DENELA 5 Per Cent Cream

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

LIDOCAINE, PRILOCAINE

Saadav alates:

Auden Mckenzie (Pharma Division) Ltd

ATC kood:

N01BB20

INN (Rahvusvaheline Nimetus):

LIDOCAINE, PRILOCAINE

Annus:

5 Per Cent

Ravimvorm:

Cream

Retsepti tüüp:

Product subject to prescription which may not be renewed (A)

Terapeutiline ala:

Amides

Volitamisolek:

Authorised

Loa andmise kuupäev:

2013-05-03

Infovoldik

Front cover
170mm
Inside spread - p2
170mm
Inside spread - p3
170mm
Back cover
170mm
WHAT TO DO IF YOU GET DENELA CREAM IN YOUR EYE:

•  Do not get Denela Cream in your eyes. This is because it may
irritate your eyes.

•  If you get Denela Cream in your eye by mistake, rinse your eye
well with lukewarm water or 

  salt (sodium chloride) solution. Be careful to avoid getting
anything in your eye until feeling returns.
IF DENELA CREAM IS ACCIDENTALLY SWALLOWED, talk to your doctor,
pharmacist or nurse straight away.
IF YOU USE MORE DENELA CREAM THAN YOU SHOULD:

•  If you use more Denela Cream than your doctor, pharmacist or
nurse has told you to, talk to one of them straight
           away, even if you do not feel any symptoms.

•  Symptoms of using too much Denela Cream are listed
below. These symptoms are unlikely to  

  happen if Denela Cream is used as recommended.

w 
Feeling light-headed or dizzy.

w 
Tingling of the skin around the mouth and numbness of the tongue.

w 
Abnormal taste.

w 
Blurred vision.

w 
Ringing in the ears.

w 
There is also a risk of 'methaemoglobinaemia' (a problem with blood
pigment levels).This is more likely 

in children and when certain medicines have been taken at the same
time. If this happens, the skin

becomes bluish-grey due to a lack of oxygen.
When you apply the cream, it is very important to exactly follow the
instructions below:
Denela Cream contains two medicines 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.
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.

•  Some types of skin graft.

•  Clea

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Denela 5% Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine 2.5% w/w (25 mg/g)
Prilocaine 2.5% w/w (25 mg/g)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
White soft cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical anaesthesia of the skin in connection with:
Intact skin prior to minor dermatological procedures (e.g. needle insertion and surgical treatment of localised
lesions) and prior to dermal procedures on larger areas e.g. split skin grafting.
Dermal procedures on newly shaven skin of large body areas e.g. laser hair removal
Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or prior to infiltration
anaesthesia of mucosa.
Topical anaesthesia of leg ulcers to facilitate mechanical cleansing/debridement.
In term newborn infants and children under the age of 18 years, Denela is indicated for local anaesthesia on intact skin
prior to minor dermatological procedures. Studies have failed to demonstrate efficacy of Denela for heel lancing in
newborn infants.
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. 1.5g/10cm
2
Minor procedures e.g. needle
insertion and surgical
treatment of localised lesions
2g (approx. half a 5g tube) for
1 to 5 hours
1)
Dermal surgical procedures on
larger areas in a hospital
setting e.g. split skin grafting
Approx. 1.5-2g/10cm
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: 600cm
2
for a
minimum of 1 hour, maximum
5 hours.
1)
HEALTH PRODUCTS R