FIBROVEIN 3% sodium tetradecyl sulfate 60mg/2mL injection ampoule

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

sodium tetradecyl sulfate, Quantity: 30 mg/mL

Sẵn có từ:

Australasian Medical & Scientific Ltd

Dạng dược phẩm:

Injection, solution

Thành phần:

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

Tuyến hành chính:

Intravenous

Các đơn vị trong gói:

5x2mL

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

Visual Identification: A clear solution; 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

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

1991-10-25

Tờ rơi thông tin

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

Đặc tính sản phẩm

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