
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
Do not inject intravascularly!
8.
EXPIRY DATE
Exp.:
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator. Do not freeze. Store in the original carton 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
Novartis Vaccines and Diagnostics GmbH
Emil-von-Behring-Strasse 76
D-35041 Marburg
GERMANY
EU/1/07/394/001; EU/1/07/394/007
EU/1/07/394/002; EU/1/07/394/008
EU/1/07/394/003; EU/1/07/394/009
13. BATCH NUMBER
Batch:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not using Braille accepted.
15
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Prefilled syringe
1.
Optaflu
(2007/2008 season)
i.m. injection
2.
METHOD OF ADMINISTRATION
3.
EXPIRY DATE
Exp.:
4.
BATCH NUMBER
Batch:
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
0.5 ml
6.
OTHER
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET: INFORMATION FOR THE USER
Optaflu suspension for injection in a pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Read all of this leaflet carefully before you start using this medicine.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
-
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 Optaflu is and what it is used for
3.
How to use Optaflu
4.
Possible side effects
5.
How to store Optaflu
6.
Further information
1.
WHAT OPTAFLU IS AND WHAT IT IS USED FOR
Optaflu is a vaccine against flu (influenza). Due to the kind of manufacturing Optaflu is free of
chicken/egg protein. For manufacturing the vaccine the influenza virus was killed and prepared in a
special way that the vaccine only contains influenza virus surface proteins (influenza virus surface
antigens). These proteins stimulate your immune system so that it can develop a protection against flu.
Optaflu is used to prevent flu in adults, especially in those who run an increased risk of experiencing
associated complications in case they fall ill with flu.
2.
BEFORE YOU USE OPTAFLU
You must NOT use Optaflu
•
if you are allergic (hypersensitive) to influenza vaccine or any of the other ingredients of
Optaflu
•
if you have an acute illness associated with fever
•
if you have an acute infection.
Take special care with Optaflu
•
you
should tell your doctor if your immune system is impaired, or if you are undergoing
treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy)
or corticosteroid medicines (see Section 2, “Taking other medicines”).
•
your
doctor or nurse
will make sure that appropriate medical treatment and supervision is
readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with
symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash)
following the administration. This reaction may occur with Optaflu as with all vaccines that are
injected.
WHILE receiving the vaccine
•
your doctor or nurse will take care not to inject Optaflu into a blood vessel.
Children and adolescents
•
Optaflu is not recommended for use in children below 18 years of age since there is no
information available.
18
-
Keep this leaflet. You may need to read it again.
2.
Before you use Optaflu
BEFORE receiving the vaccine
Taking other medicines
Special care should be taken if you are receiving Optaflu and any of the following medicines at the
same time:
•
medicines against cancer (chemotherapy), corticosteroid medicines (such as cortisone) or other
medicines affecting the immune system. Tell your doctor if you are being treated with such
medicines.
The immune response of your body may be weakened. Therefore the vaccine may work less
effectively.
•
other vaccines. Optaflu may be given at the same time as other vaccines. In this case the
vaccines should be injected into separate limbs. Note that the side effects of the vaccines may be
intensified.
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
The safety of Optaflu in pregnant and breast-feeding women has not been determined.
The limited data from influenza vaccinations in pregnant women do not indicate that there are
negative effects for the unborn child. The use of this vaccine may be considered from the second
trimester of pregnancy. For pregnant women with medical conditions that increase their risk of
complications from the flu, administration of the vaccine is recommended, irrespective of their stage
of pregnancy. Optaflu may be used during breast feeding.
Therefore your doctor will decide whether you should receive Optaflu if you are pregnant or breast-
feeding.
Important information about some of the ingredients of Optaflu
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-
free’.
3.
HOW TO USE OPTAFLU
Optaflu is applied to you by your doctor or nurse.
Usual dose
Optaflu is injected into the muscle on the top of the upper arm (deltoid muscle). Optaflu should under
no circumstances be injected into a blood vessel.
for persons of 18 years and older: 0.5 ml of Optaflu suspension.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Optaflu can cause side effects, although not everybody gets them.
The following undesirable effects have been observed during clinical trials :
Very common
in more than 1 in 10 vaccinees
Common
in more than 1 in 100 vaccinees, but less than 1 in 10 vaccinees
Uncommon
in more than 1 in 1,000 vaccinees, but less than 1 in 100 vaccinees
Rare
in more than 1 in 10,000 vaccinees, but less than 1 in 1,000 vaccinees
Very rare
in less than 1 in 10,000 vaccinees, including isolated reports
19
Very serious side effects
Tell your doctor immediately or go to the casualty department at your nearest hospital if you
experience the following side effect – you may need urgent medical attention or hospitalisation:
Very rare:
•
difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of
an anaphylactic reaction (a very severe allergic reaction)
Rare:
•
numbness and tingling sensation
•
painful disorders of the nerves, e.g. attacks of extreme pain in the face, throat or ear fits
(convulsions) (only observed with egg-derived influenza vaccines)
Also, tell your doctor immediately if you experience any of the following side effects – you may need
medical attention:
Very rare:
•
skin rashes, fever, joint pain or kidney problems which are symptoms of an inflammation of the
blood vessels
•
fever, headache, vomiting and drowsiness progressing to coma or fits (convulsions) which are
symptoms of an inflammation of the brain and spinal cord
•
weakness beginning in the legs and progressing to the arms with numbness and tingling
sensation which are symptoms of an inflammation of the nerves
Serious side effects
Tell your doctor immediately if you experience any of the following side effects – you may need
medical attention:
Very Rare:
•
bleeding or bruising which are symptoms of a low platelet count in the blood
Mild side effects
•
flu-like symptoms such as headache, feeling of discomfort, tiredness.
•
Pain, reddening.
These reactions are usually mild and only last a few days. Pain and headache were common in the
elderly.
Common:
•
sweating, joint and muscle pain, chills, hardening or swelling at the site of the injection,
bruising, fever, shivering
•
gastrointestinal disorders such as abdominal pain, diarrhoea or disturbance of the digestive tract
These reactions are usually mild and only last a few days.
Uncommon:
•
generalised skin reactions such as itching, bumps on the skin or non-specific rash
Rare:
•
swelling and pain of local lymphnodes
•
Fever greater than 39.0 °C
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.
20
Very common:
5.
HOW TO STORE OPTAFLU
Keep out of the reach and sight of children.
Do not use Optaflu after the expiry date which is stated on the label and carton. The expiry date refers
to the last day of that month.
Storage conditions of the unopened product:
•
Store in a refrigerator (2 °C to 8 °C).
•
Do not freeze.
•
Keep the pre-filled syringe in the carton in order to protect from light.
Preparation of the product before use:
Your doctor or nurse will take care that Optaflu should be allowed to reach room temperature before
use and is shaken before use.
Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Optaflu contains
The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase)*,
inactivated, of the following strains:
A/Solomon Islands/3/2006 (H1N1) like strain
(A/Solomon Islands/3/2006, IVR-145)
15 micrograms HA**
A/Wisconsin/67/2005 (H3N2) like strain
(A/Wisconsin/67/2005, NYMC X161B)
15 micrograms HA**
B/Malaysia/2506/2004 like strain
(B/ Malaysia/2506/2004)
15 micrograms HA**
……………………………………
*
produced in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the
influenza virus is grown)
**
haemagglutinin
The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the
2007/2008 season.
The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate,
disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
What Optaflu looks like and contents of the pack
Optaflu is a suspension for injection in a pre-filled syringe (ready-to-use syringe). Optaflu is a clear to
slightly opalescent suspension.
A single syringe contains 0.5 ml of suspension for injection.
Pack sizes of 1, 10 or 20 (2 x 10), each with or without needle are available.
Marketing Authorisation Holder and Manufacturer
Novartis Vaccines and Diagnostics GmbH
Emil-von-Behring-Strasse 76
D-35041 Marburg
21
per 0.5 ml dose
GERMANY
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 1611
Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 1611
България
Novartis Vaccines and Diagnostics GmbH
Teл.: +49 6421 39 7799
Magyarország
Novartis Hungária Kft.
Tel: +36 1 457 6500
Česká republika
Novartis s.r.o.
Tel: +42 022 5775 111
Malta
Novartis Vaccines and Diagnostics GmbH
Tel: +49 6421 39 7799
Danmark
Novartis Vaccines and Diagnostics GmbH
Tel: +49 6421 39 7799
Nederland
Novartis Vaccines and Diagnostics GmbH
Tel: +49 6421 39 7799
Deutschland
Novartis Vaccines and Diagnostics GmbH
Tel: +49 6421 39 7798
Norge
Novartis Vaccines and Diagnostics GmbH
Tel: +49 6421 39 7799
Eesti
Novartis Poland Sp.z o.o.
Tel.: +48 22 550 8888
Österreich
Novartis Pharma GmbH
+43 1 866 570
Ελλάδα
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 24 3111
Polska
Novartis Poland Sp.z o.o.
Tel.: +48 22 550 8888
España
Novartis Vaccines and Diagnostics, S. L.
Tel: +34 93 306 4200
Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +35 121 000 8600
France
Novartis Vaccines and Diagnostics SAS
Tél: +33 1 55 49 0030
România
Novartis Vaccines and Diagnostics GmbH
Tel: +49 6421 39 7799
Ireland
Novartis Vaccines and Diagnostics GmbH
Tel: +49 6421 39 7799
Slovenija
Novartis s.r.o
Tel: +42 022 5775 111
Ísland
Novartis Vaccines and Diagnostics GmbH
Tel: +49 6421 39 7799
Slovenská republika
Novartis s.r.o
Tel: +42 022 5775 111
Italia
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 24 3111
Suomi/Finland
Novartis Vaccines and Diagnostics GmbH
Tel: +49 6421 39 7799
Κύπρος
Novartis Vaccines and Diagnostics S.r.l.
Tel: +39 0577 24 3111
Sverige
Novartis Vaccines and Diagnostics GmbH
Tel: +49 6421 39 7799
Latvija
United Kingdom
22
Novartis Poland Sp.z o.o.
Tel.: +48 22 550 8888
Novartis Vaccines and Diagnostics Ltd
Tel: +44 845 745 1500
Lietuva
Novartis Poland Sp.z o.o.
Tel.: +48 22 550 8888
This leaflet was last approved in XX/YYYY.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web
site:
http://www.emea.europa.eu/
.
23
Source: European Medicines Agency
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