VITAMIN K3 INJECTION 10mg/1ml I.M. COMPOSITION: Each 1ml ampoule contains: Menadione Sodium Bisulfite (Vitamin K3)....... 10mg. DESCRIPTION: Vitamin K3 is a water-soluble product which favors the formation of prothrombin and speed blood-coagulation. Vitamin K3 has then an improved anti hemorrhagic activity in comparison to the natural Vitamin K. ACTION: Vitamin K3 is a synthetic analogue of Vitamin K. The advantage of the drug is its water-solubility which determines its use as an agent of choice in Vitamin K deficiency caused by "malabsorption" syndrome, cholestasis, etc. The drug is necessary for prothrombin biosynthesis in the liver, the enhancement of prothrombin in blood plasma and blood coagulability. It is necessary for the biosynthesis of some factors of blood coagulation - factor II (prothrombin), factor VII (proconvertin), factors IX and X. Its action is manifested in hypoprothrombinemia but in some cases also in normal prothrombin level in the blood. The effect of the drug is attained 2-3 days after its administration, because the process of influencing the hepatic enzyme system is slow. INDICATIONS: Insufficient production of Vitamin K in the large intestine as a result of absence of coli bacteria; disturbances of fat absorption due to obstruction of biliary ducts or other causes for the inflow of small quantities of bile into the intestines; hemorrhagic diathesis, mainly on the base of hypoprothrombinemia; prophylactically - prior to and post operations for avoiding bleeding; therapeutically - in hypothrombinemia of newborn and prematurely born infants; overdosage and intoxication with coumarin and indandione anticoagulants. Treatment with broad-spectrum antibiotics and sulfonamides leading to destruction of the intestinal flora. SIDE EFFECTS: Vitamin K3 can enhance sensitivity to ionizing radiation. It can cause flushing on the face and pain at the injection site. ADVERSE EFFECTS: Menadione Sodium Bisulfite has been associated with the development of Haemolytic anaemia, Hyperbilirubinaemia, Kernicterus, and Haemoglobinaemia. It is also been reported to cause haemolysis in patients with glucose-6-phosphate dehydrogenase deficiency. Allergic skin reactions have been reported following intramuscular. DOSAGE AND ADMINISTRATION: It may be given by intramuscular injection in doses of up to 20mg, reported after 8 to 12 hours if necessary. In the treatment of haemorrhagic disease of the newborn it may be given in a dose of 1mg intramuscularly and if necessary further doses may be given 8-hourly. PRECAUTIONS: Vitamin K3 should be doses very cautiously during the period of childbirth and for newborn babies, because overdosage can cause kernicterus in infants. AVAILABILITY: 100 ampoules of 1ml. STORAGE: Store in a cool & dry place in well-closed containers. Protect from light. Keep all the medicines out of the reach of children. VALIDITY: 3 years.