LIPIODOL ULTRA-FLUIDE INJECTION 38% W/W [SIN06035P]

Product Info

LIPIODOL ULTRA-FLUIDE INJECTION 38% W/W

[SIN06035P]

4.1. Therapeutic indications

In diagnostic radiology:
Lymphography.

In interventional radiology:
Visualisation, locating and vectoring during transarterial chemoembolisation of intermediate-stage hepatocellular carcinoma in adults.

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 scheduled for a lymphography 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.

4.3. Contraindications

• Hypersensitivity to LIPIODOL ULTRA FLUIDE (ethyl esters of iodised fatty acids of poppy seed oil).

• Pregnant women.

• Proven hyperthyroidism.

• Trauma injuries, haemorrhages or recent bleeding episodes (risk of extravasation or embolism).

• Bronchography (the product would quickly flood the bronchioles and alveoli).

Contraindications specific to use in interventional radiology:

• Transarterial chemoembolisation:
  Mixing with LIPIODOL ULTRA FLUIDE to treat hepatocellular carcinoma may cause both ischaemic and toxic effects for the gallbladder. Administration is therefore contraindicated in hepatic areas where the bile ducts are dilated, unless post-procedure drainage is possible.

• Intra-arterial injection of LIPIODOL ULTRA FLUIDE may cause total obstruction of the hepatic artery and total suppression of arterial flow. This should only be considered after having made sure, via imaging or angiography, that there is at least partial portal vascular flow.