IDflu

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
IDflu 15 microgram/strain suspension for injection 
Influenza vaccine (split virion, inactivated) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Influenza virus (inactivated, split) of the following strains*: 
 
A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)
 .............................................................................................................................. 15 micrograms HA** 
 
A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)
 .............................................................................................................................. 15 micrograms HA** 
 
B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ..................... 15 micrograms HA** 
 
Per 0.1 ml dose 
 
* propagated in fertilised hens’ eggs from healthy chicken flocks 
** haemagglutinin 
 
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for 
the 2016/2017 season. 
 
For the full list of excipients, see section 6.1. 
 
IDflu may contain residues of eggs such as ovalbumin and residues of neomycin, formaldehyde and 
octoxinol 9, which are used during the manufacturing process (see section 4.3). 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection. 
Colourless and opalescent suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an 
increased risk of associated complications. 
 
The use of IDflu should be based on official recommendations. 
 
4.2 Posology and method of administration 
 
Posology 
Individuals 60 years of age and over: 0.1 ml. 
 
Paediatric population 
IDflu is not recommended for use in children and adolescents below 18 years due to insufficient data 
on safety and efficacy. 
 

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Method of administration 
Immunisation should be carried out by intradermal route. 
The recommended site of administration is the region of the deltoid. 
 
Precautions to be taken before handling or administering the medicinal product 
For instructions on preparation of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to any 
residues such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.  
 
Immunisation shall be postponed in subjects 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 an anaphylactic event following the administration of the vaccine (see 
section 4.8). 
 
IDflu should under no circumstances be administered intravascularly. 
 
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
 
Very limited data in immunocompromised patients are available for IDflu. 
 
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not 
required. 
 
Interference with serological testing: See section 4.5. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
IDflu may be given at the same time as other vaccines. 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 results in serology tests using the ELISA method to 
detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western 
Blot technique disproves the false-positive ELISA test results. The transient false positive reactions 
could be due to the IgM response by the vaccine. 
 
4.6 Fertility, pregnancy and lactation 
 
This vaccine is intended for individuals 60 years of age and over. Therefore, this information is not 
applicable. 
 
4.7 Effects on ability to drive and use machines 
 
IDflu has no or negligible influence on the ability to drive and use machines. 
 

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4.8 Undesirable effects 
 
a. Summary of the safety profile 
 
The safety of IDflu has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees 
received an injection of IDflu. 
 
Safety evaluation was performed for all subjects during the first 3 weeks following vaccination and 
serious adverse reactions were collected during six months of follow-up for 2,974 subjects 
(population of two out of the three clinical trials). 
 
The most common reactions occurring after vaccine administration were local reactions at injection 
site. 
Apparent local reactions after intradermal administration were more frequent than after intramuscular 
administration of an adjuvanted or non-adjuvanted comparator vaccine. 
Most reactions resolved spontaneously within 1 to 3 days after onset. 
 
Systemic safety profile of IDflu is similar to the comparator vaccine, adjuvanted or non-adjuvanted, 
administered intramuscularly. 
 
After repetitive yearly injections the safety profile of IDflu is similar to the previous injections. 
 
b. Tabulated summary of adverse reactions 
 
The data below summarizes the frequencies of the adverse reactions that were recorded following 
vaccination during clinical trials and worldwide post-marketing experience, using the following 
convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare 
(≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from available data). 

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Organ class Very 
common 

Common Uncommon Rare Very 
rare 

Not known 

Immune system 
disorders 
 

     Allergic 
reactions 
including 
generalized 
skin reactions 
such as 
urticaria, 
anaphylactic 
reactions, 
angioedema, 
shock 

Nervous system 
disorders 

Headache   Paresthesia, 
neuritis 
 

  

Skin and 
subcutaneous 
tissue disorders 

  Sweating Pruritus, 
rash 

  

Musculoskeletal 
and connective 
tissue disorders 

Myalgia  Arthralgia    

General 
disorders and 
administration 
site conditions 

Local 
reactions: 
redness*, 
induration 
swelling, 
pruritus, pain 

Malaise, 
shivering, 
fever, 
 
Local 
reactions: 
ecchymosis 

Fatigue    

* In some cases, local redness lasted up to 7 days. 
 
c. Potential adverse events 
 
Based on the experience with trivalent inactivated influenza vaccines administered by intramuscular 
or deep subcutaneous injection, the following events may be reported: 
 
Blood and lymphatic system disorders 
Transient thrombocytopenia, transient lymphadenopathy 
 
Nervous system disorders 
Neuralgia, febrile convulsions, neurological disorders, such as encephalomyelitis and Guillain-Barré 
syndrome 
 
Vascular disorders 
Vasculitis associated in very rare cases with transient renal involvement 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Overdose is unlikely to have any untoward effect. 

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http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


6 

 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group:  Influenza vaccines, ATC code: J07BB02 
 
Immunogenicity 
Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to 
homologous strains or to strains closely related to the vaccine strains varies but is usually 
6-12 months. 
 
In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 
0.1 ml of IDflu by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a 
trivalent inactivated influenza vaccine administered by intramuscular route. 
 
In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or 
significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody 
(measured by HI) were assessed according to predefined criteria. 
 
Data were as follows (values in brackets show the 95% confidence intervals): 
 

 Intradermal 15µg 

 A/H1N1 A/H3N2 B 

 A/New Caledonia/ 20/99 A/Wisconsin/ 67/2005 B/Malaysia/ 2506/2004 
 N = 2,585 N = 2,586 N = 2,582 

Geometric mean of titre (1/dil) 81.7 
(78.0 ; 85.6) 

298.0 
(282 ; 315) 

39.9 
(38.3 ; 41.6) 

Seroprotection rate (%) * 77.0 
(75.3 ; 78.6) 

93.3 
(92.3 ; 94.3) 

55.7 
(53.8 ; 57.6) 

Seroconversion or significant 
increase rate (%) ** 

38.7 
(36.8 ; 40.6) 

61.3 
(59.3 ; 63.1) 

36.4 
(34.5 ; 38.3) 

Geometric mean of titre ratio 
(GMTR) 

3.97 
(3.77 ; 4.18) 

8.19 
(7.68 ; 8.74) 

3.61 
(3.47 ; 3.76) 

* Seroprotection = HI titre ≥ 40 
** Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre ≥ 40, Significant 
increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre 
GMTR: Geometric mean titre ratio of individual (post-/pre-vaccination titre). 
 
IDflu is at least as immunogenic as the comparator trivalent inactivated influenza vaccine 
administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of 
age and over. 
 
Across all three influenza strains, for the comparator intramuscular vaccine GMTs ranged between 
34.8 (1/dil) and 181.0 (1/dil), seroprotection rates ranged between 48.9% and 87.9%, seroconversion 
or significant increase rates ranged between 30.0% and 46.9% and GMTRs ranged between 3.04 and 
5.35-fold over baseline HI titres. 
 
In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of IDflu 
by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated 
adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular 
route. 
 

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IDflu is as immunogenic as the comparator trivalent adjuvanted (MF-59 containing) vaccine in terms 
of GMT for each of the 3 influenza strains with the SRH method and for 2 strains with the HI method. 
 
5.2 Pharmacokinetic properties 
 
Not applicable 
 
5.3 Preclinical safety data 
 
Non-clinical data revealed no special hazard for humans based on animal studies. The vaccine was 
immunogenic in mice and rabbits. In repeated-dose toxicity studies in rabbits there was no significant 
evidence of systemic toxicity. Nevertheless, single and repeated administrations led to transient local 
erythema and oedema. Genotoxicity and carcinogenic potential were not assessed because these 
studies are not appropriate for a vaccine. Fertility and toxicity studies to reproduction in females have 
not identified any specific potential hazard for humans. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride 
Potassium chloride 
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 syringe in the outer carton in order to protect from light. 
 
6.5 Nature and contents of container 
 
0.1 ml of suspension in a pre-filled syringe (glass) with a Micro-Injection System, with attached 
micro-needle, equipped with an elastomer plunger stopper (chlorobutyl), a tip cap (thermoplastic 
elastomer and polypropylene) and a needle shielding system. Pack size of 1 or 10 or 20. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
The vaccine should be allowed to reach room temperature before use. 
 

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8 

Micro-needle 

Window 

Finger pads 

Vaccine 

      Needle shield 

Needle cap Flange 

Plunger 

The vaccine should not be used if foreign particles are present in the suspension. 
 
It is not necessary to shake the vaccine before use. 
 
The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a 
micro-needle (1.5 mm) and a needle shielding system. 
The needle shielding system is designed to cover the micro-needle after use. 
 
 

Micro-Injection System 
 
 

  
 

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INSTRUCTION FOR USE 

 

Please read the instructions before use 

 
1/ REMOVE NEEDLE CAP  

 

2/ HOLD MICRO-INJECTION SYSTEM 
BETWEEN THUMB & MIDDLE FINGER 

 

Remove the needle cap 
from the  
Micro-Injection System.  

 

Do not purge air 
through the needle. 

 
 

Hold the system by 
placing the thumb and 
middle finger only on the 
finger pads; the index 
finger remains free. 

Do not place fingers on 
the windows. 

 

3/ INSERT NEEDLE RAPIDLY 
PERPENDICULAR TO THE SKIN  

4/ INJECT USING THE INDEX FINGER 

 

Insert the needle 
perpendicular to the skin, 
in the region of the 
deltoid, in a short, quick 
movement. 

 

 

Once the micro-needle 
has been inserted, 
maintain a light pressure 
on the surface of the skin 
and inject using the index 
finger to push on the 
plunger.  

The vein test is 
unnecessary. 

 
5/ ACTIVATE NEEDLE SHIELD BY PUSHING FIRMLY ON PLUNGER 

 
 

Remove the needle from the skin. 

Orient the needle away from you and others. 

With the same hand, push very firmly with the thumb on the plunger to activate the 
needle shield.  

You hear a click and a shield comes out to cover the needle. 

Immediately dispose of the system in the nearest sharps collector.  

Injection is considered successful whether or not the presence of a wheal is 
observed. 

In case of presence of liquid at the injection site after vaccine administration, re-
vaccination is not required.   

Activated needle shield 

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7. MARKETING AUTHORISATION HOLDER 
 
Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France. 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/08/507/004 
EU/1/08/507/005 
EU/1/08/507/006 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 24 February 2009 
Date of latest renewal: 24 February 2014 
 
 
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. 
 
 
 

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11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 
SUBSTANCE(S) AND MANUFACTURER(S)  
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 

 

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

 
Name and address of the manufacturer(s) of the biological active substance(s) 
 
Sanofi Pasteur 
Parc Industriel d’Incarville 
27100 Val-de-Reuil 
France 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Sanofi Pasteur 
Parc Industriel d’Incarville 
27100 Val-de-Reuil 
France 
 
Sanofi Pasteur 
Campus Mérieux 
1541, avenue Marcel Mérieux 
69280 Marcy l’Etoile 
France 
 
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 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
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. 
 

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

 
 

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14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

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15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Pack of 1 or 10 or 20 pre-filled syringe(s) with a Micro-Injection System 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
IDflu 15 microgram/strain, suspension for injection 
Influenza vaccine (split virion, inactivated) 
Strains 2016/2017 
 
 
2. STATEMENT OF ACTIVE SUBSTANCES 
 
Influenza virus (inactivated, split) of the following strains: 
 
A/California/7/2009 (H1N1)pdm09 - like strain 
 
A/Hong Kong/4801/2014 (H3N2) - like strain 
 
B/Brisbane/60/2008 - like strain 
 
15 µg haemagglutinin per strain per 0.1 ml dose 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen 
phosphate, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
1 pre-filled syringe (0.1 ml) with a Micro-Injection System  
10 pre-filled syringes (0.1 ml) with a Micro-Injection System  
20 pre-filled syringes (0.1 ml) with a Micro-Injection System  
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Intradermal 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. 
 
 

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7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in refrigerator. Do not freeze. 
Keep the 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 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Sanofi Pasteur SA, 
2, avenue Pont Pasteur 
F-69007 Lyon 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/08/507/004 - pack of 1 pre-filled syringe with a Micro-Injection System 
EU/1/08/507/005 - pack of 10 pre-filled syringes with a Micro-Injection System 
EU/1/08/507/006 - pack of 20 pre-filled syringes with a Micro-Injection System 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille is accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 

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18 

 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Pre-filled syringe label text 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
IDflu 15 µg/strain 2016/2017 
Influenza vaccine 
Intradermal use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.1 ml 
 
 
6. OTHER 
 
Sanofi Pasteur SA 
 
 
 

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B. PACKAGE LEAFLET 
 

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Package leaflet: Information for the user 

 
IDflu 15 microgram/strain suspension for injection 

Influenza vaccine (split virion, inactivated) 
 

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. 
- This vaccine has been prescribed for you only. Do not pass it on to others. 
- 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 IDflu is and what it is used for 
2. What you need to know before you use IDflu 
3. How to use IDflu  
4. Possible side effects 
5. How to store IDflu  
6. Contents of the pack and other information 
 
 
1. What IDflu is and what it is used for 
 
IDflu is a vaccine.This vaccine is recommended to help to protect you against flu. 
The vaccine may be administered to individuals of 60 years of age and over, especially in those who 
run an increased risk of associated complications. 
 
When an injection of IDflu is given, the immune system (body's natural defences) will develop 
protection against flu infection. 
IDflu will help to protect you against the three strains of virus contained in the vaccine, or other 
strains closely related to them. Full effect of the vaccine is generally achieved 2-3 weeks after the 
vaccination. 
 
 
2. What you need to know before you use IDflu 
 
Do not use IDflu: 
- If you are allergic to: 

• The active substances, 
• Any of the other ingredients of this vaccine (listed in section 6), 
• Any component that may be present in very small amounts such as eggs (ovalbumin, 

chicken proteins), neomycin, formaldehyde and octoxinol 9. 
- If you have an illness with fever or acute infection, the vaccination shall be postponed until 

after you have recovered. 
 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before using IDflu. 
 
- You should tell your doctor before vaccination if you have a poor immune response 

(immunosuppression) due to disease or medicines, because the vaccine may not work very well 
in this case. 

 
- This vaccine should under no circumstances be administered into a vein (intravascularly). 

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22 

 
- If, for any reason, you have a blood test within a few days following an influenza vaccination, 

please tell your doctor. Tests for HIV-1, hepatitis C virus and HTLV-1 may be affected. 
 
Children and adolescents 
IDflu is not recommended for use in children and adolescents below 18 years. 
 
Other vaccines or medicines and IDflu 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
- Other vaccines: IDflu can be given at the same time as other vaccines by using separate limbs. 

It should be noted that the side effects may be intensified. 
- Tell your doctor if you have been treated with medicines that may reduce your immune 

response such as corticosteroids (for example cortisone), medicines against cancer 
(chemotherapy), radiotherapy or other medicines affecting the immune system. In this case, the 
vaccine may not work very well. 

 
Pregnancy, breast-feeding and fertility 
This vaccine is intended for individuals 60 years of age and over. Therefore, this information is not 
applicable. 
 
Driving and using machines 
This vaccine has no or negligible influence on the ability to drive and use machines. 
 
 
3. How to use IDflu  
 
Always use this vaccine exactly as your doctor or pharmacist has told you. Check with your doctor or 
pharmacist if you are not sure. 
 
The recommended dose is 0.1 ml for individuals 60 years of age and over. 
 
IDflu is administered to you by your doctor or nurse. 
 
IDflu is given as an injection into the upper layer of the skin (preferably the muscle of the upper arm). 
 
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
 
You should see your doctor immediately if you experience symptoms of angioedema, such as: 

• Swollen face, tongue or pharynx 
• Difficulty to swallow 
• Hives and difficulties to breathe. 

 
During clinical trials and after the vaccine came on the market, the following side effects were 
reported with the use of IDflu. 
 
Very common reactions (may affect more than 1 in 10 people) 
- At the injection site: redness, hardness, swelling, itching and pain. 
- Headache and muscular pain. 
 

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Common reactions (may affect up to 1 in 10 people) 
- Bruising at the injection site. 
- Feeling generally unwell, fever (38.0°C or higher) and shivering. 
 
Uncommon reactions (may affect up to 1 in 100 people) 
- Tiredness, joint pain and increased sweating. 
 
Rare reactions (may affect up to 1 in 1000 people) 
- Tingling or numbness, inflammation of nerves, itching and rash. 
 
Reactions of not known frequency (frequency cannot be estimated from the available data) 
- Allergic reactions including skin reactions that may spread throughout the body such as hives, 

severe allergic reactions (anaphylactic reactions), swollen face, tongue or pharynx, difficulty to 
swallow, hives and difficulties to breathe (angioedema), failure of the circulatory system 
(shock) leading to medical emergency. 

 
Most of side effects listed above disappeared without treatment within 1 to 3 days after onset. In some 
cases, redness at the injection site lasted up to 7 days. 
 
The following side effects have been reported with other vaccines given to prevent flu. These side 
effects may occur with IDflu. 
• Temporary reduction in the number of blood particles called platelets which can result in 

bruising or bleeding, temporary swelling of the glands in the neck, armpit or groin.  
• Pain located on the nerve route, convulsions associated with fever, nervous system disorders 

including inflammation of the brain or spinal cord or Guillain-Barré syndrome which causes 
extreme weakness and paralysis. 

• Vessel inflammation which may result in very rare cases in temporary kidney problems. 
 
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 IDflu  
 
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 carton after EXP. The expiry date 
refers to the last day of that month. 
 
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the syringe in the outer carton in order to 
protect from light. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 

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24 

6. Contents of the pack and other information 
 
What IDflu contains 
 
The active substances are Influenza virus (inactivated split) of the following strains*: 
 
A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)
 .............................................................................................................................. 15 micrograms HA** 
 
A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)
 .............................................................................................................................. 15 micrograms HA** 
 
B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ..................... 15 micrograms HA** 
 
Per 0.1 ml dose 
 
* propagated in fertilised hens’ eggs from healthy chicken flocks 
** haemagglutinin 
 
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for 
the 2016/2017 season. 
 
The other ingredients are: sodium chloride, potassium chloride, disodium phosphate dihydrate, 
potassium dihydrogen phosphate and water for injections. 
 
What IDflu looks like and contents of the pack 
 
The vaccine is a colourless and opalescent suspension. 
 
IDflu is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection System in 
packs of 1, 10 or 20. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder: Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France. 
 
Manufacturer: 
Sanofi Pasteur - Parc Industriel d’Incarville - 27100 Val-de-Reuil - France 
Sanofi Pasteur, Campus Mérieux – 1541, avenue Marcel Mérieux – 69280 Marcy l’Etoile - France 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Sanofi Belgium  
tel.: +32 2 710.54.00  
 

Lietuva 
Sanofi – Aventis Lietuva, UAB 
Tel.: +370 5 2730967  
 

България 
Sanofi Bulgaria EOOD 
Teл.: +359 2 970 53 00 
 

Luxembourg/Luxemburg 
Sanofi Belgium  
tel.: +32 2 710.54.00  
 

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25 

Česká republika 
Sanofi Pasteur 
divize vakcín sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Magyarország 
sanofi-aventis zrt 
Tel.: +36 1 505 0055 
 

Danmark 
sanofi-aventis Denmark A/S 
Tel: +45 4516 7000  
 

Malta 
Cherubino Ltd 
Tel.: +356 21 343270 
 

Deutschland 
Sanofi-Aventis Deutschland GmbH  
Tel.: 0800 54 54 010  
Tel. aus dem Ausland: +49 69 305 21 130  
 

Nederland 
sanofi-aventis Netherlands B.V.  
Tel: +31 182 557 755  
 

Eesti 
Sanofi-Aventis Estonia OÜ 
Tel.: +372 627 3488 
 

Norge 
Sanofi-aventis Norge AS  
Tel: + 47 67 10 71 00  
 

Ελλάδα 
ΒΙΑΝΕΞ Α.Ε.  
Τηλ: +30.210.8009111  
 

Österreich 
Sanofi-Aventis GmbH 
Tel: +43 (1) 80185-0.  
 

España 
sanofi-aventis, S.A.  
Tel: +34 93 485 94 00  
 

Polska 
Sanofi Pasteur Sp. z o.o. 
Tel.: +48 22 280 05 00 
 

France 
 Sanofi Pasteur Europe  
Tél: 0800 42 43 46  
Appel depuis l’étranger : +33 1 57 63 23 23  
 

Portugal 
Sanofi – Produtos Farmacêuticos, Lda.  
Tel: + 351 21 35 89 400  
 

Hrvatska  
sanofi-aventis Croatia d.o.o 
Tel: + 385 1 6003 400 

România 
sanofi - aventis Romania SRL 
Tel.: +40(21) 317 31 36 
 

Ireland 
sanofi-aventis Ireland T/A SANOFI  
Tel: + 353 (0) 1 4035 600  
 

Slovenija 
ALPE s.p. 
Tel.: +386 (0)1 432 62 38 
 

Ísland 
Vistor  
Tel : +354 535 7000  
 

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
divízia vakcín Sanofi Pasteur   
Tel.: +421 2 33 100 100 
 

Italia 
Sanofi S.p.A.  
Tel: 800536389   
Tel dall'estero: +39 02 39394983  
 

Suomi/Finland 
Sanofi Oy  
Tel: +358 (0) 201 200 300  
 

Κύπρος 
Γ. Α. Σταμάτης & Σια Λτδ. 
Τηλ.: +357 - 22 76 62 76 
 

Sverige 
Sanofi AB 
Tel: +46 8-634 50 00  
 

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26 

Latvija 
Sanofi Aventis Latvia SIA Vakcīnu nodaļa 
Tel.: +371 67114978 
 

United Kingdom 
Sanofi 
Tel: +44 845 372 7101 
 

 
This leaflet was last revised in {MM/YYYY}. 
 
Other sources of information 
 
Detailed information on this vaccine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
--------------------------------------------------------------------------------------------------------------------------- 
The following information is intended for healthcare professionals only: 
 
• As with all injectable vaccines, appropriate medical treatment and supervision should always be 

readily available in case of anaphylactic event following the administration of the vaccine. 
• The vaccine should be allowed to reach room temperature before use. 
• The vaccine should not be used if foreign particles are present in the suspension. 
• It is not necessary to shake the vaccine before use. 
• The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a 

micro-needle (1.5 mm) and a needle shielding system. 
The needle shielding system is designed to cover the micro-needle after use. 

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27 

Micro-needle 

Window 

Finger pads 

Vaccine 

      Needle shield 

Needle cap Flange 

Plunger 

 
 
 

Micro-Injection System 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 

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28 

INSTRUCTION FOR USE 

 

Please read the instructions before use 

 
1/ REMOVE NEEDLE CAP  

 

2/ HOLD MICRO-INJECTION SYSTEM 
BETWEEN THUMB & MIDDLE FINGER 

 

Remove the needle cap 
from the  
Micro-Injection System.  

 

Do not purge air 
through the needle. 

 
 

Hold the system by 
placing the thumb and 
middle finger only on the 
finger pads; the index 
finger remains free. 

Do not place fingers on 
the windows. 

 

3/ INSERT NEEDLE RAPIDLY 
PERPENDICULAR TO THE SKIN  

4/ INJECT USING THE INDEX FINGER 

 

Insert the needle 
perpendicular to the skin, 
in the region of the 
deltoid, in a short, quick 
movement. 

 

 

Once the micro-needle 
has been inserted, 
maintain a light pressure 
on the surface of the skin 
and inject using the index 
finger to push on the 
plunger.  

The vein test is 
unnecessary. 

 
5/ ACTIVATE NEEDLE SHIELD BY PUSHING FIRMLY ON PLUNGER 

 
 

Remove the needle from the skin. 

Orient the needle away from you and others. 

With the same hand, push very firmly with the thumb on the  plunger to activate the 
needle shield.  

You hear a click and a shield comes out to cover the needle. 

Immediately dispose of the system in the nearest sharps collector.  

Injection is considered successful whether or not the presence of a wheal is 
observed. 

In case of presence of liquid at the injection site after vaccine administration, re-
vaccination is not required.   

 
 
See also section 3. HOW TO USE IDflu 
 
 

Activated needle shield 

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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) 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
	A. LABELLING
	B. PACKAGE LEAFLET