GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Nefopam Hydrochloride Injection 20mg/ml
b) Nefopam Hydrochloride Injection 20mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Nefopam Hydrochloride Injection 20mg/ml
Each ml injection contains:
Nafopam for Injection………….20mg
Water For Injection USP…………….q.s.
Excipients……………………………q.s


B) Nefopam Hydrochloride Injection 20mg/2ml
Each 2ml injection contains:
Nafopam for Injection………….20mg
Water For Injection USP…………….q.s.
Excipients……………………………q.s

THERAPEUTIC INDICATION:

Nefopam is used in the treatment of pain relief. Nefopam is a non-opioid pain reliever. It works by blocking the transmission of pain signals to the brain thereby decreasing pain perception.

DIRECTION OF USE:

For Subcutaneous, Intravenous use only
See prescribing information for dosing and administration.

CAUTION & WARNING:

CAUTION: Injection should not be used if it contains visible particulate matter.
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only. Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 25°C to 30°C
Protect from light.
Do not freeze.
Dosage: As directed by the Physician.

Nefopam Hydrochloride Injection 20mg/ml (Nefotaj) Technical Specification:

Product Name: Nefopam Hydrochloride 20 mg/ml Injection (Nefotaj)
Brand Name:Nefotaj
Strength:20mg/ml, 20mg/2ml
Dosage Form:Solution for Injection
Packing:SINGLE USE VIAL
Route of Administration:I.V & I.M 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: Analgesics and Antipyretics.
Indication: Nefopam is used in the treatment of pain relief. Nefopam is a non-opioid pain reliever. It works by blocking the transmission of pain signals to the brain thereby decreasing pain perception.
Storage:Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  1. Nefopam Hydrochloride Injection 20mg/ml
  2. Nefopam Hydrochloride Injection 20mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1.Nefopam Hydrochloride Injection 20mg/ml
Each ml injection contains:
Nafopam for Injection………….20mg
Water For Injection USP…………….q.s.
Excipients……………………………q.s

2. Nefopam Hydrochloride Injection 20mg/2ml
Each 2ml injection contains:
Nafopam for Injection………….20mg
Water For Injection USP…………….q.s.
Excipients……………………………q.s

THERAPEUTIC INDICATION:

Nefopam is used in the treatment of pain relief. Nefopam is a non-opioid pain reliever. It works by blocking the transmission of pain signals to the brain thereby decreasing pain perception.

DIRECTION OF USE:

For Subcutaneous, Intravenous use only. 

See prescribing information for dosing and administration. 

CAUTION & WARNING:

CAUTION: Injection should not be used if it contains visible particulate matter.

CAUTION: It is dangerous to take this preparation except under medical supervision.

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.

Discard Unused portion. 

Keep out of the reach of the children. 

STORAGE & DOSAGE:

Storage: Store vials at 25°C to 30°C

Protect from light.

Do not freeze.

Dosage: As directed by the Physician.