EMLA 5%

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LIDOCAINE; PRILOCAINE

متاح من:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC رمز:

N01BB54

الشكل الصيدلاني:

CREAM

تركيب:

LIDOCAINE 2.5 %; PRILOCAINE 2.5 %

طريقة التعاطي:

DERMAL

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

RECIPHARM KARLSKOGA AB, SWEDEN

المجموعة العلاجية:

PRILOCAINE, COMBINATIONS

المجال العلاجي:

PRILOCAINE, COMBINATIONS

الخصائص العلاجية:

Topical anaesthetic for superficial dermal analgesia in connection with insertion of IV catheters, blood sampling and superficial surgical procedures.

تاريخ الترخيص:

2014-10-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS׳ REGULATIONS
(PREPARATIONS) – 1986
The medicine can be sold without a doctor׳s prescription
Emla 5%
Cream
The active ingredients and their concentration:
Composition:
Lidocaine
2.5%
Prilocaine
2.5%
Inactive ingredients and allergens in the preparation –
see section 2 – “Important information about some of
the ingredients of the medicine” and section 6 – “Further
information”.
Read this leaflet carefully in its entirety before using the
medicine. This leaflet contains concise information about
the medicine. If you have any further questions, ask your
doctor or pharmacist.
Use the medicine correctly. Consult a pharmacist if you need
additional information.
1. WHAT IS THE MEDICINE INTENDED FOR?
Emla 5% is used for dermal local anasthesia, for pain relief
before procedures involving the insertion of a needle )e.g.,
an infusion, blood tests( and minor skin operations.
Emla 5% cream works by temporarily numbing the skin
surface so that it helps relieve the pain. However, you may
still feel touch and pressure in the area.
Therapeutic group: Local anesthetic of the amide group.
2. BEFORE USING THE MEDICINE
Do not use the medicine:
If you are hypersensitive )allergic( to the active ingredients,
or to any of the other ingredients contained in the medicine,
or to another similar local anesthetic )see section 6(.
Special warnings regarding the use of the medicine
Before treatment with Emla 5% cream tell the doctor if:
• You or your child have a rare inherited illness that affects
the blood, called “glucose-6-phosphate dehydrogenase
)G6PD enzyme( deficiency” )hypersensitivity to fava
beans(.
• You or your child have a problem with blood pigment levels
called “methemoglobinemia”.
• Do not use Emla 5% cream on areas with skin rash, cuts,
grazes, scratches or other open wounds, with the exception
of a leg ulcer. If any of these problems is present, check
with the doctor or pharmacist before using the medicine.
• You or your child have an

خصائص المنتج

1
1.
NAME OF THE MEDICINAL PRODUCT
EMLA
5% Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine 2.5%
Prilocaine 2.5%
For excipients, see 6.1
3.
PHARMACEUTICAL FORM
White soft homogeneous cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical anesthesia for superficial dermal analgesia in connection with
insertion of IV
catheters, blood sampling and superficial surgical procedures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
SURFACE/
AGE
PROCEDURE
APPLICATION
SKIN
Apply a thick layer of cream on the
skin and cover it with occlusive
dressing.
Adults
Approx. 1.5 g/10 cm
2
Minor procedures e.g. needle
insertion and surgical treatment of
localised lesions.
2 g (approx. half a 5 g tube) for 1
to 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)
Dermal procedures on newly
shaven skin of large body areas
e.g. laser hair removal (self-
application by patient)
Maximum recommended dose:
60g.
Maximum recommended treated
area: 600 cm
2
for a minimum of 1
hour, maximum 5 hours.
1)
Children
Minor procedures, e.g. needle
insertion and surgical treatment of
localised lesions
Approx. 1.0 g/10 cm
2
for 1 hour
(see details below)
Neonates 0-3
months
3) 8)
Up to 1.0 g and 10 cm
2
for one hour
2)
Infants 3-12
months
3)
Up to 2.0 g and 20 cm
2
for 1-4 hours
4)
2
Children 1-6
years
Up to 10.0 g and 100 cm
2
for 1-4
hours
1)
Children
7-
12 years
Up to 20.0 g and 200 cm
2
for 1-4
hours
1)
Children
with atopic
dermatitis
Prior to removal of mollusca.
Application time: 30 minutes
GENITAL
MUCOSA
Adults
Surgical treatment of localised
lesions, e.g. removal of genital
warts (condylomata accuminata)
and prior to injection of local
anaesthetics.
Approx. 5-10 g EMLA for 5-10
minutes
1)
. No occlusive dressing is
required. Commence the procedure
immediately after removal of
cream.
Prior to cervical curettage.
Administer 10 g of cream in lateral
vaginal fornices for 10 minutes.
SKIN OF MALE
GENITAL
ORGANS
Adults
Prior to injection of loc