DEXDOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MICROGRAMSML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Dexmedetomidine hydrochloride eqv Dexmedetomidine

Available from:

ORION PHARMA (SG) PTE. LTD.

ATC code:

N05CM18

Pharmaceutical form:

INFUSION, SOLUTION CONCENTRATE

Composition:

Dexmedetomidine hydrochloride eqv Dexmedetomidine 100 mcg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Orion Corporation, Orion Pharma

Authorization status:

ACTIVE

Authorization date:

2023-04-25

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Dexdor concentrate for solution for infusion 100 micrograms/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of concentrate contains dexmedetomidine hydrochloride
equivalent to 100 micrograms
dexmedetomidine.
Each 2 ml ampoule contains 200 micrograms of dexmedetomidine.
Each 2 ml vial contains 200 micrograms of dexmedetomidine.
Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Each 10 ml vial contains 1000 micrograms of dexmedetomidine.
The concentration of the final solution after dilution should be
either 4 micrograms/ml or 8
micrograms/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colourless solution, pH 4.5 – 7.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For sedation of adult ICU (Intensive Care Unit) patients requiring a
sedation level not deeper than
arousal in response to
verbal
stimulation
(corresponding
to
Richmond
Agitation-Sedation
Scale
(RASS) 0 to -3).
For sedation of non-intubated adult patients prior to and/or during
diagnostic or surgical procedures
requiring sedation, i.e. procedural/awake sedation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
FOR SEDATION OF ADULT ICU (INTENSIVE CARE UNIT) PATIENTS REQUIRING A
SEDATION LEVEL NOT DEEPER
THAN AROUSAL IN RESPONSE TO VERBAL STIMULATION (CORRESPONDING TO
RICHMOND AGITATION-SEDATION
SCALE (RASS) 0 TO -3).
For hospital use only. Dexdor should be administered by healthcare
professionals skilled in the
management of patients requiring intensive care.
Posology
Patients already intubated and sedated may switch to dexmedetomidine
with an initial infusion rate of
0.7 micrograms/kg/h which may then be adjusted stepwise within the
dose range 0.2 to
1.4 micrograms/kg/h in order to achieve the desired level of sedation,
depending on the patient’s
response. A lower starting infusion rate should be considered for
frail patients. Dexmedetomidine is
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very potent and the infusion rate i