Cerebrolysin

One ml contains 215.2 mg of Cerebrolysin concentrate in aqueous solution.
Excipients/Inactive Ingredients: Sodium hydroxide and water for injection.

Pharmacology: Cerebrolysin is a multi-modal neuropeptide drug with a fast onset of action that helps to regain and maintain the independence of patients suffering from stroke, TBI, dementia and cognitive impairment.
Cerebrolysin improves the brain's ability for self-repair by stimulating neurorecovery.
Cerebrolysin is effective, safe and well-tolerated as shown in clinical studies including randomized, double-blind, controlled trials.
Cerebrolysin is of European/Austrian quality.
Mode of Action: Cerebrolysin is a neurotrophic peptidergic drug with multimodal pharmacological properties and is indicated for the treatment of acute and chronic central nervous system (CNS) disorders. Cerebrolysin counteracts the pathophysiological mechanisms by: Support of endogenous repair and recovery processes as a consequence of injury or degenerative diseases.
Protection against pathological events and cascades caused by an injury or a degenerative disease. (See Figure 1.)

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The natural repair and recovery processes in the CNS start immediately upon injury and play an important role in the continuous defense against neurodegeneration in chronic CNS disorders (e.g. Alzheimer's disease). Cerebrolysin has shown to modify two major signalling pathways: the neurotrophic factor (NTF) and sonic hedgehog (Shh) signalling pathway. These pathways regulate on a molecular level the cellular processes of neurogenesis, angiogenesis, dendrite arborisation, axonal sprouting, myelination, and integrity of the neurovascular unit, thereby supporting the maintenance and repair of the neuronal network.
The pathological events and cascades after stroke or trauma lead to secondary injuries, which further compromise motor and cognitive functions of a patient. Among the most relevant molecular processes targeted by Cerebrolysin in the acute phase of an injury are events of the ischemic cascade, like Excitotoxicity; Uncontrolled apoptosis; Overactivation of proteolytic enzymes; Overproduction of reactive oxygen species (ROS).
In the early post-acute phase, Cerebrolysin prevents formation of toxic protein aggregates and lowers the level of inflammatory processes, both linked to neurodegeneration if not prohibited.

Clinical benefits of Cerebrolysin: see Figure 2.

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Therapeutic indications: For treatment of cerebrovascular disorders. Especially in the following indications: Senile dementia of Alzheimer's type.
Vascular dementia.
Stroke.
Craniocerebral trauma (commotion and contusion).

Dosage Recommendation: see table.

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Route of Administration: Doses between 10 ml up to a maximum of 50 ml are recommended only as a slow intravenous infusion. Dilution has to be prepared with the suggested standard infusion solutions (0.9% sodium chloride solution, Ringer solution or 5% glucose solution) in a total volume of 100 ml. Cerebrolysin should not be mixed with other drugs (vitamins, cardiovascular drugs). For the convenience and safety of the patient, the infusion should not be administered too fast. The duration of the infusion should be 15 minutes. (See Figure 3.)

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Doses of up to 5 ml can be injected undiluted intramuscularly (IM) and up to 10 ml Cerebrolysin can be injected through direct IV injection. In both cases, injection should be administered slowly over 3 minutes.

Hypersensitivity to one of the components of the drug, epilepsy, severe renal impairment.

Safety: The experience with Cerebrolysin during many years of clinical application, the information from post-marketing surveillance studies, the safety data from double-blind, placebo-controlled clinical trials and EVER's pharmacovigilance database demonstrate the excellent clinical safety profile of Cerebrolysin.
According to EMA classification (European Medicines Agency), Cerebrolysin is in the SAFE category.
In general, reported adverse drug reactions are transient and mild in intensity.
Cerebrolysin is safe and well tolerated.

Sterility Aspects: Special precautions to guarantee sterility must be taken during dilution and administration of Cerebrolysin: Remove solution from ampoules immediately before use.
Do not leave an open ampoule on the treatment table.
Always use only disposable one-way IV infusions sets and cannulas.
Start the infusion as quickly as possible after dilution.
Before and after infusion/injection flush with 0.9% NaCl solution.
When Cerebrolysin is administered via a long-term IV catheter, the catheter has to be rinsed before and after the application with physiological sodium chloride solution.
Pay special attention to recommended infusion/injection times as previously mentioned.

Nootropics & Neurotonics/Neurotrophics

C04A - PERIPHERAL VASODILATORS ; Used as peripheral vasodilators.

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