Active substanceMenadione sodium bisulfiteMenadione sodium bisulfite
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  • Dosage form: & nbspsolution for intramuscular injection
    Composition:1 ml of the preparation contains:

    Active substance:

    Menadione sodium bisulfite trihydrate -10.0 mg

    Excipients:

    Sodium disulfite (sodium metabisulphite) 1.0 mg

    Hydrochloric acid solution 0.1 M - to pH 2.2-3.5

    Water for injection - up to 1.0 ml

    Pharmacotherapeutic group:Vitamin K analogue synthetic
    ATX: & nbsp

    B.02.B.A.02   Menadion

    B.02.B.A   Vitamin K

    Indications:Hypoprothrombinemia (prevention and treatment) due to vitamin K deficiency: a clotting disorder due to a decrease in blood coagulation factor II, VII, IX, X,on the background of taking some medications (indirect anticoagulants - coumarin derivatives and indanedione, salicylates, some antibiotics), disturbances of absorption of vitamin K in the intestine (especially with obstructive jaundice), abetalipoproteinemia, parenteral nutrition.

    Treatment and prevention of hemorrhagic disease of newborns.

    Prophylactically, with surgical interventions with possible severe parenchymal hemorrhage.

    Contraindications:Hypersensitivity to the components of the drug, hypercoagulation, thromboembolism, hemolytic disease of the newborn.
    Carefully:Hepatic insufficiency, deficiency of glucose-6-phosphate dehydrogenase, pregnancy.
    Pregnancy and lactation:The study of reproduction on animals revealed an unfavorable effect on the fetus, and strictly controlled studies were not carried out in pregnant women. The use of the drug during pregnancy and during childbirth may cause a risk of hemolytic anemia, hyperbilirubinemia and nuclear jaundice in the fetus and newborn. When pregnancy is used only if the intended benefit for the mother exceeds the potential risk to the fetus.

    At the time of application of the drug, breast-feeding is stopped.

    Dosing and Administration:The drug is administered intramuscularly.

    For adults and children from 14 years: a single dose of 10-15 mg, a maximum single dose of 30 mg, a maximum daily dose of 60 mg.

    For children from 0 to 14 years:

    newborn

    up to 4 mg / day

    up to 1 year

    2-5 mg / day

    1 -2 years

    6 mg / day

    3-4 years

    8 mg / day

    5-9 years

    10 mg / day

    10-14 years old

    15 mg / day

    Duration of treatment 3-4 days, after a 4-day break, if necessary, repeat the course. The daily dose can be divided into 2-3 doses.

    When surgical interventions with possible severe parenchymal hemorrhage are prescribed within 2-3 days before the operation.

    Effect on the ability to drive transp. cf. and fur:During treatment, it is not recommended to drive vehicles, as well as engage in other activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Solution for intramuscular injection 10 mg / ml.
    Packaging:1 ml or 2 ml in ampoules.

    5 ampoules are placed in a contour cell box made of a polyvinylchloride (PVC) film or a polyethylene terephthalate (PET) film.

    1 or 2 contour mesh packages together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard.

    5 or 10 ampoules together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard with a corrugated liner.

    When packing ampoules with a dot or a ring of fracture, the ampoule scaper is not inserted.

    Storage conditions:In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:2 years.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-002094
    Date of registration:10.06.2013 / 20.12.2016
    Expiration Date:10.06.2018
    The owner of the registration certificate:ELLARA, LTD. ELLARA, LTD. Russia
    Manufacturer: & nbsp
    Information update date: & nbsp14.02.2017
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