Cerebrolysin solution for injection 215.2 mg/ml, 20 ml (4304 mg) x 5 ampoules — Made in Austria — Free Delivery

Pharmacological properties

Pharmacodynamics. Cerebrolysin - a proteolytic peptide fraction obtained from the pig brain, stimulates differentiation and improves the function of nerve cells, activates defense and recovery mechanisms. animal experiments have demonstrated that cerebrolysin has a direct effect on neuronal and synaptic plasticity, which contributes to the improvement of cognitive function. this has been demonstrated in young, adult and old animals with reduced learning ability. In experiments with models of cerebral ischemia, Cerebrolysin reduced the volume of infarction, prevented the formation of edema, stabilized microcirculation, normalized neurological and cognitive impairments, and doubled the survival rates. positive results have also been obtained during studies with models of Alzheimer's disease. in addition to the direct effect on neurons, cerebrolysin significantly increased the number of molecules that transport glucose across the geb, thus compensating for the critical energy deficit observed in this disease.

A quantitative EEG analysis of healthy volunteers and patients with vascular dementia showed a significant dose-dependent increase in neuronal activity (increased frequencies of α- and β-rhythms) after 4 weeks of treatment with Cerebrolysin. Regardless of the cause of the disease in neurodegenerative dementia of the Alzheimer's type or in vascular dementia, after treatment with Cerebrolysin, patients objectively improved cognitive functions and the ability to self-care. A clinically noticeable improvement in the patients' condition was noted already after 2 weeks of treatment with Cerebrolysin and intensified with continued therapy. A positive effect after treatment with Cerebrolysin was noted in 60–70% of patients, regardless of the type of dementia. In the case of senile dementia of the Alzheimer's type, the improvement in the clinical condition of patients continued after the end of active therapy. This was especially true for the long-term improvement in the ability to perform daily activities, as a result of which the need for outside help and supervision is reduced. Due to neurotrophic activity (similar to the action of nerve growth factor), Cerebrolysin can significantly slow down, and in some cases stop the progression of neurodegenerative processes.

High molecular weight peptides with antigenic potential are removed from the preparation during the manufacturing process.

Studies have not revealed the effect of the preparation on the immune system. Experiments have shown that Cerebrolysin does not induce antibodies or anaphylactic reactions. Cerebrolysin does not stimulate histamine receptors and does not affect the hemagglutination of erythrocytes.

Pharmacokinetics. Since the proteolytic peptide fraction obtained from the pig brain contains biologically active peptides similar or identical to those produced endogenously, it has not yet been possible to directly determine the pharmacokinetic parameters of Cerebrolysin. Indirect pharmacokinetic data were obtained on the basis of studying the pharmacodynamic profile of the preparation. After a single injection, the neurotrophic activity of the preparation Cerebrolysin in the blood plasma is manifested for almost 24 hours. The components of the preparation can penetrate the BBB. In preclinical experiments in vivo, an identical pharmacodynamic effect of the preparation on the central nervous system was established with intracerebroventricular and peripheral administration. This is indirect evidence that the components of the preparation penetrate the BBB.

Indications

Organic, metabolic disorders and neurodegenerative diseases of the brain, especially Alzheimer's disease; complications after a stroke; traumatic brain injury (condition after neurosurgical intervention, closed craniocerebral trauma, concussion).

Application

The preparation is administered intravenously or intramuscularly. undiluted cerebrolysin is administered in doses up to 5 ml / m or up to 10 ml - by intravenous injection. the preparation in doses of 10-50 ml (maximum dose) is recommended to be administered by slow intravenous infusions after dilution to a volume of 100 ml with one of the standard solutions given below. the duration of the infusion is 15-60 minutes.

After dilution with 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) or 5% glucose solution. Solution for infusion is physically and chemically stable for 24 hours when stored at room temperature in a place unprotected from light. From a microbiological point of view, the infusion solution must be administered immediately after preparation.

The optimal recommended duration of the course of treatment is 10–20 days of daily administration of the preparation.

Single injections are possible in a dose of up to 50 ml, but course therapy is more effective.

Recommended daily doses. Organic pathology of the brain, metabolic disorders and neurodegenerative diseases (dementia) - 5–30 ml.

Complications after a stroke - 10-50 ml.

Traumatic brain injury - 10-50 ml.

Neurological disorders in children - 1-2 ml.

The effectiveness of therapy increases with repeated courses. The treatment is continued until the patient's condition improves. After the initial course, the frequency of preparation administration can be reduced to 2-3 times a week. Between courses of therapy, it is necessary to take breaks with a duration of at least that of the course of treatment.

The recommended dose for children over the age of 6 months is 0.1 ml / kg of body weight (up to 2 ml / day).

Instructions for medical personnel. When Cerebrolysin is administered through a permanent intravenous catheter, the latter must be flushed with 0.9% sodium chloride solution before and after infusion of the preparation. Collect the preparation from ampoules / vials immediately before use. Only a single intake of the preparation from the ampoule / vial is allowed. Only transparent amber solutions can be used.

Contraindications

Hypersensitivity to the components of the preparation, epilepsy, severe renal dysfunction.

Side effects

The following are undesirable effects and reactions noted during clinical trials and post-marketing observations, regardless of the presence of a causal relationship with therapy with Cerebrolysin (the preparation is used to treat mainly the elderly, and these symptoms are often noted in this category of patients).

From the immune system: single (1/10 000) - hypersensitivity reactions or allergic reactions, anaphylactic shock, angioedema, fever, chills.

Metabolic disorders: rarely (1/10 000 - 1/1000) - lack of appetite.

Mental disorders: rarely (1/10 000 - 1/1000) - in isolated cases, the therapeutic effect was accompanied by agitation (with manifestations of aggression, confusion, insomnia), depression, apathy, weakness.

From the side of the nervous system: rarely (1/10 000 - 1/1000) - with very rapid administration, dizziness, tremor, headache, drowsiness are possible; single (1/10 000) - large epileptic seizures (grand mal), convulsions.

From the side of the cardiovascular system: rarely (1/10 000 - 1/1000) - hypertension, arterial hypotension; single (1/10 000) - with a very rapid introduction, palpitations, tachycardia and arrhythmia, pain in the heart are possible.

From the respiratory system: rarely (1/10 000 - 1/1000) - hyperventilation, shortness of breath, chest pain.

On the part of the digestive system: single (1/10 000) - dyspepsia, diarrhea, constipation, nausea, vomiting.

On the part of the skin and subcutaneous tissues: rarely (1/10 000 - 1/1000) - with very rapid administration, a sensation of heat, increased sweating, itching, rash (including maculopapular), urticaria, redness of the skin are possible.

General reactions and local reactions: rarely (1/10 000 - 1/1000) - increased fatigue, flu-like symptoms (for example, rhinorrhea, cough, respiratory tract infections); single (1/10 000) - reactions at the injection site, in particular erythema and burning at the injection site, local inflammatory reactions.

Others: single (1/10 000) - pain in the neck, limbs, lower back.

Special instructions

Particular care is required when prescribing Cerebrolysin to patients with allergic diathesis.

Although there is no evidence that Cerebrolysin can increase the burden on the kidneys, the preparation should not be administered to patients with severe renal impairment.

Use during pregnancy and lactation. Animal studies have not shown reproductive toxicity of the preparation. However, there are no data on the effect of the preparation on human reproductive function. Cerebrolysin can be used only after a careful assessment of the ratio of the expected benefits to the mother and the potential risk to the fetus / child. During the use of the preparation, breastfeeding should be discontinued.

Children. The preparation is used in pediatric practice in the presence of reasonable indications.

The ability to influence the reaction rate when driving vehicles and other mechanisms. Clinical studies have not revealed the effect of the preparation on the reaction rate when driving vehicles or working with other mechanisms, however, in some patients, Cerebrolysin can cause certain unwanted side effects from the nervous system and the mental sphere, as a result of which the ability to drive vehicles may be temporarily impaired and work with other mechanisms.

Interactions

Given the pharmacological profile of the preparation Cerebrolysin, special attention should be paid to the possible additive effects in the case of its simultaneous use with antidepressants or MAO inhibitors. in such cases, it is recommended to reduce the dose of antidepressants.

Cerebrolysin should not be mixed with balanced solutions of amino acids in the same infusion bottle.

Allowed the simultaneous use of the preparation Cerebrolysin with vitamins and preparations that affect the cardiovascular system, but you should not mix them in one syringe.

Incompatibility. Cerebrolysin is incompatible with solutions that change the pH of the preparation (5.0-8.0), as well as with solutions containing lipids.

Cerebrolysin should not be mixed with balanced solutions of amino acids, vitamins and cardiovascular preparations in one infusion bottle.

Overdose

There were no cases of intoxication or negative health effects due to an overdose of the preparation Cerebrolysin.

Storage conditions

In its original packaging at a temperature not exceeding 25 ° C. do not freeze!