LIPIODOL- ethiodized oil injection

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

ETHIODIZED OIL (UNII: KZW0R0686Q) (IODINE - UNII:9679TC07X4)

MAH:

Guerbet LLC

administration_route:

INTRALYMPHATIC

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

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.

authorization_status:

New Drug Application

SPC

LIPIODOL- ETHIODIZED OIL INJECTION
GUERBET LLC
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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