FIBROVEIN 0.5% sodium tetradecyl sulfate 10mg/2mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium tetradecyl sulfate, Quantity: 5 mg/mL

Available from:

Intermed Medical Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

5 x 2mL Ampoules

Prescription type:

(S4) Prescription Only Medicine

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 sclerothearpy. 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.

Product summary:

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

Authorization status:

Registered

Authorization date:

2000-09-04

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
FIBROVEIN 3%, 1%, 0.5% AND 0.2%
SODIUM TETRADECYL SULFATE INJECTION BP
Contents
WHAT IS IN THIS LEAFLET
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1
WHAT FIBROVEIN IS USED FOR
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1
BEFORE USING FIBROVEIN
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2
Taking other medicines
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2
Driving and using machinery
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2
HOW FIBROVEIN IS ADMINISTERED
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2
Adults and the elderly
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3
Children
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3
SIDE EFFECTS
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3
IN CASE OF OVERDOSE
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3
AFTER USING FIBROVEIN
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3
Storage
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3
Ingredients...........................................................................................................................................
4
PRODUCT DESCRIPTION
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Summary of Product characteristics

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