Vitamin K1 (Phytomenadione) 2 mg/0.2 ml.

Business Unit: Human

Medicine Type: Injectable

Generic Name: Vitamin K1 (Phytomenadione) 2 mg/0.2 ml.

Therapeutic Class: Vitamin-K Preparations

Indication: Babykion is a preparation of Phytomenadion (Vitamin K1). Vitamin K1 (Phytomenadione) is a procoagulant factor. Phytomenadione (Vitamin K-1) is indicated in following indications- Prophylaxis and treatment of haemorrhagic disease in the newborn. Haemorrhage or risk of haemorrhage as a result of severe hypoprothrombinemia (i.e. deficiency of clotting factors II, VII, IX and X) of various etiologies, including overdosage of courmarin-type anticoagulants, their combination with phenylbutazone, and other forms of hypovitaminosis K (e.g. in obstructive jaundice as well as liver and intestinal disorders, and after prolonged treatment with antibiotics, sulphonamides or salicylates). Prevention and treatment of bleeding due to vitamin K deficiency.

Dosage & Administration: 1st Dose: Within four hours of birth orally. 2nd Dose : At the age of four days of birth orally. 3rd Dose : At the age of four weeks of birth orally. Prophylaxis: Mild Hemorrhage or hemorrhagic tendency: The usual dose for Neonates is 2 mg orally at or just after birth. Then 2 mg on 4th-5th day and another 2 mg on 28th-30th day orally. If the oral route is unsuitable then 2 mg of drug can be administered by IM or IV route. Children over 1 year of age: Could be given 5-10 mg orally. A single 1 mg (0.1 ml) dose IM is recommended in children who are not assured of receiving a second oral dose or, in the case of breast-fed children, who are not assured of receiving a third oral dose. Therapy: Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical picture and coagulation status. Neonates with special risk factors: Pre-maturity, birth asphyxia (inadequate intake of oxygen by the baby during birth process), obstructive jaundice, inability to swallow, maternal use of anticoagulants or anti-epileptics- 1 mg intramuscularly or intravenously at birth or shortly after birth if the oral route is unsuitable. Intramuscular and intravenous doses should not exceed 0.4 mg/kg in premature infants weighing less than 2.5 kg. The size and frequency of further doses should be based on coagulation status To ensure a total protection of the newborns, 3 prophylactic doses of Vitamin K should be administered orally following the dosing schedule mentioned above.

Preparation: 0.2 ml x 5 Injection