Canada - English - Health Canada

teva canada limited - teriparatide (teriparatide acetate) - solution - 250mcg - teriparatide (teriparatide acetate) 250mcg - parathyroid agents

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

apotex corp. - teriparatide (unii: 10t9csu89i) (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 injection use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. consider discontinuing teriparatide injection 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 injection 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 injection 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 injection 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 injection 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 injection 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 injection alters the underlying metabolic bone disease seen in chronic renal impairment  [see clinical pharmacology (12.3)]. teriparatide injection, usp user manual 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. 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. a. the yellow shaft is still showing after i push in the black injection button. how do i reset my teriparatide injection 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 apotex corp (see contact information below) or your healthcare provider. - put the large needle cover on the 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 teriparatide injection 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 teriparatide delivery device with a damp cloth. - do not place the teriparatide delivery device in water, or wash or clean with any liquid. storing your teriparatide delivery device - after each use, refrigerate the teriparatide 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 delivery device with a needle attached. doing this may cause air bubbles to form in the medicine cartridge. - store the teriparatide delivery device with the white cap on. - do not freeze teriparatide injection. if the teriparatide delivery device has been frozen, throw the device away and use a new teriparatide delivery device. - if the teriparatide 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 apotex at 1-800-706-5575. - the teriparatide 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 delivery device the right way. - check the teriparatide delivery device label to make sure you have the right medicine and that it has not expired. - do not use the teriparatide delivery device if it looks damaged. look at the teriparatide medicine in the cartridge. if the medicine is not clear and colorless, or if it has particles, do not use it. call apotex 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 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 delivery device and needles out of the reach of children. - before throwing away the teriparatide delivery device, be sure to remove the pen needle. - throw away your teriparatide delivery device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies. contact information

Israel - English - Ministry of Health

abic marketing ltd, israel - teriparatide as acetate - solution for injection - teriparatide as acetate 250 mcg/ml - teriparatide - treatment of postmenopausal women with osteoporosis at high risk for fracture:teriparatide teva is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. in postmenopausal women with osteoporosis, teriparatide teva increases bmd reduces the risk of vertebral and nonvertebral fractures . increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture :teriparatide teva is indicated to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy . treatment of men and women with glucocorticoid-induced osteoporosis at high risk for fracture:teriparatide teva is indicated 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, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy

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

prasco laboratories - teriparatide (unii: 10t9csu89i) (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 injection use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. consider discontinuing teriparatide injection 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 injection use in women who are breastfeeding. the safety and effectiveness of teriparatide injection 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 injection 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 injection 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 injection 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 injection 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 injection alters the underlying metabolic bone disease seen in chronic renal impairment [see clinical pharmacology (12.3)] . teriparatide [ter-i-par-a-tide] injection user manual important: first read the medication guide that comes inside your teriparatide carton. before you use your new teriparatide delivery device, please read the entire front and back of this user manual completely. follow the directions carefully when using the teriparatide delivery device. do not share your delivery device or needles because infection or disease can be spread from one person to another. the teriparatide delivery device contains 28 days of medicine. throw away the teriparatide delivery device after 28 days, even if it is not completely empty. do not inject more than one dose of teriparatide in the same day. do not transfer teriparatide 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. - 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 teriparatide delivery device in the refrigerator. - wipe the outside of the teriparatide delivery device with a damp cloth. - do not place the teriparatide delivery device in water, or wash or clean it with any liquid. - after each use, refrigerate the teriparatide delivery device right away. read and follow the instructions in the medication guide section “how should i store teriparatide?”. - do not store the teriparatide delivery device with a needle attached. doing this may cause air bubbles to form in the medicine cartridge. - store the teriparatide delivery device with the white cap on. - do not freeze teriparatide. if the teriparatide delivery device has been frozen, throw the device away and use a new teriparatide delivery device. - if the teriparatide 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 1-866-436-7836. - the teriparatide delivery device contains 28 days of medicine. - do not transfer teriparatide 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 delivery device the right way. - check the teriparatide delivery device label to make sure you have the right medicine and that it has not expired. - do not use the teriparatide delivery device if it looks damaged. look at the teriparatide 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 teriparatide 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 delivery device and needles out of the reach of children. - before throwing away the teriparatide delivery device, be sure to remove the pen needle. - throw away your teriparatide delivery device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies. literature revised october 3, 2019 ter-0002-ifu-20191003

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

alvogen, inc. - teriparatide (unii: 10t9csu89i) (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 reactio

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

generic health pty ltd - teriparatide, quantity: 0.25 mg/ml - injection, solution - excipient ingredients: glacial acetic acid; water for injections; sodium acetate; cresol; mannitol; hydrochloric acid; sodium hydroxide - teriparatide lupin 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 lupin is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - teriparatide acetate 0.25 mg/ml - solution for injection - 250 mcg/ml - active: teriparatide acetate 0.25 mg/ml excipient: glacial acetic acid hydrochloric acid mannitol metacresol nitrogen sodium acetate trihydrate sodium hydroxide water for injection - in combination with calcium and vitamin d, for the treatment osteoporosis in postmenopausal women and in men at high risk of fracture.

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - teriparatide - osteoporosis; osteoporosis, postmenopausal - calcium homeostasis - teriparatide sun is indicated in adults.treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated.treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).

Israel - English - Ministry of Health

kamada ltd, israel - teriparatide - solution for injection - teriparatide 0.250 mg / 1 ml - teriparatide - treatment of postmenopausal women with osteoporosis at high risk for fractureteriparatide kamada is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. in postmenopausal women with osteoporosis, teriparatide kamada increases bmd reduces the risk of vertebral and nonvertebral fractures.increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fractureteriparatide kamada is indicated to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.treatment of men and women with glucocorticoid-induced osteoporosis at high risk for fractureteriparatide kamada is indicated 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, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

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

bachem americas, inc. - teriparatide acetate (unii: 9959p4v12n) (teriparatide acetate - unii:9959p4v12n) -