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medicalmeds.eu Medicines Immunoglobulins. IMMUNOGLOBULIN of the PERSON NORMAL - BIOFARMA

IMMUNOGLOBULIN OF THE PERSON NORMAL - BIOFARM

Препарат ИММУНОГЛОБУЛИН ЧЕЛОВЕКА НОРМАЛЬНЫЙ - БИОФАРМА. ЧАО "Биофарма" Украина


Producer: CIAO Biofarm Ukraine

Code of automatic telephone exchange: J06B A01

Release form: Liquid dosage forms. Solution for injections.

Indications to use: Prevention of hepatitis A. Prevention of measles. Prevention of flu. Prevention of whooping cough. Prevention of a meningococcal infection. Prevention of poliomyelitis. Hypogammaglobulinemia. Agammaglobulinemia.


General characteristics. Structure:

Active ingredients - immunoglobulins, antibody-containing various specificity.
 
the stabilizer - glycine (glycine, the aminoacetic acid).
 
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, colourless or yellowish liquid. in the course of storage emergence of an insignificant deposit which disappears at a vtryakhivaniye is possible. Drug does not contain preservative and antibiotics.




Pharmacological properties:

Drug is immunological the active protein fraction allocated from serum or the blood plasma of the person cleared and concentrated by a fractionation method alcohol. Contains from 9 to 11% of protein. The operating basis of drug are immunoglobulins, antibody-containing different specificity which concentration in blood at administration of immunoglobulin reaches a maximum in 24 hours. The elimination half-life of antibodies makes 4-5 weeks of an organism. Drug increases nonspecific resistance of an organism.


Indications to use:

Immunoglobulin is applied to prevention of infections: hepatitis A, measles, flu, whooping cough, meningococcal infection and poliomyelitis. Drug is recommended also for treatment hypo - and agammaglobulinemias, for increase in resistance of an organism in the period of reconvalescence after acute infections with a long current, long pneumonia.


Route of administration and doses:

Immunoglobulin is entered intramusculary.
 
For prevention of hepatitis A by the adult drug is appointed disposable in a dose of 3 ml, and to children – depending on age: 1-6 years – 0,75 ml;

7-10 years – 1,5 ml, of 10 years are also more senior – 3 ml. In case of emergency repeated administration of immunoglobulin is shown not earlier than in 2 months after the first use of drug.
 
For prevention of measles drug is appointed disposable to children aged from 3 months which did not hurt measles and were not imparted against this disease (no later than 6 days after contact with the patient). The drug dose depending on the state of health and time which passed from the moment of contact makes 1,5 ml or 3 ml. To adults and children at contact with patients with multi-infections drug appoint 3 ml in a dose.
 
For prevention and treatment of flu immunoglobulin is entered disposable – the adult in a dose of 6 ml, to children depending on age: up to 2 years – 1,5 ml, from 2nd to 7 years – 3 ml, to children of 7 years - 4,5 ml. At treatment of severe forms of flu repeated administration of immunoglobulin in 24-48 hours after the first introduction in above the specified doses is recommended.
 
For prevention of whooping cough the drug is administered twice with an interval of 24 hours in a single dose of 3 ml to the children who did not have whooping cough, in the shortest terms after contact with the patient, and also to the children of the first year of life weakened to the children, children aged from 1 year who are not imparted against whooping cough.
 
For prevention of a meningococcal infection the drug is administered once to children aged from 6 months till 7 years no later than 7 days after contact with the patient with a generalized form of a meningococcal infection in doses of 1,5 ml (to children up to 3 years inclusive) also by 3 ml (to children is more senior than 3 years).
 
For prevention of poliomyelitis the drug is administered once depending on the state of health in a dose of 3 both 6 ml not to the vaccinated and defectively imparted by a poliomyelitic vaccine children in naikratchayshy terms after contact with the patient with a paralytic form of poliomyelitis.
 
For treatment hypo - and agammaglobulinemias at children drug use in a dose 1 ml on 1 kg of body weight: the calculated dose can be entered into 2-3 receptions with an interval of 24 hours. Further administration of immunoglobulin is carried out according to indications not earlier than in 1 month.
 
For increase in resistance of an organism in the period of reconvalescence after acute infectious diseases with a long current and at long pneumonia the drug is administered to adults and children in a single dose of 0,15-0,2 ml on 1 kg of body weight. Frequency rate of introduction (to 4 injections) is defined by the doctor, intervals between injections make 2-3 days.
 
After administration of immunoglobulin of an inoculation against measles and epidemic parotitis carry out not earlier than in 2-3 months. After vaccination against these infections immunoglobulin should be entered not earlier than in 2 weeks.


Features of use:

Administration of drug is intravenously forbidden! 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. 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.


Interaction with other medicines:

In komleksny therapy it is combined with other groups of drugs. Reduces activity of the weakened live vaccines against measles, a rubella, epidemic parotitis, chicken pox (at introduction to the first two weeks after vaccination against measles, parotitis and a rubella of an inoculation the specified vaccines it is necessary to repeat not earlier, than in 3 months). In need of use of immunoglobulin before this term, vaccination against measles or epidemic parotitis needs to be repeated. Other infections inoculations can be carried out to any terms to or after administration of immunoglobulin.
 
Temporary increase in maintenance of the entered antibodies in the patient's blood after administration of immunoglobulin can cause false positive results of serological tests. Drug can be mixed only from 0,9% chloride sodium solution. Other drugs cannot be added to solution as change of concentration of electrolyte or value рН can cause a protein denaturation.


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 3 days antihistaminic drugs are recommended to the patients who is suffering allergic or having a serious allergic illness in an anemneza in day of administration of immunoglobulin. The persons suffering from immune general diseases (diseases of blood, connecting fabric, nephrite, etc.) should enter immunoglobulin against the background of the corresponding therapy.


Overdose:

Data on overdose of drug are not established.


Storage conditions:

Drug is stored in the dry, protected from light place at a temperature from 2 °C to 8 °C. To store in the place, unavailable to children.


Issue conditions:

According to the recipe


Packaging:

In ampoules on 1,5 ml (1 dose) and 3 ml (2 doses), on 10 ampoules in a box with a corrugated partition or a polymeric insert from a film polyvinyl chloride for placement and fixing of ampoules.



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