Сингапур - английский - HSA (Health Sciences Authority)

philips electronics singapore pte ltd - radiology / imaging - it is intended for general imaging; for interventional radiology; for cardiology, vascular, ob/gyn, acute care, er, and regional anesthesia applications; and for analysis.

Соединенные Штаты - английский - NLM (National Library of Medicine)

blueprint medicines corporation - avapritinib (unii: 513p80b4yj) (avapritinib - unii:513p80b4yj) - ayvakit® is indicated for the treatment of adults with unresectable or metastatic gist harboring a platelet-derived growth factor receptor alpha (pdgfra) exon 18 mutation, including pdgfra d842v mutations [see dosage and administration (2.2)] . ayvakit is indicated for the treatment of adult patients with advanced systemic mastocytosis (advsm). advsm includes patients with aggressive systemic mastocytosis (asm), systemic mastocytosis with an associated hematological neoplasm (sm-ahn), and mast cell leukemia (mcl). limitations of use : ayvakit is not recommended for the treatment of patients with advsm with platelet counts of less than 50 × 109 /l [see warnings and precautions (5.1)] . ayvakit is indicated for the treatment of adult patients with indolent systemic mastocytosis (ism). limitations of use : ayvakit is not recommended for the treatment of patients with ism with platelet counts of less than 50 × 109 /l [see warnings and precautions (5.1)] . none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , ayvakit can cause fetal harm when administered to a pregnant woman. there are no available data on ayvakit use in pregnant women. oral administration of avapritinib to pregnant rats during the period of organogenesis was teratogenic and embryotoxic at exposure levels approximately 31.4, 6.3 and 2.7 times the human exposure based on auc at the 25 mg, 200 mg and 300 mg dose, respectively (see data) . advise pregnant women of the potential risk to a fetus. 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. data animal data in a reproductive toxicity study, administration of avapritinib to rats during the period of organogenesis resulted in decreased fetal body weights, post-implantation loss, and increases in visceral (hydrocephaly, septal defect, and stenosis of the pulmonary trunk) and skeletal (sternum) malformations at doses greater than or equal to 10 mg/kg/day (approximately 31.4, 6.3 and 2.7 times the human exposure based on auc at the 25 mg, 200 mg and 300 mg dose, respectively). risk summary there are no data on the presence of avapritinib or its metabolites in human milk or the effects of avapritinib on the breastfed child or milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with ayvakit and for 2 weeks following the final dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating ayvakit [see use in specific populations (8.1)] . contraception ayvakit can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)]. females advise females of reproductive potential to use effective contraception during treatment with ayvakit and for 6 weeks after the final dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with ayvakit and for 6 weeks after the final dose. infertility females based on findings from animal studies, ayvakit may impair female fertility. these findings were not reversible within a two month recovery period [see nonclinical toxicology (13.1)]. males based on findings from animal studies, ayvakit may impair male fertility. these findings were not reversible within a two month recovery period [see nonclinical toxicology (13.1)] . the safety and effectiveness of ayvakit in pediatric patients have not been established. of the 204 patients with unresectable or metastatic gist who received ayvakit in navigator, 40% were 65 years or older, while 6% were 75 years and older. of the 131 patients with advsm who received ayvakit in explorer and in pathfinder, 62% were 65 years or older, while 21% were 75 years and older. of the 141 patients with ism who received ayvakit in pioneer, 6% were 65 years or older, while <1% were 75 years and older. no overall differences in safety or efficacy were observed between these patients and younger adult patients. no dose adjustment is recommended for patients with mild or moderate renal impairment [creatinine clearance (clcr) 30 to 89 ml/min estimated by cockcroft-gault]. the recommended dose of ayvakit has not been established for patients with severe renal impairment (clcr 15 to 29 ml/min) or end-stage renal disease (clcr <15 ml/min) [see clinical pharmacology (12.3)] . no dose adjustment is recommended for patients with mild [total bilirubin ≤ upper limit of normal (uln) and aspartate aminotransferase (ast) > uln or total bilirubin > 1 to 1.5 times uln and any ast], or moderate [total bilirubin >1.5 to 3 times uln and any ast] hepatic impairment. unbound auc0-inf was 61% higher in subjects with severe hepatic impairment (child-pugh class c) as compared to matched healthy subjects with normal hepatic function. a lower starting dose is recommended in patients with severe hepatic impairment [see dosage and administration (2.7)] .

Австралия - английский - Department of Health (Therapeutic Goods Administration)

femcare australia pty ltd - 46102 - irrigation tubing set, general purpose - the pathfinder plus bulb irrigator is intended for use in endoscopic procedures to provide continuous and bolus irrigant delivery.

Сингапур - английский - HSA (Health Sciences Authority)

ehc commercial singapore pte. ltd. - dental - a device that is intended for smoothing, filing or cutting during dental procedure and typically have various forms of fine-ridged cutting surfaces along part or all of their working length. this device may be use to remove gross supragingival calculus, smooth the cementoenamel junction (cej), finish the margins of the teeth or other dental restorations or enlarge the root canal.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

medical specialties australasia pty ltd - 10688 - catheter, angiography - the catheter is introduced percutaneously into the vasculature and is used to deliver contrast media for the purpose of diagnostic angiography. angiographic catheters are for use where angiographic diagnosis is indicated.

Сингапур - английский - HSA (Health Sciences Authority)

smith & nephew pte. limited - orthopaedics - the q-fix soft suture anchor system is intended to be used for soft tissue to bone fixation for: shoulder: bankart lesion repair; slap lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff repair; biceps tenodesis. foot & ankle: medial/lateral repair & reconstruction; midfoot and forefoot repair; hallux valgus reconstruction; metatarsal ligament/tendon repair/reconstruction; achilles tendon repair. elbow: ulnar/radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment. knee: extra-capsular repair: medial collateral ligament (mcl), lateral collateral ligament (lcl) & posterior oblique ligament; iliotibial band tenodesis (ibt); patellar tendon repair; vastus medialis obliquus advancement (vmo); joint capsule closure. hip: acetabular labral repair.

Сингапур - английский - HSA (Health Sciences Authority)

carl zeiss pte. ltd. - ophthalmology - the zeiss atlas corneal topography system, model 9000 is intended to measure and analyze the corneal curvature of the eye. it is an automated ac-powered videokeratoscope indicated for measuring corneal topography and assisting in corneal evaluation, corneal refractive surgery screening and post-operative monitoring, corneal pathology screening and monitoring, and contact lens selection and fitting.

Сингапур - английский - HSA (Health Sciences Authority)

spacelabs healthcare pte. ltd. - cardiovascular - the evo holter recorder is to be used for the non-invasive ambulatory recording of three channel electrocardiograms on an internal, non removable flash memory. patient ecg data from the recorders (both lifecard and evo) need to be analyzed with spacelabs healthcare holter analyzers.

Сингапур - английский - HSA (Health Sciences Authority)

spacelabs healthcare pte. ltd. - cardiovascular - the lifecard cf digital holter is to be used for the non-invasive ambulatory recording of 2 or 3 channel electrocardiograms on a standard commercial compact flash card. patient ecg data from the recorders (both lifecard and evo) need to be analyzed with spacelabs healthcare holter analyzers.

Сингапур - английский - HSA (Health Sciences Authority)

smith & nephew pte. limited - orthopaedics - the speedlock knotless fixation device is an implant that facilitates the attachment of tissue to bone. the speedlock system consists of a fixation device pre-loaded with a suture snare in an inserter handle. the speedlock implant is a knotless fixation device, in other words surgical knots are not necessary for fixation of suture to tissue. the speedlock knotless fixation device is indicated for use in the fixation of soft tissue to bone. examples of procedures include: shoulder: bankart repair, slap lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair; ankle: lateral instability, medial instability, achilles tendon repair/reconstruction, and midfoot reconstruction; foot: hallux valgus reconstruction; elbow: tennis elbow repair, biceps tendon reattachment; knee: extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; capsular reconst, itb tenodesis; patellar ligament and tendon avulsions