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Key safety and usage guidelines for the Skytrofa Auto-Injector.
Overview of the auto-injector, cartridge, and needle components.
Identifies all components included with the Skytrofa Auto-Injector package.
Instructions on charging the auto-injector and preparing the environment.
Steps to prepare the Skytrofa Auto-Injector and components before use.
Instructions on mixing the medicine within the auto-injector.
Guidance on administering the Skytrofa medication using the auto-injector.
Procedures for removing the cartridge and disposing of used components.
Identifies common issues and their solutions for the auto-injector.
Instructions for cleaning and maintaining the Skytrofa Auto-Injector.
Details on how to charge the auto-injector and use the charger.
Guidelines for storing the auto-injector between uses.
Critical safety warnings and precautions for using the auto-injector.
Information on the auto-injector's expiration date and replacement.
Details on electromagnetic compatibility standards for the device.
Detailed technical specifications of the Skytrofa Auto-Injector.
Explanation of symbols used on the auto-injector and packaging.
Details on warranty coverage and legal disclaimers for the product.
Visual identification and description of the auto-injector's components.
General| Drug Class | Growth Hormone |
|---|---|
| Manufacturer | Ascendis Pharma |
| Delivery Method | Subcutaneous injection |
| Device Type | Auto-injector |
| Brand Name | Skytrofa |
| Active Ingredient | Lonapegsomatropin |
| Route of Administration | Subcutaneous |
| Generic Name | Lonapegsomatropin |
| Indication | Treatment of growth hormone deficiency |
| Dosage Form | Injectable solution |
| Dose Adjustment | Yes, dose is individualized based on patient response. |
| Storage | Refrigerate at 2°C to 8°C (36°F to 46°F) |
| Shelf Life | 24 months |
