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Cyclolux

Cyclolux

Manufacturer:

Farmaco Healthcare

Distributor:

Unimed
Concise Prescribing Info
Contents
Gadoteric acid (as meglumine salt)
Indications/Uses
Diagnostic contrast agent used in MRI for cerebral, spinal & vertebral column diseases & other whole body pathologies eg, angiography.
Dosage/Direction for Use
Adult 0.2 mL/kg IV. Angiography May administer 2nd inj if necessary. Confirmation of isolated metastasis or detection of leptomeningeal tumours 2nd inj of 0.4 mL/kg can be administered. MRI Neonate up to 4 wk, infant up to 1 yr & severe renal impairment (GFR <30 mL/min/1.73 m2) Not to exceed 0.1 mmol/kg & not to be repeated unless w/ at least 7-days interval.
Contraindications
Hypersensitivity to gadoteric acid, meglumine or gadolinium-containing medicinal products.
Special Precautions
Discontinue use if hypersensitivity reactions occur. Not to be inj intrathecally. History of allergy (eg, seafood allergy, hay fever, hives), sensitivity to contrast media, asthma. Increased risk for nephrogenic systemic fibrosis. Patients on β-blockers & w/ bronchial asthma; CV disease; low seizure threshold. Screen patients for renal dysfunction prior to initiation. May affect ability to drive & use machines. Peri-op liver transplant patients. Acute or chronic severe renal insufficiency. Not to be used during pregnancy. Lactation. Not recommended for angiography in childn <18 yr. Neonates <4 wk & infants up to 1 yr. Elderly ≥65 yr.
Adverse Reactions
Inj site reactions, nausea, headache; vomiting, pruritus, hypersensitivity reactions.
Drug Interactions
Decreased efficacy of β-blockers, vasoactive substances, ACE inhibitors, ARBs.
MIMS Class
Radiographic & Diagnostic Agents
ATC Classification
V08CA02 - gadoteric acid ; Belongs to the class of paramagnetic agents used as magnetic resonance imaging contrast media.
Presentation/Packing
Form
Cyclolux soln for inj 0.5 mmol/mL
Packing/Price
10 mL x 1's;15 mL x 1's;20 mL x 1's
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