1. NAME OF THE MEDICINAL PRODUCT

IMUNOR

3. PHARMACEUTICAL FORM

Oral lyophilizate

Product description: Porous, white to off-white mass in the form of a cake or a dispersed powder. The powder can get adhered to the bottom or a stopper of the vial.

4.2 Posology and method of administration

Dosage
There is no difference in dosage for individual age categories. The basic cure (the basic therapeutic treatment) consists in administration of four to six doses of the product at one-week intervals. In a case of an acute infection, the treatment can be also commenced via administration of two to three doses during the first week (e.g. every other day), with the subsequent administration of further doses at one-week intervals. The selection of the therapeutic strategy is individualized and depends on the clinical development of the case and on laboratory findings in terms of immunology. As a rule, three to four therapeutic treatments are repeated in a year. In more serious cases - when the disease recurs frequently during periods between individual therapeutic treatments - the product can be administered continuously. This usually means a long-term administration of one dose at one-week or twoweek intervals.

Route of administration
After reconstitution, the product should be drunk in the morning on an empty stomach; and after half an hour, a light breakfast can be eaten. Instructions for reconstitution of this medicinal product prior to its use can be found in section 6.6.

4.4 Special warnings and precautions for use

No serious adverse drug reactions have been reported so far.

The product can be administered to patients with renal insufficiency. IMUNOR treatment should be conducted under supervision of a clinical immunologist.

4.6 Fertility, pregnancy and lactation

Pregnancy
Pregnancy is a contraindication for IMUNOR administration.

Lactation
Efficacy and tolerance of the product have not been verified in breast-feeding women so far.

4.8 Undesirable effects

IMUNOR tolerance is generally very good. The following adverse drug reactions have been reported in sporadic cases:
Gastrointestinal disorders: Manifestations of mild gastrointestinal intolerance (nausea, burning in epigastrium, vomiting);
Skin and subcutaneous tissue disorders: Itching, transient exanthema;

General disorders and administration site conditions: Fatigue, somnolence, higher sweating, headaches, feeling of internal warm.

The adverse drug reactions are mostly of a transient character and they have led to a necessity of discontinuance of the treatment in exceptional cases only.

No serious adverse drug reactions have been reported.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at the below

address:
Státní ústav pro kontrolu léčiv
Šrobárova 48
100 41 Praha 10
Web sites: www.sukl.cz/nahlasit-nezadouci-ucinek

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Immunostimulants, ATC code: L03AX

Mode of action

The mode of action of IMUNOR (transfer factor) is complex. The transfer effect on its own results in activation of non-competent lymphocytes and, thus, they are able to identify foreign antigens and react to them by proliferation and differentiation. At the same time, numerous non-specific alterations take place after IMUNOR administration.

Pharmacodynamic effects

The pharmacodynamic effects consist in activation of chemotaxis, the phagocyte activity of macrophages and polymorphonuclears, in an induction of the interferon and interleukin creation, in normalization of a number of total T lymphocytes and PHA-reacting lymphocytes, in activation of cyclic nucleotides (cGMT), in normalization of the blood picture constituents, in higher synthesis of nucleic acids, and in anti-inflammatory and antiedematous effects. The above mentioned activities do not result in exceeding the normalvalue parameters. Hence, IMUNOR seems to be a substance modulating the entire immune system; and in preclinical testing, the effect of IMUNOR did not differ markedly from the standard human transfer factor administered subcutaneously.

Clinical safety and efficacy

Based on results of clinical testing, it may be stated that IMUNOR administration resulted in an adjustment of both reduced and increased values of studied parameters (being outside the given physiological range) as ascertained at the start of the study. The values were modified during the study towards their physiological range. That is why a lower percentage of persons with out-of-limit values were recorded at the end of the study in majority of cases. IMUNOR administration has demonstrated a favorable influence on fatigue as well as sub-febrile temperatures going away, or a beneficial impact on the frequency and severity of course of infections. In vast majority of patients, the health state got improved thanks to IMUNOR.

The product tolerance was very good. Only three out of 135 patients had to be excluded from the study owing to adverse drug reactions of higher intensity.

5.3 Preclinical safety data

No particular risk for humans has been revealed based on non-clinical data obtained from conventional studies of pharmacological safety, multiple dosage toxicity, genotoxicity, carcinogenicity, or reproduction and development toxicity studies.

At preclinical testing of the transfer factor by the VÚFB (the Research Institute of Pharmacy and Biochemistry), safety of the factor was studied in a seven-day tolerance study on mice and rats. Furthermore, a special test was carried out investigating potential embryotoxicity of the product tested.

IMUNOR is very well tolerated. The seven-day administration of the product to mice and rats, dosed daily 0.15 mg/kg and 7.5 mg/kg orally (i.e. an equivalent and in a fifty-fold multiple of the supposed clinical dose), did not induce any alteration indicating the product toxic influence on clinical, hematological or biochemical parameters studied. Neither pathological/anatomical, nor histological, nor ultra-structural examination indicated toxic effects of IMUNOR.

No alterations indicating embryo-toxic activity of IMUNOR in the CHEST I and II test on a chicken embryo were confirmed. Neither mutagenic activity was ascertained.

6.2 Incompatibilities

No compatibility studies are available. Therefore, this medicinal product must not be mingled with other medicinal products.

6.4 Special precautions for storage

Store in a fridge at 2 - 8º C; the vials should be kept in their box to protect the product from light.
Do not use after expiry of the shelf-life given on the package.
Keep out of sight and reach of children.

6.6 Special precautions for handling and disposal

Reconstitute the contents of the vial before administration by adding drinking water up to the neck of the vial and moderately shake. Since the powder can get adhered to the stopper, it is advisable to close the vial again after water addition and to shake it in order to achieve a perfect reconstitution of the powder in the water. Then drink the contents on an empty stomach; a light breakfast can be taken after half an hour thereafter.

The unused medicinal product or its wastes must be disposed of in compliance with requirements of local legislation.

8. MARKETING AUTHORISATION NUMBER(S)

59/516/97-C

10. DATE OF REVISION OF THE TEXT

19.5.2015