United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - linezolid - infusion - 2mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - linezolid - infusion - 2mg/1ml

Singapore - English - HSA (Health Sciences Authority)

abbvie pte. ltd. - ritonavir - tablet, film coated - 100.0 mg - ritonavir 100.0 mg

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

sun pharmaceutical industries, inc. - ambrisentan (unii: hw6nv07qec) (ambrisentan - unii:hw6nv07qec) - ambrisentan is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): • to improve exercise ability and delay clinical worsening. studies establishing effectiveness included predominantly patients with who functional class ii–iii symptoms and etiologies of idiopathic or heritable pah (60%) or pah associated with connective tissue diseases (34%). ambrisentan may cause fetal harm when administered to a pregnant female. ambrisentan is contraindicated in females who are pregnant. ambrisentan was consistently shown to have teratogenic effects when administered to animals. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.1, 5.2) and use in specific populations (8.1)] . ambrisentan is contraindicated in patients with idiopathic pulmonary fibrosis (ipf), including ipf patients with pulmonary hypertension (who group 3) [see clinical studies (14.4)]. risk summary based on data from animal reproduction studies, ambrisentan may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy. there are limited data on ambrisentan use in pregnant women. in animal reproduction studies, ambrisentan was teratogenic in rats and rabbits at doses which resulted in exposures of 3.5 and 1.7 times, respectively, the human dose of 10 mg per day [see animal data] . if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential hazard to a fetus [see contraindications (4.1), warnings and precautions (5.1)] . 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%, respectively. data animal data ambrisentan was teratogenic at oral dosages of ≥15 mg/kg/day (auc 51.7 h•mcg/ml) in rats and ≥7 mg/kg/day (24.7 h•mcg/ml) in rabbits; it was not studied at lower dosages. these dosages are of 3.5 and 1.7 times, respectively, the human dose of 10 mg per day (14.8 h•mcg/ml) based on auc. in both species, there were abnormalities of the lower jaw and hard and soft palate, malformation of the heart and great vessels, and failure of formation of the thymus and thyroid. a preclinical study in rats has shown decreased survival of newborn pups (mid and high dosages) and effects on testicle size and fertility of pups (high dosage) following maternal treatment with ambrisentan from late gestation through weaning. the mid and high dosages were 51 x, and 170 x (on a mg/m2 body surface area basis) the maximum oral human dose of 10 mg and an average adult body weight of 70 kg. these effects were absent at a maternal dosage 17 x the human dose based on mg/m2 . risk summary it is not known whether ambrisentan is present in human milk. because many drugs are present in human milk and because of the potential for serious adverse reactions in breastfed infants from ambrisentan, a decision should be made whether to discontinue breastfeeding or discontinue ambrisentan, taking into account the importance of the drug to the mother. pregnancy testing female patients of reproductive potential must have a negative pregnancy test prior to initiation of treatment, monthly pregnancy test during treatment, and pregnancy test 1 month after stopping treatment with ambrisentan. advise patients to contact their healthcare provider if they become pregnant or suspect they may be pregnant. perform a pregnancy test if pregnancy is suspected for any reason. for positive pregnancy tests, counsel patient on the potential risk to the fetus and patient options [see boxed warning and dosage and administration (2.2)].  contraception female patients of reproductive potential must use acceptable methods of contraception during treatment with ambrisentan and for 1 month after stopping treatment with ambrisentan. patients may choose one highly effective form of contraception (intrauterine device (iud), contraceptive implant, or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods). if a partner’s vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. counsel patients on pregnancy planning and prevention, including emergency contraception, or designate counseling by another healthcare provider trained in contraceptive counseling [see boxed warning]. infertility males in a 6-month study of another endothelin receptor antagonist, bosentan, 25 male patients with who functional class iii and iv pah and normal baseline sperm count were evaluated for effects on testicular function. there was a decline in sperm count of at least 50% in 25% of the patients after 3 or 6 months of treatment with bosentan. one patient developed marked oligospermia at 3 months, and the sperm count remained low with 2 follow-up measurements over the subsequent 6 weeks. bosentan was discontinued and after 2 months the sperm count had returned to baseline levels. in 22 patients who completed 6 months of treatment, sperm count remained within the normal range and no changes in sperm morphology, sperm motility, or hormone levels were observed. based on these findings and preclinical data [see nonclinical toxicology (13.1)] from endothelin receptor antagonists, it cannot be excluded that endothelin receptor antagonists such as ambrisentan have an adverse effect on spermatogenesis. counsel patients about the potential effects on fertility [see warnings and precautions (5.5)] . safety and effectiveness of ambrisentan in pediatric patients have not been established. juvenile animal data in juvenile rats administered ambrisentan orally once daily during postnatal day 7 to 26, 36, or 62, a decrease in brain weight (−3% to −8%) with no morphologic or neurobehavioral changes occurred after breathing sounds, apnea, and hypoxia were observed, at exposures approximately 1.8 to 7.0 times human pediatric exposures at 10 mg, based on auc. in the two placebo-controlled clinical studies of ambrisentan, 21% of patients were ≥65 years old and 5% were ≥75 years old. the elderly (age ≥65 years) showed less improvement in walk distances with ambrisentan than younger patients did, but the results of such subgroup analyses must be interpreted cautiously. peripheral edema was more common in the elderly than in younger patients. the impact of renal impairment on the pharmacokinetics of ambrisentan has been examined using a population pharmacokinetic approach in pah patients with creatinine clearances ranging between 20 and 150 ml/min. there was no significant impact of mild or moderate renal impairment on exposure to ambrisentan [see clinical pharmacology (12.3)] . dose adjustment of ambrisentan in patients with mild or moderate renal impairment is therefore not required. there is no information on the exposure to ambrisentan in patients with severe renal impairment. the impact of hemodialysis on the disposition of ambrisentan has not been investigated. preexisting hepatic impairment the influence of preexisting hepatic impairment on the pharmacokinetics of ambrisentan has not been evaluated. because there is in vitro and in vivo evidence of significant metabolic and biliary contribution to the elimination of ambrisentan, hepatic impairment might be expected to have significant effects on the pharmacokinetics of ambrisentan [see clinical pharmacology (12.3)] . ambrisentan is not recommended in patients with moderate or severe hepatic impairment. there is no information on the use of ambrisentan in patients with mild preexisting impaired liver function; however, exposure to ambrisentan may be increased in these patients. elevation of liver transaminases other endothelin receptor antagonists (eras) have been associated with aminotransferase (ast, alt) elevations, hepatotoxicity, and cases of liver failure [see adverse reactions (6.1, 6.2)]. in patients who develop hepatic impairment after ambrisentan initiation, the cause of liver injury should be fully investigated. discontinue ambrisentan if elevations of liver aminotransferases are >5 x uln or if elevations are accompanied by bilirubin >2 x uln, or by signs or symptoms of liver dysfunction and other causes are excluded.

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

apotex corp. - ambrisentan (unii: hw6nv07qec) (ambrisentan - unii:hw6nv07qec) - ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): - to improve exercise ability and delay clinical worsening. studies establishing effectiveness included predominantly patients with who functional class ii–iii symptoms and etiologies of idiopathic or heritable pah (60%) or pah associated with connective tissue diseases (34%). ambrisentan tablets may cause fetal harm when administered to a pregnant female. ambrisentan tablets are contraindicated in females who are pregnant. ambrisentan was consistently shown to have teratogenic effects when administered to animals. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.1, 5.2) and use in specific populations (8.1)] . ambrisentan tablets are contraindicated in patients with idiopathic pulmonary fibrosis (ipf), including ipf patients with pulmonary hypertension (who group 3) [see clinical studies (14.4)]. risk summary based on data from animal reproduction studies, ambrisentan may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy. there are limited data on ambrisentan use in pregnant women. in animal reproduction studies, ambrisentan was teratogenic in rats and rabbits at doses which resulted in exposures of 3.5 and 1.7 times, respectively, the human dose of 10 mg per day [see animal data] . if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential hazard to a fetus [see contraindications (4.1), warnings and precautions (5.1)]. 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 2-4% and 15-20%, respectively. data animal data ambrisentan was teratogenic at oral dosages of ≥15 mg/kg/day (auc 51.7 h•mcg/ml) in rats and ≥7 mg/kg/day (24.7 h•mcg/ml) in rabbits; it was not studied at lower dosages. these dosages are of 3.5 and 1.7 times, respectively, the human dose of 10 mg per day (14.8 h•mcg/ml) based on auc. in both species, there were abnormalities of the lower jaw and hard and soft palate, malformation of the heart and great vessels, and failure of formation of the thymus and thyroid. a preclinical study in rats has shown decreased survival of newborn pups (mid and high dosages) and effects on testicle size and fertility of pups (high dosage) following maternal treatment with ambrisentan from late gestation through weaning. the mid and high dosages were 51 x, and 170 x (on a mg/m2  body surface area basis) the maximum oral human dose of 10 mg and an average adult body weight of 70 kg. these effects were absent at a maternal dosage 17 x the human dose based on mg/m2 . risk summary it is not known whether ambrisentan is present in human milk. because many drugs are present in human milk and because of the potential for serious adverse reactions in breastfed infants from ambrisentan, a decision should be made whether to discontinue breastfeeding or discontinue ambrisentan tablets, taking into account the importance of the drug to the mother. pregnancy testing female patients of reproductive potential must have a negative pregnancy test prior to initiation of treatment, monthly pregnancy test during treatment, and pregnancy test 1 month after stopping treatment with ambrisentan tablets. advise patients to contact their healthcare provider if they become pregnant or suspect they may be pregnant. perform a pregnancy test if pregnancy is suspected for any reason. for positive pregnancy tests, counsel patient on the potential risk to the fetus and patient options [see boxed warning and dosage and administration (2.2)]. contraception female patients of reproductive potential must use acceptable methods of contraception during treatment with ambrisentan tablets and for 1 month after stopping treatment with ambrisentan tablets. patients may choose one highly effective form of contraception (intrauterine device (iud), contraceptive implant, or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods). if a partner’s vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. counsel patients on pregnancy planning and prevention, including emergency contraception, or designate counseling by another healthcare provider trained in contraceptive counseling [see boxed warning]. infertility   males in a 6-month study of another endothelin receptor antagonist, bosentan, 25 male patients with who functional class iii and iv pah and normal baseline sperm count were evaluated for effects on testicular function. there was a decline in sperm count of at least 50% in 25% of the patients after 3 or 6 months of treatment with bosentan. one patient developed marked oligospermia at 3 months, and the sperm count remained low with 2 follow-up measurements over the subsequent 6 weeks. bosentan was discontinued and after 2 months the sperm count had returned to baseline levels. in 22 patients who completed 6 months of treatment, sperm count remained within the normal range and no changes in sperm morphology, sperm motility, or hormone levels were observed. based on these findings and preclinical data [see nonclinical toxicology (13.1)] from endothelin receptor antagonists, it cannot be excluded that endothelin receptor antagonists such as ambrisentan have an adverse effect on spermatogenesis. counsel patients about the potential effects on fertility [see warnings and precautions (5.5)]. safety and effectiveness of ambrisentan tablets in pediatric patients have not been established.   juvenile animal data   in juvenile rats administered ambrisentan orally once daily during postnatal day 7 to 26, 36, or 62, a decrease in brain weight (−3% to −8%) with no morphologic or neurobehavioral changes occurred after breathing sounds, apnea, and hypoxia were observed, at exposures approximately 1.8 to 7.0 times human pediatric exposures at 10 mg, based on auc. in the two placebo-controlled clinical studies of ambrisentan tablets, 21% of patients were ≥65 years old and 5% were ≥75 years old. the elderly (age ≥65 years) showed less improvement in walk distances with ambrisentan tablets than younger patients did, but the results of such subgroup analyses must be interpreted cautiously. peripheral edema was more common in the elderly than in younger patients. the impact of renal impairment on the pharmacokinetics of ambrisentan has been examined using a population pharmacokinetic approach in pah patients with creatinine clearances ranging between 20 and 150 ml/min. there was no significant impact of mild or moderate renal impairment on exposure to ambrisentan [see clinical pharmacology (12.3)] . dose adjustment of ambrisentan tablets in patients with mild or moderate renal impairment is therefore not required. there is no information on the exposure to ambrisentan in patients with severe renal impairment. the impact of hemodialysis on the disposition of ambrisentan has not been investigated. pre-existing hepatic impairment the influence of pre-existing hepatic impairment on the pharmacokinetics of ambrisentan has not been evaluated. because there is in vitro and in vivo evidence of significant metabolic and biliary contribution to the elimination of ambrisentan, hepatic impairment might be expected to have significant effects on the pharmacokinetics of ambrisentan [see clinical pharmacology (12.3)] . ambrisentan is not recommended in patients with moderate or severe hepatic impairment. there is no information on the use of ambrisentan in patients with mild pre-existing impaired liver function; however, exposure to ambrisentan may be increased in these patients. elevation of liver transaminases other endothelin receptor antagonists (eras) have been associated with aminotransferase (ast, alt) elevations, hepatotoxicity, and cases of liver failure [see adverse reactions (6.1, 6.2)]. in patients who develop hepatic impairment after ambrisentan tablets initiation, the cause of liver injury should be fully investigated. discontinue ambrisentan tablets if elevations of liver aminotransferases are >5 × uln or if elevations are accompanied by bilirubin >2 × uln, or by signs or symptoms of liver dysfunction and other causes are excluded.

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

lc & partners pty ltd - ct943 - instrument/analyser ivds - blood cell morphology analyzer, a laboratory use only device, can acquire digital images of bone marrow aspirate smears and peripheral blood smears, and perform morphological analysis by locating, pre-classifying and statistically analyze nucleated cells in the acquired images for the diagnosis of hematological diseases.

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

medis pharma pty ltd - rocuronium bromide, quantity: 100 mg - injection, solution - excipient ingredients: acetic acid; sodium hydroxide; sodium chloride; water for injections; sodium acetate trihydrate - adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, children and infants over 1 month of age.. adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated, however, this has not been studied in infants and children. rocuronium is also indicated as an adjunct in the intensive care unit (icu) to facilitate mechanical ventilation.

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

medis pharma pty ltd - rocuronium bromide, quantity: 50 mg - injection, solution - excipient ingredients: sodium hydroxide; acetic acid; water for injections; sodium acetate trihydrate; sodium chloride - adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, children and infants over 1 month of age.. adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated, however, this has not been studied in infants and children. rocuronium is also indicated as an adjunct in the intensive care unit (icu) to facilitate mechanical ventilation.

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

azurity pharmaceuticals, inc. - azilsartan kamedoxomil (unii: wec6i2k1fc) (azilsartan - unii:f9nux55p23) - azilsartan medoxomil 40 mg - edarbi is indicated for the treatment of hypertension in adults, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with edarbi. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. edarbi may be used alone or in combination with other antihypertensive agents. do not coadminister aliskiren-containing products with edarbi in patients with diabetes [see drug interactions (7)] . risk summary edarbi can cause fetal harm when administered to a pregnant woman. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see clinical considerations ). most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. when pregnancy is detected, discontinue edarbi as soon as possible. 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 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. fetal/neonatal adverse reactions oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. perform serial ultrasound examinations to assess the intra-amniotic environment. fetal testing may be appropriate, based on the week of pregnancy. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. closely observe infants with histories of in utero exposure to edarbi for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to edarbi, if oliguria or hypotension occurs, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. data animal data in peri- and postnatal rat development studies, adverse effects on pup viability, delayed incisor eruption and dilatation of the renal pelvis along with hydronephrosis were seen when azilsartan medoxomil was administered to pregnant and nursing rats at 1.2 times the mrhd on a mg/m2 basis. reproductive toxicity studies indicated that azilsartan medoxomil was not teratogenic when administered at oral doses up to 1000 mg azilsartan medoxomil/kg/day to pregnant rats (122 times the mrhd on a mg/m2 basis) or up to 50 mg azilsartan medoxomil/kg/day to pregnant rabbits (12 times the mrhd on a mg/m2 basis). m-ii also was not teratogenic in rats or rabbits at doses up to 3000 mg m-ii/kg/day. azilsartan crossed the placenta and was found in the fetuses of pregnant rats and was excreted into the milk of lactating rats. risk summary there is limited information regarding the presence of azilsartan in human milk, the effects on the breastfed infant, or the effects on milk production. azilsartan is present in rat milk. because of the potential for adverse effects on the nursing infant, advise a nursing woman that breastfeeding is not recommended during treatment with edarbi. safety and effectiveness in pediatric patients have not been established. use of edarbi is not recommended in children less than 2 years of age. it is not known whether post-natal use of azilsartan in patients less than 2 years of age, before maturation of kidney function is complete, has a long-term deleterious effect on the kidney. juvenile animal studies in juvenile rat studies, dosing with azilsartan starting on post-natal day 14 (equivalent to a neonate with morphologically and functionally immature kidneys) resulted in increased incidence of edema of the renal papilla at the end of 4-week recovery period that was non-reversible. these findings occurred in the high-dose group (10 mg/kg) and were not observed in juvenile rats dosed starting on post-natal day 21 (equivalent to a human approximately 2 years of age) or adult rats. no dose adjustment with edarbi is necessary in elderly patients. of the total patients in clinical studies with edarbi, 26% were elderly (65 years of age and older); 5% were 75 years of age and older. abnormally high serum creatinine values were more likely to be reported for patients age 75 or older. no other differences in safety or effectiveness were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see clinical pharmacology (12.3)] . dose adjustment is not required in patients with mild-to-severe renal impairment or end-stage renal disease. patients with moderate to severe renal impairment are more likely to report abnormally high serum creatinine values. no dose adjustment is necessary for subjects with mild or moderate hepatic impairment. edarbi has not been studied in patients with severe hepatic impairment [see clinical pharmacology (12.3)].

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

essential generics ltd - griseofulvin - oral tablet - 500mg