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

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

lidocaine, Quantity: 20 mg/g

Inapatikana kutoka:

Pfizer Australia Pty Ltd

INN (Jina la Kimataifa):

lidocaine (lignocaine)

Dawa fomu:

Gel

Tungo:

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

Njia ya uendeshaji:

Urethral

Vitengo katika mfuko:

10 x 10 g

Darasa:

Medicine Registered

Dawa ya aina:

(S2) Pharmacy Medicine

Matibabu dalili:

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.

Bidhaa muhtasari:

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

Idhini hali ya:

Registered

Idhini ya tarehe:

2008-10-08

Tabia za bidhaa

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