Producer: LLC MTs Ellara Rossiya
Code of automatic telephone exchange: B02BA02
Release form: Liquid dosage forms. Solution for injections.
General characteristics. Structure:
Active ingredient: sodium Menadionum bisulphite – 10 ml.
Excipients - sodium disulphite, Acidum hydrochloricum solution, water for injections.
Pharmacodynamics. The water-soluble analog of vitamin K (K3 vitamin), is a coenzyme K-epoksidreduktazy vitamin which participates in synthesis of blood-coagulation factors ІІ, VII, IX and X, and proteins of C and S. Has indirect haemo static effect due to synthesis of de novo of the corresponding blood-coagulation factors. The beginning of effect after intramuscular introduction - in 8-24 h.
Pharmacokinetics. After intramuscular introduction it is easily and quickly distributed. In insignificant quantities collects in fabrics. Having quickly passed a cycle of metabolic activation, in a liver is oxidized to a thiol form. It is removed by kidneys and with bile it is almost exclusive in the form of metabolites. High concentration of vitamin K in Calais are caused by its synthesis by intestinal microflora.
Indications to use:
Prothrombinopenia (prevention and treatment) caused by deficit of vitamin K:
- disturbance of a blood coagulation owing to decrease in maintenance of factors of II, VII, IX, X, against the background of reception of some medicines (indirect anticoagulants - derivative coumarin and an indandion, salicylates, some antibiotics) $
- disturbance of absorption of vitamin K in intestines (especially at obturatsionny jaundice), abetalipoproteinemiya, parenteral food.
Preventively at surgical interventions with possible severe parenchymatous bleeding.
Route of administration and doses:
Prothrombinopenia (prevention and treatment) caused by deficit of vitamin K. The single dose for children is more senior than 14 years and adult - 10-15 mg, daily - 30 mg. To children: 1-2 years - 6 mg/days, 3-4 years - 8 mg/days, 5-9 years - 10 mg/days, 10-14 years - 15 mg/days.
Treatment duration - 3-4 days, after a 4-day break repeat a course.
At surgical interventions with possible severe parenchymatous bleeding appoint within 2-3 days before operation.
Features of use:
Purpose of drug is shown only in case vitamin K reception inside is impossible. In a type of the postponed approach of haemo static effect drug is not used for a stop of bleedings. At hemophilia and Verlgof's disease drug is inefficient.
Local reactions: pain and hypostasis in an injection site, damage of skin in the form of spots at repeated injections to the same place.
Others: a hyperbilirubinemia, jaundice (including a kernicterus at babies); seldom - dizziness, tranzitorny decrease in the ABP, "profuse" sweat, tachycardia, "weak" filling of pulse, change of flavoring feelings.
Interaction with other medicines:
Weakens effect of indirect anticoagulants - derivative coumarin and an indandion.
Does not influence anticoagulating activity of heparin.
Simultaneous use with antibiotics of a broad spectrum of activity, quinidine, quinine, salicylates in high doses, antibacterial sulfonamides demands increase in a dose of vitamin K (owing to disturbance of its synthesis by intestinal microflora).
Co-administration with hemolitic medicines increase risk of hemolitic anemia.
With care: liver failure, pregnancy.
Symptoms: the vitamin K hypervitaminosis which is shown giperprotrombinemiy, hemolitic anemia, a hyperbilirubinemia. In isolated cases, especially at children, spasms develop.
Treatment: drug withdrawal. Under control of indicators of coagulant system of blood appoint anticoagulants.
To store in the dry place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children.
According to the recipe
Solution for intramuscular introduction of 10 mg/ml on 1 ml or 2 ml in ampoules.
5 ampoules in a blister strip packaging from a film polyvinyl chloride.
1 or 2 blister strip packagings together with the application instruction, a knife ampoule or the scarificator ampoule in a pack from a cardboard.
5 or 10 ampoules together with the application instruction, a knife ampoule or the scarificator ampoule in a pack from a cardboard with a corrugated insert.
When using ampoules with a point or a ring of a break the knife ampoule or the scarificator ampoule is not put.