Fibrovein

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sodium tetradecyl sulfate 0.2%{relative}

Available from:

New Zealand Medical & Scientific Ltd

INN (International Name):

Sodium tetradecyl sulfate 0.2%

Dosage:

0.2 %

Pharmaceutical form:

Solution for injection

Composition:

Active: Sodium tetradecyl sulfate 0.2%{relative} Excipient: Benzyl alcohol Dibasic sodium phosphate dodecahydrate Monobasic potassium phosphate Sodium hydroxide Water for injection

Units in package:

Vial, glass, 5mL, 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Cambrex Karlskoga AB

Therapeutic indications:

The treatment of minor venules and spider veins (venous flares) by injection sclerotherapy.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 5mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Summary of Product characteristics

NEW ZEALAND DATASHEET
1 PRODUCT NAME
FIBROVEIN
3.0%, 1.0%, 0.5% and 0.2% intravenous injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Tetradecyl Sulphate 3.0%, 1.0%, 0.5% and 0.2% intravenous
injection
Contains 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
Fibrovein
3%
and
1%:
For
the
treatment
of
varicose
veins
of
the
leg
by
injection
sclerotherapy.
Fibrovein 0.5%: For the treatment of varicose veins and venous flares
of the leg by injection
sclerotherapy.
Fibrovein 0.2%: For the treatment of minor venules and spider veins
(venous flares) by
injection sclerotherapy.
4.2 Dose and 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 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.
RECOMMENDED DOSES AND DOSAGE SCHEDULES:
ADULTS
Fibrovein 3.0%: 0.5 to 1.0ml of 3.0% Fibrovein injected intravenously
at each of 4 sites
(maximum 4ml).
Fibrovein 1.0%: 0.25 to 1.0ml of 1.0% Fibrovein injected intravenously
into the lumen of an
isolated
segment
of
emptied
superficial
vein,
followed
by
immediate
compression.
A
maximum of 10 sites (10ml total) m