Lipiodol® Ultra fluid

This page is intended for Healthcare Professionals only and where Lipiodol® Ultra Fluid is registered for Hysterosalpingography. It is not intended for use in USA and France.

The only oil-based contrast
agent indicated for HSG 1-9
Lipiodol® hysterosalpingography
for tubal patency
& uterine evaluation 1-9
The only oil-based contrast
agent indicated for HSG1-9
Lipiodol® hysterosalpingography
for tubal patency
& uterine evaluation1-9

Lipiodol® Ultra Fluid indication

Hysterosalpingography (HSG)

Hysterosalpingography (HSG) definition

Hysterosalpingography is a radiological examination to investigate the uterine cavity, Fallopian tubes & peritoneal cavity.
It entails the injection of contrast medium and visualization under fluoroscopy. HSG exam is recommended as part of the infertility work-up to diagnose blocked Fallopian tubes or uterine abnormalities. 10

Characterization of HSG findings

Tubal abnormalities

 Tubal occlusion
 Salpingitis isthmica nodosum
 Polyps
 Hydrosalpinx
 Peritubal adhesions

Uterine cavity abnormalities

Congenital anomalies
Polyps
Leiomyomas
Surgical changes
Synechiae
Adenomyosis
Müllerian duct anomalies

Procedure

When to perform HSG test

HSG test is performed after cessation of bleeding period & before ovulation 11
(ideally before the 12th day of the menstrual cycle for women with normal cycle length)

Gonadotropin Hormones: FSH (Follicle Stimulating Hormone) & LH (Luteinizing Hormone)
Ovarian Hormones: Estrogen & Progesterone

HSG test steps

Patient preparation

Patient lies on her back on a table under a fluoroscope, bringing legs up into gynecological position

Cervix must be cleaned with an antiseptic

Vaginal speculum gently inserted for visualization of cervix

HSG procedure

Catheter inserted through
the opening in the cervix into
the uterus

Contrast medium Lipiodol® Ultra Fluid instilled slowly through catheter into uterine cavity

Images taken of uterine cavity
and Fallopian tubes

Lipiodol® Infusion during HSG
Main Methods

Play Video


Lipiodol® HSG Procedure

Play Video

HSG Findings

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Courtesy: Dr. Kim Dreyer, Amsterdam University Medical Center (Netherlands)

Guidelines

Lipiodol® HSG is endorsed by international clinical practices guidelines 12 – 14

«…Hysterosalpingography (HSG), using either a water- or lipid-soluble contrast media, is the traditional and standard method for evaluating tubal patency and may offer some therapeutic benefit…»

«…Hysterosalpingography… : Water-soluble or oil-based radio-opaque contrast material is used to delineate the uterine cavity…» «…HSG is generally accepted as the traditional, least invasive and most cost effective method of evaluation of tubal patency in low-risk women…»

«…The potential therapeutic effect of diagnostic tubal patency testing has been debated for over 40 years. Tubal flushing might involve water- or oil-soluble media. A systematic review of eight RCTs showed a significant increase in pregnancy rates with tubal flushing using oil-soluble contrast media when compared with no treatment… Tubal flushing with oil soluble contrast media was associated with an increase in the odds of live birth…[Evidence level 1a]…»
*Hierarchy of evidence: 1a – Systematic review and meta-analysis of randomised controlled trials

Clinical cases

Normal HSGs

HSG_Norlal1_200219

Lipiodol® HSG showing normal uterine cavity and patent tubes
Courtesy: Pr. Velja Mijatovic & Dr. Kim Dreyer, Amsterdam University Medical Center (Netherlands)

Example of specific Lipiodol® droplets in the peritoneal cavity confirming tubal patency

Lipiodol® HSG showing normal uterine cavity and patent tubes
Courtesy: Pr. Velja Mijatovic & Dr. Kim Dreyer, Amsterdam University Medical Center (Netherlands)
Lipiodol® HSG showing normal uterine cavity and patent tubes
Courtesy: Pr. Velja Mijatovic & Dr. Kim Dreyer, Amsterdam University Medical Center (Netherlands)

Example of specific Lipiodol® droplets in the peritoneal cavity confirming tubal patency

Abnormal findings

Lipiodol® HSG showing Müllerian duct anomalies

Lipiodol® HSG showing proximal occlusion of the right tube; normal uterine cavity & patent left tube

Lipiodol® HSG showing uterine cavity with a filling defect near the left tubal corner due to an endometrial polyp; normal right tube with patency

Lipiodol® HSG showing bilateral hydrosalpinges with distal occlusion

Lipiodol® HSG showing Müllerian duct anomalies

Lipiodol® HSG showing proximal occlusion of the right tube; normal uterine cavity & patent left tube

Lipiodol® HSG showing uterine cavity with a filling defect near the left tubal corner due to an endometrial polyp; normal right tube with patency

Lipiodol® HSG showing bilateral hydrosalpinges with distal occlusion

Courtesy: Pr. Velja Mijatovic & Dr. Kim Dreyer, Amsterdam University Medical Center (Netherlands) – Dr. Naile Bolca Topal, Uludag University (Turkey)

Lipiodol® HSG showing Müllerian duct anomalies
Courtesy: Dr. Naile Bolca Topal, Uludag university (Turkey)
Lipiodol® HSG showing proximal occlusion of the right tube; normal uterine cavity & patent left tube
Courtesy: Pr. Velja Mijatovic & Dr. Kim Dreyer, Amsterdam University Medical Center (Netherlands)
Lipiodol® HSG showing uterine cavity with a filling defect near the left tubal corner due to an endometrial polyp; normal right tube with patency
Courtesy: Pr. Velja Mijatovic & Dr. Kim Dreyer, Amsterdam University Medical Center (Netherlands)
Lipiodol® HSG showing bilateral hydrosalpinges with distal occlusion
Courtesy: Pr. Velja Mijatovic & Dr. Kim Dreyer, Amsterdam University Medical Center (Netherlands)

Features & Benefits

Features

Benefits

Fallopian tubes & uterus visualizer

Both Fallopian tubes & uterine cavity visualization
Accurate image quality 1,15,16

Convenient

Simple
Well-tolerated – Less frequent post-procedural pain & no significant difference in pain level during the procedure compared to WSCM* group 1,6,7,15
Minimally-invasive

* WSCM: Water Soluble Contrast Medium

FAQ

No evidence of difference between OSCM* Lipiodol® & WSCM* groups 6,7,15

Miscarriage
Ectopic pregnancy

Infection
Haemorrhage

«…Rates of adverse events were low and similar in the two groups»
H2Oil study 2017 – New England Journal of Medicine 7

«…There were no significant differences in miscarriage, ectopic pregnancy & infection rates between tubal flushing with oil or water, or between oil plus water media versus water media only…»
NICE Clinical Guidelines 2013 14

* OSCM: Oil Soluble Contrast Medium; WSCM: Water Soluble Contrast Medium

Association of OSCM vs. WSCM with miscarriage 17

 
 

Association of OSCM vs. WSCM with ectopic pregnancy 17

** M-H: Mantel-Haenszel, CI: Confidence Interval

Procedural pain level: No significant difference between OSCM* & WSCM* group 7

* OSCM: Oil Soluble Contrast Medium; WSCM: Water Soluble Contrast Medium

Post-procedural pain reported less frequently in OSCM than in WSCM group 6

Review: Tubal flushing for subfertility
Comparison: WSCM versus OSCM
Outcome: Any postprocedural pain (dichotomous variable)

** M-H: Mantel-Haenszel, CI: Confidence Interval

• The total volume to be injected depends on the volume of the uterine cavity, usually not exceeding 15 mL
• Average injected volume: 9 to 10 mL 3,7

Please refer to your local prescribing information.

No evidence of difference between OSCM* Lipiodol® & WSCM* groups 6,7,15

Miscarriage
Ectopic pregnancy

Infection
Haemorrhage

«…Rates of adverse events were low and similar in the two groups»
H2Oil study 2017 – New England Journal of Medicine 7

«…There were no significant differences in miscarriage, ectopic pregnancy & infection rates between tubal flushing with oil or water, or between oil plus water media versus water media only…»
NICE Clinical Guidelines 2013 14

* OSCM: Oil Soluble Contrast Medium; WSCM: Water Soluble Contrast Medium

Association of OSCM vs. WSCM with miscarriage 17

 
 

Association of OSCM vs. WSCM with ectopic pregnancy 17

** M-H: Mantel-Haenszel, CI: Confidence Interval

Procedural pain level: No significant difference between OSCM* & WSCM* group 7

* OSCM: Oil Soluble Contrast Medium; WSCM: Water Soluble Contrast Medium

Post-procedural pain reported less frequently in OSCM than in WSCM group 6

Review: Tubal flushing for subfertility
Comparison: WSCM versus OSCM
Outcome: Any postprocedural pain (dichotomous variable)

** M-H: Mantel-Haenszel, CI: Confidence Interval

• The total volume to be injected depends on the volume of the uterine cavity, usually not exceeding 15 mL
• Average injected volume: 9 to 10 mL 3,7

Please refer to your local prescribing information.

 

Documentation

You are welcome to consult and read the following online version of our brochure and bibliography

Pharmaceutical form: Lipiodol® Ultra Fluid 480 mg Iodine per mL, solution for injection 10 mL, ethyl esters of iodized fatty acids of poppy-seed oil

Recommended dosage: Up to 20 mL, depending
on the volume of the uterine cavity

LIPIODOL® ULTRA-FLUID.
Composition:
Ethyl esters of iodized fatty acids of poppy seed oil 10 mL, corresponding to an iodine content of 480 mg/mL.
Indications (**):
In diagnostic radiology: Hysterosalpingography – Ascending urethrography – Lymphography – Sialography – Fistulography and exploration of abscesses – Exploration of frontal sinuses – Pre and post-operative cholangiography.
In interventional radiology: Visualisation and localization (by selective intra-arterial use during CT) of liver lesions in adults with known or suspected hepatocellular carcinoma – Visualisation, localisation and vectorisation during Trans-Arterial Chemo-Embolisation (TACE) of hepatocellular carcinoma at intermediate stage, in adults – Selective embolization in combination with Histoacryl glue (particularly for arteriovenous malformation or aneurysms) – Selective injections of LIPIODOL® ULTRA-FLUID into the hepatic artery for diagnostic purposes where a spiral CT scan is not practical.
•In endocrinology: Prevention of severe cases of iodine deficiency.
Posology and method of administration (*):
have to be adapted according to the type of examination, the territories explored, the age and weight of the patient. The volume to be administered depends on the particular requirements of the technique and the size of the patient.
Contraindications:
– Hypersensitivity to LIPIODOL® ULTRA-FLUID – Confirmed hyperthyroidism – Patients with traumatic injuries, recent haemorrage or bleeding – Hysterosalpingography during pregnancy or acute pelvic inflammation – Bronchography.
– In interventional radiology (Trans-Arterial Chemo-Embolization), Administration in liver areas with dilated bile ducts unless drainage has been performed.
Special warnings and special precautions for use (*):
There is a risk of hypersensitivity regardless of the dose administered.
Lymphography: Pulmonary embolism may occur immediately or after few hours to days from inadvertent systemic vascular injection or intravasation of LIPIODOL® ULTRA-FLUID: Perform radiological monitoring during LIPIODOL® ULTRA-FLUID injection and avoid use in patients with severely impaired lung function, cardiorespiratory failure or right-sided cardiac overload.
Hypersensitivity: all iodinated contrast agents can lead to minor or major hypersensitivity reactions, which can be life-threatening. These hypersensitivity reactions are of an allergic nature (known as anaphylactic reactions if they are serious) or a non-allergic nature. They can be immediate (occurring within 60 min) or delayed (not occurring until up to 7 days later). Anaphylactic reactions are immediate and can be fatal. They are dose-independent, can occur right from the first administration of the product, and are often unpredictable: avoid use in patients with a history of sensitivity to other iodinated contrast agents, bronchial asthma or allergic disorders because of an increased risk of a hypersensitivity reaction to LIPIODOL® ULTRA-FLUID.
Thyroid: can cause hyperthyroidism in predisposed patients. Lymphography saturates the thyroid with iodine for several months and thyroid exploration should be performed before radiological examination.
Chemo-Embolization: Trans-Arterial Chemo-Embolization is not recommended in patients with decompensated liver cirrhosis (Child-Pugh ≥8), advanced liver dysfunction, macroscopic invasion and/or extra-hepatic spread of the tumour. Renal insufficiency must be prevented by correct rehydration before and after the procedure. Oesophageal varices must be carefully monitored. Hepatic intra-arterial treatment can progressively cause an irreversible liver insufficiency in patients with serious liver malfunction and/or undergoing close multiple sessions. The risk of superinfection in the treated area is normally prevented by administration of antibiotics.
Embolization with glue: An early polymerisation reaction may exceptionally occur between LIPIODOL® ULTRA-FLUID and certain surgical glues, or even certain batches of glue. Before using new batches of LIPIODOL®ULTRA-FLUID or surgical glue, the compatibility of LIPIODOL® ULTRA-FLUID and the glue must be tested in vitro.
Interaction with other medicinal products and other forms of interaction (*):
Metformin, beta blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, angiotensin-receptor antagonists, diuretics, interleukin II.
Fertility, pregnancy and lactation (*):
LIPIODOL® ULTRA-FLUID must only be used in pregnant women if absolutely necessary and under strict medical supervision. Breastfeeding should be discontinued if LIPIODOL® ULTRA-FLUID must be used.
Effects on ability to drive and use machines:
The effects on ability to drive and to use machines have not been investigated.
Undesirable effects (*):
Most adverse effects are dose-related and dosage should therefore be kept as low as possible : hypersensitivity, anaphylactic reaction, anaphylactoid reaction, vomiting, diarrhea, nausea, fever, pain, dyspnea, cough, hypothyroidism, hyperthyroidism, thyroiditis, pulmonary embolism, cerebral embolism, retinal vein thrombosis, lymphoedema aggravation, hepatic vein thrombosis, granuloma.
Overdose (*):
The total dose of LIPIODOL® ULTRA-FLUID administered must not exceed 20 mL.
Pharmacodynamic properties (*):
Pharmacotherapeutic group: X-ray contrast media, iodinated; ATC code: V08A D01. Water-insoluble iodinated contrast medium.
Presentation (**):
10 mL glass ampoule.
Marketing authorization holder (*):
Guerbet – BP 57400 – F-95943 Roissy CdG cedex – FRANCE. Information: tel: 33 (0) 1 45 91 50 00.
Revision:
April 24th, 2018.

(*) For complete information please refer to the local Summary of Product Characteristics (SPC).
(**) Indications, volumes and presentations may differ from country to country.
Reporting of suspected adverse reactions is important as it helps to continuously assess the benefit-risk balance. Therefore, Guerbet encourages you to report any adverse reactions to your health authorities or to our local Guerbet representative.

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