Cellex solution for injection 0.1mg / ml, 1ml No. 5

Cerebrovascular diseases:

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

For adults, the drug is prescribed in a dose of 0.1-0.2 mg 1 time / day s / c for 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 pediatric practice have not been conducted.

Solution administration rules

The drug is administered s / c through a sterile syringe filter included in the kit.

For injection, draw the required amount of CellexЃ into a syringe, remove the needle, then put a sterile sterile syringe filter with a pore diameter of 0.22 ?m onto the syringe. Take a new needle and place it on a sterile syringe filter. The drug is ready for use.

Active substance:

cellexЃ substance-solution (frozen, in terms of protein *) 0.1 mg

Excipients: glycine - 3.75 mg, sodium hydrogen phosphate dihydrate - 2.99 mg, sodium dihydrogen phosphate monohydrate - 0.47 mg, sodium chloride - 5.85 mg, water d / i - up to 1 ml.

* Composition for 1 ml.

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

Excipients: glycine - 3.75 mg, 0.1M disodium hydrogen phosphate solution - up 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.

• epilepsy;

• manic psychosis;

• productive delirium;

• delirium;

• age up to 18 years (due to lack of clinical data).

Clinical and pharmacological group: Nootropic drug

Pharmaco-therapeutic group: Nootropic agent

pharmachologic effect

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

The drug activates secondary neuroprotection by stimulating the processes of synaptogenesis, 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 to achieve a significant limitation of the focus of brain tissue necrosis) with the restoration of microcirculation and general perfusion.

Recovery and regulatory stimulation of various CNS compartments with a systemic effect of growth factors, differentiation and signaling molecules provides a reduction in the recovery and rehabilitation time for 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 CellexЃ, the active fraction of which consists of a balanced and stable mixture of biologically active proteins and polypeptides with a total multifunctional effect, does not allow for the usual pharmacokinetic analysis of individual components.

Indications

Cerebrovascular diseases:

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

Dosage regimen

For adults, the drug is prescribed in a dose of 0.1-0.2 mg 1 time / day s / c for 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 pediatric practice have not been conducted.

Solution administration rules

The drug is administered s / c through a sterile syringe filter included in the kit.

For injection, draw the required amount of CellexЃ into a syringe, remove the needle, then put a sterile sterile syringe filter with a pore diameter of 0.22 ?m onto the syringe. Take a new needle and place it on a sterile syringe filter. The drug is ready for use.

Side effect

Allergic reactions may occur in the form of unexpressed hyperemia at the injection site, hypersensitivity reactions (skin rash, itching, angioedema), subfebrile condition, sleep disturbance, headache.

Contraindications for use

• epilepsy;

• manic psychosis;

• productive delirium;

• delirium;

• age up to 18 years (due to lack of clinical data).

Application during pregnancy and lactation

The lack of relevant studies does not allow the use of the drug in this contingent of patients.

Application in children

The use of the drug is contraindicated in children and adolescents under the age of 18 years.

special instructions

With extreme caution, it is prescribed for arterial hypertension of a malignant course in the stage of decompensation; sympatho-adrenal crises of the type of panic attacks; severe anxiety-depressive disorders.

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

The product does not contain prion infections and viruses.

Precautions for use

Care should be taken to prescribe the drug if there is a history of allergic reactions to drugs of a protein-peptide nature.

Influence on the ability to drive vehicles and use mechanisms

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

Overdose

Currently, there have been no cases of overdose of CellexЃ.

Drug interactions

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

It is possible to reduce the activity of drugs for anesthesia, tranquilizers, antipsychotics.

Storage conditions

The drug should be stored in a place protected from light and out of reach of children, at a temperature of 2 ? to 8 ? C.

Shelf life

Expiration date - 1 year.

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

Terms of sale

The drug is available with a prescription.