Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Posaconazole 100mg;
Juno Pharmaceuticals NZ Limited
100 mg
Modified release tablet
Active: Posaconazole 100mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Methacrylic acid - ethyl acrylate copolymer Microcrystalline cellulose Opadry yellow 85F520152 Propyl gallate Sodium stearyl fumarate Triethyl citrate Xylitol
Prescription
Posaconazole JUNO is indicated for use in the treatment of the following invasive fungal infections in patients 18 years of age or older: - Invasive aspergillosis in patients with disease that is refractory to, or are intolerant of, amphotericin B, itraconazole or voriconazole. - Oesophageal candidiasis or candidemia in patients with disease that is refractory to, or who are intolerant of, amphotericin B, fluconazole, or itraconazole. - Fusariosis, zygomycosis, cryptococcosis, chromoblastomycosis, and mycetoma in patients with disease refractory to other therapy, or patients who are intolerant of other therapy. - Coccidioidomycosis Posaconazole JUNO is also indicated for the prophylaxis of invasive fungal infections, including both yeasts and moulds, in 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.
Package - Contents - Shelf Life: Blister pack, PVC/PCTFE (Aclar)/Al , 12 tablets per strip - 24 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Aluminium/Aluminium or PVC/PE/PVDC/Al , 12 tablets per strip - 24 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PCTFE (Aclar)/Al , 12 tablets per strip - 96 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Aluminium/Aluminium or PVC/PE/PVDC/Al , 12 tablets per strip - 96 tablets - 36 months from date of manufacture stored at or below 25°C - Strip, Aluminium/Aluminium , 12 tablets per strip - 24 tablets - 36 months from date of manufacture stored at or below 25°C - Strip, Aluminium/Aluminium , 12 tablets per strip - 96 tablets - 36 months from date of manufacture stored at or below 25°C
2020-11-06
Posaconazole JUNO CMI 1 POSACONAZOLE JUNO MODIFIED RELEASE TABLETS _Posaconazole _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Posaconazole JUNO. 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 JUNO against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING POSACONAZOLE JUNO, ASK YOUR DOCTOR OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE TAKING POSACONAZOLE JUNO. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT POSACONAZOLE JUNO IS USED FOR Posaconazole JUNO contains the active ingredient, posaconazole. Posaconazole is a medicine that belongs to the triazole group of antifungal medicines. Posaconazole JUNO works by killing or stopping the growth of the fungi causing these infections. Posaconazole JUNO 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, cryptococcosis, 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 JUNO is usually reserved for patients who do not respond to or cannot tolerate other medicines used to treat these types of fungal infections. Posaconazole JUNO is also used to treat coccidioidomycosis, a rare and serious fungal infection. Posaconazole JUNO 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 JUNO for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY POSACONAZOLE JUNO HAS BEEN PRES Izlasiet visu dokumentu
Posaconazole Juno Datasheet v2.0 Page | 1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Posaconazole JUNO (posaconazole) modified release 100 mg tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Posaconazole JUNO modified release tablets contain 100 mg of posaconazole per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Posaconazole JUNO modified release tablets are yellow, coated, capsule-shaped tablets, debossed with “100P” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Posaconazole JUNO is indicated for use in the treatment of the following invasive fungal infections in patients 18 years of age or older: • Invasive aspergillosis in patients with disease that is refractory to, or are intolerant of, amphotericin B, itraconazole or voriconazole. • Oesophageal candidiasis or candidemia in patients with disease that is refractory to, or who are intolerant of, amphotericin B, fluconazole or itraconazole. • Fusariosis, zygomycosis, cryptococcosis, chromoblastomycosis, and mycetoma in patients with disease refractory to other therapy, or patients who are intolerant of other therapy. • Coccidioidomycosis. Posaconazole JUNO is also indicated for the prophylaxis of invasive fungal infections, including both yeasts and moulds, in 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 DOSE AND METHOD OF ADMINISTRATION 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 section 4.5 Interactions with Other Medicines and Other Forms of Interaction). NON-INTERCHANGEABILITY BETWEEN POSACONAZOLE JUNO MODIFIED RELEASE TABLETS AND POSACONAZOLE ORAL SUSPENSION (AVAILABLE FROM OTHER SPONSORS) The prescriber sho Izlasiet visu dokumentu