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

pfizer laboratories div pfizer inc - recombinant stabilized rsv a prefusion f antigen (unii: 4pdl43y9mr) (recombinant stabilized rsv a prefusion f antigen - unii:4pdl43y9mr), recombinant stabilized rsv b prefusion f antigen (unii: 34fs5xsd5q) (recombinant stabilized rsv b prefusion f antigen - unii:34fs5xsd5q) - abrysvo is a vaccine indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (lrtd) and severe lrtd caused by respiratory syncytial virus (rsv) in infants from birth through 6 months of age. abrysvo is a vaccine indicated for active immunization for the prevention of lrtd caused by rsv in individuals 60 years of age and older. do not administer abrysvo to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of abrysvo [see description (11)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to abrysvo during pregnancy. individuals who received abrysvo during pregnancy are encouraged to contact, or have their healthcare provider contact, 1-800-616-3791 to enroll in or obtain information about the registry. risk summary 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 miscarriages in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively, and the estimated background risk of fetal deaths after 20 weeks is 0.6%. study 1 enrolled 7,358 pregnant individuals who were randomized 1:1 and received abrysvo or placebo (0.5 ml dose, containing the same buffer ingredients in the same quantities as in a single dose of abrysvo [see description (11)] ) revealed no evidence for vaccine-associated increase in the risk of congenital anomalies or fetal deaths. study 2 evaluated 115 pregnant individuals who received abrysvo and 117 who received placebo. a numerical imbalance in preterm births in abrysvo recipients was observed compared to placebo recipients in these two clinical studies. available data are insufficient to establish or exclude a causal relationship between preterm birth and abrysvo [see warnings and precautions (5.1), adverse reactions (6.1), clinical considerations (8.1), data (8.1) and clinical studies (14.1)] . a developmental toxicity study was performed in female rabbits administered a vaccine formulation containing two times the antigen content of a single human dose of abrysvo prior to and during gestation. the study showed no evidence of harm to the fetus or to postnatal survival, growth, or development (see animal data) . clinical considerations maternal adverse reactions in study 1, 3,682 pregnant individuals received abrysvo and 3,676 received placebo. local and systemic adverse reactions occurred with greater frequency in the abrysvo group. serious adverse reactions observed in pregnant individuals at a higher rate in the abrysvo group compared to the placebo group included pre-eclampsia (1.8% versus 1.4%) and gestational hypertension (1.1% versus 1.0%) [see adverse reactions (6.1)] . abrysvo has not been studied in pregnant individuals less than 24 weeks gestational age, and those at increased risk for preterm birth. fetal/neonatal adverse reactions the infant safety population included 3,568 and 3,558 infants born to individuals in the abrysvo or placebo group, respectively. there were 10 (0.3%) fetal deaths in the abrysvo group and 8 (0.2%) in the placebo group. among the infants born to individuals in the abrysvo group and in the placebo group, 202 (5.7%) and 169 (4.7%), respectively, were born preterm [see warnings and precautions (5.1), adverse reactions (6.1) and clinical studies (14.1)] . low birth weight was observed in 5.1% of participants in the abrysvo group versus 4.4% in the placebo group, and neonatal jaundice was observed in 7.2% in the abrysvo group versus 6.7% in the placebo group. [see adverse reactions (6.1)] . for mortality in the neonatal period among infants born to pregnant individuals in study 1, there were 2 deaths in the abrysvo group and 5 in the placebo group, and for overall mortality including after the neonatal period there were 5 deaths in the abrysvo group and 12 in the placebo group. congenital abnormalities were reported in 5.0% in the abrysvo group and 6.2% in the placebo group. available data are insufficient to establish or exclude a causal relationship between preterm birth and abrysvo. to avoid the potential risk of preterm birth with use of abrysvo before 32 weeks of gestation, administer abrysvo as indicated in pregnant individuals at 32 through 36 weeks gestational age. data human data in study 1, 3,682 pregnant individuals received abrysvo and 3,676 received placebo at 24 through 36 weeks’ gestation. the infant safety population included 3,568 and 3,558 infants born to individuals in the abrysvo or placebo group, respectively. among the infants born to individuals in the abrysvo group and in the placebo group, 202 (5.7%) and 169 (4.7%), respectively, had adverse events of preterm birth and 180 (5.0%) and 220 (6.2%), respectively, had reported congenital malformations or anomalies. there were 10 (0.3%) fetal deaths in the abrysvo group and 8 (0.2%) in the placebo group. animal data a pre- and post-natal developmental toxicity study with an embryo-fetal developmental toxicity phase was performed in female new zealand white rabbits. rabbits were administered 4 doses by intramuscular injection: at 3 weeks and at 1 week prior to mating, and on gestation days 10 and 24. on each occasion, rabbits received 0.5 ml of a vaccine formulation containing twice the antigen content of f glycoproteins of rsv a and rsv b (120 mcg rsv pref a and 120 mcg rsv pref b), stabilized in prefusion conformation as contained in a single human dose of abrysvo [see description (11)] . no adverse effects on mating, female fertility, or on embryo/fetal or post-natal survival, growth, or development were observed. there were no vaccine-related fetal malformations or variations. risk summary it is not known whether abrysvo is excreted in human milk. data are not available to assess the effects of abrysvo on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for abrysvo and any potential adverse effects on the breastfed child from abrysvo or from the underlying maternal condition. for preventative vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. the safety and effectiveness of abrysvo to prevent rsv lrtd and severe rsv lrtd in infants born to individuals vaccinated at younger than 10 years of age have not been established. the safety and effectiveness of abrysvo to prevent rsv lrtd in non-pregnant individuals younger than 18 years of age via active immunization have not been established. abrysvo is approved for use in individuals 60 years of age and older. in study 3, of the 17,215 recipients who received abrysvo 62% (n=10,756) were aged 60-69 years of age, 32% (n=5,488) were 70-79 years of age and 6% (n=970) were ≥80 years of age [see adverse reactions (6.1) and clinical studies (14.1)] .

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

pfizer laboratories div pfizer inc - somatrogon (unii: 6d848ra61b) (somatrogon - unii:6d848ra61b) - ngenla is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone. risk summary there are no available data on ngenla use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in reproduction studies with pregnant rats, there was no evidence of embryo-fetal toxicity following administration of somatrogon-ghla subcutaneously during organogenesis at doses up to 45 times the maximum recommended human dose based on exposure (see data) . the background risk of major birth defects and miscarriage in 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% to 4% and 15% to 20%, respectively. data animal data in an embryo-fetal development toxicity study in rats, no adverse maternal or embryo-fetal effects were observed when somatrogon-ghla was administered via subcutaneous injection every 2 days from gestation day (gd) 6 to 18 at doses up to 30 mg/kg (45 times the maximum recommended human dose based on cav exposure). in a pre- and postnatal development study in rats, somatrogon-ghla was administered via subcutaneous injection to pregnant rats every 2 days from gd 6 to lactation day 20 at doses up to 30 mg/kg. there was no evidence of maternal toxicity and no adverse effects on the first generation (f1) offspring. somatrogon-ghla elicited an increase in f1 mean body weights in both sexes and increased the mean copulatory interval in f1 females at the highest dose (30 mg/kg), consistent with a longer estrous cycle length. however, there were no effects on mating indices in f1 females. risk summary there are no data on the presence of somatrogon-ghla in human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ngenla and any potential adverse effects on the breastfed infant from ngenla or from the underlying maternal condition. pregnancy testing although somatrogon-ghla did not interfere with hcg pregnancy testing in a limited number of commercial tests, interference with hcg blood and urine pregnancy testing in patients receiving somatrogon-ghla may be possible, leading to either false positive or false negative results. alternative methods (i.e., not reliant on hcg) are recommended to determine pregnancy. the safety and effectiveness of ngenla have been established for the treatment of growth failure due to inadequate secretion of endogenous growth hormone (gh) in pediatric patients aged 3 years and older [see clinical studies (14.1)] . the use of ngenla for this indication is supported by evidence from a 52‑week, multi-center, randomized, open-label, active-controlled, parallel-group phase 3 study in 224 treatment-naïve, prepubertal pediatric subjects with growth hormone deficiency. risks in pediatric patients associated with growth hormone use include: ngenla® (en’ jen-lah) (somatrogon-ghla) 24 mg injection, for subcutaneous use read this instructions for use before you start using ngenla and each time you get a new refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important information about your ngenla pen: supplies you will need each time you inject included in the carton: not included in the carton: 24 mg ngenla pen: needles to use pen needles are not included with your ngenla pen. you will need a prescription from your healthcare provider to get pen needles up to a length of 8 mm from your pharmacy. sterile needle (example) not supplied: caution: never use a bent or damaged needle. always handle pen needles with care to make sure you do not prick yourself (or anyone else) with the needle. do not attach a new needle to your pen until you are ready to take your injection. preparing for your injection step 1 - getting ready step 2 - choose and clean your injection site step 3 - check medicine step 4 - attach needle step 5 - pull off outer needle cover step 6 - pull off inner needle cap is this pen new? yes: go to new pen set up no new pen set up (priming) – for the first use of a new pen only you must set up each new pen (priming) before using it for the first time a - set priming dose b - tap cartridge holder c - press button and check for liquid setting your prescribed dose step 7 - set your dose example a: 3.8 mg shown in the dose window example b: 12.0 mg shown in the dose window what should i do if i cannot set the dose i need? what should i do if i do not have enough medicine left in my pen? only split your dose if you have been trained or told by your healthcare provider on how to do this. injecting your dose step 8 - insert the needle step 9 - inject your medicine step 10 - count to 10 step 11 - attach outer needle cover step 12 - remove the needle step 13 - replace the pen cap step 14 - after your injection storage and disposal: how should i store my pen? before first use (unused pens): after first use (up to 28 days of use): how should i dispose of the pen needles and pens? manufactured by: pfizer ireland pharmaceuticals ringaskiddy, cork, ireland us license no: 2060 lab-1452-1.0 this instructions for use has been approved by the u.s. food and drug administration.      issued: 6/2023 instructions for use ngenla® (en’ jen-lah) (somatrogon-ghla) 60 mg injection, for subcutaneous use read this instructions for use before you start using ngenla and each time you get a new refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important information about your ngenla pen: supplies you will need each time you inject included in the carton: not included in the carton: 60 mg ngenla pen: needles to use pen needles are not included with your ngenla pen. you will need a prescription from your healthcare provider to get pen needles up to a length of 8 mm from your pharmacy. sterile needle (example) not supplied: caution: never use a bent or damaged needle. always handle pen needles with care to make sure you do not prick yourself (or anyone else) with the needle. do not attach a new needle to your pen until you are ready to take your injection.  preparing for your injection step 1 - getting ready step 2 - choose and clean your injection site step 3 - check medicine step 4 - attach needle step 5 - pull off outer needle cover step 6 - pull off inner needle cap is this pen new? yes: go to new pen set up no new pen set up (priming) – for the first use of a new pen only you must set up each new pen (priming) before using it for the first time a - set priming dose b - tap cartridge holder c - press button and check for liquid setting your prescribed dose step 7 - set your dose example a: 21.5 mg shown in the dose window example b: 30.0 mg shown in the dose window what should i do if i cannot set the dose i need? what should i do if i do not have enough medicine left in my pen? only split your dose if you have been trained or told by your healthcare provider on how to do this. injecting your dose step 8 - insert the needle step 9 - inject your medicine step 10 - count to 10 step 11 - attach outer needle cover step 12 - remove the needle step 13 - replace the pen cap step 14 - after your injection storage and disposal: how should i store my pen? before first use (unused pens): after first use (up to 28 days of use): how should i dispose of the pen needles and pens? manufactured by: pfizer ireland pharmaceuticals ringaskiddy, cork, ireland us license no: 2060 lab-1454-1.0 this instructions for use has been approved by the u.s. food and drug administration      issued: 6/2023

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - bazedoxifene acetate; estrogens conjugated - tablets modified release - bazedoxifene acetate 20 mg; estrogens conjugated 0.45 mg - conjugated estrogens and bazedoxifene - treatment of the following conditions in women with a uterus:• treatment of moderate to severe vasomotor symptoms associated with menopause• prevention of postmenopausal osteoporosis

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 40 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 80 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 10 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - atorvastatin as calcium - film coated tablets - atorvastatin as calcium 20 mg - atorvastatin - atorvastatin - lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. lipitor is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorvastatin is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease lipitor is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - palbociclib - film coated tablets - palbociclib 100 mg - palbociclib - iibrance is indicated for the treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with:* an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or* fulvestrant in patients with disease progression following endocrine therapy.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - palbociclib - film coated tablets - palbociclib 125 mg - palbociclib - ibrance is indicated for the treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with:* an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or* fulvestrant in patients with disease progression following endocrine therapy.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - palbociclib - film coated tablets - palbociclib 75 mg - palbociclib - ibrance is indicated for the treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with:* an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or* fulvestrant in patients with disease progression following endocrine therapy.