Denela 5% cream

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Lidocaine; Prilocaine

Dostupno od:

Teva UK Ltd

ATC koda:

N01BB52

INN (International ime):

Lidocaine; Prilocaine

Doziranje:

25mg/1gram ; 25mg/1gram

Farmaceutski oblik:

Cutaneous cream

Administracija rute:

Cutaneous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 15020100; GTIN: 5060032243436 5060032243450 5060032243429 5060032243443

Uputa o lijeku

stramien_297x218_met_3x_2Dcode_Oss.indd 1
16-11-17 08:29
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Code
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DENELA 5% CREAM
(FOR 5 G AND PRE-MEDICATION 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.
-
-
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
1. What DENELA CREAM is and what it is used for?
2. What you need to know before you use DENELA CREAM
3. How to use DENELA CREAM
4. Possible side effects
5. How to store DENELA CREAM
6. Contents of the pack and other information
1. WHAT DENELA CREAM IS AND WHAT IT IS USED FOR
Denela Cream contains two active substances called lidocaine and
prilocaine. These belong
to a group of medicines called local anaesthetics.
Denela 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 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 Denela 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 DENELA CREAM

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Denela 5% 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
Denela 5% Cream 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 genital orga