Stati Uniti - Ingliż - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.15 g in 1 g - finacea® (azelaic acid) gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. there are no adequate and well-controlled studies in pregnant women. therefore, finacea gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. azelaic acid was administered during the period of organogenesis in all three animal species. embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. e

Stati Uniti - Ingliż - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - iopromide (unii: 712bac33mz) (iopromide - unii:712bac33mz) - iodine 240 mg in 1 ml - ultravist® injection is an iodinated contrast agent indicated for: *for information on the concentrations and doses for the pediatric population [see dosage and administration (2.3) and use in specific populations (8.4)]. risk summary there are no data on ultravist injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. iopromide crosses the placenta and reaches fetal tissues in small amounts (see data). in animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to 0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects (see data). . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general p

Stati Uniti - Ingliż - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - iopromide (unii: 712bac33mz) (iopromide - unii:712bac33mz) - ultravist® injection is an iodinated contrast agent indicated in adults pediatric patients for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this imaging bulk package. risk summary there are no data on ultravist injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. iopromide crosses the placenta and reaches fetal tissues in small amounts (see data). in animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to 0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects (see data). . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of

Stati Uniti - Ingliż - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - finerenone (unii: de2o63yv8r) (finerenone - unii:de2o63yv8r) - kerendia is indicated to reduce the risk of sustained egfr decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (ckd) associated with type 2 diabetes (t2d). kerendia is contraindicated in patients: there are no available data on kerendia use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal studies have shown developmental toxicity at exposures about 4 times those expected in humans. (see data) . the clinical significance of these findings is unclear. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. 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%,

Stati Uniti - Ingliż - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - copanlisib (unii: wi6v529fz9) (copanlisib - unii:wi6v529fz9) - copanlisib 15 mg in 1 ml - aliqopa is indicated for the treatment of adult patients with relapsed follicular lymphoma (fl) who have received at least two prior systemic therapies. none. based on findings from animal studies and the mechanism of action, aliqopa can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of copanlisib to pregnant rats during organogenesis resulted in embryo-fetal death and fetal abnormalities at maternal doses approximately 12% of the recommended dose for patients (see data) . advise pregnant women of the potential risk to a fetus. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. the background risk of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinicall

Stati Uniti - Ingliż - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - iopromide (unii: 712bac33mz) (iopromide - unii:712bac33mz) - ultravist® injection is an iodinated contrast agent indicated for: ultravist is indicated for: ultravist is indicated for: † specific concentrations and presentations of ultravist are recommended for each type of imaging procedure [see dosage and administration ( 2.2, 2.3, 2.4)]. there are no data on ultravist use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. iopromide crosses the placenta and reaches fetal tissues in small amounts (see data) . in animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss, or other advers

Stati Uniti - Ingliż - NLM (National Library of Medicine)

bayer healthcare llc. - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), calcium carbonate (unii: h0g9379fgk) (calcium cation - unii:2m83c4r6zb) - - for the temporary relief of minor aches and pains or as recommended by your doctor. - ask your doctor about other uses for bayer women’s 81 mg aspirin - if you are allergic to aspirin or any other pain reliever/fever reducer - if you have ever had an allergic reaction to this product or any of its ingredients - stomach bleeding warning applies to you - you have a history of stomach problems, such as heartburn - you have high blood pressure, heart disease, liver cirrhosis, or kidney disease - you are taking a diuretic - you have asthma stop use and ask a doctor if - an allergic reaction occurs. seek medical help right away. - you experience any of the following signs of stomach bleeding: - feel faint - vomit blood - have bloody or black stools - have stomach pain that does not get better - pain gets worse or lasts more than 10 days - redness or swelling is present - new symptoms occur - ringing in the ears or a loss of hearing occurs

Stati Uniti - Ingliż - NLM (National Library of Medicine)

bayer healthcare llc. - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - pain reliever - for the temporary relief of minor aches and pains or as recommended by your doctor. because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. - ask your doctor about other uses for bayer safety coated 325 mg aspirin - if you are allergic to aspirin or any other pain reliever/fever reducer - if you have ever had an allergic reaction to this product or any of its ingredients - stomach bleeding warning applies to you - you have a history of stomach problems, such as heartburn - you have high blood pressure, heart disease, liver cirrhosis, or kidney disease - you are taking a diuretic - you have asthma stop use and ask a doctor if - an allergic reaction occurs. seek medical help right away. - you experience any of the following signs of stomach bleeding: - feel faint - vomit blood - have bloody or black stools - have stomach pain that does not get better - pain gets worse or lasts more than 10 days - redness or swelling is present - new symptoms occur - ringing in the ears or a loss of hearing occurs

Stati Uniti - Ingliż - NLM (National Library of Medicine)

bayer healthcare llc. - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - pain reliever - for the temporary relief of minor aches and pains or as recommended by your doctor. because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. - ask your doctor about other uses for bayer safety coated 81 mg aspirin

Stati Uniti - Ingliż - NLM (National Library of Medicine)

bayer healthcare llc. - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - pain reliever ● for the temporary relief of minor aches and pains or as recommended by your doctor ● ask your doctor about other uses for bayer 81 mg cherry chewable aspirin do not use ● if you are allergic to aspirin or any other pain reliever/fever reducer ● this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor ● if you have ever had an allergic reaction to this product or any of its ingredients ● stomach bleeding warning applies to you ● you have a history of stomach problems, such as heartburn ● you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ● you are taking a diuretic ● you have asthma ● an allergic reaction occurs. seek medical help right away. ● you experience any of the following signs of stomach bleeding: ● feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better ● pain gets worse or lasts more than 10 days ● redness or swelling is present ● new symptoms occur ● ringing in the ears or a loss of hearing occurs