XYLONOR GEL tube

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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SPC SPC (SPC)
17-11-2021
PAR PAR (PAR)
20-05-2019

active_ingredient:

cetrimide, Quantity: 1.5 mg/g; lidocaine, Quantity: 50 mg/g

MAH:

Specialites Septodont Pty Ltd

pharmaceutical_form:

Gel

composition:

Excipient Ingredients: Spearmint oil; saccharin; macrogol 300; macrogol 4000; macrogol 1500

administration_route:

Topical, Buccal

units_in_package:

15g

class:

Medicine Registered

prescription_type:

(S2) Pharmacy Medicine

therapeutic_indication:

Topical anaesthesia and disinfection of the mucosa before;,- injections,- extraction of mobile, deciduous or permanent teeth,- extraction of teeth due to pyorrhoea,- adjusting and fitting of crowns & bridges,- lancing of abscesses,- scaling,Prevention of gagging during impression taking.

leaflet_short:

Visual Identification: Clear gel; Container Type: Information not supplied by sponsor; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

authorization_status:

Registered

authorization_date:

1991-10-03

SPC

                                1
AUSTRALIAN PRODUCT INFORMATION – XYLONOR (LIDOCAINE
(LIGNOCAINE), CETRIMIDE) TOPICAL ANAESTHETIC
1
NAME OF THE MEDICINE
Lidocaine (lignocaine), cetrimide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
XYLONOR SPRAY
Lidocaine (lignocaine) base
............................................... 15 g
Cetrimide
................................................................................
0.15 g
Excipient q.s. ad.
.................................................................. 100
g
Contains Saccharin and Alcohol (ethanol)
XYLONOR GEL
Lidocaine (lignocaine) base
................................................. 5 g
Cetrimide
................................................................................
0.15 g
Excipient q.s. ad.
................................................................. 100
mL
Contains Saccharin
XYLONOR PELLETS
Lidocaine (lignocaine) base
................................................. 5 g
Cetrimide
................................................................................
0.15 g
Excipient q.s. ad.
................................................................. 100
mL
Contains Saccharin
One impregnated pellet contains approximately 100 mg of the above
solution.
For the full list of excipients, see Section 6.1 List of excipients.
XYLONOR is an association of:
•
a powerful anaesthetic, Lidocaine (lignocaine),
a bactericide, Cetrimide, in a non-irritant, water-soluble excipient.
3
PHARMACEUTICAL FORM
XYLONOR GEL: clear gel
XYLONOR PELLETS: solution; pellet soaked in solution
XYLONOR SPRAY: Spray with clear solution
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
XYLONOR GEL
Topical anaesthesia and disinfection of the mucosa before:
-
injections
-
extraction of mobile, deciduous or permanent teeth
-
extraction of teeth due to pyorrhoea
-
adjusting and fitting of crowns & bridges
-
lancing of abscesses
-
scaling
Prevention of gagging during impression taking.
XYLONOR PELLETS
Topical anaesthesia and disinfection of the mucosa before:
-
injections
-
extraction of mobile, deciduou
                                
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