Canada - English - Health Canada

mylan pharmaceuticals ulc - fluticasone propionate; azelastine hydrochloride - spray, metered dose - 50mcg; 137mcg - fluticasone propionate 50mcg; azelastine hydrochloride 137mcg

Ireland - English - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - azelastine hydrochloride - eye drops, solution - 0.5 milligram(s)/millilitre - other antiallergics; azelastine

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - vinblastine sulfate - solution for injection/infusion - 1 milligram(s)/millilitre - vinca alkaloids and analogues; vinblastine

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

padagis israel pharmaceuticals ltd - 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 hydrochloride and fluticasone propionate. in animal reproduction studies, there was no evidence of fetal harm in animals at oral doses of azelastine hydrochloride approximately 10 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 530 times and higher than the maximum recommended human daily nasal dose (mrhdid) of 0.548 mg. however, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple. in animal reproduction studies, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the mrhdid on a mcg/m2 basis. teratogenicity, characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the mrhdid of 200 mcg on a mcg/m2 basis (see data) . experience with corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. 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: azelastine hydrochloride: 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 610 times the 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 25 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 530 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 1200 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 55 times the mrhdid (on a mg/m2 basis at a maternal oral dose of 3 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 1100 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 10 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 530 times the mrhdid (on mg/m2 basis at a maternal dose of 30 mg/kg/day). fluticasone propionate: in embryofetal development studies with pregnant rats and mice dosed by the subcutaneous route throughout the period of organogenesis, fluticasone propionate was teratogenic in both species. omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately 5 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). neither fetal nor maternal effects occurred in rats at approximately 1 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 30 mcg/kg/day). cleft palate and fetal skeletal variations were observed in mouse fetuses at a dose approximately 1 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 45 mcg/kg/day). neither fetal nor maternal effects occurred in mice with a dose approximately 0.4 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 15 mcg/kg/day). in an embryofetal development study with pregnant rats dosed by the nose-only inhalation route throughout the period of organogenesis, fluticasone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately 1 times the mrhdid (on a mg/m2 basis with a maternal nose-only inhalation dose of 25.7 mcg/kg/day); however, there was no evidence of teratogenicity. neither fetal nor maternal effects occurred in rats with a dose approximately 0.25 times the mrhdid (on a mg/m2 basis with a maternal nose-only inhalation dose of 5.5 mcg/kg/day). in an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.06 times the mrhdid and higher (on a mg/m2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day). teratogenicity was evident based upon a finding of cleft palate for 1 fetus at dose approximately 0.4 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 4 mcg/kg/day). neither fetal nor maternal effects occurred in rabbits with a dose approximately 0.01 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 0.08 mcg/kg/day). fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. in a pre-and post-natal development study in pregnant rats dosed from late gestation through delivery and lactation (gestation day 17 to postpartum day 22), fluticasone propionate was not associated with decreases in pup body weight, and had no effects on developmental landmarks, learning, memory, reflexes, or fertility at doses up to 2 times the mrhdid (on a mg/m2 basis with maternal subcutaneous doses up to 50 mcg/kg/day). risk summary there are no available data on the presence of azelastine hydrochloride or fluticasone propionate 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 and fluticasone propionate nasal spray use by lactating women (see clinical considerations) . fluticasone propionate is present in rat milk (see data) . other corticosteroids have been detected in human milk. however, fluticasone propionate concentrations in plasma after nasal therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low [see clinical pharmacology (12.3)] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for azelastine hydrochloride and fluticasone propionate nasal spray and any potential adverse effects on the breastfed infant from azelastine hydrochloride and fluticasone propionate nasal spray or from the underlying maternal condition. clinical considerations monitoring for adverse reactions: breastfed infants of lactating women treated with azelastine hydrochloride and fluticasone propionate nasal spray should be monitored for possible signs of milk rejection related to the bitter taste of azelastine hydrochloride. data subcutaneous administration of 10 mcg/kg of tritiated fluticasone propionate to lactating rats resulted in measurable radioactivity in the milk. the safety and effectiveness of azelastine hydrochloride and fluticasone propionate nasal spray for seasonal allergic rhinitis have been established in pediatric patients aged 6 years and older. use of azelastine hydrochloride and fluticasone propionate nasal spray for this indication in pediatric patients 6 to 11 years of age is supported by evidence from controlled clinical trials (416 patients 6 to 11 years of age with allergic rhinitis were treated with azelastine hydrochloride and fluticasone propionate nasal spray) [see adverse reactions (6.1) and clinical studies (14)] . sixty-one patients ages 4-5 years of age were treated with azelastine hydrochloride and fluticasone propionate nasal spray in the pediatric studies described above. safety findings in children 4-5 years of age were similar to those in children 6-11 years of age, but effectiveness has not been established. safety and effectiveness of azelastine hydrochloride and fluticasone propionate nasal spray have not been established in pediatric patients below the age of 4 years. controlled clinical studies have shown that nasal corticosteroids may cause a reduction in growth velocity in pediatric patients. this effect has been observed in the absence of laboratory evidence of hpa axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. the potential for “catch-up” growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. the growth of pediatric patients receiving nasal corticosteroids, including azelastine hydrochloride and fluticasone propionate nasal spray, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. clinical trials of azelastine hydrochloride and fluticasone propionate nasal spray did not include sufficient numbers of patients 65 years of age and older 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. instructions for use azelastine (a-zel-uh-steen) hydrochloride (hye-dro-klor-ide) and fluticasone (floo-tik-a-sone) propionate (pro-pee-oh-nate) nasal spray for use in your nose only. do not spray in your eyes. read the instructions for use before you start to use azelastine hydrochloride and fluticasone propionate nasal spray and each time you get a refill. there may be new information. this leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. before you use azelastine hydrochloride and fluticasone propionate nasal spray, make sure your healthcare provider shows you the right way to use it. shake the bottle gently before each use. your azelastine hydrochloride and fluticasone propionate nasal spray pump. (see figure a) instructions for using your azelastine hydrochloride and fluticasone propionate nasal spray pump. before you use azelastine hydrochloride and fluticasone propionate nasal spray for the first time, you will need to shake the bottle gently and prime the pump. for use in young children: an adult should help a young child use azelastine hydrochloride and fluticasone propionate nasal spray. (see steps 1 through 12). priming your azelastine hydrochloride and fluticasone propionate nasal spray pump before you prime the bottle, shake it gently. step 1. remove the clear plastic dust cap from the spray pump tip of the bottle. (see figure b) step 2. hold the bottle upright with two 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. using your azelastine hydrochloride and fluticasone propionate nasal spray: for use in young children: an adult should help a young child use azelastine hydrochloride and fluticasone propionate nasal spray. step 3. gently blow your nose to clear nostrils. (see figure d) step 4. shake the bottle gently. close 1 nostril with a finger. tilt your head forward slightly. keep the bottle upright and carefully place the spray pump tip ¼ to ½ inch into your other nostril. (see figure e) step 5. for each spray firmly press the pump 1 time. keep your head tilted down and at the same time, gently breathe in through your nostril. (see figure f) do not spray directly onto the nasal septum (the wall between your 2 nostrils). step 6. when you finish using azelastine hydrochloride and fluticasone propionate nasal spray, wipe the spray tip with a clean tissue or cloth. put the dust cap back on the spray pump tip of the bottle. (see figure g) each bottle of azelastine hydrochloride and fluticasone propionate nasal spray contains enough medicine for you to spray medicine from the bottle 120 times. after initial priming, do not use your bottle of azelastine hydrochloride and fluticasone propionate nasal spray after 120 sprays. you may not receive the right amount of medicine. keep track of the number of sprays you use from your bottle of azelastine hydrochloride and fluticasone propionate nasal spray and throw away the bottle even if it has medicine left in it. do not count any sprays used for initially priming the bottle. cleaning the spray pump tip: your azelastine hydrochloride and fluticasone propionate nasal spray should be cleaned at least 1 time each week. to do this: step 7. remove the dust cap and then gently pull upward on the spray pump unit to remove it from the bottle. (see figure h) step 8. wash the spray pump unit and dust cap in warm tap water. (see figure i) step 9. allow to dry completely. when dry, place the spray pump unit and dust cap back on the bottle. (see figure j) step 10. if the spray pump unit becomes blocked, it can be removed as instructed above in step 7 and placed in warm water to soak. do not try to unblock the spray pump unit by inserting a pin or other sharp object. this will damage the spray pump unit and cause you not to get the right dose of medicine. step 11. after the spray pump unit is unblocked, rinse the applicator and cap with cold water, and allow them to dry as in step 10 above. when dry, place the spray pump unit back on the bottle and put the dust cap on the spray pump tip. step 12. reprime the bottle as in steps 1 and 2 above. replace the dust cap and your azelastine hydrochloride and fluticasone propionate nasal spray is ready for use. this patient package insert and instructions for use has been approved by the u.s. food and drug administration. made in israel manufactured by padagis yeruham, israel distributed by padagis allegan, mi 49010 • www.padagis.com rev 08-21 7x900 rc j3

United States - English - 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 hydrochloride and fluticasone propionate. in animal reproduction studies, there was no evidence of fetal harm in animals at oral doses of azelastine hydrochloride approximately 10 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 530 times and higher than the maximum recommended human daily nasal dose (mrhdid) of 0.548 mg. however, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple. in animal reproduction studies, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not induce teratogenicity at a maternal toxic dose less than the mrhdid on a mcg/m2 basis. teratogenicity, characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, in rats, mice, and rabbits were observed with subcutaneously administered maternal toxic doses of fluticasone propionate less than the mrhdid of 200 mcg on a mcg/m2 basis (see data) . experience with corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. 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: azelastine hydrochloride: 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 610 times the 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 25 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 530 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 1200 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 55 times the mrhdid (on a mg/m2 basis at a maternal oral dose of 3 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 1100 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 10 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 530 times the mrhdid (on mg/m2 basis at a maternal dose of 30 mg/kg/day). fluticasone propionate: in embryofetal development studies with pregnant rats and mice dosed by the subcutaneous route throughout the period of organogenesis, fluticasone propionate was teratogenic in both species. omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately 5 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). neither fetal nor maternal effects occurred in rats at approximately 1 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 30 mcg/kg/day). cleft palate and fetal skeletal variations were observed in mouse fetuses at a dose approximately 1 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 45 mcg/kg/day). neither fetal nor maternal effects occurred in mice with a dose approximately 0.4 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 15 mcg/kg/day). in an embryofetal development study with pregnant rats dosed by the nose-only inhalation route throughout the period of organogenesis, fluticasone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately 1 times the mrhdid (on a mg/m2 basis with a maternal nose-only inhalation dose of 25.7 mcg/kg/day); however, there was no evidence of teratogenicity. neither fetal nor maternal effects occurred in rats with a dose approximately 0.25 times the mrhdid (on a mg/m2 basis with a maternal nose-only inhalation dose of 5.5 mcg/kg/day). in an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, fluticasone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.06 times the mrhdid and higher (on a mg/m2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day). teratogenicity was evident based upon a finding of cleft palate for 1 fetus at dose approximately 0.4 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 4 mcg/kg/day). neither fetal nor maternal effects occurred in rabbits with a dose approximately 0.01 times the mrhdid (on a mg/m2 basis with a maternal subcutaneous dose of 0.08 mcg/kg/day). fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. in a pre-and post-natal development study in pregnant rats dosed from late gestation through delivery and lactation (gestation day 17 to postpartum day 22), fluticasone propionate was not associated with decreases in pup body weight, and had no effects on developmental landmarks, learning, memory, reflexes, or fertility at doses up to 2 times the mrhdid (on a mg/m2 basis with maternal subcutaneous doses up to 50 mcg/kg/day). risk summary there are no available data on the presence of azelastine hydrochloride or fluticasone propionate 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 and fluticasone propionate nasal spray use by lactating women (see clinical considerations) . fluticasone propionate is present in rat milk (see data) . other corticosteroids have been detected in human milk. however, fluticasone propionate concentrations in plasma after nasal therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low [see clinical pharmacology (12.3)] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for azelastine hydrochloride and fluticasone propionate nasal spray and any potential adverse effects on the breastfed infant from azelastine hydrochloride and fluticasone propionate nasal spray or from the underlying maternal condition. clinical considerations monitoring for adverse reactions: breastfed infants of lactating women treated with azelastine hydrochloride and fluticasone propionate nasal spray should be monitored for possible signs of milk rejection related to the bitter taste of azelastine hydrochloride. data subcutaneous administration of 10 mcg/kg of tritiated fluticasone propionate to lactating rats resulted in measurable radioactivity in the milk. the safety and effectiveness of azelastine hydrochloride and fluticasone propionate nasal spray for seasonal allergic rhinitis have been established in pediatric patients aged 6 years and older. use of azelastine hydrochloride and fluticasone propionate nasal spray for this indication in pediatric patients 6 to 11 years of age is supported by evidence from controlled clinical trials (416 patients 6 to 11 years of age with allergic rhinitis were treated with azelastine hydrochloride and fluticasone propionate nasal spray) [see adverse reactions (6.1) and clinical studies (14)] . sixty-one patients ages 4-5 years of age were treated with azelastine hydrochloride and fluticasone propionate nasal spray in the pediatric studies described above. safety findings in children 4-5 years of age were similar to those in children 6-11 years of age, but effectiveness has not been established. safety and effectiveness of azelastine hydrochloride and fluticasone propionate nasal spray have not been established in pediatric patients below the age of 4 years. controlled clinical studies have shown that nasal corticosteroids may cause a reduction in growth velocity in pediatric patients. this effect has been observed in the absence of laboratory evidence of hpa axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown. the potential for “catch-up” growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied. the growth of pediatric patients receiving nasal corticosteroids, including azelastine hydrochloride and fluticasone propionate nasal spray, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. clinical trials of azelastine hydrochloride and fluticasone propionate nasal spray did not include sufficient numbers of patients 65 years of age and older 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. instructions for use azelastine (a-zel-uh-steen) hydrochloride (hye-dro-klor-ide) and fluticasone (floo-tik-a-sone) propionate (pro-pee-oh-nate) nasal spray for use in your nose only. do not spray in your eyes. read the instructions for use before you start to use azelastine hydrochloride and fluticasone propionate nasal spray and each time you get a refill. there may be new information. this leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. before you use azelastine hydrochloride and fluticasone propionate nasal spray, make sure your healthcare provider shows you the right way to use it. shake the bottle gently before each use. your azelastine hydrochloride and fluticasone propionate nasal spray pump. (see figure a) instructions for using your azelastine hydrochloride and fluticasone propionate nasal spray pump. before you use azelastine hydrochloride and fluticasone propionate nasal spray for the first time, you will need to shake the bottle gently and prime the pump. for use in young children: an adult should help a young child use azelastine hydrochloride and fluticasone propionate nasal spray. (see steps 1 through 12). priming your azelastine hydrochloride and fluticasone propionate nasal spray pump before you prime the bottle, shake it gently. step 1. remove the clear plastic dust cap from the spray pump tip of the bottle. (see figure b) hold the bottle upright with two 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 the pumping action until you see a fine mist. you should see a fine mist of the medicine after 6 pumps or less. (see figure c) •to get a fine mist of medicine, you must repeat the pumping action fast and use firm pressure against the bottom of the bottle.•if you see a stream of liquid, the spray will not work right and may cause nasal discomfort.•if you do not use azelastine hydrochloride and fluticasone propionate nasal spray for 14 or more days, you will need to shake the bottle gently, and prime the pump with 1 spray or until you see a fine mist. if you do not see a fine mist, clean the tip of the spray nozzle. see the cleaning section below.•once you see the fine mist of medicine, your azelastine hydrochloride and fluticasone propionate nasal spray pump is ready for use. for use in young children: an adult should help a young child use azelastine hydrochloride and fluticasone propionate nasal spray. step 3. gently blow your nose to clear nostrils. (see figure d) shake the bottle gently. close 1 nostril with a finger. tilt your head forward slightly. keep the bottle upright and carefully place the spray pump tip ¼ to ½ inch into your other nostril. (see figure e) for each spray firmly press the pump 1 time. keep your head tilted down and at the same time, gently breathe in through your nostril. (see figure f) do not spray directly onto the nasal septum (the wall between your 2 nostrils). •repeat step 5 in your other nostril.•do not tilt your head back. this will help to keep the medicine from going into your throat.•if the medicine goes into your throat you may get a bitter taste in your mouth. this is normal. when you finish using azelastine hydrochloride and fluticasone propionate nasal spray, wipe the spray tip with a clean tissue or cloth. put the dust cap back on the spray pump tip of the bottle. (see figure g) do not count any sprays used for initially priming the bottle. cleaning the spray pump tip: your azelastine hydrochloride and fluticasone propionate nasal spray should be cleaned at least 1 time each week. to do this: step 7. remove the dust cap and then gently pull upward on the spray pump unit to remove it from the bottle. (see figure h) step 8. wash the spray pump unit and dust cap in warm tap water. (see figure i) step 9. allow to dry completely. when dry, place the spray pump unit and dust cap back on the bottle. (see figure j) step 10. if the spray pump unit becomes blocked, it can be removed as instructed above in step 7 and placed in warm water to soak. do not try to unblock the spray pump unit by inserting a pin or other sharp object. this will damage the spray pump unit and cause you not to get the right dose of medicine. step 11. after the spray pump unit is unblocked, rinse the applicator and cap with cold water, and allow them to dry as in step 10 above. when dry, place the spray pump unit back on the bottle and put the dust cap on the spray pump tip. step 12. reprime the bottle as in steps 1 and 2 above. replace the dust cap and your azelastine hydrochloride and fluticasone propionate nasal spray is ready for use. this patient package insert and instructions for use has been approved by the u.s. food and drug administration. made in israel manufactured by perrigo yeruham, israel distributed by perrigo® allegan, mi 49010 • www.perrigorx.com rev 05-21 7x900 rc j2

Australia - English - 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: benzalkonium chloride; purified water; polysorbate 80; glycerol; disodium edetate; phenethyl alcohol; 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - azelastine hydrochloride; fluticasone propionate - nasal spray, suspension - fluticasone, combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

meda health sales ireland limited - azelastine hydrochloride - eye drops solution - 0.5 mg/ml - other antiallergics

Ireland - English - HPRA (Health Products Regulatory Authority)

brown & burk uk ltd - azelastine hydrochloride - eye drops solution - 0.5 mg/ml - other antiallergics

Ireland - English - HPRA (Health Products Regulatory Authority)

hospira uk limited - vinblastine sulfate - solution for inj/inf - 1 mg/ml - vinca alkaloids and analogues