USA - engelska - NLM (National Library of Medicine)

gland pharma limited - adenosine (unii: k72t3fs567) (adenosine - unii:k72t3fs567) - intravenous adenosine injection is indicated for the following. conversion to sinus rhythm of paroxysmal supraventricular tachycardia (psvt), including that associated with accessory bypass tracts (wolff-parkinson-white syndrome). when clinically advisable, appropriate vagal maneuvers (e.g., valsalva maneuver), should be attempted prior to adenosine injection administration. it is important to be sure the adenosine injection solution actually reaches the systemic circulation (see dosage and administration). adenosine injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. in the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosineinjection administration. intravenous adenosine injection is contraindicated in: 1. second- or third-degree a-v block (except in patients with a functioning artificial pacemaker). 2. sinus node disease, such as sick sin

USA - engelska - NLM (National Library of Medicine)

avkare - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. dual therapy omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in patients who fail thera

USA - engelska - NLM (National Library of Medicine)

novartis gene therapies, inc. - adeno-associated virus (unii: b769i4xpy3) (adeno-associated virus - unii:b769i4xpy3) - zolgensma is an adeno-associated virus (aav) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (sma) with bi-allelic mutations in the survival motor neuron 1 (smn1) gene. limitations of use - the safety and effectiveness of repeat administration of zolgensma have not been evaluated [see adverse reactions (6.2)] . - the use of zolgensma in patients with advanced sma (e.g., complete paralysis of limbs, permanent ventilator-dependence) has not been evaluated [see clinical studies (14)] . none. risk summary there are no available data regarding zolgensma use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with zolgensma. in the united states 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. risk summary there is no information available on the presence of zolgensma in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for zolgensma and any potential adverse effects on the breastfed child from zolgensma or from the underlying maternal condition. administration of zolgensma to premature neonates before reaching full-term gestational age is not recommended, because concomitant treatment with corticosteroids may adversely affect neurological development. delay zolgensma infusion until the corresponding full-term gestational age is reached. there is no information on whether breastfeeding should be restricted in mothers who may be seropositive for anti-aav9 antibodies. the safety of zolgensma was studied in pediatric patients who received zolgensma infusion at age 0.3 to 7.9 months (weight range, 3.0 kg to 8.4 kg) [see adverse reactions (6)] . the efficacy of zolgensma was studied in pediatric patients who received zolgensma infusion at age 0.5 to 7.9 months (weight range, 3.6 kg to 8.4 kg) [see clinical studies (14)] . zolgensma therapy should be carefully considered in patients with liver impairment. cases of acute serious liver injury and acute liver failure have been reported with zolgensma in patients with preexisting liver abnormalities. in clinical trials, elevation of aminotransferases was observed in patients following zolgensma infusion [see warnings and precautions (5.1)] .

USA - engelska - NLM (National Library of Medicine)

wg critical care, llc - cefepime hydrochloride (unii: i8x1o0607p) (cefepime - unii:807pw4vqe3) - cefepime for injection is indicated in the treatment of pneumonia (moderate to severe) caused by susceptible strains of streptococcus pneumoniae , including cases associated with concurrent bacteremia, pseudomonas aeruginosa , klebsiella pneumoniae , or enterobacter species. cefepime for injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. insufficient data exist to support the efficacy of cefepime monotherapy in such patients [see clinical studies (14.1)] . cefepime for injection is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of escherichia coli or klebsiella pneumoniae , when the infec

USA - engelska - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole oral tablets are indicated for the treatment of: • schizophrenia [see clinical studies ( 14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify ® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole tablets are contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions ( 6.2)] .  pregnancy exposure registry   there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsycho

USA - engelska - NLM (National Library of Medicine)

solco healthcare u.s., llc - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam is 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 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 resulted in increasing nu

USA - engelska - NLM (National Library of Medicine)

winthrop u.s, a business of sanofi-aventis u.s. llc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 6.25 mg - zolpidem tartrate extended-release tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). the clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see clinical studies (14)] . zolpidem tartrate extended-release tablets are contraindicated in patients - who have experienced complex sleep behaviors after taking zolpidem tartrate extended-release tablets [see warnings and precautions (5.1)]. - with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.4)]. risk summary neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see clinical considerationsand data] . published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects [see data] . oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses [see data] . 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%–4% and 15%–20%, respectively. clinical considerations fetal/neonatal adverse reactions zolpidem crosses the placenta and may produce respiratory depression and sedation in neonates. monitor neonates exposed to zolpidem tartrate extended-release tablets during pregnancy and labor for signs of excess sedation, hypotonia, and respiratory depression and manage accordingly. data human data published data from observational studies, birth registries, and case reports on the use of zolpidem during pregnancy do not report a clear association with zolpidem and major birth defects. there are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken zolpidem during pregnancy. these cases required artificial ventilation or intratracheal intubation. the majority of neonates recovered within hours to a few weeks after birth once treated. zolpidem has been shown to cross the placenta. animal data oral administration of zolpidem to pregnant rats during the period of organogenesis at 4, 20, and 100 mg base/kg/day, which are approximately 4, 20, and 100 times the maximum recommended human dose (mrhd) of 12.5 mg/day (10 mg zolpidem base) based on mg/m 2 body surface area, caused delayed fetal development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 20 and 100 times the mrhd based on mg/m 2 body surface area. oral administration of zolpidem to pregnant rabbits during the period of organogenesis at 1, 4, and 16 mg base/kg/day, which are approximately 2, 8, and 30 times the mrhd of 12.5 mg/day (10 mg zolpidem base) based on mg/m 2 body surface area, caused embryo-fetal death and delayed fetal development (incomplete fetal skeletal ossification) at a maternally toxic (decreased body weight gain) dose 30 times the mrhd based on mg/m 2 body surface area. oral administration of zolpidem to pregnant rats from day 15 of gestation through lactation at 4, 20, and 100 mg base/kg/day, which are approximately 4, 20, and 100 times the mrhd of 12.5 mg/day (10 mg zolpidem base) based on a mg/m 2 body surface area, delayed offspring growth and decreased survival at doses 20 and 100 times, respectively, the mrhd based on mg/m 2 body surface area. risk summary limited data from published literature report the presence of zolpidem in human milk. there are reports of excess sedation in infants exposed to zolpidem through breastmilk [see clinical considerations]. there is no information on the effects of zolpidem on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zolpidem tartrate extended-release tablets and any potential adverse effects on the breastfed infant from zolpidem tartrate extended-release tablets or from the underlying maternal condition. clinical considerations infants exposed to zolpidem tartrate extended-release tablets through breastmilk should be monitored for excess sedation, hypotonia, and respiratory depression. a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 23 hours (approximately 5 elimination half-lives) after zolpidem tartrate extended-release tablets administration in order to minimize drug exposure to a breastfed infant. zolpidem tartrate extended-release tablets are not recommended for use in children. safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established. in an 8-week study in pediatric patients (aged 6–17 years) with insomnia associated with attention-deficit/hyperactivity disorder (adhd), an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo. psychiatric and nervous system disorders comprised the most frequent (>5%) treatment-emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs 1.5%), headache (12.5% vs 9.2%), and hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see warnings and precautions (5.5)] . ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction. fda has not required pediatric studies of zolpidem tartrate extended-release tablets in the pediatric population based on these efficacy and safety findings. a total of 99 elderly (≥65 years of age) received daily doses of 6.25 mg zolpidem tartrate extended-release tablets in a 3-week placebo-controlled study. the adverse reaction profile of zolpidem tartrate extended-release tablets 6.25 mg in this population was similar to that of zolpidem tartrate extended-release tablets 12.5 mg in younger adults (≤64 years of age). dizziness was reported in 8% of zolpidem tartrate extended-release tablets–treated patients compared with 3% of those treated with placebo. the dose of zolpidem tartrate extended-release tablets in elderly patients is 6.25 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see warnings and precautions (5.2)] . women clear zolpidem tartrate from the body at a lower rate than men. c max and auc parameters of zolpidem from zolpidem tartrate extended-release tablets were, respectively, approximately 50% and 75% higher at the same dose in adult female subjects compared to adult male subjects. between 6 and 12 hours after dosing, zolpidem concentrations were 2 to 3 fold higher in adult female compared to adult male subjects. given the higher blood levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of zolpidem tartrate extended-release tablets for adult women is 6.25 mg, and the recommended dose for adult men is 6.25 or 12.5 mg. in geriatric patients, clearance of zolpidem is similar in men and women. the recommended dose of zolpidem tartrate extended-release tablets in geriatric patients is 6.25 mg regardless of gender. the recommended dose of zolpidem tartrate extended-release tablets in patients with mild to moderate hepatic impairment is 6.25 mg once daily immediately before bedtime. avoid zolpidem tartrate extended-release tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see dosage and administration (2.2), warnings and precautions (5.8), clinical pharmacology (12.3)] . zolpidem tartrate is classified as a schedule iv controlled substance by federal regulation. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects. addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common. studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg effects were difficult to distinguish from placebo. because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem, they should be monitored carefully when receiving zolpidem or any other hypnotic. use of zolpidem tartrate extended-release tablets may lead to development of physical and/or psychological dependence. this risk of dependence increases with dose and duration of treatment. the risk of abuse and dependence is also greater in patients with history of alcohol or drug abuse. zolpidem tartrate extended-release tablets should be used with extreme caution in patients with current or past alcohol or drug abuse. physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. these reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, convulsions, and delirium. the following adverse events, which are considered to meet the dsm-iii-r criteria for uncomplicated sedative/hypnotic withdrawal, were reported during zolpidem tartrate extended-release tablets clinical trials following placebo substitution occurring within 48 hours following last zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and abdominal discomfort. these reported adverse events occurred at an incidence of 1% or less. however, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. there have been postmarketing reports of abuse, dependence and withdrawal with zolpidem.

USA - engelska - NLM (National Library of Medicine)

accord healthcare inc. - prasugrel hydrochloride (unii: g89jq59i13) (prasugrel - unii:34k66tbt99) - prasugrel tablets are indicated to reduce the rate of thrombotic cv events (including stent thrombosis) in patients with acute coronary syndrome (acs) who are to be managed with percutaneous coronary intervention (pci) as follows: - patients with unstable angina (ua) or non-st-elevation myocardial infarction (nstemi). - patients with st-elevation myocardial infarction (stemi) when managed with primary or delayed pci. prasugrel tablets have been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (mi), or nonfatal stroke compared to clopidogrel. the difference between treatments was driven predominantly by mi, with no difference on strokes and little difference on cv death [see clinical studies ( 14)] . prasugrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage (ich)  [see warnings and precautions ( 5.1) and adverse reactions ( 6.1)] . prasugrel tablets are contraindicated in patients with a history of prior transient ischemic attack (tia) or stroke. in triton-timi 38 ( tr ial to assess i mprovement in t herapeutic outcomes by o ptimizing platelet inhibitio n with prasugrel), patients with a history of tia or ischemic stroke (>3 months prior to enrollment) had a higher rate of stroke on prasugrel (6.5%; of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage [ich]) than on clopidogrel (1.2%; all thrombotic). in patients without such a history, the incidence of stroke was 0.9% (0.2% ich) and 1.0% (0.3% ich) with prasugrel and clopidogrel, respectively. patients with a history of ischemic stroke within 3 months of screening and patients with a history of hemorrhagic stroke at any time were excluded from triton-timi 38. patients who experience a stroke or tia while on prasugrel generally should have therapy discontinued [see adverse reactions ( 6.1) and clinical studies ( 14)] . prasugrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to prasugrel or any component of the product [see adverse reactions ( 6.2)] . risk summary there are no data with prasugrel use in pregnant women to inform a drug-associated risk. no structural malformations were observed in animal reproductive and developmental toxicology studies when rats and rabbits were administered prasugrel during organogenesis at doses of up to 30 times the recommended therapeutic exposures in humans [see data] . due to the mechanism of action of prasugrel, and the associated identified risk of bleeding, consider the benefits and risks of prasugrel and possible risks to the fetus when prescribing prasugrel tablets to a pregnant woman [see boxed warning and warnings and precautions (5.1,5.3)] . the background risk of major birth defects and miscarriage for the indicated population is unknown. the background risk in the u.s. 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 embryo-fetal developmental toxicology studies, pregnant rats and rabbits received prasugrel at maternally toxic oral doses equivalent to more than 40 times the human exposure. a slight decrease in fetal body weight was observed, but, there were no structural malformations in either species. in prenatal and postnatal rat studies, maternal treatment with prasugrel had no effect on the behavioral or reproductive development of the offspring at doses greater than 150 times the human exposure. risk summary there is no information regarding the presence of prasugrel in human milk, the effects on the breastfed infant, or the effects on milk production. metabolites of prasugrel were found in rat milk [see data] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for prasugrel tablets and any potential adverse effects on the breastfed child from prasugrel or from the underlying maternal condition. data animal data following a 5 mg/kg oral dose of [ 14 c]-prasugrel to lactating rats, metabolites of prasugrel were detected in the maternal milk and blood. safety and effectiveness in pediatric patients have not been established. in a randomized, placebo-controlled trial, the primary objective of reducing the rate of vaso-occlusive crisis (painful crisis or acute chest syndrome) in pediatric patients, aged 2 to less than 18 years, with sickle cell anemia was not met. in triton-timi 38, 38.5% of patients were ≥65 years of age and 13.2% were ≥75 years of age. the risk of bleeding increased with advancing age in both treatment groups, although the relative risk of bleeding (prasugrel compared with clopidogrel) was similar across age groups. patients ≥75 years of age who received prasugrel 10 mg had an increased risk of fatal bleeding events (1.0%) compared to patients who received clopidogrel (0.1%). in patients ≥75 years of age, symptomatic intracranial hemorrhage occurred in 7 patients (0.8%) who received prasugrel and in 3 patients (0.3%) who received clopidogrel. because of the risk of bleeding, and because effectiveness is uncertain in patients ≥75 years of age [see clinical studies ( 14)] , use of prasugrel is generally not recommended in these patients, except in high-risk situations (diabetes and past history of myocardial infarction) where its effect appears to be greater and its use may be considered [see warnings and precautions ( 5.1), clinical pharmacology ( 12.3), and clinical studies ( 14)] . in triton-timi 38, 4.6% of patients treated with prasugrel tablets had body weight <60 kg. individuals with body weight <60 kg had an increased risk of bleeding and an increased exposure to the active metabolite of prasugrel [see dosage and administration ( 2), warnings and precautions ( 5.1), and clinical pharmacology ( 12.3)] . consider lowering the maintenance dose to 5 mg in patients <60 kg. the effectiveness and safety of the 5 mg dose have not been prospectively studied [see dosage and administration ( 2) and clinical pharmacology ( 12.3)] . no dosage adjustment is necessary for patients with renal impairment. there is limited experience in patients with end-stage renal disease, but such patients are generally at higher risk of bleeding [see warnings and precautions ( 5.1) and clinical pharmacology ( 12.3)] . no dosage adjustment is necessary in patients with mild to moderate hepatic impairment (child-pugh class a and b). the pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic disease have not been studied, but such patients are generally at higher risk of bleeding [see warnings and precautions ( 5.1) and clinical pharmacology ( 12.3)] . in healthy subjects, patients with stable atherosclerosis, and patients with acs receiving prasugrel, there was no relevant effect of genetic variation in cyp2b6, cyp2c9, cyp2c19, or cyp3a5 on the pharmacokinetics of prasugrel's active metabolite or its inhibition of platelet aggregation.

USA - engelska - NLM (National Library of Medicine)

quallent pharmaceuticals health llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: - major depressive disorder (mdd) [see clinical studies (14.1)] - generalized anxiety disorder (gad) [see clinical studies (14.2)] - social anxiety disorder (sad) [see clinical studies (14.3)] -  panic disorder (pd) [see clinical studies (14.4)] venlafaxine hydrochloride extended-release capsules are contraindicated in patients: - with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see adverse reactions (6.2)] . -  taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see dosage and administration (2.11), warnings and precautions (5.2), and drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including venlafaxine hydrochloride extended-r

USA - engelska - NLM (National Library of Medicine)

laboratorios alfa srl - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - 10% dextrose dolution has value as a source of water and calories. it is used to decrease the excessive pressure of spinal brain fluid, also a scloerisng to treat varicose veins and decrease intracranial pressure. this is a single dose container and does not contain preservatives. use the solution immediately after the bottle is opened, discard the remaining one. squeeze and inspect the bottle, discard if leaks are found or if the solution contains visible and solid particles. do not administer simultaneously with blood. do not use it unless solution is clear, and seal is intact. preparation and administration 1. check for minute leaks by squeezing the container firmly. if leaks are found, discard solution as sterility may be impaired. 2. suspend container from eyelet support. 3. remove plastic protector from ports area at the bottom of container. 4. hold the bottle in vertical position and inset pyrogen free iv administration set in the outlet port. use aseptic technique to add medication warning: additives may be incompatible. to add medication before solution administration 1. prepare medication site. 2. using syringe with 19 to 22 gauge needle, puncture inlet port and inject. 3. mix solution and medication thoroughly. for high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. to add medication during solution administration 1. close clamp on the set. 2. prepare medication site. 3. using syringe with 18 to 21 gauge needle, puncture inlet port and inject. 4. remove container from iv pole and/or turn to an upright position. 5. mix solution and medication thoroughly. 6. return container to in use position and continue administration. caution: federal law (usa) restricts this drug to use by or on the order of a licensed veterinarian.