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| Certified: | GMP |
| Dossier: | Ctd |
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Creatine Phosphate Sodium for Injection is a sterile, lyophilized powder designed for intravenous or intramuscular administration. It contains 1g of Creatine Phosphate Sodium, a high-energy phosphate compound that supports cellular energy metabolism, particularly in cardiac and skeletal muscle tissues. This formulation is widely used in clinical settings for its cardioprotective and performance-enhancing effects.
Active Ingredient: Creatine Phosphate Sodium
Formulation: Lyophilized powder in vials (1g per vial).
Reconstitution: Must be reconstituted with sterile water or compatible IV fluids before use.
Administration: Intravenous or intramuscular injection.
Packaging: Single-dose vials with or without diluent.
Cardioprotection: Used to support cardiac function in conditions such as myocardial infarction, heart failure, or during cardiac surgery.
Muscle Recovery: Enhances recovery in patients with skeletal muscle fatigue or injury.
Performance Enhancement: Used off-label by athletes to improve physical performance and reduce fatigue.
Ischemic Conditions: Protects tissues from damage caused by ischemia-reperfusion injury.
Energy Supply: Creatine phosphate serves as a rapid source of adenosine triphosphate (ATP), the primary energy currency of cells, particularly during high-energy demand or stress.
Cellular Protection: Stabilizes cell membranes and reduces oxidative stress, protecting tissues from damage during ischemia or hypoxia.
Recommended Dosage:
Adults:
Cardiac Support: 1-2g (1-2 vials) per day, administered intravenously.
Muscle Recovery: 1g (1 vial) per day, administered intramuscularly or intravenously.
Children: Dosage adjusted based on body weight and clinical condition.
Administration:
Intravenous: Reconstituted powder is diluted in compatible IV fluids (e.g., 0.9% Sodium Chloride or 5% Dextrose) and infused slowly.
Intramuscular: Reconstituted powder is injected directly into muscle tissue.
Reconstitution:
Add 5-10ml of sterile water or compatible diluent to the vial and mix gently until fully dissolved.
Rapid Energy Supply: Provides immediate ATP support for high-energy-demand tissues.
Cardioprotective Effects: Reduces damage during cardiac ischemia or surgery.
Versatile Use: Effective for cardiac support, muscle recovery, and performance enhancement.
Storage: Store at controlled room temperature (15-30°C) before reconstitution. Protect from light and moisture.
Shelf Life: Typically 24-36 months for lyophilized powder; use immediately after reconstitution.
Contraindicated in patients with known hypersensitivity to creatine phosphate or any component of the formulation.
Use with caution in patients with:
Severe renal impairment.
Electrolyte imbalances (e.g., hyperphosphatemia).
Monitor for adverse effects during administration.
Common side effects include:
Mild allergic reactions (e.g., rash, itching).
Local irritation at the injection site.
Rare but serious side effects may include:
Electrolyte imbalances (e.g., hyperphosphatemia).
Allergic reactions (e.g., anaphylaxis).
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