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

bryant ranch prepack - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride tablets are indicated to: - prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms in patients without structural heart disease. prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms in patients without structural heart disease. - prolong the time to recurrence of paroxysmal supraventricular tachycardia (psvt) associated with disabling symptoms in patients without structural heart disease. prolong the time to recurrence of paroxysmal supraventricular tachycardia (psvt) associated with disabling symptoms in patients without structural heart disease. - treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. initiate treatment in the hospital. treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. initiate treatment in the hospital. usage considerations: - the use of propafenone hydrochloride tablets in patients with permanent atrial fibrillation (af) or in patients exclusively with atrial flutter or psvt has not been evaluated. do not use propafenone hydrochloride tablets to control ventricular rate during af. the use of propafenone hydrochloride tablets in patients with permanent atrial fibrillation (af) or in patients exclusively with atrial flutter or psvt has not been evaluated. do not use propafenone hydrochloride tablets to control ventricular rate during af. - some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. concomitant treatment with drugs that increase the functional atrioventricular (av) nodal refractory period is recommended. some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. concomitant treatment with drugs that increase the functional atrioventricular (av) nodal refractory period is recommended. - the use of propafenone hydrochloride tablets in patients with chronic atrial fibrillation has not been evaluated. the use of propafenone hydrochloride tablets in patients with chronic atrial fibrillation has not been evaluated. - because of the proarrhythmic effects of  propafenone hydrochloride tablets, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks. because of the proarrhythmic effects of  propafenone hydrochloride tablets, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks. - the effect of propafenone on mortality has not been determined [see boxed warning ] . the effect of propafenone on mortality has not been determined [see boxed warning ] . propafenone hydrochloride is contraindicated in the following circumstances: - heart failure heart failure - cardiogenic shock cardiogenic shock - sinoatrial, atrioventricular and intraventricular disorders of impulse generation or conduction (e.g., sick sinus node syndrome, av block) in the absence of an artificial pacemaker sinoatrial, atrioventricular and intraventricular disorders of impulse generation or conduction (e.g., sick sinus node syndrome, av block) in the absence of an artificial pacemaker - known brugada syndrome known brugada syndrome - bradycardia bradycardia - marked hypotension marked hypotension - bronchospastic disorders or severe obstructive pulmonary disease bronchospastic disorders or severe obstructive pulmonary disease - marked electrolyte imbalance marked electrolyte imbalance risk summary there are no studies of propafenone hydrochloride in pregnant women. available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. untreated arrhythmias during pregnancy may pose a risk to the pregnant woman and fetus (see clinical considerations ). propafenone and its metabolite, 5-oh-propafenone, cross the placenta in humans. in animal studies, propafenone was not teratogenic. at maternally toxic doses (ranging from 2 to 6 times the maximum recommended human dose [mrhd]), there was evidence of adverse developmental outcomes when administered to pregnant rabbits and rats during organogenesis or when administered to pregnant rats during mid-gestation through weaning of their offspring (see data ). the estimated background risks of major birth defects and miscarriage for the indicated populations are 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 : the incidence of vt is increased and may be more symptomatic during pregnancy. ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions : propafenone and its metabolite have been shown to cross the placenta. adverse reactions such as fetal/neonatal arrhythmias have been associated with the use of other antiarrhythmic  agents by pregnant women. fetal/neonatal monitoring for signs and symptoms of arrhythmia is recommended during and after treatment of pregnant women with propafenone. labor or delivery : risk of arrhythmias may increase during labor and delivery. patients treated with propafenone hydrochloride should be monitored continuously for arrhythmias during labor and delivery [seewarnings and precautions (5.1)]. data propafenone has been shown to cause embryo-fetal mortality in rabbits and rats when given orally during organogenesis at maternally toxic doses of 150 mg/kg/day (rabbit: maternal mortality, decreased body weight gain and food consumption at approximately 3 times the mrhd on a mg/m2 basis) and 600 mg/kg/day (rat: maternal decreased body weight gain and food consumption at approximately 6 times the mrhd on a mg/m2 basis). in addition, a maternally toxic dose of 600 mg/kg/day (approximately 6 times the mrhd on a mg/m2 basis) also caused decreased fetal weights in rats. increased placental weights and delayed ossification occurred in rabbits at a dose of 30 mg/kg/day (less than the mrhd on a mg/m2 basis) in the absence of maternal toxicity. no adverse developmental outcomes in the absence of maternal toxicity were seen following oral doses of 15 mg/kg/day to rabbits or up to 270 mg/kg/day to rats administered during organogenesis (equivalent to 0.3 times or approximately 3 times the mrhd on a mg/m2 basis, respectively). in an oral study, female rats received propafenone up to 500 mg/kg/day from mid-gestation through weaning. at 90 mg/kg/day (equivalent to the mrhd on a mg/m2 basis), there were no adverse developmental outcomes in the absence of maternal toxicity. however, doses ≥180 mg/kg/day (2 or more times the mrhd on a mg/m2 basis) produced increases in maternal deaths and resulted in reductions in neonatal survival, body weight gain, and delayed development in the presence of maternal toxicity. risk summary propafenone and its active metabolite, 5-oh-propafenone, are present in human milk, but the levels are likely to be low. there are no data on the effects of propafenone on the breastfed infant or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for propafenone and any potential adverse effects on the breastfed infant from propafenone or from the underlying maternal condition. infertility males : based on human and animal studies, propafenone hydrochloride may transiently impair spermatogenesis in males. evaluation of the effects on spermatogenesis was performed in 11 healthy males given oral propafenone 300 mg b.i.d. for 4 days, which was then increased to 300 mg t.i.d. for an additional 4 days. study findings included a 28% reduction in semen sample volume on treatment day 8 and a 27% reduction in sperm count 64 days after treatment (both values remained within the laboratories normal reference range). these effects were not seen in followup visits up to 120 days after treatment. reversible decreases in spermatogenesis have been demonstrated in monkeys, dogs, and rabbits after lethal or near-lethal intravenous doses of propafenone [see nonclinical toxicology (13.1)] . the safety and effectiveness of propafenone in pediatric patients have not been established. clinical trials of propafenone hydrochloride did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger subjects. 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.

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

bryant ranch prepack - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride tablets are indicated to: usage considerations: propafenone hydrochloride tablets are contraindicated in the following circumstances: risk summary there are no studies of propafenone hydrochloride tablets in pregnant women. available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride tablets in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. untreated arrhythmias during pregnancy may pose a risk to the pregnant woman and fetus (see clinical considerations) . propafenone and its metabolite, 5-oh-propafenone, cross the placenta in humans. in animal studies, propafenone was not teratogenic. at maternally toxic doses (ranging from 2 to 6 times the maximum recommended human dose [mrhd]), there was evidence of adverse developmental outcomes when administered to pregnant rabbits and rats during organogenesis or when administered to pregnant rats during mid-gestation through weaning of their offspring (see data) . the estimated background risks of major birth defects and miscarriage for the indicated populations are 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: the incidence of vt is increased and may be more symptomatic during pregnancy. ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions: propafenone and its metabolite have been shown to cross the placenta. adverse reactions such as fetal/neonatal arrhythmias have been associated with the use of other antiarrhythmic agents by pregnant women. fetal/neonatal monitoring for signs and symptoms of arrhythmia is recommended during and after treatment of pregnant women with propafenone. labor or delivery: risk of arrhythmias may increase during labor and delivery. patients treated with propafenone hydrochloride tablets should be monitored continuously for arrhythmias during labor and delivery [see warnings and precautions (5.1)] . data propafenone has been shown to cause embryo-fetal mortality in rabbits and rats when given orally during organogenesis at maternally toxic doses of 150 mg/kg/day (rabbit: maternal mortality, decreased body weight gain and food consumption at approximately 3 times the mrhd on a mg/m2 basis) and 600 mg/kg/day (rat: maternal decreased body weight gain and food consumption at approximately 6 times the mrhd on a mg/m2 basis). in addition, a maternally toxic dose of 600 mg/kg/day (approximately 6 times the mrhd on a mg/m2 basis) also caused decreased fetal weights in rats. increased placental weights and delayed ossification occurred in rabbits at a dose of 30 mg/kg/day (less than the mrhd on a mg/m2 basis) in the absence of maternal toxicity. no adverse developmental outcomes in the absence of maternal toxicity were seen following oral doses of 15 mg/kg/day to rabbits or up to 270 mg/kg/day to rats administered during organogenesis (equivalent to 0.3 times or approximately 3 times the mrhd on a mg/m2 basis, respectively). in an oral study, female rats received propafenone up to 500 mg/kg/day from mid-gestation through weaning. at 90 mg/kg/day (equivalent to the mrhd on a mg/m2 basis), there were no adverse developmental outcomes in the absence of maternal toxicity. however, doses ≥180 mg/kg/day (2 or more times the mrhd on a mg/m2 basis) produced increases in maternal deaths and resulted in reductions in neonatal survival, body weight gain, and delayed development in the presence of maternal toxicity. risk summary propafenone and its active metabolite, 5-oh-propafenone, are present in human milk, but the levels are likely to be low. there are no data on the effects of propafenone on the breastfed infant or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for propafenone and any potential adverse effects on the breastfed infant from propafenone or from the underlying maternal condition. infertility males: based on human and animal studies, propafenone hydrochloride tablets may transiently impair spermatogenesis in males. evaluation of the effects on spermatogenesis was performed in 11 healthy males given oral propafenone 300 mg b.i.d. for 4 days, which was then increased to 300 mg t.i.d. for an additional 4 days. study findings included a 28% reduction in semen sample volume on treatment day 8 and a 27% reduction in sperm count 64 days after treatment (both values remained within the laboratories normal reference range). these effects were not seen in follow-up visits up to 120 days after treatment. reversible decreases in spermatogenesis have been demonstrated in monkeys, dogs, and rabbits after lethal or near-lethal intravenous doses of propafenone [see nonclinical toxicology (13.1)] . the safety and effectiveness of propafenone in pediatric patients have not been established. clinical trials of propafenone hydrochloride tablets did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger subjects. 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.

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

bryant ranch prepack - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target iop determined after multiple measurements over time). the iop-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see clinical studies (14)]. dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see warnings and precautions (5.1)]. dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock [see warnings and precautions (5.2)]. dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.3)]. teratogenic effects developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥2.5 mg/kg/day (37 times the recommended human ophthalmic dose) revealed malformations of the vertebral bodies. these malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. no treatment-related malformations were seen at 1 mg/kg/day (15 times the recommended human ophthalmic dose). teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. doses of 1,000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions. increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose, in this case without apparent maternotoxicity. there are no adequate and well-controlled studies in pregnant women. dorzolamide hydrochloride and timolol maleate ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether dorzolamide is excreted in human milk. timolol maleate has been detected in human milk following oral and ophthalmic drug administration. because of the potential for serious adverse reactions from dorzolamide hydrochloride and timolol maleate ophthalmic solution in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of dorzolamide hydrochloride ophthalmic solution and timolol maleate ophthalmic solution have been established when administered individually in pediatric patients aged 2 years and older. use of these drug products in these children is supported by evidence from adequate and well-controlled studies in children and adults. safety and efficacy in pediatric patients below the age of 2 years have not been established. no overall differences in safety or effectiveness have been observed between elderly and younger patients. dorzolamide (door-zole-ah-mide) hydrochloride and timolol (tye-moe-lawl) maleate ophthalmic solution for topical ophthalmic use read this instructions for use before you start using dorzolamide hydrochloride and timolol maleate ophthalmic solution 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. important information: please follow these instructions carefully when using dorzolamide hydrochloride and timolol maleate ophthalmic solution. use dorzolamide hydrochloride and timolol maleate ophthalmic solution as prescribed by your doctor. how to use ldpe the bottle the ldpe bottle is designed to assure the delivery of a precise dose of medication. before using your ldpe bottle, read the complete instructions carefully. 1. if you use other topically applied ophthalmic medications, they should be administered at least 5 minutes before or after dorzolamide hydrochloride and timolol maleate ophthalmic solution. 2. wash hands before each use. 3. before using the medication for the first time, be sure the safety seal on the bottle is unbroken. a gap between the bottle and the cap is normal for an unopened bottle. 4. tear off the safety seal to break the seal. 5. before each use, shake once and remove the screw cap. 6. invert the bottle and hold the bottle between your thumb and middle finger, with the tips of the fingers pointing towards you. 7. tilt your head back and position the bottle above the affected eye. 8. with the opposite hand, place a finger under the eye. gently pull down until a "v" pocket is made between your eye and lower lid. do not touch your eye or eyelid with the dropper tip. ophthalmic medications, if handled improperly, can become contaminated by common bacteria known to cause eye infections. serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. if you think your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle. 9. with the hand holding the bottle, place your index finger on the bottom of the bottle. push the bottom of the bottle to dispense one drop of medication. do not squeeze the sides of the bottle. keep your head tilted backward and close your eye to allow absorption of the medication into the eye. 10. repeat 6, 7, 8, & 9 with other eye if instructed to do so by your doctor. 11. replace screw cap by turning until firmly touching the bottle. 12. the dispenser tip is designed to provide a single drop; therefore, do not enlarge the hole of the dispenser tip. 13. after you have used all doses, there will be some dorzolamide hydrochloride and timolol maleate ophthalmic solution left in the bottle. you should not be concerned since an extra amount of dorzolamide hydrochloride and timolol maleate ophthalmic solution has been added and you will get the full amount of dorzolamide hydrochloride and timolol maleate ophthalmic solution that your doctor prescribed. do not attempt to remove the excess medicine from the bottle. this instructions for use has been approved by the u.s. food and drug administration revised: may 2021 manufactured by alcon laboratories, inc. fort worth, texas 76134 for sandoz inc. princeton, nj 08540 300048213-0521

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

bryant ranch prepack - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride tablets are indicated to: usage considerations: propafenone hydrochloride tablets are contraindicated in the following circumstances: risk summary there are no studies of propafenone hydrochloride tablets in pregnant women. available data from published case reports and several decades of postmarketing experience with use of propafenone hydrochloride tablets in pregnancy have not identified any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. untreated arrhythmias during pregnancy may pose a risk to the pregnant woman and fetus (see clinical considerations) . propafenone and its metabolite, 5-oh-propafenone, cross the placenta in humans. in animal studies, propafenone was not teratogenic. at maternally toxic doses (ranging from 2 to 6 times the maximum recommended human dose [mrhd]), there was evidence of adverse developmental outcomes when administered to pregnant rabbits and rats during organogenesis or when administered to pregnant rats during mid-gestation through weaning of their offspring (see data) . the estimated background risks of major birth defects and miscarriage for the indicated populations are 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: the incidence of vt is increased and may be more symptomatic during pregnancy. ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions: propafenone and its metabolite have been shown to cross the placenta. adverse reactions such as fetal/neonatal arrhythmias have been associated with the use of other antiarrhythmic agents by pregnant women. fetal/neonatal monitoring for signs and symptoms of arrhythmia is recommended during and after treatment of pregnant women with propafenone. labor or delivery: risk of arrhythmias may increase during labor and delivery. patients treated with propafenone hydrochloride tablets should be monitored continuously for arrhythmias during labor and delivery [see warnings and precautions (5.1)] . data propafenone has been shown to cause embryo-fetal mortality in rabbits and rats when given orally during organogenesis at maternally toxic doses of 150 mg/kg/day (rabbit: maternal mortality, decreased body weight gain and food consumption at approximately 3 times the mrhd on a mg/m2 basis) and 600 mg/kg/day (rat: maternal decreased body weight gain and food consumption at approximately 6 times the mrhd on a mg/m2 basis). in addition, a maternally toxic dose of 600 mg/kg/day (approximately 6 times the mrhd on a mg/m2 basis) also caused decreased fetal weights in rats. increased placental weights and delayed ossification occurred in rabbits at a dose of 30 mg/kg/day (less than the mrhd on a mg/m2 basis) in the absence of maternal toxicity. no adverse developmental outcomes in the absence of maternal toxicity were seen following oral doses of 15 mg/kg/day to rabbits or up to 270 mg/kg/day to rats administered during organogenesis (equivalent to 0.3 times or approximately 3 times the mrhd on a mg/m2 basis, respectively). in an oral study, female rats received propafenone up to 500 mg/kg/day from mid-gestation through weaning. at 90 mg/kg/day (equivalent to the mrhd on a mg/m2 basis), there were no adverse developmental outcomes in the absence of maternal toxicity. however, doses ≥180 mg/kg/day (2 or more times the mrhd on a mg/m2 basis) produced increases in maternal deaths and resulted in reductions in neonatal survival, body weight gain, and delayed development in the presence of maternal toxicity. risk summary propafenone and its active metabolite, 5-oh-propafenone, are present in human milk, but the levels are likely to be low. there are no data on the effects of propafenone on the breastfed infant or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for propafenone and any potential adverse effects on the breastfed infant from propafenone or from the underlying maternal condition. infertility males: based on human and animal studies, propafenone hydrochloride tablets may transiently impair spermatogenesis in males. evaluation of the effects on spermatogenesis was performed in 11 healthy males given oral propafenone 300 mg b.i.d. for 4 days, which was then increased to 300 mg t.i.d. for an additional 4 days. study findings included a 28% reduction in semen sample volume on treatment day 8 and a 27% reduction in sperm count 64 days after treatment (both values remained within the laboratories normal reference range). these effects were not seen in follow-up visits up to 120 days after treatment. reversible decreases in spermatogenesis have been demonstrated in monkeys, dogs, and rabbits after lethal or near-lethal intravenous doses of propafenone [see nonclinical toxicology (13.1)] . the safety and effectiveness of propafenone in pediatric patients have not been established. clinical trials of propafenone hydrochloride tablets did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger subjects. 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.

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

ah beard pty ltd - 12475 - mattress, bed, - a mattress designed to provide personalised ergonomic support and low to mid-range pressure relief for different body shapes and sizes. the mattress utilises a unique construction that allows the firmness to be adjusted to the user?s preference. it is designed to distribute the person?s weight more evenly across the surface of the mattress, resulting in reduced pressure, particularly in the hip and shoulder regions. the mattress conforms to the shape of the individual sleeper?s body, providing support in areas where more is required, such as the lower back and waist. this unique personalised sleep system allows for two different firmnesses to be achieved in the one mattress, allowing each sleep partner to select the optimum support and pressure relief for their individual body shape and size. the mattress assists in maintaining neutral spinal alignment during sleep, which is of particular benefit to those suffering from neck and back pain. the mattress is constructed of breathable foams and fabrics that allow for increased airflow around and through the mattress, dissipating heat and moisture for a more hygienic sleep surface. reducing heat and moisture build up inside the mattress reduces the incidence of bacteria, mould, dust mites and other allergens.

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

ah beard pty ltd - 12475 - mattress, bed, - a mattress utilising an advanced spring system designed to provide enhanced spinal support and promote postural alignment - irrespective of the sleeper?s size, weight or preferred sleep position. ah beard?s reflex support system has been endorsed by the international chiropractors association (ica) for its focus on spinal support and postural alignment. the innovative support system within the mattress combines two types of springs: primary pocket coils and smaller active coils. individually encased primary coils gently contour to the sleeper?s body shape, minimising pressure and maximising comfort. a high coil count produces a large spring surface area that more effectively distributes body weight across the sleep surface, further reducing pressure-points. additional active coils, two-thirds the height of the pocket coils, are positioned at varying intervals. they respond to increased body weight, delivering targeted support where it is needed, such as the upper and lower body or lumbar. this unique mattress provides a no-compromise solution to mattress selection. it provides support that is individual to the sleeper?s body shape and size, making it suitable for all body types. the reflex support system ensures that the spine is upheld with the amount of support required by each individual, promoting better sleeping posture and spinal alignment. improved sleeping posture can help reduce ailments caused by poor quality sleep, or lack of sleep, and conditions relating to poor posture and spinal alignment. irrespective of each sleeper?s size, weight or preferred sleep position, both receive the exact level of support their body needs.

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

ah beard pty ltd - 35183 - mattress, bed, general-purpose - the health rest range of mattresses are designed to provide ergonomic support and pressure relief for different body shapes and sizes. the mattress utilises a pressure relief system. it is designed to distribute the person's weight more evenly across the surface of the mattress, resulting in reduced pressure. the zipper cover is removable to allow the cover to be cleaned or replaced.

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

bryant medical pty -

Canada - English - Health Canada

mission product holdings inc - octinoxate; octisalate; oxybenzone - cream - 6.8%; 4.5%; 4.5% - octinoxate 6.8%; octisalate 4.5%; oxybenzone 4.5% - sunscreen agents

Singapore - English - HSA (Health Sciences Authority)

alcon pte ltd - ophthalmology - it is intended to provide illumination and/or irrigation.