VARIVAX POX VACCINE SYRINGE SYRINGE BT1

VARIVAX POX VACCINE SYRINGE BT1 View larger

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Pour connaître les mises en garde, les précautions d'emploi et les contre-indications, veuillez consulter la notice d'utilisation.

Description

VARIVAX Poudre et solvant pour suspension injectable Boîte de 1 Flacon de poudre + 2 aig. + seringue de solvant de 0.5 mL
Mis à jour le 16 janvier 2014

VARIVAX : ses indications

VARIVAX est indiqué chez les sujets à partir de 12 mois pour la prévention de la varicelle (voir rubriques Posologie et mode d'administration et Propriétés pharmacodynamiques).

VARIVAX peut être administré aux nourrissons à partir de l'âge de 9 mois dans certaines circonstances telles que conformément au calendrier vaccinal national ou lors de situations épidémiques (voir rubriques Posologie et mode d'administration, Interactions avec d'autres médicaments et autres formes d'interactions et Propriétés pharmacodynamiques).

VARIVAX peut aussi être administré aux sujets "réceptifs" exposés à la varicelle. Une vaccination dans les 3 jours suivant l'exposition peut prévenir une infection clinique ou modifier son développement. De plus, il existe des données limitées indiquant que la vaccination jusqu'à 5 jours après l'exposition pourrait modifier le développement de l'infection (voir rubrique Propriétés pharmacodynamiques).

Classe thérapeutique  Infectiologie - Parasitologie
Principes actifs  Virus de la varicelle
Excipients  Poudre : Saccharose,  Gélatine,  Urée,  Sodium chlorure,  L-glutamate monosodique (E621),  Phosphate disodique,  Phosphate monopotassique,  Potassium chlorure (E508),  Solvant : Eau pour préparations injectables,  Résidus du procédé de fabrication : Gélatine,  Néomycine,  Sérum de veau foetal
Statut  Ce médicament est NON SOUMIS A PRESCRIPTION MEDICALE
Prix de vente TTC  41,24 €
Tx de remboursement SS  65 %
Laboratoire  Sanofi Pasteur Msd

VARIVAX : sa posologie

Posologie

VARIVAX doit être utilisé sur la base des recommandations officielles

·         Sujets de moins de 9 mois

VARIVAX ne doit pas être administré aux sujets de moins de 9 mois.

·         Sujets de 9 mois et plus

Les sujets doivent recevoir 2 doses de VARIVAX pour assurer une protection optimale contre la varicelle (voir rubrique Propriétés pharmacodynamiques).

·         Sujets entre 9 mois et 12 mois

Dans le cas où la vaccination est initiée entre 9 mois et 12 mois, une seconde dose est nécessaire et doit être administrée après un intervalle minimum de 3 mois (voir rubrique Propriétés pharmacodynamiques).

·         Sujets de 12 mois à 12 ans

Pour les sujets de 12 mois à 12 ans, un intervalle d'au moins un mois doit être respecté entre la première et la deuxième dose (voir rubrique Propriétés pharmacodynamiques).

Note : Les recommandations officielles applicables peuvent varier pour ce qui concerne le besoin d'une ou deux doses et l'intervalle entre les doses de vaccins contenant la valence varicelle.

Les sujets âgés de 12 mois à 12 ans présentant une infection VIH asymptomatique [CDC classe 1] et ayant un pourcentage de lymphocytes T CD4+ ≥ 25 %, doivent recevoir deux doses administrées à un intervalle de 12 semaines.

·         Sujets de 13 ans et plus

Les sujets âgés de 13 ans et plus doivent recevoir deux doses administrées à un intervalle de 4 à 8 semaines. Si l'intervalle entre les doses excède 8 semaines, la deuxième dose doit être administrée le plus tôt possible (voir rubrique Propriétés pharmacodynamiques). Des données sur l'efficacité protectrice sont disponibles sur une période de 9 ans après la vaccination (voir rubrique Propriétés pharmacodynamiques). Cependant, la nécessité d'une dose de rappel n'a pas été établie.

Si VARIVAX doit être administré à des sujets séronégatifs vis-à-vis de la varicelle avant une période d'immunosuppression prévue ou possible (tels ceux en attente d'une transplantation d'organe et ceux en rémission d'une maladie maligne), le programme de vaccination devra tenir compte de l'intervalle après la deuxième dose pour que la protection maximale soit obtenue (voir rubriques Contre-indications, Mises en garde et précautions d'emploi et Propriétés pharmacodynamiques).

Il n'existe pas de donnée concernant l'efficacité ou la réponse immunitaire à VARIVAX chez les personnes séronégatives âgées de plus de 65 ans.

Mode d'administration

Le vaccin doit être injecté par voie intramusculaire (IM) ou par voie sous-cutanée (SC).

Le vaccin doit être injecté de préférence dans la région antérolatérale supérieure de la cuisse chez les enfants plus jeunes et dans la région deltoïdienne chez les enfants plus âgés, les adolescents et les adultes.

Le vaccin doit être administré par voie sous-cutanée chez les sujets présentant une thrombocytopénie ou tout trouble de la coagulation.

NE PAS INJECTER PAR VOIE INTRAVASCULAIRE.

Précautions à prendre avant manipulation ou administration du produit : Voir rubrique Instructions pour l'utilisation, la manipulation et l'élimination.

Conseils

Le virus présent dans ce vaccin est atténué mais vivant. Il peut, de façon exceptionnelle, être transmis à une personne non immunisée dans l'entourage d'une personne qui vient d'être vaccinée. En cas d'éruption de vésicules de type varicelleuse survenant après la vaccination, il est recommandé d'éviter tout contact avec des personnes immunodéprimées pendant 10 jours.

Pour garder son efficacité, ce médicament doit être conservé entre + 2 °C et + 8 °C (partie la plus froide du réfrigérateur). Toutefois, une rupture de la chaîne du froid pendant une durée limitée (quelques heures à température ambiante inférieure à 25 °C) ne devrait pas prêter à conséquence. En pratique, en cas de nécessité, un délai de quelques heures peut séparer l'achat du vaccin en pharmacie de son stockage au réfrigérateur ou de la vaccination.

Ce vaccin ne doit pas être congelé.
Effets indésirables possibles du médicament VARIVAX

Très fréquents (de 1 à 10 % des cas) : réaction douloureuse au point d'injection, fièvre modérée.

Fréquents (de 0,1 à 1 % des cas) : éruption cutanée, vésicules ressemblant à celles de la varicelle naturelle.

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Mises en garde sur les médicaments

Attention, le médicament n'est pas un produit comme les autres. Lire attentivement la notice du médicament avant de le commander. Ne laissez pas les médicaments à la portée des enfants. Si les symptômes persistent, demandez l'avis de votre médecin ou de votre pharmacien. Attention aux incompatibilités sur vos produits en cours.

Veuillez informer votre pharmacien en ligne des traitements en cours afin d'identifier d'éventuelles incompatibilités. Le formulaire de validation de commande contient un champ de message personnalisé prévu à cet effet.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance: Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

VIDAL OF THE FAMILY

VARIVAX

Chickenpox Vaccine

live varicella vaccine

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

VARIVAX: suspension for injection; Powder bottle and 0.5 ml solvent syringe with needle.
Refunded at 65%. - price: 39,93 euro (s).

Laboratory

COMPOSITION (summary)
p dose
Live attenuated varicella virus (Oka / Merck strain) > 1350 units

INDICATIONS (summary)
It is a vaccine composed of attenuated viruses : these are alive but weakened, and can not cause disease.
It is used in the prevention of varicella in adults and children over 12 months of age, in particular to reduce the risk of varicella complications in adults who have never had chickenpox (or a history of uncertain) within 3 days of exposure to the disease.
It can be given to infants from the age of 9 months under certain circumstances.
CONTRAINDICATIONS (summary)
This vaccine should not be used in the following cases:
WARNING (Contents)
In case of high fever, acute illness, it is preferable to defer vaccination.
Neomycin is used to make this vaccine. This substance persists in minute quantities in the injectable solution. Precautions are necessary in people who are allergic to it.
The febrile reactions due to this vaccine can be combated by taking paracetamol. Aspirin is not recommended for 6 weeks after injection. Indeed, rare cases of Reye's syndrome (vomiting, convulsions, liver damage), sometimes fatal, have been observed when using aspirin in children with chicken pox.
As with all vaccines , exceptional cases of severe allergic reactions have been reported; this risk justifies the need to carry out vaccination in a medical setting where emergency treatment can be undertaken without delay.
DRUG INTERACTIONS (summary)
This vaccine can be injected on the same day as other vaccines, but it should not be mixed with another injectable product in the same syringe.
The simultaneous injection of immunoglobulins may inactivate the viruses contained in the vaccine .
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
This vaccine is contraindicated during pregnancy. In addition, pregnancy should be avoided within one month of vaccine injection.

Breastfeeding:
This vaccination is not recommended during breastfeeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
The injection is carried out by way intramuscularly or subcutaneously in the thigh in infants and in the arm for the child and adult.

Usual dosage:

  • Infant from 9 to 12 months: 2 doses spaced at least 3 months.
  • Children 12 months to 12 years: 2 doses spaced at least 1 month.
  • Adult and child over 13 years: 2 doses spaced from 4 to 8 weeks.
TIPS (summary)
The virus present in this vaccine is attenuated but alive. It may exceptionally be transmitted to an unimmunized person in the entourage of a person who has just been vaccinated. In the event of an outbreak of varicella-like vesicles occurring after vaccination, it is recommended to avoid contact with immunocompromised persons for 10 days.
To maintain its effectiveness, this medication should be stored between + 2 ° C and + 8 ° C (the coldest part of the refrigerator). However, failure of the cold chain for a limited time (a few hours at room temperature below 25 ° C) should not be of any consequence. In practice, if necessary, a few hours can separate the purchase of the vaccine from pharmacy from its storage in the refrigerator or vaccination.
This vaccine should not be frozen.
POSSIBLE ADVERSE EFFECTS (summary)
Very common: painful reaction or swelling at the site of injection, moderate fever.
Common: rash , vesicles resembling those of natural varicella.
More rarely, especially in children under 12 years of age: ganglions, headache, drowsiness, agitation nervousness, apathy, abnormal dreams, tremors, conjunctivitis, ear pain, ear infections, coughs, colds, bronchitis, nausea , vomiting, abdominal pain, bloating, diarrhea, urticaria, joint or muscular pain, fatigue, malaise.


GLOSSARY (summary)


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


immune deficiency
Inability of the organization's defense systems to perform their duties; it is due to decreased white blood cells or antibodies (immunoglobulins). The most common causes of immune deficiency are genetic abnormalities, cancer treatments (chemotherapy or radiotherapy) and AIDS.


skin rash
Appearance of pimples or plaques on the skin. These lesions can be due to a food, a drug, and translate an allergy or a toxic effect. Many viruses can also cause pimple eruptions: rubella, roseola and measles are the most common.


immunoglobulins
An antibody secreted by certain white blood cells, intended to specifically neutralize a foreign substance or an infectious agent. Immunoglobulins of human origin are used as drugs; they are then purified and sterilized.
Synonym: gammaglobulins.


allergic reactions
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


Reye syndrome
Syndrome which results in vomiting and consciousness disorders of varying severity. It affects children, most often after an acute viral infection (chicken pox, flu, etc.). The use of aspirin in these diseases has been questioned, particularly in the United States and England.


immunosuppressive therapy
Treatment that decreases the immune reactions (reactions of defense of the organism against the foreign bodies). The decline in immunity is generally the objective of treatment: prevention of organ transplant rejection, treatment of autoimmune diseases. However, in some cases, the immunosuppressive effect is an undesired consequence of treatment: cancer chemotherapy, which is intended to destroy cancer cells, also affects normal blood cells and weakens patients with infections. This fragility justifies an increased medical supervision: regular blood sampling, need to report the occurrence of any fever.
Synonym: immunosuppressive therapy.


tuberculosis
Infectious disease due to the bacillus of Koch. It can affect all organs including lung, bone (Pott's disease), the urinary or genital tract, the eye.


vaccine
An injectable solution for immunizing the organism against a virus or bacterium.
There are several kinds of vaccines:
  • Live attenuated vaccines: the germ contained in the vaccine is alive but unable to cause the disease (BCG, measles, rubella, mumps, etc.).
  • Vaccines prepared from killed germs: the most immunizing parts of the virus or bacteria are used to prepare the vaccine (polio vaccines, hepatitis vaccines, etc.).
  • Vaccines containing neutralized (inactivated) toxins: in the case of tetanus, it is a toxin secreted by the germ that is responsible for the severity of the disease; the vaccine allows immunization against this toxin.


virus
A microscopic organism that penetrates the cells of the host, where it reproduces. Much smaller than bacteria, viruses are insensitive to antibiotics. They can sometimes be destroyed by antiviral substances.


way
  • Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • Set of hollow organs allowing the passage of air (airways), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 10/04/2017

Name of the medicinal product

VARIVAX, powder and solvent for suspension for injection

Living Varicella Vaccine

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

You should always use this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any of the side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or feel less well.

Do not use this medication for children.

What is in this leaflet?

1. What is VARIVAX, powder and solvent for injectable suspension and when is it used?

2. What should be known before using VARIVAX, powder and solvent for suspension for injection?

3. How to use VARIVAX, powder and solvent for suspension for injection?

4. What are the possible side effects?

5. How to store VARIVAX, powder and solvent for suspension for injection?

6. Package contents and other information.

1. WHAT VARIVAX, Powder and Solvent for Injectable Suspension AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group: viral vaccines - varicella virus, ATC code: J07BK01.

VARIVAX is a vaccine that protects against varicella from adults and children. Vaccines are used to protect you or your child against infectious diseases.

VARIVAX can be administered to people aged 12 months or older.

VARIVAX can be administered to infants from 9 months of age under certain circumstances, in accordance with the national immunization schedule or during epidemic situations.

It can also be given to people without a history of chicken pox, but who have been exposed to varicella.

Vaccination within 3 days of exposure may help prevent varicella or reduce its severity resulting in less skin lesions and shorter duration of the disease. In addition, there is limited data showing that vaccination within 5 days of exposure may reduce the severity of the disease.

Like any other vaccine, VARIVAX does not completely protect all individuals from naturally acquired varicella forms.

2. BEFORE YOU USE VARIVAX, powder and solvent for injectable suspension?

Never use VARIVAX:

· If you or your child are allergic to any of the varicella vaccines, any of the components of this vaccine (including gelatin or neomycin or any of the other ingredients mentioned in section 6).

· If you or your child have any blood disorders or any type of malignant cancer including leukemia and lymphomas that affect the immune system.

· If you or your child receive immunosuppressive therapy (including high doses of corticosteroids).

· If you or your child has a disease (such as human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)) or take drugs that weaken the immune system. Your vaccination or that of your child will depend on your immune defense level (s).

· If you or your child have a family member born with an immunodeficiency or if there is a family history of immunodeficiency.

· If you or your child have active untreated tuberculosis.

· If you or your child has a fever greater than 38.5 ° C; however, low-intensity fever does not in itself constitute a reason for not being vaccinated.

· If you are pregnant. In addition, pregnancy should be avoided during the month following vaccination.

Warnings and Precautions

The person who received VARIVAX should try to avoid having close contact with subjects who may be at high risk for up to 6 weeks after vaccination.

In the following cases, special precautions must be taken:

· If, after being vaccinated, you come into contact with someone in one of the following categories:

o subjects with a weakened immune system,

o pregnant women who have never had chicken pox,

o the newborns of mothers who had never had chicken pox.

These people may be at risk of catching chickenpox from people who have been vaccinated.

· If you regularly have close contact with people who might have a severe risk of chicken pox if they catch the vaccine strain coming from you.

Talk to your doctor or pharmacist before you or your child receives VARIVAX:

· If you or your child have a weakened immune system (eg HIV infection). You or your child should be closely monitored as the vaccine response may not be sufficient to provide protection against the disease (see section 2 "Never use VARIVAX").

Children and Youth

Not applicable.

Other drugs and VARIVAX

Inform your doctor or pharmacist if you or your child is taking or have recently taken any other medicines (or other vaccines).

If another vaccine is to be given at the same time as VARIVAX, your doctor will advise you whether or not you can receive it. VARIVAX may be administered at the same time as the following routine childhood immunizations: measles, mumps and rubella (MMR) vaccines, Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis and oral vaccine poliomyelitis.

Vaccination should be postponed for at least 5 months following a blood or plasma transfusion, administration of normal human immunoglobulins (a sterile solution of antibodies naturally extracted from a human blood donation) or immunoglobulins specific varicella (IgVZV).

After VIVIVAX, you or your child should not receive any immunoglobulin including IgVZV within one month of vaccination unless your doctor determines that it is necessary.

Vaccinated individuals should avoid the use of medicines containing aspirin (salicylates) within 6 weeks of vaccination with VARIVAX as this may cause a serious reaction called Reye's Syndrome that can affect all your organs.

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

VARIVAX with food, drink and alcohol

Not applicable.

Pregnancy and breast feeding

VARIVAX should not be given to pregnant women.

If you are pregnant, breast-feeding, thinking to be pregnant or planning a pregnancy, ask your doctor or pharmacist for advice before taking this vaccine. It is also important not to be pregnant within one month of vaccination. During this period, you must use an effective contraceptive method to avoid being pregnant.

Tell your doctor if you are breast-feeding or if you intend to breast-feed your baby. Your doctor will decide whether or not to vaccinate you with VARIVAX.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Driving and using machines

There is no information to establish that VARIVAX affects your ability to drive or use machines.

3. HOW TO USE VARIVAX, powder and solvent for suspension for injection?

VARIVAX is administered by injection as follows:

· Children from 9 months to 12 months:

In certain circumstances (according to national immunization schedule or varicella epidemics), VARIVAX can be administered between 9 and 12 months.

To ensure optimal protection against varicella, two doses of VARIVAX are required and should be administered with a minimum of 3 months interval.

· Children aged 12 months to 12 years:

To ensure optimal protection against varicella, two doses of VARIVAX should be administered at intervals of one month.

· Children aged 12 months to 12 years with asymptomatic HIV infection:

Two doses of VARIVAX should be administered at intervals of 12 weeks. Ask your doctor for more information.

· Teenagers aged 13 and over and adults:

Two doses of VARIVAX are administered. The second dose should be given 4 to 8 weeks after the first dose.

The number of doses and the dosage schedule should be determined by your doctor, based on official recommendations.

· VARIVAX should not be administered to a child less than 9 months of age.

VARIVAX should be injected into the muscle or under the skin in the outer side of the thigh or in the upper arm. In the muscle, the injection is preferentially made in the thigh in young children, whereas in the older subjects, it is preferably done in the upper part of the arm.

If you have a bleeding disorder or a low platelet count in your blood, the injection will be done subcutaneously.

Your doctor should be careful not to inject VARIVAX into the bloodstream.

If you used more VARIVAX than you should:

Overdoses are unlikely because the vaccine is supplied as a one-dose vial and is administered by a doctor or health care professional.

If you forget to use VARIVAX:

Contact your doctor who will decide if a new dose is needed and when to administer it.

If you stop using VARIVAX:

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this vaccine is likely to have undesirable effects, although not everyone is affected.

Very rarely (reported in less than 1 in 10,000 patients), a severe allergic reaction can occur including symptoms of swelling of the face, low blood pressure, and difficulty breathing, with or without rash. In general, these reactions occur very rapidly after injection.

If you notice any of these symptoms or other severe symptoms after vaccination, you should seek medical advice.

Tell your doctor if you notice any of the following rare or very rare adverse reactions:

· Bleeding or bleeding more frequent than normal; small red or purple spots, planes, the size of a pinhead under the skin; paleness.

· Severe skin rash (sores and bullous lesions localizing to the eyes, mouth, and / or genitals; red spots, which can itch beginning on the limbs and sometimes on the face and the rest of the body) Stevens-Johnson syndrome, erythema multiforme).

· Muscle weakness, abnormal sensations, tingling in the arms, legs and upper body (Guillain-Barré syndrome).

· Fever, nausea, vomiting, headache, neck stiffness and sensitivity to light (meningitis).

· Cerebral vascular accident.

· Convulsions with or without fever.

The following adverse reactions have been reported:

The most frequent reactions (reported in more than 1 in 10 patients) were:

· Fever.

· Injection site reactions: redness, pain / tenderness and swelling.

· Frequent reactions (reported by fewer than 1 in 10 patients but by more than 1 in 100 patients) were:

· High respiratory infections (nose, throat, airway).

· Irritability.

· Skin eruptions including measles / rubella / chickenpox eruptions.

· Skin rash at the injection site, itching at the injection site.

· Infrequent reactions (reported in less than 1 in 100 patients but in more than 1 in 1000 patients) were:

· Headache, drowsiness.

· Flow and itching at the level of the eyes with appearance of a crust in the eyelids (conjunctivitis).

· Cough, nasal congestion, congestion of the chest, runny nose, loss of appetite, flu.

· Digestive disorders with vomiting, cramps, diarrhea caused by a virus.

· Diarrhea, vomiting (gastroenteritis).

· Infection of the ear, sore throat.

· Crying, insomnia, trouble sleeping.

· Rash of the varicella type caused by the virus (varicella), disease caused by a virus, inflammation of the skin, diaper rash, redness of skin, rash with sweat or hot tingling, urticaria.

· Weakness / fatigue, injection site reactions including urticaria-like rash, numbness, bleeding, bluishness, skin hardening, heat sensation, heat to touch.

· Rare reactions (reported in less than 1 in 1000 patients but in more than 1 in 10,000 patients) were:

· Swelling of the lymph nodes, blues or unusual bleeding.

· Lack of emotion, nervousness, agitation, hypersomnia, abnormal dreams, emotional changes, difficulty walking, seizure with fever, trembling.

· Swelling of the eyelids, irritation of the eye.

· Pain in the ear.

· Nose bleeding, wheezing, bronchial inflammation (bronchitis), pulmonary infection, lung infection (nasal stenosis), nasal discharge (sneezing), sneezing (rhinitis) severe with fever, chills, cough, congestion and shortness of breath (pneumonia).

· White foci with sores in the mouth (fungal infection), flu-like syndrome, non-toxic bite / sting.

· Stomach pain, digestive disorders and nausea, flatulence, blood in the stool, canker sores

· Hot flushes, blisters, skin disorders and infections (including acne, blues, cold sores, eczema, urticaria, measles-like eruptions and sunburn).

· Muscle / bone pain, stiffness, hip, leg or neck pain, stiffness.

· Flow of blood or fluid from a blood vessel.

· Injection site reactions including change in skin color, traces of blows, roughness / dryness at the injection site, swelling of the lips.

The following adverse reactions have been reported during the commercialization of VARIVAX:

· Diseases of the nervous system (brain and / or spinal cord), muscle relaxation and drooping eyelid on one side of the face (Bell's paralysis), walking imbalance, dizziness, tingling or numbness in hands and feet.

· Shingles, sore throat (pharyngitis), violet or red-brown spots visible on the skin (Henoch-Schonlein purpura), secondary bacterial infections of the skin and soft tissues, including impetigo and cellulitis, varicella.

· Aplastic anemia, which may include blues or bleeding more frequent than normal; small red or purple spots, planes, the size of a pinhead under the skin; paleness.

· Nausea and vomiting.

Declaration of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE VARIVAX, powder and solvent for suspension for injection?

Keep this medicine out of the reach and sight 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 the month.

Store in a refrigerator (2 ° C - 8 ° C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What VARIVAX contains, powder and solvent for suspension for injection

· The active substance is:

live attenuated varicella virus (Oka / Merck strain) (product of human diploid cells MRC-5).

Each 0.5 ml dose of reconstituted vaccine contains a minimum of 1350 PFU (Varicella Virus (Oka / Merck strain).

· The other components are:

Powder : sucrose, hydrolyzed gelatin, urea, sodium chloride, monosodium L-glutamate, anhydrous disodium phosphate, monopotassium phosphate and potassium chloride.

Residual trace elements: neomycin.

Solvent: water for injections.

What is VARIVAX, powder and solvent for suspension for injection and contents of the pack

The vaccine consists of a white to off-white powder in a vial and a clear, colorless liquid solvent in a pre-filled syringe. The product is available in packs of 1 or 10 doses.

The solvent provided is a pre-filled syringe of water for injections with fixed or needle-free needle.

The secondary packaging of the needleless presentation may also contain 2 separate needles.

Not all pack sizes may be marketed.

Marketing Authorization Holder

MSD VACCINES

162 AVENUE JEAN JAURES

69007 LYON

Marketing Authorization Operator

MSD VACCINES

162 AVENUE JEAN JAURES

69007 LYON

Maker

MERCK SHARP & DOHME BV

WAARDERWEG 39, 2031 HAARLEM

PO BOX 581, 2003 PC HAARLEM

NETHERLANDS

Names of the medicinal product in the Member States of the European Economic Area

This medicinal product is authorized in the Member States of the European Economic Area under the following names: In accordance with the regulations in force.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

<{MM / YYYY}> <{YYYY month}.>

Other

Detailed information on this medicine is available on the ANSM website (France).

The following information is intended exclusively for healthcare professionals:

Instructions

Instructions for vaccine preparation

Parenteral injections should be visually inspected for particle presence and discoloration prior to administration.

The reconstituted vaccine should not be used if the presence of the particles is noted or if the appearance is not that of a clear, colorless to pale yellow liquid.

The vaccine should not be mixed with other medicines.

The powder of the vaccine must be reconstituted with the solvent provided.

If you are using presentations containing a pre-filled syringe of solvent without needle, packaged with 2 separate needles, one needle will be used for reconstitution and another needle for injection. The needle is fixed by turning it clockwise until it is securely attached to the syringe.

Inject the entire contents of the pre-filled syringe with water for injections into the vial containing the vaccine powder and shake gently to homogenize.

Take all the contents in the same syringe and inject the vaccine intramuscularly or subcutaneously.

Avoid contact with disinfectants during vaccine preparation.

When reconstituting the vaccine, it is recommended to use only the solvent provided in the pre-filled syringe as it does not contain preservatives or other antiviral substances that may inactivate the vaccine virus.

It is important to use separate sterile syringes and needles for each patient to prevent transmission of infectious agents from one subject to another.

The vaccine should be administered immediately after reconstitution to minimize loss of efficacy.

Discard the vaccine if it is not used within 30 minutes of its preparation.

Do not freeze the vaccine once reconstituted.

Travel Pharmacy Kit: Ready to go, here is a selection of pharmaceutical products to help you prepare your travel pharmacy kit:

- Dressings

- Bands

- Compresses

- Thermometers

- Pillbox

- Sun care

- Anti Mosquito

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