Valsts: Armēnija
Valoda: angļu
Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lansoprazole
Apotex Inc.
A02BC03
lansoprazole
30mg
capsules delayed-release
(100) plastic container
Prescription
Registered
2015-04-16
IMPORTANT: PLE ASE READ PART III: CONSUMER INFORMATION Pr APOLANSOPRAZOLE LANSOPRA Z O LE DELAYEDRELEASE CAPSULES USP THIS LEAFLET IS PART III OF A THREEPART “PRODUCT MONOGRAPH” PUBLISHED WHEN APOLANSOPRAZOLE WAS APPROVED FOR SALE IN CANADA AND IS DESIGNED SPECIFICALLY FOR CONSUMERS. THIS LEAFLET IS A SUMMARY AND WILL NOT TELL YOU EVERYTHING ABOUT APO LANSOPRAZOLE. CONTACT YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT THE DRUG. ABOUT THIS MEDICATION WHAT THE MEDICATION IS USED FOR: APO-LANSOPRAZOLE is a medicine that is indicated in the treatment of conditions where the reduction of gastric acid secretion is required, such as: · DUODENAL ULCER A duodenal ulcer is a sore on the lining of the duodenum, which is the beginning of the small intestine. · GASTRIC ULCER A gastric ulcer is a sore on the lining of the stomach. · REFLUX ESOPHAGITIS A reflux esophagitis is an inflammation of the swallowing tube (esophagus) resulting from regurgitation of gastric contents into the esophagus. Because stomach contents are acidic, this may result in irritation of the esophagus. · HEALING OF NONSTEROIDAL ANTIINFLAMMATORY DRUGS (NSAID) ASSOCIATED GASTRIC ULCER · REDUCTION OF RISK OF NSAIDASSOCIATED GASTRIC ULCER · SYMPTOMATIC GASTROESOPHAGEAL REFLUX DISEASE (SGERD) sGERD is a disorder that results from stomach acid moving backward from the stomach into the esophagus. · PATHOLOGICAL HYPERSECRETORY CONDITIONS Pathological hypersecretory conditions are conditions in which the stomach produces too much acid which comes up into the esophagus and causes heartburn. · TREATMENT OF THE BACTERIAL INFECTION CAUSED BY HELICOBACTER PYLORI (H.PYLORI) IN COMBINATION WITH OTHER MEDICATIONS (E.G., THE ANTIBIOTICS CLARITHROMYCIN AND AMOXICILLIN) TO TREAT STOMACH ULCERS. WHAT IT DOES: APO-LANSOPRAZOLE is a type of medication called a proton pump inhibitor, commonly known as PPI. There are cells in the lining of your stomach that produce the acid your body uses during digestion. The burning pain from acid ref Izlasiet visu dokumentu
APPENDIX 1.9 THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC) _ _ 1. NAME OF THE MEDICINAL PRODUCT APO-LANSOPRAZOLE Capsules 15 mg and 30 mg (Lansoprazole Delayed-Release Capsules USP 15 mg and 30 mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION COMPONENT FUNCTION OF COMPONENT %W/W QUANTITY (MG/CAPSULE) 15 MG 30 MG GRANULES Lansoprazole USP Active 18.68 15.00 30.0 Magnesium Hydroxide USP Alkalizing agent 1.067 0.857 1.714 Methylcellulose USP A15LV Filler 23.0 18.47 36.9 Poloxamer 407 NF/EP (Micro) Binder 10.67 8.57 17.14 FILM COATING (SUB-COATING) SOLUTION Purified Water USP* Carrier vehicle - 171.4 317.7 Hydroxypropyl Methylcellulose 2910 USP E5 Film-forming polymer 11.67 9.37 18.74 Polyethylene Glycol NF 8000 Plasticizer 1.67 1.34 2.68 Enteric coating solution Purified Water USP* Carrier vehicle - 34.3 68.6 Triethyl Citrate NF Plasticizer 2.56 2.06 4.11 Talc USP 500 Mesh Glidant or anti- caking agent 5.12 4.11 8.22 Methacrylic Acid Copolymer Dispersion NF** Polymer resistant to gastric fluid 25.62 68.6 137.1 TOTAL (EXCLUDING WATER) 100.0 80.3 160.6 ENCAPSULATION #4 caps, pink opaque cap and green opaque body imprinted “APO L15” in white ink Encasement - 38 $ - #3 caps, pink opaque cap and black opaque body, imprinted “APO L30” in white ink Encasement - - 48 $ TOTAL CAPSULE WEIGHT 118.3 208.6 * Purified water is excluded from the total; evaporated during the coating process. ** 30% solids $ Individual average capsule shell weight Note: Fill weights of 80.3 mg and 160.6 mg are theoretical fill weights for the 15 mg and 30 mg capsules, respectively, and will be adjusted based on assay results for the FC/EC granules. APPENDIX 1.9 THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC) _ _ 3. PHARMACEUTICAL FORM Delayed Release Capsules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NOTE: WHEN USED IN COMBINATION WITH ANTIMICROBIALS FOR THE ERADICATION OF HELICOBACTER PYLORI (_H. PYLORI_), THE PRODUCT MONOGRAPH FOR THOSE AGENTS SHOULD BE CONSULTED. ADULTS APO-LANSOPRAZOLE (Lansoprazole delayed-release capsule Izlasiet visu dokumentu