PHYDION Injection

Vitamin K1 2 mg / ml

Category:

COMPOSITION :

Phydion® Injection 2 mg/ml, each ml contains : Phytomenadione (Vitamin K1) 2 mg.

 

DESCRIPTIONS :

Phydion® with Phytomenadione (Vitamin K1) as active ingredient is available in injection 2 mg/ml.

 

INDICATIONS :

Prophylaxis and treatment of hemorrhage in newborn babies.

 

DOSAGE AND ADMINISTRATION :

  • Prophylaxis of hemorrhage in newborn babies :

0.5 to 1 mg Phytomenadione given intramuscularly, 1 – 6 hours after the baby is born.

  • Treatment of hemorrhage in newborn babies :

1 mg Phytomenadione given intramuscularly or subcutaneously.

 

CONTRAINDICATION : 

Hypersensitivity to Phytomenadione (Vitamin K1).

 

WARNINGS AND PRECAUTIONS :

  • Coagulation effects of Phytomenadione (Vitamin K1) will be produced 1 – 2 hours after drug is given.
  • Do not exceed the recommended dose.
  • Phytomenadione (Vitamin K1) is an antagonist of Coumarin anticoagulants but can not inhibit anticoagulant action of Heparin.
  • Phytomenadione (Vitamin K1) is easily degraded by light, store the drug in place that protected from light.
  • Intravenous usage should be avoided.

 

WARNING – INTRAVENOUS AND INTRAMUSCULAR USE :

 Severe reactions, including fatalities, have occured during and immediately after INTRAVENOUS injection of Phytomenadione (Vitamin K1), even when precautions have been taken to dilute the Phytomenadione (Vitamin K1) and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving Phytomenadione (Vitamin K1) for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.

 

PRESENTATION :

Phydion® Injection 2 mg/ml           Box, 5 ampoules @ 1 ml            Reg. No. DKL1602352143A1

 

STORAGE:

STORE BELOW 30ºC, PROTECT FROM LIGHT

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

PT. BERNOFARM

Sidoarjo – Indonesia