Cerebrolysin® (Cerebrolysin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCerebrolysinCerebrolysin
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  • Cerebrolysin®
    solution for injections 
    EVER Neuro Pharma GmbH     Austria
    • Dosage form: & nbspInjection.
    Composition:

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

    Excipients sodium hydroxide and water for injection.

    Description:
    Transparent solution of amber color.

    Pharmacotherapeutic group:Nootropic agent.
    ATX: & nbsp

    N.06.B.X   Other psychostimulants and nootropic drugs

    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 effectiveness 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 effects 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 - the only nootropic peptidergic drug with proven neurotrophic activity, similar to the action of natural factors of neuronal growth (NGF), but manifested in conditions of peripheral administration.

    d) functional neuromodulation: cerebrolysin has a positive effect in cases of violations of cognitive functions, 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 action, does not allow for a routine pharmacokinetic analysis of individual components.
    Indications: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 drug intolerance

    ■ acute renal failure

    ■ status epilepticus
    Carefully:With caution, the drug is prescribed in the first trimester of pregnancy and during lactation.
    Pregnancy and lactation:
    During pregnancy and during breastfeeding Cerebrolysin should be used only after a careful analysis of the relationship between the positive effect of treatment and the risk associated with its conduct. The results of experimental studies do not give grounds for believing that Cerebrolysin has some teratogenic effect or has a toxic effect on the fetus. However, similar clinical studies have not been conducted.
    Dosing and Administration:
    It is used parenterally. Doses and duration of treatment depend on the nature and severity of the disease, as well as on the patient's age. 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 injury, 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 of 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 through 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 heart rate or arrhythmia.

    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 the peripheral nervous system: In rare cases, the expected effect of activation was accompanied by excitation (manifested aggressive behavior, confusion, insomnia). There are reports of the occurrence in large cases (<0.01%) of large epileptic seizures and seizures during the treatment with Cerebrolysin.

    From 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:
    Given the pharmacological profile of Cerebrolysin, particular 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 infusions. 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 fever, 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; TO+ - 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.

    Effect on the ability to drive transp. cf. and fur:Clinical trials have shown that Cerebrolysin does not affect the ability to drive vehicles and use mechanisms.
    Form release / dosage:Injection.
    Packaging:

    Ampoules 1 ml, 2 ml.

    1 ml, 2 ml in a glass ampoule of brown color (according to the standard DIN-ISO 9187-1-B-1-br; and DIN-ISO 9187-1-B-2-br respectively; nominal capacity of 1 ml, 2 ml; type 1, Hept. F.).For 10 ampoules are placed in a contour mesh package made of PVC covered with wax paper. One contour mesh package with instructions for use is placed in a cardboard box. Ampoules 5 ml, 10 ml, 20 ml. 5 ml, 10 ml, 20 ml in a glass ampoule of brown color (according to the standard DIN-ISO 9187-1-B-5br, DIN-ISO 9187-1-B-10- br and, DIN-ISO 9187-1-B-20-br respectively; funeral capacity 5 ml, 10 ml, 20 ml; type 1, Hept. F.).

    5 ampoules are placed in a contour mesh package made of PVC coated with wax paper.

    One contour mesh package with instructions for use is placed in a cardboard box.

    Vials of 30 ml.

    To 30 ml in a bottle of brown glass, corked with a rubber stopper under an aluminum safety obkalka with a needle hole in the center and closed with a protective plastic cover (in accordance with the standard DIN-ISO 8362-4 50H br-1; nominal capacity 30 ml; type 1, Hept. F.)

    For 1 or 5 bottles with instructions for use are placed in a cardboard box.

    Packaging "in bulk"(for hospitals and for packaging at ZAO Biokom, Russia):

    For 10 ampoules (1 ml, 2 ml) is placed in a blister of PVC, covered with wax paper.

    For 50 blisters (ampules 1 ml, 2 ml) or 225 blisters (1 ml ampoules) with instructions for use are placed in a cardboard box. 5 ampoules (5 ml) are placed in a PVC blister covered with wax paper.

    90 blisters with instructions for use are placed in a cardboard box.

    5 ampoules (10 ml) are placed in a blister of PVC, covered with wax paper.

    For 36 blisters with instructions for use are placed in a cardboard box.

    5 ampoules (20 ml) are placed in a blister of PVC, covered with wax paper.

    For 20 blisters 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 leave from pharmacies:On prescription
    Registration number:П N013827 / 01
    Date of registration:08.07.2007
    The owner of the registration certificate:EVER Neuro Pharma GmbHEVER Neuro Pharma GmbH Austria
    Manufacturer: & nbsp
    Representation: & nbspEVER NEERO PHARMA GmbH EVER NEERO PHARMA GmbH Austria
    Information update date: & nbsp10.10.2015
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