Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
vericiguat, Quantity: 10 mg
Bayer Australia Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; hypromellose; purified talc; titanium dioxide; croscarmellose sodium; sodium lauryl sulfate; iron oxide yellow; magnesium stearate
Oral
14 film coated tablets, 100 film coated tablets (hospital dispensing pack), 14 film coated tablets (starter pack), 28 film coated tablets
(S4) Prescription Only Medicine
VERQUVO? is indicated in addition to standard of care therapy for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45[percent] who are stabilised after a recent heart failure decompensation event requiring admission and/or IV diuretic therapy (see Section 5.1 Pharmacodynamic properties ? Clinical trials).
Visual Identification: Round, biconvex, yellow-orange film-coated tablet with a diameter of 9 mm, debossed with 10 on one side and VC on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-11-15
VERQUVO® CMI V1.0 1 VERQUVO® 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. Please report side effects. See the full CMI for further details. 1. WHY AM I USING VERQUVO®? VERQUVO® contains the active ingredient vericiguat. VERQUVO® is used to treat heart failure. For more information, see Section 1. Why am I using VERQUVO®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE VERQUVO®? Do not use if you have ever had an allergic reaction to vericiguat 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 VERQUVO®? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with VERQUVO® and affect how it works. Do not take VERQUVO® if you are taking riociguat, or medicine for erectile dysfunction. 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 VERQUVO®? Take one (1) tablet of VERQUVO® at the same time each day with food. The usual recommended target dose of VERQUVO® is 10mg once a day. You will usually start by taking 2.5mg tablet once a day for the first 2 weeks. More instructions can be found in Section 4. How do I use VERQUVO®? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING VERQUVO®? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using VERQUVO®. • Call your doctor if you feel dizzy, lightheaded, or develop signs or symptoms of an allergic reaction. THINGS YOU SHOULD NOT DO • Do not take VERQUVO® to treat any other complaints unless your doctor tells you to. • Do not stop taking your medicine or lower the dose without checking with your doctor. DRIVING OR USING MACHINES • Be careful befo Izlasiet visu dokumentu
VERQUVO ® PI V2; CCDS 1 1 ▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION VERQUVO ® (VERICIGUAT) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Vericiguat 2 QUALITATIVE AND QUANTITATIVE COMPOSITION VERQUVO® 2.5 mg film-coated tablets Each film-coated tablet contains 2.5 mg vericiguat. VERQUVO® 5 mg film-coated tablets Each film-coated tablet contains 5 mg vericiguat. VERQUVO® 10 mg film-coated tablets Each film-coated tablet contains 10 mg vericiguat. Excipient with known effect Each 2.5 mg film-coated tablet contains 58.14 mg lactose (as monohydrate). Each 5 mg film-coated tablet contains 55.59 mg lactose (as monohydrate). Each 10 mg film-coated tablet contains 111.15 mg lactose (as monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Film-coated tablets. VERQUVO® 2.5 mg film-coated tablets Round, biconvex, white film-coated tablet with a diameter of 7 mm, debossed with “2.5” on one side and “VC” on the other side. VERQUVO® 5 mg film-coated tablets Round, biconvex, brown-red film-coated tablet with a diameter of 7 mm, debossed with “5” on one side and “VC” on the other side. VERQUVO ® PI V2; CCDS 1 2 VERQUVO® 10 mg film-coated tablets Round, biconvex, yellow-orange film-coated tablet with a diameter of 9 mm, debossed with “10” on one side and “VC” on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS VERQUVO® is indicated in addition to standard of care therapy for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45% who are stabilised after a recent heart failure decompensation event requiring admission and/or IV diuretic therapy (see Section 5.1 Pharmacodynamic properties – Clinical trials). 4.2 D OSE AND METHOD OF ADMI Izlasiet visu dokumentu