European Union - English - EMA (European Medicines Agency)

eli lilly nederland b.v. - necitumumab - carcinoma, non-small-cell lung - antineoplastic agents - portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (egfr) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.

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

eli lilly and company - necitumumab (unii: 2bt4c47rui) (necitumumab - unii:2bt4c47rui) - necitumumab 16 mg in 1 ml - portrazza™ is indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. portrazza is not indicated for treatment of non-squamous non-small cell lung cancer [see warnings and precautions (5.6) and clinical studies (14.2)] . none risk summary based on animal data and its mechanism of action, portrazza can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. disruption or depletion of egfr in animal models results in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development. the absence of egfr signaling has resulted in embryolethality as well as post-natal death in animals (see data) . no animal reproduction studies have been conducted with necitumumab. there are no available data for portrazza exposure in pregnant women. advise pregnant women of the potential risk to a fetus, and the risk to postnatal development. 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 no animal studies have been conducted to evaluate the effect of necitumumab on reproduction and fetal development; however, based on its mechanism of action, portrazza can cause fetal harm or developmental anomalies. in mice, egfr is critically important in reproductive and developmental processes including blastocyst implantation, placental development, and embryo-fetal/postnatal survival and development. reduction or elimination of embryo-fetal or maternal egfr signaling can prevent implantation, can cause embryo-fetal loss during various stages of gestation (through effects on placental development) and can cause developmental anomalies and early death in surviving fetuses. adverse developmental outcomes were observed in multiple organs in embryos/neonates of mice with disrupted egfr signaling. human igg1 is known to cross the placenta; therefore, necitumumab has the potential to be transmitted from the mother to the developing fetus. in monkeys, administration of a chimeric anti-egfr antibody that binds to an epitope overlapping that of necitumumab during the period of organogenesis resulted in detectable exposure of the antibody in the amniotic fluid and in the serum of embryos from treated dams. while no fetal malformations or other clear teratogenic effects occurred in offspring, there was an increased incidence of embryolethality and abortions. risk summary there is no information regarding the presence of necitumumab in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions in breastfed infants from portrazza, advise a nursing woman not to breastfeed during treatment with portrazza and for three months following the final dose. contraception females based on its mechanism of action, portrazza 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 portrazza and for three months following the final dose. the safety and effectiveness of portrazza have not been established in pediatric patients. of the 545 patients in the portrazza plus gemcitabine and cisplatin arm in study 1, 213 (39%) were 65 years and over, while 108 (20%) were 70 years and over. in an exploratory subgroup analysis of study 1, the hazard ratio for overall survival in patients 70 years or older was 1.03 (95% ci: 0.75, 1.42). of the adverse reactions listed in table 1 [see adverse reactions (6.1)] , there was a higher incidence (≥3%) of venous thromboembolic events including pulmonary embolism in patients age 70 and over compared to those who were younger than age 70. no formal studies have been conducted to evaluate the effect of renal impairment on the exposure to necitumumab. renal function has no influence on the exposure to necitumumab based on the population pharmacokinetic analysis of data from clinical trials [see clinical pharmacology (12.3)] . no formal studies have been conducted to evaluate the effect of hepatic impairment on the exposure to necitumumab. mild or moderate hepatic impairment has no influence on the exposure to necitumumab based on the population pharmacokinetic analysis. no patients with severe hepatic impairment were enrolled in the clinical trials with portrazza [see clinical pharmacology (12.3)] .

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

therapist support laboratory pty ltd - 41029 - orthosis, spinal, lumbosacral, corset, hernia/ptosis support - a garment made of elastic material designed to control and support the abdomen for hernias

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

tmig inc. - fenamiphos (unii: h4no3l2hbe) (pyridoxine - unii:kv2jz1bi6z), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204), selenium (unii: h6241uj22b) (selenium - unii:h6241uj22b), chromium (unii: 0r0008q3jb) (chromium - unii:0r0008q3jb), zinc sulfate (unii: 89ds0h96tb) (zinc cation - unii:13s1s8sf37) - fenamiphos 100 mg - t-support max is indicated for the clinical dietary management of the individuals with thyroid conditions. hyperthyroidism hyperthyroidism the name given to overproduction of thyrozine, causes extreme nervousness and irritability, increased heart rate and blood pressure, and weight loss. underproduction of thyrozine, or hypothyroidism, results in dry skin, brittle nails, and a lack of energy in adults. goiter, which is actually an enlarged thyroid, is a sign of thyroid insufficiency. in infants, hypothyroidism can be devastating, inhibiting physical development and causing irreversible mental retardation. hypothyroidism hypothyroidism is a condition in which the thyroid gland fails to function adequately, resulting in reduced levels of thyroid hormone in the body. cretinism is a type of hypothyroidism that occurs at birth and results in stunted physical growth and mental development. severe hypothyroidism is called myxedema. interactions with drugs before using this product, tell your doctor or pharmacist

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: gelatin; iron oxide black; polysorbate 20; purified water; ethyl lactate; sorbitan oleate; titanium dioxide; peg-40 hydrogenated castor oil; glycerol; tricaprin; lecithin - ciclosporin is indicated: ? as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. ? for induction and/or maintenance of remission in the nephrotic syndrome. ciclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see section 4.4 special warnings and precautions for use). ? for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. ? in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patien

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 50 mg - capsule, soft - excipient ingredients: gelatin; titanium dioxide; tricaprin; sorbitan oleate; lecithin; purified water; ethyl lactate; polysorbate 20; iron oxide black; peg-40 hydrogenated castor oil; glycerol - ciclosporin is indicated: ? as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. ? for induction and/or maintenance of remission in the nephrotic syndrome. ciclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see section 4.4 special warnings and precautions for use). ? for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. ? in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patien

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 100 mg - capsule, soft - excipient ingredients: gelatin; iron oxide black; ethyl lactate; lecithin; polysorbate 20; glycerol; sorbitan oleate; purified water; tricaprin; peg-40 hydrogenated castor oil; titanium dioxide - ciclosporin is indicated: ? as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. ? for induction and/or maintenance of remission in the nephrotic syndrome. ciclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see section 4.4 special warnings and precautions for use). ? for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. ? in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patien

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

etac anz pty ltd - 45052 - transport wheelchair, collapsible - transport wheelchair attendant driven collapsible

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

ferring pharmaceuticals pty ltd - ornipressin, quantity: 5 iu/ml - injection, solution - excipient ingredients: sodium acetate; glacial acetic acid; sodium chloride; water for injections - local administration: to induce ischaemia and haemostasis at the site of an operation in various types of surgery where bleeding is a problem plastic surgery: hair transplants, meloplasty, otoplasty, skin grafts, resection of tumours etc obstetrics/gynaecology: vaginal repair, vaginal hysterectomy, cone biopsy of cervix, episiotomy, myomectomy. ent surgery: tonsillectomy, submucous resection of septum, myringoplasty etc. other types of surgery: neurosurgery, orofacial surgery, surgery of head and neck, abdominal and rectal surgery, care of burns (excision of eschar).

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

hurst & co pty ltd - 62773 - general specimen collection kit ivd, transport medium - transport swabs are intended for the collection of biological samples for subsequent microbiological analysis