FIBROVEIN 3% sodium tetradecyl sulfate 30mg/1mL multidose injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

sodium tetradecyl sulfate, Quantity: 30 mg/mL

Tilgjengelig fra:

Australasian Medical & Scientific Ltd

Legemiddelform:

Injection, solution

Sammensetning:

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

Administreringsrute:

Intravenous

Enheter i pakken:

10 x 5mL

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

INDICATIONS AS AT 09 JUNE 2005 : 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 rise to adverse reactions.

Produkt oppsummering:

Visual Identification: A clear solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

1991-10-25

Informasjon til brukeren

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

Preparatomtale

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