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

medtronic australasia pty ltd - 31266 - spirometer, incentive - the incentive spirometer is intended to be used by patients following thoracic surgery or in other conditions to assist the lungs in returning to normal functioning. graduations are for self-motivation of patients and not for diagnostic use. the device is supplied nonsterile.

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table ii lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization and the iud, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. na - not available combination oral contraceptives should not be used in women with any of the following conditions: thrombophlebitis or thromboembolic disorders. a past history of deep-vein thrombophlebitis or thromboembolic disorders. cerebral-vascular or coronary-artery disease. thrombogenic valvulopathies. thrombogenic rhythm disorders. diabetes with vascular involvement. uncontrolled hypertension. known or suspected carcinoma of the breast. carcinoma of the endometrium or other known or suspecte

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

lupin limited - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table ii lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization and the iud, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. na - not available combination oral contraceptives should not be used in women with any of the following conditions: thrombophlebitis or thromboembolic disorders. a past history of deep-vein thrombophlebitis or thromboembolic disorders. cerebral-vascular or coronary-artery disease. thrombogenic valvulopathies. thrombogenic rhythm disorders. diabetes with vascular involvement. uncontrolled hypertension. known or suspected carcinoma of the breast. carcinoma of the endometrium or other known or suspecte

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

medtronic australasia pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the model 97745 controller is a nonsterile, hand held, battery-operated, external device designed for patient use. the controller will be used to allow patients to turn stimulation on/off, modify the parameters of the intellis internal neurostimulator system (ins), check device status and recharge the ins. model 97745 controller is designed to program the rechargeable and non-rechargeable neurostimulators.

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

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table i lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization and the iud, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. table i: percentage of women experiencing an unintended pregnancy during the first year of use of a contraceptive method na - not available levonorgestrel and ethinyl estradiol tablet is contraindicated in females who are known to have or develop the following conditions: thrombophlebitis or thromboembolic disorders a past history of deep-vein-thrombophlebitis or thromboembolic disorders. cerebral-vascular or coronary-artery disease. current diagnosis or history of breast cancer, which may be hormone sensitive. undiagnosed abnormal genital bleeding. cholestatic jaundice of pregnancy or jaundice with prior pill use. hepatic adenomas and carcinomas. known or suspected pregnancy. women who are receiving hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alanine aminotransferase (alt) elevations (see warnings, risk of liver enzyme elevations with concomitant hepatitis c treatment ).

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

johnson & johnson medical pty ltd - 47986 - female stress urinary incontinence surgical mesh - continence system trocar sheath/implant assembly consists of one piece blue(phthalocyanine blue,colour 74160) prolene? polypropylene mesh (tape)approx 1.1x45cm, covered by clear plastic sheath held between two white trocar sheaths,which are bonded to implant & implant sheath.trocar shaft fit inside white trocar sheaths,used to position system from vaginal incision up through abdominal wall.rigid catheter guide is nonsterile reusable available separately,intended to facilitate placement tvt exact the gynecare tvt exact continence system is intended to be used as a pubo-urethral sling for treatment of female stress urinary incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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

airlife australia holdings pty ltd - 12050 - humidifier, heated - the vyaire heated humidifier is intended to add moisture to, and to warm, the breathing gases for administration to a patient. gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract or desiccate secretions of patients whose supraglottic airways have been bypassed. this product is nonsterile, reusable, and intended to be used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

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

lima orthopaedics australia pty ltd - 60932 - shoulder glenoid fossa trial prosthesis - a copy of a final shoulder glenoid fossa prosthesis fitted temporarily to ensure the correct size of the implant is chosen, and to ensure its proper orientation and positioning. it is then removed prior to the permanent implant (all within the same procedure). it is provided nonsterile, it is a reusable device intended to be sterilized prior to use.

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

medsalv australia pty ltd - 61801 - blood pressure cuff, reprocessed - the medsalv remanufactured blood pressure cuff is intended to be used on the upper arm in conjunction with non-invasive blood pressure measurement systems. the cuff is nonsterile and is available in pediatric through adult sizes. the device is not intended for neonatal applications. medsalv remanufactured blood pressure cuff is intended to be used by a clinically trained medical professional.

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - cefotaxime sodium eqv cefotaxime - injection, powder, for solution - 0.5 g/vial - cefotaxime sodium eqv cefotaxime 0.5 g/vial