Cerebrolysin 10ml Annotation
Trade name: CEREBROLYSIN
Dosage form: Ampoules
Medicinal form: solution for injection.
Composition:
Active substance: 1 ml of aqueous solution of the drug contains 215.2 mg of Cerebrolysin concentrate (a complex of peptides obtained from the brain of a pig). The active fraction of Cerebrolysin is represented by peptides with a molecular weight of not more than 10,000 Daltons.
Excipients: sodium hydroxide and water for injection.
Description
Amber-colored transparent solution, free from mechanical inclusions.
Pharmaceutical group
Nootropic agent
Pharmacological action
Pharmacodynamics
Cerebrolysin contains low-molecular biologically active neuropeptides that penetrate the blood-brain barrier and are directly delivered to nerve cells. The drug has an organ-specific multimodal effect on the brain, i.e. it provides metabolic regulation, neuroprotection, functional neuromodulation and neurotrophic activity.
a) Metabolic regulation: Cerebrolysin increases the activity of aerobic energy metabolism in the brain, improves intracellular protein synthesis in the developing and aging brain.
b) Neutroprotection: Cerebrolysin protects neurons from the damaging effects of lactic acidosis, prevents the formation of free radicals, increases their viability and prevents the death of neurons under conditions of hypoxia and ischemia, reduces the damaging neurotoxic effects of excitatory amino acids (glutamate).
c) Neurotropic activity: Cerebrolysin is the only nootropic peptidergic drug that has neurotrophic activity similar to natural neuronal growth factors (NGF), which is manifested under conditions of peripheral administration.
d) Functional neuromodulation: Cerebrolysin has a positive effect on cognitive function and 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, prevents the usual pharmacokinetic analysis of individual components.
Indications for use
Alzheimer's disease, dementia syndrome of various genesis, chronic cerebrovascular insufficiency, ischemic stroke, traumatic brain and spinal cord injuries associated with attention deficit in children; in complex therapy - endogenous depression resistant to antidepressants.
Contraindications
Individual intolerance to the drug
Acute renal failure
Status epilepticus
Pregnancy and lactation
The drug is prescribed with caution in the first trimester of pregnancy and during lactation.
During pregnancy and lactation, Cerebrolysin can be used only after analyzing the ratio of the positive effect of treatment and the associated risk. The results of experimental studies do not provide grounds to assume whether Cerebrolysin has any effect or whether it has a toxic effect on the fetus. However, such clinical studies have not been conducted.
Directions for use and dosage
Adopted parenterally. Dosage and duration of treatment depend on the nature and severity of the disease, as well as the patient's age. Single doses of up to 50 ml may be administered, but it is best to complete the entire course of treatment.
The recommended optimal course of treatment is daily injections for 10-12 days.
| Acute conditions (ischemic stroke, head injury, complications of neurosurgical operations): | From 10 to 50 ml |
| In the residual period of cerebral stroke and traumatic brain and spinal cord injury: | From 5 to 50 ml |
| In psychoorganic syndrome and depression: | From 5 to 30 ml |
| In Alzheimer's disease, vascular and combined Alzheimer-vascular dementias: | From 5 to 30 ml |
| In neuropediatric practice: | 0.1-0.2 ml/kg of weight |
To increase the effectiveness of treatment, repeated courses of treatment may be carried out until the patient's condition improves as a result of treatment. After the first course, the frequency of doses prescribed can be reduced to 2-3 weeks.
Cerebrolysin is used in the form of injections: intramuscularly (up to 5 ml) and intravenously (up to 10 ml). Doses from 10 to 50 ml are recommended to be administered only by slow intravenous infusion, after dilution in a standard infusion solution. The duration of infusion is 15-60 minutes.
Warnings and information for medical personnel
With rapid injection, a burning sensation, sweating, dizziness may occur. Therefore, the drug is administered slowly.
The compatibility of the drug has been tested and approved (for 24 hours, at room temperature and in bright light) with the following standard infusion solutions:
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 CI- _163.48 mmol / l).
5% glucose solution.
It is permissible to administer Cerebrolysin simultaneously with vitamins and drugs that improve cardiac blood circulation, however, these drugs should not be mixed in the same syringe with Cerebrolysin.
Only clear solutions may be used and only once.
Side effects
Common side effects _ >1/100 _ 1/100 _ 1/10000 _ < 1/1000; extremely rare side effects _ < 1/10000.
In case of too rapid administration of the drug, burning sensation, sweating, dizziness and (in isolated cases) increased heart rate and arrhythmia are possible.
Gastrointestinal tract: in rare cases, loss of appetite, diarrhea, constipation, vomiting and nausea are observed.
Central nervous system and peripheral nervous system: in rare cases, a possible activating effect was accompanied by excitation (aggressive behavior, confusion, insomnia). In isolated cases (<0.01%), during treatment with Cerebrolysin, there are data on grand mal seizures and convulsions.
On the part of the immune system: in extremely rare cases, hypersensitivity or allergic reactions have been observed, manifested by headache; pain in the neck, limbs and lower back; shortness of breath, chills and a collapsing state.
Local reactions: in rare cases, redness of the skin, burning and itching at the injection site have been observed.
Other: As a result 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 (agitation, arterial hypertension, drowsiness, tremor, depression, apathy, dizziness, headache, shortness of breath, diarrhea, nausea) were identified in clinical trials and occurred equally in patients receiving Cerebrolysin and in patients from the placebo group.
Interaction with other medicinal products
Given the pharmacological profile of Cerebrolysin, special attention should be paid to possible additive effects when administered simultaneously with antidepressants and MAO inhibitors. In such cases, it is recommended to reduce the dose of the antidepressant.
Cerebrolysin and balanced amino acid solutions should not be mixed in the same infusion solution.
Cetrebrolysin is incompatible with solutions containing lipids and solutions that change the pH environment (5.0_8.0).
Effects on the ability to drive vehicles
Clinical studies have shown that cetrebrolysin does not affect the ability to drive vehicles and various mechanisms.
Release form
Injection solution for 1 ml ampoule
1 ml brown glass ampoules. 10 ampoules are placed in a polyvinyl chloride contour-cell packaging, covered with wax paper. One contour-cell packaging, together with instructions for use, is placed in a cardboard box.
Injection solution for 5 and 10 ml ampoules
5 ml, 10 ml brown glass ampoules. 5 ampoules are placed in a polyvinyl chloride contour-cell packaging, covered with wax paper. One contour-cell packaging, together with instructions for use, is placed in a cardboard box.
Injection solution vials 30 ml
30 ml brown glass vial, protected by a rubber stopper and an aluminum protective cap, which has a hole for a needle in the center. Protected from above with a plastic cap. 1 or 5 vials together with instructions for use are placed in a cardboard box.
Storage conditions
Store in a dark place at a temperature not exceeding 25 ° C, out of the reach of children.
Note: The solution should be used immediately after opening the ampoule or vial.
Shelf life
Ampoule shelf life 5 years.
Vial shelf life 4 years.
Do not use after the expiration date indicated on the packaging.
Conditions of release: Out of prescription.