SeQure® and DraKon™ Microcatheters. SeQure® and DraKon™ are microcatheters for peripheral vessels embolization. They are intended for : - Infusion of contrast media into all peripheral vessels
- Drug infusion in intra-arterial therapy
- Infusion of embolic materials
SeQure® and DraKon™ microcatheters should not be used in cerebral vessels. SeQure® and DraKon™ are authorized for commercialization in the United States and in Europe. They are also registered in Hong Kong, New Zealand and Thailand. Important Safety Information1 WARNING: FOR INTRALYMPHATIC, INTRAUNERINE 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. |
Indication and Usage LIPIODOL® (ethiodized oil) injection is a prescription oil-based radio-opaque contrast agent indicated for: - hysterosalping in adults
- lymphography in adult and pediatric patients
- selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)
Contraindications LIPIODOL® is contraindicated in patients with hypersensitivity to LIPIODOL®, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding. - 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.
- 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 lympathic obstruction, previous surgery interrupting the lymphatic system, radiation therapy to the examined area.
- LIPIODOL® Selective Hepatic Intra-arterial Injection is contraindicated in the presence of dilated bile ductrs unless external biliary drainage was perfomed before injection.
Warnings and Precautions - Pulmonary and cerebral embolism may occur immediately or after a few hours to days from inadvertent systemic vascular injection or intravasation of LIPIODOL®. Avoid use in patients with severely impaired lung function, cardiorespiratory failure or right-sided cardiac overload.
- Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occured following LIPIODOL® administration. 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®.
- LIPIODOL® hepatic intra-arterial administration can exacerbate chronic liver disease.
- Iodinated contrast media can affect thyroid function because of the free iodine content and can cause hyperthyroidism or hypothyroidism in predisposed patients.
Adverse Reactions - Hysterosalpingography - Abdominal pain, foreign body reactions, exacerbation of pelvic inflammatory disease.
- Lymphography - Cardiovascular collapse, lymphangitis, trombophlebitis, edema or exacerbation of preexisting lymphedema, delayed healing at the site of incision.
- Selective Hepatic Intra-arterial Injection - Fever, abdominal pain, nausea, and vomiting are the most common reactions; other reactions include hepatic ischemia, liver enzymes abdnormalities, transitory decrease in liver function, liver decompensation and renal insufficiency. Procedural risks include vascular complications and infections.
Use in Specific Populations - Pregnancy: There are no adequate and well-controlled studies of LIPIODOL® (ethiodized oil) injection effects in pregnant women. It is not known whether LIPIODOL® can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. The use of LIPIODOL® during pregnancy causes iodine transfer which may interfere with the thyroid function of the fetus and result in brain damage and permanent hypothyroidism.
- Lactation: LIPIODOL® is excreted in human milk. Avoid use of LIPIODOL® in a nursing woman because of risk of hypothyroidism in nursing infants. If breastfeeding is continued the neonate's thyroid function should be monitored.
- Pediatric: For lymphography use a dose of 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. Administer the smallest possible amount of LIPIODOL® according to the anatomical area to be visualized.
- Geriatric: There are no studies conducted in geriatric patients.
- Renal Impairment: Prior to an intra-arterial administration of LIPIODOL® screen all patients for renal dysfunction by obtaining history and/or laboratory tests. Consider follow-up renal function assessments for patients with a history of renal-dysfunction.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
REFERENCES - Lipiodol Full Prescribing information, Revised May 2018.
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