מדינה: ארמניה
שפה: אנגלית
מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ibandronic acid (ibandronic acid monosodium salt, monohydrate)
F. Hoffmann-La Roche Ltd.
M05BA06
ibandronic acid (ibandronic acid monosodium salt, monohydrate)
150mg
tablets film-coated
(1), (3), in blister
Prescription
Registered
2019-07-30
TABLE 2: CUMULATIVE COMMON ADVERSE DRUG REACTIONS (>1/100, ≤ 1/10) IN PHASE III OSTEOPOROSIS STUDIES THAT WERE CONSIDERED BY THE INVESTIGATOR TO BE POSSIBLY OR PROBABLY RELATED TO TREATMENT - TWO-YEAR DATA FROM STUDY BM16549 AND THREE- YEAR DATA FROM PLACEBO-CONTROLLED FRACTURE STUDY MF4411 TWO-YEAR CUMULATIVE DATA IN STUDY BM16549 THREE-YEAR DATA IN STUDY MF4411 SYSTEM ORGAN CLASS/ ADVERSE DRUG REACTION BONVIVA 150 MG ONCE MONTHLY (N=396) (%) BONVIVA 2.5 MG DAILY (N=395) (%) BONVIVA 2.5 MG DAILY (N=977) (%) PLACEBO (N=975) (%) GASTROINTESTINAL SYSTEM Gastritis 1.0 0.3 0.7 0.5 Gastroesophageal reflux disease 0.8 1.0 0.5 0.1 Esophagitis 0 1.0 0.5 0.4 Diarrhea 2.5 2.0 1.4 1.0 Abdominal pain 4.0 3.0 2.1 2.9 Dyspepsia 4.0 6.3 4.0 2.7 Nausea 3.0 3.5 1.8 2.3 NERVOUS SYSTEM Headache 0.8 1.5 0.8 0.6 GENERAL DISORDERS Influenza-like illness* 3.3 0.3 0.3 0.2 MUSCULOSKELETAL SYSTEM Muscle cramp 0.5 1.0 0.1 0.4 Musculoskeletal pain 1.0 0.5 0 0 Arthralgia 1.0 0.5 0.4 0.4 Myalgia 1.5 0.3 1.8 0.8 Musculoskeletal stiffness 1.0 0 0 0 SKIN DISORDERS Rash 0.8 1.0 1.2 0.7 GENERAL DISORDERS Influenza-like illness* 3.3 0.3 0.3 0.2 Fatigue 1.0 0.3 0.3 0.4 MUSCULOSKELETAL SYSTEM Arthralgia 1.0 0.3 0.4 0.4 Myalgia 1.5 0.3 1.8 0.8 SKIN DISORDERS Rash 0.8 1.0 1.2 0.7 Table 1: Common adverse drug reactions (>1/100, ≤ 1/10) in phase III osteoporosis studies that were considered by the investigator to be possibly or probably related to treatment - One-year data from study BM16549 and three-year data from placebo- controlled fracture study MF4411 One-year data in study BM16549 Three-year data in study MF4411 SYSTEM ORGAN CLASS/ ADVERSE DRUG REACTION BONVIVA 150 MG ONCE MONTHLY (N=396) (%) BONVIVA 2.5 MG DAILY (N=395) (%) 2.5 MG DAILY (N=977) (%) PLACEBO (N=975) (%) GASTROINTESTINAL SYSTEM Gastroesophageal reflux disease 0.5 1.0 0.4 0.1 Diarrhea 2.5 1.8 1.4 1.0 BONVIVA Abdominal pain 3.5 2.8 2.1 2.9 Dyspepsia 3.3 5.8 4.3 2.9 Nausea 3.3 3.5 1.8 2.3 Flatulence 0.5 1.0 0.4 0.7 NERVOUS SYSTEM Headache 0.8 1.5 0.8 0.6 Technical approval Date קרא את המסמך השלם
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 sodium monohydrate). Excipients with known effect: Contains 154.6 mg anhydrous lactose (equivalent to 162.75 mg lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 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 has not been established. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose 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 after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium). In case a dose is missed, patients should be instructed to take one Bonviva 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date. If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled. Patients should not take two tablets within the same week. Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate (see section 4.4 and section 4.5). The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be r קרא את המסמך השלם