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

daiichi sankyo inc. - pexidartinib hydrochloride (unii: ys6wai3xn7) (pexidartinib - unii:6783m2lv5x) - turalio is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (tgct) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , turalio may cause embryo-fetal harm when administered to a pregnant woman. the available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of turalio. oral administration of pexidartinib to pregnant animals during the period of organogenesis resulted in malformations, post-implantation loss, and abortion at maternal exposures that were approximately equal to the human exposure at the recommended dose of 800 mg (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data embryo-fetal development studies investigating the administration of pexidartinib during the period of organogenesis were conducted in rats and rabbits. in rats, pexidartinib resulted in increased post-implantation loss and fetal malformations including localized fetal edema, absence of kidney and ureter, abnormalities of the reproductive tract, and developmental variations including misshapen kidney, decreased skeletal ossification and higher mean litter proportions of slightly or moderately malaligned sternebrae at doses of 40 mg/kg (approximately equal to the human exposure at the recommended dose of 800 mg). in rabbits, administration of pexidartinib resulted in increased post-implantation loss, abortion, and fetal malformations including absence of kidney or ureter, rudimentary, misshapen or malpositioned kidney, rib abnormalities, and skeletal variations of accessory skull bones at doses of 60 mg/kg (approximately equal to the human exposure at the recommended dose of 800 mg). risk summary there are no data on the presence of pexidartinib or its metabolites in either human or animal milk or its effects on a breastfed child or on milk production. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with turalio and for at least 1 week after the final dose. turalio may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to the initiation of turalio [see use in specific populations (8.1)] . contraception females advise females of reproductive potential to use effective non-hormonal contraception during treatment with turalio and for 1 month after the final dose. counsel patients to use non-hormonal method(s) of contraception, since turalio can render hormonal contraceptives ineffective [see drug interactions (7.3), nonclinical toxicology (13.1)] . males advise male patients with female partners of reproductive potential to use effective contraception during treatment with turalio and for 1 week after the final dose [see nonclinical toxicology (13.1)] . infertility based on findings from animal studies, turalio may impair both male and female fertility [see nonclinical toxicology (13.1)]. the safety and effectiveness of turalio in pediatric patients have not been established. clinical studies of turalio did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. reduce the dose when administering turalio to patients with mild to severe renal impairment (clcr 15 to 89 ml/min, estimated by cockcroft-gault [c-g]) [see dosage and administration (2.6), clinical pharmacology (12.3)] . no dosage adjustment is recommended for patients with mild hepatic impairment (total bilirubin less than or equal to upper limit of normal [uln] with ast greater than uln or total bilirubin greater than 1 and up to 1.5 times uln with any ast) [see clinical pharmacology (12.3)] . reduce the dosage of turalio for patients with moderate hepatic impairment (total bilirubin greater than 1.5 and up to 3 times uln, not due to gilbert's syndrome, with any ast) [see dosage and administration (2.7), clinical pharmacology (12.3)] . turalio has not been studied in patients with severe hepatic impairment (total bilirubin greater than 3 to 10 times uln and any ast).

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxter sa-nv - glycine soja siebold et zucc. - glycine max merr. (ph.eur. mixture) 20% + olea europaea l. 80%, oil - refined 200 g/l - emulsion for infusion - 20 % - olive oil 160 mg/ml; soya oil 40 mg/ml - fat emulsions

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline biologicals sa-nv - hepatitis b virus surface antigen (recombinant) 20 µg/dose - suspension for injection - 20 µg/1 ml - hepatitis b virus surface antigen, recombinant 20 µg/dose - hepatitis b, purified antigen

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline biologicals sa-nv - hepatitis b virus surface antigen (recombinant) 20 µg/dose - suspension for injection - 20 µg/1 ml - hepatitis b virus surface antigen, recombinant 20 µg/dose - hepatitis b, purified antigen

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

nanoplus limited (cayman) taiwan branch - potassium hydroxide (unii: wzh3c48m4t) (hydroxide ion - unii:9159uv381p) - antimicrobial sanitizer to help decrease bacteria. hygienic disinfectant especially suited for sanitizing hands, skin or the surface that it needs.

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

nanoplus limited (cayman) taiwan branch - potassium hydroxide (unii: wzh3c48m4t) (hydroxide ion - unii:9159uv381p) - antimicrobial sanitizer to help decrease bacteria. hygienic disinfectant especially suited for sanitizing hands, skin or the surface that it needs.

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

nanoplus limited (cayman) taiwan branch - hydroxide ion (unii: 9159uv381p) (hydroxide ion - unii:9159uv381p) - antimicrobial sanitizer to help decrease bacteria. hygienic disinfectant especially suited for sanitizing hands, skin or the surface that it needs.

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

etailer limited - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer decreases bacteria on skin. - in children less than 2 months of age - on open skin wounds - if you are allergic to any of the ingredients stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

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

etailer limited - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer decreases bacteria on skin. - in children less than 2 months of age - on open skin wounds - if you are allergic to any of the ingredients stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

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

walgreens - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache