GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Norepinephrine Bitartrate Injection USP 1mg/1ml (4mg/4ml)
B. Norepinephrine Bitartrate Injection USP 2mg/1ml (4mg/2ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Norepinephrine Bitartrate Injection USP 1mg/1ml (4mg/4ml)
Each ml contains:
Norepinephrine Bitartrate USP
Equivalent to
Norepinephrine ……1mg
Excipients……………………..q.s
Water for Injection USP…..q.s

B. Norepinephrine Bitartrate Injection USP 2mg/1ml (4mg/2ml)
Each ml contains:
Norepinephrine Bitartrate USP
Equivalent to
Norepinephrine ……2mg
Excipients……………………..q.s
Water for Injection USP…..q.s


THERAPEUTIC INDICATIONS:

Norepinephrine Bitartrate Injection is indicated for blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions) and as an adjunct in the treatment of cardiac arrest and profound hypotension.

DIRECTION OF USE:

For Intravenous Infusion use.
Dilute before use.
See package inserts for usual dose and dilution information. /

CAUTION & WARNING:

CAUTION:
• Do not use if any foreign particulate matter is visible.
• Do not use the solution if its color is pinkish or darker than slightly yellow.
• Avoid contact with iron salts, alkalis, or oxidizing agents.
• Discard unused portion.
• DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
• CONTAINS SULFITES.
• This is a potent drug. Dosage should be controlled by frequent determination of blood pressure.
• Do not leave patient unattended during administration. Avoid extravasation. Read package insert carefully.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F);excursions permitted between 15°C to 30°C (59°F to 86°F).
Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Norepinephrine Bitartrate Injection USP 2mg/1ml (4mg/2ml) Technical Specification:

Product Name:Norepinephrine Bitartrate Injection USP
Brand Name:Generic
Strength:1mg/1ml (4mg/4ml), 2mg/1ml (4mg/2ml)
Dosage Form:Liquid Injection (Sterile)
Packing:Single Dose Vial/Ampoule
Route of Administration:For I.V. Infusion use 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:Anti-Hypotensive,  Vasodilators
Indication: Norepinephrine Bitartrate Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine Bitartrate Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.
Storage:Store at 20°C to 25°C (68°F to 77°F);excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Norepinephrine Bitartrate Injection USP 2mg/1ml (4mg/2ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Norepinephrine Bitartrate Injection USP 2mg/1ml (4mg/2ml)
    Each ml contains:
    Norepinephrine Bitartrate USP
    Equivalent to
    Norepinephrine ………..…2mg
    Excipients……………………..q.s
    Water for Injection USP…..q.s

THERAPEUTIC INDICATIONS:

Norepinephrine Bitartrate Injection is indicated for blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions) and as an adjunct in the treatment of cardiac arrest and profound hypotension.

DIRECTION OF USE:

For Intravenous Infusion use.
Dilute before use.
See package inserts for usual dose and dilution information.

CAUTION & WARNING:

CAUTION:

  • Do not use if any foreign particulate matter is visible.
  • Do not use the solution if its color is pinkish or darker than slightly yellow.
  • Avoid contact with iron salts, alkalis, or oxidizing agents.
  • Discard unused portion.
  • DO NOT ACCEPT IF VIAL SEAL IS BROKEN.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

  • CONTAINS SULFITES.
  • This is a potent drug. Dosage should be controlled by frequent determination of blood pressure.
  • Do not leave patient unattended during administration. Avoid extravasation. Read package insert carefully.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F);excursions permitted between 15°C to 30°C (59°F to 86°F).
Protect from light.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.