CYSTO-CONRAY II Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Liebel-Flarsheim Company LLC
Λέξεις κλειδιά
0019-0862
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1. Description
Cysto-Conray II is a sterile aqueous solution intended for instillation as a diagnostic radiopaque medium. Cysto-Conray II contains 17.2% w/v iothalamate meglumine which is 1-Deoxy-1-(methylamino)-D-glucitol ...
2. Clinical Pharmacology
The most important characteristic of contrast media is the iodine content. The relatively high atomic weight of iodine contributes sufficient radiodensity for radiographic contrast. Following instillation ...
3. Indications and Usage
Cysto-Conray II is indicated for use in retrograde cystography and cystourethrography.
4. Contraindications
See WARNINGS concerning inadvertant intrathecal administration.
5. Warnings
Severe adverse events – Inadvertent intrathecal administration Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated ...
6.1. General
Diagnostic procedures which involve the use of radiopaque diagnostic agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular ...
6.2. Information for Patients
Patients receiving diagnostic agents for instillation urography should be instructed to: Inform your physician if you are pregnant. Inform your physician if you are allergic to any food, drugs or dyes ...
6.5. Drug/Laboratory Test Interactions
Thyroid Function Tests If indicated, these tests generally should be performed prior to the administration of any iodinated agent. However, thyroid function can be evaluated after use of these agents by ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential or whether this drug affects fertility in males or females.
6.7. Pregnancy
Category C. Animal reproduction studies have not been conducted with Cysto-Conray II. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction ...
6.9. Nursing Mothers
Iothalamate salts are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, because of the potential for adverse reactions, caution ...
7. Adverse Reactions
Irritation of the bladder or ureter, common to some degree to all contrast media administered for retrograde urographic procedures, may occasionally occur. As with all contrast media, intravasation may ...
10. Dosage and Administration
Patient Preparation Unless contraindicated, an appropriate laxative is given the night before the examination. Radiographic Technique The radiographic procedure normally employed for cystography and cystourethrography ...
11. How Supplied
Cysto-Conray II Glass Bottles NDC Number 12 250 mL single dose bottles 0019-0862-50 Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616 Made in USA
12. Storage and Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs, the containers should ...