Fibrovein 1% Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium tetradecyl sulfate

Available from:

STD Pharmaceutical (Ireland) Limited

ATC code:

C05BB04

INN (International Name):

Sodium tetradecyl sulfate

Pharmaceutical form:

Solution for injection

Therapeutic area:

sodium tetradecyl sulfate

Authorization status:

Not marketed

Authorization date:

2023-05-19

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
FIBROVEIN 0.2 %, 0.5 %, 1 % & 3 % SOLUTION FOR INJECTION
sodium tetradecyl sulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or nurse.

If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Fibrovein is and what it is used for
2. What you need to know before you use Fibrovein
3. How to use Fibrovein
4. Possible side effects
5. How to store Fibrovein
6. Contents of the pack and other information
1. WHAT FIBROVEIN IS AND WHAT IT IS USED FOR
The name of your medicine is Fibrovein, which contains the active
ingredient sodium
tetradecyl sulfate.
Different strengths of Fibrovein are used in the treatment of varicose
veins, large, medium or minor
venules and spider veins.
This injection belongs to a group of medicines called sclerosants.
Sclerosants are chemical agents,
when injected into the affected vein they cause 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.
Fibrovein is only for use in adults (including the elderly).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FIBROVEIN
DO NOT USE FIBROVEIN IF YOU:

are allergic to sodium tetradecyl sulfate or to any of the other
ingredients of this medicine (listed in
section 6) or have an allergic condition

cannot walk due to any reason or bedridden

have risk of developing blood clots in your veins due to:

inherited blood disorders such as thrombophilia

having hormonal contraception or hormone replacement therapy.

being significantly overweight

smoking

immobility for long duration

have had recent blood clots in superficial or deep veins or in the
lungs
�

Summary of Product characteristics

Health Products Regulatory Authority
22 May 2023
CRN00DC4V
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fibrovein 1% Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Excipient(s) with known effect
Contains benzyl alcohol 20 mg/ml.
Contains sodium up to approximately 1.7 mg/ml.
Contains potassium 0.3 mg/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, sterile solution free from visible particles.
pH 7.5 – 7.9.
Osmolality 247 – 273 mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of uncomplicated primary varicose veins, recurrent
or residual varicose veins following surgery, reticular
veins, venules and spider veins of the lower extremities that show
simple dilation.
Fibrovein is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Fibrovein is for intravenous use only. The strength of solution
required depends on the size and degree of varicosity. Spider
veins should only be treated with the 0.2%, reticular veins with 0.5%,
the 1% solution will be found most useful for small to
medium varicosities and the 3% solution for larger varicosities. The
size of non-visible varicose veins should be measured
under ultrasound.
The sclerosant should be administered intravenously in small aliquots
at multiple sites along the vein to be treated either as a
liquid or as a sclerosant/air mixture (foam), for the treatment of
larger veins with the 1% and 3% solutions. The objective is to
achieve optimal destruction of the vessel wall with the minimum
concentration of sclerosant necessary for a clinical result. If
the concentration is too high necrosis or other adverse sequelae may
occur.
_Adults_
_CONCENTRATION_ ​
_NORMAL VOLUME INJECTED _
_INTRAVENOUSLY AT SUITABLE_
_SITES PER SESSION_ ​
_M