Lyme disease vaccine (recombinant ospa) (intramuscular route)


    Description

    Lyme disease vaccine is an active immunizing agent used to prevent infection by Lyme disease bacteria. It works by causing your body to produce its own protection (antibodies) against the bacteria.

    Lyme disease causes rash, fever, weakness, and joint and muscle pain. The disease is caused by bacteria passed to humans by the bite of infected ticks.

    The risk of getting tick-borne infections can be lessened by such precautions as wearing long-sleeved shirts and long pants, tucking pants into socks, treating clothing with tick repellent, and checking for and removing attached ticks.

    This medicine is no longer commercially available.


    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

    Lyme disease vaccine has not been tested in persons younger than 15 years of age. Use is not recommended in infants and children.

    Geriatric

    Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly as they do in younger adults. Although there is no specific information comparing use of Lyme disease vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older people than it does in younger 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    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 Lyme disease vaccine. Make sure you tell your doctor if you have any other medical problems.


    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.

    This medication is not longer on the market


    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 as soon as possible if any of the following side effects occur:

    More common

    • Numbness
    • tingling
    • unusual tiredness or weakness

    Less common

    • Bone pain
    • chills
    • cough
    • fever
    • muscle aches
    • runny or stuffy nose
    • shivering
    • skin rash, itching, redness, swelling, or other sign of irritation not present before vaccination
    • sneezing
    • sore throat
    • sweating

    Rare

    • Difficulty swallowing
    • dizziness
    • fast heartbeat
    • headache, severe
    • puffiness or swelling around eyelids
    • shortness of breath

    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

    • Back pain
    • pain in joints and/or muscles

    Less common

    • Depression
    • diarrhea
    • dizziness
    • feeling unusually cold

    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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