Cerebrolysin施普善

Cerebrolysin

Manufacturer:

Ever Neuro

Distributor:

Firma Vai Hong
/
HealthCare PharmaScience
Full Prescribing Info
Contents
Proteolytic peptide fraction from porcine brain protein.
Description
1ml contains 215.2mg of a proteolytic peptide fraction from porcine brain protein (Cerebrolysin concentrate) in aqueous solution.
Excipients/Inactive Ingredients: Sodium hydroxide and water for injections.
Action
Pharmacology: Pharmacodynamics: Experiments indicate that Cerebrolysin increases glucose penetration even with dysfunction of the blood-brain barrier, influences the glucose consumption of damaged regions of the brain, and exerts proven positive effects on disturbed oxidative cerebral metabolism after intravenous injection. The cerebral lactate concentration is also reduced.
Clinically, improvements in neurophysiological performance were quantified in all age groups by means of psychopathometric tests.
Pharmacokinetics: The proteolytic peptide fraction from porcine brain protein consists of short-chain biological peptides similar or identical to those occurring endogenously. It has not been possible to date to measure pharmacokinetic parameters directly. Indirect pharmacokinetic data were determined on the basis of the pharmacodynamic profile of Cerebrolysin. On this basis it is possible to demonstrate a neurotropic effect of Cerebrolysin in blood plasma up to 24 hours after a single administration.
Moreover, components of Cerebrolysin are able to pass the blood-brain barrier. Preclinical in vivo studies showed identical pharmacodynamic effects on the central nervous system after intra-cerebroventricular or peripheral administration. This is indirect evidence that components of Cerebrolysin pass the blood-brain barrier.
Toxicology: Preclinical Safety Data: Conventional studies on pharmacological safety, chronic toxicity, reproduction toxicity, mutagenicity and carcinogenicity indicated that there is no special risk associated with the administration to humans.
Indications/Uses
Cerebral cerebro-organically induced metabolic disorders, in particular senile dementia of the Alzheimer type; post apoplectic defunctionalization symptoms; cranio-cerebral traumata (commotio and contusio, surgical cranial interventions).
Dosage/Direction for Use
Posology: It is recommended that a course of treatment be carried out involving, wherever possible, daily administration over a total of 10-20 days.
Individual doses of up to 50ml can be given.
In general, patients receive per day: With cerebral metabolic disturbances (dementia): 5-30ml.
With post apoplectic defunctionalization symptoms, cranio-cerebral traumata: 10-50ml.
Children receive per day: 1-2ml.
To ensure success, courses of treatment may be repeated until no further improvement is achieved. In doing so the daily administration may be replaced by administration 2-3 times weekly. The individual therapy cycles should be separated by treatment-free intervals corresponding to the duration of a treatment series.
Method of Administration: Up to 5ml intramuscular, up to 10ml intravenous. In addition, an infusion is recommended in which 10ml to max. 50ml is diluted with the following standard infusion solutions and slowly administered (infusion duration approx. 15 to 60 minutes).
Compatibility with the following standard infusion solutions was tested over a 24-hour period at room temperature and under the influence of light: 0.9% sodium chloride solution (9mg 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); glucose 5%.
The simultaneous administration of vitamins, cardiac stimulants or cardiovascular agents is possible, but not in a mixed injection.
Overdosage
To date there have been no reports of impairment to health as a result of overdose or intoxication. There is no specific antidote. Any treatment given should be symptomatic.
Contraindications
Hypersensitivity towards a constituent of the preparation.
Epilepsy.
Severe renal insufficiency.
Special Precautions
Caution should be exercised in the case of allergic diathesis, epileptic diseases and major seizures since the frequency of attacks may increase.
Effect on Ability to Drive and to Use Machines: The results of clinical trials do not suggest that slower reaction times are to be expected; nonetheless, impairment of the ability to use machines or drive motor vehicles cannot be excluded and it is therefore advisable to avoid such activities.
Use In Pregnancy & Lactation
Animal experiments have produced no evidence that Cerebrolysin exerts any teratogenic influences.
However, since no observations on humans have been published, use during pregnancy and breast-feeding should be avoided unless strictly indicated.
Adverse Reactions
The required drive stimulatory effect is occasionally associated with agitation (aggressiveness, confusion, insomnia).
In rare cases there have been reports of hyperventilation, hypertension, hypotension, fatigue, tremor, depression, apathy and stupor, and influenza-like symptoms (colds, coughing, infection of the respiratory tract).
One major seizure and a case of convulsion have been associated with Cerebrolysin.
Gastrointestinal disturbances are observed very rarely (lack of appetite, dyspepsia, diarrhoea, constipation, vomiting, nausea).
Injection, especially if performed too quickly, may lead to a moderate sensation of heat or sweating, vertigo, or in isolated cases to palpitation or arrhythmia.
Local reactions at the site of administration have been observed in isolated cases, e.g. reddening of the skin, itching and burning.
Allergic or hypersensitivity reactions have been reported very rarely, e.g. tingling, dermal and local vascular reactions, pain in the neck, head and limbs, fever, slight back pain, dyspnoea, shivering and state similar to shock.
Since Cerebrolysin is used in elderly patients, the previously mentioned symptoms are for the most part typical for this age group and also frequently occur without medication.
Drug Interactions
In view of the pharmacological activity profile of Cerebrolysin the possibility of additive effects must be borne in mind during concomitant administration of antidepressants or MAO inhibitors. In such cases it is recommended that the dosage of the antidepressant be reduced.
Cerebrolysin should not be administered at the same time as balanced amino acid solutions in one infusion.
Caution For Usage
Instructions for Handling: A venous cannula that will remain in place for a longer period should be flushed with physiological saline solution before and after the Cerebrolysin infusion.
Intended only for single use withdrawal.
Use only clear, amber solutions.
Incompatibilities: Cerebrolysin is incompatible with solutions which alter the pH (5.0 - 8.0) and with solutions containing lipids.
Storage
Do not store above room temperature (up to 25 °C).
Must be protected from light - always store drug inside the outer packaging.
Shelf Life: 60 months.
ATC Classification
C04AX - Other peripheral vasodilators ; Used as peripheral vasodilators.
Presentation/Packing
Soln/concentrate for infusion (amp) 215.2 mg/mL x 10 mL x 5's.
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