CEREBROLYSIN 5 amp 10ml (complex of natural peptides)

CEREBROLYSIN contains low molecular weight biologically active neuropeptides that penetrate the BBB 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.

• Metabolic regulation. Cerebrolysin® increases the efficiency of aerobic energy metabolism in the brain, improves intracellular protein synthesis in the developing and aging brain.

• 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, reduces the damaging neurotoxic effect of excitatory amino acids (glutamate).

• Neurotrophic activity. Cerebrolysin® is the only nootropic peptidergic drug with a proven neurotrophic activity similar to that of natural neuronal growth factors (NGF), but manifested under conditions of peripheral administration.

• Functional neuromodulation. Cerebrolysin® has a positive effect on cognitive impairment, improves memory processes.

Indications:

Alzheimer's disease, dementia syndrome of various origins, 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 - with endogenous depression resistant to antidepressants.

Ingredients:

1 ml of solution contains:
active substance: Cerebrolysin® concentrate (a complex of peptides obtained from the brain of a pig) 215.2 mg;
excipients: sodium hydroxide, water for injection.

Pharmacotherapeutic group: nootropic agent

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.

Contraindications:

• individual intolerance to the drug;
• severe renal failure;
• status epilepticus.

With caution: the drug is used for allergic diathesis, epileptic diseases, including generalized epilepsy, due to a possible increase in the frequency of seizures.

USE IN PREGNANCY AND DURING BREASTFEEDING
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 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:

It is applied parenterally. Doses and duration of treatment depend on the nature and severity of the disease, as well as on the age of the patient. It is possible to prescribe single doses, the value of which can reach 50 ml, but it is more preferable to conduct 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): 10 ml - 50 ml
• In the residual period of cerebral stroke and traumatic injury to the brain and spinal cord: 5 ml - 50 ml
• With psychoorganic syndrome and depression: 5 ml - 30 ml
• In Alzheimer's disease, dementia of vascular and combined Alzheimer's-vascular genesis:  5 ml - 30 ml
• In neuropediatric practice: 0.1-0.2 ml/kg of body weight
To increase the effectiveness of treatment repeated courses can be carried out as long as there is an improvement in the patient's condition 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 as an injection: 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 dilution with the proposed standard solutions for infusion.
The duration of the infusion is from 15 to 60 minutes.

Side effects:

The frequency of adverse reactions was determined in accordance with the recommendations of the World Health Organization:
Very common: (≥1/10)
Common: (≥1/100 to <1/10)
Uncommon: (≥1/1000 to <1/100)
Rare: (≥1/10000 to <1/1000)
Very rare, including isolated reports: (<1/10000)

Classification of lesions of systems and organs. Frequency. Side effects
Immune system disorders: Very rare Individual hypersensitivity, allergic reactions, skin reactions, pain in the neck, head and limbs, fever, mild back pain, shortness of breath, chills, collapsing condition.
Metabolic and nutritional disorders: Rare Loss of appetite.
Psychiatric disorders: Rare. The expected effect of activation is accompanied by agitation, manifested by aggressive behavior, confusion, insomnia.
Nervous system disorders: Rare. Injection too quickly may cause dizziness.
Very rare. Isolated cases of generalized epilepsy and one case of seizures have been associated with Cerebrolysin.
Cardiac disorders: Very rare. Too rapid administration of the drug can lead to increased heart rate and arrhythmias.
Gastrointestinal disorders: Very rare. Dyspepsia, diarrhea, constipation, nausea, vomiting.
Skin and subcutaneous tissue disorders: Rare. In case of excessively rapid administration, a feeling of heat, sweating, itching may occur.
General disorders and disorders at the injection site: Very rarely. Redness, itching, burning at the injection site.
In one study, an association was reported between the use of the drug in rare cases (> 1/10,000 to < 1/1,000) with hyperventilation, hypertension, hypotension, fatigue, tremor, possible development of depression, apathy and / or drowsiness, flu-like symptoms ( colds, coughs, respiratory infections).
Since Cerebrolysin is mainly used in elderly patients, the above symptoms of the diseases are typical for this age group and often also occur without the use of the drug.
It should be noted that some undesirable effects (excitation, arterial hypertension, arterial hypotension, lethargy, tremor, depression, apathy, dizziness, headache, shortness of breath, diarrhea, nausea) were identified during clinical trials and occurred equally in patients treated with Cerebrolysin and in patients in the placebo group.
If any of the side effects listed in the instructions get worse or if you notice any other side effects not listed in the instructions, tell your doctor.

Notification in case of suspected side effects:
It is important to report side effects after the drug is registered in order to ensure continuous monitoring of the risk-benefit ratio of the drug. Healthcare professionals are asked to report any side effects observed with the use of the drug through the national system for reporting adverse reactions and / or to the address of the Representative Office indicated below.

Overdose: not found.

Drug interaction:

Given the pharmacological profile of Cerebrolysin, special attention should be paid to possible additive effects when co-administered with antidepressants or MAO inhibitors. In such cases it is recommended to reduce the dose of the antidepressant.
The use of high doses of Cerebrolysin (30 - 40 ml) in combination with high doses of MAO inhibitors can cause an increase in blood pressure.
Do not mix Cerebrolysin and Balanced Amino Acid Solutions in the same solution for infusion.
Cerebrolysin is incompatible with solutions containing lipids and with solutions that change the pH of the medium (5.0-8.0).

Special instructions:

With excessively rapid injection a feeling of heat, sweating, dizziness may occur. Therefore, the drug should be administered slowly.
The compatibility of the drug (within 24 hours at room temperature and the presence of light) has been tested and confirmed 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; Cl- - 163.48 mmol/l).
• 5% glucose solution
Simultaneous administration 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.
Use only clear solution and only once.

IMPACT ON DRIVING ABILITY
Clinical trials have shown that Cerebrolysin does not affect the ability to drive vehicles and use machines.

Storage temperature: 2℃ to 25℃

Special storage conditions:

Store in a place protected from light at a temperature not exceeding 25°C.
Keep out of the reach of children!
Note: after opening the ampoule, the solution should be used immediately.

Guaranteed authenticity and quality:

100% Original from EVER PHARMA JENA / EVER NEURO PHARMA 

Development and production:

EVER PHARMA JENA / EVER NEURO PHARMA