Consumer medicine information

Fibrovein 3%, 1%, 0.5% and 0.2%

Sodium tetradecyl sulfate

BRAND INFORMATION

Brand name

Fibrovein

Active ingredient

Sodium tetradecyl sulfate

Schedule

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about FIBROVEIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using FIBROVEIN against the benefits they expect it will have for you. It is important that you follow the instructions before and after treatment with FIBROVEIN.

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.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

WHAT FIBROVEIN IS USED FOR

FIBROVEIN contains sodium tetradecyl sulfate, which is one of the group of medicines known as sclerosants.

FIBROVEIN is only for use in adults (including the elderly) in a procedure called compression sclerotherapy; for the treatment of varicose veins.

BEFORE USING FIBROVEIN

FIBROVEIN should not be used if you have any of the following medical conditions. Before starting treatment, you must tell your doctor if you:

are pregnant, trying to become pregnant or breast feeding
have previously experienced a reaction to FIBROVEIN or any other product containing sodium tetradecyl sulfate
are allergic (hypersensitive) to other medicines or to a variety of foods
are a smoker
suffer from any of the following medical conditions:
- asthma, lung disease, breathing problems or any allergic disease
- tumours or any blood disorders
- diabetes
- thyroid problems
- difficulty walking
- any skin problems
- recent surgery
- recent blood clots in superficial or deep veins or in the lungs
- recent surgery
- twisted veins (varicose veins) caused by pelvic or abdominal tumours, unless the tumour has been removed
- any kind of infection
- severe heart disease
- excessive fluid accumulation in the lungs causing shortness of breath
- blockage in an artery
- problems with closing of valves in deep veins (valvular incompetence)
are taking any of these medicines:
- the oral contraceptive pill
- medicines for the treatment of blood clots (thrombosis)
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 duration
- having hormonal contraception or hormone replacement therapy.
- smoking

FIBROVEIN should be administered only by experienced healthcare professionals experienced in venous anatomy and familiar with proper injection technique. Before using this injection, you may be tested to see if you have any problems with the closing of the valves in your veins.

During one treatment session, up to 10 sites of each limb may be injected with the lower strength solutions.

Your doctor will ask you questions about your health and will inform you about the potential side effects of this procedure.

Your doctor will monitor you during and after the sclerotherapy for signs of hypersensitivity (redness, itching, cough) or neurological symptoms (visual disorders, migraine, tingling or numbness). He will ask you to come back for a follow up visit.

Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Driving and using machinery
After the treatment with this injection, you may be told to wear a bandage and/or compression stockings to help reduce inflammation and pigmentation of the skin which could affect your ability to drive.

HOW FIBROVEIN IS ADMINISTERED

Your doctor should use ultrasound guidance in the treatment of non-visible varicose veins.

Your doctor will decide on the areas to treat and the right dose for you. The usual doses are as follows:

Adults and the elderly
Dosage varies between 0.1 and 2 ml for each injection. A maximum of 10 ml of the three lower strength injections may be used, however no more than 4 ml is used when the strongest injection is used.

Due to the limited volume of sclerosant authorised, repeated sessions of sclerotherapy may be necessary.

Children
FIBROVEIN is not intended for use for children.

After you have been treated with FIBROVEIN, you should follow your doctor’s advice. You may be told to wear a bandage and or/compression stockings to help reduce inflammation and pigmentation of the skin.

SIDE EFFECTS

Like all medicines, FIBROVEIN can cause side effects, although not everybody gets them.

Common (at least 1 in 100 but less than 1 in 10 patients):

Pain or burning (short term at the injection site)
Superficial inflammation of the vein
Growth of very fine spider veins in the treated area (matting)

Uncommon (at least 1 in 1,000 but less than 1 in 100 patients):

Local allergic and non-allergic skin reactions e.g. redness of skin, itchy skin, rash or swelling of the skin
Growth of fine spider veins in treated area
Blood clots in deep veins (Deep vein thrombosis possibly due to underlying disease)
Skin discolouration may occur (a small semi-permanent (up to 18 months)

Rare (at least 1 in 10,000 but less than 1 in 1,000 patients):

Local tissue death of skin and more rarely of nerves

Very rare (less than or 1 in 10,000 patients):

Coughing, shortness of breath, sensation of pressure/tightness in the chest
Burning, tingling, prickling or itching of the skin
Headache, migraine, feeling faint
Confusion, dizziness, loss of consciousness
Fever, hot flushes, asthma, red itchy skin (hives) or severe allergic reactions (anaphylactic shock)
Nausea, vomiting, diarrhoea, feeling of swollen/thick tongue, dry mouth
Visual disturbances
Weakness, stroke like symptoms
Blockage of artery due to a clot (stroke, transient ischemic attack, pulmonary embolism)
Inflammation of blood vessels, failure of blood circulation
Death of tissue following intra-arterial injection

If you experience any serious side effects or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.

The most serious side effects are:

a very severe form of allergic reaction (anaphylactic shock). It is extremely rare but should be treated immediately, otherwise it may be fatal
a blood clot in the lungs. To avoid this very rare serious event, this product is contra-indicated in patients who have a risk of clots in veins and arteries (risk of thrombosis).

IN CASE OF OVERDOSE

No cases of overdosage with FIBROVEIN have been reported.

AFTER USING FIBROVEIN

Storage

Keep out the reach and sight of children.

Store below 25°C, away from direct sunlight. The injection should be stored in the outer carton to protect it from light. Do not freeze.

FIBROVEIN should not be used after the expiry date given on the carton; the expiry date refers to the last day of the month.

For single use only. Once the container is opened, the contents should be used immediately. Any remaining product should be discarded

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Ingredients

The active ingredient in FIBROVEIN 0.2%, 0.5%, 1% and 3% is sodium tetradecyl sulfate.

The other ingredients are: benzyl alcohol (20 mg/ml or 2%), dibasic sodium phosphate, monobasic potassium phosphate, water for injections, sodium hydroxide (to adjust the pH).

PRODUCT DESCRIPTION

FIBROVEIN is a sterile clear and colourless solution for injection in clear glass ampoules or vials. It has a pH of 7.6,

Different strengths of FIBROVEIN are used in the treatment of varicose veins, large, medium or minor venules and spider veins.

FIBROVEIN comes in 4 strengths.

FIBROVEIN 3%, sodium tetradecyl sulfate 30 mg/1 mL in 10X5 mL vials or 60 mg/2 mL 5X2 mL ampoules
FIBROVEIN 1%, sodium tetradecyl sulfate 20 mg/2 mL, 5X2 mLampoules
FIBROVEIN 0.5%, sodium tetradecyl sulfate 10 mg/2 mL, 5X2 mLampoules
FIBROVEIN 0.2%, sodium tetradecyl sulfate 2mg/1 mL 10X5 mL vials

SPONSOR

Australasian Medical & Scientific Limited
2 McCabe Place,
Chatswood NSW 2067

Australian Registration Number

FIBROVEIN 3% 10X5 mL vials AUSTR29772

FIBROVEIN 3%, 5X2 mL ampoules AUSTR29638

FIBROVEIN 1%, 5X2 mL ampoules AUSTR73362

FIBROVEIN 0.5%, 5X2 mL ampoules AUSTR73361

FIBROVEIN 0.2% 10X5 mL vials AUST R 73360

Date of preparation
Last revised in February 2021

Published by MIMS March 2021

BRAND INFORMATION

Brand name

Fibrovein

Active ingredient

Sodium tetradecyl sulfate

Schedule

1 Name of Medicine

Sodium tetradecyl sulfate.

2 Qualitative and Quantitative Composition

Fibrovein 0.2% solution for injection.

Each mL solution for injection contains 2 mg sodium tetradecyl sulfate.
Each 5 mL vial contains 10 mg sodium tetradecyl sulfate.

Fibrovein 0.5% solution for injection.

Each mL solution for injection contains 5 mg sodium tetradecyl sulfate.
Each 2 mL ampoule contains 10 mg sodium tetradecyl sulfate.

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.

Fibrovein 3% solution for injection.

Each mL solution for injection contains 30 mg sodium tetradecyl sulfate.
Each 2 mL ampoule contains 60 mg sodium tetradecyl sulfate.
Each 5 mL vial contains 150 mg sodium tetradecyl sulfate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Clear, colourless, sterile solution free from visible particles.

4 Clinical Particulars

4.1 Therapeutic Indications

The solution is designed for injection directly into the lumen of the varicose vein and is used as a sclerosant in the treatment of uncomplicated varicose veins of the leg by compression sclerotherapy.
The strength of Fibrovein 0.2%, 0.5%, 1.0% and 3% selected depends on the size of the veins to be treated. Fibrovein 3% is for the treatment of large superficial varicose veins. Fibrovein 1% is for the treatment of small varicose veins and the larger venules. Minor venules and spider veins (venous flares) should be treated with Fibrovein 0.5% or 0.2%. The selection of the incorrect strength particularly in the case of minor venules and spider veins is liable to give rise to adverse reactions.

4.2 Dose and Method of Administration

Adults and the elderly (not recommended for use in children).

Fibrovein 3%.

Dosage 0.5 to 1 mL at each of four sites (maximum 4 mL).
A dose of 0.5-1 mL is introduced into the superficial vein over the site of an incompetent perforating vein. A 25 gauge needle is recommended. It is never necessary or desirable to inject more than 1 mL at any one site and often half this volume will produce the desired effect. Three or four such injections can be given into one limb at the same visit.

Fibrovein 1%.

Dosage 0.25-1 mL at each of 10 sites (maximum 10 mL).
A dose of 0.25 to 1 mL of Fibrovein is injected directly into the lumen of an isolated segment of emptied superficial vein, followed by immediate continuous compression. A maximum of ten sites (10 mL) total may be injected during one treatment session.

Fibrovein 0.5%.

Dosage 0.25-1 mL at each of 10 sites (maximum 10 mL).
A dose of 0.25 to 1 mL of Fibrovein 0.5% is injected directly into the lumen of an isolated segment of emptied superficial vein, followed by immediate continuous compression. A maximum of ten sites (10 mL total) may be injected during one treatment session.

Fibrovein 0.2%.

Dosage 0.1-1 mL at each of 10 sites (maximum 10 mL).
A dose of 0.1 to 1 mL of Fibrovein 0.2% is injected directly into the lumen of an isolated segment of emptied superficial vein, followed by immediate continuous compression. A maximum of ten sites (10 mL total) may be injected during one treatment session.

Method of administration.

Fibrovein should only be administered by medical practitioners experienced in injection sclerotherapy.
Strict aseptic technique must be maintained while handling Fibrovein.
Fibrovein is a single-use parenteral product. Once the container is opened, use immediately and discard any unused portion.
Visually inspect for particulate matter before use. Solutions that contain particulate matter should not be used.

Compression therapy technique and aftercare.

The treatment of varicose veins by compression sclerotherapy is directed towards the restoration of the efficiency of the synchronised pumping systems within the leg by permanently destroying the leaking points rather than by the eradication of the superficial tortuous veins of the limb. Localisation of the incompetent perforating veins is the supremely important object of diagnosis.
Treatment comprises the permanent blocking of the offending leak by producing a short fibrotic segment of vein involving the area of the junction of the perforating and superficial veins. This can be achieved by carrying out the following procedure:
1. The first injection should be given at the most distal chosen site. The following needle sizes are recommended: Fibrovein 3% 25 gauge needle; Fibrovein 1% 27 gauge needle; Fibrovein 0.5% 30 gauge needle. Compression should be applied immediately and before the adjacent site is injected.
2. The sclerosant should be introduced into this vein after it has been emptied.
3. The sclerosant should be maintained within the empty and isolated segment of the vein for approximately 30 seconds.
4. Compression should be applied immediately to the site of injection. It should be uninterrupted and must be maintained for 6 weeks after the last chosen site is injected. One should feel quite confident that, when the patient stands erect, the internal pressure of the blood in the adjacent unobliterated vein cannot reopen the segment; otherwise compression should be reapplied. The segment of the veins should have become a palpable, firm fibrous cord and there should be no sign of tenderness.
5. Application of compression is most suitably obtained by firm bandaging with a number of strong cotton crepe bandages and by incorporating therein shaped rubber pads over the sites of injection.
A class 1 elastic stocking applied over the bandage aids compression and the retention of the bandages in position. For Fibrovein 1% the compression regime may be replaced by the use of class 2 or 3 graduated compression elastic stocking at an early stage. It must, however, be remembered that the process of fibrosis is not shortened for smaller veins and adequate compression must be maintained for 6 weeks.

Walking.

Walking should commence as soon as possible after the completion of treatment and last for at least one hour. Subsequent daily walking of one hours duration is essential.

Standing.

Patients must be advised to avoid even short periods of standing still.
The injection of Fibrovein 0.5% and Fibrovein 0.2% should be made slowly so that the blood content of these veins is expelled. In the treatment of spider veins and fine spider veins an air block technique may be used, for this a shaken foam, or a small amount of air (0.05 mL) is first injected into the venous flare followed by the sclerosant which is then seen to flow around the veins with immediate blanching. Even with Fibrovein 0.5% and Fibrovein 0.2%, extra vascular injection should be avoided. Injected sites should be compressed with a bandage within half a minute of injection and this pressure continued whilst the other sites are injected at the same session. The bandage may be replaced by a class 2 graduated elastic stocking at the end of the session and this compression maintained throughout the ensuing 2 to 3 weeks. Periods of inactive standing should be avoided.
The use of a small dose, the isolation of the injection within the vein segment and the application of immediate adequate and lasting compression are of supreme importance in obtaining a good result.

4.3 Contraindications

Not recommended for the treatment of varicose veins by compression sclerotherapy when any of the following factors are present:
Hypersensitivity to active substance or any of the excipients listed (see Section 6.1 List of Excipients) and allergic conditions.
Unable to walk due to any cause, bedridden patient. As the recommended treatment involved daily periods of walking by the patient, it is not advisable to embark upon treatment if for any reason the patient cannot walk at least 5 km each day.
Obese legs. It is recommended that patients with obese legs should not receive treatment. In many cases this obesity may be corrected by dieting, after which time treatment may be commenced.
High risk of thrombosis e.g. a congenital predisposition to blood clots or multiple risk factors such as hormonal contraception or hormone replacement therapy, significant obesity, smoking or extended periods of immobility.
Recent acute superficial thrombophlebitis, deep vein thrombosis or pulmonary embolism.
Recent surgery.
Varicosities caused by pelvic or abdominal tumours unless the tumour has been removed.
Uncontrolled systemic disease such as diabetes mellitus, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.
Evolutive cancer.
Significant valvular or deep vein incompetence.
Occlusive arterial disease.
Huge superficial veins with wide open communications to deeper veins.
Phlebitis migrans.
Acute cellulitis.
Acute infections.

4.4 Special Warnings and Precautions for Use

General precautions.

Fibrovein should only be administered by a healthcare professional experienced in venous anatomy and the diagnosis and treatment of conditions affecting the venous system and familiar with proper injection technique.
Emergency resuscitation equipment should be immediately available. Allergic reactions, including anaphylaxis have been reported. The possibility of an anaphylactic reaction should be kept in mind, and the physician should be prepared to treat it appropriately.
Before treatment, healthcare professional should investigate patient's risk factors and inform them about the risks of the technique.
As a reminder, sclerotherapy is contraindicated in patients with high risk of thromboembolic events, but should also be avoided in most situations at lower risk. Sclerotherapy is notably not recommended in patients with a history of thromboembolic events. Nevertheless, if sclerotherapy is judged necessary, preventive anticoagulation can be initiated.

Migraine.

Previous migraine sufferers should be treated with care. Patients with previous migraine have been shown to be more likely to suffer from visual disturbances and migraine. Use smaller volumes in patients with history of migraine.

Lymphoedema.

If venous insufficiency is associated with lymphoedema, the sclerosant injection may worsen local pain and inflammation for days or several weeks. Patients should be informed of this expected phase, which does not compromise efficacy.

Extravasation.

Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, extreme care in intravenous needle placement and using the minimal effective volume at each injection site are important. Pigmentation may be more likely to result if blood is extravasated at the injection site (particularly when treating smaller surface veins) and compression is not used. Special care should be exercised when injecting above and posterior to the medial malleolus where the posterior tibial artery may be at risk of inadvertent injection.

Intra-arterial injection.

Sclerosants must never be injected into an artery as this can cause extended tissue necrosis and may result in loss of the extremity. Injection under duplex ultrasound is recommended in order to avoid extravasations and arterial injection.
Healthcare professional should monitor the patient during and after the administration of Fibrovein. Symptoms of hypersensitivity (redness, pruritus, cough) or neurological symptoms (scotoma, amaurosis, migraine with aura, paraesthesia, focal deficit) may happen.

Respiratory disease.

Special care should be taken in patients with laboured breathing (bronchial asthma) or a strong predisposition to allergies (see Section 4.2 Dose and Method of Administration).

Pre-injection evaluation.

Because of the danger of thrombosis extension into the deep venous system, thorough pre-injection evaluation for valvular competency should be carried out and slow injections with a small amount (not over 2 mL) of the preparation should be injected into the varicosity. Deep venous patency must be determined by non-invasive testing such as duplex ultrasound. Venous sclerotherapy should not be undertaken if tests such as Trendelenburg and Perthes, and angiography show significant valvular or deep venous incompetence.

Follow-up.

Healthcare professional should see the patient again after 1 month for a control of treatment efficacy and safety, by clinical and ultrasound evaluation.
The development of deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of superficial varicosities. Patients should have post-treatment follow-up of sufficient duration to assess for the development of deep vein thrombosis. Embolism may occur as long as four weeks after injection of sodium tetradecyl sulfate. Adequate post-treatment compression may decrease the incidence of deep vein thrombosis.

Allergy.

A history of allergy should be taken from all patients prior to treatment. Special care should be taken in patients with laboured breathing (bronchial asthma) or a strong predisposition to allergies (see Section 4.2 Dose and Method of Administration).
In particular allergic reactions to previous injections of sodium tetradecyl sulfate should be noted (see Section 4.3 Contraindications). A higher incidence of allergic reaction is thought to result from repeated treatment involving sodium tetradecyl sulfate injection and may involve intervals of several years between courses of injection. Where special caution is indicated a test dose of 0.25 to 0.5 mL of Fibrovein 0.2%, 0.5%, 1.0% and 3% should be given up to 24 hours before any further therapy. The single test dose should be injected into the lumen of a vein selected for treatment; the appropriate strength of Fibrovein 0.2%, 0.5%, 1.0% and 3% should be selected according to vein size.

Anaphylaxis.

Medical practitioners should monitor the patient during and after the administration of Fibrovein 0.2%, 0.5%, 1.0% and 3%. Symptoms of hypersensitivity (redness, pruritus, cough) or neurological symptoms (scotoma, amaurosis, migraine with aura, paresthesia, focal deficit) may happen.
Emergency resuscitation equipment should be immediately available. Allergic reactions, including anaphylaxis have been reported. Serious anaphylactoid reactions require immediate emergency treatment.
The Fibrovein 0.2%, 0.5%, 1.0% and 3% injection must be stopped immediately and emergency treatment with adrenaline, oxygen and intravenous steroids should be commenced. Adrenaline should be used early at the first suspicion of anaphylaxis. Airway management, including intubation should always be administered as indicated. The treatment of varicose veins with Fibrovein 0.2%, 0.5%, 1.0% and 3% should not be undertaken in settings where the emergency treatment of anaphylaxis is not immediately available.

Underlying arterial disease.

Extreme caution in use is required in patients with underlying arterial disease such as severe peripheral atherosclerosis or thromboangiitis obliterans (Buerger's disease).

Foot and malleolar area.

Special care is required when injecting the foot and malleolar area where the risk of inadvertent injection into an artery may be increased.

Excipients.

This medicinal product contains: less than 1 mmol sodium (23 mg) per vial/ampoule, i.e. essentially 'sodium-free'; less than 1 mmol potassium (39 mg) per vial/ampoule, i.e. essentially 'potassium-free'.

Use in the elderly.

No specific dose recommendations apply.

Paediatric use.

The safety and efficacy of Fibrovein in children and adolescents have not been established. Not recommended for use in children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Heparin should not be used in the same syringe.
There is no data on drug interactions.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

It is not known whether sodium tetradecyl sulfate affects fertility.
(Category B2)
Safety for use in pregnancy has not been established. There are no or limited amount of data from the use of sodium tetradecyl sulfate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Therefore use in pregnancy is not recommended.

Category B2.

Animal reproduction studies have not been conducted with sodium tetradecyl sulfate, nor have studies been performed in pregnant women. Because it is not known whether sodium tetradecyl sulfate can cause foetal harm when administered to pregnant women, the use of sodium tetradecyl sulfate in pregnancy is not recommended.
It is not known whether sodium tetradecyl sulfate is distributed into human or animal milk, therefore use in lactation is not recommended.

4.7 Effects on Ability to Drive and Use Machines

Fibrovein has no or negligible direct influence on the ability to drive and use machines. However, a bandage and/or compression stockings may be added after treatment. This could affect the ability to drive.

4.8 Adverse Effects (Undesirable Effects)

The most commonly reported adverse effects are pain on injection, urticaria, superficial thrombophlebitis and temporary skin pigmentation after treatment. Very rarely a permanent discoloration may remain along the path of the sclerosed vein segment. Ulceration may occur following extravasation of the drug. It is important to use the lowest strength that will sclerose the vein as many of the common side effects are caused by using a concentration that is too high.
Extravascular injection will give rise to pain, and may produce necrosis and ulceration if close to surface.
Intra-arterial injection although very rare has been reported resulting in significant tissue necrosis including loss of the extremity.
The most serious side effects are anaphylactic shock and pulmonary embolism and deaths have been reported in patients receiving sodium tetradecyl sulfate.
Adverse events are listed below by system organ class and estimated frequency from published clinical data. Frequencies are defined using the following convention: very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1000 to < 1/100; rare ≥ 1/10,000 to < 1/1000; very rare (includes isolated reports) < 1/10,000. See Table 1.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

No case of systemic overdose has been reported. Using a higher concentration than recommended in small veins may lead to pigmentation and/or local tissue necrosis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacotherapeutic group: Vasoprotectives, Sclerosing agents for local injections, ATC code C05BB04.
The action of sodium tetradecyl sulfate in this technique is considered to be that of irritation to the intima of the vein wall, so that on compression of the vein, fibrosis takes place and the vein is thus permanently occluded by the development of fibrosis in the wall of the compressed vein.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

There are no satisfactory human pharmacodynamic or pharmacokinetic studies with Fibrovein 0.2%, 0.5%, 1.0% and 3%.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

The mutagenic and carcinogenic potential of sodium tetradecyl sulfate has not been investigated.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzyl alcohol, dibasic sodium phosphate dodecahydrate, monobasic potassium phosphate, sodium hydroxide (for pH adjustment), water for injections.

6.2 Incompatibilities

This medicinal product is not compatible with heparin.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the ARTG. The expiry date can be found on the packaging.
After first opening, the medicinal product should be used immediately.
The in-use period of each 5mL multidose vial is a single session of therapy and for use in the treatment of a single patient. Unused vial contents should be discarded immediately afterwards.

6.4 Special Precautions for Storage

Store below 25°C. Do not freeze. Protect from direct sunlight.
Keep the vial/ampoule in the outer carton in order to protect from light.

6.5 Nature and Contents of Container

Fibrovein 3% 30 mg/1 mL, 10 x 5 mL glass vials AUSTR29772.
Fibrovein 3% 60 mg/2 mL, 5 x 2 mL glass ampoules AUSTR29638.
Fibrovein 1% 20 mg/2 mL, 5 x 2 mL glass ampoules AUSTR73362.
Fibrovein 0.5% 10 mg/2 mL, 5 x 2 mL glass ampoules AUSTR73361.
Fibrovein 0.2% 2 mg/1 mL, 10 x 5 mL glass vials AUSTR73360.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

C₁₄H₂₉NaSO₄.
Sodium tetradecyl sulfate has two chiral centres and is presented as the all racemate (all-rac-4-ethyl-1-isobutyloctyl sulfate).

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Fibrovein 3%, 1%, 0.5% and 0.2%

Sodium tetradecyl sulfate

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