Sterile Acetylcysteine Solution USP 20%W/V

GENERIC NAME OF MEDICINAL PRODUCT:

A. Sterile Acetylcysteine Solution USP 10%W/V
B. Sterile Acetylcysteine Solution USP 20%W/V

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Sterile Acetylcysteine Solution USP 10%W/V
Each ml contains:
Acetylcysteine USP………10%W/V
Water for Injections IP….q.s

2. Sterile Acetylcysteine Solution USP 20%W/V
Each ml contains:
Acetylcysteine USP………20%W/V
Water for Injections IP….q.s

THERAPEUTIC INDICATION:

Acetylcysteine is used to help thin and loosen mucus in the airways due to certain lung diseases (such as emphysema, bronchitis, cystic fibrosis, pneumonia).

DIRECTION OF USE:

Solution for Inhalation only.
See package insert for usual dosage.

CAUTION AND SCHEDULE:

CAUTION: Do not use the solution if it contains any foreign particulate matter.
NOT FOR INJECTION.
A change on color may occur after opening. This does not change the efficacy of the drug.
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 place.
Protect from light.
DOSAGE: As directed by the Physician.

Sterile Acetylcysteine Solution USP 20%W/V Technical Specification:

Product Name:Sterile Acetylcysteine Solution USP
Brand Name:Generic
Strength:10% W/V,  20%W/V
Dosage Form:Liquid Injection
Packing:2ml,  5ml Single Dose Vials
Route of Administration:For Inhalation only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Mucolytic agent (Expectorant), Antidote
Indication: Acetylcysteine is used to help thin and loosen mucus in the airways due to certain lung diseases (such as emphysema, bronchitis, cystic fibrosis, pneumonia).
Storage:Store below 25℃. Store in a cool place. Protect from light

GENERIC NAME OF MEDICINAL PRODUCT:

  • Sterile Acetylcysteine Solution USP 20%W/V

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Sterile Acetylcysteine Solution USP 20%W/V
    Each ml contains:
    Acetylcysteine USP………20%W/V
    Water for Injections IP….q.s

THERAPEUTIC INDICATION:

Acetylcysteine is used to help thin and loosen mucus in the airways due to certain lung diseases (such as emphysema, bronchitis, cystic fibrosis, pneumonia).

DIRECTION OF USE:

Solution for Inhalation only (Nebulizer).
See package insert for usual dosage.

CAUTION AND SCHEDULE:

CAUTION: Do not use the solution if it contains any foreign particulate matter.
NOT FOR INJECTION.
A change on color may occur after opening. This does not change the efficacy of the drug.
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 place.
Protect from light.

DOSAGE: As directed by the Physician.