Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - cytomegalovirus infections - antivirals for systemic use - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot).consideration should be given to official guidance on the appropriate use of antiviral agents.

Misri - Kiingereza - EDA (Egyptian Drug Authority)

city pharma -egypt - sulphadimidine sodium 100 gm (equivalent to 92.67 gm sulphadimidine base) /100gm - water soluble powder

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

takeda pharmaceuticals australia pty ltd - maribavir, quantity: 200 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; purified talc; brilliant blue fcf aluminium lake; polyvinyl alcohol; macrogol 3350 - treatment of adults with post-transplant cytomegalovirus (cmv) infection and disease resistant, refractory or intolerant to one or more prior therapies (see 4.3 contraindications and, 4.4 special warnings and precautions for use).

Israeli - Kiingereza - Ministry of Health

takeda israel ltd - maribavir - film coated tablets - maribavir 200 mg - maribavir - livtencity is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (cmv) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.

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

bayer cropscience pty ltd - pyrasulfotole; bromoxynil mixed heptanoic acid & octanoic acid esters; mefenpyr-diethyl; liquid hydrocarbon - emulsifiable concentrate - pyrasulfotole ungrouped active 37.5 g/l; bromoxynil mixed heptanoic acid & octanoic acid esters ester active 210.0 g/l; mefenpyr-diethyl pyrazoline other 9.4 g/l; liquid hydrocarbon solvent other 381.0 g/l - herbicide - barley - see label for exceptions | cereal rye - see label | triticale - see label | wheat - see label for exceptions | tritical - amsinckia, yellow burrweed - seedling | bedstraw | bifora, carrot weed or bird's eye | bindweed | capeweed | corn gromwell, ironweed or sheepweed | deadnettle | fumitory | indian hedge mustard | paterson's curse | prickly lettuce | saffron thistle | shepherd's purse | sowthistles | three cornered jack or doublegee | turnip weed | volunteer canola | volunteer chickpea | volunteer faba bean | volunteer field pea | volunteer lentil | volunteer lucerne - seedling | volunteer lupin | volunteer medic | volunteer vetch or tares | wild radish or radish weed | wild turnip | wireweed, knotweed or hogweed | amsinckia angustifolia | amsinckia calycina | amsinckia hispida | amsinckia intermedia | amsinckia lycopsoides | brassica campestris | brassica rapa ssp. sylvestris | brassica rapa var. sylvestris | buglossiodes arvense | burr grass | burrgrass | common lucerne | corn sowthistle | cornbine (uk) | echium lycopsis | echium spp. | european bindweed | fallopia aviculare | false star thistle | field bindweed | field morni

Marekani - Kiingereza - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - maribavir (unii: ptb4x93he1) (maribavir - unii:ptb4x93he1) - livtencity is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (cmv) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet [see use in specific populations (8.4) and clinical studies (14)] . none. risk summary no adequate human data are available to establish whether livtencity poses a risk to pregnancy outcomes. in animal reproduction studies, embryo-fetal survival was decreased in rats, but not in rabbits, at maribavir exposures less than those observed in humans at the recommended human dose (rhd) (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. 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 in a combined fertility and embryofetal development study, maribavir was administered to male and female rats at oral doses of 100, 200, or 400 mg/kg/day. females were dosed for 15 consecutive days prior to pairing, throughout pairing, and up to gestation day (gd) 17, while males were dosed 29 days prior to mating and throughout mating. a decrease in the number of viable fetuses and increase in early resorptions and post-implantation losses were observed at ≥100 mg/kg/day (at exposures approximately half the human exposure at the rhd). intermittent reduced body weight gain was observed in pregnant animals at ≥200 mg/kg/day. maribavir had no effect on embryo-fetal growth or development at dose levels up to 400 mg/kg/day, at exposures similar to those observed in humans at the rhd. no significant toxicological effects on embryo-fetal growth or development were observed in rabbits when maribavir was administered at oral doses up to 100 mg/kg/day from gd 8 to 20, at exposures approximately half the human exposure at the rhd. in the pre-and post-natal developmental toxicity study, maribavir was administered to pregnant rats at oral doses of 50, 150, or 400 mg/kg/day from gd 7 to post-natal day (pnd) 21. a delay in developmental milestones was observed, including pinna detachment at doses ≥150 mg/kg/day and eye opening and preputial separation associated with reduced bodyweight gain of the offspring at 400 mg/kg/day. in addition, decreased fetal survival and litter loss was observed due to maternal toxicity and poor maternal care, respectively, at doses ≥150 mg/kg/day. no effects were observed at 50 mg/kg/day (which is estimated to be less than the human exposure at the rhd). no effects on number of offspring, proportion of males, number of live pups, or survival to pnd 4 were observed at any dose in the offspring born to the second generation. risk summary it is not known whether maribavir or its metabolites are present in human or animal milk, affect milk production, or have effects on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for livtencity and any potential adverse effects to the breast-fed child. the recommended dosing regimen in pediatric patients 12 years of age and older and weighing at least 35 kg is the same as that in adults. use of livtencity in this age group is based on the following: - evidence from controlled studies of livtencity in adults - population pharmacokinetic (pk) modeling and simulation demonstrating that age and body weight had no clinically meaningful effect on plasma exposures of livtencity - livtencity exposure is expected to be similar between adults and children 12 years of age and older and weighing at least 35 kg - the course of the disease is similar between adults and pediatric patients to allow extrapolation of data in adults to pediatric patients [see dosage and administration (2.2), clinical pharmacology (12.3) and clinical studies (14)] the safety and effectiveness of livtencity have not been established in children younger than 12 years of age. no dosage adjustment is required for patients over 65 years of age based on the results from population pharmacokinetics analysis [see clinical pharmacology (12.3)] and efficacy and safety data from the clinical studies. in the clinical study 303, 54 patients aged 65 years and over were treated with livtencity. safety, effectiveness, and pharmacokinetics were consistent between elderly patients (≥65 years) and younger patients (<65 years). no dose adjustment of livtencity is needed for patients with mild, moderate, or severe renal impairment [see clinical pharmacology (12.3)] . administration of livtencity in patients with end stage renal disease (esrd), including patients on dialysis, has not been studied. no dose adjustment of livtencity is needed for patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment [see clinical pharmacology (12.3)] . administration of livtencity in patients with severe hepatic impairment has not been studied. livtencity (liv-ten-city) (maribavir) tablets, for oral use this instructions for use contains information on how to prepare and give a dose of livtencity tablets by breaking apart (dispersing) or crushing in drinking water and taking by mouth; or dispersing and giving through a nasogastric (ng) or orogastric (og) tube. read this instructions for use before you prepare or give the first dose of livtencity, and each time you get a refill. ask your healthcare provider or pharmacist if you have any questions. important information you need to know before preparing a dose of livtencity: - you can break apart (disperse) the tablets in drinking water or crush the tablets and mix with drinking water. the tablet will not be completely dispersed in the mixture. - do not mix livtencity with any liquid other than drinking water. - livtencity tablets that have been dispersed in drinking water can be given through a nasogastric (ng) or orogastric (og) tube (french size 10 or larger). - you can prepare the mixture ahead of time and store at room temperature 68°f to 77°f (20°c to 25°c) for up to 8 hours. preparing a dose of livtencity by dispersing or crushing tablets and taking by mouth: gather the following supplies: - small, clean container to place tablets and water in - drinking water step 1: choose a clean, flat work surface. place all supplies on the work surface. step 2: wash and dry your hands well. step 3: get the prescribed number of livtencity tablets needed to prepare the dose. step 4: place the livtencity tablets into the container. note: if you prefer, you can crush the tablets with a spoon before adding water. step 5: add the amount of drinking water needed for your prescribed dose. step 6: swirl the container gently to disperse the tablets in the water and swallow the mixture right away. the mixture will have a bitter taste. step 7: rinse the container with 15 ml of drinking water and swallow the mixture. repeat step 7. check that no pieces of tablet are left in the container. repeat step 7 until no pieces remain. preparing and giving a dose of livtencity through a nasogastric (ng) or orogastric (og) tube: gather the following supplies: - 50 ml or 60 ml syringe - drinking water step 1: remove the cap (if capped) and plunger out of a 50 ml or 60 ml syringe. add 2 tablets into the syringe body and place the plunger back in the syringe. note: only 2 tablets can be given through the ng or og tube at a time. step 2: withdraw 30 ml of drinking water into the syringe. step 3: hold the syringe with the tip pointing upward. pull the plunger back so there is some air space in the syringe. if there is a cap, place the cap back on the syringe. shake the syringe well for about 30 to 45 seconds or until the tablets are completely dispersed. be careful not to spill the contents of the syringe. step 4: remove the cap (if capped) from the syringe again and attach the syringe to the ng or og tube and give the mixture right away. step 5: withdraw 15 ml of drinking water into the same syringe and flush through the ng or og tube. repeat step 5. check that no pieces of tablet are left in the syringe. repeat step 5 until no pieces remain. note: if your prescribed dose is more than 2 tablets, repeat steps 1 through 5 until you give the full prescribed dose. storing livtencity: - store livtencity at room temperature 68°f to 77°f (20°c to 25°c). keep livtencity and all medicines out of the reach of children. for more information, go to www.explorelivtencity.com or call 1-877-takeda-7 (1-877-825-3327). distributed by: takeda pharmaceuticals america, inc., lexington, ma 02421 livtencity® and the livtencity logo® are registered trademarks of takeda pharmaceuticals international ag. takeda® and the takeda logo® are registered trademarks of takeda pharmaceutical company limited. ©2024 takeda pharmaceuticals u.s.a., inc. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. mar358 r4 revised: march 2024

Misri - Kiingereza - EDA (Egyptian Drug Authority)

city pharma a.r.e - flunixin meglumine 8.3 gm equivalent to 5 gm flunixin. - injectable solution

Misri - Kiingereza - EDA (Egyptian Drug Authority)

city pharma - oxytetracycline hcl 62.5 mg (equivalent to oxytetracycline base 50 mg)/1ml - solution for injection

Singapoo - Kiingereza - HSA (Health Sciences Authority)

micro asia trading pte. ltd. - orthopaedics - disposable shaver blades and burrs are use to shave or bur away damaged soft tissue and bone during arthroscopic joint surgeries.

Kanada - Kiingereza - Health Canada

takeda canada inc - maribavir - tablet - 200mg - maribavir 200mg