Ensure catheter and venous patency before the injection of Clariscan. Extravasation into tissues during Clariscan administration may result in tissue irritation.
Pharmacy Bulk Package Preparation:
Do not use the Pharmacy Bulk Package for direct intravenous infusion.
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Do not use if tamper-evident ring is broken or missing.
Perform the transfer of Clariscan from the Pharmacy Bulk Package in an aseptic work area, such as laminar flow hood and using aseptic technique and suitable transfer device. Penetrate the closure only one time.
Once the container closure is punctured, do not remove the Pharmacy Bulk Package from the aseptic work area.
The Pharmacy Bulk Package is used as a multiple dose container with an appropriate transfer device for filling empty sterile syringes.
Use each individual dose of Clariscan promptly following withdrawal from the Pharmacy Bulk Package.
Use the contents of the Pharmacy Bulk Package within 24 hours after initial puncture.
Adverse reactions
The most common adverse reactions (≥ 0.2%) associated with gadoterate meglumine in clinical trials were nausea, headache, injection site pain, injection site coldness and rash.
Serious adverse reactions in the postmarketing experience have been reported with gadoterate meglumine. These serious adverse reactions include but are not limited to: arrhythmia, cardiac arrest, respiratory arrest, pharyngeal edema, laryngospasm, bronchospasm, coma and convulsion.
Use in specific populations
Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive. Because of the potential risks of gadolinium to the fetus, use Clariscan only if imaging is essential during pregnancy and cannot be delayed. Advise pregnant women of the potential risk of fetal exposure to GBCAs.
Lactation: There are no data on the presence of gadoterate in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk.
Pediatric use: The safety and efficacy of gadoterate meglumine at a single dose of 0.1 mmol/kg has been established in pediatric patients from 2 to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older. Adverse reactions in pediatric patients were similar to those reported in adults. No dosage adjustment according to age is necessary in pediatric patients. No cases of NSF associated with gadoterate meglumine or any other GBCA have been identified in pediatric patients age 6 years and younger. The safety of gadoterate meglumine has not been established in preterm neonates.
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