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

carilion materials management - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline 1 mg - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix pregnancy category c. there are no adequate and well-controlled studies of chantix use in pregnant women. in animal studies, chantix caused decreased fetal weights, increased auditory startle response, and decreased fertility in offspring. chantix should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in reproductive and developmental toxicity studies, pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. these exposures were 36 (rats) and 50 (rabbits) times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 1 mg twice daily. while no fetal structural abnormalities occurred in either species, reduced fetal weights occurred in rabbits at the highest dose (e

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

carilion materials management - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix pregnancy category c. there are no adequate and well-controlled studies of chantix use in pregnant women. in animal studies, chantix caused decreased fetal weights, increased auditory startle response, and decreased fertility in offspring. chantix should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in reproductive and developmental toxicity studies, pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. these exposures were 36 (rats) and 50 (rabbits) times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 1 mg twice daily. while no fetal structural abnormalities occurred in either species, reduced fetal weights occurred in rabbits at the highest dose (e

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

citra labs llc - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl), trisodium citrate dihydrate (unii: b22547b95k) (anhydrous citric acid - unii:xf417d3psl) - dextrose monohydrate 0.245 g in 10 ml - anticoagulant citrate dextrose solution, solution a, u.s.p. (acd-a), is intended for use as an anticoagulant in the extracorporeal blood processing with autologous prp systems in production of platelet rich plasma (prp). refer to the manufacturer's operator's manual of the autologous prp system for the directions for use. not for direct intravenous infusion

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

csl plasma inc. - trisodium citrate dihydrate (unii: b22547b95k) (anhydrous citric acid - unii:xf417d3psl) - anticoagulant sodium citrate 4% w/v solution usp is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [see dosage and administration (2).] do not infuse anticoagulant sodium citrate 4% w/v solution usp directly to the donor. anticoagulant sodium citrate 4% w/v solution usp has not been adequately studied in controlled clinical trials with specific populations.

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

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline 1 mg - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

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

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

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

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

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

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

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

terumo bct, ltd - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium citrate, unspecified form (unii: 1q73q2julr) (sodium cation - unii:lyr4m0nh37), citric acid monohydrate (unii: 2968phw8qp) (anhydrous citric acid - unii:xf417d3psl) - anticoagulant citrate dextrose solution usp (acd) solution a is an anticoagulant intended for use only with devices that prepare platelet rich plasma (prp) products for extracorporeal use. [see dosage and administration (2).] not for preparation of blood products for transfusion or for direct intravenous infusion. anticoagulant citrate dextrose solution usp (acd) solution a has not been studied in controlled clinical trials with specific populations.

Australia - English - Department of Health (Therapeutic Goods Administration)

terumo bct australia pty ltd - 46812 - blood storage solution, anticoagulation - anticoagulant intended for blood component collection procedures