Singapūra - angļu - HSA (Health Sciences Authority)

singapore smart tech pte. ltd. - dental - dental devices designed to influence the shape and/or function of the stomatognathic system through the application of physical force. it includes orthodontic anchor plate, orthodontic anchoring screw, orthodontic arch wire, orthodontic arch wire/bracket fixation ring, orthodontic bands, orthodontic brackets, orthodontic bracket adhesive, orthodontic clasps, orthodontic chin cap, orthodontic extraoral headgear, orthodontic face bow, orthodontic ligature, orthodontic magnet, orthodontic spring, orthodontic tube, orthodontic wire. gmdn no. for orthodontic wires is 16204

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

nowrez & ismail shukri company - isopropyl alcohol (unii: nd2m416302) (isopropyl alcohol - unii:nd2m416302) - first aid antiseptic • first aid to help prevent the risk of infection in minor cuts, scrapes and burns

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

fallien cosmeceuticals, ltd - titanium dioxide (unii: 15fix9v2jp) (titanium dioxide - unii:15fix9v2jp), zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) - sunscreen sunscreen helps prevent sunburn. if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

forreal pharma - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites. lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas.   lidocaine 4% cream is contraindicated in patients with sensitivity to amide type local anesthetics or to any component of the product.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

plum valleypharma llc - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine and prilocaine cream, 2.5%/2.5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

Jordānija - angļu - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة مستودع الأدوية الأردني - the jordan drugstore co - deferasirox 90 milligram/1 tablet - 90 milligram/1 tablet

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

catalyst pharmaceuticals, inc. - perampanel (unii: h821664npk) (perampanel - unii:h821664npk) - fycompa is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. fycompa is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as fycompa, during pregnancy. encourage women who are taking fycompa during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no adequate data on the developmental risk associated with use in pregnant women.  in animal studies, perampanel induced developmental toxicity in pregnant rat and rabbit at clinically relevant doses [see data] . 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of perampanel (1, 3, or 10 mg/kg/day) to pregnant rats throughout organogenesis resulted in an increase in visceral abnormalities (diverticulum of the intestine) at all doses tested; maternal toxicity was observed at the mid and high doses. in a dose-ranging study at higher oral doses (10, 30, or 60 mg/kg/day), embryo lethality and reduced fetal body weight were observed at the mid and high doses tested. the lowest dose tested (1 mg/kg/day) is similar to a human dose of 8 mg/day based on body surface area (mg/m2 ). upon oral administration of perampanel (1, 3, or 10 mg/kg/day) to pregnant rabbits throughout organogenesis, embryo lethality and maternal toxicity were observed at the mid and high doses tested; the no-effect dose for embryo-fetal developmental toxicity in rabbit (1 mg/kg/day) is approximately 2 times a human dose of 8 mg/day based on body surface area (mg/m2 ). oral administration of perampanel (1, 3, or 10 mg/kg/day) to rats throughout gestation and lactation resulted in fetal and pup deaths at the mid and high doses (associated with maternal toxicity) and delayed sexual maturation in males and females at the highest dose tested. no effects were observed on measures of neurobehavioral or reproductive function in the offspring. the no-effect dose for pre- and postnatal developmental toxicity in rat (1 mg/kg/day) is similar to a human dose of 8 mg/day based on body surface area (mg/m2 ). risk summary there are no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.  perampanel and/or its metabolites are present in rat milk, and are detected at concentrations higher than that in maternal plasma. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fycompa and any potential adverse effects on the breastfed child from fycompa or from the underlying maternal condition. contraception use of fycompa may reduce the efficacy of hormonal contraceptives containing levonorgestrel. advise women taking fycompa who are using a levonorgestrel-containing contraceptive to use an additional non-hormonal form of contraception while using fycompa and for a month after discontinuation [see drug interactions (7.1), clinical pharmacology (12.3)]. safety and effectiveness of fycompa for the treatment of partial-onset seizures have been established in pediatric patients 4 years of age and older. the safety and effectiveness of fycompa in patients 12 years of age and older was established by three randomized double-blind, placebo-controlled, multicenter studies, which included 72 pediatric patients between 12 and 16 years of age exposed to fycompa [see clinical pharmacology (12.3) and clinical studies (14.1)] .  use of fycompa for the treatment of partial-onset seizures in pediatric patients 4 years to less than 12 years of age is supported by evidence from adequate and well-controlled studies of fycompa in patients 12 years of age and older with partial onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 225 pediatric patients 4 years to less than 12 years of age treated with fycompa [see adverse reactions (6.1) and clinical pharmacology (12.3)] . the safety and efficacy of fycompa for the adjunctive therapy of primary generalized tonic-clonic seizures in pediatric patients 12 years of age and older was established in a single randomized double-blind, placebo-controlled, multicenter trial (n=164), which included 11 pediatric patients 12 to 16 years of age exposed to fycompa; an additional 6 patients were treated with fycompa in the open-label extension of the study [see clinical studies (14.2)] . the safety and effectiveness of fycompa for the treatment of partial-onset seizures in pediatric patients less than 4 years of age or for the treatment of primary generalized tonic-clonic seizures in pediatric patients less than 12 years of age have not been established. juvenile animal data oral administration of perampanel (1, 3, 3/10/30 mg/kg/day; high dose increased on postnatal days [pnd] 28 and 56) to young rats for 12 weeks starting on pnd 7 resulted in reduced body weight, reduced growth, neurobehavioral impairment (water maze performance and auditory startle habituation) at the mid and high doses, and delayed sexual maturation at the high doses. cns signs (reduced activity, incoordination, excessive grooming/scratching), pup death, decreased hindlimb splay, and decreased hindlimb grip strength were observed at all doses. effects on pup body weight, pup growth, hindlimb splay, impairment in the water maze performance, and auditory startle persisted after dosing was stopped. a no-effect dose for postnatal developmental toxicity was not identified in this study. oral administration of perampanel (1, 5, 5/10 mg/kg/day; high dose increased on pnd 56) to juvenile dogs for 33 weeks, starting on pnd 42, resulted in cns signs (incoordination, excessive grooming/licking/scratching, spatial disorientation, and/or ataxic gait) at all doses tested. clinical studies of fycompa did not include sufficient numbers of patients aged 65 and over to determine the safety and efficacy of fycompa in the elderly population. because of increased likelihood for adverse reactions in the elderly, dosing titration should proceed slowly in patients aged 65 years and older [see dosage and administration (2.5)] . use of fycompa in patients with severe hepatic impairment is not recommended, and dosage adjustments are recommended in patients with mild or moderate hepatic impairment [see dosage and administration (2.4), clinical pharmacology (12.3)] . dose adjustment is not required in patients with mild renal impairment. fycompa should be used with caution in patients with moderate renal impairment, and slower titration may be considered. use in patients with severe renal impairment or patients undergoing hemodialysis is not recommended [see  dosage and administration (2.5), clinical pharmacology (12.3)] . fycompa contains perampanel and is listed as a schedule iii controlled substance. prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. drug abuse and drug addiction are separate and distinct from physical dependence (for example, abuse may not be accompanied by physical dependence) [see drug abuse and dependence (9.3)] . studies of human abuse potential were performed to evaluate the abuse potential of fycompa (8 mg, 24 mg, and 36 mg) as compared to alprazolam c-iv (1.5 mg and 3 mg), and oral ketamine c-iii (100 mg) in recreational polydrug users. supra-therapeutic doses of fycompa 24 and 36 mg produced responses for “euphoria” that were similar to ketamine 100 mg and alprazolam 3 mg. for “high,” fycompa 24 mg and 36 mg produced responses comparable to ketamine 100 mg and significantly higher than both doses of alprazolam on a visual analog scale (vas). “drug liking,” “overall drug liking,” and “take drug again” for fycompa were each statistically lower than ketamine 100 mg. in addition, for “bad drug effects,” fycompa 24 mg and 36 mg produced responses significantly higher than ketamine 100 mg.  for “sedation,” fycompa 24 and 36 mg produced responses similar to alprazolam 3 mg and higher than ketamine 100 mg.  additionally, on vas measures related to dissociative phenomena such as “floating,” “spaced out,” and “detached,” fycompa at supratherapeutic doses produced responses similar to ketamine 100 mg and greater than both doses of alprazolam tested. of note, due to somnolence a number of subjects had missing data around tmax of fycompa. the above described data might represent an underestimate of fycompa’s effects. the duration of effects of higher doses of fycompa on the majority of measures was much greater than alprazolam 3 mg and ketamine 100 mg. in this study, the incidence of euphoria following fycompa administration 8 mg, 24 mg, and 36 mg was 37%, 46%, 46%, respectively, which was higher than alprazolam 3 mg (13%) but lower than ketamine 100 mg (89%). physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug.  a nonclinical dependence study in rats demonstrated withdrawal symptoms, including hyperreactivity to handling, muscle rigidity, and decreases in food consumption and body weights. fycompa may cause dependence and withdrawal symptoms that may include anxiety, nervousness, irritability, fatigue, lethargy, asthenia, mood swings, and insomnia.    instructions for use fycompa® (fī-com-puh) (perampanel) oral suspension read this instructions for use before you start using fycompa oral suspension and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. prepare the fycompa oral suspension dose you will need the following supplies: see figure a • fycompa oral suspension bottle • bottle adapter • dosing syringe (2 dosing syringes are included in the fycompa oral suspension box) figure a step 1. remove the fycompa oral suspension bottle, bottle adapter, and 2 syringes from the box. see figure a step 2. shake the bottle well before each use. see figure b figure b  step 3. uncap the bottle and insert the bottle adapter into the bottle by pressing downward. see figure c and figure d figure c  figure d after the bottle adapter is in place, it cannot be removed. step 4. check the dose in milliliters (ml) as prescribed by your healthcare provider. find this number on the syringe. see  figure e figure e  step 5.  push the plunger of the syringe all the way down then insert the syringe into the upright bottle through the opening in the bottle adapter. see figure f figure f  step 6. with the syringe in place, turn the bottle upside down. pull the plunger to withdraw the dose prescribed by your healthcare provider (the amount of liquid medicine in step 4).  if you see air bubbles in the oral syringe, fully push in the plunger so that the oral solution flows back into the bottle. then, withdraw the prescribed dose of oral suspension. see  figure g  figure g  measure the mls of medicine from the end of the plunger. step 7. if the dose is more than 20 ml, you can use: • 2 syringes or • 1 syringe, taking 2 steps to draw up the medicine in that same syringe for example: if the dose is 24 ml, draw up 20 ml in the first syringe and the remaining 4 ml in the second syringe. or if the dose is 24 ml, draw up 20 ml in the single syringe and squirt the medicine into the mouth, then draw up the remaining 4 ml in that same syringe. if the dose is more than 20 ml, repeat steps 4 through 6 when drawing up the remaining dose of medicine. step 8. turn the bottle right-side up and remove the syringe from the bottle adapter. see figure h figure h  step 9. slowly squirt the fycompa oral suspension directly into the corner of the mouth until all of the liquid medicine is given. if you need 2 syringes for the dose, slowly squirt the medicine from the first syringe into the mouth, then slowly squirt the medicine from the second syringe into the mouth. see figure i figure i  step 10. rinse the syringe (or syringes) with tap water after each use. see figure j • fill a cup with water • pull back on the plunger and draw the water from the cup into the syringe • push down on the plunger to release the water into the sink figure j  step 11. cap the bottle tightly. the cap will fit over the bottle adapter. see figure k figure k  how should i store fycompa oral suspension? - store fycompa oral suspension below 86°f (30°c).  do not freeze. - replace the cap tightly after opening.  - use fycompa oral suspension within 90 days after the bottle is first opened. - after 90 days safely throw away any fycompa oral suspension that has not been used. this instructions for use has been approved by the u.s. food and drug administration. fycompa® is a registered trademark owned by catalyst pharmaceuticals, inc. marketed by catalyst pharmaceuticals, inc., coral gables, fl 33134 ©2023 catalyst pharmaceuticals, inc. revised: 06/2023

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine delayed-release capsules are indicated for the treatment of: - major depressive disorder in adults - generalized anxiety disorder in adults and pediatric patients 7 years of age and older - diabetic peripheral neuropathic pain in adults - fibromyalgia in adults and pediatric patients 13 years of age and older - chronic musculoskeletal pain in adults the use of maois intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is contraindicated [see dosage and administration ( 2.8) and warnings and precautions ( 5.4)]. starting duloxetine in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration ( 2.9) and warnings and precautions ( 5.4)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors the pregnancy outcomes in women exposed to antidepressants, including duloxetine, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for antidepressants at 1-866-961-2388 or online at https://womensmentalhealth.org/research/pregnancyregistry/. risk summary   data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. data from published literature and from a postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes (see data) . there are risks associated with untreated depression and fibromyalgia in pregnancy, and with exposure to snris and ssris, including duloxetine, during pregnancy (see clinical considerations). in rats and rabbits treated with duloxetine during the period of organogenesis, fetal weights were decreased but there was no evidence of developmental effects at doses up to 3 times and 6 times, respectively, the maximum recommended human dose (mrhd) of 120 mg/day given to adolescents on a mg/m 2 basis. when duloxetine was administered orally to pregnant rats throughout gestation and lactation, pup weights at birth and pup survival to 1 day postpartum were decreased at a dose 2 times the mrhd given to adolescents on a mg/m 2 basis. at this dose, pup behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity were observed. post-weaning growth was not adversely affected. 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. clinical considerations disease-associated maternal and/or embryo/fetal risk women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. this finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. pregnant women with fibromyalgia are at increased risk for adverse maternal and infant outcomes including preterm premature rupture of membranes, preterm birth, small for gestational age, intrauterine growth restriction, placental disruption, and venous thrombosis. it is not known if these adverse maternal and fetal outcomes are a direct result of fibromyalgia or other comorbid factors.   maternal adverse reactions use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions ( 5.5)].   fetal/neonatal adverse reaction neonates exposed to duloxetine and other snris or ssris late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these findings are consistent with either a direct toxic effect of the snris or ssris, or possibly, a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions ( 5.4)] . data human data data from a postmarketing retrospective claims-based cohort study found an increased risk for postpartum hemorrhage among 955 pregnant women exposed to duloxetine in the last month of pregnancy compared to 4,128,460 unexposed pregnant women (adjusted relative risk: 1.53; 95% ci: 1.08 to 2.18). the same study did not find a clinically meaningful increase in the risk for major birth defects in the comparison of 2532 women exposed to duloxetine in the first trimester of pregnancy to 1,284,827 unexposed women after adjusting for several confounders. methodologic limitations include possible residual confounding, misclassification of exposure and outcomes, lack of direct measures of disease severity, and lack of information about alcohol use, nutrition, and over-the-counter medication exposures. animal data in animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/fetal and postnatal development. when duloxetine was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of malformations or developmental variations at doses up to 45 mg/kg/day [3 times and 6 times, respectively, the mrhd of 120 mg/day given to adolescents on a mg/m 2 basis]. however, fetal weights were decreased at this dose, with a no-effect dose of 10 mg/kg/day (approximately equal to the mrhd in rats and 2 times the mrhd in rabbits). when duloxetine was administered orally to pregnant rats throughout gestation and lactation, the survival of pups to 1 day postpartum and pup body weights at birth and during the lactation period were decreased at a dose of 30 mg/kg/day (2 times the mrhd given to adolescents on a mg/m 2 basis); the no-effect dose was 10 mg/kg/day. furthermore, behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity, were observed in pups following maternal exposure to 30 mg/kg/day. post-weaning growth and reproductive performance of the progeny were not affected adversely by maternal duloxetine treatment. risk summary data from published literature report the presence of duloxetine in human milk (see data) . there are reports of sedation, poor feeding, and poor weight gain in infants exposed to duloxetine through breast milk (see clinical considerations) . there are no data on the effect of duloxetine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for duloxetine and any potential adverse effects on the breastfed child from duloxetine or from the underlying maternal condition. clinical considerations infants exposed to duloxetine should be monitored for sedation, poor feeding and poor weight gain. data disposition of duloxetine was studied in 6 lactating women who were at least 12 weeks postpartum and had elected to wean their infants. the women were given 40 mg of duloxetine twice daily for 3.5 days. the peak concentration measured in breast milk occurred at a median of 3 hours after the dose. the amount of duloxetine in breast milk was approximately 7 mcg/day while on that dose; the estimated daily infant dose was approximately 2 mcg/kg/day,which is less than 1% of the maternal dose. the presence of duloxetine metabolites in breast milk was not examined. the safety and effectiveness of duloxetine have been established for treatment of generalized anxiety disorder (gad) in patients 7 years to 17 years of age and for treatment of juvenile fibromyalgia syndrome in patients 13 years to 17 years of age. the safety and effectiveness of duloxetine have not been established in pediatric patients with major depressive disorder (mdd), diabetic peripheral neuropathic pain, or chronic musculoskeletal pain. antidepressants increased the risk of suicidal thoughts and behavior in pediatric patients. monitor all pediatric patients being treated with antidepressants for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of treatment, or at times of dosage changes [see warnings and precautions ( 5.1)] . perform regular monitoring of weight and growth in pediatric patients treated with duloxetine [see adverse reactions ( 6.1)]. generalized anxiety disorder use of duloxetine for the treatment of gad in patients 7 years to 17 years of age is supported by one 10-week, placebo-controlled trial (gad-6). the study included 272 pediatric patients with gad of which 47% were 7 years to 11 years of age (53% were 12 years to 17 years of age). duloxetine   demonstrated superiority over placebo as measured by greater improvement in the pediatric anxiety rating scale (pars) for gad severity score [see clinical studies ( 14.3)]. the safety and effectiveness of duloxetine for the treatment of gad in pediatric patients less than 7 years of age have not been established. fibromyalgia use of duloxetine for treatment of fibromyalgia in patients 13 years to 17 years of age is supported by a 13-week placebo-controlled trial in 184 patients with juvenile fibromyalgia syndrome (study fm-4). duloxetine showed improvement over placebo on the primary endpoint, change from baseline to end-of-treatment on the brief pain inventory (bpi) – modified short form: adolescent version 24-hour average pain severity rating [see clinical studies ( 14.5)]. the safety and effectiveness of duloxetine for the treatment of fibromyalgia in patients less than 13 years of age have not been established. major depressive disorder the safety and effectiveness of duloxetine have not been established in pediatric patients for the treatment of mdd. efficacy of duloxetine was not demonstrated in two 10-week, placebo-controlled trials with 800 pediatric patients aged 7 years to 17 years old with mdd (mdd-6 and mdd-7). neither duloxetine nor an active control (approved for treatment of pediatric mdd) was superior to placebo. the most frequently observed adverse reactions in the mdd pediatric clinical trials included nausea, headache, decreased weight, and abdominal pain. decreased appetite and weight loss have been observed in association with the use of ssris and snris.   juvenile animal toxicology data  duloxetine administration to young rats from post-natal day 21 (weaning) through post-natal day 90 (adult) resulted in decreased body weights that persisted into adulthood, but recovered when drug treatment was discontinued; slightly delayed (~1.5 days) sexual maturation in females, without any effect on fertility; and a delay in learning a complex task in adulthood, which was not observed after drug treatment was discontinued. these effects were observed at the high dose of 45 mg/kg/day (2 times the mrhd, for a child); the no-effect-level was 20 mg/kg/day (≈1 times the mrhd, for a child). geriatric exposure in premarketing clinical trials of duloxetine - of the 2,418 patients in mdd trials, 6% (143) were 65 years of age or over. - of the 1,041 patients in clbp trials, 21% (221) were 65 years of age or over. - of the 487 patients in oa trials, 41% (197) were 65 years of age or over. - of   the 1,074 patients in the dpnp trials, 33% (357) were 65 years of age or over. - of the 1,761 patients in fm trials, 8% (140) were 65 years of age or over. in the mdd, gad, dpnp, fm, oa, and clbp studies, no overall differences in safety or effectiveness were generally observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between these geriatric and younger adult patients, but greater sensitivity of some older patients cannot be ruled out. ssris and snris, including duloxetine have been associated with clinically significant hyponatremia in geriatric patients, who may be at greater risk for this adverse reaction [see warnings and precautions ( 5.13)] . in an analysis of data from all placebo-controlled-trials, duloxetine -treated patients reported a higher rate of falls compared to placebo-treated patients. the increased risk appears to be proportional to a patient’s underlying risk for falls. underlying risk appears to increase steadily with age. as geriatric patients tend to have a higher prevalence of risk factors for falls such as medications, medical comorbidities and gait disturbances, the impact of increasing age by itself on falls during duloxetine treatment is unclear. falls with serious consequences including bone fractures and hospitalizations have been reported with duloxetine use [see warnings and precautions ( 5.3) and adverse reactions ( 6.1)] .  the pharmacokinetics of duloxetine after a single dose of 40 mg were compared in healthy elderly females (65 years to 77 years) and healthy middle-age females (32 years to 50 years). there was no difference in the c max , but the auc of duloxetine was somewhat (about 25%) higher and the half-life about 4 hours longer in the elderly females. population pharmacokinetic analyses suggest that the typical values for clearance decrease by approximately 1% for each year of age between 25 years to 75 years of age; but age as a predictive factor only accounts for a small percentage of between-patient variability. dosage adjustment based on the age of the adult patient is not necessary. duloxetine's half-life is similar in men and women. dosage adjustment based on gender is not necessary. duloxetine bioavailability (auc) appears to be reduced by about one-third in smokers. dosage modifications are not recommended for smokers. no specific pharmacokinetic study was conducted to investigate the effects of race. patients with clinically evident hepatic impairment have decreased duloxetine metabolism and elimination. after a single 20 mg dose of duloxetine, 6 cirrhotic patients with moderate liver impairment (child-pugh class b) had a mean plasma duloxetine clearance about 15% that of age- and gender-matched healthy subjects, with a 5-fold increase in mean exposure (auc). although c max was similar to normals in the cirrhotic patients, the half-life was about 3 times longer [see dosage and administration ( 2.7) and warnings and precautions ( 5.14)] . limited data are available on the effects of duloxetine in patients with end-stage renal disease (esrd). after a single 60 mg dose of duloxetine, c max and auc values were approximately 100% greater in patients with esrd receiving chronic intermittent hemodialysis than in subjects with normal renal function. the elimination half-life, however, was similar in both groups. the aucs of the major circulating metabolites, 4-hydroxy duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate, largely excreted in urine, were approximately 7- to 9-fold higher and would be expected to increase further with multiple dosing. population pk analyses suggest that mild to moderate degrees of renal impairment (estimated crcl 30 to 80 ml/min) have no significant effect on duloxetine apparent clearance [see dosage and administration ( 2.7) and warnings and precautions ( 5.14)] . in animal studies, duloxetine did not demonstrate barbiturate-like (depressant) abuse potential. while duloxetine has not been systematically studied in humans for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. however, it is not possible to predict on the basis of premarketing experience 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 misuse or abuse of duloxetine (e.g., development of tolerance, incrementation of dose, drug-seeking behavior). in drug dependence studies, duloxetine did not demonstrate dependence-producing potential in rats.

Dienvidāfrikas Republika - angļu - South African Health Products Regulatory Authority (SAHPRA)

lebasi pharmaceuticals (pty) ltd - tablet - 90,0 mg - each tablet contains ticagrelor 90,0 mg

Dienvidāfrikas Republika - angļu - South African Health Products Regulatory Authority (SAHPRA)

lebasi pharmaceuticals (pty) ltd - tablet - 90,0 mg - each tablet contains ticagrelor 90,0 mg