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Cerebrolysin 215 mg/ml (10ml)

Cerebrolysin 215 mg/ml (10ml)

Cerebrolysin

Pharmaceutical Product
  • Authorised as a prescription medicine by various national medicines agencies (e.g., in Austria and multiple other countries) with an approved Summary of Product Characteristics for solution for injection 215.2 mg/ml.
  • Manufactured according to Good Manufacturing Practice (GMP) standards for sterile parenteral pharmaceuticals.
  • Quality, safety and efficacy supported by clinical data in approved neurological indications, as summarized in official prescribing information and references from the marketing authorisation holder.
Neuroprotective solution for injection

Description

Cerebrolysin 215 mg/ml (10ml) is a prescription-only neuropeptide drug for parenteral use, containing a standardized concentrate of low-molecular-weight peptides and amino acids derived from porcine brain tissue. Supplied as a clear, injectable solution in a 10 ml vial at a strength of 215.2 mg/ml of Cerebrolysin concentrate, it is classified as a neuroprotective and nootropic agent. Cerebrolysin is used in neurology for the treatment of cerebrovascular and neurodegenerative disorders, including senile dementia of Alzheimer’s type, vascular dementia, stroke, and craniocerebral trauma. It exerts multimodal effects, supporting neuronal survival, neuroplasticity and functional recovery. Although sometimes marketed on aesthetic and wellness platforms for \cognitive support\, it remains a potent prescription medicine that must only be administered under medical supervision.

Bnefits

  • Provides multimodal neuroprotective and neurotrophic effects, supporting neuron survival and function.
  • Supports treatment of cerebrovascular and neurodegenerative conditions such as Alzheimer-type dementia, vascular dementia and post-stroke states.
  • Used as an adjunct in rehabilitation after craniocerebral trauma (head injury) to support cognitive and functional recovery.
  • May improve memory, attention, vigilance and global cognitive performance in selected patients when used as part of a supervised treatment plan.
  • Contains low-molecular-weight peptides and amino acids capable of crossing the blood–brain barrier, enabling direct central nervous system activity.
  • Offered in ready-to-use solution for injection, compatible with intravenous infusion or intramuscular administration by healthcare professionals.

Indications

  • Treatment of cerebrovascular disorders as specified in official prescribing information.
  • Senile dementia of Alzheimer’s type (as part of a comprehensive treatment plan under specialist supervision).
  • Vascular dementia and mixed dementia where indicated by a specialist.
  • Functional recovery and neuroprotection after ischemic stroke and related cerebrovascular events.
  • Craniocerebral trauma (commotio and contusio) as an adjunct to standard care in appropriate patients.
  • Other physician-determined neurological indications where the benefit–risk profile is considered favourable and local regulatory approvals permit.

Composition

  • Active substance: Cerebrolysin concentrate 215.2 mg per 1 ml of solution (mixture of peptides and amino acids obtained from purified porcine brain protein).
  • Each 10 ml vial contains 2152 mg of Cerebrolysin concentrate in aqueous solution.
  • Excipients: sodium hydroxide (for pH adjustment) and water for injection.
  • The solution does not contain proteins, lipids or high-molecular-weight antigenic compounds; molecular weight of peptide fraction is typically under 10 kDa.

Formulation

  • Pharmaceutical form: clear solution for injection / infusion.
  • Strength: 215.2 mg/ml Cerebrolysin concentrate.
  • Route of administration: intravenous infusion or intramuscular injection, strictly by healthcare professionals in accordance with the approved prescribing information.
  • Legal status in countries where authorised: Prescription Only Medicine (POM).

Packaging

  • Type I glass vial containing 10 ml of sterile solution for injection, sealed with a rubber stopper and aluminium cap.
  • Vials are typically packed in cardboard cartons (various pack sizes depending on market; the referenced product is a 10 ml single vial presentation).
  • Outer packaging is labelled with product name (Cerebrolysin), strength (215.2 mg/ml), volume (10 ml), batch number, expiry date and storage information.
  • A package leaflet / prescribing information document is supplied in markets where the product is authorised through formal channels.

Usage

  • Cerebrolysin is a prescription medicine and must only be administered by qualified healthcare professionals familiar with its use.
  • The route of administration (intravenous infusion or intramuscular injection), dosage, frequency and duration of therapy must be determined individually by a physician based on the indication, severity of disease, patient age and comorbidities.
  • For intravenous use, the solution is typically diluted in a compatible infusion fluid and administered as a slow infusion according to the official prescribing information.
  • Patients should be monitored clinically during and after administration for any adverse reactions such as changes in blood pressure, heart rate, or neurological status.
  • Cerebrolysin must not be mixed with solutions containing lipids or amino acids, and incompatibilities with certain other injectable preparations should be taken into account.
  • Under no circumstances should patients self-inject or adjust their regimen without explicit medical guidance.
  • Any unused solution in an opened vial should be discarded; vials are intended for single-use according to standard parenteral medication practice.

Contraindications

  • Known hypersensitivity to Cerebrolysin or any of its components.
  • Epilepsy or a history of generalized epileptic seizures, where Cerebrolysin is generally contraindicated or used only with extreme caution according to official guidance.
  • Severe renal impairment, as the product is not recommended in patients with markedly reduced kidney function.
  • Any other contraindications specified in the country-specific Summary of Product Characteristics or prescribing information.
  • Use outside supervised medical settings, or for self-medication, is considered inappropriate and unsafe.

Adverse Effects

  • Headache and dizziness or vertigo.
  • Nausea, vomiting or gastrointestinal discomfort.
  • Agitation, restlessness, anxiety or insomnia.
  • Transient sweating, flushing, or flu-like symptoms including fever and malaise.
  • Confusion, hallucinations or changes in mental status in susceptible individuals.
  • Cardiovascular changes such as transient increases or decreases in blood pressure or heart rate have been reported in some patients.
  • Local reactions at the injection site, such as pain, redness or irritation.
  • Very rare hypersensitivity reactions; any signs of severe allergic response (e.g., dyspnoea, angioedema, widespread rash) require immediate medical attention.
  • Most reported adverse reactions are usually mild and transient, but all suspected adverse effects should be evaluated by a physician.

Storage Conditions

  • Store in the original outer carton to protect from light.
  • Do not freeze the solution.
  • Store at controlled room temperature, typically below 25°C or as stated in the national product label.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date printed on the vial and carton.
  • Once a vial has been opened, any unused solution should be discarded; do not store for later use.

Duration

Treatment duration is individualized and determined by the prescribing neurologist or specialist. Courses often range from several days to a few weeks per treatment cycle in clinical practice, with possible repeated cycles depending on indication, response and tolerability, always in accordance with official prescribing information and local guidelines.

Onset

Pharmacological activity at the neuronal level begins as the active peptides reach effective concentrations in the central nervous system; clinically, improvements in cognitive or neurological function may appear gradually over days to weeks of therapy and vary considerably between patients and indications.

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