GENERIC NAME OF MEDICINAL PRODUCT:

A. Noradrenaline Bitartrate Injection IP 2mg/1ml (4mg/2ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Noradrenaline Bitartrate Injection IP 2mg/1ml (4mg/2ml)
Each ml contains:
Noradrenaline Bitartrate IP……………2mg
(Equivalent to Noradrenaline 1mg)
Water for Injection IP…………………….q.s

THERAPEUTIC INDICATION:

Noradrenaline 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 use only.
1 volume of solution diluted to 250 volumes with sodium chloride and Dextrose Injection or with Dextrose Injection (5%W/V) to produce Noradrenaline Bitartrate Injection, which must be used immediately after the preparation.
Refer enclosed leaflet for further information.

CAUTION AND SCHEDULE:

CAUTION:
• Do not use if any foreign particulate matter is visible.
• Do not use if a solution is brown or contains a precipitate.
• DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
• Discard unused portion.
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25℃.
Store in a cool, dry and dark place.
protected from light.
Do not freeze.
DOSAGE: As directed by the Physician.

Noradrenaline Bitartrate Injection I.P. 2mg/1ml (4mg/2ml) Technical Specification:

Product Name:Noradrenaline Bitartrate Injection I.P.
Brand Name:Generic
Strength:2mg/1ml (4mg/2ml)
Dosage Form:Liquid Injection (Sterile)
Packing:2ml Ampoule
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Anti-Hypotensive,  Vasodilators
Indication: Noradrenaline 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 in a cool, dry and dark place protected from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Noradrenaline Bitartrate Injection IP 2mg/1ml (4mg/2ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

THERAPEUTIC INDICATION:

Noradrenaline 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 use only.
1 volume of solution diluted to 250 volumes with sodium chloride and Dextrose Injection or with Dextrose Injection (5%W/V) to produce Noradrenaline Bitartrate Injection, which must be used immediately after the preparation.
Refer enclosed leaflet for further information.

CAUTION AND SCHEDULE:

CAUTION:

  • Do not use if any foreign particulate matter is visible.
  • Do not use if a solution is brown or contains a precipitate.
  • DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
  • Discard unused portion.
  • KEEP OUT OF REACH AND SIGHT OF CHILDREN.

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE:

Store below 25℃.
Store in a cool, dry and dark place.
protected from light.
Do not freeze.

DOSAGE: As directed by the Physician.