qanastek/EMEA-V3 huggingface dataset:
The recommended starting dose of ZYPREXA VELOTAB depends on the disease being treated:
Id- doża inizzjali rrakomandata għall- pilloli ta ’ ZYPREXA VELOTAB tiddependi mill- marda li tkun qed tiġi trattata:
10 mg/ day is used in schizophrenia and in the prevention of manic episodes, and 15 mg/ day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg/ day.
Doża ta ’ 10mg kuljum tintuża għall- iskiżofrenija u fil- prevenzjoni ta ’ episodji manijaċi, u 15- il mg kuljum fit- trattament ta ’ episodji manijaċi, sakemm ma tintużax ma ’ mediċini oħra, f’ liema każ id- doża inizzjali tista ’ tkun ta ’ 10mg kuljum.
The dose is adjusted according to how well the patient responds to and tolerates the treatment; the usual dose range is between 5 and 20 mg/ day.
Id- doża tiġi aġġustata skond kemm il - pazjent jirrispondi tajjeb u jittolera t- trattament; normalment id- doża tvarja bejn 5 u 20mg kuljum.
The orodispersible tablets are taken by being placed on the tongue, where they disintegrate quickly in the saliva, or by mixing them in water before swallowing.
Il - pilloli li jdubu fil- ħalq jittieħdu billi jitpoġġew fuq l- ilsien, fejn jinħallu malajr fil- bżieq, jew inkella billi tħallathom ma ’ l- ilma qabel tiblagħhom.
Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose (5 mg/ day).
Pazjenti li jkollhom iktar minn 65 sena u pazjenti li jkollhom problemi bil- fwied jew bil- kliewi jista ’ jkollhom bżonn ta ’ doża iktar baxxa fil- bidu (5mg kuljum).
How does ZYPREXA VELOTAB work?
Kif taħdem ZYPREXA VELOTAB?
The active substance in ZYPREXA VELOTAB, olanzapine, is an antipsychotic medicine.
ZYPREXA VELOTAB hija mediċina li fiha s- sustanza attiva olanzapine, li hija mediċina antipsikotika.
It is known as an ‘ atypical’ antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Hija magħrufa bħala antipsikotiku ‘ atipiku ’ minħabba li hija differenti minn mediċini antipsikotiċi li ilhom disponibbli mis- snin ħamsin.
This disrupts signals transmitted between brain cells by ‘ neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
Mhux magħruf eżatt kif taħdem, iżda teħel ma ’ diversi riċetturi differenti fuq is- superfiċje taċ- ċelloli tan- nervituri tal- moħħ.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Dan ifixkel is- sinjali trażmessi bejn iċ- ċelloli tal- moħħ permezz ta ’ ‘ newrotrażmettituri ’, kimiċi li jħallu liċ- ċelloli tal- moħħ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has ZYPREXA VELOTAB been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged jikkomunikaw ma ’ xulxin.
ZYPREXA VELOTAB contains the same active substance as another medicine already authorised in the European Union, called ZYPREXA.
ZYPREXA VELOTAB fiha l- istess sustanza attiva bħal dik ta ’ mediċina oħra li diġà ġiet awtorizzata fl- Unjoni Ewropea, bl- isem ta ’ ZYPREXA.
Because of this, the studies done with ZYPREXA were used to support the use of ZYPREXA VELOTAB.
Minħabba f’ hekk, l- istudji magħmula b’ ZYPREXA ġew użata sabiex jappoġġaw l- użu ta ’ ZYPREXA VELOTAB.
Three studies were also carried to show that, when taken by mouth, the two medicines result in equivalent levels of olanzapine in the blood.
Ġew ukoll mwettqa tliet studji oħra sabiex juru li, meta meħuda mill- ħalq, iż- żewġ mediċini jirriżultaw f’ livelli ekwivalenti ta ’ olanzapine fid - demm.
What benefit has ZYPREXA VELOTAB shown during the studies?
Liema benefiċċju wriet ZYPREXA VELOTAB waqt l- istudji li ġew mwettqa?
Like ZYPREXA, ZYPREXA VELOTAB was more effective at improving symptoms than placebo (a dummy treatment).
Bħal ZYPREXA, ZYPREXA VELOTAB kienet effettiva iktar mill- plaċebo (trattament finta) fit- titjib tas- sintomi.
ZYPREXA VELOTAB was as effective as the medicines it was compared with for the treatment of schizophrenia, the treatment of moderate to severe manic episodes, and the prevention of recurrence in patients with bipolar disorder.
ZYPREZA VELOTAB kienet effettiva daqs il- mediċini li ġiet mqabbla magħhom għat - trattament ta ’ l- iskiżofrenija, għat- trattament ta ’ episodji manijaċi minn moderati sa severi, u dawk li ma jħallux pazjenti b’ disturbi bipolari jirkadu.
What is the risk associated with ZYPREXA VELOTAB?
X’ inhu r- riskju assoċjat ma ’ ZYPREXA VELOTAB?
The most common side effects with ZYPREXA VELOTAB (seen in more than 1 patient in 10) are somnolence (sleepiness), weight gain, and raised levels of prolactin (a hormone).
L- aktar effetti sekondarji komuni ma ’ ZYPREXA VELOTAB (dehru f’ aktar minn pazjent 1 minn kull 10) huma s- somnolenza (ngħas), żieda fil- piż, u żieda fil- livelli ta ’ prolactin (ormon).
For the full list of all side effects reported with ZYPREXA VELOTAB, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati f’ ZYPREXA VELOTAB, ara l- Fuljett ta ’ Tagħrif tal- Pakkett.
ZYPREXA VELOTAB should not be used in people who may be hypersensitive (allergic) to olanzapine or any of the other ingredients.
ZYPREXA VELOTAB m’ għandux jintuża f’ persuni li jistgħu jkunu sensittivi ż- żejjed (allerġiċi) għal olanzapine jew kull ingredjent ieħor.
ZYPREXA VELOTAB should not be used in patients at risk of narrow-angle glaucoma (raised pressure inside the eye).
ZYPREXA VELOTAB m’ għandux jintuża minn pazjenti li jkollhom riskju ta ’ narrow- angla glaucoma (pressjoni għolja ġewwa l- għajn).
Why has ZYPREXA VELOTAB been approved?
Għaliex ġiet approvata ZYPREXA VELOTAB?
The Committee for Medicinal products for Human Use (CHMP) decided that ZYPREXA VELOTAB’ s benefits are greater than its risks for the treatment of schizophrenia, including the maintenance of clinical improvement during continuation therapy in patients who have shown an initial treatment response, the treatment of moderate to severe manic episode and the prevention of recurrence in patients with bipolar disorder.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li ZYPREXA għandha iktar benefiċċji milli riskji meta tintuża għat- trattament ta ’ l- iskiżofrenija, inkluż iż- żamma ta ’ titjib kliniku waqt it- terapija ta ’ kontinwazzjoni f’ pazjenti li jkunu wrew rispons inizjali għat - trattament, fit- trattament ta ’ episodji manijaċi minn moderati sa severi u biex pazjenti b’ disturbi bipolari ma jerġgħux jirkadu.
The Committee recommended that ZYPREXA VELOTAB be given marketing authorisation.
Il- Kumitat irrakomanda li ZYPREXA VELOTAB tingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Other information about ZYPREXA VELOTAB:
Aktar tagħrif dwar ZYPREXA VELOTAB:
The European Commission granted a marketing authorisation valid throughout the European Union to Eli Lilly Nederland BV for ZYPREXA VELOTAB on 3 February 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, lil Eli Lilly Nederland BV għal ZYPREXA VELOTAB fit- 3 ta ’ Frar tas- sena 2000.
The marketing authorisation was renewed on 3 February 2005 and on 27 September 2006.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet aġġornata fil- 3 ta ’ Frar ta ’ l- 2005 u s- 27 ta ’ Settembru 2006.
The full EPAR for ZYPREXA VELOTAB is available here.
L- EPAR sħiħ għal ZYPREXA VELOTAB jista ’ jinstab hawnhekk.
ZYPREXA VELOTAB 5 mg orodispersible tablets
ZYPREXA VELOTAB 5 mg pilloli li jin allu fil - alq
Each orodispersible tablet contains 5 mg olanzapine.
Kull pillola li tin all fil - alq g andha 5 mg olanzapine.
Each orodispersible tablet contains 0.60 mg aspartame, 0.1125 mg sodium methyl parahydroxybenzoate, 0.0375 mg sodium propyl parahydroxybenzoate.
Kull pillola li tin all fil - alq fiha 0. 60 mg aspartame 0. 1125 mg sodium methyl parahydroxybenzoate 0. 0375 mg sodium propyl parahydroxybenzoate.
Orodispersible tablet
Pillola li tin all fil - alq
Yellow, round, freeze dried, rapid-dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration.
Preparazzjoni li tin all malajr, safra u b’ forma tonda li titqieghed fil - alq jew inkella g andha ti i ma lula fl- ilma jew f 'xarba o ra adegwata biex tittie ed. xi
Adults Olanzapine is indicated for the treatment of schizophrenia.
Adulti Olanzapine hija indikata g at- trattament ta ’ l- iski ofrenja.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapine hija effettiva biex i omm it- titjib kliniku waqt terapija kontinwa f 'pazjenti li wrew reazzjoni g at- trattament tal- bidu.
Olanzapine is indicated for the treatment of moderate to severe manic episode.
Olanzapine hija indikata g at- trattament ta' episodju ta' manija moderat jew serju.
In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).
F' pazjenti li l- episodju ta' manija tag hom irrea ixxa g at- trattament ta ’ olanzapine, olanzapine hija indikata g all- prevenzjoni ta 'rikorrenza f' pazjenti b 'ordni bipolari (ara sezzjoni 5. 1). di
4.2 Posology and method of administration
4. 2 Po olo ija u metodu ta 'kif g andu jing ata
Adults Schizophrenia:
Adulti Ski ofrenja:
The recommended starting dose for olanzapine is 10 mg/ day.
Id- do a tal- bidu rakkomandata g alolanzapine hija 10 mg / urnata.
Manic episode:
Episodju ta' manija:
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- do a tal- bidu hija ta 'mg b ala do a wa da kuljum bil- monoterapija jew 15 10 mg kuljum f' terapija flimkien ma 'sustanza o ra (ara sezzjoni 5. 1). xi
Preventing recurrence in bipolar disorder:
Il- prevenzjoni tar- rikorrenza fid- di ordni bipolari:
The recommended starting dose is 10 mg/ day.
Id- do a rakkomandata tal- bidu hija 10 mg / urnata.
For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose.
Jekk ikun hemm episodju did ta '
If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
ta' depressjoni, it- trattament b’ olanzapine g andu jitkompla (bl- a jar u u tad- do a skond il- b onn), b' terapija supplimentari biex ikunu trattati s- sintomi tal- burdata, kif indikat klinikament.
During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/ day.
Waqt it- trattament g as- ski ofrenja, g al episodju ta' manija u g all- prevenzjoni tar- rikorrenza fid - di ordni bipolari, d- do a ta 'kuljum jista' sussegwentement ji i a ustat fuq il- ba i ta 'l- istat kliniku individwali minn 5 mg sa 20 mg / urnata. jieda g al do a akbar mid- do a tal- bidu rakkomandata
An increase to a dose greater than the recommended starting dose is advised only after
2 g andha ting ata biss wara rivalutazzjoni klinika xierqa u eneralment g andha ssir f '
2 appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
Olanzapine tista '
Olanzapine can be given without regards for meals as absorption is not affected by food.
assorbiment ma ji ix affettwat mill- ikel.
Gradual tapering of the dose should be considered when discontinuing olanzapine.
It- tnaqqis gradwali tad- do a g andu ji i kkunsidrat meta titwaqqaf olanzapine.
ZYPREXA VELOTAB Orodispersible Tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Il- pillola ta ’ ZYPREXA VELOTAB li tin all fil - alq g andha titpo a fil - alq, fejn tin all malajr fil - b ieq, u g alhekk tista 'tinbela' ilment.
Removal of the intact orodispersible tablet from the mouth is difficult.
Min abba li l- pillola li tin all fil - alq hija fra li, g andha tittie ed e att kif tinfeta il- folja.
Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Inkella, tista 'all e att qabel tittie ed f'
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.
biex tittie ed (meraq tal- larin, meraq tat- tuffie, alib jew kafe).
Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption.
Il- pillola olanzapine li tin all fil - alq hija bioekwivalenti g all- pilloli ta' olanzapine miksija, b 'u rata estensjoni ta' l- assorbiment simili.
It has the same dosage and frequency of administration as olanzapine coated tablets.
G andha l- istess do a u frekwenza fit- te id b al pilloli ta 'olanzapine miksija.
Olanzapine orodispersible tablets may be used as an alternative to olanzapine coated tablets.
Pilloli ta 'olanzapine li jin allu fil - alq jistg u jintu aw b ala alternattiva g all - pilloli ta' olanzapine miksija.
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 g all- u u fit- tfal u fl- adolexxenti ta ’ ta t it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effika ja.
A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see sections 4.4, 4.8, 5.1 and 5.2).
Fl- istudji ta ’ terminu qasir, ie rrapportat ammont akbar ta ’ ieda fil- pi u tibdil fix- xa mijiet u prolactin f’ pazjenti adolexxenti milli fl- istudji ta ’ pazjenti adulti (ara sezzjonijiet 4. 4, 4. 8, 5. 1 u 5. 2).
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 Do a anqas tal- bidu (5 mg / urnata) mhux indikata normalment imma g andha ti i kkunsidrata g al dawk li g andhom 65 jew fuqhom meta fatturi klini i jindikaw hekk (ara wkoll sezzjoni 4. 4).
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
Indeboliment renali u/ jew epatiku Do a anqas tal- bidu (5 mg / urnata) g andha ti i kkunsidrata g al dawn il- pazjenti.
In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
F 'ijiet ta' ka insuffi jenza tal- fwied moderata (irro i, Child- Pugh Klassi A jew B), id- do a tal- bidu g andha tkun 5 mg u ti died biss b' kawtela.
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Sess Id- do a tal- bidu u l- firxa tad- do a m 'andhomx g alfejn jinbidlu normalment g all- pazjenti nisa g f' paragun ma 'pazjenti r iel.
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Dawk li jpejpu Id- do a tal- bidu u l- medda tad- do i m 'andhomx g alfejn jinbidlu normalment g al dawk li ma g jpejpux f' paragun ma 'dawk li jpejpu.
Dose escalation, when indicated, should be conservative in such patients.
Meta hemm aktar minn fattur wie ed li jista 'jirri ulta f' metaboli mu aktar bil- mod (sess femminili, età erjatrika, individwu ma jpejjipx), g andha ting ata kunsiderazzjoni biex titnaqqas id- do a tal- bidu. jieda fid- do a, meta indikata, g andha tkun konservattiva f' dawn il- pazjenti.
In cases where dose increments of 2.5 mg are considered necessary, ZYPREXA coated tablets should be used.
F’ ka ijiet fejn jidher li jkun hemm il- b onn li d- do a ti died b’ 2. 5 mg, g andhom jintu aw il- pilloli miksija ZYPREXA
Patients with known risk of narrow-angle glaucoma.
Pazjenti li g andhom ir - riskju ta' glawkoma tat- tip narrow angle.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Waqt trattament bl- antipsikoti i, titjib fil- kundizzjoni klinika tal- pazjent g andu mnejn isir fuq medda ta ’ diversi granet g al xi ftit gimg at.
Patients should be closely monitored during this period.
Il- pazjenti g andhom ji u monitorjati sew waqt dan il- perjodu.
3 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.
3 Psiko i relatata mad- demenzja u/ jew disturbi fil- komportament Olanzapine mhux approvat g at- trattament tal- psiko i relatata mad- demenzja u/ jew disturbi fil - komportament, u mhux irrakkomandat g all- u u f’ dan il- grupp partikolari ta ’ pazjenti, dovut g al ieda fil- mortalità u r- riskju ta ’ in ident erebro- vaskulari.
In placebo-controlled clinical trials (6- 12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis 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 klini i kkontrollati bil- pla ebo (li damu minn 6 sa 12- il img a), fuq pazjenti anzjani (età medja 78 sena) li kelhom psiko i relatata mad- demenzja u/ jew disturbi fil- komportament, kien hemm ieda ta ’ darbtejn akbar fl- in idenza ta ’ mwiet fil- pazjenti ttrattati b' olanzapine, mqabbla ma ’ pazjenti ttrattati bil- pla ebo (3. 5% kontra 1. 5%, rispettivament).
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
L- in idenza og la ta ’ l- imwiet ma kienitx asso jata mad- do a ta ’ olanzapine (do a medja kuljum ta ’ 4. 4 mg) jew it- tul ta ’ mien tat- trattament.
Risk factors that may predispose this patient population to increased mortality include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e. g., pneumonia, with or without aspiration), or concomitant use of benzodiazepines.
Il- fatturi ta ’ riskju li jistg u jippredisponu dan il- grupp ta ’ pazjenti g al ieda fil- mortalità jinkludu l- età ta ’ > 65 sena, id- diffikulta biex wie ed jibla ’, is- sedazzjoni, il- malnutriment u d- deidrazzjoni, kundizzjonijiet tal- pulmun (e pulmonite, bil - jew fl- assenza ta ’ l- aspirazzjoni), jew l- u u konkomittanti ta 'benzodiazepines.
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
Madankollu, l - in idenza ta ’ l- imwiet kienet og la f’ dawk ittrattati b' olanzapine minn dik fil- pazjenti ttrattati bil - pla ebo, indipendentement minn dawn il- fatturi ta ’ riskju.
In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Fl- istess studji klini i, kienu rrapportati avvenimenti avversi erebro- vaskulari (CVAE e puplesija, attakki iskemi i momentanji) inklu i l- imwiet.
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
Kien hemm ieda ta ’ 3 darbiet akbar ta ’ CVAE f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- pla ebo (1. 3% kontra 0. 4%, rispettivament).
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Il- pazjenti kollha ttrattati b' olanzapine jew bi pla ebo u li kellhom avveniment erebro- vaskulari, kellhom fatturi ta ’ riskju li kienu je istu minn qabel.
Age > 75 years and vascular/ mixed type dementia were identified as risk factors for CVAE in association with olanzapine treatment.
L- età ta ’ > 75 sena u d - demenzja tat- tip vaskulari jew im allta kienu identifikati b ala fatturi ta ’ riskju g al CVAE f’ asso jazzjoni ma ’ trattament b 'istudji.
The efficacy of olanzapine was not established in these trials.
L- effika ja ta ’ olanzapine ma kienitx stabbilita f’ dawn l -
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
olanzapine fit- trattament tal- psiko i asso jata ma 'l- agonisti ta ’ dopamine
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
pla ebo (ara sezzjoni 4. 8), u olanzapine ma kienx aktar effettiv mill- pla ebo fit- trattament tas- sintomi psikoti i.
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- do a l- aktar baxxa u effettiva tal- medi ini kontra l- marda ta ’ Parkinson (agonist ta ’ dopamine) u biex jibqg u fuq l- istess medi ini u do i kontra l- marda ta ’ Parkinson matul l- istudju.
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
15
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal product.
Is- Sindromu Newrolettiku Malinn (NMS) NMS tista '
Rare cases reported as NMS have also been received in association with olanzapine.
asso jazzjoni ma 'olanzapine ukoll.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Manifestazzjonijiet klini i ta 'NMS huma deni g oli, ebusija tal- muskoli, stat mentali alterat u evidenza ta' instabbiltà awtonomika (pressjoni tad- demm jew tal- polz irregolari, takikardija, dijafore i, u ta bit tal- qalb irregolari).
Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Sinjali o ra jistg u jinkludu creatinine phosphokinase elevat, mijoglobina fl- awrina (rabdomajoli i) u insuffi jenza akuta renali.
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicines, including olanzapine must be discontinued.
Jekk pazjent ji viluppa sinjali u sintomi li huma indikattivi ta 'NMS, jew ikollu deni g oli bla ebda spjegazzjoni u ming ajr manifestazzjonijiet klini i o ra ta' NMS, g andhom jitwaqqfu l- medi ini antipsikoti i kollha, inklu olanzapine.
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
koma kienu rrappurtati b’ mod rari, inklu i xi ka ijiet fatali (ara sezzjoni 4. 8).
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
F 'ka ijiet, iet xi rapurtata jieda fil- pi tal - isem u din tista' tkun fattur ta ’ predisposizzjoni.
Appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus for which regular glucose control is recommended.
fatturi ta' riskju g all- i vilupp ta ’ dijabete mellitus u li g alihom huwa rakkomandat li b’ mod regolari ji i e aminat iz- zokkor fid- demm.
Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo- controlled clinical trials (see section 4.8).
Tibdil fil- livelli tax- xa mijiet Fi studji klini i kkontrollati bi pla ebo, ie osservat tibdil mhux mixtieq fil- livell tax- xa mijiet f’ pazjenti kkurati b’ olanzapine (ara sezzjoni 4. 8).
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
4 b’ mod klinikamet xieraq spe jalment f’ pazjenti b’ ammonti mhux normali ta ’ xa mijiet fid- demm u f’ pazjenti li g andhom fatturi ta ’ riskju g all- i vilupp ta ’ disturbi fix- xa mijiet.
4 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Attività antikoliner ika Waqt li olanzapine wera attività antikoliner ika in vitro, ersperjenza waqt il- provi klini i uriet in idenza baxxa ta 'rajjiet relatati.
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, min abba li esperjenza klinika b 'olanzapine f' pazjenti b' mard konkomitanti hija limitata, g andha tittie ed kawtela meta jkun preskritt g all- pazjenti b' ipertrofija tal- prostata, jew b 'ileus paralitiku u kundizzjonijiet relatati.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
G andha tittie ed kawtela f '
Caution should be exercised in patients with elevated ALT and/ or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicines.
AST elevati, f' pazjenti b' kundizzjonijiet li kienu hemm qabel, asso jati b 'erva funzjonali limitata tal - ri fwied, u f' pazjenti li qed ikunu trattati b' medi ini li jistu' jkunu tossi i g all- fwied.
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
Fil- ka ta' ALT u/ jew AST elevati waqt it- trattament, g andha ti i organi ata investigazzjoni o ra u g andha ti i kkunsidrata tnaqqis fid- do a.
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
F 'ijiet fejn saret dijanjo i ta ’ l- epatite( inklu il- mard tal- fwied ka epato ellulari, kolestatiku jew tat- tip im allat), it- trattament ta' olanzapine g andu 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 myeloproliferative disease.
Newtropenja G andha tittie ed kawtela f 'pazjenti b' numru baxx ta ’ lewko iti u/ jew numru baxx ta - elluli newtrofili g al kwalunkwe ra uni, dawk il- pazjenti li qed jie du xi medi ini li huma mag rufa li jikkaw aw newtropenja, f'
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
In- newtropenja kienet rappurtata spiss meta xi olanzapine u l- valproate intu aw flimkien (ara Sezzjoni 4. 8).
Discontinuation of treatment Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (< 0.01%) when olanzapine is stopped abruptly.
Twaqqif tal- kura B’ mod rari afna ew irrappurtati (< 0. 01%) sintomi akuti b al g araq, insomnja, rog da, ansjetà, tqallig, jew rimettar meta olanzapine twaqqaf f 'daqqa.
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.
Madankollu, b al b' antipsikoti i o ra, g andha tittie ed kawtela meta olanzapine jing ata ma '
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.
mag rufa li j idu l- intervall QTc, spe jalment fl- anzjani, f 'pazjenti b' sindromu kon enitali ta' twil, QT insuffi jenza tal- qalb kon estiva, ipertrofija tal- qalb, potassju baxx fid- demm jew manjesju baxx fid - demm.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported.
Tromboemboli mu B’ mod rari afna (< 0. 01%) iet irrapportata asso jazzjoni temporali bejn il- kura b’ olanzapine u t - tromboemboli mu fil- vini.
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Relazzjoni kaw ali bejn l- okkorrenza ta ’ tromboemboli mu fil- vini u l - kura b’ olanzapine ma ietx stabbilita.
However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e. g. immobilisation of patients, should be identified and preventive measures undertaken.
Madankollu peress li pazjenti b’ skizofrenija afna drabi jippre entaw b’ fatturi ta ’ riskju akkwi iti g at- tromboemboli mu fil- vini, il- fatturi possibbli kollha ta ’ riskju ta ’ VTE e. l- immobbilizzazzjoni tal- pazjenti, g andhom ji u identifikati u me uda l- mi uri ta ’ prevenzjoni.
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 enerali fis- CNS Min abba l- effetti primarji ta' olanzapine fuq is- CNS g andha tittie ed kawtela meta dan jing ata flimkien ma 'medi ini o ra li ja ixxu entralment u meta jittie ed ma' l- alko ol.
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Min abba li in vitro juri antagoni mu g al dopamine, olanzapine jista 'jantagonizza l- effetti diretti u indiretti ta' l- agonisti ta ’ dopamine.
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.
so etti g all- fatturi li jistg u jbaxxu l- limitu ta 'l- a essjonijiet.
Seizures have been reported to occur rarely in patients when treated with olanzapine.
Kienu rarament rappurtati a essjonijiet f '
In most of these cases, a history of seizures or risk factors for seizures were reported.
a essjonijiet jew fatturi ta 'riskju g al a essjonijiet kienu rappurtati.
5 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Diskajne ja Tardiva Fi studji komparattivi li damu sena jew anqas, olanzapine kien asso jat ma 'idenza mnaqqsa ta' in diskajne ja f 'ultat tat- trattament b'
However the risk of tardive dyskinesia increases with long term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
tardiva ji died b 'espo izzjoni g al mien twil, u g alhekk jekk jidhru s- sinjali jew is- sintomi ta' diskajne ja tardiva f 'pazjenti li qed jie du olanzapine, g andu ji i kkunsidrat tnaqqis fid- do a jew il - waqfien.
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Dawn is- sintomi jistg u ji diedu bi - mien kif ukoll jo or u wara li jitwaqqaf it- trattament.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Pressjoni baxxa mal- waqfien Pressjoni baxxa mal- waqfien iet osservata rari fl- anzjani fil- provi klini i ta' olanzapine.
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
B al b' antipsikoti i o ra, huwa rakkomandat li l- pressjoni tad- demm tkun me uda perjodikament f '' fuq minn 65 sena. l
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
L- u u fit- tfal u fl- adolexxenti ta t it- 18- il sena
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
sena wrew reazzjonijiet avversi varji, fosthom ieda fil- pi, tibdil fil- parametri metaboli i u ieda fil - livelli ta' prolactin.
Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
L- effetti fit- tul asso jati ma' dawn l- avvenimenti ma ewx studjati u g adhom mhux mag rufa (ara sezzjonijiet 4. 8 u 5. 1).
Phenylalanine ZYPREXA VELOTAB orodispersible tablet contains aspartame, which is a source of phenylalanine.
Phenylalanine ZYPREXA VELOTAB pillola li tin all fil - alq g andha l- aspartame, li hija sors ta ’ phenylalanine.
May be harmful for people with phenylketonuria.
Tista ’ tkun ta ’ periklu g al nies b’ phenylketonuria.
Mannitol ZYPREXA VELOTAB orodispersible tablet contains mannitol.
Mannitol ZYPREXA VELOTAB pillola li tin all fil - alq fiha mannitol.
Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate Olanzapine orodispersible tablet contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.
Sodium methyl parahydroxybenzoate u sodium propyl parahydroxybenzoate Il- pillola ta' l- olanzapineolanzapine li tin all fil - alq g andha sodium methyl parahydroxybenzoate u sodium propyl parahydroxybenzoate.
These preservatives are known to cause urticaria.
4. 5 Prodotti medi inali o ra li ma jaqblux ma 'dan il- prodott u affarijiet o ra li jistg u jibdlu l- effett farma ewtiku tal- prodott
Generally, delayed type reactions such as contact dermatitis may occur, but rarely immediate reactions with bronchospasm may occur.
Studji dwar l- effett ta ’ medi ini jew ta ’ affarijiet o ra fuq l- effett farma ewtiku tal- prodott saru fl - adulti biss.
4.5 Interaction with other medicinal products and other forms of interaction
Potenzjal t' interazzjonijiet ma 'olanzapine Min abba li olanzapine hija metaboli ata b'
Interaction studies have only been performed in adults.
CYP1A2, sustanzi li jistg u spe ifikament jikka unaw
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.
jew jinibixxu din l- i oen ima jistg u jaffettwaw il- komportament farmakokinetiku ta 'olanzapine.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Attivazzjoni ta 'CYP1A2 Il- metaboli mu ta’ olanzapine jista' i kkaw at mit- tipjip u b '
Only slight to moderate increase in olanzapine clearance has been observed.
tnaqqis fil- kon entrazzjoni ta 'olanzapine. iet osservata jieda g ira sa moderata fil- clearance ta' olanzapine mill - isem.
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 klini i x 'aktarx huma limitati, imma hija rakkomandata l - osservazzjoni klinika u tista' i kkunsidrata jieda fid- do a ta 'Sezzjoni 4. 2).
Inhibition of CYP1A2 Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
6 Inibizzjoni ta 'CYP1A2 Fluvoxamine, inibitur spe ifiku ta' CYP1A2, deher li jinibixxi sinifikatament il- metaboli mu ta 'olanzapine.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
fluvoxamine kienet 54% fin- nisa li ma
The mean increase in olanzapine AUC was 52% and 108% respectively.
I - jieda medja fl- AUC ta 'olanzapine kienet 52% u 108% rispettivament.
A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
ju aw fluvoxamine jew xi inibituri o ra ta 'CYP1A2, b al ciprofloxacin.
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated.
tnaqqis fid- do a ta' olanzapine jekk jinbeda xi trattament b 'inibitur ta' CYP1A2.
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.
Biodisponibbiltà mnaqqsa Fa am attivat inaqqas il- biodisponibilità ta' olanzapine li tittie ed mill - alq b 'sa 60% u g andu 50 jittie ed g al ta' l- inqas sag tejn qabel jew wara olanzapine.
6 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), do i b’ wa diet t 'anta idi (aluminium, magnesium) jew cimetidine ma nstabux li jaffettwaw sinifikatament il- komportament farmakokinetiku ta' olanzapine.
Potential for olanzapine to affect other medicinal products Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Il- potenzjal ta 'olanzapine biex jaffetwa prodotti medi inali o ra Olanzapine jista' jantagonizza l- effetti ta' l- antagonisti ta ’ dopamine diretti jew indiretti.
1A2, 2D6, 2C9, 2C19, 3A4).
Olanzapine ma jinibixxix l- i oen imi CYP450 prin ipali in vitro (e 1A2, 2D6, 2C19, 3A4).
Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
G alhekk, ma hemm ebda reazzjoni partikolari mistennija kif verifikat minn studji in vitro fejn ma nstabet ebda inibizzjoni tal- metaboli mu tas- sustanzi attivi li ejjin: anti- dipressant tri ikliku (jirrapre enta l- aktar il- passa permezz ta 'CYP2D6), warfarina (CYP2C9), theophylline (CYP1A2) jew diazepam (CYP3A4 u 2C19).
Olanzapine showed no interaction when co-administered with lithium or biperiden.
Olanzapine ma wera ebda reazzjoni meta ttie ed flimkien ma ’ lithium jew biperiden.
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- pla ma ma ndikatx li tibdil fid- do a valproate huwa me tie wara l- introduzzjoni ta 'olanzapine ukoll.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
pazjenti li jixorbu l- alko ol jew li jie du prodotti medi inali li jistg u jikkaw aw depressjoni tas- sistema nervu a entrali.
The concomitant use of olanzapine with anti-Parkinsonian medicinal products in patients with Parkinson's disease and dementia is not recommended (see section 4.4).
Mhux rakkomandat l- u u konkomitanti ta 'olanzapine ma' prodotti medi inali kontra l- Parkinson f 'pazjenti bil- marda ta' Parkinson u d- demenzja (ara sezzjoni 4. 4).
QTc interval Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
L- Intervall QTc G andha tintu a l- kawtela jekk olanzapine qieg ed jing ata flimkien ma' prodotti medi inali mag rufa li jtawlu l- intervall QTc (ara sezzjoni 4. 4).
There are no adequate and well-controlled studies in pregnant women.
Ma hemm ebda studji adegwati u kkontrollati sewwa f 'waqt it- tqala.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Il- pazjenti g andhom nisa jing ataw parir biex jg arrfu lit- tabib tag hom jekk jinqabdu tqal jew jekk qed jippjanaw li jinqabdu tqal waqt it- trattament b’ olanzapine.
Nevertheless, because human experience is limited, olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Madankollu, min abba li l- esperjenza fil- bniedem hija limitata, olanzapine g andha tintu a biss waqt it- tqala jekk il- benefi ju li jista' jkun hemm ji ustifika r- riskju li jista' jkun hemm fuq il- fetu.
Spontaneous reports have been very rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
Rapporti spontanji u rari kienu rapportati dwar rog da, ipertonja, letar ija u ng as, fi trabi mwielda lill ommijiet li u aw olanzapine waqt l- a ar 3 xhur tat- tqala.
In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Fi studju fuq nisa b 'ithom li qed ireddg u, olanzapine tfa a fil - alib tas- sider.
Mean infant exposure (mg/ kg) at steady state was estimated to be 1.8% of the maternal olanzapine dose (mg/ kg).
Il- kon entrazzjoni sa medja fi studju stabbli tat- trabi kienet stimata li kienet 1. 8% tad- do a ta' olanzapine fl- omm.
Patients should be advised not to breast-feed an infant if they are taking olanzapine.
Pazjenti g andhom jing ataw parir biex ma jreddawx tarbija jekk qed jie du olanzapine.
4.7 Effects on ability to drive and use machines
7 4. 7 Effetti fuq il - ila biex issuq u t addem magni
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 - ila biex issuq jew t addem magni. Min abba li olanzapine jista 'jikkaw a sonnolenza u sturdament, il- pazjenti g andhom ji u av ati dwar l- u u ta' magni, inklu i l - karozzi.
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,
Adulti Fi studji klini i, l- aktar reazzjonijiet avversi li ew irrapportati b 'frekwenti (jidhru f' 1% tal - pazjenti) u li huma asso jati ma 'u ta'
7 transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
l- olanzapine kienu sonnolenza, ieda fil- pi, eosinofilja,
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
Fit- tabella li ejja huma mni la r- reazzjonijiet avversi u t- testijiet tal- laboratorju osservati minn rapporti mag mula b’ mod spontanju u minn studji klini i.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
L- effetti li huma l- aktar serji tni lu l- ewwel, segwiti minn dawk anqas serji.
The frequency terms listed are defined as follows:
It- termini ta' frekwenza elenkati huma mfissra kif ej:
Very common (10%), common (1% and < 10%), uncommon (0.1% and < 1%), rare (0.01% and < 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
Komuni afna (> 10%), komuni (> 1% u < 10%), mhux komuni (> 0. 1% u < 1%), rari (> 0. 01% u < 0. 1%), rari afna (< 0. 01%), mhux mag rufa (ma jistg ux ji u stmati mill- informazzjoni li hemm disponibbli).
Very common
Komuni afna Komuni
Not known
Mhux mag rufa
Thrombocytopenia
Trombo itopenja
Immune system disorders Allergic reaction Metabolism and nutrition disorders Weight gain1
Disturbi fis- sistema immuni Reazzjoni aller ika Disturbi fil- metaboli mu u n- nutrizzjoni ieda fil- pi 1
Elevated cholesterol levels2,3 Elevated glucose levels4 Elevated triglyceride levels2,5 Glucosuria Increased appetite
kolesterol2, 3 Livelli g olja ta 'glucose4 Livelli g olja ta' trigli eridi2, 5 Glukosurja ieda fl- aptit
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
tad- dijabete, xi kultant asso jata ma ’ ketoa ido i jew koma inklu i xi ka ijiet fatali (ara sezzjoni 4. 4) Ipotermja
Nervous system disorders Somnolence Cardiac disorders
Disturbi fis- sistema nervu a Sonnolenza
Dizziness Akathisia6 Parkinsonism6 Dyskinesia6
Sturdament Akatizja6 Parkinsoni mu6 Diskine ja6
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
A essjonijiet li fil - ma oranza tag hom kien irrappurtat passat mediku ta 'a essjonijiet jew fatturi tar- riskju g all - a essjonijiet Sindromu Newrolettiku Malinn (ara sezzjoni 4. 4) Distonja (tinkludi okulo irazzjoni) Diskine ja tardiva Sintomi ta' twaqqif tal - kura7
Vascular disorders
8 Disturbi fil- qalb Disturbi vaskulari
Ventricular tachycardia/ fibrillation, sudden death (see section 4.4)
Takikardija / fibrillazzjoni ventrikulari, mewt g all- g arrieda (ara sezzjoni 4. 4)
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
Tromboemboli mu (inklu l- emboli mu pulmonari u t- trombo i tal- vini fil- fond)
Mild, transient anticholinergic effects including constipation and dry mouth
Effetti antikoliner i i fief u li jg addu malajr inklu i stitikezza u alq xott
8 Hepato-biliary disorders
Disturbi fil- fwied u fil- marrara
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
tal- fwied (ALT, AST) bla sintomi u li tg addi malajr, spe jalmet fil - bidu tal- kura (ara sezzjoni 4. 4)
Hepatitis (including hepatocellular, cholestatic or mixed liver injury)
tal- fwied tat- tip epato ellulari, kolestatiku jew tat - tnejn flimkien)
Skin and subcutaneous tissue disorders
Disturbi fil - ilda u fit- tessuti ta 'ta t il - ilda
Photosensitivity reaction Alopecia
Reazzjoni ta 'fotosensittività Alope ja
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 Rabdomijoli i Disturbi fil- kliewi u fis- sistema urinarja E itazzjoni urinarja Disturbi fis- sistema riproduttiva u fis- sider Prijapi mu Disturbi enerali u kondizzjonijiet ta 'mnejn jing ata Astenja G eja Edima Investigazzjonijiet Livelli elevati ta'
High creatine phosphokinase Increased total bilirubin
phosphokinase g oli ieda fil- bilirubin totali
Weight gain 7% of baseline body weight was very common and 15% of baseline body weight was common.
iet osservata ieda fil- pi, klinikament sinifikanti, fil- linja ba i ta ’ l- Indi i tal- Massa tal - isem (Body Mass Index - BMI), fil- kategoriji kollha. ieda fil- pi ta ’ 7% mil- linja ba i tal- pi tal - isem kienet komuni afna u ta ’ 15% mil- linja ba i tal- pi tal - isem kienet komuni.
Patients gaining 25% of their baseline body weight with long-term exposure were very common.
Kien komuni afna li wara espo izzjoni g al perijodu twil ta ’ mien il- pazjenti jkollhom ieda fil- pi ba ilari tag hom ta ’ 25%.
2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
2 I - idiet medji fil- livelli tax- xa mijiet waqt is- sawm (kolesterol totali, LDL kolesterol, u trigli eridi) kienu og la f’ pazjent li fil- linja ba i ma wrewx evidenza ta ’ problemi fil- kontroll tax- xa mijiet.