Package leaflet: Information for the user

Solvent for the preparation of a suspension for injection
vial
live
Please read all of this leaflet carefully before vaccination of an adult or child,
as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This vaccine is intended for a specific adult or child. Do not pass it on to others. It may harm someone else, even if their symptoms of illness are the same.
If any side effects occur, including side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of the leaflet:
What VARIVAX is and what it is used for
Important information before VARIVAX is given to an adult or child
When not to use VARIVAX
Warnings and precautions
Interactions with other medicines
Pregnancy and breastfeeding
Effects on ability to drive and use machines
How to use VARIVAX
Possible side effects
How to store VARIVAX
Contents of the pack and other information

What VARIVAX is and what it is used for
VARIVAX is a vaccine that helps protect adults and children against varicella (chickenpox). Vaccines are used in adults or children to prevent infectious diseases.
VARIVAX vaccine can be given to individuals aged 12 months and older.
VARIVAX vaccine may also be administered to infants from 9 months of age in specific circumstances, for example, to comply with the national immunisation schedule or in the event of exposure to varicella.
The vaccine may also be given to individuals who have never had chickenpox but have been in close contact with people suffering from chickenpox.
Administration of the vaccine within 3 to 5 days after exposure to the virus may prevent the occurrence of chickenpox or reduce the severity of the disease by decreasing the number of skin lesions and duration of illness. In addition, there is limited information on the possibility of reducing disease severity if the vaccine is administered within 96 hours after exposure to the virus.
Like all vaccines, VARIVAX does not provide complete protection against chickenpox for all individuals.

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 or to any of the components of this vaccine, including neomycin (which may be present in trace amounts)
if the adult or child has malignant tumours of any kind, particularly leukaemia and lymphomas affecting the immune system
if the adult or child is receiving immunosuppressive therapy, including high-dose corticosteroids
if the adult or child has any disease affecting the immune system (e.g., human immunodeficiency virus [HIV] infection or acquired immunodeficiency syndrome [AIDS]) or is taking medication that suppresses the immune system. Whether the adult or child should receive the vaccine will depend on the level of immune function
if a family member of the adult or child has a congenital immunodeficiency or if the adult or child has had immunodeficiency disorders
if the adult or child has active, untreated tuberculosis
if the adult or child has a body temperature exceeding 38.5°C; however, a mild fever is not a reason to delay vaccination
if the woman is pregnant. In addition, pregnancy should be avoided for 1 month after vaccination.

Warnings and precautions:
In rare cases, there is a possibility of transmitting chickenpox, including its severe form,
from a person vaccinated with VARIVAX. This may affect individuals who have not previously
had chickenpox, as well as individuals belonging to one of the following groups:

those with a weakened immune system;
pregnant women who have never had chickenpox;
newborns whose mothers have never had chickenpox.

As far as possible, individuals vaccinated with VARIVAX should, for a period of up to 6 weeks after
vaccination, avoid close contact with anyone belonging to one of the above-mentioned groups. Inform your doctor if you suspect that anyone belonging to one of the above-mentioned groups will have close contact with a vaccinated person.
Inform your doctor or pharmacist before vaccination if:

the immune system of the adult or child is weakened (e.g., due to HIV infection). In such cases, the adult or child should be informed that the vaccine may not provide sufficiently effective protection against the disease (see section "When not to use VARIVAX").

Tell your doctor or pharmacist about any medicines currently being taken or recently taken by the adult or child.
If VARIVAX is to be administered at the same time as another vaccine, your doctor will advise whether it can be given or not. VARIVAX may be administered at the same time as the following vaccines routinely used in childhood:
measles, mumps and rubella (MMR) vaccine, vaccines against hepatitis B, diphtheria, tetanus, pertussis (whooping cough), and oral polio vaccine.
VARIVAX may be administered at different injection sites simultaneously with the pneumococcal conjugate vaccine.
Vaccination should be postponed for at least 5 months after administration of immunoglobulin containing varicella antibodies.
For at least 5 months after vaccination with VARIVAX, the patient should not receive any other live vaccines unless the doctor considers it necessary.
Individuals who have received the vaccine should avoid using products containing salicylic acid (e.g., aspirin) after vaccination due to the possibility of developing a serious condition called Reye's syndrome, which may affect all organs of the body.

Pregnancy and breastfeeding
VARIVAX should not be given to pregnant women.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before receiving the vaccine. Furthermore, it is important that the patient does not become pregnant within one month after receiving the vaccine. Women should use an effective method of contraception during this time to avoid pregnancy.
Women who are breastfeeding or intend to breastfeed should inform their doctor, who will decide whether they should receive VARIVAX.

Effects on ability to drive and use machines
There are no data available on the effects of the vaccine on the ability to drive vehicles or operate machinery.

The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".
The medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e., essentially "potassium-free".

How to use VARIVAX
VARIVAX is administered by injection according to the following schedule:

Infants from 9 months: In specific circumstances (e.g., to comply with the national immunisation schedule or after exposure to varicella), VARIVAX may be administered from 9 months of age. To ensure optimal protection against chickenpox, a second dose should be given at least 3 months after the first dose.
Children from 12 months to 12 years: To ensure optimal protection against chickenpox, two doses should be administered with an interval of at least one month.
Children from 12 months to 12 years with asymptomatic infection: VARIVAX should be administered by injection with an interval of 12 weeks. More information will be provided by healthcare professionals.
Adolescents and adults: VARIVAX is administered by injection in two doses. The second dose should be given 4 to 8 weeks after the first dose.

The number and timing of doses should be determined by a doctor, following official recommendations.
VARIVAX should not be administered to children under 9 months of age.
The vaccine should be administered by intramuscular injection into the outer aspect of the thigh in infants and young children or into the deltoid muscle of the upper arm in older children and adults.
For individuals with bleeding disorders or low platelet counts, the vaccine should be administered by subcutaneous injection.
The vaccine must not be injected intravenously.

Overdose with VARIVAX
Overdose is very unlikely, as the vaccine is supplied in pre-filled syringes and administered by a healthcare professional.

Missed dose of VARIVAX
Consult your doctor, who will decide whether a dose is necessary and when it should be administered.

Possible side effects
Like all vaccines and medicines, this vaccine can cause side effects, although not everyone will experience them.
Very rarely (reported in fewer than 1 in 10,000 people), a severe allergic reaction may occur, which may include swelling of the face, low blood pressure, and breathing difficulties, with or without a rash. These reactions often occur shortly after injection. If any of these symptoms occur after vaccination or if other severe symptoms appear, seek immediate medical help.
Inform your doctor if any of the following rare or very rare side effects occur:

increased tendency to bruising or bleeding; appearance of red, flat spots under the skin; severe paleness of the skin
severe blistering, which may occur in the genital area; red, often itchy spots on the skin, initially located on the limbs, and sometimes also on the face and rest of the body (Stevens-Johnson syndrome, erythema multiforme)
muscle weakness, drooping of the upper eyelid (Guillain-Barré syndrome)
fever, nausea, vomiting, headache, neck stiffness, sensitivity to light (meningitis)
joint pain, with or without fever

The following side effects have been reported:

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

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

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

respiratory tract infection, sore throat
irritability
flat, red skin with small spots merging together
swelling at the injection site, itching at the injection site

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

headache, drowsiness
itchy eyes
nasal mucosa congestion
viral gastroenteritis with vomiting, cramps, diarrhoea
diarrhoea, vomiting (gastroenteritis)
ear infection, sore throat
crying, insomnia, sleep disturbances
chickenpox-like rash caused by the vaccine virus
weakness/tiredness, general malaise; at the injection site: numbness, bleeding, bruising, hardened, raised skin lesions, sensation of warmth, warmth to the touch

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

enlarged lymph nodes, increased tendency to bleeding
bone pain, difficulties associated with fever, shivering
eyelid swelling, eye irritation
sensation of nasal congestion, sometimes accompanied by pulsating pain; pain in the lungs (rhinitis), wheezing, swelling of the airways (bronchitis), lung infection, severe lung infection with fever, chills, cough, congestion (pneumonia)
stomach pain and nausea, presence of blood in stool
sudden facial flushing, blisters
muscle/bone pain, muscle soreness, stiffness
at the injection site, in the limb

Side effects reported after the introduction of VARIVAX vaccine include:

after vaccination with vaccines containing live, attenuated varicella virus, infection or inflammation of the brain or meninges has been observed in several cases; in some cases, this condition led to death, particularly in individuals with a weakened immune system (as stated, VARIVAX should never be used in individuals with a weakened immune system). If the patient experiences loss or decreased consciousness, seizures, or loss of motor control accompanied by fever and headache, seek immediate medical attention, as these may be symptoms of infection or inflammation of the brain. Inform the doctor or pharmacist that the patient received a live, attenuated varicella vaccine.
nervous system disorders (brain, spinal cord), e.g., muscle weakness and paralysis, unsteadiness when walking, dizziness, tingling or numbness of hands and feet, inflammation of the membranes covering the spinal cord due to infection
shingles, sore throat (pharyngitis), purple or red spots on the entire skin (purpura), secondary bacterial infections of the skin and soft tissues including cellulitis, chickenpox, aplastic anaemia, which may manifest as increased tendency to bruising and bleeding, flat spots under the skin, paleness of the skin

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products. Adverse effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of the medicine.

How to store the vaccine
Keep the vaccine out of the reach and sight 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 the stated month.
Store and transport in a refrigerated state (2°C to 8°C). Do not freeze. Keep the vial in its outer packaging to protect from light.
After reconstitution, the vaccine should be used immediately. However, it has been shown that the reconstituted vaccine remains stable for up to 30 minutes.
Vaccines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of vaccines no longer required. These measures will help protect the environment.

Contents of the pack and other information
Active substance:
Live attenuated varicella virus (Oka/Merck strain) (grown on MRC-5 cells).
Each dose contains not less than 3.3 log10 plaque-forming units (PFU) of the virus.

Other ingredients:
Gelatin
Substances present in trace amounts: neomycin.
Water for injections

What VARIVAX looks like and contents of the pack
Pharmaceutical form: powder and solvent for a suspension for injection
The vaccine consists of a white or off-white powder in a vial and a clear, colourless, liquid solvent in a vial.
The vaccine is available in packs containing one dose or 10 doses.
The solvent is water for injections in a vial. The pack may also contain 2 separate needles.
Not all pack sizes may be marketed.
For more detailed information, please contact the local representative in the following European Economic Area countries under the following names:
Bulgaria; Czech Republic; Italy; Latvia; Hungary; Slovenia; Slovakia

Information intended exclusively for healthcare professionals:

The vial contains a white or off-white powder. The vial contains a clear, colourless, liquid solvent. After reconstitution, the vaccine is a clear liquid, colourless to pale yellow.
Avoid contact with disinfectants.
For reconstitution of the vaccine, only the solvent provided in the vial should be used.
It is important to use a separate, sterile syringe and needle for each patient to avoid transmission of infectious agents from one person to another.
One needle should be used for reconstitution and a separate, new needle for injection.

Instructions for preparing the vaccine
After attaching the needle, firmly place it on the syringe tip and secure it.
Inject the entire contents of the solvent vial into the vial with the powder. Gently shake to thoroughly mix the solution.
Inspect the reconstituted vaccine for any particulate matter or abnormal appearance. Do not administer the vaccine if, after reconstitution, particulate matter is visible or if the solution is not clear and colourless to pale yellow.
It is recommended that the vaccine be administered immediately after reconstitution to minimise loss of potency. If the vaccine is not used within 30 minutes, it must be discarded.
Do not freeze the vaccine.
Withdraw the entire contents of the vial into the syringe, change the needle, and administer the vaccine subcutaneously or intramuscularly.
Dispose of used materials according to local regulations.
See also section 3 "How to use VARIVAX".