KOATE (antihemophilic factor- human kit KOATE (antihemophilic factor- human kit

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Antihemophilic Factor Human (UNII: 839MOZ74GK) (Antihemophilic Factor Human - UNII:839MOZ74GK)

থেকে পাওয়া:

KEDRION BIOPHARMA, INC.

INN (আন্তর্জাতিক নাম):

Antihemophilic Factor Human

রচনা:

Antihemophilic Factor Human 250 [iU] in 5 mL

থেরাপিউটিক ইঙ্গিত:

KOĀTE® is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A (hereditary Factor VIII deficiency). Limitation of Use KOĀTE is not indicated for the treatment of von Willebrand disease. KOĀTE is contraindicated in patients who have had hypersensitivity reactions, including anaphylaxis, to KOĀTE or its components. [see Description (11) ] Risk Summary There are no data with KOĀTE use in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using KOĀTE. It is not known whether KOĀTE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. KOĀTE should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary There is no information regarding the presence of KOĀTE in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for KOĀTE and any potential adverse effects on the breast-fed infant from KOĀTE or from the underlying maternal condition. Safety and efficacy studies have been performed in 20 previously treated pediatric patients aged 2.5 to 16 years. Subjects received 208 infusions of KOĀTE for treatment or control of bleeding episodes, including perioperative management, and routine prophylaxis. Children have shorter half-life and lower recovery of Factor VIII than adults. Because clearance of Factor VIII (based on per kilogram body weight) is higher in children, higher or more frequent dosing may be needed. Clinical studies of KOĀTE did not include any subjects aged 65 and over to determine whether they respond differently from younger subjects. Individualize dose selection for geriatric patients.

পণ্য সারাংশ:

How Supplied KOĀTE is supplied in single-use vials containing 250, 500 or 1,000 IU of Factor VIII activity, packaged with 5 mL or 10 mL of Sterile Water for Injection, one sterile double-ended transfer needle, one sterile filter needle, and one sterile administration set. The actual amount of KOĀTE in IU is stated on each carton and vial label. Components used in the packaging of KOĀTE are not made with natural rubber latex. Strength NDC Number Carton (Kit) 250 IU 76125-250-20, 76125-253-25 or 76125-258-02 500 IU 76125-667-30, 76125-662-50 or 76125-661-02 1,000 IU 76125-672-50, 76125-674-10 or 76125-675-12 Storage and Handling

অনুমোদন অবস্থা:

Biologic Licensing Application

পণ্য বৈশিষ্ট্য

KOATE - ANTIHEMOPHILIC FACTOR (HUMAN)
KOATE - ANTIHEMOPHILIC FACTOR (HUMAN)
KEDRION BIOPHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KOĀTE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KOĀTE.
KOĀTE , ANTIHEMOPHILIC FACTOR (HUMAN)
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
KOĀTE is a human plasma-derived antihemophilic factor indicated for
the control and prevention of
bleeding episodes or in order to perform emergency and elective
surgery in patients with hemophilia A
(hereditary Factor VIII deficiency). (1)
Limitation of Use
KOĀTE is not indicated for the treatment of von Willebrand disease.
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY.
• Each vial of KOĀTE contains the labeled amount of Factor VIII in
international units (IU). (2)
• Required Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise
(IU/dL or % of normal) x 0.5
• Frequency of KOĀTE administration is determined by the type of
bleeding episode and the
recommendation of the treating physician.
DOSAGE FORMS AND STRENGTHS
KOĀTE is available as a lyophilized powder for reconstitution in
single-use vials of 250, 500, and 1,000
international units of Factor VIII activity. (3)
CONTRAINDICATIONS
Do not use in patients who have known hypersensitivity reactions,
including anaphylaxis, to KOĀTE or its
components. (4)
WARNINGS AND PRECAUTIONS
• Hypersensitivity reactions, including anaphylaxis, are possible.
Should symptoms occur, discontinue
KOĀTE and administer appropriate treatment. (5.1)
• Development of neutralizing antibodies (inhibitors) may occur. If
expected plasma Factor VIII activity
levels are not attained, or if bleeding is not controlled with an
appropriate dose, perform an assay that
measures Factor VIII inhibitor concentration. (5.2)
• Monitor for intravascular hemolysis and decreasing hematocrit
values in patients with A, B or AB blood
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