CEREBROLYSIN

Cerebrolysin: official instructions for use

INSTRUCTIONS

On medical use of the drug

Registration number:

P N013827 / 01-080707

Trade name of the drug: Cerebrolysin®

International name of the drug: none

Dosage form:

injection

COMPOSITION.

Active substance: 1 ml of the aqueous solution of the preparation contains 215.2 mg of cerebrolysin concentrate (a complex of peptides derived from the brain of a pig). The active fraction of Cerebrolysin is represented by peptides, whose molecular weight does not exceed 10,000 daltons.

Auxiliary substances sodium hydroxide and water for injection.


DESCRIPTION

Transparent solution of amber color.


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 organospecific multimodal effect on the brain, i.e. Provides metabolic regulation, neuroprotection, functional neuromodulation and neurotrophic activity.

A) metabolic regulation: cerebrolysin improves the efficiency of aerobic energy metabolism of 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, improves survival and prevents the death of neurons in conditions of hypoxia and ischemia, 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 that of natural neuronal growth factors (NGF), but is manifested in conditions of peripheral administration.

D) functional neuromodulation: cerebrolysin has a positive effect in cases of cognitive impairment, memory processes

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 a routine pharmacokinetic analysis of individual components.

INDICATIONS FOR USE

Alzheimer's disease, a syndrome of dementia of various genesis, chronic cerebrovascular insufficiency, ischemic stroke, traumatic brain and spinal cord injuries; Mental retardation in children, hyperactivity and attention deficit in children; In complex therapy - with endogenous depression, resistant to antidepressants

CONTRAINDICATIONS

Individual intolerance to the drug

Acute renal failure

Status epilepticus

PREGNANCY AND LACTATION

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

During pregnancy and during breastfeeding, Cerebrolysin should only be used after a careful analysis of the relationship between the positive effect of treatment and the risk associated with its administration. 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.

METHOD OF USE AND DOSES

It is used parenterally. Doses 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 administer single doses, the amount of which can reach 50 ml, but more preferably a course of treatment.

The recommended optimal course of treatment is a daily injection for 10-20 days.

• Acute conditions (ischemic stroke, craniocerebral trauma, complications of neurosurgical operations): from 10 ml to 50 ml

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

• With psychoorganic syndrome and depression: from 5 ml to 30 ml

• In Alzheimer's disease, dementia of vascular and associated Alzheimer's-vascular genesis: from 5 ml to 30 ml

• In neuropediatric practice: 0.1-0.2 ml / kg body weight

To improve the effectiveness of treatment, repeated courses can be conducted as long as there is an improvement in the patient's condition due to treatment. After the first course, the frequency of prescribing can be reduced to 2 or 3 times a week.

Cerebrolysin is used in the form of injections: intramuscularly (up to 5 ml) and intravenously (up to 10 ml). Doses of 10 ml to 50 ml are recommended only with slow intravenous infusions after dilution with the proposed standard solutions for infusion. The duration of the infusion is 15 to 60 minutes.

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.

In case of excessive rapid administration, in rare cases, a sensation of heat, sweating, dizziness and (in rare cases) possible rapid heartbeat or arrhythmias.

From the gastrointestinal tract: in rare cases, loss of appetite, dyspepsia, diarrhea, constipation, nausea and vomiting were observed.

From the side of the central nervous system and peripheral nervous system: in rare cases, the expected effect of activation was accompanied by excitation (manifested aggressive behavior, confusion, insomnia). There are reports of occurrence in isolated cases (From the side of the immune system: in extremely rare cases, there were reactions of hypersensitivity or allergic reactions manifested by headache, pain in the neck, extremities, lower back, shortness of breath, chills and a collapsoid condition.

Local reactions: in rare cases, redness of the skin, itching and burning at the injection site.

Other: according to the results of studies, extremely rare cases of hyperventilation, arterial hypertension, arterial hypotension, fatigue, tremor, depression, apathy, dizziness and flu-like symptoms (cough, runny nose, respiratory tract infections) have been reported.

It should be noted that some undesirable effects (excitation, arterial hypertension, arterial hypotension, lethargy, tremor, depression, apathy, dizziness, headache, dyspnea, diarrhea, nausea) were detected during clinical trials and occurred in the same way as in patients, Who received Cerebrolysin, and in patients of the placebo group.

OVERDOSE

Not found

INTERACTION WITH OTHER DRUGS

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

Do not mix in a single solution for infusion Cerebrolysin and balanced solutions of amino acids.

Cerebrolysin is incompatible with solutions that contain lipids, and with solutions that modify the pH of the medium (5.0-8.0).

SPECIAL INSTRUCTIONS

If the injection is performed too quickly, a sensation of heat, sweating, dizziness is possible. Therefore, the drug should be administered slowly.

The compatibility of the preparation was checked and confirmed (for 24 hours at room temperature and illumination) with the following standard solutions for infusion:

0.9% solution of sodium chloride (9 mg NaCl / ml).

Ringer's solution (Na + = 153.98 mmol / L, Ca2 + - 2.74 mmol / L, K + - 4.02 mmol / L, SG -163.48 mmol / l).

5% glucose solution

Simultaneous administration of Cerebrolysin with vitamins and preparations that improve cardiac circulation is allowed, but these preparations should not be mixed in the same syringe with Cerebrolysin. Use only a clear solution and only once.

INFLUENCE ON THE ABILITY TO MANAGEMENT OF VEHICLES

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

FORM OF ISSUE

Solution for injection of 1 ml ampoule

1 ml in a glass ampoules of brown color. For 10 ampoules are placed in a contour mesh package made of PVC covered with wax paper. One contour pack with instructions for use is placed in a cardboard box.

Packing in bulk

For 10 ampoules (1 ml) is placed in a blister of PVC, covered with wax paper. For 50 or 225 blisters with instructions for use are placed in a cardboard box.


Solution for injection of 5 ml ampoule and 10 ml

5 ml, 10 ml in a glass ampoule brown. 5 ampoules are placed in a contour mesh package made of PVC covered with wax paper. One contour pack with instructions for use is placed in a cardboard box.


Solution for injection bottles 30 ml

To 30 ml in a bottle of brown glass, corked with a rubber stopper under an aluminum safety obkalka with a hole for the needle in the center and closed with a protective plastic cover. For 1 or 5 bottles with instructions for use are placed in a cardboard box.


STORAGE CONDITIONS

Store in a dark place at a temperature of no higher than 25 ° C,

Keep out of the reach of children.

Note: after opening the ampoule / vial the solution should be used immediately.


SHELF LIFE

The shelf life of ampoules is 5 years.

The shelf life of the vials is 4 years.

Do not use after the expiry date printed on the package.


TERMS OF RELEASE FROM PHARMACY

On prescription


MANUFACTURER

EVER Neuro Pharma GmbH A-4866 Unterach, Austria, Europe.