Xylocaine 2.0% with adrenaline (epinephrine) 1:200,000 20mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lidocaine hydrochloride, Quantity: 20 mg/mL; adrenaline (epinephrine) acid tartrate, Quantity: 9.1 microgram/mL (Equivalent: adrenaline (epinephrine), Qty 5 microgram/mL)

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous, Intramuscular, Epidural, Infiltration

Units in package:

20mL x 5

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

XYLOCAINE solutions are indicated for the production of local or regional anaesthesia by the following techniques: infiltration, intravenous regional anaesthesia - excluding solutions with adrenaline, peripheral nerve block such as intercostal block, major plexus block such as brachial plexus block, epidural block, subarachnoid block.

Product summary:

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

Authorization status:

Registered

Authorization date:

1991-08-13

Patient Information leaflet

XYLOCAINE
®
AND XYLOCAINE WITH ADRENALINE INJECTION
1
XYLOCAINE
® AND
XYLOCAINE WITH
ADRENALINE
INJECTION
_Lidocaine (Lignocaine) hydrochloride _
_Lidocaine (Lignocaine) 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
Xylocaine. It does not contain all the
information that is known about
Xylocaine.
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 taking
Xylocaine 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 WITH THE MEDICINE.
You may need to read it again.
WHAT XYLOCAINE IS
FOR
Xylocaine is used to prevent or
relieve pain, but it will not put you to
sleep.
Xylocaine is also used after surgery
to relieve pain. It can also be used to
make childbirth less painful.
Xylocaine belongs to a group of
medicines called local anaesthetics.
It is injected into the body where it
makes the nerves unable to pass
messages to the brain.
Depending on the amount used,
Xylocaine will either totally stop
pain or will cause a partial loss of
feeling.
Xylocaine is sometimes combined
with adrenaline (epinephrine) to
make it last longer. Adrenaline
(epinephrine) makes the blood
vessels at the site of injection
narrower, which keeps the Xylocaine
where it is needed for a longer time.
Your doctor will have explained why
you are being treated with Xylocaine
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.
Xylocaine is not addictive.
BEFORE YOU ARE GIVEN
XYLOCAINE
_WHEN YOU MUST NOT USE IT _
IF YOU ARE PREGNANT OR
BREASTFEEDING DO NOT USE XYLOCAINE
UNLESS YOUR DOCTOR SAY

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
XYLOCAINE AND XYLOCAINE WITH ADRENALINE
Lidocaine (lignocaine) hydrochloride
Lidocaine (lignocaine) hydrochloride with adrenaline (epinephrine)
acid tartrate
(Injection solutions for the production of local or regional
anaesthesia)
1
NAME OF THE MEDICINE
XYLOCAINE: lidocaine (lignocaine) hydrochloride
XYLOCAINE with ADRENALINE: lidocaine (lignocaine) hydrochloride and
adrenaline
(epinephrine) acid tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plain aqueous solutions are sterile, isotonic and contain lidocaine
(lignocaine) hydrochloride,
sodium chloride, sodium hydroxide and/or hydrochloric acid for pH
adjustment and water for
injections.
Lidocaine (lignocaine) hydrochloride with adrenaline (epinephrine)
acid tartrate solutions are
also sterile and isotonic, and in addition contain adrenaline
(epinephrine) acid tartrate and
sodium metabisulfite.
Excipients with known effect: XYLOCAINE with ADRENALINE contains
sulphites.
XYLOCAINE solutions contain no antimicrobial agent and should be used
only once and any
residue discarded.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Clear, colourless solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
XYLOCAINE solutions are indicated for the production of local or
regional anaesthesia by
the following techniques:
−
infiltration,
−
intravenous regional anaesthesia – excluding solutions with
adrenaline
(epinephrine) acid tartrate,
−
peripheral nerve block such as intercostal block,
−
major plexus block such as brachial plexus block,
−
epidural block,
−
subarachnoid block.
4.2
D
OSE AND METHOD OF ADMINISTRATION
2
The lowest dosage and volume that results in effective anaesthesia
should be used and should
be based on the status of the patient and the type of regional
anaesthesia intended.
XYLOCAINE solutions contain no antimicrobial agent and should be used
only once and any
residue discarded.
Lidocaine (lignocaine) should be administered with great caution to