Xylocaine 1% with Adrenaline 1:100,000

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Adrenaline acid tartrate 0.018mg equivalent to 10 µg adrenaline;  ; Lidocaine hydrochloride monohydrate 10.7mg equivalent to 10 mg lignocaine hydrochloride anhydrous; Adrenaline acid tartrate 0.018mg equivalent to 10 µg adrenaline; Lidocaine hydrochloride monohydrate 10.7mg equivalent to 10 mg lignocaine hydrochloride anhydrous

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Adrenaline acid tartrate 0.018 mg (= 10 µg adrenaline)

Pharmaceutical form:

Solution for injection

Composition:

Active: Adrenaline acid tartrate 0.018mg equivalent to 10 µg adrenaline   Lidocaine hydrochloride monohydrate 10.7mg equivalent to 10 mg lignocaine hydrochloride anhydrous Excipient: Hydrochloric acid as 2M solution for pH adjustment (pH 3.3-5.0) Methyl hydroxybenzoate Sodium chloride Sodium hydroxide as 2M solution for pH adjustment (pH 3.3-5.0) Sodium metabisulfite Water for injection Active: Adrenaline acid tartrate 0.018mg equivalent to 10 µg adrenaline Lidocaine hydrochloride monohydrate 10.7mg equivalent to 10 mg lignocaine hydrochloride anhydrous Excipient: Hydrochloric acid as 2M solution for pH adjustment Nitrogen as Nitrogen for injection Sodium chloride Sodium hydroxide as 2M solution for pH adjustment Sodium metabisulfite Water for injection

Units in package:

Ampoule, glass, 10x5mL, 50 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Boehringer Ingelheim Pharma GmbH & Co KG

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 10x5mL - 50 mL - 18 months from date of manufacture stored at or below 25°C - Ampoule, glass, 5mLx 50 - 250 mL - 18 months from date of manufacture stored at or below 25°C - Vial, glass, multi-dose, 5 x 20mL - 100 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

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