qanastek/EMEA-V3 huggingface dataset:
Other possible side effects: frequency cannot be estimated from the available data. • Allergic reaction (e.g. swelling in the mouth and throat, itching, rash). • Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma. • Lowering of normal body temperature. • Seizures, usually associated with a history of seizures (epilepsy). • Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. • Spasms of the muscle of the eye causing rolling movement of the eye. • Abnormal rhythms of the heart. • Sudden unexplained death. • Blood clots such as deep venous thrombosis of the leg or blood clot on the lung. • Inflammation of the pancreas causing severe stomach pain, fever and sickness. • Liver disease appearing as yellowing of the skin and white parts of the eyes. • Muscle disease presenting as unexplained aches and pains. • Difficulty in passing urine. • Prolonged and/or painful erection.
Effetti sekondarji oħra possibbli: ma tistax tiġi stmata frekwenza mill- informazzjoni disponibbli • Reazzjonijiet allerġiċi (eż. nefħa fil- ħalq u l- gerżuma, ħakk, raxx). • Dijabete jew dijabete li tmur għall- agħar, kultant assoċjata ma 'ketoaċidożi (ketoni fid- demm u fl- awrina) jew koma. • Titbaxxa t- temperatura normali tal- ġisem. • Aċċessjonijiet, normalment assoċjati ma' storja ta 'aċċessjonijiet (epilessija). • Taħlita ta' deni, nifs mgħaġġel, għaraq, ebusija tal- muskoli u ħedla jew ngħas. • Spażmi tal- muskolu ta 'l- għajn li jikkawża taqlib ta' l- għajn. • Ritmi mhux normali tal- qalb. • Mewt għal għarrieda u inspjegabbli. • Tagħqid tad- demm bħal trombożi fil- vini fondi tas- sieq jew tagħqid tad- demm fil- pulmun. • Infjammazjoni tal- frixa li tikkawża wġigħ qawwi fl- istonku, deni u taqlib.
While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking.
Waqt li qed jieħdu l- olanzapine, il- pazjenti anzjani bid- demenzja jistgħu jsofru minn puplesija, il - pnewmonja, l- inkontinenza ta ’ l- awrina, waqgħat, għeja kbira, alluċinazzjonijiet viżivi, żjieda fit - temperatura tal- ġisem, ħmura fil- ġilda u jistgħu jkollhom problemi fil- mixi.
In patients with Parkinson's disease oral olanzapine may worsen the symptoms.
F' pazjenti li għandhom il- marda ta 'Parkinson ZYPADHERA tista' tagħmel is- sintomi agħar.
75 Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods.
Rari, nisa li kienu qed jieħdu mediċini ta 'dawn it- tip għal żmien twil bdew inixxu ħalib mis- sider u tilfu xi pirjid jew kellhom pirjid rregolari.
If this persists tell your doctor as soon as possible.
Jekk dawn jippersistu għid lit- tabib tiegħek.
Very rarely babies born to mothers who have taken oral olanzapine in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.
Rarament ħafna trabi li jitwieldu lil ommijiet li ħadu ZYPADHERA fl- aħħar stadju tat- tqala (l- aħħar tlett xhur) jista 'jkollhom rogħda, ngħas u ħedla.
HOW TO STORE ZYPADHERA
KIF TAĦŻEN ZYPADHERA
The injection must not be given after the expiry date which is stated on the ZYPADHERA carton.
L- injezzjoni m’ għandhiex tingħata wara d- data ta ’ skadenza li tidher fuq il- kartuna ta ’ ZYPADHERA.
After reconstitution in the vial the medicine is stable for 24 hours.
Wara r- rikostituzzjoni fil- kunjett, il- mediċina hija stabbli għal 24 siegħa.
If the medicine is not used right away, it should be shaken vigorously to re-suspend.
Jekk il- mediċina mhijiex użata immedjatament, il- kunjett għandu jiġi mħawwad sew sabiex terġa ’ tifforma suspensjoni.
Once withdrawn from vial into the syringe, the suspension should be used immediately.
Ladarba tinġibed mill- kunjett għal ġos- siringa, is- suspensjoni għandha tiġi użata immedjatament.
Chemical and physical stability of the suspension in the vials has been demonstrated for 24 hours at 20-25 °C.
Ġie muri li l- istabbilità kimika u fiżika tas- suspensjoni fil- kunjetti tibqa ’ għal 24 siegħa f’ temperatura ta ’ 20- 25°C.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 20-25°C
Jekk dan ma jseħħx, iż - żminijiet ta ’ ħażna waqt l- użu u l- kundizzjonijiet ta ’ qabel l- użu huma r- responsabbiltà ta ’ min qed jagħmel użu mill- prodott u normalment ma jkunux iżjed minn 24 siegħa f’ temperatura ta ’ 20- 25°C.
What ZYPADHERA contains The active substance is olanzapine.
Is- sustanza attiva hi olanzapine.
Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal 210 mg olanzapine Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal 300 mg olanzapine Kull kunjett fih olanzapine pamoate monohydrate ekwivalenti għal 405 mg olanzapine Wara r- rikostituzzjoni:
Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
1 ml ta ’ suspensjoni fih 150 mg/ ml olanzapine.
The solvent ingredients are croscarmellose sodium, mannitol, polysorbate 80, water for injections, hydrochloric acid and sodium hydroxide.
Is- sustanzi l- oħra tas- solvent huma croscarmellose sodium, mannitol, polysorbate 80, ilma għall - injezzjonijiet, hydrochloric acid u sodium hydroxide.
What ZYPADHERA looks like and contents of the pack One carton contains one vial of powder for prolonged release suspension for injection and one vial of 3 ml solvent.
Kartuna waħda fiha kunjett wieħed ta ’ trab għal suspensjoni għall- injezzjoni li terħi l- mediċina bil - mod u kunjett wieħed ta ’ 3 ml ta ’ solvent.
ZYPADHERA powder for prolonged release suspension for injection comes as a yellow powder in a clear glass vial.
76 It- trab ta ’ ZYPADHERA għal suspensjoni għall- injezzjoni li terħi l- mediċina bil- mod jiġi bħala trab isfar ġo kunjett ċar tal- ħġieġ.
Your doctor or nurse will make it into a suspension that will be given as an injection using the vial of solvent for ZYPADHERA that comes as a clear, colourless to slightly yellow solution in a clear glass vial.
It- tabib jew in- ners jagħmluh f' suspensjoni li tingħata bħala injezzjoni permezz tal- kunjett tas- solvent għal ZYPADHERA u dan jiġi bħala soluzzjoni ċara, bla kulur jew li jagħti xi ftit fl- isfar, ġo kunjett ċar tal- ħġieġ.
Marketing Authorisation Holder and Manufacturer Eli Lilly Nederland BV, Grootslag 1 – 5, NL-3991 RA, Houten, The Netherlands.
Eli Lilly Nederland BV, Grootslag 1 - 5, NL- 3991 RA, Houten, L- Olanda.
KG, Teichweg 3, D-35396 Giessen, Germany.
KG, Teichweg 3, D- 35396 Giessen, Il - Ġermanja.
Tel: + 39 055 42571 Κύπρος Phadisco Ltd Τηλ: + 357 22 715000 Latvija Eli Lilly Holdings Limited, pārstāvniecība Latvijā Tel: + 371 7364000 Lietuva Eli Lilly Holdings Limited atstovybė Tel: + 370 (5) 2649600
Tel: + 39 - 055 42571 Κύπρος Phadisco Ltd Τηλ: +357 22 715000
Tel: + 421 220 663 111 Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358 (0) 9 8545 250 Sverige Eli Lilly Sweden AB Tel: + 46 (0) 8 7378800 United Kingdom Eli Lilly and Company Limited Tel: +44 (0) 1256 315999
Tel: + 421 220 663 111 Suomi/ Finland Oy Eli Lilly Finland Ab Puh/ Tel: +358 (0) 9 8545 250 Sverige Eli Lilly Sweden AB Tel: + 46 - (0) 8 7378800
EPAR summary for the public This document is a summary of the European Public Assessment Report (EPAR).
Sommarju ta ’ l- EPAR għall- pubbliku Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR).
What is Zyprexa?
X’ inhu Zyprexa?
Zyprexa is a medicine containing the active substance olanzapine.
Zyprexa huwa mediċina li fiha s- sustanza attiva olanzapine.
It is available as tablets (round and white:
Jiġi fil- forma ta ’ pilloli (tondi u bojod:
15 mg; pink and oval:
2. 5, 5, 7. 5 u 10 mg; blu u ovali: 15 mg; roża u ovali:
20 mg) and as a powder to be made up into a solution for injection.
20 mg) u bħala trab sabiex issir minnu soluzzjoni għall- injezzjoni.
What is Zyprexa used for?
Għal xiex jntuża Zyprexa?
Zyprexa is used to treat adults with schizophrenia.
Zyprexa jintuża fit- trattament ta 'l- iskizofrenija.
Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
L- iskizofrenija hija marda mentali li għandha għadd ta 'sintomi, inkluż disturbi fil- ħsieb u fid- diskors, alluċinazzjonijiet (il- pazjent jisma ’ jew jara affarijiet li ma jeżistux), suspetti u delirji (ħsibijiet żbaljati).
Zyprexa is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Zyprexa huwa effikaċi wkoll biex iżżomm it- titjib li jkun sar f’ pazjenti li jkunu rrispondew għal kors inizjali ta ’ trattament.
Zyprexa is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Zyprexa jintuża wkoll fit- trattament ta ’ każijiet moderati jew severi tal- manija (burdata estremament tajba) fl- adulti.
It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness with alternating periods of high mood and depression) who have responded to an initial course of treatment.
Jista ’ jintuża wkoll biex jipprevjeni l- feġġa mill- ġdid ta ’ dawn l- episodji (meta s - sintomi jerġgħu joħorġu) f’ adulti b’ disturbi polari (marda mentali b’ perjodi jalternaw bejn burdata tajba ħafna u depressjoni) li jkunu rrispondew għal kors inizjali ta ’ trattament.
Zyprexa is usually taken by mouth, but the injection can be used for the rapid control of agitation or disturbed behaviour in adults with schizophrenia or a manic episode, when taking the medicine by mouth is not appropriate.
Zyprexa ġeneralment jittieħed oralment, iżda l- injezzjoni tista ’ tintuża wkoll għall- kontroll rapidu ta ’ l- aġitazzjoni jew ta ’ l- imġiba disturbata f’ adulti bl- iskizofrenija jew b’ episodji manijaċi, meta t- teħid tal- mediċina b’ mod orali ma jkunx approprijat.
How is Zyprexa used?
Kif jintuża Zyprexa?
10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Id- doża inizjali rrakkomandata għall- pilloli ta ’ Zyprexa tiddependi mill- marda li tkun qed tiġi ttrattata: doża ta ’ 10 mg kuljum tintuża għall- iskizofrenija u fil- prevenzjoni ta ’ każijiet manijaċi, u 15- il mg kuljum fit- trattament ta ’ episodji manijaċi, sakemm ma tkunx qed tittieħed flimkien ma ’ mediċini oħra, f’ liema każ id- doża inizjali tista ’ tkun ta ’ 10 mg kuljum.
The dose is adjusted according to how well the patient responds to and tolerates the treatment.
Id- doża tiġi aġġustata skond kemm il - pazjent jirrispondi tajjeb u jittollera t- trattament.
The usual dose range is between 5 and 20 mg per day.
Id- doża normalment tvarja bejn 5 u 20 mg kuljum.
The usual dose when using the injection is 10 mg as a single injection into a muscle.
Id- doża normali meta tintuża l- injezzjoni hi ta ’ 10 mg bħala injezzjoni waħdanija f’ muskolu.
This can be followed if needed by a further injection of 5 or 10 mg two hours later.
Jekk dan ikun meħtieġ, din tista ’ tiġi segwita b’ injezzjoni oħra ta ’ 5 jew 10 mg sagħtejn wara.
Lower doses may be needed for patients over 65 years of age (5 mg per day for the tablets and 2.5 to 5 mg for the injection) and for patients who have problems with their liver or kidneys (5 mg per day for both the tablets and injection).
Pazjenti ta ’ iktar minn 65 sena jista ’ jkollhom bżonn ta ’ dożi iktar baxxi (5 mg kuljum għall- pilloli u bejn 2. 5 u 5 mg għall- injezzjoni) kif ukoll pazjenti li jkollhom problemi bil- fwied jew bil- kliewi (5 mg kuljum għall- pilloli u għall- injezzjoni).
In all cases, the maximum dose of Zyprexa that can be given in a day, using tablets or injection, is 20 mg.
Fil- każijiet kollha, id- doża massima ta ’ Zyprexa li tista ’ tingħata f’ jum wieħed, kemm bħala pilloli kif ukoll bħala injezzjoni, hi ta ’ 20 mg.
How does Zyprexa work?
Kif jaħdem Zyprexa?
The active substance in Zyprexa, olanzapine, is an antipsychotic medicine.
Is- sustanza attiva f’ Zyprexa, olanzapine, hija mediċina antipsikotika.
It is known as an ‘ atypical’ antipsychotic because it is different from the older antipsychotic medicines that have been available 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Hija magħrufa bħala antipsikotiku 'atipiku' minħabba li hija differenti minn mediċini antipsikotiċi li ilhom disponibbli mis - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. since the 1950s.
Reproduction is authorised provided the source is acknowledged snin ħamsin.
Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain.
Mhux magħruf eżatt kif taħdem, iżda teħel ma ’ diversi riċetturi differenti fuq is - superfiċje taċ- ċelloli tan- nervituri tal- moħħ.
This disrupts signals transmitted between brain cells by ‘ neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
Dan ifixkel is- sinjali trażmessi bejn iċ- ċelloli tal- moħħ permezz ta ’ ‘ newrotrażmettituri ’, sustanzi kimiċi li jippermettu liċ- ċelloli tal- moħħ jikkomunikaw ma ’ xulxin.
It is thought that olanzapine’ s beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Hu maħsub li l- effett benefiku ta ’ olanzapine huwa dovut għall- imblokkar tar- riċetturi għan - newrotrażmettituri 5- idrossitripamina (5- hydroxytrypamine) (imsejħa wkoll serotonina) u dopamina.
Since these neurotransmitters are involved in schizophrenia and in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Billi dawn in- newrotrażmettituri għandhom sehem fl- iskizofrenija u fid- disturbi bipolari, olanzapine jgħin fin- normalizzazzjoni ta ’ l- attività tal- moħħ, u b’ hekk inaqqas is- sintomi ta ’ dawn il- mardiet.
How has Zyprexa been studied?
Kif ġie studjat Zyprexa?
In schizophrenia, Zyprexa tablets have been studied in about 3,000 adults, in which their effectiveness was compared with that of placebo (a dummy treatment) or haloperidol (another antipsychotic medicine).
Fl- iskizofrenija, il- pilloli ta ’ Zyprexa ġew studjati f’ madwar 3, 000 adult fejn l- effikaċja tagħhom ġiet imqabbla ma ’ dik ta ’ plaċebo (trattamet finta) jew ma ’ haloperidol (mediċina antipsikotika oħra).
All four studies lasted six weeks, but the patients stayed on the medicine for up to a year or more.
L - erba ’ studji damu sitt ġimgħat, iżda l- pazjenti damu jieħdu l- mediċina sa sena jew iktar wara.
In the treatment of acute manic episodes in adults with bipolar disorder, Zyprexa tablets were compared with placebo, haloperidol or valproate (another medicine used in manic episodes) in five studies, including one where patients were also receiving other medicines.
Fit- trattament ta ’ każijiet manijaċi akuti f’ adulti b’ disturbi bipolari, il- pilloli ta ’ Zyprexa tqabblu ma ’ plaċebo, ma ’ haloperidol jew ma ’ valproate (mediċina oħra użata fl- episodji manijaċi) f’ ħames studji, inkluż wieħed li fih il- pazjenti kienu qed jieħdu wkoll mediċini oħra.
In the prevention of manic episodes, Zyprexa tablets were studied in 1,162 adults.
Fil- prevenzjoni ta ’ każijiet manijaċi, il- pilloli ta ’ Zyprexa ġew studjati f’ 1, 162 pazjent adult.
Their effectiveness was compared with that of placebo or lithium (another medicine used in bipolar disorder).
L- effikaċja tagħhom tqabblet ma ’ dik ta ’ plaċebo jew tal- litju (mediċina oħra użata fid- disturbi bipolari).
The injection was studied in 581 adults with schizophrenia (compared with placebo or injected haloperidol) and 228 manic adults (compared with placebo or injected lorazepam, another medicine used in manic episodes).
L- injezzjoni ġiet studjata f’ 581 adult bl- iskizofrenija (meta mqabbla ma ’ plaċebo jew haloperidol injettat) u f’ 228 pazjent adult manijaku (meta imqabbla ma ’ plaċebo jew ma ’ lorazepam injettat, mediċina oħra wżata fil- każijiet manijaċi).
In all studies, the effectiveness of Zyprexa was assessed using various symptom rating scales.
Fl- istudji kollha, l- effikaċja ta ’ Zyprexa ġiet valutata permezz ta ’ diversi skali tal- valutazzjoni tas - sintomi.
What benefit has Zyprexa shown during the studies?
X’ benefiċċji wera Zyprexa f’ dawn l- istudji?
In all studies, Zyprexa as tablets and as injections was more effective at improving symptoms than placebo.
F’ dawn l- istudji kollha, Zyprexa fil- forma ta ’ pilloli u bħala injezzjonijiet kien effikaċi iktar mill - plaċebo fit- titjib tas- sintomi.
Zyprexa tablets were at least as effective as the medicines they were compared with for the treatment of schizophrenia (haloperidol), the treatment of moderate to severe manic episodes (haloperidol and valproate), and the prevention of recurrence in patients with bipolar disorder (lithium).
Ta ’ l- inqas, il- pilloli ta ’ Zyprexa kienu effikaċi daqs il- mediċini li tqabblet magħhom għat- trattament ta ’ l- iskizofrenija (haloperidol), għat- trattament ta ’ każijiet manijaċi moderati sa severi (haloperidol u valproate), u dawk biex ma jħallux pazjenti b’ disturbi bipolari jirkadu (litju).
The injection was also shown to be more effective than lorazepam (at a relatively low dose) in manic patients, and as effective as haloperidol in schizophrenia.
L- injezzjoni kienet ukoll iktar effikaċi minn lorazepam (f’ doża relattivament baxxa) f’ pazjenti manijaċi, u effikaċi daqs haloperidol fl- iskizofrenija.
What is the risk associated with Zyprexa?
X’ inhu r- riskju assoċjat ma ’ Zyprexa?
The most common side effects with Zyprexa (seen in more than 1 patient in 10) are somnolence (sleepiness), weight gain and raised levels of prolactin (a hormone).
L- iktar effetti sekondarji komuni (li dehru f’ iktar minn pazjent wieħed minn kull 10) ta ’ Zyprexa huma l- ħedla tan- ngħas, żieda fil- piż u żieda fil- livelli ta ’ prolattina (ormon).
For the full list of all side effects reported with Zyprexa, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtata b’ Zyprexa, ara l- Fuljett ta ’ Tagħrif.
Zyprexa should not be used in people who may be hypersensitive (allergic) to olanzapine or any of the other ingredients.
Zyprexa m’ għandux jintuża minn persuni allerġiċi għal olanzapine jew għal xi sustanzi oħra tiegħu.
Zyprexa should not be used in patients at risk of narrow-angle glaucoma (raised pressure inside the eye).
Zyprexa m’ għandux jintuża minn pazjenti li jkollhom riskju ta ’ narrow- angle glaucoma (pressjoni għolja ġol- għajn).
Why has Zyprexa been approved?
Għaliex ġie approvat Zyprexa?
The Committee for Medicinal Products for Human Use (CHMP) decided that Zyprexa’ s benefits are greater than its risks, in adults, 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, the prevention of recurrence in patients with bipolar disorder, and for the injection, the rapid control of agitation or disturbed behaviour in patients with schizophrenia or a manic episode, when oral therapy is not appropriate.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Zyprexa għandu iktar benefiċċji milli riskji meta tintuża fl- adulti għat- trattament ta ’ l- iskizofrenija, inkluż iż- żamma ta ’ titjib kliniku waqt it- terapija ta ’ kontinwazzjoni f’ pazjenti li jkunu wrew rispons inizjali għat - trattament, fit- trattament ta ’ każijiet manijaċi minn moderati sa severi, biex pazjenti b’ disturbi bipolari ma jirkadux, u, fil- każ ta ’ l- injezzjoni, il- kontroll rapidu ta ’ l- aġitazzjoni jew ta ’ l- imġiba disturbata f’ pazjenti bl- iskizofrenija jew f’ każijiet manijaċi, meta t- terapija orali ma tkunx adatta.
The Committee recommended that Zyprexa be given marketing authorisation.
Il- Kumitat irrakkomanda li Zyprexa jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Zyprexa:
Aktar tagħrif dwar Zyprexa:
The European Commission granted a marketing authorisation valid throughout the European Union to Eli Lilly Nederland BV for Zyprexa on 27 September 1996.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha lil Eli Lilly Nederland BV għal Zyprexa fis- 27 ta ’ Settembru 1996.
The marketing authorisation was renewed on 27 September 2001 and on 27 September 2006.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fis- 27 ta ’ Settembru 2001 u fis- 27 ta ’ Settembru 2006.
The full EPAR for Zyprexa is available here.
L- EPAR sħiħ dwar Zyprexa huwa disponibbli minn hawn.
ZYPREXA 2.5 mg coated tablets
ZYPREXA 2. 5 mg pilloli miksija.
Each coated tablet contains 2.5 mg olanzapine.
Kull pillola miksija għandha 2. 5 mg olanzapine.
For a full list of excipients, see section 6.1.
Kull pillola miksija fiha 102 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Round, white, coated tablets imprinted with “ LILLY” and a numeric identicode “ 4112”.
Pilloli, tondi, bojod u miksijin, stampati b '"LILLY" u b' kodiċi ta' l- identità numeriku "4112".
1.5%, respectively).
Fi studji kliniċi kkontrollati bil- plaċebo (li damu minn 6 sa 12- il ġimgħa), fuq pazjenti anzjani (età medja 78 sena) li kellhom psikożi relatata mad- demenzja u/ jew disturbi fil- komportament, kien hemm żieda ta ’ darbtejn akbar fl- inċidenza ta ’ mwiet fil- pazjenti ttrattati b' olanzapine, mqabbla ma ’ pazjenti ttrattati bil- plaċebo (3. 5% kontra 1. 5%, rispettivament).
0.4%, respectively).
Kien hemm żieda ta ’ 3 darbiet akbar ta ’ CVAE f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċebo (1. 3% kontra 0. 4U%, rispettivament).
3 CVAE in association with olanzapine treatment.
3 ċerebro- vaskulari, kellhom fatturi ta ’ riskju li kienu jeżistu minn qabel.
4 myeloproliferative disease.
4 jikkawżaw newtropenja, f' pazjenti b ’ passat ta 'tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal - mudullun minħabba t- teħid ta' xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
Lactose ZYPREXA tablets contain lactose.
5 Lactose Il- pilloli ZYPREXA fihom l- lactose.
5 4.5 Interaction with other medicinal products and other forms of interaction
Studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott saru fl - adulti biss.
Interaction studies have only been performed in adults.
Potenzjal t' interazzjonijiet ma 'olanzapine U
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.
Minħabba li olanzapine hija metaboliżżata b 'CYP1A2, sustanzi li jistgħu speċifikament jikkaġunaw jew jinibixxu din l- iżoenzima jistgħu 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.
Il- metaboliżmu ta’ olanzapine jista 'jiġi kkawżat mit- tipjip u b' carbamazepine, li jistgħu jwasslu għal tnaqqis fil- konċentrazzjoni ta 'olanzapine.
Inhibition of CYP1A2 Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Fluvoxamine, inibitur speċifiku ta' CYP1A2, deher li jinibixxi sinifikatament il- metaboliżmu ta 'olanzapine.
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.
Faħam attivat inaqqas il- biodisponibilità ta 'olanzapine li tittieħed mill- ħalq b' 50 sa 60% u għandu jittieħed għal ta 'l- inqas sagħtejn qabel jew wara olanzapine.
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 mediċinali oħra U
Olanzapine does not inhibit the main CYP450 isoenzymes in vitro (e. g.
Olanzapine jista 'jantagonizza l- effetti ta' l- antagonisti ta ’ dopamine diretti jew indiretti.
Very common
7
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4)
Aċċessjonijiet li fil - maġġoranza tagħhom kien rrappurtat passat mediku ta 'aċċessjonijiet jew fatturi tar- riskju għall - aċċessjonijiet Sindromu Newrolettiku Malinn (ara sezzjoni 4. 4) Distonja (tinkludi okuloġirazzjoni) Diskineżja tardiva Sintomi ta' twaqqif tal - kura7
Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7 Cardiac disorders Vascular disorders
Disturbi vaskulari
Increased alkaline phosphatase
Żieda f' alkaline phosphatase
Clinically significant weight gain was observed
osservata żieda fil- piż, klinikament sinifikanti, fil- linja bażi ta ’ l- Indiċi tal- Massa tal- Ġisem P PĠiet
across all baseline Body Mass
(Body Mass Index - BMI), fil- kategoriji kollha.
8 3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (≥ 6.2 mmol/ l).
3 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 5. 17 mmol/ l) li żdiedu għal għoljin (≥ 6. 2 mmol/ l).
Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
Espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 48 ġimgħa) Il- proporzjon ta ’ pazjenti li kellhom tibdil avvers, klinikament sinifikanti fiż- żieda fil- piż, fil- glucose, fil- kolesterol totali/ LDL/ HDL jew trigliċeridi żdied maż- żmien.
Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
9 Tagħrif addizzjonali dwar popolazzjonijiet speċjali Fi studji kliniċi f’ pazjenti anzjani bid- demenzja, trattament b' olanzapine kien assoċjat ma ’ inċidenza ogħla ta ’ mwiet u reazzjonijiet avversi ċerebro- vaskulari meta mqabbla mal- plaċebo (ara wkoll sezzjoni 4. 4).
9 The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
It- tabella li ġejja tiġbor fil- qosor ir- reazzjonijiet avversi rrapportati b' frekwenza akbar f' pazjenti adolexxenti (minn 13 sa 17- il sena) milli f' pazjenti adulti jew reazzjonijiet avversi li ġew identifikati biss waqt studji kliniċi ta ’ terminu qasir f' pazjenti adolexxenti.
The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
L- ammont ta ’ żieda fil- piż u l - proporzjon ta ’ pazjenti adolexxenti li kellhom żieda fil- piż klinikament sinifikanti kienu akbar b’ espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 24 ġimgħa) milli b’ espożizzjoni għal perijodu qasir ta’ żmien..
With long-term exposure (at least 24 weeks), approximately half of adolescent patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
B’ espożizzjoni għal perijodu twil ta ’ żmien (għallinqas 24 ġimgħa) kważi nofs il- pazjenti adolexxenti żiedu ≥ 15% u kważi terz żiedu ≥ 25% mill- piż bażilari
10 Observed for fasting normal levels at baseline (< 1.016 mmol/ l) which increased to high (≥ 1.467 mmol/ l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/ l - < 1.467 mmol/ l) to high (≥ 1.467 mmol/ l).
Fost il- pazjenti adolexxenti, il- medja taż- żieda fil- piż kienet l- iżjed f’ pazjenti li bħala piż bażilari kellhom piż żejjed jew kienu obeżi.
10 Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Trattament sintomatiku u l- monitoraġġ tal- funzjoni ta 'l- organi vitali għandhom isiru skond il- qagħda klinika, inkluż it- trattament għall- pressjoni baxxa u kolass taċ- ċirkolazzjoni u sosteniment pulmonari.
N05A H03.
Grupp farmako- terapewtiku: antipsikotiku, kodiċi ATC N05A H03.
Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Studji elettrofiżjoloġiċi wrew illi olanzapine selettivament naqqas l- attività mesolimbiċi tan- newroni dopaminerġiċi (A10)
Olanzapine also
Fit- tieni studju ta '12- il xhar dwar ir- rikorrenza preventiva f' pazjenti b' episodju ta' manija li kienu U
11 showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
ikkontrollati b’ olanzapine u l- lithium flimkien, kienu mbgħad mqassmin mingħajr għażla u mogħtija U
In a second 12-month recurrence prevention study in manic episode patients who achieved remission with a combination of olanzapine and lithium and were then randomised to olanzapine or lithium alone, olanzapine was statistically non-inferior to lithium on the primary endpoint of bipolar recurrence (olanzapine 30.0%, lithium 38.3%; p = 0.055).
olanzapine jew il- lithium waħdu. Olanzapine kien statistikament mhux inferjuri għall- lithium fuq l - għan ewlieni ta 'rikorrenza bipolari (olanzapine 30. 0%, lithium 38. 3%; p = 0. 055).
12 The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Il- clearance ta’ olanzapine mill- plażma huwa anqas f' pazjenti anzjani f' paragun ma 'suġġetti żgħar, fin - nisa f' paragun ma' l- irġiel, u f' dawk li ma jpejpux f' paragun ma 'dawk li jpejpu.
Tablet core Lactose monohydrate Hyprolose Crospovidone Microcrystalline cellulose Magnesium stearate
Il- qalba tal- pillola Lactose monohydrate Hyprolose Crospovidone Microcrystalline cellulose Magnesium stearate
Tablet coat Hypromellose Color mixture white (hypromellose, titanium dioxide E171, macrogol, polysorbate 80) Carnauba wax Edible blue ink (shellac, macrogol, propylene glycol, indigo carmine E132)
Il- kisja tal- pillola Hypromellose Kulur tat- taħlita abjad (hypromellose, titanium dioxide E171, macrogol, polysorbate 80) Carnauba wax
Store in the original package in order to protect from light and moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa 'mid- dawl u mill- umdità.
Cold-formed aluminium blister strips in cartons of 28, 35, 56 or 70 tablets per carton.
Strixxi ta ’ folji ta 'l- aluminju cold- formed f' kartuni ta' 28, 35, 56 jew 70 pillola kull kartuna.
EU/ 1/ 96/ 022/ 002 - ZYPREXA - 2.5 mg - coated tablets - 28 tablets, per box.
EU/ 1/ 96/ 022/ 002 – ZYPREXA - 2. 5 mg – pilloli miksija – 28 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 019 - ZYPREXA - 2.5 mg - coated tablets - 56 tablets, per box.
EU/ 1/ 96/ 022/ 019 – ZYPREXA - 2. 5 mg – pilloli miksija – 56 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 023 - ZYPREXA - 2.5 mg - coated tablets - 35 tablets, per box.
EU/ 1/ 96/ 022/ 023 – ZYPREXA - 2. 5 mg – pilloli miksija – 35 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 029 - ZYPREXA - 2.5 mg - coated tablets - 70 tablets, per box.
EU/ 1/ 96/ 022/ 029 – ZYPREXA - 2. 5 mg – pilloli miksija – 70 pillola, kull kaxxa.
27 September 1996 Date of latest renewal:
27 ta ’ Settembru 1996 Data ta ’ l- aħħar tiġdid:
27 September 2006
27 ta ’ Settembru 2006
ZYPREXA 5 mg coated tablets
ZYPREXA 5 mg pilloli miksija.
Each coated tablet contains 5 mg olanzapine.
Kull pillola miksija għandha 5 mg olanzapine.
For a full list of excipients, see section 6.1.
Kull pillola miksija fiha 156 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Round, white, coated tablets imprinted with “ LILLY” and a numeric identicode “ 4115”.
Pilloli, tondi, bojod u miksijin, stampati b '"LILLY" u b' kodiċi ta' l- identità numeriku "4115".
There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo (1.3% vs.
Kien hemm żieda ta ’ 3 darbiet akbar ta ’ CVAE f’ pazjenti ttattati b' olanzapine, meta mqabblin ma ’ pazjenti ttrattati bil- plaċebo (1. 3% kontra 0. 4U%,
0.4%, respectively).
17 rispettivament).
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with
18 Newtropenja Għandha tittieħed kawtela f' pazjenti b 'numru baxx ta ’ lewkoċiti u/ jew numru baxx taċ- ċelluli newtrofili għal kwalunkwe raġuni, dawk il- pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw newtropenja, f' pazjenti b ’ passat ta' tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal - mudullun minħabba t- teħid ta 'xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
ZYPREXA tablets contain lactose.
Lactose Il- pilloli ZYPREXA fihom l- lactose.
19 4.5 Interaction with other medicinal products and other forms of interaction
Studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott saru fl - adulti biss.
Induction of CYP1A2 The metabolism of olanzapine may be induced by smoking and carbamazepine, which may lead to reduced olanzapine concentrations.
tnaqqis fil- konċentrazzjoni ta 'olanzapine.
Inhibition of CYP1A2 Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
Fluvoxamine, inibitur speċifiku ta' CYP1A2, deher li jinibixxi sinifikatament il- metaboliżmu ta 'U
Very common
21
22 3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (≥ 6.2 mmol/ l).
3 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 5. 17 mmol/ l) li żdiedu għal għoljin (≥ 6. 2 mmol/ l).
Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
23 Tagħrif addizzjonali dwar popolazzjonijiet speċjali Fi studji kliniċi f’ pazjenti anzjani bid- demenzja, trattament b' olanzapine kien assoċjat ma ’ inċidenza ogħla ta ’ mwiet u reazzjonijiet avversi ċerebro- vaskulari meta mqabbla mal- plaċebo (ara wkoll sezzjoni 4. 4).
23 The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
It- tabella li ġejja tiġbor fil- qosor ir- reazzjonijiet avversi rrapportati b' frekwenza akbar f' pazjenti adolexxenti (minn 13 sa 17- il sena) milli f' pazjenti adulti jew reazzjonijiet avversi li ġew identifikati biss waqt studji kliniċi ta ’ terminu qasir f' pazjenti adolexxenti.
Signs andsSymptoms Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Sintomi komuni ħafna meta ittieħdet doża eċċessiva (> 10% inċidenza) jinkludu takikardija, aġitazzjoni/ aggressività, diżartrija, sintomi ekstrapiramidali varji, u telf tas- sensi li tvarja minn sedazzjoni sa koma.
24 Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function.
Trattament sintomatiku u l- monitoraġġ tal- funzjoni ta 'l- organi vitali għandhom isiru skond il- qagħda klinika, inkluż it- trattament għall- pressjoni baxxa u kolass taċ- ċirkolazzjoni u sosteniment pulmonari.
Pharmacotherapeutic group: antipsychotic, ATC code N05A H03.
Grupp farmako- terapewtiku: antipsikotiku, kodiċi ATC N05A H03.
25 showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
ikkontrollati b’ olanzapine u l- lithium flimkien, kienu mbgħad mqassmin mingħajr għażla u mogħtija U
26 The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Il- clearance ta’ olanzapine mill- plażma huwa anqas f' pazjenti anzjani f' paragun ma 'suġġetti żgħar, fin - nisa f' paragun ma' l- irġiel, u f' dawk li ma jpejpux f' paragun ma 'dawk li jpejpu.
EU/ 1/ 96/ 022/ 004 - ZYPREXA - 5 mg - coated tablets - 28 tablets, per box.
EU/ 1/ 96/ 022/ 004 – ZYPREXA - 5 mg – pilloli miksija – 28 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 020 - ZYPREXA - 5 mg - coated tablets - 56 tablets, per box.
EU/ 1/ 96/ 022/ 020 – ZYPREXA - 5 mg – pilloli miksija – 56 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 024 - ZYPREXA - 5 mg - coated tablets - 35 tablets, per box.
EU/ 1/ 96/ 022/ 024 – ZYPREXA - 5 mg – pilloli miksija – 35 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 030 - ZYPREXA - 5 mg - coated tablets - 70 tablets, per box.
EU/ 1/ 96/ 022/ 030 – ZYPREXA - 5 mg – pilloli miksija – 70 pillola, kull kaxxa.
ZYPREXA 7.5 mg coated tablets
ZYPREXA 7. 5 mg pilloli miksija.
Each coated tablet contains 7.5 mg olanzapine.
Kull pillola miksija għandha 7. 5 mg olanzapine.
For a full list of excipients, see section 6.1.
Kull pillola miksija fiha 234 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Round, white, coated tablets imprinted with “ LILLY” and a numeric identicode “ 4116”.
Pilloli, tondi, bojod u miksijin, stampati b '"LILLY" u b' kodiċi ta' l- identità numeriku "4116".
ZYPREXA tablets contain lactose.
33 Lactose Il- pilloli ZYPREXA fihom l- lactose.
33 4.5 Interaction with other medicinal products and other forms of interaction
Studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott saru fl - adulti biss.
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).
34 Mhux rakkomandat l- użu konkomitanti ta 'olanzapine ma' prodotti mediċinali kontra l - Parkinson f' pazjenti bil- marda ta 'Parkinson u d- demenzja (ara sezzjoni 4. 4).
Very common
35
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4)
Aċċessjonijiet li fil - maġġoranza tagħhom kien irrappurtat passat mediku ta 'aċċessjonijiet jew fatturi tar- riskju għall - aċċessjonijiet Sindromu Newrolettiku Malinn (ara sezzjoni 4. 4) Distonja (tinkludi okuloġirazzjoni) Diskineżja tardiva Sintomi ta' twaqqif tal - kura7
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels8 1
Disturbi muskolu- skeltrali u tal- connective tissue Rabdomijoliżi Disturbi fil- kliewi u fis- sistema urinarja Eżitazzjoni urinarja Disturbi fis- sistema riproduttiva u fis- sider Prijapiżmu Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Astenja Għaja Edima Investigazzjonijiet Livelli elevati ta' prolactin fil- plażma 8 1
Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
37 Tagħrif addizzjonali dwar popolazzjonijiet speċjali Fi studji kliniċi f’ pazjenti anzjani bid- demenzja, trattament b' olanzapine kien assoċjat ma ’ inċidenza ogħla ta ’ mwiet u reazzjonijiet avversi ċerebro- vaskulari meta mqabbla mal- plaċebo (ara wkoll sezzjoni 4. 4).
39 showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
ikkontrollati b’ olanzapine u l- lithium flimkien, kienu mbgħad mqassmin mingħajr għażla u mogħtija U
5.2 Pharmacokinetic properties
40 5. 2 Tagħrif farmakokinetiku
EU/ 1/ 96/ 022/ 011 - ZYPREXA - 7.5 mg - coated tablets - 28 tablets, per box.
EU/ 1/ 96/ 022/ 011 – ZYPREXA - 7. 5 mg – pilloli miksija – 28 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 006 - ZYPREXA - 7.5 mg - coated tablets - 56 tablets, per box.
EU/ 1/ 96/ 022/ 006 – ZYPREXA - 7. 5 mg – pilloli miksija – 56 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 025 - ZYPREXA – 7.5 mg - coated tablets - 35 tablets, per box.
EU/ 1/ 96/ 022/ 025 – ZYPREXA - 7. 5 mg – pilloli miksija – 35 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 031 - ZYPREXA – 7.5 mg - coated tablets - 70 tablets, per box.
EU/ 1/ 96/ 022/ 031 – ZYPREXA - 7. 5 mg – pilloli miksija – 70 pillola, kull kaxxa.
ZYPREXA 10 mg coated tablets.
ZYPREXA 10 mg pilloli miksija.
Each coated tablet contains 10 mg olanzapine.
Kull pillola miksija għandha 10 mg olanzapine.
For a full list of excipients, see section 6.1.
Kull pillola miksija fiha 312 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Round, white, coated tablets imprinted with “ LILLY” and a numeric identicode “ 4117”.
Pilloli, tondi, bojod u miksijin, stampati b '"LILLY" u b' kodiċi ta' l- identità numeriku "4117".
47 4.5 Interaction with other medicinal products and other forms of interaction
Studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott saru fl - adulti biss.
Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
51 Tagħrif addizzjonali dwar popolazzjonijiet speċjali Fi studji kliniċi f’ pazjenti anzjani bid- demenzja, trattament b' olanzapine kien assoċjat ma ’ inċidenza ogħla ta ’ mwiet u reazzjonijiet avversi ċerebro- vaskulari meta mqabbla mal- plaċebo (ara wkoll sezzjoni 4. 4).
The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term 51 clinical trials in adolescent patients.
It- tabella li ġejja tiġbor fil- qosor ir- reazzjonijiet avversi rrapportati b' frekwenza akbar f' pazjenti adolexxenti (minn 13 sa 17- il sena) milli f' pazjenti adulti jew reazzjonijiet avversi li ġew identifikati biss waqt studji kliniċi ta ’ terminu qasir f' pazjenti adolexxenti.
53 showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
ikkontrollati b’ olanzapine u l- lithium flimkien, kienu mbgħad mqassmin mingħajr għażla u mogħtija U
5.2 Pharmacokinetic properties
54 5. 2 Tagħrif farmakokinetiku
Cold-formed aluminium blister strips in cartons of 7, 28, 35, 56 or 70 tablets per carton.
Strixxi ta ’ folji ta 'l- aluminju cold- formed f' kartuni ta' 7, 28, 35, 56 jew 70 pillola kull kartuna.
EU/ 1/ 96/ 022/ 008 - ZYPREXA - 10 mg - coated tablets - 7 tablets, per box.
EU/ 1/ 96/ 022/ 008 – ZYPREXA - 10 mg – pilloli miksija – 7 pilloli, kull kaxxa.
EU/ 1/ 96/ 022/ 009 - ZYPREXA - 10 mg - coated tablets - 28 tablets, per box.
EU/ 1/ 96/ 022/ 009 – ZYPREXA - 10 mg – pilloli miksija – 28 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 010 - ZYPREXA - 10 mg - coated tablets - 56 tablets, per box.
EU/ 1/ 96/ 022/ 010 – ZYPREXA - 10 mg – pilloli miksija – 56 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 026 - ZYPREXA - 10 mg - coated tablets - 35 tablets, per box.
EU/ 1/ 96/ 022/ 026 – ZYPREXA - 10 mg – pilloli miksija – 35 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 032 - ZYPREXA - 10 mg - coated tablets - 70 tablets, per box.
EU/ 1/ 96/ 022/ 032 – ZYPREXA - 10 mg – pilloli miksija – 70 pillola, kull kaxxa.
ZYPREXA 15 mg coated tablets
ZYPREXA 15 mg pilloli miksija.
Each coated tablet contains 15 mg olanzapine.
Kull pillola miksija għandha 15 mgolanzapine.
For a full list of excipients, see section 6.1.
Kull pillola miksija fiha 178 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Elliptical, blue, coated tablets debossed with “ LILLY” and a numeric identicode “ 4415”.
Pilloli, tondi, bojod u miksijin, stampati b '"LILLY" u b' kodiċi ta' l- identità numeriku "4415".
58 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
58 Tfal u adolexxenti Olanzapine mhux irrakkomandat għall- użu fit- tfal u fl- adolexxenti ta ’ taħt it- 18- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
59 CVAE in association with olanzapine treatment.
59 rispettivament).
60 myeloproliferative disease.
60 Newtropenja Għandha tittieħed kawtela f' pazjenti b 'numru baxx ta ’ lewkoċiti u/ jew numru baxx taċ- ċelluli newtrofili għal kwalunkwe raġuni, dawk il- pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw newtropenja, f' pazjenti b ’ passat ta' tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal - mudullun minħabba t- teħid ta 'xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
Use in children and adolescents under 18 years of age Olanzapine is not indicated for use in the treatment of children and adolescents.
61 L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Olanzapine mhux indikat għall- użu fil- kura tat- tfal u adolexxenti.
61 4.5 Interaction with other medicinal products and other forms of interaction
Studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott saru fl - adulti biss.
General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
62 Attività tas- CNS ġenerali Għandha tittieħed kawtela f' pazjenti li jixorbu l- alkoħol jew li jieħdu prodotti mediċinali li jistgħu jikkawżaw depressjoni tas- sistema nervuża ċentrali.
Very common
63
64 3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (≥ 6.2 mmol/ l).
3 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 5. 17 mmol/ l) li żdiedu għal għoljin (≥ 6. 2 mmol/ l).
Additional information on special populations In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher incidence of death and cerebrovascular adverse reactions compared to placebo (see also section 4.4).
65 Tagħrif addizzjonali dwar popolazzjonijiet speċjali Fi studji kliniċi f’ pazjenti anzjani bid- demenzja, trattament b' olanzapine kien assoċjat ma ’ inċidenza ogħla ta ’ mwiet u reazzjonijiet avversi ċerebro- vaskulari meta mqabbla mal- plaċebo (ara wkoll sezzjoni 4. 4).
65 The following table summarises the adverse reactions reported with a greater frequency in adolescent patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term clinical trials in adolescent patients.
It- tabella li ġejja tiġbor fil- qosor ir- reazzjonijiet avversi rrapportati b' frekwenza akbar f' pazjenti adolexxenti (minn 13 sa 17- il sena) milli f' pazjenti adulti jew reazzjonijiet avversi li ġew identifikati biss waqt studji kliniċi ta ’ terminu qasir f' pazjenti adolexxenti.