PHYTONADIONE injection, emulsion

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Phytonadione (UNII: A034SE7857) (Phytonadione - UNII:A034SE7857)

থেকে পাওয়া:

International Medication Systems, Limited

INN (আন্তর্জাতিক নাম):

Phytonadione

রচনা:

Phytonadione 1 mg in 0.5 mL

প্রশাসন রুট:

INTRAMUSCULAR

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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. Phytonadione Injectable Emulsion, USP is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. Hypersensitivity to phytonadione or any other component of this medication [see Warnings a

পণ্য সারাংশ:

Phytonadione Injectable Emulsion, USP is a yellow, sterile, aqueous colloidal solution and is supplied in unit use packages containing one single-dose vial and a SAF-T-Jet® vial injector, 27 G. x ½” 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. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect Phytonadione Injectable Emulsion, USP from light. Store container in closed original carton until contents have been used.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

PHYTONADIONE- PHYTONADIONE INJECTION, EMULSION
INTERNATIONAL MEDICATION SYSTEMS, LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
WARNING – HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND
INTRAMUSCULAR
USE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
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 FEASIBLE
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 caused by
vitamin K deficiency or interference with vitamin K activity.
• Anticoagulant-induced hypoprothrombinemia deficiency caused by
coumarin or indane-
dione 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