Information for professionals
Name of product:

IMUNOR

Qualitative and quantitative composition:

The active ingredient in a bottle Transferendi factor suillus 10 mg. Solvent: drinking water.

Pharmaceutical form:

IMUNOR is a lyophilized solution for oral use. This is an ultra-soluble extract prepared from peripheral leukocytes pork blood (transfer factor). Product Description: Porous material to yellowish white in the form of a cookie or divided powder. The powder may stick to the bottom of the vial or stopper.

Therapeutic indications:

The active substance is a mixture of low molecular weight peptides and nucleoproteins grafts with a low molecular weight (less than 12,000 D) products, including regulatory T cells that are released under physiological conditions of immunocompetent cells in the immune response. The relative composition of a mixture of low molecular weight substances is characterized by the ratio of absorbances at 260 and 280 nm. A260 / A280 greater than or equal to 1.8. The product IMUNOR is indicated for the treatment especially in cases of laboratory-proven disorders of cellular immunity (reduction of total T lymphocytes, reduced CD4 + helper T lymphocytes, increased CD8 + T supresorických lymphocytes), as well as in clinical cases of disease, which is known to be generally impaired cellular immunity associated. It is also indicated for deficiency of humoral immunity with laboratory evidence of decreased levels of immunoglobulins and fluctuating findings impaired cellular immunity, with the clinical picture of recurrent infections of various sites. This may include the following types of disease: primary immunodeficiency: for example, common variable immunodeficiency particular manifestations of chronic and recurrent bacterial infections and evidence of disturbed function of cellular immunity. Secondary immunodeficiency: adjuvant therapy for prolonged convalescence after some viral diseases, conditions after difficult surgery under general anesthesia with reduced symptoms imunocompentence; adjuvant treatment of malignant disease in the phase after chemotherapy and radiotherapy in the symptomatology of reduced immune function of organism (recurrent infections, subfebrilie, fatigue , leukopenia), recovery after septic conditions. Chronic and recurrent infections difficult to respond to conventional therapy. Chronic fatigue syndrome - cases with the finding of reduction parameters of cellular immunity. Recurrent herpetic disease (herpes simplex, genital herpes). It proved also in the treatment of some allergic diseases (bronchial asthma) as an adjunct to standard therapy (antihistamines, preventive immunotherapeuticals) or other immunotherapy (autovakcíny, hyposensitization). It is used also in the treatment of superficial fungal diseases.

Dosage and administration:

Dosing for each age category distinction. The basic cure is to provide a specimen 4-6 doses administered at one-week intervals (basic medical treatment). In the case of acute infection treatment can be also initiated with 2-3 doses during the first week (eg every other day), followed by administration of additional doses at one-week intervals. The choice of treatment strategy is individual and depends on the clinical development of the case and immunological laboratory findings. Usually 3-4 treatments are applied per year. In severe cases, when the interval between treatments is a treatment of early recurrences, it is possible to proceed with continuous administration. This usually mean long-term administration of 1 dose in one-or two-week intervals.

Contradications:

IMUNOR is not recommended during pregnancy, other contraindications are not known.

Special warnings and precautions for use:

Serious adverse effects were observed. Efficacy and tolerability of the preparation in children has not been verified. The product can be administered to patients with renal insufficiency. Treatment IMUNOR to be kept under the supervision of a clinical immunologist, the drug should not be used beyond the expiration date.

Interaction with other medicinal products and other forms of interaction:

MUNOR drug interactions are known.

Pregnancy and lactation:

Pregnancy is a contradication to administration IMUNOR. Efficacy and tolerability of the preparation in nursing women has not been verified.

ffects on ability to drive and use machines:

The product can be classified into groups a) safe or unlikely to influence.

Adverse effects:

IMUNOR Forbearance is generally very good. Occasionally observed were mild gastrointestinal intolerance symptoms (nausea, epigastric burning, vomiting), general symptoms (fatigue, drowsiness, increased sweating, headache, feeling of inner warmth) or skin symptoms (itching, rash ephemeral). Side effects are usually transient and rarely lead to the need to discontinue treatment. Significant side effects were observed.

Overdose:

In pre-clinical evaluation of transfer factor VÚFB was observed in the seven-day safety study of tolerance in mice and rats. In addition, a special test was conducted focusing on the possible embryotoxicity test preparation. IMUNOR substance is very well tolerated. Seven-day administration of mice and rats at doses of 0.15 mg / kg and 7.5 mg / kg did not produce the observed clinical parameters, haematological, biochemical or no changes, testifying to its toxic effects. Pathological-anatomical, histological and ultrastructural examination also did nothing that would indicate to the toxic effects IMUNOR. IMUNOR test in CHEST I and II on chicken embryo did not induce changes that would draw attention to its embryotoxic effects. Also been found mutagenic effects. The people there, considering the results of preclinical tests overdose tested.

Pharmacodynamic properties:

Mechanism of action IMUNOR (transfer factor) is complex. Custom transfer effect leads to activation of lymphocytes incompetent, so they are able to recognize foreign antigenes and respond to proliferation and differentiation. At the same time after IMUNOR a number of non-specific changes. Lie in the activation of chemotaxis, phagocytic activity of macrophages and polymorphonuclears in the induction of interferon and interleukins, to increase the number E and PHA responsive lymphocytes, the activation of cyclic nucleotides (cGMT), normalization of blood counts components in increasing the synthesis of nucleic acids, the anti-inflammatory and action. These activities do not result in exceeding the normal parameters. IMUNOR thus appears as a substance modulating the immune system and pre-clinical testing, the effect IMUNOR significantly different from the standard human transfer factor administered sc Based on the results of a clinical trial, we can say that the administration IMUNOR treatment led to lower and higher values ​​of the monitored indicators (located outside the reported physiological range), detected at baseline. These values ​​were modified during the study toward the physiological range, it was in the majority of monitored parameters recorded at the end of the study subjects with a lower percentage mimohraničními values. IMUNOR administration showed beneficial effects of fatigue on the retreat, subfebrilií and the frequency and severity of the infection. For the vast majority of patients were a consequence of administration IMUNOR to improve health. Tolerance of the preparation was very good, only 3 patients from 135 studies had to be terminated prematurely due to adverse effects of stronger intensity.

Pharmacokinetic properties:

A pharmacokinetic study was carried out for technical reasons. This is an ultra-soluble extract prepared from peripheral blood leukocytes pork. The active substance is a mixture of low molecular weight peptides and nucleoproteins grafts with a low molecular weight (less than 12 000 D) products, including regulatory T cells that are released under physiological conditions of immunocompetent cells in the immune response. This mixture of substances could not be distinguished from the methods available to the body´s own substances.

Preclinical safety:

The seven-tolerance test were observed toxic effects even when administered padesátinásobné therapeutic dose. Also, Embryotoxicity and mutagenicity tests were negative.

List of ingredients:

The product does not contain any additional ingredients.

Incompatibilities:

It dissolves in the drinking water bottle, other substances may be added to the solution.

Shelf life:

The Unopened shelf life of 18 months. After reconstitution as directed, the product immediately.

Special precautions for storage:

Store in a refrigerator at 2-8 ° C. Keep vial in outer carton to protect from light. Do not use after expiry date stated on the label. Keep out of reach and sight of children.

Nature and contents of container:

Glass bottle closed 3 ml lyophilisation stopper and screw cap thermoplastic. The bottles are packed 4 pieces in a cardboard box (IPN 16-94) along with the package insert.

Instructions for use and handling:

Contents 1 bottle before using dissolved under gentle shaking at about 3 ml (bottle neck) of drinking water. The content of the drinks on an empty stomach for 1/2 hour can consume a light breakfast.

Marketing Authorisation Holder:

ImunomedicA as Chuderov 118, 400 02 Usti nad Labem, Czech Republic

Registration number:

59/516/97-C

Date of first authorization / renewal:

25.6.1997

Revision Date of text:

6.5.2009

Documents to download
Summary of product
   Summary of product
   (pdf, 45 kB)
Certificate SVP
   Certificate SVP
   (pdf, 302 kB)
VPOIS & pharmacovigilance
Qualified Person for Pharmacovigilance
Ing. Ivan Svoboda
email: ivan.svoboda@sdpharma.cz
phone:    +420 603 223 038

Contact person for a publicly accessible scientific service of the product
MUDr. Dalibor Jílek, CSc.
email: dalibor.jilek@cbox.cz
phone:    +420 723 908 104