Cerebrolysin, solution for injection 20ml ampoules 5pcs

Composition

1 ml-cerebrolysin concentrate (complex of peptides* obtained from pig brain) 215.2 mg

* molecular weight not more than 10,000 daltons.

Pharmacological action

A nootropic drug.

Cerebrolysin contains low-molecular biologically active neuropeptides that penetrate the BBB and directly reach 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:  the drug Cerebrolysin increases the efficiency of aerobic energy metabolism of the brain, improves intracellular protein synthesis in the developing and aging brain.

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

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

Functional neuromodulation:  the drug has a positive effect on memory processes in cases of cognitive impairment.

Indications

-Alzheimer’s disease;

– dementia syndrome of various origins;

– chronic cerebrovascular insufficiency—

– ischemic stroke;

— traumatic brain and spinal cord injuries;

— mental retardation in children;

— disorders associated with attention deficit in children;

– endogenous depression resistant to antidepressants (as part of complex therapy).

Use during pregnancy and 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 any teratogenic effect or has a toxic effect on the fetus.

However, no similar clinical trials have been conducted.

Recommendations for use

The drug is used parenterally. The dose and duration of use depend on the nature and severity of the disease, as well as on the age of the patient. A single dose of the drug up to 50 ml is possible, but a course of treatment is more preferable.

The recommended course of treatment is daily injections for 10-20 days.

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

Cerebrolysin is used parenterally in the form of IV injections (up to 5 ml) and IV injections (up to 10 ml). The drug in a dose of 10 ml to 50 ml is recommended to be administered only by slow intravenous infusions after dilution with standard infusion solutions. The duration of infusions is from 15 to 60 minutes.

Contraindications

-severe renal failure;

– epileptic status;

– hypersensitivity to the drug.

With caution, the drug should be prescribed for allergic diathesis, epileptic diseases, including generalized epilepsy, due to the possible increase in the frequency of seizures.

Side effects

The frequency of adverse reactions was determined in accordance with WHO recommendations: very common: (≥1/10); common: (≥1/100 to

From the immune system:  very rarely – increased individual sensitivity, allergic reactions.

Mental disorders:  rarely – the intended activation effect is accompanied by agitation, aggressive behavior, confusion, insomnia.

Nervous system disorders:  rarely, too rapid use of the drug can lead to dizziness; very rarely, isolated cases of generalized epilepsy and one case of seizures were associated with Cerebrolysin.

From the cardiovascular system:  very rare-too rapid use of the drug can lead to palpitations and arrhythmias.

From the digestive system:  very rarely – dyspepsia, diarrhea, constipation, nausea, vomiting; rarely – loss of appetite.

Skin and subcutaneous tissue disorders:  very rarely-skin reactions; rarely – with excessively rapid use, a feeling of heat, sweating, itching is possible.

General disorders and disorders at the injection site:  very rarely – redness, itching, burning at the injection site, pain in the neck, head and limbs, fever, mild back pain, shortness of breath, chills, collaptoid state.

One study reported an association between the use of the drug in rare cases (from >1/10,000 to>

Since Cerebrolysin is mainly used in elderly patients, the above symptoms of diseases are typical for this age group and often occur without taking the drug.

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

If any of the side effects indicated in the instructions are aggravated or any other side effects are noted that are not specified in the instructions, the patient should inform the attending physician.

Notification in case of suspected side effects

It is important to report side effects after registration of the drug in order to ensure continuous monitoring of the risk-benefit ratio of the drug. Health professionals are asked to report all cases of side effects observed during the use of the drug through the national systems for reporting adverse reactions and/or to the address of the company’s representative office.

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 or MAO inhibitors. In such cases, it is recommended to reduce the dose of an antidepressant. The use of Cerebrolysin in high doses (30-40 ml) in combination with MAO inhibitors in high doses may cause an increase in blood pressure.

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 (5.0-8.0).

Overdose

No overdose cases of Cerebrolysin have been reported.

Special instructions

If the injections are performed too quickly, a feeling of heat, sweating, and dizziness may occur. Therefore, the drug should be administered slowly.

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, Ringer’s solution,5% dextrose (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 Cerebrolysin.

Use only a clear solution of Cerebrolysin and only once.

Influence on the ability to drive motor vehicles and manage mechanisms

Clinical studies have shown that Cerebrolysin does not affect the ability to drive vehicles and use mechanisms.

Storage conditions

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C.

Expiration date

The shelf life of the drug in ampoules is 5 years, in vials-4 years. Do not use after the expiration date indicated on the package.

Active ingredient

Brain Peptide Complex

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

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

Indications

Concussion and other traumatic brain injuries, Low learning ability, Acquired Dementia, Asthenia, Delayed mental development in children, Alzheimer’s disease, Depression, Stroke consequences