| Product Name: | Amiodarone Sterile Concentrate BP |
| Brand Name: | (GENERICS) |
| Strength: | 150mg/3ml, 450mg/9ml, 900mg/18ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 3ml Ampoule |
| Route of Administration: | For Intravenous Infusion 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: | Anti-Arrhythmic, Cardiovascular system |
| Indication: | Amiodarone belongs to a group of medicine called anti-arrhythmic. It is used to treat uneven heartbeats, Wolff-Parkinson-White Syndrome, and other types of fast or uneven heartbeats such as atrial flutter or atrial fibrillation. |
| Storage: | Store below 30°C. Protect from light. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Amiodarone Sterile Concentrate BP 150mg/3ml
- Amiodarone Sterile Concentrate BP 450mg/9ml
- Amiodarone Sterile Concentrate BP 900mg/18ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Amiodarone Sterile Concentrate BP 150mg/3ml (50mg/ml)
Each ml contains:
Amiodarone Hydrochloride BP ……………. 50mg
Water for injection BP………… q.s - Amiodarone Sterile Concentrate BP 450mg/3ml
Each ml contains:
Amiodarone Hydrochloride BP ……………. 50mg
Water for injection BP………… q.s - Amiodarone Sterile Concentrate BP 900mg/18ml
Each ml contains:
Amiodarone Hydrochloride BP ……………. 50mg
Water for injection BP………… q.s
THERAPEUTIC INDICATION:
Amiodarone belongs to a group of medicine called anti-arrhythmic. It is used to treat uneven heartbeats, Wolff-Parkinson-White Syndrome, and other types of fast or uneven heartbeats such as atrial flutter or atrial fibrillation.
DIRECTION OF USE:
For Intravenous Infusion use.The solution must be diluted with Glucose Intravenous Infusion.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible, please do not use the solution & return for a replacement.
NOT FOR USE IN NEWBORNS.
Discard any unused portion.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 30°C. Protect from light. Do not freeze.
Dosage: As directed by the Physician.