GENERIC NAME OF THE MEDICINAL PRODUCT:

A)Dobutamine Hydrochloride Dry Powder for Injection (Lyophilized) 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A)Dobutamine Hydrochloride Dry Powder for Injection (Lyophilized) 250mg
Each vial contains:
Dobutamine Hydrochloride
Equivalent to Anhydrous Dobutamine Hcl……….250mg
Excipients………………………q.s.

THERAPEUTIC INDICATIONS:

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.

CAUTION & SCHEDULE:

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 a Registered Medical Practitioner.
Avoid use with alkaline solution.
You should not self-administer this medicine at home.
This Product is only for Hospital supplies.
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.

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.

Dobutamine Hydrochloride Dry Powder for Injection (Lyophilized) 250mg Technical specification:

Product Name:Dobutamine Hydrochloride Dry Powder for Injection (Lyophilized)
Brand Name:(GENERICS)
Strength:250mg
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, Stability Studies, GMP
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 Dry Powder for Injection (Lyophilized) 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dobutamine Hydrochloride Dry Powder for Injection (Lyophilized) 250mg
    Each vial contains:
    Dobutamine Hydrochloride
    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 a 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.