Καναδάς - Αγγλικά - Health Canada

apotex inc - varenicline (varenicline tartrate); varenicline (varenicline tartrate) - kit - 0.5mg; 1mg - varenicline (varenicline tartrate) 0.5mg; varenicline (varenicline tartrate) 1mg - miscellaneous autonomic drugs

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline tablets are indicated for use as an aid to smoking cessation treatment. varenicline tablets are contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline.   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

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline tablets are indicated for use as an aid to smoking cessation treatment. varenicline tablets are contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline.   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

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

ascend laboratories, llc - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline tablet is indicated for use as an aid to smoking cessation treatment. varenicline tablet is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline tablets. 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

Καναδάς - Αγγλικά - Health Canada

pharmascience inc - varenicline (varenicline tartrate) - tablet - 0.5mg - varenicline (varenicline tartrate) 0.5mg - miscellaneous autonomic drugs

Καναδάς - Αγγλικά - Health Canada

pharmascience inc - varenicline (varenicline tartrate) - tablet - 1mg - varenicline (varenicline tartrate) 1mg - miscellaneous autonomic drugs

Καναδάς - Αγγλικά - Health Canada

pharmascience inc - varenicline (varenicline tartrate); varenicline (varenicline tartrate) - kit - 0.5mg; 1mg - varenicline (varenicline tartrate) 0.5mg; varenicline (varenicline tartrate) 1mg - miscellaneous autonomic drugs

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - varenicline tartrate, quantity: 1.71 mg (equivalent: varenicline, qty 1 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate; hypromellose; triacetin; hyprolose; titanium dioxide; indigo carmine aluminium lake; magnesium stearate - varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - varenicline tartrate, quantity: 1.71 mg (equivalent: varenicline, qty 1 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate; hypromellose; hyprolose; titanium dioxide; magnesium stearate; triacetin; indigo carmine aluminium lake - varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

Ηνωμένες Πολιτείες - Αγγλικά - 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