Xylocaine 2%

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lidocaine hydrochloride monohydrate 21.3mg equivalent to 20 mg lignocaine hydrochloride anhydrous;  ;  

Available from:

Dentsply Sirona (NZ) Limited

INN (International Name):

Lidocaine hydrochloride monohydrate 21.3 mg (=20 mg lignocaine hydrochloride anhydrous)

Dosage:

2 %

Pharmaceutical form:

Solution for injection

Composition:

Active: Lidocaine hydrochloride monohydrate 21.3mg equivalent to 20 mg lignocaine hydrochloride anhydrous     Excipient: Sodium chloride Sodium hydroxide as 2M solution for pH adjustment Water for injection

Units in package:

Cartridge, glass, 2.2mL x 100, 220 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Moehs Catalana SL

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, 2.2mL x 100 - 220 mL - 36 months from date of manufacture stored at or below 25°C - Cartridge, plastic, 2.2mL x 100 - 220 mL - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Summary of Product characteristics

X
YLOCAINE
Data Sheet
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Xylocaine 1% Solution for Injection
Xylocaine 2% Solution for Injection
Xylocaine 1% with Adrenaline 1:100,000 Solution for Injection
Xylocaine 1% with Adrenaline 1:200,000 Solution for Injection
Xylocaine 2% with Adrenaline 1:200,000 Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Xylocaine 1%: Each mL of solution for injection contains 10mg of
lidocaine hydrochloride.
Xylocaine 2%: Each mL of solution for injection contains 20mg of
lidocaine hydrochloride.
Xylocaine 1% with Adrenaline 1:100,000: Each mL of solution for
injection contains 10mg of
lidocaine hydrochloride and 10micrograms of adrenaline (epinephrine)
as acid tartrate.
Xylocaine 1% with Adrenaline 1:200,000: Each mL of solution for
injection contains 10mg of
lidocaine hydrochloride and 5micrograms of adrenaline (epinephrine) as
acid tartrate.
Xylocaine 2% with Adrenaline 1:200,000: Each mL of solution for
injection contains 20mg of
lidocaine hydrochloride and 5micrograms of adrenaline (epinephrine) as
acid tartrate.
(Note: Lidocaine is another name for lignocaine. Lidocaine is used in
this document.
Epinephrine is another name for adrenaline. Adrenaline is mostly used
in this document.)
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
X
YLOCAINE
solution for injection is a sterile, isotonic aqueous solution. The pH
of the solution
is 5.0-7.0. The ampoules are free from preservatives and are intended
for single use only.
X
YLOCAINE
with adrenaline solution for injection is a sterile, isotonic aqueous
solution. It
contains sodium metabisulphite as an antioxidant. The pH of the
solution is 3.3-5.0.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
X
YLOCAINE
solutions are indicated for the production of local or regional
anaesthesia by the
following techniques:
•
local infiltration
•
minor or major nerve blocks
•
epidural block
•
arthroscopy
•
intravenous regional anaesthesia
X
YLOCAINE
Data Sheet
Copyright
2
4.2
DOSE AND METHOD OF ADMINISTRA