PHYTONADIONE injection, emulsion

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)

থেকে পাওয়া:

General Injectables & Vaccines, Inc

INN (আন্তর্জাতিক নাম):

PHYTONADIONE

রচনা:

PHYTONADIONE 1 mg in 0.5 mL

প্রশাসন রুট:

PARENTERAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

1.1 Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Phytonadione Injectable Emulsion, USP is indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity; - anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; - hypoprothrombinemia due to antibacterial therapy; - hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; - other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. 1.2 Prophylaxis and Treatment of Vitamin K-Deficiency Bleeding in Neonates Phytonadione Injectable Emulsion, USP is indicated for prophylaxi

পণ্য সারাংশ:

Phytonadione Injectable Emulsion, USP is a yellow, sterile, aueous colloidal solution and is supplied in unit use packages containing one single-dose vial and a SAF-T-Jet vial injector, 27 G. x 1/2" needle. Phytonadione Injectable Emulsion USP, 1 mg in 0.5 mL Stock No. 1240 NDC 76329-1240-1 10 individual cartons shrink wrapped as a group of 10 cartons. Syringe Assembly Directions: See User Guide USE ASEPTIC TECHNIQUE Do not remove from carton or assemble until ready to use.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

PHYTONADIONE- PHYTONADIONE INJECTION, EMULSION
GENERAL INJECTABLES & VACCINES, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
PHYTONADIONE INJECTION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHYTONADIONE
INJECTABLE EMULSION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
PHYTONADIONE INJECTABLE EMULSION, USP.
PHYTONADIONE INJECTION, FOR INTRAVENOUS, INTRAMUSCULAR, AND
SUBCUTANEOUS USE.
INITIAL U.S. APPROVAL: 1960
FATAL HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS, HAVE
OCCURRED DURING AND
IMMEDIATELY AFTER INTRAVENOUS AND INTRAMUSCULAR INJECTION OF
PHYTONADIONE
INJECTABLE EMULSION, USP. REACTIONS HAVE OCCURRED DESPITE DILUTION TO
AVOID RAPID
INFUSION AND UPON FIRST AND SUBSEQUENT DOSES. AVOID THE INTRAVENOUS
AND
INTRAMUSCULAR ROUTES OF ADMINISTRATION UNLESS THE SUBCUTANEOUS ROUTE
IS NOT REASIBLE
AND THE SERIOUS RISK IS JUSTIFIED. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Cutaneous Reactions (5.3) 04/2018
INDICATIONS AND USAGE
Phytonadione Injectable Emulsion, USP is a vitamin K replacement
indicated for the treatment of the
following coagulation disorders which are due to faulty formation of
factors II, VII, IX and X when cause by
vitamin K deficiency or interference with vitamin K activity. (1)
Anticoagulant-induced hypoprothrombinemia deficiency caused by
coumarin or indanedione
derivatives; (1.1)
Hypoprothrombinemia due to antibacterial therapy; (1.1)
Hypoprothrombinemia secondary to factors limiting absorption or
synthesis of vitamin K, e.g.,
obstructive jaundice, biliary fistula, sprue, ulcerative colitis,
celiac disease, intestinal resection, cystic
fibrosis of the pancreas, and regional enteritis; (1.1)
Other drug-induced hypoprothrombinemia where is it definitely shown
that the result is due to
interference with vitamin K metabolism, e.g., salicylates. (1.1)
Phytonadione Injectable Emulsion, USP is indicated for prophylaxis and
treatment of vitamin K-deficiency
bleeding in neonates. (1.2) (1)
DOSAGE AND ADMINISTRATION
Administer Phytonadio