Acetylcysteine Injection 1g/5ml

GENERIC NAME OF MEDICINAL PRODUCT:

A. Acetylcysteine Injection 200mg/1ml
B. Acetylcysteine Injection 400mg/2ml
C. Acetylcysteine Injection 1gm/5ml
D. Acetylcysteine Injection 6000mg/30ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Acetylcysteine Injection 200mg/1ml
Each ml contains:
Acetylcysteine USP………..200mg
Water for Injections IP…..q.s

B. Acetylcysteine Injection 400mg/2ml
Each ml contains:
Acetylcysteine USP………..200mg
Water for Injections IP…..q.s

C. Acetylcysteine Injection 1gm/5ml
Each ml contains:
Acetylcysteine USP………..200mg
Water for Injections IP…..q.s

D. Acetylcysteine Injection 6000mg/30ml
Each ml contains:
Acetylcysteine USP………..200mg
Water for Injections IP…..q.s

THERAPEUTIC 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).

DIRECTION OF USE:

For Intravenous use only.
Refer enclosed leaflet for further information.

CAUTION AND SCHEDULE:

CAUTION: Do not use if any foreign particulate matter is observed inside the Ampoule.
It is dangerous to take this drug except under expert medical supervision.
DO NOT ACCEPT IF AMPOUL SEAL IS BROKEN.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Discard unused portion.
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 at a temperature not exceeding 25°C. Protect from light.
DOSAGE: Use strictly as directed by the Physician.

Acetylcysteine Injection 1g/5ml Technical Specification:

Product Name:Acetylcysteine Injection
Brand Name:Generic
Strength:200mg/1ml,  400mg/2ml, 1g/5ml, 6000mg/30ml
Dosage Form:Liquid Injection (Sterile)
Packing:1ml, 2ml, 5ml, 30ml Single Dose 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: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 a temperature not exceeding 25°C. Protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Acetylcysteine Injection 1g/5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Acetylcysteine Injection 1g/5ml
    Each ml contains:
    Acetylcysteine USP………..200mg
    Water for Injections IP…..q.s

THERAPEUTIC 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).

DIRECTION OF USE:

For Intravenous use only.
Refer enclosed leaflet for further information.

CAUTION AND SCHEDULE:

CAUTION: Do not use if any foreign particulate matter is observed inside the Ampoule.
It is dangerous to take this drug except under expert medical supervision.
DO NOT ACCEPT IF AMPOUL SEAL IS BROKEN.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Discard unused portion.

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 at a temperature not exceeding 25°C. Protect from light.

DOSAGE:  Use strictly as directed by the Physician.