PRECEDEX™ IN 0.9% SODIUM CHLORIDE INJECTION 4MCGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Dexmedetomidine HCl 4.72 mcg/ml eqv Dexmedetomidine

Available from:

PFIZER PRIVATE LIMITED

ATC code:

N05CM18

Pharmaceutical form:

INFUSION, SOLUTION

Composition:

Dexmedetomidine HCl 4.72 mcg/ml eqv Dexmedetomidine 4 mcg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Hospira Inc.

Authorization status:

ACTIVE

Authorization date:

2019-05-23

Summary of Product characteristics

PRECEDEX™ (DEXMEDETOMIDINE HYDROCHLORIDE) IN 0.9% SODIUM CHLORIDE
INJECTION 4
MCG/ML
FOR INTRAVENOUS USE.
1
INDICATIONS AND USAGE
1.1
INTENSIVE CARE UNIT SEDATION
PRECEDEX is indicated for sedation of initially intubated and
mechanically ventilated
patients during treatment in an intensive care setting. PRECEDEX
should be administered by
continuous infusion not to exceed 24 hours.
PRECEDEX has been continuously infused in mechanically ventilated
patients prior to
extubation, during extubation, and post-extubation. It is not
necessary to discontinue
PRECEDEX prior to extubation.
1.2
PROCEDURAL SEDATION
PRECEDEX is indicated for sedation of non-intubated patients prior to
and/or during surgical
and other procedures.
2
DOSAGE AND ADMINISTRATION
2.1
DOSING GUIDELINES
•
PRECEDEX dosing should be individualized and titrated to desired
clinical response.
•
PRECEDEX is not indicated for infusions lasting longer than 24 hours.
•
PRECEDEX should be administered using a controlled infusion device.
2.2
DOSAGE INFORMATION
TABLE 1: DOSAGE INFORMATION
INDICATION
DOSAGE AND ADMINISTRATION
INITIATION OF INTENSIVE
CARE UNIT SEDATION
FOR ADULT PATIENTS:
a loading infusion of one mcg/kg over 10
MINUTES
.
FOR PATIENTS OVER 65 YEARS OF AGE:
a dose reduction should be
considered
_ _
[
_see Use in Specific Populations (8.4)_
].
FOR ADULT PATIENTS WITH IMPAIRED HEPATIC FUNCTION:
a dose reduction
should be considered [
_see Use in Specific Populations (8.5), Clinical _
_Pharmacology (12.3)_
].
MAINTENANCE OF
INTENSIVE CARE UNIT
SEDATION
FOR ADULT PATIENTS:
a maintenance infusion of 0.2 to 0.7 mcg/kg/
HOUR
.
The rate of the maintenance infusion should be adjusted to achieve the
desired level of sedation.
FOR PATIENTS OVER 65 YEARS OF AGE:
a dose reduction should be
considered [
_see Use in Specific Populations (8.4)_
].
FOR ADULT PATIENTS WITH IMPAIRED HEPATIC FUNCTION:
a dose reduction
should be considered [
_see Use in Specific Populations (8.5), Clinical _
_Pharmacology (12.3)_
]
INITIATION OF
PROCEDURAL SEDATION
FOR ADULT PATIE