Țară: Armenia
Limbă: engleză
Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
phytomenadione
F. Hoffmann-La Roche Ltd.
phytomenadione
2mg/0,2ml
solution for injection/oral
Prescription
10178705 FE FY KONAKION ® MM 2MG/0.2ML PAEDIATRIC Phytomenadione COMPOSITION _Active ingredient: _ phytomenadione (synthetic vitamin K 1 ). One amber glass ampoule contains 0.2 ml of a clear mixed-micelle solution of 2 mg vitamin K 1 (filling volume 0.3 ml) for oral or parenteral administration. _Excipients_ : glycocholic acid, sodium hydroxide, lecithin, hydrochloric acid, water for injection. PROPERTIES AND EFFECTS The presence of vitamin K 1 , the active ingredient of Konakion MM paediatric, is essential for the formation of prothrombin, factors VII, IX and X, and the coagulation inhibitors protein C and protein S in the body. Vitamin K 1 does not readily cross the placental barrier from mother to child and is poorly excreted in breast milk. Lack of vitamin K 1 leads to an increased tendency to hemorrhagic disease in the newborn. Vitamin K 1 administration, which promotes synthesis of the above-mentioned coagulation factors by the liver, can reverse an abnormal coagulation status and bleeding due to vitamin K 1 deficiency. INDICATIONS AND USAGE _Documented indications_ Prophylaxis and treatment of hemorrhagic disease of the newborn. DOSAGE AND ADMINISTRATION _Prophylaxis_ For all healthy neonates of 36 weeks gestation and older: 1 mg administered by intramuscular injection at birth or soon after birth or 2 mg orally at birth or soon after birth; the oral dose should be followed by a further dose of 2 mg at four to seven days of age. A further 2 mg oral dose should be given 1 month after birth. In exclusively formula-fed infants the third oral dose can be omitted. A single 1 mg (0.1 ml) dose intramuscularly is recommended in children who are not assured of receiving a second oral dose or, in the case of breastfed children, who are not assured of receiving a third oral dose. Preterm neonates of less than 36 weeks gestation, weighing 2.5 kg or greater, and term neonates at special risk (e.g. prematurity, birth asphyxia, obstructive jaundice, inability to swallow, maternal use of anticoagulants or antiepileptics) Citiți documentul complet
Summary of Product Characteristics Konakion MM 2 mg/0.2 ml paediatric 1 KONAKION ® MM 2MG/0.2ML PAEDIATRIC Phytomenadione COMPOSITION _Active ingredient: _phytomenadione (synthetic vitamin K 1 ). One amber glass ampoule contains 0.2 ml of a clear mixed-micelle solution of 2 mg vitamin K 1 (filling volume 0.3 ml) for oral or parenteral administration. _Excipients_: glycocholic acid, sodium hydroxide, lecithin, hydrochloric acid, water for injection. PROPERTIES AND EFFECTS The presence of vitamin K 1 , the active ingredient of Konakion MM paediatric, is essential for the formation of prothrombin, factors VII, IX and X, and the coagulation inhibitors protein C and protein S in the body. Vitamin K 1 does not readily cross the placental barrier from mother to child and is poorly excreted in breast milk. Lack of vitamin K 1 leads to an increased tendency to hemorrhagic disease in the newborn. Vitamin K 1 administration, which promotes synthesis of the above-mentioned coagulation factors by the liver, can reverse an abnormal coagulation status and bleeding due to vitamin K 1 deficiency. INDICATIONS AND USAGE _Documented indications_ Prophylaxis and treatment of hemorrhagic disease of the newborn. DOSAGE AND ADMINISTRATION _Prophylaxis_ For all healthy neonates of 36 weeks gestation and older: 1 mg administered by intramuscular injection at birth or soon after birth or 2 mg orally at birth or soon after birth; the oral dose should be followed by a further dose of 2 mg at four to seven days of age. A further 2 mg oral dose should be given 1 month after birth. In exclusively formula-fed infants the third oral dose can be omitted. Summary of Product Characteristics Konakion MM 2 mg/0.2 ml paediatric 2 A single 1 mg (0.1 ml) dose intramuscularly is recommended in children who are not assured of receiving a second oral dose or, in the case of breastfed children, who are not assured of receiving a third oral dose. Preterm neonates of less than 36 weeks gestation, weighing 2.5 kg or greater, and term neonates at special risk ( Citiți documentul complet