Emla 5% cream

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Lidocaine; Prilocaine

Tilgjengelig fra:

Aspen Pharma Trading Ltd

ATC-kode:

N01BB52

INN (International Name):

Lidocaine; Prilocaine

Dosering :

25mg/1gram ; 25mg/1gram

Legemiddelform:

Cutaneous cream

Administreringsrute:

Cutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 15020100; GTIN: 5014162003996 5014162003835 5000455019218 5000455018112

Informasjon til brukeren

Read all of this leaflet carefully before you or
your child start using this medicine because it
contains important information for you.
Always use this medicine exactly as described in this
leaflet or as your doctor, pharmacist or nurse has
told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your doctor, pharmacist or nurse if you need
more information or advice.
•
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What EMLA Cream is and what it is used for
2.
What you need to know before you use
EMLA Cream
3.
How to use EMLA Cream
4.
Possible side effects
5.
How to store EMLA Cream
6.
Contents of the pack and other information
1.
What EMLA Cream is and what it is used for
EMLA Cream contains two active substances called
lidocaine and prilocaine. These belong to a group of
medicines called local anaesthetics.
EMLA Cream works by numbing the surface of the
skin for a short time. It is put on the skin before
certain medical procedures. This helps to stop pain
on the skin; however you may still have the feelings
of pressure and touch.
Adults, Adolescents and Children
It can be used to numb the skin before:
•
Having a needle put in (for example, if you are
having an injection or a blood test).
•
Minor skin operations.
Adults and Adolescents
It can also be used:
•
To numb the genitals before:
-
Having an injection.
-
Medical procedures such as removal of warts.
A doctor or nurse should apply EMLA Cream on the
genitals.
Adults
It can also be used to numb the skin before:
•
Cleansing or removal of damaged skin of leg ulcers.
For other purposes than application to intact skin, the
product should be used only upon recommendation
of a doctor, nurse or pharmacist.
2. What you need to know before you use
EMLA Cream
Do not use EMLA Cream:
•
if you are allergic to lidocaine or prilocaine, other
similar local anaesthetics or any of the other
ingredients of this medic

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
EMLA
™
Cream 5%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine 2.5% w/w (25 mg/g)
Prilocaine 2.5% w/w (25 mg/g)
For excipients, see 6.1
3
PHARMACEUTICAL FORM
White soft cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EMLA Cream is indicated for:
•
Topical anaesthesia of the skin in connection with:
o
needle insertion, e.g. intravenous catheters or blood sampling;
o
superficial surgical procedures;
in adults and in the paediatric population.
•
Topical anaesthesia of the genital mucosa, e.g. prior to superficial
surgical
procedures or infiltration anaesthesia; in adults and adolescents
≥
12 years
•
Topical anaesthesia of leg ulcers to facilitate mechanical
cleansing/debridement in adults only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Administration of EMLA Cream on genital mucosa, genital skin or leg
ulcers should
only be performed by or under the supervision of a healthcare
professional.
Posology
_Adults and adolescents _
The details of the Indications or Procedures for use, with Dosage and
Application
Time are provided in Tables 1 and 2.
For further guidance on the appropriate use of the product in such
procedures, please
refer to _Method of administration. _
_ _
Table 1
Adults and adolescents 12 years of age and above
INDICATION/PROCEDURE
DOSAGE AND APPLICATION TIME
SKIN
Minor procedures, e.g. needle insertion and
surgical treatment of localised lesions.
2 g (approx half a 5 g tube) or approx.
1.5 g/10 cm
2
for 1 to 5 hours
1)
.
Dermal procedures on newly shaven skin of
large body areas, e.g. laser hair removal (self-
application by patient)
Maximum recommended dose: 60 g.
Maximum recommended treated area; 600
cm
2
for a minimum of 1 hour, maximum 5
hours
1)
.
Dermal surgical procedures on larger areas in
a hospital setting, e.g. split-skin grafting.
Approx 1.5-2 g/10 cm
2
for 2 to 5 hours
1)
.
Skin of male genital organs
Prior to injection of local anaesthetics
Skin of female genital organs
Prior to injection of local