Echovist (Galactose)

ECHOVIST®

Berlex Canada

Galactose

Ultrasound Contrast Agent

Action And Clinical Pharmacology: Echovist is an ultrasound contrast agent consisting of a suspension of micron-sized air bubbles, formed upon reconstitution of specially formulated galactose granules with an aqueous galactose solution. Following intrauterine administration of the suspension, the bubbles serve to enhance ultrasound signals from the uterine cavity and fallopian tubes, thus enabling better visualization of these structures.

Upon completion of the ultrasound procedure, most of the administered galactose is discharged from the uterus into the cervix and vagina. The remainder is absorbed into the systemic circulation and rapidly metabolized to glucose by the liver.

Indications And Clinical Uses: Hysterosalpingo-contrast Sonography (HyCoSy): The product is indicated for contrast enhancement during ultrasound examination of the uterine cavity and fallopian tubes, including evaluation of tubal patency in infertility investigations.

Contra-Indications: Patients with galactosemia, pelvic inflammatory disease and pregnancy. tag_WarningWarnings

Manufacturers’ Warnings In Clinical States: Aseptic conditions must be maintained during administration to reduce the potential risk of ascending infection.

Precautions: Hypotension: Caution should be exercised in women with autonomic lability or unstable blood pressure, since there is a possible risk of vasovagal reaction, and therefore transient hypotension.

Pregnancy and Lactation : If pregnancy is suspected, the product should not be used (see Contraindications). Since galactose is a natural component of breast milk, there is no contraindication for the use of the product during lactation.

Children: The safety and efficacy of the product in children have not been established.

Drug Interactions: The interaction of galactose with drugs or contrast imaging agents has not been fully investigated. In clinical trials, there was no evidence of an interaction between the product and local or general anesthetics.

Adverse Reactions: The safety was evaluated in clinical trials involving a total of 1 326 patients undergoing ultrasound examination of the uterus and/or fallopian tubes. Approximately 20% of patients received local or general anesthesia prior to the ultrasound procedure. The most common adverse events reported in the patients who did not receive anesthesia were: pain 54.9%, nausea 2.6%, syncope 2.0%, vasovagal symptoms 2.0% and vomiting 1.2%. In general, pain associated with the product was mild and did not require analgesia. Adverse events rarely prevented the completion of the ultrasound and serious adverse events were uncommon.

The following adverse events were reported in less than 1% of patients: Cardiovascular: bradycardia, hypotension.

Nervous System: dizziness, grand mal seizure.

Body as a Whole: fever, malaise, pain in extremity, discomfort, general weakness, taste perversion, increased sweating, hot flashes.

Respiratory: hyperventilation, respiratory disorder.

Gastrointestinal: diarrhea, vomiting, intestinal perforation.

Genitourinary: salpingitis, vaginal bleeding, vaginal discharge, endometrial injury.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: The risk of accidental overdose with the product is extremely remote. Any overdose should be treated by prompt initiation of symptomatic therapy.

Dosage And Administration: Enhancement of the ultrasound signal is dependent on the volume of suspension administered. For examination of the uterine cavity, 2 to 5 mL is usually sufficient. For examination of the fallopian tubes, the addition of further 1 to 2 mL increments should be added under ultrasound control. In general, a total volume of 15 mL is sufficient, with a recommended maximum volume of 30 mL.

A balloon catheter for hysterosalpingo-contrast sonography (HyCoSy) should be used for the administration. The patient should be prepared for the procedure prior to the reconstitution of the granules.

Echovist granules are to be reconstituted with Echovist solution in the following manner: 1. Ensure that the vials of granules and solution are at room temperature. 2. Remove the plastic cap from the vial containing the galactose solution and withdraw the entire contents using a syringe. 3. Remove the plastic cap from the vial containing the granules and insert the mini-spike provided. Transfer the galactose solution in the syringe to the vial of granules through the mini-spike. 4. Shake vigorously by hand for 5 to 10 seconds to produce a homogenous milky-white suspension. Withdraw the suspension through the mini-spike into the syringe and administer immediately.

Take care not to warm the suspension with the hands and avoid using excessive negative pressure when withdrawing the suspension into the syringe.

Once reconstituted, the suspension is stable for approximately 5 minutes without any loss of echogenicity.

Unused portion should be discarded.

Reconstitution: Once reconstituted, Echovist is a suspension of slowly soluble galactose microparticles in a 20% (w/v) aqueous galactose solution with an initial overall microparticle concentration of approximately 200 mg/mL. The median diameter of the galactose microparticles is 2 µm, with 99% of them being less than or equal to 8 µm.

Osmolality of freshly prepared suspension, at 37°C= 1 699 mOsm/kg.

Osmolality upon complete dissolution of the suspension, at 37°C=2 960 mOsm/kg.

Viscosity (rotational viscosimeter) of freshly prepared suspension, at 25°C=approximately 4 mPa.s.

Stability and Storage: The vials of granules and solution should be protected from light and stored between 15 and 30°C.

Once reconstituted, the suspension is stable for approximately 5 minutes without any loss of echogenicity.

Availability And Storage: Each g of granules contains: galactose 1 g. Each mL of sterile aqueous solution contains: galactose 20% (w/v). Cartons containing 1 vial of granules consisting of 3 g of galactose 100%, and 1 vial of solution consisting of 13.5 mL of sterile aqueous galactose 20% (w/v). A mini-spike is also included for reconstitution.

ECHOVIST® Berlex Canada Galactose Ultrasound Contrast Agent

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