Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
sevelamer carbonate
Sanofi-Aventis Australia Pty Ltd
sevelamer carbonate
Registered
SEVELAMER CARBONATE WINTHROP ® 1 SEVELAMER CARBONATE WINTHROP ® _Sevelamer carbonate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sevelamer Carbonate Winthrop. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Sevelamer Carbonate Winthrop against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET . You may need to read it again. WHAT SEVELAMER CARBONATE WINTHROP IS USED FOR Sevelamer Carbonate Winthrop contains the active substance sevelamer carbonate and is used to treat hyperphosphatemia, a condition caused by too much dietary phosphorus being retained in your body due to a diseased kidney. Increased levels of serum phosphorus can lead to hard deposits in your body called calcification. These deposits can stiffen your blood vessels and make it harder for blood to be pumped around the body. Sevelamer Carbonate Winthrop helps to remove excess phosphorus that has built up in your body by binding the phosphorus that is in the food that you eat. Your doctor, however, may have prescribed Sevelamer Carbonate Winthrop for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU . This medicine is only available with a doctor's prescription. BEFORE YOU TAKE SEVELAMER CARBONATE WINTHROP _WHEN YOU MUST NOT TAKE _ _SEVELAMER CARBONATE _ _WINTHROP _ DO NOT TAKE SEVELAMER CARBONATE WINTHROP IF YOU HAVE AN ALLERGY TO: • any medicine containing sevelamer carbonate (the active ingredient) • any of the ingredients listed at the end of this leaflet • any other similar medicine, such as sevelamer hydrochloride. Symptoms that may indicate an allergic reaction include • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue Read the complete document
PRODUCT INFORMATION Sevelamer Carbonate Winthrop - sevelamer carbonate sevelamer-winthrop-ccdsv4-piv3-21aug17 1 PRODUCT INFORMATION SEVELAMER CARBONATE WINTHROP NAME OF MEDICINE AUSTRALIAN APPROVED NAME Sevelamer carbonate CHEMICAL STRUCTURE The structure is presented in Figure 1. FIGURE 1 - STRUCTURE OF SEVELAMER CARBONATE PRODUCT INFORMATION Sevelamer Carbonate Winthrop - sevelamer carbonate sevelamer-winthrop-ccdsv4-piv3-21aug17 2 The primary amine groups shown in the structure are derived directly from poly (allylamine hydrochloride). The cross - linking groups consist of two secondary amine groups derived from poly (allylamine hydrochloride) and one molecule of epichlorohydrin . Molecular Formula: (C 3 H 7 N.nH 2 CO 3 ) 810z (C 9 H 18 N 2 O.nH 2 CO 3 ) 95z where z = a large number Chemical Name: poly (allylamine- _co-N,N’_ -diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. CAS REGISTRY NUMBER 845273-93-0 DESCRIPTION Sevelamer Carbonate Winthrop contains sevelamer, a non-absorbed phosphate binding cross- linked polymer, free of metal and calcium. Sevelamer is a white to off-white powder comprising of a partial carbonate salt with approximately 40 % amine carbonate and 60 % free base. Sevelamer carbonate is amorphous, hygroscopic and hydrophilic, but insoluble in water with a pH range of 8-10.5 as a 1% aqueous slurry. Each Sevelamer Carbonate Winthrop film-coated tablet contains 800 mg of sevelamer carbonate on an anhydrous basis. Sevelamer Carbonate Winthrop tablets contain the following excipients: microcrystalline cellulose, sodium chloride, purified water and zinc stearate. The tablet coating contains hypromellose and diacetylated monoglycerides. The tablet printing ink also contains hypromellose in addition to iron oxide black ink, propylene glycol, isopropyl alcohol. Each Sevelamer Carbonate Winthrop sachet contains 1.6 g or 2.4 g of sevelamer carbonate for oral suspension on an anhydrous basis. Each sachet of Sevelamer Carbonate Winthrop powder contains the following excipients: RB26 Genzyme N&A c Read the complete document