Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibandronic sodium monohydrate
Sun Pharmaceutical Industries Europe B.V.
M05BA06
Ibandronic sodium monohydrate
1mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 8718309129675
IBANDRONIC ACID 3 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Summary of Product Characteristics Updated 16-May-2017 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company 1. Name of the medicinal product Ibandronic acid SUN 3 mg solution for injection in pre-filled syringe 2. Qualitative and quantitative composition One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as 3.375 mg ibandronic acid, monosodium salt, monohydrate). The concentration of ibandronic acid in the solution for injection is 1 mg per ml. Excipients with known effect: Sodium. Each pre filled syringed contains 0.476 mmol (10.95 mg) of sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection in pre-filled syringe. Clear, colourless solution with pH between 4.80 and 6.00 and osmolality between 280 and 320 mOsm/kg. 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 Patients treated with ibandronic acid should be given the package leaflet and the patient reminder card. Posology The recommended dose of ibandronic acid is 3 mg, administered as an intravenous injection over 15-30 seconds, every three months. Patients must receive supplemental calcium and vitamin D (see section 4.4 and section 4.5). 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. The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of ibandronic acid on an individual patient basis, particularly after 5 or more years of use. _Special populations_ _Patients with renal impairment_ N Lugege kogu dokumenti