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

generic health pty ltd - teriparatide, quantity: 0.25 mg/ml - injection, solution - excipient ingredients: mannitol; water for injections; sodium acetate; glacial acetic acid; cresol; hydrochloric acid; sodium hydroxide - teriparatide gh is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures. ,teriparatide gh is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

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

generic health pty ltd - teriparatide, quantity: 0.25 mg/ml - injection, solution - excipient ingredients: mannitol; water for injections; glacial acetic acid; sodium acetate; cresol; hydrochloric acid; sodium hydroxide - teriparatide lapl is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures. ,teriparatide lapl is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

Jepang - Inggris - すりの適正使用協議会 RAD-AR Council, Japan

asahi kasei pharma corporation - teriparatide acetate - injection

Irlandia - Inggris - HPRA (Health Products Regulatory Authority)

teva b.v. - teriparatide - solution for injection in pre-filled pen - 20/80 - parathyroid hormones and analogues; teriparatide

Amerika Serikat - Inggris - NLM (National Library of Medicine)

eli lilly and company - teriparatide (unii: 10t9csu89i) (teriparatide - unii:10t9csu89i) - teriparatide 250 ug in 1 ml - forteo is indicated: - for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. in postmenopausal women with osteoporosis, forteo reduces the risk of vertebral and nonvertebral fractures. - to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. - for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. forteo is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. hypersensitivity reactions have included angioedema and anaphylaxis [see adverse reactions (6.3)] . risk summary there are no available data on forteo use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. consider discontinuing forteo when pregnancy is recognized. in animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m2 ), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. the background risk in the us general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in animal reproduction studies, pregnant mice received teriparatide during organogenesis at subcutaneous doses equivalent to 8 to 267 times the human dose (based on body surface area, mcg/m2 ). at subcutaneous doses ≥60 times the human dose, the fetuses showed an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib). when pregnant rats received teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings. in a perinatal/postnatal study in pregnant rats dosed subcutaneously from organogenesis through lactation, mild growth retardation was observed in female offspring at doses ≥120 times the human dose. mild growth retardation in male offspring and reduced motor activity in both male and female offspring were observed at maternal doses of 540 times the human dose. there were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively. risk summary it is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant. avoid forteo use in women who are breastfeeding. the safety and effectiveness of forteo have not been established in pediatric patients. pediatric patients are at higher baseline risk of osteosarcoma because of open epiphyses [see warnings and precautions (5.1)] . of the patients who received forteo in the osteoporosis trial of 1637 postmenopausal women, 75% were 65 years of age and older and 23% were 75 years of age and older. of the patients who received forteo in the trial of 437 men with primary or hypogonadal osteoporosis, 39% were 65 years of age and over and 13% were 75 years of age and over. of the 214 patients who received forteo in the glucocorticoid induced osteoporosis trial, 28% were 65 years of age and older and 9% were 75 years of age and older. no overall differences in safety or effectiveness of forteo have been observed between patients 65 years of age and older and younger adult patients. no studies have been performed in patients with hepatic impairment [see clinical pharmacology (12.3)] . in 5 patients with severe renal impairment (crcl<30 ml/minute), the auc and t1/2 of teriparatide were increased by 73% and 77%, respectively. maximum serum concentration of teriparatide was not increased. it is unknown whether forteo alters the underlying metabolic bone disease seen in chronic renal impairment [see clinical pharmacology (12.3)] . forteo® (for-tay-o) teriparatide injection user manual important: first read the medication guide that comes inside your forteo carton. before you use your new forteo delivery device, please read the entire front and back of this user manual completely. follow the directions carefully when using the forteo delivery device. do not share your delivery device or needles because infection or disease can be spread from one person to another. the forteo delivery device contains 28 days of medicine. throw away the forteo delivery device after 28 days, even if it is not completely empty. do not inject more than one dose of forteo in the same day. do not transfer forteo to a syringe. wash your hands before every injection. prepare the injection site as your healthcare provider instructed. for more information, or if you have any questions, turn to the back of this page. forteo® (for-tay-o) teriparatide injection a. the yellow shaft is still showing after i push in the black injection button. how do i reset my forteo delivery device? - if you have already injected, do not inject yourself a second time on the same day. - remove the needle. - attach a new needle, pull off the large needle cover and save it. - pull out the black injection button until it stops. check to make sure the red stripe shows. - pull off the small needle protector and throw away. - point the needle down into an empty container. push in the black injection button until it stops. hold it in and slowly count to five. you may see a small stream or drop of fluid. when you have finished, the black injection button should be all the way in. - if you still see the yellow shaft showing, contact eli lilly and company (see contact information below) or your healthcare provider. - put the large needle cover on needle. unscrew the needle all the way by giving the needle cover 3 to 5 counter-clockwise turns. pull off the covered needle and throw away as instructed by your healthcare provider. push the white cap back on, and put your forteo delivery device in the refrigerator. - put the large needle cover on the needle. - use the large needle cover to unscrew the needle. - unscrew the needle all the way by giving the large needle cover 3 to 5 counter-clockwise turns. - if you still cannot get the needle off, ask someone to help you. e. what should i do if i have difficulty pulling out the black injection button? - wipe the outside of the forteo delivery device with a damp cloth. - do not place the forteo delivery device in water, or wash or clean it with any liquid. storing your forteo delivery device - after each use, refrigerate the forteo delivery device right away. read and follow the instructions in the medication guide section “how should i store forteo?”. - do not store the forteo delivery device with a needle attached. doing this may cause air bubbles to form in the medicine cartridge. - store the forteo delivery device with the white cap on. - do not freeze forteo. if the forteo delivery device has been frozen, throw the device away and use a new forteo delivery device. - if the forteo delivery device has been left out of the refrigerator, do not throw the delivery device away. place the delivery device back in the refrigerator and call eli lilly and company at 1-866-4forteo (1-866-436-7836). - the forteo delivery device contains 28 days of medicine. - do not transfer forteo to a syringe. this may result in you taking the wrong dose of medicine. - read and follow the instructions in the user manual so that you use your forteo delivery device the right way. - check the forteo delivery device label to make sure you have the right medicine and that it has not expired. - do not use the forteo delivery device if it looks damaged. look at the forteo medicine in the cartridge. if the medicine is not clear and colorless, or if it has particles, do not use it. call eli lilly and company if you notice any of these (see contact information ). - use a new needle for each injection. - during injection, you may hear one or more clicks – this is normal. - the forteo delivery device is not recommended for use by the blind or by those who have vision problems without help from a person trained in the proper use of the device. - keep your forteo delivery device and needles out of the reach of children. - before throwing away the forteo delivery device, be sure to remove the pen needle. - throw away your forteo delivery device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies. contact information literature revised october 3, 2019 for-0002-ifu-20191003

Amerika Serikat - Inggris - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - teriparatide acetate (unii: 9959p4v12n) (teriparatide - unii:10t9csu89i) - teriparatide injection is indicated: - for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. in postmenopausal women with osteoporosis, teriparatide injection reduces the risk of vertebral and nonvertebral fractures. - to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. - for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. teriparatide injection is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. hypersensitivity reactions have included angioedema and anaphylaxis [see adverse reactions (6.3)] . risk summary there are no available data on teriparatide use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. consider discontinuing teriparatide when pregnancy is recognized. in animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m2 ), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. the background risk in the us general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in animal reproduction studies, pregnant mice received teriparatide during organogenesis at subcutaneous doses equivalent to 8 to 267 times the human dose (based on body surface area, mcg/m2 ). at subcutaneous doses ≥60 times the human dose, the fetuses showed an increased incidence of skeletal deviations or variations (interrupted rib, extra vertebra or rib). when pregnant rats received teriparatide during organogenesis at subcutaneous doses 16 to 540 times the human dose, the fetuses showed no abnormal findings. in a perinatal/postnatal study in pregnant rats dosed subcutaneously from organogenesis through lactation, mild growth retardation was observed in female offspring at doses ≥120 times the human dose. mild growth retardation in male offspring and reduced motor activity in both male and female offspring were observed at maternal doses of 540 times the human dose. there were no developmental or reproductive effects in mice or rats at doses 8 or 16 times the human dose, respectively. risk summary it is not known whether teriparatide is excreted in human milk, affects human milk production, or has effects on the breastfed infant. avoid teriparatide use in women who are breastfeeding. the safety and effectiveness of teriparatide have not been established in pediatric patients. pediatric patients are at higher baseline risk of osteosarcoma because of open epiphyses [see warnings and precautions (5.1)] . of the patients who received teriparatide in the osteoporosis trial of 1637 postmenopausal women, 75% were 65 years of age and older and 23% were 75 years of age and older. of the patients who received teriparatide in the trial of 437 men with primary or hypogonadal osteoporosis, 39% were 65 years of age and over and 13% were 75 years of age and over. of the 214 patients who received teriparatide in the glucocorticoid induced osteoporosis trial, 28% were 65 years of age and older and 9% were 75 years of age and older. no overall differences in safety or effectiveness of teriparatide have been observed between patients 65 years of age and older and younger adult patients. no studies have been performed in patients with hepatic impairment [see clinical pharmacology (12.3)] . in 5 patients with severe renal impairment (crcl<30 ml/minute), the auc and t1/2 of teriparatide were increased by 73% and 77%, respectively. maximum serum concentration of teriparatide was not increased. it is unknown whether teriparatide alters the underlying metabolic bone disease seen in chronic renal impairment [see clinical pharmacology (12.3)] . teriparatide   (ter" i par' a tide)  injection important: first read the medication guide that comes inside your teriparatide injection carton. before you use your new teriparatide injection delivery device, please read the entire front and back of this user manual completely. follow the directions carefully when using the teriparatide injection delivery device. do not share your delivery device or needles because infection or disease can be spread from one person to another. the teriparatide injection delivery device contains 28 days of medicine. throw away the teriparatide injection delivery device after 28 days, even if it is not completely empty. do not inject more than one dose of teriparatide injection in the same day. do not transfer teriparatide injection to a syringe. teriparatide injection delivery device parts* wash your hands before every injection. prepare the injection site as your healthcare provider instructed. 1 pull off blue cap check the teriparatide injection delivery device label to make sure you have the right medicine and that it has not expired. do not use if the teriparatide injection delivery device looks damaged, if the medicine in the cartridge is not clear and colorless, or if it has particles in it. 2 attach new needle pull off paper tab. push needle straight onto medicine cartridge. screw on needle clockwise until firmly attached. pull off large needle cover and save it. 3 set dose pull out black injection button until it  stops . if you cannot pull out the black injection button see troubleshooting, problem e, on back page. check to make sure red stripe shows. pull off small needle protector and throw away. 4 inject dose gently hold a fold of skin on your thigh or abdomen and insert needle straight into skin. push in black injection button until it stops. hold it in and count to 5 slowly.  you must wait until the count of 5 to make sure you receive the correct dose. then pull the needle from skin. important 5 confirm dose after completing the injection: once the needle is removed from the skin, take your thumb off the black injection button. check to make sure the black injection button is all the way in. if the yellow shaft does not show, you have finished the injection steps the right way. you should not see any of the yellow shaft. if you do and have already injected the medicine, do not inject yourself a second time on the same day. instead, you must reset the teriparatide injection delivery device (see troubleshooting, problem a, on back page). 6 remove needle put large needle cover on needle. do not try to put the needle cover back on with your hands. unscrew the covered needle all the way by giving the large needle cover 3 to 5 counter-clockwise turns. pull off needle and throw away in a puncture-resistant container. push blue cap back on. right after use, place teriparatide injection delivery device in the refrigerator.   for more information, or if you have any questions, turn to the back of this page.   teriparatide   (ter" i par' a tide)  injection troubleshooting problem solution a.  the yellow shaft is still showing after i push in the black injection button. how do i reset my teriparatide injection delivery device? to reset the teriparatide injection delivery device, follow the steps below. 1 if you have already injected, do not inject yourself a second time on the same  day. 2 remove the needle. 3 attach a new needle, pull off the large needle cover and save it. 4 pull out the black injection button until it stops. check to make sure the red stripe shows. 5 pull off the small needle protector and throw away. 6 point the needle down into an empty container. push in the black injection button until it stops. hold it in and slowly count to five. you may see a small stream or drop of fluid. when you have finished, the black injection button should be all the way in. 7 if you still see the yellow shaft showing, contact teva (see contact information below) or your healthcare provider. 8 put the large needle cover on needle. unscrew the needle all the way by giving the needle cover 3 to 5 counter-clockwise turns. pull off the covered needle and throw away as instructed by your healthcare provider. push the blue cap back on, and put your teriparatide injection delivery device in the refrigerator. you can prevent this problem by always using a new needle for each injection, and by pushing the black injection button all the way in and slowly counting to five. b.  how can i tell if my teriparatide injection delivery device works? the black injection button should be all the way in to show that the full dose of medicine has been injected from the teriparatide injection delivery device. use a new needle every time you inject to be sure your teriparatide injection delivery device will work properly. c.  i see an air bubble in my teriparatide injection delivery device. a small air bubble will not affect your dose and it will not harm you. you can continue to take your dose as usual. d.  i cannot get the needle off. 1. put the large needle cover on the needle. 2. use the large needle cover to unscrew the needle. 3. unscrew the needle all the way by giving the large needle cover 3 to 5 counter-clockwise turns. 4. if you still cannot get the needle off, ask someone to help you. e.  what should i do if i have difficulty pulling out the black injection button? change to a new teriparatide injection delivery device to take your dose as instructed by your healthcare provider. when the black injection button becomes hard to pull out, this means there is not enough medicine in your teriparatide injection delivery device for another dose. you may still see some medicine left in the cartridge. cleaning and storage cleaning your teriparatide injection delivery device - wipe the outside of the teriparatide injection delivery device with a damp cloth. - do not place the teriparatide injection delivery device in water, or wash or clean it with any liquid. storing your teriparatide injection delivery device - after each use, refrigerate the teriparatide injection delivery device right away. read and follow the instructions in the medication guide section “how should i store teriparatide injection?”. - do not store the teriparatide injection delivery device with a needle attached. doing this may cause air bubbles to form in the medicine cartridge. - store the teriparatide injection delivery device with the blue cap on. - do not freeze teriparatide injection. if the teriparatide injection delivery device has been frozen, throw the device away and use a new teriparatide injection delivery device. - if the teriparatide injection delivery device has been left out of the refrigerator, do not throw the delivery device away. place the delivery device back in the refrigerator and call teva pharmaceuticals usa, inc. at 1-888-838-2872.   other important notes - the teriparatide injection delivery device contains 28 days of medicine. - do not transfer teriparatide injection to a syringe. this may result in you taking the wrong dose of medicine. - read and follow the instructions in the user manual so that you use your teriparatide injection delivery device the right way. - check the teriparatide injection delivery device label to make sure you have the right medicine and that it has not expired. - do not use the teriparatide injection delivery device if it looks damaged. look at the teriparatide injection medicine in the cartridge. if the medicine is not clear and colorless, or if it has particles, do not use it. call teva pharmaceuticals usa, inc. if you notice any of these ( see contact information) . - use a new needle for each injection. - during injection, you may hear one or more clicks – this is normal. - the teriparatide injection delivery device is not recommended for use by the blind or by those who have vision problems without help from a person trained in the proper use of the device. - keep your teriparatide injection delivery device and needles out of the reach of children.   disposal of pen needles and delivery device disposal of pen needles and the teriparatide injection delivery device - before throwing away the teriparatide injection delivery device, be sure to remove the pen needle. - throw away your teriparatide injection delivery device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies. dispose of the teriparatide injection delivery device 28 days after first use. 1st use date ______ / ______ / ______ throw away after ______ / ______ / ______ contact information if you have questions or need help with your teriparatide injection delivery device, contact teva pharmaceuticals usa, inc. at 1-888-838-2872 or  your healthcare provider. keep this and all medications out of the reach of children. manufactured in croatia by: pliva hrvatska d.o.o., zagreb, croatia manufactured for: teva pharmaceuticals usa, inc., parsippany, nj 07054 iss. 11/2021

Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

boucher & muir (new zealand) limited t/a bnm group - teriparatide 0.25 mg/ml (as acetate) - solution for injection - 250 mcg/ml - active: teriparatide 0.25 mg/ml (as acetate) excipient: glacial acetic acid hydrochloric acid mannitol metacresol nitrogen sodium acetate sodium hydroxide water for injection - teriparatide bnm is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

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

gedeon richter australia pty ltd - teriparatide, quantity: 250 microgram/ml - injection, solution - excipient ingredients: metacresol; water for injections; sodium hydroxide; hydrochloric acid; glacial acetic acid; mannitol; sodium acetate trihydrate - terrosa is indicated for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures.,terrosa is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

Malaysia - Inggris - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

accord healthcare sdn.bhd. - teriparatide -

Kanada - Inggris - Health Canada

apotex inc - teriparatide - solution - 250mcg - teriparatide 250mcg - parathyroid agents