Emla Patch

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lidocaine 2.5%; Prilocaine 2.5%

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Lidocaine 2.5%

Pharmaceutical form:

Dermal patch

Composition:

Active: Lidocaine 2.5% Prilocaine 2.5% Excipient: Carbomer Polyoxyl 35 castor oil Purified water Sodium hydroxide

Units in package:

Sachet, laminate, 1g, 20 dose units

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Cambrex Karlskoga AB

Therapeutic indications:

Topical anaesthesia of the skin prior to insertion of I.V. catheters, blood sampling, vaccination, superficial surgical procedures, including split skin grafting.

Product summary:

Package - Contents - Shelf Life: Sachet, laminate, 1g - 2 patches - 24 months from date of manufacture stored at or below 30°C - Sachet, laminate, 1g - 20 patches - 24 months from date of manufacture stored at or below 30°C

Authorization date:

1993-07-29

Patient Information leaflet

EMLA CMI
1(6)
EMLA
PRILOCAINE 2.5%, LIDOCAINE 2.5%
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
EMLA. It does not contain all
the information that is known about EMLA.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor or pharmacist will
have weighed the risks of you
using EMLA 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 EMLA IS USED FOR
EMLA is used as a local anaesthetic (i.e. for pain relief) on the skin
prior to procedures. These
procedures can include taking blood samples, vaccination, skin
grafting, cleaning leg ulcers, inserting
an intravenous catheter, minor superficial cosmetic procedures and
procedures on genital skin.
EMLA is available as a cream (EMLA CREAM) which is applied then
covered with a dressing, or as a
patch (EMLA PATCH), which has the cream and dressing all ready to use.
Follow all directions given to you by your doctor or pharmacist
carefully. They may differ from the
information contained in this leaflet.
EMLA is a mixture of two local anaesthetics, lidocaine and prilocaine.
These local anaesthetics are combined with special agents which allow
the products to pass through
the skin. Once through the skin the numbing effect they produce allows
minor surgical procedures to
be done without you feeling any pain. However you may still experience
sensations such as pressure
and touch in this area.
EMLA is not addictive.
EMLA is available from your pharmacy.
BEFORE YOU USE EMLA
_WHEN YOU MUST NOT USE IT _
EMLA should only be used on unbroken skin. Do not use EMLA on areas
with an infection, skin
rash, cuts, grazes or other open wounds, with the exception of leg
ulcers. If any of these problems
are present, check with your doctor or pharmacist before using EMLA.
If you are going to have a vac

Summary of Product characteristics

EMLA
Data Sheet
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
EMLA
CREAM
5%
EMLA
PATCH
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CREAM
Each gram of cream contains lidocaine 25 mg and prilocaine 25 mg.
PATCH
Each patch contains lidocaine 25 mg and prilocaine 25 mg.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
CREAM
White, soft, hydrophilic cream.
PATCH
EMLA
PATCH
is a unit-dose formulation of EMLA in the form of an occlusive
dressing. It is
composed of a laminate backing, an absorbent cellulose disc and an
adhesive tape frame.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EMLA
PATCH AND C
REAM
Topical anaesthesia of the skin prior to insertion of IV catheters,
blood sampling, vaccination
(see Section 4.4), superficial surgical procedures, including split
skin grafting.
EMLA
CREAM
Topical anaesthesia of leg ulcers to facilitate mechanical cleansing
or debridement.
Topical anaesthesia of the female genital mucosa and male genital skin
for example, prior to
superficial surgical procedures or infiltration anaesthesia.
Topical anaesthesia of the skin prior to minor superficial cosmetic
procedures.
4.2
DOSE AND METHOD OF ADMINISTRATION
EMLA CREAM
SURFACE / AGE
PROCEDURE
APPLICATION
EMLA
Data Sheet
2
SURFACE / AGE
PROCEDURE
APPLICATION
SKIN
A thick layer of cream to the skin, under an
occlusive dressing
Adults
Approximately 1.5g / 10 cm²
Minor procedures, e.g. needle
insertion, cosmetic procedures
8
and surgical treatment of localised
lesions
2 g (approximately half a 5 g tube) for a
minimum of 1 hour, maximum 5 hours
1
)
Dermal procedures on larger
areas in a hospital setting, e.g.
split-skin grafting
Approximately 1.5-2 g / 10 cm² for a minimum of
2 hours, maximum 5 hours
1
Newly shaven skin of large body
areas (in an outpatient setting)
Maximum recommended dose: 60 g. Maximum
recommended treated area; 600 cm
2
for a
minimum of 1 hour, maximum 5 hours
Children
Neonates 0-2
months
3)
Infants 3-11
months
3)
Minor procedures, e.g. needle
insertion and surgical treatment of
localised lesions
Appro