Varivax

PACKAGE LEAFLET

Package leaflet: information for the user

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

Varicella vaccine (live)
Please read this leaflet carefully before you or your child are vaccinated because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This vaccine has been prescribed for you or your child. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What VARIVAX is and what it is used for
2. What you need to know before you or your child receive VARIVAX
3. How VARIVAX is administered
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 used to protect adults and children against varicella (chickenpox). Vaccines are used to protect you or your child from infectious diseases.
VARIVAX can be administered to individuals aged 12 months and older.
VARIVAX may also be given to children aged 9 months and older under particular circumstances, such as alignment with national vaccination programmes or during outbreaks.
VARIVAX can also be administered to individuals who have never contracted the varicella virus but who have been in contact with people affected by varicella.
Vaccination within 3 days of exposure may help prevent varicella or reduce its severity, resulting in fewer skin lesions and a shorter duration of illness. In addition, limited data indicate that vaccination up to 5 days after exposure may reduce the severity of the disease.
Like other vaccines, VARIVAX does not fully protect all individuals against naturally acquired varicella.

2. What you should know before you or your child receives VARIVAX

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 section 6) or to neomycin (which may be present as a residual trace).
• you or your child has blood disorders or any type of malignant neoplasm, including leukemias and lymphomas affecting the immune system.
• you or your child is being treated with medicines that suppress the immune system (including high-dose corticosteroids).
• you or your child has any illness (such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)) or is taking medicines that may weaken the immune system. The decision to administer the vaccine will depend on your immune defense levels.
• you or your child has a family member born with immunodeficiency or a family history of immunodeficiency.
• you or your child has untreated active tuberculosis.
• you or your child has a fever with a temperature above 38.5 °C; however, a low-grade fever does not in itself constitute a reason for not being vaccinated.
• you are pregnant. In addition, pregnancy must be avoided during the first month following vaccination.

Warnings and precautions
In rare cases, it is possible to contract chickenpox, including severe chickenpox, from a person who
has been vaccinated with VARIVAX. This may occur in individuals who have neither been previously
vaccinated nor had chickenpox, as well as in individuals falling into any of the following
categories:

• individuals with a weakened immune system.
• pregnant women who have never had chickenpox.
• newborns whose mothers have never had chickenpox.
  Individuals vaccinated with VARIVAX should, whenever possible, avoid close contact for at least 6
  weeks after vaccination with anyone falling into any of the above categories. Inform your doctor if
  anyone in these categories may come into close contact with the vaccinated person.
  Talk to your doctor or pharmacist before you or your child receives VARIVAX:

• if you or your child has a weakened immune system (such as due to HIV infection). You or your child should be closely monitored, as the immune response to the vaccine may not be sufficient to ensure protection against the disease (see section 2 “Do not use VARIVAX if”).

Other medicines (or other vaccines) and VARIVAX
Inform your doctor or pharmacist if you or your child is taking or has recently taken any other
medicines (or other vaccines).
If other vaccines need to be administered simultaneously with VARIVAX, your doctor or healthcare
professional will inform you whether this is possible. VARIVAX may be administered during the same
vaccination session as other childhood vaccines such as: measles, mumps and rubella (MMR) vaccine,
vaccines against Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis (whooping
cough), and oral polio vaccine.
VARIVAX may be administered together with a conjugated pneumococcal vaccine during the same
vaccination session, using separate injection sites.
Vaccination should be postponed for at least 5 months after plasma or blood transfusions, or after
administration of normal human immunoglobulins (sterile solution of naturally produced antibodies
from donated human blood) or specific varicella zoster immunoglobulins (VZIG).
After vaccination with VARIVAX, you or your child should not receive any immunoglobulins, including
VZIG, during the first month following vaccination, unless your doctor decides it is necessary.
Individuals receiving the vaccine must avoid using products containing aspirin (salicylates) for 6 weeks
following VARIVAX vaccination, as these medicines may cause a serious condition called Reye's syndrome, which can affect all organs of the body.

Pregnancy and breastfeeding
VARIVAX must not be administered to pregnant women.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before receiving this vaccine. In addition, it is important to avoid
pregnancy during the first month following vaccination. During this period, you must use an effective
contraceptive method to prevent pregnancy.
Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will decide whether or not
to administer VARIVAX.

Driving and using machines
There is no information suggesting that VARIVAX has effects on the ability to drive or use machines.

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

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

3. How VARIVAX is administered

VARIVAX will be administered by a doctor or healthcare professional.
VARIVAX must be given by injection as follows:
Children from 9 months to 12 months of age:
Under specific circumstances (alignment with national vaccination programmes or in cases of
chickenpox outbreak), VARIVAX may be administered between 9 and 12 months of age. To
ensure optimal protection against chickenpox, two doses must 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 must be administered at least one month apart.
Children from 12 months to 12 years of age with asymptomatic HIV:
VARIVAX must be administered in two doses by injection, 12 weeks apart. Please consult your healthcare provider for further information.
Individuals 13 years of age and older:
VARIVAX is administered in two doses by injection, 4 to 8 weeks apart.
The number and frequency of doses to be administered should be determined by the doctor according to official recommendations.
VARIVAX must not be administered to children under 9 months of age.
VARIVAX must be administered by intramuscular or subcutaneous injection into the outer area of the thigh or upper arm. For intramuscular injections, the thigh is generally preferred in young children, while the upper arm is the preferred injection site in older individuals.
In case of blood coagulation disorders or low platelet levels in the blood, the injection should be given subcutaneously.
The doctor or healthcare professional will take care to ensure that VARIVAX is not injected directly into a blood vessel.
If you use more VARIVAX than you should
Overdose is highly unlikely since the vaccine is supplied 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 whether a dose is needed and when it should be administered.

4. Possible side effects

Like all vaccines and medicines, this vaccine may cause side effects, although not everybody will experience them.
Very rarely (reported in fewer than 1 in 10,000 people), severe allergic reactions may occur, with symptoms that may include swelling of the face, low blood pressure, and breathing difficulties, with or without skin rash. These reactions often occur immediately after vaccination. If any of these symptoms or other serious symptoms occur after vaccination, you must consult a doctor immediately.
Inform your doctor if you notice any of the following rare or very rare side effects:

• bruising or abnormal bleeding; flat, red or purple pinpoint spots under the skin; marked paleness
• severe skin rash (ulcers and blistering which may affect the eyes, mouth and/or genitals; red patches, often itchy, starting on the limbs and sometimes on the face and other parts of the body) (Stevens-Johnson syndrome; erythema multiforme)
• muscle weakness, abnormal sensations, tingling in the arms, legs, and upper part of the body (Guillain-Barré syndrome)
• fever, feeling unwell, vomiting, headache, stiff neck, and sensitivity to light (meningitis)
• stroke
• seizures (fits), with or without fever

The following side effects have been observed:
Very common side effects (reported in more than 1 in 10 people) were:

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

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

• upper respiratory tract infection (nose, throat, airways)
• irritability
• skin rash, rash with red areas of skin (macules) and small raised confluent spots (papules), chickenpox-like rash
• rash at the injection site, itching at the injection site

Uncommon side effects (reported in fewer than 1 in 100 people but in more than 1 in 1,000) were:

• headache, drowsiness
• eye discharge and itching with crusting on the eyelids (conjunctivitis)
• cough, nasal congestion, chest congestion, runny nose, loss of appetite
• stomach problems with vomiting, cramps, diarrhea caused by virus
• diarrhea, vomiting (gastroenteritis)
• ear infection, sore throat
• crying, difficulty falling asleep, sleep disturbances
• chickenpox-like rash caused by virus, feeling unwell due to virus, skin inflammation, skin redness, hives
• weakness/tiredness, general feeling of being unwell, injection site reactions including numbness, bleeding, bruising, hardened and raised areas of skin, sensation of warmth, warmth to touch

Rare side effects (reported in fewer than 1 in 1,000 people but in more than 1 in 10,000) were:

• swelling of glands, bruising or abnormal bleeding
• agitation, excessive drowsiness, walking difficulties, febrile seizures, tremor
• swelling of the eyelids, eye irritation
• ear pain
• nasal congestion sometimes accompanied by pulsating pain and pressure or pain in the face (sinusitis), sneezing, lung congestion, runny nose (rhinitis), shortness of breath, inflammation of the lung airways (bronchitis), lung infection, severe lung infection with fever, chills, cough, congestion, and labored breathing (pneumonia)
• flu-like illness
• stomach ache, stomach problems and feeling unwell, blood in stools, mouth ulcers
• hot flushes, blisters, skin disorders (including bruising and hives)
• bone and muscle pain, sore muscles, stiffness
• injection site reactions including skin color changes and hives-like rash

Side effects reported after the marketing of VARIVAX include:

• diseases of the central nervous system (brain and/or spinal cord) such as facial muscle weakness and drooping eyelid on one side of the face (Bell’s palsy), walking difficulties, dizziness, tingling or numbness of hands and feet, brain inflammation (encephalitis), inflammation of the membranes covering the brain and spinal cord not caused by bacterial infection (aseptic meningitis), fainting
• shingles, sore throat (pharyngitis), purple or reddish-brown spots visible under the skin (Schönlein-Henoch purpura), secondary bacterial infections of the skin and soft tissues (including cellulitis), chickenpox, aplastic anemia, which may include bruising or abnormal bleeding; flat, red or purple pinpoint spots under the skin; marked paleness.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 refers to the last day of that month.
Store and transport in the refrigerator (2 °C – 8 °C). Do not freeze. Keep the vial in the outer packaging to protect the medicine from light.
The vaccine must be used immediately after reconstitution. However, stability during use has been demonstrated for 30 minutes at temperatures between +20 °C and +25 °C.
Do not dispose of any vaccine via wastewater or household waste. Ask your pharmacist how to dispose of vaccines no longer in use. This will help protect the environment.

6. Package contents and other information

What VARIVAX contains
The active substance is: live attenuated varicella virus (Oka/Merck strain) (produced on human diploid cells MRC-5).
Each 0.5 mL dose of reconstituted vaccine contains: a minimum of 1,350 PFU (plaque-forming units) of varicella virus (Oka/Merck strain).
Other components are:
Powder:
Sucrose, hydrolysed gelatine, urea, sodium chloride, sodium glutamate, sodium phosphate dibasic anhydrous, potassium phosphate monobasic and potassium chloride.
Residual components present in trace amounts: neomycin.
Solvent:
Water for injections.

Description of the appearance of VARIVAX and contents of the pack
Pharmaceutical form: powder and solvent for injectable suspension
The vaccine consists of a white to off-white powder contained in a vial and a solvent presented as a clear, colourless liquid contained in a pre-filled syringe. The product is available in packs of one or 10 doses.
The solvent is supplied in a pre-filled syringe containing water for injections. The pack may also contain 2 separate needles.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MSD Italia S.r.l.
Via Vitorchiano, 151
00189 Rome
Italy

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) 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)
PROVARIVAX
Nederland

The following information is intended for healthcare professionals only:

Instructions
Before reconstitution, the vial contains a white to off-white powder and the pre-filled syringe contains a solvent that appears as a clear, colourless liquid. The reconstituted vaccine is a clear liquid ranging from colourless to pale yellow.
Avoid contact with disinfectants.
Only use the solvent provided in the pre-filled syringe for reconstitution of the vaccine.
A separate sterile syringe and needle must be used for each patient to prevent transmission of infectious agents from one individual to another.
A needle should be used for reconstitution and a separate new needle for injection.

Instructions for vaccine preparation
For administration, the needle must be securely attached to the tip of the syringe and fixed by rotating it a quarter turn (90°).
Inject the entire contents of the pre-filled syringe into the vial containing the powder.
Gently agitate until complete mixing is achieved.
The reconstituted vaccine should be inspected visually for the presence of foreign particles and/or physical changes. The vaccine must not be used if particulate matter is observed or if the appearance is not that of a clear liquid ranging from colourless to pale yellow 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.
Do not freeze the reconstituted vaccine.

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

Any unused medicine and waste materials derived from this medicine should be disposed of in accordance with local regulations.
See also section 3 How VARIVAX is administered