INSTRUCTIONS FOR MEDICAL USE
CEBROLAN
Trade name of drug: CEBROLAN
Active substance (INN): Cerebrolysin
Pharmaceutical form: Solution for injection
Contents:
1 ml of the solution contains:
Active substance: Cerebrolysin concentrate 215.2 mg/ml or 40 mg/ml powder (amino acid peptide complex derived from porcine or bovine brain)
Excipients: Sodium hydroxide, water for injection.
Description: clear amber colored solution.
Pharmacotherapeutic group: Nootropic agent.
ATX code: N06BX
Pharmacological properties
Pharmacodynamics
The drug is a concentrate containing low-molecular-weight biologically active neuropeptides that penetrate through the blood-brain barrier and reach the nerve cells directly.
The drug increases the efficiency of aerobic energy metabolism of the brain, improves intracellular protein synthesis in the developing and aging brain.
It protects neurons from damaging effects.
The drug has neuron-specific neurotrophic activity.
The drug has a positive effect on cognitive impairment, improves concentration, memorization and reproduction of information associated with short-term memory, increases the ability to acquire and retain skills, enhances the process of mental activity, improves mood, promotes positive emotions, thus having a modulating effect on behavior.
Pharmacokinetics
A complex composition of the drug, the active fraction of which consists of a balanced and stable mixture of biologically active oligopeptides with a total multifunctional effect, does not allow the usual pharmacokinetic analysis of the individual components.
Indications for use
Cerebrovascular insufficiency (discirculatory encephalopathy), ischemic stroke (acute phase and rehabilitation phase), conditions after hemorrhagic stroke, traumatic brain injury (brain concussion, craniocerebral injury, conditions after surgical intervention on the brain), mental retardation in children, decreased ability to concentrate in children, dementia syndrome of different genesis (presenile – Alzheimer’s disease, senile Alzheimer’s type, vascular – multi-infarct form, mixed forms), endogenous depression, resistant to antidepressants (in combination therapy).
Dosage and administration
The drug is used parenterally. The dose and duration of administration depend on the nature and severity of the illness, as well as the age of the patient. Single drug administration in dose up to 50 ml is possible, but treatment course is more preferable. Recommended course of treatment is daily injections for 10-20 days.
Acute conditions (ischemic stroke, craniocerebral trauma, complications of neurosurgical operations) – from 10 ml to 50 ml
In the residual period of cerebral stroke and traumatic brain and spinal cord injury – from 5 ml to 50 ml
Psycho-Organic Syndrome and Depression – 5 ml to 30 ml.
Alzheimer’s disease, dementia of vascular and combined Alzheimer’s disease and vascular genesis. 5 ml to 30 ml in neuropedical practice 0.1-0.2 ml/kg body weight.
To increase the effectiveness of treatment, repeated courses may be given as long as improvement of patient’s condition due to treatment is observed. After the first course the frequency of injections may be reduced to 2 or 3 times a week.
The drug is administered parenterally as an intravenous injection (up to 5 ml) and an intravenous injection (up to 10 ml). The drug in dose from 10 ml to 50 ml is recommended to be administered only by slow intravenous infusions after dilution with standard solutions for infusion. The infusion duration is 15 min to 60 min.
Side effects
Digestive system: nausea, vomiting, diarrhea, anorexia, abdominal pain, pseudomembranous enterocolitis, increased liver transaminases activity, hyperbilirubinemia, hepatitis, dysbacteriosis.
Cardiovascular system: decreased BP, vascular collapse, tachycardia.
Metabolism: hypoglycemia (increased appetite, sweating, shivering).
CNS and peripheral nervous system: headache, dizziness, weakness, drowsiness, insomnia, paresthesias, anxiety, fear, hallucinations, confusion, depression, motor disorders, seizures.
Sensory organs: disorders of vision, hearing, smell, taste and tactile sensitivity.
Musculoskeletal system: arthralgia, myalgia, tendon rupture, muscle weakness, tendinitis.
Urinary system disorders: hypercreatininemia, interstitial nephritis.
Blood system: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.
Dermatological reactions: photosensitization, itching, swelling of the skin and mucous membranes, erythema malignant exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome).
Allergic reactions: urticaria, bronchospasm, choking, anaphylactic shock, allergic pneumonitis, vasculitis. Other: exacerbation of porphyria, rhabdomyolysis, persistent fever, development of superinfection.
Contraindications
Hypersensitivity, acute renal failure, epileptic status.
Caution: pregnancy (I trimester), lactation.
Drug interactions
Increases the effect of antidepressants.
Special indications
After opening the ampoule, the solution should be used immediately.
Administration of the drug during pregnancy (especially during the first trimester) and lactation is possible only after careful analysis of the ratio of the positive effect of the treatment and the risk associated with its use.
The drug has no effect on driving a vehicle and operating potentially dangerous mechanisms.
Precautions
Caution should be exercised in case of allergic diathesis, epilepsy, grand mal seizures.
Overdose
Overdosing caused by use of the drug has not yet been described.
Form of production
In 1 ml, 2 ml, 5 ml or 10 ml ampoules.
Storage conditions
Store in a dry, dark place at a temperature not more than 25ºC. Keep out of the reach of children!
Shelf life
2 years. Do not use after the expiration date.
Conditions of dispensing from pharmacies
Released by a doctor’s prescription.