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

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

sodium tetradecyl sulfate, Quantity: 10 mg/mL

Disponível em:

Intermed Medical Pty Ltd

Forma farmacêutica:

Injection, solution

Composição:

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

Via de administração:

Intravenous

Unidades em pacote:

5 x 2mL Ampoules

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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.

Resumo do produto:

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

Status de autorização:

Licence status A

Data de autorização:

2000-09-04

Folheto informativo - Bula

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

Características técnicas

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