США - англійська - NLM (National Library of Medicine)

spectrum pharmaceuticals, inc. - ibritumomab tiuxetan (unii: 4q52c550xk) (ibritumomab tiuxetan - unii:4q52c550xk) - ibritumomab tiuxetan 1.6 mg in 1 ml - zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular b-cell non-hodgkin's lymphoma (nhl). zevalin is indicated for the treatment of previously untreated follicular nhl in adult patients who achieve a partial or complete response to first-line chemotherapy. none. risk summary based on its radioactivity, y-90 zevalin may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . immunoglobulins are known to cross the placenta. there are no available data on zevalin use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. advise women of childbearing potential to use adequate contraception for a minimum of twelve months. inform women who become pregnant while receiving zevalin of the potential fetal risks. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other

США - англійська - NLM (National Library of Medicine)

acrotech biopharma inc - ibritumomab tiuxetan (unii: 4q52c550xk) (ibritumomab tiuxetan - unii:4q52c550xk) - zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular b-cell non-hodgkin's lymphoma (nhl). zevalin is indicated for the treatment of previously untreated follicular nhl in adult patients who achieve a partial or complete response to first-line chemotherapy. none. risk summary based on its radioactivity, y-90 zevalin may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]  . immunoglobulins are known to cross the placenta. there are no available data on zevalin use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. advise women of childbearing potential to use adequate contraception for a minimum of twelve months. inform women who become pregnant while receiving zevalin of the potential fetal risks. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other

Австралія - англійська - APVMA (Australian Pesticides and Veterinary Medicines Authority)

apvma permit - ethylene(98%) - unspecified class

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

innovative medical technologies pty ltd - 36169 - laser, erbium:yag - this is a laser used in surgical procedures that uses erbium/yttrium-aluminum garnet (yag) as the substrate.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

endotherapeutics pty ltd - 36170 - surgical ho:yag laser system - a laser used in surgical procedures with holmium/yttrium-aluminium-garnet as the substrate.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

meditron pty ltd - 35940 - laser, nd:yag - a laser used in surgical procedures using a crystal comprising neodymium and yttrium-aluminium-garnet as the substrate.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 61710 - manual-afterloading brachytherapy system storage container - for use in the administration of therasphere yttrium-90 glass microspheres only. the reusable administration accessory kit ensures optimal layout of the administration set and dose vial to facilitate monitoring of the infusion process and provides beta radiation shielding.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd - 61711 - manual-afterloading brachytherapy system source delivery procedure kit - for use in the administration of therasphere yttrium-90 glass microspheres only. the administration set consists of a sterile disposable tubing set and one empty sterile vial. the pre-assembled tubing set contains a needle plunger assembly and an integrated 20 cc syringe. the administration set is designed to efficiently transfer the microspheres from the dose vial to the patient catheter.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

innovative medical technologies pty ltd - 47884 - surgical/dermatological er:yag laser system - a mains electricity (ac-powered) light amplification by stimulated emission of radiation (laser) device assembly in which input energy is used to excite a rod of yttrium-aluminium-garnet (yag) crystal doped with erbium (er) as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (em) radiation. the lasers's high-water affinity and high-fluency pulses produce a narrow zone of damage around the tissue vaporization crater. it includes a light source, delivery/positioning device(s), and controls/foot-switch and is intended to incise, excise, vaporise, ablate, and coagulate both soft or cartilaginous as well as hard osseous and dental tissue in a range of medical specialties including: dermatology, plastic surgery (including aesthetic surgery), otorhinolaryngology, dental and maxillofacial surgery, podiatry and gynaecology. treatments include scar revision, epidermal benign disorder, pigmented lesions, skin laxity (tightening), wrinkles (skin resurfacing) seborrhoea keratosis, nevi and xanthelasmas, conservative dentistry and implant procedures, endodontic and periodontal surgery, obstructive sleep apnoea, removal of warts and hpv lesions, stress urinary incontinence and vaginal relaxation syndrome.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

gritter dental australia pty ltd - 47880 - dental solid-state laser system - these lasers are all-tissue dental devices which utilize an erbium, chromium: yttrium, scandium, gallium garnet (er,cr:ysgg) solid-state laser energy and water atomization technology to cut, shave, contour, roughen, etch and reset oral hard tissues and direct laser energy to perform oral soft tissue incision, excision, ablation and coagulation.