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

bristol-myers squibb australia pty ltd - hydroxyurea -

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - testosterone undecylate 1000mg;   - solution for injection - 1000 mg/4ml - active: testosterone undecylate 1000mg   excipient: benzyl benzoate castor oil - testosterone replacement in primary and secondary male hypogonadism

European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - docetaxel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - antineoplastic agents - treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - ibandronic acid - breast neoplasms; neoplasm metastasis; fractures, bone; osteoporosis, postmenopausal - drugs for treatment of bone diseases - ibandronic acid 50mgibandronic acid teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.ibandronic acid 150mgtreatment of osteoporosis in postmenopausal women at increased risk of fracture. a reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

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

bayer australia ltd - testosterone undecanoate -

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

e.r. squibb & sons, l.l.c. - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydroxyurea 500 mg - hydrea is indicated for the treatment of: hydrea is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. hydrea can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology (12.1) ] . there are no data with hydrea use in pregnant women to inform a drug-associated risk. in animal reproduction studies, administration of hydroxyurea to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m2 basis (see data) . advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with hydrea. 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. hydroxyurea has been demonstrated to be a potent

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

h2-pharma llc - hydroxyurea (unii: x6q56qn5qc) (hydroxyurea - unii:x6q56qn5qc) - hydrea is indicated for the treatment of: hydrea is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. hydrea can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology (12.1) ] . there are no data with hydrea use in pregnant women to inform a drug-associated risk. in animal reproduction studies, administration of hydroxyurea to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m2 basis (see data) . advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with hydrea. 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. hydroxyurea has been demonstrated to be a potent teratogen in a wide variety of animal models, including mice, hamsters, cats, miniature swine, dogs, and monkeys at doses within 1-fold of the human dose given on a mg/m2 basis. hydroxyurea is embryotoxic and causes fetal malformations (partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae) at 180 mg/kg/day (about 0.8 times the maximum recommended human daily dose on a mg/m2 basis) in rats and at 30 mg/kg/day (about 0.3 times the maximum recommended human daily dose on a mg/m2 basis) in rabbits. embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays. hydroxyurea crosses the placenta. single doses of ≥375 mg/kg (about 1.7 times the maximum recommended human daily dose on a mg/m2 basis) to rats caused growth retardation and impaired learning ability. hydroxyurea is excreted in human milk. because of the potential for serious adverse reactions in a breastfed infant from hydroxyurea, including carcinogenicity, discontinue breastfeeding during treatment with hydrea. verify the pregnancy status of females of reproductive potential prior to initiating hydrea therapy. hydrea 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 and after treatment with hydrea for at least 6 months after therapy. advise females to immediately report pregnancy. hydrea may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. males with female sexual partners of reproductive potential should use effective contraception during and after treatment with hydrea for at least 1 year after therapy [see nonclinical toxicology (13.1)] . based on findings in animals and humans, male fertility may be compromised by treatment with hydrea. azoospermia or oligospermia, sometimes reversible, has been observed in men. inform male patients about the possibility of sperm conservation before the start of therapy [see adverse reactions (6) and nonclinical toxicology (13.1)] . safety and effectiveness in pediatric patients have not been established. elderly patients may be more sensitive to the effects of hydroxyurea and may require a lower dose regimen. hydroxyurea is excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration (2.3)] . the exposure to hydroxyurea is higher in patients with creatinine clearance of less than 60 ml/min or in patients with end-stage renal disease (esrd). reduce dosage and closely monitor the hematologic parameters when hydrea is to be administered to these patients [see dosage and administration (2.3) and clinical pharmacology (12.3)] . there are no data that support specific guidance for dosage adjustment in patients with hepatic impairment. close monitoring of hematologic parameters is advised in these patients.

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

drewson international pty ltd t/a briggate medical company - 16437 - chair, examination/treatment, - podiatry patient's chair which enables the podiatrist to place the patient into the relevant position for examination/treatment.

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

drewson international pty ltd t/a briggate medical company - 16437 - chair, examination/treatment, - podiatry patients chair which enables the podiatrist to place the patient into the relevant position for examination/treatment.

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

nutrien ag solutions limited - tebuconazole; triflumuron - suspension concentrates for seed treatment (fs) - tebuconazole triazole active 25.0 g/l; triflumuron uron active 4.0 g/l - mixed function seed treat - barley | oats | wheat - bunt | covered smut (bunt) - tilletia spp. | flag smut on cereal | granary weevil | lesser grain borer | loose smut - u. segetum var. avenae | rice weevil | rust-red flour beetle | sawtoothed grain beetle | bunt | common bunt | grain borer | seedborne flag smut | soilborne flag smut | trilletia tritici