USA - engelsk - NLM (National Library of Medicine)

oxford pharmaceuticals, llc - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405- 6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ risk summary published prospective cohort studies, case series, and case reports over several decades with trazodone hydrochloride tablets use in pregnant women have not identifie

Singapore - engelsk - HSA (Health Sciences Authority)

dh regsys consulting pte. ltd. - microbiology - the t-spot®.tb assay is an in vitro diagnostic test for the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens and is intended for use as an aid in the diagnosis of tuberculosis (tb) infection. the t-spot.tb assay is a simplified enzyme-linked immunospot (elispot) method which enumerates individual tb-specific activated effector t cells.

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

zimmer biomet pty ltd - 34195 - unicondylar knee prosthesis - a polyethylene knee bearing designed to be used in the lateral knee compartment with the lateral tibial tray. the bearing has a slightly domed bottom face that is congruent with the matching bioconcaved tibial tray upper face to assist in resisting lateral dislocation during deep flexion. biomet uk ltd. knee joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients. whilst these devices are generally successful in attaining these goals they cannot be expected to withstand the activity levels and loads of normal healthy bone. the indications for use of the joint replacement prostheses include: 1)osteoarthritis, rheumatoid arthritis or traumatic arthritis 2)failure of a previous joint replacement procedure 3)correction of varus, valgus or post-traumatic deformity 4)correction or revision of unsuccessful osteotomy or arthrodesis.

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

highgate grajen pty -

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

highgate grajen pty -

USA - engelsk - NLM (National Library of Medicine)

oxford pharmaceuticals, llc - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride tablets, usp are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets, usp has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, usp relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: the above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. however, mild depressive symptoms are common in gad. the effectiveness of buspirone hydrochloride tablets, usp in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. there is no body of evidence available that systematically addresses the appropriate duration of treatment for gad. however, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets, usp for 1 year without ill effect. therefore, the physician who elects to use buspirone hydrochloride tablets, usp for extended periods should periodically reassess the usefulness of the drug for the individual patient. buspirone hydrochloride tablets, usp are contraindicated in patients hypersensitive to buspirone hydrochloride. the use of monoamine oxidase inhibitors (maois) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. the use of buspirone within 14 days of stopping an maoi intended to treat depression is also contraindicated. starting buspirone in a patient who is being treated with reversible maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see warnings, dosage and administration and drug interactions). buspirone hydrochloride, usp is not a controlled substance. in human and animal studies, buspirone has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations. none of the subjects were able to distinguish between buspirone hydrochloride tablets, usp and placebo. by contrast, subjects showed a statistically significant preference for methaqualone and diazepam. studies in monkeys, mice, and rats have indicated that buspirone lacks potential for abuse. following chronic administration in the rat, abrupt withdrawal of buspirone did not result in the loss of body weight commonly observed with substances that cause physical dependency. although there is no direct evidence that buspirone hydrochloride tablets, usp cause physical dependence or drug-seeking behavior, it is difficult to predict from experiments the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of buspirone hydrochloride tablets, usp misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

USA - engelsk - NLM (National Library of Medicine)

oxford pharmaceuticals, llc - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine besylate tablets are indicated for the treatment of hypertension, 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 amlodipine besylate tablets. 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. amlodipine besylate tablets may be used alone or in combination with other antihypertensive agents. chronic stable angina amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. amlodipine besylate tablets may be used alone or in combination with other antianginal agents. vasospastic an gina (prinzmetal's or variant an gina ) amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents. angiographically documented cad in patients with recently documented cad by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine. risk summary the limited available data based on post-marketing reports with amlodipine besylate tablets use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see clinical considerations] . in animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (mrhd), respectively. however for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose [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 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. data animal data no evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (approximately 10 and 20 times the mrhd based on body surface area, respectively) during their respective periods of major organogenesis. however for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose. risk summary limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. no adverse effects of amlodipine on the breastfed infant have been observed. there is no available information on the effects of amlodipine on milk production. amlodipine besylate tablets (2.5 to 5 mg daily) are effective in lowering blood pressure in patients 6 to 17 years [see clinical studies (14.1)]. effect of amlodipine besylate tablets on blood pressure in patients less than 6 years of age is not known. clinical studies of amlodipine besylate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient 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 disease or other drug therapy. elderly patients have decreased clearance of amlodipine with a resulting increase of auc of approximately 40 to 60%, and a lower initial dose may be required [see dosage and administration (2.1)].

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

zimmer biomet pty ltd - 34195 - unicondylar knee prosthesis - the femoral component of a unicompartmental knee designed to maintain full congruency with the meniscal bearing. it has a tinbn coating to reduce the release of metallic ions. the oxford partial knee is intended for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and is intended to be implanted with bone cement.

USA - engelsk - NLM (National Library of Medicine)

oxford pharmaceuticals, llc - cyclobenzaprine hydrochloride (unii: 0ve05jys2p) (cyclobenzaprine - unii:69o5wqq5ti) - cyclobenzaprine hcl tablets, usp are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. cyclobenzaprine hcl tablets, usp should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hcl tablets, usp has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. hypersensitivity to any component of this product. concomitant use of monoamine oxidase (mao) inhibitors or within 14 days after

USA - engelsk - NLM (National Library of Medicine)

oxford pharmaceuticals, llc - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. methocarbamol does not directly relax tense skeletal muscles in man. methocarbamol is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.