GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each hard gelatin capsule contains:
Nimodipine USP…………………..30mg
Excipients……………………………… q.s
Approved Colours are used in capsule shells.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Protect from light and freezing.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Nimodipine Capsules 30mg Technical Specification:
| Product Name: | Nimodipine Capsules |
| Brand Name: | Generic |
| Strength: | (30mg) |
| Dosage Form: | Capsules (Hard gelatin) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Central Nervous System, Neurology |
| Indication: | Nimodipine is used to decrease brain damage that may be caused by a subarachnoid hemorrhage (bleeding in the space surrounding the brain that occurs when a weakened blood vessel in the brain bursts). Nimodipine is in a class of medications called calcium channel blockers. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and freezing. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Nimodipine Capsules 30mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Nimodipine Capsules 30mg
Each hard gelatin capsule contains:
Nimodipine USP…………………..30mg
Excipients……………………………… q.s
Approved Colours are used in capsule shells.
THERAPEUTIC INDICATIONS:
Nimodipine is used to decrease brain damage that may be caused by a subarachnoid hemorrhage (bleeding in the space surrounding the brain that occurs when a weakened blood vessel in the brain bursts). Nimodipine is in a class of medications called calcium channel blockers.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and freezing.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
