DEXMEDETOMIDINE EVER PHARMA dexmedetomidine (as hydrochloride) 200 microgram/2 mL concentrated injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dexmedetomidine hydrochloride, Quantity: 236.4 microgram (Equivalent: dexmedetomidine, Qty 200 microgram)

Available from:

Interpharma Pty Ltd

INN (International Name):

dexmedetomidine hydrochloride

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intravenous

Units in package:

5 x 2 mL, 25 x 2 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ICU sedation.,For sedation of initially intubated patients during treatment in an intensive care setting. The use of DEXMEDETOMIDINE EVER PHARMA 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:

Visual Identification: Clear, colourless aqueous solution in clear Type 1 glass ampoule; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-07-13

Patient Information leaflet

InterPharma Pty Ltd
Version 2.1
1
DEXMEDETOMIDINE EVER PHARMA_ _
DEXMEDETOMIDINE (DEX-MED-E-TOH-MED-EEN) (AS HYDROCHLORIDE)_ _
CONCENTRATED INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
DEXMEDETOMIDINE EVER
PHARMA. 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 EVER
PHARMA 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.
You may need to read it again.
WHAT IS
DEXMEDETOMIDINE
EVER PHARMA USED
FOR
_INTENSIVE CARE SEDATION _
DEXMEDETOMIDINE EVER
PHARMA 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 EVER
PHARMA 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 EVER
PHARMA is only available with
a doctor's prescription.
BEFORE YOU ARE
GIVEN
DEXMEDETOMIDINE
EVER PHARMA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE
DEXMEDETOMIDINE
EVER PHARMA 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 t

Summary of Product characteristics

1
Version 3.6
AUSTRALIAN PRODUCT INFORMATION – DEXMEDETOMIDINE EVER
PHARMA DEXMEDETOMIDINE (AS HYDROCHLORIDE) 100 MICROGRAM/ML
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Dexmedetomidine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexmedetomidine hydrochloride is a white or almost white powder,
freely soluble in water and its
pKa is 7.1. The partition coefficient in octanol: water at pH 7.84 is
2.89.
DEXMEDETOMIDINE EVER PHARMA is a clear, colourless, sterile and
isotonic concentrated
solution with a pH of 4.5 to 7.0. DEXMEDETOMIDINE EVER PHARMA is a
concentrated
sterile, non-pyrogenic solution suitable for intravenous infusion
after dilution. Each 1 mL of
DEXMEDETOMIDINE
EVER
PHARMA
contains
118
microgram
of
dexmedetomidine
hydrochloride (equivalent to 100 microgram dexmedetomidine base). The
solution is preservative-
free and contains no additives or chemical stabilisers.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
DEXMEDETOMIDINE EVER PHARMA is presented in a 2 mL, 4 mL and 10 mL
vials or 2 mL,
4 mL and 10 mL ampoules, 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 EVER PHARMA 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 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 hydrochloride administration in young, healthy
volunteers with high vagal tone
or with different routes of administration including rapid intravenous
or bol