Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
tolvaptan, Quantity: 45 mg
Otsuka Australia Pharmaceutical Pty Ltd
Tolvaptan
Tablet
Excipient Ingredients: hyprolose; lactose monohydrate; maize starch; microcrystalline cellulose; indigo carmine aluminium lake; magnesium stearate
Oral
56 tablets
(S4) Prescription Only Medicine
JINARC is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease (see PHARMACOLOGY).
Visual Identification: A blue square shallow-convex tablet debossed with "OTSUKA" and "45" on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-03-24
JINARC ® J i n a r c 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. 1. WHY AM I USING JINARC? JINARC contains the active ingredient tolvaptan. JINARC is used to treat a disease called Autosomal Dominant Polycystic Kidney Disease (ADPKD). For more information, see Section 1. Why am I using JINARC? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE JINARC? Do not use if you have ever had an allergic reaction to JINARC 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 JINARC? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with JINARC 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 JINARC? • JINARC is to be taken in two different doses every day. • The dose combinations are 45 mg + 15 mg or 60 mg + 30 mg or 90 mg + 30 mg. More instructions can be found in Section 4. How do I use JINARC? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING JINARC? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using JINARC • MAKE SURE YOU DRINK ENOUGH WATER THINGS YOU SHOULD NOT DO • Do not stop using this medicine or change the dosage without checking with your doctor • Do not take JINARC to treat any other complaints unless your doctor tells you to • Do not give your medicine to anyone else, even if they have the same condition as you DRIVING OR USING MACHINES • JINARC may cause side effects that can affect your ability to drive or use machines • JINARC may make you feel dizzy or sleepy, particularly at the beginning of treatment. If this happens to you, do not drive or use any tools or machines. DRIN Lesen Sie das vollständige Dokument
Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION JINARC ® (TOLVAPTAN) TABLETS Tolvaptan has been associated with idiosyncratic elevations of blood alanine and aspartate aminotransferases (ALT and AST), rarely associated with concomitant elevations in bilirubin- total (BT). To help mitigate the risk of liver injury, blood testing for hepatic transaminases is required prior to initiation of JINARC, then continually monthly for 18 months, then every 3 months thereafter during treatment with JINARC. (See Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE.). Prescriber education and certification on the risk of liver injury and the importance of regular liver function monitoring is mandatory. These are available through the IMADJIN ® Program, which is run and maintained by, or for, the sponsor of JINARC (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 1 NAME OF THE MEDICINE Tolvaptan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION JINARC tablets for oral use contain 15 mg, 30 mg, 45 mg, 60 mg or 90 mg of tolvaptan. Excipients with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM JINARC 15 mg Tablet: A blue triangular shallow-convex tablet debossed with “OTSUKA” and “15” on one side. JINARC 30 mg Tablet: A blue round shallow-convex tablet debossed with “OTSUKA” and “30” on one side. JINARC 45 mg Tablet: A blue square shallow-convex tablet debossed with “OTSUKA and “45” on one side. JINARC 60 mg Tablet: A blue modified rectangular shallow convex tablet debossed with “OTSUKA” and “60” on one side. JINARC 90 mg Tablet: A blue pentagonal shallow-convex tablet debossed with “OTSUKA” and “90” on one side. Page 2 of 28 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS JINARC is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 3 at initiation of treatment with evidence o Lesen Sie das vollständige Dokument