Octagam

Active material: plasma protein. Immunoglobulin
When ATH: J06BA02
CCF: Preparation, affecting the immune system. Immunoglobulin
ICD-10 codes (testimony): (B) 23.2, B24, C90.0, Q91.1, D69.3, D80, D81, D82.0, D83, G61.0, M30.3, Z94
When CSF: 14.05
Manufacturer: MANIFOLD GROWTH Pharmazeutika Produktionsges m. b. H. (Austria)

Pharmaceutical form, composition and packaging

Solution for infusion clear or slightly opalescent, colorless to pale yellow.

Excipients: maltose, 3-n-butyl phosphate, oktoksinol (Triton x-100), water d / and.

20 ml – glass bottles (1) – packs cardboard.
50 ml – glass bottles (1) – packs cardboard.
100 ml – glass bottles (1) – packs cardboard.
200 ml – glass bottles (1) – packs cardboard.

Pharmacological action

Oktagamsoderzhit basically immunoglobulins G – antibodies can cause various infections. Distribution of immunoglobulin subclasses G (IgG) the preparation of the same, as in natural plasma and has all the properties of the, typical for healthy human. Effective dose of the drug can restore low levels of IgG to its normal level. IgG molecules are not affected as a consequence of the chemical or enzymatic effects. Antibody activity is fully preserved.

Sales contains not more than 3% Polymers, the contents of the monomers and dimers is not less than 90%.

Pharmacokinetics

Distribution

Sales after the on/in the introduction immediately enters the bloodstream. Relatively quickly distributed between plasma and vnesosudistym space. The equilibrium state is achieved on 3-5 d.

Deduction

T_1/2 is about 26-34 d. The Value Of T_1/2 may vary in different patients, especially when primary immunodeficiency.

Immunoglobulins and IgG complexes are destroyed by the cells of the RES.

Testimony

Zamestitelynaya therapy:

-primary immunodeficiency syndromes, incl. congenital agammaglobulinemia and hypogammaglobulinemia, neklassificiruemyj variable immunodeficiencies, severe combined immunodeficiencies, Wiskott-Aldrich Syndrome;

— mielomnaya disease or chronic lymphoblastic with severe secondary gipogammaglobulinemiej and recurrent infections;

-recurrent infection in children with congenital HIV infection.

Immunomodulirujushhaja therapy:

-trombozitopenica idiopathic Purpura in adults and children with a high risk of bleeding or prior to surgery for the correction of platelet;

- Guillain-Barre syndrome;

-Kawasaki disease;

- Bone marrow transplantation.

Dosage regimen

Dose and duration of therapy is determined individually, Depending on the evidence and the patient farmakokineticeskih parameters. As a recommendation of the product can be used in the following doses.

Substitution therapy in primary immunodeficiencies: mode introduction should contribute to the achievement of the equilibrium level of IgG in plasma within 4-6 g / l (the determination should be carried out before each subsequent infusion). Since the beginning of the treatment it requires 3-6 months. The recommended starting dose is 400-800 mg/kg depending on the clinical situation (eg, in acute infections), followed by 200 mg / kg every 3 of the week. Dose, necessary to achieve the level of 6 g / l, It is between 200 to 800 mg / kg / month. The interval between wvedeniami when reaching a stable level ranging from 2 to 4 weeks. For a more precise definition of the input dosage and intervals introduction recommended periodic measurement of IgG.

Substitution therapy in multiple myeloma or chronic limfoleikoze with severe secondary recurrent infections and gipogammaglobulinemiej; in children with congenital HIV infection and recurrent infections: The recommended dose is 200-400 mg / kg every 3-4 of the week.

Idiopaticheskaya trombotsitopenicheskaya purpura: When treating acute episodes- 0.8-1 g/kg in 1 day, If necessary, re-introduction to the 3 day or 400 mg / kg / day for 2-5 days. Treatment can be repeated in the case of a repeat of the episode.

Guillain Barre syndrome: 400 mg / kg / day for 3-7 days.

Kawasaki diseases: introduced 1.6-2 g/kg in equal doses for 2-5 days or one dose of 2 g / kg. Patients should simultaneously take acetylsalicylic acid.

Bone marrow transplantation: immunoglobulin can be used as a component of the preparatory therapy, and after transplantation. The dose is determined individually. The recommended starting dose is 500 mg / kg / week. Duration of treatment – 3 months after transplantation.

Terms of administration of the solution

Sales should be in/in with initial velocity 0.75-1 mL/min for 15 m (15 drops / min), then 1.2-1.5 mL/min in the following 15 m (25 drops / min). If it was not observed any unwanted reactions, the speed of the remaining portion may be increased to the maximum possible – 3 ml / min (54 drops/min).

Before the introduction of the solution should be brought to room temperature or body temperature.

Infuziu should be conducted through a separate system for on/in the introduction, not mixing Oktagams other drugs.

Muddy, containing sludge solution application shall not be. Any number of the remaining solution should be disposed of.

Side effect

Flu-like symptoms: chills, headache, hyperthermia.

From the digestive system: nausea, vomiting.

Cardio-vascular system: decrease in blood pressure; rarely – collapse; When cerebral ischemia or heart, in elderly patients, obesity, pronounced hypovolemia, increased plasma viscosity (eg, at gipergammaglobulinemii, giperfibrinogenemii, sickle cell disease), occlusive vascular diseases – transient ischemic attack and/or thromboembolic complications.

From the urinary system: giperkreatininemiя, acute renal failure (especially in renal failure in history, for patients with diabetes, gipovolemii, obesity, concomitant therapy nefrotoksicnami drugs, in patients over 65 years).

From the hematopoietic system: in a few cases – passing haemolytic anaemia, gemoliz.

Allergic reactions: skin rash, itch; rarely – anaphylactic shock.

Other: arthralgia, back pain and lower back pain; in a few cases – reversible aseptic meningitis; for patients with diabetes – giperglikemiâ.

In the case of side effects should decrease the rate of injection or terminate infusion.

Contraindications

-intolerance or sensitivity to gomologichnym Antisera, especially in extremely rare cases and immunoglobulin deficiency (IgA), When the patient has antibodies to IgA.

Pregnancy and lactation

Sales should use caution in pregnancy.

The safety of drugs in pregnancy in humans has not been studied. Clinical experience of applying immunoglobulins proves, that their introduction will not have any adverse effects on pregnancy, fetus and newborn.

Immunoglobulins are made with breast milk, While antibodies may have a protective effect in the newborn.

Cautions

At the time of the introduction of the drug should monitor the patient.

Patients, receive immunoglobulins in/in, It is necessary to carry out adequate hydratation before infusion, monitor diuresis, content of serum creatinine; exclude the application of diuretics, acting on the renal tubules.

Introduction of immunoglobulin in high doses may lead to increased plasma viscosity, that increases the risk of ischemia and thromboembolic complications. The most frequent adverse reactions can occur at high speed the introduction, When hypo- and agammaglobulinemia (against the backdrop of IgA deficiency or without it), with the introduction of immunoglobulin for the first time, or, rarely, When translated into another introduction immunoglobulin or after a long period of time after the last infusion.

The first introduction of the preparation should be carried out slowly, at no more than 0.016 ml / kg / min. Particularly careful monitoring required for patients, not previously receiving drugs immunoglobulin, receiving alternative treatment drug, or after a long break after the last injection of immunoglobulin. Such patients require monitoring during the entire period of the first infusion, as well as for 1 hours after the end of the introduction. The remaining patients should be supervised during the first 20 min infusion.

We recommend that you register the serial number of the drug each introduction.

During treatment, tranzithornoe increasing various passively migrated antibodies in a patient's blood can lead to lozhnopolozhitel'nym the results of serological tests.

Passive transfer of antibodies to jeritrocitarnym antigens (eg, A, (B) or (D)) you might change the results of the serological tests with some eritrocitariani Allo-antibodies (eg, sample Kumbsa), affect the number of reticulocytes and gaptoglobina.

Maltose, the information contained in the Product Sales, can affect the performance of glucose in the blood and urine in his laboratory determination.

When applying the preparations of blood or human plasma cannot be completely eliminated the chance of contracting infectious diseases. This also applies to agents of infections previously unknown nature.

In the manufacture of the drug Sales, the following measures are applied, to the exception of transfusional deliver viruses: the selection of healthy donors, testing each portion of plasma and plasma pool for the presence of hepatitis B antigen, antibodies to HIV 1 and 2, hepatitis c; analysis of plasma fractions for the presence of hepatitis c virus genetic material; special procedures for removal/inactivation of viruses using a system solvent/detergent (SD), included in the manufacturing process of the drug, the effectiveness of which has been confirmed in a viral model. These procedures are effective for inactivating deletion/human immunodeficiency virus, hepatitis viruses B and C, but may have limited effectiveness against bezobolochechnyh virus, such as hepatitis a and Parvovirus B19.

Effects on ability to drive vehicles and management mechanisms

Does not affect the ability to drive vehicles and other activities, require high concentration and speed of psychomotor reactions.

Overdose

Symptoms: water retention in the body, increased blood viscosity (especially in patients with impaired kidney or in the elderly).

Treatment: symptomatic therapy.

Drug Interactions

Introduction Oktagama may reduce the efficacy of live attenuated virus vaccines against measles, smallpox, Rubella, mumps and varicella for the period from 6 Sun. to 3 Months. Before the live attenuated viral vaccines, vaccination should be at least 3 months after the use of the drug. When Cory this effect may persist for up to 1 year. In this context, the use of measles vaccine among persons, obtaining the drug for 4-12 months before inoculations, You must check the titre measles antibodies.

Contraindicated use Oktagamaodnovremenno with calcium glukonatom in infants.

Pharmaceutical interaction

Sales should not be confused with other drugs.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, the dark place at a temperature between 2° to 25° c; Do not freeze. Shelf-life of the drug in vials 20 ml – 1.5 year, in vial 50 ml, 100 ml, 200 ml – 2 year.