Deproteinized Calf Blood Extractives Injection, often referred to by its brand name (such as Actovegin), is an extract derived from calf blood that is used for its purported neuroprotective and tissue-regenerative properties. Below is the general specification:
1. Composition:
- Active Ingredient: Deproteinized calf blood extractives.
- Concentration: 200 mg per 5 mL solution.
- Formulation: Aqueous solution suitable for intravenous (IV) or intramuscular (IM) injection.
2. Pharmacological Action:
- Neuroprotective and Cytoprotective Effects: Enhances oxygen utilization and glucose uptake in cells, especially under hypoxic or ischemic conditions.
- Enhanced Metabolism and Tissue Repair: Improves tissue oxygenation, energy metabolism, and blood flow to aid tissue repair and recovery.
- Supports Cellular Regeneration: Believed to stimulate regeneration of damaged cells by enhancing cellular processes.
3. Indications:
- Stroke Recovery and Ischemic Conditions: Often used post-stroke and in ischemic diseases to support brain recovery.
- Peripheral Arterial Disease (PAD): Improves symptoms of PAD, such as pain and wound healing in affected areas.
- Diabetic Neuropathy and Other Nerve Disorders: Sometimes used for managing symptoms of neuropathy, especially in diabetic patients.
- Wound Healing: Increases healing in burns, cuts, and ulcers due to its tissue-regenerative effects.
4. Dosage and Administration:
- Route: Typically administered intravenously or intramuscularly.
- Typical Dosage: Commonly ranges between 5-20 mL per day, depending on the condition, severity, and physician recommendation. It can be given over 10-20 days, often in initial high doses that taper off as needed.
5. Storage Conditions:
- Temperature: Store at controlled room temperature, generally 2°C to 25°C.
- Protect from Light: Must be stored away from direct light.
- Shelf Life: Generally, a 2-3 year shelf life when stored according to guidelines.
6. Contraindications:
- Allergic Reactions: Contraindicated in patients with known hypersensitivity to calf blood derivatives or any component of the injection.
- Fluid Retention Issues: Caution in patients with heart failure, pulmonary edema, or renal impairment, as it may cause fluid overload.
7. Precautions and Warnings:
- Allergic Reactions: Monitor for signs such as rash, itching, or swelling.
- Severe Renal or Cardiovascular Disease: Use with caution as the drug may exacerbate these conditions.
- Pregnancy and Lactation: Use only if the potential benefit justifies the potential risk to the fetus or infant.
8. Side Effects:
- Common: Fever, skin reactions at the injection site, headache, dizziness.
- Rare: Severe allergic reactions, including anaphylaxis, hypotension, and tachycardia.
9. Packaging:
- Typically packaged in glass ampoules or vials containing 5 mL per unit, with single-dose and multi-dose options depending on the treatment requirements.
As with all therapeutic injections, this product should be administered under the supervision of a healthcare professional who can monitor for adverse reactions and assess the efficacy of the treatment.
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