国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
RANITIDINE HCl
GLAXOSMITHKLINE PTE LTD
A02BA02
150 mg/10 ml
SYRUP
RANITIDINE HCl 150 mg/10 ml
ORAL
Prescription Only
ASPEN BAD OLDESLOE GmbH
ACTIVE
1989-04-19
1 NAME OF THE MEDICINAL PRODUCT ZALTRAP 25 mg/ml Concentrate for Solution for Infusion QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate for solution for infusion contains 25 mg aflibercept* One vial of 4 ml of concentrate contains 100 mg of aflibercept One vial of 8 ml of concentrate contains 200 mg of aflibercept * Aflibercept is produced in a Chinese hamster ovary (CHO) K-1 mammalian expression system by recombinant DNA technology. For the full list of excipients, see section List of Excipients. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate) The concentrate is a clear colourless to pale yellow solution CLINICAL PARTICULARS THERAPEUTIC INDICATIONS ZALTRAP in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy is indicated in adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen. POSOLOGY AND METHOD OF ADMINISTRATION ZALTRAP should be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Posology The recommended dose of ZALTRAP, administered as an intravenous infusion over 1 hour, is 4 mg/kg of body weight, followed by the FOLFIRI regimen. This is considered as one treatment cycle. The FOLFIRI regimen to be used is irinotecan 180 mg/m 2 intravenous infusion over 90 minutes and folinic acid (dl racemic) 400 mg/m² intravenous infusion over 2 hours at the same time on day 1 using a Y-line, followed by 5-fluorouracil (5-FU) 400 mg/m² intravenous bolus, followed by 5-FU 2400 mg/m² continuous intravenous infusion over 46 hours. The treatment cycle is repeated every 2 weeks. ZALTRAP treatment should be continued until disease progression or unacceptable toxicity 阅读完整的文件
ZANTAC™ RANITIDINE HYDROCHLORIDE QUALITATIVE AND QUANTITATIVE COMPOSITION For all presentations, ranitidine is present as the hydrochloride salt. _SYRUP: _ Ranitidine 150 mg in 10 ml. _TABLETS: _ Ranitidine 150 mg or 300 mg. _INJECTION: _ Ranitidine 50 mg in 2 ml aqueous solution (25 mg/ml). PHARMACEUTICAL FORM _ORAL FORMULATIONS _ Syrup. Tablets: film-coated. _PARENTERAL FORMULATION _ Injection. CLINICAL PARTICULARS INDICATIONS _ORAL FORMULATIONS: _ - Duodenal ulcer and benign gastric ulcer, including that associated with non- steroidal anti-inflammatory agents. - Post-operative ulcer. - Reflux oesophagitis. - Zollinger-Ellison Syndrome. - Chronic episodic dyspepsia, characterised by pain (epigastric or retrosternal) which is related to meals or disturbs sleep but not associated with the above conditions. - Prophylaxis of stress ulceration in seriously ill patients. - Prophylaxis of recurrent haemorrhage from peptic ulcer. - Prophylaxis of Mendelson's syndrome. _INJECTION: _ - Duodenal ulcer. - Benign gastric ulcer. - Post-operative ulcer. - Reflux oesophagitis. - Zollinger-Ellison Syndrome. - Prophylaxis of stress ulceration in seriously ill. - Prophylaxis of recurrent haemorrhage from peptic ulcer. - Prophylaxis of Mendelson's syndrome. DOSAGE AND ADMINISTRATION GENERAL INFORMATION: Syrup: _ZANTAC_ syrup contains approximately 7.5%w/v ethanol (alcohol), i.e. up to 405 mg per 5 ml spoonful (approximately a teaspoonful) which is equivalent to about 11 ml of beer or 5 ml of wine. _ _ POPULATIONS • ADULTS/ADOLESCENTS (12 YEARS AND OVER)_ _ _ORAL FORMULATIONS: _ DUODENAL ULCER AND BENIGN GASTRIC ULCER ACUTE TREATMENT The standard dosage regimen for duodenal or benign gastric ulcer is 150 mg twice daily or 300 mg once nightly. In most cases of duodenal ulcer or benign gastric ulcer healing occurs within 4 weeks. Healing usually occurs after a further 4 weeks in those not fully healed after the initial 4 weeks. In duodenal ulcer 300 mg twice daily for 4 weeks results in healing rates which are higher than those a 阅读完整的文件