XYLONOR GEL tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

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 indications:

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.

Product summary:

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:

Licence status A

Authorization date:

1991-10-02

Summary of Product characteristics

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