MARCAIN 0.125% WITH FENTANYL 100 mcg/20mL bupivacaine hydrochloride 1.25mg/mL and fentanyl 5 mcg/mL (citrate) 20mL injection ampoule

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

bupivacaine hydrochloride, Quantity: 1.25 mg/mL (Equivalent: bupivacaine hydrochloride monohydrate, Qty 1.32 mg/mL); fentanyl citrate, Quantity: 7.9 microgram/mL (Equivalent: fentanyl, Qty 5 microgram/mL)

Доступно од:

Aspen Pharmacare Australia Pty Ltd

INN (Међународно име):

bupivacaine hydrochloride,Fentanyl citrate

Фармацеутски облик:

Injection, solution

Састав:

Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide

Пут администрације:

Epidural

Јединице у пакету:

20mL x 5

Тип рецептора:

(S8) Controlled Drug

Терапеутске индикације:

Marcain 0.125% with fentanyl is intended for post-operative or obstetric epidural analgesia.

Резиме производа:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус ауторизације:

Registered

Датум одобрења:

2006-03-15

Информативни летак

MARCAIN
WITH FENTANYL
1
MARCAIN
WITH
FENTANYL
_Bupivacaine hydrochloride with fentanyl citrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
MARCAIN with FENTANYL. It
does not contain all the information
that is known about MARCAIN with
FENTANYL.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you being given
MARCAIN with FENTANYL
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 MARCAIN WITH
FENTANYL IS FOR
MARCAIN with FENTANYL is
used after surgery to treat post-
operative pain.
It can also be used to make childbirth
less painful.
MARCAIN belongs to a group of
medicines called local anaesthetics.
When injected, it makes the nerves
nearby unable to pass messages to
the brain and will therefore prevent
or relieve pain.
FENTANYL belongs to a group of
medicines called narcotic analgesics.
It is a powerful drug used to relieve
pain.
MARCAIN with FENTANYL is a
combination of the two drugs and
produces anaesthesia (loss of feeling)
and analgesia (pain relief).
Your doctor will have explained why
you are being treated with
MARCAIN with FENTANYL and
told you what dose you will be given.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They may differ from the
information contained in this leaflet.
Your doctor may prescribe this
medicine for another use. Ask your
doctor if you want more information.
As it contains fentanyl, MARCAIN
with FENTANYL can be addictive,
but when it is used only to relieve or
prevent pain it is unlikely to become
habit forming.
BEFORE YOU ARE GIVEN
MARCAIN WITH
FENTANYL
_WHEN YOU MUST NOT HAVE IT _
ASK YOUR DOCTOR ABOUT THE RISKS
AND BENEFITS OF BEING GIVEN
MARCAIN WITH FENTANYL
WHILE YOU ARE PREGNANT OR
BREASTFEEDING.
We do not know if it is safe for you
to be

Карактеристике производа

1
AUSTRALIAN PRODUCT INFORMATION
MARCAIN
 0.125% WITH FENTANYL 100MCG/20ML INJECTION AMPOULE
MARCAIN
 0.125% WITH FENTANYL 100MCG/20ML INJECTION VIAL
MARCAIN
 0.125% WITH FENTANYL 1000MCG/200ML INJECTION BAG
BUPIVACAINE HYDROCHLORIDE 1.25MG/ML (AS MONOHYDRATE) WITH
FENTANYL 5 MICROGRAM/ML (AS CITRATE)
NOT FOR INTRAVENOUS INFUSION UNDER ANY CIRCUMSTANCES
1
NAME OF THE MEDICINE
Bupivacaine hydrochloride with fentanyl (as citrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Marcain 0.125% with fentanyl 5 microgram/mL is a sterile, isotonic
aqueous solution
containing bupivacaine hydrochloride (as monohydrate) 1.25mg/mL and
fentanyl (as
citrate) 5 microgram/mL as the active ingredients. They also contain
sodium chloride
and water for injections with nominal osmolality of 298mOsmol/kg. The
pH of the
solution is adjusted with sodium hydroxide or hydrochloric acid to
remain between 4.0-
6.5 during the approved shelf-life.
3
PHARMACEUTICAL FORM
A clear, colourless solution for injection or infusion.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Marcain 0.125% with fentanyl 5 microgram/mL is intended for
post-operative or
obstetric epidural analgesia.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The lowest dosage that results in effective analgesia should be used
and should be
based on the status of the patient and the analgesia required.
2
RECOMMENDED
DOSAGES
FOR
MARCAIN
0.125%
WITH
FENTANYL
5
microgram/mL FOR INFUSION FOR ANALGESIA IN THE AVERAGE HEALTHY
70KG ADULT PATIENT.
PROCEDURE
VOLUME DOSE
bupivacaine
fentanyl
OBSTETRICS/GYNAECOLOGY EPIDURAL/CAUDAL
(vaginal delivery, vacuum extraction, first, second stage)
Bolus dose,
6 - 10 mL
7.5 - 12.5 mg
30 - 50
if required
microgram
followed by
EPIDURAL INFUSION
4 - 10 ML/HR
5 - 12.5 MG/HR
20 - 50
MICROGRAM/HR
POSTOPERATIVE ANALGESIA EPIDURAL
Bolus dose,
6 - 10 mL
7.5 - 12.5 mg
30 - 50
if required
microgram
followed by
EPIDURAL INFUSION*
4 - 10 ML/HR
5 - 12.5 MG/HR
20 - 50
MICROGRAM/HR
MAXIMUM HOURLY DOSE (INFUSION + BOLUS)
10 mL
12.5 mg
50 microgram
* for up to 48 h