Acetylcysteine Injection 400mg/2ml

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Acetylcysteine Injection 200mg/1ml
B. Acetylcysteine Injection 400mg/2ml
C. Acetylcysteine Injection 1gm/5ml
D. Acetylcysteine Injection 6g/30ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Acetylcysteine Injection 1gm/5ml
Each ml contains:
Acetylcysteine USP………………………..200mg
Edetate Disodium Dihydrate USP…..0.5mg
Water for Injection USP…………………q.s
*No preservatives

B. Acetylcysteine Injection 400mg/2ml
Each ml contains:
Acetylcysteine USP………………………..200mg
Edetate Disodium Dihydrate USP…..0.5mg
Water for Injection USP…………………q.s
*No preservatives

C. Acetylcysteine Injection 1gm/5ml
Each ml contains:
Acetylcysteine USP………………………..200mg
Edetate Disodium Dihydrate USP…..0.5mg
Water for Injection USP…………………q.s
*No preservatives

D. Acetylcysteine Injection 6g/30ml
Each ml contains:
Acetylcysteine USP………………………..200mg
Edetate Disodium Dihydrate USP…..0.5mg
Water for Injection USP…………………q.s
*No preservatives

THERAPEUTIC INDICATIONS:

Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).

DIRECTION OF USE:

For Intravenous use only.
Must be further diluted prior to Intravenous use for 30ml Vial.
See package insert for dosage information.

CAUTION & WARNING:

CAUTION: The injection should not be used It contains visible particulate matter.
Do not use if previously opened.
Discard unused portion.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at the room temperature 20°C 25°C (68°F to 77°F).
Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Acetylcysteine Injection 400mg/2ml Technical Specification:

Product Name:Acetylcysteine Injection
Brand Name:Generic
Strength:200mg/1ml, 400mg/2ml,  1g/5ml,  6gm/30ml
Dosage Form:Liquid Injection (Sterile)
Packing:Single Dose Vials
Route of Administration:For I.V. 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:Mucolytic agent (Expectorant), Antidote
Indication: Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).
Storage:Store at the room temperature 20°C 25°C (68°F to 77°F). Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Acetylcysteine Injection 400mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Acetylcysteine Injection 400mg/2ml
    Each ml contains:
    Acetylcysteine USP………………………..200mg
    Edetate Disodium Dihydrate USP…..0.5mg
    Water for Injection USP…………………q.s
    *No preservatives

THERAPEUTIC INDICATIONS:

Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).

DIRECTION OF USE:

For Intravenous use only.
Must be further diluted prior to Intravenous use for 30ml Vial.
See package insert for dosage information.

CAUTION & Warning:

CAUTION: The injection should not be used It contains visible particulate matter.
Do not use if previously opened.
Discard unused portion.

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

STORAGE & DOSAGE:

Storage: Store at the room temperature 20°C 25°C (68°F to 77°F).
Protect from light.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.