Dexmedetomidine Ever Pharma

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dexmedetomidine hydrochloride 0.1182 mg/mL equivalent to dexmedetomidine 0.1mg/mL

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Pharmaceutical form:

Concentrate for injection

Composition:

Active: Dexmedetomidine hydrochloride 0.1182 mg/mL equivalent to dexmedetomidine 0.1mg/mL 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 Hydrochloride Ever Pharma 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: Ampoule, glass, Type 1, 5 x 2 mL - 5 dose units - 48 months from date of manufacture stored at or below 25°C - Ampoule, glass, Type 1, 25 x 2 mL - 25 dose units - 48 months from date of manufacture stored at or below 25°C - Vial, glass, Type I with rubber stopper and an Al crimp cap with a plastic flip-off, 1 x 2 mL - 1 dose units - 48 months from date of manufacture stored at or below 25°C - Vial, glass, Type I with rubber stopper and an Al crimp cap with a plastic flip-off, 5 x 2 mL - 5 dose units - 48 months from date of manufacture stored at or below 25°C - Vial, glass, Type 1, 25 x 2 mL - 25 dose units - 48 months from date of manufacture stored at or below 25°C

Authorization date:

2020-07-20

Patient Information leaflet

DEXMEDETOMIDINE HYDROCHLORIDE EVER PHARMA
Version 1.0 Feb 2020
1
New Zealand Consumer Medicine Information
DEXMEDETOMIDINE HYDROCHLORIDE EVER
PHARMA
DEXMEDETOMIDINE (AS HYDROCHLORIDE)
100 microgram/1mL Concentrate for Infusion
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about DEXMEDETOMIDINE
HYDROCHLORIDE
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 HYDROCHLORIDE 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 WITH THE MEDICINE.
You may need to read it again.
WHAT IS DEXMEDETOMIDINE HYDROCHLORIDE EVER
PHARMA IS USED FOR
_INTENSIVE CARE SEDATION _
DEXMEDETOMIDINE HYDROCHLORIDE 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 HYDROCHLORIDE 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.
DEXMEDETOMIDINE HYDROCHLORIDE EVER PHARMA
Version 1.0 Feb 2020
2
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 HYDROCHLORIDE EVER PHARMA is only available with a
doctor's
prescription. It is not addictive.
BEFORE YOU USE DEXMEDETOMIDINE HYDROCHLORIDE
EVER PHARMA
_WHEN YOU MUST NOT USE IT _
Do not use DEXMEDETOMIDINE HYDROCHLORIDE EVER PHARMA if you have an
allergy
to:
•
any medicine containing dexmedetomid

Summary of Product characteristics

Version 1.1 28 May 2021
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
DEXMEDETOMIDINE HYDROCHLORIDE EVER PHARMA 100 micrograms/1mL
concentrate for infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in DEXMEDETOMIDINE HYDROCHLORIDE EVER PHARMA is
dexmedetomidine as hydrochloride. Each 1 mL of DEXMEDETOMIDINE
HYDROCHLORIDE EVER PHARMA Concentrate for solution contains 118
micrograms of
dexmedetomidine hydrochloride (equivalent to 100 micrograms
dexmedetomidine base) and 9
mg of sodium chloride in water for injections. The solution is
preservative-free and contains no
additives or chemical stabilisers.
DEXMEDETOMIDINE HYDROCHLORIDE EVER PHARMA is presented in a 2 mL vial,
containing 236 micrograms of dexmedetomidine hydrochloride (equivalent
to 200 micrograms
dexmedetomidine base), and must be diluted prior to use.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Concentrate for infusion
DEXMEDETOMIDINE HYDROCHLORIDE EVER PHARMA is a sterile, non-pyrogenic
solution suitable for intravenous infusion following dilution.
DEXMEDETOMIDINE HYDROCHLORIDE EVER PHARMA (dexmedetomidine
hydrochloride) 100 micrograms/mL is supplied as clear, colourless,
isotonic solutions with a
pH of 4.5 to 7.0. DEXMEDETOMIDINE HYDROCHLORIDE EVER PHARMA is
presented
in 2 mL, 4 mL and 10 mL vials or 2 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 HYDROCHLORIDE 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.
Version 1.1 28 May 2021
Page 2
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
ph