Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع ادوية شاوي و رشيدات و مسنات - shawi & rushedat drug store - ceftriaxone 1 g - 1 g

Ireland - English - HPRA (Health Products Regulatory Authority)

roche products ltd - lidocaine hydrochloride - solution for injection - 3.5 millilitre

Ireland - English - HPRA (Health Products Regulatory Authority)

roche products limited - lidocaine hydrochloride - solution for injection - 3.5 millilitre

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

cephalon, llc - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil 100 mg - provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use in osa, provigil is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. if continuous positive airway pressure (cpap) is the treatment of choice for a patient, a maximal effort to treat with cpap for an adequate period of time should be made prior to initiating and during treatment with provigil for excessive sleepiness. provigil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . pregnancy category c there are no adequate and well-controlled studies of modafinil in pregnant women. intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of r- and s-modafinil) and armodafinil (the r-enantiomer of modafinil). although the pharmacology of modafinil is not identical to that of the sympathomimetic amines, it does share some pharmacologic properties with this class. certain of these drugs have been associated with intrauterine growth restriction and spontaneous abortions. whether the cases reported with modafinil are drug-related is unknown. in studies of modafinil and armodafinil conducted in rats (modafinil, armodafinil) and rabbits (modafinil), developmental toxicity was observed at clinically relevant plasma exposures. provigil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. modafinil (50, 100, or 200 mg/kg/day) administered orally to pregnant rats throughout organogenesis caused, in the absence of maternal toxicity, an increase in resorptions and an increased incidence of visceral and skeletal variations in the offspring at the highest dose tested. the higher no-effect dose for embryofetal developmental toxicity in rats (100 mg/kg/day) was associated with a plasma modafinil auc less than that in humans at the recommended human dose (rhd) of provigil (200 mg/day). however, in a subsequent study of up to 480 mg/kg/day of modafinil, no adverse effects on embryofetal development were observed. oral administration of armodafinil (60, 200, or 600 mg/kg/day) to pregnant rats throughout organogenesis resulted in increased incidences of fetal visceral and skeletal variations and decreased fetal body weight at the highest dose tested. the highest no-effect dose for embryofetal developmental toxicity in rats (200 mg/kg/day) was associated with a plasma armodafinil auc less than that in humans at the rhd of provigil. modafinil administered orally to pregnant rabbits throughout organogenesis at doses of up to 100 mg/kg/day had no effect on embryofetal development; however, the doses used were too low to adequately assess the effects of modafinil on embryofetal development.  in a subsequent developmental toxicity study evaluating doses of 45, 90, and 180 mg/kg/day in pregnant rabbits, the incidences of fetal structural alterations and embryofetal death were increased at the highest dose. the highest no-effect dose for developmental toxicity (100 mg/kg/day) was associated with a plasma modafinil auc similar to that in humans at the rhd of provigil. modafinil administration to rats throughout gestation and lactation at oral doses of up to 200 mg/kg/day resulted in decreased viability in the offspring at doses greater than 20 mg/kg/day, a dose resulting in a plasma modafinil auc less than that in humans at the rhd of provigil. no effects on postnatal developmental and neurobehavioral parameters were observed in surviving offspring. pregnancy registry a pregnancy registry has been established to collect information on the pregnancy outcomes of women exposed to provigil. healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-866-404-4106 (toll free). it is not known whether modafinil or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when provigil is administered to a nursing woman. safety and effectiveness in pediatric patients have not been established. provigil is not approved in this population for any indication. serious skin rashes, including erythema multiforme major (emm) and stevens-johnson syndrome (sjs) have been associated with modafinil use in pediatric patients [see warnings and precautions (5.1)] . in a controlled 6-week study, 165 pediatric patients (aged 5-17 years) with narcolepsy were treated with modafinil (n=123), or placebo (n=42). there were no statistically significant differences favoring modafinil over placebo in prolonging sleep latency as measured by mslt, or in perceptions of sleepiness as determined by the clinical global impression-clinician scale (cgi-c). in the controlled and open-label clinical studies, treatment emergent adverse reactions of the psychiatric and nervous system included tourette’s syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations, and suicidal ideation. transient leukopenia, which resolved without medical intervention, was also observed. in the controlled clinical study, 3 of 38 girls, ages 12 or older, treated with modafinil experienced dysmenorrhea compared to 0 of 10 girls who received placebo. there were three 7 to 9 week, double-blind, placebo-controlled, parallel group studies in children and adolescents (aged 6-17 years) with attention-deficit hyperactivity disorder (adhd). two of the studies were flexible-dose studies (up to 425 mg/day), and the third was a fixed-dose study (340 mg/day for patients <30 kg and 425 mg/day for patients ≥30 kg). although these studies showed statistically significant differences favoring modafinil over placebo in reducing adhd symptoms as measured by the adhd-rs (school version), there were 3 cases of serious rash including one case of possible sjs among 933 patients exposed to modafinil in this program. modafinil is not approved for use in treating adhd. in clinical trials, experience in a limited number of modafinil-treated patients who were greater than 65 years of age showed an incidence of adverse reactions similar to other age groups. in elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. therefore, consideration should be given to the use of lower doses and close monitoring in this population [see dosage and administration (2.4) and clinical pharmacology (12.3)]. in patients with severe hepatic impairment, the dose of provigil should be reduced to one-half of that recommended for patients with normal hepatic function [see dosage and administration (2.3) and clinical pharmacology (12.3)] . provigil contains modafinil, a schedule iv controlled substance. in humans, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other cns stimulants. in in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. in some studies, modafinil was also partially discriminated as stimulant-like. physicians should follow patients closely, especially those with a history of drug and/or stimulant (e.g., methylphenidate, amphetamine, or cocaine) abuse. patients should be observed for signs of misuse or abuse (e.g., incrementation of doses or drug-seeking behavior). the abuse potential of modafinil (200, 400, and 800 mg) was assessed relative to methylphenidate (45 and 90 mg) in an inpatient study in individuals experienced with drugs of abuse. results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled cns stimulants (methylphenidate). in one placebo-controlled clinical trial, the effects of modafinil withdrawal were monitored following 9 weeks of modafinil use. there were no reported withdrawal symptoms with modafinil during 14 days of observation, although sleepiness returned in narcoleptic patients.

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

cephalon, llc - omacetaxine mepesuccinate (unii: 6fg8041s5b) (omacetaxine - unii:84mi6oyn4z) - omacetaxine mepesuccinate 3.5 mg in 1 ml - synribo is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (cml) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (tki). none. risk summary based on its mechanism of action and findings from animal studies, synribo can cause fetal harm when administered to pregnant women. in animal reproduction studies, subcutaneous administration of omacetaxine mepesuccinate to pregnant mice during organogenesis at doses approximately 0.25 to 0.5 times the maximum recommended human doses (mrhd) resulted in embryo-fetal mortality, structural abnormalities, and alterations to growth (see data) . there are no available data on synribo use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. advise pregnant women of the potential risk to a fetus [see warnings and precautions (5.4)] .  the estimated background risk of major birth defects and miscarriage for the indi

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

cephalon, llc - armodafinil (unii: v63xwa605i) (armodafinil - unii:v63xwa605i) - armodafinil 50 mg - nuvigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (osa), narcolepsy, or shift work disorder (swd). limitations of use in osa, nuvigil is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. if continuous positive airway pressure (cpap) is the treatment of choice for a patient, a maximal effort to treat with cpap for an adequate period of time should be made prior to initiating nuvigil for excessive sleepiness. nuvigil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nuvigil during pregnancy. healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-866-404-4106. risk summary limited available d

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

cephalon, llc - tiagabine hydrochloride (unii: dqh6t6d8oy) (tiagabine - unii:z80i64hmnp) - tiagabine hydrochloride 2 mg - gabitril (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. gabitril is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. the abuse and dependence potential of gabitril have not been evaluated in human studies.

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

cephalon, inc. - rituximab (unii: 4f4x42syq6) (rituximab - unii:4f4x42syq6) - truxima (rituximab-abbs) is indicated for the treatment of adult patients with: - relapsed or refractory, low-grade or follicular, cd20-positive, b-cell nhl as a single agent. - previously untreated follicular, cd20-positive, b-cell nhl in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. - non-progressing (including stable disease), low-grade, cd20-positive, b-cell nhl as a single agent after first-line cyclophosphamide, vincristine, and prednisone (cvp) chemotherapy. - previously untreated diffuse large b-cell, cd20-positive nhl in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (chop) or other anthracycline-based chemotherapy regimens. truxima is indicated, in combination with fludarabine and cyclophosphamide (fc), for the treatment of adult patients with previously untreated and previously treated cd20-positive cll. truxima, in combination w