Cerebrolysin injection solution ampoules 10ml N5
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Release form
Solution
Composition
1 ml solution for injections contains: active substance: concentrate of cerebrolysin (a complex of peptides derived from the brain of a pig) 215.2 mg, excipients: sodium hydroxide, water for injection.
Pharmacological effect
Nootropic drug. Cerebrolysin contains low molecular weight biologically active neuropeptides that penetrate through the BBB and directly reach 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. Metabolic regulation: the drug Cerebrolysin increases the efficiency of the aerobic energy metabolism of the brain, improves intracellular protein synthesis in the developing and aging brain. Neuroprotection: the drug protects neurons from the damaging effect of lactic acidosis, prevents the formation of free radicals, increases survival and prevents neuron death in conditions of hypoxia and ischemia, reduces the damaging neurotoxic effect of excitatory amino acids (glutamate). Neurotrophic activity: the drug Cerebrolysin is the only nootropic peptidergic drug with proven neurotrophic activity, similar to the action of natural neuronal growth factors (NGF), but manifested in the conditions of peripheral administration. Functional neuromodulation: the drug has a positive effect in cases of cognitive impairment on the 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, does not allow for the usual pharmacokinetic analysis of individual components.
Indications
Alzheimer's disease. Syndrome of dementia of various genesis. Chronic cerebrovascular insufficiency. Ischemic stroke. Traumatic injuries of the brain and spinal cord. Mental retardation in children. Hyperactivity and attention deficit in children. In complex therapy for endogenous depression resistant to antidepressants.
Contraindications
Individual intolerance to the drug. Acute renal failure. Epileptic status.
Precautionary measures
With excessively rapid administration, in rare cases, a sensation of heat, sweating, dizziness, and in rare instances - rapid heartbeat or arrhythmias. Therefore, the drug should be administered slowly. The compatibility of the drug (for 24 hours at room temperature and light) with the following standard solutions for infusions has been checked and confirmed: - 0.9% sodium chloride-Ringer's solution (Na + - 153.98 mmol / l ; Ca2 + - 2.74 mmol / l; K + - 4.02 mmol / l; Cl- - 163.48 mmol / l) - 5% glucose solution. Simultaneous prescription of vitamins and drugs that improve heart circulation is allowed, but these drugs do not mix in the same syringe with Cerebrolysin. Use only clear solution and only once.
Use during pregnancy and lactation
Caution should be used Cerebrolysin in the first trimester of pregnancy and lactation. The use of the drug during pregnancy and during breastfeeding is possible only in the case when the intended benefits to the mother outweigh the potential risk to the fetus / newborn. The results of experimental studies do not suggest that Cerebrolysin has any teratogenic effect or has a toxic effect on the fetus. However, similar clinical studies have not been conducted.
Dosage and administration
Intramuscularly (up to 5 ml), intravenously (up to 10 ml), intravenously, by slow infusion (from 10 to 50 ml). Doses and duration of treatment depend on the nature and severity of the disease, as well as on the age of the patient. You can assign single doses, the value of which can reach 50 ml, but more preferably a course of treatment. The recommended optimal course of treatment is daily injections for 10–20 days. Acute conditions (ischemic stroke, TBI, complications after neurosurgical operations) - from 10 to 50 ml. The residual period of cerebral stroke and traumatic injury of the brain and spinal cord is from 5 to 50 ml. Psychoorganic syndrome and depression - from 5 to 30 ml. Alzheimer's disease, dementia of vascular and combined Alzheimer's-vascular genesis - from 5 to 30 ml.In neuropediatric practice - 0.1–0.2 ml / kg. To improve the effectiveness of treatment, repeated courses may be conducted, until the patient's condition is improved due to treatment. After the first course, the frequency of dose can be reduced to 2 or 3 times a week. Doses from 10 to 50 ml are recommended to be administered only through slow intravenous infusions after dilution with the proposed standard solutions for infusions. The duration of infusion is from 15 to 60 minutes.
Side effects
Reaction to the introduction of an excessively rapid introduction in rare cases, you may feel the heat, sweating, dizziness. in isolated cases, palpitations or arrhythmias. Therefore, the medication should be administered slowly. From the gastrointestinal tract rarely - loss of appetite, dyspepsia, diarrhea, constipation, nausea and vomiting. From the CNS and peripheral nervous system: in rare cases, the intended effect of activation is accompanied by agitation (manifested aggressive behavior, confusion, insomnia). There are reports of occurrence in isolated cases (On the part of the immune system, extremely rarely - hypersensitivity reactions or allergic reactions, manifested by headache, pain in the neck, extremities, lower spins, shortness of breath, chills and collaptoid state. Local reactions rarely - redness of the skin, itching and burning sensation at the injection site. Others are extremely rare - according to the results of research, cases of hyperventilation, arterial hypertension, arterial hypotension, fatigue, tremor, depression, apathy have been reported, dizziness and flu-like symptoms (cough, runny nose, respiratory tract infections). It should be noted that some adverse effects (agitation, arterial hypertension, arterial hypotension, lethargy, tremor, depression, apathy, dizziness, headache, shortness of breath, diarrhea, nausea) identified during clinical trials and occurred equally as patients treated with Cerebrolysin, and in patients of the placebo group.
Overdose
Currently, cases of an overdose of the drug Cerebrolysin were reported.
Interaction with other drugs
With the simultaneous use of Cerebrolysin with antidepressants or MAO inhibitors, mutual enhancement of their action is possible.In such cases, it is recommended to reduce the dose of antidepressant. Pharmaceutical interaction: Cerebrolysin is incompatible with solutions containing lipids and with solutions that change the pH of the medium (5.0-8.0).
special instructions
After opening the ampoule / vial Cerebrolysin solution should be used immediately. If the injection is too fast, you may feel hot, sweating, dizziness. Therefore, the drug should be administered slowly. Compatibility of the drug was tested and confirmed (within 24 hours at room temperature and the presence of light) with the following standard solutions for infusions: 0.9% sodium chloride solution, Ringer's solution, 5% dextrose (glucose) solution. The simultaneous use of Cerebrolysin with vitamins and drugs that improve cardiac circulation is allowed, but these drugs should not be mixed in the same syringe with Cerebrolysin. Do not mix in one solution for infusion Cerebrolysin and balanced solutions of amino acids. You should use only a clear solution of Cerebrolysin and only once. Impact on the ability to drive motor vehicles and control mechanisms: Clinical trials have shown that Cerebrolysin does not affect the ability to drive vehicles and the use of mechanisms.