qanastek/EMEA-V3 huggingface dataset:
The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%.
It- teħid flimkien mal- faħam attivat wera li jnaqqas il- biodisponibilità orali ta 'olanzapine b' 50% sa 60%.
Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Trattament sintomatiku u l- monitoraġġ tal- funzjoni ta 'l- organi vitali għandhom isiru skond il- qagħda klinika, inkluż it- trattament għall- pressjoni baxxa u kolass taċ- ċirkolazzjoni u sosteniment pulmonari.
Do not use epinephrine, dopamine, or other sympathomimetic agents with beta agonist activity since beta stimulation may worsen hypotension.
Tużax epinephrine, dopamine, jew sustanzi oħra simpatomimatiċi b 'attività beta- agonista għax l - istimulazzjoni beta tista' taggrava l- pressjoni baxxa.
Cardiovascular monitoring is necessary to detect possible arrhythmias.
Huwa neċessarju l- monitoraġġ kardjovaskulari biex tinduna b’ taħbit irregolari tal- qalb li jista ’ jseħħ.
Close medical supervision and monitoring should continue until the patient recovers.
Għandha tkompli s- superviżjoni medika mill - qrib u l- monitoraġġ jitkompla sakemm il- pazjent jirkupra.
N05AH03.
Grupp farmako- terapewtiku: antipsikotiku, kodiċi ATC N05A H03.
Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Olanzapine hija sustanza antipsikotika, kontra l- manija u stabilizzatur tal- burdata li turi profil farmakoloġiku ta 'firxa wiesa' ta 'sistemi ta' riċetturi.
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5 HT2A/ 2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α 1 adrenergic; and histamine H1 receptors.
Studji fuq l- imġieba ta 'l- annimali li ingħataw B
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal - profil tar- riċettur li jorbot.
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater 5 HT2 than D2 activity in vivo, models.
Olanzapine wera affinità akbar in vitro għal serotonin 5HT2 milli għar - riċetturi ta ’ dopamine D2 u attività in vivo akbar għal 5HT2 milli għal D2.
Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Studji elettrofiżjoloġiċi wrew illi olanzapine selettivament naqqas l- attività mesolimbiċi tan- newroni dopaminerġiċi (A10) waqt li kellu ftit effett fuq il- passaġġ (A9) tal- corpus striatum involuti fil- funzjoni motorjali.
Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor undesirable-effects.
Olanzapine naqset ir- rispons kundizzjonat u ta 'skansar, test indikattiv ta' l- attività antipsikotika, f' dożi
Unlike some other antipsychotic agents, olanzapine increases responding in an “ anxiolytic” test.
Kuntrarju għall- mediċini oħra antipsikotiċi, olanzapine iżid ir- rispons f' test anksjolitiku.
In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5 HT2A than dopamine D2 receptor occupancy.
Fi studju b' doża waħda orali (10 mg) fejn intużat it- tomografija bl- Emissjoni tal- Pozitroni (PET) f' voluntiera b' saħħithom, olanzapine ipproduċa okkupanza ta '5HT2A ogħla mir- riċettur ta ’ dopamine D2.
In addition, a SPECT imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic- and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Ma 'dan, studju b ’ (SPECT) f' pazjenti skiżofreniċi wera li l- pazjenti li jirreagixxu għal olanzapine kellhom okkupanza strijatali D2 anqas milli f' pazjenti li rrispondew għal xi antipsikotiċi oħra jew għal risperidone, waqt li kienu komparabbli għall- pazjenti li irrispondew għal clozapine.
In two of two placebo and two of three comparator controlled trials with over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms.
Fi provi kkontrollati tnejn minn tnejn bil- plaċebo u tnejn minn tlieta bil- komparatur b' aktar minn 2, 900 pazjenti skiżofreniċi li għandhom kemm sintomi negattivi kif ukoll sintomi pożittivi, olanzapine kien assoċjat ma 'titjib akbar, statistikament sinifikanti, f' sintomi negattivi kif ukoll pożittivi.
In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
F’ studju komparattiv, double- blind u multinazzjonali ta ’ skiżofrenija, ta ’ manifestazzjonijiet skiżoaffettivi u disturbi relatati oħra li kien jinkludi 1, 481 pazjent li kellhom gravità differenti ta ’ l - assoċjati sintomi dipressivi (medja ta ’ punteġg ta ’ 16. 6 meħud fil- bidu tal- kura skond l- iskala li tivvaluta d- dipressjoni ta ’ Montgomery- Asberg), analiżi prospettiva sekondarja tat- tibdil fil- punteġġ ta ’ l- atteġġament bejn il- bidu u fl- aħħar tal- kura wriet titjib statistikament sinifikanti (p= 0. 001) favur olanzapine (- 6. 0) kontra haloperidol (- 3. 1).
In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
F' pazjenti b' diżordni ta 'manija jew diżordni bipolari b' episodju mħallat, olanzapine wera effikaċja superjuri għall- plaċebo u għal valproate semisodium (divaproex) fit- tnaqqis ta' sintomi manijaċi f' aktar minn 3 ġimgħat.
Olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Olanzapine wera wkoll riżultati effikaċji li jistgħu jiġu kumparati ma 'haloperidol fit - termini tal- proporzjon ta' pazjenti f' remissjoni sintomatika minn manija u depressjoni f '6 u 12- il ġimgħa.
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
Fi studju ta 'terapija ta' pazjenti trattati flimkien b’ lithium jew b’ valproate għal minimu ta 'ġimgħatejn, iż- żjieda ta' olanzapine 10 mg (terapija flimkien ma ’ lithium jew valproate) wara 6 ġimgħat irriżultat f' tnaqqis akbar tas- sintomi tal- manija milli b' monoterapija b’ lithium jew b’ valproate.
11 In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
ikkontrollatiU b’ olanzapine, imbagħd kienu mogħtija mingħajr għażla olanzapine jew il- plaċebo, olanzapine wera superjorita sinifikanti u statistikament superjuri fuq il- plaċebo fuq l- għan ewlieni tar - rikorrenza bipolari.
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Olanzapine uriet ukoll vantaġġ statistiku u sinifikanti fuq il- plaċebo fil - prevenzjoni, kemm f' attakki ġodda ta 'manija kif ukoll f' attakki ġodda ta' depressjoni.
In a second 12 month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
olanzapine jew il- lithium waħdu. Olanzapine kien statistikament mhux inferjuri għall- lithium fuq l - għan ewlieni ta 'rikorrenza bipolari (olanzapine 30. 0%, lithium 38. 3%; p = 0. 055).
In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
Fi studju ta '18- il xhar f' pazjenti b' manija jew b' episodji mħallta stabilizzati fuq olanzapine flimkien ma' stabilizzatur tal- burdata (lithium jew valproate), l- użu fit- tul ta 'olanzapine flimkien ma’ lithium jew l- valproate ma kienx statistikament sinifikanti superjuri għall- lithium jew għall- valproate waħdu biex jittardja r- rikorrenza bipolari, kif definit skond il- kriterji (dijanjostiċi) tas- sindromu.
Paediatric population The experience in adolescents (ages 13 to 17 years) is limited to short term efficacy data in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Popolazzjoni pedjatrika L- esperjenza fl- adolexxenti (minn 13 sa 17- il sena) hija limitata għal dejta dwar l- effikaċja għal żmien qasir fl- iskiżofrenja (6 ġimgħat) u manija assoċjata ma 'mard bipolari tat- tip I (3 ġimgħat) u li involvew anqas minn 200 adolexxent.
Olanzapine was used as a flexible dose starting with 2.5 and ranging up to 20 mg/ day.
Id- doża ta ’ Olanzapine ma kienitx fissa u bdiet b' 2. 5 u telgħat sa 20 mg/ ġurnata.
During treatment with olanzapine, adolescents gained significantly more weight compared with adults.
Waqt il- kura b' olanzapine, l- adolexxenti żiedu aktar fil- piż b' mod sinifikanti meta mqabbel ma 'l- adulti.
The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Il- grad ta 'tibdil fil- kolesterol totali waqt is- sawm, kolesterol tat- tip LDL, trigliċeridi, u prolactin (ara sezzjonijiet 4. 4 u 4. 8) kien akbar fl- adolexxenti milli fl- adulti.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
M' hemmx tagħrif dwar il- manteniment ta 'l- effett u hemm tagħrif limitat dwar is- sigurtà fit- tul (ara sezzjonijiet 4. 4 u 4. 8).
5.2 Pharmacokinetic properties
12 5. 2 Tagħrif farmakokinetiku
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
Olanzapine hija assorbita sew wara li tittieħed mill- ħalq, tilħaq l- ogħla konċentrazzjonijiet fil- plażma fi żmien 5 sa 8 sigħat.
The absorption is not affected by food.
L- assorbiment ma jiġix affetwat mill- ikel.
Absolute oral bioavailability relative to intravenous administration has not been determined.
Il- biodisponibilità 'assoluta orali relattiva għal amministrazzjoni fil- vina ma' kienitx determinata.
Olanzapine is metabolized in the liver by conjugative and oxidative pathways.
Olanzapine hija metabolizzata fil- fwied minn metodi konjugattivi u ossidattivi.
The major circulating metabolite is the 10-N-glucuronide, which does not pass the blood brain barrier.
Il- prodott metaboliku li l- aktar jiċċirkola huwa 10- N - glukoronide, li ma jaqsamx il- barriera bejn id- demm u l- moħħ.
Cytochromes P450- CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl metabolites, both exhibited significantly less in vivo pharmacological activity than olanzapine in animal studies.
It- tnejn dehru sinifikatament anqas f' attività farmakoloġika in vivo milli olanzapine fi studji fuq l- annimali.
The predominant pharmacologic activity is from the parent olanzapine.
L- attività farmakoloġika predominanti ġejja minn olanzapine nnifsu.
After oral administration, the mean terminal elimination half-life of olanzapine in healthy subjects varied on the basis of age and gender.
Wara li jittieħed mill- ħalq, il- medja tal- half life ta 'l- eliminazzjoni terminali ta' olanzapine f' suġġetti b' saħħithom varjat fuq il- bażi ta 'l- età' u sess.
In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/ hr).
F' anzjani b' saħħithom (65 u fuqhom) f' paragun ma 'pazjenti mhux anzjani, il- half life ta' l - eliminazzjoni medja twalet (51. 8 paragun ma '33. 8 siegħa) u t- tneħħija tnaqqset (17. 5 paragun ma' 18. 2 l/ hr).
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
Il- varjabilità farmakokinetika osservata fl- anzjani hija fl- istess livell ta 'dawk li mhux anzjani.
In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
F' 44 pazjenti skiżofreniċi li għandhom > 65 sena, id- dosaġġ minn 5 sa 20 mg/ ġurnata ma kienx assoċjat ma 'xi profil distint ta' avvenimenti avversi.
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/ hr).
F 'pazjenti femminili f' paragun ma' dawk maskili il- medja tal- half life ta 'l- eliminazzjoni ġiet kemmxejn mtawla (36. 7 kontra 32. 3 sigħat) u t- tneħħija tnaqqset (18. 9 kontra 27. 3 l/ hr).
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Madankollu, olanzapine (5- 20 mg) wera profil ta 'sigurtà kumparabbli f' pazjenti nisa (n=467) u f' pazjenti rġiel (n=869).
In renally impaired patients (creatinine clearance < 10 ml/ min) versus healthy subjects, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/ hr).
F' pazjenti b' mard tal- kliewi (tneħħija tal- krejatinina < 10 ml/ min) f' paragun ma 'pazjenti b' saħħithom, ma kienx hemm differenza sinifikanti fil- medja tal- half life ta' l- eliminazzjoni (37. 7 kontra 32. 4 siegħa) jew il- clearance (21. 2 kontra 25. 0 l/ hr).
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Studju ta ’ tqabbil tal- piżijiet wera bejn wieħed u ieħor 57% ta 'olanzapine radjuattiv fl- urina, prinċipalment bħala prodotti metaboliċi.
12 In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/ hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/ hr, respectively).
F' pazjenti li jpejpu u għandhom disfunzjoni tal- fwied ħafifa, il- half life ta 'l- eliminazzjoni medja (39. 3 siegħa) twalet u t- tneħħija (18. 0 l/ hr) tnaqqset bħal f' pazjenti b' saħħithom li ma jpejpux (48. 8 siegħa u 14. 1 l/ hr, rispettivament).
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
F' pazjenti li ma jpejpux f' paragun ma 'dawk li jpejpu (irġiel u nisa) il- medja tal- half life ta' l - eliminazzjoni kien imtawwal (38. 6 kontra 30. 4 siegħa) u l- clearance tnaqqset (18. 6 kontra 27. 7 l/ hr).
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Il- clearance ta’ olanzapine mill- plażma huwa anqas f' pazjenti anzjani f' paragun ma 'suġġetti żgħar, fin - nisa f' paragun ma' l- irġiel, u f' dawk li ma jpejpux f' paragun ma 'dawk li jpejpu.
However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Madankollu, l- impatt ta 'l- età, is- sess, jew tat- tipjip fuq il- clearance ta' olanzapine u fuq il- half life huwa żgħir f' paragun mal- varjabilità totali ta 'bejn individwi.
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Fi studju ta 'pazjenti kawkasi, Ġappuniżi, u Ċiniżi, ma kien hemm ebda differenzi fil- parametri farmakokinetiċi fost it- tliet popolazzjonijiet.
The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1000 ng/ ml.
Ir- rabta mal- proteina fil- plażma ta' olanzapine kienet madwar 93% fuq il- firxa tal- konċentrazzjoni ta 'madwar 7 sa xi 1000 ng/ ml.
Olanzapine is bound predominantly to albumin and α 1-acid-glycoprotein.
Olanzapine hija fil- biċċa ’ l kbira marbuta ma 'l- albumina u ∝B1- aċid - B
Paediatric population Adolescents (ages 13 to 17 years):
Popolazzjoni pedjatrika Adolexxenti (minn 13 sa 17- il sena):
The pharmacokinetics of olanzapine are similar between adolescents and adults.
Il- farmakokinetika ta 'olanzapine fl- adolexxenti u fl- adulti hija simili.
In clinical studies, the average olanzapine exposure was approximately 27% higher in adolescents.
Fi studji kliniċi, il- medja ta 'espożizzjoni għal olanzapine kienet bejn wieħed u ieħor ta' 27% ogħla fl- adolexxenti.
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Id- differenzi demografiċi bejn l- adolexxenti u l- adulti jinkludu medja anqas ta 'piż tal- ġisem u anqas adolexxenti kienu jpejpu.
Such factors possibly contribute to the higher average exposure observed in adolescents.
Fatturi bħal dawn x' aktarx li jikkontribwixxu għall - medja ta 'espożizzjoni ogħla osservata fl- adolexxenti.
5.3 Preclinical safety data
Tossiċità akuta (doża waħda) U
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Sinjali ta 'tossiċità orali fir- rodenti kienu simili għas- sustanzi newrolettiċi qawwija: attività baxxa, koma, rogħda, konvulżjonijiet kloniċi, salivazzjoni, u tnaqqis fiż- żjieda tal- piż.
The median lethal doses were approximately 210 mg/ kg (mice) and 175 mg/ kg (rats).
Id- dożi medjani li jwasslu għall- mewt kienu bejn wieħed u ieħor 210 mg/ kg (ġrieden) u 175 mg/ kg (firien).
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
Il- klieb felħu dożi orali b’ wahdiet sa 100 mg/ kg mingħajr mortalità.
Clinical signs included sedation, ataxia, tremors, increased heart rate, labored respiration, miosis, and anorexia.
Sinjali kliniċi inkludew sedazzjoni, atassja, rogħda, żjieda fir- rata tal- qalb, diffikultà fir- respirazzjoni, tidjiq tal- pupilla ta 'l- għajn, u l- anoreksja.
In monkeys, single oral doses up to 100 mg/ kg resulted in prostration and, at higher doses, semi-consciousness.
Fix- xadini, dożi orali b’ wahdiet sa 100 mg/ kg irriżultaw f' prostrazzjoni u, f' dożi ogħla, telf parzjali mis- sensi.
Repeated-dose toxicity In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Fi studji sa 3 xhur fil- ġrieden u sa sena fil- firien u fil- klieb, l- effetti li ippredominaw kienu d - depressjoni CNS, effetti antikolinerġiċi, u diżordnijiet periferali ematoloġiċi.
Tolerance developed to the CNS depression.
Żviluppat it- tolleranza għad- depressjoni CNS.
Growth parameters were decreased at high doses.
Il- parametri ta 'l- iżvilupp kienu mnaqqsa b' dożi għoljin.
Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.
Effetti riversibbli konsistenti ma 'prolaktin elevat fil- firien inkludew tnaqqis fil- piż ta' l- ovarji u ta 'l- utru u tibdiliet morfoloġiċi fl- epitilju tal- vaġina u fis- sider.
Haematologic toxicity:
Tossiċità ematoloġika:
Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
Effetti fuq il- parametri ematoloġiċi nstabu f' kull speċi, inklużi tnaqqis relatat mad- doża fil- lewkoċiti li jiċċirkolaw fil- ġrieden u tnaqqis mhux speċifiku fil- lewkoċiti li jiċċirkolaw fil- firien; madankollu, ma nstabet l- ebda prova ta 'ċitotossiċità tal- mudullun.
Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12 mg dose).
Newtropenja, tromboċitopenja jew l- anemija riversibbli żviluppaw fi ftit klieb ittrattati b '8 jew 10 mg/ kg/ ġurnata (espożizzjoni totali ta' olanzapine [erja taħt il- kurva] hija 12 sa 15- il darba aktar minn dik ta 'raġel mogħti doża ta' 12 mg).
In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.
Fi klieb fejn l- għadd taċ- ċelluli tad- demm huwa anqas minn normal, ma kien hemm ebda effetti avversi fuq ċelloli proġenituri u ċelloli proliferanti tal- mudullun.
Reproductive toxicity Olanzapine had no teratogenic effects.
Olanzapine ma kellha ebda effetti teratoġeniċi.
Sedation affected mating performance of male rats.
Is- sedazzjoni affettwat il- ħila ta ’ tgħammir tal- firien ta 'sess maskili.
Estrous cycles were affected at doses of 1.1 mg/ kg (3 times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/ kg (9 times the maximum human dose).
Iċ- ċikli estruwi kienu affettwati b' dożi ta '1. 1 mg/ kg (3 darbiet id- doża massima fil - bniedem) u l- parametri tar- riproduzzjoni kienu influwenzati fil- firien mogħtija 3 mg/ kg (9 darbiet id - doża massima fil- bniedem).
In the offspring of rats given olanzapine, delays in fetal development and transient decreases in offspring activity levels were seen.
Fil- frieħ tal- firien mogħtija olanzapine, kienu osservati dewmien fl - iżvilupp tal- fetu u tnaqqis għal xi żmien fl- attività tal- frieħ.
Mutagenicity
Mutaġeniċità U
13 Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Olanzapine ma ikkawżatx mutaġeniċità jew klastoġeniċità f' firxa sħiħata 'testijiet standard, li nkludew testijiet ta' mutazzjoni tal- mikrobi kif ukoll testijiet fuq il- mammiferi kemm in vitro kif ukoll in vivo.
Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Ibbażat fuq riżultati ta 'studji fuq il- ġrieden u l- firien, kien konkluż li olanzapine mhuwiex kanċeroġeniku.
Tablet core Lactose monohydrate Maize starch Pregelatinised maize starch Crospovidone type A Magnesium stearate
Qalba tal- pillola Lactose monohydrate Lamtu tal- qamħirrum Lamtu tal- qamħirrum preġelatinizzat Crospovidone tip A Stjerejt tal- Manjezju
Tablet coat Opadry White OY-B-28920 containing:
Rita tal- pillola Opadry White OY- B- 28920 li fih:
Polyvinyl alcohol Titanium dioxide E171 Talc E553b Lecithin soya E322 Xanthan gum E415
14 Terra E553b Leċitin tas- soja E322 Gomma Xantan E415
Not applicable.
Ma jgħoddux f' dan il- każ
6.3 Shelf life
6. 3 Zmien kemm idum tajjeb il- prodott mediċinali
Blister 2.5 mg
Folja 2. 5 mg 18- ilxahar
Tablet containers 2.5 mg 18 months
Kontenituri tal- pilloli 2. 5 mg
Do not store above 25 °C.
Taħżinhomx f’ temperatura ta ’ ‘ l fuq minn 25 °C.
Olanzapine Mylan 2.5 mg film-coated tablets:
Olanzapine Mylan 2. 5 mg pilloli miksijin b’ rita:
Cold-formed aluminium/ aluminium blister in cartons of 28, 35, 56 & 70 film-coated tablets per carton.
Folja maħduma bierda ta ’ aluminju/ aluminju f’ kaxex ta ’ 28, 35, 56 & 70 pillola miksija b’ rita f’ kull kaxxa.
Polypropylene tablet containers with tamper evident polyethylene closure containing 250 & 500 film- coated tablets per tablet container.
Kontenituri tal- pilloli tal- polipropilin b’ qafla li tikxef meta jsir xi tbagħbis li jkun fihom 250 u 500 pillola miksijin b’ rita f’ kull kontenitur tal- pilloli.
Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali..
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
Informazzjoni dettaljata fuq dan il- prodotti tinsab fuq is- sit eletroniku ta l- Agenzija Ewropeja tal - Medicine (EMEA) http: // www. emea. europa. eu.
Olanzapine Mylan 5 mg film-coated tablets
OLANZAPINE MYLAN 5 mg f’ pilloli miksijin b’ rita
Each film-coated tablet contains 5 mg olanzapine.
Kull pillola miksija b’ rita fiha 5 mg olanzapine.
For the 5 mg:
Sustanzi mhux attivi Għal dik ta ’ 5 mg:
152 mg lactose anhydrous per tablet.
152 mg anhydrous lactose kull pillola.
The film-coating of each 5 mg tablet contains 0.12 mg soya lecithin
Sustanzi mhux attivi Il- kisi b’ rita ta ’ kull pillola ta ’ 5 mg fiha 0. 12 mg leċitin tas- soja.
8.0 mm, round, normal convex, white film-coated tablets debossed “ OZ 5 ” on one side and “ G” on the other side.
Pilloli ta ’ 8. 0 mm, tondi, mżaqqa normali, bojod miksijin b’ rita imnaqqxa b ’ “ OZ 5 ” fuq naħa waħda u b ’ “ G ” fuq in- naħa l- oħra.
In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).
F' pazjenti li l- episodju ta 'manija tagħhom irreaġixxa għat- trattament ta’ olanzapine, olanzapine hija indikata għall- prevenzjoni ta' rikorrenza f' pazjenti b' diżordni bipolari (ara sezzjoni 5. 1).
If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
Jekk ikun hemm episodju ġdid ta 'manija, imħallat, jew ta' depressjoni, it- trattament b’ olanzapine għandu jitkompla (bl- aħjar użu tad- doża skond il- bżonn), b' terapija supplimentari biex ikunu trattati s- sintomi tal- burdata, kif indikat klinikament.
16 During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/ day.
Waqt it- trattament għas- skiżofrenja, għal episodju ta 'manija u għall- prevenzjoni tar- rikorrenza fid - diżordni bipolari, d- dożaġġ ta' kuljum jista 'sussegwentement jiġi aġġustat fuq il- bażi ta' l- istat kliniku
An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
Żjieda għal doża akbar mid- doża tal- bidu rakkomandata għandha tingħata biss wara rivalutazzjoni klinika xierqa u ġeneralment għandha ssir f' intervalli ta 'mhux anqas minn 24 siegħa.
A lower starting dose (5 mg) should be considered for such patients.
Indeboliment renali u/ jew epatiku Doża anqas tal- bidu (5 mg/ ġurnata) għandha tiġi kkunsidrata għal dawn il- pazjenti.
In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
F' każijiet ta 'insuffiċjenza tal- fwied moderata (ċirrożi, Child- Pugh Klassi A jew B), id- doża tal- bidu għandha tkun 5 mg u tiżdied biss b' kawtela.
(see sections 4.5 and 5.2.)
(Ara sezzjonijiet 4. 5 u 5. 2).
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
17 inċidenza ta ’ l- imwiet kienet ogħla f’ dawk ittrattati b' olanzapine minn dik fil- pazjenti ttrattati bil - plaċebo, indipendentement minn dawn il- fatturi ta ’ riskju.
17 In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Fl- istess studji kliniċi, kienu rrapportati avvenimenti avversi ċerebro- vaskulari (CVAE eż puplesija, attakki iskemiċi momentanji) inklużi l- imwiet.
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Fi studji kliniċi, id- deterjorament fis- sintomi tal- marda ta’ Parkinson u alluċinazzjonijiet kienu rrappurtati b’ mod komuni ħafna u aktar ta 'spiss milli bil - plaċebo (ara sezzjoni 4. 8), u olanzapine ma kienx aktar effettiv mill- plaċebo fit- trattament tas- sintomi psikotiċi.
In these trials, patients were initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
F' dawn l- istudji, il- pazjenti inizjalment kellhom ikunu stabblizzati fuq id- doża l- aktar baxxa u effettiva tal- mediċini kontra l- marda ta ’ Parkinson (agonist ta ’ dopamine) u biex jibqgħu fuq l- istess mediċini u dożi kontra l- marda ta ’ Parkinson matul l- istudju.
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
18 u/ jew AST elevati waqt it- trattament, għandha tiġi organiżżata investigazzjoni oħra u għandha tiġi kkunsidrata tnaqqis fid- doża.
18 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.
Newtropenja Għandha tittieħed kawtela f' pazjenti b 'numru baxx ta ’ lewkoċiti u/ jew numru baxx taċ- ċelluli newtrofili għal kwalunkwe raġuni, dawk il- pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw newtropenja, f' pazjenti b ’ passat ta' tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal - mudullun minħabba t- teħid ta 'xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
19 Pressjoni baxxa mal- waqfien ġiet osservata rari fl- anzjani fil- provi kliniċi ta 'olanzapine.
19 Lactose Olanzapine tablets contain lactose monohydrate.
Lactose Il- pilloli OLANZAPINE fihom l- lactose.
Patients who are allergic to peanut or soya must not take these tablets.
Pazjenti li huma allergici għallkarawett jew is- soja, ma jistawx jieħdu dawn il- pilloli.
The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
tnaqqis fil- konċentrazzjoni ta 'olanzapine.
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).
Il- konsegwenzi kliniċi x' aktarx huma limitati, imma hija rakkomandata l - osservazzjoni klinika u tista 'tiġi kkunsidrata żjieda fid- doża ta' olanzapine jekk din tkun meħtieġa (ara Sezzjoni 4. 2).
Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Fluvoxamine, inibitur speċifiku ta' CYP1A2, deher li jinibixxi sinifikatament il- metaboliżmu ta 'U
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female nonsmokers and 77% male smokers.
Iż- żjieda medja f’ olanzapine Cmax wara t- teħid ta 'fluvoxamine kienet 54% fin- nisa li ma jpejpux u 77% fl- irġiel li jpejpu.
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Fluoxetine (inibitur CYP2D6), dożi b’ waħdiet t 'antaċidi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il- komportament farmakokinetiku ta' olanzapine.
1A2, 2D6, 2C9, 2C19, 3A4).
Olanzapine ma jinibixxix l- iżoenżimi CYP450 prinċipali in vitro (eż 1A2, 2D6, 2C19, 3A4).
Olanzapine showed no interaction when co-administered with lithium or biperiden.
20 Olanzapine ma wera ebda reazzjoni meta ttieħed flimkien ma ’ lithium jew biperiden.
20 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
Leucopenia Neutropenia
Lewkopenja
Immune system disorders Allergic reaction Metabolism and nutrition disorders Weight gain1
21 Newtropenja Disturbi fis- sistema immuni Reazzjoni allerġika Disturbi fil- metaboliżmu u n- nutrizzjoni Żieda fil- piż1
Nervous system disorders Somnolence
Disturbi fis- sistema nervuża Sonnolenza Disturbi fil- qalb
Dizziness Akathisia6 Parkinsonism6
Sturdament Akatizja6 Parkinsoniżmu6 Diskineżja6
Seizures where in most cases a history of seizures or risk factors for seizures
Aċċessjonijiet li fil - maġġoranza tagħhom kien rrappurtat passat mediku ta 'aċċessjonijiet jew fatturi tar- riskju għall - aċċessjonijiet Sindromu Newrolettiku Malinn (ara sezzjoni 4. 4) Distonja (tinkludi okuloġirazzjoni) Diskineżja tardiva Sintomi ta' twaqqif tal - kura7
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Takikardija / fibrillazzjoni ventrikulari, mewt għall- għarrieda (ara sezzjoni 4. 4)
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
Epatite (inkluż mard tal- fwied tat- tip epatoċellulari, kolestatiku jew tat - tnejn flimkien)
Photosensitivity reaction Alopecia
Reazzjoni ta 'fotosensittività Alopeċja
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 Elevated plasma
22 Disturbi muskolu- skeltrali u tal- connective tissue Rabdomijoliżi Disturbi fil- kliewi u fis- sistema urinarja Eżitazzjoni urinarja Disturbi fis- sistema riproduttiva u fis- sider Prijapiżmu Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Astenja Għeja Edima Investigazzjonijiet Livelli elevati ta' prolactin fil- plażma 8 1
phosphokinase Increased total bilirubin
Creatine phosphokinase għoli Żieda fil- bilirubin totali
phosphatase
Żieda f' alkaline phosphatase
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
(Body Mass Index - BMI), fil- kategoriji kollha.
Weight gain ≥ 7% of baseline body weight was very common and ≥ 15% of baseline body weight was common.
Żieda fil- piż ta ’ ≥ 7% mil- linja bażi tal- piż tal- ġisem kienet komuni ħafna u ta ’ ≥ 15% mil- linja bażi tal- piż tal- ġisem kienet komuni.
22 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
2 Iż- żidiet medji fil- livelli tax- xaħmijiet waqt is- sawm (kolesterol totali, LDL kolesterol, u trigliċeridi) kienu ogħla f’ pazjent li fil- linja bażi ma wrewx evidenza ta ’ problemi fil- kontroll tax- xaħmijiet.
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).
23 Fi studji kliniċi f’ pazjenti anzjani bid- demenzja, trattament b' olanzapine kien assoċjat ma ’ inċidenza ogħla ta ’ mwiet u reazzjonijiet avversi ċerebro- vaskulari meta mqabbla mal- plaċebo (ara wkoll sezzjoni 4. 4).
23 Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Tfal u adolexxenti Olanzapine mhux indikat għall- użu fit- tfal u pazjenti adolexxenti taħt it- 18- il sena.
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (≥ 1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/ l - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
24 10 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 1. 016 mmol/ l) li żdiedu għal għoljin (≥ 1. 467 mmol/ l) u tibdil fit- trigliċeridi waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 1. 016 mmol/ l - < 1. 467 mmol/ l) għal għoljin (≥ 1. 467 mmol/ l).
Management of overdose
L- Immaniġġar ta 'Doża Eċċessiva U
24 There is no specific antidote for olanzapine.
Ma hemm ebda antidotu speċifiku għal olanzapine.
In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
F’ studju komparattiv, double- blind u multinazzjonali ta ’ skiżofrenija, ta ’ manifestazzjonijiet skiżoaffettivi u disturbi relatati oħra li kien jinkludi 1, 481 pazjent li kellhom gravità differenti ta ’ l - assoċjati sintomi dipressivi (medja ta ’ punteġg ta ’ 16. 6 meħud fil- bidu tal- kura skond l- iskala li tivvaluta d- dipressjoni ta ’ Montgomery- Asberg), analiżi prospettiva sekondarja tat- tibdil fil- punteġġ ta ’ l- atteġġament bejn il- bidu u fl- aħħar tal- kura wriet titjib statistikament sinifikanti (p=0. 001) favur olanzapine (- 6. 0) kontra haloperidol (- 3. 1).
25 In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
ikkontrollatiU b’ olanzapine, imbagħd kienu mogħtija mingħajr għażla olanzapine jew il- plaċebo, olanzapine wera superjorita sinifikanti u statistikament superjuri fuq il- plaċebo fuq l- għan ewlieni tar - rikorrenza bipolari.
5.2 Pharmacokinetic properties
26 5. 2 Tagħrif farmakokinetiku
26 In smoking subjects with mild hepatic dysfunction, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/ hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/ hr, respectively).
F' pazjenti li jpejpu u għandhom disfunzjoni tal- fwied ħafifa, il- half life ta 'l- eliminazzjoni medja (39. 3 siegħa) twalet u t- tneħħija (18. 0 l/ hr) tnaqqset bħal f' pazjenti b' saħħithom li ma jpejpux (48. 8 siegħa u 14. 1 l/ hr, rispettivament).
27 Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Olanzapine ma ikkawżatx mutaġeniċità jew klastoġeniċità f' firxa sħiħata 'testijiet standard, li nkludew testijiet ta' mutazzjoni tal- mikrobi kif ukoll testijiet fuq il- mammiferi kemm in vitro kif ukoll in vivo.
Polyvinyl alcohol Titanium dioxide E171 Talc E553b Lecithin soya E322 Xanthan gum E415
28 Terra E553b Leċitin tas- soja E322 Gomma xantan E415
Blister 5 mg 18 months.
Folja 5 mg 18- ilxahar
Tablet containers 5 mg
Kontenituri tal- pilloli 5 mg
18 months
18- ilxahar
Olanzapine Mylan 5 mg film-coated tablets:
Olanzapine Mylan 5 mg pilloli miksijin b’ rita:
Polypropylene tablet containers with tamper evident polyethylene closure containing 250 & 500 tablets per tablet container.
Kontenituri tal- pilloli tal- polipropilin b’ qafla li tikxef meta jsir xi tbagħbis li jkun fihom 250 u 500 pillola miksijin b’ rita f’ kull kontenitur tal- pilloli.
Olanzapine Mylan 7.5 mg film-coated tablets
OLANZAPINE MYLAN 7. 5 mg pilloli miksijin b’ rita
Each film-coated tablet contains 7.5 mg olanzapine.
Kull pillola miksija b’ rita fiha 7. 5 mg olanzapine.
For the 7.5 mg:
Sustanzi mhux attivi Għal dik ta ’ 7. 5 mg:
228 mg lactose anhydrous per tablet.
Kull pillola miksija b’ rita fiha 228 mg anhydrous lactose.
The film-coating of each 7.5 mg tablet contains 0.18 mg soya lecithin
Sustanzi mhux attivi Ir- rita li tiksi kull pillola ta ’ 7. 5 mg fiha 0. 18 mg leċitin tas- soja.
9.0 mm, round, normal convex, white film-coated tablets debossed “ OZ 7.5 ” on one side and “ G” on the other side.
9. 0 mm, tonda, mżaqqa normali, pilloli bojod miksija b’ rita b ’ “ OZ 7. 5 ” imnaqqax fuq naħa waħda u b ’ “ G ” fuq in- naħa l- oħra.
The recommended starting dose for olanzapine is 10 mg/ day.
Id- doża tal- bidu rakkomandata għalolanzapine hija 10 mg/ ġurnata.
30 During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/ day.
Waqt it- trattament għas- skiżofrenja, għal episodju ta 'manija u għall- prevenzjoni tar- rikorrenza fid - diżordni bipolari, d- dożaġġ ta' kuljum jista 'sussegwentement jiġi aġġustat fuq il- bażi ta' l- istat kliniku
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
31 inċidenza ta ’ l- imwiet kienet ogħla f’ dawk ittrattati b' olanzapine minn dik fil- pazjenti ttrattati bil - plaċebo, indipendentement minn dawn il- fatturi ta ’ riskju.
31 In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Fl- istess studji kliniċi, kienu rrapportati avvenimenti avversi ċerebro- vaskulari (CVAE eż puplesija, attakki iskemiċi momentanji) inklużi l- imwiet.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Funzjoni epatikd Elevazzjonijiet li ma jurux sintomi ta 'l- enżimi transaminases tal- fwied, ALT, AST għal żmien qasir kienu komuni, speċjalment fil- bidu tat- trattament.
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
32 u/ jew AST elevati waqt it- trattament, għandha tiġi organiżżata investigazzjoni oħra u għandha tiġi kkunsidrata tnaqqis fid- doża.
32 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.
Newtropenja Għandha tittieħed kawtela f' pazjenti b 'numru baxx ta ’ lewkoċiti u/ jew numru baxx taċ- ċelluli newtrofili għal kwalunkwe raġuni, dawk il- pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw newtropenja, f' pazjenti b ’ passat ta' tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal - mudullun minħabba t- teħid ta 'xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
33 Pressjoni baxxa mal- waqfien ġiet osservata rari fl- anzjani fil- provi kliniċi ta 'olanzapine.
33 Olanzapine tablets contain lactose monohydrate.
Lactose Il- pilloli OLANZAPINE fihom l- lactose.
Olanzapine showed no interaction when co-administered with lithium or biperiden.
34 Olanzapine ma wera ebda reazzjoni meta ttieħed flimkien ma ’ lithium jew biperiden.
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).
Mhux rakkomandat l- użu konkomitanti ta 'olanzapine ma' prodotti mediċinali kontra l - Parkinson f' pazjenti bil- marda ta 'Parkinson u d- demenzja (ara sezzjoni 4. 4).
34 There are no adequate and well-controlled studies in pregnant women.
Ma hemm ebda studji adegwati u kkontrollati sewwa f' nisa waqt it- tqala.
Blood and the lymphatic system disorders
Disturbi tad- demm u tas- sistema limfatika 35
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant
Aċċessjonijiet li fil - maġġoranza tagħhom kien irrappurtat passat mediku ta 'aċċessjonijiet jew fatturi tar- riskju għall - aċċessjonijiet Sindromu Newrolettiku Malinn (ara sezzjoni 4. 4) Distonja (tinkludi okuloġirazzjoni) Diskineżja tardiva Sintomi ta' twaqqif tal - kura7
syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7 Cardiac disorders Vascular disorders
Disturbi vaskulari
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 Elevated plasma prolactin levels8 1
36 Alopeċja Disturbi muskolu- skeltrali u tal- connective tissue Rabdomijoliżi Disturbi fil- kliewi u fis- sistema urinarja Eżitazzjoni urinarja Disturbi fis- sistema riproduttiva u fis- sider Prijapiżmu Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Astenja Għaja Edima Investigazzjonijiet Livelli elevati ta'
High creatine phosphokinase Increased total bilirubin
phosphokinase għoli Żieda fil- bilirubin totali
Increased alkaine phosphatase
phosphatase
36 3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (≥ 6.2 mmol/ l).
3 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 5. 17 mmol/ l) li żdiedu għal għoljin (≥ 6. 2 mmol/ l).
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).
Tagħrif addizzjonali dwar popolazzjonijiet speċjali 37 Fi studji kliniċi f’ pazjenti anzjani bid- demenzja, trattament b' olanzapine kien assoċjat ma ’ inċidenza ogħla ta ’ mwiet u reazzjonijiet avversi ċerebro- vaskulari meta mqabbla mal- plaċebo (ara wkoll sezzjoni 4. 4).
Children and adolescents Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Tfal u adolexxenti Olanzapine mhux indikat għall- użu fit- tfal u pazjenti adolexxenti taħt it- 18- il sena.
37 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.
It- tabella li ġejja tiġbor fil- qosor ir- reazzjonijiet avversi rrapportati b' frekwenza akbar f' pazjenti adolexxenti (minn 13 sa 17- il sena) milli f' pazjenti adulti jew reazzjonijiet avversi li ġew identifikati biss waqt studji kliniċi ta ’ terminu qasir f' pazjenti adolexxenti.
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (≥ 1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/ l - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
38 10 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 1. 016 mmol/ l) li żdiedu għal għoljin (≥ 1. 467 mmol/ l) u tibdil fit- trigliċeridi waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 1. 016 mmol/ l - < 1. 467 mmol/ l) għal għoljin (≥ 1. 467 mmol/ l).
Management of overdose There is no specific antidote for olanzapine.
Ma hemm ebda antidotu speċifiku għal olanzapine.