TSEREBROLYZYN
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: EBEWE Neuro Pharma GmbH (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 ml – vials of dark glass (10) – packings Valium planimetric (1) – packs cardboard.
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 ml – vials of dark glass (5) – packings Valium planimetric (1) – packs cardboard.
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 ml – vials of dark glass (5) – packings Valium planimetric (1) – packs cardboard.
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 ml – vials of dark glass (1) – packs cardboard.
30 ml – vials of dark glass (5) – packs cardboard.
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® – only peptidergic nootropic drug with proven neurotrophic activity, 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: rarely – feeling the heat, Sweating, dizziness; in a few cases – tachycardia or fibrillation.
From the digestive system: rarely – loss of appetite, dyspepsia, diarrhea, constipation, nausea and vomiting.
From the central and peripheral nervous system: rarely – excitation, exhibit aggressive behavior, confusion, insomnia; in a few cases – grand mal seizures, convulsions.
Allergic reactions: in a few cases – hypersensitivity reactions, manifesting headache, by pain in the neck, limbs, lower back, shortness of breath, chills and collaptoid state.
Local reactions: rarely – dermahemia, 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: in a few cases – arterial hypertension, hypotension.
From the central and peripheral nervous system: in a few cases – fatigue, tremor, depression, apathy, dizziness.
Other: in a few cases – hyperventilation, 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. Shelf life in ampules – 5 years. Shelf-life of the drug in vials – 4 year.
