VITAMIN K1 EMULSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VITAMIN K1

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

B02BA01

INN (International Name):

PHYTOMENADIONE

Dosage:

10MG

Pharmaceutical form:

EMULSION

Composition:

VITAMIN K1 10MG

Administration route:

INTRAMUSCULAR

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

VITAMIN K ACTIVITY

Product summary:

Active ingredient group (AIG) number: 0108526001; AHFS:

Authorization status:

APPROVED

Authorization date:

2024-02-16

Summary of Product characteristics

_Vitamin K1 _
_Page 1 of 10 _
_ _
PRESCRIBING INFORMATION
VITAMIN K
1
(PHYTONADIONE INJECTABLE EMULSION USP)
10 MG / ML
1 MG / 0.5 ML
STERILE
Sandoz Canada Inc.
110 Rue de Lauzon
Date of revision: February 16, 2024
Boucherville, QC, Canada Control Number: 278964
J4B 1E6
_Vitamin K1 _
_page _2 of 10_ _
PRESCRIBING INFORMATION
VITAMIN K
1
(PHYTONADIONE INJECTABLE EMULSION USP)
10 MG / ML
1 MG / 0.5 ML
STERILE
CHEMISTRY
Phytonadione is a synthetic fat soluble naphthoquinone derivative
which is identical to naturally
occurring vitamin K
1
. Vitamin K
1
differs from other naturally occurring types of vitamin K in the
degree of saturation and length of its 20-carbon polyisoprenoid side
chain. Phytonadione occurs as a
mixture of cis and trans isomers, with the cis isomer not exceeding
20%. Phytonadione occurs as a
clear, yellow to amber, very viscous, odourless or practically
odourless liquid, having a specific gravity
of about 0.967. It is stable in air, but decomposes on exposure to
sunlight. Phytonadione is soluble in
dehydrated alcohol, chloroform, ether, and vegetable oils. The drug is
slightly soluble in alcohol and
insoluble in water.
DETAILED PHARMACOLOGY
Phytonadione possesses the same type and degree of activity as
naturally occurring vitamin K
1
. The
latter is necessary for the production by the liver of the following
coagulation factors: prothrombin
(factor II), proconvertin (factor VII), plasma thromboplastin
component (factor IX), and Stuart factor
(factor X). Studies indicate that vitamin K is involved in
carboxylation of the preformed inactive
precursors of these coagulation factors. The resulting
gamma-carboxyglutamyl residues are required for
the calcium-dependent phospholipid binding exhibited by active vitamin
K-dependent clotting factors.
In adequate doses, phytonadione reverses the inhibitory effect of
coumarin and indanedione derivatives
on the synthesis of these factors. A rare genetic mutation of the
vitamin K receptor site which is
associated with resistance to coumarin and indanedione derivat