Dexmedetomidine

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Dexmedetomidine hydrochloride 0.118 mg/mL equivalent to dexmedetomidine 0.100 mg/1 mL

Fáanlegur frá:

Medsurge Pharma Limited

Lyfjaform:

Concentrate for infusion

Samsetning:

Active: Dexmedetomidine hydrochloride 0.118 mg/mL equivalent to dexmedetomidine 0.100 mg/1 mL Excipient: Nitrogen Sodium chloride Water for injection

Gerð lyfseðils:

Prescription

Ábendingar:

ICU Sedation: For sedation of initially intubated patients during treatment in an intensive care setting. The use of dexmedetomidine 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.

Vörulýsing:

Package - Contents - Shelf Life: Ampoule, glass, Type 1 glass ampoule filled with 2 mL - 5 dose units - 60 months from date of manufacture stored at or below 25°C - Ampoule, glass, Type 1 glass ampoule filled with 2 mL - 10 dose units - 60 months from date of manufacture stored at or below 25°C - Ampoule, glass, Type 1 glass ampoule filled with 2 mL - 25 dose units - 60 months from date of manufacture stored at or below 25°C

Leyfisdagur:

2022-02-17

Upplýsingar fylgiseðill

Dexmedetomidine Medicianz Edition-02 July 2023
1
DEXMEDETOMIDINE
_DEXMEDETOMIDINE (DEX-MED-E-TOH-MED-EEN) HYDROCHLORIDE _
_ _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dexmedetomidine
Medicianz. 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 using dexmedetomidine against
the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DEXMEDETOMIDINE
MEDICIANZ 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 Medicianz is
available only with a doctor's
prescription.
BEFORE YOU ARE GIVEN
DEXMEDETOMIDINE
MEDICIANZ
_WHEN YOU MUST NOT USE IT _
DO NOT USE DEXMEDETOMIDINE
MEDICIANZ 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 hives on the skin
DO NOT US

Vara einkenni

Dexmedetomidine Medicianz-data-sheet-v2.0
Page 1 of 22
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Dexmedetomidine
Medicianz
(
Dexmedetomidine
hydrochloride
118
mcg/mL
equivalent
to
dexmedetomidine 100 mcg/mL
) concentrate for IV infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in Dexmedetomidine Medicianz is dexmedetomidine
as hydrochloride.
Each 1 mL of dexmedetomidine (as hydrochloride) injection contains 118
micrograms of
dexmedetomidine hydrochloride (equivalent to 100 micrograms of
dexmedetomidine base)
and 8.83 mg of sodium chloride in Water for Injections.
Each 2 mL of dexmedetomidine (as hydrochloride) injection contains 236
micrograms of
dexmedetomidine hydrochloride (equivalent to 200 micrograms of
dexmedetomidine base)
and 17.66 mg of sodium chloride in Water for Injections.
Each 4 mL of dexmedetomidine (as hydrochloride) injection contains 472
micrograms of
dexmedetomidine hydrochloride (equivalent to 400 micrograms of
dexmedetomidine base)
and 35.32 mg of sodium chloride in Water for Injections.
Each 10 mL of dexmedetomidine (as hydrochloride) injection contains
1180 micrograms of
dexmedetomidine hydrochloride (equivalent to 1000 micrograms of
dexmedetomidine base)
and 88.30 mg of sodium chloride in Water for Injections.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrated Injection.
Dexmedetomidine Medicianz is a sterile, non-pyrogenic solution
suitable for intravenous
(IV) infusion following dilution.
Dexmedetomidine
Medicianz
(dexmedetomidine
hydrochloride)
100
microgram/mL
is
supplied as a sterile, clear and colourless or yellowish, isotonic
solution with a pH of 4.5 to
7.0.
Dexmedetomidine Medicianz is presented in a 2 mL ampoule, 4 mL vial or
10 mL vial and
must be diluted prior to use.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ICU (INTENSIVE CARE UNIT) SEDATION
For sedation of initially intubated patients during treatment in an
intensive care setting. The
use of dexmedetomidine by continuous infusion in these patients should
not exce