Država: Singapur
Jezik: engleski
Izvor: HSA (Health Sciences Authority)
Ibandronic acid (Ibandronate form)
DKSH SINGAPORE PTE. LTD.
M05BA06
168.75 mg
TABLET, FILM COATED
Ibandronic acid (Ibandronate form) 168.75 mg
ORAL
Prescription Only
PENN PHARMACEUTICAL SERVICES LTD
ACTIVE
2006-06-19
Umschlag-Aussenseite ® FILM-COATED TABLET 150 MG PLANNING WHEN TO TAKE BONVIVA TABLET The dose of Bonviva 150 mg 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 1 st 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. 2 PEEL-OFF STICKERS FOR YOUR PERSONAL CALENDAR Monthly tablet Monthly tablet Monthly tablet It is important to keep taking Bonviva tablet 150 mg every month. Remember to contact your doctor when you need a new prescription. 3 4 IN THIS PLANNING WHEN TO TAKE BONVIVA TABLET PAGE LEAFLET: with peel-off stickers for your personal calendar 2 1. NAME OF THE MEDICINAL PRODUCT 6 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 6 3. PHARMACEUTICAL FORM 7 4. CLINICAL PARTICULARS 7 5. PHARMACOLOGICAL PROPERTIES 38 6. PHARMACEUTICAL PARTICULARS 67 5 1. NAME OF THE MEDICINAL PRODUCT Bonviva 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic sodium monohydrate). ® FILM-COATED TABLET 150 MG 6 _Excipients _ Each film-coated tablet contains 162.75 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to off white film-coated tablets, Pročitajte cijeli dokument
281 Guides Text free One year data in study BM 16549 Three year data in study MF 4411 Bonviva 150mg once monthly (N=396) (%) Bonviva 2.5 mg daily (N=395) (%) Bonviva 2.5 mg daily (N=977) (%) Placebo (N=975) (%) System Organ Class/ Adverse drug reaction GASTROINTESTINAL SYSTEM Gastro-oesophageal reflux disease Diarrhoea Abdominal pain Dyspepsia Nausea Flatulence NERVOUS SYSTEM Headache GENERAL DISORDERS Influenza like illness* Fatigue Arthralgia MUSCULOSKELETAL SYSTEM Rash SKIN DISORDERS 0.5 1.0 0.4 0.1 2.5 1.8 1.4 1.0 3.5 2.8 2.1 2.9 3.3 3.3 3.5 5.8 4.3 2.9 1.8 2.3 0.5 1.0 0.4 0.7 0.8 0.8 1.5 0.6 0.3 3.3 0.3 0.2 0.3 0.3 1.0 0.4 1.0 1.0 1.2 0.3 0.4 0.4 0.8 0.7 Two year cumulative data in study BM 16549 Three year data in study MF 4411 Bonviva 150mg once monthly (N=396) (%) Bonviva 2.5 mg daily (N=395) (%) Bonviva 2.5 mg daily (N=977) (%) Placebo (N=975) (%) System Organ Class/ Adverse drug reaction GASTROINTESTINAL SYSTEM Gastro-oesophageal reflux disease Diarrhoea Abdominal pain Dyspepsia Nausea Gastritis NERVOUS SYSTEM Headache 4.0 6.3 4.0 2.7 3.0 3.5 1.8 2.3 4.0 3.0 2.1 2.9 2.5 1.0 0.3 2.0 1.4 1.0 0.7 0.5 0.8 1.0 0.5 0.1 0.8 0.8 1.5 0.6 Oesophagitis 0 1.0 0.5 0.4 GENERAL DISORDERS Influenza like illness* 0.3 3.3 0.3 0.2 Myalgia 0.3 1.5 1.8 0.8 FILM-COATED TABLET SG 704-3722 PIL WM 04 FILM-COATED TABLET 1. NAME OF THE MEDICINAL PRODUCT Bonviva 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic sodium monohydrate) Excipients Each film-coated tablet contains 162.75 mg lactose monohydrate. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to off white film-coated tablets, of oblong shape marked “BNVA” on one side, and “150” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures Pročitajte cijeli dokument