The specification for Cerebroprotein Hydrolysate Injection generally includes the following details. Please note that exact specifications may vary based on the manufacturer and the regulatory guidelines in different countries.
1. Composition:
- Active Ingredient: Cerebroprotein Hydrolysate, derived from porcine brain proteins.
- Concentration: Typically available in concentrations like 10 mg/mL, though higher concentrations are also available, depending on the indication.
- Formulation: An aqueous solution suitable for intravenous (IV) or intramuscular (IM) injection.
2. Pharmacological Action:
- Neurotrophic Effects: Provides peptides and amino acids that may support neuron survival and regeneration.
- Neuroprotective Effects: Offers protection against oxidative damage and supports brain function recovery.
- Enhancement of Synaptic Plasticity: Believed to support neurotransmission and neural plasticity, potentially improving cognitive function.
3. Indications:
- Stroke Rehabilitation: Post-stroke brain recovery support.
- Traumatic Brain Injury (TBI): Promotes recovery in brain injuries.
- Neurodegenerative Diseases: Includes dementia, Alzheimer's disease, and other cognitive disorders.
- Mild Cognitive Impairments and Aging: Sometimes used to improve age-related cognitive decline.
4. Dosage and Administration:
- Route: Typically administered intravenously or intramuscularly.
- Typical Dosage: Varies by condition but is often prescribed in the range of 10-30 mL daily, usually over a 10-14 day course. This may vary based on clinical needs and doctor recommendations.
5. Storage Conditions:
- Temperature: Store at a controlled room temperature, generally between 2°C and 8°C.
- Protect from Light: Protect from direct sunlight to avoid degradation.
- Shelf Life: Generally 2-3 years from the date of manufacture if stored under recommended conditions.
6. Contraindications:
- Allergy: Contraindicated in patients with known hypersensitivity to cerebroprotein hydrolysate or any of its components.
- Severe Kidney Disease: Use with caution in patients with renal impairment, as the drug's elimination may be affected.
7. Precautions and Warnings:
- Allergic Reactions: Monitor for signs of allergic reaction, such as rash, itching, or difficulty breathing.
- Seizures: Use cautiously in individuals with seizure disorders.
- Pregnancy and Lactation: Should be avoided during pregnancy and breastfeeding unless absolutely necessary.
8. Side Effects:
- Common: Headache, dizziness, nausea, and transient pain at the injection site.
- Serious but Rare: Allergic reactions, hypertension, and agitation.
9. Packaging:
- Typically packaged in vials or ampoules containing single-dose units, often 5 mL, 10 mL, or 30 mL depending on the dosage requirements.
As with all medications, Cerebroprotein Hydrolysate Injection should only be administered by qualified healthcare professionals following a thorough medical evaluation and under proper clinical supervision.
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