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

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline 0.5 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)

aphena pharma solutions - tennessee, llc - 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 human data on the use of chantix in pregnant women are not sufficient to inform a drug associated risk. 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 approximately 30% in infants of women who smoke durin

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

proficient rx lp - 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

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

mavlab pty. ltd. - oxytetracycline - oral powder, pre-mix - oxytetracycline antibiotic active 93.0 g/kg - antibiotic & related - calf | pigs | poultry broilers (meat for human consum) | poultry layers (eggs for human consump) | beef calf | boar | bovine | c - antibiotic - anti-infective | abrasions | abscesses | airsacculitis | antiseptic | avian mycoplasmas | blackhead | body odours | bowed tendons | broad spectrum | burns | coccidiosis | coliform complex | conjunctivitis | cowpox | cracks | crusts | dandruff | dermatological disorders | dermatosis | dry skin | dysentery | eczema | endometritis | enteric diseases | enzootic pneumonia | feed efficiency | fungal infections | girth galls | infections | inflammed pads | itching | keratolytic | lacerations | mastitis | mycoplasmas | odours | open wounds | otitis | pruritis | queensland itch | respiratory disease | saddle rash | salmonellosis | scabs | scaly skin | sheath rot | skin irritations | sores | swine dysentery | teat cracking | teat infections | topical infections | udder sores | weight gain | wire cuts | wounds

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)

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

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

lacorium health international pty ltd - tolnaftate, quantity: 10 mg/g - cream - excipient ingredients: menthol; purified water; glycerol; monobasic sodium phosphate; cetyl alcohol; aloe vera; lavender oil; propylene glycol; urea; dl-alpha-tocopheryl acetate; polysorbate 60; cetostearyl alcohol; benzalkonium chloride; ceteareth-20; white soft paraffin; light liquid paraffin - for the treatment of athlete's foot and ringworm. antifungal action relieves itchy, burning and irritated feet. provides soothing, cooling effect for irritated, painful feet. provides rapid, effective relief of itchy, cracked skin associated with athlete's foot. protects feet from various micro-organisms, bacteria and germs. moisturizes and hydrates dry,cracked, flaky skin.

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

teva pharma australia pty ltd - budesonide, quantity: 320 microgram; formoterol fumarate dihydrate, quantity: 9 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: duoresp spiromax is indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see section 4.2 dose and method of administration).,duoresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): duoresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. duoresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.

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

teva pharma australia pty ltd - budesonide, quantity: 160 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: duoresp spiromax is indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see section 4.2 dose and method of administration).,duoresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): duoresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. duoresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.