| Product Name: | Noradrenaline Bitartrate Injection USP |
| Brand Name: | Generic |
| Strength: | 2mg/1ml (4mg/2ml) |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 2ml, 4ml 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: | 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 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:
- Noradrenaline Bitartrate Injection USP 2mg/1ml (4mg/2ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Noradrenaline Bitartrate Injection USP 2mg/1ml (4mg/2ml)
Each ml contains:
Noradrenaline Bitartrate USP
Equivalent to
Noradrenaline …….…1mg
Excipients……………………..q.s
Water for Injection USP…..q.s
THERAPEUTIC INDICATIONS:
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 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.