qanastek/EMEA-V3 huggingface dataset:
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
Is- Sindromu Newrolettiku Malinn (NMS) NMS tista 'tkun kundizzjoni fatali assoċjata ma' prodotti mediċinali antipsikotiċi.
Rare cases reported as NMS have also been received in association with olanzapine.
Każijiet rari li ġew rappurtati bħala NMS kienu rrappurtati f' assoċjazzjoni ma 'olanzapine wkoll.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Tibdil fil- livell tal- lipidi għandu jiġi kkontrollat b’ mod klinikamet xieraq speċjalment f’ pazjenti b’ ammont mhux normali ta ’ lipidi fid- demm u f’ pazjenti li għandhom fatturi ta ’ riskju għall- iżvilupp ta ’ disturbi fil- lipidi.
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
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
18 illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
18 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.
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
L- Intervall QT Fi studji kliniċi, żidiet fil- QTc li kienu klinikament sinifikanti (korrezzjoni fil- QT skond Fridericia [QTcF] > 500 millisekondi [msek] f’ kwalunkwe ħin wara l- valur bażiku f’ pazjenti b’ valur bażiku ta ’ QTcF < 500 msek) ma kienux komuni (0. 1% sa 1%) f’ pazjenti kkurati b’ olanzapine, b’ ebda differenza sinfikativa fl- avvenimenti assoċjati kardijaċi meta mqabbla ma ’ plaċebo.
However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
Madankollu, bħal b' antipsikotiċi oħra, għandha tittieħed kawtela meta olanzapine jinkiteb ma 'mediċini oħra li huma magħrufa li jżidu l- intervall QTc, speċjalment fl- anzjani, f' pazjenti b' sindromu konġenitali ta' QT twil, insuffiċjenza tal- qalb konġestiva, ipertrofija tal- qalb, potassju baxx fid- demm jew manjesju baxx fid - demm.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers 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.
20 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.
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, sturdament, akatiżja, parkinsoniżmu (ara sezzjoni 4. 4), diskineżja, pressjoni baxxa mal- waqfien, effetti antikolinerġiċi, żieda fil- livelli tat- transaminases tal- fwied li ma jurux sintomi u li huma momentanji (ara sezzjoni 4. 4), raxx, astenja, għeja u edima.
Dizziness Akathisia6 Parkinsonism6 Dyskinesia6
(ara sezzjoni 4. 4) Ipotermja
Mild, transient anticholinergic effects including constipation and dry mouth
Takikardija / fibrillazzjoni ventrikulari, mewt għal għarrieda (ara sezzjoni 4. 4)
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
Disturbi gastro- intestinali Pankreatite Effetti antikolinerġiċi ħfief u li jgħaddu malajr inklużi stitikezza u ħalq xott Disturbi fil- fwied u fil- marrara Epatite (inkluż mard Żieda ta 'transaminases tal- fwied tat- tip tal- fwied (ALT, AST) epatoċellulari, bla sintomi u li tgħaddi kolestatiku jew tat - malajr, speċjalmet fil - tnejn flimkien) bidu tal- kura (ara sezzjoni 4. 4)
Skin and subcutaneous tissue disorders
22 Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda
Photosensitivity
Reazzjoni ta 'fotosensittività Alopeċja
22 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 total fasting cholesterol levels from borderline at baseline (≥ 5.17- < 6.2 mmol/ l) to high (≥ 6.2 mmol/ l) were very common.
Tibdil fil- livelli tal- kolesterol totali waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 5. 17 mmol/ l - < 6. 2 mmol/ l) għal għoljin (≥ 6. 2 mmol/ l) kienu komuni.
6 In clinical trials, the incidence of parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
6 Fi studji kliniċi, l- inċidenza tal- marda ta 'Parkinson u distonja f' pazjenti kkurati b ’ olanzapine kienet numerikament ogħla, imma statistikament mhux sinifikatament differenti mill- plaċebo.
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.
23 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.
23 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 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).
Very common adverse reactions associated with the use of olanzapine in this patient group were abnormal gait and falls.
Reazzjonijiet avversi komuni ħafna assoċjati ma ’ l- użu ta’ olanzapine f’ dan il- grupp ta ’ pazjenti kienu mixja mhux normali u waqgħat.
Olanzapine administered with lithium or valproate resulted in increased levels (≥ 10%) of tremor, dry mouth, increased appetite, and weight gain.
Olanzapine mogħti ma 'lithium jew valproate rriżulta f’ żieda fil- livelli (> 10%) ta' rogħda, nixfa fil- ħalq, żieda fl- aptit, u żieda fil- piż.
Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with bipolar disorder was associated with an increase of ≥ 7% from baseline body weight in 39.9% of patients.
Trattament b ’ olanzapine għal żmien twil (sa 12- il xahar) bl- għan ta 'prevenzjoni ta' episodju ieħor f' pazjenti b' mard bipolari kien assoċjat ma 'żieda ta' ≥ 7% mil- linja bażi tal- piż tal- ġisem f '39. 9% tal - pazjenti.
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
24 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 - 24 < 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).
Signs andsSymptoms Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Sinjali u sintomi Sintomi komuni ħafna meta ittieħdet doża eċċessiva (> 10% inċidenza) jinkludu takikardija, aġitazzjoni/ aggressività, diżartrija, sintomi ekstrapiramidali varji, u telf tas- sensi li tvarja minn sedazzjoni sa koma.
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
25 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.
25 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.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
26 tagħrif dwar il- manteniment ta 'l- effett u hemm tagħrif limitat dwar is- sigurtà fit- tul (ara sezzjonijiet 4. 4 u 4. 8).
26 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.
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 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).
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.
27 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.
Tossiċità ta 'dożi repetuti 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.
Tablet coating:
28 Il- kisja tal- pillola:
OPA/ Aluminium/ PVC-Aluminium blisters in cartons of 28, 30, 35, 50, 56 or 70 film-coated tablets per carton.
Folji ta ’ OPA/ Aluminium/ PVC- Aluminium f’ kartun ta ’ 28, 30, 35, 50, 56 jew 70 miksija b’ rita kull kartuna.
EU/ 1/ 07/ 427/ 004 – Olanzapine Teva – 5 mg – film-coated tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 005 – Olanzapine Teva – 5 mg – film-coated tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 039 – Olanzapine Teva – 5 mg – film-coated tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 006 – Olanzapine Teva – 5 mg – film-coated tablets – 50 tablets, per box EU/ 1/ 07/ 427/ 007 – Olanzapine Teva – 5 mg – film-coated tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 049 – Olanzapine Teva – 5 mg – film-coated tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 049 – Olanzapine Teva – 5 mg – pilloli miksija b’ rita – 70 pillola, kull kaxxa.
Olanzapine Teva 7.5 mg film-coated tablets
Olanzapine Teva 7. 5 mg pilloli miksija b’ rita
Each film-coated tablet contains 103.3 mg lactose.
Kull pillola miksija b’ rita fiha 103. 3 mg lactose.
A white, biconvex, round tablet, with the inscription “ OL 7.5 ” on one side.
Pillola bajda tonda u mżaqqa li fuqha hemm miktub “ OL 7. 5 ” fuq naħa waħda.
Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapine tista 'tingħata fuq l- ikel jew fuq stonku vojt għax l -
30 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
It- tnaqqis gradwali tad- doża għandu jiġi kkunsidrat meta titwaqqaf olanzapine.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Il- pazjenti kollha ttrattati b' olanzapine jew bi plaċebo u li kellhom avveniment
31 CVAE in association with olanzapine treatment.
31 ċerebro- vaskulari, kellhom fatturi ta ’ riskju li kienu jeżistu minn qabel.
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment, should be discontinued.
F' każijiet fejn saret dijanjożi ta ’ l- epatite( inkluż il- mard tal- fwied epatoċellulari, kolestatiku jew tat- tip imħallat), it- trattament ta 'olanzapine għandu jitwaqqaf.
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
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
32 myeloproliferative disease.
32 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.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with
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.
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
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
Skin and subcutaneous tissue disorders
36 Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda
36 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 Għaja Edima Investigazzjonijiet Żieda f' alkaline Livelli elevati ta' prolactin fil- plażma 8 1
Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17- < 6.2 mmol/ l) to high (≥ 6.2 mmol/ l) were very common.
Tibdil fil- livelli tal- kolesterol totali waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 5. 17 mmol/ l - < 6. 2 mmol/ l) għal għoljin (≥ 6. 2 mmol/ l) kienu komuni 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.
37 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.
37 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 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.
38 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 - 38 < 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).
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
39 olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal - profil tar- riċettur li jorbot.
39 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.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
40 tagħrif dwar il- manteniment ta 'l- effett u hemm tagħrif limitat dwar is- sigurtà fit- tul (ara sezzjonijiet 4. 4 u 4. 8).
40 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.
41 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.
Tossiċità ta 'dożi repetuti 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.
Tablet coating:
42 Il- kisja tal- pillola:
42 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
OPA/ Aluminium/ PVC-Aluminium blisters in cartons of 28, 30, 35, 56 or 70 film-coated tablets per carton.
Folji ta ’ OPA/ Aluminium/ PVC- Aluminium f’ kartun ta ’ 28, 30, 35, 56 jew 70 pillola miksija b’ rita f’ kull kartuna.
EU/ 1/ 07/ 427/ 008 – Olanzapine Teva – 7.5 mg – film-coated tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 009 – Olanzapine Teva – 7.5 mg – film-coated tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 040 – Olanzapine Teva – 7.5 mg – film-coated tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 010 – Olanzapine Teva – 7.5 mg – film-coated tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 050 – Olanzapine Teva – 7.5 mg – film-coated tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 050 – Olanzapine Teva – 7. 5 mg – pilloli miksija b’ rita – 70 pillola, kull kaxxa.
Olanzapine Teva 10 mg film-coated tablets
Olanzapine Teva 10 mg pilloli miksija b’ rita
Each film-coated tablet contains 137.8 mg lactose.
Kull pillola miksija b’ rita fiha 137. 8 mg lactose.
A white, biconvex, round tablet, with the inscription “ OL 10 ” on one side.
Pillola bajda tonda u mżaqqa li fuqha hemm miktub “ OL 10 ” fuq naħa waħda.
44 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
It- tnaqqis gradwali tad- doża għandu jiġi kkunsidrat meta titwaqqaf olanzapine.
Patients with known risk of narrow-angle glaucoma.
Pazjenti li għandhom ir - riskju ta 'glawkoma tat- tip narrow angle.
0.4%, respectively).
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%,
45 CVAE in association with olanzapine treatment.
45 rispettivament).
46 myeloproliferative disease.
46 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.
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.
Biodisponibilità 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 required after the introduction of concomitant olanzapine.
48 Osservazzjoni terapewtika tal- livelli ta ’ valproate fil- plażma ma ndikatx li tibdil fid- dożaġġ tal - valproate huwa meħtieġ wara l- introduzzjoni ta 'olanzapine ukoll.
Very common
49
Nervous system disorders Somnolence
trigliċeridi2, 5 Glikosurja Żieda fl- aptit
Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7 Cardiac disorders Vascular disorders
Disturbi fis- sistema nervuża Sonnolenza Disturbi fil- qalb
Skin and subcutaneous tissue disorders
50 Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda
Clinically significant weight gain was observed
Ġiet osservata żieda fil- piż, klinikament sinifikanti, fil- linja bażi ta ’ l- Indiċi tal- Massa tal- Ġisem (Body Mass Index - BMI), fil- kategoriji kollha.
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.
51 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.
9 Weight gain ≥ 7% of baseline body weight (kg) was very common and ≥ 15% of baseline body weight was common.
52 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.
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
53 olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal - profil tar- riċettur li jorbot.
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
Fi studju ta '12- il xahar ta' prevenzjoni ta 'rikorrenza f' pazjenti b' episodju ta' manija, li kienu diġà ikkontrollati 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.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
54 tagħrif dwar il- manteniment ta 'l- effett u hemm tagħrif limitat dwar is- sigurtà fit- tul (ara sezzjonijiet 4. 4 u 4. 8).
In non-smoking versus smoking subjects (males and females) the mean elimination half-life was
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).
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.
Tossiċità ta 'dożi repetuti 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.
55 Carcinogenicity Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Kanċeroġeniċità Ibbażat fuq riżultati ta 'studji fuq il- ġrieden u l- firien, kien konkluż li olanzapine mhuwiex kanċeroġeniku.
Lactose monohydrate Hydroxypropylcellulose Crospovidone type A Silica colloidal anhydrous Microcrystalline cellulose Magnesium stearate Tablet coating:
Lactose monohydrate Hydroxypropylcellulose Crospovidone type A Silica, colloidal anhydrous Microcrystalline cellulose Magnesium stearate
OPA/ Aluminium/ PVC-Aluminium blisters in cartons of 7, 28, 30, 35, 50, 56 or 70 film-coated tablets per carton.
Folji ta ’ OPA/ Aluminium/ PVC- Aluminium f’ kartun ta ’ 7, 28, 30, 35, 50, 56 jew 70 pillola miksija b’ rita f’ kull kartuna.
EU/ 1/ 07/ 427/ 011 – Olanzapine Teva – 10 mg – film-coated tablets – 7 tablets, per box EU/ 1/ 07/ 427/ 012 – Olanzapine Teva – 10 mg – film-coated tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 013 – Olanzapine Teva – 10 mg – film-coated tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 041 – Olanzapine Teva – 10 mg – film-coated tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 014 – Olanzapine Teva – 10 mg – film-coated tablets – 50 tablets, per box
EU/ 1/ 07/ 427/ 014 – Olanzapine Teva – 10 mg – pilloli miksija b’ rita – 50 pillola, kull kaxxa.
56 EU/ 1/ 07/ 427/ 015 – Olanzapine Teva – 10 mg – film-coated tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 051 – Olanzapine Teva – 10 mg – film-coated tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 042 – Olanzapine Teva – 10 mg – pilloli miksija b’ rita – 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
57 Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu
Olanzapine Teva 15 mg film-coated tablets
Olanzapine Teva 15 mg pilloli miksija b’ rita
Each film-coated tablet contains 15 mg olanzapine.
Kull pillola miksija b’ rita fiha 15 mg olanzapine.
Each film-coated tablet contains 206.7 mg lactose.
Kull pillola miksija b’ rita fiha 206. 7 mg lactose.
A light blue, biconvex, oval tablet, with the inscription “ OL 15 ” on one side.
Pillola ċelesti ċara ovali u mżaqqa li fuqha hemm miktub “ OL 15 ” fuq naħa waħda.
58 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Tfal u adolexxenti Olanzapine mhux irrakkomandat għall- użu fit- tfal u fl- adolexxenti ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
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%,
0.4%, respectively).
60 rispettivament).
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
61 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.
61 4.5 Interaction with other medicinal products 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
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
63 Osservazzjoni terapewtika tal- livelli ta ’ valproate fil- plażma ma ndikatx li tibdil fid- dożaġġ tal - valproate huwa meħtieġ wara l- introduzzjoni ta 'olanzapine ukoll.
63 Very common
64
Skin and subcutaneous tissue disorders
65 Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda
64 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.
66 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.
65 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 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.
67 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 - 66 < 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 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.
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
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 - profil tar- riċettur li jorbot.
67 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.
68 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 plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1,000 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.
69 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.
Tossiċità ta 'dożi repetuti 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.
Hypromellose Colour mixture blue (polydextrose, hypromellose, glycerol diacetate, macrogol 8000, titanium dioxide E171, indigo carmine E132)
Hypromellose Kulur ta ’ taħlita bajda (polydextrose, hypromellose, glycerol diacetate, macrogol 8000, titanium dioxide E171 indigo carmine E132)
70 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
OPA/ Aluminium/ PVC-Aluminium blisters in cartons of 28, 30, 35, 50, 56 or 70 film-coated tablets per carton.
Folji ta ’ OPA/ Aluminium/ PVC- Aluminium f’ kartun ta ’ 28, 30, 35, 50 or 56 pillola miksija b’ rita kull kartuna.
EU/ 1/ 07/ 427/ 016 – Olanzapine Teva – 15 mg – film-coated tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 017 – Olanzapine Teva – 15 mg – film-coated tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 042 – Olanzapine Teva – 15 mg – film-coated tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 018 – Olanzapine Teva – 15 mg – film-coated tablets – 50 tablets, per box EU/ 1/ 07/ 427/ 019 – Olanzapine Teva – 15 mg – film-coated tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 052 – Olanzapine Teva – 15 mg – film-coated tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 052 – Olanzapine Teva – 15 mg – pilloli miksija b’ rita – 70 pillola, kull kaxxa.
Olanzapine Teva 20 mg film-coated tablets
Olanzapine Teva 20 mg pilloli miksija b’ rita
Each film-coated tablet contains 275.5 mg lactose.
Kull pillola miksija b’ rita fiha 275. 5 mg lactose.
A pink, biconvex, oval tablet, with the inscription “ OL 20 ” on one side.
Pillola roża ovali u mżaqqa li fuqha hemm miktub “ OL 20 ” fuq naħa waħda.
72 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Tfal u adolexxenti Olanzapine mhux irrakkomandat għall- użu fit- tfal u fl- adolexxenti ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
0.4%, respectively).
74 rispettivament).
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
75 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.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
76 L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Olanzapine mhux indikat għall- użu fil- kura tat- tfal u adolexxenti.
75 4.5 Interaction with other medicinal products 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
Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
77 Osservazzjoni terapewtika tal- livelli ta ’ valproate fil- plażma ma ndikatx li tibdil fid- dożaġġ tal - valproate huwa meħtieġ wara l- introduzzjoni ta 'olanzapine ukoll.
77 Very common
78
Skin and subcutaneous tissue disorders
79 Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda
78 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.
80 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.
79 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 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.
81 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 - 80 < 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).
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
82 olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal - profil tar- riċettur li jorbot.
In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers,
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).
83 tagħrif dwar il- manteniment ta 'l- effett u hemm tagħrif limitat dwar is- sigurtà fit- tul (ara sezzjonijiet 4. 4 u 4. 8).
Cytochromes P450- CYP1A2 and P450-CYP2D6 contribute to the formation of the N-desmethyl and 2-hydroxymethyl
L - enżimi ċitokromju P450- CYP1A2 u P450- CYP2D6 jikkontrbwixxu għall- formazzjoni ta 'prodotti metaboliċi tat- tip N- desmethyl u 2- hydroxymethyl.
82 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.
83 were CNS depression, anticholinergic effects, and peripheral haematological disorders.
Tossiċità ta 'dożi repetuti 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.
Hypromellose Colour mixture pink (polydextrose, hypromellose, glycerol diacetate, macrogol 8000, titanium dioxide E171, iron oxide red E172)
Hypromellose Kulur ta ’ taħlita bajda (polydextrose, hypromellose, glycerol diacetate, macrogol 8000, titanium dioxide E171, iron oxide red E172)
84 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
EU/ 1/ 07/ 427/ 020 – Olanzapine Teva – 20 mg – film-coated tablets – 28 tablets, per box EU/ 1/ 07/ 427/ 021 – Olanzapine Teva – 20 mg – film-coated tablets – 30 tablets, per box EU/ 1/ 07/ 427/ 043 – Olanzapine Teva – 20 mg – film-coated tablets – 35 tablets, per box EU/ 1/ 07/ 427/ 022 – Olanzapine Teva – 20 mg – film-coated tablets – 56 tablets, per box EU/ 1/ 07/ 427/ 053 – Olanzapine Teva – 20 mg – film-coated tablets – 70 tablets, per box
EU/ 1/ 07/ 427/ 053 – Olanzapine Teva – 20 mg – pilloli miksija b’ rita – 70 pillola, kull kaxxa.
Olanzapine Teva 5 mg orodispersible tablets
Olanzapine Teva 5 mg pilloli jinħallu fil- ħalq
Each 5 mg orodispersible tablet contains 5 mg olanzapine.
Kull pillola ta ’ 5 mg li tinħall fil- ħalq fiha 5 mg olanzapine.
Each 5 mg orodispersible tablet contains 0.4 mg tartrazine lake (E102).
Kull pillola ta ’ 5 mg li tinħall fil- ħalq fiha 0. 4 mg tartrazine lake (E102).
For a full list of excipients, see section 6.1.
Kull pillola li tinħall fil- ħalq fiha 1 mg D- Glucose Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Orodispersible tablet
Pillola li tinħall fil- ħalq
A dark yellow, flat, round tablet, plain on both sides.
Pillola tonda ta ’ lewn isfar skur, ċatta u sempliċi fuq żewġ naħat.
Adults Olanzapine is indicated for the treatment of schizophrenia.
Adulti Olanzapine hija indikata għat- trattament ta ’ l- iskiżofrenja.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapine hija effettiva biex iżżomm it- titjib kliniku waqt terapija kontinwa f' pazjenti li wrew reazzjoni għat- trattament tal- bidu.
86 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.
Removal of the intact orodispersible tablet from the mouth is difficult.
Huwa diffiċli li tneħħi mill- ħalq il- pillola intatta magħmula biex tinħall fil- ħalq.
Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Peress li l- pillola li tinħall fil- ħalq hija fraġli, għandha tittieħed eżatt kif tinfetaħ il - folja.
Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before administration.
Inkella, tista ’ tinħall f’ tazza ilma mimlija jew ma’ xarba oħra xierqa (meraq tal- larinġ, meraq tat - tuffieħ, ħalib jew kafe).
Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption.
Il- pillola olanzapine li tinħall fil- ħalq hija bioekwivalenti għall- pilloli ta 'olanzapine miksija, b' rata u estensjoni ta' l- assorbiment simili.
It has the same dosage and frequency of administration as olanzapine coated tablets.
Għandha l- istess dożaġġ u frekwenza fit- teħid bħal pilloli ta 'olanzapine miksija.
Olanzapine orodispersible tablets may be used as an alternative to olanzapine coated tablets.
Pilloli ta 'olanzapine li jinħallu fil- ħalq jistgħu jintużaw bħala alternattiva għall - pilloli ta' olanzapine miksija.
Elderly 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).