Optaflu

1

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 2

1. NAME OF THE MEDICINAL PRODUCT 
 
Optaflu suspension for injection in pre-filled syringe 
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 
 
(2015/2016 season) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following 
strains: 
 
A/California/7/2009 (H1N1)pdm09 - like strain  
(A/Brisbane/10/2010, wild type) 15 micrograms HA** 
 
A/Switzerland/9715293/2013 (H3N2) - like strain  
(A/South Australia/55/2014, wild type) 15 micrograms HA** 
 
B/Phuket/3073/2013 – like strain 
(B/Utah/9/2014, wild type) 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 2015/2016 season. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection in pre-filled syringe. 
Clear to slightly opalescent. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Prophylaxis of influenza for adults, especially in those who run an increased risk of associated 
complications. 
 
Optaflu should be used in accordance to Official guidance. 
 
4.2 Posology and method of administration 
 
Posology 
 
Adults from the age of 18 years: 
One dose of 0.5 ml 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 3

Paediatric population 
 
The safety and efficacy of Optaflu in children and adolescents less than 18 years of age have not yet 
been established. No data are available. Therefore, Optaflu is not recommended for use in children and 
adolescents less than 18 years of age (see section 5.1). 
 
Method of administration 
 
Immunisation should be carried out by intramuscular injection into the deltoid muscle. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
Immunisation shall be postponed in patients with febrile illness or acute infection. 
 
4.4 Special warnings and precautions for use 
 
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. 
 
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to 
the needle injection. This can be accompanied by several neurological signs such as transient visual 
disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that 
procedures are in place to avoid injury from faints. 
 
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
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 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. 
 
4.6 Fertility, pregnancy and lactation 
 
The safety of Optaflu in pregnancy and breast-feeding has not been assessed in clinical trials. 
 
Pregnancy 
In general data from influenza vaccinations in pregnant women do not indicate adverse foetal and 
maternal outcomes attributable to the vaccine. Animal studies do not indicate reproductive toxicity 
(see Section 5.3 – Preclinical safety data). 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. 
 
Breast-feeding 
There is no human data on use of Optaflu during lactation. No effects on the breastfed newborn /infant 
are anticipated. Optaflu may be used during lactation 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 4

Fertility 
No human fertility data are available. Animal data have not shown effects on female fertility 
(see section 5.3). Male fertility has not been assessed in animals (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Optaflu has minor influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
a) Summary of safety profile 
 
The safety of Optaflu has been assessed in seven randomized, active controlled clinical trials 
performed as part of the development program. Overall 7253 single doses of Optaflu were 
administered to 6180 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 6700 vaccinees during six 
months of follow-up. 
 
b) Summary of adverse reactions 
 
Adverse reactions are listed according to the following frequency: 
Very Common (≥1/10) 
Common (≥1/100 -<1/10) 
Uncommon (≥1/1,000 - <1/100) 
Rare (≥1/10,000 - <1/1,000) 
Very Rare (<1/10,000) 
Not known (cannot be estimated from the available data) 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
The following adverse reactions have been observed: 
 
Table 1: 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 

Not known 
(cannot be 
estimated 

from available 
data) 

Nervous system 
disorders - Headache*    

- Neurological 
disorders, 
such as Guillain 
Barré syndrome, 
encephalomyelitis 
and neuritis 

- Paraesthesia

Vascular 
disorders     

- Vasculitis, 
possibly 
associated with 
transient renal 
involvement 

 

Immune system 
disorders     

- Allergic 
reactions, 
in very rare 
cases leading to 
shock 

- Angioedema

Blood and 
lymphatic 
system disorders 

   
- Local 

lymphadeno-
pathy 

- Thrombo-
cytopenia**  

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 5

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 

Not known 
(cannot be 
estimated 

from available 
data) 

Musculoskeletal 
and connective 
tissue disorders 

- Myalgia* - Arthralgia*     

General 
disorders and 
administration 
site disorders 

- Erythema* 
- Injection 

site pain* 
- Malaise* 
- Fatigue* 

- Swelling* 
- Ecchymosis* 
- Induration* 
- Fever greater 

than 38.0C* 
- Shivering/ 

chills* 
- Gastrointestinal 

disorders such 
as abdominal 
pain, diarrhoea 
or dyspepsia* 

 - Fever greater than 39.0°C  

- Extensive 
swelling of 
injected 
limb 

Skin and 
subcutaneous 
tissue disorders 

 - Sweating* 

- Generalised 
skin reaction
s including 
pruritus, 
urticaria or 
non-specific 
rash 

   

* These reactions usually disappeared within 1-2 days without treatment. 
** Thrombocytopenia (some very rare cases were severe with platelet counts less than 5000 per mm3) 
 
In the elderly frequencies were similar, except for myalgia, headache and injection site 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). 
 
Post-marketing surveillance: 
 
So far there is limited post-marketing experience with Optaflu. 
 
The following additional adverse reactions were reported from post-marketing surveillance with 
egg-based seasonal trivalent vaccines: 
 
Nervous system disorders: 
 
Neuralgia, convulsion, febrile convulsion. 
 
Reporting of suspected adverse reactions: 
 
Reporting of suspected adverse reactions after authorisation of the medicinal products is important. 
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionols are asked to report any suspected adverse reactions via the national reporting sytem 
listed in Appendix V. 
 
4.9 Overdose 
 
No case of overdose has been reported for Optaflu. 
 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 6

5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02 
 
Efficacy against Culture-Confirmed Influenza 
 
A multinational (US, Finland, and Poland), randomized, observer-blinded, placebo-controlled trial was 
performed to assess clinical efficacy and safety of Optaflu during the 2007-2008 influenza season in 
adults aged 18 to 49 years. A total of 11,404 subjects were enrolled to receive Optaflu (N=3828), 
Agrippal (N=3676) or placebo (N=3900) in a 1:1:1 ratio. Among the overall study population enrolled, 
the mean age was 33 years, 55% were female, 84% were Caucasian, 7% were Black, 7% were 
Hispanic, and 2% were of other ethnic origin. 
 
Optaflu efficacy was defined as the prevention of culture-confirmed symptomatic influenza illness 
caused by viruses antigenically matched to those in the vaccine compared to placebo. Influenza cases 
were identified by active and passive surveillance of influenza-like illness (ILI). ILI was defined 
according to Centers for Disease Control and Prevention (CDC) case definition, i.e., a fever (oral 
temperature ≥ 100.0°F / 38°C) and cough or sore throat. After an episode of ILI, nose and throat swab 
samples were collected for analysis. Vaccine efficacies against vaccine-matched influenza viral 
strains, against all influenza viral strains, and against individual influenza viral subtypes were 
calculated (Tables 2 and 3). 
 
Table 2: Vaccine Efficacy against Culture-Confirmed Influenza 
 

 Number of 
subjects per 

protocol 

Number of 
subjects with 

influenza 

Attack 
Rate (%) 

Vaccine Efficacy* 

% Lower Limit of One- Sided 97.5% CI 
Antigenically Matched Strains 

Optaflu 3776 7 0.19 83.8 61.0 
Placebo 3843 44 1.14 -- -- 

All Culture-Confirmed Influenza 
Optaflu 3776 42 1.11 69.5 55.0 
Placebo 3843 140 3.64 -- -- 

* Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy of each influenza vaccine 
relative to placebo based on the Sidak-corrected score confidence intervals for the two relative risks. 
Vaccine Efficacy = (1 - Relative Risk) x 100 % 

 
Table 3: Comparative Efficacy of Optaflu versus Placebo against Culture-Confirmed 

Influenza by Influenza Viral Subtype 
 

 Optaflu 
(N=3776) 

Placebo 
(N=3843) 

Vaccine Efficacy* 

Attack 
Rate (%) 

Number of Subjects 
with Influenza 

Attack 
Rate (%) 

Number of Subjects 
with Influenza 

% Lower Limit of 
One-Sided 97.5% CI 

Antigenically Matched Strains 
A/H3N2** 0. 05  2 0 0 -- -- 
A/H1N1 0.13 5 1.12 43 88.2 67.4 
B** 0 0 0.03 1 -- -- 

All Culture-Confirmed Influenza 
A/H3N2 0.16 6 0.65 25 75.6 35.1 
A/H1N1 0.16 6 1.48 57 89.3 73.0 
B 0.79 30 1.59 61 49.9 18.2 

* Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy of each influenza vaccine 
relative to placebo based on the Sidak-corrected score confidence intervals for the two relative risks. 
Vaccine Efficacy = (1 - Relative Risk) x 100 %; 

** There were too few cases of influenza due to vaccine-matched influenza A/H3N2 or B to adequately 
assess vaccine efficacy. 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 7

 
Immunogenicity 
 
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): 
 
Table 4: Immunogenicity in Adults 
 

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): 
 
Table 5: Immunogenicity in Elderly 
 

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. 
 
Paediatric population 
 
Optaflu has not been studied in the paediatric population and therefore, data on immune response are 
not available for this age group. 
 
The European Medicines Agency has deferred the obligation to submit the results of studies 
withOptaflu in one or more subsets of the paediatric population in the prevention of influenza 
(see section 4.2 for information on paediatric use). 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 8

5.2 Pharmacokinetic properties 
 
Not applicable 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional repeat dose toxicity 
studies. 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. 
 
No evidence of reproductive or developmental toxicity was seen in a study where the human dose of 
Optaflu was administered prior to and during gestatioin to female rabbits. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
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. 
Keep the pre-filled syringe in the outer 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 multipacks containing 20 (2 packs of 10) pre-filled syringes, each with or 
without needle. 
 
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. 
 
Visually inspect the contents of each Optaflu syringe for particulate matter and/or change in colour 
prior to administration. If either condition exists, do not administer the vaccine. 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 9

Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Seqirus GmbH  
Emil-von-Behring-Strasse 76 
D-35041 Marburg 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/394/001 – EU/1/07/394/011 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 01 June 2007 
Date of latest renewal: 01 June 2012 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/ 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 10

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 11

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
Novartis Influenza Vaccines Marburg GmbH 
Emil-von-Behring-Strasse 76 
D-35041 Marburg 
Germany 
 
Name and address of the manufacturer responsible for batch release 
 
Novartis Influenza Vaccines Marburg 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 OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 Official batch release 
 
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be 
undertaken by a state laboratory or a laboratory designated for that purpose. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic Safety Update Reports (PSURs) 
 
The PSUR cycle for the medicinal product should follow a twice-yearly cycle until otherwise agreed 
by the CHMP. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
 Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 
 At the request of the European Medicines Agency; 
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 
same time. 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 12

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 13

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 14

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton Box for syringe(s) with needle 
- 1 pre-filled syringe (0.5 ml) with needle 
- 10 pre-filled syringes (0.5 ml) with needle 
 
Carton box for syringe(s) without needle 
- 1 pre-filled syringe (0.5 ml) without needle 
- 10 pre-filled syringes (0.5 ml) without needle 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Optaflu suspension for injection in pre-filled syringe 
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 
(2015/2016 season) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following 
strains: 
 
A/California/7/2009 (H1N1)pdm09 - like strain  15 micrograms HA** 
 
A/Switzerland/9715293/2013 (H3N2) - like strain   15 micrograms HA** 
 
B/Phuket/3073/2013 – like strain 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 2015/2016 season. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate 
dihydrate, potassium dihydrogen phosphate and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
1 pre-filled syringe (0.5 ml) with needle 
10 pre-filled syringes (0.5 ml) with needle 
1 pre-filled syringe (0.5 ml) without needle 
10 pre-filled syringes (0.5 ml) without needle 
 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 15

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intramuscular use. The vaccine should be allowed to reach room temperature before use. 
Shake before use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach 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. Keep the pre-filled syringe in the outer 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 

 
Dispose of in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Seqirus GmbH 
Emil-von-Behring-Strasse 76 
D-35041 Marburg 
GERMANY 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/394/001 
EU/1/07/394/002 
EU/1/07/394/004 
EU/1/07/394/005 
EU/1/07/394/007 
EU/1/07/394/008 
EU/1/07/394/010 
EU/1/07/394/011 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 16

 
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. 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 17

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACK 
- Outer carton box for containing 2 carton boxes with 10 syringes each (with or without needles) 
 
Outer carton box will include “Blue Box”. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Optaflu suspension for injection in pre-filled syringe 
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 
(2015/2016 season) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following 
strains: 
 
A/California/7/2009 (H1N1)pdm09 - like strain  15 micrograms HA** 
 
A/Switzerland/9715293/2013 (H3N2) - like strain  15 micrograms HA** 
 
B/Phuket/3073/2013 – like strain 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 2015/2016 season. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate 
dihydrate, potassium dihydrogen phosphate and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
 
Multipack: 20 (2 packs of 10) pre-filled syringes (0.5 ml) without needle 
Multipack: 20 (2 packs of 10) pre-filled syringes (0.5 ml) with needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intramuscular use. 
The vaccine should be allowed to reach room temperature before use. 
Shake before use. 
Read the package leaflet before use. 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 18

 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the site and reach 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. Keep the pre-filled syringe in the outer 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 

 
Dispose of in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Seqirus GmbH 
Emil-von-Behring-Strasse 76 
D-35041 Marburg 
GERMANY 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/394/003 
EU/1/07/394/006 
EU/1/07/394/009 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 19

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not using Braille accepted. 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 20

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
MULTIPACK 
- Inner Carton Box for 10 pre-filled syringes with needles 
- Inner Carton Box for 10 pre-filled syringes without needles 
 
Inner carton box will not include “Blue Box”. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Optaflu suspension for injection in pre-filled syringe 
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 
(2015/2016 season) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following 
strains: 
 
A/California/7/2009 (H1N1)pdm09 - like strain  15 micrograms HA** 
 
A/Switzerland/9715293/2013 (H3N2) - like strain  15 micrograms HA** 
 
B/Phuket/3073/2013 – like strain 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 2015/2016 season. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate 
dihydrate, potassium dihydrogen phosphate and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
 
10 pre-filled syringes with needle. Component of a multipack, can’t be sold separately. 
10 pre-filled syringes without needle. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intramuscular use. The vaccine should be allowed to reach room temperature before use. 
Shake before use. 
Read the package leaflet before use. 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 21

 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach 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. Keep the pre-filled syringe in the outer 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 

 
Dispose of in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Seqirus GmbH 
Emil-von-Behring-Strasse 76 
D-35041 Marburg 
GERMANY 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/07/394/003 
EU/1/07/394/006 
EU/1/07/394/009 
 
 
13. BATCH NUMBER 
 
Batch: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 22

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not using Braille accepted. 
 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 23

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Prefilled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Optaflu 
(2015/2016 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 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 24

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 25

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 receive this vaccine because it contains important 
information for you. 
 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Optaflu is and what it is used for 
2. What you need to know before you receive Optaflu 
3. How Optaflu is given 
4. Possible side effects 
5. How to store Optaflu 
6. Contents of the pack and other 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. 
When a person is given the vaccine, the immune system (the body’s natural defence system) will 
produce its own protection against the influenza virus. None of the ingredients in the vaccine can 
cause the 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. 
 
The vaccine targets three strains of influenza virus following the recommendations by the World 
Health Organisation for the 2015/2016 season. 
 
 
2. What you need to know before you receive OPTAFLU 
 
You should not receive Optaflu 
 if you are allergic to influenza vaccine or any of the other ingredients of this vaccine (listed in 

section 6) 
 if you have an acute infection. 
 
Warnings and precautions 
 
Talk to your doctor, pharmacist or nurse before receiving Optaflu. 
 
BEFORE receiving the vaccine 
 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. 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 26

 Fainting can occur following, or even before, any needle injection. Therefore tell the doctor or 
nurse if you fainted with a previous injection. 

 if you have an acute illness associated with fever. 
 
If you need a blood test to look for evidence of infection with certain viruses in the first few weeks 
after vaccination with Optaflu, the result of the test may not be correct. Tell the doctor requesting the 
test that you have recently received Optaflu. 
 
Other medicines and Optaflu 
Tell your doctor or nurse if you are using, have recently used or might use any other medicines, 
including medicines obtained without a prescription or if you have recently received any other 
vaccine. 
 
If you take any medicines against cancer (chemotherapy), corticosteroid medicines (such as cortisone) 
or other medicines affecting the immune system, the immune response of your body may be 
weakened. Therefore, the vaccine may work less effectively. 
 
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. 
 
Pregnancy, breast-feeding and fertility 
 
Pregnancy: 
Tell your doctor if you are pregnant, think you may be pregnant or plan to become pregnant. Your 
doctor will decide if you should receive Optaflu.  
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. 
 
Breast-feeding: 
Optaflu may be used during breast feeding. 
 
Fertility: 
No human fertility data are available. Animal data have not shown effects on female fertility. 
 
Driving and using machines 
Optaflu may have a minor effect on your ability to drive and use machines. 
 
Optaflu contains sodium chloride and potassium chloride 
This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’. 
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’. 
 
 
3. How OPTAFLU is given 
 
Optaflu is given to you by your doctor or nurse. Optaflu should under no circumstances be injected 
into a blood vessel. 
 
Adults from the age of 18 years: 
One dose of 0.5 ml 
Optaflu is injected into the muscle on the top of the upper arm (deltoid muscle). 
 
Children and adolescents: 
Optaflu is not recommended for use in children below 18 years of age since there is no information 
available. 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 27

 
4. Possible side effects 
 
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
The following side effects have been observed during clinical trials and post-marketing surveillance: 
 
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: 
 
Not known (cannot be estimated from the available data) 
 swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other 

part of the body (angioedema) 
 
Very rare (affects less than 1 user in 10,000): 
 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 (affects 1 to 10 users in 10,000): 
 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 (affects less than 1 user in 10,000): 
 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: 
 
Not known (cannot be estimated from the available data) 
 extensive swelling of injected limb 
 
Very Rare (affects less than 1 user in 10,000): 
 bleeding or bruising which are symptoms of a low platelet count in the blood 
 
Mild side effects 
 
Not known (cannot be estimated from the available data): 
 numbness and tingling sensation 
 
Very common (affects more than 1 user in 10): 
 flu-like symptoms such as headache, feeling of discomfort, tiredness, muscle pain. 
 injection site pain, reddening. 
These reactions are usually mild and only last a few days. Injection site pain and headache were 
common in the elderly. 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 28

Common (affects 1 to 10 users in 100): 
 sweating, joint 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 (affects 1 to 10 users in 1,000): 
 generalised skin reactions such as itching, bumps on the skin or non-specific rash 
 
Rare (affects 1 to 10 users in 10,000): 
 swelling and pain of local lymphnodes 
 Fever greater than 39.0 °C 
 
Reporting of side effects. 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet.You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store OPTAFLU 
 
Keep this vaccine out of the sight and reach of children. 
 
Do not use this vaccine after the expiry date which is stated on the label and carton after EXP. The 
expiry date refers to the last day of that month. 
 
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. 
 
Do not throw away any medicines via wastewater or household waste. Ask you pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Optaflu contains 
The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase)*, 
inactivated, of the following strains: 
 
A/California/7/2009 (H1N1)pdm09 - like strain  
(A/Brisbane/10/2010, wild type) 15 micrograms HA** 
 
A/Switzerland/9715293/2013 (H3N2) - like strain  
(A/South Australia/55/2014, wild type) 15 micrograms HA** 
 
B/Phuket/3073/2013 – like strain 
(B/Utah/9/2014, wild type) 15 micrograms HA** 
 per 0.5 ml dose 
………………………………………. 
* produced in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which 

the influenza virus is grown) 
** haemagglutinin 
 
The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, 
disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections. 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d



 

 29

 
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. 
Optaflu is available in packs containing 1 or 10 pre-filled syringes and in multipacks 
comprising 2 cartons, each containing 10 pre-filled syringes. All pack sizes are available with or 
without needle(s). 
 
Marketing Authorisation Holder and Manufacturer 
 
Seqirus GmbH 
Emil-von-Behring-Strasse 76 
D-35041 Marburg 
Germany 
 
 
This leaflet was last revised in. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 
 
 

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET