Dexmedetomidine-Teva

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dexmedetomidine hydrochloride 118 µg/mL (equiv 100 µg/mL dexmedetomidine)

Available from:

Teva Pharma (New Zealand) Limited

Dosage:

100 mcg/mL

Pharmaceutical form:

Concentrate for infusion

Composition:

Active: Dexmedetomidine hydrochloride 118 µg/mL (equiv 100 µg/mL dexmedetomidine) Excipient: Sodium chloride Water for injection

Prescription type:

Prescription

Therapeutic indications:

For sedation of initially intubated patients during treatment in an intensive care setting. The use of Dexmedetomidine-Teva by continuous intubation in these patents should not exceed 24 hours. For sedation of non-intubated patients prior to and/or during surgical and other procedures.

Product summary:

Package - Contents - Shelf Life: Vial, glass, clear type 1, 2 mL fill in cardboard carton - 5 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, clear type 1, 2 mL fill in cardboard carton - 25 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2017-08-16

Patient Information leaflet

DEXMEDETOMIDINE-TEVA
®
V3.0
1
DEXMEDETOMIDINE-
TEVA®
_Dexmedetomidine (dex-med-e-toh-med-een) hydrochloride _
CONSUMER MEDICINE INFORMATION
Consumer Name:
Pharmacist Name:
Consumer Address:
Pharmacist Address:
Date of Dispensing:
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dexmedetomidine.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits.
Your doctor has weighed the risks of
you taking Dexmedetomidine against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
DEXMEDETOMIDINE IS
USED FOR
_INTENSIVE CARE SEDATION _
Dexmedetomidine can be used as a
sedative (calming agent) if adults
need to be calm or sleepy in the
Intensive Care Unit whilst they are
being ventilated (on a breathing
machine). It may be given as an
infusion up to 24 hours.
_PROCEDURAL SEDATION _
Dexmedetomidine can be given to
adults prior to an operation if they
are not on a ventilator (breathing
machine) if it is required for the
procedure or surgery that they be
sleepy and calm.
This medicine belongs to a group of
medicines called alpha-2-receptor
agonists. This medicine works by its
actions on brain chemicals.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Dexmedetomidine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
DEXMEDETOMIDINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DEXMEDETOMIDINE IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
dexmedetomidine hydrochloride
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or

Summary of Product characteristics

Data Sheet: Dexmedetomidine-Teva
1
Version 3.1
DATA SHEET
1.
PRODUCT NAME
Dexmedetomidine-Teva (Dexmedetomidine hydrochloride) (100
micrograms/mL) concentrate for
infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexmedetomidine-Teva is a sterile, non-pyrogenic solution suitable for
intravenous infusion.
The active ingredient in Dexmedetomidine-Teva is dexmedetomidine as
hydrochloride.
Each 2 mL of Dexmedetomidine-Teva contains 236 micrograms of
dexmedetomidine hydrochloride
(equivalent to 200 micrograms dexmedetomidine base) and 18 mg of
sodium chloride in water for
injections. The solution is preservative-free and contains no
additives or chemical stabilisers.
Dexmedetomidine-Teva is presented in a 2 mL vial, and must be diluted
prior to use.
For a full list of excipients, see
SECTION 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for infusion.
Dexmedetomidine-Teva (dexmedetomidine hydrochloride) 100 micrograms/mL
is supplied
clear, colourless isotonic solution with a pH 4.5 – 7.0.
Dexmedetomidine-Teva is presented
in 2 mL vial and must be diluted prior to use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ICU Sedation
For sedation of initially intubated patients during treatment in an
intensive care setting. The use of
Dexmedetomidine-Teva 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.
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.
Data Sheet: Dexmedetomidine-Teva
2
Version 3.1
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 o