qanastek/EMEA-V3 huggingface dataset:
Because olanzapine has already been authorised in the EU as Zyprexa, the company used some of the data from Zyprexa to support the use of Zypadhera.
Billi l- olanzapina diġà hija awtorizzata fl- UE bħala Zyprexa, il- kumpanija użat parti mid- dejta dwar Zyprexa biex tappoġġja l- użu ta ’ Zypadhera.
Zypadhera has been studied in two main studies involving adults with schizophrenia.
Zypadhera ġie eżaminat f’ żewġ studji ewlenin li involvew adulti skizofreniċi.
The first looked at the initial treatment of schizophrenia and the second looked at the maintenance of response to olanzapine treatment: • the study of initial treatment compared the effects of three doses of Zypadhera with those of placebo (dummy injections) in 404 patients.
L- ewwel wieħed eżamina t- trattament inizjali tal- iskizofrenija filwaqt li t- tieni wieħed eżamina l- manteniment tar - risposta għat- trattament b’ olanzapina: • l- istudju fuq it- trattament inizjali qabbel l- effett ta ’ tliet dożi ta ’ Zypadhera ma ’ dawk ta ’ plaċebo (injezzjonijiet finti) fuq 404 pazjenti.
The main measure of effectiveness was the change in symptoms measured on a standard scale for schizophrenia after eight weeks; • the study of maintenance treatment compared the effects of four doses of Zypadhera with those of olanzapine taken by mouth in 1,065 patients.
Il- kejl ewlieni tal- effikaċja kien il- varjazzjoni tas- sintomi mkejla wara tmien ġimgħat permezz ta ’ skala standard għall- iskizofrenija; • l- istudju fuq it- trattament ta ’ manteniment qabbel l- effett ta ’ erba ’ dożi ta ’ Zypadhera ma ’ dawk tal- olanzapina meħuda mill- ħalq f’ 1, 065 pazjent.
Three of the doses of Zypadhera were ‘ high’ (300 mg and 150 mg every two weeks, and 405 mg every four weeks) and one was ‘ low’ (45 mg every four weeks).
Tliet dożi ta ’ Zypadhera kienu ‘ għoljin ’ (300 mg u 150 mg kull ġimagħtejn, u 405 mg kull erba ’ ġimgħat) filwaqt li waħda kienet ‘ baxxa ’ (45 mg kull erba ’ ġimgħat).
All of the patients in this study had been stabilised with other treatments for schizophrenia and had been taking olanzapine by mouth for at least six weeks before the study began.
Il- pazjenti kollha li ħadu sehem f’ dan l- istudju ġew stabbilizzati permezz ta ’ trattamenti oħrajn għall- iskizofrenija u, meta nbeda l- istudju, diġà kienu jieħdu l - olanzapina minn ħalqhom minn tal- anqas sitt ġimgħat.
The main measures of effectiveness were the time taken for symptoms to get worse and the number of patients whose symptoms got worse over 24 weeks.
Il- kejl ewlieni tal- effikaċja kienu ż- żmien li jgħaddi sa ma s- sintomi jiggravaw u l- għadd ta ’ pazjenti li fihom is- sintomi ggravaw matul 24 ġimgħa.
What benefit has Zypadhera shown during the studies?
X’ benefiċċji wera Zypadhera fl- istudji mwettqa?
In the study of the initial treatment of schizophrenia, Zypadhera was more effective than placebo.
Fl- istudju fuq it- trattament inizjali tal- iskizofrenija, Zypadhera rriżulta aktar efficaci mill- plaċebo.
Symptom scores were around 100 points at the start of the study, but had fallen by around 25 points in the patients receiving Zypadhera after eight weeks, compared with around 9 points in the patients receiving placebo.
Il - punteġġi relatati mas- sintomi kienu madwar 100 punt fil- bidu tal- istudju iżda fil- pazjenti ttrattati b’ Zypadhera kienu naqsu b’ madwar 25 punt wara tmien ġimgħat, meta mqabbla ma ’ madwar 9 punti fil- pazjenti ttrattati bil- plaċebo.
The effectiveness of Zypadhera was greater than placebo from the second week of treatment onwards.
L- effikaċja ta ’ Zypadhera rriżultat akbar meta mqabbla mal- plaċebo mit- tieni ġimgħa ta ’ trattament.
In the study looking at the maintenance of response to olanzapine treatment, Zypadhera was as effective as olanzapine taken by mouth:
Fl- istudju fuq il- manteniment tar- risposta għat- trattament b’ olanzapina, Zypadhera rriżulta effikaċi daqs l- olanzapina meħuda mill- ħalq:
10% of the patients receiving Zypadhera every two weeks had a worsening of symptoms, compared with 7% of those taking olanzapine by mouth.
10% tal- pazjenti ttrattati b’ Zypadhera kull ġimagħtejn iggravawlhom is- sintomi meta mqabbla mas- 7% ta ’ dawk ittrattati bl- olanzapina mill- ħalq.
The ‘ high’ doses of Zypadhera were more effective at preventing a worsening of symptoms than the ‘ low’ dose.
Id- dożi ‘ għoljin ’ ta ’ Zypadhera rriżultaw aktar effikaċi fil- prevenzjoni tal- iggravar tas- sintomi meta mqabbla mad- doża ‘ baxxa ’.
What is the risk associated with Zypadhera?
X’ inhu r- riskju assoċjat ma ’ Zypadhera?
The most common side effects with Zypadhera (seen in more than 1 patient in 10) are weight gain, somnolence (sleepiness) and raised levels of prolactin (a hormone).
L- effetti sekondarji l- aktar komuni b’ Zypadhera (li dehru f’ aktar minn pazjent 1 minn 10) huma żieda fil- piż, ħedla tan- ngħas u żieda fil- livelli tal- prolattina (ormon).
For the full list of all side effects reported with Zypadhera, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati b’ Zypadhera, ara l- Fuljett ta ’ Tagħrif.
Zypadhera should not be used in patients who may be hypersensitive (allergic) to olanzapine or any of the other ingredients.
Zypadhera ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għall- olanzapina jew għal kwalunkwe ingredjent ieħor tagħha.
It must not be used in patients at risk of narrow-angle glaucoma (raised pressure inside the eye).
Zypadhera ma għandux jintuża f’ pazjenti li jkollhom riskju ta ’ glawkoma b’ angolu dejjaq (żieda fil- pressjoni fl- għajnejn).
Why has Zypadhera been approved?
2/ 3 Għaliex ġie approvat Zypadhera?
The Committee for Medicinal Products for Human Use (CHMP) noted that Zypadhera is effective both in the initial treatment of schizophrenia and in maintaining a response to treatment in schizophrenia.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) innota li Zypadhera huwa effikaċi kemm fit- trattament inizjali tal- iskizofrenija kif ukoll fil- manteniment tar- risposta għat - trattament fl- iskizofrenija.
However, it noted that prolonged-release injections are not suitable for use as initial treatment, because the medicine takes at least a week to reduce symptoms and patients may need rapid control of symptoms.
Madankollu, innota li l- injezzjonijiet b’ rilaxx fit- tul mhumiex adatti bħala trattament inizjali billi t- tnaqqis tas- sintomi ma jibdiex qabel ġimgħa, filwaqt li l- pazjent jista ’ jkunlu meħtieġ kontroll rapidu tas- sintomi.
In addition, it is not possible to stop treatment after giving a prolonged-release 2/ 3 injection, which would not be suitable for patients experiencing side effects.
Barra minn dan, fil- każ ta ’ injezzjoni b’ rilaxx fit- tul mhuwiex possibbli li jitwaqqaf it- trattament, pereżempju fil- każ ta ’ pazjenti b’ effetti sekondarji.
Therefore, the Committee decided that Zypadhera’ s benefits are greater than its risks for maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.
Għaldaqstant, il- Kumitat iddeċieda li l- benefiċċji ta ’ Zypadhera huma ogħla mir- riskji tiegħu għall- manteniment tat - trattament ta ’ pazjenti adulti bl- iskizofrenija biżżejjed stabbilizzati bi trattament akut b’ olanzapina.
The Committee recommended that Zypadhera be given marketing authorisation.
Il - Kumitat irrakkomanda li Zypadhera jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Zypadhera?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sikur ta ’ Zypadhera?
The company that makes Zypadhera will provide an educational programme for doctors, nurses and pharmacists and a card for patients in all Member States, reminding them of how to use the medicine safely.
Il- kumpanija li tipproduċi Zypadhera se tipprovdi programm edukattiv għat- tobba, l- infermiera u l - ispiżjara kif ukoll skeda għall- pazjenti tal- Istati Membri kollha li fiha jitfakkru l- modi ta ’ użu sikur tal - mediċina.
These will include information on what to do before and after each injection, the differences between Zypadhera and other injectable medicines containing olanzapine, and the recommendations on how patients should be monitored.
Din se tinkludi informazzjoni dwar x’ għandek tagħmel qabel u wara kull injezzjoni, id - differenzi bejn Zypadhera u mediċini injettabbli oħra li fihom l- olanzapina u rakkomandazzjonijiet fuq is- sorveljanza tal- pazjenti.
Other information about Zypadhera:
Aktar tagħrif dwar Zypadhera:
The European Commission granted a marketing authorisation valid throughout the EU for Zypadhera to Eli Lilly Nederland BV on 19 November 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Zypadhera lil Eli Lilly Nederland BV fit- 19 ta ’ Novembru 2008.
The full EPAR for Zypadhera can be found here.
L- EPAR sħiħ għal Zypadhera jista ’ jiġi kkonsultat hawn.
powder and solvent for prolonged release suspension for injection
trab u solvent għal
Intramuscular use
Għall- użu minn ġol -
Powder: vial (glass) Solvent: vial (glass)
Trab: kunjett (ħġieġ)
powder and solvent for prolonged release suspension for injection
trab u solvent għal suspensjoni għall - injezzjoni biex terħi l - mediċina bil- mod
Intramuscular use
Għall- użu minn ġol - muskoli
1 vial + 1 vial
Kunjett 1 + kunjett 1
ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection.
ZYPADHERA 210 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil- mod.
Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal 210 mg olanzapine.
After reconstitution each 1 ml suspension contains 150 mg olanzapine.
Wara r - rikostituzzjoni kull millilitru ta ’ suspensjoni fih 150 mg olanzapine.
Powder and solvent for prolonged release suspension for injection:
Trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil- mod:
Powder: yellow solid Solvent: clear, colourless to slightly yellow solution.
Trab: solidu isfar Solvent: soluzzjoni ċara, bla kulur tagħti ftit fl- isfar.
Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.
Kura ta ’ manteniment f’ pazjenti adulti bi skiżofrenja li kienu stabbli b’ mod suffiċjenti waqt kura akuta b’ olanzapine meħuda b’ mod orali.
FOR INTRAMUSCULAR USE ONLY.
GĦALL- UŻU GĦAL ĠOL- MUSKOLI BISS.
DO NOT ADMINISTER INTRAVENOUSLY OR SUBCUTANEOUSLY.
TAGĦTIX ĠOL- VINI JEW TAĦT IL- ĠILDA.
ZYPADHERA should only be administered by deep intramuscular gluteal injection by a healthcare professional trained in the appropriate injection technique and in locations where postinjection observation and access to appropriate medical care in the case of overdose can be assured.
ZYPADHERA għandu jingħata biss b’ injezzjoni fil- fond ġol- muskoli glutejali minn professjonist tal - kura tas- saħħa mħarreġ fit- teknika adattata ta ’ l- injezzjoni u f’ lok fejn jistgħu jiġu assigurati l - osservazzjoni wara l- injezzjoni u l- aċċess għal kura medika xierqa f’ każ ta ’ doża eċċessiva.
After each injection, patients should be observed in a health care facility by appropriately qualified personnel for at least 3 hours for signs and symptoms consistent with olanzapine overdose.
Wara kull injezzjoni, il- pazjenti għandhom jiġu osservati f’ faċilità tal- kura tas- saħħa għal mill- anqas 3 sigħat għal sinjali u sintomi konsistenti ma ’ doża eċċessiva ta ’ olanzapine minn personal ikkwalifikat b’ mod xieraq.
It should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose.
Għandu jiġi kkonfermat li l- pazjent ikun jaf x’ inhu jagħmel, jaf fejn jinsab, u mingħajr ebda sinjali u sintomi ta ’ doża eċċessiva.
If an overdose is suspected, close medical supervision and monitoring should continue until examination indicates that signs and symptoms have resolved (See section 4.4.).
Jekk tiġi ssuspettata doża eċċessiva, għandhom jitkomplew mill- qrib is- superviżjoni medika u l- monitoraġġ sakemm l- eżami jindika li s- sinjali u s- sintomi ġew solvuti (Ara sezzjoni 4. 4).
Patients should be treated initially with oral olanzapine before administering ZYPADHERA, to establish tolerability and response.
Għal bidu, qabel ma jingħata ZYPADHERA, l- pazjenti għandhom jiġu kkurati b’ olanzapine meħuda b’ mod orali sabiex tiġi stabbilita t- tollerabbilità u r- rispons.
For Instructions for Use, see section 6.6.
Għall- Istruzzjonijiet għall- Użu, ara sezzjoni 6. 6.
Do not confuse ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection with olanzapine 10 mg powder for solution for injection.
Tifxilx ZYPADHERA 210 mg trab u solvent għal suspensjoni għall- injezzjoni li terħi l- mediċina bil - mod ma ’ olanzapine 10 mg trab għal soluzzjoni għall- injezzjoni.
In order to identify the first ZYPADHERA dose for all patients the scheme in Table 1 should be considered.
Sabiex tiġi identifikata l- ewwel doża ta ’ ZYPADHERA fil- pazjenti kollha għandha tiġi kkunsidrata l - iskema f’ Tabella 1.
2 Table 1
Doża tal- Bidu Rrakkomanadata ta ’ ZYPADHERA 210 mg/ ġimagħtejn jew 405 mg/ 4 ġimgħat
Recommended dose scheme between oral olanzapine and ZYPADHERA
Doża ta ’ Manteniment wara Xahrejn Kura b’ ZYPADHERA 150 mg/ ġimagħtejn jew 300 mg/ 4 ġimgħat
Target Oral Dose 10 mg/ day 15 mg/ day 20 mg/ day
15 mg/ jum 20 mg/ jum
Olanzapine Recommended Starting Dose of Maintenance Dose after 2 Months of ZYPADHERA ZYPADHERA Treatment 210 mg/ 2 weeks or 405 mg/ 4 weeks 150 mg/ 2 weeks or 300 mg/ 4 weeks 300 mg/ 2 weeks 210 mg/ 2 weeks or 405 mg/ 4 weeks 300 mg/ 2 weeks 300 mg/ 2 weeks
210 mg/ ġimagħtejn jew 405 mg/ 4 ġimgħat 300 mg/ ġimagħtejn
Dose Adjustment Patients should be monitored carefully for signs of relapse during the first one to two months of treatment.
Il- pazjenti għandhom jiġu osservati bir- reqqa għal sinjali ta ’ rikaduta matul l- ewwel xahar sa xahrejn ta ’ kura.
During antipsychotic treatment, improvement in the patient’ s clinical condition may take several days to some weeks.
Titjib fil- kundizzjoni klinika tal- pazjent b’ kura ta ’ antipsikotoċi jista ’ jieħu minn ħafna ġranet sa ftit ġimgħat.
Patients should be closely monitored during this period.
Il- pazjenti għandhom jiġu osservati mill- qrib f’ dan il - perijodu.
During treatment dosage may subsequently be adjusted on the basis of individual clinical status.
Matul il- kura, id- dożaġġ jista ’ jiġi sussegwentement aġġustat fuq il- bażi ta ’ l- istat kliniku individwali.
After clinical reassessment dosage may be adjusted within the range 150 mg to 300 mg every 2 weeks or 300 to 405 mg every 4 weeks.
Wara rivalutazzjoni klinika d- dożaġġ jista ’ jiġi aġġustat f’ skala ta ’ bejn 150 mg sa 300 mg kull ġimagħtejn jew 300 sa 405 mg kull 4 ġimgħat.
(Table 1)
(Tabella 1)
Supplementation Supplementation with oral olanzapine was not authorised in double-blind clinical studies.
Tisħiħ It- tisħiħ b’ olanzapine mill- ħalq ma ġiex awtorizzat fi studji kliniċi tat- tip double- blind.
If oral olanzapine supplementation is clinically indicated, then the combined total dose of olanzapine from both formulations should not exceed the corresponding maximum oral olanzapine dose of 20 mg/ day.
Jekk it- tisħiħ b’ olanzapine mill- ħalq huwa klinikament indikat, id- doża totali kkombinata ta ’ olanzapine miż- żewġ formulazzjonijiet m’ għandiex tkun aktar mid- doża massima analoga ta ’ olanzapine mill- ħalq li hi 20 mg/ jum.
Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from ZYPADHERA to other antipsychotic medicinal products.
Bdil għal prodotti mediċinali antipsikotiċi oħra M’ hemmx tagħrif miġbur b’ mod sistematiku li jindirizza speċifikament il- bdil ta ’ pazjenti minn ZYPADHERA għal prodotti mediċinali antipsikotici oħra.
Due to the slow dissolution of the olanzapine pamoate salt which provides a slow continuous release of olanzapine that is complete approximately six to eight months after the last injection, supervision by a clinician, especially during the first 2 months after discontinuation of ZYPADHERA, is needed when switching to another antipsychotic product and is considered medically appropriate.
Minħabba t- taħlil bil- mod tal- melħ olanzapine pamoate li jerħi olanzapine bil- mod u b’ mod kontinwu u komplet f’ madwar sitt sa tmien xhur wara l- aħħar injezzjoni, tinħtieġ is- superviżjoni ta ’ tabib, speċjalment matul l- ewwel xahrejn wara t- twaqqif ta ’ ZYPADHERA, meta jsir il- bdil għal prodott antipsikotiku ieħor u meta jiġi kkunsidrat bżonjuż mil- lat mediku.
Elderly patients ZYPADHERA has not been systematically studied in elderly patients (> 65 years).
Pazjenti anzjani ZYPADHERA ma ġiex studjat b’ mod sistematiku f’ pazjenti anzjani (> 65 sena).
ZYPADHERA is not recommended for treatment in the elderly population unless a well-tolerated and effective dosage regimen using oral olanzapine has been established.
ZYPADHERA mhux irrakkomandat għall- kura fil- popolazzjoni anzjana sakemm ma tkunx ġiet stabbilita rutina ta ’ dożagġ ittollerata tajjeb u effettiva b’ olanzapine mill- ħalq.
A lower starting dose (150 mg/ 4 weeks) is not routinely indicated, but should be considered for those 65 and over when clinical factors warrant.
Doża tal- bidu aktar baxxa (150 mg/ 4 ġimgħat) mhijiex regolarment indikata, iżda għandha tiġi kkunsidrata għal dawk li għandhom 65 sena u fuqhom meta l- fatturi kliniċi jiġġustifikaw dan.
ZYPADHERA is not recommended to be started in patients > 75 years (see section 4.4).
ZYPADHERA mhux irrakkomandat li jinbeda f’ pazjenti ta ’ > 75 sena (ara sezzjoni 4. 4).
Patients with renal and/ or hepatic impairment Unless a well-tolerated and effective dosage regimen using oral olanzapine has been established in such patients, ZYPADHERA should not be used.
Pazjenti b’ indeboliment tal- kliewi u/ jew tal- fwied Sakemm ma tkunx ġiet stabbilita rutina ta ’ dożagġ ittollerata tajjeb u effettiva b’ olanzapine mill- ħalq, ZYPADHERA m’ għandux jintuża.
A lower starting dose (150 mg every 4 weeks) should be considered for such patients.
F’ dawn il- pazjenti doża tal- bidu aktar baxxa (150 mg kull 4 gimgħat) għandha tiġi kkunsidrata.
In cases of moderate hepatic insufficiency (cirrhosis, Child- Pugh Class A or B), the starting dose should be 150 mg every 4 weeks and only increased with caution.
F’ każi ta ’ insuffiċjenza epatika moderata (ċirrożi, Child- Pugh Klassi A jew B), id- doża tal- bidu għandha tkun ta ’ 150 mg kull 4 ġimgħat u tiżdied biss b’ kawtela.
Gender The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Sess Id- doża tal- bidu u l- iskala tad- doża m’ għandhomx għalfejn jinbidlu regolarment għall- pazjenti nisa kkomparati ma ’ pazjenti rġiel.
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Min ipejjep Id- doża tal- bidu u l- iskala tad- doża m’ għandhomx għalfejn jinbidlu regolarment għal dawk li ma jpejpux ikkomparati ma ’ dawk li jpejpu.
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the dose.
Meta jkun hemm aktar minn fattur wieħed li jista ’ jirriżulta f’ metaboliżmu aktar bil- mod (sess femminili, età ġerjatrika, individwu li ma jpejjipx), għandha tingħata kunsiderazzjoni biex titnaqqas id- doża.
When indicated, dose escalation should be performed with caution in these patients.
Żieda fid- doża, meta indikata, għandha ssir b’ kawtela f’ dawn il- pazjenti.
Paediatric patients
3 Pazjenti pedjatriċi ZYPADHERA mhux irrakkomandat għall- użu fit- tfal u adolexxenti taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
3 ZYPADHERA is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
4. 3 Kontra- indikazzjonijiet
Patients with known risk of narrow-angle glaucoma.
Pazjenti b’ riskju magħruf ta ’ glawkoma ta ’ angolu dejjaq.
Special care must be taken to apply appropriate injection technique to avoid inadvertent intravascular or subcutaneous injection (see section 6.6).
Għandha tingħata attenzjoni speċjali meta tiġi applikata t- teknika adattata ta ’ l- injezzjoni sabiex tiġi evitata injezzjoni involontarja intravaskulari jew taħt il- ġilda (ara sezzjoni 6. 6).
Use in patients who are in an acutely agitated or severely psychotic state ZYPADHERA should not be used to treat patients with schizophrenia who are in an acutely agitated or severely psychotic state such that immediate symptom control is warranted.
ZYPADHERA m’ għandux jintuża għall- kura ta ’ pazjenti bi skiżofrenja li qegħdin fi stat ta ’ aġitazzjoni akuta jew ta ’ psikożi severa u li jkollhom bżonn ta ’ kura immedjata tas- sintomi.
Post-injection syndrome During pre-marketing clinical studies, events that presented with signs and symptoms consistent with olanzapine overdose, were reported in patients following an injection of ZYPADHERA.
Sindromu ta ’ wara l- injezzjoni Fi studji klinici qabel it- tqegħid fis- suq, ġew irrapportati ġrajjiet li ppreżentaw b’ sinjali u sintomi konsistenti ma ’ doża eċċessiva ta ’ olanzapine f’ pazjenti wara li ħadu injezzjoni ta ’ ZYPADHERA.
These events occurred in < 0.1% of injections and approximately 1.4% of patients.
Dawn il- ġrajjiet seħħew f ’ < 0. 1% ta ’ l- injezzjonijiet u f’ madwar 1. 4% tal- pazjenti.
Most of these patients have developed symptoms of sedation (ranging from mild in severity up to coma) and/ or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment).
Ħafna minn dawn il- pazjenti żviluppaw sintomi ta ’ sedazzjoni (li jvarjaw minn ħfief fis- severità sa koma) u/ jew delirju (inklużi konfużjoni, diżorjentament, aġitazzjoni, ansjetà u indeboliment konoxxittiv ieħor).
Other symptoms noted include extrapyramidal symptoms, dysarthria, ataxia, aggression, dizziness, weakness, hypertension and convulsion.
Sintomi oħra li ġew innutati jinkludu sintomi ekstrapiramidali, disartrija, atassja, aggressjoni, sturdament, debbulizza, pressjoni għolja jew possibiltà ta ’ konvulsjoni.
In most cases, initial signs and symptoms related to this event have appeared within 1 hour following injection, and in all cases full recovery was reported to have occurred within 24 – 72 hours after injection.
F’ ħafna każijiet, sinjali u sintomi inizjali relatati ma ’ din il- ġrajja dehru fi żmien siegħa wara l- injezzjoni, u fil- każijiet kollha ġie rrapportat li f’ 24 – 72 siegħa wara l- injezzjoni kien hemm irkuprar komplet.
Events occurred rarely (< 1 in 1,000 injections) between 1 and 3 hours, and very rarely (< 1 in 10,000 injections) after 3 hours.
Ġrajjiet seħħew rari (< 1 f’ 1, 000 injezzjoni) bejn siegħa u 3 sigħat, u rari ħafna (< 1 f’ 10, 000 injezzjoni) wara 3 sigħat.
Patients should be advised about this potential risk and the need to be observed for 3 hours in a healthcare facility each time ZYPADHERA is administered.
Il- pazjenti għandhom jiġu avżati b’ dan ir- riskju potenzjali u l - ħtieġa li jkunu osservati għal 3 sigħat f’ faċilità tal- kura tas- saħħa kull darba li jingħataw ZYPADHERA.
Prior to giving the injection, the healthcare professional should determine that the patient will not travel alone to their destination.
Qabel ma tingħata l- injezzjoni, il- professjonist tal- kura tas- saħħa għandu jara li l- pazjent ma jmurx lura fid- destinazzjoni tiegħu waħdu.
After each injection, patients should be observed in a healthcare facility by appropriately qualified personnel for at least 3 hours for signs and symptoms consistent with olanzapine overdose.
Wara kull injezzjoni, il- pazjenti għandhom jiġu osservati minn personal ikkwalifikat għal mill- anqas 3 sigħat f’ faċilità tal- kura tas- saħħa għal sinjali u sintomi konsistenti ma ’ doża eċċessiva ta ’ olanzapine.
It should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose.
Għandu jiġi kkonfermat li l- pazjent jaf x’ inhu jagħmel, jaf fejn jinsab, u mingħajr ebda sinjali u sintomi ta ’ doża eċċessiva.
If an overdose is suspected, close medical supervision and monitoring should continue until examination indicates that signs and symptoms have resolved.
Jekk tkun issuspettata doża eċċessiva, għandhom jitkomplew mill- qrib is - superviżjoni medika u l- monitoraġġ sakemm l- eżami jindika li s- sinjali u s- sintomi ġew solvuti.
For the remainder of the day after injection, patients should be advised to be vigilant for signs and symptoms of overdose secondary to post injection adverse reactions, be able to obtain assistance if needed and should not drive or operate machinery (see section 4.7).
Għall- bqija tal- ġurnata wara l- injezzjoni, il- pazjenti għandhom jingħataw parir li joqgħodu attenti għas- sinjali u s- sintomi ta ’ doża eċċessiva sekondarja għal reazzjonijiet avversi ta ’ wara l- injezzjoni, ikunu kapaċi jitolbu għall- għajnuna jekk meħtieġ u m’ għandhomx isuqu jew iħaddmu magni (ara sezzjoni 4. 7).
If parenteral benzodiazepines are essential for management of post injection adverse reactions, careful evaluation of clinical status for excessive sedation and cardiorespiratory depression is recommended.
Jekk benzodiazepines permezz ta ’ injezzjoni jkunu essenzjali għall- immaniġġar ta ’ reazzjonijiet avversi ta ’ wara l- injezzjoni, huwa rrakkomandat li ssir valutazzjoni bir- reqqa ta ’ l- istat kliniku għal sedazzjoni eċċessiva u depressjoni kardjorespiratorja.
(see section 4.5)
(ara sezzjoni 4. 5)
Injection Site Related Adverse Events The most commonly reported injection site related adverse event was pain.
Reazzjonijiet avversi relatati mas- sit ta ’ l- injezzjoni Ir- reazzjoni avversa relatata mas- sit ta ’ l- injezzjoni li ġiet irrapportata b’ mod l- aktar komuni kienet l - uġigħ.
The majority of these events was reported to be of “ mild” to “ moderate” severity.
Il- maġġoranza ta ’ dawn il- ġrajjiet ġew irrapportati li kienu “ ħfief ” sa “ moderati ” fil- qawwa.
In the event of an injection site related adverse event occuring, appropriate measures to manage these events should be taken.
F’ każ li sseħħ reazzjoni avversa relatata mas- sit ta ’ l- injezzjoni, għandhom jittieħdu l- miżuri xierqa sabiex jiġu kkontrollati dawn il- ġrajjiet.
(see section 4.8)
(ara sezzjoni 4. 8)
4 in mortality and the risk of cerebrovascular accident.
4 Psikożi relatata mad- demenzja u/ jew disturbi fl- imġiba Olanzapine mhux approvat għall- kura ta ’ psikożi relatata mad- demenzja u/ jew disturbi fl- imġiba u mhux irrakkomandat għall- użu f’ dan il- grupp partikolari ta ’ pazjenti minħabba żieda fil- mortalità u r - riskju ta ’ puplesija.
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 oral olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
Fi studji kliniċi kkontrollati bil- plaċebo (li damu minn 6 sa 12- il ġimgħa) f’ pazjenti anzjani (età medja ta ’ 78 sena) li kellhom psikożi relatata mad- demenzja u/ jew disturbi fl - imġiba, kien hemm żieda doppja fl- inċidenza ta ’ mwiet fil- pazjenti kkurati b’ olanzapine mill- ħalq meta mqabbla ma ’ pazjenti kkurati bil- plaċebo (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- inċidenza ogħla ta ’ mwiet ma ġietx assoċjata mad- doża ta ’ olanzapine (doża medja kuljum ta ’ 4. 4 mg) jew it- tul ta ’ żmien tal- kura.
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 jistgħu jippredisponu dan il- grupp ta ’ pazjenti għal żieda fil - mortalità jinkludu l- età ta ’ > 65 sena, id- disfaġja, is- sedazzjoni, il- malnutriment u d- deidrazzjoni, kundizzjonijiet tal- pulmun (eż. pulmonite, bl- aspirazzjoni jew mingħajrha), jew l- użu konkomitanti ta ’ benzodiazepines.
However, the incidence of death was higher in oral olanzapine-treated than in placebo-treated patients independent of these risk factors.
Madanakollu, l- inċidenza ta ’ mwiet kienet ogħla f’ dawk ikkurati b’ olanzapine mill - ħalq minn dawk il- pazjenti kkurati bil- plaċebo, 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 kliniċi, ġew irrapportati ġrajjiet avversi ċerebrovaskulari (CVAE eż. puplesija, attakki iskemiċi temporanji) inkluż l- imwiet.
There was a 3-fold increase in CVAE in patients treated with oral olanzapine compared to patients treated with placebo (1.3% vs.
Kien hemm żieda ta ’ 3 darbiet aktar ta ’ CVAE f’ pazjenti kkurati b’ olanzapine mill- ħalq, meta mqabbla ma ’ pazjenti kkurati bil- plaċebo (1. 3% kontra 0. 4%, rispettivament).
All oral olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Il- pazjenti kollha kkurati b’ olanzapine mill- ħalq u l- plaċebo, li kellhom ġrajja avversa ċerebrovaskulari, kellhom il- fatturi ta ’ riskju 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 vaskulari/ imħallta kienu identifikati bħala fatturi ta ’ riskju għal CVAE f’ assoċjazzjoni ma ’ kura b’ olanzapine.
The efficacy of olanzapine was not established in these trials.
L- effikaċja ta ’ olanzapine ma ġietx stabbilita f’ dawn l- istudji.
Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.
Marda ta ’ Parkinson Mhux irrakkomandat l- użu ta ’ olanzapine fil- kura tal- psikożi assoċjata ma ’ l- agonisti ta ’ dopamine f’ pazjenti li għandhom il- marda ta ’ Parkinson.
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and oral olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Fi studji kliniċi, ġie rrappurtat b’ mod komuni ħafna u aktar ta ’ spiss li s- sintomatoloġija ta ’ Parkinson u l- alluċinazzjonijiet imorru għall- agħar aktar milli bil- plaċebo (ara sezzjoni 4. 8), u olanzapine mill- ħalq ma kienx aktar effettiv mill- plaċebo fil- kura tas - sintomi psikotiċi.
In these trials, patients were initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
F’ dawn l- istudji, il- pazjenti inizjalment kellhom ikunu stabblizzati fuq id- doża l - aktar baxxa u effettiva ta ’ prodotti mediċinali kontra l- Parkinson (agonist ta ’ dopamine) u jibqgħu fuq l- istess dożi u prodotti mediċinali kontra l- Parkinson matul l- istudju.
Oral olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgement.
Olanzapine mill- ħalq inbeda b’ 2. 5 mg/ jum u żdied bil- mod għall- massimu ta ’ 15 mg/ jum fuq il- bażi tal- ġudizzju tar- riċerkatur.
Neuroleptic Malignant Syndrome (NMS) NMS is a potentially life-threatening condition associated with antipsychotic medicinal products.
Sindromu Newrolettiku Malinn (NMS) NMS huwa kundizzjoni potenzjalment fatali assoċjat ma ’ prodotti mediċinali antipsikotiċi.
Rare cases reported as NMS have also been received in association with oral olanzapine.
Każijiet rari li ġew irrappurtati bħala NMS kienu rrappurtati wkoll f' assoċjazzjoni ma ’ olanzapine mill- ħalq.
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).
Il - manifestazzjonijiet kliniċi ta ’ NMS huma deni għoli, ebusija tal- muskoli, stat mentali mibdul, u evidenza ta ’ instabbilità awtonomika (polz jew pressjoni tad- demm irregolari, takikardija, dijaforeżi, u taħbit tal- qalb irregolari).
Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Sinjali oħra jistgħu jinkludu creatinine phosphokinase elevat, mijoglobina fl - urina (rabdomajoliżi) u indeboliment akut tal- kliewi.
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 jiżviluppa sinjali u sintomi ta ’ NMS, jew ikollu deni għoli bla ebda spjegazzjoni mingħajr manifestazzjonijiet kliniċi oħra ta ’ NMS, għandhom jitwaqqfu l- mediċini antipsikotiċi kollha, inkluż 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).
Zokkor għoli fid- demm u dijabete Zokkor għoli fid- demm u/ jew żvilupp jew iggravar tad- dijabete xi kultant assoċjati ma ’ ketoaċidożi jew koma kienu rrappurtati b’ mod rari, inklużi xi każijiet fatali (ara sezzjoni 4. 8).
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
F’ xi każijiet, ġiet irrapurtata żieda fil- piż tal- ġisem li tista ’ tkun fattur ta ’ predisposizzjoni.
Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Huwa rakkomandat monitoraġġ kliniku xieraq skont il- linji gwida antipsikotiċi użati normalment.
Patients treated with any antipsychotic agents, including ZYPADHERA, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Pazjenti kkurati b’ sustanzi antipsikotiċi, inkluż ZYPADHERA, għandhom ikunu taħt osservazzjoni għal sinjali u sintomi ta ’ zokkor għoli fid- demm (bħal polidipsja, poliurja, polifaġja, u għeja) u pazjenti bid- dijabete mellitus jew b’ fatturi ta ’ riskju għall- iżvilupp tad- dijabete mellitus għandhom ikunu mmonitorjati b’ mod regolari fil- każ li l- kontroll tal- glucose imur għall- agħar.
Weight should be monitored regularly.
Il- piż għandu jiġi mmonitorjat b’ mod regolari.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
5 klinikamet adattat speċjalment f’ pazjenti b’ ammonti mhux normali ta ’ lipidi fid- demm u f’ pazjenti li għandhom fatturi ta ’ riskju għall- iżvilupp ta ’ disturbi fil- lipidi.
Patients treated with any antipsychotic agents, including ZYPADHERA, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines.
Pazjenti kkurati b’ sustanzi antipsikotiċi, inkluż ZYPADHERA, għandhom jiġu mmonitorjati b’ mod regolari għal- lipidi skont il - linji gwida antipsikotiċi użati normalment.
5 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Attività antikolinerġika Waqt li olanzapine wera attività antikolinerġika in vitro, esperjenza waqt l- istudji kliniċi wriet inċidenza baxxa ta ’ ġrajjiet 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.
Madanakollu, minħabba li esperjenza klinika b’ olanzapine f’ pazjenti b’ mard konkomitanti hija limitata, għandha tittieħed kawtela meta jinkiteb għall- pazjenti b’ ipertrofija tal- prostata, jew b’ ileus paralitiku u kundizzjonijiet relatati.
Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Funzjoni tal- fwied Livelli għolja ta ’ transaminases tal- fwied, ALT, AST, temporanji u mingħajr sintomi kienu komuni, speċjalment fil- bidu tal- kura.
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.
Għandha tittieħed kawtela f’ pazjenti b’ livelli għolja ta ’ ALT u/ jew AST, f’ pazjenti b’ sinjali u sintomi ta ’ indeboliment tal- fwied, f’ pazjenti b’ kundizzjonijiet li kienu hemm minn qabel u huma assoċjati ma ’ riżerva funzjonali limitata tal- fwied, u f’ pazjenti li qed ikunu kkurati b’ mediċini potenzjalment tossiċi għall- fwied.
In the event of elevated ALT and/ or AST during treatment, follow- up should be organised and dose reduction should be considered.
Fil- każ ta ’ livelli għolja ta ’ ALT u/ jew AST waqt il - kura, għandha tiġi organizzata investigazzjoni wara l- kura u għandu jiġi kkunsidrat tnaqqis fid- doża.
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
F’ każijiet fejn saret dijanjosi ta ’ l- epatite (inkluż ħsara fil- fwied tat- tip epatoċellulari, kolestatiku jew imħallta), il- kura b’ olanzapine għandha titwaqqaf.
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
Newtropenja Għandha tittieħed kawtela f’ pazjenti li għal xi raġuni għandhom l- għadd ta ’ lewkoċiti u/ jew newtrofili baxx, f’ pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw in- newtropenja, f’ pazjenti b’ passat ta ’ tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal- mudullun ikkaġunati minn xi mediċina, f’ pazjenti b’ tnaqqis fil- funzjoni tal- mudullun ikkaġunat minn mard konkomitanti, terapija bir- raġġi jew kimoterapija u f’ pazjenti b’ kundizzjonijiet b’ numru għoli ta ’ ċelluli eosinofili jew b’ xi mard majeloproliferattiva.
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
In- newtropenja kienet irrappurtata b’ mod komuni meta olanzapine u valproate intużaw 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 oral olanzapine is stopped abruptly.
Twaqqif tal- kura Sintomi akuti bħal għaraq, insomnja, rogħda, ansjetà, dardir, jew rimettar ġew irrappurtati b’ mod rari ħafna (< 0. 01%) meta olanzapine mill- ħalq twaqqaf f’ daqqa.
QT interval In clinical trials with oral olanzapine, 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 b’ olanzapine mill- ħalq, żidiet fil- QTc li kienu klinikament sinifikanti (korrezzjoni fil - QT skont Fridericia [QTcF] > 500 millisekondi [msek] f’ kwalunkwe ħin wara l- kejl tal- valur bażilari U
In clinical trials with olanzapine powder for solution for injection or ZYPADHERA, olanzapine was not associated with a persistent increase in absolute QT or in QTc intervals.
Fi studji kliniċi b’ olanzapine trab għal soluzzjoni għall- injezzjoni jew ZYPADHERA, olanzapine ma kienx assoċjat ma ’ żieda persistenti fil- QT assolut jew fl- intervalli QTc.
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.
Madanakollu, 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.
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established.
Relazzjoni każwali bejn l- okkorrenza ta ’ tromboemboliżmu fil- vini u l - kura b’ olanzapine ma ġietx 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.
Madanakollu, peress li pazjenti bi skiżofrenja ħafna drabi jippreżentaw b’ fatturi ta ’ riskju akkwiżiti għat- tromboemboliżmu fil- vini, il- fatturi possibbli kollha ta ’ riskju ta ’ VTE eż. l- immobbilizzazzjoni tal- pazjenti, għandhom jiġu identifikati u jittieħdu miżuri 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.
Minħabba li in vitro jikkaġuna
As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
6 antagoniżmu ma ’ 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.
Aċċessjonijiet Olanzapine għandu jintuża b’ kawtela f’ pazjenti li għandhom passat ta ’ aċċessjonijiet jew li huma suġġetti għall- fatturi li jistgħu jbaxxu l- limitu għall- aċċessjonijiet.
Seizures have been reported to occur rarely in patients when treated with olanzapine.
Ġie rrappurtat li aċċessjonijiet seħħew b’ mod rari f’ pazjenti meta kienu kkurati b’ olanzapine.
In most of these cases, a history of seizures or risk factors for seizures were reported.
Fil- maġġoranza ta ’ dawn il- każijiet, passat ta ’ aċċessjonijiet jew fatturi ta ’ riskju għal aċċessjonijiet kienu rrappurtati.
6 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Diskajneżja Tardiva Fi studji komparattivi li damu sena jew anqas, olanzapine kien assoċjat ma ’ inċidenza mnaqqsa ta ’ diskajneżja minħabba l- kura, b’ mod statistikament sinifikanti.
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.
Madanakollu, ir- riskju ta ’ diskajneżja tardiva jiżdied b’ espożizzjoni għal żmien twil, u għalhekk jekk jidhru s- sinjali jew is- sintomi ta ’ diskajneżja tardiva f’ pazjenti li qed jieħdu olanzapine, għandu jiġi kkunsidrat it- tnaqqis fid- doża jew il- waqfien.
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Dawn is- sintomi jistgħu jiżdiedu biż- żmien kif ukoll joħorġu wara li titwaqqaf il- kura.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Pressjoni baxxa mal- waqfien Pressjoni baxxa mal- waqfien ma ġietx osservata ta ’ spiss fl- anzjani fi studji kliniċi ta ’ olanzapine.
As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
Bħal b’ antipsikotiċi oħra, huwa rrakkomandat li l- pressjoni tad- demm tkun meħuda perjodikament f’ pazjenti ’ l fuq minn 65 sena.
Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
Studji f’ pazjenti bejn it- 13 u s- 17- il sena wrew reazzjonijiet avversi varji, fosthom żieda fil- piż, tibdil fil- parametri metaboliċi u żieda 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 assoċjati ma ’ dawn il- ġrajjiet ma ġewx studjati u għadhom mhux magħrufa (ara sezzjonijiet 4. 8 u 5. 1).
Use in elderly patients (> 75 years) No information on the use of ZYPADHERA in patients > 75 years is available.
Użu f’ pazjenti anzjani (> 75sena) M’ hemmx tagħrif dwar l- użu ta ’ ZYPADHERA f’ pazjenti > 75 sena.
Due to biochemical and physiological modification and reduction of muscular mass, this formulation is not recommended to be started in this sub-group of patients.
Minħabba l- modifikazzjoni fil - bijokimika u l- fiżjoloġija u t- tnaqqis fil- massa muskolari, din il- formulazzjoni mhijiex irrakkomandata li tinbeda f’ dan is- sottogrupp ta ’ pazjenti.
Caution should be exercised in patients who receive medicinal products that can induce hypotension or sedation.
Għandha tittieħed il- kawtela f’ pazjenti li jieħdu prodotti mediċinali li jistgħu jikkawżaw il- pressjoni baxxa jew is- sedazzjoni.
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.
Effetti potenzjali ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku ta ’ olanzapine Billi olanzapine jiġi mmetabolizzat permezz ta ’ CYP1A2, sustanzi li jistgħu b’ mod speċifiku jikkaġunaw jew jimpedixxu din l- isoenzima jistgħu jaffettwaw il- farmakokinetika ta ’ olanzapine.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
Induzzjoni ta ’ CYP1A2 It- tipjip u carbamazepine jistgħu jikkawżaw il- metaboliżmu ta’ olanzapine, li jista ’ jwassal għal tnaqqis fil- konċentrazzjoni ta ’ olanzapine.
Only slight to moderate increase in olanzapine clearance has been observed.
Ġiet osservata żieda żgħira sa moderata biss fit- tneħħija ta ’ olanzapine.
The clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.2).
Il- konsegwenzi kliniċi x’ aktarx huma limitati, iżda l- osservazzjoni klinika hija rrakkomandata u tista ’ tiġi kkunsidrata żieda fid- doża ta ’ olanzapine jekk meħtieġ (ara sezzjoni 4. 2).
Inhibition of CYP1A2 Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Ġie muri li fluvoxamine, inibitur speċifiku ta ’ CYP1A2, jimpedixxi b’ mod sinifikanti l- metaboliżmu ta ’ olanzapine.
The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non- smokers and 77% male smokers.
Iż- żieda medja f’ olanzapine Cmax wara t- teħid ta ’ fluvoxamine kienet ta ’ 54% fin- nisa li ma jpejpux u ta ’ 77% fl- irġiel li jpejpu.
The mean increase in olanzapine AUC was 52% and 108% respectively.
Iż- żieda medja fl- AUC ta ’ olanzapine kienet ta ’ 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.
7 qed jużaw fluvoxamine jew xi inibituri oħra ta ’ CYP1A2, bħal ciprofloxacin.
A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated.
Għandu jiġi kkunsidrat tnaqqis fid- doża ta ’ olanzapine jekk tinbeda kura b’ inibitur ta ’ CYP1A2.
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Fluoxetine (inibitur ta ’ CYP2D6), dożi b’ waħda ta ’ antaċidi (aluminju, manjesju) jew cimetidine ma nstabux li jaffettwaw b’ mod sinifikanti l- farmakokinetika ta ’ olanzapine.