Целлекс

General characteristics. Structure:

Active agent: Целлекс substance-solution (frozen in terms of protein * - 0,100 mg).

Excipients: Glycine - 3,75 mg, hydrophosphate Sodium a dihydrate - 2,99 mg, dihydrophosphate Sodium monohydrate - 0,47 mg, Sodium chloride - 5,85 mg, water for injections to 1,0 ml.

* − Structure on 1 ml:

Active agent: Polypeptides from a brain of embryos of pigs, in terms of crude protein 0,9 − 2,4 mg (nominal content of crude protein is 1,65 mg on 1 ml of substance).

Excipients: Glycine - 3,75 mg; 0,1M of hydrophosphate dinatrium solution to рН 7,8 (about 0,8 mg of dry matter), Sodium of chloride of 5,85 mg, Polisorbata-80 0,005 mg, the Water purified to 1 ml.

Description: transparent colourless or inodorous light yellow liquid or with a specific smell. Opalescence is allowed. Availability of separate threads of a coagulate is allowed.

Rules of administration of solution: The drug is administered subcutaneously via the sterile shpritsevy filter which is included in the package. For introduction gain the necessary number of Tselleks in the syringe, remove a needle, then put on the syringe the sterile shpritsevy filter with a diameter of time of 0,22 microns. Take a new needle and put on it the sterile shpritsevy filter. Drug is ready to use.

Pharmacological properties:

Pharmacodynamics.

Availability of tkanespetsifichesky alarm proteins and polypeptides - growth factors, factors of a differentiation of nervous cells in drug causes its direct neuroreparative action, due to regulation of concentration of a pool of neurotransmitters, with braking of a spilover of exciting amino acids.

Drug activates secondary neuroprotection due to stimulation of processes of a sinaptogenez, recovery of signals of an autophagy, improvement of fabric immunoregulation with braking of immunogene cytotoxicity of macrophages. At the same time tkanespetsifichesky and systemic reparative action of drug with recovery of regenerative and reparative potential of cells of a brain, reduction of number of the damaged cells and expressiveness of perifocal hypostasis in a penumbra zone (allows to achieve considerable restriction of the center of a necrosis of brain fabric) with recovery of microcirculation and the general perfusion is noted.

Recovery and regulatory stimulation of various kompartment of TsNS with system influence of growth factors, a differentiation and alarm molecules provides decrease in terms of recovery and rehabilitation of patients with damages of the central and peripheral nervous system of vascular genesis and recovery of motive, sensitive and cognitive functions. 

The therapeutic effect usually develops in 3-5 days after the beginning of administration of drug.

Pharmacokinetics.

The complex list of Tselleks which active fraction consists of the balanced and stable mix of biologically active proteins and polypeptides possessing total multifunctional action does not allow to carry out the usual pharmacokinetic analysis of separate components.

Indications to use:

Cerebrovascular diseases: 

- acute disorders of cerebral circulation in the acute and early rehabilitation period of a course of a disease as a part of complex therapy.

Route of administration and doses:

The adult drug appoint in a dose 0,1 - 0,2 mg of 1 times a day subcutaneously within 10 days depending on weight of a condition of the patient. If necessary conduct a repeated course in 10 days. Researches on use of drug in children's practice were not conducted.

Precautionary measures at use: it is necessary to appoint with care drug in the presence in the anamnesis of allergic reactions to drugs of the proteinaceous and peptide nature.

Features of use:

With extra care it is appointed at arterial hypertension of a malignant current in a decompensation stage; sympathoadrenal crises as the panic attacks; the expressed alarming and depressive frustration.

At pregnancy effect of drug is not studied.

Drug does not contain prion infections and viruses.

Influence on ability to manage vehicles and other mechanisms. 

Now there are no data on influence of drug of Tselleks on ability to driving and work with the mechanisms requiring special attention and speed of mental and motor reactions.

Side effects:

Allergic reactions in the form of not expressed hyperemia in an injection site, hypersensitivity reactions (skin rash, an itch, a Quincke's disease), subfebrile condition, a sleep disorder, a headache can be noted.

Interaction with other medicines:

At combined use with psychogogic drugs and alcohol perhaps psychomotor excitement, sleep disorders.

Reduction of activity of anesthetics, tranquilizers, neuroleptics is possible.

Contraindications:

Epilepsy, maniacal psychosis, productive nonsense, delirium, age up to 18 years (in connection with insufficiency of clinical data).

Overdose:

Now cases of overdose of drug of Tselleks are noted.

Storage conditions:

In the place protected from light, at a temperature from 2 °C to 8 °C  . To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Solution for hypodermic introduction of 0,1 mg/ml.

 

On 1 ml or 2 ml in ampoules of dark glass with a capacity of 1 ml or 2 ml the import, having a ring tension for opening, or the ampoules having a break point.

On 1 ampoule on 1 ml in a blister strip packaging from a film polyvinyl chloride.

On 1 ampoule on 2 ml in a blister strip packaging from a film polyvinyl chloride.

On 2 ampoules on 1 ml in a blister strip packaging from a film polyvinyl chloride.

On 2 ampoules on 2 ml in a blister strip packaging from a film polyvinyl chloride.

On 5 ampoules on 1 ml in a blister strip packaging from a film polyvinyl chloride.

On 5 ampoules on 2 ml in a blister strip packaging from a film polyvinyl chloride.

1 or 2 blister strip packagings together with the application instruction place in a pack cardboard.