CELLEX 0.1 mg/ml solution for subcutaneous administration 1 ml ampoule 5 pcs.

CELLEX® is a modern nootropic preparation.

Active ingredient: Proteins and polypeptides of the embryonic brain of animal origin.

Composition per 1 ml:

Active substance: polypeptides from the brain of pig embryos, in terms of total protein 0.9-2.4 mg (nominal content of total protein 1.65 mg per 1 ml of substance);

Excipients: glycine 3.75 mg, 0.1 M disodium hydrogen phosphate solution to pH 7.8 (about 0.8 mg of dry matter), sodium chloride 5.85 mg, polysorbate-80 0.005 mg, purified water up to 1 ml.

Dosage form: solution for subcutaneous administration. Transparent, colorless or light yellow liquid, odorless or with a specific odor. Opalescence is allowed. The presence of separate threads of coagulum is allowed.

Pharmacotherapeutic group: nootropic agent

Pharmacodynamics:

The presence of tissue-specific signaling proteins and polypeptides - growth factors, nerve cell differentiation factors in the drug determines its direct neuroreparative effect, due to the regulation of the concentrations of the pool of neurotransmitters, with inhibition of the spillover of excitatory amino acids.

The drug activates secondary neuroprotection by stimulating synaptogenesis processes, restoring autophagy signals, improving tissue immunoregulation with inhibition of immunogenic cytotoxicity of macrophages. At the same time, a tissue-specific and systemic reparative effect of the drug is noted with the restoration of the regenerative and reparative potential of brain cells, a decrease in the number of damaged cells and the severity of perifocal edema in the penumbra zone (allows for significant limitation of the focus of brain tissue necrosis) with the restoration of microcirculation and general perfusion.

Restoration and regulatory stimulation of various compartments of the central nervous system with the systemic influence of growth factors, differentiation and signaling molecules ensures a reduction in the time of recovery and rehabilitation of patients with damage to the central and peripheral nervous system of vascular origin and restoration of motor, sensory and cognitive functions.

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

Pharmacokinetics:

The complex composition of Cellex®, the active fraction of which consists of a balanced and stable mixture of biologically active proteins and polypeptides with a total polyfunctional effect, does not allow for conventional pharmacokinetic analysis of individual components.

Indications:

Cerebrovascular diseases:

acute cerebrovascular accidents in the acute and early rehabilitation period of the disease as part of complex therapy.

Contraindications:

Epilepsy, manic psychosis, productive delirium, delirium, age under 18 years (due to insufficient clinical data).

Carefully:

If you have a history of allergic reactions to drugs of a protein-peptide nature.

Pregnancy and lactation:

The lack of appropriate studies does not allow the drug to be used in this group of patients.

Directions for use and dosage:

For adults, the drug is prescribed in a dose of 0.1-0.2 mg 1 time per day subcutaneously for 10 days, depending on the severity of the patient’s condition. If necessary, repeat the course after 10 days. Studies on the use of the drug in pediatric practice have not been conducted.

Rules for introducing the solution:

The drug is administered subcutaneously through a sterile syringe filter included in the kit.

For administration, draw the required amount of Cellex® into the syringe, remove the needle, then put a sterile syringe filter with a pore diameter of 0.22 microns on the syringe. Take a new needle and place it on a sterile syringe filter. The drug is ready for use.

Side effects:

Allergic reactions may occur in the form of mild hyperemia at the injection site, hypersensitivity reactions (skin rash, itching, angioedema), low-grade fever, sleep disturbance, headache.

Overdose:

Currently, there are no cases of overdose of Cellex®.

Interaction:

When used together with psychostimulant drugs and alcohol, psychomotor agitation and sleep disturbances are possible.

It is possible to reduce the activity of anesthetics, tranquilizers, and antipsychotics.

Special instructions:

It is prescribed with extreme caution for arterial hypertension of a malignant course in the decompensation stage; sympatho-adrenal crises like panic attacks; severe anxiety and depressive disorders.

During pregnancy, the effect of the drug has not been studied.

The drug does not contain prion infections or viruses.

Impact on the ability to drive vehicles and machinery:

Currently, there is no data on the effect of the drug Cellex® on the ability to drive a car and work with mechanisms that require increased attention and speed of mental and motor reactions.

Release form/dosage:

Solution for subcutaneous administration, 0.1 mg/ml

Package:

1 ml or 2 ml in dark glass ampoules with a capacity of 1 ml or 2 ml imported, having a tension ring for opening, or ampoules with a breaking point. Color marking of ampoules in the form of two green stripes is allowed.

5 ampoules of 1 ml each in a blister pack made of polyvinyl chloride film.

1 or 2 blister packs along with instructions for use are placed in a cardboard box.

Sterile syringe filters with a pore diameter of 0.22 microns are placed in the pack in an amount equal to the number of ampoules.

Storage conditions:

In a place protected from light, at a temperature of 2 to 8 ° C.

Keep out of the reach of children.

Best before date:

2 years.

Do not use after the expiration date stated on the package.

Guaranteed authenticity and quality:

100% Original from PHARM-SYNTHESIS (Russian Federation)

Development and production:

PHARM-SYNTHESIS (Russian Federation)