Pentaglobin

Pentaglobin – the drug containing the immunoglobulin of the person normal [IgG+IgA+IgM] including a wide range of antibodies, active concerning causative agents of various infections and their toxins.

Form of release and structure

Dosage form of Pentaglobin – solution for infusions: light yellow or colourless liquid, slightly opalescent or transparent (on 10 ml in ampoules, in a cardboard pack 1 ampoule; on 10, 20, 50 or 100 ml in bottles of colourless glass with a rubber bung under an aluminum cap, in a cardboard pack 1 bottle).

For infusions contains in 1 ml of solution:

• Active agent: proteins of plasma of the person – 50 mg (more than 95% immunoglobulin (Ig), including IgA – 6 mg makes, IgM – 6 mg, IgG – 38 mg);
• Auxiliary components: chlorine ions, ions of sodium, a dextrose monohydrate, water for injections.

Indications to use

• Bacterial infections – for the accompanying therapy in a combination with antibiotics;
• Immunodeficiency or heavy secondary antibody deficiency syndrome (immune insufficiency or the suppressed host defense) – as replacement therapy.

Contraindications

• Hypersensitivity to immunoglobulin of the person, especially at patients with deficit of immunoglobulin A and existence in blood of antibodies against it;
• Individual intolerance of components of drug.

With care it is necessary to use immunoglobulins during pregnancy and breastfeeding.

Route of administration and dosage

The pentaglobin is intended for intravenous (in/in) drop introductions.

By preparation for infusion it is necessary to be convinced visually of lack of suspended particles in solution and its compliance to physical properties. It is impossible to use drug in the presence in it a deposit.

It is possible to mix solution only from 0,9% chloride sodium solution for injections.

Before opening of an ampoule its contents should be heated to body temperature or room temperature.

It is necessary to open ampoules and bottles just before performing infusion.

Speed of infusion has age restrictions:

• Newborns and babies: by means of a perfusor from calculation for 1,7 ml on 1 kg of body weight an hour;
• Children: on 0,4 ml on 1 kg of body weight an hour;
• Adults: the first 100 ml on 0,4 ml 1 kg of weight an hour, then about 0,2 ml on 1 kg of weight an hour before achievement within three days of the speed of 15 ml on 1 kg of body weight are continuous.

The dose of drug is appointed by the doctor taking into account disease severity and the immune status of the patient.

The recommended dosing mode:

• Heavy bacterial infections, replacement therapy at children with an immunodeficiency and a secondary antibody deficiency syndrome: on 5 ml on 1 kg of weight of the child daily, a course of treatment 3 days;
• Heavy bacterial infections at adults and children: daily – from calculation for 5 ml on 1 kg of weight of the patient, a course of treatment 3 days;
• Replacement therapy at adults and children with a secondary antibody deficiency syndrome and an immunodeficiency: on 3-5 ml on 1 kg of body weight, in need of carrying out a repeated course it is necessary to take a break of 7 days.

The repeated course is appointed depending on the clinical course of a disease.

The solution rest in an ampoule or a bottle is subject to utilization.

Side effects

• Are possible: nausea, fever, vomiting, temperature increase, headache, allergic reactions, easy dorsodynia, arthralgias;
• Seldom: sudden lowering of arterial pressure, emergence of symptoms of aseptic meningitis, hemolitic anemia (hemolysis), passing tranzitorny skin reaction (a hyperemia, rash), an acute renal failure, increase in concentration of creatinine in blood serum;
• In isolated cases: an acute anaphylaxis (including at absence at the patient of hypersensitivity at the previous introduction); symptoms of thrombosis at patients with an excess weight, a heavy hypovolemia, disturbance of blood supply of heart or brain (cardiological or cerebral ischemia), in old age.

Special instructions

The risk of emergence of certain heavy side effects can be in direct dependence on infusion speed therefore it is necessary to observe strictly recommended rate of administering of Pentaglobin.

Thicket are subject to development of the undesirable phenomena: patients with an agammaglobulinemia or a hypoagammaglobulinemia at existence or lack of deficit of immunoglobulin A if use of immunoglobulin of the person was carried out long ago or is made for the first time, and in rare instances – upon transition to other drugs of immunoglobulin.

Extremely rare reactions of hypersensitivity appear at patients with absence in blood of immunoglobulin A and in the presence to it antibodies.

At development of shock against the background of reactions of intolerance carrying out emergency measures of antishock therapy is necessary.

To avoid possible complications it is necessary to begin administration of drug with the speed of 0,4 ml on 1 kg of weight an hour, having convinced of lack of symptoms of allergic reactions, to pass to the recommended rate of administering, under careful observation of a condition of the patient. After administration of drug the condition of the patient needs to be controlled within 20 minutes. The patients receiving Pentaglobin for the first time or after a long break demand special control during performing infusion and within one hour after its termination.

Cases of an acute renal failure at administration of immunoglobulin can meet more often at the patients with the diabetes mellitus, a renal failure, excess weight lowered by the volume of the circulating blood taking medicine with nephrotoxic action 65 years are aged more senior. At administration of drug it is necessary to provide sufficient consumption of liquid prior to infusion, control of amount of urine, content of creatinine of serum, an exception of the accompanying therapy with diuretics. If negative influence of immunoglobulin on function of kidneys is diagnosed, administration of solution should be stopped.

For treatment of patients with accessory factors of risk of development of renal failures and an acute renal failure it is recommended to use immunoglobulin drugs without sucrose and to observe rate of administering no more than 0,4 ml on 1 kg of weight an hour.

Pentaglobin's influence on ability of the patient to control of vehicles and mechanisms is not established.

Medicinal interaction

The pentaglobin can negatively influence live virus vaccines against measles, a rubella, chicken pox, epidemic parotitis therefore it is necessary to begin vaccination not earlier, than in 3 months after administration of immunoglobulin. The measles inoculation can be done only after performing blood test on definition of existence at the patient of the corresponding antibodies.

When carrying out laboratory serological researches after administration of immunoglobulin receiving false positive analysis findings is possible. Passive introduction of antibodies against antigens of erythrocytes can exert impact on the following serological parameters: alloantibodies to erythrocytes, гаптоглобин, quantity of reticulocytes.

The risk of development of undesirable effects increases at appointment to babies of Pentaglobin in combination with a calcium gluconate.

Terms and storage conditions

To store in the place protected from light at a temperature up to 2-8 °C, not to freeze. To protect from children.

Period of validity – 2 years.