États-Unis - anglais - NLM (National Library of Medicine)

ascend laboratories, llc - tobramycin (unii: vz8rrz51vk) (tobramycin - unii:vz8rrz51vk) - tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with pseudomonas aeruginosa. safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (fev1 ) <25% or >75% predicted, or patients colonized with burkholderia cepacia [see clinical studies (14)]. tobramycin inhalation solution is contraindicated in patients with a known hypersensitivity to any aminoglycoside. risk summary aminoglycosides can cause fetal harm. published literature reports that use of streptomycin, an aminoglycoside, can cause total, irreversible, bilateral congenital deafness when administered to a pregnant woman [see warnings and precautions (5.5)] . although there are no available data on tobramycin inhalation solution use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see clinical pharmacology (12.3)]. there are risks to the mother associated with cystic fibrosis in pregnancy (see clinical considerations). in animal reproduction studies with subcutaneous administration of tobramycin in pregnant rats and rabbits during organogenesis, there were no adverse developmental outcomes; however, ototoxicity was not evaluated in the offspring from these studies (see data). advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are 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. clinical considerations disease-associated maternal and/or embryo/fetal risk cystic fibrosis may increase the risk for preterm delivery. data animal data no reproductive toxicity studies have been conducted with tobramycin inhalation solution (tobramycin administered by inhalation). however, subcutaneous administration of tobramycin at doses of up to 100 (rat) or 20 (rabbit) mg/kg/day during organogenesis was not associated with adverse developmental outcomes. doses of tobramycin ≥40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of adverse developmental outcomes. ototoxicity was not evaluated in offspring during non-clinical reproductive toxicity studies with tobramycin. risk summary there are no data on the presence of tobramycin inhalation solution in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. limited published data on other formulations of tobramycin in lactating women indicate that tobramycin is present in human milk. however, systemic absorption of tobramycin following inhaled administration is expected to be minimal [see clinical pharmacology (12.3)]. tobramycin may cause alteration in the intestinal flora of the breastfeeding infant (see clinical considerations). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tobramycin inhalation solution and any potential adverse effects on the breastfed infant from tobramycin inhalation solution or from the underlying maternal condition. clinical considerations tobramycin may cause intestinal flora alteration. advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). the safety and efficacy of tobramycin inhalation solution in pediatric patients under 6 years of age has not been established. the use of tobramycin inhalation solution is not indicated in children <6 years of age [see indications and usage (1) and dosage and administration (2)]. clinical studies of tobramycin inhalation solution did not include patients aged 65 years and over. tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see warnings and precautions (5.3)]. tobramycin (toe-bra-mye-sin) inhalation solution for oral inhalation use read this instructions for use before you start using tobramycin inhalation solution 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. tobramycin inhalation solution is made for inhalation using a pari lc plustm reusable nebulizer and a devilbiss® pulmo-aide® air compressor. tobramycin inhalation solution can be taken at home, school, or at work. the following instructions tell you how to use the devilbiss pulmo-aide air compressor and pari lc plus reusable nebulizer to administer tobramycin inhalation solution. you will need the following supplies (see figure a): - 1 tobramycin inhalation solution plastic ampule (tobramycin inhalation solution is packaged with 7 ampules in each foil pouch) - devilbiss pulmo-aide air compressor - pari lc plus reusable nebulizer - tubing to connect the nebulizer and compressor - clean paper or cloth towels - nose clips (optional) (figure a) it is important that your nebulizer and compressor function properly before starting your tobramycin inhalation solution therapy. note: read the manufacturer care and use instructions for important information. prepare your tobramycin for inhalation therapy step 1: wash your hands thoroughly with soap and water. step 2: open the foil pouch. step 3: separate 1 tobramycin inhalation solution ampule by gently pulling apart at the bottom tabs (see figure b). place the remaining tobramycin inhalation solution ampules in the refrigerator. (figure b) step 4: check the expiration date stamped on the tobramycin inhalation solution ampule (see figure c). do not use the tobramycin inhalation solution ampule if the expiration date has passed. (figure c) step 5: check that the tobramycin inhalation solution ampule medicine is clear and does not have particles. - unrefrigerated tobramycin inhalation solution, which is normally slightly yellow, may darken with age. this color change does not mean there is any change in the quality of the medicine. - do not use the tobramycin inhalation solution ampule if the medicine is cloudy or has particles. - throw it away and get a new one. step 6: lay out the parts of a pari lc plus reusable nebulizer package on a clean, dry paper or cloth towel. you should have the following parts (see figure d): - nebulizer top and bottom (nebulizer cup) assembly - inspiratory valve cap - mouthpiece with valve - tubing (figure d) step 7: remove the nebulizer top from the nebulizer cup by twisting the nebulizer top counter-clockwise, and then lifting off (see figure e). (figure e) step 8: place the nebulizer top on the clean paper or cloth towel by standing the nebulizer cup upright on the towel (see figure f). (figure f) step 9: connect one end of the tubing to the compressor air outlet (see figure g). the tubing should fit tightly. (figure g) step 10: plug in your compressor to an electrical outlet (see figure h). (figure h) step 11: open the tobramycin inhalation solution ampule by holding the bottom tab with 1 hand and twisting off the top of the tobramycin inhalation solution ampule with the other hand (see figure i). be careful not to squeeze the tobramycin inhalation solution ampule until you are ready to empty all the medicine into the nebulizer cup. (figure i) step 12: squeeze all the medicine of the tobramycin inhalation solution ampule into the nebulizer cup (see figure j). (figure j) step 13: replace the nebulizer top. to replace the nebulizer top insert the nebulizer top into the nebulizer cup with the semi-circle halfway down the stem of the nebulizer top facing the nebulizer outlet. turn the nebulizer top clockwise until securely fastened to the nebulizer cup. (see figure k). (figure k) step 14: push the mouthpiece straight onto the nebulizer outlet (see figure l). (figure l) step 15: firmly push the inspiratory valve cap straight down onto the nebulizer top (see figure m). the inspiratory valve cap will fit tightly. (figure m) step 16: hold the nebulizer cup upright and firmly push the free end of the tubing from the compressor to the air intake on the bottom of the nebulizer cup (see figure n). make sure to keep the nebulizer cup upright. (figure n) giving your tobramycin inhalation therapy step 17: turn on the compressor (see figure o). (figure o) step 18: check for a steady mist from the mouthpiece (see figure p). if there is no mist, check all tubing connections and make sure that the compressor is working properly. (figure p) step 19: sit or stand in an upright position that will allow you to breathe normally. place the mouthpiece between your teeth and on top of your tongue and breathe normally only through your mouth (see figure q). nose clips may help you breathe through your mouth and not through your nose. do not block the airflow with your tongue. (figure q) step 20: keep breathing in your tobramycin inhalation solution medicine for at least 15 minutes to get your full dose. continue therapy until all your tobramycin inhalation solution medicine is gone, and there is no longer any mist being made. you may hear a sputtering sound coming from the mouthpiece when the nebulizer cup is empty. the entire tobramycin inhalation solution therapy should take about 15 minutes to complete. if you are interrupted, need to cough or rest during your tobramycin inhalation solution treatment, turn off the compressor to save your medicine. turn the compressor back on when you are ready to restart your treatment. follow the nebulizer cleaning and disinfecting instructions after completing your therapy. after your tobramycin inhalation therapy cleaning your nebulizer to reduce the risk of infection, illness or injury from contamination, you must thoroughly clean all parts of the nebulizer as instructed after each treatment. never use a nebulizer with a clogged nozzle. if the nozzle is clogged, no aerosol mist is made, and your therapy will not be as effective. replace the nebulizer if clogging occurs. 1) remove tubing from nebulizer and disassemble nebulizer parts. 2) wash all parts (except tubing) with warm water and liquid dish soap. 3) rinse thoroughly with warm water and shake out water. 4) air dry or hand dry nebulizer parts on a clean, lint-free cloth. reassemble nebulizer when dry, and store. you can also wash all parts of the nebulizer in a dishwasher (except tubing). 1) place the nebulizer parts in a dishwasher basket. 2) place the dishwasher basket on the top rack of the dishwasher. 3) remove and dry the parts when the cycle is complete. disinfecting your nebulizer your nebulizer is for your use only. do not share your nebulizer with other people. you must disinfect the nebulizer every other treatment day. failure to disinfect the nebulizer every other treatment day could lead to serious or fatal illness. clean the nebulizer as described above. every other treatment day, disinfect the nebulizer parts (except tubing) by boiling them in water for a full 10 minutes. dry parts on a clean, lint-free cloth. care and use of your pulmo-aide compressor follow the manufacturer instructions for care and use of your compressor. filter change: - devilbiss compressor filters should be changed every 6 months or sooner if the filter turns completely gray in color. compressor cleaning: - with power switch in the "off" position, unplug power cord from wall outlet. - wipe outside of the compressor cabinet with a clean, damp cloth every few days to keep dust free. caution: do not submerge in water because this will damage the compressor. how should i store tobramycin inhalation solution? - store tobramycin inhalation solution ampules in a refrigerator between 36°f to 46°f (2°c to 8°c) until needed. - you may store the tobramycin inhalation solution ampules in the foil pouches (opened or unopened) at room temperature 77°f (25°c) for up to 28 days. - do not use tobramycin inhalation solution ampules if they have been stored at room temperature for more than 28 days. - protect tobramycin inhalation solution ampules from light. keep tobramycin inhalation solution and all medicines out of the reach of children.   this instructions for use has been approved by the u.s. food and drug administration. additional information nebulizer: 1-800-327-8632 compressor: 1-800-338-1988 tobramycin inhalation solution: call 1-877-272-7901. manufactured by: holopack verpackungstechnik gmbh bahnhofstraβe 74429 – sulzbach- laufen, germany distributed by: ascend laboratories, llc parsippany, nj 07054 the brands listed are trademarks of their respective owners. revised: february, 2023

États-Unis - anglais - NLM (National Library of Medicine)

ascend laboratories, llc - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg - itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. blastomycosis, pulmonary and extrapulmonary 2. histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3. aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin b therapy. specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology,serology) should be obtained before therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: 1. onychomycosis of the toenail, with or without fingernail involveme

États-Unis - anglais - NLM (National Library of Medicine)

ascend laboratories, llc - nifedipine (unii: i9zf7l6g2l) (nifedipine - unii:i9zf7l6g2l) - i. vasospastic angina nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by st segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. in those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers. ii. chronic stable angina (classical effort-associated

États-Unis - anglais - NLM (National Library of Medicine)

ascend laboratories, llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride tablets usp are contraindicated in patients with: 1. renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions ). 2. known hypersensitivity to metformin hydrochloride 3. acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride tablets usp should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

États-Unis - anglais - NLM (National Library of Medicine)

ascend laboratories, llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tramadol hydrochloride and acetaminophen tablets is indicated for the short-term (five days or less) management of acute pain. tramadol hydrochloride and acetaminophen tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, acetaminophen, any other component of this product or opioids. tramadol hydrochloride and acetaminophen tablets are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. tramadol hydrochloride and acetaminophen tablets may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride and acetaminophen tablets, a tramadol containing product, can be abused and may be subject to criminal diversion.   addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmenta

États-Unis - anglais - NLM (National Library of Medicine)

ascend laboratories, llc - hydralazine hydrochloride (unii: fd171b778y) (hydralazine - unii:26nak24ls8) - essential hypertension, alone or as an adjunct. hypersensitivity to hydralazine ; coronary artery disease; mitral valvular rheumatic heart disease.

États-Unis - anglais - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam 15 mg - temazepam capsules, usp are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules, usp should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. benzodiazepines may cause fetal harm when administered to a pregnant woman. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. reproduction studies in animals with temazepam were performed in rats and rabbits. in a perinatal-postnatal study in rats, oral doses of 60

États-Unis - anglais - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam capsules, usp are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. benzodiazepines may cause fetal harm when administered to a pregnant woman. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. reproduction studies in animals with temazepam were performed in rats and rabbits. in a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day r

États-Unis - anglais - NLM (National Library of Medicine)

ascend laboratories, llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - adults sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (pah) (world health organization [who] group i) in adults to improve exercise ability and delay clinical worsening [see clinical studies (14)].   additional information is approved for viatris specialty llc's revatio® (sildenafil) product. however, due to viatris specialty llc's marketing exclusivity rights, this drug product is not labeled with that information. sildenafil is contraindicated in patients with: ·     concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see warnings and precautions (5.1)] . ·      concomitant use of riociguat, a guanylate cyclase stimulator. phosphodiesterase-5 (pde-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. ·    known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. hypersensitivity, including anaphylacti

États-Unis - anglais - NLM (National Library of Medicine)

h.j. harkins company, inc. - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam 15 mg - temazepam capsules, usp are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. benzodiazepines may cause fetal harm when administered to a pregnant woman. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. reproductio