Vaxigrip - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Influenza vaccine prepared with “split” fragmented viruses, inactivated Season 2015/2016

Vaxigrip, suspension for injection in pre-filled syringe

Indications Why is Vaxigrip used? What is it for?

Vaxigrip is a vaccine.

This vaccine helps protect you or your child against the flu.

The use of Vaxigrip should be based on official recommendations.

When a person is given Vaxigrip the immune system (the body's natural defense system) will produce its own protection (antibodies) against the disease. None of the components contained in the vaccine can cause flu.

Influenza is a disease that can spread rapidly and is caused by different strains of viruses that can change each year. This is why you or your child may need to be vaccinated every year. "flu runs during the cold months, between October and March. If you or your child were not vaccinated in the fall, it is still reasonable to carry out the vaccination until the spring season, as you or your child run the risk of catching the flu until this time of year. Your doctor will be able to advise you on the best time for vaccination.

Vaxigrip is indicated to protect you or your child against the three virus strains contained in the vaccine starting approximately 2-3 weeks after vaccination.

The incubation period for flu is a few days, so if you or your child were exposed to the flu immediately before or after being vaccinated, you or your child could still get the disease.

The vaccine will not protect you or your child from the common cold, even if some of the symptoms are similar to those of the flu.

Contraindications When Vaxigrip should not be used

To make sure that Vaxigrip is a suitable vaccine for you or your child, it is important to tell your doctor or pharmacist if you or your child have any of the conditions listed below. If any information is not clear, ask your doctor or pharmacist for an explanation.

Do not use Vaxigrip

  • If you or your child are allergic (hypersensitive):

- the active ingredients, or

- to any of the other ingredients of this vaccine, (listed in section 6), or

- to any component that may be present in very small quantities such as eggs (ovalbumin or, chicken protein), neomycin, formaldehyde or 9-octoxinol,

  • If you or your child have an illness with a high or moderate fever or an acute illness, vaccination should be postponed until you or your child have recovered.

Precautions for use What you need to know before taking Vaxigrip

Talk to your doctor or pharmacist before you are given Vaxigrip

Tell your doctor before vaccination if you or your child have:

  • a reduced immune response (immunodeficiency or taking medicines that affect the immune system).
  • bruising or bleeding problems

Your doctor will decide whether you or your child should receive the vaccine.

If, for any reason, you or your child have a blood test a few days after the flu vaccination, please tell your doctor. This is important as false positive results have been observed in some patients who had recently been vaccinated.

As with all vaccines, Vaxigrip may not fully protect all people who have been vaccinated.

Interactions Which drugs or foods may change the effect of Vaxigrip

Tell your doctor or pharmacist if you or your child are taking or have recently taken any other vaccines or medicines,

  • Vaxigrip can be administered at the same time as other vaccines, by injecting into different limbs. It must be considered that, in this case, the adverse events may be more intense.
  • The immunological response may be reduced when treated with immunosuppressive drugs, such as corticosteroids, cytotoxic drugs or radiotherapy.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this medicine.

Flu vaccines can be used at all stages of pregnancy. Compared to the first quarter, a larger set of safety data is available for the second and third quarters; however, data from the use of influenza vaccines worldwide does not show that the vaccine can have harmful effects on the mother or baby.

Vaxigrip can be given if you are breastfeeding. Your doctor / pharmacist will decide whether you should be vaccinated with Vaxigrip.

Driving and using machines

Vaxigrip has no or negligible influence on the ability to drive or use machines.

Vaxigrip contains potassium and sodium

This medicinal product contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose, so it is essentially "potassium-free" and "sodium-free".

Dose, Method and Time of Administration How to use Vaxigrip: Posology

Dosage

Adults should receive a 0.5 ml dose.

Use in children

Children aged 36 months or older should receive a 0.5 ml dose.

Babies 6 to 35 months of age are given a 0.25 ml dose.

If required by national recommendations, a 0.5 ml dose can be administered.

If your child is less than 9 years of age and has not previously been vaccinated against influenza, a second dose of the vaccine should be given after an interval of at least 4 weeks.

Method and routes of administration

Your doctor will administer the recommended dose of the vaccine by intramuscular or deep subcutaneous injection.

Ask your doctor or pharmacist if you have any further questions regarding the use of this medicine.

Overdose What to do if you have taken too much Vaxigrip

In some cases, more than the recommended dose was used.

In these cases, when side effects were reported, the information was in line with what is described in Section 4.

Side Effects What are the side effects of Vaxigrip

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

Allergic reactions

See a doctor IMMEDIATELY if you or your child report:

- Severe allergic reactions:

  • Severe allergic reactions which can lead to medical emergency with low blood pressure, fast and shallow breathing, rapid heart rate and weak pulse, cold and clammy skin, dizziness, which can lead to collapse (shock).
  • More noticeable swelling of the head and neck, including the face, lips, tongue, throat or any other part of the body, which may cause difficulty in swallowing or breathing (angioedema)

- Allergic reactions such as:

  • skin reactions that can spread over the whole body with itching, hives, rash, redness (erythema).

These side effects are rare (may affect up to 1 in 1,000 people), with the exception of urticaria which is reported as uncommon (may affect up to 1 in 100 people) in children 3 to 8 years of age.

Other reported side effects

Very common (may affect more than 1 in 10 people) in adults and the elderly:

  • Headache
  • Muscular pain
  • Unusual general feeling of being unwell, tired or weak
  • Reactions at the injection site: pain, redness, swelling, hardness, itching

Very common (may affect more than 1 in 10 people) in the pediatric population *:

  • Unusual crying headache, irritability, drowsiness
  • Muscular pain
  • Diarrhea
  • Decrease or loss of appetite
  • General feeling of being unwell, fever, tremor
  • Reactions at the injection site: pain, redness, swelling, hardness

Common (may affect up to 1 in 10 people) in adults and the elderly:

  • Pain in the joints
  • Increased sweating
  • Injection site reactions: bruising, itching
  • Chills, fever, general feeling of being unwell, unusual tiredness or weakness

Common (may affect up to 1 in 10 people) in the pediatric population *:

  • Dizziness
  • Insomnia
  • He retched
  • Fever, chills, Injection site reactions: bruising, itching, discomfort, swelling, warmth

Uncommon (may affect up to 1 in 100 people) in adults and the elderly:

  • Swelling of the glands in the neck, armpits or groin
  • Somnolence, dizziness
  • Feeling sick (nausea), diarrhea
  • Flu-like syndrome
  • Reactions at the injection site: feeling sick, warmth

Uncommon (may affect up to 1 in 100 people) in the pediatric population *:

  • Swelling of the glands in the neck, armpits or groin
  • Diarrhea
  • Injection site reactions: haemorrhage, heat * Children / adolescents 6 months to 17 years of age

Rare (may affect up to 1 in 1000 people) in adults and the elderly:

  • Numbness or pins and needles (paraesthesia), decreased sensation (hypoesthesia), numbness, pain and weakness in the arm (brachial radiculitis), nerve pain (neuralgia)
  • Swelling of the glands in the neck, armpits or groin

Frequency not known (frequency cannot be estimated from the available data)

  • Swelling of the glands in the neck, armpits or groin
  • Numbness or pins and needles (paraesthesia)
  • Pain localized to the nerve pathways (neuralgia)
  • Attacks (convulsions)
  • Neurological disorders that can result in neck stiffness, confusion, numbness, pain and weakness in the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
  • Inflammation of blood vessels (vasculitis) which can lead to skin rashes or in rare cases to temporary kidney problems
  • Temporary reduction in the number of certain types of blood cells called platelets a low number of these cells can cause excessive bruising or bleeding (transient thrombocytopenia)

These side effects usually occurred within 3 days after vaccination and disappeared within 1 to 3 days without treatment. Most of these side effects were mild or moderate in intensity.

In adults

In the elderly

From 6 to 35 months of age

From 3 to 8 years of age

9 to 17 years of age

From 6 months to 17 years of age

Reporting of side effects

If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

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 package after the abbreviation EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 ° C - 8 ° C). Do not freeze. Store the syringe in the outer case to protect it from light.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to dispose of the medicine you no longer use. This will help protect the environment.

What Vaxigrip contains

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

A / California / 7/2009 (H1N1) pdm 09 - equivalent strain (A / California / 7/2009, NYMC X-179A). …… 15 micrograms HA **

A / Switzerland / 9715293/2013 (H3N2) - equivalent strain (A / South Australia / 55/2014, IVR-175) ……. 15 micrograms HA **

B / Phuket / 3073/2013 ……… ... 15 micrograms HA **

For a 0.5 ml dose.

* grown in fertilized chicken eggs from healthy chicken farms

** hemagglutinin

The composition of this vaccine complies with the recommendations of the WHO (World Health Organization) (Northern hemisphere) and the decisions of the E.U. adopted for the 2015/2016 season.

The other ingredients are: a buffer solution containing sodium chloride, sodium phosphate dihydrate, potassium dihydrogen phosphate, potassium chloride, water for injections.

What Vaxigrip looks like and contents of the pack

Vaxigrip is a suspension for injection that comes in a 0.5 ml pre-filled syringe in packs of 1, 10, 20 or 50 units. Not all pack sizes may be marketed.

The vaccine, after being gently shaken, appears as a slightly whitish and opalescent liquid.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Vaxigrip can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on the ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical data of 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 HOLDER OF THE ALL AUTHORIZATION "PLACING ON MARKETING 08.0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF PR IMA AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

VAXIGRIP SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Influenza virus (inactivated "split") of the following strains *:

• A / California / 7/2009 (H1N1) pdm 09 - equivalent strain (A / California / 7/2009, NYMC X-179A) .................... .......................................... 15 mcg HA **

• A / Switzerland / 9715293/2013 (H3N2) - equivalent strain (A / South Australia / 55/2014, IVR-175) ...................... .......................................... 15 mcg HA **

• B / Phuket / 3073/2013 .......................................... ........ 15 mcg HA **

for a 0.5 ml dose

* grown in fertilized chicken eggs from healthy chicken farms

** hemagglutinin

This vaccine complies with the recommendations of the World Health Organization (for the northern hemisphere) and the decisions of the European Union for the 2015/2016 season.

For the full list of excipients, see Section 6.1.

VAXIGRIP may contain traces of eggs, such as ovalbumin, and of neomycin, formaldehyde and 9-octoxinol, which are components used during the manufacturing process (see Section 4.3).

03.0 PHARMACEUTICAL FORM

Suspension for injection in pre-filled syringe.

The vaccine, after being gently shaken, appears as a slightly whitish and opalescent liquid.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Flu prophylaxis.

VAXIGRIP is indicated in adults and children from 6 months of age.

VAXIGRIP must be used in accordance with official recommendations.


04.2 Posology and method of administration

Dosage

Adults: 0.5 ml.

Pediatric population

Children over 36 months: 0.5 ml.

Children aged 6 to 35 months: 0.25 ml. Clinical data are limited. See Section 6.6 for more information on administering the 0.25 mL dose.

If required by national recommendations, a 0.5 ml dose can be administered.

Children under the age of 9 who have not previously been vaccinated should be given a second dose after an interval of at least 4 weeks.

Children less than 6 months: The safety and efficacy of VAXIGRIP in children less than 6 months of age have not been established. There are no data available.

Method of administration

Immunization should be done by deep intramuscular or subcutaneous injection.

For adults and children over 36 months of age: the recommended site for intramuscular injection is the deltoid muscle.

For infants 12 to 35 months of age: The recommended site for intramuscular injection is the anterolateral area of ​​the thigh (or the deltoid muscle if muscle mass is sufficient).

For infants 6 to 11 months of age: The recommended site for intramuscular injection is the anterolateral area of ​​the thigh.

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.


04.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients listed in Section 6.1 or to any component that may be present in trace amounts such as eggs (ovalbumin, chicken protein), neomycin, formaldehyde and 9-octoxinol.

Vaccination should be postponed in case of moderate, acute or severe febrile illness.


04.4 Special warnings and appropriate precautions for use

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in the event of an anaphylactic reaction following the administration of the vaccine.

VAXIGRIP should under no circumstances be administered intravascularly.

As with all intramuscularly administered vaccines, the vaccine should be administered with caution to individuals with thrombocytopenia or a bleeding disorder, as bleeding may occur in these individuals following intramuscular administration.

As with any other vaccine, vaccination with VAXIGRIP may not protect 100% of susceptible individuals.

The antibody response may be insufficient in patients with endogenous or iatrogenic immunosuppression.

Interference with serological tests

See Section 4.5.


04.5 Interactions with other medicinal products and other forms of interaction

VAXIGRIP can be given at the same time as other vaccines. Immunization must be performed in different limbs. It must be considered that concomitant administration may intensify adverse reactions.

The immunological response may be reduced if the patient is being treated with immunosuppressive drugs.

Following influenza vaccination, false positive results have been observed in serological tests to identify antibodies to HIV1, Hepatitis C and, above all, HTLV1, when conducted with the ELISA method. The Western Blot technique allows to refute the False Positive ELISA Results These transient false positive reactions may be due to the IgM response to the vaccine.


04.6 Pregnancy and breastfeeding

Pregnancy

Inactivated influenza vaccines can be used at all stages of pregnancy. More extensive security datasets are available for the second and third quarters rather than the first; however, data from the worldwide use of inactivated influenza vaccines do not indicate any adverse fetal and maternal adverse events attributable to the vaccine.

Feeding time

VAXIGRIP can be used during breastfeeding.

Fertility

No fertility data are available.


04.7 Effects on ability to drive and use machines

VAXIGRIP has no or negligible influence on the ability to drive and use machines.


04.8 Undesirable effects

to. Summary of the safety profile

In recent clinical studies, approximately 10,000 subjects from 6 months of age have received VAXIGRIP.

Based on the immunization history and age of the children, the dosage and number of doses were different (see Pediatric population in subsection b. Table of adverse reactions).

Solicited reactions typically occurred within the first 3 days of VAXIGRIP administration, resolved spontaneously within 1 to 3 days of onset. Most solicited adverse reactions were mild to moderate in intensity.

The solicited adverse reaction most frequently reported within 7 days of VAXIGRIP injection was injection site pain in the entire population except in infants 6 to 35 months, where irritability was more frequently reported.

The solicited systemic adverse reaction most frequently reported within 7 days after VAXIGRIP injection was headache in adults, elderly and children 9 to 17 years of age and malaise in children 3 to 8 years of age.

Adverse reactions solicited were generally less frequent in the elderly than in adults.

b. Table of adverse reactions

The data below summarize the frequencies of adverse reactions recorded following vaccination with VAXIGRIP during clinical trials and during post-marketing experience worldwide.

Adverse events are ranked by frequency using the following convention:

Very common (≥1 / 10);

Common (≥1 / 100,

Uncommon (≥1 / 1,000 y

Rare (≥1 / 10,000 y

Very rare (

Not known (cannot be estimated from the available data).

Adults and the elderly

The safety profile below is based on data from more than 4,300 adults and 5,000 elderly people over 60 years of age.

ADVERSE REACTIONS FREQUENCY Disorders of the blood and lymphatic system Lymphadenopathy Uncommon Transient thrombocytopenia Not known Disorders of the immune system Allergic reactions such as: face edema, urticaria, pruritus, generalized itching, erythema, generalized erythema, rash Rare Severe allergic reactions such as dyspnoea, angioedema, shock Not known Nervous system disorders Headache Very common Vertigo, sleepiness Uncommon Hypoesthesia, paraesthesia, neuralgia, brachial radiculitis Rare Convulsions, neurological disorders, such as encephalomyelitis, neuritis, Guillain Barré syndrome Not known Vascular pathologies Vasculitis such as Schonlein-Henoch purpura, in some cases with transient renal involvement Not known Gastrointestinal disorders Diarrhea, nausea Uncommon Skin and subcutaneous tissue disorders Increased sweating common Musculoskeletal and connective tissue disorders Myalgia Very common Arthralgia common General disorders and administration site conditions Injection site pain / tenderness, injection site erythema / redness, injection site edema / swelling, injection site induration, feeling unwell, asthenia, injection site itching Very common Fever, chills / stiffness, bruising / bruising at the injection site common Flu-like syndrome, injection site warmth, injection site discomfort Uncommon

Rare in the elderly

Reported in adults during clinical trials

Reported in the elderly during clinical trials

Common in the elderly

Not known in adults

Not known in Senior citizens

b. Pediatric population

Depending on the immunization history, children 6 months to 8 years of age received one or two doses of VAXIGRIP. Children from 6 to 35 months of age received the 0.25 ml formulation, children from 3 years of age received the 0.5 ml formulation.

• Children / adolescents from 3 to 17 years of age:

The safety profile below is based on data obtained in more than 300 children aged 3 to 8 years and approximately 70 children / adolescents aged 9 to 17 years.

In children 3 to 8 years of age, the solicited adverse reactions most frequently reported within 7 days of VAXIGRIP injection were pain / tenderness at the injection site (56.3%), feeling sick (27.3%) , myalgia (25.5%) and erythema / redness at the injection site (23.4%).

In children / adolescents 9 to 17 years of age, the solicited adverse reactions most frequently reported within 7 days after VAXIGRIP injection were pain / tenderness at the injection site (54.5% to 70.6%), headache (22.4% to 23.6%), myalgia (12.7% to 17.6%) and injection site erythema / redness (5.5% to 17.6%).

The data below summarize the frequencies of adverse reactions recorded in children / adolescents 3 to 17 years of age after vaccination with VAXIGRIP during clinical trials and during post-marketing experience worldwide.

ADVERSE REACTIONS FREQUENCY Disorders of the blood and lymphatic system Lymphadenopathy Uncommon Transient thrombocytopenia Not known Disorders of the immune system Urticaria Uncommon Allergic reactions such as itching, erythematous rash, dyspnoea, angioedema, shock Not known Nervous system disorders Headache Very common Dizziness common Neuralgia, paraesthesia, seizures, neurological disorders, such as encephalomyelitis, neuritis, and Guillain Barré syndrome Not known Vascular pathologies Vasculitis such as Schonlein-Henoch purpura, in some cases with transient renal involvement Not known Gastrointestinal disorders Diarrhea Uncommon Musculoskeletal and connective tissue disorders Myalgia Very common General disorders and administration site conditions Injection site pain / tenderness, injection site erythema / redness, injection site edema / swelling, injection site induration, feeling sick Very common Fever, chills / stiffness, injection site bruising / bruising, injection site discomfort, injection site itching common Heat at the injection site, bleeding at the injection site Uncommon

Reported during clinical trials in children 3 to 8 years of age

Reported in clinical trials in children / adolescents 9 to 17 years of age

Common in children / adolescents 9 to 17 years of age

Very common in children / adolescents from 9 to 17 years of age

Not known in children / adolescents 9 to 17 years of age

• Children from 6 to 35 months of age:

The safety profile reported below is based on data obtained in approximately 50 children aged 6 to 35 months.

In a clinical study, the most frequently reported stressed adverse reactions within 3 days after VAXIGRIP injection were injection site pain (23.5%), irritability (23.5%), fever (20.6%) and unusual crying (20.6%).

In another study, the solicited adverse reactions most frequently reported within 7 days after VAXIGRIP injection were irritability (60%), fever (50%), decreased appetite (35%) and unusual crying (30%). ).

The data below summarize the frequencies of adverse reactions recorded in infants 6 to 35 months of age within 3 or 7 days after the administration of one or two 0.25 ml doses of VAXIGRIP, during these two clinical studies and during the post-marketing experience worldwide:

ADVERSE REACTIONS FREQUENCY Disorders of the blood and lymphatic system Transient thrombocytopenia, lymphadenopathy Not known Disorders of the immune system Urticaria Not known Allergic reactions such as itching, erythematous rash, dyspnoea, angioedema, shock Not known Pathologies of metabolism and nutrition Decreased appetite, anorexia Very common Psychiatric disorders Unusual crying, irritability Very common Insomnia common Nervous system disorders Drowsiness Very common Paresthesia, convulsions, neurological disorders such as encephalomyelitis Not known Vascular pathologies Vasculitis such as Schonlein-Henoch purpura, in some cases with transient renal involvement Not known Gastrointestinal disorders Diarrhea Very common He retched common General disorders and administration site conditions Injection site pain / tenderness, injection site erythema / redness, injection site edema / swelling, injection site induration, fever Very common Itching at the injection site, bruising at the injection site common

Report within 3 days after VAXIGRIP injection

c. Other special populations

Although only a limited number of subjects with co-morbidities were enrolled, studies conducted on patients who have undergone a kidney transplant, asthmatic patients, or children from 6 months to 3 years of age with diseases that put them at a particularly high risk of developing severe influenza-related complications, did not show large differences in terms of the safety profile of VAXIGRIP in these populations.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous 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. "address http://www.agenziafarmaco.gov.it/it/responsabili.


04.9 Overdose

There have been reports of administration above the recommended dose (overdose) with VAXIGRIP. When adverse reactions were reported, the information was consistent with the known safety profile of VAXIGRIP described in section 4.8.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: Influenza vaccine

ATC code: J07BB02

An antibody immune response is usually induced within 2-3 weeks. The duration of induced post-vaccination immunity is variable but is generally between 6 and 12 months.


05.2 "Pharmacokinetic properties

Not applicable.


05.3 Preclinical safety data

Not applicable.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Buffer solution:

sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, water for injections.


06.2 Incompatibility

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


06.3 Period of validity

1 years.


06.4 Special precautions for storage

Store in a refrigerator (2 ° C - 8 ° C). Do not freeze. Store the syringe in the outer case to protect it from light.


06.5 Nature of the immediate packaging and contents of the package

0.5 ml suspension in pre-filled syringe (type I glass) with pre-welded needle, with plunger seal (chlorobromobutyl or chlorobutyl or bromobutyl elastomer) - pack sizes of 1, 10, 20 or 50.

0.5 ml suspension in pre-filled syringe (type I glass) without needle, with plunger seal (chlorobromobutyl or chlorobutyl or bromobutyl elastomer) - pack sizes of 1, 10, 20 or 50.

Not all pack sizes may be marketed.


06.6 Instructions for use and handling

The vaccine must be brought to room temperature before use.

Shake before use. Visually inspect prior to administration.

The vaccine should not be used if foreign particles are observed in the suspension.

Instructions for administration of 0.25 ml in children from 6 to 35 months of age

When a dose of 0.25 ml is indicated, in order to eliminate half the volume of the syringe from

0.5ml, hold the syringe upright and push the plunger seal until you reach the black thin line printed on the syringe. Inject the remaining 0.25 ml volume. See also Section 4.2.

Unused medicine or waste derived from this medicine must be disposed of in accordance with local regulations.

07.0 MARKETING AUTHORIZATION HOLDER

Sanofi Pasteur MSD Snc

162 avenue Jean Jaurès 69007

Lyon (France)

08.0 MARKETING AUTHORIZATION NUMBER

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 20 PRE-FILLED SYRINGES OF 0.5 ML WITH NEEDLE - AIC N. 026032286

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 1 PRE-FILLED SYRINGE OF 0.5 ML WITH NEEDLE - AIC n. 026032209

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 1 PRE-FILLED SYRINGE OF 0.5 ML WITH NEW CAP - AIC n. 026032375

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 1 PRE-FILLED SYRINGE OF 0.5 ML WITHOUT NEEDLE - AIC n. 026032300

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 10 PRE-FILLED SYRINGES OF 0.5 ML WITH NEEDLE - AIC n. 026032274

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 10 PRE-FILLED SYRINGES OF 0.5 ML WITH NEW CAP - AIC N. 026032387

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 10 PRE-FILLED SYRINGES OF 0.5 ML WITHOUT NEEDLE - AIC N. 026032312

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 20 PRE-FILLED SYRINGES OF 0.5 ML WITH NEW CAP - AIC N. 026032399

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 20 PRE-FILLED SYRINGES OF 0.5 ML WITHOUT NEEDLE - AIC N. 026032324

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 50 PRE-FILLED SYRINGES OF 0.5 ML WITH NEEDLE - AIC N. 026032298

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 50 PRE-FILLED SYRINGES OF 0.5 ML WITH NEW CAP - AIC N. 026032401

"INJECTABLE SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS USE" 50 PRE-FILLED SYRINGES OF 0.5 ML WITHOUT NEEDLE - AIC N. 026032336

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

July 1998 / June 2009

10.0 DATE OF REVISION OF THE TEXT

October 2015

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

none:  health fetal-health vaccination