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.


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.

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.