natgillin/translations-raw huggingface dataset:
24 timer efter dosering.
Absorption Following a single dose, INVEGA exhibits a gradual ascending release rate, allowing the plasma concentrations of paliperidone to steadily rise to reach peak plasma concentration (Cmax) approximately 24 hours after dosing.
Ved administration af INVEGA én gang dagligt opnås steady state- koncentration af paliperidon hos de fleste mennesker efter 4- 5 dage.
With once-daily dosing of INVEGA, steady-state concentrations of paliperidone are attained within 4-5 days of dosing in most subjects.
INVEGAS afgivelsesegenskaber medfører minimale udsving i koncentrations- fluktuationen sammenlignet med risperidon med hurtig afgivelse (fluktuationsindeks 38% over for 125%).
The release characteristics of INVEGA result in minimal peak-trough fluctuations as compared to those observed with immediate-release risperidone (fluctuation index 38% versus 125%).
Paliperidons absolutte perorale biotilgængelighed efter administration af INVEGA er 28% (90% CI af 23% - 33%).
The absolute oral bioavailability of paliperidone following INVEGA administration is 28% (90% CI of 23%-33%).
Administration af paliperidon depottabletter sammen med et standardmåltid med højt indhold af fedt og kalorier øger paliperidons Cmax og AUC med op til 50- 60% i forhold til administration i fastende tilstand.
Administration of paliperidone prolonged-release tablets with a standard high-fat/ high-caloric meal increases Cmax and AUC of paliperidone by up to 50-60% compared with administration in the fasting state.
Fordeling Paliperidon fordeles hurtigt.
Distribution Paliperidone is rapidly distributed.
Paliperidons plasmaproteinbinding er 74%.
The plasma protein binding of paliperidone is 74%.
Det bindes primært til alfa- 1- syre glykoprotein og albumin.
It binds primarily to α 1-acid glycoprotein and albumin.
Biotransformation og eliminering En uge efter administration af en enkelt peroral dosis på 1 mg 14C- paliperidon med hurtig afgivelse blev 59% af dosis udskilt uforandret med urinen, hvilket indikerer, at paliperidon ikke metaboliseres ekstensivt af leveren.
Biotransformation and elimination One week following administration of a single oral dose of 1 mg immediate-release 14C-paliperidone, 59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised by the liver.
80% af den administrede radioaktivitet blev genfundet i urinen og 11% i fæces.
Approximately 80% of the administered radioactivity was recovered in urine and 11% in the faeces.
Der er identificeret fire metaboliske processer in vivo, hvoraf ingen udgjorde mere end 6, 5% af dosis, nemlig dealkylering, hydroxylering, dehydrogenering og benzisoxazolspaltning.
Four metabolic pathways have been identified in vivo, none of which accounted for more than 6.5% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Selv om in vitro- forsøg tyder på, at CYP2D6 og CYP3A4 spiller en rolle i metaboliseringen af paliperidon, findes der ingen in vivo- evidens for, at disse isozymer spiller en signifikant rolle i metaboliseringen af paliperidon.
Although in vitro studies suggested a role for CYP2D6 and CYP3A4 in the metabolism of paliperidone, there is no evidence in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Populationsfarmakokinetiske analyser indikerer, at der er en ikke mærkbar forskel i paliperidons tilsyneladende clearance efter administration af INVEGA mellem personer med ekstensiv metabolisering og personer med nedsat metabolisering af CYP2D6- substrater.
Population pharmacokinetics analyses indicated no discernable difference on the apparent clearance of paliperidone after administration of INVEGA between extensive metabolisers and poor metabolisers of CYP2D6 substrates.
In vitro- forsøg med humane levermikrosomer har vist, at paliperidon ikke væsentligt hæmmer metaboliseringen af lægemidler, som metaboliseres af cytokrom P450- isozymer, herunder CYP1A2, CYP2A6, CYP2C8/ 9/ 10, CYP2D6, CYP2E1, CYP3A4 og CYP3A5.
In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/ 9/ 10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5.
23 timer.
The terminal elimination half-life of paliperidone is about 23 hours.
In vitro- forsøg har vist, at paliperidon er et P- gp- substrat og en svag hæmmer af P- gp ved høje koncentrationer.
In vitro studies have shown that paliperidone is a P-gp substrate and a weak inhibitor of P-gp at high concentrations.
Der foreligger ingen in vivo- data, og den kliniske relevans kendes ikke.
No in vivo data are available and the clinical relevance is unknown.
11 Nedsat leverfunktion Paliperidon metaboliseres ikke ekstensivt i leveren.
Hepatic Impairment Paliperidone is not extensively metabolized in the liver.
I et forsøg med patienter med moderat nedsat leverfunktion (Child- Pugh- klasse B) var plasmakoncentrationerne af frit paliperidon de samme som hos raske forsøgsdeltagere.
In a study in subjects with moderate hepatic impairment (Child-Pugh class B), the plasma concentrations of free paliperidone were similar to those of healthy subjects.
Der foreligger ingen data for patienter med svært nedsat leverfunktion (Child- Pugh - klasse C).
No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Nedsat nyrefunktion Elimineringen af paliperidon falder med faldende nyrefunktion.
11 Renal Impairment Elimination of paliperidone decreased with decreasing renal function.
Hos personer med nedsat nyrefunktion var paliperidons totale clearance nedsat med 32% ved let (kreatininclearance [CrCl] = 50 til < 80 ml/ min.), 64% ved moderat (CrCl = 30 til < 50 ml/ min.) og 71% ved svært (CrCl = < 30 ml/ min.) nedsat nyrefunktion.
Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% in mild (Creatinine Clearance [Cr Cl] = 50 to < 80 ml/ min), 64% in moderate (CrCl = 30 to < 50 ml/ min), and 71% in severe (CrCl = < 30 ml/ min) renal impairment.
Paliperidons gennemsnitlige terminale elimineringshalveringstid var 24, 40 og 51 timer hos personer med henholdsvis let, moderat og svært nedsat nyrefunktion sammenlignet med 23 timer hos personer med normal nyrefunktion (CrCl ≥ 80 ml/ min).
The mean terminal elimination half-life of paliperidone was 24, 40, and 51 hours in subjects with mild, moderate, and severe renal impairment, respectively, compared with 23 hours in subjects with normal renal function (CrCl ≥ 80 ml/ min).
Ældre Data fra et farmakokinetisk forsøg med ældre patienter (≥ 65 år, n = 26) indikerer, at paliperidons tilsyneladende steady state- clearance efter administration af INVEGA var 20% lavere sammenlignet med voksne patienter (18- 45 år, n = 28).
Elderly Data from a pharmacokinetic study in elderly subjects (≥ 65 years of age, n = 26) indicated that the apparent steady-state clearance of paliperidone following INVEGA administration was 20% lower compared to that of adult subjects (18-45 years of age, n = 28).
Race En farmakokinetisk populationsanalyse har ikke vist tegn på racerelaterede forskelle i paliperidons farmakokinetiske egenskaber efter administration af INVEGA.
Race Population pharmacokinetics analysis revealed no evidence of race-related differences in the pharmacokinetics of paliperidone following INVEGA administration.
19% lavere hos kvinder end hos mænd.
Gender The apparent clearance of paliperidone following INVEGA administration is approximately 19% lower in women than men.
Denne forskel kan generelt forklares ved forskelle i fedtfri legemsmasse og kreatinin- clearance mellem mænd og kvinder.
This difference is largely explained by differences in lean body mass and creatinine clearance between men and women.
Rygning bør derfor ikke have nogen effekt på paliperidons farmakokinetiske egenskaber.
Smoking Status Based on in vitro studies utilising human liver enzymes, paliperidone is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of paliperidone.
En farmakokinetisk populationsanalyse har vist en lidt lavere eksponering for paliperidon hos rygere end hos ikke- rygere.
A population pharmacokinetic analysis showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Toksicitetsforsøg med gentagne doser af paliperidon til rotter og hunde viste primært farmakologiske effekter som sedation og prolaktinmedierede virkninger på mammakirtler og genitalier.
Repeat-dose toxicity studies of paliperidone in rat and dog showed mainly pharmacological effects, such as sedation and prolactin-mediated effects on mammary glands and genitals.
Paliperidon var ikke teratogenisk hos rotter og kaniner.
Paliperidone was not teratogenic in rat and rabbit.
I rottereproduktionsforsøg med risperidon, som omdannes ekstensivt til paliperidon hos rotter og mennesker, blev der observeret en reduktion i afkommets fødselsvægt og overlevelse.
In rat reproduction studies using risperidone, which is extensively converted to paliperidone in rats and humans, a reduction was observed in the birth weight and survival of the offspring.
Andre dopaminantagonister har ved administraion til gravide dyr forårsaget negative virkninger på indlæring og motorisk udvikling hos afkommet.
Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring.
Paliperidon var ikke genotoksisk i en række forsøg.
Paliperidone was not genotoxic in a battery of tests.
I karcinogenicitetsforsøg med peroral risperidon til rotter og mus blev der set en stigning i hypofyseadenomer (mus), endokrine pankreasadenomer (rotter) og mammakirteladenomer (begge arter).
In oral carcinogenicity studies of risperidone in rats and mice, increases in pituitary gland adenomas (mouse), endocrine pancreas adenomas (rat), and mammary gland adenomas (both species) were seen.
Disse tumorer kan være relateret til den langvarige dopamin- D2- antagonisme og hyperprolaktinæmi.
These tumours can be related to prolonged dopamine D2 antagonism and hyperprolactinemia.
1, 5 mg tablet:
For the 1.5 mg tablet:
12 Polyethylenoxid 200K Natriumchlorid Povidon (K29- 32) Stearinsyre Butylhydroxytoluen (E321) Jernoxid (sort) (E172) Polyethylenoxid 7000K Jernoxid (rød) (E172) Hydroxyethylcellulose Polyethylenglycol 3350 Celluloseacetat
12 Stearic acid Butyl hydroxytoluene (E321) Iron oxide (black) (E172) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Hypromellose Titandioxid (E171) Polyethylenglycol 400 Jernoxid (gul) (E172) Jernoxid (rød) (E172) Carnaubavoks
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (yellow) (E172) Ferric oxide (red) (E172) Carnauba wax
Flaske af hvid HDPE (high- density polyethylene) med induktionsforsegling og børnesikkert låg af polypropylen.
White high-density polyethylene (HDPE) bottle with induction sealing and polypropylene child- resistant closure.
Hver flaske indeholder to poser à 1 g med tørremiddel af silicagel (silikonedioxid) (poserne er af fødevaregodkendt polyethylen).
Each bottle contains two 1 g dessicant silica gel (silicone dioxide) pouches (pouch is food approved polyethylene).
30 og 350 depottabletter.
Pack sizes of 30 and 350 prolonged-release tablets.
• PVC (polyvinylchlorid) lamineret med PCTFE (polychlortrifluorethylen) / bagside af perforerbart aluminium.
• Polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/ aluminium push- through layer.
14, 28, 30, 49, 56 og 98 depottabletter.
Pack sizes of 14, 28, 30, 49, 56, and 98 prolonged-release tablets.
13 Eller
Or
• Hvid PVC (polyvinylchlorid) lamineret med PCTFE (polychlortrifluorethylen) / bagside af perforerbart aluminium.
• White polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/ aluminium push- through layer.
Eller
13 Or
• OPA (orienteret polyamid) - aluminium- PVC (polyvinylchlorid) / bagside af perforerbart aluminium.
• Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/ aluminium push-through layer.
14, 28, 49, 56 og 98 depottabletter.
Pack sizes of 14, 28, 49, 56, and 98 prolonged-release tablets.
Janssen- Cilag International NV Turnhoutseweg 30 B- 2340 Beerse Belgien
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu/
Hver tablet indeholder 13, 2 mg lactose.
Each tablet contains 13.2 mg lactose.
Kapselformede hvide tabletter med tre lag med teksten ” PAL 3 ”
Trilayer capsule-shaped white tablets printed with “ PAL 3”
Dosis kan dog øges til 3 mg én gang dagligt efter klinisk
For patients with moderate to severe renal impairment (creatinine clearance ≥ 10 to < 50 ml/ min), the recommended initial dose of INVEGA is 1.5 mg every day, which may be increased to 3 mg once daily
15 revurdering.
15 after clinical reassessment.
Ældre Den anbefalede dosis til ældre med normal nyrefunktion (≥ 80 ml/ min.) er den samme som for voksne med normal nyrefunktion.
Elderly Dosing recommendations for elderly patients with normal renal function (≥ 80 ml/ min) are the same as for adults with normal renal function.
16 INVEGA (3, 6, 9 og 12 mg), blev ortostatisk hypotension rapporteret hos 2, 5% af de patienter, som fik INVEGA, sammenlignet med 0, 8% af de patienter, som fik placebo.
16 Based on pooled data from the three, placebo-controlled, 6-week, fixed-dose trials with INVEGA (3, 6, 9, and 12 mg), orthostatic hypotension was reported by 2.5% of subjects treated with INVEGA compared with 0.8% of subjects treated with placebo.
INVEGA bør anvendes med forsigtighed til patienter med kendt kardiovaskulær sygdom (f. eks. hjerteinsufficiens, myokardieinfarkt eller iskæmi eller ledningsforstyrrelser), cerebrovaskulær sygdom eller tilstande, som prædisponerer patienten for hypotension (f. eks. dehydrering og hypovolæmi).
INVEGA should be used with caution in patients with known cardiovascular disease (e. g., heart failure, myocardial infarction or ischaemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e. g., dehydration and hypovolemia).
Manifestationen af denne øgede sensitivitet kan omfatte forvirring, sløvhed, postural instabilitet med hyppige fald samt ekstrapyramidale symptomer.
Parkinson’ s disease and dementia with Lewy bodies Physicians should weigh the risks versus the benefits when prescribing antipsychotic medicinal products, including INVEGA, to patients with Parkinson’ s Disease or Dementia with Lewy Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased
17 Priapisme Det er rapporteret, at lægemidler med alfaadrenergt blokerende virkning kan inducere priapisme.
Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Lactoseindhold (kun for 3 mg tabletter) Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Lactose content (pertains only to the 3 mg tablets) Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Co- administration af INVEGA en gang daglig med carbamazepin 200 mg to gange daglig forårsagede et fald på omkring 37% i gennemsnitlig steady- state Cmax og AUCpaliperidon.
18 Co-administration of INVEGA once daily with carbamazepine 200 mg twice daily caused a decrease of approximately 37% in the mean steady-state Cmax and AUC of paliperidone.
Ved start af behandling med carbamazepin skal doseringen af INVEGA re- evalueres og øges om nødvendigt.
On initiation of carbamazepine, the dose of INVEGA should be re-evaluated and increased if necessary.
19 Systemorganklasser
19 System Organ Class
Tonisk- kloniske kramper, synkope, dyskinesi, postural svimmelhed
grand mal convulsion, syncope, dyskinesia, dizziness postural,,
Takykardi, sinustakykardi, grenblok, AV- blok af 1. grad, bradykardi
Tachycardia, sinus tachycardia, bundle branch
Vaskulære sygdomme Mave- tarmkanalen
block, atrioventricular block first degree, bradycardia, Vascular disorders Gastrointestinal disorders
20 Nervesystemet
agitation, anorgasmia, anxiety, blunted affect, confusional state, insomnia, libido decreased, listless, mania, middle insomnia, nervousness, restlessness, sleep disorder 20
21 Ældre I et forsøg med ældre patienter med skizofreni svarede sikkerhedsprofilen til den for ikke- ældre patienter.
21 Elderly In a study conducted in elderly subjects with schizophrenia, the safety profile was similar to that seen in non-elderly subjects.
22 adrenerge receptorer.
22 Mechanism of Action Paliperidone is a selective blocking agent of monoamine effects, whose pharmacological properties are different from that of traditional neuroleptics.
Den farmakologiske aktivitet for (+) - og (-) - paliperidonenantiomererne er kvalitativt og kvantitativt ens.
Paliperidone also blocks alfa1-adrenergic receptors and blocks, to a lesser extent, H1-histaminergic and alfa2-adrenergic receptors.
23 mg, men disse resultater vises ikke, eftersom dette er over den maksimale, anbefalede daglige dosis på 12 mg.
A 15 mg dose was also included in Study R076477-SCH-305, but results are not presented since this is above the maximum recommended daily dose of 12 mg.
24 Nedsat leverfunktion Paliperidon metaboliseres ikke ekstensivt i leveren.
Hepatic Impairment Paliperidone is not extensively metabolized in the liver.
Nedsat nyrefunktion Elimineringen af paliperidon falder med faldende nyrefunktion.
24 Renal Impairment Elimination of paliperidone decreased with decreasing renal function.
Hos personer med nedsat nyrefunktion var paliperidons totale clearance nedsat med 32% ved let (kreatininclearance [CrCl] = 50 til < 80 ml/ min.), 64% ved moderat (CrCl = 30 til < 50 ml/ min.) og 71% ved svært (CrCl = < 30 ml/ min.) nedsat nyrefunktion.
Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% in mild (Creatinine Clearance [CrCl] = 50 to < 80 ml/ min), 64% in moderate (CrCl = 30 to < 50 ml/ min), and 71% in severe (CrCl = < 30 ml/ min) renal impairment.
3 mg tablet:
For the 3 mg tablet:
25 Overtrukket tabletkerne:
Coated tablet core:
Polyethylenoxid 200K Natriumchlorid Povidon (K29- 32) Stearinsyre Butylhydroxytoluen (E321) Jernoxid (gul) (E172) Polyethylenoxid 7000K Jernoxid (rød) (E172) Hydroxyethylcellulose Polyethylenglycol 3350 Celluloseacetat
25 Stearic acid Butyl hydroxytoluene (E321) Ferric oxide (yellow) (E172) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Hypromellose Titandioxid (E171) Lactosemonohydrat Triacetin Carnaubavoks
Hypromellose Titanium dioxide (E171) Lactose monohydrate Triacetin Carnauba wax
26 Eller
Or
• OPA (orienteret polyamid) - aluminium- PVC (polyvinylchlorid) / bagside af perforerbart aluminium.
26 • Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/ aluminium push-through layer.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/ FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse:
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
INVEGA 6 mg- depottabletter
INVEGA 6 mg prolonged-release tablets
Kapselformede beige tabletter med tre lag med teksten ” PAL 6 ”
Trilayer capsule-shaped beige tablets printed with “ PAL 6”
28 Ældre Den anbefalede dosis til ældre med normal nyrefunktion (≥ 80 ml/ min.) er den samme som for voksne med normal nyrefunktion.
28 Elderly Dosing recommendations for elderly patients with normal renal function (≥ 80 ml/ min) are the same as for adults with normal renal function.
Overfølsomhed over for det aktive stof, over for risperidon eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substance, risperidone, or to any of the excipients.
INVEGA bør anvendes med forsigtighed til patienter med kendt kardiovaskulær sygdom (f. eks. hjerteinsufficiens, myokardieinfarkt eller
INVEGA should be used with caution in patients with known
29 iskæmi eller ledningsforstyrrelser), cerebrovaskulær sygdom eller tilstande, som prædisponerer patienten for hypotension (f. eks. dehydrering og hypovolæmi).
29 cardiovascular disease (e. g., heart failure, myocardial infarction or ischaemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e. g., dehydration and hypovolemia).
Så længe andet ikke er påvist, betragtes erfaringerne med risperidon også værende gældende for paliperidon.
Hence, until data demonstrate otherwise the experience from risperidone is considered valid also for paliperidone.
30 Priapisme Det er rapporteret, at lægemidler med alfaadrenergt blokerende virkning kan inducere priapisme.
30 Priapism Medicines with alpha-adrenergic blocking effects have been reported to induce priapism.
4. 8) bør INVEGA anvendes med forsigtighed i kombination med andre centralt virkende lægemidler, f. eks. anxiolytika, antipsykotika, hypnotika, opiater etc. eller alkohol.
Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines e. g. anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
4. 4) ses en additiv effekt, når INVEGA indgives sammen med andre lægemidler med dette potentiale, f. eks. andre antipsykotika, eller tricykliske antidepressiva.
Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when INVEGA is administered with other therapeutic agents that have this potentiale. g. other antipsychotics, tricyclics.
Der bør udvises forsigtighed, hvis paliperidon administreres samtidig med lægemidler, der vides at sænke krampetærsklen (f. eks. phenothiazin eller butyrophenon, tricykliske antidepressiva eller SSRI, tramadol, mefloqin ect.).
Caution is advised if paliperidone is combined with other medicines know to lower the seizure threshold (i. e. phenothiazines or butyrophenones, tricyclics or SSRIs, tramadol, mefloquine, etc.).
Dette fald er i stor udstrækning forårsaget af en øgning i renal clearance af paliperidon med 35%, sandsynligvis som et resultat af induktion af renal P- gp forårsaget af carbamazepin.
This decrease is caused, to a substantial degree, by a 35% increase in renal clearance of paliperidone likely as a result of induction of renal P-gp by carbamazepine.
31 re- evalueres og øges om nødvendigt.
On initiation of carbamazepine, the dose of INVEGA should 31 be re-evaluated and increased if necessary.
Lægemidler, som påvirker den gastrointerstinale transittid, kan påvirke absorptionen af paliperidon, f. eks. meclopramid.
Medicinal products affecting gastrointestinal transit time may affect the absorption of paliperidone, e. g. metoclopramide.
De hyppigst rapporterede bivirkninger i de kliniske forsøg var: hovedpine, takykardi, akatisi, sinustakykardi, ekstrapyramidal bivirkninger (EPS), forstyrrelse, somnolens, svimmelhed, sedation, tremor, hypertoni, dystoni, ortostatisk hypotension og mundtørhed.
The most frequently reported adverse drug reactions (ADRs) reported in clinical trials were headache, tachycardia, akathisia, sinus tachycardia, extrapyramidal disorder, somnolence, dizziness, sedation, tremor, hypertonia, dystonia, orthostatic hypotension, and dry mouth.
Systemorganklasser
32 System Organ Class
almindelig Immunsystemet Metabolisme og ernæring
Immune system disorders
Anafylaktisk reaktion Øget appetit
anaphylactic reaction
Psykiske forstyrrelser
Metabolism and nutrition disorders
32 Systemorganklasser
increased appetite
Bivirkning Hyppighed
Psychiatric disorders
Almindelig
nightmare
almindelig Nervesystemet
Nervous system disorders