2% Xylocaine DENTAL with Adrenaline (epinephrine) 1:80,000

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Adrenaline acid tartrate 0.0227mg equivalent to 12.5 µg adrenaline;  ; Lidocaine hydrochloride monohydrate 21.3mg equivalent to 20 mg Lignocaine hydrochloride anhydrous

Предлага се от:

Dentsply Sirona (NZ) Limited

INN (Международно Name):

Adrenaline acid tartrate 0.0227 mg (= 12.5 µg adrenaline)

Лекарствена форма:

Solution for injection

Композиция:

Active: Adrenaline acid tartrate 0.0227mg equivalent to 12.5 µg adrenaline   Lidocaine hydrochloride monohydrate 21.3mg equivalent to 20 mg Lignocaine hydrochloride anhydrous Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Sodium metabisulfite Water for injection

Броя в опаковка:

Cartridge, glass, 2.2mL auto asp, 100 dose units

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Boehringer Ingelheim Pharma GmbH & Co KG

Терапевтични показания:

The product is indicated for the production of local nerve anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques. Lidocaine solutions with adrenaline are recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis.

Каталог на резюме:

Package - Contents - Shelf Life: Cartridge, glass, 2.2mL auto asp - 50 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate - Cartridge, glass, 2.2mL std - 50 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate - Cartridge, glass, 2.2mL auto asp - 100 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate - Cartridge, glass, 2.2mL std - 100 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate - Cartridge, glass, 1.8mL auto asp - 100 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate - Cartridge, glass, 1.8mL std - 100 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate

Дата Оторизация:

1969-12-31

Листовка

Xylocaine

Dental
1(3)
2% XYLOCAINE
 DENTAL WITH
ADRENALINE (EPINEPHRINE) 1:80,000
Lidocaine (lignocaine) hydrochloride
Adrenaline (epinephrine) acid tartrate
CONSUMER MEDICINE INFORMATION
________________________________________________________________________
WHAT IS IN THIS LEAFLET
________________________________________________________________________
XYLOCAINE
and
LIDOCAINE (ALSO
KNOWN AS LIGNOCAINE),
are different
names for the same medicine -
which is used as to stop pain during
dental procedures. It is only called
XYLOCAINE DENTAL
in this leaflet.
This leaflet answers some of the
common questions people ask about
XYLOCAINE DENTAL
. It does not
contain all the information that is
known about
XYLOCAINE DENTAL
.
It does not take the place of talking
to your dentist or pharmacist.
All medicines have risks and
benefits. Your dentist will have
weighed the risks of you being
given
XYLOCAINE DENTAL
against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DENTIST OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to
read it again.
________________________________________________________________________
WHAT XYLOCAINE
DENTAL IS FOR
________________________________________________________________________
XYLOCAINE DENTAL
is used to prevent
or relieve pain during dental
procedures, but it will not put you
to sleep.
XYLOCAINE DENTAL
belongs to a
group of medicines called local
anaesthetics. It is injected into the
mouth where it makes the nerves
unable to pass messages to the
brain.
Depending on the amount used,
XYLOCAINE DENTAL
will either totally
stop pain or will cause a partial loss
of feeling.
XYLOCAINE DENTAL
contains
adrenaline (also known as
epinephrine) to make it last longer.
Adrenaline (epinephrine) makes the
blood vessels at the site of injection
narrower, which means you bleed
less and it is easier for your dentist
to see what is happening.
Your dentist will have explained
why you are being treated with
XYLOCAINE DENTAL
.
FOLLOW ALL
DIREC

Данни за продукта

2% XYLOCAINE
® DENTAL WITH ADRENALINE (EPINEPHRINE)
1:80,000
DATA SHEET
DENTSPLY SIRONA (NZ) LTD
1 of 7
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
2% Xylocaine
®
DENTAL with adrenaline (epinephrine) 1:80,000 Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2% Xylocaine
®
DENTAL with adrenaline (epinephrine) 1:80,000 consists of lidocaine
(lignocaine) hydrochloride 2% (21.3 mg/mL) and adrenaline
(epinephrine) acid tartrate (22.7
mcg/mL) in a 1:80,000 strength.
2% Xylocaine
®
DENTAL with adrenaline (epinephrine) 1:80,000 contains the excipient
with
known effect, sodium metabisulfite. For the full list of excipients,
see Section 6.1 List of
excipients.
3
PHARMACEUTICAL FORM
2% Xylocaine
®
DENTAL with adrenaline (epinephrine) 1:80,000 is a sterile aqueous
solution.
The pH of the solution is 3.3 – 5.0.
Lidocaine (lignocaine) hydrochloride 46.9 milligram/2.2 mL +
adrenaline (epinephrine) acid
tartrate 49.9 microgram/2.2 mL
2.2 mL standard and self-aspirating cartridges
The cartridges are free from preservatives and are intended for single
use only.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lidocaine (lignocaine) solutions are indicated for the production of
local nerve anaesthesia in
routine dental procedures and oral surgery by means of infiltration
and nerve block
techniques.
Lidocaine (lignocaine) solutions with adrenaline (epinephrine) are
recommended for oral
surgery requiring prolonged duration of anaesthesia and haemostasis.
4.2 DOSE AND METHOD OF ADMINISTRATION
2% Xylocaine
®
DENTAL with adrenaline (epinephrine) 1:80,000 has a rapid onset of
action
after infiltration, averaging 2-3 minutes. Inferior alveolar nerve
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. inferior alveolar
nerve block, anaesthesia lasts for 2 hours or longer.
Injections should always be mad