AQUAMEPHYTON phytonadione injection emulsion

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Teligent Pharma, Inc.

INN:

PHYTONADIONE

composition:

PHYTONADIONE 2 mg in 1 mL

prescription_type:

PRESCRIPTION DRUG

authorization_status:

New Drug Application

SPC

AQUAMEPHYTON - PHYTONADIONE INJECTION, EMULSION
TELIGENT PHARMA, INC.
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AQUAMEPHYTON®
(PHYTONADIONE)
AQUEOUS COLLOIDAL SOLUTION OF VITAMIN K
WARNING — INTRAVENOUS AND INTRAMUSCULAR USE
Severe reactions, including fatalities, have occurred during and
immediately after
INTRAVENOUS injection of AquaMEPHYTON (Phytonadione), even when
precautions have
been taken to dilute the AquaMEPHYTON and to avoid rapid infusion.
Severe reactions, including
fatalities, have also been reported following INTRAMUSCULAR
administration. Typically these
severe reactions have resembled hypersensitivity or anaphylaxis,
including shock and cardiac
and/or respiratory arrest. Some patients have exhibited these severe
reactions on receiving
AquaMEPHYTON for the first time. Therefore the INTRAVENOUS and
INTRAMUSCULAR
routes should be restricted to those situations where the subcutaneous
route is not feasible and
the serious risk involved is considered justified.
DESCRIPTION
Phytonadione is a vitamin, which is a clear, yellow to amber, viscous,
odorless or nearly odorless
liquid. It is insoluble in water, soluble in chloroform and slightly
soluble in ethanol. It has a molecular
weight of 450.70.
Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical
formula is C
H O and its
structural formula is:
AquaMEPHYTON injection is a yellow, sterile, aqueous colloidal
solution of vitamin K , with a pH of
5.0 to 7.0, available for injection by the intravenous, intramuscular,
and subcutaneous routes.
Each milliliter contains:
Phytonadione 2 mg or 10 mg
Inactive ingredients:
Polyoxyethylated fatty acid derivative 70 mg
Dextrose 37.5 mg
Water for injection, q.s. 1 mL
Added as preservative:
Benzyl alcohol 9 mg
1
31
46
2
1
CLINICAL PHARMACOLOGY
AquaMEPHYTON aqueous colloidal solution of vitamin K for parenteral
injection, possesses the
same type and degree of activity as does naturally-occurring vitamin
K, which is necessary for the
production via the liver of active prothrombin (factor II),
proconvertin (factor VII), plasma
thrombopl