Aclasta may also be used for other purposes not listed in this medication guide. We specialize in hunting gear and accessories and a variety of digital game calls that are proudly manufactured in the usa. Aclasta 5 mg infusion is used to treat or prevent osteoporosis in postmenopausal women. It is also approved to treat pagets disease of the bone. Ask your doctor, pharmacist or nurse for advice before taking this medicine. This is approximately three times the annual cost of alendronate.
To start viewing messages, select the forum that you want to visit from the selection below. Aclasta 5 mg100 ml solution for infusion contains 5 mg zoledronic acid anhydrous, corresponding to 5. Aclasta 5 mg solution for infusion summary of product characteristics smpc by novartis pharmaceuticals uk ltd. Aclasta should not be given to this patient population. Aclasta is also used to treat pagets disease of bone. Over the past decade, novartis pharmaceuticals canada has introduced 20 new medicines that have had an important impact on patients suffering from a wide variety of major illnesses including cancer, cardiovascular diseases, alzheimers disease, agerelated macular degeneration, organ transplantation and osteoporosis. Date of revision dorval, quebec, h9s 1a9, v december 8, 2011 control number. The recommended dose is a single intravenous infusion of 5 mg aclasta. Qualitative and quantitative composition aclasta 5 mg100 ml solution for infusion contains 5 mg zoledronic acid anhydrous, corresponding to 5. Aclasta 5 mg solution for infusion is ready for use. Aclasta 5 mg solution for infusion patient information leaflet pil by novartis pharmaceuticals uk ltd. The active substance in aclasta, zoledronic acid, is a bisphosphonate. Patients who have broken their hip should receive aclasta at least two weeks after the operation to repair the fracture.
Zoledronic acid monohydrate is a white, crystalline powder. Did anyone else noticed these side effects of aclasta. Aclasta zoledronic acid patent spc expiry paediatric. Aclasta is used to treats pagets disease and osteoporosis in postmenopausal women.
These include osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, and pagets disease of bone. Meeting highlights from the committee for medicinal products for human use chmp 16 february 2012. Zoledronic acid inhibits the release of calcium from bones. This is a disease where the normal process of bone growth is changed.
Two of the four studies compared the effects of zoledronic acid aclasta with alendronate in postmenopausal women with a low bone mineral density. Transparency committee opinion 29 april 2009 aclasta 5. There are no data available for children under 5 years of age. Aclasta 5 mg solution for infusion patient information. Single and multiple 5 and 15minute infusions of 2, 4, 8 and 16 mg zoledronic acid in 64 patients yielded the. It is also used for the prevention and treatment of osteoporosis in men and women who are on corticosteroid therapy. Only clear solution free from particles and discoloration should be used. It is given as a onceyearly infusion for osteoporosis in patients aged 70 years of age or older with a bone mineral density tscore of 2. Infusions take about 15 minutes and must be done at a specialized clinic by a nurse or. Full text of aclasta product monograph internet archive.
On this page about aclasta you will find information relating to side effects, age restrictions, food interactions, whether the medicine is available at a government subsidised price on the pharmaceutical benefits scheme pbs as well as other useful information. It is given by injection into a vein common side effects include fever, joint pain, high blood pressure, diarrhea, and feeling tired. Information for the user aclasta 5 mg solution for infusion. Alendronate fosamax or etidronate in osteoporosis patients.
Products consumer medicine information cmi what is consumer medicine information cmi. Aclasta 5 mg solution for infusion summary of product characteristics smpc emc source. Aclasta must not be mixed or given intravenously with any other medicinal product and must be given through a separate. The study has shown that aclasta zoledronic acid, traded as reclast in the usa, preserved bone mass in postmenopausal osteoporotic patients who were given annual infusions of the product for six years. Aclasta in english with contextual examples mymemory. Aclasta is the only bisphosphonate approved in the eu and us to reduce the risk of fractures at all key osteoporotic fracture sites, like the hip, spine, and other bones in the treatment of postmenopausal osteoporosis8. Although zoledronic acid is marketed by novartis as a monohydrate, doses refer to the anhydrous substance. Single and multiple 5 and 15minute infusions of 2, 4, 8 and 16 mg zoledronic. If you feel dizzy while taking aclasta, do not drive or use. Product monograph praclasta zoledronic acid injection 5 mg100 ml solution for intravenous infusion bone metabolism regulator novartis pharmaceuticals canada inc.
Patients who received zoledronic acid aclasta experienced reductions in new vertebral and nonvertebral fractures. What aclasta is used for the active ingredient in aclasta is zoledronic acid, which belongs to a group of medicines called. Get aclasta 5mg online in pakistan and pay cash on delivery avail flat 15% discount on card payments. Aclasta should not be used in children and adolescents below 18 years of age. Glucocorticoids are widely used to treat inflammatory conditions such as asthma and rheumatoid arthritis, but also cause bone loss and can increase the. Aclasta definition of aclasta by medical dictionary. It belongs to a group of medicines called bisphosphonates. Aclasta 5 mg solution for infusion patients leaflet. Aclasta infusions for osteoporosis cashmere medical practice. Aclasta is given as an infusion lasting at least 15 minutes. Australian product information aclasta zoledronic acid 1. Currently available data for children aged 5 to 17 years are described in section 5.
Efficacy of zoledronic acid in preventing collapse of the osteonecrotic femoral head ezapcofh the safety and scientific validity of this study is. It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue. Composicion, indicaciones, presentacion y contraindicaciones. Aclasta 5 mg 1 vial 100 ml price from seif in egypt. Aclasta contains zoledronic acid sometimes called zoledronate. Aclasta 5 mg 1 vial 100 ml price from seif in egypt yaoota. Dosage forms, composition and packaging section of the product monograph. September 11, 2014 aclasta is a registered trademark. Aclasta is also used to treat pagets disease of the bone in adults. Since the first days, i have been experienced severe hair loss and neck pain. Aclasta 5 mg solution for infusion summary for the public. Zoledronic acid, also known as zoledronate, is a medication used to treat a number of bone diseases. This can be repeated once a year in patients being treated for osteoporosis. Aclasta 5 mg solution for infusion summary of product.
Each bottle with 100 ml of solution contains 5 mg zoledronic acid as monohydrate. Full text of aclasta product monograph see other formats product monograph pr aclasta zoledronic acid injection 5 mg100 ml solution for intravenous infusion bone metabolism regulator novartis pharmaceuticals canada inc. The medicine can only be obtained with a prescription. This leads to less bone loss in osteoporosis and less disease activity in pagets disease. Je lance donc le set up dans le dossier driverswindows64 bits. Had an infusion of aclasta on friday 10 april woke up sat morning 1am unable to walk heavy chest my body spasmed back ect ambulance called no amount of pain medication eased the pain. The chemical structure of zoledronic acid monohydrate is. Aclasta is used to treat osteoporosis a disease that makes bones fragile in women who have been through the menopause and in men. Aclasta zoledronic acid 5 mg solution for infusion. Aclasta a bisphosphonate is administered once every 12 years via a 15 minute intravenous infusion, and replaces daily or weekly tablets e. I had a history of osteopenia,and was put on fosamax. Aclasta treated patients aged 75 years and older exhibited a 60% reduction in the risk of vertebral fractures compared to placebo patients p aclasta demonstrated a consistent effect over 3 years, resulting in a 41% reduction.
Osteoporosis is a disease which causes bones to become less dense, gradually making them weaker, more brittle and likely to break. The committee indicated that the large price premium for zoledronic acid aclasta is not justified given the lack of a therapeutic advantage. It is soluble in water, most soluble at neutral ph 290 mgml. If you have any concerns about having this medicine, ask your doctor or pharmacist. Efficacy of zoledronic acid in preventing collapse of the. Aclasta is a solution for infusion drip into a vein that contains the active substance zoledronic acid. I was unable to tolerate it due to my reflux disease, so,i stopped taking it.
This can be repeated once a year in patients being treated for. Zoledronic acid aclasta for osteoporosis nps medicinewise. Taking aclasta aclasta is given once a year by an intravenous iv infusion. This medicine can also be used to bring down high levels of calcium in the blood that may be caused by some cancers.
411 548 366 1291 642 369 15 1205 970 1398 760 1543 1078 230 1410 342 85 1410 988 572 511 57 837 478 946 750 690 868 456 917