Meruvax

DRUG DESCRIPTION

MERUVAX® II (Rubella Virus Vaccine Live) is a live virus vaccine for vaccination against rubella (German measles).

MERUVAX (rubella virus vaccine live) II is a sterile lyophilized preparation of the Wistar Institute RA 27/3 strain of live attenuated rubella virus. The virus was adapted to and propagated in WI-38 human diploid lung fibroblasts.1,2

The growth medium is Minimum Essential Medium (MEM) [a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum] containing human serum albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests.

The cells, virus pools, fetal bovine serum, and human albumin are all screened for the absence of adventitious agents. Human albumin is processed using the Cohn cold ethanol fractionation procedure.

The reconstituted vaccine is for subcutaneous administration. Each 0.5 mL dose contains not less than 1,000 TCID50 (tissue culture infectious doses) of rubella virus. Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), human albumin (0.3 mg), fetal bovine serum ( < 1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin. The product contains no preservative.

Before reconstitution, the lyophilized vaccine is a light yellow compact crystalline plug. MERUVAX (rubella virus vaccine live) II, when reconstituted as directed, is clear yellow.

What are the possible side effects of rubella virus vaccines (Meruvax II)?

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 measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of...

Read All Potential Side Effects and See Pictures of Meruvax »

What are the precautions when taking rubella virus vaccine live (Meruvax)?

Before receiving rubella 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness with a high fever over 101 degrees F (38 degrees C), decreased immune function from other medications (see also Drug Interactions), decreased immune function from other illness (e.g., advanced HIV/AIDS, leukemia, lymphoma, other cancer affecting the bone marrow or lymph nodes), immune problems with certain white blood cells...

Read All Potential Precautions of Meruvax »

What are the possible side effects of rubella virus vaccines (Meruvax II)?

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 measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of...

Read All Potential Side Effects and See Pictures of Meruvax »

What are the precautions when taking rubella virus vaccine live (Meruvax)?

Before receiving rubella 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness with a high fever over 101 degrees F (38 degrees C), decreased immune function from other medications (see also Drug Interactions), decreased immune function from other illness (e.g., advanced HIV/AIDS, leukemia, lymphoma, other cancer affecting the bone marrow or lymph nodes), immune problems with certain white blood cells...

Read All Potential Precautions of Meruvax »

What are the possible side effects of rubella virus vaccines (Meruvax II)?

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 measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of...

Read All Potential Side Effects and See Pictures of Meruvax »

What are the precautions when taking rubella virus vaccine live (Meruvax)?

Before receiving rubella 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness with a high fever over 101 degrees F (38 degrees C), decreased immune function from other medications (see also Drug Interactions), decreased immune function from other illness (e.g., advanced HIV/AIDS, leukemia, lymphoma, other cancer affecting the bone marrow or lymph nodes), immune problems with certain white blood cells...

Read All Potential Precautions of Meruvax »

What are the possible side effects of rubella virus vaccines (Meruvax II)?

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 measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of...

Read All Potential Side Effects and See Pictures of Meruvax »

What are the precautions when taking rubella virus vaccine live (Meruvax)?

Before receiving rubella 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness with a high fever over 101 degrees F (38 degrees C), decreased immune function from other medications (see also Drug Interactions), decreased immune function from other illness (e.g., advanced HIV/AIDS, leukemia, lymphoma, other cancer affecting the bone marrow or lymph nodes), immune problems with certain white blood cells...

Read All Potential Precautions of Meruvax »


Meruvax Consumer (continued)

SIDE EFFECTS: Pain/redness/swelling at the injection site may occur. Other side effects may include fever, irritability, mild swollen glands (lymph nodes), measles-like rash, hives, tiredness, sore throat, dizziness, headache, nausea, vomiting, diarrhea, and body aches. These rubella-like symptoms may occur 11 to 20 days after vaccination and are usually mild and temporary, often persisting 1 to 5 days. If any of these effects last longer than 5 days 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: joint pain/stiffness, tingling/numbness/pain in the arms/legs, fainting.

Tell your doctor immediately if any of these rare but very serious side effects occur: persistent joint pain/stiffness, easy bruising/bleeding within 2 weeks to 2 months of vaccination, swollen/painful testicles in men, inability to make muscles of the legs/arms work (paralysis), seizures, mental/mood changes (e.g., unusual behavior, severe drowsiness, stiff neck, visual sensitivity to light), decreased hearing, vision problems.

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 rubella 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness with a high fever over 101 degrees F (38 degrees C), decreased immune function from other medications (see also Drug Interactions), decreased immune function from other illness (e.g., advanced HIV/AIDS, leukemia, lymphoma, other cancer affecting the bone marrow or lymph nodes), immune problems with certain white blood cells (T-cells), low or abnormal blood antibodies (hypogammaglobulinemia, dysgammaglobulinemia), untreated tuberculosis (TB) infection.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood clotting cells (platelets), HIV infection without symptoms, brain injury, seizures due to fever.

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 rubella virus vaccine, you should not become pregnant for at least 3 months after the vaccination. Discuss the possible risks with your doctor.

The live, weakened virus in this vaccine is known to pass into breast milk. Rare cases of mild illness in nursing infants have been reported. Consult your doctor before breast-feeding.

Even if your nursing infant is exposed to rubella virus from breast-feeding, he/she should still receive the vaccine at 12 months.


Meruvax Patient Information Including Side Effects

Brand Names: Meruvax II

Generic Name: rubella virus vaccine (Pronunciation: roo BEL a VYE rus vax EEN)

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

What is rubella virus vaccine (Meruvax)?

Rubella is a serious disease caused by a virus. It is spread from person to person through the air.

Rubella virus (also called German Measles) causes skin rash, fever, swollen glands, and joint pain. Becoming infected with rubella during pregnancy can result in a miscarriage or serious birth defects.

The rubella virus vaccine is used to help prevent this disease in adults and children who are at least 12 months old.

This vaccine works by exposing you 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.

Rubella virus vaccine is for use in children between the ages of 12 months and 6 years old, and in adults who have never received the vaccine or had the diseases.

Although immunization against rubella virus is available in a single vaccine, it may be best for you to receive a combination measles, mumps, and rubella (MMR) vaccine. Follow your doctor's instructions.

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

What are the possible side effects of rubella virus vaccines (Meruvax)?

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 measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. 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:

  • high fever (within a few hours or a few days after the vaccine);
  • swollen glands;
  • easy bruising or bleeding, unusual weakness;
  • joint swelling or stiffness that continues for several weeks after vaccination;
  • weakness, severe lower back pain, numbness or tingly feeling in your feet and spreading upward;
  • problems with hearing, vision, speech, swallowing, or bladder and bowel functions;
  • slow heart rate, trouble breathing, feeling like you might pass out;
  • seizure (black-out or convulsions); or
  • severe blistering, peeling, and red skin rash.

Less serious side effects include:

  • low fever, sore throat, cough, runny nose;
  • headache, dizziness, feeling tired or irritable;
  • nausea, vomiting, diarrhea;
  • joint or muscle pain;
  • numbness or tingly feeling; or
  • redness, pain, swelling, or a lump where the shot was given.

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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

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

Although immunization against rubella virus is available in a single vaccine, it may be best for you to receive a combination measles, mumps, and rubella (MMR) vaccine. Follow your doctor's instructions.

You should not receive a rubella virus vaccine if you are pregnant. Wait until after your child is born to receive the vaccine. Avoid becoming pregnant for at least 3 months after receiving a rubella virus vaccine.

The first rubella virus vaccine is usually given to a child who is 12 to 15 month old. The booster shots are then given between 4 and 6 years of age. A measles, mumps, and rubella (MMR) vaccine should then be given before the child starts elementary school.

Adults born after 1956 should receive at least one measles, mumps, and rubella vaccination if they have never had the diseases or received an MMR vaccine during their lifetime.

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 minor cold or low 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.

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 rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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