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

emergo asia pacific pty ltd t/a emergo australia - 35948 - probe, surgical, arthroscopy - the device is indicated for use in diagnostic arthroscopic applications to move and manipulate the soft tissue within a joint cavity. the device is used as determined by a licensed physician.

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

emergo asia pacific pty ltd t/a emergo australia - 62570 - rigid arthroscope, single-use - the device is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. it may be supplied with or without a tablet.

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

emergo asia pacific pty ltd t/a emergo australia - 58962 - single-axis stabilizing knee prosthesis - the device is intended for transfemoral amputees and is designed to restore some function of an anatomical knee joint.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

ncs healthcare of ky, llc dba vangard labs - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam is indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies (14.1)]. meloxicam is indicated for relief of the signs and symptoms of rheumatoid arthritis [see clinical studies (14.1) ]. meloxicam is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg [see dosage and administration (2.4) and clinical studies (14.2)]. meloxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see warnings and precautions (5.7, 5.9)]. - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)]. - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1

Amerika Serikat - Inggris - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam is indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies (14.1)]. meloxicam is indicated for relief of the signs and symptoms of rheumatoid arthritis [see clinical studies (14.1) ]. meloxicam is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weighs ≥ 60 kg [see dosage and administration (2.4) and clinical studies (14.2)]. meloxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see warnings and precautions (5.7,5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7,5.8) ] - in the setting of coronary artery bypass graft (cabg) surger

Amerika Serikat - Inggris - NLM (National Library of Medicine)

remedyrepack inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - voltaren gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. - voltaren gel has not been evaluated for use on the spine, hip, or shoulder. voltaren gel is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see warnings and precautions ( 5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions ( 5.7, 5.8)] . - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions ( 5.1 ) ] pregnancy category c prior to 30 weeks

Amerika Serikat - Inggris - NLM (National Library of Medicine)

cipla usa inc. - testosterone cypionate (unii: m0xw1ubi14) (testosterone - unii:3xmk78s47o) - testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. - primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. - hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or lhrh deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. safety and efficacy of testosterone cypionate in men with "age -related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. - known hypersensitivity to the drug - males with carcinoma of the breast - males with known or suspected carcinoma of the prostate gland - women who are pregnant (see precautions, pregnancy) - patients with serious cardiac, hepatic or renal disease (see warnings) controlled substance testosterone cypionate injection contains testosterone, a schedule iii c

Amerika Serikat - Inggris - NLM (National Library of Medicine)

cipla usa inc. - isoproterenol hydrochloride (unii: dia2a74855) (isoproterenol - unii:l628tt009w) - isoproterenol hydrochloride injection is indicated:        to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output        for bronchospasm occurring during anesthesia isoproterenol hydrochloride injection is contraindicated in patients with:       tachycardia       ventricular arrhythmias       angina pectoris risk summary   prolonged experience with isoproterenol use in pregnant women over several decades, based on published literature, do not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. however, there are risks to the mother and fetus associated with isoproterenol use during labor or delivery (see clinical considerations).   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 united states 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 hypotension associated with shock is a medical emergency in pregnancy which can be fatal if left untreated. delaying treatment in pregnant women with hypotension associated with shock may increase the risk of maternal and fetal morbidity and mortality. life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of isoproterenol on the fetus.   labor and delivery isoproterenol usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labor. avoid isoproterenol during the second stage of labor. avoid isoproterenol in obstetrics when maternal blood pressure exceeds 130/80 mmhg.   although isoproterenol may improve maternal hypotension associated with shock, it may result in uterine vasoconstriction, decreased uterine blood flow, uterine atony with hemorrhage, and fetal anoxia. risk summary   there is no information regarding the presence of isoproterenol in milk or the effects of isoproterenol on the breastfed infant or on milk production. however, due to its short half-life, isoproterenol exposure is expected to be very low in the breastfed infant. safety and efficacy of isoproterenol in pediatric patients have not been established. intravenous infusions of isoproterenol in refractory asthmatic children at rates of 0.05-2.7 µg/kg/min have caused clinical deterioration, myocardial necrosis, congestive heart failure and death. the risks of cardiac toxicity appear to be increased by some factors [acidosis, hypoxemia, coadministration of corticosteroids, coadministration of methylxanthines (theophylline, theobromine) or aminophylline] that are especially likely to be present in these patients. if i.v. isoproterenol is used in children with refractory asthma, patient monitoring must include continuous assessment of vital signs, frequent electrocardiography, and daily measurements of cardiac enzymes, including cpk-mb. clinical studies of isoproterenol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects in clinical circumstances. there are, however, some data that suggest that elderly healthy or hypertensive patients are less responsive to beta-adrenergic stimulation than are younger subjects. in general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

cipla usa inc. - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine hydrochloride ophthalmic solution usp, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. olopatadine hydrochloride ophthalmic solution usp, 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution usp, 0.1%.

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

paragon care group australia pty ltd trading as immulab - ct943 - instrument/analyser ivds - automated instrument to be used as an in vitro diagnostic device for the purposes of processing, examining and/or providing information about a clinical specimen under gmdn ct943 instrument/analyser ivds