CEPROTIN- protein c concentrate human kit

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Takeda Pharmaceuticals America, Inc.

INN (Nome Internazionale):

PROTEIN C

Composizione:

PROTEIN C 500 [iU] in 5 mL

Indicazioni terapeutiche:

CEPROTIN, Protein C Concentrate (Human), is an anticoagulant indicated for neonates, pediatric and adult patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans. None. Risk Summary There are no data with CEPROTIN use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with CEPROTIN. It is also not known whether CEPROTIN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CEPROTIN has not been studied for use during labor and delivery. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively, regardless of drug exposure. Risk Summary There is no information regarding the presence of CEPROTIN in human milk, the effect on the breastfed infant, or the effects on milk production. CEPROTIN has not been studied for use in nursing mothers

Dettagli prodotto:

CEPROTIN, Protein C Concentrate (Human), is supplied as a sterile, white or cream colored, lyophilized powder for IV injection. It has a pH between 6.7 and 7.3 and an osmolality not lower than 240 mosmol/kg. One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 mL of normal plasma. The potency (IU) is determined using a chromogenic substrate method referenced against the World Health Organization (WHO) International Standard (86/622). CEPROTIN is available in single-dose vials that contain the following nominal product strengths: : 500 IU per vial: (NDC: 0944-4177-05) : 1000 IU per vial: (NDC: 0944-4179-10) Actual potency is printed on the vial label. One package of CEPROTIN contains one glass vial of CEPROTIN powder, one glass vial of Sterile Water for Injection, USP, one transfer needle, one filter needle, one full prescribing physician insert and one patient package insert. CEPROTIN, packaged for sale, is stable for 3 years when stored refrigerated at 2°C–8°C (36°F-46°F). Do not freeze in order to prevent damage to the diluent vial. Store the vial in the original carton to protect it from light. The reconstituted solution should be used within 3 hours of reconstitution. Do not use beyond the expiration date on the CEPROTIN vial.

Stato dell'autorizzazione:

Biologic Licensing Application

Scheda tecnica

CEPROTIN- PROTEIN C CONCENTRATE HUMAN
TAKEDA PHARMACEUTICALS AMERICA, 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: 2007
INDICATIONS AND USAGE
CEPROTIN, Protein C Concentrate (Human), is an anticoagulant indicated
for neonates, pediatric and adult
patients with severe congenital Protein C deficiency for the
prevention and treatment of venous
thrombosis and purpura fulminans. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS ADMINISTRATION ONLY.
Initiate treatment under the supervision of a physician experienced in
using coagulation
factors/inhibitors where monitoring of Protein C activity is feasible.
(2.1)
Table provides the CEPROTIN dosing schedule for acute episodes,
short-term prophylaxis, and long-
term prophylaxis*
INITIAL DOSE
SUBSEQUENT 3 DOSES
MAINTENANCE DOSE
*Dosing is based upon a clinical trial of 15 patients.
*
†
Acute Episodes, Short-
term Prophylaxis
100-120 IU/kg
60-80 IU/kg
Q 6 hours
45-60 IU/kg
Q 6 or Q 12 hours
Long-term Prophylaxis
NA
NA
45-60 IU/kg
Q 12 hours
Administer CEPROTIN at a maximum injection rate of 2 mL per minute
except for children with a
bodyweight of < 10 kg, where the injection rate should not exceed a
rate of 0.2 mL/kg/minute.
DOSAGE FORMS AND STRENGTHS
: Approximately 500 IU/vial (3)
: Approximately 1000 IU/vial (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Discontinue administration of CEPROTIN if symptoms of
hypersensitivity/allergic reactions occur. (2.1,
5.1, 6)
Because CEPROTIN is made from human plasma, it may carry a risk of
transmitting infectious agents,
e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and
theoretically, the Creutzfeldt-Jakob
disease agent. (5.2, 11)
Simultaneous administration of CEPROTIN with tPA and/or anticoagulants
may increase the risk of
bleeding. (5.3)
CE