País: Armênia
Língua: inglês
Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pantoprazole (pantoprazole sodium sesquihydrate)
KRKA d.d.
A02BC02
pantoprazole (pantoprazole sodium sesquihydrate)
40mg
tablets gastro-resistant
(14/1x14/) in blister, (28/2x14/) in blister, (56/4x14/) in blister
Prescription
Registered
2021-08-24
PI_Text018840_1 – Updated: Page 1 of 11 1. NAME OF THE MEDICINAL PRODUCT Nolpaza ® 40 mg gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 40 mg pantoprazole as 45.10 mg pantoprazole sodium sesquihydrate. Excipient: Each gastro-resistant tablet contains 36 mg sorbitol (E420). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet Light yellowish brown, oval, slightly biconvex film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults and adolescents 12 years of age and above_ - Reflux oesophagitis _ _ _Adults_ - Eradication of _Helicobacter pylori _(_H. pylori_) in combination with appropriate antibiotic therapy in patients with _H. pylori _associated ulcers. - Gastric and duodenal ulcers. - Zollinger-Ellison syndrome and other pathological hypersecretory conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND ABOVE_ Reflux oesophagitis One Nolpaza 40 mg gastro-resistant tablet per day. In individual cases, the dose may be doubled (increase to 2 Nolpaza 40 mg gastro-resistant tablets daily), especially when there has been no response to other treatment. A 4-week period is usually required for the treatment of reflux oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks. PI_Text018840_1 – Updated: Page 2 of 11 _ADULTS_ Eradication of _H. pylori_ in combination with two appropriate antibiotics In _H. pylori _positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved. Considerations should be given to official local guidance (e.g. national recommendations) regarding bacterial resistance and the appropriate use and prescription of antibacterial agents. Depending upon the resistance pattern, the following combinations can be recommended for the eradication of _H. pylori_: a) twice daily one Nolpaza 40 mg gastro-resistant tablet + twice da Leia o documento completo