संयुक्त राज्य - अंग्रेज़ी - 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)] .

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

macleods pharmaceuticals limited - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)  ] . important limitations of use pioglitazone tablets, usp exerts its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets usp should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3) ]. • initiation in patients with established new york heart association (nyha) class iii or iv heart failure [see boxed warning]. (4) • use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone hydrochloride.(4) risk summary limited data with pioglitazone hydrochloride in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or misca

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

cipla usa inc. - bleomycin sulfate (unii: 7dp3ntv15t) (bleomycin - unii:40s1vhn69b) - bleomycin for injection should be considered a palliative treatment. it has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: squamous cell carcinoma: head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. the response to bleomycin for injection is poorer in patients with previously irradiated head and neck cancer. lymphomas: hodgkin's disease, non-hodgkin's lymphoma. testicular carcinoma: embryonal cell, choriocarcinoma, and teratocarcinoma. bleomycin for injection has also been shown to be useful in the management of: malignant pleural effusion: bleomycin for injection is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions. bleomycin for injection is contraindicated in patients who have demonstrated

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

leo pharma limited - ingenol mebutate 0.015%{relative} ((70 µg per tube)) - topical gel - 0.015% w/w - active: ingenol mebutate 0.015%{relative} ((70 µg per tube)) excipient: benzyl alcohol citric acid monohydrate hyetellose isopropyl alcohol purified water sodium citrate dihydrate - topical treatment of solar (actinic) keratoses in adults

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

leo pharma limited - ingenol mebutate 0.05%{relative} ((235 µg per tube)) - topical gel - 0.05% w/w - active: ingenol mebutate 0.05%{relative} ((235 µg per tube)) excipient: benzyl alcohol citric acid monohydrate hyetellose isopropyl alcohol purified water sodium citrate dihydrate - topical treatment of solar (actinic) keratoses in adults

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

leo pharma limited - sodium fusidate 250mg; sodium fusidate 250mg - film coated tablet - 250 mg - active: sodium fusidate 250mg excipient: colloidal silicon dioxide crospovidone gelatin hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose povidone purified talc titanium dioxide active: sodium fusidate 250mg excipient: colloidal silicon dioxide crospovidone dl-alpha tocopheryl acetate hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose purified talc titanium dioxide - treatment of localised as well as generalised staphylococcal infections (e.g. abscesses, furunculosis, wound infections, pneumonia, peritonitis, osteomyelitis, septicaemia, enteritis and otorhinolaryngeal infections).

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

leo pharma limited - calcipotriol 50 µg/g - topical cream - 50 mcg/g - active: calcipotriol 50 µg/g excipient: cetomacrogol 1000 cetostearyl alcohol dibasic sodium phosphate dihydrate disodium edetate dihydrate glycerol liquid paraffin n-(3-chloroallyl)hexaminium chloride purified water white soft paraffin

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

leo pharma limited - calcipotriol 50 µg/ml - topical solution - 50 mcg/g - active: calcipotriol 50 µg/ml excipient: hyprolose isopropyl alcohol levomenthol propylene glycol purified water sodium citrate dihydrate

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

macleods pharmaceuticals limited - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 20 mg - pantoprazole sodium delayed-release tablets are indicated for: pantoprazole sodium delayed-release tablets are  indicated in adults for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets are  indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium delayed-release tablets are  indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. • pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of the for

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

macleods pharmaceuticals limited - risedronate sodium (unii: ofg5exg60l) (risedronic acid - unii:km2z91756z) - risedronate sodium 5 mg - risedronate sodium tablets, usp are indicated for the treatment and prevention of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, risedronate sodium tablets, usp reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see clinical studies (14.1, 14.2) ]. risedronate sodium tablets, usp are indicated for treatment to increase bone mass in men with osteoporosis. risedronate sodium tablets, usp are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin d. risedronate sodium tablets, usp are indicated for treatment of paget's disease of bone in men and women. the optimal duration of use has not been determined. t