シンガポール - 英語 - HSA (Health Sciences Authority)

transmedic pte ltd - orthopaedics - indicated for skeletally mature patients with degenerative disc disease (ddd) or for painful segmental degeneration of the disc and/or facet joints. semi-rigid stabilization use of the rod coupler is indicated for segmental degeneration or minor segmental instability (disc and/or facet joints) including grade 1 spondylolisthesis. fusion use of the fusion components are indicated for monosegmental or multisegemental stabilization of the thoracic and lumbar spine for supporting fusion. fusion may be necessary due to: • degenerative instability • pseudarthrosis / delayed union • post-discectomy syndrome • spondylolisthesis • degenerative lumbar scoliosis • lumbar spinal canal stenosis • fracture • tumor • long idiopathic or congenital deformities

フィリピン - 英語 - FDA (Food And Drug Administration)

for: paradigm pharma (thailand) co., ltd.; importer: pacific healthcare philippines, inc.; distributor: pacific healthcare philippines, inc. - plantago ovata forssk. (ispaghula husk) - powder for oral suspension (orange flavor) - 3.4 g/11 g

フィリピン - 英語 - FDA (Food And Drug Administration)

for: paradigm pharma (thailand) co., ltd.; importer: pacific healthcare philippines, inc.; distributor: pacific healthcare philippines, inc. - ranitidine (as hydrochloride) - film-coated tablet - 150mg

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

almatica pharma inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 450 mg - forfivo xl (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with mdd. the efficacy of the sustained-release formulation of bupropion in the maintenance treatment of mdd was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see clinical studies (14)] . the physician who elects to use forfivo xl for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. 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 data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall (see data) . there are risks to the mother associated with untreated depression (see clinical considerations) . when bupropion was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 10 times the maximum recommended human dose (mrhd) of 450 mg/day. when given to pregnant rabbits during organogenesis, non-dose-related increases in incidence of fetal malformations and skeletal variations were observed at doses approximately equal to the mrhd and greater. decreased fetal weights were seen at doses twice the mrhd and greater (see data) . the estimated background risk for major birth defects and miscarriage are unknown for the indicated population. all pregnancies have a background rate 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 a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. the women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. data human data data from the international bupropion pregnancy registry (675 first-trimester exposures) and a retrospective cohort study using the united healthcare database (1,213 first-trimester exposures) did not show an increased risk for malformations overall. the registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations. no increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. the prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international pregnancy registry was 1.3% (9 cardiovascular malformations/675 first-trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%). data from the united healthcare database, which has a limited number of exposed cases with cardiovascular malformations, and a case-controlled study (6,853 infants with cardiovascular malformations and 5,753 with non-cardiovascular malformations) from the national birth defects prevention study (nbdps) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester. study findings on bupropion exposure during the first trimester and risk for left ventricular outflow tract obstruction (lvoto) are inconsistent and do not allow conclusions regarding possible association. the united healthcare database lacked sufficient power to evaluate this association; the nbdps found increased risk for lvoto (n = 10; adjusted odds ratio (or) = 2.6; 95% ci: 1.2, 5.7) and the slone epidemiology case-control study did not find increased risk for lvoto. study findings on bupropion exposure during the first trimester and risk for ventricular septal defect (vsd) are inconsistent and do not allow conclusions regarding a possible drug association. the slone epidemiology study found an increased risk for vsd following first trimester maternal bupropion exposure (n = 17; adjusted or = 2.5; 95% ci: 1.3, 5.0) but did not find an increased risk for any other cardiovascular malformations studied (including lvoto as above). the nbdps and united healthcare database study did not find an association between first trimester maternal bupropion exposure and vsd. for the findings of lvoto and vsd, the studies were limited by the small number of exposed cases, inconsistent findings among studies, and the potential for chance findings from multiple comparisons in case-control studies. animal data in studies conducted in pregnant rats and rabbits, bupropion was administered orally during the period of organogenesis at doses of up to 450 and 150 mg/kg/day, respectively (approximately 10 and 6 times the mrhd, respectively, on a mg/m2 basis). there was no evidence of fetal malformations in rats. when given to pregnant rabbits, during organogenesis, non-dose-related increases in incidence of fetal malformations and skeletal variations were observed at the lowest dose tested (25 mg/kg/day, approximately equal to the mrhd on a mg/m2 basis) and greater. decreased fetal weights were observed at doses of 50 mg/kg/day (approximately 2 times the mrhd on a mg/m2 basis) and greater. no maternal toxicity was evident at doses of 50 mg/kg/day or less. in a pre- and postnatal development study, bupropion administered orally to pregnant rats at doses of up to 150 mg/kg/day (approximately 3 times the mrhd on a mg/m2 basis) from embryonic implantation through lactation had no effect on pup growth or development. risk summary data from published literature report the presence of bupropion and its metabolites in human milk (see data) . there are no data on the effects of bupropion or its metabolites on milk production. limited data from postmarketing reports have not identified a clear association of adverse reactions in the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for forfivo xl and any potential adverse effects on the breastfed child from forfivo xl or from the underlying maternal condition. data in a lactation study of ten women, levels of orally dosed bupropion and its active metabolites were measured in expressed milk. the average daily infant exposure (assuming 150 ml/kg daily consumption) to bupropion and its active metabolites was 2% of the maternal weight-adjusted dose. postmarketing reports have described seizures in breastfed infants. the relationship of bupropion exposure and these seizures is unclear. safety and effectiveness in the pediatric population have not been established. when considering the use of forfivo xl in a child or adolescent, balance the potential risks with the clinical need [see boxed warning, and warnings and precautions (5.1)] . of the approximately 6000 patients who participated in clinical trials with bupropion hydrochloride sustained-release tablets (depression and smoking cessation studies), 275 were ≥ 65 years of age and 47 were ≥ 75 years of age. in addition, several hundred patients ≥ 65 years of age participated in clinical trials using the immediate-release formulation of bupropion hydrochloride (depression studies). no overall differences in safety or effectiveness were observed between these subjects and younger subjects. reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. bupropion is extensively metabolized in the liver to active metabolites, which are further metabolized and excreted by the kidneys. the risk of adverse reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, it may be necessary to consider this factor in dose selection; it may be useful to monitor renal function [see dosage and administration (2.6), use in specific populations (8.6), and clinical pharmacology (12.3)] . because there is no lower strength for forfivo xl, forfivo xl is not recommended in patients with renal impairment [see clinical pharmacology (12.3)] . because there is no lower strength for forfivo xl, forfivo xl is not recommended in patients with hepatic impairment [see clinical pharmacology (12.3)] . bupropion is not a controlled substance. humans controlled clinical studies of bupropion hydrochloride (immediate-release formulation) conducted in normal volunteers, in subjects with a history of multiple drug abuse, and in depressed patients demonstrated an increase in motor activity and agitation/excitement. in a population of individuals experienced with drugs of abuse, a single dose of 400 mg of bupropion hydrochloride produced mild amphetamine-like activity as compared to placebo on the morphine-benzedrine subscale of the addiction research center inventories (arci), and a score intermediate between placebo and amphetamine on the liking scale of the arci. these scales measure general feelings of euphoria and drug desirability. findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs. nonetheless, evidence from single-dose studies does suggest that the recommended daily dosage of bupropion when administered in divided doses is not likely to be significantly reinforcing to amphetamine or cns-stimulant abusers. however, higher doses (that could not be tested because of the risk of seizure) might be modestly attractive to those who abuse cns-stimulant drugs. bupropion hydrochloride extended-release tablets are intended for oral use only. the inhalation of crushed tablets or injection of dissolved bupropion has been reported. seizures and/or cases of death have been reported when bupropion has been administered intranasally or by parenteral injection. animals studies in rodents and primates demonstrated that bupropion exhibits some pharmacologic actions common to psychostimulants. in rodents, it has been shown to increase locomotor activity, elicit a mild stereotyped behavioral response, and increase rates of responding in several schedule-controlled behavior paradigms. in primate models assessing the positive reinforcing effects of psychoactive drugs, bupropion was self-administered intravenously. in rats, bupropion produced amphetamine-like and cocaine-like discriminative stimulus effects in drug discrimination paradigms used to characterize the subjective effects of psychoactive drugs.

シンガポール - 英語 - HSA (Health Sciences Authority)

medtronic international, ltd. - general hospital - the paradigm infusion pump is an ambulatory, battery operated, rate-programmable microdiffusion pump. indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

シンガポール - 英語 - HSA (Health Sciences Authority)

medtronic international, ltd. - general hospital - the paradigm quick-set infusion sets are indicated for the subcutaneous infusion of medication, including insulin, from a medtronic minimed paradigm infusion pump and reservoir.

シンガポール - 英語 - HSA (Health Sciences Authority)

medtronic international, ltd. - general hospital - the paradigm silhouette infusion sets are indicated for the subcutaneous infusion of medication, including insulin, from a medtronic minimed paradigm infusion pump and reservoir.

シンガポール - 英語 - HSA (Health Sciences Authority)

medtronic international, ltd. - general hospital - it is indicated for the continuous delievery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. in addition, the pump system is indicated for continuous periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes. the pump displays real-time glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. pump history can be downloaded to a computer for analysis of historical glucose values. the real-time glucose values provided by the paradigm 522/722 pump systems are not intended to be used directly for making therapy adjustments. rather, they provide an indication that a confirmation fingerstick measurement may be required. all therapy adjustments should be based on measurements obtained using a home glucose monitor and not based on the value displayed by the pump.

シンガポール - 英語 - HSA (Health Sciences Authority)

medtronic international, ltd. - general hospital - is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. in addition, the pump system is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes. the pump displays continuous glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. pump history can be downloaded to a computer for analysis of historical glucose values. the continuous glucose values displayed by the paradigm veo pump systems are not intended to be used directly for making therapy adjustments. rather, they provide an indication that a confirmation fingerstick measurement may be required. all therapy adjustments should be based on measurements obtained using a home glucose monitor and not based on the value displayed by the pump.

トルコ - 英語 - Ecolab

ecolab deutschland gmbh -