GENERIC NAME OF 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 IP………….0.35ml
Water for Injections IP……..q.s


B. Etomidate Injection USP 40mg/20ml
Each ml contains:
Etomidate USP………………..2mg
Propylene Glycol IP………….0.35ml
Water for Injections IP……..q.s

THERAPEUTIC 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.

DIRECTION OF USE:

For Intravenous use only.
Please refer accompanying package insert for detailed dosage, direction of use and precautions.

CAUTION AND SCHEDULE:

CAUTION: Do not use if any foreign particulate matter is visible.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Etomidate may negatively affect the ability to drive and use machines.
Discard unused portion of the content.
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 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)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
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 MEDICINAL PRODUCT:

  • Etomidate Injection USP 20mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Etomidate Injection USP 20mg/10ml
    Each ml contains:
    Etomidate USP………………..2mg
    Propylene Glycol IP………….0.35ml
    Water for Injections IP……..q.s

THERAPEUTIC 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.

DIRECTION OF USE:

For Intravenous use only.
Please refer accompanying package insert for detailed dosage, direction of use and precautions.

CAUTION AND SCHEDULE:

CAUTION: Do not use if any foreign particulate matter is visible.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Etomidate may negatively affect the ability to drive and use machines.
Discard unused portion of the content.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

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 20°C to 25°C (68° to 77°F).
Protect from light.
Do not freeze.

DOSAGE: As directed by the Physician.