XYLONOR Spray Solution 15% w/w

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lidocaine, Quantity: 150 mg/g; cetrimide, Quantity: 1.5 mg/g

Available from:

Specialites Septodont Pty Ltd

INN (International Name):

Cetrimide,lidocaine (lignocaine)

Pharmaceutical form:

Spray, solution

Composition:

Excipient Ingredients: saccharin; Spearmint oil; dipropylene glycol; ethanol

Administration route:

Topical, Buccal

Units in package:

1 x 36G

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 1 JANUARY 1991: Topical anaesthesia of the mucous membrane of the buccal cavity, before: Nerve block or local anaesthetic injection, Extraction of mobile, deciduous or permanent teeth, Adjustment and fitting of crowns and bridges, Or adjustmentof bands in orthodontic treatments; Lancing of sub mucosal abscesses, Scaling.

Product summary:

Visual Identification: Clear solution.; Container Type: Bottle; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-07-13

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: dressing, medicated; 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 mobil