TSEREBROLYZYN

Published by
Vladimir Andreevich Didenko

Active material: peptide complex, derived from porcine brain
When ATH: N06BX
CCF: Nootropics
ICD-10 codes (testimony): F00, F01, F32, F33, F79, F90.0, G30, G45, G93.4, I63, I67.2, I69, S06, T90
When CSF: 02.14.01.01
Manufacturer: Waro Pharma Jehbhh (Austria)

Pharmaceutical form, composition and packaging

Solution for injection water, clear, amber.

1 ml
peptide complex, derived from porcine brain 215.2 mg

Excipients: Sodium hydroxide, water d / and.

1 мл – ампулы темного стекла (10) – упаковки ячейковые контурные (1) – пачки картонные.

Solution for injection water, clear, amber.

1 ml 1 amp.
peptide complex, derived from porcine brain 215.2 mg 1.076 g

Excipients: Sodium hydroxide, water d / and.

5 мл – ампулы темного стекла (5) – упаковки ячейковые контурные (1) – пачки картонные.

Solution for injection water, clear, amber.

1 ml 1 amp.
peptide complex, derived from porcine brain 215.2 mg 2.152 g

Excipients: Sodium hydroxide, water d / and.

10 мл – ампулы темного стекла (5) – упаковки ячейковые контурные (1) – пачки картонные.

Solution for injection water, clear, amber.

1 ml 1 fl.
peptide complex, derived from porcine brain 215.2 mg 6.456 g

Excipients: Sodium hydroxide, water d / and.

30 мл – флаконы темного стекла (1) – пачки картонные.
30 мл – флаконы темного стекла (5) – пачки картонные.

Pharmacological action

Nootropics.

Tserebrolyzyn® It contains low molecular weight biologically active neuropeptides, that penetrate the blood-brain barrier and enter directly to the nerve cells. The drug has an organ multimodal action on the brain, ie. It provides metabolic regulation, neuroprotection, neuromodulation and functional neurotrophic activity.

Metabolic regulation:

drug Cere® improves aerobic energy metabolism of the brain, improves the intracellular protein synthesis in the developing and aging brain.

The neuroprotective effect: drug protects neurons from the damaging effect of lactic acidosis, It prevents the formation of free radicals, perezhivayemost increases and prevents neuronal death in conditions of hypoxia and ischemia, It reduces the damaging neurotoxic effects of excitatory amino acids (Glutamate).

Neurotrophic Activity: drug Cere® – единственный ноотропный пептидергический препарат с доказанной нейротрофической активностью, similar to the action of natural neuronal growth factors (NGF), but manifested in a peripheral administration.

Functional Neuromodulation: the drug has a positive effect in cognitive impairment, It improves concentration, memory processes.

Pharmacokinetics

The complex structure of Cere®, active fraction which consists of a balanced and stable mixture of biologically active oligopeptides, possessing a total of multifunctional action of, It does not allow for normal pharmacokinetic analysis of individual components.

Testimony

- Alzheimer's disease;

- A syndrome of dementia of different genesis;

- Chronic cerebrovascular insufficiency;

- Ischemic stroke;

- Traumatic injury of the brain and spinal cord;

- Mental retardation in children;

- Hyperactivity and attention deficit disorder in children;

- Endogenous depression, resistant to antidepressants (in the complex therapy).

Dosage regimen

The drug should be administered parenterally. Dose and duration of administration depends on the nature and severity of the disease, as well as the patient's age. Probably single administration at a dose of 50 ml, however more preferred to conduct the treatment.

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

Reading Dose
Acute (ischemic stroke, traumatic brain injury, complications of neurosurgical operations) from 10 ml to 50 ml
In the residual period of stroke and traumatic brain and spinal cord from 5 ml to 50 ml
Psychoorganic syndrome and depression from 5 ml to 30 ml
Alzheimer's Disease, vascular dementia and combined altsgeymerovo-vascular genesis from 5 ml to 30 ml
In practice neyropediatricheskoy 0.1-0.2 ml / kg body weight

To increase the effectiveness of treatment can be repeated courses until, until there is improvement in the patient's condition as a result of treatment. After the first year the frequency of injections can be reduced to 2 or 3 once a week.

Tserebrolyzyn® used parenterally in the form of w / o Injection (to 5 ml) and I / injection (to 10 ml). The preparation at a dose of 10 ml to 50 ml recommended to enter only through the slow I / infusion after dilution standard solution for infusion. The duration of infusion is between 15 to 60 m.

After opening the ampoule / vial solution Cere® should be used immediately.

Side effect

Side effects are common (>1/100, <1/10); rarely (>1/1000, <1/100); in some cases (>1/10 000, <1/1000); in a few cases (<1/10 000).

When excessively rapid introduction: редко – ощущение жара, Sweating, dizziness; в единичных случаях – тахикардия или аритмия.

From the digestive system: редко – потеря аппетита, dyspepsia, diarrhea, constipation, nausea and vomiting.

From the central and peripheral nervous system: редко – возбуждение, exhibit aggressive behavior, confusion, insomnia; в единичных случаях – большие эпилептические припадки, convulsions.

Allergic reactions: в единичных случаях – реакции повышенной чувствительности, manifesting headache, by pain in the neck, limbs, lower back, shortness of breath, chills and collaptoid state.

Local reactions: редко – гиперемия кожи, itching and burning at the injection site.

By the results of clinical trials It reported the occurrence of the following side effects:

Cardio-vascular system: в единичных случаях – артериальная гипертензия, hypotension.

From the central and peripheral nervous system: в единичных случаях – усталость, tremor, depression, apathy, dizziness.

Other: в единичных случаях – гипервентиляция, flu-like symptoms (cough, cold, respiratory tract infections).

It should be taken into account, Some undesirable effects (excitation, arterial hypertension, hypotension, slackness, tremor, depression, apathy, dizziness, headache, breathlessness, diarrhea, nausea) They were identified during clinical trials and there were equally in patients, treated Cere®, and patients on placebo.

Contraindications

- Acute renal failure;

- Status epilepticus;

- Hypersensitivity to the drug.

Pregnancy and lactation

Caution should be used Cere® I trimester of pregnancy and lactation.

Use of the drug during pregnancy and lactation is possible only in the case, when the intended benefits to the mother outweighs the potential risk to the fetus / newborn.

Results experimental studies do not give reason to believe, Cerebrolysin® It has any teratogenic or have toxic effects on the fetus. However, similar clinical studies have not been conducted.

Cautions

When excessively rapid implementation of injections possible feeling of heat, Sweating, dizziness. Therefore, the drug should be administered slowly.

Tested and confirmed the compatibility of the drug (during 24 hours at room temperature and the presence of light) with the following standard solution for infusion: 0.9% sodium chloride solution, Ringer, 5% Dextrose (Glucose).

It allowed the simultaneous use of Cere® with vitamins and drugs, improves cardiac circulation, However, these drugs should not be mixed in the same syringe with Cere®.

Do not mix in the same solution for infusion Cere® and balanced amino acid solutions.

Use only clear solution Cere® and only once.

Effects on ability to drive vehicles and management mechanisms

Clinical trials have shown, Cerebrolysin® It has no effect on the ability to drive vehicles and use mechanisms.

Overdose

Currently, cases of drug overdose Cere® not reported.

Drug Interactions

In an application Cere® with antidepressants or MAO inhibitors may enhance their mutual action. In such cases it is recommended to reduce the dose of the antidepressant.

Pharmaceutical interaction

Tserebrolyzyn® incompatible with solutions, composed of lipids, and solutions, altering pH (5.0-8.0).

Do not mix in one package solution for infusion Cere® and balanced amino acid solutions.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, dark place at a temperature no higher than 25 ° C. Срок годности препарата в ампулах – 5 years. Срок годности препарата во флаконах – 4 year.

Published by
Vladimir Andreevich Didenko

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