Expiration date: 09/2028

Active substance: Cerebrolysin

Pharmachologic effect: neurometabolic, nootropic

Pharmacodynamics

Cerebrolysin contains low molecular weight biologically active neuropeptides, which penetrate the blood-brain barrier and enter directly to the nerve cells. Organ-specific drug has multimodal action on the brain, i.e. It provides metabolic regulation, neuroprotection, functional neuromodulation and neurotrophic activity.

Metabolic regulation: Cerebrolysin improves the efficiency of aerobic energy metabolism of the brain, improves intracellular protein synthesis in the developing and aging brain.

Neuroprotection: Cerebrolysin protects neurons from damaging effects of lactic acidosis, prevents the formation of free radicals, improves survival and prevents neuronal death in conditions of hypoxia and ischemia, reduces the damaging neurotoxic effects of excitatory amino acids (glutamate).

Neurotrophic activity: Cerebrolysin - only peptidergic nootropic drug with proven neurotrophic activity similar to the action of natural factors of neuronal growth (NGF), but manifests itself in a peripheral administration.

Functional Neuromodulation: Cerebrolysin has a positive effect in disorders of cognitive functions in the process of remembering.

Pharmacokinetics

Cerebrolysin drug complex composition, active fraction which consists of a balanced and stable mixture of biologically active oligopeptides, having a total polyfunctional effect, does not allow the usual pharmacokinetic analysis of the individual components.

Testimony

• Alzheimer's disease;
  
• dementia syndrome of different genesis;
  
• chronic cerebrovascular insufficiency;
  
• ischemic stroke;
  
• traumatic injuries of the brain and spinal cord;
  
• mental retardation in children;
  
• hyperactivity and attention deficit disorder in children;
  
• in the complex therapy of endogenous depression, resistant to antidepressants.
  

Contraindications

• idiosyncrasy of the drug;
  
• acute renal failure;
  
• status epilepticus.
  

Pregnancy and breast-feeding

With careful preparation is prescribed in the I trimester of pregnancy and lactation.

During pregnancy and during breastfeeding Cerebrolysin should be used only after a thorough analysis of the ratio of the positive effect of the treatment and the risks associated with its implementation. The experimental results do not suggest that Cerebrolysin teratogenic or has a toxic effect on the fetus. However, similar clinical studies have not been conducted.

Side effects

The frequency of side effects: often -> 1/100 to <1/10; rarely -> 1 / 1000- <1/100; very rarely -> 1/10000 <1/1000; rarely - <1/10000.

The reaction to the rapid introduction: the overly rapid introduction in rare cases a feeling of heat, sweating, dizziness; in rare cases - possible heart palpitations or arrhythmia. Therefore, the drug should be administered slowly.

On the part of the digestive tract: rare - loss of appetite, indigestion, diarrhea, constipation, nausea and vomiting.

From the central and peripheral nervous system: in rare cases, the alleged effect was accompanied by activation of the excitation (exhibit aggressive behavior, confusion, insomnia). There are reports of occurrence in rare cases (<0.01%) during the period of treatment with Cerebrolysin large seizures and convulsions.

Immune system: very rarely - hypersensitivity reactions or allergic reactions, manifesting a headache, pain in the neck, legs, lower back, shortness of breath, chills and collaptoid state.

Local reactions: seldom - skin redness, itching and burning at the injection site.

Other: rarely - on the results of studies reported cases of hyperventilation, hypertension, hypotension, fatigue, tremor, depression, apathy, dizziness and flu-like symptoms (cough, runny nose, respiratory tract infections).

It should be noted that some of the undesirable effects (agitation, hypertension, hypotension, lethargy, tremor, depression, apathy, dizziness, headache, shortness of breath, diarrhea, nausea) were identified during clinical trials and occurred equally in patients, Cerebrolysin treated and placebo patients.

Interaction

Given the pharmacological profile of the drug Cerebrolysin should pay special attention to possible additive effects when coadministered with antidepressants, including MAO inhibitors. In such cases it is recommended to reduce the dose of antidepressant.

Do not mix in the same solution for infusion Cerebrolysin and balanced amino acid solutions.

Cerebrolysin incompatible with solutions, which contain lipids and with solutions which alter the pH (5-8).

Dosing and Administration

V / m (5 ml) / w (10 mL) in / by slow infusion (10 to 50 ml).

Dose and duration of treatment depends on the nature and severity of the disease and the patient's age. Possible to assign single doses, which may reach the magnitude of 50 ml, but more preferably, a course of treatment. The recommended optimal course of treatment - daily injection for 10-20 days.

Acute conditions (ischemic stroke, head trauma, complications after neurosurgical operations) - from 10 to 50 ml.

The residual period of stroke and traumatic damage to the brain and spinal cord - from 5 to 50 ml.

Psycho-organic syndrome of depression and - from 5 to 30 ml.

Alzheimer's disease, vascular dementia and Alzheimer's combined-vascular origin - from 5 to 30 ml.

In practice neyropediatricheskoy - 0.1-0.2 ml / kg.

To improve the effectiveness of the treatment can be carried out repeated courses, until there is improvement in the patient following treatment. After the first dose rate frequency assignment may be reduced to 2 or 3 times a week.

Doses of 10 to 50 ml is recommended to enter only through slow in / in infusion after dilution proposed standard solutions for infusion. The duration of infusion was 15 to 60 min.

Overdose: Not found.

Special instructions

Tested and confirmed the compatibility of the drug (for 24 hours at room temperature and the presence of light) with the following standard solutions for infusion:

• 0.9% sodium chloride solution (9 mg NaCl / ml);
  
• Ringer's solution (Na + - 153,98 mmol / l Ca2 + - 2.74 mmol / L, K + - 4.02 mmol / l; Cl- - 163,48 mmol / l).
  
• 5% glucose solution.
  

Allowed the simultaneous use of the drug Cerebrolysin with vitamins and drugs that improve heart circulation, however, these drugs should not be mixed in the same syringe with the drug Cerebrolysin. Use only clear solution should be, and only once.

Effects on ability to drive and use machines. Clinical trials have shown that Cerebrolysin has no effect on the ability to drive vehicles and use machinery.

Release Form: Injection.

1, 2 ml glass ampoules in brown color (according to standard DIN-ISO 9187-1-B-1-br; and DIN-ISO 9187-1-B-2-br respectively; nominal capacity of 1, 2 ml; type 1, Heb. F.). 10 amp. in blisters made of PVC, covered with wax paper. 1 blisters in a carton box.

5, 10, 20 ml brown glass ampoules (according to DIN-ISO 9187-1-B-5-br Standard, DIN-ISO 9187-1-B-10-br and DIN-ISO 9187-1- B-20-br, respectively; nominal capacity 5, 10, 20 ml, type 1, Heb F.).. 5 amp. in blisters made of PVC, covered with wax paper. 1 blisters in a carton box.

Packing in bulk (for hospitals and for packaging in the JSC "Biocom", Russia): 10 Amp. (1 ml) in PVC blister covered with wax paper. 50 or 225 blisters in a cardboard box.

Manufacturer

1. Ever Neuro Pharma GmbH. Mondzeeshtrasse 11, A-4866 Unterach, Austria.

2. Avery Pharma GmbH Jena. Otto-Schott-Strasse 15, 07745 Jena, Germany.

3. Hameln Pharmaceuticals GmbH. Langes Feld 13, 31789 Hameln, Germany.

The company - the holder of the registration certificate and the Issuing Quality Control: Ever Neuro Pharma GmbH. Mondzeeshtrasse 11, A-4866 Unterach, Austria.

Packer, the company undertaking producing quality control (for amp 1 ml.): JSC "Biocom",. 355016, Russia, Stavropol, Chapaevsky pr., 54.

Tel .: (8652) 36-53-56, 36-53-54; Fax: (8652) 36-53-55.

Representation of company "Ever Neuro Pharma GmbH": 127055, Moscow, ul. Butyrsky shaft, 68/70, p. 1.

Tel .: (495) 933-87-02; fax: (495) 933-87-15.

Storage conditions

In the dark place at a temperature no higher than 25 ° C.

Keep out of the reach of children.

The shelf life: 5 years.

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