Cerebrin (Solution) Instructions for Use

Marketing Authorization Holder

B-PHARM, LLC (Russia)

Manufactured By

Fncirip Named After M.P. Chumakov Ran, Fsbsi (Russia)

Or

Kursk Biopharmaceutical Plant – Firm "Biok", FKP (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Dosage Form

Cerebrin

Solution for injection: amp. 1 ml or 2 ml 10 pcs., 5 ml or 10 ml 5 pcs., vial 10 ml or 20 ml 5 pcs.

Dosage Form, Packaging, and Composition

Solution for injection transparent, from yellowish to yellowish-brown color.

Excipients : sodium hydroxide – 2.1 mg, water for injection – up to 1 ml.

1 ml – ampoules of neutral glass (5) – contour cell packaging (2) – cardboard packs.
2 ml – ampoules of neutral glass (5) – contour cell packaging (2) – cardboard packs.
5 ml – ampoules of neutral glass (5) – contour cell packaging (1) – cardboard packs.
10 ml – ampoules of neutral glass (5) – contour cell packaging (1) – cardboard packs.
10 ml – vials of neutral glass (5) – contour cell packaging (1) – cardboard packs.
20 ml – vials of neutral glass (5) – contour cell packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Nootropic agent. Contains low molecular weight biologically active neuropeptides that penetrate the BBB and directly reach nerve cells.

It has an organ-specific multimodal effect on the brain, i.e., it provides metabolic regulation, neuroprotection, functional neuromodulation, and neurotrophic activity.

It increases the efficiency of aerobic energy metabolism of the brain, improves intracellular protein synthesis in the developing and aging brain.

It protects neurons from the damaging effects of lactic acidosis, prevents the formation of free radicals, increases the survival and prevents the death of neurons under conditions of hypoxia and ischemia, and reduces the damaging neurotoxic effect of excitatory amino acids (glutamate).

Neurotrophic activity is similar to the action of natural neuronal growth factors, and it manifests itself under conditions of peripheral administration. It has a positive effect on cognitive function impairments and memory processes.

Pharmacokinetics

The complex composition of the complex, 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 a conventional pharmacokinetic analysis of individual components.

Indications

Alzheimer’s disease; cognitive impairment syndrome of various origins, including dementia; chronic cerebrovascular insufficiency (chronic cerebral ischemia, dyscirculatory encephalopathy); ischemic stroke; traumatic brain injury; mental retardation in children; hyperactivity and attention deficit in children; in complex therapy – for endogenous depression resistant to antidepressants.

ICD codes

Dosage Regimen

Administer parenterally via intramuscular or intravenous injection.

Determine the dose and duration based on the nature and severity of the disease and the patient’s age.

For a single dose, administer up to 50 ml.

Prefer a course of treatment over single doses.

For the optimal treatment course, administer daily injections for 10 to 20 days.

Adjust the regimen for pediatric patients according to age and clinical condition.

For intravenous administration, inject slowly to avoid adverse reactions like dizziness or tachycardia.

Do not exceed the recommended daily volume.

Monitor patients for tolerance throughout the treatment course.

Repeat treatment courses if necessary, after a treatment-free interval as determined by the physician.

Adverse Reactions

Immune system disorders very rarely – increased individual sensitivity, allergic reactions, skin reactions, pain in the neck, head and limbs, fever, mild back pain, shortness of breath, chills, collapse-like state.

Metabolism and nutrition disorders rarely – loss of appetite.

Psychiatric disorders rarely – the presumed activation effect is accompanied by agitation, manifested by aggressive behavior, confusion, insomnia.

Nervous system disorders rarely – dizziness with too rapid administration of the complex; very rarely – isolated cases of generalized epilepsy and one case of seizure development.

Cardiac disorders very rarely – increased heartbeat and arrhythmia with too rapid administration of the complex.

Gastrointestinal disorders very rarely – dyspepsia, diarrhea, constipation, nausea, vomiting.

Skin and subcutaneous tissue disorders rarely – feeling of heat, sweating, itching with too rapid administration of the complex.

General disorders and administration site conditions very rarely – redness, itching, burning at the injection site.

Contraindications

Individual intolerance to the components of the complex; severe renal failure; epileptic status.

With caution

In allergic diatheses, diseases of an epileptic nature, including generalized epilepsy (an increase in the frequency of seizures is possible).

Use in Pregnancy and Lactation

The use of the complex during pregnancy and breastfeeding is possible only after a thorough analysis of the ratio of the positive effect of treatment and the risk associated with its implementation.

Drug Interactions

When the peptide complex is co-administered with antidepressants or MAO inhibitors, the development of additive effects is possible, and a reduction in the dose of the antidepressant is recommended.

The use of the complex in high doses (30-40 ml) in combination with high doses of MAO inhibitors may cause an increase in blood pressure.

The peptide complex should not be mixed in the same infusion solution with amino acid solutions.

It is incompatible with solutions containing lipids and with solutions that change the pH of the medium (5.0-8.0).

Effect on ability to drive vehicles and machinery

During the use of the peptide complex, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.