Cerebrolysinum of 1 ml (secondary packaging)

General characteristics. Structure:

Active ingredient: 1 ml of aqueous solution of drug contains 215,2 mg of a concentrate of Cerebrolysinum (a complex of the peptides received from a brain of a pig). The active fraction of Cerebrolysinum is presented by peptides which molecular weight does not exceed 10 Ltd companies дальтон.

Sodium excipients hydroxide and water for injections.

Description: Transparent solution of amber color.

Pharmacological properties:

Pharmacodynamics. Cerebrolysinum contains low-molecular biologically active neuropeptids which get through a blood-brain barrier and directly; arrive to nervous cells. Drug possesses organospetsifichesky multimodal action on a brain, i.e. provides metabolic regulation, neuroprotection, functional neuromodulation and neurotrophic activity.

a) metabolic regulation: Cerebrolysinum increases efficiency of aerobic power metabolism of a brain, improves intracellular synthesis of protein in the developing and growing old brain.

b) neuroprotection: Cerebrolysinum protects neurons from the damaging action of a laktatsidoz, prevents education of free radicals, increases survival and prevents death of neurons in the conditions of a hypoxia and ischemia, reduces the damaging neurotoxic effect of exciting amino acids (glutamate).

c) neurotrophic activity: Cerebrolysinum - the only nootropic peptidergichesky drug with the proved neurotrophic activity similar to action of natural factors of the neyronalny growth (NGF) but which is shown in the conditions of peripheral introduction.

d) functional neuromodulation: Cerebrolysinum the Pharmacokinetics exerts positive impact at disturbances of cognitive functions, on storing processes

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

Indications to use:

Alzheimer's disease, syndrome of dementia of various genesis, chronic cerebrovascular insufficiency, ischemic stroke, traumatic injuries of a head and spinal cord; a delay of intellectual development in children, a hyperactivity and deficit of attention at children; in complex therapy - at an endogenous depression, resistant to antidepressants. 

Route of administration and doses:

It is applied parenterally. Doses and duration of treatment depend on character and disease severity, and also on age of the patient. Purpose of single doses which size can reach 50 ml is possible, however carrying out a course of treatment is more preferable.

The recommended optimum course of treatment represents daily injections within 10-20 days.

• Acute states (ischemic stroke, cranial brain injury, complications of neurosurgical operations):	from 10 ml to 50 ml
• In the residual period of a brain stroke and traumatic injury of a head and spinal cord:	from 5 ml to 50 ml
• At a psychoorganic syndrome and a depression:	from 5 ml to 30 ml
• At Alzheimer's disease, dementia of the vascular and combined altsgeymerovsko-vascular genesis:	from 5 ml to 30 ml
• In neuropediatric practice:	0,1-0,2 ml/kg of weight

For increase in efficiency of treatment repeated courses can be conducted until improvement of a condition of the patient owing to treatment is observed. After carrying out the first course frequency of purpose of doses can be reduced to 2 or 3 weekly.

Cerebrolysinum is applied in the form of injections: intramusculary (to 5 ml) and intravenously (to 10 ml). Doses from 10 ml to 50 ml are recommended to be entered only by means of slow intravenous infusions after cultivation by the offered standard solutions for infusions. Duration of infusion makes from 15 to 60 minutes.

Features of use:

With care drug is appointed in a trimester of pregnancy and in the period of a lactation.             

During pregnancy and during breastfeeding Cerebrolysinum should be applied only after the careful analysis of a ratio of positive effect of the treatment and risk connected with its carrying out. Results of pilot studies do not give the grounds to believe that Cerebrolysinum possesses any teratogenic action or exerts toxic impact on a fruit. However similar clinical trials were not conducted.

Side effects:

Frequent side effects — more than 1/100 — less than 1/10; rare side effects

—  more than 1/1000 — less than 1/100; very rare side effects — more than 1/10000

—  less than 1/1000; extremely rare side effects — less than 1/10000.

At excessively bystry introduction the feeling of heat, perspiration, dizziness is in rare instances possible and (in isolated cases) tachycardia or arrhythmias is possible.

From digestive tract: appetite loss, dyspepsia, diarrhea, locks, nausea and vomiting were in rare instances observed.                                              

From TsNS and peripheral nervous system: in rare instances the estimated effect of activation was followed by the excitement (shown by an agressive behavior, confusion of consciousness, sleeplessness). There are messages on emergence in isolated cases.

 From immune system: in extremely exceptional cases hypersensitivity reactions or the allergic reactions which are shown a headache were noted; pain in a neck, extremities, a lower back; asthma, fever and kollaptoidny state.

Local reactions: erubescence, an itch and burning in the place of an injection is in rare instances noted.

Others: by results of researches it was reported about extremely exceptional cases of a hyperventilation, arterial hypertension, arterial hypotonia, fatigue, a tremor, a depression, apathy, dizziness and grippopodobny symptoms (cough, cold, respiratory infections).

It is necessary to consider that some undesirable effects (excitement, an arterial hypertension, arterial hypotonia, slackness, a tremor, a depression, apathy, dizziness, a headache, an asthma, diarrhea, nausea) were revealed during clinical tests and arose equally as at the patients receiving Cerebrolysinum and at patients of group of placebo.

Interaction with other medicines:

Taking into account a pharmacological profile of Cerebrolysinum it is necessary to pay special attention of a naa to possible additive effects at joint appointment with antidepressants or MAO inhibitors. In such cases it is recommended to lower - an antidepressant dose. It is not necessary to mix in one solution for infusions Cerebrolysinum and the balanced solutions of amino acids.

Cerebrolysinum is incompatible with solutions which part lipids, and with the solutions changing рН environments (5,0-8,0) are. SPECIAL INSTRUCTIONS

At excessively bystry performance of injections the feeling of heat, perspiration, dizziness is possible. Therefore the drug should be administered slowly. Compatibility of drug (within 24 hours is checked and confirmed at the room temperature and existence of lighting) with the following standard solutions for infusions:

■ 0,9% solution of sodium of chloride (9 mg of NaCI/ml).

■  Ringer's Solution (Na * - 153,98 mmol/l; ^{Sa2 +} - 2,74 mmol/l; To * - 4,02 mmol/l; SG - 163,48 mmol/l).

■ 5% solution of glucose

Co-administration of Cerebrolysinum with the vitamins and drugs improving cordial blood circulation is allowed, however these drugs should not be mixed in one syringe with Cerebrolysinum. To use only transparent solution and only once.

Contraindications:

- individual intolerance of drug
- acute renal failure
- epileptic status

Overdose:

It is not revealed.

Storage conditions:

To store in the place protected from light at a temperature not above 25 °C, to preserve Carefully against children.

Note: after opening of an ampoule/bottle solution has to be used immediately.

Issue conditions:

According to the recipe

Packaging:

Solution for injections of an ampoule of 1 ml

On 1 ml in glass ampoules of brown color. On 10 ampoules place in the blister strip packaging from PVC covered with wax paper. One blister strip packaging with the application instruction is placed in a cardboard pack. Packaging of "in bulk"

On 10 ampoules (1 ml) place in the blister from PVC covered with wax paper. On 50 or 225 blisters with the application instruction place in a cardboard box. Solution for injections of an ampoule of 5 ml and 10 ml

On 5 ml, 10 ml in glass ampoules of brown color. On 5 ampoules place in the blister strip packaging from PVC covered with wax paper. One blister strip packaging with the application instruction is placed in a cardboard pack. Solution for injections bottles of 30 ml

On 30 ml in the bottle from brown glass corked by a rubber bung under an aluminum safety running in sotverstiy for a needle in the center and closed by a protective plastic cover. On 1 or 5 bottles with the application instruction place in a cardboard pack.