Intanza

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

 

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1. NAME OF THE MEDICINAL PRODUCT 

 

INTANZA 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/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275) 

 ............................................................................................................................. 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 2017/2018 season. 

 

For the full list of excipients, see section 6.1. 

 

INTANZA 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 INTANZA 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 

INTANZA 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). 

 

INTANZA 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 INTANZA. 

 

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 

 

INTANZA 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 

 

INTANZA 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 INTANZA has been assessed in 3 open-label randomised clinical trials, 3,372 vaccinees 

received an injection of INTANZA. 

 

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 INTANZA is similar to the comparator vaccine, adjuvanted or non-

adjuvanted, administered intramuscularly. 

 

After repetitive yearly injections the safety profile of INTANZA 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. 

 

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


6 

4.9 Overdose 

 

Overdose is unlikely to have any untoward effect. 

 

 

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 INTANZA 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). 

 

INTANZA 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. 

 

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In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of 

INTANZA 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. 

 

INTANZA 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 

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Micro-needle 

Window 

Finger pads 

Vaccine 

      Needle shield 

Needle cap 
Flange 

Plunger 

 

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. 

 

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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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.   

 

4/ INJECT USING THE INDEX FINGER 

Insert the needle 

perpendicular to 

the skin, in the 

region of the 

deltoid, in a short, 

quick movement. 

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. 

 

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 

 

 1/ REMOVE NEEDLE CAP  2/ HOLD MICRO-INJECTION SYSTEM 

BETWEEN THUMB & MIDDLE FINGER  

3/ INSERT NEEDLE RAPIDLY 

PERPENDICULAR TO THE SKIN  

Please read the instruction before use 

 

INSTRUCTIONS FOR USE 

Activated needle shield 

                    Click 

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7. MARKETING AUTHORISATION HOLDER 

 

Sanofi Pasteur Europe, 2 Avenue Pont Pasteur, 69007 Lyon, France. 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/08/505/004  

EU/1/08/505/005  

EU/1/08/505/006 

 

 

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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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 

 

INTANZA 15 microgram/strain, suspension for injection 

Influenza vaccine (split virion, inactivated) 

Strains 2017/2018 

 

 

2. STATEMENT OF ACTIVE SUBSTANCES 

 

Influenza virus (inactivated, split) of the following strains: 

 

A/Michigan/45/2015 (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. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

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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 Europe  

2 Avenue Pont Pasteur  

69007 Lyon  

France 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/08/505/004 - pack of 1 pre-filled syringe with a Micro-Injection System 

EU/1/08/505/005 - pack of 10 pre-filled syringes with a Micro-Injection System 

EU/1/08/505/006 - 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. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC:  

SN:  

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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 

 

INTANZA 15 µg/strain 2017/2018 

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 Europe 

 

 

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B. PACKAGE LEAFLET 

 

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Package leaflet: Information for the user 

 

INTANZA 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 INTANZA is and what it is used for 

2. What you need to know before you use INTANZA 

3. How to use INTANZA  

4. Possible side effects 

5. How to store INTANZA  

6. Contents of the pack and other information 

 

 

1. What INTANZA is and what it is used for 

 

INTANZA 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 INTANZA is given, the immune system (body's natural defences) will develop 

protection against flu infection. 

INTANZA 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 INTANZA 

 

Do not use INTANZA: 

- 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 INTANZA. 

 

- 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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- 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 

INTANZA is not recommended for use in children and adolescents below 18 years. 

 

Other vaccines or medicines and INTANZA 

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 

 

- Other vaccines: INTANZA 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 INTANZA  

 

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. 

 

INTANZA is administered to you by your doctor or nurse. 

 

INTANZA 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 INTANZA. 

 

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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23 

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 INTANZA. 

 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 INTANZA  

 

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. 

 

 

6. Contents of the pack and other information 

 

What INTANZA contains 

 

The active substances are Influenza virus (inactivated split) of the following strains*: 

 

 

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


24 

A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275) 

 ................................................................................................................................ 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 2017/2018 season. 

 

The other ingredients are: sodium chloride, potassium chloride, disodium phosphate dihydrate, 

potassium dihydrogen phosphate and water for injections. 

 

What INTANZA looks like and contents of the pack 

 

The vaccine is a colourless and opalescent suspension. 

 

INTANZA 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 Europe, 2 Avenue Pont Pasteur, 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  

 

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 

 

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25 

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  

 

Latvija 

Sanofi Aventis Latvia SIA Vakcīnu nodaļa 

Tel.: +371 67114978 

 

United Kingdom 

Sanofi 

Tel: +44 845 372 7101 

 

 

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26 

Micro-needle 

Window 

Finger pads 

Vaccine 

      Needle shield 

Needle cap 
Flange 

Plunger 

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. 

 

 

 

Micro-Injection System 

 

 

 

 

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27 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See also section 3. HOW TO USE INTANZA 

 

 

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. 

 

4/ INJECT USING THE INDEX FINGER 

Insert the needle 

perpendicular to 

the skin, in the 

region of the 

deltoid, in a short, 

quick movement. 

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. 

 

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 

 

 1/ REMOVE NEEDLE CAP  2/ HOLD MICRO-INJECTION SYSTEM 

BETWEEN THUMB & MIDDLE FINGER  

3/ INSERT NEEDLE RAPIDLY 

PERPENDICULAR TO THE SKIN  

Please read the instruction before use 

 

INSTRUCTIONS FOR USE 

Activated needle shield 

                    Click 

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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