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Fibrovein 3% Solution for Injection (5 x 2ml)

Fibrovein 3% Solution for Injection (5 x 2ml)

Fibrovein

Prescription medicine
  • UK Licensed prescription Only medicine (POM) containing sodium tetradecyl sulfate (ATC code C05BB04)
  • Product licensed and regulated by the MHRA via national marketing authorisations
  • Manufactured under current Good Manufacturing Practice (cGMP) and compliant with British Pharmacopoeia specifications for STS sclerosing solution
Sclerosant for varicose and thread veins

Description

Fibrovein 3% Solution for Injection is a prescription-only, detergent-based sclerosant containing sodium tetradecyl sulfate 30 mg/ml. It is licensed for intravenous use in adults for the treatment of varicose veins and other lower-limb venous dilatations. Supplied here as 5 x 2 ml glass ampoules, Fibrovein 3% is used by trained healthcare professionals during sclerotherapy procedures to damage and collapse the targeted vein wall, causing the vein to close and be gradually reabsorbed, thereby reducing visible varicosities and associated symptoms.

Bnefits

  • Licensed sclerosant for the treatment of varicose veins and other lower-limb venous dilatations
  • Contains sodium tetradecyl sulfate 30 mg/ml for effective endothelial damage and vein closure
  • Used in sclerotherapy to collapse and fade problem veins, improving cosmetic appearance
  • Can treat larger varicose veins when used at 3% strength by appropriately trained practitioners
  • Sterile, clear, aqueous solution manufactured under cGMP and compliant with British Pharmacopoeia specifications
  • Available in convenient 2 ml ampoules for controlled dosing at multiple injection sites

Indications

  • Treatment of uncomplicated primary varicose veins of the lower extremities
  • Treatment of recurrent or residual varicose veins following surgery
  • Treatment of reticular veins, venules and spider veins of the lower limbs that show simple dilation (overall Fibrovein range; 3% strength is typically used for larger varicosities)
  • Aesthetic sclerotherapy of suitable lower-limb varicose veins in adults when performed by appropriately trained healthcare professionals

Composition

  • Active: Sodium tetradecyl sulfate 30 mg/ml (3% w/v)
  • Benzyl alcohol 20 mg/ml (2%)
  • Disodium phosphate dodecahydrate
  • Potassium dihydrogen phosphate
  • Sodium hydroxide (for pH adjustment)
  • Water for injections

Formulation

  • Sterile, clear, colourless aqueous solution for injection
  • Detergent-based sclerosant (anionic surfactant) buffered to approximately pH 7.5–7.9
  • Single-use parenteral product intended for intravenous administration only

Packaging

  • Glass Type I 2 ml ampoules, pack size 5 x 2 ml
  • Outer carton protecting ampoules from light
  • Other pack formats (e.g. 5 ml vials) exist but this presentation is specifically 5 ampoules of 2 ml each

Usage

  • For intravenous use only and only by healthcare professionals experienced in venous anatomy, venous disease and sclerotherapy injection techniques.
  • Select the appropriate Fibrovein strength based on vein size; 3% solution is generally used for larger varicose veins according to prescribing information.
  • Using strict aseptic technique, the sclerosant is injected intravenously in small aliquots at multiple sites along the target vein segment.
  • Avoid extravasation and intra-arterial injection; carefully confirm intravascular placement before injecting and inject slowly.
  • Use the minimum effective concentration and volume required to achieve adequate damage to the vessel wall; excessive concentration or volume can increase the risk of necrosis and other complications.
  • Fibrovein is a single-use product: once an ampoule is opened, use immediately and discard any remaining solution.
  • Patients should be mobilised after treatment whenever possible and may require compression (e.g. bandages or stockings) according to local protocols.
  • Patients must not self-administer this medicine under any circumstances.

Contraindications

  • Hypersensitivity to sodium tetradecyl sulfate or any excipient (including benzyl alcohol) and general allergic conditions
  • Patients unable to walk for any reason or who are bedridden
  • High risk of thrombosis (e.g. congenital thrombophilia or multiple risk factors such as hormonal contraception or hormone replacement therapy, significant obesity, smoking or prolonged 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 or acute respiratory or skin diseases
  • Evolutive (active) cancer
  • Significant valvular incompetence of the deep veins
  • Occlusive arterial disease of the lower limbs
  • Large superficial veins with wide open communications to deep veins
  • Phlebitis migrans, acute cellulitis or acute infections
  • Known symptomatic patent foramen ovale (PFO) is a contraindication when using foamed sclerosant

Adverse Effects

  • Very common / common: pain or burning at the injection site, local irritation, superficial phlebitis, skin discolouration or hyperpigmentation at the treated area, matting (fine new spider veins).
  • Uncommon: local allergic or non-allergic skin reactions such as erythema, pruritus, rash or swelling; transient visual disturbances.
  • Rare: cough, shortness of breath, chest tightness, headache or migraine, dizziness, feeling faint, confusion or loss of consciousness.
  • Very rare: severe allergic reactions including anaphylactic shock (potentially life-threatening), urticaria, fever, hot flushes, nausea, vomiting, diarrhoea, oral or tongue swelling, dry mouth.
  • Other reported: inflammation of blood vessels, superficial vein thrombosis, deep vein thrombosis, pulmonary embolism, stroke-like or transient neurological events, tissue necrosis (especially following extravasation or inadvertent intra-arterial injection).

Storage Conditions

  • Keep out of the sight and reach of children.
  • This medicinal product does not require special temperature storage conditions in Temperature Zone 1; for other zones, do not store above 25°C.
  • Do not freeze.
  • Store ampoules in the outer carton to protect from light.
  • Single-use only: once an ampoule is opened, use immediately and discard any unused solution.
  • Do not use after the expiry date stated on the label and carton (EXP).
  • Dispose of unused product or waste material in accordance with local requirements; do not dispose via wastewater or household rubbish.

Duration

Sclerotherapy with Fibrovein 3% is administered as one or more treatment sessions according to vein extent and response; repeat sessions may be scheduled weeks apart at the prescriber\u2019s discretion.

Onset

Endothelial damage and vein closure occur shortly after injection, but visible fading and clinical improvement in varicose or thread veins typically evolve over weeks to months as the treated vein is reabsorbed.

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