FIBROVEIN 1.0% sodium tetradecyl sulfate 20mg/2ml injection ampoule

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

sodium tetradecyl sulfate, Quantity: 10 mg/mL

Disponible des:

Intermed Medical Pty Ltd

formulario farmacéutico:

Injection, solution

Composición:

Excipient Ingredients: benzyl alcohol; dibasic sodium phosphate dodecahydrate; monobasic potassium phosphate; water for injections; sodium hydroxide

Vía de administración:

Intravenous

Unidades en paquete:

5 x 2mL Ampoules

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

The solution is designed for injection directly into the lumen of the varicose vein and is used as a sclerosant in the treatment of uncomplicated varicose veins of the leg by compression sclerotherapy. The strength of FIBROVEIN selected depends on the size of the veins to be treated. FIBROVEIN 3% is for the treatment of large superficial varicose veins. FIBROVEIN 1% is for the treatment of small varicose veins and the larger venules. Minor venules and spider veins (venous flares) should be treated with FIBROVEIN 0.5% or 0.2%. The selection of the incorrect strength particularly in the case of minor venules and spider veins is liable to give risk to adverse reactions.

Resumen del producto:

Visual Identification: Clear, colourless solution, free from insoluble matter.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estat d'Autorització:

Licence status A

Data d'autorització:

2000-09-04

Informació per a l'usuari

AUSTRALIAN
PRODUCT INFORMATION
FIBROVEIN™ 0.2%, 0.5%, 1.0% AND 3%
(Sodium tetradecyl sulfate)
Solution for Injection
1
NAME OF THE MEDICINE
Sodium tetradecyl sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FIBROVEIN 0.2% Solution for Injection
Each mL solution for injection contains 2 mg sodium tetradecyl
sulfate.
Each 5 mL vial contains 10 mg sodium tetradecyl sulfate.
FIBROVEIN 0.5% Solution for Injection
Each mL solution for injection contains 5 mg sodium tetradecyl
sulfate.
Each 2 mL ampoule contains 10 mg sodium tetradecyl sulfate.
FIBROVEIN 1% Solution for Injection
Each mL solution for injection contains 10 mg sodium tetradecyl
sulfate.
Each 2 mL ampoule contains 20 mg sodium tetradecyl sulfate.
FIBROVEIN 3% Solution for Injection
Each mL solution for injection contains 30 mg sodium tetradecyl
sulfate.
Each 2 mL ampoule contains 60 mg sodium tetradecyl sulfate.
Each 5 mL vial contains 150 mg sodium tetradecyl sulfate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for Injection.
Clear, colourless, sterile solution free from visible particles.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The solution is designed for injection directly into the lumen of the
varicose vein and is used as a sclerosant in the
treatment of uncomplicated varicose veins of the leg by compression
sclerotherapy.
The strength of FIBROVEIN 0.2%, 0.5%, 1.0% AND 3% selected depends on
the size of the veins to be treated.
FIBROVEIN 3% is for the treatment of large superficial varicose veins.
FIBROVEIN 1% is for the treatment of
small varicose veins and the larger venules. Minor venules and spider
veins (venous flares) should be treated with
FIBROVEIN 0.5% or 0.2%. The selection of the incorrect strength
particularly in the case of minor venules and
spider veins is liable to give rise to adverse reactions.
4.2 DOSE AND METHOD OF ADMINISTRATION
Adults and the elderly (not recommended for use in children)
FIBROVEIN 3%
Dosage 0.5 to 1mL at each of four sites (maximum 4mL).
A dose

Fitxa tècnica

AUSTRALIAN
PRODUCT INFORMATION
FIBROVEIN™ 0.2%, 0.5%, 1.0% AND 3%
(Sodium tetradecyl sulfate)
Solution for Injection
1
NAME OF THE MEDICINE
Sodium tetradecyl sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FIBROVEIN 0.2% Solution for Injection
Each mL solution for injection contains 2 mg sodium tetradecyl
sulfate.
Each 5 mL vial contains 10 mg sodium tetradecyl sulfate.
FIBROVEIN 0.5% Solution for Injection
Each mL solution for injection contains 5 mg sodium tetradecyl
sulfate.
Each 2 mL ampoule contains 10 mg sodium tetradecyl sulfate.
FIBROVEIN 1% Solution for Injection
Each mL solution for injection contains 10 mg sodium tetradecyl
sulfate.
Each 2 mL ampoule contains 20 mg sodium tetradecyl sulfate.
FIBROVEIN 3% Solution for Injection
Each mL solution for injection contains 30 mg sodium tetradecyl
sulfate.
Each 2 mL ampoule contains 60 mg sodium tetradecyl sulfate.
Each 5 mL vial contains 150 mg sodium tetradecyl sulfate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for Injection.
Clear, colourless, sterile solution free from visible particles.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The solution is designed for injection directly into the lumen of the
varicose vein and is used as a sclerosant in the
treatment of uncomplicated varicose veins of the leg by compression
sclerotherapy.
The strength of FIBROVEIN 0.2%, 0.5%, 1.0% AND 3% selected depends on
the size of the veins to be treated.
FIBROVEIN 3% is for the treatment of large superficial varicose veins.
FIBROVEIN 1% is for the treatment of
small varicose veins and the larger venules. Minor venules and spider
veins (venous flares) should be treated with
FIBROVEIN 0.5% or 0.2%. The selection of the incorrect strength
particularly in the case of minor venules and
spider veins is liable to give rise to adverse reactions.
4.2 DOSE AND METHOD OF ADMINISTRATION
Adults and the elderly (not recommended for use in children)
FIBROVEIN 3%
Dosage 0.5 to 1mL at each of four sites (maximum 4mL).
A dose