CLARISCAN SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 MMOL/ML

GE HEALTHCARE AS (OSLO SITE) (NORWAY)🇸🇬 Health Sciences Authority

Approval Date: May 24, 2019
Approval ID: c53e21413938456d
Company: GE HEALTHCARE AS (OSLO SITE) (NORWAY)
Type: Therapeutic

Approval Details

Approval Id: c53e21413938456d
Drug Name: CLARISCAN SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 MMOL/ML
Product Name: CLARISCAN SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 MMOL/ML
Approval Number: SIN15694P
Approval Date: 2019-05-24
Registrant: GE HEALTHCARE PTE. LTD.
Licence Holder: GE HEALTHCARE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SOLUTION
Dosage: 4.2 Posology and method of administration This medicinal product should only be administered by trained healthcare professionals with technical expertise in performing and interpreting gadolinium enhanced MRI. Posology Adults including the elderly: The recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg which is sufficient to provide diagnostically adequate contrast. Children (aged 2 years and above): The adult dose applies to these patients. The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patient’s body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section. Whole body MRI (including lesions of the liver, kidneys, pancreas, pelvis, lungs, heart, breast, and musculoskeletal system) The recommended dose is 0.1 mmol/kg BW, i.e. 0.2 mL/kg BW to provide diagnostically adequate contrast. Special populations Impaired renal function The adult dose applies to patients with mild to moderate renal impairment (GFR ≥ 30 ml/min/1.73m2). Clariscan should only be used in patients with severe renal impairment (GFR < 30 mL /min/1.73m2) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI (see 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If it is necessary to use Clariscan the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Clariscan injections should not be repeated unless the interval between injections is at least 7 days. Impaired hepatic function The adult dose applies to these patients. Caution is recommended, especially in the case of perioperative liver transplantation period (see above impaired renal function). Elderly (aged 65 years and above) No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric population (aged 2–18 years) Encephalic and Spinal MRI, Whole body MRI: The recommended and maximum dose of Clariscan is 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Method of administration The product is indicated for intravenous administration only. Infusion rate: 3–5 mL/min (higher infusion rates up to 120 mL/min, i.e. 2 mL/sec, may be used for angiographic procedures). For instructions on preparation and disposal, see 6.6 Instructions for use/handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the administration, the patient should be kept under observation for at least half an hour, since experience shows that the majority of undesirable effects occur within this time. For single patient use only, any unused solution should be discarded. Paediatric population (2–18 years). Depending on the amount of Clariscan to be given to the child, it is preferable to use Clariscan vials with a single use syringe of a volume adapted to this amount in order to have a better precision of the injected volume. In neonates and infants the required dose should be administered by hand. Image acquisition Contrast enhanced MRI may be initiated immediately after administration of the agent. Optimal imaging: within 45 minutes after injection. Optimal image sequence: T1-weighted
Route Of Administration: INTRAVENOUS
Indication Info: 4.1 Indications This medicinal product is for diagnostic use only. Clariscan is a contrast agent indicated for enhancement of the contrast in Magnetic Resonance Imaging for a better visualization/delineation. <ul class="dash"> <li>Neuroradiology: tumour of the spine and the surrounding tissues, intracranial tumours.</li> <li>Abdominal radiology: primary and secondary tumours.</li> <li>Primary tumour of the bone and soft tissues.</li> </ul> Clariscan should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI).
Contraindications: 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in 6.1 List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Atc Code: V08CA02
Atc Item Name: gadoteric acid
Pharma Manufacturer Name: GE HEALTHCARE PTE. LTD.

Active Ingredients

Gadoterate meglumine 376.9mg/ml eqv Gadoteric acid

279.3mg/ml

GADOTERATE MEGLUMINE 376.9 MG/ML EQV GADOTERIC ACID

279.3 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 24, 2019

Approval ID

c53e21413938456d

Type

Therapeutic

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