| 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
- Dexmedetomidine Hydrochloride Injection 80mcg/1ml
- Dexmedetomidine Hydrochloride Injection 100mcg/1ml
- Dexmedetomidine Hydrochloride Injection 200mcg/2ml
- Dexmedetomidine Hydrochloride Injection 400mcg/4ml
- Dexmedetomidine Hydrochloride Injection 1000mcg/10ml
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:
- 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.
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.