| Product Name: | Dobutamine Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 250mg/5ml (50mg/ml), 250mg/20ml (12.5mg/ml) |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 5ml Ampoule, 20ml, 40ml vial (sinlge-dose) |
| Route of Administration: | For I.V. Infusion after dilution only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Cardiovascular System, Cardiology |
| Indication: | Dobutamine is a medication used in the treatment of cardiogenic shock (as a result of inadequate tissue perfusion) and severe heart failure. It may also be used in certain types of cardiac stress tests. |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Dobutamine Injection USP 250mg/5ml (50mg/ml)
- Dobutamine Injection USP 250mg/20ml (12.5mg/ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Dobutamine Injection USP 250mg/5ml (50mg/ml)Each ml contains:
Dobutamine Hydrochloride USP
Equivalent to Dobutamine ……….50mg
Excipients………………………q.s.
Water for Injection USP………….q.s. - Dobutamine Injection USP 250mg/20ml (12.5mg/ml)Each ml contains:
Dobutamine Hydrochloride USP
Equivalent to Dobutamine ……….12.5mg
Excipients………………………q.s.
Water for Injection USP………….q.s.
THERAPEUTIC INDICATION:
Dobutamine is a medication used in the treatment of cardiogenic shock (as a result of inadequate tissue perfusion) and severe heart failure. It may also be used in certain types of cardiac stress tests.
DIRECTION OF USE:
For Intravenous Infusion only
Must be diluted prior to use
Use within 24 hrs. after dilution.
CAUTION & WARNING:
- CAUTION: Do not use it if any foreign particulate matter is visible.
- Dobutamine is Oxygen sensitive. Do not use If the solution is discolored or contains a precipitate, it must be discarded.
- DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
- 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 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Contains no Antimicrobial Preservatives.
Discard unused portions.
Dosage: As directed by the Physician.