VARIVAX powder and solvent for injectable suspension in pre-filled syringe

2. What you need to know before you or your child receive VARIVAX

Do not use VARIVAX if:

• you or your child are allergic to any varicella vaccine, or to any of the other components of this vaccine (listed in section 6) or neomycin (which may be present as a residual in trace amounts).
• you or your child have a blood disorder or any type of cancer, including leukemia and lymphomas that affect the immune system.
• you or your child are receiving immunosuppressive therapy (including high-dose corticosteroids).
• you or your child have a disease (such as Human Immunodeficiency Virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS)) or are taking any medication that may weaken the immune system. Whether you or your child receive the vaccine will depend on the level of your immune system.
• you or your child have a family member who was born with immunodeficiency, or there is a family history of immunodeficiency.
• you or your child have active untreated tuberculosis.
• you or your child have a fever >38.5°C; however, a lower fever is not a reason in itself not to be vaccinated.
• you are pregnant. Additionally, pregnancy should be avoided for 1 month after vaccination.

Warnings and precautions:

In rare circumstances, it is possible to contract chickenpox, including severe chickenpox, from someone who has been vaccinated with VARIVAX. This can occur in people who have not been previously vaccinated or who have not had chickenpox, as well as in people who are in one of the following categories:

• individuals with a weakened immune system.
• pregnant women who have not had chickenpox.
• newborns whose mothers have not had chickenpox.

Whenever possible, people who have been vaccinated with VARIVAX should try to avoid close contact, until 6 weeks after vaccination, with anyone who is in one of the above categories. Inform your doctor if someone is in one of the above categories and is expected to be in close contact with the person being vaccinated.

Consult your doctor or pharmacist before you or your child are vaccinated with VARIVAX:

• if you or your child have a weakened immune system (e.g. HIV infection). You or your child should be closely monitored as the response to vaccination may not be sufficient to ensure protection against the disease (see section 2 "Do not use VARIVAX if")

Use of VARIVAX with other medicines (or other vaccines):

Tell your doctor or pharmacist if you or your child are using or have recently used any other medicines (or other vaccines).

If any vaccine is to be given at the same time as VARIVAX, your doctor or healthcare professional will advise whether it can be given or not. VARIVAX can be given at the same time as the following routine childhood vaccinations: measles, mumps, and rubella (MMR) vaccine, Haemophilus influenzae type b vaccine, hepatitis B vaccine, diphtheria, tetanus, pertussis (whooping cough) vaccine, and oral polio vaccine.

VARIVAX can be given with a pneumococcal conjugate vaccine at the same time in different injection sites.

Vaccination should be delayed for at least 5 months after blood or plasma transfusions or the administration of human normal immunoglobulin (a sterile solution of antibodies produced naturally from human blood from donors) or varicella-zoster immunoglobulin (VZIG).

After vaccination with VARIVAX, you or your child should not receive any immunoglobulin, including VZIG, for 1 month, unless your doctor decides it is necessary.

Recipients of the vaccine should avoid products containing aspirin (salicylates) for 6 weeks after vaccination with VARIVAX, as it may cause a serious disease called Reye's syndrome that can affect all organs of the body.

Pregnancy and breastfeeding

VARIVAX should not be given to pregnant women.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given the vaccine. It is also important that you do not become pregnant for 1 month after vaccination. During this time, you should use an effective method of contraception to prevent pregnancy.

Tell your doctor if you are breastfeeding or think you may be breastfeeding. Your doctor will decide whether you should receive VARIVAX.

Driving and using machines

There is no information to suggest that VARIVAX may affect your ability to drive or use machines.

VARIVAX contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

VARIVAX contains potassium

This medicine contains potassium, less than 1 mmol (39 mg) per dose; this is essentially "potassium-free".

3. How to administer VARIVAX

VARIVAX should be administered by your doctor or healthcare professional.

VARIVAX should be administered by injection as follows:

• Babies from 9 to 12 months of age:

In special circumstances (to comply with national vaccination schedules or in outbreak situations), VARIVAX can be given between 9 and 12 months of age. To ensure optimal protection against chickenpox, two doses of VARIVAX are needed, which should be given at least 3 months apart.

• Children from 12 months to 12 years of age:

To ensure optimal protection against chickenpox, two doses of VARIVAX should be given with a minimum interval of 1 month.

• Children from 12 months to 12 years of age with asymptomatic HIV:

VARIVAX should be given in two doses by injection with an interval of 12 weeks. Ask your doctor for more information.

• Adolescents from 13 years of age and adults:

VARIVAX is given in two doses by injection. The second dose should be given 4 to 8 weeks after the first dose.

The number of doses and the time they are given will be determined by your doctor based on 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 outer part of the thigh or in the upper arm. Usually, for muscle injections, the thigh is preferred in young children, while the upper arm is preferred in older individuals.

If you have a blood clotting disorder or low platelet count, the injection will be given under the skin.

Your doctor or healthcare professional should ensure that VARIVAX is not injected into the bloodstream.

If you use more VARIVAX than you should

Overdose is very unlikely because the vaccine is presented in single-dose vials and is administered by a doctor or healthcare professional.

If you think you have missed a dose of VARIVAX

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

4. Possible side effects

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 individuals), a severe allergic reaction may occur, which can include facial swelling, low blood pressure, and difficulty breathing with or without a rash. These reactions usually occur soon after the injection. If you notice any of these symptoms or other serious symptoms after vaccination, seek medical attention immediately.

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

• bruising or bleeding more easily than normal; pinpoint red or purple spots under the skin; pale skin
• severe skin rash (ulcers and blisters that can affect the eyes, mouth, and/or genitals; red spots that often itch, starting on the extremities and sometimes on the face and 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, dizziness, vomiting, headache, stiff neck, and sensitivity to light (meningitis)
• stroke
• seizures with or without fever

The following side effects have been observed:

Very common reactions (reported in more than 1 in 10individuals):

• fever
• redness of the skin at the injection site, pain/tenderness/pain at the injection site, and swelling

Common reactions (reported in less than 1 in 10 but more than 1 in 100individuals):

• upper respiratory tract infection (nose, throat, and airways)
• irritability
• rash, flat red spots on the skin, and small bumps that merge
• rash at the injection site, itching at the injection site

Uncommon reactions (reported in less than 1 in 100 but more than 1 in 1,000individuals):

• headache, drowsiness
• discharge and itching in the eyes with crusts on the eyelids (conjunctivitis)
• cough, nasal congestion, chest congestion, runny nose, loss of appetite
• stomach pain with vomiting, cramps, diarrhea caused by a virus
• diarrhea, vomiting (gastroenteritis)
• ear infection, sore throat
• crying, inability to sleep, sleep disturbances
• chickenpox-like rash caused by a virus (chickenpox), viral disease, skin inflammation, redness of the skin, hives
• weakness/fatigue, general feeling of being unwell, reaction at the injection site including numbness, bleeding, bruising, hardening of a small area of skin, feeling of heat, warmth to the touch

Rare reactions (reported in less than 1 in 1,000 but more than 1 in 10,000individuals):

• swollen glands, bruising or bleeding more easily than normal
• agitation, increased sleepiness, gait disturbances, febrile seizures, tremors
• swollen eyelids, eye irritation
• ear pain
• nasal congestion sometimes with sharp pain and facial pressure or pain (sinusitis), sneezing, chest congestion, runny nose (rhinitis), wheezing, bronchial swelling (bronchitis), lung infection, severe lung infection with fever, chills, cough, congestion, and shortness of breath (pneumonia)
• flu-like illness
• stomach pain, stomach upset and feeling sick, blood in the stool, mouth ulcers
• flushing, blisters, skin disorders (including bruising and hives)
• musculoskeletal pain, muscle pain, stiffness
• reactions at the injection site including change in skin color and rash in the form of hives

Side effects that have been reported during the marketing of VARIVAX include:

• diseases affecting the nervous system (brain and/or spinal cord) such as facial weakness, eyelid drooping (Bell's palsy), gait disturbances, dizziness, tingling or numbness in hands and feet, brain inflammation (encephalitis), inflammation of the membranes covering the brain and spinal cord not caused by a bacterial infection (aseptic meningitis), fainting
• shingles, sore throat (pharyngitis), purple or reddish-brown spots visible along the skin (Henoch-Schönlein purpura), secondary bacterial infections of the skin and soft tissues (including cellulitis), chickenpox, aplastic anemia, which can include bruising or bleeding more easily than normal; pinpoint red or purple spots under the skin; pale skin

Reporting of side effects

If you experience 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 through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of VARIVAX

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date stated on the carton after EXP.

The expiry date is the last day of the month stated.

Store and transport refrigerated (between 2°C and 8°C). Do not freeze. Keep the vial in the outer packaging to protect it from light.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Composition of VARIVAX

The active ingredient is:live attenuated varicella virus (Oka/Merck strain) (produced in human diploid cells MRC-5).

Each 0.5 ml dose of the reconstituted vaccine contains: a minimum of 1,350 PFU (plaque-forming units) of varicella virus (Oka/Merck strain).

The other excipients are:

Powder:

Sucrose, hydrolyzed gelatin, urea, sodium chloride, monosodium L-glutamate, anhydrous disodium phosphate, potassium dihydrogen phosphate, and potassium chloride.

Residual component traces: neomycin

Solvent:

Water for injectable preparations.

Appearance of the product and container contents

Pharmaceutical form: powder and solvent for injectable suspension.

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 is presented as a pre-filled syringe of water for injectable preparations. The secondary packaging may also contain 2 separate needles.

Not all pack sizes may be marketed

Marketing authorization holder and manufacturer

Marketing authorization holder

Schering-Plough, S.A.

Josefa Valcárcel, 42

28027 Madrid, Spain

Phone: 91 3210600

Manufacturer

Merck Sharp & Dohme BV

Waaderweg 39

2031 BN Haarlem

Netherlands

Local representative:

Merck Sharp & Dohme of Spain, S.A.

Josefa Valcárcel, 42

28027 Madrid, Spain

Phone: 91 3210600

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

VARIVAX

Belgium; Bulgaria; Czech Republic; Denmark; Germany; Estonia; Greece; Spain; France; Croatia; Ireland; Iceland; Italy; Cyprus; Latvia; Lithuania; Luxembourg; Hungary; Malta; Norway; Austria; Poland; Portugal; Romania; Slovenia; Slovakia; Finland; Sweden

PROVARIVAX

Netherlands

Date of last revision of this leaflet:01/2025.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Instructions

Before reconstitution, the vial contains a white to off-white powder and the pre-filled syringe contains a clear, colorless liquid solvent. The reconstituted vaccine is a clear, colorless to pale yellow liquid.

Avoid contact with disinfectants.

To reconstitute the vaccine, use only the solvent provided in the pre-filled syringe.

It is essential to use a new sterile syringe and needle for each individual to prevent the transmission of infectious agents from one person to another.

A needle for reconstitution and a different needle for injection should be used.

Instructions for preparing the vaccine

To attach the needle, firmly place it on the end of the syringe and secure it with a twist.

Inject the entire contents of the pre-filled syringe into the vial containing the powder. Gently shake to mix thoroughly.

The reconstituted vaccine should be visually inspected for any foreign particles and/or variation in its physical appearance. The vaccine should not be used if any foreign particles are detected or if the appearance is not a clear, colorless to pale yellow liquid after reconstitution.

It is recommended that the vaccine be administered immediately after reconstitution to minimize loss of potency. Discard the reconstituted vaccine if not used within 30 minutes of preparation.

Do not freeze the reconstituted vaccine.

Withdraw the entire contents of the vial into a syringe, change the needle, and inject the vaccine subcutaneously or intramuscularly.

Disposal of unused medicinal products and all materials that have come into contact with them should be done in accordance with local regulations.

See also section 3 How to administer VARIVAX