资料单张
PACKAGE LEAFLET: INFORMATION FOR THE USER
EMLA 5% W/W CREAM
(FOR 5 X 5 G PACK)
lidocaine/prilocaine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions,
ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk
to your doctor or pharmacist. 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:
o
Having an injection.
o
Medical procedures such as removal of warts.
A doctor or nurse should supervise the use of EMLA Cream on
the genitals.
ADULTS
阅读完整的文件
产品特点
1.
NAME OF THE MEDICINAL PRODUCT
EMLA 5% w/w Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains:
Lidocaine 2.5% w/w (25 mg)
Prilocaine 2.5% w/w (25 mg)
Excipients with known effect:
Contains macrogolglycerol hydroxystearate (19 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
A white, soft, homogeneous aqueous 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
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.
Page 1 of 14
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. 1.5g/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 h
阅读完整的文件