Xylocaine 0.5% (25mg/5mL) ampoule

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

lidocaine hydrochloride, Quantity: 5 mg/mL

זמין מ:

Aspen Pharmacare Australia Pty Ltd

טופס פרצבטיות:

Injection, solution

הרכב:

Excipient Ingredients: water for injections; sodium chloride; sodium hydroxide

מסלול נתינה (של תרופות):

Intravenous, Intramuscular, Epidural, Infiltration

יחידות באריזה:

5mL x 10, 5mL x 50

סיווג:

Medicine Registered

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

XYLOCAINE solutions are indicated for the production of local or regional anaesthesia by the following techniques; infiltration, intravenous regional anaesthesia - excluding solutions with adrenaline, peripheral nerve block such as intercostal block, major plexus block such as brachial plexus block, epidural block, subarachnoid block

leaflet_short:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

1991-08-13

מאפייני מוצר

1
AUSTRALIAN PRODUCT INFORMATION
XYLOCAINE AND XYLOCAINE WITH ADRENALINE
Lidocaine (lignocaine) hydrochloride
Lidocaine (lignocaine) hydrochloride with adrenaline (epinephrine)
acid tartrate
(Injection solutions for the production of local or regional
anaesthesia)
1
NAME OF THE MEDICINE
XYLOCAINE: lidocaine (lignocaine) hydrochloride
XYLOCAINE with ADRENALINE: lidocaine (lignocaine) hydrochloride and
adrenaline
(epinephrine) acid tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plain aqueous solutions are sterile, isotonic and contain lidocaine
(lignocaine) hydrochloride,
sodium chloride, sodium hydroxide and/or hydrochloric acid for pH
adjustment and water for
injections.
Lidocaine (lignocaine) hydrochloride with adrenaline (epinephrine)
acid tartrate solutions are
also sterile and isotonic, and in addition contain adrenaline
(epinephrine) acid tartrate and
sodium metabisulfite.
Excipients with known effect: XYLOCAINE with ADRENALINE contains
sulphites.
XYLOCAINE solutions contain no antimicrobial agent and should be used
only once and any
residue discarded.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Clear, colourless solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
XYLOCAINE solutions are indicated for the production of local or
regional anaesthesia by
the following techniques:
−
infiltration,
−
intravenous regional anaesthesia – excluding solutions with
adrenaline
(epinephrine) acid tartrate,
−
peripheral nerve block such as intercostal block,
−
major plexus block such as brachial plexus block,
−
epidural block,
−
subarachnoid block.
4.2
D
OSE AND METHOD OF ADMINISTRATION
2
The lowest dosage and volume that results in effective anaesthesia
should be used and should
be based on the status of the patient and the type of regional
anaesthesia intended.
XYLOCAINE solutions contain no antimicrobial agent and should be used
only once and any
residue discarded.
Lidocaine (lignocaine) should be administered with great caution to