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boehringer ingelheim pharmaceuticals, inc. - spesolimab (unii: 5ib2j79mcx) (spesolimab - unii:5ib2j79mcx) - spevigo is indicated for the treatment of generalized pustular psoriasis (gpp) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. spevigo is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in spevigo. reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (dress) [see warnings and precautions (5.3) and adverse reactions (6.1)] . risk summary the limited data on the use of spevigo in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. human igg is known to cross the placental barrier; therefore, spevigo may be transmitted from the mother to the developing fetus. in an animal reproduction study, intravenous administration of a surrogate antibody against il36r in mice during the period of organogenesis did not elicit any reproductive toxicity (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data embryo-fetal development and pre- and postnatal development toxicity studies were performed in mice using a surrogate mouse specific il36r antagonist monoclonal antibody. in the embryo-fetal development study, the surrogate was administered intravenously at doses up to 50 mg/kg to pregnant female mice twice weekly during the period of organogenesis. the surrogate was not associated with embryo-fetal lethality or fetal malformations. in the pre- and postnatal development toxicity study, the surrogate was administered intravenously at doses up to 50 mg/kg to pregnant female mice twice weekly from gestation day 6 through lactation day 18. there were no maternal effects observed. there were no treatment-related effects observed on postnatal developmental, neurobehavioral, or reproductive performance of offspring. risk summary there are no data on the presence of spesolimab-sbzo in human milk, the effects on the breastfed infant, or the effects on milk production. spesolimab-sbzo is a monoclonal antibody and is expected to be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for spevigo and any potential adverse effects on the breastfed infant from spevigo or from the underlying maternal condition. the safety and effectiveness of spevigo for the treatment of gpp have been established in pediatric patients 12 years of age and older and weighing at least 40 kg. use of spevigo for this indication is supported by data from a randomized, placebo-controlled study which included 6 pediatric subjects 14 to 17 years of age with a history of gpp treated with subcutaneous spevigo (study effisayil-2) and evidence from an adequate and well-controlled study of intravenous spevigo in adults with gpp (study effisayil-1), with additional pharmacokinetic analyses showing similar drug exposure levels in adults and pediatric subjects 12 years of age and older and weighing 40 kg or more [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . the safety and effectiveness of spevigo in pediatric patients younger than 12 years of age or in pediatric patients weighing less than 40 kg have not been established. there were 2 (6%) intravenous spevigo-treated subjects 65 to 74 years of age and no subjects 75 years of age or older in study effisayil-1. there were 6 (7%) subcutaneous spevigo-treated subjects 65 to 74 years of age and 1 (1%) subject 75 years of age in study effisayil-2. clinical studies of spevigo did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects. this instructions for use contains information on how to inject spevigo. read both sides of this instructions for use before you use spevigo for the first time and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment. your healthcare provider should show you or your child the right way to inject spevigo before you try to inject yourself or your child for the first time. in children 12 to 17 years of age, spevigo should be given under supervision of an adult. spevigo comes in a prefilled syringe with a safety cover. spevigo is for one-time use only. do not reuse the prefilled syringes. your healthcare provider has prescribed a dose of spevigo for you or your child that requires 2 injections (2 prefilled syringes) to deliver a complete dose. you must inject the contents of both spevigo prefilled syringes that come in the carton to deliver the complete dose. getting to know spevigo: spevigo comes in a prefilled syringe with a safety cover. the needle is pulled back into the safety cover after injection. guide to parts: the figure below shows spevigo before use, and after use with the activated safety cover. important information you need to know before injecting spevigo: - you must inject the contents of both spevigo prefilled syringes to deliver a complete dose. - inspect the spevigo carton to be sure that you have the correct medicine, 2 prefilled syringes for your or your child's prescribed dose, for any damage, and the expiration date. - do not use spevigo if the liquid is cloudy or contains flakes or large or colored particles. - do not use spevigo if the expiration date (exp) has passed. - do not use spevigo if the prefilled syringe has been dropped. - do not remove the cap until you are ready to inject. - inject spevigo under the skin (subcutaneous injection) in either the upper thighs or stomach-area (abdomen). do not inject spevigo into any other area of the body. storing spevigo: - store spevigo prefilled syringes in the refrigerator between 36°f to 46°f (2°c to 8°c). - do not freeze spevigo. do not use spevigo if frozen, even if it has been thawed. - store spevigo in the original carton until use to protect from light. keep spevigo and all medicines out of the reach of children. - take the spevigo carton out of the refrigerator and remove the prefilled syringes from the carton. - gather supplies listed above and place them on a clean, flat work surface in a well-lit area. - if you do not have all the supplies listed above, contact your pharmacist. - see step 10: "disposing of the used spevigo prefilled syringes and caps." - wait 15 to 30 minutes to allow the medicine to reach room temperature to avoid discomfort during injection. do not speed up the warming process in any way, such as using the microwave or placing the syringe in warm water. - do not leave the prefilled syringes in direct sunlight. - do not remove the needle cap until you are ready to inject. - wash your hands well with soap and water and dry them. - check to make sure the medicine name spevigo and dose on your prefilled syringes match your or your child's prescribed dose. - check the expiration date on both prefilled syringes. do not use if the expiration date has passed. - check both prefilled syringes for damage, cracks, and leakage. do not use if any part of the prefilled syringes appear cracked, broken, or are leaking. - make sure the medicine in both prefilled syringes is clear and colorless to slightly brownish-yellow. it may contain tiny white or clear particles. do not use if the medicine is cloudy or has flakes or large or colored particles in it. - it is normal to see air bubbles, they do not need to be removed. - do not use if the spevigo prefilled syringes have been dropped. - you may use an area on your: upper thighs or stomach-area (abdomen) , except for an area 2 inches around your navel (belly button). - upper thighs or - stomach-area (abdomen) , except for an area 2 inches around your navel (belly button). - choose a different injection site each time you inject, at least 1 inch away from the last injection site. alternate between upper thigh or stomach-area for each complete dose. - do not inject an area near your waistline or belly button. - do not inject into areas that are tender, bruised, red, hard, or scarred. - do not inject through clothes. - clean the injection site with an alcohol wipe and let air dry. - do not touch this area again before injecting. - do not fan or blow on the clean area. - hold the prefilled syringe by the finger grip with one hand. with the other hand, pull the cap straight off. do not pull on or hold the plunger rod. do not twist the cap. twisting the cap could damage the needle. do not use the prefilled syringe if the needle is bent or damaged. if you accidentally bend the needle, do not attempt to straighten it. - do not pull on or hold the plunger rod. - do not twist the cap. twisting the cap could damage the needle. - do not use the prefilled syringe if the needle is bent or damaged. if you accidentally bend the needle, do not attempt to straighten it. - throw away the cap. see step 10: "disposing of the used spevigo prefilled syringes and caps. - inject spevigo right away after removing the cap. do not try to recap the needle. re-capping can lead to needle-stick injury. do not touch the needle or let the needle touch anything before injecting. - do not try to recap the needle. re-capping can lead to needle-stick injury. - do not touch the needle or let the needle touch anything before injecting. - gently pinch the area of cleaned skin around your injection site and hold it firmly. - keep the skin pinched during the entire injection. you will inject into the pinched skin. - do not let go until you have removed the needle from your skin at end of the injection. - hold the prefilled syringe by the blue finger grip. avoid touching the blue thumb pad. - using a quick, "dart-like" motion, insert the needle into the pinched skin at about a 45-degree angle . - do not move the needle while inserting or during the injection. - use your thumb to slowly press down on the blue thumb pad to push the plunger rod down inside the syringe body. - continue pressing on the blue thumb pad until the plunger rod has moved all the way down. - make sure that the blue thumb pad cannot be pressed any further so that the built-in safety cover can be activated. - slowly remove your thumb from the blue thumb pad, to move the needle out of your skin and up into the safety cover. check that the thumb pad springs back and that the needle is inside the safety cover. if the needle is not inside the safety cover call your healthcare provider. you may not have received a full dose. - check that the thumb pad springs back and that the needle is inside the safety cover. - if the needle is not inside the safety cover call your healthcare provider. you may not have received a full dose. - if there is bleeding, press a cotton ball or gauze on the site for a few seconds. - do not rub the injection site. - apply an adhesive bandage if needed. - choose a different injection site. the new injection site should be at least 1 inch away from last injection site. alternate between upper thigh or stomach-area for each complete dose. - get second prefilled syringe. - repeat steps 4 through 8 right away. - then continue to step 10. - put the used prefilled syringes and caps in an fda-cleared sharps disposal container right away after use. - do not throw away (dispose of) the prefilled syringes and caps in the household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak resistant, and - properly labeled to warn of hazardous waste inside the container. - do not reuse the prefilled syringes. - do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this. - do not recycle your used sharps disposal container. manufactured by: boehringer ingelheim pharmaceuticals, inc., ridgefield, ct 06877 usa us license number 2006 licensed from: boehringer ingelheim international gmbh, ingelheim, germany spevigo is a registered trademark of and used under license from boehringer ingelheim international gmbh. copyright © 2024 boehringer ingelheim international gmbh all rights reserved col12534ac152024 for more information about spevigo, including current prescribing information and medication guide, go to www.spevigo.com , scan the code below, or call boehringer ingelheim pharmaceuticals, inc. at 1-800-542-6257. this instructions for use has been approved by the u.s. food and drug administration. approved: 03/2024

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boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - linagliptin 2.5 mg - jentadueto xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use jentadueto xr is not recommended in patients with type 1 diabetes mellitus. jentadueto xr has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using jentadueto xr [see warnings and precautions (5.2)]. jentadueto xr is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)]. - acute or chronic metabolic acidosis, including diabetic ketoacidosis [see warnings and precautions (5.1)]. - hypersensitivity to linagliptin, metformin, or any of the excipients in jentadueto xr, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see warnings and precautions (5.4) and adve

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boehringer ingelheim pharmaceuticals, inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u) - empagliflozin 10 mg - jardiance is indicated: - to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. - to reduce the risk of sustained decline in egfr, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. - to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. - as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. limitations of use jardiance is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.1)] . jardiance is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an egfr less than 30 ml/min/1.73 m2 . jardiance is likely to be ineffective in t

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

boehringer ingelheim pharmaceuticals, inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u), linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - empagliflozin 10 mg - glyxambi is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see clinical studies (14.2)] . limitations of use glyxambi is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.1)] . glyxambi has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using glyxambi [see warnings and precautions (5.2)]. glyxambi is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an egfr less than 30 ml/min/1.73 m2 . glyxambi is likely to be ineffecti

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

boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - linagliptin 2.5 mg - jentadueto is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use jentadueto is not recommended in patients with type 1 diabetes mellitus. jentadueto has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using jentadueto [see warnings and precautions (5.2)]. jentadueto is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)]. - acute or chronic metabolic acidosis, including diabetic ketoacidosis [see warnings and precautions (5.1)]. - hypersensitivity to linagliptin, metformin, or any of the excipients in jentadueto, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see warnings and precautions (5.4) and adverse reactions (6.1

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

boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - linagliptin 5 mg - tradjenta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use tradjenta is not recommended in patients with type 1 diabetes mellitus as it would not be effective. tradjenta has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using tradjenta [see warnings and precautions (5.1)]. tradjenta is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in tradjenta, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see warnings and precautions (5.3) and adverse reactions (6)]. risk summary the limited data with tradjenta use in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated

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boehringer ingelheim pharmaceuticals inc. - dabigatran etexilate mesylate (unii: sc7nuw5iit) (dabigatran - unii:i0vm4m70gc) - dabigatran etexilate 75 mg - pradaxa capsules is indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. pradaxa capsules is indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5-10 days. pradaxa capsules is indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated. pradaxa capsules is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients who have undergone hip replacement surgery. pradaxa capsules is indicated for the treatment of venous thromboembolic events (vte) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days [see dosage and administration (2.3)] . pradaxa capsules is indicated to reduce the risk of recurrence of vte in pediatric patients 8 to less than 18 years of age who have been previously treated [see dosage and administration (2.3)] . pradaxa is contraindicated in patients with: - active pathological bleeding [see warnings and precautions (5.2) and adverse reactions (6.1)] - history of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see adverse reactions (6.1)] - mechanical prosthetic heart valve [see warnings and precautions (5.4)] risk summary the limited available data on pradaxa use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. there are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with the use of anticoagulants (see clinical considerations) . in pregnant rats treated from implantation until weaning, dabigatran increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition at an exposure 2.6 times the human exposure. at a similar exposure, dabigatran decreased the number of implantations when rats were treated prior to mating and up to implantation (gestation day 6). dabigatran administered to pregnant rats and rabbits during organogenesis up to exposures 8 and 13 times the human exposure, respectively, did not induce major malformations. however, the incidence of delayed or irregular ossification of fetal skull bones and vertebrae was increased in the rat (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. fetal/neonatal adverse reaction use of anticoagulants, including pradaxa, may increase the risk of bleeding in the fetus and neonate. monitor neonates for bleeding [see warnings and precautions (5.2)]. labor or delivery all patients receiving anticoagulants, including pregnant women, are at risk for bleeding. pradaxa use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. consider discontinuation or use of shorter acting anticoagulant as delivery approaches [see warnings and precautions (5.2, 5.3)] . data animal data dabigatran has been shown to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3.0 times the human exposure at mrhd of 300 mg/day based on area under the curve [auc] comparisons) prior to mating and up to implantation (gestation day 6). treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition. dabigatran administered to pregnant rats and rabbits during organogenesis up to maternally toxic doses of 200 mg/kg (8 and 13 times the human exposure, respectively, at a mrhd of 300 mg/day based on auc comparisons) did not induce major malformations, but increased the incidence of delayed or irregular ossification of fetal skull bones and vertebrae in the rat. death of offspring and mother rats during labor in association with uterine bleeding occurred during treatment of pregnant rats from implantation (gestation day 7) to weaning (lactation day 21) with dabigatran at a dose of 70 mg/kg (about 2.6 times the human exposure at mrhd of 300 mg/day based on auc comparisons). risk summary there are no data on the presence of dabigatran in human milk, the effects on the breastfed child, or on milk production. dabigatran and/or its metabolites were present in rat milk. breastfeeding is not recommended during treatment with pradaxa. females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including pradaxa should be assessed in females of reproductive potential and those with abnormal uterine bleeding. the safety and effectiveness of pradaxa capsules for the treatment and the reduction in risk of recurrence of venous thromboembolism have been established in pediatric patients 8 to less than 18 years of age. use of pradaxa for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients. these studies included an open-label, randomized, parallel-group study and an open-label, single-arm safety study [see adverse reactions (6.1) and clinical studies (14.4, 14.5)] . other age-appropriate pediatric dosage forms of dabigatran etexilate are available for pediatric patients less than 8 years of age for these indications. safety and effectiveness of pradaxa capsules have not been established in pediatric patients with non-valvular atrial fibrillation or those who have undergone hip replacement surgery. of the total number of patients in the re-ly study, 82% were 65 and over, while 40% were 75 and over. the risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups [see warnings and precautions (5), adverse reactions (6.1), and clinical studies (14.1)] . reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients no dose adjustment of pradaxa is recommended in patients with mild or moderate renal impairment [see clinical pharmacology (12.3)] . reduce the dose of pradaxa in patients with severe renal impairment (crcl 15-30 ml/min) [see dosage and administration (2.2, 2.4) and clinical pharmacology (12.3)] . dosing recommendations for patients with crcl < 15 ml/min or on dialysis cannot be provided. adjust dose appropriately in patients with renal impairment receiving concomitant p-gp inhibitors [see warnings and precautions (5.5), drug interactions (7.1), and clinical pharmacology (12.3)]. treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients patients with severe renal impairment (crcl ≤ 30 ml/min) were excluded from re-cover. dosing recommendations for patients with crcl ≤ 30 ml/min or on dialysis cannot be provided. avoid use of pradaxa with concomitant p-gp inhibitors in patients with crcl < 50 ml/min [see warnings and precautions (5.5), drug interactions (7.2), and clinical pharmacology (12.3)]. prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients following hip replacement surgery patients with severe renal impairment (crcl < 30 ml/min) were excluded from re-novate and re-novate ii. dosing recommendations for patients with crcl < 30 ml/min or on dialysis cannot be provided. avoid use of pradaxa with concomitant p-gp inhibitors in patients with crcl < 50 ml/min [see warnings and precautions (5.5), drug interactions (7.3), and clinical pharmacology (12.2, 12.3)]. treatment and reduction in the risk of recurrence of vte in pediatric patients pradaxa has not been studied in pediatric patients with egfr < 50 ml/min/1.73 m2 . reduced renal function could increase exposure. dosing recommendations cannot be provided for treatment of these patients. avoid use of pradaxa capsules in these patients [see dosage and administration (2.4)].

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boehringer ingelheim pharmaceuticals, inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 400 mg - viramune xr is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (bsa) of 1.17 m2 or greater [see clinical studies (14.1, 14.2)] . limitations of use: - adult females with cd4+ cell counts greater than 250 cells/mm3 or - adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)]. viramune xr is contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)] . - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. healthcare providers are encouraged to register pat

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boehringer ingelheim pharmaceuticals, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg - mobic is indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies (14.1) ]. mobic is indicated for relief of the signs and symptoms of rheumatoid arthritis [see clinical studies (14.1) ]. mobic is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg [see dosage and administration (2.4) and clinical studies (14.2) ]. mobic is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] risk summa

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boehringer ingelheim pharmaceuticals, inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - empagliflozin 5 mg - synjardy synjardy is a combination of empagliflozin and metformin hydrochloride (hcl) indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. synjardy xr synjardy xr is a combination of empagliflozin and metformin hcl indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. empagliflozin empagliflozin, when used as a component of synjardy or synjardy xr, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: - cardiovascular death in adults with established cardiovascular disease. - cardiovascular death and hospitalization for heart failure in adults with heart failure. limitations of use - synjardy and synjardy xr are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.2)] . - because