Cerebrolysin, solution for injection 2ml ampoules 10pcs

Composition

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1 ml of solution for injection contains:

Active ingredient:

cerebrolysin concentrate (complex of peptides derived from pig brain) 215.2 mg,

excipients:

sodium hydroxide;

water for injection

Pharmacological action

Pharmacodynamics

Cerebrolysin contains low-molecular biologically active neuropeptides that penetrate the BBB and directly enter the nerve cells. The drug has an organ-specific multimodal effect on the brain, i. e. it provides metabolic regulation, neuroprotection, functional neuromodulation and neurotrophic activity.

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

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

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

Functional neuromodulation:  Cerebrolysin has a positive effect on cognitive impairment and memory processes.

Pharmacokinetics

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

Indications

• Alzheimer’s disease;
• dementia syndrome of various origins;
• chronic cerebrovascular insufficiency;
• ischemic stroke;
• traumatic brain and spinal cord injuries;
• mental retardation in children;
• hyperactivity and attention deficit in children;
• in complex therapy for endogenous depression resistant to antidepressants.

Use during pregnancy and lactation

With caution, the drug is prescribed in the first trimester of pregnancy and during lactation.

During pregnancy and lactation, Cerebrolysin should be used only after careful analysis of the ratio of the positive effect of treatment and the risk associated with its implementation.

The results of experimental studies do not give grounds to believe that Cerebrolysin has a teratogenic effect or has a toxic effect on the fetus. However, no similar clinical trials have been conducted.

Contraindications

• individual intolerance to the drug;
• acute renal failure;
• epileptic status.

Side effects

Reaction to the introduction:  when administered too quickly, in rare cases, a feeling of heat, sweating, dizziness may occur; in isolated cases, rapid heartbeat or arrhythmias may occur. Therefore, the drug should be administered slowly.

From the gastrointestinal tract:  rarely — loss of appetite, dyspepsia, diarrhea, constipation, nausea and vomiting.

From the central nervous system and peripheral nervous system: in rare cases, the intended activation effect was accompanied by arousal (manifested by aggressive behavior, confusion, insomnia). There are reports of occurrence in isolated cases (

From the immune system:  extremely rare-hypersensitivity reactions or allergic reactions, manifested by headache, pain in the neck, limbs, lower back, shortness of breath, chills and collaptoid state.

Local reactions:  rarely — redness of the skin, itching and burning at the injection site.

Other services:  Extremely rare-studies have reported cases of hyperventilation, hypertension, hypotension, fatigue, tremor, depression, apathy, dizziness, and flu-like symptoms (cough, runny nose, and respiratory tract infections).

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

Interaction

Taking into account the pharmacological profile of the drug Cerebrolysin, special attention should be paid to possible additive effects when co-administered with antidepressants, including MAO inhibitors. In such cases, it is recommended to reduce the dose of an antidepressant.

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

Cerebrolysin is incompatible with solutions containing lipids and with solutions that change the pH of the medium [5-8].

How to take, course of use and dosage

Intramuscularly (up to 5 ml), intravenously (up to 10 ml), intravenously, by slow infusion (from 10 to 50 ml).

The dose and duration of treatment depend on the nature and severity of the disease, as well as on the age of the patient. It is possible to prescribe single doses, the value of which can reach 50 ml, but it is more preferable to conduct a course of treatment. The recommended optimal course of treatment is daily injections for 10-20 days.

Acute conditions (ischemic stroke, TBI, complications after neurosurgical operations) — from 10 to 50 ml.

The residual period of cerebral stroke and traumatic brain and spinal cord injury is from 5 to 50 ml.

Psychoorganic syndrome and depression — from 5 to 30 ml.

Alzheimer’s disease, dementia of vascular and combined Alzheimer’s-vascular genesis-from 5 to 30 ml.

In neuropediatric practice-0.1-0.2 ml/kg —

To increase the effectiveness of treatment, repeated courses can be performed, as long as the patient’s condition improves due to treatment. After the first course, the frequency of prescribing doses can be reduced to 2 or 3 times a week.

Doses from 10 to 50 ml are recommended to be administered only by slow intravenous infusions after dilution with the proposed standard infusion solutions. The duration of infusions is from 15 to 60 minutes.

Special instructions

The compatibility of the drug (within 24 hours at room temperature and in the presence of lighting) with the following standard solutions for infusions was checked and confirmed:

– 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.

Concomitant use of the drug Cerebrolysin with vitamins and drugs that improve heart circulation is allowed, but these drugs should not be mixed in the same syringe with the drug Cerebrolysin. Use only a clear solution and only once.

Influence on the ability to drive vehicles and work with mechanisms. Clinical trials have shown that Cerebrolysin has no effect on the ability to drive vehicles and use mechanisms.

Storage conditions

The drug should be stored in a dark place at a temperature not exceeding 25°C.

Shelf

life is 5 years.

Active ingredient

Brain Peptide Complex

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Description

Nursing mothers as prescribed by a doctor, Pregnant women in the second and third trimester as prescribed by a doctor, Adults as prescribed by a doctor, Children as prescribed by a doctor

Indications

Consequences of stroke, Delayed mental development in children, Alzheimer’s disease, Concussion and other traumatic brain injuries, Depression, Asthenia, Acquired dementia, Low learning ability