Ethiodized Oil (Lipiodol)

Trade Name : LIPIODOL

Guerbet LLC

INJECTION

Strength 480 mg/mL

ETHIODIZED OIL

Delivery Process

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ethiodized Oil (Lipiodol) which is also known as LIPIODOL and Manufactured by Guerbet LLC. It is available in strength of 480 mg/mL per ml. Read more

Ethiodized Oil (Lipiodol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • ufeffWARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY
  • Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ().n
  • WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLYn n nPulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ().n
  • Lipiodol is an oil-based radio-opaque contrast agent indicated for:
  • Lipiodol is an oil-based radiopaque contrast agent indicated for:
  • hysterosalpingography in adults
  • lymphography in adult and pediatric patients
  • selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)
  • Use au00a0disposable syringe to draw and inject Lipiodol.
  • Hysterosalpingography
  • Lymphography
  • unilateral lymphography of the upper extremities: 2 to 4 mL
  • unilateral lymphography of the lower extremities: 6 to 8 mL
  • penile lymphography: 2 to 3 mL
  • cervical lymphography: 1 to 2 mLPediatric patients:
  • Inject a minimum of 1 mL to a maximum of 6 mL according to the anatomical area to be visualized. Do not exceed 0.25 mL/kg.
  • Selective Hepatic Intra-arterial Use
  • Each milliliter of Lipiodol contains 480 mg/mL of Iodine organically combined with ethyl esters of fatty acids of poppy seed oil.
  • Each mL of Lipiodol contains 480 mg Iodine organically combined with ethyl esters of fatty acids of poppy seed oil.
  • Lipiodol is contraindicated in patients with hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding.
  • Hysterosalpingography
  • Lipiodol hysterosalpingography is contraindicated in pregnancy, acute pelvic inflammatory disease, marked cervical erosion, endocervicitis and intrauterine bleeding, in the immediate pre-or postmenstrual phase, or within 30 days of curettage or conization.u00a0[see]n
  • Lymphography
  • Lipiodol Lymphography is contraindicated in patients with a right to left cardiac shunt, advanced pulmonary disease, tissue trauma or hemorrhage advanced neoplastic disease with expected lymphatic obstruction, previous surgery interrupting the lymphatic system, radiation therapy to the examined area.
  • Selective Hepatic Intra-arterial Use Patients with HCCn
  • Lipiodol use is contraindicated in areas of the liver where the bile ducts are dilated unless external biliary drainage was performed before injection.
  • Hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding.
  • Lipiodol Hysterosalpingography is contraindicated in:
  • Lipiodol Lymphography is contraindicated in:
  • Lipiodol Selective Hepatic Intra-arterial Injection is contraindicated in:
  • No data
  • Pulmonary and cerebral embolism: avoid use in patients with severely impaired lung function, cardiorespiratory failure or right-sided cardiac overload ()
  • Hypersensitivity reactions: 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 ()
  • Exacerbation of chronic liver disease ()
  • Thyroid dysfunction ()
  • The following adverse reactions (Table 1) have been identified during post approval use of Lipiodol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • The following adverse reactions are described in more detail in other sections of the prescribing information: Pulmonary and cerebral embolism [see ] Hypersensitivity reactions [see ] Exacerbation of chronic liver disease [see ]
  • Thyroid dysfunction [see ]. Thyroid dysfunction in the mother and the infant of a subsequent pregnancy[See Use in Specific Populations ()]
  • Hysterosalpingography
  • Abdominal pain, foreign body reactions, exacerbation of pelvic inflammatory disease, salpingitis or pelvic peritonitis have been reportedafter the examination in case of latent infection.
  • Lymphography
  • Lymphangitis, thrombophlebitis, edema or exacerbation of preexisting lymphedema, dyspnea and cough, iodism (headache, soreness of mouth and pharynx, coryza and skin rash), allergic dermatitis, lipogranuloma, delayed healing at the site of incision.
  • Selective Hepatic Intra-arterial Injectionn
  • Abdominal pain, nausea, and vomiting are the most common reactions; other reactions includeu00a0hepatic vein thrombosis, hepatic ischemia, liver enzymes abnormalities, transitory decrease in liver function, liver decompensation and renal insufficiency. Procedural risks include vascular complications and infections.n
  • Adverse reactions caused by Lipiodol include hypersensitivity reactions, pulmonary embolism, pulmonary dysfunction, exacerbation of liver disease, procedural complications, abdominal pain, fever, nausea, vomiting, and thyroid dysfunction.
  • To report SUSPECTED ADVERSE REACTIONS, contact GUERBET LLC at 1-877-729-6679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Following Lipiodol administration, ethiodized oil remains in the body for several months. Ethiodized oil interferes with radioactive iodine uptake by the thyroid for several weeks to months may impair visualization of thyroid scintigraphy and reduce effectiveness of iodine 131 treatment.
  • Lipiodol may interfere with thyroid function testing and with radioactive iodine uptake by the thyroid tissue during diagnostic or therapeutic procedures. ()
  • No data
  • Pregnancy:
  • Lactation:
  • Overdose may lead to respiratory, cardiac or cerebral complications, which can potentially be fatal. Microembolisms to multiple organs may occur more frequently after overdose. Promptly initiate symptomatic treatment and support of vital functions.
  • Lipiodol, ethiodized oil injection, is a sterile injectable radio-opaque agent. Each milliliter contains 480 mg of Iodine organically combined with ethyl esters of fatty acids of poppy seed oil. The precise structure of Lipiodol is unknown.
  • Lipiodol is a sterile, clear, pale yellow to amber colored oil. Lipiodol has a viscosity of 34 u2013 70 mPau0387s at 20u00b0C, and a density of 1.28 g/cm at 20u00b0C.
  • No data
  • Long-term studies in animals have not been performed to evaluate carcinogenic potential. Lipiodol did not demonstrate mutagenic potential in bacterial reverse mutation assays , in a chromosomal aberration test in the mouse lymphoma assay , and was negative in an in vivo micronucleus test in rats after intravenous injection of 479 mg I/kg.
  • Lipiodol is supplied in a box of one 10 mL ampoule, NDC 67684-1901-1.
  • Lipiodol is supplied in a box of one 10 mL vial, NDC 67684-1901-2.Each vial is closed with a rubber stopper and sealed with an aluminum cap.
  • Store at controlled room temperature 15u00b0-30u00b0C (59u00b0-86u00b0F) [see USP, Controlled Room Temperature (CRT)]. Protect from light. Remove from carton only upon use.
  • Hypersensitivity Reactions
  • Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after Lipiodol administration. Advisethe patient to report any signs or symptoms of hypersensitivity reactions during the procedure and to seek medical attention for signs orsymptoms experienced after discharge .
  • Thyroid Dysfunction
  • Advise patients concerning the risk of hyper- or hypothyroidism flowing the use of Lipiodol due to ethiodized oil remaining in the bodyfor several months. Instruct patients to follow up with their physician if they become pregnant or develop any signs of thyroid dysfunction in the months after administration .
  • Rx Only
  • Guerbet LLC
  • 821 Alexander Road, Suite 204
  • Princeton, New Jersey 08540, USA
  • For further information or ordering, call
  • 1-877-729-6679
  • Ampoules manufactured for Guerbet LLC by:
  • Jubilant HollisterStier General Partnership, Canada
  • Vials manufactured for Guerbet LLC by: Recipharm Monts, France
  • Revised 06/2020
  • Warnings and Precautions,u00a0Thyroid Dysfunction ()
  • u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a06/2020
  • No data
  • No data

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