REMIFENTANIL SANDOZ remifentanil (as hydrochloride) 5mg powder for injection vial

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

remifentanil hydrochloride, Quantity: 5.5 IU/mg (Equivalent: remifentanil, Qty 5 mg)

Dostupné z:

Sandoz Pty Ltd

INN (Medzinárodný Name):

Remifentanil hydrochloride

Forma lieku:

Injection, powder for

Zloženie:

Excipient Ingredients: glycine; nitrogen; hydrochloric acid

Spôsob podávania:

Intravenous Infusion, Intravenous Bolus

Počet v balení:

5

Typ predpisu:

(S8) Controlled Drug

Terapeutické indikácie:

-as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery in adults.,-as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years.,-for continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery -,when endotracheal intubation and controlled ventilation are anticipated.,-for provision of analgesia and sedation in mechanically ventilated intensive care patients.

Prehľad produktov:

Visual Identification: 10mL clear glass vial with a latex-free rubber stopper, containing a white to almost white powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Registered

Dátum Autorizácia:

2013-03-25

Príbalový leták

Remifentanil Sandoz

powder for injection
1
REMIFENTANIL SANDOZ

_ _
REMIFENTANIL [AS HYDROCHLORIDE]_ _POWDER FOR INJECTION_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Remifentanil Sandoz.
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 being given this
medicine against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT REMIFENTANIL SANDOZ IS USED FOR
This medicine is used as an anaesthetic with other anaesthetics to
produce and/or maintain heavy sleep
during your operation. If you are a cardiac patient, it may also be
used to help relieve strong pain
immediately following your operation.
Remifentanil Sandoz may also be used for patients in the Intensive
Care Unit to maintain sleep and
relieve pain.
It contains the active ingredient remifentanil. Remifentanil_ _belongs
to a group of medicines called_ _
opioids. It differs from other medicines in this group by its very
quick onset and very short duration of
action.
ASK YOUR DOCTOR OR ANAESTHETIST IF YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another reason.
As with other opioids, this medicine can be addictive. This is
unlikely to happen when Remifentanil
Sandoz is used during your operation.
BEFORE YOU ARE GIVEN REMIFENTANIL SANDOZ
_WHEN YOU MUST NOT BE GIVEN REMIFENTANIL SANDOZ _
DO NOT USE THIS MEDICINE IF YOU HAVE AN ALLERGY TO:

remifentanil or to any of the other ingredients listed at the end of
this leaflet under Product
Description.
Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing
Remifentanil Sandoz

Powder for Injection
2

swelling of the face, lips, ton

Súhrn charakteristických

_Product Information _
_ _
_Page _
_Remifentanil Sandoz 1mg, 2mg, 5mg Powder for Injection _
_02/2016 _
_Sandoz Pty Ltd _
_ _
_Version 04 _
_1_
_ _
PRODUCT INFORMATION
REMIFENTANIL SANDOZ
® 1MG, 2MG, 5MG POWDER FOR INJECTION
NAME OF THE MEDICINE
_Active Ingredient:_ Remifentanil hydrochloride
_Chemical Name_:
1-(2-Methoxycarbonyl-ethyl)-4-(phenylpropionyl-amino)-
piperidine-4-carboxylic acid methyl ester hydrochloride.
_Chemical structure: _
_CAS:_ 132539-07-2
_Empirical formula:_ C
20
H
28
N
2
O
5
.HCl
_MW:_ 412.9
DESCRIPTION
The log P n-octanol/water is 17.9. Remifentanil HCl possesses no
chiral centres.
Remifentanil Sandoz Powder for Injection is supplied as sterile,
non-pyrogenic,
preservative-free lyophilised powder for intravenous administration.
The product
requires reconstitution and dilution before use.
Remifentanil
Sandoz
1mg
Powder
for
Injection
contains
1mg
remifentanil
(as
hydrochloride).
Remifentanil
Sandoz
2mg
Powder
for
Injection
contains
2mg
remifentanil
(as
hydrochloride).
Remifentanil
Sandoz
5mg
Powder
for
Injection
contains
5mg
remifentanil
(as
hydrochloride).
Remifentanil
Sandoz
Powder
for
Injection
also
contains
the
following
inactive
ingredients: glycine, hydrochloric acid.
PHARMACOLOGY
_Product Information _
_ _
_Page _
_Remifentanil Sandoz 1mg, 2mg, 5mg Powder for Injection _
_02/2016 _
_Sandoz Pty Ltd _
_ _
_Version 04 _
_2_
_ _
Pharmacodynamics
Remifentanil
is
a
potent,
selective,
4-anilidopiperidine
μ-opioid
agonist
with
pharmacological action typical of this class of compound. It is
distinguished from
other 4-anilidopiperidines (fentanyl analogues) by its rapid onset and
very short
duration of action. The μ-opioid activity of remifentanil is
antagonised by naloxone.
Remifentanil in humans has a rapid blood-brain equilibration half-time
of 1 ± 1
minutes (mean ± SD) and a rapid onset of action. The pharmacodynamic
effects of
remifentanil
closely
follow
the
measured
blood
concentrations,
allowing
direct
correlation between dose, blood levels and response. Blood
concentration decreas