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.
GENERIC NAME OF MEDICINAL PRODUCT:
(A) Dobutamine Hydrochloride Injection USP 250mg/vial (12.5mg/ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
(A) Dobutamine Hydrochloride Injection USP 250mg/vial (12.5mg/ml)
Each vial contains:
Dobutamine Hydrochloride USP
Equivalent to Anhydrous Dobutamine Hcl……….250mg
Excipients………………………q.s.
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.
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.
• 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.
Contains no Antimicrobial Preservatives.
Discard unused portion.
Dosage: As directed by Physician.
