Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
sevelamer carbonate
Sanofi-Aventis Australia Pty Ltd
sevelamer carbonate
Registered
RENVELA ® 1 RENVELA ® _Sevelamer carbonate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Renvela. 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 Renvela 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 RENVELA IS USED FOR Renvela 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. Renvela 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 Renvela 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 RENVELA _WHEN YOU MUST NOT TAKE _ _RENVELA _ DO NOT TAKE RENVELA 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 or other parts of the body • rash, itching or hives on the skin Tell your doctor if you are experiencing these symptoms. DO NOT TAKE RENVELA IF YOU : • have hypophosphatemia, a condition where you do not have enough phosphorus in Přečtěte si celý dokument
PRODUCT INFORMATION August 2017 Renvela - sevelamer carbonate renvela-ccdsv4-piv3-21aug17 1 PRODUCT INFORMATION RENVELA NAME OF MEDICINE AUSTRALIAN APPROVED NAME Sevelamer carbonate CHEMICAL STRUCTURE The structure is presented in Figure 1. FIGURE 1 - STRUCTURE OF SEVELAMER CARBONATE 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 . PRODUCT INFORMATION August 2017 Renvela - sevelamer carbonate renvela-ccdsv4-piv3-21aug17 2 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 Renvela 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 Renvela film-coated tablet contains 800 mg of sevelamer carbonate on an anhydrous basis. Renvela 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 Renvela sachet contains 1.6 g or 2.4 g of sevelamer carbonate for oral suspension on an anhydrous basis. Each sachet of Renvela powder contains the following excipients: RB26 Genzyme N&A citrus cream FL PWD #24660 (PI-109424), propylene glycol alginate, sodium chloride, sucralose, and iron oxide yellow. PHARMACOLOGY PHARMACODYNAMICS MECHANISM OF ACTION Pa Přečtěte si celý dokument