Denela 50 mg/g crème

País: Países Bajos

Idioma: neerlandés

Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredientes activos:

LIDOCAÏNE ; PRILOCAÏNE

Disponible desde:

Teva B.V. Swensweg 5 2031 GA HAARLEM

Código ATC:

N01BB20

Designación común internacional (DCI):

LIDOCAINE ; PRILOCAÏNE

formulario farmacéutico:

Crème

Composición:

CARBOMEER 974P ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; NATRIUMHYDROXIDE (E 524) ; WATER, GEZUIVERD,

Vía de administración:

Cutaan gebruik

Área terapéutica:

Combinations

Resumen del producto:

Hulpstoffen: CARBOMEER 974P; MACROGOLGLYCEROLHYDROXYSTEARAAT; NATRIUMHYDROXIDE (E 524); WATER, GEZUIVERD;

Fecha de autorización:

2014-10-13

Información para el usuario

BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
DENELA 50 MG/G CRÈME (FOR 5 G AND PRE-MEDICATION PACKS)
(FOR 30 G SURGICAL PACKS)
LIDOCAINE & PRILOCAINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What /.../ is and what it is used for?
2.
What you need to know before you use /.../
3.
How to use /.../
4.
Possible side effects
5.
How to store /.../
6.
Contents of the pack and other information
1.
WHAT /.../ IS AND WHAT IT IS USED FOR
/.../ contains two active substances called lidocaine and prilocaine.
These belong to a group of
medicines called local anaesthetics.
/.../ 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 on adults to numb the genitals before:
-
Having an injection.
-
Medical procedures such as removal of warts.
A doctor or nurse should supervise the use of /.../ 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
reco

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Denela 50 mg/g crème
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 25 mg of lidocaine and 25 mg of
prilocaine.
Excipient with known effect: macrogolglycerol hydroxystearate. Each
gram of cream contains 19 mg
of macrogolglycerol hydroxystearate (hydrogenated polyoxyl castor oil)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
White soft cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
/.../ is indicated for:
-
Topical anaesthesia of the skin in connection with:
-
needle insertion and injections eg. intravenous catheters, blood
sampling or vaccination;
-
superficial surgical procedures, e.g.laser treatment and hair removal
-
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.
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/10cm
2
for 1 to 5 hours
1)
Dermal surgical procedures on larger areas
Approx. 1.5-2 g/10 cm
2
for 2 to 5 hours
1)
in a hospital setting e.g. split skin grafting.
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)
Skin of male genital orga