natgillin/translations-raw huggingface dataset:
Appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus for which regular glucose control is recommended.
Posebno pri sladkornih bolnikih in bolnikih z dejavniki tveganja za razvoj sladkorne bolezni, za katero je priporočen reden nadzor glukoze, je priporočeno ustrezno klinično spremljanje.
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
Spremembe lipidov V kliničnih preskušanjih, kontroliranih s placebom, so pri bolnikih zdravljenih z olanzapinom opažali neželene spremembe lipidov (glejte poglavje 4. 8).
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Antiholinergično delovanje Medtem ko je olanzapin pokazal antiholinergično delovanje v pogojih in vitro, so izkušnje kliničnih preskušanj razkrile majhno incidenco s tem povezanih dogodkov.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Jetrno delovanje Pogosto so opažali prehodna, asimptomatska zvišanja jetrnih transaminaz, ALT, AST, posebno na začetku zdravljenja.
Caution should be exercised in patients with elevated ALT and/ or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicinal products.
Pri bolnikih s zvišano ALT in/ ali AST, bolnikih z znaki in simptomi okvarjenega delovanja jeter, bolnikih s prej obstoječimi stanji, povezanimi z omejeno jetrno funkcionalno rezervo, in pri bolnikih, ki se zdravijo s potencialno hepatotoksičnimi zdravili, je potrebna previdnost.
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
V primeru zvišanja ALT in/ ali AST med zdravljenjem je treba vrednosti spremljati in pretehtati znižanje
Neutropenia
4 odmerka.
4 Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
To velja tudi za bolnike, pri katerih se je v preteklosti pojavilo z zdravili povzročeno zavrto delovanje kostnega mozga ali so prejemali zdravila, toksična za kostni mozeg, pri bolnikih z zavrtim delovanjem kostnega mozga zaradi sočasne bolezni, obsevanja ali kemoterapije ter pri bolnikih s hipereozinofilnimi stanji ali mieloproliferativno boleznijo.
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
Ob sočasni uporabi olanzapina in valproata so pogosto poročali o nevtropeniji (glejte poglavje 4. 8).
Discontinuation of treatment Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (< 0.01%) when olanzapine is stopped abruptly.
Prekinitev zdravljenja Zelo redko (< 0, 01%) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
QT interval V kliničnih preskušanjih so bila klinično pomembna podaljšanja QTc (QT korekcija Fridericia [QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 msek) pri bolnikih, zdravljenih z olanzapinom, redka (od 0, 1% do 1%), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicinal products known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Vendar pa je kot pri drugih antipsihotikih potrebna previdnost, kadar predpisujemo olanzapin skupaj z zdravili, za katera je znano, da podaljšujejo QTc interval, posebno pri starejših, pri bolnikih s prirojenim sindromom dolgega QT intervala, kongestivnim popuščanjem srca, hipertrofijo srca, hipokaliemijo ali hipomagnezemijo.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
Trombembolija Zelo redko (< 0, 01%) so poročali o občasnih povezavah med zdravljenjem z olanzapinom in vensko tromboembolijo.
However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e. g. immobilisation of patients, should be identified and preventive measures undertaken.
Vendar, ker imajo bolniki s shizofrenijo pogosto prisotne pridobljene dejavnike tveganja za vensko tromboembolijo, je treba ugotoviti vse možne dejavnike tveganja za VTE, kot npr. imobilizacija bolnikov ter izvesti preventivne ukrepe.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicinal products and alcohol.
Splošno delovanje na osrednje živčevje Glede na primarne učinke olanzapina na osrednje živčevje je potrebna previdnost, kadar se ga jemlje v kombinaciji z drugimi osrednje delujočimi zdravili in alkoholom.
Seizures Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold.
Epileptični napadi Olanzapin je treba uporabljati previdno pri bolnikih, ki so imeli v preteklosti epileptične napade ali so podvrženi dejavnikom, ki bi lahko znižali prag za epileptične napade.
Seizures have been reported to occur rarely in patients when treated with olanzapine.
Pri bolnikih, ki so se zdravili z olanzapinom, so o epileptičnih napadih poročali redko.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Tardivne diskinezije V primerjalnih študijah, ki so trajale eno leto ali manj, so olanzapin povezovali s statistično značilno manjšo incidenco diskinezij, ki se pojavijo ob zdravljenju.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Posturalna hipotenzija V kliničnih preskušanjih olanzapina so pri starejših redko poročali o posturalni hipotenziji.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
Uporaba pri otrocih in mladostnikih mlajših od 18 let
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
Študije pri bolnikih, starih 13- 17 let kažejo na različne neželene učinke, vključno s povečanjem telesne mase, spremembami v kazalcih presnove in zvišanjih ravni prolaktina.
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
Dolgoročnih posledic, povezanih s temi učinki niso preučevali in ostajajo neznani (glejte poglavji 4. 8 in 5. 1).
5 Olanzapine tablets contain lactose monohydrate.
Laktoza OLANZAPIN MYLAN tablete vsebujejo laktozo monohidrat.
The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Indukcija CYP1A2 Presnovo olanzapina lahko pospešita kajenje in karbamazepin, kar lahko povzroči znižane koncentracije olanzapina.
The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.2).
Klinične posledice so verjetno omejene, vendar je priporočeno spremljanje kliničnega stanja in zvišanje odmerka olanzapina, če je potrebno (glejte poglavje 4. 2).
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female nonsmokers and 77% male smokers.
Srednje zvišanje Cmax olanzapina po dajanju fluvoksamina je bilo 54% pri ženskah nekadilkah in 77% pri moških kadilcih.
The mean increase in olanzapine AUC was 52% and 108% respectively.
Srednje povečanje AUC olanzapina je bilo 52% oziroma 108%.
Activated charcoal reduces the bioavailability of oral olanzapine by 50% to 60% and should be taken at least 2 hours before or after olanzapine.
Zmanjšana biološka uporabnost Aktivno oglje zmanjša biološko uporabnost peroralnega olanzapina za 50 do 60% in ga je treba zaužiti vsaj 2 uri pred olanzapinom ali vsaj dve uri po njem.
Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Zmožnost vplivanja olanzapina na druga zdravila Olanzapin lahko nasprotuje učinkom direktnih in indirektnih dopaminskih agonistov.
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
Olanzapin ne zavira glavnih izoencimov CYP450 v pogojih in vitro (npr.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Splošno delovanje na osrednje živčevje Pri bolnikih, ki uživajo alkohol ali prejemajo zdravila, ki lahko povzročijo depresijo osrednjega živčevja, je potrebna previdnost.
The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
6 Sočasna uporaba olanzapina z antiparkinsonskimi zdravili pri bolnikih s Parkinsonovo boleznijo in demenco ni priporočena (glejte poglavje 4. 4).
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
QTc interval Potrebna je previdnost če dajemo olanzapin sočasno z zdravili za katera je znano, da podaljšujejo QTc interval (glejte poglavje 4. 4).
Spontaneous reports have been very rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
Zelo redko so spontano poročali o tresenju, hipertoniji, letargiji in zaspanosti pri dojenčkih, rojenih materam, ki so uporabljale olanzapin v tretjem trimesečju.
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
Srednjo izpostavitev dojenčka (mg/ kg) v stanju dinamičnega ravnovesja so ocenili na 1, 8% materinega odmerka olanzapina (mg/ kg).
Adults The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
Odrasli Najpogosteje poročani (opažene pri ≥ 1% bolnikov) neželeni učinki, povezani z uporabo olanzapina v kliničnih preskušanjih, so bili zaspanost, povečanje telesne mase, eozinofilija, zvišane ravni prolaktina, holesterola, glukoze in trigliceridov (glejte poglavje 4. 4), glikozurija, povečan apetit, omotica, akatizija, parkinsonizem (glejte poglavje 4. 4), diskinezija, ortostatska hipotenzija, antiholinergični učinki, prehodna asimptomatska zvišanja jetrnih transaminaz (glejte poglave 4. 4), izpuščaj, astenija, utrujenost in edem.
Very common (≥ 10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and < 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 10%), pogosti (≥ 1% in < 10%), občasni (≥ 0, 1% in < 1%), redki (≥ 0, 01% in < 0, 1%), zelo redki (< 0, 01%), ni znano (ocena ni možna iz danih podatkov).
Leucopenia Neutropenia
Levkopenija Nevtropenija
Immune system disorders Allergic reaction Metabolism and nutrition disorders Weight gain1
Bolezni imunskega sistema Alergijska reakcija Presnovne in prehranske motnje Povečanje telesne mase1
Elevated cholesterol levels2,3 Elevated glucose levels4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
Zvišane ravni holesterola2, 3 Zvišane ravni glukoze4 Zvišane ravni trigliceridov2, 5
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Razvoj ali poslabšanje sladkorne bolezni, občasno povezane s ketoacidozo ali komo, vključno z nekaj
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
Epileptični napadi, pri katerih so jih v večini primerov imeli že kdaj prej ali so poročali o dejavnikih tveganja za epileptične napade Nevroleptični maligni sindrom (glejte poglavje 4. 4) Distonija (vključno z okulogiracijo) Tardivne diskinezije Odtegnitveni simptomi7
Bradycardia QTc prolongation (see section 4.4)
Bradikardija Podaljšanje QTc (glejte poglavje 4. 4)
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Prekatna tahikardija/ fibrilacija, nenadna smrt (glejte poglavje 4. 4)
Orthostatic hypotension
Bolezni prebavil
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
Ortostatska hipotenzija
Gastrointestinal disorders
Trombembolija (vključno s pljučno embolijo in globoko vensko trombozo)
Hepato-biliary disorders
Bolezni jeter, žolčnika in žolčevodov Bolezni kože in podkožja
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
Prehodna asimptomatska zvišanja jetrnih transaminaz (ALT, AST), posebno na začetku zdravljenja (glejte poglavje 4. 4)
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Hepatitis (vključno s hepatocelularno, holestatsko ali mešano okvaro jeter)
Photosensitivity reaction Alopecia
Fotosenzitivnostne reakcije Alopecija
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations 1
Bolezni mišično- skeletnega sistema in vezivnega tkiva Rabdomioliza Bolezni sečil Težave z začetkom mokrenja Motnje reprodukcije in dojk Priapizem Splošne težave in spremembe na mestu aplikacije Astenija Utrujenost Oteklina
Elevated plasma prolactin levels8
8 Preiskave Zvišane plazemske koncentracije prolaktina8 1
High creatine phosphokinase Increased total bilirubin
Visoka kreatin fosfokinaza Zvišan celokupni bilirubin
Increased alkaine phosphatase
Zvišana alkalna fosfataza
Weight gain ≥ 7% of baseline body weight was very common and ≥ 15% of baseline
Zvečanje telesne mase za ≥ 7% od osnovne telesne mase je bilo zelo pogosto ter pogosto za ≥ 15%.
Patients gaining ≥ 25% of their baseline body weight with long-term exposure were very common.
Zvečanje osnovne telesne mase za ≥ 25% se je pri dolgoročni izpostavljenosti bolnikov pojavljalo zelo pogosto.
3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (≥ 6.2 mmol/ l).
3 Opazovano pri osnovnih normalnih ravneh na tešče (< 5, 17 mmol/ l), ki so se povišale na visoke (≥ 6, 2 mmol/ l).
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17- < 6.2 mmol) to high (≥ 6.2 mmol) were very common.
Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 5, 17 mmol/ l - < 6, 2 mmol/ l) na visoke (≥ 6, 2 mmol/ l).
4 Observed for fasting normal levels at baseline (< 5.56 mmol/ l) which increased to high (≥ 7 mmol/ l).
4 Opazovano pri osnovnih normalnih ravneh na tešče (< 5, 56 mmol/ l), ki so se povišale na visoke (≥ 7 mmol/ l).
Changes in fasting glucose from borderline at baseline (≥ 5.56- < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
Zelo pogoste so bile spremembe v ravneh glukoze na tešče z mejnih osnovnih vrednosti (≥ 5, 56 mmol/ l - < 7 mmol/ l) na visoke (≥ 7 mmol/ l).
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
5 Opazovano pri osnovnih normalnih ravneh na tešče (< 1, 69 mmol/ l), ki so se povišale na visoke (≥ 2, 26 mmol/ l).
Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/ l- < 2.26 mmol/ l) to high (≥ 2.26 mmol/ l) were very common.
Zelo pogoste so bile spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1, 69 mmol/ l - < 2, 26 mmol/ l) na visoke (≥ 2, 26 mmol/ l).
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
6 V kliničnih preskušanjih je bila incidenca parkinsonizma in distonije pri bolnikih, zdravljenih z olanzapinom, številčno večja, a se ni statistično značilno razlikovala od placeba.
Olanzapine-treated patients had a lower incidence of parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Z olanzapinom zdravljeni bolniki so imeli manjšo incidenco parkinsonizma, akatizije in distonije v primerjavi s titriranimi odmerki haloperidola.
In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it can not be concluded at present that olanzapine produces less tardive dyskinesia and/ or other tardive extrapyramidal syndromes.
Zaradi pomanjkanja podrobnih anamnestičnih podatkov o preteklih posameznih akutnih in poznih ekstrapiramidnih motnjah gibanja trenutno ni možno zaključiti, da olanzapin povzroča manj tardivnih diskinezij in/ ali drugih zapoznelih ekstrapiramidnih sindromov.
8 Associated clinical manifestations (e. g., gynaecomastia, galactorrhoea, and breast enlargement) were rare.
8 Redka so bila povezana klinična izražanja (npr. ginekomastija, galaktoreja in povečanje prsi).
In most patients, levels returned to normal ranges without cessation of treatment.
Pri večini bolnikov so se ravni vrnile v normalne meje brez ukinitve zdravljenja.
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HCL cholesterol or triglycerides increased over time.
Dolgoročna izpostavljenost (najmanj 48 tednov) Delež bolnikov, ki so imeli neželene, klinično značilne spremembe telesne mase, glukoze, celokupnega/ LDL/ HDL holesterola ali trigliceridov se je s časom povečal.
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.
Pri odraslih bolnikih, ki so zaključili 9- 12 mesecev terapije, se je razmerje zvišanja povprečne glukoze v krvi upočasnilo po približno 4- 6 mesecih.
Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
Dodatne informacije glede posebnih skupin bolnikov V kliničnih preskušanjih pri starejših bolnikih z demenco je bilo zdravljenje z olanzapinom povezano z višjo incidenco smrti in cerebrovaskularnih neželenih reakcij v primerjavi s placebom (glejte poglavje 4. 4).
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’ s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
V kliničnih preskušanjih pri bolnikih s psihozami povzročenimi z zdravili (dopaminski agonisti) povezanimi s Parkinsonovo boleznijo, so pogosto ter pogosteje kot pri placebu poročali o poslabšanju simptomatologije Parkinsonove bolezni in halucinacijah.
In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels.
9 V enem kliničnem preskušanju pri bolnikih z bipolarno manijo, je kombinirano zdravljenje z valproatom in olanzapinom povzročilo incidenco nevtropenije 4, 1%; možen vzročni dejavnik so lahko visoke plazemske ravni valproata.
Olanzapine administered with lithium or valproate resulted in increased levels (≥ 10%) of tremor, dry mouth, increased appetite, and weight gain.
Olanzapin dan z litijem ali valproatom je povzročil zvišane ravni (≥ 10%) tresenja, suhih ust, povečanega apetita in povečanja telesne mase.
During treatment with olanzapine in combination with lithium or divalproex, an increase of ≥ 7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to 6 weeks).
Med zdravljenjem z olanzapinom v kombinaciji z litijem ali divalproeksom se je pri 17, 4% bolnikov med akutnim zdravljenjem (do 6 tednov) pojavilo povečanje telesne mase za > 7% od osnovne.
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.
Dolgoročno zdravljenje z olanzapinom (do 12 mesecev) za preprečevanje ponovnega pojava bolezni pri bolnikih z bipolarno motnjo je bilo povezano s povečanjem telesne mase za ≥ 7% z osnove pri 39, 9% bolnikov.
9 Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Otroci in mladostniki Olanzapin ni indiciran za zdravljenje otrok in mladostnikov mlajših od 18 let.
The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
Naslednja tabela vključuje neželene učinke, ki so jih poročali z višjo pogostnostjo pri mladostnikih (starih 13- 17 let) kot pri odraslih bolnikih ali neželene učinke, ki so jih ugotovili samo v kratkoročnih kliničnih preskušanjih pri mladostnikih.
Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Videti je, da se klinično značilno zvečanje telesne mase (≥ 7%) pojavlja pogosteje pri populaciji mladostnikov v primerjavi z odraslimi pri primerljivi izpostavljenosti.
The magnitude of weight gain and the propotion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Obseg povečanja telesne mase ter razmerje mladostnikov, ki so imeli klinično značilno zvečanje telesne mase, sta bila višja pri dolgoročni izpostavljenosti (najmanj 24 tednov) kot pri kratkoročni izpostavljenosti.
Very common (≥ 10%), common (≥ 1% and < 10%).
Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 10%), pogosti (≥ 1% in < 10%).
Common:
Povečanje telesne mase9, zvišane ravni trigliceridov10, povečan apetit Pogosti:
Elevated cholesterol levels11 Nervous system disorders Very common:
Zvišane ravni holesterola11 Bolezni živčevja Zelo pogosti:
Gastrointestinal disorders Common:
Sedacija (vključno s: hipersomnijo, letargijo, zaspanostjo) Bolezni prebavil Pogosti:
Dry mouth Hepato-biliary disorders Very common:
Suha usta Bolezni jeter, žolčnika in žolčevodov Zelo pogosti: