Vitamina K1solution for injection

Vitamina K1 solution for injection

ANTIHEMORRHAGICS

Presentation:

Vial containing 10 mL.

Species:

Composition

Vitamin K1 (phytomenadione) 10 mg
Excipients q.s. 1 mL

Therapeutic Action

Vitamin K1 is an antidote for warfarin poisoning.

Indications for Use

To be used in cattle, sheep, goats, horses, swine, dogs and cats.
To be used in case of bleeding or danger of bleeding due to acute hypoprothrombinemia induced by different factors, including the ingestion of coumarin-based compounds, usually present in commercial rodenticides.
It is also indicated for the treatment of all cases of hypovitaminosis K, such as those produced by cholestatic jaundice, hepatic or intestinal disorders and for the prolonged administration of antibiotics, sulfonamides or salicylates.

Route of Administration

 IM and SC. If IV administration is essential, the drug shall be administered slowly.

Dosage and Instructions for Use

Cattle, horses, swine, sheep and goats:
Acute hypoprothrombinemia (with hemorrhage):
Intravenous route: Administer 0.5 to 2.5 mg/kg body weight, at a rate not to exceed 10 mg/min (mature animals) or 5 mg/min (newborn/ young animals).
Non-acute hypoprothrombinemia: Intramuscular or subcutaneous route. Administer 0.5 to 2.5 mg/kg body weight.

Dogs and Cats:
Acute hypoprothrombinemia (with hemorrhage):
Intravenous route: Administer 0.5 to 2.5 mg/kg body weight, at a rate not to exceed 5 mg/min.
Non-acute hypoprothrombinemia:
Intramuscular or subcutaneous route. Administer 0.5 to 2.5 mg/kg body weight.

Contraindications / Warnings / Precautions

Hypersensitivity to any of the components in the formulation.
Whenever possible, the drug shall be administered IM or SC.
If IV administration is essential, the drug shall be administered slowly, at the indicated rate. Monitor prothrombin time and adjust dose accordingly.
Frequency and amount of doses should be determined by prothrombin time response and clinical condition. If 6 or 8 hours after parenteral administration of Vitamin K1 the prothrombin time has not been shortened satisfactorily, the dose should be repeated.
In the event of shock or excessive blood loss, the use of whole blood or component therapy is indicated.
The smallest effective dose should be sought to minimize the risk of adverse reaction.
In some cases, when the drug needs to be administered by the IV route, it may be necessary to dilute it with 0.9% Sodium Chloride solution, Dextrose solution (5%), or with a mixture of Dextrose solution (5%) and 0.9% Sodium Chloride solution in equal parts; in order to facilitate slow administration. Other diluents should not be used. When dilutions are indicated, administration should be started immediately after mixing with the diluent, and unused portions of the solution should be discarded.
Immediate coagulant effect should not be expected after administration of the drug. A minimum of 1 to 2 hours is required for measurable improvements in the prothrombin time. Whole blood or blood serum therapy may be necessary if the bleeding is severe.
Phytonadione (Vitamin K1) will not counteract the effect of heparin.
In case of liver diseases, large doses of Vitamin K1 do not guarantee the success of the treatment, if response to initial therapy is unsatisfactory.
Failure to respond to Vitamin K1 indicates that the dosage schedule should be adjusted.
Severe reactions, including fatalities, may occur during and immediately after intravenous injection, if precautions have not been taken to dilute the drug and if above infusion rate guidelines are not followed. These severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some animals have exhibited these severe reactions, especially on receiving the drug for the first time. Therefore, the intravenous route should be avoided unless it is strictly necessary. It should only be used when the serious risk involved is considered justified.

Disponible

- Argentina
- Paraguay