GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Etomidate Injection USP 20mg/10ml
B. Etomidate Injection USP 40mg/20ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Etomidate Injection USP 20mg/10ml
Each ml contains:
Etomidate USP……….2mg
Propylene glycol…….35%W/V
Water for Injections USP……..q.s


B. Etomidate Injection USP 40mg/20ml
Each ml contains:
Etomidate USP………2mg
Propylene glycol……35%W/V
Water for Injections USP……..q.s

THERAPEUTIC INDICATIONS:

Etomidate is indicated for sedation, during maintenance of anesthesia, and for short operative procedures such as reducing dislocated joints, tracheal intubation, cardioversion, dilation and curettage, or cervical conization.

DIRECTION OF USE:

For Intravenous use only.
Refer package insert for full prescribing information.

CAUTION & WARNING:

CAUTION: Do not use the injection if the foreign particulate matter is visible.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER 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° to 77°F).
Protect from light.
Do not freeze.
DOSAGE: As directed by the Physician.

Etomidate Injection USP 20mg/10ml Technical Specification:

Product Name:Etomidate Injection USP
Brand Name:Generic
Strength:20mg/10ml40mg/20ml
Dosage Form:Liquid Injection (Sterile and Nonpyrogenic)
Packing:2mg/ml- 10ml Single Dose Vial/Ampoule
2mg/ml- 20ml Single Dose Vial/Ampoule
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:Sedative-hypnotics(Non-barbiturate) , Induction Agent
Indication: Etomidate is indicated for sedation, during maintenance of anesthesia, and for short operative procedures such as reducing dislocated joints, tracheal intubation, cardioversion, dilation and curettage, or cervical conization.
Storage:Store at 20°C to 25°C (68° to 77°F). Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Etomidate Injection USP 20mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Etomidate Injection USP 20mg/10ml
    Each ml contains:
    Etomidate USP……….2mg
    Propylene glycol…….35%W/V
    Water for Injections USP……..q.s

THERAPEUTIC INDICATIONS:

Etomidate is indicated for sedation, during maintenance of anesthesia, and for short operative procedures such as reducing dislocated joints, tracheal intubation, cardioversion, dilation and curettage, or cervical conization.

DIRECTION OF USE:

For Intravenous use only
Refer package insert for full prescribing information.

CAUTION & Warning:

CAUTION: Do not use the injection if the foreign particulate matter is visible.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER 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° to 77°F).
Protect from light.
Do not freeze.

Dosage: As directed by the Physician.