Protein c, human (intravenous route)


    Brand Name

    US Brand Name

    Ceprotin


    Description

    Protein C is a protein produced naturally in the body. It is used in patients with severe congenital protein C deficiency to prevent and treat venous thrombosis (harmful blood clots form in the blood vessels) and purpura fulminans (harmful blood clots form in the skin) .

    Protein C is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns .

    This medicine is available only with your doctor's prescription .

    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 pediatrics-specific problems that would limit the usefulness of human protein C in children .

    Geriatric

    Appropriate studies on the relationship of age to the effects of human protein C have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date .

    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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Defibrotide

    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.

    • Abciximab
    • Aceclofenac
    • Acemetacin
    • Alipogene Tiparvovec
    • Alteplase, Recombinant
    • Amtolmetin Guacil
    • Anagrelide
    • Anistreplase
    • Apixaban
    • Aspirin
    • Betrixaban
    • Bromfenac
    • Bufexamac
    • Cangrelor
    • Caplacizumab-yhdp
    • Celecoxib
    • Choline Salicylate
    • Cilostazol
    • Citalopram
    • Clonixin
    • Clopidogrel
    • Collagenase, Clostridium histolyticum
    • Curcumin
    • Dabigatran Etexilate
    • Desvenlafaxine
    • Dexibuprofen
    • Dexketoprofen
    • Diclofenac
    • Diflunisal
    • Dipyridamole
    • Dipyrone
    • Droxicam
    • Edoxaban
    • Epoprostenol
    • Eptifibatide
    • Escitalopram
    • Etodolac
    • Etofenamate
    • Etoricoxib
    • Felbinac

    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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Bleeding problems—This medicine contains heparin. Using this medicine may make your bleeding problem worse .
    • Kidney disease or
    • Other conditions that require low sodium diets (e.g., high blood pressure)—This medicine contains sodium and may make these conditions worse .

    Proper Use

    A nurse or other trained health care professional will give you this medicine. This medicine is given through a needle placed in one of your veins .


    Precautions

    It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects .

    This medicine may cause allergic reactions. Stop using this medicine and tell your doctor right away if you have itching, hives, trouble breathing, or any swelling of your hands, face, or mouth when you use this medicine .


    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

    • Fainting or loss of consciousness
    • fast or irregular breathing
    • itching
    • lightheadedness
    • skin rash
    • swelling of eyes or eyelids
    • tightness in chest and/or wheezing
    • trouble with breathing

    Incidence not known

    • Blurred vision
    • confusion
    • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
    • fever
    • sweating
    • unusual tiredness or weakness

    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:

    Incidence not known

    • Increased sweating
    • restlessness

    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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