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

apotex corp. - cefazolin sodium (unii: p380m0454z) (cefazolin - unii:ihs69l0y4t) - cefazolin 1 g - cefazolin for injection, usp is indicated in the treatment of the following serious infections due to susceptible organisms: respiratory tract infections: due to s. pneumoniae, klebsiella species , h. influenzae, s. aureus (penicillin-sensitive and penicillin-resistant), and group a beta-hemolytic streptococci . injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefazolin for injection, usp is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin for injection, usp in the subsequent prevention of rheumatic fever are not available at present. urinary tract infections: due to e. coli, p. mirabilis, klebsiella species, and some strains of enterobacter and enterococci . skin and skin structure infections:  due to s. aureus (penicillin-sensitive and penicillin-resistant), group a beta-hemolytic streptococci, and other strains of streptococci. biliary tract infections: due to e. coli, various strains of streptococci, p. mirabilis,  klebsiella species, and s. aureus. bone and joint infections: due to s. aureus. genital infections: (i.e., prostatitis, epididymitis) due to e. coli, p. mirabilis, klebsiella species, and some strains of enterococci . septicemia:  due to s. pneumoniae, s. aureus (penicillin-sensitive and penicillin-resistant), p. mirabilis, e. coli, and  klebsiella species. endocarditis:  due to s. aureus (penicillin-sensitive and penicillin-resistant) and group a beta-hemolytic streptococci . perioperative prophylaxis: the prophylactic administration of cefazolin for injection, usp preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). the perioperative use of cefazolin for injection, usp may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). the prophylactic administration of cefazolin for injection, usp should usually be discontinued within a 24-hour period after the surgical procedure.  in surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection, usp may be continued for 3 to 5 days following the completion of surgery. if there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (see dosage and administration.) to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin for injection, usp and other antibacterial drugs, cefazolin for injection, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. cefazolin for injection, usp is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

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

apotex corp. - cefazolin sodium (unii: p380m0454z) (cefazolin - unii:ihs69l0y4t) - cefazolin for injection, usp is indicated in the treatment of the following serious infections due to susceptible organisms: respiratory tract infections: due to s. pneumoniae, klebsiella species, h. influenzae, s. aureus (penicillin-sensitive and penicillin-resistant), and group a beta-hemolytic streptococci. injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefazolin for injection, usp is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin for injection, usp in the subsequent prevention of rheumatic fever are not available at present. urinary tract infections: due to e. coli, p. mirabilis, klebsiella species, and some strains of enterobacter and enterococci. skin and skin structure infections:  due to s. aureus (penicillin-sensitive and penicillin-resistant), group a beta-hemolytic streptococci, and other strains of streptococci. biliary tract infections: due to e. coli, various strains of streptococci, p. mirabilis,  klebsiella species, and s. aureus. bone and joint infections: due to s. aureus. genital infections: (i.e., prostatitis, epididymitis) due to e. coli, p. mirabilis, klebsiella species, and some strains of enterococci. septicemia:  due to s. pneumoniae, s. aureus (penicillin-sensitive and penicillin-resistant), p. mirabilis, e. coli, and klebsiella species. endocarditis:  due to s. aureus (penicillin-sensitive and penicillin-resistant) and group a beta-hemolytic streptococci. perioperative prophylaxis: the prophylactic administration of cefazolin for injection, usp preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). the perioperative use of cefazolin for injection, usp may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). the prophylactic administration of cefazolin for injection, usp should usually be discontinued within a 24-hour period after the surgical procedure.  in surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection, usp may be continued for 3 to 5 days following the completion of surgery. if there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (see dosage and administration.) to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin for injection, usp and other antibacterial drugs, cefazolin for injection, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. cefazolin for injection, usp is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

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

apotex corp. - teriparatide (unii: 10t9csu89i) (teriparatide - unii:10t9csu89i) - teriparatide injection 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, teriparatide injection 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. teriparatide injection 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 teriparatide injection use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. consider discontinuing teriparatide injection 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 teriparatide use in women who are breastfeeding. the safety and effectiveness of teriparatide injection 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 teriparatide injection 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 teriparatide injection 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 teriparatide injection 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 teriparatide injection 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 teriparatide injection alters the underlying metabolic bone disease seen in chronic renal impairment  [see clinical pharmacology (12.3)]. teriparatide injection, usp user manual important: first read the medication guide that comes inside your teriparatide injection carton . before you use your new teriparatide injection delivery device, please read the entire front and back of this user manual completely. follow the directions carefully when using the teriparatide injection delivery device. do not share your delivery device or needles because infection or disease can be spread from one person to another. the teriparatide injection delivery device contains 28 days of medicine. throw away the teriparatide injection delivery device after 28 days, even if it is not completely empty. do not inject more than one dose of teriparatide injection in the same day. do not transfer teriparatide injection 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. a. the yellow shaft is still showing after i push in the black injection button. how do i reset my teriparatide injection 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 apotex corp (see contact information below) or your healthcare provider. - put the large needle cover on the 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 teriparatide injection 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 teriparatide delivery device with a damp cloth. - do not place the teriparatide delivery device in water, or wash or clean with any liquid. storing your teriparatide delivery device - after each use, refrigerate the teriparatide delivery device right away. read and follow the instructions in the medication guide section “how should i store teriparatide injection?”. - do not store the teriparatide delivery device with a needle attached. doing this may cause air bubbles to form in the medicine cartridge. - store the teriparatide delivery device with the white cap on. - do not freeze teriparatide injection. if the teriparatide delivery device has been frozen, throw the device away and use a new teriparatide delivery device. - if the teriparatide 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 apotex at 1-800-706-5575. - the teriparatide delivery device contains 28 days of medicine. - do not transfer teriparatide injection 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 teriparatide delivery device the right way. - check the teriparatide delivery device label to make sure you have the right medicine and that it has not expired. - do not use the teriparatide delivery device if it looks damaged. look at the teriparatide medicine in the cartridge. if the medicine is not clear and colorless, or if it has particles, do not use it. call apotex 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 teriparatide 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 teriparatide delivery device and needles out of the reach of children. - before throwing away the teriparatide delivery device, be sure to remove the pen needle. - throw away your teriparatide delivery device and used needles as instructed by your healthcare provider, local or state laws, or institutional policies. contact information

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

apotex corp. - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon 200 [iu] - calcitonin salmon (synthetic origin) nasal spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. fracture reduction efficacy has not been demonstrated. calcitonin salmon (synthetic origin) nasal spray should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). - due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see warnings and precautions (5.4)] . - calcitonin salmon (synthetic origin) nasal spray has not been shown to increase spinal bone mineral density in early postmenopausal women. hypersensitivity to calcitonin salmon or any of the excipients. reactions have included anaphylactic shock, anaphylaxis, bronchospasm, and swelling of the tongue or throat [see warnings and precautions (5.1)] . risk summary calcitonin salmon nasal spray is not indicated for use in females of reproductive potential. there are no data with the use of calcitonin salmon nasal spray in pregnant women. in an animal reproduction study, subcutaneous administration of calcitonin-salmon to pregnant rabbits during organogenesis at 418 times the recommended parenteral human dose caused a decrease in fetal birth weights. no adverse developmental outcome was observed in the rat with subcutaneous administration of calcitonin-salmon at 9 times the recommended human parenteral dose based on body surface area (see data).   data animal data calcitonin salmon has been shown to cause a decrease in fetal birth weights in rabbits when given by subcutaneous injection in doses 4 to 18 times the parenteral dose (of 54 international units/m2 ) and 70 to 278 times the intranasal dose recommended for human use based on body surface area.   no embryo/fetal toxicities related to calcitonin salmon nasal spray were reported from maternal subcutaneous daily doses in rats up to 80 international units/kg/day from gestation day 6 to 15. risk summary calcitonin salmon nasal spray is not indicated for use in females of reproductive potential. there is no information on the presence of calcitonin-salmon in human milk, the effects on the breastfed child, or the effects on milk production. calcitonin has been shown to inhibit lactation in rats. safety and effectiveness in pediatric patients have not been established. in a multi-centered, double-blind, randomized clinical study of calcitonin salmon nasal spray, 279 patients were less than 65 years old, while 467 patients were 65 to 74 years old and 196 patients were 75 years old and older. compared to subjects less than 65 years old, the incidence of nasal adverse reactions (rhinitis, irritation, erythema, and excoriation) was higher in patients over the age of 65, particularly among those over the age of 75. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. calcitonin salmon (synthetic origin) (kal" si toe' nin) nasal spray for nasal use only. important information about your calcitonin salmon (synthetic origin) nasal spray: - a single spray of calcitonin salmon (synthetic origin) nasal spray contains 1 daily dose of medicine. - each calcitonin salmon (synthetic origin) nasal spray bottle contains the right amount of medicine. the bottle may not be completely filled to the top. this is normal. - this package contains 1 bottle of calcitonin salmon (synthetic origin) nasal spray with attached pump. - store unopened bottles of calcitonin salmon (synthetic origin) nasal spray in the refrigerator between 2°c to 8°c (36°f to 46°f). do not freeze. - after you open your bottle of calcitonin salmon (synthetic origin) nasal spray, store it at room temperature between 20°c to 25°c (68°f to 77°f) in an upright position. do not shake the bottle. - to make sure you get the right dose of calcitonin salmon (synthetic origin) nasal spray medicine you must prime each new bottle and pump before you use it for the first time. - check to see if the bottle and pump has already been primed by pressing on the pump 1 time. see figure 2. - if you see a full spray from the pump, the bottle and pump has already been primed for you. - if you do not see a full spray, you must prime the bottle and pump. - hold the bottle upright with your pointer finger and middle finger on the 2 side arms of the pump, and your thumb on the bottom of the bottle. firmly press down on the arms of the pump and press down again if needed until you see a full spray of medicine. see figure 2. - now your calcitonin salmon (synthetic origin) nasal spray is ready for you to use. - do not prime the pump before you use it each day because this will waste your medicine. - keep your head upright. carefully tilt the bottle and place the nose spray pump into 1 side of your nose. - give 1 spray of calcitonin salmon (synthetic origin) nasal spray, 1 time daily, in 1 side of your nose (nostril). spray your medicine in a different side of your nose each day. - you do not need to breathe or inhale while you are giving your dose. - you may not feel the spray inside your nose. - some of the medicine may drip out of your nose. this is normal, and you are still getting all of the medicine you need. - dry the nose spray pump with a clean cloth. - be careful not to push down on the pump while you are putting the cap back on it. - do not refrigerate calcitonin salmon (synthetic origin) nasal spray between doses. - store calcitonin salmon (synthetic origin) nasal spray upright. - do not shake the bottle. when should i throw away calcitonin salmon (synthetic origin) nasal spray? - unopened, refrigerated bottles can be used until the expiration date stamped on the bottle and box. - throw away calcitonin salmon (synthetic origin) nasal spray after you use 14 doses (2 ml fill) or 30 doses (3.7 ml fill) (sprays). - throw away calcitonin salmon (synthetic origin) nasal spray bottles left at room temperature (opened or unopened) for more than 30 days (2 ml fill) or 35 days (3.7 ml fill). for more information on calcitonin salmon (synthetic origin) nasal spray, call apotex corp. at 1-800-706-5575. this patient information and instructions for use has been approved by the u.s. food and drug administration. apotex inc. calcitonin salmon (synthetic origin) nasal spray revised: november 2017

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

apotex corp. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug- induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate or any of its inactive ingredients. in addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

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

apotex corp. - icatibant acetate (unii: 325o8467xk) (icatibant - unii:7pg89g35q7) - icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (hae) in adults 18 years of age and older. none. risk summary available data from published literature and the pharmacovigilance database with icatibant injection use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, icatibant, administered by the subcutaneous route during the period of organogenesis, did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits at doses approximately 0.025 times the maximum recommended human dose (mrhd) and higher. decreased embryofetal survival was observed in rabbits at a subcutaneous dose that was 13 times the mrhd. in a pre- and post-natal development study in rats, delayed parturition was observed at subcutaneous doses 0.5 times the mrhd and higher, which resulted in deaths of dams at doses 2 times the mrhd and higher. fetal death and early pup deaths were observed with doses 2 times the mrhd ( 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% to 4% and 15% to 20%, respectively. data animal data in an embryo-fetal development study with rats that received icatibant from gestation days 7 to 18, there was no evidence of any treatment-related structural abnormalities or effects on embryo-fetal survival with maternal doses up to 2.7 times the mrhd (on a mg/m 2 basis with maternal subcutaneous doses up to 25 mg/kg/day). in a fertility and early embryonic development study with rats, icatibant increased pre­implantation loss at a dose that was 7 times the mrhd (on an auc basis at a maternal dose of 10 mg/kg/day). in an embryo-fetal development study with rabbits that received icatibant from gestation days 7 to 18, premature birth and abortion rates increased at doses approximately 0.025 times the mrhd and higher (on a mg/m 2 basis at maternal subcutaneous doses of 0.1 mg/kg and higher). icatibant treatment resulted in dose-related decreases of total implantations and total number of live fetuses as well as dose-related increases of percent pre-implantation loss at a dose that was 13 times the mrhd (on an auc basis with a maternal subcutaneous dose of 10 mg/kg/day). there was no evidence of any treatment-related structural abnormalities with maternal doses up to 13 times the mrhd (on an auc basis with maternal subcutaneous doses up to 10 mg/kg/day). in a pre- and post-natal development study in the rat, dams received icatibant by the subcutaneous route at doses of 1, 3, and 10 mg/kg/day from gestation day 6 to post-partum (ppd) day 20. delayed parturition was observed at doses 0.5 times the mrhd and higher (on an auc basis with maternal subcutaneous doses of 1 mg/kg/day and higher), which resulted in deaths of dams at doses 2 times the mrhd and higher (on an auc basis with maternal subcutaneous doses of 3 mg/kg/day and higher). fetal death and increased pup deaths through ppd 4 were observed with doses 2 times the mrhd (on an auc with a maternal subcutaneous dose of 3 mg/kg/day and higher). impairment of pup righting reflex and decreased pup hair growth were also observed at 7 times the mrhd (on an auc basis with a maternal dose of 10 mg/kg). icatibant and the m2 metabolite were found in maternal milk following subcutaneous administration of icatibant. the no effect dose for f1 pups was identified at a dose 0.5 times the mrhd (on an auc basis with a maternal subcutaneous dose of 1 mg/kg/day). a no effect dose was not identified for f 0 maternal toxicity. risk summary there are no data on the presence of icatibant in human milk, the effects on the breastfed infant, or the effects on milk production. icatibant and the m2 metabolite were found in rat milk following subcutaneous administration of icatibant (  see data  ). when a drug is present in animal milk, it is likely that the drug will be present in human milk. however, systemic absorption of icatibant in infants is not expected after oral exposure through breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for icatibant injection and any potential adverse effects on the breastfed child from icatibant injection or from the underlying maternal condition. data animal data icatibant is excreted into the milk of lactating rats at concentrations that sometimes slightly exceeded those measured in the maternal plasma. safety and effectiveness in pediatric patients below the age of 18 years have not been established. juvenile toxicity data subcutaneous daily administration of icatibant to young rats during the juvenile period of development (postnatal days 22-70) delayed the sexual maturation of male reproductive tissues (atrophy of testes and epididymides) at exposures approximating one-third or greater the mrhd on a mg/m 2 basis. impaired fertility and reproductive performance were also observed in male rats at the end of the postnatal treatment period at exposures approximating the mrhd or greater on a mg/m 2 basis. no effects were observed in females at exposures approximating 3-fold the mrhd on a mg/m 2 basis. the observed tissue findings in males were consistent with those seen in sexually mature rats and dogs and are attributed to antagonism of the bradykinin b2 receptor and subsequent effects on gonadotropins. the observed effects may be a consequence of daily icatibant administration. toxicity to the testis did not occur in dogs treated twice a week for 9 months [see carcinogenesis, mutagenesis, impairment of fertility (13.1) ] . clinical studies of icatibant injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. elderly patients are likely to have increased systemic exposure to icatibant injection compared to younger (18-45 years) patients [see clinical pharmacology (12.3) ] . since other reported clinical experience has not identified differences in efficacy and safety between elderly and younger patients, no dose adjustment is recommended. icatibant injection was studied in patients with mild to moderate (child pugh scores of 5 to 8) hepatic impairment. no change in systemic exposure is noted in these patient populations. no dose adjustment is required in patients with hepatic impairment [see clinical pharmacology (12.3) ] . although a formal renal impairment study has not been conducted, 10 of 37 patients treated with icatibant injection had hepatorenal syndrome with glomerular filtration rate (gfr) below 60 ml/min. icatibant injection is cleared non-renally and hence it is not expected to show any change in systemic exposure in patients with impaired renal function. no dose adjustment is required in patients with renal impairment [see clinical pharmacology (12.3) ] . icatibant (eye-kat-i-bant) injection, for subcutaneous use step 1. preparing your dose of icatibant injection - wash your hands with soap and water. - you will need the following supplies: your icatibant injection carton that includes 1 single-dose icatibant injection prefilled syringe and 1 needle. 1 alcohol wipe the medicine inside your icatibant injection prefilled syringe should be clear and colorless. do not use your icatibant injection prefilled syringe if the solution contains particles, is cloudy, or has an unusual color. - your icatibant injection carton that includes 1 single-dose icatibant injection prefilled syringe and 1 needle. - 1 alcohol wipe - the medicine inside your icatibant injection prefilled syringe should be clear and colorless. do not use your icatibant injection prefilled syringe if the solution contains particles, is cloudy, or has an unusual color. figure a                                                                             step 2. remove the prefilled syringe and needle from the carton. see figure b . figure b                                                                             step 3. remove the seal from the needle cap (the needle should remain inside the protective needle cap until ready to use). see figure c . figure c                                                                            step 4. remove the protective cap from the end of the pre-filled syringe by unscrewing the cap. hold the syringe firmly . carefully attach the needle to the prefilled syringe containing the colorless icatibant injection solution. see figure d . figure d                                                                           step 5. firmly screw the needle on the prefilled syringe. be careful not to remove the needle from the needle cap. see figure e . figure e                                                                        preparing the injection site step 6. choose the injection site. the injection site should be a fold of skin on your stomach, about 2 to 4 inches (5 to 10 cm) below your belly button on either side. see figure f . the area you choose for injection should be at least 2 inches (5 cm) away from any scars. do not choose an area that is bruised, swollen, or painful. figure f                                                                          step 7. clean your icatibant injection site with an alcohol wipe and allow it to dry. see figure g . figure g                                                                           injecting your icatibant injection step 8. remove the needle from the needle cap by holding the needle cap and carefully pulling the syringe . do not pull up on the plunger. see figure h . figure h                                                                               step 9. hold the icatibant injection prefilled syringe in 1 hand, between your fingers and thumb. see figure i . figure i                                                                             step 10. use your other hand to gently pinch the fold of skin you cleaned with the alcohol wipe between your thumb and fingers for your injection. see figure j . figure j                                                                            step 11. hold the syringe between a 45-to-90 degree angle to your skin with the needle facing the fold of skin you are holding. see figure k . figure k                                                                             step 12. hold the fold of skin. bring the syringe to the skin and quickly insert the needle into the skin fold. see figure l . figure l                                                                               step 13. push the plunger, at the top of the syringe, for at least 30 seconds until no icatibant injection is in the syringe. see figure m . figure m                                                                         step 14. release the skin fold and gently pull the needle out. see figure n . figure n                                                                           disposal of your used icatibant injection prefilled syringe step 15. place your used icatibant injection syringe, with the needle attached, in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your 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. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal . do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. figure o                                                                          manufactured by: nang kuang pharmaceutical co., ltd. no.1001, zhongshan rd., xinhua dist., tainan city 71243, taiwan distributed by: apotex corp. weston, florida 33326 this patient information and instructions for use have been approved by the u.s. food and drug administration. revised: february 2024 issued: 022924-02 2620000000u595

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

apotex corp. - deferoxamine mesylate (unii: v9tko7eo6k) (deferoxamine - unii:j06y7mxw4d) - deferoxamine mesylate for injection, usp, is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias. acute iron intoxication deferoxamine mesylate is an adjunct to, and not a substitute for, standard measures used in treating acute iron intoxication, which may include the following: induction of emesis with syrup of ipecac; gastric lavage; suction and maintenance of a clear airway; control of shock with intravenous fluids, blood, oxygen, and vasopressors; and correction of acidosis. chronic iron overload deferoxamine mesylate can promote iron excretion in patients with secondary iron overload from multiple transfusions (as may occur in the treatment of some chronic anemias, including thalassemia). long-term therapy with deferoxamine mesylate slows accumulation of hepatic iron and retards or eliminates progression of hepatic fibrosis. iron mobilization with deferoxamine mesylate is relatively poor in patients under the age of 3 years with relatively little iron overload. the drug should ordinarily not be given to such patients unless significant iron mobilization (e.g., 1 mg or more of iron per day) can be demonstrated. deferoxamine mesylate is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder. known hypersensitivity to the active substance. deferoxamine mesylate is contraindicated in patients with severe renal disease or anuria, since the drug and the iron chelate are excreted primarily by the kidney. (see warnings).

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

apotex corp. - deferoxamine mesylate (unii: v9tko7eo6k) (deferoxamine - unii:j06y7mxw4d) - deferoxamine mesylate for injection, usp, is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias. acute iron intoxication deferoxamine mesylate is an adjunct to, and not a substitute for, standard measures used in treating acute iron intoxication, which may include the following: induction of emesis with syrup of ipecac; gastric lavage; suction and maintenance of a clear airway; control of shock with intravenous fluids, blood, oxygen, and vasopressors; and correction of acidosis. chronic iron overload deferoxamine mesylate can promote iron excretion in patients with secondary iron overload from multiple transfusions (as may occur in the treatment of some chronic anemias, including thalassemia). long-term therapy with deferoxamine mesylate slows accumulation of hepatic iron and retards or eliminates progression of hepatic fibrosis. iron mobilization with deferoxamine mesylate is relatively poor in patients under the age of 3 years with relatively little iron overload. the drug should ordinarily not be given to such patients unless significant iron mobilization (e.g., 1 mg or more of iron per day) can be demonstrated. deferoxamine mesylate is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder. known hypersensitivity to the active substance. deferoxamine mesylate is contraindicated in patients with severe renal disease or anuria, since the drug and the iron chelate are excreted primarily by the kidney. (see warnings).

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

apotex corp. - fluphenazine hydrochloride (unii: zou145w1xl) (fluphenazine - unii:s79426a41z) - fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic  disorders. fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients  with mental retardation. phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. the presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. fluphenazine hydrochloride is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.  

Ireland - English - HPRA (Health Products Regulatory Authority)

apotex europe b.v. - alendronate sodium trihydrate - tablets - 70 milligram