Immunomax
(Registrier-Nr: R N001919/02-2006)


Instruction for medical application of
Immunomax® preparation

Ministry of health of the russian federation

AUTHORISED:
[SIGNATURE] V.E. Akimochkin,
Head of the Department
of State Supervision over
Drugs and Medical Equipment,
Ministry of Health of Russia
9 December 2002
APPROVED:
Pharmacological Committee,
Ministry of Health of Russia
11 July 2002
Record no. 3

Instruction on the Medical Use of Immunomax

Registration number: P No.001919/02-2002

Commercial name: Immunomax

MNN: not assigned

Chemical name: acidic peptidoglycan having a molecular weight of 1000-40000 kDa

Dosage form: lyophilised powder, to be dissolved for intramuscular injections

Description: the drug is a white lyophilised powder

Composition: 100 or 200 U of Immunomax

Pharmacotherapeutic group: an immunomodulator

Pharmacological characteristics: Immunomax enhances the immunity to viral and bacterial infections. The immunopharmacological mechanisms underlying the effect of the drug are the activation of the following components of the immune system: NK cells, which intensely express CD69 activation molecules 2-3 h after Immunomax administration; circulating monocytes, which 2-4 h after the activation with Immunomax begin to secrete cytokines, including interleukin-8 and interleukin-1?, and tumour necrosis factor-?; neutrophilic granulocytes, the activation of which is mediated by monocytes; the drug has no direct effect on neutrophilic granulocytes. Interleukin-8 secreted by monocytes results in the activation of neutrophilic granulocytes, which becomes manifest 24 h after the Immunomax administration; tissue macrophages, in which morphology is altered, the production of bactericide substances is enhanced, and the 5'-nucleotidase activity is changed; and the formation of antibodies against soluble and corpuscular antigens.

Immunomax enhances protection against infections caused by viruses (human papillomavirus, herpes simplex virus, parvovirus, carnivore plague virus, etc.) or bacteria (colibacillus, salmonella, staphylococcus, chlamydia, mycoplasma, ureaplasma, etc.). This effect is expressed in adults and infants after the administration of the drug by various ways: intramuscularly, intravenously, intraperitoneally, or per os.

Pharmacokinetics of the drug has not been studied because of its peptidoglycan nature and very low effective doses.

Indications:

Contraindications:

The drug should not be administered to persons with hypersensitivity to Immunomax.

Children under 12 years of age.

Pregnancy and lactation:

There are no data on the effect of Immunomax on pregnant women. Like other drugs, Immunomax should not be used during pregnancy unless the advantages for the patient overbalance the risk for the foetus.

Immunomax is not recommended to breastfeeding mothers.

Administration and doses:

The recommended dose for adults and children over 12 years of age is 100-200 U intramuscularly once a day.

The contents of a vial (ampoule) is dissolved before use in 1 ml of water for injections and injected intramuscularly at a dose of 100-200 U, depending on the disease severity. The course of treatment consists of six injections on days 1, 2, 3, 8, 9, and 10 of treatment.

Interaction with other drugs:

Not described.

Side effects:

Not found.

Form of manufacturing:

The drug is manufactured in the form of white sterile lyophilised powder in vials or ampoules containing 100 or 200 U of Immunomax.

Shelf life:

The shelf life is two years.

Storage conditions:

The drug should be stored at a temperature from +4 to +8°C.

Retail conditions:

Not to be sold without prescription.

Manufacturer:

Immapharma, Ltd., 18 Gamalei str., Moscow, 123098 Russia,
phone: 193-4339, 193-6805.
[SIGNATURE]
Prof. V.V. Chel'tsov,
Director of the Institute of Preclinical and Clinical Expert Assessment of Drugs
[STAMP: Institute of Preclinical and Clinical Expert Assessment of Drugs Research Centre for Expert Assessment of Medical Products Ministry of Health of the Russian Federation
FEDERAL STATE INSTITUTION
MOSCOW]