Israel - English - Ministry of Health

eli lilly israel ltd, israel - olanzapine - tablets orodispersible - olanzapine 10 mg - olanzapine - olanzapine - acute and maintenance treatment of schizophrenia. zyprexa is indicated for the management of the manifestations of psychotic disorders. zyprexa is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. prevention of recurrence in bipolar disorder : in patients whose manic episode has responded to olanzapine treatment zyprexa is indicated for the prevention of recurrence in patients with bipolar disorder. combination therapy in bipolar i disorder: the combination of zyprexa with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder.

Israel - English - Ministry of Health

eli lilly israel ltd - gemcitabine as hydrochloride - lyophilic powder for concentrated infusion - gemcitabine as hydrochloride 1 g/vial - pyrimidine analogues - palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-fu refractory pancreatic cancer. gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage. breast cancer: gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.prior chemotherapy should have included an anthracycline unless clinically contraindicated. ovarian cancer: gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed at least six months after platinum - based therapy.

Israel - English - Ministry of Health

eli lilly israel ltd - gemcitabine as hydrochloride - lyophilic powder for concentrated infusion - gemcitabine as hydrochloride 1 g/vial - pyrimidine analogues - palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-fu refractory pancreatic cancer. gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage. breast cancer: gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.prior chemotherapy should have included an anthracycline unless clinically contraindicated. ovarian cancer: gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed at least six months after platinum - based therapy.

United States - English - 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

Israel - English - Ministry of Health

eli lilly israel ltd, israel - olanzapine - tablets - olanzapine 5 mg - olanzapine - acute and maintenance treatment of schizophrenia. zyprexa is indicated for the management of the manifestations of psychotic disorders. zyprexa is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder. prevention of recurrence in bipolar disorder : in patients whose manic episode has responded to olanzapine treatment zyprexa is indicated for the prevention of recurrence in patients with bipolar disorder. combination therapy in bipolar i disorder: the combination of zyprexa with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with bipolar i disorder.

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

physicians total care, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug - astelin® nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older. astelin® nasal spray is contraindicated in patients with a known hypersensitivity to azelastine hydrochloride or any of its components. for intranasal use only important: follow instructions carefully to ensure proper dosing. dosing: the dosage of astelin® nasal spray is 1 spray per nostril twice daily for pediatric patients (ages 5-11 years) with seasonal allergic rhinitis. for patients age 12 and older with seasonal allergic rhinitis the dosage is one or two sprays per nostril twice daily. for patients age 12 and older with nonallergic vasomotor rhinitis the dosage is two sprays per nostril twice daily. keep your head tilted downward when spraying. alternate s

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

endo pharmaceuticals inc. - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) - histrelin acetate 50 mg - supprelin la (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (cpp). children with cpp (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). they also show a significantly advanced bone age that can result in diminished adult height attainment. prior to initiation of treatment a clinical diagnosis of cpp should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (lh) and follicle stimulating hormone (fsh) following stimulation with a gnrh analog, and assessment of bone age versus chronological age. baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adre

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

ingenus pharmaceuticals nj, llc - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride 30 mg

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

sun pharmaceutical industries, inc. - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

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

lupin pharmaceuticals,inc. - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline is indicated for the treatment of symptoms of dry mouth in patients with sjÖgren's syndrome. cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.