Țară: Armenia
Limbă: engleză
Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ibandronic acid (ibandronic acid monosodium monohydrate)
F. Hoffmann-La Roche Ltd.
ibandronic acid (ibandronic acid monosodium monohydrate)
150mg
tablets film-coated
Prescription
® 150 MG FILM-COATED TABLETS Ibandronic acid Umschlag-Aussenseite 10174522_NP9376.indd 1 19.04.2016 09:09:36 2 PLANNING WHEN TO TAKE BONVIVA The dose of Bonviva is one tablet once a month. Choose one day of the month that will be easy to remember: – either the same date (such as the 1st of each month) – or the same day (such as the first Sunday of each month). Use the peel-off stickers below to mark the dates on your calendar. Once you’ve taken your tablet, put a tick in the box on the sticker. Bild 1 Bonviva Umschlag-Innenseite 10174522_NP9376.indd 2 19.04.2016 09:09:36 3 PEEL-OFF STICKERS FOR YOUR PERSONAL CALENDAR Monthly tablet Monthly tablet Monthly tablet It’s important to keep taking Bonviva every month. Remember to contact your doctor when you need a new prescription. 10174522_NP9376.indd 3 19.04.2016 09:09:37 10174522_NP9376.indd 4 19.04.2016 09:09:37 5 IN THIS LEAFLET: PLANNING WHEN TO TAKE BONVIVA PAGE WITH PEEL-OFF STICKERS FOR YOUR PERSONAL CALENDAR 2 1. DESCRIPTION 7 2. CLINICAL PARTICULARS 8 3. PHARMACOLOGICAL PROPERTIES AND EFFECTS 38 4. PHARMACEUTICAL PARTICULARS 58 10174522_NP9376.indd 5 19.04.2016 09:09:37 ® 150 MG FILM-COATED TABLETS Ibandronic acid 10174522_NP9376.indd 6 19.04.2016 09:09:37 7 BISPHOSPHONATES – DRUGS FOR TREATMENT OF BONE DISEASES (M05) 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Bonviva is a nitrogen-containing bisphosphonate. 1.2 TYPE OF DOSAGE FORM Film-coated tablets. 1.3 ROUTE OF ADMINISTRATION Oral. 1.4 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: ibandronic acid, monosodium salt, monohydrate. 10174522_NP9376.indd 7 19.04.2016 09:09:37 8 One 150 mg film-coated tablet contains 168.75 mg of ibandronic acid, monosodium salt, monohydrate equivalent to 150 mg of ibandronic acid. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) _TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS _ Bonviva 150 mg is indicated for the treatment of postmenopausal osteoporosis, to reduce the risk of fractures. Osteoporosis may be confirmed by the finding of l Citiți documentul complet
December 2015 Summary of Product Characteristics Ro 200-5450 Bonviva film-coated tablets December 2015 1 BONVIVA ® Ibandronic acid BISPHOSPHONATES – DRUGS FOR TREATMENT OF BONE DISEASES (M05) 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Bonviva is a nitrogen-containing bisphosphonate. 1.2 TYPE OF DOSAGE FORM Film-coated tablets. 1.3 ROUTE OF ADMINISTRATION Oral. 1.4 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: ibandronic acid, monosodium salt, monohydrate. One 150 mg film-coated tablet contains 168.75 mg of ibandronic acid, monosodium salt, monohydrate equivalent to 150 mg of ibandronic acid. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) _TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS_ Bonviva 150 mg is indicated for the treatment of postmenopausal osteoporosis, to reduce the risk of fractures. Osteoporosis may be confirmed by the finding of low bone mass (T-score <-2.0 SD) and the presence or history of osteoporotic fracture, or a low bone mass (T-score < -2.5 SD) in the absence of documented pre-existing osteoporotic fracture. 2.2 DOSAGE AND ADMINISTRATION The recommended dose of Bonviva for treatment is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month. Bonviva should be taken 60 minutes before the first food or drink (other than water) of the day (see section 2.4.3 Interactions with other Medicinal Products and other Forms of Interaction, Drug-Food Interactions) or any other oral medication or supplementation (including calcium): – Tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position. Patients should not lie down for 60 minutes after taking Bonviva. December 2015 Summary of Product Characteristics Ro 200-5450 Bonviva film-coated tablets December 2015 2 – Plain water is the only drink that should be taken with Bonviva. Please note that some mineral waters may have a higher concentration of calcium and therefore should n Citiți documentul complet