PRECEDEX CONCENTRATE FOR SOLUTION FOR INFUSION 100 mcgml (Vial)

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

DEXMEDETOMIDINE HCl EQV DEXMEDETOMIDINE BASE

Prieinama:

PFIZER PRIVATE LIMITED

ATC kodas:

N05CM18

Dozė:

100 mcg/ml

Vaisto forma:

INJECTION

Sudėtis:

DEXMEDETOMIDINE HCl EQV DEXMEDETOMIDINE BASE 100 mcg/ml

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

Prescription Only

Pagaminta:

HOSPIRA INC

Autorizacija statusas:

ACTIVE

Leidimo data:

2000-05-30

Pakuotės lapelis

HIGHLIGHTS OF PRESCRIBING INFORMATION 
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE 
DEXMEDETOMIDINE HYDROCHLORIDE SAFELY AND EFFECTIVELY.  SEE FULL 
PRESCRIBING INFORMATION FOR PRECEDEX.   

PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION  
FOR INTRAVENOUS INFUSION FOLLOWING DILUTION 
INITIAL U.S. APPROVAL: 1999 
----------------------------RECENT
MAJOR CHANGES-------------------------- 
Indications and Usage, Procedural Sedation (1.2) 

10/2008 
Dosage and Administration, Procedural Sedation (2.2)   
10/2008 
Adverse Reactions, Clinical Studies Experience (6.1)   
10/2008 
Clinical Studies, Procedural Sedation (14.2)   

10/2008 
----------------------------INDICATIONS AND
USAGE--------------------------- 
Precedex is a relatively selective alpha
2
-adrenergic agonist indicated for: 
•  Sedation of initially intubated and mechanically ventilated
patients during 
treatment in an intensive care setting. Administer Precedex
by continuous 
infusion not to exceed 24 hours. (1.1)  
•  Sedation of non-intubated patients prior to and/or during
surgical and other 
procedures. (1.2) 
----------------------DOSAGE
AND ADMINISTRATION----------------------- 
•  Individualize and titrate Precedex dosing to desired clinical
effect. (2.1) 
•  Administer Precedex using a controlled infusion device. (2.1) 
•  Dilute vial contents in 0.9% sodium chloride solution
to achieve required 
concentration (4 mcg/mL) prior to administration. (2.4) 

For Intensive Care Unit Sedation:  Generally initiate
at one mcg/kg over 10 
minutes, followed by a maintenance infusion of 0.2 to
0.7 mcg/kg/hr. (2.2) 
For  Procedural Sedation:  Generally initiate at one mcg/kg over
10 minutes, 
followed by a maintenance infusion initiated at 0.6 mcg/kg/hr and
titrated to 
achieve desired clinical effect with doses ranging from 0.2 to
1 mcg/kg/hr. 
Alternative doses recommended for patients over 65 years

Prekės savybės

PRECEDEX
™ CONCENTRATE FOR SOLUTION FOR INFUSION
100 MCG/ML (VIAL)
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/h. 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 PATIENTS:
a loading infusion of one
mcg/kg
over
10
minute