Midazolam Injection USP 5mg/5ml

Product Name:	Midazolam Injection USP
Brand Name:	(Generic)
Strength:	2mg/2ml, 5mg/ml, 5mg/5ml, 10mg/2ml, 10mg/10ml, 50mg/10ml
Dosage Form:	Liquid Injection (Sterile)
Packing:	2mL, 5mL, 10mL Vial
Route of Administration:	For I.M./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:	CNS – Stimulants Benzodiazepines
Indication:	Midazolam injection is used before medical procedures and surgery to cause drowsiness, relieve anxiety, and prevent any memory of the event. It is also sometimes given as part of the Anaesthesia during surgery to produce a loss of consciousness.
Storage:	Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature).

GENERIC NAME OF MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Midazolam Injection USP 2mg/2ml
Each ml contains:
Midazolam Hydrochloride USP
Equivalent to Midazolam ………… 1mg
Benzyl Alcohol USP……….1% v/v
Water for Injection USP ………….……. q.s.
Midazolam Injection USP 5mg/ml
Each ml contains:
Midazolam Hydrochloride USP
Equivalent to Midazolam ………… 5mg
Benzyl Alcohol USP……….1% v/v
Water for Injection USP ………….……. q.s.
Midazolam Injection USP 5mg/5ml
Each ml contains:
Midazolam Hydrochloride USP
Equivalent to Midazolam ………… 1mg
Benzyl Alcohol USP……….1% v/v
Water for Injection USP ………….……. q.s.
Midazolam Injection USP 10mg/2ml
Each ml contains:
Midazolam Hydrochloride USP
Equivalent to Midazolam ………… 5mg
Benzyl Alcohol USP……….1% v/v
Water for Injection USP ………….……. q.s.
Midazolam Injection USP 10mg/10ml
Each ml contains:
Midazolam Hydrochloride USP
Equivalent to Midazolam ………… 1mg
Benzyl Alcohol USP……….1% v/v
Water for Injection USP ………….……. q.s.
Midazolam Injection USP 50mg/10ml
Each ml contains:
Midazolam Hydrochloride USP
Equivalent to Midazolam ………… 5mg
Benzyl Alcohol USP……….1% v/v
Water for Injection USP ………….……. q.s.

THERAPEUTIC INDICATION:

Midazolam injection is used before medical procedures and surgery to cause drowsiness, relieve anxiety, and prevent any memory of the event. It is also sometimes given as part of the Anaesthesia during surgery to produce a loss of consciousness.

PACKING:

2mL, 5mL, 10mL Vial

CAUTION AND WARNING:

CAUTION: Do not use if solution is not clear or has suspended matter.
Any portion of the contents remaining should be discarded.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
It is dangerous to take this preparation except in accordance with the medical advice.

STORAGE AND DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature).
KEEP OUT OF REACH OF CHILDREN.
Dosage: As directed by the Physician.