RX ITEM-Koate Dvi 250 (+ ) Vial 5Ml By ASD Healthcare

KOATE � antihemophilic factor (human)
KEDRION BIOPHARMA, INC.

Figures 1-8Label 76125-252-21Label 76125-669-31Label 76125-673-51Carton 76125-256-20 250 IUCarton 76125-668-30 500 IUCarton 76125-676-50 1000 IULabel 13533-000-05 10 mL DiluentLabel 13533-000-04 5mL Diluent
1 INDICATIONS AND USAGE

KO?TE� 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

KO?TE is not indicated for the treatment of von Willebrand disease.

2 DOSAGE AND ADMINISTRATION

For intravenous use after reconstitution only.

2.1 Dose
Dose and duration of treatment depend on the severity of the Factor VIII deficiency, location and extent of bleeding, and the patient�s clinical condition.
Each vial of KO?TE is labeled with the actual Factor VIII potency in international units (IU). Calculation of the required dose of Factor VIII is based on the empirical finding that one IU of Factor VIII per kg body weight raises the plasma Factor VIII activity by approximately 2% of normal activity or 2 IU/dL.
The required dose can be determined using the following formula:
Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (% normal or IU/dL) x 0.5
Estimate the expected in vivo peak increase in Factor VIII level, expressed as IU/dL (or % normal), using the following formula:
Estimated Increment of Factor VIII

(% normal or IU/dL) = [Total Dose (IU)/Body Weight (kg)] x 2
Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses. Base the dose and frequency on the individual clinical response.

RX ITEM-Koate Dvi 250 (+ ) Vial 5Ml By A
NDC 76125-0250-20 UPC/GTIN No. Mfg.Part No.39567

Koate Dvi 250 (+ ) Vial 5Ml By ASD Healt
BRAND: KOATE NDC: 76125-0250-20,76125025020 UPC: , ASD Specialty Healthcare-Special Order

ANTIHEMOPHILIC FACTOR, HU
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