USA - engelsk - 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

USA - engelsk - 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

USA - engelsk - 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

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - granisetron hydrochloride -

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - granisetron hydrochloride -

Canada - engelsk - Health Canada

sandoz canada incorporated - granisetron (granisetron hydrochloride) - liquid - 1mg - granisetron (granisetron hydrochloride) 1mg - 5-ht3 receptor antagonists

Canada - engelsk - Health Canada

sandoz canada incorporated - granisetron (granisetron hydrochloride) - solution - 1mg - granisetron (granisetron hydrochloride) 1mg - 5-ht3 receptor antagonists

Canada - engelsk - Health Canada

omega laboratories limited - granisetron (granisetron hydrochloride) - liquid - 1mg - granisetron (granisetron hydrochloride) 1mg - 5-ht3 receptor antagonists

Malta - engelsk - Medicines Authority

actavis group ptc ehf - granisetron hydrochloride - coated tablet - granisetron hydrochloride 1.12 mg - antiemetics and antinauseants

Malta - engelsk - Medicines Authority

actavis group ptc ehf - granisetron hydrochloride - coated tablet - granisetron hydrochloride 2.24 mg - antiemetics and antinauseants