Active substance: 1 ml of an aqueous solution of the drug contains 215.2 mg of cerebrolysin concentrate (a complex of peptides obtained from the pig’s brain). The active fraction of Cerebrolysin is represented by peptides, the molecular weight of which does not exceed 10,000 daltons.
Excipients sodium hydroxide and water for injection.
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 efficiency of aerobic energy metabolism in 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, increases survival and prevents neuronal death under conditions of hypoxia and ischemia, and reduces the damaging neurotoxic effect of excitatory amino acids (glutamate).
c) neurotrophic activity: Cerebrolysin is the only nootropic peptidergic drug with proven neurotrophic activity, similar to the action of natural neuronal growth factors (NGF), but manifested under conditions of peripheral administration.
d) functional neuromodulation: Cerebrolysin has a positive effect on impaired cognitive functions, on the processes of memorization
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, does not allow for the usual pharmacokinetic analysis of individual components.
INDICATIONS FOR USE
Alzheimer’s disease, dementia syndrome of various origins, 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
individual intolerance to the drug
acute renal failure
PREGNANCY AND LACTATION
The drug is prescribed with caution in the first trimester of pregnancy and during lactation.
During pregnancy and during breastfeeding, Cerebrolysin should be used only after a careful analysis of the ratio of the positive effect of treatment and the risk associated with its implementation. The results of experimental studies do not give grounds to believe that Cerebrolysin has any teratogenic effect or has a toxic effect on the fetus. However, similar clinical studies have not been conducted.
METHOD OF APPLICATION AND DOSE
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. Perhaps the appointment of single doses, the value of which can reach 50 ml, but it is more preferable to carry out a course of treatment.
The recommended optimal course of treatment is daily injections for 10-20 days.
• Acute conditions (ischemic stroke, traumatic brain injury, complications of neurosurgical operations): from 10 ml to 50 ml
• In the residual period of cerebral stroke and traumatic injury to the brain and spinal cord: from 5 ml to 50 ml
• For psychoorganic syndrome and depression: from 5 ml to 30 ml
• For Alzheimer’s disease, dementia of vascular and combined Alzheimer’s-vascular genesis: from 5 ml to 30 ml
• In neuropediatric practice: 0.1-0.2 ml / kg body weight
To increase the effectiveness of treatment, repeated courses can be carried out until the patient’s condition improves due to treatment. After the first course, the frequency of prescribing doses 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 from 10 ml to 50 ml are recommended to be administered only by slow intravenous infusions after reconstitution with the proposed standard infusion solutions. The duration of the infusion is 15 to 60 minutes.
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.
With excessively rapid administration, in rare cases, a sensation of heat, sweating, dizziness and (in isolated cases) possible heart palpitations or arrhythmias may occur.
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 peripheral nervous system: in rare cases, the alleged activation effect was accompanied by excitement (manifested by aggressive behavior, confusion, insomnia). There are reports of the occurrence in isolated cases (<0.01%) of large epileptic seizures and seizures during treatment with Cerebrolysin.
From the side of the immune system: in extremely rare cases, hypersensitivity reactions or allergic reactions manifested by headache were noted; pain in the neck, limbs, lower back; shortness of breath, chills and collaptoid condition.
Local reactions: in rare cases, there is redness of the skin, itching and burning at the injection site.
Others: 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 (agitation, arterial hypertension, arterial hypotension, lethargy, tremor, depression, apathy, dizziness, headache, shortness of breath, diarrhea, nausea) were identified in clinical trials and occurred to the same extent as in patients, treated with Cerebrolysin and in patients in the placebo group.
INTERACTION WITH OTHER MEDICINAL PRODUCTS
Taking into account the pharmacological profile of Cerebrolysin, special attention should be paid to the possible additive effects when administered together with antidepressants or 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 solution for infusion.
Cerebrolysin is incompatible with solutions that contain lipids, and with solutions that change the pH of the medium (5.0-8.0).
If the injections are performed too quickly, a feeling of heat, sweating, and dizziness may occur. Therefore, the drug should be administered slowly.
The drug has been tested and confirmed to be compatible (within 24 hours at room temperature and light) with the following standard solutions for infusion:
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; SG -163.48 mmol / L).
5% glucose solution
Simultaneous administration of Cerebrolysin with vitamins and drugs that improve cardiac circulation is allowed, however, these drugs should not be mixed in the same syringe with Cerebrolysin. Use only clear solution and only once.
INFLUENCE ON THE ABILITY TO DRIVE VEHICLES
Clinical trials have shown that Cerebrolysin does not affect the ability to drive vehicles and use mechanisms.
Solution for injection ampoules 1 ml
1 ml in brown glass ampoules. 10 ampoules are placed in a PVC blister, covered with wax paper. One blister strip with instructions for use is placed in a cardboard box.
“In bulk” packaging
10 ampoules (1 ml) are placed in a PVC blister covered with wax paper. 50 or 225 blisters with instructions for use are placed in a cardboard box.
Solution for injection ampoules 5 ml and 10 ml
5 ml, 10 ml in brown glass ampoules. 5 ampoules are placed in a PVC blister, covered with wax paper. One blister strip with instructions for use is placed in a cardboard box.
Solution for injection vials 30 ml
30 ml each in a brown glass bottle, sealed with a rubber stopper under an aluminum safety roll-in with a hole for a needle in the center and closed with a protective plastic cap. 1 or 5 vials with instructions for use are placed in a cardboard box.
Store in a dark place at a temperature not exceeding 25 ° С,
Keep out of reach of children.
Note: after opening the ampoule / vial, the solution should be used immediately.
The shelf life of ampoules is 5 years.
The shelf life of the vials is 4 years.
Do not use after the expiration date printed on the package.