국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
gadoteridol, Quantity: 279.3 mg/mL
Bracco Pty Ltd
Injection, solution
Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid; trometamol; calteridol calcium
Intravenous
5 x 15mL, 1 x 15mL
Not scheduled. Not considered by committee
Do not freeze (syringe only). ProHance is indicated for use in adults and children from 2 years of ge for enhancement of magnetic images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity. ProHance can also be used for whole body MRI.
Visual Identification: Clear, colourless to slightly yellow solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2000-09-01
PROHANCE ® GADOTERIDOL CONSUMER MEDICINE INFORMATION PROHANCE ® INJECTION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about ProHance ® . It does not contain all the available information. It does not take the place of talking with your radiologist, your doctor or your pharmacist. All products of this type have risks and benefits. Your radiologist and your doctor have weighed the risk of you being given ProHance ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS PREPARATION, ASK YOUR RADIOLOGIST, DOCTOR OR PHARMACIST. Keep this leaflet. You might need to read it again. WHAT PROHANCE ® IS USED FOR AND HOW IT WORKS Prohance ® is a substance known as a paramagnetic contrast medium. It is used in magnetic resonance imaging (MRI) to enhance or improve the scans or images (pictures) of certain parts of the body (in particular, the brain, spine and surrounding tissue), obtained by MRI alone. ProHance ® can also be used for whole body MRI, including the head, neck, liver, breast, musculoskeletal system (all of the muscles, bones, joints and related structures that are involved in the movement of the parts and organs of the body) and diseases of the soft tissues. ProHance ® is given by injection into a vein. ProHance ® is not recommended for use in children under the age of 2 years as there is not enough experience with the use of ProHance ® in this group. MRI is a medical technology which uses magnetic fields and radio waves to produce images of parts of the body, which a doctor can then use to make a diagnosis. MRI examinations are carried out by specialist doctors called radiologists, using sophisticated medical equipment. MRI does not use X-rays and therefore the minor risks associated with X-rays are avoided. BEFORE YOU HAVE AN INJECTION OF PROHANCE ® _YOU MUST _NOT _HAVE AN INJECTION OF PROHANCE_ ® : If you are allergic to the active ingredient of ProHance ® , gadoteridol, or the other ingredients in ProHance ® injection, or t 전체 문서 읽기
1 of 11 AUSTRALIAN PRODUCT INFORMATION - PROHANCE ® (GADOTERIDOL) 1 NAME OF THE MEDICINE Gadoteridol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ProHance ® (gadoteridol) is a nonionic paramagnetic contrast medium for magnetic resonance imaging (MRI). Chemically, gadoteridol is [10-(2-hydroxypropyl-O)-1,4,7,10-tetra- azacyclododecane-1,4,7-triyltriacetato O 1 , O 4 , O 7 , N 1 , N 4 , N 7 , N 10 (3-)]gadolinium(III). Gadoteridol is freely soluble in water and methanol, soluble in isopropanol, sparingly soluble in dimethylformamide, slightly soluble in acetonitrile and methylene chloride and very slightly soluble in ethyl acetate, acetone, toluene and hexane. ProHance ® contains gadoteridol 279.3mg per mL (0.5M). ProHance ® has a pH of 6.5 to 8. Pertinent physicochemical data follow: PARAMETER Osmolality (mOsmol/kg water) @ 37°C: 630 Viscosity (cP) @ 20°C: 2.0 Viscosity (cP) @ 37°C: 1.3 Specific Gravity @ 25°C: 1.140 Density (g/mL) @ 25°C: 1.137 Octanol:H 2 O coefficient: -3.68 ± 0.02 ProHance ® has an osmolality 2.2 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Sterile clear colourless to slightly yellow solution for intravenous injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ProHance ® is indicated for use in adults and children from 2 years of age for enhancement of magnetic resonance images of intracranial and spinal lesions where there is an abnormal blood-brain barrier or abnormal vascularity. ProHance ® can also be used for whole body MRI. 4.2 DOSE AND METHOD OF ADMINISTRATION ProHance ® is administered by intravenous injection. ProHance ® vials and syringes contain no antimicrobial agent and are for single use only. They are to be used once only and any residue discarded. Extreme caution during injection of any contrast media is necessary to avoid extravasation. Adults The recommended dose range of ProHance ® for imaging most brain and spine patholog 전체 문서 읽기