Marcain 0.25% with adrenaline (epinephrine) 1:400,000 20mL injection vial

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

adrenaline (epinephrine) acid tartrate, Quantity: 4.5 microgram/mL (Equivalent: adrenaline (epinephrine), Qty 2.5 microgram/mL); bupivacaine hydrochloride, Quantity: 2.5 mg/mL (Equivalent: bupivacaine hydrochloride monohydrate, Qty 2.64 mg/mL)

Tilgængelig fra:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

adrenaline (epinephrine) acid tartrate,bupivacaine hydrochloride

Lægemiddelform:

Injection, solution

Sammensætning:

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

Indgivelsesvej:

Epidural, Intramuscular, Infiltration, Subcutaneous

Enheder i pakken:

20mL x 5

Klasse:

Medicine Registered

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

MARCAIN solutions are indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: Surgical anaesthesia; Epidural block for surgery, Field block (minor and major nerve blocks and infiltration). Analgesia; Continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. Field block (minor nerve block and infiltration). The choice of 4 strengths, 0.125%, 0.25%, 0.375% and 0.5%, makes it possible to vary the degree of motor blockade.

Produkt oversigt:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Licence status A

Autorisation dato:

2006-09-01

Indlægsseddel

MARCAIN
®
AND MARCAIN WITH ADRENALINE INJECTION
1
MARCAIN
®
AND
MARCAIN WITH
ADRENALINE INJECTION
_Bupivacaine hydrochloride _
_Bupivacaine hydrochloride and adrenaline (epinephrine) (as acid
tartrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
MARCAIN. It does not contain all
the information that is known about
MARCAIN.
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 using
MARCAIN 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 MARCAIN IS FOR
MARCAIN is used to prevent or
relieve pain, but it will not put you to
sleep.
MARCAIN is also used after surgery
to relieve 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.
Depending on the amount used,
MARCAIN will either totally stop
pain or will cause a partial loss of
feeling.
MARCAIN is sometimes combined
with adrenaline to make it last
longer. Adrenaline makes the blood
vessels at the site of injection
narrower, which keeps the
MARCAIN where it is needed for a
longer time.
Your doctor will have explained why
you are being treated with
MARCAIN 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 uses other than those
listed above. Ask your doctor if you
want more information.
MARCAIN is not addictive
BEFORE YOU ARE GIVEN
MARCAIN
_WHEN YOU MUST NOT BE GIVEN _
_IT _
ASK YOUR DOCTOR ABOUT THE RISKS
AND BENEFITS OF BEING GIVEN
MARCAIN WHILE YOU ARE PREGNANT
OR BREASTFEEDING.
We

Produktets egenskaber

MARCAIN AND MARCAIN WITH ADRENALINE Product Information
1(21)
AUSTRALIAN PRODUCT INFORMATION
Bupivacaine Hydrochloride
Bupivacaine Hydrochloride and Adrenaline (Epinephrine) (as Acid
Tartrate)
(MARCAIN AND MARCAIN WITH ADRENALINE)
(Injection solutions for the production of local or regional
anaesthesia)
NOT FOR INTRAVENOUS ADMINISTRATION UNDER ANY CIRCUMSTANCES
1.
NAME OF THE MEDICINE
Bupivacaine hydrochloride with or without adrenaline (epinephrine)
acid tartrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MARCAIN solutions are available with or without adrenaline.
MARCAIN 0.125% EPIDURAL INFUSION
bupivacaine hydrochloride 1.25 mg/mL
MARCAIN 0.25%
bupivacaine hydrochloride 2.5 mg/mL
MARCAIN 0.25% WITH ADRENALINE 1:400,000
bupivacaine hydrochloride 2.5 mg/mL with adrenaline (epinephrine) 2.5
(as acid
tartrate) microgram/mL
MARCAIN 0.375%
bupivacaine hydrochloride 3.75 mg/mL
MARCAIN 0.5%
bupivacaine hydrochloride 5 mg/mL
MARCAIN 0.5% WITH ADRENALINE 1:200,000
bupivacaine hydrochloride 5 mg/mL with adrenaline (epinephrine) 5 (as
acid
tartrate) microgram/mL
MARCAIN solutions for injection are sterile, isotonic aqueous
solutions of
bupivacaine hydrochloride in Water for Injections BP. 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.
MARCAIN with adrenaline solutions for injection are sterile, isotonic
aqueous
solutions of bupivacaine hydrochloride in Water for Injections BP. The
pH of the
solution is adjusted with sodium hydroxide or hydrochloric acid to
remain between
3.3 - 5.0.
MARCAIN AND MARCAIN WITH ADRENALINE Product Information
2(21)
MARCAIN with adrenaline also contains sodium metabisulfite as an
antioxidant.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Clear, colourless solution for injection or infusion
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MARCAIN solutions are indicated for the production of local or
regional
anaesthesia and analgesia in individuals as follo