Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibandronic sodium monohydrate
Accord Healthcare Ltd
M05BA06
Ibandronic sodium monohydrate
1mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 5055565716854
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IBANDRONIC ACID ACCORD 3 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE ibandronic acid 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. WHAT IS IN THIS LEAFLET 1. What Ibandronic acid Accord is and what it is used for 2. What you need to know before you receive Ibandronic acid Accord 3. How to use Ibandronic acid Accord 4. Possible side effects 5. How to store Ibandronic acid Accord 6. Contents of the pack and other information 1. WHAT IBANDRONIC ACID ACCORD IS AND WHAT IT IS USED FOR Ibandronic acid Accord belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid. Ibandronic acid Accord 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 Accord may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip. IBANDRONIC ACID ACCORD IS PRESCRIBED TO YOU TO TREAT POSTMENOPAUSAL OSTEOPOROSIS BECAUSE YOU HAVE AN INCREASED RISK OF FRACTURES . Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopause, a woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy. The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis. Other things that can increase the risk of fractures include: not enough calcium and vitamin D in the diet smoking cigarettes, or drinking too much alcohol not enough walking or other weight-bearing exercise Olvassa el a teljes dokumentumot
OBJECT 1 IBANDRONIC ACID ACCORD 3 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Summary of Product Characteristics Updated 22-Sep-2017 | Accord Healthcare Limited 1. Name of the medicinal product Ibandronic acid Accord 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 sodium monohydrate). Each ml of solution contains 1 mg ibandronic acid. For the full list of excipients, see section 6.1 3. Pharmaceutical form Solution for injection (injection) Clear, colourless solution. 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 _ 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 creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies includin Olvassa el a teljes dokumentumot