Pharmacological properties

Pharmacodynamics. Cerebrolysinum — the proteolytic peptide fraction received from a brain of pigs stimulates differentiation and improves function of neurons, activates mechanisms of protection and restoration. experiments on animals showed that Cerebrolysinum has direct impact on neuronalny and synoptic plasticity which promotes improvement of cognitive functions. it is shown on young, mature and old animals with reduced ability to training. in experiments with models of cerebral ischemia Cerebrolysinum reduced heart attack volume, prevented formation of hypostasis, stabilized microcirculation, normalized neurologic and cognitive disturbances and doubled survival indicators. positive takes are received also during the researches with Alzheimer's disease models. except direct action considerably increased quantity of molecules which transport glucose through geb by neurons, Cerebrolysinum, compensating thus the critical energy shortage noted in this disease.

substantial dose-dependent increase of neuronalny activity (increase in frequencies α- and β-rhythms) after 4 weeks of the Cerebrolysinum medicament treatment. Irrespective of a cause of illness in neurodegenerative dementia of altsgeymerovsky type or in vascular dementia, after the Cerebrolysinum medicament treatment at patients cognitive functions and ability to self-service objectively improved. Clinically noticeable improvement of a condition of patients was noted already in 2 weeks of the Cerebrolysinum medicament treatment and amplified at therapy continuation. The positive effect after the Cerebrolysinum medicament treatment was noted at 60–70% of patients irrespective of a type of dementia. In case of senile dementia of altsgeymerovsky type the improvement of a clinical condition of patients remained also after the end of active therapy. Especially it concerned long-term improvement of ability to daily activity therefore the need for assistance and supervision behind them decreases. Thanks to neurotrophic activity (like action of a nerve growth factor) Cerebrolysinum can slow down considerably, and in certain cases and to stop progressing of neurodegenerative processes.

Peptides with a big molecular weight with an antigenic potential are removed from medicament in the course of production.

Research were not revealed by influences of medicament on the immune system. Experiments showed that Cerebrolysinum does not cause antibody formation or anaphylactic reactions. Cerebrolysinum does not stimulate receptors of a histamine and does not influence hemagglutination of erythrocytes.

Pharmacokinetics. As the proteolytic peptide fraction received from a brain of pigs contains biologically active peptides similar or identical to produced is endogenous, Tserebrolizin yet directly is not possible to determine pharmacokinetic parameters of drug. Indirect pharmacokinetic data are obtained on the basis of studying a pharmakodinamichesky profile of drug. After single introduction the neurotrophic activity of the medicament Cerebrolysinum in blood plasma is shown during nearly 24 h. Components of medicament can get through GEB. In preclinical experiments of in Vivo the identical pharmakodinamichesky effect of medicament on central nervous system at intratserebroventrikulyarny and peripheral introduction is established. It is indirect evidence of the fact that components of medicament get through GEB.

Indication

Organic, metabolic disturbances and neurodegenerative diseases of a brain, especially Alzheimer's disease; complications after a stroke; traumatic injuries of a brain (a state after neurosurgical intervention, the closed craniocereberal injuries, concussion).

Drug is administered by

in/in or in oil. not divorced Cerebrolysinum is entered in doses to 5 ml in oil or up to 10 ml — way in to injections. the medicament in doses of 10-50 ml (maximum dose) is recommended to be administered by slow in/in infusions after cultivation up to the volume of 100 ml of one from the standard solutions given below. duration of infusion is 15–60 min.

After cultivation of 0.9% sodium chloride solution (9 mg of NaCl/ml), Ringera solution (Na ⁺ 153.98 mmol/l, Ca ²⁺ 2.74 mmol/l, K ⁺ 4.02 mmol/l, Cl ^– 163.48 mmol/l) or 5% glucose solution. Solution for infusion is physically and chemically stable for 24 h at storage at the room temperature in the place, unprotected from light. From the microbiological point of view solution for infusions needs to be entered at once after preparation.

Optimum recommended duration of a course of treatment is 10–20 days of daily administration of drug.

one-time introductions in a dose to 50 ml Are possible

, but more effective is course therapy.

Recommended daily doses. Organic pathology of a brain, metabolic disturbances and neurodegenerative diseases (dementia) — 5–30 ml.

Complication after a stroke — 10–50 ml.

Traumatic injuries of a brain — 10–50 ml.

Neurologic disturbances at children — 1–2 ml.

Efficiency of therapy increases when carrying out repeated courses. Treatment is continued until improvement of a condition of the patient is noted. After carrying out an initial course the frequency of administration of medicament can be reduced up to 2–3 times a week. Between courses of therapy it is necessary to take a break lasting not less that of a course of treatment.

Recommended dose for children aged is more senior than 6 months makes 0.1 ml/kg of body weight (to 2 ml/days).

Instruction for medical personnel. At administration of the medicament Cerebrolysinum through constant in/in a catheter the last it is necessary to wash 0.9% with chloride sodium solution before medicament infusion. It is necessary to gather medicament from ampoules/bottle just before use. Only the single intake of medicament from an ampoule/bottle is allowed. It is possible to use only transparent solutions of amber color.

Contraindication

Hypersensitivity to medicament components, epilepsy, heavy renal failures.

Side effects

undesirable effects and reactions noted during clinical trials and postmarketingovy observations irrespective of existence of a causal relationship with therapy by medicament Cerebrolysinum (medicament is used for treatment mainly elderly people, and the specified symptoms often note at this category of patients).

from the immune system: single (1/10,000) — reactions of hypersensitivity or allergic reactions, an acute anaphylaxis, a Quincke's disease, fever, a fever.

Metabolic disturbances: seldom (1/10,000 — 1/1000) — lack of appetite.

Mental disorders: seldom (1/10,000 — 1/1000) — in isolated cases the therapeutic effect was followed by agitation (with aggression manifestations, confusion of consciousness, insomnia), a depression, apathy, weakness.

from nervous system: seldom (1/10,000 — 1/1000) — at very fast introduction the dizziness, a tremor, a headache, drowsiness are possible; single (1/10,000) — big epileptic attacks (grand mal), spasms.

from a cardiovascular system: seldom (1/10,000 — 1/1000) — AG, arterial hypotension; single (1/10,000) — at very fast introduction heart consciousness, tachycardia and arrhythmia, a heartache are possible.

from a respiratory system: seldom (1/10,000 — 1/1000) — a hyperventilation, short wind, a stethalgia.

from digestive system: single (1/10,000) — dyspepsia, diarrhea, a constipation, nausea, vomiting.

from skin and hypodermic fabrics: seldom (1/10,000 — 1/1000) — at very fast introduction the feeling of heat, the strengthened sweating, an itching, rash (including makulopapulezny), a small tortoiseshell, erubescence are possible.

Reaction of the general character and local reactions: seldom (1/10,000 — 1/1000) — increased fatigue, grippopodobny symptoms (for example a rhinorrhea, cough, respiratory infections); single (1/10,000) — reactions in the injection site, in particular an erythema and burning in the place of an injection, local inflammatory reactions.

Others: single (1/10,000) — pain in a neck, extremities, a lower back.

Special instructions

Extra care is necessary when prescribing Cerebrolysinum for patients with allergic diathesis.

certificates that Cerebrolysinum can increase load of kidneys, the medicament should not be administered the patient with a heavy renal failure.

Use during pregnancy and feeding by a breast. Researches on animals did not show reproductive toxicity of drug. However data about influences of medicament on reproductive function of the person are absent. Cerebrolysinum can be applied only after careful assessment of a ratio of the expected advantage to mother and potential risk to the fruit/child. For the period of medicament use the feeding by a breast should be stopped.

Children. Drug is used in pediatric practice in the presence of reasonable indications.

Ability to influence speed of response at control of vehicles and other mechanisms. In clinical trials the influence of medicament on speed of response at control of vehicles or work with other mechanisms is not revealed, however Cerebrolysinum can cause certain undesirable side effects from nervous system and the mental sphere in some patients owing to what the ability to control of vehicles and work with other mechanisms can temporarily be broken.

Interaction

Considering a pharmacological profile of medicament Cerebrolysinum, it is necessary to pay special attention to possible additive effects in case of its simultaneous use with antidepressants or Mao's inhibitors. in such cases it is recommended to reduce doses of antidepressants.

Cerebrolysinum should not be mixed with the balanced solutions of amino acids in one infusional bottle.

allows simultaneous use of the medicament Cerebrolysinum with the vitamins and medicaments influencing a cardiovascular system, however it is not necessary to mix them in one syringe.

Incompatibility. Cerebrolysinum is incompatible with solutions which change rn medicament (5.0-8.0) and also with the solutions containing lipids.

Cerebrolysinum should not be mixed with the balanced solutions of amino acids, vitamins and cardiovascular medicaments in one infusional bottle.

Overdose

noted cases of intoxication or negative impact on health owing to medicament overdose Cerebrolysinum.

Storage conditions

In original packing at a temperature not above 25 °C. not to freeze!