VARITHENA POLIDOCANOL INJECTABLE FOAM 10MG/ML [SIN15433P]

Product Info

VARITHENA POLIDOCANOL INJECTABLE FOAM 10MG/ML

[SIN15433P]

1. INDICATIONS AND USAGE
VARITHENA (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

2. DOSAGE AND ADMINISTRATION
For intravenous use only.

The specific VARITHENA dose should be used as directed for the venous disease to be treated.

VARITHENA is intended for intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities. Use up to 5 mL per injection and no more than 15 mL per session. Those physicians administering VARITHENA 1% for the treatment of GSV must possess a working knowledge of the use of duplex ultrasound in venous disease.

Physicians administering VARITHENA must be experienced with venous procedures and be trained in the administration of VARITHENA.

Activate VARITHENA using the VARITHENA oxygen canister and polidocanol canister (see Instructions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Once a VARITHENA transfer unit is in place, foam can be generated and transferred to a syringe. Discard the syringe contents if there are any visible bubbles. Administer the injectable foam within 75 seconds of extraction from the canister to maintain injectable foam properties. Use a new sterile syringe after each injection. Use a new VARITHENA transfer unit for each treatment session.

Local anesthetic may be administered prior to cannula insertion but neither tumescent anesthesia nor patient sedation is required. Cannulate the vein to be treated using ultrasound guidance to confirm venous access.

Inject freshly generated VARITHENA injectable foam slowly (approximately 1 mL/second in the GSV and 0.5 mL/second in accessory veins or varicosities) while monitoring using ultrasound. Confirm venospasm of the treated vein using ultrasound

When treating the proximal GSV, stop the injection when VARITHENA is 3–5 cm distal to the saphenofemoral junction (SFJ).

Apply compression bandaging and stockings and have the patient walk for at least 10 minutes, while being monitored. Maintain compression for 2 weeks after treatment.

Repeat treatment may be necessary if the size and extent of the veins to be treated require more than 15 mL of VARITHENA. Separate treatment sessions by a minimum of 5 days.

Retained coagulum may be removed by aspiration (microthrombectomy) to improve comfort and reduce skin staining.

4. CONTRAINDICATIONS
The use of VARITHENA is contraindicated in patients with:

• Known allergy to polidocanol [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]

• Acute thromboembolic disease

• Thrombophilia