VARIVAX® powder and solvent for suspension for injection in a pre-filled syringe

Varicella Vaccine (live)

VARIVAX is a vaccine to help protect adults and children against chickenpox (varicella). Vaccines are used to protect you or your child against infectious diseases.

VARIVAX can be administered to persons 12 months of age or older.

VARIVAX may also be administered to infants from 9 months of age under special circumstances, such as to conform with national vaccination schedules or in outbreak situations.

It may also be given to persons who have no history of chickenpox, but who have been exposed to someone who has chickenpox.

Vaccination within 3 days of exposure may help prevent chickenpox or reduce the severity of disease, resulting in fewer skin lesions and shorter duration of illness. In addition, there is limited information that being vaccinated up to 5 days after exposure may reduce disease severity.

As with other vaccines, VARIVAX does not completely protect all individuals from naturally acquired chickenpox.

VARIVAX will be administered by your doctor or health care professional.

VARIVAX is given by injection as follows:

• Infants from 9 months to 12 months of age:
  Under special circumstances (to conform with national vaccination schedules or in outbreaks of chickenpox), VARIVAX may be administered between 9 and 12 months of age. To ensure optimal protection against chickenpox, two doses of VARIVAX are needed and should be given at least three months apart.
• Children from 12 months to 12 years of age:
  To ensure optimal protection against chickenpox, two doses of VARIVAX should be given at least one month apart.
• Children from 12 months to 12 years of age with asymptomatic HIV:
  VARIVAX should be given as two doses by injection 12 weeks apart. Please ask your healthcare provider for more information.
• Teenagers 13 years of age and older and adults:
  VARIVAX is given as two doses by injection. The second dose should be given 4 to 8 weeks after the first dose.

The number and timing of doses should be determined by your doctor, using the official recommendations.

VARIVAX should not be given to children under 9 months of age.

VARIVAX should be injected into the muscle or under the skin either in the area of the outer thigh or of the upper arm. Usually for injections into the muscle, the thigh area is preferred in young children, whereas for older individuals, the upper arm area is the preferred injection site.

If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be given under the skin.

Your doctor or health care professional will take care that VARIVAX is not injected into the bloodstream.

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

Very rarely (reported in less than 1 in 10,000 people), a severe allergic reaction may occur with symptoms that may include facial swelling, low blood pressure, and difficulty breathing, with or without rash. These reactions often occur very soon after the injection. If any of these symptoms or other serious symptoms are noticed after vaccination, you must seek immediate medical attention.

Tell your doctor if you notice any of the following rare or very rare side effects:

• bruising or bleeding more easily than normal; red or purple, flat, pinhead spots under the skin, severe paleness
• severe skin rash (ulcers and blistering that may involve the eyes, mouth, and/or genitals; red, often itchy spots which start 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, feeling sick, vomiting, headache, stiff neck and sensitivity to light (meningitis)
• stroke
• seizures (fits) with or without a fever

The following side effects have been observed:

Very common reactions (reported by more than 1 out of 10 people) were:

• fever
• injection site redness of the skin, pain/sensitivity to touch/soreness, and swelling

Common reactions (reported by less than 1 out of 10 but more than 1 out of 100 people) were:

• upper respiratory tract infection (nose, throat, airway)
• irritability
• rash, rash with flat, red skin and small confluent bumps, varicella-like rash
• injection site rash, itching at the injection site

Uncommon reactions (reported by less than 1 out of 100 but more than 1 out of 1,000 people) were:

• headache, drowsiness
• discharge and itching of the eyes with crusting of eyelids (conjunctivitis)
• cough, nasal congestion, chest congestion, runny nose, loss of appetite
• upset stomach with vomiting, cramps, diarrhoea caused by a virus
• diarrhoea, vomiting (gastroenteritis)
• ear infection, sore throat
• crying, inability to sleep, sleep disorders
• varicella skin rash caused by virus (chicken pox), illness caused by a virus, inflammation of the skin, redness of the skin, hives
• weakness/fatigue, generally feeling unwell, injection site reactions including numbness, bleeding, bruising, hardened raised area of the skin, warm feeling, warm to touch

Rare reactions (reported by less than 1 out of 1,000 people but more than 1 out of 10,000 people) were:

• swollen glands, bruising or bleeding more easily than normal
• agitation, sleeping too much, difficulty walking, seizures with a fever, shaking
• swelling of eyelid, irritation of eye
• ear pain
• feeling of fullness in the nose sometimes with throbbing ache and facial pressure or pain (sinusitis), sneezing, congestion in the lung, runny nose (rhinitis), wheezing, swelling of the tubes relating to the lungs (bronchitis), lung infection, severe lung infection with fever, chills, cough, congestion and shortness of breath (pneumonia)
• flu-like illness
• stomach pain, upset stomach and feeling sick, blood in the stool, mouth ulcer
• flushing, blisters, skin disorders (including bruising, and hives)
• muscle/bone pain, aching muscles, stiffness
• injection site reactions including changes in skin colour and hive-like rash

Side effects that have been reported during marketed use of VARIVAX include:

• illnesses affecting the nervous system (brain and/or spinal cord) such as sagging facial muscles and drooping eyelid on one side of the face (Bell's palsy), walking unsteadily, dizziness, tingling or numbness of the hands and feet, inflammation of the brain (encephalitis), inflammation of the coverings of the brain and spinal cord not caused by bacterial infection (aseptic meningitis), fainting
• shingles, sore throat (pharyngitis), purple or red-brown spots visible through the skin (Henoch-Schönlein purpura), secondary bacterial infections of the skin and soft tissues (including cellulitis), chickenpox (varicella), aplastic anaemia, which may include bruising or bleeding more easily than normal; red or purple, flat, pinhead spots under the skin; severe paleness

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiry date which is stated on the box after EXP.

The expiry date refers to the last day of that month.

Store and transport refrigerated (2 °C – 8 °C). Do not freeze. Keep the vial in the outer carton in order to protect from light.

After reconstitution, the vaccine should be used immediately. However, the in-use stability has been demonstrated for 30 minutes between +20 °C and +25 °C.

Do not throw away any vaccines via wastewater or household waste. Ask your pharmacist how to throw away vaccines you no longer use. These measures will help to protect the environment.

This medicine is authorised in the Member States of the European Economic Area, in the United Kingdom (Northern Ireland) and Great Britain under the following names:

VARIVAX

België/Belgique/Belgien; България; Česká republika; Danmark; Deutschland; Eesti; Ελλάδα; España; France; Hrvatska; Ireland; Ísland; Italia; Kύπρος; Latvija; Lietuva; Luxembourg/Luxemburg; Magyarország; Malta; Norge; Österreich; Polska; Portugal; România; Slovenija; Slovenská republika; Suomi/Finland; Sverige; United Kingdom (Northern Ireland), Great Britain

PROVARIVAX

Nederland