United States - English - NLM (National Library of Medicine)

cardinal health - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 4 mg

United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride in men. alosetron hydrochloride should not be initiated in patients with constipation

United States - English - NLM (National Library of Medicine)

avkare, inc. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men. alosetron hydrochloride should not be initiated in patients with constipation [see warnings an

United States - English - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men. alosetron hydrochloride tablets should not be initiated in patients with constipation [see warnings and precautions (5.1) ]. alosetron hydrochloride tablets are contraindicated in patients with a history of the following: concomitant administration of alosetron hydrochloride tablets with fluvoxamine is contraindicated. fluvoxamine, a known strong inhibitor of cyp1a2, has been shown to increase mean alosetron plasma concentrations (auc) approximately 6

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated withalosetron tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron tablets in men. alosetron hydrochloride should not be initiated in patients with constipation [see warnings and precautions (5.1)] . alosetron hydrochlori

United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - alosetron hydrochloride (unii: 2f5r1a46yw) (alosetron - unii:13z9hth115) - alosetron 0.5 mg - alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (ibs) who have: - chronic ibs symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. diarrhea-predominant ibs is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to ibs. because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men. alosetron hydrochloride should not be initiated in patients with constipation [see warnings and

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - granisetron as hydrochloride - tablets - granisetron as hydrochloride 1 mg - granisetron - granisetron - prevention of nausea and vomiting induced by cytostatic therapy.

United States - English - NLM (National Library of Medicine)

dr.reddy's laboratories limited - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron 0.05 mg in 1 ml - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial and repea

United States - English - NLM (National Library of Medicine)

sandoz inc - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron 0.25 mg in 5 ml - palonosetron injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hcl injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: • acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemoth

United States - English - NLM (National Library of Medicine)

cardinal health - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 2 mg in 1 ml - ondansetron injection, usp is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin [see clinical studies (14.1)]. ondansetron injection, usp is approved for patients aged 6 months and older. ondansetron injection, usp is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection, usp is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection, usp and experience nausea and/or vomiting postoperatively, ondansetron injection, usp may be given to prevent further episodes [see clinical studies (14.3)]. ondansetron injection, usp