Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESOMEPRAZOLE MAGNESIUM
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
ESOMEPRAZOLE MAGNESIUM
14tablet Tablets; 28tablet Tablets
TORRENT PHARMACEUTICALS LTD
NEXPRO TABLETS _ _ Esomeprazole Magnesium (20 mg, 40 mg) _ _ _ _ 1 _ _ _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Nexpro used for 2. How Nexpro works 3. Before you use Nexpro 4. How to use Nexpro 5. While you are using it 6. Side effects 7. Storage and Disposal of Nexpro 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT NEXPRO IS USED FOR _Gastro-Oesophageal _ _Reflux _ _Disease _ _(GERD): _ Nexpro is taken to treat reflux oesophagitis. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (oesophagus). _Peptic _ _Ulcers _ _Associated _ _with _ _Helicobacter pylori Infection: _ Most people who have a peptic (gastric and duodenal) ulcer also have a bacterium called Helicobacter pylori in their stomach. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. If you have a peptic ulcer, your doctor will prescribe Nexpro with antibiotics. When Nexpro and antibiotics are taken together, they work to kill the bacterium and let your ulcer heal. _Patients _ _requiring _ _continued _ _NSAID _ _therapy: _ Nexpro is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation. Nexpro is also taken to help heal and prevent ulcers caused by NSAIDs. _Prolonged treatment after IV induced _ _prevention _ _of _ _rebleeding _ _of _ _peptic _ _ulcers: _ When peptic ulcers become severe enough, they start to bleed. You may receive treatment injected into your veins initially. This treatment may be followed with Nexpro tablets prescribed by your doctor for a longer period of time. This is to help your ulcer/s to heal. _Treatment _ _of _ _Zollinger _ _Ellison _ _Syndrome: _ Nexpro is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces large amounts of acid, much more than in ulcers or reflux disease. HOW NEXPRO Pročitajte cijeli dokument
PRODUCT NAME : ITEM / PACK : DESIGN STYLE : CODE : DIMENSIONS (MM) : ART WORK SIZE : DATE : Reviewed By NO. OF COLORS: 1 COUNTRY : Malaysia Front/Back Nexpro Tablets Insert S/S 180 x 340 xxxxxxxxxx-5253 Black 04-06-2020 PANTONE SHADE NOS.: ACTIVITIES DEPARTMENT NAME SIGNATURE DATE Prepared By PKG.DEV PKG.DEV LOCATION : Chhatral QUALITY Approved By NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) NEXPRO TABLETS 20 MG Each gastro- resistant tablet contains Esomeprazole magnesium equivalent to Esomeprazole ............. 20 mg Colours: Red oxide of Iron and Titanium Dioxide NEXPRO TABLETS 40 MG Each gastro-resistant tablet contains Esomeprazole magnesium equivalent to Esomeprazole ............. 40 mg Colours: Red oxide of Iron and Titanium Dioxide PRODUCT DESCRIPTION Esomeprazole Tablets 20 mg are brick red colored, round shape, biconvex, film coated tablets, imprinted with “20” on one side with black ink and plain on other side. Esomeprazole Tablets 40 mg are brick red colored, round shape, beveled edge, biconvex, film coated tablets, imprinted with “40” on one side with black ink and plain on other side. DOSAGE FORM Gastro resistant Tablets PHARMACODYNAMICS PHARMACODYNAMICS Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. Both the R- and S-isomer of omeprazole have similar pharmacodynamic activity. SITE AND MECHANISM OF ACTION Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+K+-ATPase - the acid pump and inhibits both basal and stimulated acid secretion. EFFECT ON GASTRIC ACID SECRETION After oral dosing with esomeprazole 20 mg and 40 mg the onset of effect occurs within one hour. After repeated administration with 20 mg esomeprazole once daily for five days, mean peak acid output after pentagastrin stimulation is decreased 90% wh Pročitajte cijeli dokument