Dexmedetomidine Hydrochloride Injection 1000mcg/10ml

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Dexmedetomidine Hydrochloride Injection 50mcg/0.5ml
(B) Dexmedetomidine Hydrochloride Injection 100mcg/ml
(C) Dexmedetomidine Hydrochloride Injection 200mcg/2ml
(D) Dexmedetomidine Hydrochloride Injection 400mcg/4ml
(E) Dexmedetomidine Hydrochloride Injection 1000mcg/10ml
 (F) Dexmedetomidine Hydrochloride Injection 200mcg/50ml
(G) Dexmedetomidine Hydrochloride Injection 400mcg/100ml
(H) Dexmedetomidine Hydrochloride Injection 5mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Dexmedetomidine Hydrochloride Injection 50mcg/0.5ml
Each 0.5ml contains:
Dexmedetomidine Hydrochloride USP
Equivalent to Dexmedetomidine……………50mcg Sodium Chloride USP……………………………..0.9 % w/v Water for Injection USP……………………………….q.s.

B) Dexmedetomidine Hydrochloride Injection 100mcg/ml Each ml contains:
Dexmedetomidine Hydrochloride USP
Equivalent to Dexmedetomidine……………100mcg Sodium Chloride USP……………………………..0.9 % w/v Water for Injection USP……………………………….q.s.

C) Dexmedetomidine Hydrochloride Injection 200mcg/2ml Each ml contains:
Dexmedetomidine Hydrochloride USP
Equivalent to Dexmedetomidine……………100mcg Sodium Chloride USP……………………………..0.9 % w/v Water for Injection USP……………………………….q.s.

Dexmedetomidine Hydrochloride Injection 400mcg/4ml Each ml contains:
Dexmedetomidine Hydrochloride USP
Equivalent to Dexmedetomidine……………100mcg
Water for Injection USP……………………………….q.s.

Dexmedetomidine Hydrochloride Injection 1000mcg/10ml Each ml contains:
Dexmedetomidine Hydrochloride USP
Equivalent to Dexmedetomidine……………100mcg
Water for Injection USP……………………………….q.s.

Dexmedetomidine Hydrochloride Injection 200mcg/50ml Each ml contains:
Dexmedetomidine ……………………………..4mcg
Provided as Dexmedetomidine hydrochloride USP……………4.72mcg
Sodium Chloride USP……………………………..9.0 mg
Water for Injection USP……………………………….q.s.

Dexmedetomidine Hydrochloride Injection 400mcg/100ml Each ml contains:
Dexmedetomidine ……………………………..4mcg
Provided as Dexmedetomidine hydrochloride USP……………4.72mcg
Sodium Chloride USP……………………………..9.0 mg
Water for Injection USP……………………………….q.s.

Dexmedetomidine Hydrochloride Injection 5mg/10ml
Each ml contains:
Dexmedetomidine hydrochloride………………………0.5mg
methylparaben……………………………………………1.6mg
Propylparaben……………………………………………9.0mg
Water for injection………………………………………..q.s.

THERAPEUTIC INDICATION:

It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care or awake sedation during different diagnostic or surgical procedures.

CAUTION & WARNING:

CAUTION: Do not use if solution is not clear or has suspended matter.
The solution is preservatives free & contains no additives of chemical stabilizers.
KEEP OUT OF REACH OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store below 25°C. Protected from light. Do not freeze..
Discard the unused portion
Dosage: As directed by Physician.

Dexmedetomidine Hydrochloride Injection 1000mcg/10ml Technical Specification:

Product Name:Dexmedetomidine Hydrochloride Injection
Brand Name:(GENERICS)
Strength:50mcg/0.5ml, 100mcg/ml, 200ml/2ml, 400mcg/4mL, 1000mcg/10mL, 200mcg/50mL, 400mcg/100mL, 5mg/10ml
Dosage Form:Liquid Injection (Sterile)
Packing:1ml Ampoule, 2ml, 10ml, Vial
Route of Administration:For IV Infusion after dilution.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Sedatives & Hypnotics.
Indication: It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care or awake sedation during different diagnostic or surgical procedures
Storage:Store below 25°C. Protected from light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Dexmedetomidine Hydrochloride Injection 1000mcg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dexmedetomidine Hydrochloride Injection 1000mcg/10ml
    Each ml contains:
    Dexmedetomidine Hydrochloride USP
    Equivalent to Dexmedetomidine……………100mcg
    Water for Injection USP……………………………….q.s.

THERAPEUTIC INDICATION:

It is used to provide sedation (a state of calm, drowsiness, or sleep) for adult patients in hospital intensive care or awake sedation during different diagnostic or surgical procedures.

CAUTION & Warning:

CAUTION: Do not use it if the solution is not clear or has suspended matter.
The solution is preservative-free & contains no additives or chemical stabilizers.

KEEP OUT OF REACH OF CHILDREN.

WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store below 25°C. Protected from light. Do not freeze.
Discard the unused portion.

Dosage: As directed by the Physician.