GENERIC NAME OF MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each vial contains:
Dobutamine Hydrochloride USP
Equivalent to Anhydrous Dobutamine Hcl……….250mg
Excipients………………………q.s.
THERAPEUTIC INDICATION:
DIRECTION OF USE:
Must be diluted prior to use
Use within 24 hrs. after dilution. I.V. infusion after dilution, at least 50ml.
CAUTION & WARNING:
• Dobutamine is Oxygen sensitive. Do not use If the solution is discolored or contains precipitate, it must be discarded.
• DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
• For I.V. infusion after dilution, at least 50ml.
• Preservative Not Added.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner. Avoid use with alkaline solution.
You should Not Self-Administer this medicine at home.
This Product is only for Hospital supplies.
STORAGE & DOSAGE:
Contains no Antimicrobial Preservatives.
Discard unused portion.
Dosage: As directed by Physician.
Dobutamine Hydrochloride Injection USP 250mg/vial Technical specification:
Product Name: | Dobutamine Hydrochloride Injection USP |
Brand Name: | (GENERICS) |
Strength: | 250mg/vial |
Dosage Form: | Dry Powder Injection (Lyophilized) |
Packing: | 20ml vial |
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 15°C to 30°C, See USP controlled room temperature. Protect from light. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Dobutamine Hydrochloride Injection USP 250mg/vial
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Dobutamine Hydrochloride Injection USP 250mg/vial
Each vial contains:
Dobutamine Hydrochloride USP
Equivalent to Anhydrous Dobutamine Hcl……….250mg
Excipients………………………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.
I.V. infusion after dilution, at least 50ml.
CAUTION & Warning:
CAUTION:
- Do not use if any foreign particulate matter is visible.
- Dobutamine is Oxygen sensitive. Do not use If the solution is discolored or contains precipitate, it must be discarded.
- DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
- KEEP OUT OF REACH AND SIGHT OF CHILDREN.
- For I.V. infusion after dilution, at least 50ml.
- Preservative not Added.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Avoid use with alkaline solution.
You should not self-Administer this medicine at home.
This Product is only for Hospital supplies.
STORAGE & DOSAGE:
Storage: Store at 15°C to 30°C, See USP controlled room temperature. Protect from light.
Contains No Antimicrobial Preservatives.
Discard Unused Portion.
Dosage: As directed by Physician.