Dexmedetomidine Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dexmedetomidine hydrochloride 0.118 mg/mL equivalent to Dexmedetomidine 0.100mg/mL;  

Available from:

Viatris Limited

INN (International Name):

Dexmedetomidine hydrochloride 0.118 mg/mL (equivalent to Dexmedetomidine 0.100mg/mL)

Dosage:

200 mcg/2mL

Pharmaceutical form:

Concentrate for infusion

Composition:

Active: Dexmedetomidine hydrochloride 0.118 mg/mL equivalent to Dexmedetomidine 0.100mg/mL   Excipient: Sodium chloride Water for injection

Prescription type:

Prescription

Manufactured by:

Alcami Wisconsin Corporation

Therapeutic indications:

ICU Sedation: For sedation of initially intubated patients during treatment in an intensive care setting. The use of Dexmedetomidine Viatris by continuous infusion in these patients should not exceed 24 hours. Procedural Sedation: For sedation of non-intubated patients prior to and/or during surgical and other procedures.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 3 ml Type 1 vial, Closure: Rubber stopper, Al seal and plastic flip top cap - 5 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours diluted stored between 20°C - 25°C

Authorization date:

2016-03-24

Summary of Product characteristics

Page 1 of 20
NEW ZEALAND DATA SHEET
DEXMEDETOMIDINE VIATRIS
1. PRODUCT NAME
Dexmedetomidine Viatris, 200 micrograms/2 mL, concentrated injection
for intravenous solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of concentrate contains 118 micrograms of dexmedetomidine
hydrochloride (equivalent
to 100 micrograms dexmedetomidine base).
Each 2 mL vial contains 200 micrograms of dexmedetomidine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Dexmedetomidine hydrochloride is a sterile, nonpyrogenic solution
suitable for intravenous infusion
following dilution.
Dexmedetomidine hydrochloride is a white or almost white powder,
freely soluble in water and its
pKa is 7.1. Dexmedetomidine is supplied as a clear, colourless,
isotonic solution with a pH of 4.5 to
7.0. Its partition coefficient in octanol: water at pH 7.84 is 2.89.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
ICU SEDATION
For sedation of initially adult intubated patients during treatment in
an intensive care setting. The use
of Dexmedetomidine Viatris by continuous infusion in these patients
should not exceed 24 hours.
PROCEDURAL SEDATION
For sedation of non-intubated adult patients prior to and/or during
surgical and other procedures.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
NOTE:
Dexmedetomidine
hydrochloride
should
be
administered
only
by
persons
skilled
in
anaesthetics or in the management of patients in the intensive care
setting. Due to the known
pharmacological effects, patients should be continuously monitored.
Clinically
significant
events
of
bradycardia
and
sinus
arrest
have
been
associated
with
dexmedetomidine administration in young, healthy volunteers with high
vagal tone or with different
routes of administration including rapid intravenous or bolus
administration of dexmedetomidine.
Page 2 of 20
DOSE
Dexmedetomidine should be individualised and titrated to the desired
clinical effect.
_ICU SEDATION _
INITIATION
For adult patients, Dexmedetomidine Viatris is generally initiated
with a loading