Brand Name

    US Brand Name

    Imovax Rabies

    Rabavert


    Description

    Rabies vaccine is an active immunizing agent used to prevent infection caused by the rabies virus. The vaccine works by causing your body to produce its own protection (antibodies) against the rabies virus.

    Rabies vaccine is used in two ways. Rabies vaccine is given to persons who have been exposed (eg, by a bite, scratch, or lick) to an animal that is known, or thought, to have rabies. This is called post-exposure prophylaxis. Rabies vaccine may also be given ahead of time to persons who have a high risk of getting infected with rabies virus. These persons include veterinarians, animal handlers, or travelers who will spend more than 1 month in countries having a high rate of rabies infection, and persons who live, work, or take vacations in wild areas of the country where they are likely to come into contact with wild animals. This is called pre-exposure prophylaxis.

    Rabies infection is a serious, and often fatal, infection. In the U.S., rabies in wild animals, especially raccoons, skunks, foxes, and bats, accounts for most cases of rabies passed on to humans, pets, and other domestic animals. In Canada, the animals most often infected with rabies are foxes, skunks, bats, dogs, and cats. Horses, swine, and cattle also have been known to become infected with rabies. In much of the rest of the world, including Latin America, Africa, and Asia, dogs account for most cases of rabies passed on to humans.

    If you are being (or will be) treated for a possible rabies infection while traveling outside of the U.S. or Canada, contact your doctor as soon as you return to the U.S. or Canada, since it may be necessary for you to have additional treatment.

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

    This product is available in the following dosage forms:

    • Powder for Suspension

    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

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of rabies vaccine in children.

    Geriatric

    No information is available on the relationship of age to the effects of rabies vaccine in geriatric patients.

    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 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.

    • Atidarsagene Autotemcel
    • Chloroquine
    • Elivaldogene Autotemcel
    • Teplizumab-mzwv
    • Ublituximab-xiiy

    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:

    • Illness with fever, severe—The symptoms of the condition may be confused with the possible side effects of the vaccine.
    • Immune system problems—May decrease the useful effects of the vaccine.

    Proper Use

    You will receive this vaccine while you are in a hospital or clinic. A nurse or other trained health professional will give you this vaccine. The vaccine is injected into the upper arm muscle (deltoid). Very young or small children may have the vaccine injected into the upper leg (thigh) muscle.

    If you are a veterinarian, work with animals, or will be going to a country where rabies is common, you are at risk for exposure to the rabies virus. If you are getting the vaccine because you are at risk of being exposed to rabies, you will receive 3 doses on 3 different days within a 1-month period.

    If you have already received the vaccine in the past and have been exposed to the rabies virus, you will need to get 2 doses on 2 different days within a 1-month period.

    If you have not yet received the vaccine and were exposed to the rabies virus, you will need a total of 5 doses on 5 different days within a 1-month period. You will also receive a shot of rabies immune globulin.

    In order for the rabies vaccine to work properly, it is very important that you do not miss any doses. Keep your appointments with your doctor.

    Missed Dose

    Call your doctor or pharmacist for instructions.


    Precautions

    It is very important that your doctor check you or your child's progress at regular visits to make sure that this vaccine is working properly. Blood tests may be needed to check for unwanted effects.

    This medicine is made from donated human blood. There is a very small risk for the transmission of viral diseases. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    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 or nurse immediately if any of the following side effects occur:

    Incidence not known

    • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
    • confusion
    • cough
    • difficulty with moving
    • difficulty with swallowing
    • fast heartbeat
    • feeling of discomfort
    • irritability
    • lack or loss of strength
    • muscle pain, stiffness, or weakness
    • paralysis or severe weakness of the legs
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • rash
    • seizures
    • skin rash, hives, or redness
    • stiffness of arms, legs, or neck
    • swelling of the joints
    • swollen, painful, or tender lymph glands in the neck, armpit, or groin
    • tightness in the chest
    • unusual tiredness
    • 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

    • Chills
    • dizziness
    • fever
    • general feeling of discomfort or illness
    • headache
    • itching, pain, redness, or swelling at the injection site
    • muscle or joint aches
    • nausea
    • stomach pain

    Incidence not known

    • Bruising at the injection site
    • diarrhea

    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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