KCENTRA- prothrombin, coagulation factor vii human, coagulation factor ix human, coagulation factor x human, protein c, protein

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

16-05-2023

इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।

सक्रिय संघटक:

PROTHROMBIN (UNII: 8FB1K07F16) (PROTHROMBIN - UNII:8FB1K07F16), COAGULATION FACTOR VII HUMAN (UNII: 4156XVB4QD) (COAGULATION FACTOR VII HUMAN - UNII:4156XVB4QD), COAGULATION FACTOR IX HUMAN (UNII: 6U90Y1795T) (COAGULATION FACTOR IX HUMAN - UNII:6U90Y1795T), COAGULATION FACTOR X HUMAN (UNII: 0P94UQE6SY) (COAGULATION FACTOR X HUMAN - UNII:0P94UQE6SY), Protein C (UNII: 3Z6S89TXPW) (Protein C - UNII:3Z6S89TXPW), Protein S Human (UNII: 90J3F6N5FN) (Protein S Human - UNII:90J3F6N5FN)

थमां उपलब्ध:

CSL Behring GmbH

INN (इंटरनेशनल नाम):

PROTHROMBIN

रचना:

PROTHROMBIN 590 U in 20 mL

चिकित्सीय संकेत:

KCENTRA, (Prothrombin Complex Concentrate (Human)), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with: - acute major bleeding or - need for an urgent surgery/invasive procedure. KCENTRA is contraindicated in: - Patients with known anaphylactic or severe systemic reactions to KCENTRA or any components in KCENTRA including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin. - Patients with disseminated intravascular coagulation (DIC). - Patients with known heparin-induced thrombocytopenia (HIT). KCENTRA contains heparin [see Description (11)] . Risk Summary There are no data with KCENTRA use in pregnancy to inform on drug-associated risk. Animal reproduction studies have not been conducted with KCENTRA. It is not known whether KCENTRA can cause fetal harm when administered to a pregnant woman or can affect reproduction

उत्पाद समीक्षा:

Table 17. How Supplied Each kit consists of the following: Storage and Handling Prior to Reconstitution After Reconstitution KCENTRA must be used within 4 hours following reconstitution. Reconstituted KCENTRA can be stored at 2–25°C. If cooled, the solution should be warmed to 20–25°C prior to administration. Do not freeze. Discard partially used vials.

प्राधिकरण का दर्जा:

Biologic Licensing Application

उत्पाद विशेषताएं

KCENTRA- PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR
IX
HUMAN, COAGULATION FACTOR X HUMAN, PROTEIN C, PROTEIN S HUMAN, AND
WATER
CSL BEHRING GMBH
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KCENTRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KCENTRA.
KCENTRA (PROTHROMBIN COMPLEX CONCENTRATE (HUMAN))
FOR INTRAVENOUS USE, LYOPHILIZED POWDER FOR RECONSTITUTION
INITIAL U.S. APPROVAL: 2013
WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS
PATIENTS BEING TREATED WITH VITAMIN K ANTAGONISTS (VKA) THERAPY HAVE
UNDERLYING
DISEASE STATES THAT PREDISPOSE THEM TO THROMBOEMBOLIC EVENTS.
POTENTIAL BENEFITS OF
REVERSING VKA SHOULD BE WEIGHED AGAINST THE POTENTIAL RISKS OF
THROMBOEMBOLIC
EVENTS, ESPECIALLY IN PATIENTS WITH THE HISTORY OF A THROMBOEMBOLIC
EVENT. RESUMPTION
OF ANTICOAGULATION SHOULD BE CAREFULLY CONSIDERED AS SOON AS THE RISK
OF
THROMBOEMBOLIC EVENTS OUTWEIGHS THE RISK OF ACUTE BLEEDING.
BOTH FATAL AND NON-FATAL ARTERIAL AND VENOUS THROMBOEMBOLIC
COMPLICATIONS HAVE
BEEN REPORTED WITH KCENTRA IN CLINICAL TRIALS AND POST MARKETING
SURVEILLANCE. MONITOR
PATIENTS RECEIVING KCENTRA FOR SIGNS AND SYMPTOMS OF THROMBOEMBOLIC
EVENTS.
KCENTRA WAS NOT STUDIED IN SUBJECTS WHO HAD A THROMBOEMBOLIC EVENT,
MYOCARDIAL
INFARCTION, DISSEMINATED INTRAVASCULAR COAGULATION, CEREBRAL VASCULAR
ACCIDENT,
TRANSIENT ISCHEMIC ATTACK, UNSTABLE ANGINA PECTORIS, OR SEVERE
PERIPHERAL VASCULAR
DISEASE WITHIN THE PRIOR 3 MONTHS. KCENTRA MAY NOT BE SUITABLE IN
PATIENTS WITH
THROMBOEMBOLIC EVENTS IN THE PRIOR 3 MONTHS. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2)
05/2023
INDICATIONS AND USAGE
KCENTRA, Prothrombin Complex Concentrate (Human), is a blood
coagulation factor replacement product
indicated for the urgent reversal of acquired coagulation factor
deficiency induced by Vitamin K antagonist
(VKA, e.g., warfarin) therapy in adult patients with:
acute major bleeding or
need for an urgent surgery/invasive procedure. (1)
D

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