Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
Strontium ranelate
Servier Laboratories (Australia) Pty Ltd
Medicine Registered
PROTOS ® 2G _Strontium ranelate (pronounced stron-tee-um ran-ell-ate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PROTOS. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medications have risks and benefits. Your doctor has considered this before prescribing PROTOS for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICATION, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PROTOS IS The name of your medicine is PROTOS. The medicine contains the active ingredient strontium ranelate. PROTOS does not contain any hormones. WHAT PROTOS IS USED FOR PROTOS is usually prescribed for severe (established) osteoporosis. Osteoporosis is a disease of older people. PROTOS is not recommended for children, or pregnant women. PROTOS is available only with a doctor's prescription. There is no evidence that PROTOS is addictive. _WHY PROTOS IS USED FOR_ _OSTEOPOROSIS_ Bone is a living tissue just like most other parts of your body. Your body is constantly breaking down old bone and making new bone tissue to keep your skeleton healthy and strong. When you have osteoporosis, your body breaks down more bone than it forms. Bone loss then gradually occurs making your bones thinner and more fragile. PROTOS helps by increasing new bone formation and slowing bone breakdown. Osteoporosis is especially common in women after the menopause (change of life). The menopause occurs when the ovaries stop producing the female hormone oestrogen, or are removed (sometimes with a hysterectomy). The earlier a woman reaches menopause, the greater the risk of osteoporosis. Osteoporosis can also occur in men. Many people with osteoporosis have no symptoms so you may not even have been aware that you have it. However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists. A fracture may even occu Lire le document complet
PROTOS _®_ 2G – PRODUCT INFORMATION 1 (13) Version 14 PROTOS ® NAME OF THE DRUG _PROTOS_ _®_ _ _ strontium ranelate 2g DESCRIPTION Description of substance and solubility: Strontium ranelate is a yellowish-white non- hygroscopic powder. It crystallises as a nonahydrate form but one water molecule is particularly labile and this leads to a compound containing either 8 or 9 water molecules per strontium ranelate molecule. Strontium ranelate is slightly soluble in purified water (3.7mg/mL at saturation point) and practically insoluble in organic solvents (eg, methanol). _Excipients: _Aspartame (E951, a source of phenylalanine), maltodextrin, mannitol. _Chemical name: strontium ranelate _ _ _ _CAS Registry Number: 135459-90-4 _ _Molecular formula:_ C 12 H 6 N 2 O 8 SSr 2 _Chemical structure: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ PHARMACOLOGY _ _ _S_trontium ranelate has a dual effect on bone metabolism. _In vitro_ it increases bone formation by increasing osteoblast precursor replication and collagen synthesis, and reduces bone resorption by altering osteoclast ultrastructure and decreasing resorbing activity in bone cell culture. The activity of strontium ranelate on both long bones and vertebral bodies was studied in various animal models. Strontium ranelate generally increased bone formation and decreased bone resorption and improved bone biomechanical properties such as bone strength. In bone tissue, strontium is adsorbed onto the crystal surface and substitutes for calcium in the apatite crystal of the newly formed bone, up to a ratio of 1 strontium atom to 10 calcium atoms. Strontium ranelate does not modify the crystal characteristics. In animals, Lire le document complet