Ország: Kanada
Nyelv: angol
Forrás: Health Canada
VITAMIN K1
SANDOZ CANADA INCORPORATED
B02BA01
PHYTOMENADIONE
2MG
EMULSION
VITAMIN K1 2MG
INTRAMUSCULAR
15G/50G
Prescription
VITAMIN K ACTIVITY
Active ingredient group (AIG) number: 0108526002; AHFS:
APPROVED
2024-02-16
_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 Olvassa el a teljes dokumentumot