Dexmedetomidine Accord

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Dexmedetomidine hydrochloride 118 µg/mL equivalent to equivalent to 100 micrograms/mL Dexmedetomidine

Disponível em:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Dosagem:

200 mcg/2mL

Forma farmacêutica:

Concentrate for injection

Composição:

Active: Dexmedetomidine hydrochloride 118 µg/mL equivalent to equivalent to 100 micrograms/mL Dexmedetomidine Excipient: Sodium chloride Water for injection

Tipo de prescrição:

Prescription

Indicações terapêuticas:

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

Resumo do produto:

Package - Contents - Shelf Life: Vial, glass, Type I glass vial closed with rubber stopper and Al seal - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)

Data de autorização:

2020-05-08

Folheto informativo - Bula

Dexmedetomidine Accord – version 2.0
1
DEXMEDETOMIDINE ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN DEXMEDETOMIDINE ACCORD?
Dexmedetomidine Accord contains the active ingredient dexmedetomidine
(as hydrochloride). Dexmedetomidine Accord
belongs to a group of medicines called alpha-2-receptor agonists. It
is 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). Dexmedetomidine Accord
can be given to adults prior to an operation if they are not on a
ventilator if it is required for the procedure or surgery that
they be sleepy and calm. It works by its actions on brain chemicals.
For more information, see Section 1. Why am I using Dexmedetomidine
Accord? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN DEXMEDETOMIDINE ACCORD?
Do not use if you have ever had an allergic reaction to any medicine
containing dexmedetomidine hydrochloride or any of the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Dexmedetomidine Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Dexmedetomidine Accord and affect
how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW WILL I BE GIVEN DEXMEDETOMIDINE ACCORD?
Dexmedetomidine Accord will be given to you by a doctor or a nurse.
More instructions can be found in Section 4. How will I be given
Dexmedetomidine Accord? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN DEXMEDETOMIDINE ACCORD?
THINGS YOU
SHOULD DO
•
If you are about to have any blood tests, tell your doctor that you
are being g

Características técnicas

Page 1 of 17
NEW ZEALAND DATA SHEET
DEXMEDETOMIDINE ACCORD (DEXMEDETOMIDINE) CONCENTRATE
FOR INFUSION
1
PRODUCT NAME
Dexmedetomidine Accord 200 micrograms/2 mL Concentrate for Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in Dexmedetomidine Accord is dexmedetomidine
hydrochloride. Each 1 mL of
Dexmedetomidine Accord Concentrate for infusion 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 Accord 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 Accord is a sterile, non-pyrogenic solution suitable
for intravenous infusion
following dilution.
Dexmedetomidine Accord (dexmedetomidine (as hydrochloride)) 100
micrograms/mL is supplied as
clear, colourless, isotonic solutions with a pH of 4.5 to 7.0.
Dexmedetomidine Accord is presented in a
2 mL vial and must be diluted prior to use.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ICU SEDATION
For sedation of initially intubated patients during treatment in an
intensive care setting. The use of
Dexmedetomidine Accord 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
D
OSE 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 dexmedeto