Xylocaine 2% w/v with Adrenaline (Epinephrine) 1:80,000 DENTAL Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LIDOCAINE HYDROCHLORIDE; Adrenaline (Epinephrine) Tartrate

Available from:

DENTSPLY DeTrey GmbH

ATC code:

N01BB; N01BB04

INN (International Name):

LIDOCAINE HYDROCHLORIDE; Adrenaline (Epinephrine) Tartrate

Dosage:

2 percent weight/volume

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

Amides; prilocaine

Authorization status:

Marketed

Authorization date:

1980-04-01

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
XYLOCAINE
® 2% W/V WITH ADRENALINE (EPINEPHRINE) 1:80,000 DENTAL
SOLUTION FOR INJECTION
Lidocaine Hydrochloride Anhydrous 2% w/v Adrenaline (epinephrine)
1:80,000
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 dentist or doctor.
-
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.
-
Normally a dentist or dental hygienist will use this product on you in
the dental surgery. It is
unlikely that you will be permitted to take this medicine home.
-
If you get any side effects, talk to your dentist or doctor. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xylocaine 2% with Adrenaline (epinephrine) 1:80,000 DENTAL is and
what it is used for
2.
What you need to know before being given Xylocaine 2% with Adrenaline
(epinephrine)
1:80,000 DENTAL
3.
How Xylocaine 2% with Adrenaline (epinephrine) 1:80,000 DENTAL will be
given
4.
Possible side effects
5.
How to store Xylocaine 2% with Adrenaline (epinephrine) 1:80,000
DENTAL
6.
Contents of the pack and other information
1.
WHAT XYLOCAINE 2% WITH ADRENALINE (EPINEPHRINE) 1:80,000 DENTAL IS AND
WHAT IT IS USED
FOR
Xylocaine 2% with Adrenaline (epinephrine) 1:80,000 DENTAL is a
solution for injection. It contains
lidocaine and adrenaline.
Lidocaine is a type of medicine called a local anaesthetic
(anaesthetics are medicines which numb an
area of the body). Adrenaline is a type of medicine called a
vasoconstrictor (these are medicines
which make the blood vessels at the site of injection narrower) which
means that you will bleed less
and the effects of the medicine will last longer.
It is used to stop pain during dental procedures.
2.
WHAT YOU NEED TO KNOW BEFORE BEING GIVEN XYLOCAINE 2% W

Summary of Product characteristics

HealthProductsRegulatoryAuthority
27March2019
CRN008Z54
Page1of8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xylocaine2%w/vwithAdrenaline(Epinephrine)1:80,000DENTALSolutionforInjection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EachmlofsolutioncontainsLidocaineHydrochlorideequivalenttolidocainehydrochlorideanhydrous20
mg(44 mgper
2.2
mlcartridge),andAdrenaline(Epinephrine)Tartrateequivalenttoadrenaline(epinephrine)12.5
micrograms
(27.5 microgramsper2.2 mlcartridge).
Excipients-containssodiummetabisulphite(E223).
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Solutionforinjection.
Aclearcolourlesssterileaqueoussolution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Xylocaine2%withAdrenaline(Epinephrine)1:80,000DENTALisalocalanaestheticsolutionforuseindentalinfiltration
anaesthesiaandalldentalnerveblocktechniques.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route:Infiltrationbyinjection
Posology
Xylocaine2%withAdrenaline(Epinephrine)1:80,000DENTALhasarapidonsetofactionafterinfiltration,withanaverageof
2‑3minutes.Mandibularblockrequires5minutesormoretotakefulleffect.Thedurationofeffectiveanaesthesiavariesin
individualsanddependsonthetypeofanaesthetictechnique.Theaveragedurationofusefulanaesthesiaafterinfiltrationis60
minutes.Aftersuccessfulregionalanaesthesia,e.g.mandibularblock,anaesthesialastsfor2hoursorlonger.
Thelowestdosagethatresultsineffectiveanaesthesiashouldbeused.Thedosagewillalsodependontheareaoftheoral
cavityt