Bimeda
(Phytonadione)
Aqueous Colloidal Solution
10 mg per mL
FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
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 C31H46O2.
VETA-K1® Injection is a yellow, sterile, aqueous colloidal solution of Vitamin K1, with a pH of 5.0 to 7.0, available for injection by intravenous, intramuscular, and subcutaneous routes.
EACH mL CONTAINS: Phytonadione 10
mg; Polyoxyethylated fatty acid derivative 65 mg; Dextrose monohydrate
37.5 mg; Butylated hydroxyanisole 1 mg; Butylated hydroxytoluene 1 mg;
Citric acid 8.4 mg; Sodium phosphate 17.2 mg with Benzyl Alcohol 0.9%
w/v added as a preservative.
CLINICAL PHARMACOLOGY: VETA-K1® Injection aqueous colloidal solution of vitamin K1
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 thromboplastin component (factor IX),
and Stuart factor (factor X). The prothrombin test is sensitive to the
levels of three of these four factors -- II, VII and X. Vitamin K is an
essential cofactor for a microsomal enzyme that catalyzes the
post-translational carboxylation of multiple, specific, peptide-bound
glutamic acid residues in inactive hepatic precursors of factors II,
VII, IX and X. The resulting gamma-carboxyglutamic acid residues
convert the precursors into active coagulation factors that are
subsequently secreted by liver cells into the blood.
Phytonadione is readily absorbed following
intramuscular administration. After absorption, phytonadione is
initially concentrated in the liver, but the concentration declines
rapidly. Very little vitamin K accumulates in tissues. Little is known
about the metabolic fate of vitamin K. Almost no free unmetabolized
vitamin K appears in bile or urine.
In normal animals, phytonadione is virtually devoid of
pharmacodynamic activity. However, in animals deficient in vitamin K,
the pharmacological action of vitamin K is related to its normal
physiological function, that is, to promote the hepatic biosynthesis of
vitamin K dependent clotting factors.
The action of the aqueous colloidal
solution, when administered intravenously, is generally detectable
within an hour or two and hemorrhage is usually controlled within 3 to
6 hours. A normal prothrombin level may often be obtained in 12 to 14
hours.
INDICATIONS: VETA-K1® Injection
is indicated in 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.
VETA-K1® Injection
is indicated in cattle, calves, horses, swine, sheep, goats, dogs, and
cats to counter hypoprothrombinemia induced by ingestion of
anticoagulant rodenticides.
VETA-K1® Injection
is also indicated to counter hypoprothrombinemia caused by consumption
of bishydroxycoumarin found in spoiled and moldy sweet clover.
DOSAGE AND ADMINISTRATION:
Cattle, Calves, Horses, Swine, Sheep, and Goats:
Acute hypoprothrombinemia (with hemorrhage) and Non-acute
hypoprothrombinemia - 0.5 - 2.5 mg/kg subcutaneously OR intramuscularly.
Dogs and Cats: Acute
hypoprothrombinemia (with hemorrhage) and Non-acute hypoprothrombinemia
- 0.25 - 5.0 mg/kg subcutaneously OR intramuscularly. Use higher end of
dose for second generation rodenticides.
Whenever possible, VETA-K1® Injection
should be given by the subcutaneous or intramuscular route. When
intravenous administration is considered unavoidable, the drug should
be diluted and injected very slowly, not exceeding 1 mg per minute.
DIRECTIONS FOR DILUTION: VETA-K1® Injection
may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose,
Injection, or 5% Dextrose and Sodium Chloride Injection. Other Diluents
Should Not Be Used. When dilutions are indicated, administration should
be started immediately after mixture with the diluent, and unused
portions of the dilution should be discarded.
Whole blood or component therapy may be indicated if
bleeding is excessive. This therapy, however, does not correct the
underlying disorder and VETA-K1® Injection
should be given concurrently. In the event of shock or excessive blood
loss, the use of whole blood or component therapy is indicated.
CONTRAINDICATIONS: Hypersensitivity to any component of this medication.
PRECAUTIONS: Drug Interactions:
Temporary resistance to prothrombin-depressing anticoagulants may
result, especially when larger doses of phytonadione are used. If
relatively large doses have been employed, it may be necessary when
reinstituting anticoagulant therapy to use somewhat larger doses of
prothrombin-depressing anticoagulant, or to use one which acts on a
different principle, such as heparin sodium.
Laboratory tests: Prothrombin time should be checked regularly as clinical conditions indicate.
Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration,
whenever solution and container permit.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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WARNING - INTRAVENOUS USE: Severe
reactions, including fatalities, have occurred during and immediately
after INTRAVENOUS injection of phytonadione, even when precautions have
been taken to dilute the phytonadione and to avoid rapid infusion.
Typically these severe reactions have resembled hypersensitivity or
anaphylaxis, including shock and cardiac and/or respiratory arrest.
Some animals have exhibited these severe reactions on receiving
phytonadione for the first time. Therefore the INTRAVENOUS route should
be restricted to those situations where other routes are not feasible
and the serious risk involved is considered justified.
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An immediate coagulant effect should not be expected after administration of phytonadione. A minimum of 1 to 2 hours is required for measurable improvement in the prothrombin time. Whole blood or component therapy may be necessary if the bleeding is severe.
Phytonadione will not counteract the anticoagulant action of heparin.
When vitamin K1 is used to
correct excessive anticoagulant-induced hypoprothrombinemia,
anticoagulant therapy still being indicated, the patient is again faced
with the clotting hazards existing prior to starting the anticoagulant
therapy. Phytonadione is not a clotting agent, but overzealous therapy
with vitamin K1 may restore conditions
which originally permitted thromboembolic phenomena. Dosage should be
kept as low as possible, and prothrombin time should be checked
regularly as clinical conditions indicate.
Repeated large doses of vitamin K are not warranted in
liver disease if the response to initial use of the vitamin is
unsatisfactory. Failure to respond to vitamin K may indicate that the
condition being treated is inherently unresponsive to vitamin K.
ADVERSE REACTIONS: Deaths have
occurred following intravenous injection. (SEE WARNING). Pain, swelling
and tenderness at the injection site may occur. Intramuscular injection
may result in hematomas. The possibility of allergic sensitivity,
including an anaphylactoid reaction, should be kept in mind.
STORAGE: Protect from light at all times. Store in a dark place at controlled room temperature between 15° and 30°C (59° - 86°F).
Manufactured by: Bimeda-MTC Animal Health, Inc. Cambridge, ON Canada
Bimeda, Inc. and Bimeda-MTC Animal Health Inc. are Divisions of Cross Vetpharm Group Ltd.
Veta-K1 is a Registered Trademark of Bimeda, Inc.
Manufactured for: Bimeda, Inc., Oakbrook Terrace, IL 60181
Net Contents:
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Prod No.
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100 mL
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1VIT015
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8VIT064C Rev.05.06
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NAC No.: 13990492