Antithrombin iii human (intravenous route)


    Brand Name

    US Brand Name

    Thrombate III


    Description

    Antithrombin III human injection is used to prevent and treat blood clotting problems (eg, thromboembolism) and prevent clots in the blood vessels before or after surgery or during certain medical procedures in patients with hereditary antithrombin deficiency.

    This medicine is to be given only by or under the supervision of your doctor.

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, 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 antithrombin III human injection in children. Safety and efficacy have been established.

    Geriatric

    Appropriate studies on the relationship of age to the effects of antithrombin III human injection have not been performed in the geriatric population. Safety and efficacy have not been established.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 medicine, 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.

    Using this medicine 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.

    • Chamomile
    • Papaya
    • Tan-Shen

    Using this medicine 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.

    • Chondroitin
    • Coenzyme Q10
    • Dong Quai
    • Ginger
    • Vitamin A

    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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Avocado

    Proper Use

    A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins.


    Precautions

    It is very important that your doctor check your progress closely for any problems that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.

    This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

    This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, Creutzfeldt-Jakob disease) to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription and 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:

    More common

    • Chest pain or discomfort
    • pain or cramps
    • trouble breathing

    Less common

    • Collection of blood under the skin
    • deep, dark purple bruise
    • itching, pain, redness, or swelling at the injection site

    Incidence not known

    • Chest tightness
    • chills
    • cough
    • difficulty swallowing
    • dizziness, lightheadedness, or fainting
    • fast heartbeat
    • fever
    • hives, skin rash
    • nausea
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • 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

    • Change in taste
    • loss of taste

    Less common

    • Blurred vision

    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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