Pfizer (Australia) LIGNOCAINE 2% GEL WITH CHLORHEXIDINE 0.05% sterile pre-filled syringe

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

lidocaine, Quantity: 20 mg/mL; chlorhexidine gluconate, Quantity: 0.5 mg/mL

Saadav alates:

Pfizer Australia Pty Ltd

Ravimvorm:

Gel

Koostis:

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

Manustamisviis:

Urethral

Ühikuid pakis:

10 x 10 mL

Klass:

Medicine Registered

Retsepti tüüp:

(S2) Pharmacy Medicine

Näidustused:

For local anaesthesia and lubrication of the urethra prior to catheterization. Cystoscopy and symptomatic treatment of painful cystisis and urethritis.

Toote kokkuvõte:

Visual Identification: Clear colourless gel; Container Type: Syringe; Container Material: PP; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

1991-07-09

Toote omadused

Version:
pfpligcg11020
Supersedes:
pfpligcg10316
Page 1 of 10
AUSTRALIAN
PRODUCT
INFORMATION
–
LIGNOCAINE 2% GEL WITH CHLORHEXIDINE
0.05%
[LIDOCAINE
(LIGNOCAINE)
AND
CHLORHEXIDINE
GLUCONATE]
1.
NAME OF THE MEDICINE
Lidocaine (lignocaine) and chlorhexidine gluconate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lignocaine 2% Gel with Chlorhexidine 0.05% is a sterile, colourless,
water-soluble gel
containing lidocaine (lignocaine) 20 mg/mL, chlorhexidine gluconate
500 micrograms/mL,
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
When lignocaine is used for surface anaesthesia it should be
remembered that it may be rapidly
absorbed via the mucous membranes and systemic effects may occur.
Reactions and complications are best avoided by employing the minimum
effective dosage.
Debilitated or elderly patients and children should be given doses
relative 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.
Version:
pfpligcg11020
Supersedes:
pfpligcg10316
Page 2 of 10
MALES
The usual dose required for adequate analgesia is 20 mL (equiv.
lignocaine 400 mg).
The gel is instilled slowly into the urethra until it reaches the
external sphincter, proximal to
the prostate, where a certain resistance is fe