powder and liquid for injection, solution in a pre-filled syringe
Varicella vaccine, live
What Varilrix is and what it is used for
Varilrix is a vaccine used in people from 12 months of age to protect them against chickenpox (varicella). In special circumstances, Varilrix can be given to infants from the age of 9 months.
If a person is vaccinated within 3 days of being in contact with someone who has chickenpox, the vaccination may help prevent chickenpox or make the disease milder.
How Varilrix works
When a person is vaccinated with Varilrix, the immune system (the body’s natural defense system) produces antibodies that protect the person from being infected with the chicken pox virus (varicella).
Varilux contains weakened viruses and it is very unlikely that the vaccine would cause chickenpox in healthy people.
As with all vaccines, Varilrix may not provide complete protection for everyone vaccinated.
What you need to know before you/your child receives Varilrix
Do not use Varilrix:
- if you/your child have any disease (e.g. a blood disease, cancer, infection with the human immunodeficiency virus ( HIV ) or acquired immunodeficiency syndrome ( AIDS ) or are taking any medicine (even high doses of corticosteroids ) that weakens the immune system. If you or your child receives the vaccine depends on the level of your immune system, see “Warnings and precautions” in section 2.
- if you/your child are allergic to any ingredient in this vaccine (listed in section 6). Signs of an allergic reaction may include skin itching, shortness of breath, and swelling of the face or tongue.
- if you/your child is allergic to neomycin (an antibiotic ). However, known contact dermatitis (skin rash on direct contact with an allergen, e.g. neomycin ) is not an obstacle to vaccination.
- if you/your child previously had an allergic reaction to a chickenpox vaccine.
- if you are pregnant. In addition, pregnancy must be avoided for 1 month after vaccination.
Warnings and precautions
Talk to a doctor, pharmacist, or nurse before you/your child receives Varilrix:
- if you/your child has a serious infection with a high fever. It may be necessary to postpone the vaccination until you/your child is healthy again. A milder infection such as a cold should not require postponing the vaccination but talk to your doctor first.
- if you/your child has a weakened immune system due to diseases (e.g. HIV infection ) and/or treatments. You/your child should be closely monitored as the response to the vaccine may not be sufficient to ensure protection against the disease (see “Do not use Varilrix” in section 2).
- if you/your child has a bleeding disorder or bruises easily.
Fainting may occur (mainly in young people) after, or even before, any needle injection. Therefore, tell the doctor or nurse if you/your child has fainted during an injection before.
Like other vaccines, Varilrix may not give you or your child complete protection against chickenpox. However, people who have been vaccinated and get chickenpox usually get a much milder illness than people who have not been vaccinated.
In rare cases, the weakened virus it can be transferred from a vaccinated person to other people. This has mainly happened when the vaccinated person has some rashes or blisters. Healthy people who are infected in this way usually get a mild rash.
When you or your child has been vaccinated, for 6 weeks after the vaccination, avoid close contact with the following people as much as possible:
- people with a weakened immune system
- pregnant women who have not had chickenpox or have not been vaccinated against chickenpox
- newborn babies of mothers who have not had chickenpox or who have not been vaccinated against chickenpox.
Other medicines and Varilrix
Tell the doctor or pharmacist if you/your child are taking, have recently taken, or maybe taking other medicines.
Tell the doctor if you or your child should be tested for tuberculosis. If such a test is performed within 6 weeks of vaccination with Varilrix, the result may be unreliable.
Vaccination must be postponed for at least 3 months if you or your child has received a blood transfusion or human antibodies (immunoglobulins).
After vaccination with Varilrix, the intake of salicylic acid (a substance found in some antipyretic and pain-relieving medicines) should be avoided for 6 weeks, as it can cause a serious illness called Rey’s syndrome, which can affect any organ in the body.
Varilux can be given at the same time as other vaccines. Different injection sites are used for each vaccine.
Pregnancy and breastfeeding
Varilux should not be given to pregnant women.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving 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 breastfeeding or intend to start breastfeeding. The doctor decides whether you can be vaccinated with Varilrix.
Driving ability and use of machinery
Varilrix has no or negligible effect on the ability to drive and use machines. Some of the side effects mentioned in section 4 Possible side effects may, however, temporarily affect the ability to drive vehicles or use machines.
You 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. A 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.
Varilrix contains sorbitol and phenylalanine
This medicine contains 6 mg of sorbitol per dose.
This medicine contains 331 micrograms of phenylalanine per dose. Phenylalanine can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in the body.
How Varilrix is used
Varilrix is injected under the skin or into a muscle, either in the upper arm or in the outer thigh.
Children from the age of 12 months should receive 2 doses of Varilrix at least 6 weeks apart. The time between the first and second dose must not be shorter than 4 weeks.
In special circumstances, the first dose of Varilrix can be given to infants between 9 and 11 months of age. In that case, two doses are needed but must be given at least 3 months apart.
People who are at risk of becoming seriously ill from chicken pox, e.g. people who are being treated for cancer, may receive more doses of you. The time between the first and second dose must not be shorter than 4 weeks.
The doctor decides when vaccination should take place and with how many doses, based on official recommendations.
If you or your child has received too much Varilrix
Overdose is unlikely because the vaccine is supplied in a vial containing one dose, and is given by a doctor or nurse. Only a few cases of accidental injection have been reported, and in only a few of these were abnormal drowsiness and convulsions observed.
If you think you or your child have missed a dose of Varilrix
Contact a doctor, who will decide if a dose is needed and when it should be given.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can be caused by this vaccine:
- Very common (may affect more than 1 in 10 people)
- pain and redness at the injection site.
- Common (may affect up to 1 in 10 people)
- skin rash (rash and/or blisters)
- injection site swelling*
- fever, 38 °C and higher (measured in the rectum)*.
- Uncommon (may affect up to 1 in 100 people)
- upper respiratory tract infection
- sore throat and difficulty swallowing ( pharyngitis )
- swollen lymph nodes
- irritability
- headache
- drowsiness
- cough
- itchy, runny, or stuffy nose, sneezing ( rhinitis )
- nausea
- vomiting
- chickenpox-like rash
- itching
- joint pain
- muscle pain
- fever above 39.5 °C (measured in the rectum)
- fatigue
- general malaise.
- Rare (may affect up to 1 in 1,000 people)
- eye inflammation ( conjunctivitis )
- stomach pain
- diarrhea
- itchy raised skin rash ( hives ).
*Swelling at the injection site and fever is a very common side effects in adolescents and adults. Swelling may also be very common in children under 13 years of age after the second dose.
The following side effects have been reported in a few cases with routine use of Varilrix:
- shingles ( herpes zoster)
- small dots in the skin due to bleeding, or easier bruising, due to a lower number of platelets (a type of blood cell )
- allergic reaction. Skin rash that may itch or blister, swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure, and loss of consciousness. Such reactions may occur before you have left the doctor’s office. If you or your child develop any of these symptoms, contact a doctor immediately.
- infection or inflammation of the brain, spinal cord, or peripheral nerves, leading to temporary difficulty walking (unsteadiness) and/or temporary difficulty coordinating body movements, stroke (clot in the brain leading to a stoppage of blood flow)
- convulsions
- inflammation, narrowing, or blockage of blood vessels. This can lead to unusual bleeding or bruising of the skin (Henoch-Schönlein purpura), a fever lasting more than 5 days, and a simultaneous rash on the trunk, sometimes with scaly skin on the hands and fingers and reddened eyes, lips, throat, and tongue (Kawasaki disease)
- erythema multiforme (symptoms are red, often itchy patches, similar to the rash of measles, which start on the arms and legs and sometimes on the face and the rest of the body).
How to store Varilrix
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
Store and transport cold (2 °C–8 °C).
Store in the original packaging. Light sensitive.
After preparation, the vaccine should be administered as soon as possible.
If this is not possible, it has been shown that reconstituted vaccine can be stored for up to 90 minutes at room temperature (25 °C) or up to 8 hours in a refrigerator (2 °C–8 °C). If the vaccine has not been used within these time frames and conditions, it should be discarded.
Vaccines should not be thrown down the drain or among the 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 ingredient in Varilrix has weakened varicella virus (strain Oka) produced in MRC-5 ( human diploid cell culture). One dose of Varilrix (0.5 ml) contains weakened varicella virus (strain Oka) at least 10 3.3 PFU ( plaque forming units)
- Other ingredients:
Powder: amino acids (contains phenylalanine), anhydrous lactose, sorbitol (E420), mannitol (E421)
Diluent: water for injections.
Appearance and package sizes of the medicine
Varilrix is a powder and liquid for injection, solution (powder in a vial for 1 dose and diluent in a pre-filled syringe (0.5 ml)) with or without needles in the following pack sizes:
- with a separate needle: pack sizes of 1 or 10 doses.
- with 2 separate needles: pack sizes 1 or 10 doses.
- without a needle: pack sizes of 1 or 10 doses.
Varilrix is a slightly cream-colored to yellowish or pink powder and the diluent (water for injections ) is clear and colorless and is used to prepare the vaccine.
Marketing Authorisation Holder:
GlaxoSmithKline AB
Box 516
169 29 Solna
Tel: 08-638 93 00
E-mail: info.produkt@gsk.com
Manufacturer
GlaxoSmithKline Biologicals SA
Rue de l’Institut 89
B-1330 Rixen species
Belgium