CEPROTIN protein concentrate human

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

PROTEIN C (UNII: 3Z6S89TXPW) (PROTEIN C - UNII:3Z6S89TXPW)

Dostępny od:

Baxalta US Inc

INN (International Nazwa):

PROTEIN C

Skład:

PROTEIN C 100 [iU] in 1 mL

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

Biologic Licensing Application

Charakterystyka produktu

CEPROTIN- PROTEIN C CONCENTRATE HUMAN
BAXALTA US INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEPROTIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CEPROTIN.
CEPROTIN [PROTEIN C CONCENTRATE (HUMAN)] LYOPHILIZED POWDER FOR
SOLUTION FOR INJECTION
INITIAL U.S. APPROVAL: 2010
INDICATIONS AND USAGE
CEPROTIN is indicated for patients with severe congenital Protein C
deficiency for the prevention and treatment of
venous thrombosis and purpura fulminans. CEPROTIN is indicated as a
replacement therapy for pediatric and adult
patients. _(1.1)_
DOSAGE AND ADMINISTRATION
INITIATE TREATMENT UNDER THE SUPERVISION OF A PHYSICIAN EXPERIENCED IN
USING COAGULATION FACTORS/INHIBITORS
WHERE MONITORING OF PROTEIN C ACTIVITY IS FEASIBLE. _(2.1)_
NA = Not applicable; Q = every.
*
†
‡
CEPROTIN DOSING SCHEDULE FOR ACUTE EPISODES, SHORT-TERM PROPHYLAXIS
AND LONG-TERM PROPHYLAXIS
INITIAL DOSE
SUBSEQUENT 3
DO SE S
MAINTENANCE
DO SE
Acute Episode /
Short-term Prophylaxis
100-120 IU/kg
60 - 80 IU/kg
Q 6 hours
45 - 60 IU/kg
Q 6 or 12 hours
Long-term Prophylaxis
NA
NA
45 - 60 IU/kg
Q 12 hours
Store at 2°C – 8°C (36°F-46°F) and protect from light. Avoid
freezing. Administer via intravenous injection within 3 hours
of reconstitution. _(16)_
DOSAGE FORMS AND STRENGTHS
Blue Bar: Approximately 500 IU/vial _(3)_
Green Bar: Approximately 1000 IU/vial _(3)_
Each single-dose vial contains the following excipients: 8 mg/mL human
albumin, 4.4 mg/mL trisodium citrate dihydrate
and 8.8 mg/mL sodium chloride when reconstituted with the appropriate
amount of diluent. _(3)_
CONTRAINDICATIONS
None. _(4)_
WARNINGS AND PRECAUTIONS
Discontinue administration if symptoms of hypersensitivity/allergic
reactions occur. _(2.1, 5.1, 6.1)_
Made from pooled human plasma. The possibility of transmitting
infectious agents cannot be ruled out. _(5.2, 11)_
Simultaneous administration with tPA and/or anticoagulants may
increase risk of bleeding. _(5.3)_
Contains heparin. If hepa