Dexmedetomidine Hydrochloride Injection 80mcg/1ml

Dexmedetomidine Hydrochloride Injection 80mcg/1ml
Product Name:Dexmedetomidine Hydrochloride Injection
Brand Name:Generic
Strength:80mcg/1ml, 100mcg/ml, 200mcg/2ml, 400mcg/4ml, 1000mcg/10ml
Dosage Form:Liquid Injection (Sterile)
Packing:0.5ml, 1ml, 2ml Ampoule
Route of Administration:For IV Infusion after dilution.
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Sedatives & Hypnotics.
Indication:For sedation of initially and mechanically ventilated patients during treatment in an intensive care setting. Sedation of non-intubated patients prior to and/or during surgical and other procedures.
Storage:Store below 25°C. Protected from light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dexmedetomidine Hydrochloride Injection 80mcg/1ml
    Each 0.5ml contains:Dexmedetomidine Hydrochloride USPEquivalent to Dexmedetomidine……………80mcg
    Sodium Chloride IP……………………………..0.9 % w/v
    Water for Injection IP……………………………….q.s.
  • Dexmedetomidine Hydrochloride Injection 100mcg/1ml
    Each 0.5ml contains:Dexmedetomidine Hydrochloride USPEquivalent to Dexmedetomidine……………100mcg
    Sodium Chloride IP……………………………..0.9 % w/v
    Water for Injection IP……………………………….q.s.
  • Dexmedetomidine Hydrochloride Injection 200mcg/2ml
    Each 0.5ml contains:Dexmedetomidine Hydrochloride USPEquivalent to Dexmedetomidine……………200mcg
    Sodium Chloride IP……………………………..0.9 % w/v
    Water for Injection IP……………………………….q.s.
  • Dexmedetomidine Hydrochloride Injection 400mcg/4ml
    Each 0.5ml contains:Dexmedetomidine Hydrochloride USPEquivalent to Dexmedetomidine……………400mcg
    Sodium Chloride IP……………………………..0.9 % w/v
    Water for Injection IP……………………………….q.s.
  • Dexmedetomidine Hydrochloride Injection 1000mcg/10ml
    Each 0.5ml contains:Dexmedetomidine Hydrochloride USPEquivalent to Dexmedetomidine……………1000mcg
    Sodium Chloride IP……………………………..0.9 % w/v
    Water for Injection IP……………………………….q.s.

THERAPEUTIC INDICATION:

  1. For sedation of initially and mechanically ventilated patients during treatment in an intensive care setting.
  2. Sedation of non-intubated patients prior to and/or during surgical and other procedures.

DIRECTION OF USE:

For IV Infusion after dilution.

CAUTION AND SCHEDULE:

CAUTION: NOT TO BE USED IF SOLUTION CONTAINS VISIBLE SOLID PARTICLES.
Discard any unused portion. 
WARNING: Not to be sold by retail without the prescription of Specialists.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C. Protected from light. Do not freeze
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by the Physician.

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