Cellex - instructions for use, dose, side effects, contraindications

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Dosage form: & nbsphypodermic solution

Composition: Composition of nand 1 ml:

Active substance:
Cellex® substance-solution (frozen in terms of protein *)	0.100 mg
Auxiliary substances:
Glycine	3.75 mg
Sodium hydrogen phosphate dihydrate	2.99 mg
Sodium dihydrogen phosphate monohydrate	0.47 mg
Sodium chloride	5.85 mg
Water for Injection	up to 1.0 ml

* - Composition per 1 ml:

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

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

Description:

Transparent colorless or light yellow liquid, odorless or with a specific odor. Opalescence is allowed. Presence of separate strands of coagulum.

Pharmacotherapeutic group:nootropic remedy

ATX: & nbsp

Other psychostimulants and nootropic drugs

Pharmacodynamics:

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

The drug activates secondary neuroprotection due to stimulation of synaptogenesis processes, restoration of autophagy signals, improvement of tissue immunoregulation with inhibition of immunogenic cytotoxicity of macrophages. In this case, the tissue-specific and systemic reparative effect of the drug is noted with the restoration of the regenerative and reparative potential of brain cells, the reduction in the number of damaged cells and the severity of perifocal edema in the penumbra region (allows a significant restriction of the necrosis of the brain tissue) with restoration of microcirculation and general perfusion.

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

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

Pharmacokinetics:

The complex composition of Tsellesa®, whose active fraction consists of a balanced and stable mixture of biologically active proteins and polypeptides with a total polyfunctional effect, does not allow for a routine pharmacokinetic analysis of individual components,

Indications:

Ccerebrovascular diseases:

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

Contraindications:

Epilepsy, manic psychosis, productive delirium, delirium, age under 18 (due to the lack of clinical data).

Carefully:In the presence of an anamnesis of allergic reactions to preparations of protein-peptide nature.

Pregnancy and lactation:

The absence of appropriate studies does not allow the use of the drug in this contingent of patients.

Dosing and Administration:

Adults the drug is prescribed in a dose of 0.1-0.2 mg once a day subcutaneously within 10 days, depending on the severity of the patient's condition. If necessary, repeat the course in 10 days. Studies on the use of the drug in children's practice have not been conducted.

Rules for administering the solution

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

For the administration, the required amount of Tsellex® is poured into the syringe, the needle is removed, then a sterile syringe filter with a pore diameter of 0.22 μm is put on the syringe. Take a new needle and put it on a sterile syringe filter. The drug is ready for use.

Side effects:

There may be allergic reactions in the form of unexpressed hyperemia at the injection site, a hypersensitivity reaction (skin rash, itching, angioedema), subfebrile condition, sleep disturbance, headache.

Overdose:Currently there have been no cases of overdose of Cellex®.

Interaction:

When combined with psychostimulating drugs and alcohol, psychomotor agitation, sleep disturbances are possible.

Possible a decrease in the activity of funds for anesthesia, tranquilizers, neuroleptics.

Special instructions:

With special care is prescribed for arterial hypertension malignant course in the stage of decompensation; sympathetic adrenal crises by the type of panic attacks; expressed anxiety-depressive disorders.

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

The drug does not contain prion infections and viruses.

Effect on the ability to drive transp. cf. and fur:

At present, there is no evidence of the effect of Zelleks® on the ability to drive and work with mechanisms that require increased attention and speed of mental and motor reactions.

Form release / dosage:

Solution for subcutaneous administration, 0.1 mg / ml.

Packaging:

1 ml or 2 ml in dark glass ampoules with a capacity of 1 ml or 2 ml imported, having a ring of tension for dissection, or ampoules having a fracture point. The color marking of ampoules in the form of two green strips is allowed.

1 ampoule of 1 ml each in a contour mesh package made of a polyvinyl chloride film.

1 ampoule of 2 ml each in a contour cell pack of film polyvinyl chloride.

2 ampoules of 1 ml each in the contour cell packaging of films polyvinyl chloride.

2 ampoules of 2 ml each in the contour cell packaging of films polyvinyl chloride.

5 ampoules of 1 ml per circuit cell packaging of films polyvinyl chloride.

5 ampoules of 2 ml each in the contour cell packaging of films polyvinyl chloride.

1 or 2 contour mesh packages together with the instruction for use are placed in a cardboard pack.

Sterile syringe filters with a pore diameter of 0.22 μm are added to the packet in an amount equal to the number of ampoules.

Storage conditions:

In the dark place at a temperature of 2 to 8 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001393

Date of registration:20.12.2011 / 08.12.2015

Date of cancellation:2016-12-20

The owner of the registration certificate:FARM-SYNTHESIS, CJSC FARM-SYNTHESIS, CJSC Russia

Manufacturer: & nbsp

FARM-SYNTHESIS, CJSC Russia

Company DEKO, LLC Russia

Information update date: & nbsp13.03.2016

Illustrated instructions

Instructions

Cellex® (Cellex®)