Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
gadoteric acid, Quantity: 279.32 mg/mL
GE Healthcare Australia Pty Ltd
Solution
Excipient Ingredients: meglumine; water for injections; tetraxetan
Intravenous
10, 1
exempt from scheduling - Appendix A; prescription medicine
Clariscan is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see clinical studies).
Visual Identification: Clariscan is a clear, colourless to yellow solution; Container Type: Syringe; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-01-11
Clariscan - Consumer Medicine Information Page 1 of 3 CLARISCAN ® INJECTION _GADOTERIC ACID_ CONSUMER MEDICINE INFORMATION (CMI) WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with: • acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m 2 ), or • acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. WHAT IS IN THIS LEAFLET This leaflet provides only a summary of the information known about Clariscan. It does not contain all the available information. It does not take the place of talking to your doctor or health care professional. All diagnostic agents have risks and benefits. Your doctor has weighed the risks of you using Clariscan against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS DIAGNOSTIC AGENT, ASK YOUR DOCTOR OR RADIOLOGIST. IF YOU HAVE ANY QUESTIONS, WANT TO KNOW MORE ABOUT CLARISCAN OR ARE UNSURE ABOUT ANYTHING, ASK YOUR SPECIALIST OR RADIOLOGIST. KEEP THIS LEAFLET. You may need to read it again. Remember that this injection is only for you. Only a doctor can prescribe it for you. WHAT CLARISCAN IS USED FOR Clariscan contains gadoteric acid, which is made from gadolinium oxide (a magnetic agent) and DOTA, which binds with the gadolinium oxide to make a contrast agent to help diagnosis in MRI (magnetic resonance imaging). This is injected into your veins just before a MRI examination. MRI is a form of medical diagnostic imaging that forms pictures after detecting water molecules in normal and abnormal tissues. This is done using a complex system of magnets and radiowaves. BEFORE YOU ARE GIVEN CLARISCAN _WHEN YOU MUST NOT BE _ _GIVEN IT_ YOU MUST NOT BE GIVEN CLARISCAN IF YOU HAVE: • EVER HAD AN ALLERGIC (HYPERSENSITIVE) REACTION TO THE ACTIVE SUBSTANCE, GADOTERIC ACID, OR TO THE OTHER INGREDIENTS IN CLARISCAN. Symptoms of an allergic reaction may includ Read the complete document
Page 1 of 11 PRODUCT INFORMATION CLARISCAN Gadoteric acid 0.5 mmol/ mL solution for injection Gadoteric acid 0.5 mmol/ mL solution for injection in pre-filled syringe NAME OF TH E MEDICINE Clariscan (gadoteric acid) paramagnetic contrast medium for Magnetic Resonance Imaging (MRI). The structural formula of gadoteric acid is shown below: CHEMICAL NAME: GADOTERIC ACID FORMULA C 16 H 25 GdN 4 O 8 MOLAR MASS 558.64 g/mol The CAS Registry Number is 72573-82-1. DESCRIPTION Clariscan is a clear, colourless to yellow solution available in glass vials or pre-filled syringes intended for intravenous injection. Each vial or pre-filled syringe contains the active ingredient gadoteric acid 279.32 mg/mL (0.5 M). Gadoteric acid is a 1:1 complex of the paramagnetic ion gadolinium oxide 90.62 mg/mL with tetraxetan (1,4,7,10–tetraazacyclododecane–N,N’,N’’,N’’’–tetraacetic acid or DOTA) 202.46 mg/mL. Clariscan also contains the excipients meglumine 97.6 mg/mL, excess tetraxetan 0.25 mg/mL and water for injections. Page 2 of 11 Chemical characteristics of the formulation: • The product is hypertonic with tonicity 4.6 times that of the plasma (Osmolality:1350 mOsm.kg -1 , )Viscosity at 20°C: 3.2 mPa.s, Viscosity at 37°C: 2.0 mPa.s, pH: 6.5 – 8.0 • Density of solution: 1.349g/mL PHARMACOLOGY Gadoteric acid has paramagnetic properties which increase contrast enhancement in magnetic resonance imaging. The presence of 7 unpaired electrons in the gadolinium outer shell explains that this ion has a high magnetic moment and thus a strong paramagnetic effect. Gadoteric acid shortens the longitudinal relaxation time (T1) and the transverse relaxation time (T2) of water protons in tissues where it is distributed. At clinical doses the major effect is on T1 relaxation time. This results in an increased signal intensity in T1-weighted sequences and allows a better visualisation of abnormal structures or lesions. Gadoteric acid has no specific pharmacodynamic activity and is biologically inert. PHARMACOKINETICS: After i Read the complete document