Varivax

PATIENT INFORMATION LEAFLET

Information leaflet attached to the packaging: information for the user

VARIVAX, powder and solvent for suspension for injection

in a pre-filled syringe

Live varicella vaccine

Please read this leaflet carefully before an adult or child is vaccinated, as it contains important information for the patient.

• Please keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This vaccine has been prescribed for a specific adult or child. Do not pass it on to others. The vaccine may harm others, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What VARIVAX is and what it is used for
• 2. Important information before VARIVAX is given to an adult or child
• 3. How to use VARIVAX
• 4. Possible side effects
• 5. How to store VARIVAX
• 6. Contents of the pack and other information

1. What VARIVAX is and what it is used for

VARIVAX is a vaccine that helps protect adults and children against chickenpox. Vaccines are used to protect adults and children against infectious diseases.
VARIVAX can be given to people from 12 months of age or older.
VARIVAX can also be given to infants from 9 months of age in special circumstances, for example to comply with the vaccination schedule in a given country or in the event of a chickenpox epidemic.
The vaccine can also be given to people who have never had chickenpox but have been in contact with people with chickenpox.
Vaccination within 3 days of exposure to the virus may prevent chickenpox or reduce the severity of the disease by reducing the number of skin lesions and shortening the duration of the disease. Additionally, there is limited information on the possibility of reducing the severity of the disease when vaccinated within 5 days of exposure to the virus.
Like other vaccines, VARIVAX does not provide complete protection against chickenpox in all people.

2. Important information before VARIVAX is given to an adult or child

When not to use VARIVAX:

• if the adult or child is allergic to any varicella vaccine, to any of the components of this vaccine (listed in section 6) or to neomycin (which may be present in trace amounts),
• if the adult or child has a blood disorder or cancer of any kind, including leukemia and lymphoma affecting the immune system,
• if the adult or child is receiving immunosuppressive treatment (including high doses of corticosteroids),
• if the adult or child has any disease (such as HIV infection or AIDS) or is taking any medicine that weakens the immune system. Whether the adult or child receives the vaccine will depend on the level of immunity,
• if a family member of the adult or child has a congenital immune deficiency or if there is a history of immune deficiencies in the adult's or child's family,
• if the adult or child has active, untreated tuberculosis,
• if the adult or child has a fever over 38.5°C; however, a low-grade fever is not a reason to contraindicate vaccination,
• if the woman is pregnant. Additionally, pregnancy should be avoided for 1 month after vaccination.

Warnings and precautions:

In rare cases, it is possible to contract chickenpox, including severe chickenpox, from a person vaccinated with VARIVAX. This can affect people who have not been previously vaccinated or who have not had chickenpox, as well as people in the following groups:

• people with weakened immune systems;
• pregnant women who have not had chickenpox;
• newborns whose mothers have not had chickenpox. Whenever possible, people vaccinated with VARIVAX should avoid close contact with anyone in these groups for up to 6 weeks after vaccination. Tell your doctor if you think anyone in these groups will have close contact with the vaccinated person. Before VARIVAX is given to an adult or child, tell your doctor:
• if the adult or child has a weakened immune system (e.g. due to HIV infection). The adult or child should be closely monitored as the vaccine may not provide sufficient protection against the disease (see section 2 "When not to use VARIVAX").

VARIVAX and other medicines (or other vaccines):

Tell your doctor or pharmacist about all medicines (or other vaccines) the adult or child is taking or has recently taken.
If another 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 vaccines:
measles, mumps and rubella (MMR) vaccine, Haemophilus influenzae type b vaccine, hepatitis B vaccine, diphtheria, tetanus and pertussis (whooping cough) vaccine, and oral polio vaccine.
VARIVAX can be given at the same visit, in different injection sites, with pneumococcal conjugate vaccine.
Vaccination should be delayed for at least 5 months after any blood transfusion or human immunoglobulin administration (a sterile solution of naturally produced antibodies obtained from donated human blood) or varicella zoster immune globulin (VZIG).
For 1 month after VARIVAX vaccination, do not give the patient any immunoglobulins, including VZIG, unless your doctor considers it necessary.
People who have been vaccinated should avoid taking products containing acetylsalicylic acid (salicylates) for 6 weeks after VARIVAX vaccination due to the risk of a serious condition called Reye's syndrome, which can affect all organs.

Pregnancy and breastfeeding

VARIVAX should not be given to pregnant women.
If you are pregnant or breastfeeding, think you may be pregnant or plan to have a baby, ask your doctor or pharmacist for advice before vaccination. Additionally, it is important that for 1 month after receiving the vaccine, the patient does not become pregnant. Women should use effective contraception during this time to avoid becoming pregnant.
Women who are breastfeeding or plan to breastfeed should inform their doctor. The doctor will decide whether the patient can receive VARIVAX.

Driving and using machines

There is no information to suggest that VARIVAX affects the ability to drive or use machines.

VARIVAX contains sodium

The vaccine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially sodium-free.

VARIVAX contains potassium

The vaccine contains less than 1 mmol (39 mg) of potassium per dose, which is essentially potassium-free.

3. How to use VARIVAX

VARIVAX will be given by a doctor or a representative of the medical staff.
VARIVAX is given as an injection according to the following schedule:

• Infants from 9 to 12 months: In special circumstances (to comply with the vaccination schedule in a given country or in the event of a chickenpox epidemic), VARIVAX can be given from 9 to 12 months of age. To ensure optimal protection against chickenpox, two doses of VARIVAX should be given at least 3 months apart.
• Children from 12 months to 12 years: To ensure optimal protection against chickenpox, two doses of VARIVAX should be given at least 1 month apart.
• Children from 12 months to 12 years with asymptomatic HIV infection: VARIVAX should be given in two doses 12 weeks apart. For more information, ask your healthcare professional.
• Adolescents 13 years of age and older and adults: VARIVAX is given as two injections. The second dose should be given 4 to 8 weeks after the first dose. The number and timing of doses should be determined by the doctor, following official recommendations. VARIVAX should not be given to children under 9 months of age. VARIVAX should be given as an injection into the fatty tissue under the skin or into the muscle of the outer thigh or upper arm. For small children, the preferred injection site for intramuscular injections is the thigh, while for older individuals, the preferred injection site is the upper arm. For people with bleeding disorders or low platelet count, the vaccine should be given as a subcutaneous injection. The doctor or healthcare professional will ensure that VARIVAX is not injected into a blood vessel.

Overdose of VARIVAX

Overdose is very unlikely as the vaccine is available in single-dose vials and is given by a doctor or healthcare professional.

Missed dose of VARIVAX

Consult your doctor, who will decide if a dose of VARIVAX is needed and when it should be given.

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 people), a severe allergic reaction may occur with symptoms that may include swelling of the face, low blood pressure, and difficulty breathing with or without a rash. These reactions usually occur very soon after injection. If any of these symptoms occur after vaccination or if other severe symptoms appear, seek medical attention immediately.
Tell your doctor if you experience any of the following rare or very rare side effects:

• unusual bruising or bleeding; red or purple flat, pinpoint spots under the skin; severe pallor
• severe skin rash (ulcers and blisters that may occur around the eyes, mouth, and (or) genitals; red, often itchy patches on the skin initially on the limbs, and sometimes also on the face and the rest of the body) (Stevens-Johnson syndrome; erythema multiforme)
• muscle weakness, sensory disturbances, tingling sensation in hands, feet, and upper body (Guillain-Barré syndrome)
• fever, nausea, vomiting, headache, stiff neck, and sensitivity to light (meningitis)
• stroke
• seizures (fits) with or without fever Observe the following side effects: Very common reactions (reported in more than 1 in 10 people):
• fever
• redness of the skin, pain/tenderness/soreness and swelling at the injection site Common reactions (reported in less than 1 in 10 people but more than 1 in 100 people):
• upper respiratory tract infection (nose, throat, respiratory tract)
• irritability
• rash, flat, red, and scaly skin and small merging bumps, chickenpox-like rash
• rash at the injection site, itching at the injection site Uncommon reactions (reported in less than 1 in 100 people but more than 1 in 1000 people):
• headache, drowsiness
• eye discharge and itching of the eyes with eyelid swelling (conjunctivitis)
• cough, runny nose, chest congestion, common cold, loss of appetite
• viral gastroenteritis with vomiting, cramps, diarrhea
• diarrhea, vomiting (gastroenteritis)
• ear infection, sore throat
• tearfulness, insomnia, sleep disturbances
• varicella-like rash, viral disease, skin infection, skin redness, urticaria
• weakness/fatigue, general feeling of being unwell, reactions at the injection site including numbness, bleeding, bruising, induration, warmth, and redness Rare reactions (reported in less than 1 in 1000 people but more than 1 in 10,000 people):
• lymphadenopathy, unusual bruising or bleeding
• agitation, excessive drowsiness, difficulty walking, febrile seizures, tremors
• eyelid swelling, eye irritation
• ear pain
• nasal congestion, which may be accompanied by pulsating pain and a feeling of pressure or pain in the face (sinusitis), sneezing, wheezing, bronchitis, pneumonia, severe pneumonia with fever, chills, cough, congestion, and shortness of breath
• flu-like illness
• abdominal pain, gastrointestinal disorder, and nausea, blood in stool, oral ulcers
• sudden flushing of the face, blisters, skin diseases (including bruising and urticaria)
• muscle pain/bone pain, muscle tenderness
• reactions at the injection site, including skin discoloration and urticaria-like rash The following side effects have been reported after VARIVAX was marketed:
• nervous system disorders (brain and (or) spinal cord), such as muscle weakness and drooping eyelid on one side of the face (Bell's palsy), unsteady gait, dizziness, tingling or numbness of hands and feet, encephalitis, aseptic meningitis
• shingles, sore throat (pharyngitis), purple or reddish-brown, pinpoint spots on the skin (Henoch-Schönlein purpura), secondary bacterial infections of the skin and soft tissues (including cellulitis), chickenpox, aplastic anemia, which may manifest as unusual bruising or bleeding; red or purple flat, pinpoint spots under the skin; severe pallor

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VARIVAX

Keep the 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 refers to the last day of that month.
Store and transport refrigerated (2°C – 8°C). Do not freeze. Store the vial in the outer packaging to protect from light.
After reconstitution, the vaccine should be used immediately. However, it has been shown that the vaccine remains stable for 30 minutes at a temperature of +20°C to +25°C.
Vaccines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of vaccines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What VARIVAX contains

The active substance is: live attenuated varicella virus (Oka/Merck strain) (grown in human diploid cell culture MRC-5).
Each 0.5 ml dose of the vaccine after reconstitution contains: at least 1350 PFU (virus titration units) of varicella virus (Oka/Merck strain).

Other ingredients are: Powder:

Sucrose, hydrolyzed gelatin, urea, sodium chloride, sodium L-glutamine, anhydrous disodium phosphate, potassium dihydrogen phosphate, and potassium chloride.
Ingredients present in trace amounts: neomycin.
Solvent:
Water for injections

What VARIVAX looks like and contents of the pack

Pharmaceutical form: powder and solvent for suspension for injection
VARIVAX consists of a white or almost white powder in a vial and a clear, colorless, liquid solvent in a pre-filled syringe. The product is available in packs containing 1 dose or 10 doses.
The solvent is water for injections in a pre-filled syringe. The pack may also contain 2 separate needles.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
NetherlandsMSD Polska Sp. z o. o.
Tel: (+48) 22 549 51 00
[email protected]

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 the leaflet: 01/2025

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Information intended for healthcare professionals only:

Instructions

Before reconstitution, the vial contains a white or almost white powder, and the pre-filled syringe contains a clear, colorless, liquid solvent. After reconstitution, the vaccine is a clear, colorless to pale yellow liquid.
Avoid contact with disinfectants.
Only the solvent provided in the pre-filled syringe should be used to reconstitute the vaccine.
It is important to use a separate, sterile syringe and needle for each patient to avoid transmitting infectious agents from one person to another.
Use one needle for reconstitution and a separate, new needle for injection.
Instructions for preparing the vaccine
To attach the needle, screw it tightly onto the syringe and secure by turning.
Inject the entire contents of the pre-filled syringe into the vial of powder. Gently shake to mix the solution thoroughly.
Inspect the reconstituted vaccine for any particulate matter and (or) abnormal appearance. Do not administer the vaccine if any particulate matter is visible after reconstitution or if the solution is not clear and colorless to pale yellow.

It is recommended to administer the vaccine immediately after reconstitution to minimize loss of potency. If the vaccine is not used within 30 minutes after reconstitution, it should be discarded.

Do not freeze the vaccine after reconstitution.

Draw the entire contents of the vial into the syringe, change the needle, and inject the vaccine subcutaneously or intramuscularly.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

See also section 3 How to use VARIVAX