Pfizer (Australia) LIGNOCAINE 2% GEL lidocaine (lignocaine) 2% w/w sterile pre-filled syringe

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

lidocaine, Quantity: 20 mg/g

Commercializzato da:

Pfizer Australia Pty Ltd

INN (Nome Internazionale):

lidocaine (lignocaine)

Forma farmaceutica:

Gel

Composizione:

Excipient Ingredients: glacial acetic acid; propylene glycol; sodium hydroxide; hyetellose; acetic acid; water for injections

Via di somministrazione:

Urethral

Confezione:

10 x 10 g

Classe:

Medicine Registered

Tipo di ricetta:

(S2) Pharmacy Medicine

Indicazioni terapeutiche:

For local anaesthesia and lubrication of the urethra prior to catheterisation, exploration by sound and other endourethral operations and examinations, cystoscopy and symptomatic treatment of painful cystitis and urethritis.

Dettagli prodotto:

Visual Identification: Clear colourless gel.; Container Type: Syringe; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2008-10-08

Scheda tecnica

Version: pfpligng11020
Supersedes: pfpligng11008
Page 1 of 9
AUSTRALIAN
PRODUCT
INFORMATION
LIGNOCAINE 2% GEL [LIDOCAINE (LIGNOCAINE)]
1.
NAME OF THE MEDICINE
Lidocaine (lignocaine).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lignocaine
2%
Gel
is
a
clear,
colourless,
sterile,
preservative-free
water-soluble
gel
containing 20 mg/g lidocaine (lignocaine), propylene glycol,
hyetellose, glacial acetic acid,
sodium hydroxide and acetic acid (for pH adjustment) and water for
injections.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Clear colourless gel.
_ _
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local anaesthesia and lubrication during catheterisation, exploration
by sound and other
endourethral operations and examinations.
Cystoscopy and symptomatic treatment of painful cystitis and
urethritis.
4.2 DOSE AND METHOD OF ADMINISTRATION
As with any local anaesthetic, reactions and complications are best
averted by employing the
minimum effective dosage. Debilitated or elderly patients and children
should be given doses
according to their age and physical condition.
The dose of topical lignocaine should be taken into consideration in
estimating the total dose
of lignocaine if parenteral lignocaine is to be administered
concomitantly.
The following dosage recommendations should be regarded as a guide.
The clinician’s
experience and knowledge of the patient’s physical status are of
importance in calculating the
required dose. 1 mL of Lignocaine 2% Gel is approximately equal to 1 g
of Lignocaine 2%
Gel.
MALES
The usual dose required for adequate analgesia is 20 mL (equiv.
lignocaine 400mg).
Version: pfpligng11020
Supersedes: pfpligng11008
Page 2 of 9
The gel is instilled slowly into the urethra until it reaches the
external sphincter, proximal to
the prostate, where a certain resistance is felt. Compression is then
applied for several
minutes at the corona. The remaining gel is administered, filling the
length of the urethra.
For procedures such as sounding or cys