Σλοβενία - Σλοβενικά - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

teva b.v. - teriparatid - raztopina za injiciranje - teriparatid 20 µg / 1 odmerek - teriparatid

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

par pharmaceuticals, inc. - dexmethylphenidate hydrochloride (unii: 1678ok0e08) (dexmethylphenidate - unii:m32rh9mfgp) - dexmethylphenidate hydrochloride 15 mg - dexmethylphenidate hydrochloride extended-release capsules is indicated for the treatment of attention deficit hyperactivity disorder (adhd) [see clinical studies (14)] . - hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release capsules. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see adverse reactions (6.1)] . - concomitant treatment with monoamine oxidase inhibitors (maois) or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including dexmethylphenidate hydrochloride extended-release capsules, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhdmedications/. risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. published studies and post-marketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy ( see clinical considerations ). embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times the maximum recommended human dose (mrhd) of 20 mg/day given to adults based on plasma levels. a decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the mrhd of 20 mg/day given to adults based on plasma levels ( 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. clinical considerations fetal/neonatal adverse reactions cns stimulants such as dexmethylphenidate hydrochloride extended-release capsules, can cause vasoconstriction and thereby decrease placental perfusion. no fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. animal data in embryo-fetal development studies conducted in rats and rabbits, dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. no evidence of malformations was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. when dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, postweaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. at the highest doses tested, plasma levels [area under the curve (aucs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with 20 mg/day. plasma levels in adults were comparatively similar to plasma levels in adolescents. racemic methylphenidate has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis. risk summary dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. limited published literature, based on milk sampling from seven mothers’ reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. there are no reports of adverse effects on the breastfed infant and no effects on milk production. long-term neurodevelopmental effects on infants from stimulant exposure are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dexmethylphenidate hydrochloride extended-release capsules and any potential adverse effects on the breastfed infant from dexmethylphenidate hydrochloride extended-release capsules or from the underlying maternal condition. clinical considerations monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. the safety and effectiveness of dexmethylphenidate hydrochloride extended-release capsules in pediatric patients less than 6 years have not been established. the safety and effectiveness of dexmethylphenidate hydrochloride extended-release capsules for the treatment of adhd have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials [see clinical studies (14.2)] . the long-term efficacy of dexmethylphenidate hydrochloride extended-release capsules in pediatric patients has not been established. long term suppression of growth growth should be monitored during treatment with stimulants, including dexmethylphenidate hydrochloride extended-release capsules. pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.7)] . juvenile animal toxicity data rats treated with racemic methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. a deficit in acquisition of a specific learning task was observed in females only. the doses at which these findings were observed are at least 6 times the mrhd of 60 mg/day given to children on a mg/m 2 basis. in a study conducted in young rats, racemic methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10). when these animals were tested as adults (postnatal weeks 13 to14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the mrhd of 60 mg/day of racemic methylphenidate given to children on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the mrhd given to children on a mg/m 2 basis). the no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the mrhd given to children on a mg/m 2 basis). the clinical significance of the long-term behavioral effects observed in rats is unknown. dexmethylphenidate hydrochloride extended-release capsules have not been studied in the geriatric population. dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a schedule ii controlled substance. cns stimulants, including dexmethylphenidate hydrochloride extended-release capsules, other methylphenidate-containing products, and amphetamines have a high potential for abuse. abuse is characterized by impaired control over drug use despite harm, and craving. signs and symptoms of cns stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. abusers of cns stimulants may chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death [see overdosage (10)] . to reduce the abuse of cns stimulants including dexmethylphenidate hydrochloride extended-release capsules, assess the risk of abuse prior to prescribing. after prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of cns stimulants [see how supplied/storage and handling (16)] , monitor for signs of abuse while on therapy, and reevaluate the need for dexmethylphenidate hydrochloride extended-release capsules use. tolerance tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) can occur during chronic therapy with cns stimulants, including dexmethylphenidate hydrochloride extended-release capsules. dependence physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with cns stimulants including dexmethylphenidate hydrochloride extended-release capsules. withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of cns stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

par pharmaceutical, inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 40 mg - fluoxetine is indicated for the treatment of: - acute and maintenance treatment of major depressive disorder [see clinical studies (14.1)]. - acute and maintenance treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) [see clinical studies (14.2 )]. - acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa [see clinical studies (14.3) ]. - acute treatment of panic disorder, with or without agoraphobia [see clinical studies (14.4) ]. fluoxetine and olanzapine in combination is indicated for the treatment of: - acute treatment of depressive episodes associated with bipolar i disorder. - treatment resistant depression (major depressive disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). treatment resistant depression (major depressive disorder in patients, who do not respond to 2 separate trials of different antid

Καναδάς - Αγγλικά - Health Canada

avir pharma inc. - sincalide - powder for solution - 5mcg - sincalide 5mcg - gallbladder function

Ολλανδία - Ολλανδικά - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

pharmachemie b.v. - paroxetine hydrochloride 0,5-water samenstelling overeenkomend met; paroxetine; - filmomhulde tablet - paroxetine

Ολλανδία - Ολλανδικά - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

jubilant pharmaceuticals n.v. guldensporenpark 22, blok c 9820 merelbeke (belgiË) - paroxetinehydrochloride 0,5-water 11,4 mg/stuk samenstelling overeenkomend met ; paroxetine 10 mg/stuk - filmomhulde tablet - calciumwaterstoffosfaat 2-water (e 341) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; polysorbaat 80 (e 433) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd, calciumwaterstoffosfaat 2-water (e 341) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat (e468) ; polysorbaat 80 (e 433) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd - paroxetine

Ολλανδία - Ολλανδικά - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

jubilant pharmaceuticals n.v. guldensporenpark 22, blok c 9820 merelbeke (belgiË) - paroxetinehydrochloride 0,5-water 22,8 mg/stuk samenstelling overeenkomend met ; paroxetine 20 mg/stuk - filmomhulde tablet - calciumwaterstoffosfaat 2-water (e 341) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; polysorbaat 80 (e 433) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd, calciumwaterstoffosfaat 2-water (e 341) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat (e468) ; polysorbaat 80 (e 433) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd - paroxetine

Ολλανδία - Ολλανδικά - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

jubilant pharmaceuticals n.v. guldensporenpark 22, blok c 9820 merelbeke (belgiË) - paroxetinehydrochloride 0,5-water 34,1 mg/stuk samenstelling overeenkomend met ; paroxetine 30 mg/stuk - filmomhulde tablet - calciumwaterstoffosfaat 2-water (e 341) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; indigokarmijn aluminiumlak (e 132) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; polysorbaat 80 (e 433) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd, calciumwaterstoffosfaat 2-water (e 341) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; indigokarmijn aluminiumlak (e 132) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat (e468) ; polysorbaat 80 (e 433) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd - paroxetine

Ολλανδία - Ολλανδικά - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

jubilant pharmaceuticals n.v. guldensporenpark 22, blok c 9820 merelbeke (belgiË) - paroxetinehydrochloride 0,5-water 45,5 mg/stuk samenstelling overeenkomend met ; paroxetine 40 mg/stuk - filmomhulde tablet - calciumwaterstoffosfaat 2-water (e 341) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat ; polysorbaat 80 (e 433) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd, calciumwaterstoffosfaat 2-water (e 341) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 400 ; magnesiumstearaat (e 470b) ; natriumzetmeelglycolaat (e468) ; polysorbaat 80 (e 433) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd - paroxetine

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

par pharmaceutical, inc. - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 500 mg in 20 ml - mycophenolate mofetil (mmf) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies (14.1)], heart [see clinical studies (14.2)] or liver transplants [see clinical studies (14.3)] , in combination with other immunosuppressants. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product. mycophenolate mofetil for injection is contraindicated in patients who are allergic to polysorbate 80 (tween). pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the registry, visit  www.mycophenolaterems.