Estados Unidos - inglês - 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

Estados Unidos - inglês - NLM (National Library of Medicine)

h.j. harkins company, inc. - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin 3 mg in 1 ml - tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution. clinical studies have shown tobramycin to be safe and effective for use in children. tobramycin ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.

Estados Unidos - inglês - NLM (National Library of Medicine)

lannett company, inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin 10 mg in 1 ml - doxepin is recommended for the treatment of: 1. psychoneurotic patients with depression and/or anxiety. 2. depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. the target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in pediatric patients under 12 years of age. doxepin is contraindicated in individuals who have s

Estados Unidos - inglês - NLM (National Library of Medicine)

lannett company, inc. - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam 5 mg in 5 ml - diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

permobil australia - 11100 - cushion, sitting, wheelchair - contour foam cushion with gel overlay

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

the boots company plc - hydrocortisone - cutaneous ointment - 10mg/1gram

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

the boots company plc - hydrocortisone acetate - cutaneous cream - 10mg/1gram

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

sigma company limited - iron polymaltose, quantity: 318 mg (equivalent: iron, qty 100 mg) - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - indications as at 8 april 2002: for the treatment of iron deficiency anaemia in the following circumstances: * when oral therapy is contraindicated. * when enteric absorption of iron is defective. * when patient non-compliance or persistent gastrointestinal intolerance makes oral therapy impractical.

Estados Unidos - inglês - NLM (National Library of Medicine)

lannett company, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. metadate er is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. specific etiology of th

Estados Unidos - inglês - NLM (National Library of Medicine)

lannett company, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. spec