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

wockhardt usa llc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 0.1 mg in 1 ml - granisetron hydrochloride injection is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. pregnancy  category  b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predi

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

wockhardt usa llc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg in 1 ml - granisetron hydrochloride injection is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. pregnancy  category  b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predi

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

hikma pharmaceuticals usa inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg in 1 ml - granisetron hydrochloride injection, usp is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction  studies  have  been  performed  in  pregnant  rats  at  intravenous  doses  up  to  9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. benzyl alcohol may cross the placenta. granisetron hydrochloride injection 1 mg/ml is preserved with benzyl alcohol and should be used in pregnancy only if the benefit outweighs the potential risk. it is not known whether granisetron is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when granisetron hydrochloride injection is administered to a nursing woman. benzyl alcohol, a component of granisetron hydrochloride injection 1 mg/ml, has been associated with serious adverse reactions and death, particularly in neonates [see warnings and precautions (5.4)] . chemotherapy-induced nausea and vomiting [see dosage and administration (2)] for use in chemotherapy-induced nausea and vomiting in pediatric patients 2 to 16 years of age. safety and effectiveness in pediatric patients under 2 years of age have not been established. postoperative nausea and vomiting safety and efficacy have not been established in pediatric patients for the prevention of postoperative nausea and vomiting (ponv). granisetron has been evaluated in a pediatric patient clinical trial for use in the prevention of ponv. due to the lack of efficacy and the qt prolongation observed in this trial, use of granisetron for the prevention of ponv in children is not recommended. the trial was a prospective, multicenter, randomized, double-blind, parallel-group trial that evaluated 157 children aged 2 to 16 years who were undergoing elective surgery for tonsillectomy or adenotonsillectomy. the purpose of the trial was to assess two dose levels (20 mcg/kg and 40 mcg/kg) of intravenous granisetron in the prevention of ponv. there was no active comparator or placebo. the primary endpoint was total control of nausea and vomiting (defined as no nausea, vomiting/retching, or use of rescue medication) in the 24 hours following surgery. efficacy was not established due to lack of a dose response. the trial also included standard 12 lead ecgs performed pre-dose and after the induction of anesthesia. ecgs were repeated at the end of surgery after the administration of granisetron and just prior to reversal of anesthesia. qt prolongation was seen at both dose levels. five patients in this trial experienced an increase of ≥ 60 msec in qtcf. in addition, there were two patients whose qtcf was ≥ 500 msec. interpretation of the qtcf prolongation was confounded by multiple factors, including the use of concomitant medication and the lack of either a placebo or active control. a thorough qt trial in adults has not been performed. other adverse events that occurred in the study included: vomiting (5 to 8%), post-procedural hemorrhage (3 to 5%), and dehydration (0 to 5%). pediatric patients under 2 years of age have not been studied. during chemotherapy clinical trials, 713 patients 65 years of age or older received granisetron hydrochloride injection. the safety and effectiveness were similar in patients of various ages.

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

cipla usa inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 0.1 mg in 1 ml - granisetron hydrochloride injection is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: •  the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not alw

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

cipla usa inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg in 1 ml - granisetron hydrochloride injection is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not alwa

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

sagent pharmaceuticals - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg in 1 ml - granisetron hydrochloride injection, usp is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not

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

taro pharmaceuticals u.s.a., inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg - granisetron hydrochloride usp is indicated for the prevention of: - nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. - nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. granisetron hydrochloride usp is contraindicated in patients with known hypersensitivity to the drug or any of its components.

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

teva pharmaceuticals usa, inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg - granisetron hydrochloride tablets are indicated for the prevention of: - nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. - nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. granisetron hydrochloride tablets are contraindicated in patients with known hypersensitivity to the drug or any of its components. manufactured in israel by: teva pharmaceutical ind. ltd. jerusalem, 9777402, israel manufactured for: teva pharmaceuticals usa, inc. north wales, pa 19454 rev. f 2/2016

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

sandoz inc. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg in 1 ml - granisetron hydrochloride injection, usp is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. pregnancy category b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. benzyl alcohol may cross the placenta. granisetron hydrochlori

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

auromedics pharma llc - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg in 1 ml - granisetron hydrochloride injection, usp  is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. - the prevention and treatment of postoperative nausea and vomiting in adults. 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/or vomiting must be avoided during the postoperative period, granisetron hydrochloride injection usp is recommended even where the incidence of postoperative nausea and/or vomiting is low.  granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects p regnancy category b reproduction studies have been performed in pregnant rat