ארצות הברית - אנגלית - NLM (National Library of Medicine)

oyster point pharma - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - tyrvaya (varenicline solution) nasal spray is indicated for the treatment of the signs and symptoms of dry eye disease. none risk summary there are no available data on tyrvaya use in pregnant women to inform any drug associated risks. in animal reproduction studies, varenicline did not produce malformations at clinically relevant doses. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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. data animal data pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. while no fetal structural abnormalities occurred in either species, maternal toxicity, characterized by reduced body weight gain, and reduced fetal weights occurred in rabbits at the highest dose (4864 times the mrhd on a mg/m2 basis). in a pre- and postnatal development study, pregnant rats received up to 15 mg/kg/day of oral varenicline succinate from organogenesis through lactation. maternal toxicity, characterized by a decrease in body weight gain, was observed at 15 mg/kg/day (1216 times the mrhd on a mg/m2 basis). decreased fertility and increased auditory startle response occurred in offspring at the highest maternal dose of 15 mg/kg/day. risk summary there are no data on the presence of varenicline in human milk, the effects on the breastfed infant, or the effects on milk production. in animal studies varenicline was present in milk of lactating rats. however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk. the lack of clinical data during lactation precludes a clear determination of the risk of tyrvaya to an infant during lactation; however, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tyrvaya and any potential adverse effects on the breastfed child from tyrvaya. safety and efficacy of tyrvaya in pediatric patients have not been established.  no overall differences in safety or effectiveness have been observed between elderly and younger adult patients. instructions for use   tyrvaya ®   (teer-vye-ah) (varenicline solution ) n asal s pray , for intranasal use read this instructions for use before you start using tyrvaya and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. - tyrvaya is for use in the nose. - do not shake the bottles. - the tyrvaya carton contains enough medicine for 30 days.  each carton has 2 glass nasal spray bottles. each nasal spray bottle has enough medicine for 15 days of treatment.   do not open the second nasal spray bottle until you have used the entire first bottle.  - each carton has 2 glass nasal spray bottles. - each nasal spray bottle has enough medicine for 15 days of treatment.   - do not open the second nasal spray bottle until you have used the entire first bottle.  - reprime : if you do not use tyrvaya for more than 5 days , you will need to reprime the nasal spray bottle with 1 spray before you start using it. to reprime, hold the nasal spray bottle upright and away from your face and fully  press and release the nasal spray applicator 1   time . - avoid priming the nasal spray bottle more than needed : priming the nasal spray bottle more than needed will reduce the amount of medicine in the nasal spray bottle. this instructions for use has been approved by the u.s. food and drug administration. tyrvaya® is a registered trademark of oyster point pharma, inc., a viatris company. tyrvaya® and/or the use of tyrvaya® in a method may be covered by one or more patents or patent applications, available at www.oysterpointrx.com/patent-notices. manufactured for: oyster point pharma, inc., 202 carnegie center, suite 106, princeton, nj 08540 ©2023 oyster point pharma, inc.                                     revised: 2/2024

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 41039 - orthosis, spinal, cervical, collar - to maintain and support head and neck

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

optos australia pty ltd - 41670 - radiology picture archiving and communication system application software - web-based application intended for use in storing, managing, and displaying patient data, videos and images from computerized instruments or video documentation systems. the application is not intended for use with radiological devices or the images captured by radiological systems.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

optos australia pty ltd - 47952 - scanning-laser ophthalmic imaging system - this device is indicated for use as a wide field imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest themselves in the retina.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

optos australia pty ltd - 47952 - scanning-laser ophthalmic imaging system - this device is indicated for use as a wide field imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest themselves in the retina and fluoresced retina.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

optos australia pty ltd - 47952 - scanning-laser ophthalmic imaging system - intended to be used as a wide field and retinal autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in the retina.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - ganciclovir sodium, quantity: 546 mg (equivalent: ganciclovir, qty 500 mg) - injection, powder for - excipient ingredients: - ganciclovir sxp (ganciclovir) administered as the iv infusion is indicated for the palliative treatment of confirmed sight-threatening cytomegalovirus (cmv) disease in aids and other severely immunocompromised individuals. it is indicated for the treatment of confirmed cmv pneumonitis in bone marrow transplant patients. it is also indicated for the prophylaxis of cmv infection and disease following bone marrow and solid organ transplantation in patients at risk of cmv disease.,note: ganciclovir sxp (ganciclovir) is not indicated for congenital or neonatal cmv disease; nor for the treatment of cmv infection in non-immunocompromised individuals.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

bsn medical (aust) pty ltd - 41534 - stocking, - the devices are intended for use as ready-to-wear stockings for the management of venous indications requiring compression therapy.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

bsn medical (aust) pty ltd - 45606 - compression garment - short stretch compression garments for control of mild, moderate, and severe swelling from lymphatic and other swelling disorders.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

optos australia pty ltd - 64004 - scanning-laser ophthalmoscope/retinal optical coherence tomography system - the p200te is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. it is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell complex (gcc) and optic disc, under mydriatic and non-mydriatic conditions. it is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps. the p200te system includes a reference database, allowing results of oct analysis to be compared to reference data. the p200te is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.