Rubella virus vaccine, live (subcutaneous route)


    Brand Name

    US Brand Name

    Meruvax II


    Description

    Rubella virus vaccine live is an active immunizing agent used to prevent infection by the rubella virus. It works by causing your body to produce its own protection (antibodies) against the virus infection.

    Rubella (also known as German measles) is a serious infection that causes miscarriages, stillbirths, or birth defects in unborn babies when pregnant women get the disease. While immunization against rubella is recommended for everyone, it is especially important for women of child-bearing age.

    Immunization against rubella is also important for employees in medical facilities, adolescents and adult men, persons traveling outside the U.S., and all children 12 months of age and older, including school-aged children.

    Immunization against rubella is not recommended for infants less than 12 months of age, because antibodies they received from their mothers before birth may interfere with the effectiveness of the vaccine. Children who were immunized against rubella before 12 months of age should be immunized again.

    You can be considered immune to rubella only if you received rubella vaccine on or after your first birthday and have the medical record to prove it, or if you have had a blood test showing immunity to rubella. A past history of having a rubella infection does not prove immunity, because the signs of rubella infection are not reliable enough to be certain that you have had the disease.

    Since vaccination with rubella vaccine may not provide protection for everyone, you may want to ask your doctor to check your immunity to the rubella virus 6 to 8 weeks following your vaccination. This may be especially important if you are a woman of child-bearing age who is likely to become pregnant in the future.

    This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.


    Before Using

    In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Use is not recommended for infants less than 12 months of age. This medicine has been tested in older infants and children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

    Breastfeeding

    Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

    • Alemtuzumab
    • Bendamustine
    • Bortezomib
    • Bosutinib
    • Cabazitaxel
    • Capecitabine
    • Carboplatin
    • Carfilzomib
    • Carmustine
    • Chlorambucil
    • Cisplatin
    • Cladribine
    • Clofarabine
    • Cyclophosphamide
    • Cytarabine
    • Cytarabine Liposome
    • Dacarbazine
    • Dasatinib
    • Daunorubicin
    • Daunorubicin Citrate Liposome
    • Daunorubicin Liposome
    • Deflazacort
    • Docetaxel
    • Doxorubicin
    • Epirubicin
    • Etoposide
    • Fludarabine
    • Fluorouracil
    • Gemcitabine
    • Gemtuzumab Ozogamicin
    • Hydroxyurea
    • Idarubicin
    • Ifosfamide
    • Imatinib
    • Interferon Alfa
    • Irinotecan
    • Irinotecan Liposome
    • Lomustine
    • Mechlorethamine
    • Melphalan

    Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Adalimumab
    • Anifrolumab-fnia
    • Ansuvimab-zykl
    • Antithymocyte Globulin Rabbit
    • Atidarsagene Autotemcel
    • Atoltivimab
    • Axicabtagene Ciloleucel
    • Azathioprine
    • Baricitinib
    • Belatacept
    • Betibeglogene Autotemcel
    • Bimekizumab-bkzx
    • Brexucabtagene Autoleucel
    • Brodalumab
    • Canakinumab
    • Certolizumab Pegol
    • Cyclosporine
    • Deucravacitinib
    • Deuruxolitinib
    • Dupilumab
    • Efgartigimod Alfa-fcab
    • Elivaldogene Autotemcel
    • Emapalumab-lzsg
    • Etanercept
    • Etrasimod
    • Everolimus
    • Fidanacogene Elaparvovec-dzkt
    • Fingolimod
    • Golimumab
    • Guselkumab
    • Hyaluronidase
    • Immune Globulin
    • Inebilizumab-cdon
    • Infliximab
    • Ixekizumab
    • Leflunomide
    • Leniolisib
    • Lovotibeglogene Autotemcel
    • Mirikizumab-mrkz
    • Mycophenolate Mofetil

    Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abatacept
    • Cytomegalovirus Immune Globulin, Human
    • Hepatitis B Immune Globulin
    • Rabies Immune Globulin
    • Respiratory Syncytial Virus Immune Globulin, Human
    • Tetanus Immune Globulin
    • Vaccinia Immune Globulin, Human
    • Varicella-Zoster Immune Globulin

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Immune deficiency condition (or family history of)—Condition may increase the chance and severity of side effects of the vaccine and/or may decrease the useful effects of the vaccine
    • Severe illness with fever—The symptoms of the condition may be confused with the possible side effects of the vaccine

    Proper Use

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For injection dosage form:
      • For prevention of rubella:
        • Adults and children 12 months of age and older—One dose injected under the skin.
        • Children up to 12 months of age—Use is not recommended.

    Precautions

    Do not become pregnant for 3 months after receiving rubella vaccine without first checking with your doctor. There is a chance that this vaccine may cause birth defects.

    Tell your doctor that you have received this vaccine:

    • if you are to receive a tuberculin skin test within 4 to 6 weeks after receiving this vaccine. The results of the test may be affected by this vaccine.
    • if you are to receive blood transfusions or other blood products within 2 weeks after receiving this vaccine.
    • if you are to receive gamma globulin or other immune globulins within 2 weeks after receiving this vaccine.

    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Symptoms of allergic reaction

    • Difficulty in breathing or swallowing
    • hives
    • itching, especially of feet or hands
    • reddening of skin, especially around ears
    • swelling of eyes, face, or inside of nose
    • unusual tiredness or weakness (sudden and severe)

    Check with your doctor as soon as possible if any of the following side effects occur:

    Less common

    • Pain or tenderness of eyes

    Rare

    • Bruising or purple spots on skin
    • confusion
    • convulsions (seizures)
    • headache (severe or continuing)
    • pain, numbness, or tingling of hands, arms, legs, or feet
    • stiff neck
    • unusual irritability
    • vomiting

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Burning or stinging at place of injection
    • skin rash
    • swelling of glands in neck

    Less common

    • Aches or pain in joints
    • headache (mild), sore throat, runny nose, or fever
    • itching, swelling, redness, tenderness, or hard lump at place of injection
    • nausea
    • vague feeling of bodily discomfort

    The above side effects (especially aches or pain in joints) are more likely to occur in adults, particularly women.

    Some of the above side effects may not occur until 1 to 4 weeks after immunization and usually last less than 1 week. Aches or pain in joints may not occur until 1 to 10 weeks after immunization, and usually lasts less than 1 week. Check with your doctor if this side effect continues or is bothersome.

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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