Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
posaconazole, Quantity: 100 mg
Dr Reddys Laboratories Australia Pty Ltd
Tablet, modified release
Excipient Ingredients: croscarmellose sodium; macrogol 400; hypromellose acetate succinate; silicon dioxide; triacetin; purified talc; hyprolose; iron oxide red; magnesium stearate; titanium dioxide; microcrystalline cellulose; hypromellose
Oral
96, 24
(S4) Prescription Only Medicine
POSACONAZOLE DR.REDDY'S (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: ,? Invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. ,? Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. ,POSACONAZOLE DR.REDDY'S is also indicated for the: ,? Prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.
Visual Identification: Brown, capsule-shaped, bevelled edge, film-coated tablet, debossed with '470' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-07-24
POSACONAZOLE DR.REDDY’S 1 POSACONAZOLE DR.REDDY’S MODIFIED RELEASE TABLETS _Posaconazole_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about POSACONAZOLE DR.REDDY’S. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking POSACONAZOLE DR.REDDY’S against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING POSACONAZOLE DR.REDDY’S, ASK YOUR DOCTOR OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE TAKING POSACONAZOLE DR.REDDY ’ S. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT POSACONAZOLE DR.REDDY’S IS USED FOR POSACONAZOLE DR.REDDY’S contains the active ingredient, posaconazole. Posaconazole is a medicine that belongs to the triazole group of antifungal medicines. POSACONAZOLE DR.REDDY’S works by killing or stopping the growth of the fungi causing these infections. POSACONAZOLE DR.REDDY’S Modified Release Tablets are used for: • The treatment of invasive aspergillosis, a fungal infection caused by a fungus called aspergillus • The treatment of other serious fungal infections called fusariosis, zygomycosis, chromoblastomycosis and mycetoma. These types of fungal infections usually occur in some patients who may have lowered resistance to infection due to poor immunity. Treatment of these serious fungal infections with POSACONAZOLE DR.REDDY’S is usually reserved for patients who do not respond to or cannot tolerate other medicines used to treat these types of fungal infections. POSACONAZOLE DR.REDDY’S is also used to treat coccidioidomycosis, a rare and serious fungal infection. POSACONAZOLE DR.REDDY’S is also used to prevent fungal infections, such as yeasts and moulds, from occurring in patients who are at high-risk of developing these infections. Your doctor may have prescribed POSACONAZOLE DR.REDDY’S for another Baca dokumen lengkapnya
AUSTRALIAN PRODUCT INFORMATION – POSACONAZOLE DR.REDDY’S (POSACONAZOLE) MODIFIED RELEASE TABLETS 1 NAME OF THE MEDICINE Posaconazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified release tablet contains 100 mg of posaconzole. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM POSACONAZOLE DR.REDDY’S MODIFIED RELEASE TABLET is a brown, capsule shaped, bevelled edge, film coated tablet, debossed with ‘470’ on one side and plain on other side . 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS POSACONAZOLE DR.REDDY’S (posaconazole) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older: • Invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. • Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. POSACONAZOLE DR.REDDY’S is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients. 4.2 D OSE AND METHOD OF ADMINISTRATION POSACONAZOLE DR.REDDY’S Modified Release Tablets should be swallowed whole, and not be divided, crushed, or chewed. POSACONAZOLE DR.REDDY’S Modified Release Tablets may be taken without regard to food intake. Coadministration of drugs that can decrease the plasma concentrations of posaconazole should generally be avoided unless the benefit outweighs the risk. If such drugs are necessary, patients should be monitored closely for breakthrough fungal infections (see 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS). 1 ADMINISTRATION INSTRUCTIONS FOR POSACONAZOLE DR.REDDY’S MODIFIED RELEASE TABLETS REFRACTORY INVASIVE FUNGAL INFECTIONS (IFI) / INTOLERANT PATIENTS WITH IFI: Loading d Baca dokumen lengkapnya