| Product Name: | Hyoscine Butylbromide Injection BP |
| Brand Name: | (GENERICS) |
| Strength: | 10mg/mL, 20mg/ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 1ml, 2ml Ampoule |
| Route of Administration: | For IM/SC/IV Injection use. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Gastroenterological, Antispasmodic |
| Indication: | Hyoscine butylbromide is an antispasmodic drug indicated for the treatment of abdominal pain associated with cramps induced by gastrointestinal (GI) spasms. |
| Storage: | Store at a temperature not exceeding 30°C protected from light and moisture. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Hyoscine Butylbromide Injection BP 10mg/ml
- Hyoscine Butylbromide Injection BP 20mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Hyoscine Butylbromide Injection BP 10mg/ml
Each ml contains:
Hyoscine Butylbromide BP ……………. 10mg
Water for injection BP………… q.s - Hyoscine Butylbromide Injection BP 20mg/ml
Each ml contains:
Hyoscine Butylbromide BP ……………. 20mg
Water for injection BP………… q.s
THERAPEUTIC INDICATION:
Hyoscine butylbromide is an antispasmodic drug indicated for the treatment of abdominal pain associated with cramps induced by gastrointestinal (GI) spasms.
CAUTION & WARNING:
- CAUTION: Do not use it if any particle, leakage, or breakage is found.
- DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
- Discard any unused solution.
- KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 30°C protected from light and moisture.
Dosage: As directed by the Physician.