LIPIODOL ULTRA-FLUIDE INJECTION 38% w/w

INJECTION

**4.2. Posology and method of administration** **Posology** In diagnostic radiology: - Lymphography 8mL max per extremity _Paediatric population_ In children, the dosage is reduced according to bodyweight with an average dosage of 0.20 mL/kg. _Elderly subjects_ The product must be administered with caution to patients over 65 years of age with underlying cardiovascular, respiratory or nervous system conditions. Given that part of the product temporarily embolises the pulmonary capillaries, cardiorespiratory failure in an elderly patient may require adaptation of the dose following assessment of the benefit-risk ratio. In interventional radiology: - Transarterial chemoembolisation of hepatocellular carcinoma The dose of LIPIODOL ULTRA FLUIDE depends on the extent of the lesion but generally must not exceed a total dose of 15 ml in adults. _Paediatric population:_ The safety and efficacy of LIPIODOL ULTRA FLUIDE in transarterial chemoembolisation of hepatocellular carcinoma in children have not yet been established. _Elderly people:_ The product must be administered with caution to patients over 65 years of age with underlying cardiovascular, respiratory or nervous system conditions. The injected dose must not exceed 10 ml in order to prevent a possible untargeted pulmonary embolism occurring during hepatic chemoembolisation. **Method of administration** LIPIODOL ULTRA FLUIDE must be administered by slow injection or catheterisation using a suitable glass syringe or other delivery devices where compatibility with LIPIODOL ULTRA FLUIDE has been demonstrated. The instructions on use for such devices must be followed (see section 6.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In diagnostic radiology: - Lymphography Administration takes the form of lymphatic catheterisation. It may be preceded by the injection of a dye to locate the lymphatic vessels. In interventional radiology: - Transarterial chemoembolisation of hepatocellular carcinoma Administration is by intra-arterial selective catheterisation of the hepatic artery. The procedure must be performed in an interventional radiology room with the appropriate equipment. LIPIODOL ULTRA FLUIDE may be mixed with anti-cancer medicines such as cisplatin, doxorubicin, epirubicin and mitomycin. The instructions and precautions for use regarding anti-cancer medicines must be strictly adhered to. Instructions for preparing the mixture of LIPIODOL ULTRA FLUIDE with an anti-cancer medicine: - Prepare two syringes large enough to hold the total mixture volume: the first syringe containing the anti-cancer medicine solution, and the second syringe containing LIPIODOL ULTRA FLUIDE. - Connect the two syringes to a three-way valve. - Shake back and forth between the two syringes 15 to 20 times to obtain a homogeneous mixture. It is recommended that the syringe containing the anti-cancer medicine be pushed first. - The mixture must be prepared immediately before use and must be used immediately after preparation (within 3 hours). If necessary, the mixture may be homogenised again as described above during the interventional radiology procedure. - Once the correct mixture has been obtained, use a 1 ml to 3 ml syringe for injection into the micro-catheter. The procedure may be repeated every 4 to 8 weeks depending on the tumour response and the patient’s condition.