Varivax

DRUG DESCRIPTION

VARIVAX* [Varicella Virus Vaccine Live (Oka/Merck)] is a preparation of the Oka/Merck strain of live, attenuated varicella virus. The virus was initially obtained from a child with natural varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5) that were free of adventitious agents. This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers.

VARIVAX (varicella virus vaccine live) , when reconstituted as directed, is a sterile preparation for subcutaneous administration. Each 0.5 mL dose contains the following: a minimum of 1350 PFU (plaque forming units) of Oka/Merck varicella virus when reconstituted and stored at room temperature for 30 minutes, approximately 25 mg of sucrose, 12.5 mg hydrolyzed gelatin, 3.2 mg sodium chloride, 0.5 mg monosodium L-glutamate, 0.45 mg of sodium phosphate dibasic, 0.08 mg of potassium phosphate monobasic, 0.08 mg of potassium chloride; residual components of MRC-5 cells including DNA and protein; and trace quantities of sodium phosphate monobasic, EDTA, neomycin, and fetal bovine serum. The product contains no preservative.

To maintain potency, the lyophilized vaccine must be kept frozen at an average temperature of -15C (+5F) or colder and must be used before the expiration date (see HOW SUPPLIED, Stability and Storage). Storage in any freezer (e.g., chest, frost-free) that reliably maintains an average temperature of -15C (+5F) or colder and has a separate sealed freezer door is acceptable.

What are the possible side effects of this vaccine (Varivax)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely...

Read All Potential Side Effects and See Pictures of Varivax

What are the precautions when taking varicella virus vaccine live (Varivax)?

Before receiving varicella virus vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, gelatin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: illness with a high fever over 101 degrees F (38 degrees C), immune system problems (such as due to HIV infection, cancer treatment, organ transplant), decreased immune function from other medications (see also Drug Interactions), untreated tuberculosis (TB) infection.

There is a small risk that you may expose others to infection with chickenpox for up to 6 weeks after you...

Read All Potential Precautions of Varivax


Varivax Consumer (continued)

SIDE EFFECTS: Pain/redness/bruising/swelling at the injection site, fever, or mild chickenpox-like rash may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. However, report all side effects to the doctor.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving varicella virus vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, gelatin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: illness with a high fever over 101 degrees F (38 degrees C), immune system problems (such as due to HIV infection, cancer treatment, organ transplant), decreased immune function from other medications (see also Drug Interactions), untreated tuberculosis (TB) infection.

There is a small risk that you may expose others to infection with chickenpox for up to 6 weeks after you have been vaccinated. You should avoid being in the same room with people with immune system problems, pregnant women who have not had chickenpox, children/partners of mothers who have not had chickenpox, and newborn babies born at less than 28 weeks of pregnancy.

This medication must not be used during pregnancy. There is some risk that it may harm an unborn baby. If you have been vaccinated with varicella virus vaccine, you should not become pregnant for at least 3 months after the vaccination. Discuss the possible risks with your doctor.

It is unknown if the varicella virus in this vaccine passes into breast milk. Consult your doctor before breast-feeding.


Varivax Patient Information Including Side Effects

Brand Names: Varivax

Generic Name: varicella virus (chickenpox) vaccine (Pronunciation: VAR i SEL a VYE rus vax EEN)

  • What is varicella virus vaccine (Varivax)?
  • What are the possible side effects of this vaccine (Varivax)?
  • What is the most important information I should know about this vaccine (Varivax)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Varivax)?
  • How is this vaccine given (Varivax)?
  • What happens if I miss a dose (Varivax)?
  • What happens if I overdose (Varivax)?
  • What should I avoid before or after receiving this vaccine (Varivax)?
  • What other drugs will affect varicella virus vaccine (Varivax)?
  • Where can I get more information?

What is varicella virus vaccine (Varivax)?

Varicella (commonly known as chickenpox) is a common childhood disease that causes fever, skin rash, and a breakout of fluid-filled blisters on the skin. Most people who receive this vaccine will not get chickenpox, or will get only a mild case and will recover faster.

Chickenpox is usually mild, but it can be serious or even fatal in young infants and in adults. It can lead to severe skin infection, breathing problems, brain damage, or death. A person who has had chickenpox can develop herpes zoster (also called shingles) later in life, which causes severe nerve pain, and hearing or vision problems, which may last for months or years.

Chickenpox is spread from person to person through the air, or by coming into contact with the fluid from a chickenpox blister.

Varicella virus vaccine is for use in adults and children who are at least 12 months old.

This vaccine works by exposing your child to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the varicella virus vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Varivax)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • cough, tight feeling in your chest, breathing problems;
  • seizure (black-out or convulsions);
  • easy bruising or bleeding, unusual weakness;
  • behavior changes; or
  • high fever (within a few hours or a few weeks after the vaccine).

Less serious side effects include:

  • redness, pain, or swelling where the shot was given;
  • low fever;
  • mild skin rash;
  • runny or stuffy nose, cough, sore throat;
  • headache, tired feeling;
  • sleep problems (insomnia);
  • joint or muscle pain; or
  • nausea, vomiting, stomach pain, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about this vaccine (Varivax)?

The varicella vaccine is given in a series of shots. The first shot is usually given to a child who is 12 to 15 months old. The booster shot is then given at 4 to 6 years of age, or at least 3 months after the first dose.

If you are at least 13 years old and you have never had chickenpox or received this vaccine, you should receive two varicella virus vaccines at least 28 days apart.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Do not give salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others to a child under 18 for at least 6 weeks after he or she has received varicella vaccine. A serious condition called Reye's Syndrome has been reported in young people with chickenpox who take aspirin or salicylates.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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