Posology : מינונים

4.2. Posology and method of administration
Posology
In diagnostic radiology:
•       Lymphography
Administer via a catheter inserted into a lymph duct. A dye can first be injected to locate the lymph ducts.
The usual dose is 5 to 7 mL via the strict lymphatic route to enhance contrast in an extremity (depending on the height of the subject), i.e. 10 to 14 mL for bilateral lymphography of the feet.
Patients with low weight
The dose must be reduced proportionally in this population.
Elderly
The product must be administered with special care in patients over 65 years of age with underlying diseases of the cardiovascular, respiratory or nervous systems. Given that part of the product temporarily embolises the pulmonary capillaries, the dose must be adjusted in elderly patients with cardiorespiratory insufficiency or the examination must be cancelled.
In interventional radiology
•   Trans-Arterial Chemo-Embolisation of hepatocellular carcinoma:
The dose of LIPIODOL ULTRA-FLUID depends on the extent of the lesion, but should usually not exceed a total dose of 15 mL in adults.
Paediatric population
The efficacy and safety of the use of LIPIODOL ULTRA-FLUID for Trans-Arterial Chemo-Embolisation of hepatocellular carcinoma have not been established in children .
Elderly
The product must be administered with special care in patients over 65 years of age with underlying diseases of the cardiovascular, respiratory or nervous systems.
Method of administration
LIPIODOL ULTRA-FLUID must be administered by slow injection or by catheterization, using a suitable glass syringe or other delivery devices for which compatibility with LIPIODOL ULTRA FLUIDE has been demonstrated. The instructions on use for such devices must be followed (see section 6.2).
In interventional radiology:
•     Trans-arterial chemo-embolisation of hepatocellular carcinoma The administration is by selective intra-arterial catheterization of the hepatic artery. The procedure should be performed within a typical interventional radiology setting with the appropriate equipment.
LIPIODOL ULTRA-FLUID can be mixed with anticancer drugs such as cisplatin, doxorubicin, epirubicin and mitomycin.
Instructions and precautions for use of the anticancer drugs must be strictly followed.


Instructions for preparation of the mixture of LIPIODOL ULTRA-FLUID with an anticancer drug: - Prepare two syringes large enough to contain the total volume of the mixture. The first syringe contains the anticancer drug solution, the second syringe contains LIPIODOL ULTRA-FLUID.
- Connect the two syringes to a 3-way stopcock.
- Perform 15 to 20 back and forth movements between the two syringes to obtain a homogeneous mixture. It is recommended to start by pushing the syringe with the anticancer drug first .
- The mixture is to be prepared at the time of use and must be used immediately after preparation (within 3 hours). If necessary, during the interventional radiology procedure, the mixture may be re- homogenized as described above.
- When the adequate mixture is obtained, use a 1 to 3 mL syringe to inject in the micro-catheter.
The procedure may be repeated every 4 to 8 weeks according to tumor response and the patient’s condition.