Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 03 February 2017
CONTRAINDICATIONS Hysterosalpingographic agents are contraindicated in pregnant women and those suspected of being pregnant.
Hysterosalpingography should not be performed during the menstrual period nor when
The procedure should not be attempted within 30 days following curettage or conization or within six months following the termination of pregnancy.
PRECAUTIONS 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
In patients having or suspected of having carcinoma of the uterus and/or uterine tubes, the possible dispersion of carcinogenic cells during hysterosalpingography should be borne in mind.
The possibility of a reaction should always be considered.
Information for the Patient).
Information for the Patient Patients receiving diagnostic agents for intrauterine radiography should be given the following information: This drug has been prescribed to perform an X-ray study of the uterus and uterine tubes.
Patients should be questioned regarding a recent history (within 30 days) of curettage or conization, pregnancy or a recent history (within six months) of termination of pregnancy, and a history of
Patients should consult the physician if, at some future date, any thyroid tests are planned.
The iodine in this agent may interfere with some thyroid tests.
This drug may cause
Drug/Laboratory Test Interactions Thyroid Function Tests Because a
However, thyroid function can be evaluated after use of any iodinated contrast agents by using T3 resin uptake or
Pregnancy See CONTRAINDICATIONS.
Nursing Mothers Diatrizoate meglumine and iodipamide meglumine administered intravascularly has been found to be excreted in breast milk.
Hypersensitivity reactions, which include sweating, flushing, pruritus, urticaria, skin rashes, arthralgia, respiratory
Dizziness, syncope, hypotension, chills, fever,
It should be kept in mind that the serious or anaphylactoid reactions that may occur with intravascular administration of radiopaque contrast agents are theoretically possible following administration by other routes.
DOSAGE AND ADMINISTRATION As a
Patients should be counseled prior to radiographic examination (see PRECAUTIONS, Information for the Patient).
Preparation of the patient: Hysterosalpingography should be performed three to five days after the cessation of the patient 's menstrual period as a precautionary measure.
An enema and vaginal douche one hour before
The patient should empty her bladder before the examination.
Dosage: 3 to 4 mL of Sinografin, administered in fractional doses of approximately 1 mL, are usually
Total doses varying from 1.5 to 10 mL have been employed with
Administration: The patient is placed in
A Graves-type vaginal speculum is introduced,
A tenaculum is placed on the cervical lip, usually the anterior lip.
The two-way cannula valve is opened and all air bubbles in the cannula and syringe are expressed.
About 1.5 to 2 mL of Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) are
The cannula tip is inserted into the cervical canal so that
Squeezing the trigger of the cannula to provide simultaneous traction on the tenaculum and forward pressure on the cannula should give a nonleaking cervical seal.
The syringe should be rinsed as soon after the procedure as possible to prevent freezing of the plunger.
The connection at the external os is checked for
Radiography: A scout film may be made before the medium is administered.
After the initial fractional injection, a film should be made using a Bucky diaphragm.
After each successive injection of 1 mL, a film is taken,
Further injection and subsequent films can be made as
Clinical experience indicates that tubal patency, if present, will be demonstrable at the time of the injection and
General Diatrizoate Meglumine and lodipamide Meglumine Injection should be inspected visually for particulate matter and
In the event that crystallization occurs,
If cloudiness persists, the preparation should not be used.
Allow the solution to
|Date Last Revised||19-12-2014|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Storage Store at 20-25°C (68-77°F) [See USP]. Protect from light.|
|Marketing authorisation holder||BRACCO DIAGNOSTICS INC|