Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ibandronic acid
Roche Diagnostics GmbH
ibandronic acid
1mg/ml
solution for i/v injection
Prescription
10174402 FE GENISYS-NO. 10174402 DATA MATRIX: (92)10174402 PRINTING COLOURS: PANTONE 281 FORMAT: 594X420 MM FOLDING FORMAT: 99X35 MM REPLACES GENISYS-NO. 10164035 TYPE SIZE: 9 PT DRAWING NORM 01.07.14, VERSION C ® 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 Pre-filled syringe. 1.3 ROUTE OF ADMINISTRATION Intravenous. 1.4 STERILE / RADIOACTIVE STATEMENT Sterile product. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient:_ Ibandronic acid, monosodium salt, monohydrate. _Solution for injection:_ Each pre-filled syringe contains 3.375 mg ibandronic acid, monosodium salt, monohydrate equivalent to 3 mg of ibandronic acid in 3 ml of solution. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) Bonviva is indicated for the treatment of postmenopausal osteoporosis, to reduce the risk of fractures. _TREATMENT OF OSTEOPOROSIS: _ 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 3 mg intravenous injection (administered as an intravenous injection over 15-30 seconds) every three months. Patients must receive supplemental calcium and vitamin D. If a dose is missed, the injection should be administered as soon as convenient. Thereafter, injections should be scheduled every 3 months from the date of the last injection. 2.2.1 SPECIAL DOSAGE INSTRUCTIONS _Patients with hepatic impairment_ No dosage adjustment is necessary (see section 3.2.4 Pharmacokinetics in Special Populations). _Patients with renal impairment _ No dosage adjustment is necessary for patients with serum creatinine ≤ 200 μmol/l (2.3 mg/dl) or where creatinine clearance (measured or estimated) ≥ 30 ml/min. Bonv Прочитать полный документ
December 2015 Summary of Product Characteristics Ro 200-5450 Bonviva pre-filled syringes 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 Pre-filled syringe. 1.3 ROUTE OF ADMINISTRATION Intravenous. 1.4 STERILE / RADIOACTIVE STATEMENT Sterile product. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient_: Ibandronic acid, monosodium salt, monohydrate. _Solution for injection_: Each pre-filled syringe contains 3.375 mg ibandronic acid, monosodium salt, monohydrate equivalent to 3 mg of ibandronic acid in 3 ml of solution. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) Bonviva is indicated for the treatment of postmenopausal osteoporosis, to reduce the risk of fractures. _TREATMENT OF OSTEOPOROSIS: _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 3 mg intravenous injection (administered as an intravenous injection over 15-30 seconds) every three months. December 2015 Summary of Product Characteristics Ro 200-5450 Bonviva pre-filled syringes December 2015 2 Patients must receive supplemental calcium and vitamin D. If a dose is missed, the injection should be administered as soon as convenient. Thereafter, injections should be scheduled every 3 months from the date of the last injection. 2.2.1 SPECIAL DOSAGE INSTRUCTIONS _Patients with hepatic impairment _ No dosage adjustment is necessary (see section 3.2.4 Pharmacokinetics in Special Populations). _Patients with renal impairment _ No dosage adjustment is necessary for patients with serum creatinine ≤ 200 μmol/l (2.3 mg/dl) or where creatinine clearance (measured or estimated) ≥ 30 ml Прочитать полный документ