Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibandronic sodium monohydrate
Actavis UK Ltd
M05BA06
Ibandronic sodium monohydrate
1mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 5012617022653
Ibandronic acid 1mg/ml (3mg in 3ml) Solution for injection PIL UK item no: AAAJ1344 print proof no: 03 origination date: 29-06-2016 originated by: MH revision date: 23-08-2016 revised by: MD dimensions: 250 x 680 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: 29-06-2016 supplier: Synthon Spain technically app. date: 22-08-2016 min pt size: 7pt TECHNICAL APPROVAL * Please note that only Actavis Global Artwork Studios are permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. ! _Continued over page_ IBANDRONIC ACID 3MG SOLUTION FOR INJECTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • The full name of this medicine is Ibandronic acid 3mg Solution for Injection but within the leaflet it will be referred to as Ibandronic acid. WHAT IS IN THIS LEAFLET: 1 WHAT IBANDRONIC ACID IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE IBANDRONIC ACID 3 HOW TO RECEIVE IBANDRONIC ACID 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE IBANDRONIC ACID 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT IBANDRONIC ACID IS AND WHAT IT IS USED FOR Ibandronic acid belongs to a group of medicines called BISPHOSPHONATES. It contains the active substance ibandronic acid. Ibandronic acid may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won’t be able to see or feel a difference. Ibandronic acid may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip. IBANDRONIC A Olvassa el a teljes dokumentumot
OBJECT 1 IBANDRONIC ACID 3MG SOLUTION FOR INJECTION Summary of Product Characteristics Updated 14-Sep-2016 | Accord-UK Ltd 1. Name of the medicinal product Ibandronic acid Actavis 3mg Solution for Injection 2. Qualitative and quantitative composition One pre-filled syringe of 3 ml solution for injection 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 (less than 1 mmol per dose) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection. Clear, colourless solution. The pH of the solution is 4.9 5.5. 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 injections should be given the package leaflet and 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 vitamins 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 _ Ibandronic acid injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a crea Olvassa el a teljes dokumentumot