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* Clariscan has been approved in more than 70 countries globally, with more than seven million patient doses shipped, and now offers a wider range of packaging solutions.
* Clariscan in pre-filled syringes offers potential advantages for workflow safety and efficiency.
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Marlborough, US --
Already available in glass vials and plastic polymer bottles, the approval of Clariscan in crystal clear polymer pre-filled syringes adds to the range of packaging solutions available to meet departmental needs and follows the recent FDA approval of Clariscan's +PLUSPAK Pharmacy Bulk Package. This patented, pharmaceutical grade polypropylene bottle is the only FDA-approved polymer bottle for an MRI contrast agent.
With injuries from glass bottles making up an estimated 16 percent of sharps injuries in healthcare settings, Clariscan's +PLUSPAK - and now plastic pre-filled syringes - both have the potential to improve workflow efficiencies while helping to reduce the associated risk of sharps injuries. With the approach of the
Clariscan - now approved in over 70 countries globally - is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Please see Clariscan Important Safety Information, including Boxed Warning, below.
"The addition of pre-filled syringes expands the Clariscan portfolio to address a wider range of departmental requirements" said Dr
Clariscan is manufactured in
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CLARISCAN(TM) (gadoterate meglumine) injection for intravenous use
PRODUCT INDICATIONS AND USE:
CLARISCAN(TM) (gadoterate meglumine) is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine, and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
IMPORTANT SAFETY INFORMATION ABOUT CLARISCAN(TM)
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The risk for NSF appears highest among patients with:
Chronic, severe kidney disease (GFR 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
For patients at highest risk for NSF, do not exceed the recommended Clariscan dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.
Contraindications
History of clinically important hypersensitivity reactions to Clariscan.
Warnings and precautions
Nephrogenic Systemic Fibrosis (NSF):
NSF has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeat dosing appear to increase the risk.
Hypersensitivity reactions:
Anaphylactic and anaphylactoid reactions have been reported with gadoterate meglumine, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of gadoterate meglumine administration and resolved with prompt emergency treatment.
Before Clariscan administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Clariscan.
Administer Clariscan only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, including personnel trained in resuscitation.
Gadolinium retention:
Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by brain, skin, kidney, liver and spleen. The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs.
Consequences of gadolinium retention in the brain have not been established. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.
Acute kidney injury:
In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging.
Extravasation and injection site reactions:
Ensure catheter and venous patency before the injection of Clariscan. Extravasation into tissues during Clariscan administration may result in tissue irritation.
Pre-filled syringes must not be frozen. Frozen syringes should be discarded.
Pharmacy Bulk Package Preparation:
Do not use the Pharmacy Bulk Package for direct intravenous infusion.
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: 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: While no data is available for gadoterate meglumine, 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 have been established in pediatric patients from birth (term neonates >= 37 weeks gestational age) to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older, and clinical data in 52 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data. Safety of gadoterate meglumine has not been established in preterm neonates.
Please see Full Prescribing Information for Clariscan, including Boxed Warning and Medication Guide, for additional important safety information. Click hereto access the Full Prescribing information.
To report SUSPECTED ADVERSE REACTIONS, contact
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