Združene države Amerike - angleščina - NLM (National Library of Medicine)

maia pharmaceuticals, inc. - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults to: - stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. sincalide for injection is contraindicated in patients with: - a history of a hypersensitivity reaction to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)]. - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide for inj

Združene države Amerike - angleščina - NLM (National Library of Medicine)

endo pharmaceuticals inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 2.5 mg - percocet is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve percocet for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia percocet is contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to oxycodone, acetaminophen, or any other component of the product (e.g., anaphylaxis) [see warnings, adverse reactions ] percocet contains oxycodone, a

Združene države Amerike - angleščina - NLM (National Library of Medicine)

par pharmaceutical, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 2.5 mg - endocet is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.  limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve endocet for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia endocet is contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to oxycodone, acetaminophen, or any other component of the product (e.g., anaphylaxis) [see warnings , adverse reactions ] endocet contains oxycodone, a

Združene države Amerike - angleščina - NLM (National Library of Medicine)

ferring pharmaceuticals inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - endometrin® (progesterone) is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology (art) treatment program for infertile women. endometrin is contraindicated in individuals with any of the following conditions: - previous allergic reactions to progesterone or any of the ingredients of endometrin [see description (11) ] - undiagnosed vaginal bleeding - known missed abortion or ectopic pregnancy - liver disease - known or suspected malignancy of the breast or genital organs - active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events endometrin has been used to support embryo implantation and maintain clinical pregnancy in one clinical study. the live birth outcomes of these pregnancies were as follows: - among the 404 subjects treated with endometrin twice daily, 143 subjects had live births consisting of 85 singletons, 56 twins, and 2 triplets. in this treatment group, 1

Združene države Amerike - angleščina - NLM (National Library of Medicine)

endo pharmaceuticals inc. - collagenase clostridium histolyticum (unii: 9x7o8v25it) (collagenase clostridium histolyticum - unii:9x7o8v25it) - collagenase clostridium histolyticum 0.9 mg - xiaflex is indicated for the treatment of adult patients with dupuytren’s contracture with a palpable cord. xiaflex is indicated for the treatment of adult men with peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. xiaflex is contraindicated in: - the treatment of peyronie’s plaques that involve the penile urethra due to potential risk to this structure. - patients with a history of hypersensitivity to xiaflex or to collagenase used in any other therapeutic application or application method [see warnings and precautions (5.4)] . pregnancy category b there are no adequate and well-controlled studies of xiaflex in pregnant women. because animal reproduction studies are not always predictive of human response, xiaflex should be used during pregnancy only if clearly needed. risk summary based on animal data, xiaflex is not predicted to increase the risk for major developmental abnormalities in humans. human data human pharmacokinetic studies

Združene države Amerike - angleščina - NLM (National Library of Medicine)

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

Združene države Amerike - angleščina - NLM (National Library of Medicine)

endo pharmaceuticals inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 50 mg in 5 g - testim is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of testim in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been esta

Združene države Amerike - angleščina - NLM (National Library of Medicine)

endo pharmaceuticals inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 10 mg in 1 g - voltaren gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. voltaren gel is contraindicated in the following patients: pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation risk summary use of nsaids, including voltaren gel, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including voltaren gel, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of voltaren gel in pregnant women. human and animal studies indicate that diclofenac crosses the placenta. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2

Združene države Amerike - angleščina - NLM (National Library of Medicine)

endo pharmaceuticals inc. - oxymorphone hydrochloride (unii: 5y2ei94nbc) (oxymorphone - unii:9vxa968e0c) - oxymorphone hydrochloride 5 mg - opana is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1) ], reserve opana for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia opana is contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3) ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.6) ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.11) ] - hypersensitivity to oxymorphone (e.g., anaphylaxis, an

Združene države Amerike - angleščina - NLM (National Library of Medicine)

ipsen biopharmaceuticals, inc. - mecasermin (unii: 7gr9i2683o) (mecasermin - unii:7gr9i2683o) - mecasermin 40 mg in 4 ml - severe primary igf-1 deficiency (primary igfd) increlex is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with: - severe primary igf-1 deficiency or - growth hormone (gh) gene deletion who have developed neutralizing antibodies to gh. severe primary igf-1 deficiency (igfd) is defined by: - height standard deviation score ≤ –3.0 and - basal igf-1 standard deviation score ≤ –3.0 and - normal or elevated growth hormone (gh). limitations of use: increlex is not a substitute to gh for approved gh indications. increlex is not indicated for use in patients with secondary forms of igf-1 deficiency, such as gh deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory corticosteroids. - known hypersensitivity increlex should not be used by patients who are allergic to mecasermin (rhigf-1) or any of the inactive ingredients in increlex, or who have experienced a severe hypersensitivity to increlex [see warnings and precautions (5.2) and adverse reactions (6.3)]. - closed epiphyses increlex should not be used for growth promotion in patients with closed epiphyses. - malignant neoplasia increlex is contraindicated in pediatric patients with malignant neoplasia or a history of malignancy [see warnings and precautions (5.7) and adverse reactions (6.3)]. risk summary there are no available data on increlex use in pregnant women. exposure to increlex during pregnancy is unlikely because the drug is not indicated for use after epiphyseal closure. in animal reproduction studies, there were no observed embryo-fetal development abnormalities with intravenous administration of increlex to pregnant rats and rabbits during fetal organogenesis given at exposures up to 11 and 3 times the maximum recommended human dose (mrhd) of 0.24 mg/kg/day based on body surface area (bsa), respectively (see data) . the estimated background risk of birth defects and miscarriage for the indicated population is unknown. 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. data animal data studies to assess embryo-fetal toxicity evaluated the effects of increlex during organogenesis in sprague dawley rats given 1, 4, and 16 mg/kg/day and in new zealand white rabbits given 0.125, 0.5, and 2 mg/kg/day, administered intravenously. there were no observed embryo-fetal developmental abnormalities in rats given up to 16 mg/kg/day (11 times the mrhd based on bsa comparison). in the rabbit study, the noael for fetal toxicity was 0.5 mg/kg/day (approximately equivalent to the mrhd based on bsa) due to an increase in fetal death at 2 mg/kg. increlex displayed no teratogenicity or maternal toxicity in rabbits given up to 2 mg/kg (3 times the mrhd based on bsa). risk summary there is no information available on the presence of mecasermin in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for increlex and any potential adverse effects on the breast-fed child from increlex or from the underlying maternal condition. toxicity (gasping syndrome) with benzyl alcohol serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 mg/kg/day to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 mmol/l to 1.378 mmol/l). increlex contains 9 mg/ml benzyl alcohol as a preservative. additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. use of increlex in infants is not recommended [see warnings and precautions (5.8)] . safety and effectiveness in pediatric patients below the age of 2 years of age have not been established. the safety and effectiveness of increlex in patients aged 65 and over has not been established. instructions for use increlex® (eenk-ruh-lex) (mecasermin) injection for subcutaneous use read this instructions for use before you start using increlex and each time you get a refill. there may be new information. this information does not take the place of talking to your child's doctor about your child's medical condition or treatment. do not share your child's needles and syringes with another person. your child may give another person an infection or your child could get an infection from them. important : - inject increlex exactly as your child's doctor or nurse has shown you. - follow your doctor's instructions for the type of syringe and needle to use to prepare and inject your child's dose of increlex . - always use a new, unopened needle and syringe for each injection. - only use single-use, disposable needles and syringes. never reuse disposable needles and syringes. - throw away used needles and syringes in a puncture-resistant, disposable sharps container as soon as you finish giving the injection. see step 5 "how should i throw away (dispose of) used needles and syringes? " at the end of these instructions. supplies needed to give the injection: - 1 vial of increlex - 1 alcohol swab - 1 gauze or cotton ball - alcohol (to clean the skin at the injection site) - 1 sharps container for throwing away (disposing of) used needles and syringes. see step 5 "how should i throw away (dispose of) used needles and syringes? " at the end of these instructions. preparing the dose: - wash your hands before getting increlex ready for your child's injection. - check the liquid to make sure it is clear and colorless. do not use if it is cloudy or if you see particles. - check the expiration date printed on the label of the vial. do not use increlex if the expiration date has passed. - if you are using a new vial, remove the protective cap. do not remove the rubber top (see figure 1). figure 1: remove the protective cap - wipe the rubber top on the vial with an alcohol swab (see figure 2). figure 2: wipe rubber top with alcohol swab - before putting the needle into the vial, pull back on plunger to draw air into the syringe equal to the increlex dose. put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see figure 3). figure 3: inject air into vial - leave the syringe in the vial and turn both upside down. hold the syringe and vial firmly (see figure 4). figure 4: prepare to withdraw liquid - make sure the tip of the needle is in the liquid (see figure 5). pull the plunger to withdraw the correct dose into the syringe (see figure 6). figure 5: tip in liquidfigure 6: withdraw correct dose - before you take the needle out of the vial, check the syringe for air bubbles. if bubbles are in the syringe, hold the vial and syringe with needle straight up and tap the side of the syringe until the bubbles float to the top. push the bubbles out with the plunger and draw liquid back in until you have the correct dose (see figure 7). figure 7: remove air bubbles and refill syringe - remove the needle from the vial. do not let the needle touch anything. you are now ready to inject (see figure 8). figure 8: ready to inject injecting the dose: inject increlex exactly as your child's doctor or nurse has shown you. do not give the increlex injection if your child is unable to eat within 20 minutes before or after the injection . - put used needles and syringes 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. - do not try to touch the needle. - 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. - 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 to throw away 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. - for the safety and health of you and others, needles and used syringes must never be re-used. - the used alcohol swabs, cotton balls, and gauze may be placed in your household trash. - do not 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. - always keep the sharps disposal container out of the reach of children. how should i store increlex? - before opening : store new, unopened vials of increlex in the refrigerator between 36°f to 46°f (2°c to 8°c). - after opening : store opened vials of increlex in the refrigerator between 36°f to 46°f (2°c to 8°c) for 30 days after you start using the vial. throw away any unused increlex after 30 days. - do not freeze increlex. if a vial freezes, throw it away. - keep increlex out of direct light. - do not use increlex after the expiration date printed on the label. keep increlex and all medicines out of reach of children. this instructions for use has been approved by the u.s. food and drug administration. for additional information, call 855-463-5127. manufactured by: ipsen biopharmaceuticals, inc. cambridge, ma 02142 usa u.s. license no. 2194 www.ipsenus.com revised: october 2023