Fibro-Vein 3.0% w/v Solution for Injection (2 ml ampoule)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium tetradecyl sulfate

Available from:

STD Pharmaceutical Products Ltd

ATC code:

C05BB; C05BB04

INN (International Name):

Sodium tetradecyl sulfate

Dosage:

3 percent weight/volume

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Sclerosing agents for local injection; sodium tetradecyl sulfate

Authorization status:

Marketed

Authorization date:

2001-05-04

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fibro-Vein 3.0% w/v Solution for Injection (2 ml ampoule).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains sodium tetradecyl sulfate 3.0% w/v (equivalent to 30 mg/ml).
Excipients: Contains benzyl alcohol 20 mg/ml, sodium 2.43 mg/ml and
potassium 0.29 mg/ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of varicose veins of the leg by injection
sclerotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION
For intravenous administration into the lumen of an isolated segment
of emptied vein followed by immediate
continuous compression.
RECOMMENDED DOSES AND DOSAGE SCHEDULES
_Adults_
0.25 to 1.0ml of 3.0% fibro-vein injected intravenously at a maximum
of 4 sites (maximum 4 ml).
_Children_
Not recommended in children.
_Elderly_
As for adults.
4.3 CONTRAINDICATIONS
1.
Allergy to sodium tetradecyl sulfate or to any component of the
preparation.
2.
Patients unable to walk due to any cause.
3.
Patients currently taking oral contraceptives.
4.
Significant obesity.
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5.
Acute superficial thrombophlebitis.
6.
Local or systemic infection.
7.
Varicosities caused by pelvic or abdomin