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

teleflex medical australia pty ltd - 38369 - protection equipment, radiation, shielding material, ionizing - to reduce and protect medical personnel against scatter radiation.

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

add-tech pty ltd - 30881 - protection equipment, light therapy, eyewear - a polycarbonate protective eye wear intended to be worn over the eyes to protect users eyes from blood and fluid splashes.

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

yatsal distributors pty ltd - 42047 - protection equipment, - a device intended to support or protect part of the body (palm, elbow, knee) from undesired adverse event effect.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ensystex australasia pty ltd - bifenthrin - granular formulation - bifenthrin pyrethroid active 2.0 g/kg - insecticide - buildings - around | domestic building/structure - external a | turf | chemical soil barrier | chemical soil treatment zones | c - african black beetle | ant | argentine stem weevil | coastal brown ant | flea - ctenocephalides spp. | flea - larvae (ctenocephalides spp.) | funnel ant | lawn armyworm | meat ant | sod webworm | stinging ant | sugar ant | tick | argentine ant | banded sugar ant | grass caterpillar | grass grub | lawn caterpillar | madeira ant | pharaoh ant

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - meningococcal oligosaccharide - group c 10ug (conjugated with 5 mcg diphtheria crm 197 protein);   - suspension for injection - 0.5 ml - active: meningococcal oligosaccharide - group c 10ug (conjugated with 5 mcg diphtheria crm 197 protein)   excipient: aluminium phosphate sodium chloride water for injection - active immunisation of children from 6 weeks of age, adolescents and adults for the prevention of invasive disease caused by neisseria meningitidis serogroup c.

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

glaxosmithkline australia pty ltd - podophyllotoxin -

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ensystex australasia pty ltd - imiprothrin; cypermethrin - aerosol - imiprothrin ungrouped active 1.4 g/kg; cypermethrin pyrethroid active 2.0 g/kg - household insecticide - carpet | domestic pest control | entrances | indoor hidden areas | infested area - general | pest control - carpet, woollen good - ant | bed bug | carpet beetle | clothes moth | cockroach | crawling insect | flea | millipede | silverfish | spider | ants | argentine ant | bedbug | cockroachs | ctenocephalides spp. | fleas | ground fleas | large cockroach | niditinea spp. | pharaoh ant | silverfish | small cockroach | tinea spp. | tineola spp.

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

daiichi sankyo inc. - trastuzumab deruxtecan (unii: 5384hk7574) (trastuzumab deruxtecan - unii:5384hk7574) - enhertu is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received a prior anti-her2-based regimen either: - in the metastatic setting, or - in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. enhertu is indicated for the treatment of adult patients with unresectable or metastatic her2-low (ihc 1+ or ihc 2+/ish-) breast cancer, as determined by an fda-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy [see dosage and administration (2.1)] . enhertu is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (nsclc) whose tumors have activating her2 (erbb2) mutations, as detected by an fda-approved test, and who have received a prior systemic therapy. this indication is approved under accelerated approval based on objective response rate and duration of response [see clinical studies (14.3)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. enhertu is indicated for the treatment of adult patients with locally advanced or metastatic her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen. none. risk summary based on its mechanism of action, enhertu can cause fetal harm when administered to a pregnant woman. there are no available data on the use of enhertu in pregnant women. in postmarketing reports, use of a her2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death (see data ). based on its mechanism of action, the topoisomerase inhibitor component of enhertu, dxd, can also cause embryo-fetal harm when administered to a pregnant woman because it is genotoxic and targets actively dividing cells [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] . advise patients of the potential risks to a fetus. there are clinical considerations if enhertu is used in pregnant women, or if a patient becomes pregnant within 7 months after the last dose of enhertu (see clinical considerations ). 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 fetal/neonatal adverse reactions monitor women who received enhertu during pregnancy or within 7 months prior to conception for oligohydramnios. if oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care. data human data there are no available data on the use of enhertu in pregnant women. in postmarketing reports in pregnant women receiving a her2-directed antibody, cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported. these case reports described oligohydramnios in pregnant women who received a her2-directed antibody either alone or in combination with chemotherapy. in some case reports, amniotic fluid index increased after use of a her2-directed antibody was stopped. animal data there were no animal reproductive or developmental toxicity studies conducted with fam-trastuzumab deruxtecan-nxki. risk summary there is no data regarding the presence of fam-trastuzumab deruxtecan-nxki in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with enhertu and for 7 months after the last dose. pregnancy testing verify pregnancy status of females of reproductive potential prior to initiation of enhertu. contraception females enhertu can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with enhertu and for 7 months after the last dose. males because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with enhertu and for 4 months after the last dose [see nonclinical toxicology (13.1)] . infertility based on findings in animal toxicity studies, enhertu may impair male reproductive function and fertility [see nonclinical toxicology (13.1)] . safety and effectiveness of enhertu have not been established in pediatric patients. of the 1287 patients with breast cancer treated with enhertu 5.4 mg/kg, 22% were 65 years or older and 3.8% were 75 years or older. no overall differences in efficacy within clinical studies were observed between patients ≥65 years of age compared to younger patients. there was a higher incidence of grade 3-4 adverse reactions observed in patients aged 65 years or older (59%) as compared to younger patients (49%)., of the 101 patients with unresectable or metastatic her2-mutant nsclc treated with enhertu 5.4 mg/kg, 40% were 65 years or older and 8% were 75 years or older. no overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. of the 125 patients with locally advanced or metastatic her2-positive gastric or gej adenocarcinoma treated with enhertu 6.4 mg/kg in destiny-gastric01, 56% were 65 years or older and 14% were 75 years or older. no overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. no dose adjustment of enhertu is required in patients with mild (creatinine clearance [clcr] ≥60 and <90 ml/min) or moderate (clcr ≥30 and <60 ml/min) renal impairment [see clinical pharmacology (12.3)] . a higher incidence of grade 1 and 2 ild/pneumonitis has been observed in patients with moderate renal impairment [see warnings and precautions (5.1)]. monitor patients with moderate renal impairment more frequently. the recommended dosage of enhertu has not been established for patients with severe renal impairment (clcr <30 ml/min) [see clinical pharmacology (12.3)]. no dose adjustment of enhertu is required in patients with mild (total bilirubin ≤uln and any 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. in patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor, dxd [see dosage and administration (2.3)]. the recommended dosage of enhertu has not been established for patients with severe hepatic impairment (total bilirubin >3 times uln and any ast) [see clinical pharmacology (12.3)].

Singapore - English - HSA (Health Sciences Authority)

starkey hearing technologies singapore pte ltd - ear, nose & throat - an air conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing. hearing aids are available in multiple gain/output levels appropriate to treat hearing losses ranging from mild to profound. the multiflex tinnitus technology is a tool to generate sounds to be used in a tinnitus management program to relieve patients suffering from tinnitus. the target population is primarily the adult population over 18 years of age.

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

precise medical supplies pty ltd - 36309 - protection equipment, laser beam, shield, eye, patient - protective eye shield for patient during laser procedures