India - English - Central Drugs Standard Control Organization

zydus cadila - vit.b1,vit.b2,vit.b3,vit.b5,vit.b6,vit.b12,vit.c,folic acid,zinc sulph. - cap - 10mg,10mg,50mg,12.5mg,3mg,15mcg,150mg,1mg,27.5mg - 10

India - English - Central Drugs Standard Control Organization

zydus cadila - vit.b1,vit.b2,vit.b3,vit.b5,vit.b6,vit.b12,vit.c,folic acid - cap - 10mg,10mg,100mg,5mg,2.5mg,10mcg,150mg,1.5mg - 10

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

virbac (australia) pty ltd - caffeine | quinine sulfate | calcium glycerophosphate | cobalt (ii) sulfate | copper sulfate | ammonium ferric citrate | potassium glycerophosphate | magnesium glycerophosphate | manganese glycerophosphate | sodium glycerophosphate | vitamin b3 = nicotinamide | riboflavin-5-phosphate sodium | vitamin b1 hydrochloride = thiamine hydrochloride | vitamin b6 = pyridoxine - nutrition & metabolism - dog - greyhound | racing greyhound - mineral and nutritional additive | acetonaemia | actinobacillosis | amino acid supplement | amino acids | bone fragility | bone growth | calcium supplement | cartilage strength | copper deficiency | egg shell | fatty acid deficiency | fatty liver | glucose | grass tetany | hepatotoxic drugs | hypocalcaemia | hypomagnesaemia | ileitis | iodine deficiencies | lactating | laxative | l-carnitine supplement | liver abscess | liver damage | lysine deficiencies | milk fever | mineral additive | myopathies | myositis syndrome | pangamic acid | phosphorous supplement | rickets | selenium deficiency | shell strength | soft bone disease | vitamin b12 | vitamin d supplement | vitamin e deficiencies | zinc deficiencies

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

endo pharmaceuticals inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 10 mg in 0.5 g - fortesta is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired) – testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol, heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone [fsh] and luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired) – gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low serum testosterone concentrations but have gonadotropins in the normal or low range. limitations of use - safety and efficacy of fortesta in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - safety and efficacy of fortesta in males <18 years old have not been established [see use in specific populations (8.4)] . - fortesta is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see warnings and precautions (5.1) and adverse reactions (6.1)] . - fortesta is contraindicated in women who are pregnant. testosterone can cause virilization of the female fetus when administered to a pregnant woman [see use in specific populations (8.1, 8.2)] . risk summary fortesta is contraindicated in pregnant women. testosterone is teratogenic and may cause fetal harm based on data from animal studies and its mechanism of action [see contraindications (4) and clinical pharmacology (12.1)] . exposure of a female fetus to androgens may result in varying degrees of virilization. in animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. these studies did not meet current standards for nonclinical development toxicity studies. data animal data in developmental studies conducted in rats, rabbits, pigs, sheep, and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis. testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. increased pituitary weight was seen in both sexes. testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy. risk summary fortesta is not indicated for use in females. infertility during treatment with large doses of exogenous androgens, including fortesta, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see warnings and precautions (5.8)] , possibly leading to adverse effects on semen parameters including sperm count. reduced fertility is observed in some men taking testosterone replacement therapy. testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see drug abuse and dependence (9.2)] . with either type of use, the impact on fertility may be irreversible. the safety and efficacy of fortesta in pediatric patients <18 years old has not been established. improper use may result in acceleration of bone age and premature closure of epiphyses. there have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing fortesta to determine whether efficacy in those over 65 years of age differs from younger subjects. of the 149 patients enrolled in the pivotal clinical study utilizing fortesta, 20 were over 65 years of age. additionally, there are insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer. geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of bph. no studies were conducted in patients with renal impairment. no studies were conducted in patients with hepatic impairment. fortesta contains testosterone, a schedule iii controlled substance in the controlled substances act. drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. abuse and misuse of testosterone are seen in male and female adults and adolescents. testosterone, often in combination with other anabolic androgenic steroids (aas), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. there have been reports of misuse of men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. abuse-related adverse reactions serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, and aggression. the following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. the following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. the following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. behaviors associated with addiction continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: - taking greater dosages than prescribed - continued drug use despite medical and social problems due to drug use - spending significant time to obtain the drug when supplies of the drug are interrupted - giving a higher priority to drug use than other obligations - having difficulty in discontinuing the drug despite desires and attempts to do so - experiencing withdrawal symptoms upon abrupt discontinuation of use physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. drug dependence in individuals using approved doses of testosterone for approved indications has not been documented. instructions for use fortesta® (for-tes-ta) ciii (testosterone) gel for topical use read this instructions for use for fortesta before you start using it and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. applying fortesta: - apply fortesta only to areas that will be covered by shorts or pants. - fortesta should be applied to the front and inner part of your thighs only. do not apply fortesta to the area of the thigh closest to the scrotum. do not apply fortesta to any other parts of your body such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms. - apply fortesta in the morning. if you shower or bathe, fortesta should be applied afterwards. - avoid swimming, showering, or bathing for at least 2 hours after you apply fortesta. - fortesta is flammable until dry. let fortesta dry before smoking or going near an open flame. - wash your hands with soap and water right after you apply fortesta. - before using a new canister of fortesta for the first time, you will need to prime the pump. to prime the fortesta pump, gently push down on the pump 8 times. do not use any fortesta that comes out while priming. wash it down the sink or throw it in the trash to avoid accidental exposure to others. your fortesta pump is now ready to use. - use fortesta exactly as your healthcare provider tells you to use it. your healthcare provider will tell you the dose of fortesta that is right for you. - press down on the pump to apply the medicine directly on clean, dry, skin that is not broken on the front and inner part of your thighs. use 1 finger to gently rub fortesta evenly onto the front and inner part of each thigh. - let the application site dry completely before putting on shorts or pants. - wash your hands right away with soap and water. how should i store fortesta? - store fortesta at room temperature between 68ºf to 77ºf (20ºc to 25ºc). - when it is time to throw away the canister, safely throw away used fortesta in the household trash. be careful to prevent accidental exposure of children or pets. - keep fortesta away from fire. - do not freeze fortesta. keep fortesta and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. revised: 05/2019

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

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

eli lilly australia pty ltd - teriparatide, quantity: 250 microgram - injection, solution - excipient ingredients: glacial acetic acid; sodium acetate; hydrochloric acid; mannitol; sodium hydroxide; water for injections; metacresol - forteo 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. forteo is indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

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

ceva sante animale - gleptoferron (unii: 898723iqhq) (gleptoferron - unii:898723iqhq) - gleptoforte® (gleptoferron) 200 mg/ml of iron solution for intramuscular injection not for use in humans keep out of reach of children approved by fda under anada # 200-587 description:  gleptoforte® is a sterile aqueous colloidal solution of gleptoferron, a macromolecular complex of ferric hydroxide and dextran glucoheptonic acid. each milliliter contains 200 mg of elemental iron. the solution contains 0.5% phenol as preservative. actions:  gleptoforte® contains gleptoferron which provides a rapidly absorbed and readily utilizable form of iron for the prevention and treatment of baby pig anemia. indications:  gleptoforte® is recommended for both the routine prevention and treatment of baby pig anemia due to iron deciency. notice: organic iron preparations injected intramuscularly into pigs beyond 4 weeks of age may cause staining of the muscle tissue.

New Zealand - English - Medsafe (Medicines Safety Authority)

eli lilly and company (nz) limited - teriparatide 250 µg/ml (rhpth(1-34));   - solution for injection - 250 mcg/ml - active: teriparatide 250 µg/ml (rhpth(1-34))   excipient: glacial acetic acid hydrochloric acid mannitol metacresol sodium acetate sodium hydroxide water for injection - forteo, in combination with calcium and vitamin d, is indicated for the treatment of osteoporosis in postmenopausal women and in men at high risk of fracture.

New Zealand - English - Ministry for Primary Industries

bayer new zealand limited - phenmedipham; desmedipham - phenmedipham 160 g/litre; desmedipham 160 g/litre - herbicide

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios syva, s.a.u - dexamethasone sodium phosphate - solution for injection - 2 milligram(s)/millilitre - dexamethasone - cats, cattle, dogs, horses, pigs - corticosteroid