Phytomenadione (vitamin K 1)
And dosage form:
Emulsion for injection Each vial contains:
Phytomenadione (vitamin K 1) ............................. 2.0 mg and 10 mg
Vehicle cbp 0.2 ml and 1 ml.
Bleeding or risk of bleeding as a result of severe hypoprothrombinemia due to deficiency of clotting factors II, V, VII and X.
For the prophylaxis and treatment of hemorrhagic disease of the newborn.
PHYTOMENADIONE should not be administered to patients with known hypersensitivity to any component of the formula hypersensitivity.
Parenteral administration is associated with a potential risk of kernicterus in premature infants weighing less than a 2.5 kg.
Avoid high doses of PHYTOMENADIONE if it is to continue anticoagulation therapy.
Effects on ability to drive and use machines has not been observed PHYTOMENADIONE influence on the ability to drive or operate machinery.
RESTRICTIONS OF USE DURING PREGNANCY AND Lactation
PHYTOMENADIONE be administered to pregnant women as long as the benefit to the mother outweighs the risk to the fetus.
Lactation: Only a small fraction of vitamin K 1 passes into breast milk. At therapeutic doses, administration of PHYTOMENADIONE mothers breastfeeding does not pose a risk to the newborn.
There are isolated reports of anaphylactic reactions after parenteral administration PHYTOMENADIONE.
Very rarely it described venous irritation or phlebitis associated with IV administration of PHYTOMENADIONE.
Intramuscular: Risk of bruises if hemorrhagic syndrome, particularly in patients treated with oral anticoagulants.
In rare cases, it can cause local irritation at the injection site.
Vitamin K 1 antagonizes the effect of coumarin anticoagulants. Coadministration of anticonvulsants can impair the action of vitamin K 1.
PRECAUTIONS IN RELATION TO EFFECTS OF Carcinogenesis, Mutagenesis, Impairment Fertility:
So far no one has reports of carcinogenicity, mutagenicity, teratogenicity or fertility associated with this drug.
DOSAGE AND ADMINISTRATION:
Usual adult dose:
Fatal major bleeding risk, eg during anticoagulant therapy: after withdrawal of anticoagulant therapy, a dose of 10-20 mg (1-2 ampoules PHYTOMENADIONE 10 is given slowly (at least 30 seconds) intravenously mg).
Less severe bleeding or bleeding tendency: The recommended dose is 10 mg (1 vial) administered intramuscularly. It should be given a second dose (up to 20 mg) if sufficient effect is observed after 8-12 hours.
Dosage in special cases:
Elderly: In this group of patients it should be at the lower limits of the ranges recommended for adults.
Children older than one year: If the doctor deems it necessary, the recommended dose for these children is 5-10 mg / day IV or IM
For all healthy neonates: A dose of 2 mg orally at birth or soon after, followed by 2 mg after 4-7 days.
Exclusively breastfed infants: In addition to the recommended dose for infants should be given 2 mg orally after a period of 4 to 6 weeks.
Infants with special risk: 1 mg IM or IV at birth or shortly thereafter, when oral administration is not possible for medical reasons. Intramuscular and intravenous doses should not exceed 0.4 mg / kg in children weighing less than 2.5 kg.
Treatment of hemorrhagic disease of the newborn: Initially, 1 mg intravenously.
REPRESENTATIONS AND MANAGEMENT THE Overdosage:
Not attributable to hypervitaminosis K1 clinical syndrome known.
RECOMMENDED STORAGE: Store at room temperture to no more than 25 ° C. Protect from light.
LEGENDS OF PROTECTION:
Your purchase requires a medical prescription. Do not take if you look
phase separation or turbidity content. Do not be
the reach of children
NAME AND ADDRESS OF THE LABORATORY:
See presentation or presentations.
PRESENTATION OR PRESENTATIONS:
Source: SSA Catalog Generic Exchangeable Drugs for pharmacies