qanastek/EMEA-V3 huggingface dataset:
In cases where dose increments of 2.5 mg are considered necessary, Olanzapine Teva film-coated tablets should be used.
F’ każijiet meta inkrimenti tad- doża b’ 2. 5 mg huma meħtieġa, pilloli Miksija b’ Rita ta ’ Olanzapine Teva għandhom jintużaw.
(See sections 4.5 and 5.2.)
(ara sezzjonijiet 4. 5 u 5. 2).
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis
88 Psikożi relatata mad- demenzja u/ jew disturbi fil- komportament Olanzapine mhux approvat għat- trattament tal- psikożi relatata mad- demenzja u/ jew disturbi fil - komportament, u mhux irrakkomandat għall- użu f’ dan il- grupp partikolari ta ’ pazjenti, dovut għal żieda fil- mortalità u r- riskju ta ’ inċident ċerebro- vaskulari.
87 and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
Fi studji kliniċi kkontrollati bil- plaċebo (li damu minn 6 sa 12- il ġimgħa), fuq pazjenti anzjani (età medja 78 sena) li kelhom psikożi relatata mad- demenzja u/ jew disturbi fil- komportament, kien hemm żieda ta ’ darbtejn akbar fl- inċidenza ta ’ mwiet fil- pazjenti ttrattati b' olanzapine, mqabbla ma ’ pazjenti ttrattati bil- plaċebo (3. 5% kontra 1. 5%, rispettivament).
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
Kien hemm żieda ta ’ 3 darbiet akbar ta ’ CVAE f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċebo (1. 3% kontra 0. 4%, rispettivament).
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.
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
89 Attività antikolinerġika Waqt li olanzapine wera attività antikolinerġika in vitro, ersperjenza waqt il- provi kliniċi uriet inċidenza baxxa ta 'ġrajjiet relatati.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate
Funzjoni epatika Elevazzjonijiet li ma jurux sintomi ta 'l- enżimi transaminases tal- fwied, ALT, AST għal żmien qasir kienu komuni, speċjalment fil- bidu tat- trattament.
Neutropenia 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.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Attività ġenerali fis- CNS Minħabba l- effetti primarji ta 'olanzapine fuq is- CNS għandha tittieħed kawtela meta dan jingħata flimkien ma' mediċini oħra li jaġixxu ċentralment u meta jittieħed ma 'l- alkoħol.
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.
Kienu rarament rappurtati
Seizures have been reported to occur rarely in patients when treated with olanzapine.
90 aċċessjonijiet f' pazjenti meta trattati b' olanzapine.
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over
Bħal b' antipsikotiċi oħra, huwa rakkomandat li l- pressjoni tad- demm tkun meħuda perjodikament f' pazjenti 'l fuq minn 65 sena.
The tablets are fragile and should not be pushed through the blister.
Il- pazjenti għandhom ikunu osservati mill- qrib waqt dan il - perijodu.
The backing should be peeled off to remove the tablet from the blister.
Il- parti ta ’ wara għandha titqaxxar biex toħroġ il- pillola minn ġol- folja.
D-Glucose:
D- Glucose:
Olanzapine Teva orodispersible tablet contains D-glucose: patients with rare glucose- galactose malabsorption should not take this medicine.
Il- pilloli li jinħallu fil- ħalq ta ’ Olanzapine Teva fihom D- Glucose: pazjenti li għandhom problemi ta ’ assorbiment ta ’ glukożju- gallatożju m’ għandhomx jieħdu din il- mediċina.
Tartrazine lake (E102):
Tartrazine lake (E102):
Olanzapine Teva orodispersible tablet contains tartrazine lake (E102): may cause allergic reactions.
Il- pilloli li jinħallu fil- ħalq ta ’ Olanzapine Teva fihom tartrazine lake (E102): jista ’ jikkawża reazzjonijiet allerġiċi.
Potential interactions affecting olanzapine Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Potenzjal t' interazzjonijiet ma 'olanzapine Minħabba li olanzapine hija metaboliżżata b' CYP1A2, sustanzi li jistgħu speċifikament jikkaġunaw jew jinibixxu din l- iżoenżima jistgħu jaffettwaw il- komportament farmakokinetiku ta 'olanzapine.
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
91 jużaw fluvoxamine jew xi inibituri oħra ta 'CYP1A2, bħal ciprofloxacin.
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Fluvoxetine (inibitur CYP2D6), dożi b’ waħdiet t 'antaċidi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il- komportament farmakokinetiku ta' olanzapine.
90 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
Osservazzjoni terapewtika tal- livelli ta ’ valproate fil- plażma ma ndikatx li tibdil fid- dożaġġ tal - valproate huwa meħtieġ wara l- introduzzjoni ta 'olanzapine ukoll.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Il- pazjenti għandhom jingħataw parir biex jgħarrfu lit- tabib tagħhom jekk jinqabdu tqal jew jekk qed jippjanaw li jinqabdu tqal waqt it- trattament b’ olanzapine.
Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni. Minħabba li olanzapine jista 'jikkawża sonnolenza u sturdament, il- pazjenti għandhom jiġu avżati dwar l- użu ta' magni, inklużi l - karozzi.
4.8 Undesirable effects
92 4. 8 Effetti mhux mixtieqa
91 Very common
93
Skin and subcutaneous tissue disorders
94 Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda
92 reaction Alopecia 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
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 Żieda f' alkaline Livelli elevati ta' prolactin fil- plażma 8 1
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
95 Espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 48 ġimgħa) Il- proporzjon ta ’ pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż- żieda fil- piż, fil- glucose, fil- kolesterol totali/ LDL/ HDL jew trigliċeridi żdied maż- żmien.
93 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 section 4.4).
Tagħrif addizzjonali dwar popolazzjonijiet speċjali 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).
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
96 9 Żieda fil- piż ta '≥ 7% mil- linja bażi tal- piż tal- ġisem (kg) kienet komuni ħafna u ta' ≥ 15% mil- linja bażi tal- piż tal- ġisem kienet komuni.
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 - 94 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
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).
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5HT2A/ 2C, 5HT3, 5HT6; 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
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
97 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 5HT2 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.
95 In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5HT2A 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 Single Photon Emission Computed Tomography (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 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).
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Fi studju ta '12- il xahar ta' prevenzjoni ta 'rikorrenza f' pazjenti b' episodju ta' manija, li kienu diġà ikkontrollati b’ olanzapine, imbagħad 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 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).
Fit- tieni studju ta '12- il xhar dwar ir- rikorrenza preventiva f' pazjenti b' episodju ta' manija li kienu ikkontrollati b’ olanzapine u l- lithium flimkien, kienu mbagħad mqassmin mingħajr għażla u mogħtija 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.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
98 tagħrif dwar il- manteniment ta 'l- effett u hemm tagħrif limitat dwar is- sigurtà fit- tul (ara sezzjonijiet 4. 4 u 4. 8).
96 administration has not been determined
Il- biodisponibilità assoluta orali relattiva għal amministrazzjoni fil- vina ma 'kienitx determinata.
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.
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. 21 l/ hr).
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hrs) and the clearance was reduced (18.9 versus 27.3 l/ hr).
F 'pazjenti femminili f' paragun ma' dawk maskili l- 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).
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.
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 ∝1- acid - glycoprotein.
Dogs tolerated single oral doses up to 100 mg/ kg without mortality.
Il- klieb felħu dożi orali b’ waħdiet sa 100 mg/ kg mingħajr mortalità.
Clinical signs included sedation, ataxia, tremors, increased heart rate,
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’ waħdiet sa 100 mg/ kg irriżultaw f' prostrazzjoni u, f' dożi ogħla, telf parzjali mis- sensi.
Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [area under the curve] 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).
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.
Mutaġeniċità Olanzapine ma ikkawżatx mutaġeniċità jew klastoġeniċità f' firxa sħiħa ta 'testijiet standard, li nkludew testijiet ta' mutazzjoni tal- mikrobi kif ukoll testijiet fuq il- mammiferi kemm in vitro kif ukoll in vivo.
Mannitol (E421) Sodium starch glycolate (type A) D-glucose Vanilla flavouring Tartrazine lake (E102)
Mannitol (E421) Sodium starch glycolate (type A) D- glucose Benna tal- vanilla Tartrazine lake (E102)
6.2 Incompatibilities
2 snin
Store in the original package in order to protect from light and moisture.
Aħżen fil- pakkett oriġinali biex tilqa ’ mid- dawl u mill- umdità.
98 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
OPA/ Aluminium/ PVC-Aluminium polyester blisters in cartons of 28, 30, 35, 50, 56 or 70 orodispersible tablets per carton.
Folji ta ’ OPA/ Aluminium/ PVC- Aluminium f’ kartun ta ’ 28, 30, 35, 56 jew 70 pillola li jinħallu fil- ħalq f’ kull kartuna.
EU/ 1/ 07/ 427/ 023 – Olanzapine Teva – 5 mg – orodispersible tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 024 – Olanzapine Teva – 5 mg – orodispersible tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 044 – Olanzapine Teva – 5 mg – orodispersible tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 025 – Olanzapine Teva – 5 mg – orodispersible tablets – 50 tablets, per box EU/ 1/ 07/ 427/ 026 – Olanzapine Teva – 5 mg – orodispersible tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 054 – Olanzapine Teva – 5 mg – orodispersible tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 054 – Olanzapine Teva – 5 mg – pilloli jinħallu fil- ħalq – 70 pillola, kull kaxxa.
DATE OF REVISION OF THE TEXT
DATE TA 'META ĠIET RIVEDUTA L- KITBA
Olanzapine Teva 10 mg orodispersible tablets
Olanzapine Teva 10 mg pilloli jinħallu fil- ħalq
Each 10 mg orodispersible tablet contains 10 mg olanzapine.
Kull pillola li tinħall fil- ħalq fiha 10 mg olanzapine.
Each orodispersible tablet contains 1 mg D-Glucose.
Kull pillola li tinħall fil- ħalq fiha 1 mg D- Glucose.
A yellow, flat, round tablet, plain on both sides.
Pillola ta ’ lewn safrani, ċatta, tonda u sempliċi fuq iż- żewġ naħat.
100 Olanzapine Teva Orodispersible Tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Il- pillola ta ’ Olanzapine Teva li tinħall fil- ħalq għandha titpoġġa fil- ħalq, fejn tinħall malajr fil- bżieq, sabiex tkun tista ’ tinbela ’ faċilment.
In cases where dose increments of 2.5 mg are considered necessary, Olanzapine Teva coated tablets should be used.
F’ każijiet meta inkrimenti tad- doża b’ 2. 5 mg huma meħtieġa, pilloli Miksija b’ Rita ta ’ Olanzapine Teva għandhom jintużaw.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Psikożi relatata mad- demenzja u/ jew disturbi fil- komportament Olanzapine mhux approvat għat- trattament tal- psikożi relatata mad- demenzja u/ jew disturbi fil - komportament, u mhux irrakkomandat għall- użu f’ dan il- grupp partikolari ta ’ pazjenti, dovut għal żieda fil- mortalità u r- riskju ta ’ inċident ċerebro- vaskulari.
Patients should be closely monitored during this period.
Fi studji kliniċi kkontrollati bil- plaċebo (li
Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
103 damu minn 6 sa 12- il ġimgħa), fuq pazjenti anzjani (età medja 78 sena) li kelhom psikożi relatata mad- demenzja u/ jew disturbi fil- komportament, kien hemm żieda ta ’ darbtejn akbar fl- inċidenza ta ’ mwiet fil- pazjenti ttrattati b' olanzapine, mqabbla ma ’ pazjenti ttrattati bil- plaċebo (3. 5% kontra 1. 5%, rispettivament).
1.5%, respectively).
L- inċidenza ogħla ta ’ l- imwiet ma kienitx assoċjata mad- doża ta ’ olanzapine (doża medja kuljum ta ’ 4. 4 mg) jew it- tul ta ’ żmien tat- trattament.
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 dożi u mediċini kontra l- marda ta ’ Parkinson matul l- istudju.
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions.
Madankollu, minħabba li esperjenza klinika b' olanzapine f' pazjenti
Caution should be
104 b' mard konkomitanti hija limitata, għandha tittieħed kawtela meta jkun preskritt għall- pazjenti b' ipertrofija tal- prostata, jew b' ileus paralitiku u kundizzjonijiet relatati.
102 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 medicines.
Għandha tittieħed kawtela f' pazjenti b 'ALT u/ jew AST elevati, f' pazjenti b' kundizzjonijiet li kienu hemm qabel, assoċjati b' riżerva funzjonali limitata tal - fwied, u f' pazjenti li qed ikunu trattati b' mediċini li jistu' jkunu tossiċi għall- fwied.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
105 Diskajneżja Tardiva Fi studji komparattivi li damu sena jew anqas, olanzapine kien assoċjat ma 'inċidenza mnaqqsa ta' diskajneżja f' riżultat tat- trattament b' sinifikat statistikament validu.
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).
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
106 Fluvoxetine (inibitur CYP2D6), dożi b’ waħdiet t 'antaċidi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il- komportament farmakokinetiku ta' olanzapine.
104 General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Attività tas- CNS ġenerali Għandha tittieħed kawtela f' pazjenti li jixorbu l- alkoħol jew li jieħdu prodotti mediċinali li jistgħu jikkawżaw depressjoni tas- sistema nervuża ċentrali.
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg) Patients should be advised not to breast-feed an infant if they are taking olanzapine.
Pazjenti għandhom jingħataw parir biex ma jreddawx tarbija jekk qed jieħdu olanzapine.
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
107 Fit- tabella li ġejja huma mniżżla r- reazzjonijiet avversi u t- testijiet tal- laboratorju osservati minn rapporti magħmula b’ mod spontanju u minn studji kliniċi.
105 Very common
108
Skin and subcutaneous tissue disorders
109 Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda
106 reaction Alopecia 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
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 Żieda f' alkaline Livelli elevati ta' prolactin fil- plażma 8 1
Changes in fasting glucose from borderline at baseline (≥ 5.56 - < 7 mmol/ l) to high (≥ 7 mmol/ l) were very common.
Tibdil fil- livelli taz- zokkor waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 5. 56 - < 7 mmol/ l) għal għoljin (≥ 7m mol/ l) kienu komuni ħafna ħafna.
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
110 Espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 48 ġimgħa) Il- proporzjon ta ’ pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż- żieda fil- piż, fil- glucose, fil- kolesterol totali/ LDL/ HDL jew trigliċeridi żdied maż- żmien.
107 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 section 4.4).
Tagħrif addizzjonali dwar popolazzjonijiet speċjali 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).
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
111 9 Żieda fil- piż ta '≥ 7% mil- linja bażi tal- piż tal- ġisem (kg) kienet komuni ħafna u ta' ≥ 15% mil- linja bażi tal- piż tal- ġisem kienet komuni.
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 - 108 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
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).
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5HT2A/ 2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α 1 adrenergic; and histamine H1 receptors.
Fi studji ta 'qabel l- użu kliniku, olanzapine wera firxa ta' affinitajiet għar- riċetturi (Ki; < 100 nM) serotoniċi 5HT2A/ 2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5: riċetturi muskariniċi kolinerġiċi m1- m5; ∝ 1 adrenerġiċi; u riċetturi ta 'l- istamina H1.
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Studji fuq l- imġieba ta 'l- annimali li ingħataw olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal -
109 In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5HT2A 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.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
113 tagħrif dwar il- manteniment ta 'l- effett u hemm tagħrif limitat dwar is- sigurtà fit- tul (ara sezzjonijiet 4. 4 u 4. 8).
110 administration has not been determined
Il- biodisponibilità assoluta orali relattiva għal amministrazzjoni fil- vina ma 'kienitx determinata.
Mannitol (E421) Sodium starch glycolate (type A) D-glucose Vanilla flavouring
Mannitol (E421) Sodium starch glycolate (type A) D- glucose Benna tal- vanilla
6.3 Shelf life
115 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
2 years
2 snin
Store in the original package in order to protect from light and moisture.
Aħżen fil- pakkett oriġinali biex tilqa ’ mid- dawl.
112 OPA/ Aluminium/ PVC-Aluminium polyester blisters in cartons of 28, 30, 35, 50, 56 or 70 orodispersible tablets per carton.
Folji ta ’ OPA/ Aluminium/ PVC- Aluminium f’ kartun ta ’ 28, 30, 35, 50, 56 jew 70 pillola li jinħallu fil - ħalq f’ kull kartuna.
EU/ 1/ 07/ 427/ 027 – Olanzapine Teva – 10 mg – orodispersible tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 028 – Olanzapine Teva – 10 mg – orodispersible tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 045 – Olanzapine Teva – 10 mg – orodispersible tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 029 – Olanzapine Teva – 10 mg – orodispersible tablets – 50 tablets, per box EU/ 1/ 07/ 427/ 030 – Olanzapine Teva – 10 mg – orodispersible tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 055 – Olanzapine Teva – 10 mg – orodispersible tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 055 – Olanzapine Teva – 10 mg – pilloli jinħallu fil- ħalq – 70 pillola, kull kaxxa.
Olanzapine Teva 15 mg orodispersible tablets
Olanzapine Teva 15 mg pilloli jinħallu fil- ħalq
Each 15 mg orodispersible tablet contains 0.2 mg sunset yellow lake (E110).
Kull pillola li tinħall fil- ħalq fiha 15 mg olanzapine.
Each orodispersible tablet contains 1 mg D-Glucose.
Kull pillola li tinħall fil- ħalq fiha 1 mg D- Glucose
A mottled orange, flat, round tablet, plain on both sides.
Pillola tonda u ċatta oranġjo bi dbabar, sempliċi fuq iż- żewġ naħat.
Olanzapine Teva Orodispersible Tablet should be placed in the mouth, where it will rapidly disperse in
Il- pillola ta ’ Olanzapine Teva li tinħall fil- ħalq għandha titpoġġa fil- ħalq, fejn tinħall malajr fil- bżieq, sabiex tkun tista ’ tinbela ’ faċilment.
Elderly patients A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Anzjani Doża anqas tal- bidu (5 mg/ ġurnata) mhux indikata normalment imma għandha tiġi kkunsidrata għal dawk li għandhom 65 jew fuqhom meta fatturi kliniċi jindikaw hekk (ara wkoll sezzjoni 4. 4).
Patients should be closely monitored during this period.
Fi studji kliniċi kkontrollati bil- plaċebo (li damu minn 6 sa 12- il ġimgħa), fuq pazjenti anzjani (età medja 78 sena) li kelhom psikożi relatata
1.5%,
118 mad- demenzja u/ jew disturbi fil- komportament, kien hemm żieda ta ’ darbtejn akbar fl- inċidenza ta ’ mwiet fil- pazjenti ttrattati b' olanzapine, mqabbla ma ’ pazjenti ttrattati bil- plaċebo (3. 5% kontra 1. 5%, rispettivament).
Caution should be
119 b' mard konkomitanti hija limitata, għandha tittieħed kawtela meta jkun preskritt għall- pazjenti b' ipertrofija tal- prostata, jew b' ileus paralitiku u kundizzjonijiet relatati.
116 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 medicines.
Għandha tittieħed kawtela f' pazjenti b 'ALT u/ jew AST elevati, f' pazjenti b' kundizzjonijiet li kienu hemm qabel, assoċjati b' riżerva funzjonali limitata tal - fwied, u f' pazjenti li qed ikunu trattati b' mediċini li jistu' jkunu tossiċi għall- fwied.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
120 Diskajneżja Tardiva Fi studji komparattivi li damu sena jew anqas, olanzapine kien assoċjat ma 'inċidenza mnaqqsa ta' diskajneżja f' riżultat tat- trattament b' sinifikat statistikament validu.
Sunset yellow lake (E110):
Sunset yellow lake (E110):
Olanzapine Teva orodispersible tablet contains sunset yellow lake (E110): may cause allergic reactions.
Il- pilloli li jinħallu fil- ħalq ta ’ Olanzapine Teva fihom sunset yellow lake (E110): jista ’ jikkaġuna reazzjonijiet allerġiċi.
4.5 Interaction with other medicaments and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma 'dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Decreased bioavailability Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60% and should be taken at least 2 hours before or after olanzapine.
121 Biodisponibbiltà mnaqqsa Faħam attivat inaqqas il- biodisponibilità ta 'olanzapine li tittieħed mill- ħalq b' 50 sa 60% u għandu jittieħed għal ta 'l- inqas sagħtejn qabel jew wara olanzapine.
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is
Osservazzjoni terapewtika tal- livelli ta ’ valproate fil- plażma ma ndikatx li tibdil fid- dożaġġ tal - valproate huwa meħtieġ wara l- introduzzjoni ta 'olanzapine ukoll.
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.
Adulti Fi studji kliniċi, l- aktar reazzjonijiet avversi li ġew irrapportati b' mod frekwenti (jidhru f '> 1% tal - pazjenti) u li huma assoċjati ma' l- użu ta 'l- olanzapine kienu sonnolenza, żieda fil- piż, eosinofilja, livelli għolja ta' prolactin, kolesterol, glucose u trigliċeridi (ara sezzjoni 4. 4), glikosurja, żieda fl- aptit,
119 Very common
123
Skin and subcutaneous tissue disorders
124 Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda
120 reaction Alopecia 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
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 Żieda f' alkaline Livelli elevati ta' prolactin fil- plażma 8 1
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
125 Espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 48 ġimgħa) Il- proporzjon ta ’ pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż- żieda fil- piż, fil- glucose, fil- kolesterol totali/ LDL/ HDL jew trigliċeridi żdied maż- żmien.
121 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 section 4.4).
Tagħrif addizzjonali dwar popolazzjonijiet speċjali 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).
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
126 9 Żieda fil- piż ta '≥ 7% mil- linja bażi tal- piż tal- ġisem (kg) kienet komuni ħafna u ta' ≥ 15% mil- linja bażi tal- piż tal- ġisem kienet komuni.
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 - 122 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
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).
123 In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5HT2A 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.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
128 tagħrif dwar il- manteniment ta 'l- effett u hemm tagħrif limitat dwar is- sigurtà fit- tul (ara sezzjonijiet 4. 4 u 4. 8).
124 administration has not been determined
Il- biodisponibilità assoluta orali relattiva għal amministrazzjoni fil- vina ma 'kienitx determinata.
Mannitol (E421) Sodium starch glycolate (type A) D-glucose Vanilla flavouring Sunset Yellow lake (E110)
Mannitol (E421) Sodium starch glycolate (type A) D- glucose Benna tal- vanilla Sunset Yellow lake (E110)
126 OPA/ Aluminium/ PVC-Aluminium polyester blisters in cartons of 28, 30, 35, 50, 56 or 70 orodispersible tablets per carton.
Folji ta ’ OPA/ Aluminium/ PVC- Aluminium f’ kartun ta ’ 28, 30, 35, 50, 56 jew 70 pillola li jinħallu fil - ħalq f’ kull kartuna.
EU/ 1/ 07/ 427/ 031 – Olanzapine Teva – 15 mg – orodispersible tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 032 – Olanzapine Teva – 15 mg – orodispersible tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 046 – Olanzapine Teva – 15 mg – orodispersible tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 033 – Olanzapine Teva – 15 mg – orodispersible tablets – 50 tablets, per box EU/ 1/ 07/ 427/ 034 – Olanzapine Teva – 15 mg – orodispersible tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 056 – Olanzapine Teva – 15 mg – orodispersible tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 056 – Olanzapine Teva – 15 mg – pilloli jinħallu fil- ħalq – 70 pillola, kull kaxxa.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
Olanzapine Teva 20 mg orodispersible tablets
Olanzapine Teva 20 mg pilloli jinħallu fil- ħalq
Each 20 mg orodispersible tablet contains 20 mg olanzapine.
Kull pillola li tinħall fil- ħalq fiha 20 mg olanzapine.
A green, flat, round tablet, plain on both sides.
Pillola tonda ta ’ lewn ħadrani, ċatta, sempliċi fuq iż- żewġ naħat.
The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Id- doża tal- bidu hija ta '15 mg bħala doża waħda kuljum bil- monoterapija jew 10 mg kuljum f' terapija flimkien ma' xi sustanza oħra (Ara sezzjoni 5. 1).
128 Olanzapine Teva Orodispersible Tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Il- pillola ta ’ Olanzapine Teva li tinħall fil- ħalq għandha titpoġġa fil- ħalq, fejn tinħall malajr fil- bżieq, sabiex tkun tista ’ tinbela ’ faċilment.
Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
133 damu minn 6 sa 12- il ġimgħa), fuq pazjenti anzjani (età medja 78 sena) li kelhom psikożi relatata mad- demenzja u/ jew disturbi fil- komportament, kien hemm żieda ta ’ darbtejn akbar fl- inċidenza ta ’ mwiet fil- pazjenti ttrattati b' olanzapine, mqabbla ma ’ pazjenti ttrattati bil- plaċebo (3. 5% kontra 1. 5%, rispettivament).
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate
134 b' mard konkomitanti hija limitata, għandha tittieħed kawtela meta jkun preskritt għall- pazjenti b' ipertrofija tal- prostata, jew b' ileus paralitiku u kundizzjonijiet relatati.
130 transferase (AST) have been seen commonly, especially in early treatment.
Funzjoni epatika Elevazzjonijiet li ma jurux sintomi ta 'l- enżimi transaminases tal- fwied, ALT, AST għal żmien qasir kienu komuni, speċjalment fil- bidu tat- trattament.
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
135 Diskajneżja Tardiva Fi studji komparattivi li damu sena jew anqas, olanzapine kien assoċjat ma 'inċidenza mnaqqsa ta' diskajneżja f' riżultat tat- trattament b' sinifikat statistikament validu.
As with
Pressjoni baxxa mal- waqfien Pressjoni baxxa mal- waqfien ġiet osservata rari fl- anzjani fil- provi kliniċi ta 'olanzapine.
131 other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
Bħal b' antipsikotiċi oħra, huwa rakkomandat li l- pressjoni tad- demm tkun meħuda perjodikament f' pazjenti 'l fuq minn 65 sena.
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
136 Fluvoxetine (inibitur CYP2D6), dożi b’ waħdiet t 'antaċidi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il- komportament farmakokinetiku ta' olanzapine.
132 General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Attività tas- CNS ġenerali Għandha tittieħed kawtela f' pazjenti li jixorbu l- alkoħol jew li jieħdu prodotti mediċinali li jistgħu jikkawżaw depressjoni tas- sistema nervuża ċentrali.
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
137 Fit- tabella li ġejja huma mniżżla r- reazzjonijiet avversi u t- testijiet tal- laboratorju osservati minn rapporti magħmula b’ mod spontanju u minn studji kliniċi.
133 Very common
138
Skin and subcutaneous tissue disorders
139 Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda
134 reaction Alopecia 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
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 Żieda f' alkaline Livelli elevati ta' prolactin fil- plażma 8 1
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
140 Espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 48 ġimgħa) Il- proporzjon ta ’ pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż- żieda fil- piż, fil- glucose, fil- kolesterol totali/ LDL/ HDL jew trigliċeridi żdied maż- żmien.
135 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 section 4.4).
Tagħrif addizzjonali dwar popolazzjonijiet speċjali 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).
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
141 9 Żieda fil- piż ta '≥ 7% mil- linja bażi tal- piż tal- ġisem (kg) kienet komuni ħafna u ta' ≥ 15% mil- linja bażi tal- piż tal- ġisem kienet komuni.
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 - 136 < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
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).
137 In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5HT2A 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.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
143 tagħrif dwar il- manteniment ta 'l- effett u hemm tagħrif limitat dwar is- sigurtà fit- tul (ara sezzjonijiet 4. 4 u 4. 8).