BIOVEINS of MOHO® BIOVENUM MONO® (immunoglobulin of the person normal liquid)

General characteristics. Structure:

Active ingredients: immunological active protein fraction of immunoglobulin G.

 excipients: a maltose - from 8% to 10%.

Main properties: drug is immunological the active protein fraction allocated from serum or the blood plasma of the person checked for lack of antibodies to VICh-1, VICh-2, to a virus of hepatitis C and a surface antigen of a virus of hepatitis B, cleared and concentrated by a fractionation method the spirtovodny besieging solutions to the virus inactivation which passed a stage solvent-detergentnym with method. Transparent or slightly opalescent liquid, colourless or yellowish color. The insignificant deposit disappearing when stirring is sometimes observed. Drug does not contain preservative and antibiotics.

Pharmacological properties:

Drug is immunological the active protein fraction allocated from the blood plasma of the person cleared and concentrated by a fractionation method alcohol.

Contains from 4,5 to 5,5% of protein.

Drug has low anticomplementary activity as a result of additional purification of the immunoglobulins received by a spirit method of the aggregated proteins and impurity.

Active component of drug are the immunoglobulins having activity of antibodies of various specificity. Drug has also nonspecific activity which is shown in increase in resistance of an organism.

Indications to use:

Severe toxic forms of bacterial and viral infections. The postoperative complications at children and adults which are followed by a septicaemia. The replacing therapy at primary and secondary immunodeficiences.

Route of administration and doses:

The drug is administered intravenously, kapelno. Rate of administering for children has to make from 0,08 to 0,5 ml/min. depending on body weight, for adults - 1-1,5 ml/min. More bystry introduction can cause development of kollaptoidny reaction.

At treatment of bacterial and viral infections the single dose of drug at children has to make 4,0 ml (200 mg/kg of body weight). Drug drive one or twice. At treatment of bacterial and viral infections at adults the single dose of drug has to make 2,0 ml (100 mg/kg of body weight) within 4 days.

At primary immunodeficience at patients with an inborn agammaglobulinemia and a hypogammaglobulinemia – from 4,0 to 6,0 ml (200-300 mg/kg of body weight). The course repeats in 3-4 weeks.

At secondary immunodeficience at patients with chronic lymphocytic leukemia - 4,0-10,0 ml (200-500 mg/kg of body weight). The course repeats in 3-4 weeks.

At an idiopathic Werlhof's disease drug appoint in a dose 8 ml (400 mg/kg of body weight) within 5 days in a row or appoint 20 ml (1 g/kg of body weight) within 2 days in a row. At clinical instructions on need of increase in number of thrombocytes it is periodically possible to enter a maintenance dose.

At a syndrome of Kawasaki интраглобин appoint in a dose 20 - 40 ml (1-2 g/kg) once as addition to therapy with acetylsalicylic acid.

At a syndrome to Giyena-Barra, chronic inflammatory demyelinating neuropathy – 0,4 g/kg within 5 days. If necessary 5-day courses of treatment repeat bucketed 4 weeks.

Drug Bioven ^моно® is used only in the conditions of a hospital at observance of all rules of an asepsis. Before introduction bottles maintain at a temperature (20±2) °C not less than 2 hours. The muddy and containing a deposit solutions are not subject to use.

After administration of drug of an inoculation against measles and epidemic parotitis carry out not earlier than in 3 months. After vaccination against these infections the drug should be administered   not earlier than in 2 weeks; in case of need use Bioven ^моно® before this term vaccination against measles or epidemic parotitis should be repeated. Other infections inoculations can be carried out to any terms to or after administration of drug.

Features of use:

After the termination of a period of validity use of drug is inadmissible. Drug is not subject to requality control and extension of a period of validity after its termination.

Side effects:

Reactions to administration of immunoglobulin, as a rule, are absent. The fever, a headache, nausea, vomiting, allergic reactions are possible. In rare instances local reactions in the form of a hyperemia and temperature increase to ^37,5os within the first days can develop. At certain people with the changed reactivity allergic reactions of various type, and in exclusively exceptional cases – an acute anaphylaxis can develop. In this regard the persons who received drug have to be under medical observation within 30 minutes. Rooms of carrying out inoculations have to be provided with means of antishock therapy.

Interaction with other medicines:

Transfusion therapy by drug Bioven ^моно® can be combined using other medicines.

Contraindications:

Administration of immunoglobulin is contraindicated to the persons having heavy allergic reactions to introduction of proteinaceous blood preparations of the person in the anamnesis. And in the next 8 days after the termination of a course of treatment antihistaminic drugs are recommended to the patients who is suffering allergic or having a serious allergic illness (bronchial asthma, atopic dermatitis, a recurrent small tortoiseshell) in an anemneza against the background of administration of immunoglobulin. To the persons suffering from immune general diseases (immune diseases of blood, collagenoses, nephrite, etc.) drug is appointed after consultation of the corresponding specialist. In the period of an aggravation of allergic process introduction drug is carried out according to the conclusion of the allergist according to vital indications.

Storage conditions:

Drug is stored in the dry, protected from light place at a temperature from +2˚C to + 10C. To store in the place, unavailable to children. Transportation is carried out at a temperature from +2˚C to + 10C.

Issue conditions:

According to the recipe

Packaging:

In bottles on 50 ml.