Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
Budesonide
AstraZeneca Pty Ltd
Medicine Registered
ENTOCORT(R) 1 ENTOCORT(R) _Budesonide_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Entocort. 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 Entocort against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING ENTOCORT, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR ENTOCORT. You may need to read it again. WHAT ENTOCORT IS FOR Entocort is used in the treatment of Crohn's disease. It can be used to treat acute attacks. Crohn's disease is an inflammatory disease of the bowel. It mainly affects the small bowel and the first part of the large bowel and causes symptoms such as stomach pain, diarrhoea and fever. Entocort contains budesonide. This belongs to the group of medicines called corticosteroids, which are used to help reduce inflammation in many parts of the body. Entocort capsules are designed to release their contents in the small bowel and the first part of the large bowel. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ENTOCORT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Entocort is not addictive. Entocort is available only with a doctor's prescription. BEFORE YOU TAKE ENTOCORT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ENTOCORT IF YOU HAVE AN ALLERGY TO: * any medicine containing budesonide * any ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: - rash, itching or hives on the skin - shortness of breath, wheezing or difficulty breathing - swelling of the face, lips, tongue or other parts of the body. DO NOT GIVE ENTOCORT TO CHILDREN. There is no information available on its use in children. DO NOT Прочитајте комплетан документ
Entocort ® Capsules Product Information 1 (9) ENTOCORT ® PRODUCT INFORMATION (Budesonide controlled ileal release capsules) NAME OF THE DRUG The active ingredient in ENTOCORT is budesonide. The CAS Registry Number for budesonide (11 β, 16α) is 51333-22-3. The Australian Approved Name is budesonide. The chemical structure for budesonide is O CH 3 HO CH 3 C=O CH 2 OH O O C CH 2 CH 2 CH 3 H (22) DESCRIPTION The active ingredient, budesonide, is a non-halogenated glucocorticoid structurally related to 16 α hydroxyprednisolone. The chemical name is 16α,17α-22R, S-propylmethylenedioxy-pregna-1,4-diene-11 β, 21-diol-3, 20-dione. Budesonide is a white to off-white powder, freely soluble in chloroform, sparingly soluble in ethanol and practically insoluble in water and heptane. Budesonide is a mixture of two epimeric forms, epimer A and epimer B, in a 50:50 ratio. The epimer mixture melts with decomposition between 224°C and 231.5°C. ENTOCORT is a hard gelatine capsule filled with gastric acid-resistant, prolonged release granules for oral use. The granules are practically insoluble in gastric juice and have prolonged release properties adjusted to release budesonide in the ileum and the ascending colon. In addition to budesonide, ENTOCORT capsules contain ethylcellulose, tributyl acetylcitrate, methacrylic acid copolymer, triethyl citrate, dimethicone, Polysorbate 80, purified talc and sugar spheres. The capsule shell is made from gelatin, with the colouring agents titanium dioxide and iron oxide. 2009-Jan-29_Entocort PI.doc Entocort ® Capsules Product Information 2 (9) PHARMACOLOGY Studies in animals and humans have shown an advantageous ratio between topical anti-inflammatory activity and systemic glucocorticoid effect over a wide dose range. This is explained by the extensive first-pass hepatic degradation of budesonide after systemic absorption, approximately 8 Прочитајте комплетан документ