| Product Name: | Glatiramer acetate |
| Brand Name: | Generic |
| Strength: | 20mg/ml |
| Dosage Form: | Liquid Injection |
| Route of Administration: | subcutaneous injection |
| Packing: | packs of 30 single-use 20 mg/1 mL pre-filled glass syringes. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Immunosuppressant |
| Indication: | Glatiramer is indicated to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and/or active secondary progressive disease in adults. |
| Storage: | KEEP REFRIGERATED (2 to 8°C/38° to 46°F) AND PROTECT FROM LIGHT. Keep this and all medication out of the reach of children. Discard unused portion. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Glatiramer acetate 20mg injection
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Glatiramer acetate 20mg injection
Each ml contains
Glatiramer acetate ………….20mg
Inactive Ingredients: mannitol 20 mg
sterile water for injection.
THERAPEUTIC INDICATIONS:
Glatiramer is indicated to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and/or active secondary progressive disease in adults.
STORAGE & DOSAGE:
Storage: KEEP REFRIGERATED (2 to 8°C/38° to 46°F) AND PROTECT FROM LIGHT.
Keep this and all medication out of the reach of children.
Discard unused portion.
DOSAGE:
Inject 20 mg three times a week