Cerebrolysin solution for injection, 20ml No. 5

• 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

The drug is administered 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 administration of the drug in a dose of up to 50 ml is possible, however, it is more preferable to carry out a course of treatment.

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

Indication / Dose

Acute conditions (ischemic stroke, traumatic brain injury, complications of neurosurgical operations) from 10 ml to 50 ml

In the residual period of cerebral stroke and traumatic injury to the brain and spinal cord from 5 ml to 50 ml

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

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

In neuropediatric practice 0.1-0.2 ml / kg body weight

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

CerebrolysinЃ is used parenterally in the form of intramuscular injections (up to 5 ml) and intravenous 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 the infusion is 15 to 60 minutes.

Active substance: 1 ml of an aqueous solution of the drug contains 215.2 mg of cerebrolysin concentrate (a complex of peptides obtained from the pig's brain).

The active fraction of Cerebrolysin is represented by peptides, the molecular weight of which does not exceed 10,000 daltons.

Excipients sodium hydroxide and water for injection.

• individual intolerance to the drug

• acute renal failure

• status epilepticus

Trade name of the drug: CerebrolysinЃ

International name of the drug: absent

Dosage form:

injection

COMPOSITION.
Active substance: 1 ml of an aqueous solution of the drug contains 215.2 mg of cerebrolysin concentrate (a complex of peptides obtained from the pig's brain).

The active fraction of Cerebrolysin is represented by peptides, the molecular weight of which does not exceed 10,000 daltons.

Excipients sodium hydroxide and water for injection.

DESCRIPTION A
clear amber solution.

PHARMACOTHERAPEUTIC GROUP: nootropic agent

ATX code: N06BX

PHARMACHOLOGIC EFFECT.

Pharmacodynamics
Cerebrolysin contains low molecular weight biologically active neuropeptides that penetrate the blood-brain barrier and directly enter the nerve cells. The drug has an organ-specific multimodal effect on the brain, i.e. provides metabolic regulation, neuroprotection, functional neuromodulation and neurotrophic activity.
a) metabolic regulation: cerebrolysin increases the efficiency of aerobic energy metabolism in the brain, improves intracellular protein synthesis in the developing and aging brain.
b) neuroprotection:Cerebrolysin protects neurons from the damaging effect of lactic acidosis, prevents the formation of free radicals, increases survival and prevents neuronal death under conditions of hypoxia and ischemia, and reduces the damaging neurotoxic effect of excitatory amino acids (glutamate).
c) neurotrophic activity: Cerebrolysin is the only nootropic peptidergic drug with proven neurotrophic activity, similar to the action of natural neuronal growth factors (NGF), but manifested under conditions of peripheral administration.
d) functional neuromodulation: cerebrolysin has a positive effect on impaired cognitive functions, on the processes of memorization

Pharmacokinetics The
complex composition of 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 FOR USE

• 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

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

CONTRAINDICATIONS

• individual intolerance to the drug

• acute renal failure

• status epilepticus

PREGNANCY AND LACTATION
The drug is prescribed with caution in the first trimester of pregnancy and during lactation.

During pregnancy and during breastfeeding, Cerebrolysin should be used only after a 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, similar clinical studies have not been conducted.

Dosage regimen

The drug is administered 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 administration of the drug in a dose of up to 50 ml is possible, however, it is more preferable to carry out a course of treatment.

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

Indication / Dose

Acute conditions (ischemic stroke, traumatic brain injury, complications of neurosurgical operations) from 10 ml to 50 ml

In the residual period of cerebral stroke and traumatic injury to the brain and spinal cord from 5 ml to 50 ml

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

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

In neuropediatric practice 0.1-0.2 ml / kg body weight

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

CerebrolysinЃ is used parenterally in the form of intramuscular injections (up to 5 ml) and intravenous 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 the infusion is 15 to 60 minutes.

Side effect

The frequency of adverse reactions was determined in accordance with the WHO recommendations: very often: (1/10); often: (from 1/100 to <1/10); infrequently (from 1/1000 to <1/100); rarely (from 1/10 000 to <1/1000); very rare, including isolated messages (<1/10 000).

From the side of the immune system: very rarely - increased individual sensitivity, allergic reactions.

Mental disorders: rarely - the alleged activation effect is accompanied by excitement, manifested by aggressive behavior, confusion, insomnia.

From the side of the nervous system: rarely - too rapid administration of the drug may lead to dizziness; very rarely - isolated cases of generalized epilepsy and one case of seizures was associated with Cerebrolysin.

From the side of the cardiovascular system: very rarely - too rapid administration of the drug can lead to increased heart rate and arrhythmias.

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

On the part of the skin and subcutaneous tissues: very rarely - skin reactions; rarely - with excessively rapid administration, a sensation 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 extremities, fever, mild back pain, shortness of breath, chills, collapsing state.

According to the results of one study, an association was reported between the use of the drug in rare cases (from> 1/10 000 to <1/1000) with hyperventilation, arterial hypertension, hypotension, fatigue, tremor, the possible development of depression, apathy and / or drowsiness, flu-like symptoms (colds, coughs, respiratory tract infections).

Since CerebrolysinЃ is used mainly 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, arterial hypotension, lethargy, tremor, depression, apathy, dizziness, headache, shortness of breath, diarrhea, nausea) were identified in clinical studies and occurred to the same extent as in patients, who received CerebrolysinЃ and in patients in the placebo group.

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

Notification in case of suspected side effects

It is important to report side effects after registration of a medicinal product in order to ensure continuous monitoring of the risk-benefit ratio of the medicinal product. Healthcare professionals are asked to report all adverse events observed with the drug through the national adverse reaction reporting systems and / or to the company representative.

Application for impaired renal function

Contraindicated in severe renal failure.

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 illumination) with the following standard solutions for infusion was tested and confirmed: 0.9% sodium chloride solution, Ringer's solution, 5% dextrose (glucose) solution.

Allowed the simultaneous use of the drug CerebrolysinЃ with vitamins and drugs that improve cardiac circulation, however, 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 vehicles and use mechanisms

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

Overdose

No cases of overdose of the drug Cerebrolysin have been reported.

Drug interactions

Taking into account the pharmacological profile of CerebrolysinЃ, special attention should be paid to possible additive effects when administered together with antidepressants or MAO inhibitors. In such cases, it is recommended to reduce the dose of the antidepressant. The use of the drug CerebrolysinЃ in high doses (30-40 ml) in combination with MAO inhibitors in high doses can cause an increase in blood pressure.

CerebrolysinЃ and balanced amino acid solutions should not be mixed in the same solution for infusion.

CerebrolysinЃ is incompatible with solutions that contain lipids and solutions that change the pH of the medium (5.0-8.0).

Storage conditions

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

Shelf life

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

Terms of sale

The drug is available with a prescription.

Contacts for inquiries

EVER NEURO PHARMA GMBH (Austria)