Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
ETHIODIZED OIL (UNII: KZW0R0686Q) (IODINE - UNII:9679TC07X4)
Guerbet LLC
INTRALYMPHATIC
PRESCRIPTION DRUG
Lipiodol is an oil-based radio-opaque 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) 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, and within 30 days of curettage or conization or patients with known or suspected reproductive tract neoplasia due to the risk of peritoneal spread of neoplasm. [see Use in Specific Populations (8.1) . ] Lymphography Lipiodol Lymphography is contraindicated in patients with a right to left cardiac shunt, advanced pulmonary disease, tissue trauma or hemorrhage advanced neoplastic diseas
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 15°-30°C (59°-86°F) [see USP, Controlled Room Temperature (CRT)]. Protect from light. Remove from carton only upon use.
New Drug Application
LIPIODOL- ETHIODIZED OIL INJECTION GUERBET LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LIPIODOL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LIPIODOL. LIPIODOL® (ETHIODIZED OIL) INJECTION, FOR INTRAUTERINE, INTRALYMPHATIC, OR INTRA-ARTERIAL USE INITIAL U.S. APPROVAL: 1954 WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA- ARTERIAL USE ONLY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ 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 (5.1). RECENT MAJOR CHANGES Contraindications (4) 11/2022 Warnings and Precautions, Thyroid Dysfunction (5.4) 4/2022 INDICATIONS AND USAGE Lipiodol is an oil-based radiopaque contrast agent indicated for: (1) hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) DOSAGE AND ADMINISTRATION Use a disposable syringe to draw and inject Lipiodol. (2) HYSTEROSALPINGOGRAPHY Inject increments of 2 mL of Lipiodol into the endometrial cavity until tubal patency is determined; stop the injection if the patient develops excessive discomfort. Inject with radiologic monitoring. LYMPHOGRAPHY Inject Lipiodol into a lymphatic vessel with radiologic monitoring. Adults: 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 mL Pediatric 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 Inject 1.5 to 15 mL of Lipiodol slowly under continuous radiologic monitoring. Do not exceed 20 mL total dosage. DOSAGE FORMS AND STRENGTHS Each mL of Lipiodol contains 480 mg Iodine Прочетете целия документ