Denela 25 mg/g + 25 mg/g Kräm

Land: Schweden

Sprache: Schwedisch

Quelle: Läkemedelsverket (Medical Products Agency)

Wirkstoff:

lidokain; prilokain

Verfügbar ab:

Teva B.V.

ATC-Code:

N01BB20

INN (Internationale Bezeichnung):

lidocaine; prilocaine

Dosierung:

25 mg/g + 25 mg/g

Darreichungsform:

Kräm

Zusammensetzung:

makrogolglycerolhydroxistearat Hjälpämne; lidokain 25 mg Aktiv substans; prilokain 25 mg Aktiv substans

Klasse:

Apotek

Verschreibungstyp:

Receptbelagt

Therapiebereich:

Kombinationer

Produktbesonderheiten:

Förpacknings: Tub, 1 x 5 g (utan täckförband); Tub, 1 x 5 g (med 2 täckförband); Tub, 5 x 5 g (med 12 täckförband); Tub, 1 x 30 g

Berechtigungsstatus:

Godkänd

Berechtigungsdatum:

2014-06-26

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DENELA 25 MG/G + 25 MG/G CREAM
(FOR 5 G AND PRE-MEDICATION PACKS)
(FOR 30 G SURGICAL PACKS)
LIDOCAINE/PRILOCAINE
Rx:
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, pharmacist or
nurse.
-
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.
OTC:
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
have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist 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.
[To be completed nationally]
WHAT IS 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).
-

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Denela 25 mg/g + 25mg/g cream
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 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)
Skin of male gen