powder and liquid for injection, suspension in a pre-filled syringe
varicella vaccine (live)
What Varivax is and what it is used for
Varivax is a vaccine used to protect adults and children against chichickenpoxaricella). Vaccines are used to protect you or your child against infectious diseases.
Varivax can be administered to people 12 months of age or older.
Varivax can also be administered to infants from 9 months of age under special circumstances, such as following national vaccination programs or in outbreak situations.
It can also be given to people who have not had chickenpox, but who have been exposed to someone who has chickenpox.
Vaccination within 3 days of exposure can help prevent chickenpox or reduce the severity of the disease, resulting in fewer rashes and a shorter duration of illness. In addition, there is limited information that vaccination up to 5 days after exposure can reduce the severity of the disease.
As with other vaccines, Varivax does not completely protect all individuals from naturally acquired chickenpox.
What you need to know before you or your child receives Varivax
Do not use Varivax if:
- you or your child are allergic to any chickenpox vaccine, any other ingredient in this vaccine (listed in section 6), or to neomycin (which may be present as a trace residue).
- you or your child have a blood disorder or any type of cancer including leukemia and lymphoma that affects the immune system.
- you or your child are receiving immunosuppressive treatment (including high doses of corticosteroids ).
- you or your child have a disease (eg human immunodeficiency virus ( HIV ) or acquired immunodeficiency syndrome ( AIDS )) or take any medicine that weakens the immune system. Whether you or your child receives the vaccine depends on the level of your immune system.
- you or your child has a family member who was born with a compromised immune system, or if there were nowno prepreviousmily members with a compromised immune system.
- you or your child have active, untreated tuberculosis .
- ou or your child has a temperature that exceeds 38.5°C. However, a low fever alone is not a reason not to get vaccinated.
- you are pregnant In addition, pregnancy should be avoided for 1 month after vaccination.
Warnings and precautions
In rare cases, it is possible to get chickenpox, including severe chickenpox, from a person who has been vaccinated with Varivax. This can happen to people who have not previously been vaccinated or had chickenpox and people who belong to any of the following categories:
- people with weakened immune systems.
- pregnant women who have never had chickenpox.
- newborn babies whose mothers never had chickenpox.
Whenever possible, people who have been vaccinated with Varivax should try to avoid close contact with anyone belonging to any of the above categories for up to 6 weeks after vaccination. Tell the doctor if there is anyone belonging to any of the above categories who are expected to be in close contact with the person being vaccinated.
Talk to a doctor or pharmacist before you or your child receive Varivax:
- if you or your child has a weakened immune system (e.g. HIV infection ) . ou or your child should be closely monitored as the response to the vaccine may not be sufficient to ensure protection against the disease (see section 2 “Do not use Varivax”).
Other medicines (or other vaccines) and Varivax
Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines).
If any other type of vaccine is planned to be given at the same time as Varivax, the doctor or healthcare professional will inform you whether or not this vaccine can be given. Varivax can be given at the same time as the following routine childhood vaccinations: measles, mumps an,d rubella vaccine (MPR), vaccines against Haemophilus influenzae type b, hepatitis B, diphtheria , etanus, pertussis (whooping cough) and oral polio vaccine.
Vaccination should be delayed for at least 5 months after blood or plasma transfusions, administration of normal human immunoglobulin (a sterile solution of naturally produced antibodies taken from donated human blood), or after varicella zoster immunoglobulin (VZIG) has been given.
After vaccination with Varivax, you or your child should not receive any immunoglobulin , ncluding VZIG, for 1 month after vaccination unless the doctor decides it is necessary.
Vaccinated people should avoid products containing acetylsalicylic acid for 6 weeks after vaccination with Varivax as this can cause a serious condition called Reye’s syndrome which can affect all organs of the body.
Pregnancy and breastfeeding
Varivax should not be given to pregnant women.
If you are pregnant or brebreastfeedinghink you may be pregnant or, are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine. It is also important that you do not become pregnant within a month of receiving the vaccine. During this time, you must use effective contraception to avoid pregnancy.
Inform the doctor if you are brebreastfeeding if you intend to brebreastfeedhe doctor will decide whether you should receive Varivax.
Driving ability and use of machinery
There is no information to suggest that Varivax affects your ability to drive or use machines.
You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects .
Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Varivax contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose , i.e. it is almost “sodium-free”.
Varivax contains potassium
This medicine contains less than 1 mmol (39 mg) of potassium per dose , i.e. it is almost “potassium-free”.
How Varivax is given
Varivax will be administered by a doctor or healthcare professional.
Varivax is given as an injection as follows:
- Infants from 9 months to 12 months of age:In special circumstances (in accordance with national vaccination programs or in case of chickenpox outbreaks) Varivax can be administered between 9 and 12 months of age. To ensure optimal protection against chicken pox, two doses of Varivax are needed and they should 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 should be given at least one month apart.
- Children from 12 months to 12 years of age with asymptomatic HIV:Varivax should be given as two doses by injection 12 weeks apart. Ask the healthcare professional for further information.
- Teenagers from the age of 13 and adults:Varivax is given as two doses or as an injection . The second dose should be given 4 to 8 weeks after the first dose .
The number of doses and the timing of the doses must 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. For young children, injection into the muscle, in the thigh is preferred, for older children and adults the upper arm is recommended.
If you have a clotting disorder or low levels of platelets , an injection will be given under the skin.
The doctor or healthcare professional will make sure that Varivax is not injected into a blood vessel.
If you have used too much Varivax
Overdose is very unlikely as the vaccine is supplied in vials containing a single dose and is given by a doctor or healthcare professional.
If you think you have missed a dose of Varivax
Contact your doctor who will determine if you need a dose and when it should be given.
Possible side effects
Like all vaccines and medicines, this vaccine can cause side effects , but not all users will get them.
Very rarely (reported by fewer than 1 in 10,000 people), a serious 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 often occur very soon after injection one. If any of these symptoms or other serious symptoms are observed after vaccination, you should see a doctor immediately.
Tell your doctor if you notice any of the following rare or very rare side effects:
- if you bleed or bruise more easily than usual; red or purple, flat, pinhead-sized spots under the skin, very pale skin
- severe skin rashes, sores and blisters that may involve the eyes, mouth and/or genitals; red, often itchy spots that start on the extremities and sometimes on the face and the rest of the body, (Stevens–Johnson syndrome; erythema multiforme)
- muscle weakness, abnormal sensation, crawling in the arms, legs and upper body (Guillain–Barré syndrome)
- fever, nausea, 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 by more than 1 in 10 people) were:
- fever
- redness of the skin at the injection site, pain/tenderness to the touch/tenderness and swelling
Common reactions (reported by less than 1 in 10 but more than 1 in 100 people) were:
- upper respiratory tract infection (nose, throat, airways)
- irritability
- rash, rash with flat, red skin and small confluent nodules, chickenpox-like rash
- rash at the injection site, itching at the injection site
Uncommon reactions (reported by fewer than 1 in 100 but more than 1 in 1,000 people) were:
- headache, drowsiness
- watery and itchy eyes with crusted eyelids ( conjunctivitis )
- cough, nasal congestion, congestion in the chest, runny nose, loss of appetite
- upset stomach with vomiting, cramps, diarrhea caused by viruses
- diarrhoea, vomiting ( gastroenteritis )
- ear infection, sore throat
- crying, insomnia, sleep disturbances
- chicken pox rash caused by virus , viral disease, skin inflammation, skin redness, hives
- weakness/fatigue, general malaise, injection site reactions such as hives, numbness, bleeding, bruising, hardened raised skin area, feeling warm, warm to the touch
Rare reactions (reported by fewer than 1 in 1,000 but more than 1 in 10,000 people) were:
- swollen glands , the person bleeds or bruises more easily than normal
- restlessness, sleeping too much, difficulty walking, febrile convulsions, tremors
- swelling of eyelids, irritated eyes
- earache
- stuffy nose sometimes with throbbing pain and pressure or pain in the face (sinusitis), sneezing, runny nose (rhinitis), wheezing, lung-related swelling of the airways ( bronchitis ), lung infection, severe lung infection with fever, chills, cough, chest tightness and shortness of breath ( pneumonia )
- flu-like illness
- stomach ache, upset stomach and nausea, blood in the stool, mouth ulcers
- redness , blisters, skin problems (including bruising and hives)
- muscle/bone pain, aching muscles, stiffness
- injection site reactions such as skin color changes
Side effects that have been reported since the introduction of Varivax to the market are:
- disease affecting the nervous system (brain and/or spinal cord) such as sunken facial muscles and drooping eyelids on one side of the face (Bell’s palsy), unsteady gait, dizziness, crawling or numbness in the hands and feet, inflammation of the brain ( encephalitis ), meningitis not caused by bacterial infection (aseptic meningitis )
- shingles , sore throat ( pharyngitis ), purple or reddish-brown spots visible through the skin (Henoch–Schönlein purpura), secondary bacterial infections of the skin and soft tissues such as (such as cellulitis ), chicken pox (varicella), aplastic anemia , which may include: easier to less bruising than normal; red or purple, flat, pinhead-sized spots under the skin, very pale skin.
How Varivax should be stored
Keep this vaccine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP.
The expiration date is the last day of the specified month.
Store and transport cold (2°C–8°C). Do not freeze. Store the vial in the outer carton. Light sensitive.
After preparation , the vaccine should be used immediately. The shelf life of the ready-made vaccine is 30 minutes between +20°C and +25°C.
Vaccines should not be thrown down the drain or among household waste. Ask your pharmacist how to dispose of vaccines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is: live attenuated varicella virus (strain Oka/Merck) (produced in MRC‑5 human diploid cells).
Each 0.5 ml dose of reconstituted vaccine contains: at least 1,350 PFU (plaque forming units) varicella virus (strain Oka/Merck).
Other ingredients are:
Powder:
Sucrose, hydrolysed gelatin, urea, sodium chloride, sodium -L- glutamate , anhydrous disodium phosphate, potassium dihydrogen phosphate and potassium chloride.
Residual components in trace amounts: neomycin .
Diluent:
Appearance and package sizes of the medicine
Preparation form: powder and liquid for injection , suspension
The vaccine consists of a white to off-white powder in a vial and a clear colorless liquid solution in a pre-filled syringe . The product is available in packs of one or 10 doses.
The liquid supplied is a pre-filled syringe with water for injections. The package may also contain two separate needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands
Manufacturer responsible for batch release
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands
This medicine is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the names:
WAX WAX
Belgium; Bulgaria; Cyprus; Denmark; Estonia; Finland; France; United Kingdom (Northern Ireland); Greece; Ireland; Iceland; Italy; Croatia; Latvia; Lithuania; Luxembourg; Malta; Norway; Poland; Portugal; Romania; Slovakia; Slovenia; Spain; Sweden; Czech Republic; Germany; Hungary; Austria
TRIAL WAX
Netherlands