Fibrovein 0.2% solution for injection 5ml vials

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Sodium tetradecyl sulfate

Saatavilla:

STD Pharmaceutical Products Ltd

ATC-koodi:

C05BB04

INN (Kansainvälinen yleisnimi):

Sodium tetradecyl sulfate

Annos:

2mg/1ml

Lääkemuoto:

Solution for injection

Antoreitti:

Intravenous

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 02130000; GTIN: 5019363102011

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
FIBROVEIN 3%, 1%, 0.5% AND 0.2% SOLUTION FOR INJECTION
Sodium tetradecyl sulphate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
−
Keep this leaflet. You may need to read it again.
−
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 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
sulphate.
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
YOU SHOULD NOT USE FIBROVEIN IF YOU:
•
are allergic (hypersensitive) to sodium tetradecyl sulphate or to any
of the other ingredients in
Fibrovein (listed in section 6)
•
cannot walk due to any reason
•
have severe inflammation of veins in the legs (acute phlebitis)
•
have blood clots in your veins (thrombosis)
•
have risk of developing blood clots in your veins due to:
•
inherited blood disorders such as thrombophilia
•
being significantly overweight
•
immobility for long

Valmisteyhteenveto

OBJECT 1
FIBROVEIN 3%
Summary of Product Characteristics Updated 19-Feb-2016 | STD
Pharmaceutical Products Ltd
1. Name of the medicinal product
Fibrovein 3.0%, 1.0%, 0.5%, 0.2% Solution for Injection
2. Qualitative and quantitative composition
Fibrovein 3.0%
Each ml solution for injection contains 30mg Sodium Tetradecyl
Sulfate.
Each 2ml ampoule contains 60mg Sodium Tetradecyl Sulfate.
Each 5ml vial contains 150mg Sodium Tetradecyl Sulfate.
Fibrovein 1.0%
Each ml solution for injection contains 10mg Sodium Tetradecyl
Sulfate.
Each 2ml ampoule contains 20mg Sodium Tetradecyl Sulfate.
Fibrovein 0.5%
Each ml solution for injection contains 5mg Sodium Tetradecyl Sulfate.
Each 2ml ampoule contains 10 mg Sodium Tetradecyl Sulfate.
Fibrovein 0.2%
Each ml solution for injection contains 2mg Sodium Tetradecyl Sulfate.
Each 5ml vial contains 10 mg Sodium Tetradecyl Sulfate.
Contain benzyl alcohol 20mg/ml. For a full list of excipients, see
section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear, colourless, sterile solution.
pH 7.5 – 7.9.
Osmolarity 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
Method of administration
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 vei