Precedex

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Dexmedetomidine hydrochloride 118 µg/mL equivalent to dexmedetomidine 100 µg/mL;  

Prieinama:

Pfizer New Zealand Limited

INN (Tarptautinis Pavadinimas):

Dexmedetomidine hydrochloride 118 µg/mL (equivalent to dexmedetomidine 10 0µg/mL)

Dozė:

100 mcg/mL

Vaisto forma:

Concentrate for infusion

Sudėtis:

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

Vienetai pakuotėje:

Ampoule, glass, clear, 2 ml, 5 dose units

Klasė:

Prescription

Recepto tipas:

Prescription

Pagaminta:

Fermion Oy

Terapinės indikacijos:

For sedation of initially intubated patients during treatment in an intensive care setting. The use of Precedex 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.

Produkto santrauka:

Package - Contents - Shelf Life: Ampoule, glass, clear, 2 ml - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, clear, 2 ml - 5 dose units - 36 months from date of manufacture stored at or below 25°C

Leidimo data:

1999-06-10

Pakuotės lapelis

PRECEDEX®
1
PRECEDEX®
_Dexmedetomidine (dex-med-e-toh-med-een) hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PRECEDEX. 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 PRECEDEX
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 PRECEDEX IS
USED FOR
_INTENSIVE CARE SEDATION_
PRECEDEX 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_
PRECEDEX 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.
PRECEDEX is available only with a
doctor's prescription.
BEFORE YOU ARE GIVEN
PRECEDEX
_WHEN YOU MUST NOT BE GIVEN_
_IT _
DO NOT USE PRECEDEX 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
THIS MEDICINE SHOULD NOT BE USED
AFTER THE EXPIRY DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
THIS PRODUCT IS NOT SUITABLE

Prekės savybės

Version: pfdpreci10723
Supersedes: pfdpreci11022
Page 1 of 23
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
PRECEDEX
®
100 micrograms/mL Concentrate for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in PRECEDEX is dexmedetomidine as hydrochloride.
Each 1 mL of
PRECEDEX Concentrate for Infusion 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.
PRECEDEX 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 full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for infusion.
PRECEDEX is a sterile, non-pyrogenic solution suitable for intravenous
(IV)
infusion
following dilution.
PRECEDEX (dexmedetomidine hydrochloride)
100 micrograms/mL is supplied as clear,
colourless, isotonic solutions with a pH of 4.5 to 7.0. PRECEDEX is
presented in 2 mL vials
and must be diluted prior to use.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ICU (INTENSIVE CARE UNIT) SEDATION
For sedation of initially adult intubated patients during treatment in
an intensive care setting.
The use of PRECEDEX by continuous infusion in these patients should
not exceed 24 hours.
PROCEDURAL SEDATION
For sedation of non-intubated adult patients prior to and/or during
surgical and other
procedures.
Version: pfdpreci10723
Supersedes: pfdpreci11022
Page 2 of 23
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.
Clinically significant events of bradycardia and sinus arrest have
been associated with
dexmedetomidine administration in young, healthy vol