VITAMIN K1 INJECTION 10MG 1ML

VITAMIN K1 INJECTION 10MG 1ML

  • Documents: GMP,COPP,CTD

VITAMIN K1 INJECTION 10MG 1ML

Indications:

Vitamin K1 Injection is indicated as an antidote to anticoagulant drugs of the coumarin type in the treatment of haemorrhage or threatened haemorrhage, associated with a low blood level of prothrombin or factor VII.

Dosage and Administration:

Vitamin K1 Injection is for intravenous injection.

For adults:

Severe or life-threatening haemorrhage, e.g. during anticoagulant therapy: The coumarin anticoagulant should be withdrawn and an intravenous injection of Vitamin K1 Injection given slowly (over at least 30 seconds) at a dose of 5-10 mg together with prothrombin complex concentrate (PCC).

Reversal of anticoagulation prior to surgery:

Patients who require emergency surgery that can be delayed for 6-12 hours can be given 5 mg intravenous vitamin K1 to reverse the anticoagulant effect. If surgery cannot be delayed, PCC can be given in addition to intravenous vitamin K1 and the INR checked before surgery.

For elderly:

Elderly patients tend to be more sensitive to reversal of anticoagulation with Vitamin K1 Injection. The dosage for this patient group should therefore be at the lower end of the ranges recommended.

For children aged 1 to 18 years:

It is advisable that a haematologist is consulted about appropriate investigation and treatment in any child in whom Vitamin K1 Injection is being considered.

Precautions & Warning:

In potentially fatal and severe haemorrhage due to overdosage of coumarin anticoagulants, intravenous injections of Vitamin K1 Injection must be administered slowly and not more than 40 mg should be given during a period of 24 hours. Vitamin K1 Injection therapy should be accompanied by a more immediate effective treatment such as transfusion of whole blood or blood clotting factors. When patients with prosthetic heart valves are given transfusions for the treatment of severe or potentially fatal haemorrhage, fresh frozen plasma should be used. The use of vitamin K1 in patients with mechanical heart valves is generally to be avoided, unless there is major bleeding.

Large doses of Vitamin K1 Injection (not more than 40 mg per day) should be avoided if it is intended to continue with anticoagulant therapy because there is no experience with doses above this maximum of 40 mg per day and higher doses may give rise to unexpected adverse events. Clinical studies have shown a sufficient decrease in the INR with the recommended dosage. If haemorrhage is severe, a transfusion of fresh whole blood may be necessary whilst awaiting the effect of the vitamin K1.

Vitamin K1 is not an antidote to heparin.

Contra-indications:

Use in patients with a known hypersensitivity to any of the constituents.

This medicine should not be administered intramuscularly because the IM route exhibits depot characteristics and continued release of vitamin K1 would lead to difficulties with the re-institution of anticoagulation therapy. Furthermore, IM injections given to anticoagulated subjects cause a risk of haematoma formation.

Drug interactions:

No significant interactions are known other than antagonism of coumarin anticoagulants.

Storage instructions:

The recommended maximum storage temperature is 25°C. Do not use if the solution is turbid.