qanastek/EMEA-V3 huggingface dataset:
66 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.
67 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
68 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 coat Hypromellose Colour mixture light blue (titanium dioxide E171, lactose monohydrate, hypromellose, triacetin, indigo carmine colour (E132)) Carnauba wax
Il- kisja tal- pillola Hypromellose Colour mixture light blue (titanium dioxide E171, lactose monohydrate, hypromellose, triacetin, indigo carmine colour (E132))
EU/ 1/ 96/ 022/ 012 - ZYPREXA - 15 mg - coated tablets - 28 tablets, per box.
EU/ 1/ 96/ 022/ 012 – ZYPREXA - 15 mg – pilloli miksija – 28 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 021 - ZYPREXA - 15 mg - coated tablets - 56 tablets, per box.
EU/ 1/ 96/ 022/ 021 – ZYPREXA - 15 mg – pilloli miksija – 56 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 027 - ZYPREXA - 15 mg - coated tablets - 35 tablets, per box.
EU/ 1/ 96/ 022/ 027 – ZYPREXA - 15 mg – pilloli miksija – 35 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 033 - ZYPREXA - 15 mg - coated tablets - 70 tablets, per box.
EU/ 1/ 96/ 022/ 033 – ZYPREXA - 15 mg – pilloli miksija – 70 pillola, kull kaxxa.
ZYPREXA 20 mg coated tablets
ZYPREXA 20 mg pilloli miksija.
Each coated tablet contains 20 mg olanzapine.
Kull pillola miksija għandha 20 mg olanzapine.
For a full list of excipients, see section 6.1.
Kull pillola miksija fiha 238 mg lactose monohydrate Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Pink, elliptical, coated tablets debossed with “ LILLY” and a numeric identicode, “ 4420”.
Pilloli, tondi, bojod u miksijin, stampati b '"LILLY" u b' kodiċi ta' l- identità numeriku "4420".
72 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
72 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.
73 CVAE in association with olanzapine treatment.
73 rispettivament).
74 myeloproliferative disease.
74 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.
75 L- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena Olanzapine mhux indikat għall- użu fil- kura tat- tfal u adolexxenti.
75 4.5 Interaction with other medicinal products and other forms of interaction
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.
76 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
77
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).
79 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).
81 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
Tablet coat Hypromellose Colour mixture pink (titanium dioxide E171, macrogol, lactose monohydrate, hypromellose, synthetic red iron oxide) Carnauba wax
Il- kisja tal- pillola Hypromellose Colour mixture light blue (titanium dioxide E171, lactose monohydrate, hypromellose, triacetin, indigo carmine colour (E132))
EU/ 1/ 96/ 022/ 014 - ZYPREXA - 20 mg - coated tablets - 28 tablets, per box.
EU/ 1/ 96/ 022/ 014 – ZYPREXA - 20 mg – pilloli miksija – 28 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 022 - ZYPREXA - 20 mg - coated tablets - 56 tablets, per box.
EU/ 1/ 96/ 022/ 022 – ZYPREXA - 20 mg – pilloli miksija – 56 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 028 - ZYPREXA - 20 mg - coated tablets - 35 tablets, per box.
EU/ 1/ 96/ 022/ 028 – ZYPREXA - 20 mg – pilloli miksija – 35 pillola, kull kaxxa.
EU/ 1/ 96/ 022/ 034 - ZYPREXA - 20 mg - coated tablets - 70 tablets, per box.
EU/ 1/ 96/ 022/ 034 – ZYPREXA - 20 mg – pilloli miksija – 70 pillola, kull kaxxa.
ZYPREXA 10 mg powder for solution for injection
ZYPREXA 10 mg trab għal soluzzjoni għall- injezzjoni.
Each vial contains 10 mg olanzapine.
Kull fjala għandha 10 mg olanzapine.
After reconstitution each ml of the solution contains 5 mg olanzapine.
Wara r- rikostituzzjoni kull ml ta 'soluzzjoni fih 5 mg olanzapine.
Powder for solution for injection Yellow lyophilised powder.
Trab għal soluzzjoni għall- injezzjoni Trab isfar lajofilizzat.
Adults ZYPREXA powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate.
Adulti ZYPREXA trab li jinħall f’ soluzzjoni għall- injezzjoni hija jndikata għall- kontroll mgħaġġel ta 'l - aġitazzjoni u mġieba mħawda f' pazjenti bi skiżofrenja jew episodju ta' manija, meta t- terapija li tittieħed mill- ħalq ma tkunx xierqa.
Treatment with ZYPREXA powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.
Trattament b' ZYPREXA trab li jinħall f’ soluzzjoni għall - injezzjoni għandu jitwaqqaf u għandu jibda l- użu ta 'olanzapine mill- ħalq hekk kif ikun xieraq klinikament.
Adults For intramuscular use.
Adulti Ghal uzu intramuskolari.
Do not administer intravenously or subcutaneously.
Tagħtihx ġol- vina jew taħt il- ġilda.
ZYPREXA powder for solution for injection is intended for short term use only, for up to a maximum of three consecutive days.
ZYPREXA trab jinħall f’ soluzzjoni għall- injezzjoni huwa għal użu għal żmien qasir biss, għal massimu ta ’ tlett ġranet konsekuttivi.
The maximum daily dose of olanzapine (including all formulations of olanzapine) is 20 mg.
Id- doża massima ta ’ kuljum ta ’ olanzapine (inklużi l- kompożizzjonijiet kollha ta ’ olanzapine) hija ta ’ 20 mg.
The recommended initial dose for olanzapine injection is 10 mg, administered as a single intramuscular injection.
Id- doża tal- bidu rakkomandata għall- injezzjoni ta 'olanzapine hija 10 mg, tingħata bħala injezzjoni intramuskolari.
A lower dose (5 mg or 7.5 mg) may be given, on the basis of individual clinical status, which should also include consideration of medicinal products already administered either for maintenance or acute treatment (see section 4.4).
Tista 'tingħata doża anqas (5 mg jew 7. 5 mg), skond l- istat kliniku individwali li għandu jagħti kas tal- prodotti mediċinali li diġà ngħataw jew bħala manteniment tal- kura jew bħala kura akuta (ara sezzjoni 4. 4).
A second injection, 5-10 mg, may be administered 2 hours after the first injection on the basis of individual clinical status.
It- tieni injezzjoni, 5- 10 mg, tista 'tingħata sagħtejn wara l- ewwel injezzjoni skond l- istat kliniku individwali.
Not more than three injections should be given in any 24 hour period and the maximum daily dose of olanzapine of 20 mg (including all formulations) should not be exceeded.
F’ perijodu ta ’ 24 siegħa m’ għandhomx jingħataw iżjed minn tliet injezzjonijiet u d- doża massima ta 'kuljum ta ’ 20 mg ta' olanzapine (inklużi l - kompożizzjonijiet kollha) m’ għandhiex tinqabeż.
ZYPREXA powder for solution for injection should be reconstituted in accordance with the recommendation in section 6.6.
ZYPREXA trab għal soluzzjoni għall- injezzjoni għandha titħallat skond ir- rakkomandazzjonijiet f' sezzjoni 6. 6.
For further information on continued treatment with oral olanzapine (5 to 20 mg daily), see the Summary of Product Characteristics for ZYPREXA coated tablets or ZYPREXA VELOTAB orodispersible tablets.
Għal aktar tagħrif dwar it- tkomplija tat- trattament b' olanzapine orali (5 sa 20 mg kuljum), ara l - Karatteristiċi tal- Prodott fil- Qosor ta ’ ZYPREXA pilloli miksija jew ZYPREXA VELOTAB pilloli li jinħallu mill- ħalq.
Children and adolescents There is no experience in children.
86 Tfal u adolexxenti M’ hemm ebda esperjenza ta ’ użu fit- tfal.
ZYPREXA powder for solution for injection is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
ZYPREXA trab għal soluzzjoni għall- injezzjoni m’ hijiex rakkomandata li tintuża fit- tfal u fl- adolexxenti minħabba nuqqas ta ’ tagħrif dwar is- sigurtà u l - effikaċja.
86 Elderly The recommended starting dose in elderly patients (> 60 years) is 2.5 - 5 mg.
Anzjani Id- doża rakkomandata tal- bidu f' pazjenti anzjani (> 60 sena) hija 2. 5 – 5 mg.
Depending on the patient's clinical status (see section 4.4), a second injection, 2.5 - 5 mg, may be administered 2 hours after the first injection.
Skond l- istat kliniku tal - pazjent (ara sezzjoni 4. 4), it- tieni injezzjoni, 2. 5 – 5 mg tista 'tingħata sagħtejn wara l- ewwel injezzjoni.
Not more than 3 injections should be given in any 24 hour period and the maximum daily dose of 20 mg (including all formulations) of olanzapine should not be exceeded.
M' għandhomx jingħataw aktar minn 3 injezzjonijiet fi żmien 24 siegħa u d- doża massima ta ’ kuljum ta ’ 20 mg (imklużi l- kompożizzjonijiet kollha) ta ’ olanzapine m’ għandhiex tinqabeż.
Renal and/ or hepatic impairment A lower starting dose (5 mg) should be considered for such patients.
Indeboliment tal- kliewi u/ jew tal- fwied Għandha tiġi kunsidrata doża tal- bidu aktar baxxa (5 mg) għal dawn il- pazjenti.
In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
F' każijiet ta 'insuffiċjenza tal- fwied moderata (ċirrożi, Child Pugh Klassi A jew B), id- doża tal- bidu għandha tkun 5 mg u miżjuda biss b' attenzjoni.
Gender The dose and dose range need not be routinely altered for female patients relative to male patients.
Sess Id- doża tal- bidu u l- firxa tad- doża m' għandhomx għalfejn jinbidlu skond ir- rutina għall- pazjenti nisa f' paragun ma 'pazjenti rġiel abbażi tas- sess biss.
Smokers The dose and dose range need not be routinely altered for non-smokers relative to smokers.
Dawk li jpejpu Id- doża tal- bidu u l- ammont tad- doża m' għandhomx għalfejn jinbidlu skond ir- rutina għal dawk li ma jpejpux f' paragun 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 hemm aktar minn fattur wieħed li jista 'jirriżulta f' metaboliżmu aktar bil- mod (sess femminili, età ġerjatrika, individwu ma jpejjipx), għandha tingħata konsiderazzjoni biex titnaqqas id- doża.
Additional injections, when indicated, should be conservative in such patients.
Aktar injezzjonijiet, meta indikati, għandhom ikunu konservattivi f' dawn il- pazjenti.
4.3 Contraindications
4. 3 Kontra- Indikazzjonijiet
The efficacy of IM olanzapine has not been established in patients with agitation and disturbed behaviours related to conditions other than schizophrenia or manic episode.
L- effikaċja ta 'IM olanzapine ma kienitx stabbilita f' pazjenti b' aġitazzjoni u mġieba disturbata relatata ma' kundizzjonijiet oħra minbarra l- iskiżofrenja jew episodju ta 'manija.
Unstable medical conditions IM olanzapine should not be administered to patients with unstable medical conditions, such as acute myocardial infarction, unstable angina pectoris, severe hypotension and/ or bradycardia, sick sinus syndrome, or following heart surgery.
Kundizzjonijiet mediċi instabbli IM olanzapine m' għandiex tingħata lill- pazjenti li għandhom kundizzjonijiet mediċi mhux stabbli, bħall- infart akut tal- mijokardju, anġina pectoris mhux stabbli, pressjoni baxxa ħafna u/ jew bradikardja, sindromi tas- sinus marid, jew wara kirurġija tal- qalb.
If the patient’ s medical history with regard to these unstable medical conditions cannot be determined, the risks and benefits of IM olanzapine should be considered in relation to other alternative treatments.
Jekk il- passat mediku tal- pazjent relatat ma 'dawn il- kundizzjonijiet mediċi mhux stabbli ma jistax jiġi determinat, għandhom jiġu kkunsidrati r - riskji u l- benefiċji ta' IM olanzapine f' relazzjoni ma 'trattamenti oħra alternattivi.
Concomitant use of benzodiazepines and other medicinal products Special caution is necessary in patients who have received treatment with other medicinal products having haemodynamic properties similar to those of intramuscular olanzapine including other antipsychotics (oral and/ or intramuscular) and benzodiazepines (see section 4.5).
L- użu konkomitanti ta 'benżodijażepini u prodotti mediċinali oħra Hija meħtieġa attenzjoni speċjali f' pazjenti li ngħataw kura bi prodotti mediċinali oħra li għandhom kwalitajiet emodinamiċi simili għal dawk ta' olanzapine intramuskolari fosthom antipsikotiċi oħra (orali u/ jew intramuskolari) u beżodijażepini (ara sezzjoni 4. 5).
Temporal association of treatment with IM olanzapine with hypotension, bradycardia, respiratory depression and death has been very rarely (< 0.01%) reported particularly in patients who have received benzodiazepines and/ or other antipsychotics (see section 4.8).
Assoċjazzjoni temporali tal- kura b' olanzapine IM ma 'pressjoni baxxa, bradikardija, depressjoni respiratorja u mewt ġiet irraportata b' mod rari ħafna (< 0. 01%) speċjalment f' pazjenti li kienu ngħataw benżodijażepini u/ jew antipsikotiċi oħra (ara sezzjoni 4. 8).
Simultaneous injection of intramuscular olanzapine and parenteral benzodiazepine is not recommended (see sections 4.5 and 6.2).
Injezzjoni ta 'olanzapine intramuskolari flimkien ma' benżodijażepini parenterali ma kienux studjati u għalhekk mhux rakkomandati (ara sezzjonijiet 4. 5 u 6. 2).
If the patient is considered to need parenteral benzodiazepine treatment, this should not be given until at least one hour after IM olanzapine administration.
87 bżonn trattament bil- benżodijażepini parenterali, dan m' għandux jingħata sa ta 'l- anqas siegħa wara li tingħata IM olanzapine.
If the patient has received parenteral benzodiazepine, IM olanzapine administration should only be considered after careful evaluation of clinical status and the patient should be closely monitored for excessive sedation and cardiorespiratory depression.
Jekk il- pazjent irċieva benżodijażepin parenterali, IM olanzapine għandha tingħata wara evalwazzjoni b' reqqa ta 'l- istat kliniku u l- pazjent għandu jiġi osservat mill- qrib minħabba sedazzjoni eċċessiva u depressjoni kardjorespiratorja.
87 Hypotension It is extremely important that patients receiving intramuscular olanzapine should be closely observed for hypotension including postural hypotension, bradyarrhythmia and/ or hypoventilation, particularly for the first 4 hours following injection and close observation should be continued after this period if clinically indicated.
Pressjoni baxxa Huwa importanti ħafna li pazjenti li jirċievu olanzapine intramuskolari għandhom jiġu osservati bir - reqqa għall- pressjoni baxxa inkluża pressjoni baxxa mal- waqfien, bradyarrythmia u/ jew qtugħ ta 'nifs, speċjalment għal l- ewwel erba ’ sigħat wara l- injezzjoni u jekk huwa klinikament indikat din l - osservazzjoni bir- reqqa għanha titkompla anki wara dan il- perijodu.
Blood pressure, pulse, respiratory rate and level of consciousness should be observed regularly and remedial treatment provided if required.
Il- pressjoni, il- polz, ir- rata tan - nifs u l- livell kemm il- pazjent huwa f' sensieħ għandhom jiġu osservati b’ mod regolari u jekk hemm bżonn għandha tingħata kura ta ’ rimedju.
Patients should remain recumbent if dizzy or drowsy after injection until examination indicates that they are not experiencing hypotension including postural hypotension, bradyarrhythmia and/ or hypoventilation.
Il- pazjenti għandhom jibqgħu minduda jekk sturduti jew imħeddla wara l- injezzjoni sakemm l- eżami jindika li mhux qed jesperjenzaw pressjoni baxxa inkluża pressjoni baxxa mal- waqfien, bradyarrythmia u/ jew qtugħ ta 'nifs.
The safety and efficacy of IM olanzapine has not been evaluated in patients with alcohol or drug intoxication (either with prescribed or illicit drugs) (see section 4.5).
Is- sigurtà u l- effikaċja ta ’ IM olanzapine ma ġewx evalwati f’ pazjenti b’ intossikazzjoni alkoħolika jew jatroġenika (mediċinali mgħotija kemm mit- tabib u kemm b’ mod illegali) (ara sezzjoni 4. 5).
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Manifestazzjonijiet kliniċi ta 'NMS huma deni għoli, ebusija tal- muskoli, stat mentali alterat u evidenza ta' instabbiltà awtonomika (pressjoni tad- demm jew tal- polz irregolari, takikardija, dijaforeżi,
88 Appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus for which regular glucose control is recommended.
Għandu jingħata parir għal monitoraġġ kliniku xieraq speċjalment f' pazjenti li għandhom id- dijabete u f' pazjenti li għandhom fatturi ta 'riskju għall- iżvilupp ta ’ dijabete mellitus u li għalihom huwa rakkomandat li b’ mod regolari jiġi eżaminat iz- zokkor fid- demm.
Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during oral clinical trials revealed a low incidence of related events.
Attività antikolinerġika Waqt li olanzapine wera attività antikolinerġika in vitro, ersperjenza waqt il- provi kliniċi uriet inċidenza baxxa ta 'ġrajjiet relatati.
In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
F' każijiet fejn saret dijanjożi ta ’ l- epatite (li jinkludi ħsara fil- fwied epatoċellulari, kolestatitiku jew tat- tip imħallat), it- trattament ta 'olanzapine għandu jitwaqqaf.
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
Newtropenja Għandha tittieħed kawtela f' pazjenti b' numru baxx ta ’ lewkoċiti u/ jew numru baxx taċ- ċelluli newtrofili għal kwalunkwe raġuni, dawk il- pazjenti li qed jieħdu xi mediċini li huma magħrufa li jikkawżaw newtropenja, f' pazjenti b ’ passat ta 'tnaqqis fil- funzjoni tal- mudullun jew tossiċità tal - mudullun minħabba t- teħid ta' xi mediċina, f' pazjenti b' tnaqqis fil- funzjoni tal- mudullun minħabba xi marda konkomitanti, trattament bir- raġġi jew kimoterapija u f' pazjenti b' kundizzjonijiet b' numru għoli taċ- ċelluli eżinofili jew b' xi marda majeloproliferattiva.
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly (see section 4.8).
In- newtropenja kienet rappurtata spiss meta olanzapine u valproate intużaw flimkien (ara Sezzjoni 4. 8).
QT interval In clinical trials with oral administration, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
L- Intervall QT Fi studji kliniċi, żidiet fil- QTc li kienu klinikament sinifikanti (korrezzjoni fil- QT skond Fridericia [QTcF] U > 500 millisekondi [msek] f’ kwalunkwe ħin wara l- valur bażiku f’ pazjenti b’ valur bażiku ta ’ QTcF < 500 msek) ma kienux komuni (0. 1% sa 1%) f’ pazjenti kkurati b’ olanzapine, b’ ebda differenza sinifikattiva fl- avvenimenti assoċjati kardijaċi meta mqabbla ma ’ plaċebo.
Thromboembolism Temporal association of olanzapine treatment and venous thromboembolism has very rarely (< 0.01%) been reported..
89 Tromboemboliżmu B’ mod rari ħafna (< 0. 01%) ġiet irrapportata assoċjazzjoni temporali bejn il- kura b’ olanzapine u t - tromboemboliżmu fil- vini.
89 General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
Attività tas- CNS ġenerali Minħabba l- effetti primarji ta 'olanzapine fuq is- CNS għandha tittieħed kawtela meta dan jingħata flimkien ma' mediċini oħra li jaġixxu ċentralment u meta jittieħed ma 'l- alkoħol.
Tardive Dyskinesia In comparator oral 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 f' riżultat tat- trattament b' sinifikat statistikament validu.
Postural hypotension Postural hypotension was infrequently observed in the elderly in oral olanzapine clinical trials.
Pressjoni baxxa mal- waqfien Pressjoni baxxa mal- waqfien ġiet osservata rari fl- anzjani fil- provi kliniċi ta 'olanzapine.
IM olanzapine has not been studied in patients with alcohol or drug intoxication (see section 4.4).
IM olanzapine ma kienetx studjata f' pazjenti b' intossikazzjoni b' alkoħol jew drogi (ara sezzjoni 4. 4).
Caution should be exercised in patients who consume alcohol or receive medicinal products that can induce hypotension, bradycardia, respiratory or central nervous system depression (see section 4.4).
Għandha tittieħed attenzjoni f' pazjenti li jixorbu l- alkoħol jew li jingħataw prodotti mediċinali li jistgħu jinduċu pressjoni baxxa, bradikardja, tnaqqis fin- nifs jew depressjoni tas- sistema nervuża ċentrali (ara sezzjoni 4. 4).
Potential for interaction following intramuscular injection In a single dose intramuscular study of olanzapine 5 mg, administered 1 hour before intramuscular lorazepam 2 mg (metabolised by glucuronidation), the pharmacokinetics of both medicines were unchanged.
Potenzjal għal reazzjoni wara injezzjoni intramuskolari Fi studju ta 'doża waħda intramuskolari ta' olanzapine 5 mg, li ngħatat siegħa qabel lorazepam 2 mg mgħoti minn ġol- muskoli (metabolizzata b 'glukoronidazzjoni), il- komportament farmakokinetiku taż - żewġ mediċini ma kinux mibdula.
However, the combination added to the somnolence observed with either medicines alone.
Madankollu, it- teħid flimkien żiedet il- ħedla osservata meta dawn il- mediċini jittieħdu waħidhom.
Concomitant injection of olanzapine and parenteral benzodiazepine is not recommended (see sections 4.4 and 6.2).
Injezzjoni ta 'olanzapine flimkien ma' benzodijazepin parenterali ma kinietx studjata u għalhekk m' hijiex rakkomandata (ara sezzjonijiet 4. 4 u 6. 2).
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- iżoenżima jistgħu jaffettwaw il- komportament farmakokinetiku 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).
90 osservazzjoni klinika u tista 'tiġi kkunsidrata żjieda fid- doża ta' olanzapine jekk din tkun meħtieġa (ara Sezzjoni 4. 2).
90 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 (see section 6.2).
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' agonisti ta ’ dopamine diretti jew indiretti (ara sezzjoni 6. 2).
4.7 Effects on ability to drive and use machines
91 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
A common (1-10%) undesirable effect associated with the use of intramuscular olanzapine in clinical trials was somnolence.
Fi provi kliniċi, effett mhux mixtieq komuni (1- 10%) assoċjat ma ’ olanzapine mgħoti minn ġol - muskoli kien is- sonnolenza.
In post marketing reports, temporal association of treatment with IM olanzapine with cases of respiratory depression, hypotension or bradycardia and death have been very rarely reported, mostly in patients who concomitantly received benzodiazepines, and/ or other antipsychotic medicinal products or who were treated in excess of olanzapine recommended daily doses (see sections 4.4 and 4.5).
F’ rapporti ta ’ wara t- tqegħid fis- suq, b’ mod rari ġew irrapportati assoċjazzjoni temporali bejn il- kura b’ olanzapine mgħoti minn ġol- muskoli u każijiet ta ’ qtugħ ta ’ nifs, pressjoni baxxa tad- demm jew bradikardija u mewt, l- iżjed f’ pazjenti li rċevew fl- istess ħin benżodijażepini u/ jew prodotti mediċinali antipsikotiċi oħra jew li ġew ikkurati b’ dożi ta ’ kuljum ta ’ olanzapine li kienu iżjed minn dawk rakkomandati (ara sezzjoni 4. 4 u 4. 5).
91 The following table is based on the undesirable effects and laboratory investigations from clinical trials with ZYPREXA powder for solution for injection rather than oral olanzapine.
It- tabella li ġejja hija bbażata fuq l- effetti mhux mixtieqa u l- investigazzjonijiet fil- laboratorju minn provi kliniċi b’ ZYPREXA trab għal soluzzjoni għall- injezzjoni aktar minn b’ olanzapine orali.
Cardiac disorders Common (1-10%):
Disturbi kardijaċi Komuni (1- 10%):
Bradycardia with or without hypotension or syncope, tachycardia.
Bradikardija bi pressjoni baxxa jew mingħajrha jew sinkope, takikardja.
Uncommon (0.1-1%):
Mhux komuni (0. 1 - 1%):
Vascular Disorders Common (1-10%):
Pawża tas- sinus tal- qalb Disturbi vaskulari Komuni (1- 10%):
Respiratory disorders Uncommon (0.1-1%):
Pressjoni baxxa mal- waqfien, Pressjoni baxxa Disturbi tan- nifs Mhux komuni (0. 1 - 1%):
General disorders and administration site conditions Common (1-10%):
Qtugħ ta 'nifs Disturbi ġenerali u kundizzjonijiet tas- sit ta' fejn tingħata Komuni (1- 10%):
Injection site discomfort.
Skumdità ta 'fejn tingħata l- injezzjoni
The undesirable effects listed below have been observed following administration of oral olanzapine, but may also occur following administration of ZYPREXA powder for solution for injection.
L- effetti mhux mixtieqa mniżżla hawn isfel kienu osservati wara li ttieħdet olanzapine mill- ħalq, imma jistgħu jidhru wara li tittieħed ZYPREXA trab għal soluzzjoni għall- injezzjoni.
Very common
92
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration)
Aċċessjonijiet li fil - maġġoranza tagħhom kien irappurtat 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
Tardive dyskinesia Discontinuation symptoms7 Cardiac disorders Vascular disorders
Disturbi vaskulari
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
Disturbi muskolu- skeltrali u tal- connective tissue Rabdomijoliżi Disturbi fil- kliewi u fis- sistema urinarja Eżitazzjoni urinarja Disturbi fis- sistema riproduttiva u fis- sider Prijapiżmu Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Astenja Għeja Edima Investigazzjonijiet Livelli elevati ta' prolactin fil- plażma 8
93 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).
94 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).
94 Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2% of overdose cases) and cardiopulmonary arrest.
Sintomi oħra morbużi ta 'doża eċċessiva li huma medicament sinifikanti jinkludu delirju, konvulżjoni, koma, possibilment sindromu Newrolettiku Malinn, depressjoni respiratorja, aspirazzjoni fil- passaġġ respiratorju, pressjoni tad- demm għolja jew baxxa, taħbit tal- qalb irregolari (< 2% tal- każijiet ta' doża eċċessiva) u arrest kardjopulmonari.
Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
95 Olanzapine hija sustanza antipsikotika, kontra l- manija u stabilizzatur tal- burdata li turi profil farmakoloġiku ta 'firxa wiesa' ta 'sistemi ta' riċetturi.
In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5-HT2A/ 2C, 5-HT3, 5-HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors m1-m5; α -1 adrenergic; and histamine H1 receptors.
Fi studji ta 'qabel l- użu kliniku, olanzapine wera firxa ta' affinitajiet għar- riċetturi (Ki; < 100 nM) serotoniċi 5HT2A/ 2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5: riċetturi muskariniċi kolinerġiċi m1- m5; ∝ 1 adrenerġiċi; u riċetturi ta 'l- istamina H1.
Animal behavioural studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Studji fuq l- imġieba ta 'l- annimali li ingħataw olanzapine indikaw antagoniżmu għal 5HT, għal dopamine, u għal dak kolinerġiku, konsistenti mal - profil tar- riċettur li jorbot.
Olanzapine demonstrated a greater in-vitro affinity for serotonin 5-HT2 than dopamine D2 receptors and greater 5- HT2 than D2 activity in vivo, models.
Olanzapine wera affinità akbar in vitro għal serotonin 5HT2 milli għar - riċetturi ta ’ dopamine D2 u attività in vivo akbar għal 5HT2 milli għal D2.
In a single oral dose (10 mg) Positron Emission tomography (PET) study in healthy volunteers, olanzapine produced a higher 5-HT2A than dopamine D2 receptor occupancy.
Fi studju b' doża waħda orali (10 mg) fejn intużat it- tomografija bl- Emissjoni tal- Pozitroni (PET) f' voluntiera b' saħħithom, olanzapine ipproduċa okkupanza ta '5HT2A ogħla mir- riċettur ta ’ dopamine D2.
In two of two placebo and two of three comparator controlled trials with oral olanzapine in over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms.
Fi provi kkontrollati tnejn minn tnejn bil- plaċebo u tnejn minn tlieta bil- komparatur b' aktar minn 2, 900 pazjenti skiżofreniċi li għandhom kemm sintomi negattivi kif ukoll sintomi pożittivi, olanzapine kien assoċjat ma 'titjib akbar, statistikament sinifikanti, f' sintomi negattivi kif ukoll pożittivi.
In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary
F’ studju komparattiv, double- blind u multinazzjonali ta ’ skiżofrenija, ta ’ manifestazzjonijiet skiżoaffettivi u disturbi relatati oħra li kien jinkludi 1, 481 pazjent li kellhom gravità differenti fl - assoċjati sintomi dipressivi (medja ta ’ punteġg ta ’ 16. 6 meħud fil- bidu tal- kura skond l- iskala li tivvaluta d- dipressjoni ta ’ Montgomery- Asberg), analiżi prospettiva sekondarja tat- tibdil fil- punteġġ ta ’ l- atteġġament bejn il- bidu u fl- aħħar tal- kura wriet titjib statistikament sinifikanti (p=0. 001) favur olanzapine (- 6. 0) kontra haloperidol (- 3. 1).
In patients with manic or mixed episode of bipolar disorder, oral olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
F' pazjenti b' diżordni ta 'manija jew diżordni bipolari b' episodju mħallat, olanzapine wera effikaċja superjuri għall- plaċebo u għal valproate semisodium (divaproex) fit- tnaqqis ta' sintomi manijaċi f' aktar minn 3 ġimgħat.
Oral olanzapine also demonstrated comparable efficacy results to haloperidol in terms of the proportion of patients in symptomatic remission from mania and depression at 6 and 12 weeks.
Olanzapine wera wkoll riżultati effikaċji li jistgħu jiġu kumparati ma 'haloperidol fit - termini tal- proporzjon ta' pazjenti f' remissjoni sintomatika minn manija u depressjoni f '6 u 12- il ġimgħa.
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of oral olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
Fi studju ta 'terapija ta' pazjenti trattati flimkien b’ lithium jew b’ valproate għal minimu ta 'ġimgħatejn, iż- żjieda ta' olanzapine 10 mg (terapija flimkien ma ’ lithium jew valproate) wara 6 ġimgħat irriżultat f' tnaqqis akbar tas- sintomi tal- manija milli b' monoterapija b’ lithium jew b’ valproate.
In a 12-month recurrence prevention study in manic episode patients who achieved remission on olanzapine and were then randomised to olanzapine or placebo, olanzapine demonstrated statistically significant superiority over placebo on the primary endpoint of bipolar recurrence.
ikkontrollatiU bolanzapine, imbagħd kienu mogħtija mingħajr għażla olanzapine jew il- plaċebo, olanzapine wera superjorita sinifikanti u statistikament superjuri fuq il- plaċebo fuq l- għan ewlieni tar - rikorrenza bipolari. olanzapine uriet ukoll vantaġġ statistiku u sinifikanti fuq il- plaċebo fil - prevenzjoni, kemm f' attakki ġodda ta 'manija kif ukoll f' attakki ġodda ta' depressjoni.
Olanzapine also showed a statistically significant advantage over placebo in terms of preventing either recurrence into mania or recurrence into depression.
Fit- tieni studju ta '12- il xhar dwar ir- rikorrenza preventiva f' pazjenti b' episodju ta' manija li kienu 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).
5.2 Pharmacokinetic properties
96 5. 2 Tagħrif farmakokinetiku
In a pharmacokinetic study in healthy volunteers, a dose of 5 mg of ZYPREXA powder for solution for injection produced a maximum plasma concentration (Cmax) approximately 5 times higher than that seen with the same dose of olanzapine administered orally.
Fi studju farmakokinetiku f' voluntiera b' saħħithom, doża ta '5 mg ta' ZYPREXA trab jinħall f’ soluzzjoni għall- injezzjoni wasslet għal konċentrazzjoni massima tal- plażma (Cmax) bejn wieħed u ieħor 5 darbiet ogħla minn dik li dehret bl- istess doża ta 'olanzapine meħuda mill- ħalq.
The Cmax occurs earlier after intramuscular compared to oral use (15 to 45 minutes versus 5 to 8 hours).
Il- Cmax tintlaħaq qabel b’ użu intramuskolari kumparat ma ’ l- użu mill- ħalq (minn 15 sa 45 minuta kontra 5 sa 8 sigħat).
As with oral use, Cmax and area under the curve after intramuscular use are directly proportional to the dose administered.
Bħall- użu mill- ħalq, is- Cmax u l- erja taħt il- kurva wara użu intramuskolari huma direttament proporzjonali mad- doża mogħtija.
For the same dose of olanzapine administered intramuscularly and orally, the associated area under the curve, half-life, clearance and volume of distribution are similar.
Għall- istess doża ta 'olanzapine meħuda intramuskolari u mill- ħalq, l- erja taħt il- kurva assoċjata, il- half life tal- prodott, il- clearance u l- volum ta' distribuzzjoni huma simili.
The metabolic profiles following intramuscular and oral use are similar.
Il- profili metaboliċi wara l- użu tal- prodott intramuskolari u mill- ħalq huma simili.
In non-smoking versus smoking subjects (males and females) administered olanzapine intramuscularly the mean elimination half-life was prolonged (38.6 versus 30.4 hr) and the clearance was reduced (18.6 versus 27.7 l/ hr).
F' pazjenti li ma jpejpux f' paragun ma dawk li jpejpu (irġiel u nisa) mogħtija olanzapine ġol- muskoli il - medja tal- half life ta ’ l- eliminazzjoni twalet (38. 6 kontra 30. 4 sigħat) u l- clearance tnaqqset (18. 6 kontra 27. 7 l/ hr).
Additional pharmacokinetic data following administration of oral olanzapine are described below.
Aktar tagħrif farmakokinetiku wara teħid ta 'olanzapine mill- ħalq huwa deskritt hawn taħt.
Olanzapine is metabolised in the liver by conjugative and oxidative pathways.
Olanzapine hija metabolizzata fil- fwied minn metodi konjugattivi u ossidattivi.
In healthy elderly (65 and over) versus non-elderly subjects administered oral olanzapine, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/ hr).
F' anzjani b' saħħithom (65 u fuqhom) f' paragun ma 'pazjenti mhux anzjani, il- half life ta' l - eliminazzjoni medja twalet (51. 8 paragun ma '33. 8 siegħa) u t- tneħħija tnaqqset (17. 5 paragun ma' 18. 2 l/ hr).
The pharmacokinetic variability observed in the elderly is within the range for the non- elderly.
Il- varjabilità farmakokinetika osservata fl- anzjani hija fl- istess livell ta 'dawk li mhux anzjani.
96 In female versus male subjects administered oral olanzapine the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hrs) and the clearance was reduced (18.9 versus 27.3 l/ hr).
F 'pazjenti femminili f' paragun ma' dawk maskili l- medja tal- half life ta 'l- eliminazzjoni ġiet kemmxejn mtawla (36. 7 kontra 32. 3 sigħat) u t- tneħħija tnaqqset (18. 9 kontra 27. 3 l/ hr).
In renally impaired patients (creatinine clearance < 10 ml/ min) versus healthy subjects administered oral olanzapine, there was no significant difference in mean elimination half-life (37.7 versus 32.4 hr) or clearance (21.2 versus 25.0 l/ hr).
F' pazjenti b' mard tal- kliewi (tneħħija tal- krejatinina < 10 ml/ min) f' paragun ma 'pazjenti b' saħħithom, ma kienx hemm differenza sinifikanti fil- medja tal- half life ta' l- eliminazzjoni (37. 7 kontra 32. 4 siegħa) jew il- clearance (21. 2 kontra 25. 0 l/ hr).
In smoking subjects with mild hepatic dysfunction administered olanzapine orally, mean elimination half-life (39.3 hr) was prolonged and clearance (18.0 l/ hr) was reduced analogous to non-smoking healthy subjects (48.8 hr and 14.1 l/ hr, respectively).
F' pazjenti li jpejpu u għandhom disfunzjoni tal- fwied ħafifa, il- half life ta 'l- eliminazzjoni medja (39. 3 siegħa) twalet u t- tneħħija (18. 0 l/ hr) tnaqqset bħal f' pazjenti b' saħħithom li ma jpejpux (48. 8 siegħa u 14. 1 l/ hr, rispettivament).
The plasma protein binding of olanzapine was about 93% over the concentration range of about 7 to about 1,000 ng/ ml.
97 Ir- rabta mal- proteina fil- plażma ta 'olanzapine kienet madwar 93% fuq il- firxa tal- konċentrazzjoni ta' madwar 7 sa xi 1000 ng/ ml.
Olanzapine is bound predominantly to albumin and α 1-acid-glycoprotein.
Olanzapine hija fil- biċċa ’ l kbira marbuta ma 'l- albumina u ∝B1- acid - B
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent antipsychotic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
Sinjali ta 'tossiċità orali fir- rodenti kienu simili għas- sustanzi newrolettiċi qawwija: attività baxxa, koma, rogħda, konvulżjonijiet kloniċi, salivazzjoni, u tnaqqis fiż- żjieda tal- piż.
Clinical signs included sedation, ataxia, tremors, increased heart rate, laboured respiration, miosis, and anorexia.
Sinjali kliniċi inkludew sedazzjoni, atassja, rogħda, żjieda fir- rata tal- qalb, diffikultà fir- respirazzjoni, tidjiq tal- pupilla ta 'l- għajn, u l- anoreksja.
Haematologic toxicity Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found.
Tossiċità ematoloġika Effetti fuq il- parametri ematoloġiċi nstabu f' kull speċi, inklużi tnaqqis relatat mad- doża fil- lewkoċiti li jiċċirkolaw fil- ġrieden u tnaqqis mhux speċifiku fil- lewkoċiti li jiċċirkolaw fil- firien; madankollu, ma nstabet l- ebda prova ta 'ċitotossiċità tal- mudullun.
Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/ kg/ day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Newtropenja, tromboċitopenja jew l- anemija riversibbli żviluppaw fi ftit klieb ittrattati b '8 jew 10 mg/ kg/ ġurnata (espożizzjoni totali ta' olanzapine [erja taħt il- kurva] hija 12 sa 15- il darba aktar minn dik ta 'raġel mogħti doża ta' 12 mg).
In cytopenic dogs, there were no undesirable effects on progenitor and proliferating cells in the bone marrow.
Fi klieb fejn l- għadd taċ- ċelluli tad- demm huwa anqas minn normal, ma kien hemm ebda effetti avversi fuq ċelloli proġenituri u ċelloli proliferanti tal- mudullun.
In the offspring of rats given olanzapine, delays in foetal development and transient decreases in offspring activity levels were seen.
Fil- frieħ tal- firien mogħtija olanzapine, kienu osservati dewmien fl - iżvilupp tal- fetu u tnaqqis għal xi żmien fl- attività tal- frieħ.
97 Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and oral in vivo mammalian tests.
Olanzapine ma ikkawżatx mutaġeniċità jew klastoġeniċità f' firxa sħiħa ta 'testijiet standard, li nkludew testijiet ta' mutazzjoni tal- mikrobi kif ukoll testijiet fuq il- mammiferi kemm in vitro kif ukoll in vivo.
Carcinogenicity Based on the results of oral studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Ibbażat fuq riżultati ta 'studji fuq il- ġrieden u l- firien, kien konkluż li olanzapine mhuwiex kanċeroġeniku.
• Lactose monohydrate • Tartaric acid, E334 • Hydrochloric acid. • Sodium hydroxide.
• Lactose monohydrate • Tartaric acid, E334 • Hydrochloric acid. • Sodium hydroxide..
6.2 Incompatibilities
98 6. 2 Inkompatibilitajiet
Olanzapine for injection should not be combined in a syringe with diazepam injection because precipitation occurs when these products are mixed.
Olanzapine għall- injezzjoni m’ għandhiex titħallat f’ siringa ma ’ injezzjoni ta ’ diazepam għax meta dawn il- prodotti jitħalltu jkun hemm preċipitażżjoni.
Lorazepam injection should not be used to reconstitute olanzapine for injection as this combination results in a delayed reconstitution time.
Injezzjoni ta ’ lorazepam m’ għandhiex tiġi użata biex tiġi rikostitwita l- injezzjoni ta ’ olanzapine għax din it- taħlita ttawwal il- ħin ta ’ rikostituzzjoni.
Olanzapine for injection should not be combined in a syringe with haloperidol injection because the resulting low pH has been shown to degrade olanzapine over time.
Olanzapine għall- injezzjoni m’ għandhiex titħallat f’ siringa ma ’ injezzjoni ta ’ haloperidol għax ġie muri li maż- żmien il- pH baxx li jirriżulta minn din it- taħlita jnaqqas l- effett ta ’ olanzapine.
3 years.
6. 3 Zmien kemm idum tajjeb il- prodott mediċinali
Solution (after reconstitution):
Sentejn Soluzzjoni (wara li tiġi mħallta):
1 hour.
Siegħa.
Do not store above 25º C.
Taħżinx f' temperatura 'l fuq minn 25° C.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Għall - kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikostitwit, ara sezzjoni 6. 3.
Type I, 5 ml glass vial.
Fjala tal- ħġieġ tat- tip I, ta '5 ml.
One carton contains 1 or 10 vial(s).
Kartuna waħda għandha 1 jew 10 Fjala( i).
6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom meta jintrema
Reconstitute ZYPREXA only with water for injections using standard aseptic techniques for reconstitution of parenteral products.
Ħallat ZYPREXA ma 'ilma għall- injezzjonijiet biss billi tuża metodi asettiċi tas- soltu għat- taħlit ta' prodotti parenterali.
No other solutions should be used for reconstitution (see section 6.2).
Ebda soluzzjonijiet oħra m' għandhom jintużaw għat- taħlita (ara sezzjoni 6. 2).
Withdraw 2.1 ml of water for injection into a sterile syringe.
Iġbed 2. 1 ml ta 'ilma għall- injezzjonijiet f' siringa sterilizzata.
Inject into a vial of ZYPREXA.
Injetta fi fjala ta 'ZYPREXA
Rotate the vial until the contents have completely dissolved, giving a yellow coloured solution.
Dawwar il- fjala sakemm il- kontenut jinħall kompletament, f' soluzzjoni ta 'kulur isfar.
The vial contains 11.0 mg olanzapine as a solution of 5 mg/ ml (1 mg olanzapine is retained in the vial and syringe, thus allowing delivery of 10 mg olanzapine).
Il- fjala għandha 11. 0 mg olanzapine bħala soluzzjoni ta '5 mg/ ml (1 mg olanzapine tibqa fil- fjala u fis - siringa, b’ hekk tkun tista tinjetta 10 mg ta' olanzapine).
The following table provides injection volumes for delivering various doses of olanzapine:
It- tabella li ġejja tipprovdi volumi ta 'injezzjoni biex tagħti dożi varji ta' olanzapine:
Dose (mg) 10 7.5 5 2.5
Doża (mg) 10 7. 5 5 2. 5
Volume of injection (ml) 2.0 1.5 1.0 0.5
Volum ta 'injezzjoni (ml) 2. 0 1. 5 1. 0 0. 5
Administer the solution intramuscularly.
Agħti is- soluzzjoni intramuskolari.
Do not administer intravenously or subcutaneously.
Tagħtijhiex ġol- vina jew taħt il- ġilda.