Summaries of product characteristics

Summaries of product characteristics

Lipiodol® Ultra-Fluid
(Iodinated ethyl esters of fatty acids of poppy seed oil)



Lipiodol® indication in vascular embolization

Selective embolization in combination with cyanoacrylate-based glue (particularly for arteriovenous malformation or aneurysms)

Vascular anomaly embolization

Embolic vascular occlusion may be performed at any level from large arteries or veins to capillary beds, it may be temporary or permanent for treating a wide variety of conditions

Used to treat a wide variety of conditions:
• To slow down or block blood flow
• To induce liver lobe hypertrophy

For complete information please refer to country's local SPC

Know more about legal notice Lipiodol®

Show More
IR Image 1

Vascular anomalies(7)

  • « Vascular tumours and vascular malformations are common vasculose anomalies characteristic for dissimilar clinical course, specific biological as well as immune cytological and histological properties.»
  • « In 80% of cases, hemangiomas are single lesions observed dominantly on body integuments with their most common location on the head (60%), trunk (25%) and limbs (15%).»

Lipiodol® Ultra Fluid in vascular anomalies embolization




- Immediate anomaly visualization & localization for real time procedure guiding (8,9) 
- Per-procedure complete anomaly filling visual confirmation (8,10,11) 

Vectorizer & Timer

- Radiopacity & increased polymerization time thanks to Lipiodol® & NBCA mixture (1,2,4,12) 
- Modification of polymerization time according to the Lipiodol® & glue ratio (2,10,11,13,14)

References - Vascular

Mastering polymerization time for a better management of Abnormal Vascular Embolization

1.Takeuchi Y. et al., Guidelines for the use of NBCA in vascular embolization devised by the Committee of Practice Guidelines of the Japanese Society of Interventional Radiology (CGJSIR), 2012 edition, Jpn J Radiol, 2014; 32:500–517.

2.LEE BB. et al., Consensus Document of the International Union of Angiology (IUA)-2013 Current concepts on the management of arterio-venous malformations, International Angiology, 2013;32(1):11-36.

3.Seewald S et al., A standardized injection technique and regimen ensures success and safety of N-butyl-2-cyanoacrylate injection for the treatment of gastric fundal varices, Gastrointestinal endoscopy, 2008,68(3): 447-454

4.American Society for Gastrointestinal Endoscopy. Tissue adhesives: cyanoacrylate glue and fibrin sealant, Gastrointestinal Endoscopy, 2013;78: 2. 209-215.

5.Madhusudhan KS. et al., Endovascular Embolization of Visceral Artery Pseudoaneurysms Using Modified Injection Technique with N-Butyl Cyanoacrylate Glue, J VascInterv Radiol, 2015;26:1718–1725.

6.Lo GH. et al., A Prospective, Randomized Trial of Butyl Cyanoacrylate Injection Versus Band Ligation in the Management of Bleeding Gastric Varices, Hepatology,2001; 33( 5), 1060-1064.

7.Wójcicki P. et al., Epidemiology, Diagnostics and Treatment of Vascular Tumours and Malformations, Adv Clin Exp Med, 2014; 23, 3, 475–484.

8.Singh V. et al., Cyanoacrylate therapy for the treatment of gastric varices: a new method, Journal of Digestive Diseases, 2016;17: 392–398.

9.Urbano J. et al., Sclerosis and varicocele embolization with N-butyl cyanoacrylate: experience in 41 patients, Acta Radiol., 2014; 55(2):179-185.

10.Kwak H.S. et al, Percutaneous Transportal Sclerotherapy with N-Butyl-2-Cyanoacrylate for Gastric Varices: Technique and Clinical Efficacy, Korean J. Radiol. 2008; 9:526-533.

11.Kanematsu M. et al., Postpartum Hemorrhage in Coagulopathic Patients: Preliminary Experience with Uterine Arterial Embolization with N-Butyl Cyanoacrylate, J. Vasc. Interv. Radiol, 2011; 22:1773-1776.

12.Simons M.E. et al., Peripheral vascular malformations: diagnosis and percutaneous management, Can. Assoc. Radiol. J., 2001; 52(4):242-251.

13.Loffroy R. et al., Endovascular Therapeutic Embolisation: An Overview of Occluding Agents and their Effects on Embolised Tissues, Curr. Vasc. Pharmacol., 2009; 7:250-263.

14.Gandini R. et al., Transcatheter Embolization of a Large Symptomatic Pelvic Arteriovenous Malformation with Glubran 2 Acrylic Glue, Cardiovasc. Intervent. Radiol. 2008; 31:1030-1033.

15.Bellemann N. et al., Portal vein embolization using a Histoacryl / Lipiodol mixture before right liver resection, Dig. Surg., 2012; 29:236-242.

Lipiodol D2


Lipiodol® - Indication in HCC

Visualization, Localization and Vectorization during Trans-Arterial Chemoembolization (TACE) of hepatocellular carcinoma (HCC) at intermediate stage, in adults

HCC etiology (5)

  • Hepatitis B & C
  • Prolonged alcohol abuse
  • Non alcoholic steato hepatitis (NASH)

Conventional Trans Arterial Chemoembolization (cTACE)

  • cTACE = Lipiodol® TACE
  • Intratumor injection of Lipiodol® + anticancer agent (such as Cisplatin, Doxorubicin, Epirubicin and Mitomycin)
  • Complementary embolization with gelatin sponge or particules
Show More

Lipiodol® in HCC management



Tumor, visualizer & localizer

- Immediate timer visualization & localization for real time procedure guiding(6)

- Per-procedure complete tumor filling visual confirmation for patient prognosis(7)

Chemotherapeutic drug vectorizer

- Proximal & distal drug delivery thanks to droplets defomability & size diversity(8)

- Improved patient Overall Survival up to 45 months(9)

- Endorsed by international guidelines as Standard-of-Care(5, 10, 11, 12)

Transient dual embolizer 

- Index & daughter nodules necrosis thanks to dual arterioportal embolization(13)

- Transient occlusion authorizing repeated treatment(14)

References - Liver

1. Ikeda M. et al., Prospective Study of Transcatheter Arterial Chemoembolization for Unresectable Hepatocellular Carcinoma: An Asian Cooperative Study between Japan and Korea J. Vasc. Interv. Radiol. 2013; 24: 490-500

2. Lo C.M. et al. Randomized Controlled Trial of Transarterial Lipiodol Chemoembolization for Unresectable Hepatocellular Carcinoma Hepatology 2002; 35: 1164-1171

3. Llovet J.M. et al. arterial embolization or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial The Lancet 2002; 359: 1734-1739

4. Llovet J.M. et al . Systematic Review of Randomized Trials for Unresectable Hepatocellular Carcinoma: Chemoembolization Improves Survival Hepathology 2003; 37: 429-442

5. EASL-EORTC Clinical Practice Guidelines for the Management of Hepatocellular Carcinoma. J. Hepatol. 2018

6. Chen M. et al., High Dose Iodized Oil Transcatheter Arterial Chemoembolization for Patients with Large Hepatocellular Carcinoma World. gastroenterol. 2002; 8: 74-78.

7. Takayasu K. et al., Comparison of CT Findings with Resected Specimens After Chemoembolization with Iodized Oil for Hepatocellular Carcinoma AJR. 2000;175:699–704.

8. De Baere t. et al., Circulatory alterations induced by intra-arterial injection of iodized oil emulsions of iodized oil and doxorubicin: experimental study, Radiology.1995; 194: 165-170.

9. Europe: EASL-EORTC / Clinical Pratice Guidelines / Journal of Hepatology 2012 vol. 56; 908–943.

10. US Guidelines: Bruix J. AASLD Practice Guidelines; American Association for Study of the Liver Diseases;Hepatology 2011; Vol. 53, No. 3.

11. Chinese guidelines 2011 edition, Chin. Clin. Oncol. 2012; 1:10.

12. Japanese Guidelines: Hepatology Research 2010; 40 (Suppl. 1): 96–112.

13. Terayama N. et al., Accumulation of Iodized Oil Within the Non-Neoplastic Liver Adjacent to Hepatocellular Carcinoma via the Drainage Routes of the Tumor After Transcatheter Arterial Embolization CVIR. 2001; 24:383-387.

14. Georgiades C. et al. Lack of response after initial chemoembolization for hepatocellular carcinoma: Does it predict of subsequent treatment, Radiology. 2012; 265(1): 115-123.

15. Kan Z. et al. Liver anatomy: microcirculation of the liver, Sem. Intervent. Radiology 2008; 25: 77-85.

16. Thierry de Baere et al., Treatment of Liver Tumors with Lipiodol TACE: Technical Recommendations from Experts Opinion. Cardiovasc Intervent Radiol,2016;39:334–343.

17. Kudo M. et al., Orantinib versus placebo combined with transcatheter arterial chemoembolisation in patients with unresectable hepatocellular carcinoma (ORIENTAL): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet gastroenterol Hepatol.2018; (3) 37-46.

18. Ikeda M. et al.,Transarterial chemoembolization with miriplatin vs. epirubicin for unresectable hepatocellular carcinoma: a phase III randomized trial. J Gastroenterol.2018; 53:281–290.

C1 Lipiodol®

Lipiodol®: indication in lymphography

Indications in diagnostic radiology – Lymphography.

Indications in interventional radiology – Selective embolization in combination with Histoacryl glue (particularly for arteriovenous malformation or aneurysms).

For complete information please refer to country's local SPC

Know more about legal notice Lipiodol®


Lipiodol® site of injection for lymphangiography

2 methods:

 Intranodal Lymphangiography:
• Inject Lipiodol® into inguinal lymph node

Pedal Lymphangiography:
• Inject Lipiodol® into isolated vessel on the dorsum foot below the ankle

Lipiodol® Ultra Fluid in Lymphography



Visualizer & Localizer

- Immediate visualization of lymphatic anomalies 
- Localization for real time procedure guiding (6,7,8)


- Decrease the amount of leakage
- Improve Lymphedema (9)

Vectorizer & Timer - Gives radiopacity & modification polymerization time according to the Lipiodol® & glue ratio (10)

References - Lymphatics

Solution of Visualization For Abnormal Lymphatic System

1.Edward Wolfgang Lee, et al., Lymphangiography to Treat Postoperative Lymphatic Leakage: A Technical Review Korean J Radiol, 2014;15(6):724-732.

2.Ryota Kawasaki et al., Therapeutic Effectiveness of Diagnostic Lymphangiography for Refractory Postoperative Chylothorax and Chylous Ascites: Correlation With Radiologic Findings and Preceding Medical Treatment, AJR, 2013; 201:659–666.

3.Lee BB, et al., IUA-ISVI consensus for diagnosis guideline of chronic lymphedema of the limbs, Edizioni Minerva Medica, 2014,

4.Kimberly Levenhagen, et al.,, Diagnosis of Upper-Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of APTA, American Physical Therapy Association. Phys Ther., 2017;97: 729–745.

5.Saebeom Hur, et al., Early Experience in the Management of Postoperative Lymphatic Leakage Using Lipiodol Lymphangiography and Adjunctive Glue Embolization.J VascI Interv Radiol, 2016;27:1177–1186.

6.Tatjana Gruber-Rouh, et al., Direct lymphangiography as treatment option of lymphatic leakage:Indications, outcomes and role in patient’s management, European Journal of Radiology, 2014;83:2167–2171.

7.Tetsuya Abe, et al., Therapeutic strategy for chylous leakage after esophagectomy: focusing on lymphangiography using lipiodol, Esophagus, 2016;13:237–244.

8.Sho Kitagawa, et al., Ulrasound-Guided Intranodal Lymphangiography With Ethiodized Oil to Treat Chylous Ascites, ACG Case Rep J, 2016;3(4):e95.

9.F. M. Go´mez, et al., Transnodal Lymphangiography in the Diagnosis and Treatment of Genital Lymphedema, Cardiovasc Intervent Radiol, 2012;35:1488–1491.

10.Shuji Kariya, et al., Embolization for Thoracic Duct Collateral Leakage in High-Output Chylothorax After Thoracic Surgery, Cardiovasc Intervent Radiol, 2017; 40:55–60.

11.Yoolim Baek, et al., Lymphatic Leak Occurring After Surgical Lymph NodeDissection: A Preliminary Study Assessing the Feasibility and Outcome of Lymphatic Embolization, Cardiovasc Intervent Radiol, 2016;39:1728–1735.

12.Tetsuya Abe, et al., Therapeutic strategy for chylous leakage after esophagectomy: focusing on lymphangiography using lipiodol, Esophagus, 2016;13:237–244