Prospecto: information for the user

VARIVAX powder and solvent for injectable suspensionin pre-filled syringe

varicella vaccine (live virus)

Read this prospectus carefully before you or your child are vaccinated, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This vaccine has been prescribed for you or your child and should not be given to other people.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospectus. See section4.

1.What VARIVAX is and for what it is used

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

3.How to administer VARIVAX

4.Possible adverse effects

5.Storage of VARIVAX

6. Contents of the package and additional information

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

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

VARIVAX can be administered to children 9 months of age under special circumstances, such as to meet national vaccination schedules or in the event of an epidemic outbreak.

It can also be administered to individuals without a history of chickenpox, but who have been exposed to someone with the disease.

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

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

Do not use VARIVAX if:

• You or your child is allergic to any varicella vaccine, or to any of the other components of this vaccine (listed in section6) or neomycin (which may be present as a residue in trace amounts).
• You or your child has any blood disorder or any type of malignant cancer, including leukemia and lymphomas that affect the immune system.
• You or your child is receiving immunosuppressive therapy (including high doses of corticosteroids).
• You or your childhas any disease (such as Human Immunodeficiency Virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS)) or is taking any medication thatmay weaken the immune system. Whether you or your child should receive the vaccine will depend on the level of your defenses.
• You or your child has a family member who was born with immunodeficiency, or there is a family history of immunodeficiency.
• You or your child presents active untreated tuberculosis.
• You or your child presents a fever >38.5°C;however, a fever below this level is not a reason in itself to not vaccinate.
• You are pregnant. Additionally, pregnancy should be avoided for 1month after vaccination.

Warnings and precautions:

In rare circumstances, it is possible to contract varicella, including severe varicella, from a person who has been vaccinated with VARIVAX.This can occur in individuals who have not been previously vaccinated or who have not had varicella, as well as in individuals who fall into one of the following categories:

Whenever possible, individuals who have been vaccinated with VARIVAX should attempt to avoid close contact, for at least 6weeks after vaccination, with anyone who falls into one of the above categories.Inform your doctor if someone falls into 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 is vaccinated with VARIVAX:

• if you or your child has a weakened immune system (e.g. HIV infection). You or your child should be closely monitored since the response to the vaccine may not be sufficient to ensure protection against the disease (see section2 “Do not use VARIVAX if”)

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

Inform your doctor or pharmacist if you or your child is using or has recently used other medications (or other vaccines).

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

VARIVAX can be administered with a conjugated pneumococcal vaccine, at the same time in different injection sites.

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

After vaccination with VARIVAX, you or your child should not receive any immunoglobulin, including IGVZ, during the following month, unless your doctor decides it is necessary.

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

Pregnancy and breastfeeding

VARIVAX should not be administered to pregnant women.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before the vaccine is administered. It is also important that you do not become pregnant during the month following vaccination. During this time, an effective contraceptive method should be used to avoid pregnancy.

Inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will decide whether you should receive VARIVAX.

Driving and operating machinery

There is no information to suggest that VARIVAX may affect your ability to drive or operate machinery.

VARIVAX contains sodium

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

VARIVAX contains potassium

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

VARIVAX should be administered by your doctor or healthcare professional.

VARIVAX should be administered by injection as detailed below:

• Babies from 9 to 12 months of age:

In special circumstances (to meet national vaccination schedules or in situations of varicella epidemic outbreaks), VARIVAX can be administered between 9 and 12 months of age.To ensure optimal protection against varicella, two doses of VARIVAX are required, which must be administered after a minimum interval of 3 months.

• Children from 12 months to 12 years of age:

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

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

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

The number of doses and the time at which they should be administered will be determined by your doctor based on official recommendations.

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

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

If you have any bleeding disorder or low platelet count in the blood, the injection will be administered 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 highly unlikely due to the fact that the vaccine is presented in single-dose vials and is administered by a doctor or healthcare professional.

If you think you have forgotten a dose of VARIVAX

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

Like all vaccines and medications, this vaccine may cause side effects, although not everyone will experience them.

Very rarely (reported in fewer 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 shortly after the injection. If you observe any of these symptoms or other severe symptoms after vaccination, seek immediate medical attention..

Inform your doctor if you observe any of the following rare or very rare side effects:

• petechiae or increased bleeding tendency; flat, red or purple spots under the skin; intense paleness
• intense skin rash (ulcers and blisters that may affect the eyes, mouth, and/or genitals; red spots that frequently itch, which begin to appear on the extremities and, in some cases, 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, dizziness, vomiting, headache, torticollis, and light sensitivity (meningitis)
• stroke
• attacks (seizures) with or without fever

The following side effects have been observed:

Frequent side effects (reported in more than 1 in 10 individuals):

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

Common side effects (reported in fewer than 1 in 10 but more than 1 in 100 individuals):

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

Rare side effects (reported in fewer than 1 in 100 but more than 1 in 1,000 individuals):

• swollen lymph nodes, petechiae or increased bleeding tendency
• agitation, increased sleep hours, gait disturbances, seizures with fever, tremors
• swollen eyelid, eye irritation
• ear pain
• nasal congestion sometimes with stabbing pain and facial pressure or pain (sinusitis), sneezing, chest congestion, nasal discharge (rhinitis), wheezing, bronchiolar swelling (bronchitis), severe lung infection, severe lung infection with fever, chills, cough, congestion, and shortness of breath (pneumonia)
• influenza-like illness
• stomach pain, stomach discomfort, and feeling unwell, blood in the stool, mouth ulcers
• flushing, vesicles, skin alterations (including petechiae and rashes)
• muscle and bone pain, muscle pain, stiffness
• reactions at the injection site, including skin color change and rash in the form of rashes

The following side effects have been reported during the marketing of VARIVAX:

• diseases affecting the nervous system (brain and/or spinal cord) such as facial muscle weakness and eyelid drooping on one side of the face (Bell's palsy), gait disturbances, dizziness, tingling or numbness in hands and feet,inflammation of the brain (encephalitis),inflammation of the membranes covering the brain and spinal cord not caused by a bacterial infection (aseptic meningitis), fainting
• herpes zoster, sore throat (pharyngitis), purple or reddish-brown spots visible along the skin (Henoch-Schönlein purpura), secondary bacterial skin and soft tissue infections (including cellulitis), varicella, aplastic anemia, which may include petechiae or bleeding tendency; flat, red or purple spots under the skin, intense paleness

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the packaging after CAD.

The expiration date is the last day of the month indicated.

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

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

VARIVAX Composition

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

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

The other excipients are:

Dry powder:

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

Traces of residual components: neomycin

Solvent:

Water for injection.

Product appearance and packaging contents

Pharmaceutical form: powder and solvent for injectable suspension.

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

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

Not all pack sizes may be marketed

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Merck Sharp & Dohme de España, S.A.

Josefa Valcárcel, 42

28027Madrid

Tel.: 91 3210600

Manufacturer responsible

Merck Sharp & Dohme BV

Waaderweg 39

2031 BN Haarlem

Netherlands

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 the last review of this leaflet:01/2025.

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Instructions

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

Avoid contact with disinfectants.

To reconstitute the vaccine, use only the solvent included 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 separate needle should be used for reconstitution and injection.

Instructions for vaccine preparation

To place the needle, firmly attach it to 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 agitate to mix thoroughly.

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

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

Do not freeze the reconstituted vaccine.

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

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

See also section 3 How to administer VARIVAX