Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - hydrochlorothiazide, quantity: 12.5 mg; irbesartan, quantity: 150 mg - tablet, film coated - excipient ingredients: povidone; hypromellose; colloidal anhydrous silica; mannitol; polysorbate 80; sodium starch glycollate type b; magnesium stearate; titanium dioxide; iron oxide yellow; iron oxide red; carnauba wax; macrogol 3350 - indicated for the treatment of hypertension. treatment should not be initiated with this fixed-dose combination.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

theramex australia pty ltd - levonorgestrel, quantity: 150 microgram; ethinylestradiol, quantity: 30 microgram - tablet, film coated - excipient ingredients: lactose; hypromellose; microcrystalline cellulose; magnesium stearate; polysorbate 80; titanium dioxide; macrogol 400; allura red ac aluminium lake; brilliant blue fcf aluminium lake - seasonique is indicated for use as an oral contraceptive.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - levonorgestrel, quantity: 150 microgram; ethinylestradiol, quantity: 30 microgram - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; maize starch; pregelatinised maize starch; titanium dioxide; hypromellose; macrogol 400 - oral contraception

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - levonorgestrel, quantity: 150 microgram; ethinylestradiol, quantity: 30 microgram - tablet, film coated - excipient ingredients: magnesium stearate; maize starch; lactose monohydrate; pregelatinised maize starch; titanium dioxide; hypromellose; macrogol 400 - oral contraception

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - desogestrel, quantity: 150 microgram; ethinylestradiol, quantity: 30 microgram - tablet - excipient ingredients: povidone; titanium dioxide; magnesium stearate; maize starch; hypromellose; polysorbate 80; triacetin; indigo carmine aluminium lake; colloidal anhydrous silica; iron oxide yellow; lactose monohydrate - oral contraception

Združene države Amerike - angleščina - NLM (National Library of Medicine)

macleods pharmaceuticals limited - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - • clopidogrel is indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel should be administered in conjunction with aspirin. • clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel is indicated to reduce the rate of mi and stroke. clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions (6.2)] . risk summary available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see data]. there are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see clinical considerations ]. no evidence of fetotoxicity was observed when clopidogrel was administered to pregnant rats and rabbits during organogenesis at doses corresponding to 65 and 78 times the recommended daily human dose [see data ]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defects, 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%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk myocardial infarction and stroke are medical emergencies. therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of clopidogrel on the fetus. labor or delivery clopidogrel use during labor or delivery will increase the risk of maternal bleeding and hemorrhage. avoid neuraxial blockade during clopidogrel use because of the risk of spinal hematoma. when possible, discontinue clopidogrel 5 to 7 days prior to labor, delivery, or neuraxial blockade. data human data the available data from published case reports over two decades of postmarketing use have not identified an association with clopidogrel use in pregnancy and major birth defects, miscarriage, or adverse fetal outcomes. animal data embryo-fetal developmental toxicology studies were performed in pregnant rats and rabbits with doses up to 500 and 300 mg/kg/day, respectively, administered during organogenesis. these doses, corresponding to 65 and 78 times the recommended daily human dose, respectively, on a mg/m2 basis, revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. risk summary there are no data on the presence of clopidogrel in human milk or the effects on milk production. no adverse effects on breastfed infants have been observed with maternal clopidogrel use during lactation in a small number of postmarketing cases. studies in rats have shown that clopidogrel and/or its metabolites are present in the milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for clopidogrel and any potential adverse effects on the breastfed infant from clopidogrel or from underlying maternal condition. safety and effectiveness in pediatric populations have not been established. a randomized, placebo-controlled trial (clarinet) did not demonstrate a clinical benefit of clopidogrel in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt. possible factors contributing to this outcome were the dose of clopidogrel, the concomitant administration of aspirin, and the late initiation of therapy following shunt palliation. it cannot be ruled out that a trial with a different design would demonstrate a clinical benefit in this patient population. of the total number of subjects in the caprie and cure controlled clinical studies, approximately 50% of patients treated with clopidogrel  were 65 years of age and older, and 15% were 75 years and older. in commit, approximately 58% of the patients treated with clopidogrel were 60 years and older, 26% of whom were 70 years and older. the observed risk of bleeding events with clopidogrel plus aspirin versus placebo plus aspirin by age category is provided in table 1 and table 2 for the cure and commit trials, respectively [see adverse reactions (6.1)] . no dosage adjustment is necessary in elderly patients. experience is limited in patients with severe and moderate renal impairment [see clinical pharmacology (12.2)]. no dosage adjustment is necessary in patients with hepatic impairment [see clinical pharmacology (12.2)] .

Združene države Amerike - angleščina - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 50 mg - trazodone hydrochloride tablets usp are indicated for the treatment of major depressive disorder (mdd) in adults. the efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone [see clinical studies (14) ]. none. pregnancy category c trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. there was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. trazodone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human milk. caution should b

Združene države Amerike - angleščina - NLM (National Library of Medicine)

proficient rx lp - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 50 mg - trazodone hydrochloride tablets usp are indicated for the treatment of major depressive disorder (mdd) in adults. the efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone [see clinical studies (14) ]. none. pregnancy category c trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. there was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. trazodone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human milk. caution should b

Združene države Amerike - angleščina - NLM (National Library of Medicine)

novartis pharmaceutical corporation - hypromellose 2910 (4000 mpa.s) (unii: rn3152op35) (hypromellose 2910 (4000 mpa.s) - unii:rn3152op35) - hypromellose 2910 (4000 mpa.s) 0.002 l in 1 l - lubricant - relieves dryness of the eye. - temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind and sun. - as a protectant against further irritation. do not use - if solution changes color or becomes cloudy - if you are sensitive to any ingredient in this product stop use and ask a doctor if  you experience any of the following: - eye pain - changes in vision - continued redness or irritation of the eye - condition worsens or persists for more than 72 hours

Združene države Amerike - angleščina - NLM (National Library of Medicine)

novartis pharmaceutical corporation - hypromellose 2910 (4000 mpa.s) (unii: rn3152op35) (hypromellose 2910 (4000 mpa.s) - unii:rn3152op35) - hypromellose 2910 (4000 mpa.s) 0.003 l in 1 l