Fibro-Vein 0.5% w/v Solution for Injection

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Sodium tetradecyl sulfate

Pieejams no:

STD Pharmaceutical Products Ltd

ATĶ kods:

C05BB; C05BB04

SNN (starptautisko nepatentēto nosaukumu):

Sodium tetradecyl sulfate

Deva:

0.5 percent weight/volume

Zāļu forma:

Solution for injection

Receptes veids:

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

Ārstniecības joma:

Sclerosing agents for local injection; sodium tetradecyl sulfate

Autorizācija statuss:

Marketed

Autorizācija datums:

2001-05-04

Lietošanas instrukcija

PACKAGE LEAFLET:
INFORMATION FOR THE USER
FIBRO-VEIN 0.2% W/V, 0.5% W/V, 1% W/V AND 3% W/V
SOLUTION FOR INJECTION
Sodium tetradecyl sulphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN
THIS INJECTION.

Keep this leaflet. You may need to read it again
while you are receiving your treatment.

If you have any further questions, please ask your
doctor or pharmacist.

This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.

If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Fibro-Vein Injection is and what it is used for
2.
Before you are given Fibro-Vein Injection
3.
Your treatment with Fibro-Vein Injection
4.
Possible side effects
5.
How to store Fibro-Vein Injection
6.
Further information
1.
WHAT FIBRO-VEIN INJECTION IS AND WHAT IT IS
USED FOR
The name of your medicine is Fibro-Vein Injection,
which contains the active ingredient sodium tetradecyl
sulphate.
This injection belongs to a group of medicines called
sclerosants. Sclerosants are chemical agents, when
injected into the affected vein causes the lining of the
vein walls to swell and the walls stick together. This
stops the flow of blood and the vein turns into scar
tissue. In a few weeks, the vein should fade.
Different strengths of Fibro-Vein Injection are used in
the treatment of varicose veins, minor venules and
spider veins.
2.
BEFORE YOU TAKE FIBRO-VEIN INJECTION
YOU SHOULD NOT TAKE FIBRO-VEIN INJECTION IF YOU:

are allergic (hypersensitive) to sodium tetradecyl
sulphate or to any of the other ingredients in
Fibro-Vein Injection (see section 6, Further
information)

cannot walk due to any reason

have severe inflammation of veins in the
legs(acute phlebitis)

have blood clots in your veins (thrombosis)

have twisted veins (varicose veins) caused by
pelvic or abdominal tumours

are significantly overweight

have any ki

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fibro-Vein 0.5% w/v Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains sodium tetradecyl sulfate 0.5% w/v (equivalent to 5 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 and venous flares 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 0.5% fibro-vein injected intravenously at a maximum
of 10 sites (maximum 10ml).
_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 abdo