Israël - anglais - Ministry of Health

megapharm ltd - azelastine hydrochloride - eye drops, solution - azelastine hydrochloride 0.05 % - azelastine - azelastine - symptomatic treatment and prevention of seasonal allergic conjunctivitis.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - azelastine hydrochloride, quantity: 137 microgram/actuation (equivalent: azelastine, qty 125 microgram/actuation); fluticasone propionate, quantity: 50 microgram/actuation - spray, nasal - excipient ingredients: purified water; benzalkonium chloride; polysorbate 80; phenethyl alcohol; disodium edetate; glycerol; microcrystalline cellulose; carmellose sodium - symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 12 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.

États-Unis - anglais - NLM (National Library of Medicine)

bryant ranch prepack - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. risk summary limited data from postmarketing experience over decades of use with azelastine hydrochloride in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.096 mg. however, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 an embryo-fetal development study in mice dosed during the period of organogenesis, azelastine hydrochloride caused embryo-fetal death, structural abnormalities (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at approximately 300 times the maximum recommended human daily intranasal dose (mrhdid) in adults (on a mg/m2 basis at a maternal oral dose of 68.6 mg/kg/day), which also caused maternal toxicity as evidenced by decreased maternal body weight. neither fetal nor maternal effects occurred in mice at approximately 15 times the mrhdid in adults (on a mg/m2 basis at a maternal oral dose of 3 mg/kg/day). in an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, azelastine hydrochloride caused structural abnormalities (oligo-and brachydactylia), delayed ossification, and skeletal variations, in the absence of maternal toxicity, at approximately 270 times the mrhdid in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day). azelastine hydrochloride caused embryo-fetal death and decreased fetal weight and severe maternal toxicity at approximately 610 times the mrhdid (on a mg/m2 basis at a maternal oral dose of 68.6 mg/kg/day). neither fetal nor maternal effects occurred at approximately 20 times the mrhdid (on a mg/m2 basis at a maternal oral dose of 2 mg/kg/day). in an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, azelastine hydrochloride caused abortion, delayed ossification and decreased fetal weight and severe maternal toxicity at approximately 530 times the mrhdid in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day). neither fetal nor maternal effects occurred at approximately 5 times the mrhdid (on a mg/m2 basis at a maternal oral dose of 0.3 mg/kg/day). in a prenatal and postnatal development study in pregnant rats dosed from late in the gestation period and through the lactation period from gestation day 17 through lactation day 21, azelastine hydrochloride produced no adverse developmental effects on pups at maternal doses up to approximately 270 times the mrhdid (on mg/m2 basis at a maternal dose of 30 mg/kg/day). risk summary there are no data on the presence of azelastine hydrochloride in human milk, the effects on the breastfed infant, or the effects on milk production. breastfed infants should be monitored for signs of milk rejection during azelastine hydrochloride nasal spray use by lactating women (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for azelastine hydrochloride nasal spray and any potential adverse effects on the breastfed infant from azelastine hydrochloride nasal spray or from the underlying maternal condition. clinical considerations monitoring for adverse reactions breastfed infants of lactating women treated with azelastine hydrochloride nasal spray should be monitored for possible signs of milk rejection related to the bitter taste of azelastine hydrochloride. the safety and effectiveness of azelastine hydrochloride nasal spray for the treatment of symptoms of seasonal allergic rhinitis have been established for patients 5 years and older [see adverse reactions (6.1) and clinical studies (14.1) ]. the safety and effectiveness of azelastine hydrochloride nasal spray for the treatment of vasomotor rhinitis have been established for patients 12 years and older [see adverse reactions (6.1) and clinical studies (14.2) ]. the safety and effectiveness of azelastine hydrochloride nasal spray in pediatric patients below the age of 5 years with seasonal allergic rhinitis and in pediatric patients below the age of 12 years with vasomotor rhinitis have not been established. clinical trials of azelastine hydrochloride nasal spray did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. azelastine hydrochloride nasal spray for the correct dose of medicine: - keep your head tilted downward when spraying into your nostril. - change nostrils each time you use the spray. - breathe gently and do not tip your head back after using the spray. this will keep the medicine from running down into your throat. you may get a bitter taste in your mouth. figure a identifies the parts of your azelastine hydrochloride nasal spray pump before you use azelastine hydrochloride nasal spray for the first time, you will need to prime the bottle. priming your azelastine hydrochloride nasal spray remove the white dust cover over the tip of the pump and the white safety clip just under the "shoulders" of the pump (see figure b ). hold the bottle upright with 2 fingers on the shoulders of the spray pump unit and - put your thumb on the bottom of the bottle. press upward with your thumb and release for the pumping action. repeat this until you see a fine mist (see figure c ). - to get a fine mist you must pump the spray fast and use firm pressure against the bottom of the bottle. if you see a stream of liquid, the pump is not working correctly and you may have nasal discomfort. - this should happen in 4 sprays or less. now your pump is primed and ready to use. - do not use azelastine hydrochloride nasal spray unless you see a fine mist after you do the priming sprays. if you do not see a fine mist, clean the tip of the spray nozzle. see the "cleaning the spray tip of your azelastine hydrochloride nasal spray" section below. - if you do not use azelastine hydrochloride nasal spray for 3 or more days, you will need to prime the pump with 2 sprays or until you see a fine mist. using your azelastine hydrochloride nasal spray step 1. blow your nose to clear your nostrils. step 2. keep your head tilted downward toward your toes. step 3. place the spray tip about ¼ inch to ½ inch into 1 nostril. hold bottle upright and aim the spray tip toward the back of your nose (see figure d ). step 4. close your other nostril with a finger. press the pump 1 time and sniff gently at the same time, keeping your head tilted forward and down (see figure e ). step 5. repeat step 3 and step 4 in your other nostril. step 6. if your healthcare provider tells you to use 2 sprays in each nostril, repeat steps 2 through 4 above for the second spray in each nostril. step 7. breathe in gently, and do not tilt your head back after using azelastine hydrochloride nasal spray. this will help to keep the medicine from going into your throat. step 8. when you finish using your azelastine hydrochloride nasal spray, wipe the spray tip with a clean tissue or cloth. put the safety clip and dust cover back on the bottle. cleaning the spray tip of your azelastine hydrochloride nasal spray - if the spray tip opening is clogged, do not use a pin or pointed object to unclog the tip. unscrew the spray pump unit from the bottle by turning it to the left (counter-clockwise) (see figure f ). - soak only the spray pump unit in warm water. squirt the spray unit several times while holding it under water. use the pumping action to clear the opening in the tip (see figure g ). figure f figure g - let the spray pump unit air dry. make sure it is dry before you put it back onto the bottle. - put the spray pump unit back into the open bottle and tighten it by turning clockwise (to the right). - to keep the medicine from leaking out, use firm pressure when you put the pump back onto the bottle. - after cleaning, follow the instructions for priming. this patient information and instructions for use has been approved by the u.s. food and drug administration. distributed by: breckenridge pharmaceutical, inc. berlin, ct 06037 manufactured by: woodfield pharmaceutical, llc houston, tx 77099 revised: 08/2019

États-Unis - anglais - NLM (National Library of Medicine)

bryant ranch prepack - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x), fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - azelastine hydrochloride and fluticasone propionate nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. none. risk summary limited data from postmarketing experience with azelastine hydrochloride and fluticasone propionate nasal spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. the individual components of azelastine hydrochloride and fluticasone propionate nasal spray have been marketed for decades. while the data regarding the use of nasal preparations of fluticasone propionate in pregnancy are limited, data from clinical studies of inhaled fluticasone propionate do not indicate an increased risk of adverse maternal or fetal outcomes. animal reproduction studies with azelastine hydrochloride and fluticasone propionate nasal spray are not available; however, studies are available with its individual components, azelastine hydro

Israël - anglais - Ministry of Health

pharma shalom - mizolastine - film coated tablets - mizolastine 10 mg - mizolastine - mizolastine - symptomatic treatment of seasonal allergic rhinoconjuctivitis (hay fever), perennial allergic rhino-conjuctivitis and urticaria.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 1000 mg - solution - excipient ingredients: monobasic sodium phosphate; alanine; water for injections - prolastin? c liquid is an alpha-1-proteinase inhibitor indicated to increase serum alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha-1-antitrypsin and with clinically significant emphysema (fev1 <80%).,the data for clinical efficacy of prolastin? c liquid is derived from changes in the biomarkers alpha-1 anti-protease level and ct lung density. efficacy on fev1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials.,clinical trials have only included patients who were not smoking.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 4000 mg - liquid, multipurpose - excipient ingredients: monobasic sodium phosphate monohydrate; alanine; water for injections - prolastin? c liquid is an alpha-1-proteinase inhibitor indicated to increase serum alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha-1- antitrypsin and with clinically significant emphysema (fev1 <80%).,the data for clinical efficacy of prolastin? c liquid is derived from changes in the biomarkers alpha-1 anti-protease level and ct lung density. efficacy on fev1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials.,clinical trials have only included patients who were not smoking.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 500 mg - liquid, multipurpose - excipient ingredients: monobasic sodium phosphate monohydrate; alanine; water for injections - prolastin? c liquid is an alpha-1-proteinase inhibitor indicated to increase serum alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha-1- antitrypsin and with clinically significant emphysema (fev1 <80%).,the data for clinical efficacy of prolastin? c liquid is derived from changes in the biomarkers alpha-1 anti-protease level and ct lung density. efficacy on fev1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials.,clinical trials have only included patients who were not smoking.

États-Unis - anglais - NLM (National Library of Medicine)

shoreline pharmaceuticals, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

hospira nz ltd - vinblastine sulfate 10mg - powder for injection - 10 mg - active: vinblastine sulfate 10mg excipient: benzyl alcohol sodium chloride water for injection