Xylocaine 2% with Adrenaline (Epinephrine) (1:200,000) Solution for Injection

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Adrenaline tartrate; Lidocaine hydrochloride

Fáanlegur frá:

Aspen Pharma Trading Limited

ATC númer:

N01BB; N01BB52

INN (Alþjóðlegt nafn):

Adrenaline tartrate; Lidocaine hydrochloride

Skammtar:

2 (1:200,000 percent volume/volume

Lyfjaform:

Solution for injection

Gerð lyfseðils:

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

Lækningarsvæði:

Amides; lidocaine, combinations

Leyfisstaða:

Marketed

Leyfisdagur:

1980-04-01

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
XYLOCAINE 2% WITH ADRENALINE (EPINEPHRINE) (1:200,000) SOLUTION FOR
INJECTION
anhydrous lidocaine hydrochloride / adrenaline (epinephrine)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS GIVEN TO
YOU 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 or nurse.
•
If you get any side effects, talk to your doctor or nurse. See section
4.
WHAT IS IN THIS LEAFLET:
1. What Xylocaine with adrenaline is and what it is used for
2. What you need to know before Xylocaine with adrenaline is given to
you
3. How Xylocaine with adrenaline is given to you
4. Possible side effects
5. How to store Xylocaine with adrenaline
6. Contents of the pack and other information
1.
WHAT XYLOCAINE WITH ADRENALINE IS AND WHAT IT IS USED FOR
The name of your medicine is ‘Xylocaine 2% with Adrenaline
(Epinephrine) (1:200,000)’. It is referred to as
‘Xylocaine with adrenaline’ in the rest of this leaflet.
Xylocaine with adrenaline
is used to numb (anaesthetise) part of the body for surgical
operations or to
provide pain relief.
Xylocaine with adrenaline
is used in adults and children above 12 years to:
•
numb (anaesthetise) the area of the body where surgery is to be
performed.
•
provide pain relief in labour, after surgery or after acute injury.
•
treat certain types of chronic pain.
Xylocaine with adrenaline contains two different medicines: lidocaine
and adrenaline (epinephrine). Each of
these works in a different way.
•
Lidocaine belongs to a group of medicines called local anaesthetics.
These medicines numb
(anaesthetise) parts of the body.
•
Adrenaline belongs to a group of medicines called vasoconstrictors.
These medicines make the blood
vessels where the injection is given narrower. This means you will
bleed less and the effects of the
medicine will last longer.
2.
WHAT YOU NEED TO KNOW BEFORE XYLOCAINE WITH ADRENALINE IS GIVEN TO YOU
YOU MUST NOT BE GIVEN XYL

Vara einkenni

Health Products Regulatory Authority
24 February 2020
CRN009JZJ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xylocaine 2% with Adrenaline (Epinephrine) (1:200,000) Solution for
Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains lidocaine hydrochloride equivalent to 20
mg of lidocaine hydrochloride anhydrous (400 mg per 20
ml vial) and adrenaline (epinephrine) tartrate equivalent to 5
micrograms of adrenaline (epinephrine) (100 micrograms per 20
ml vial).
Excipients with known effect:
Each ml of solution also contains 0.5 mg sodium metabisulphite (E223),
1 mg methyl parahydroxybenzoate (E218) and 2.49 mg
of sodium.
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 is indicated for local anaesthesia in
adults and children above 12 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN ABOVE 12 YEARS OF AGE
Route: Infiltration by injection
The dosage is adjusted according to the response of the patient and
the site of administration. The lowest concentration and
smallest dose producing the required effect should be given (see
section 4.4). Individual variations in onset and duration occur.
Solutions containing adrenaline may be used to prolong anaesthesia and
reduce systemic absorption (see section 5.2). The risk
of systemic effects of adrenaline with large volumes of
adrenaline-containing solutions should be considered.
The maximum single dose of Xylocaine, when given with adrenaline, is 7
mg/kg or 500 mg total, whichever is the lower.
Concomitant use of lidocaine via other routes should be borne in mind.
The following table is a guide to dosage for the more commonly used
techniques in the average adult. The figures reflect the
expected average dose range needed. Standard textbooks should be
consulted for factors affecting specific block techniques
and for indi