GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Neostigmine Methylsulfate Injection USP 0.5mg/ml
B. Neostigmine Methylsulfate Injection USP 2.5mg/5ml
C. Neostigmine Methylsulfate Injection USP 5mg/10ml
D. Neostigmine Methylsulfate Injection USP 10mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Neostigmine Methylsulfate Injection USP 0.5mg/ml
Each ml contains:
Neostigmine Methylsulfate USP………….0.5mg
Excipients……………………………………….……q.s
Water for Injection USP…………….…………q.s

B. Neostigmine Methylsulfate Injection USP 2.5mg/5ml
Each ml contains:
Neostigmine Methylsulfate USP………….0.5mg
Excipients……………………………………….……q.s
Water for Injection USP…………….…………q.s


C. Neostigmine Methylsulfate Injection USP 5mg/10ml
Each ml contains:
Neostigmine Methylsulfate USP………….0.5mg
Excipients……………………………………….……q.s
Water for Injection USP………………….……q.s

D. Neostigmine Methylsulfate Injection USP 10mg/10ml
Each ml contains:
Neostigmine Methylsulfate USP………….1mg
Excipients………………………………….…………q.s
Water for Injection USP……………………….q.s

THERAPEUTIC INDICATIONS:

Neostigmine methylsulfate Injection is an anticholinesterase agent used to treat myasthenia gravis, postoperative distention and urinary retention, and to reverse effects of non-depolarizing neuromuscular blocking agents after surgery.

DIRECTION OF USE:

Neostigmine Methylsulfate Injection is administered by intravenous, Intramuscular , Subcutaneous use.
Neostigmine should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.
Prior to Neostigmine Methylsulfate Injection administration and up until complete recovery of normal ventilation, the patient should be well ventilated and a patent airway maintained.
See package insert for full prescribing information.

CAUTION & WARNING:

CAUTION: The injection should not be used if it contains visible particulate matter.
Before administrating Intravenously read enclosed directions carefully.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F). Protect from light.
Store vials in tray until ready for use.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Neostigmine Methylsulfate Injection USP 2.5mg/5ml Technical Specification:

Product Name:Neostigmine Methylsulfate Injection USP
Brand Name:Generic
Strength:0.5mg/ml, 2.5mg/5ml, 5mg/10ml,  10mg/10ml
Dosage Form:Liquid Injection
Packing:0.5mg/ml- 1ml Single Dose Ampoule
0.5mg/ml– 5ml Single Dose Ampoule
0.5mg/ml-10 ml Multiple dose Vial/ Ampoule)
1mg/ml- 10 ml Multiple dose Vial/ Ampoule)
Route of Administration:For I.M. / Slow I.V. / S.C. use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Acetylcholinesterase Inhibitors, Peripheral
Indication: Neostigmine methylsulfate injection is an anticholinesterase agent used to treat myasthenia gravis, postoperative distention and urinary retention, and to reverse effects of non-depolarizing neuromuscular blocking agents after surgery.
Storage:Store at 20°C to 25°C (68°F to 77°F). Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Neostigmine Methylsulfate Injection USP 2.5mg/5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Neostigmine Methylsulfate Injection USP 2.5mg/5ml
    Each ml contains:
    Neostigmine Methylsulfate USP………….0.5mg
    Excipients……………………………………q.s
    Water for Injection USP…………….………q.s

THERAPEUTIC INDICATIONS:

Neostigmine methylsulfate Injection is ananticholinesterase agent used to treat myasthenia gravis, postoperative distention and urinary retention, and to reverse effects of non-depolarizing neuromuscular blocking agents after surgery.

DIRECTION OF USE:

Neostigmine Methylsulfate Injection is administered by intravenous, Intramuscular , Subcutaneous use.
Neostigmine should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.
Prior to Neostigmine Methylsulfate Injection administration and up until complete recovery of normal ventilation, the patient should be well ventilated and a patent airway maintained.
See package insert for full prescribing information.

CAUTION & Warning:

CAUTION: The injection should not be used if it contains visible particulate matter.
Before administrating Intravenously read enclosed directions carefully.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.

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

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F). Protect from light.
Store vials in tray until ready for use.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.