LIPIODOL ULTRA-FLUIDE INJECTION 38% W/W

LABORATOIRES GUERBET - FRANCEDELPHARM TOURS (FRANCE)🇸🇬 Health Sciences Authority

Approval Date: Oct 27, 1994
Approval ID: 45b1336c9579a384
Company: LABORATOIRES GUERBET - FRANCEDELPHARM TOURS (FRANCE)
Type: Therapeutic

Approval Details

Approval Id: 45b1336c9579a384
Drug Name: LIPIODOL ULTRA-FLUIDE INJECTION 38% W/W
Product Name: LIPIODOL ULTRA-FLUIDE INJECTION 38% W/W
Approval Number: SIN06035P
Approval Date: 1994-10-27
Registrant: TRANSMEDIC PTE LTD
Licence Holder: TRANSMEDIC PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION
Dosage: 4.2. Posology and method of administration Posology In diagnostic radiology: <ul> <li> 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. </li> </ul> In interventional radiology: <ul> <li> 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. </li> </ul> 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: <ul> <li> Lymphography Administration takes the form of lymphatic catheterisation. It may be preceded by the injection of a dye to locate the lymphatic vessels. </li> </ul> In interventional radiology: <ul> <li> 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: <ul class="dash"> <li>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.</li> <li>Connect the two syringes to a three-way valve.</li> <li>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.</li> <li>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.</li> <li>Once the correct mixture has been obtained, use a 1 ml to 3 ml syringe for injection into the micro-catheter.</li> </ul> The procedure may be repeated every 4 to 8 weeks depending on the tumour response and the patient’s condition. </li> </ul>
Route Of Administration: INTRA-ARTERIAL, INTRALYMPHATIC
Indication Info: 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.
Contraindications: 4.3. Contraindications <ul> <li>Hypersensitivity to LIPIODOL ULTRA FLUIDE (ethyl esters of iodised fatty acids of poppy seed oil).</li> <li>Pregnant women.</li> <li>Proven hyperthyroidism.</li> <li>Trauma injuries, haemorrhages or recent bleeding episodes (risk of extravasation or embolism).</li> <li>Bronchography (the product would quickly flood the bronchioles and alveoli).</li> </ul> Contraindications specific to use in interventional radiology: <ul> <li>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.</li> <li>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.</li> </ul>
Atc Code: V08AD01
Atc Item Name: ethyl esters of iodised fatty acids
Pharma Manufacturer Name: TRANSMEDIC PTE LTD
Company Detail Path: /organization/transmedic-pte-ltd

Active Ingredients

ETHYL ESTERS OF IODISED FATTY ACIDS OF POPPY-SEED OIL

38% w/w

ETHYL ESTERS OF IODISED FATTY ACIDS OF POPPY-SEED OIL

38% w/w

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 27, 1994

Approval ID

45b1336c9579a384

Type

Therapeutic

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