Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
perflutren, Quantity: 1.1 mg/mL
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
Perflutren
Injection, suspension
Excipient Ingredients: sodium chloride; propylene glycol; water for injections; dipalmitoylphosphatidylcholine; N-(methoxy-PEG-5000 carbamoyl)-dipalmitoylphosphatidylethanolamine sodium; sodium dipalmitoylphosphatidate; glycerol; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate
Intravenous
4 vials, each containing at least 1.5 mL liquid
Not scheduled. Not considered by committee
This medicinal product is for diagnostic use only. DEFINITY is indicated for use in patients in contrast-enhanced diagnostic ultrasound imaging to improve the characterization of focal lesions of the liver and kidney. DEFINITY is indicated for use in patients with suboptimal echocardiograms to provide opacification of cardiac chambers, improvement of left ventricular endocardial border delineation and assessment of regional wall at both rest and stress.
Visual Identification: A clear, colourless, sterile, nonpyrogenic, hypertonic liquid, which upon activation with the aid of a VialmixTM, provides a homogeneous, opaque, milky white injectable suspension of perflutren lipid microspheres.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2007-01-30
DEFINITY 1 DEFINITY PERFLUTREN LIPID MICROSPHERE INJECTION VIAL CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING [MEDICINE NAME]? DEFINITY contains the active ingredient perflutren. DEFINITY is used in patients on contrast-enhanced diagnostic ultrasound imaging to improve characterisation of focal lesions of the liver and kidney. It is also used in patients with suboptimal echocardiograms to provide opacification of cardiac chambers, improvement of left ventricular endocardial border delineation and assessment of regional wall motion at both rest and stress. For more information, see Section 1. Why am I using [medicine name]? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DEFINITY ? Do not use if you have ever had an allergic reaction to DEFINITY , Polyethylene glycol or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use [medicine name]? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DEFINITY and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE DEFINITY ? • Your doctor will decide how much you will be given DEFINITY . This depends on which organ (liver, kidney or heart) is being examined and other factors such as weight. • DEFINITY is given as an injection or infusion (drip) into a vein. More instructions can be found in Section 4. How do I use [medicine name]? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DEFINITY ? THINGS YOU SHOULD DO • Remind any docto Lire le document complet
AUSTRALIAN PRODUCT INFORMATION – DEFINITY PERFLUTREN LIPID MICROSPHERE INJECTION VIAL (PERFLUTREN) DISPERSION FOR INTRAVENOUS INJECTION 1 NAME OF THE MEDICINE perflutren 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The perflutren lipid microspheres are composed of perflutren encapsulated in an outer lipid shell consisting of (R) - hexadecanoic acid, 1 –[(phosphonoxy)methyl]-1,2-ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl-l0-oxo-7-[(l-oxohexadecyl)oxy]-3,4,9-trioxa-4- phosphapentacosan-l-aminium, 4-oxide, inner salt (abbreviated DPPC); and (R) ά-[6-hydroxy-6-oxido-9- [(1-oxohexadecyl)oxy]5,7,11-trioxa-2-aza-6-phosphahexacos-1-yl]-ω-methoxypoly(ox-l,2-ethanediyl), commonly called N-(MethoxyPolyEthylene Glycol 5000 carbamoyl)-1,2-DiPalmitoyl-sn-glycero-3- PhosphatidylEthanolamine, monosodium salt (abbreviated MPEG5000 DPPE). Prior to VIALMIX TM activation, the DEFINITY ® vial contains 6.52_ _mg/mL perflutren in the headspace. Each mL of the clear liquid contains 0.75 mg lipid blend (consisting of 0.045 mg DPPA, 0.401 mg DPPC, and 0.304 mg MPEG5000 DPPE), 103.5 mg propylene glycol, 126.2 mg glycerin, 2.34 mg monobasic sodium phosphate monohydrate, 2.16 mg dibasic sodium phosphate heptahydrate, and 4.87 mg sodium chloride in Water for Injection. The pH is 6.2-6.8. After activating the contents of the vial in a VIALMIX TM , each mL of the milky white suspension contains a maximum of 1.2 x 10 10 perflutren lipid microspheres, and about 1.1 mg/mL perflutren. The microsphere particle size parameters are listed in Table 1 below: Table 1 Microsphere Size Distribution Microsphere particle size parameters Mean diameter range 1.1 μm — 3.3 μm Percent less than 10 μm 98% Maximum diameter 20 μm Octafluoropropane and perfluoropropane are synonyms for perflutren. 3 PHARMACEUTICAL FORM DEFINITY ® contains a clear, colourless, sterile, nonpyrogenic, hypertonic liquid, which upon activation with the aid of a VIALMIX TM , provides a homogeneous, opaque, milky white injectable suspen Lire le document complet