qanastek/EMEA-V3 huggingface dataset:
38 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.
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 b’ olanzapine, imbagħd kienu mogħtija mingħajr għażla olanzapine jew il- plaċebo, olanzapine wera superjorita sinifikanti u statistikament superjuri fuq il- plaċebo fuq l- għan ewlieni tar - rikorrenza bipolari.
Olanzapine also
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.
39 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
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
40 Olanzapine hija assorbita sew wara li tittieħed mill- ħalq, tilħaq l- ogħla konċentrazzjonijiet fil- plażma fi żmien 5 sa 8 sigħat.
In smoking subjects with mild hepatic dysfunction, 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).
40 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.
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
41 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.
Mutagenicity Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Olanzapine ma ikkawżatx mutaġeniċità jew klastoġeniċità f' firxa sħiħata 'testijiet standard, li nkludew testijiet ta' mutazzjoni tal- mikrobi kif ukoll testijiet fuq il- mammiferi kemm in vitro kif ukoll in vivo.
Polyvinyl alcohol Titanium dioxide E171 Talc E553b Lecithin soya E322 Xanthan gum E415
Alkol polivinil Diossidu tat- titanju E171 Terra E553b Leċitin tas- soja E322 Gomma Xantan E415
6.2 Incompatibilities
42 6. 2 Inkompatibilitajiet
Blister 7.5 mg
Folji 7. 5 mg
Tablet containers 7.5 mg 18 months
Konenituri tal- pilloli ta ’ 7. 5 mg
Olanzapine Mylan 7.5 mg film-coated tablets:
Olanzapine Mylan 2. 5 mg pilloli miksijin b’ rita:
Cold-formed aluminium/ aluminium blister in cartons of 28, 35, 56 & 70 film-coated tablets per carton.
Folji maħduma bierda ta ’ l- aluminju/ aluminju f’ kaxex ta ’ 28, 35, 56 & 70 pillola miksija b’ rita f ’ kull kaxxa.
Polypropylene tablet containers with tamper evident polyethylene closure containing 100 film-coated tablets per tablet container.
Kontenituri tal- pilloli tal- polipropilin b’ qafla li tikxef meta jsir xi tbagħbis li jkun fihom 100 pillola miksijin b’ rita f’ kull kontenitur tal- pilloli.
Olanzapine Mylan 10 mg film-coated tablets
OLANZAPINE MYLAN 10 mg pilloli miksijin b’ rita
Each film-coated tablet contains 10 mg olanzapine.
Kull pillola miksija b’ rita fiha 10 mg olanzapine.
For the 10 mg:
Sustanzi mhux attivi Għal dik ta ’ 10 mg:
304 mg lactose anhydrous per tablet.
304 mg anhydrous lactose kull pillola.
The film-coating of each 10 mg tablet contains 0.24 mg soya lecithin
Sustanzi mhux attivi Il- kisja b’ rita ta ’ kull pillola ta ’ 10 mg tablet fiha 0. 24 mg leċitin tas- soja.
10.2 mm, round, normal convex, white film-coated tablets debossed “ OZ 10 ” on one side and “ G” on the other side.
Pilloli ta ’ 10. 2 mm, tondi, mżaqqa normali, imnaqqxa b ’ “ OZ 10 ” fuq naħa waħda u b ’ “ G ” fuq in - naħa l- oħra.
44 During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/ day.
Waqt it- trattament għas- skiżofrenja, għal episodju ta 'manija u għall- prevenzjoni tar- rikorrenza fid - diżordni bipolari, d- dożaġġ ta' kuljum jista 'sussegwentement jiġi aġġustat fuq il- bażi ta' l- istat kliniku
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
45 inċidenza ta ’ l- imwiet kienet ogħla f’ dawk ittrattati b' olanzapine minn dik fil- pazjenti ttrattati bil - plaċebo, indipendentement minn dawn il- fatturi ta ’ riskju.
45 In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Fl- istess studji kliniċi, kienu rrapportati avvenimenti avversi ċerebro- vaskulari (CVAE eż puplesija, attakki iskemiċi momentanji) inklużi l- imwiet.
Olanzapine was started at 2.5 mg/ day and titrated to a maximum of 15 mg/ day based on investigator judgment.
Olanzapine nbeda b '2. 5 mg/ ġurnata u żdied bil- mod għall- massimu ta' 15 mg/ ġurnata ibbażat fuq il- ġudizzju tar- riċerkatur.
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
46 u/ jew AST elevati waqt it- trattament, għandha tiġi organiżżata investigazzjoni oħra u għandha tiġi kkunsidrata tnaqqis fid- doża.
46 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.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
47 Pressjoni baxxa mal- waqfien ġiet osservata rari fl- anzjani fil- provi kliniċi ta 'olanzapine.
47 Olanzapine tablets contain lactose monohydrate.
Lactose Il- pilloli OLANZAPINE fihom l- lactose.
Decreased bioavailability:
Biodisponibilità mnaqqsa U
Olanzapine showed no interaction when co-administered with lithium or biperiden.
48 Olanzapine ma wera ebda reazzjoni meta ttieħed flimkien ma ’ lithium jew biperiden.
48 There are no adequate and well-controlled studies in pregnant women.
Ma hemm ebda studji adegwati u kkontrollati sewwa f' nisa waqt it- tqala.
Immune system disorders Allergic reaction Metabolism and nutrition disorders Weight gain1
49 Newtropenja Disturbi fis- sistema immuni Reazzjoni allerġika Disturbi fil- metaboliżmu u n- nutrizzjoni Żieda fil- piż1
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
50 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
High creatine phosphokinase Increased total bilirubin
Creatine phosphokinase għoli Żieda fil- bilirubin totali
Increased alkaine phosphatase
Żieda f' alkaline phosphatase
50 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).
51 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).
51 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.
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).
52 10 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 1. 016 mmol/ l) li żdiedu għal għoljin (≥ 1. 467 mmol/ l) u tibdil fit- trigliċeridi waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 1. 016 mmol/ l - < 1. 467 mmol/ l) għal għoljin (≥ 1. 467 mmol/ l).
52 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.
53 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
Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours.
54 Olanzapine hija assorbita sew wara li tittieħed mill- ħalq, tilħaq l- ogħla konċentrazzjonijiet fil- plażma fi żmien 5 sa 8 sigħat.
54 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.
Acute (single-dose) toxicity Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain.
55 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.
Polyvinyl alcohol Titanium dioxide E171 Talc E553b Lecithin soya E322 Xanthan gum E415
Alkol polivinil Diossidu tat- titanju E171 Terra E553b Leċitin tas- soja E322 Gomma xantan E415
Blister 10 mg
Folji 10 mg 18- ilxahar
Tablet containers 10 mg 18 months
Kontenituri tal- pilloli 10 mg
Olanzapine Mylan 10 mg film-coated tablets:
Olanzapine Mylan 10 mg pilloli miksijin b’ rita:
Cold-formed aluminium/ aluminium blister in cartons of 7, 28, 35, 56 & 70 film-coated tablets per carton.
Folji maħduma bierda ta ’ l- aluminju/ aluminju f’ kaxex ta ’ 28, 35, 56 & 70 pillola miksija b’ rita f’ kull kaxxa.
Polypropylene tablet containers with tamper evident polyethylene closure containing 100 & 500 film- coated tablets per tablet container.
Kontenituri tal- pilloli tal- polipropilin b’ qafla li tikxef meta jsir xi tbagħbis li jkun fihom 100 u 500 pillola miksijin b’ rita f’ kull kontenitur tal- pilloli.
Olanzapine Mylan 15 mg film-coated tablets
OLANZAPINE MYLAN 15 mg pilloli miksijin b’ rita
Each film-coated tablet contains 15 mg olanzapine.
Kull pillola miksija b’ rita fiha 15 mgolanzapine.
For the 15 mg:
Sustanzi mhux attivi Għal dik ta ’ 15 mg:
183 mg lactose anhydrous per tablet.
183 mg anhydrous lactose kull pillola.
The film-coating of each 15 mg tablet contains 0.15 mg soya lecithin
Sustanzi mhux attivi Il- kisi b’ rita ta ’ kull pillola ta ’ 15 mg fiha 0. 15 mg leċitin tas- soja.
12.2 mm x 6.7 mm, elliptical, normal convex, white film-coated tablets debossed “ OZ 15 ” on one side and “ G” on the other side.
Pilloli ta ’ 12. 2 mm x 6. 7 mm, ellittiċi, mżaqqa normali, bojod miksijin b’ rita imnaqqxa b ’ “ OZ 15 ” fuq naħa waħda u b ’ “ G ” fuq in- naħa l- oħra.
58 During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/ day.
Waqt it- trattament għas- skiżofrenja, għal episodju ta 'manija u għall- prevenzjoni tar- rikorrenza fid - diżordni bipolari, d- dożaġġ ta' kuljum jista 'sussegwentement jiġi aġġustat fuq il- bażi ta' l- istat kliniku
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
59 inċidenza ta ’ l- imwiet kienet ogħla f’ dawk ittrattati b' olanzapine minn dik fil- pazjenti ttrattati bil - plaċebo, indipendentement minn dawn il- fatturi ta ’ riskju.
59 In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Fl- istess studji kliniċi, kienu rrapportati avvenimenti avversi ċerebro- vaskulari (CVAE eż puplesija, attakki iskemiċi momentanji) inklużi l- imwiet.
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
60 u/ jew AST elevati waqt it- trattament, għandha tiġi organiżżata investigazzjoni oħra u għandha tiġi kkunsidrata tnaqqis fid- doża.
60 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.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
61 Pressjoni baxxa mal- waqfien ġiet osservata rari fl- anzjani fil- provi kliniċi ta 'olanzapine.
61 Olanzapine tablets contain lactose monohydrate.
Lactose Il- pilloli OLANZAPINE fihom l- lactose.
Olanzapine showed no interaction when co-administered with lithium or biperiden.
62 Olanzapine ma wera ebda reazzjoni meta ttieħed flimkien ma ’ lithium jew biperiden.
62 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
63
63 Newtropenja Disturbi fis- sistema immuni Reazzjoni allerġika Disturbi fil- metaboliżmu u n- nutrizzjoni Żieda fil- piż1
Seizures where in most cases a history of seizures or risk factors
Livelli għolja ta 'kolesterol2, 3 Livelli għolja ta' glucose4 Livelli għolja ta 'trigliċeridi2, 5 Glikosurja Żieda fl- aptit
Cardiac disorders
Disturbi fis- sistema nervuża Sonnolenza Disturbi fil- qalb
Dyskinesia6
Sturdament Akatizja6 Parkinsoniżmu6 Diskineżja6
for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
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
64 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
64 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
2 Iż- żidiet medji fil- livelli tax- xaħmijiet waqt is- sawm (kolesterol totali, LDL kolesterol, u trigliċeridi) kienu ogħla f’ pazjent li fil- linja bażi ma wrewx evidenza ta ’ problemi fil- kontroll tax- xaħmijiet.
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 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 Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Tfal u adolexxenti Olanzapine mhux indikat għall- użu fit- tfal u pazjenti adolexxenti taħt it- 18- il sena.
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).
66 10 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 1. 016 mmol/ l) li żdiedu għal għoljin (≥ 1. 467 mmol/ l) u tibdil fit- trigliċeridi waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 1. 016 mmol/ l - < 1. 467 mmol/ l) għal għoljin (≥ 1. 467 mmol/ l).
66 There is no specific antidote for olanzapine.
Ma hemm ebda antidotu speċifiku għal olanzapine.
67 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 b’ olanzapine, imbagħd kienu mogħtija mingħajr għażla olanzapine jew il- plaċebo, olanzapine wera superjorita sinifikanti u statistikament superjuri fuq il- plaċebo fuq l- għan ewlieni tar - rikorrenza bipolari.
68 In smoking subjects with mild hepatic dysfunction, 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).
69 Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.
Olanzapine ma ikkawżatx mutaġeniċità jew klastoġeniċità f' firxa sħiħata 'testijiet standard, li nkludew testijiet ta' mutazzjoni tal- mikrobi kif ukoll testijiet fuq il- mammiferi kemm in vitro kif ukoll in vivo.
Polyvinyl alcohol Titanium dioxide E171 Talc E553b Lecithin soya E322 Xanthan gum E415
70 Terra E553b Leċitin tas- soja E322 Gomma xantan E415
Blister 15 mg
Folja 15 mg sentejn
Tablet containers 15 mg
Kontenituri tal- pilloli 15 mg
Olanzapine Mylan 15 mg film-coated tablets:
Olanzapine Mylan 15 mg pilloli miksijin b’ rita:
Cold-formed aluminium/ aluminium blister in cartons of 28, 35, 56 & 70 film-coated tablets per carton.
Folja maħduma bierda ta ’ l- aluminju/ aluminju f’ kaxex ta ’ 28, 35, 56 & 70 pillola miksija b’ rita f’ kull kaxxa.
Olanzapine Mylan 20 mg film-coated tablets
OLANZAPINE MYLAN 20 mg f’ pilloli miksijin b’ rita
Each film-coated tablet contains 20 mg olanzapine.
Kull pillola miksija b’ rita fiha 20 mg olanzapine.
Excipient
Sustanzi mhux attivi
For the 20 mg:
Għal dik ta ’ 20 mg:
244 mg lactose anhydrous per tablet.
244 mg lactose anhydrous kull pillola.
The film-coating of each 20 mg tablet contains 0.20 mg soya lecithin
Il- kisi b’ rita ta ’ kull pillola ta ’ 5 mg fiha 0. 20 mg leċitin tas- soja.
13.4 mm x 7.3 mm, elliptical, normal convex, white film-coated tablets debossed “ OZ 20 ” on one side and “ G” on the other side.
Pilloli ta ’ 13. 4 mm x 7. 3 mm, ellittiċi, mżaqqa normali, bojod miksijin b’ rita imnaqqxa b ’ “ OZ 20 ” fuq naħa waħda u b ’ “ G ” fuq in- naħa l- oħra.
72 During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/ day.
72 Waqt it- trattament għas- skiżofrenja, għal episodju ta 'manija u għall- prevenzjoni tar- rikorrenza fid - diżordni bipolari, d- dożaġġ ta' kuljum jista 'sussegwentement jiġi aġġustat fuq il- bażi ta' l- istat kliniku individwali minn 5 mg sa 20 mg/ ġurnata.
Risk factors that may predispose this patient population to increased mortality include age > 65 years, dysphagia, sedation, malnutrition and dehydration, pulmonary conditions (e. g., pneumonia, with or without aspiration), or concomitant use of benzodiazepines.
Il- fatturi ta ’ riskju li jistgħu jippredisponu dan il- grupp ta ’ pazjenti għal żieda fil- mortalità jinkludu l- età ta ’ > 65 sena, id- diffikulta biex wieħed
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
Madankollu, l - inċidenza ta ’ l- imwiet kienet ogħla f’ dawk ittrattati b' olanzapine minn dik fil- pazjenti ttrattati bil - plaċebo, indipendentement minn dawn il- fatturi ta ’ riskju.
73 In the same clinical trials, cerebrovascular adverse events (CVAE e. g., stroke, transient ischemic attack), including fatalities, were reported.
Fl- istess studji kliniċi, kienu rrapportati avvenimenti avversi ċerebro- vaskulari (CVAE eż puplesija, attakki iskemiċi momentanji) inklużi l- imwiet.
Caution should be exercised in patients with elevated ALT and/ or AST, in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic medicinal products.
74 AST elevati, f' pazjenti b' kundizzjonijiet li kienu hemm qabel, assoċjati b' riżerva funzjonali limitata tal - fwied, u f' pazjenti li qed ikunu trattati b' mediċini li jistu 'jkunu tossiċi għall- fwied.
In the event of elevated ALT and/ or AST during treatment, follow-up should be organised and dose reduction should be considered.
Fil- każ ta 'ALT u/ jew AST elevati waqt it- trattament, għandha tiġi organiżżata investigazzjoni oħra u għandha tiġi kkunsidrata tnaqqis fid- doża.
74 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.
Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
75 Pressjoni baxxa mal- waqfien ġiet osservata rari fl- anzjani fil- provi kliniċi ta 'olanzapine.
75 Olanzapine tablets contain lactose monohydrate.
Lactose Il- pilloli OLANZAPINE fihom l- lactose.
Olanzapine showed no interaction when co-administered with lithium or biperiden.
76 Olanzapine ma wera ebda reazzjoni meta ttieħed flimkien ma ’ lithium jew biperiden.
76 There are no adequate and well-controlled studies in pregnant women.
Ma hemm ebda studji adegwati u kkontrollati sewwa f' nisa waqt it- tqala.
Blood and the lymphatic system disorders
Disturbi tad- demm u tas- sistema limfatika 77
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
78 Alopeċja 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'
78 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).
Tagħrif addizzjonali dwar popolazzjonijiet speċjali 79 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).
79 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.
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).
80 10 Innotat għal livelli normali waqt is- sawm fil- linja bażi (< 1. 016 mmol/ l) li żdiedu għal għoljin (≥ 1. 467 mmol/ l) u tibdil fit- trigliċeridi waqt is- sawm mil- limitu tan- normal fil- linja bażi (≥ 1. 016 mmol/ l - < 1. 467 mmol/ l) għal għoljin (≥ 1. 467 mmol/ l).
80 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.
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 analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
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).
81 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
5.2 Pharmacokinetic properties
82 5. 2 Tagħrif farmakokinetiku
82 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.
Polyvinyl alcohol Titanium dioxide E171 Talc E553b Lecithin soya E322 Xanthan gum E415
84 Terra E553b Leċitin tas- soja E322 Gomma xantan E415
Blister 20 mg
Folji 20 mg sentejn
Tablet containers 20 mg
Kontenituri tal- pilloli 20 mg
Olanzapine Mylan 20 mg film-coated tablets:
Olanzapine Mylan 20 mg pilloli miksijin b’ rita:
Cold-formed aluminium/ aluminium blister in cartons of 28, 35, 56 & 70 film-coated tablets per carton.
Folja maħduma bierda ta ’ - aluminju/ aluminju f’ kaxex ta ’ 28, 35, 56 & 70 pillola miksija b’ rita f’ kull kaxxa.
85 ANNEX II
85 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Name and address of the manufacturers responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott U
McDermott Laboratories Ltd. t/ a Gerard Laboratories 35/ 36 Baldoyle Industrial Estate Grange road Dublin 13 Ireland
McDermott Laboratories Ltd. t- a Gerard Laboratories 35- 36 Baldoyle Industrial Estate Grange road Dublin 13 Irlanda
Mylan BV Dieselweg 25, 3752 LB, Bunschoten The Netherlands
Mylan BV Dieselweg 25, 3752 LB, Bunschoten L- Olanda
Mylan S. A. S 34, rue Saint Romain, 69359 Lyon Cedex 08 France
Mylan S. A. S 34, rue Saint Romain, 69359 Lyon Cedex 08 Franza
Mylan S. A. S ZAC des Gaulnes, 10, boulevard de lattre de Tassigny, 69330 Meyzieu France
Mylan S. A. S ZAC des Gaulnes, 10, boulevard de lattre de Tassigny, 69330 Meyzieu Franza
Pharma Pack Kft 2040 Hungary, Budaörs, Vasút u.13 Hungary
Pharma Pack Kft 2040 Hungary, Budaörs, Vasút u. 13 Ungerija
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Il- fuljett stampat tal- pakkett tal- prodott mediċinali għandu jsemmi l- isem u l- indirizz tal- manifattur responsabbli għar- rilaxx tal- kunsinna li tkun.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Medicinal product subject to medical prescription.
Prodott mediċinali suġġett għar- riċetta medika.
The MAH must ensure that the system of pharmacovigilance, as described in version 1.3 (21 April 2008) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market PSURs
Sistema ta ’ farmakoviġilanza Id- DAM għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 1. 3 (21 ta ’ April ta ’ l- 2008) ippreżentat fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għall- Ħruġ fis- Suq, qieghda fis- seħħ u taħdem qabel u waqt li l- prodott ikun fis- suq
The PSUR submission schedule for Olanzapine Mylan Film-coated tablets should follow the PSURs submission schedule for the reference medicinal product.
PSURs Il- preżentata ta ’ l- iskeda PSUR għall- pilloli miksija b’ rita ta ’ l- Olanzapine Mylan għandha ssir wara l - preżentata ta ’ skeda ta ’ PSURs għall- prodott mediċinali ta ’ referenza.
87 ANNEX III
87 ANNESS III
89 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
89 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Olanzapine Mylan 2.5 mg film-coated tablets Olanzapine
OLANZAPINE MYLAN 2. 5 mg pilloli miksijin b’ rita olanzapine
Each tablet contains 2.5 mg olanzapine.
Kull pillola miksija fiha 2. 5mg olanzapine
Contains lactose monohydrate and soya lecithin.
Fih il- monoidrat tal- lattożju u l- leċitin tas- soja.
28 film-coated tablets 35 film-coated tablets 56 film-coated tablets 70 film-coated tablets
28 pilloli miksijin b’ rita 35 pilloli miksijin b’ rita 56 pilloli miksijin b’ rita 70 pilloli miksijin b’ rita
Do not store above 25 °C.
Taħżnux f’ temperatura ‘ l fuq minn 25 °C.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIM I TA 'PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
Generics [UK] Limited Potters Bar, Hertfordshire, EN6 1TL, UK
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, UK
Olanzapine 2.5 mg
OLANZAPINE 2. 5 mg
91 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
91 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Olanzapine Mylan 2.5 mg tablets Olanzapine
OLANZAPINE MYLAN 2. 5 mg pilloli Olanzapine
92 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
92 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Olanzapine Mylan 5 mg film-coated tablets Olanzapine
OLANZAPINE MYLAN 5 mg pilloli miksijin b’ rita olanzapine
Each tablet contains 5 mg olanzapine.
Kull pillola miksija fiha 5 mg olanzapine
94 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
94 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Olanzapine Mylan 5 mg tablets Olanzapine
OLANZAPINE MYLAN 5 mg pilloli Olanzapine
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
95 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
95 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Olanzapine Mylan 7.5 mg film-coated tablets Olanzapine
OLANZAPINE MYLAN 7. 5 mg pilloli miksijin b’ rita olanzapine
Each tablet contains 7.5 mg olanzapine.
Kull pillola miksija fiha 7. 5mg olanzapine
Olanzapine 7.5 mg
OLANZAPINE 7. 5 mg
97 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
97 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER FOIL
FOLJI
Olanzapine Mylan 7.5 mg tablets Olanzapine
OLANZAPINE MYLAN 7. 5 mg pilloli Olanzapine
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
98 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Olanzapine Mylan 10 mg film-coated tablets Olanzapine
OLANZAPINE MYLAN 10 mg pilloli miksijin b’ rita olanzapine
Each tablet contains 10 mg olanzapine.
Kull pillola miksija fiha 10 mg olanzapine
7 film-coated tablets 28 film-coated tablets 35 film-coated tablets 56 film-coated tablets 70 film-coated tablets
7 pilloli miksijin b’ rita 28 pilloli miksijin b’ rita 35 pilloli miksijin b’ rita 56 pilloli miksijin b’ rita 70 pilloli miksijin b’ rita
Do not store above 25 °C 99 10.
Taħżnux f’ temperatura ‘ l fuq minn 25 °C.
100 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
100 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Olanzapine Mylan 10 mg tablets Olanzapine
OLANZAPINE MYLAN 10 mg pillola Olanzapine
101 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
101 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Olanzapine Mylan 15 mg film-coated tablets Olanzapine
OLANZAPINE MYLAN 15 mg pilloli miksijin b’ rita olanzapine
Each tablet contains 15 mg olanzapine.
Kull pillola miksija fiha 15 mg olanzapine
Do not store above 25 °C.
102 Taħżnux f’ temperatura ‘ l fuq minn 25 °C.
103 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
103 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Olanzapine Mylan 15 mg tablets Olanzapine
OLANZAPINE MYLAN 15 mg pillola Olanzapine
104 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
104 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Olanzapine Mylan 20 mg film-coated tablets Olanzapine
OLANZAPINE MYLAN 20 mg pilloli miksijin b’ rita olanzapine
Each tablet contains 20 mg olanzapine.
Kull pillola miksija fiha 20 mg olanzapine
106 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
106 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Olanzapine Mylan 20 mg tablets Olanzapine
OLANZAPINE MYLAN 20 mg pilloli Olanzapine
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
107 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
107 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
SECURITAINER LABEL AND CARTON LABEL
TABELLA TA ’ FUQ IL BOTT SIKUR U L- PAKKETT TA ’ BARRA
250 film-coated tablets 500 film-coated tablets
250 pilloli miksijin b’ rita 500 pilloli miksijin b’ rita
Do not store above 25 °C
Taħżnux f’ temperatura ‘ l fuq minn 25 °C.
Generics [UK] LimitedPotters Bar, Hertfordshire, EN6 1TL, UK
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, UK
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
109 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Contains lactose monohydrate.
Fih il- monoidrat tal- lattożju u l- leċitin tas- soja.
111 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
111 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
113 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
113 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
100 film-coated tablets 500 film-coated tablets
100 pilloli miksijin b’ rita 500 pilloli miksijin b’ rita
115 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
115 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
117 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
117 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
120 PACKAGE LEAFLET:
120 FULJETT TA 'TAGĦRIF:
Olanzapine Mylan 2.5 mg film-coated tablets Olanzapine Mylan 5 mg film-coated tablets Olanzapine Mylan 7.5 mg film-coated tablets Olanzapine Mylan 10 mg film-coated tablets Olanzapine Mylan 15 mg film-coated tablets Olanzapine Mylan 20 mg film-coated tablets
OLANZAPINE MYLAN 2. 5 mg, pilloli miksija OLANZAPINE MYLAN 5 mg, pilloli miksija OLANZAPINE MYLAN 7. 5 mg, pilloli miksija OLANZAPINE MYLAN 10 mg, pilloli miksija OLANZAPINE MYLAN 15 mg, pilloli miksija OLANZAPINE MYLAN 20 mg, pilloli miksija
Olanzapine
olanzapine
Do not pass it on to others.
M' għandekx tgħaddiha lill- persuni oħra.
It may harm them, even
Tista 'tagħmlilhom il -
if their symptoms are the same as yours.
ħsara, anki jekk ikollhom l- istess sintomi bħall tiegħek.
What Olanzapine Mylan is and what it is used for 2.
X’ inhi OLANZAPINE MYLAN u għalxiex tintuża 2.
Before you take Olanzapine Mylan 3.
3.
WHAT OLANZAPINE MYLAN IS AND WHAT IT IS USED FOR
X’ INHI OLANZAPINE MYLAN U GĦALXIEX TINTUŻA
Olanzapine belongs to a group of medicines called antipsychotics.
OLANZAPINE MYLAN tappartjeni għall- grupp ta 'mediċini msejħa antipsikotiċi.
Olanzapine is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
OLANZAPINE MYLAN hija użata biex tiġi kurata marda b' sintomi bħal li tisma ', li tara jew li tħoss affarijiet li mhux qegħdin hemm, twemmin żbaljat, suspetti mhux tas- soltu, u li tingħalaq fik innifsek.
People with this disease may also feel depressed, anxious or tense.
Nies b' din il- marda jistgħu wkoll iħossuhom imdejjqin, anzjużi jew taħt tensjoni.
Olanzapine is used to treat a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
OLANZAPINE MYLAN hija użata biex tiġi kkurata kundizzjoni b' sintomi bħal li tħossok fi stat ta 'ferħ eċċessiv, li jkollok ammonti ta' enerġija eċċessiva, li jkollok bżonn ħafna anqas irqgħad mis- soltu, li titkellem mgħaġġel b' ħafna ħsibijiet jiġru f' moħħok u xi kultant tista 'tirrita ruħek ħafna.
It is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with this condition.
Hija ukoll stabbiliżżatur tal- burdata li jipprevjeni li jerġa jkun hemm l- inkapaċità assoċjata mat- taqlib tal- burdata bejn stat ta 'ferħ jew dwejjaq eċċessiv assoċjat ma' din il- kundizzjoni.
BEFORE YOU TAKE OLANZAPINE MYLAN
QABEL MA TIEĦU OLANZAPINE MYLAN
Do not take Olanzapine Mylan
Tieħux OLANZAPINE MYLAN:
- if you are allergic (hypersensitive) to olanzapine, peanut or soya or any of the other ingredients
- jekk għandek allerġija (ipersensittività) għall- olanzapin, għall- karawett jew għas- soja jew għal xi
of Olanzapine Mylan An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
wieħed mill- ingredjenti ta ’ l- Olanzapine Mylan Reazzjoni allergika tintagħraf minn ponot, ħakk, wiċċ minfuħ, xuftejn minfuħin jew mill- qtugħ ta ’ nifs.
If this has happened to you, tell your doctor.
Jekk ġralek hekk, igħid lit- tabib tiegħek.
- if you have been previously diagnosed with eye problems such as certain kinds of glaucoma
Oqgħod attent ħafna b' OLANZAPINE MYLAN:
(increased pressure in the eye).
Jekk
If this
- Rari ħafna, mediċini ta 'dan it- tip jikkawżaw taħlita ta' deni, nifs mgħaġġel, għaraq, ebusija tal -
happens after you have been given Olanzapine Mylan tell your doctor.
Jekk jiġrilek hekk għid lit tabib tiegħek minnufih.
- Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating,
- L- użu ta ’ OLANZAPINE MYLAN f’ pazjenti anzjani bid- demenzja mhux irrakkomandat għax
muscle stiffness and drowsiness or sleepiness.
jista ’ jkollu effetti serji mhux mixtieqa.
- The use of olanzapine in elderly patients with dementia is not recommended as it may have
Jekk issoffri minn xi mard elenkat hawn taħt għid lit- tabib tiegħek mill- aktar fis possibli:
If you suffer from any of the following illnesses tell your doctor as soon as possible: • Diabetes • Heart disease • Liver or kidney disease • Parkinson’ s disease • Epilepsy • Prostate problems • A blocked intestine (Paralytic ileus) • Blood disorders • Stroke or “ mini” stroke (temporary symptoms of stroke)
• Dijabete • Mard tal- qalb • Mard tal- fwied jew tal- kliewi • Mard ta 'Parkinson • Epilessija • Problemi tal- prostata • Intestin ibblokkat (Ileus paralitiku) • Disturbi tad- demm • Puplesija jew puplesija “ ħafifa ” (sintomi temporanji ta' puplesija)
If you suffer from dementia, you or your carer/ relative should tell your doctor if you have ever had a stroke or “ mini” stroke.
Jekk tbati mid- demenzja, int jew min jieħu ħsiebek jew xi qarib għandu jgħid lit- tabUib tiegħek jekk qatt kellek xi puplesija jew puplesija “ żgħira ”.
As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Bħala prekawzjoni ta 'rutina, jekk għandek' l fuq minn 65 sena l- pressjoni tiegħek tista 'tiġi eżaminata mit- tabib tiegħek.
Olanzapine Mylan is not for patients who are under 18 years.
OLANZAPINE MYLAN mhux għal pazjenti li għandhom anqas minn 18- il sena.
Only take other medicines while you are on Olanzapine Mylan if your doctor tells you that you can.
Ħu biss mediċini oħra waqt li qed tieħu OLANZAPINE MYLAN jekk it- tabib tiegħek jgħidlek li tista ’.
You might feel drowsy if Olanzapine Mylan is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Jista 'jkun li tħossok imħeddel jekk tieħu OLANZAPINE MYLAN flimkien ma' anti- dipressanti jew mediċini għall- ansjetà jew biex jgħinuk torqod (kalmanti).
You should tell your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as it may be necessary to change your Olanzapine Mylan dose.
Għandek tgħarraf lit- tabib tiegħek jekk qed tieħu fluvoxamine (anti- dipressant), jew ciprofloxacin (antibijotiku), għax jista 'jkun hemm bżonn li tbiddel id- doża tiegħek ta' OLANZAPINE MYLAN.
Especially tell your doctor if you are taking medicines for Parkinson’ s disease.
Speċjalment għid lit- tabib tiegħek jekk qed tieħu mediċini għall- marda ta 'Parkinson.
Do not drink any alcohol if you have been given Olanzapine Mylan as olanzapine and alcohol together may make you feel drowsy.
Meta tieħu OLANZAPINE MYLAN ma ’ l- ikel u max- xorb Tixrobx alkoħol jekk qed tieħu OLANZAPINE MYLAN għax OLANZAPINE MYLAN u l- alkoħol flimkien jistgħu iħeddluk.
Tell your doctor as soon as possible if you are pregnant or think you may be pregnant.
Tqala u Treddigħ Għid lit- tabib tiegħek minnufih jekk inti inqbadt tqila jew jekk taħseb li inti tqila.
You should not take this medicine when pregnant, unless you have discussed this with your doctor.
M' għandekx tieħu din il- mediċina waqt it- tqala sakemm ma tkunx iddiskutejtha mat- tabib tiegħek.
You should not be given this medicine when breast-feeding, as small amounts of olanzapine can pass into breast milk.
M' għandekx tingħata din il- mediċina meta tkun qed tredda ’, għax ammonti żgħar ta ’ OLANZAPINE MYLAN jistgħu jgħaddu fil- ħalib tas- sider.
There is a risk of feeling drowsy when you are given Olanzapine Mylan.
Sewqan u tħaddim ta 'magni Hemm ir- riskju li tħossok imħeddel meta tingħata OLANZAPINE MYLAN.
If this happens do not drive or operate any tools or machines.
Jekk jiġrilek hekk issuqx u m' għandekx tagħmel użu minn għodda jew tħaddem magni.
Tell your doctor.
Għid lit- tabib tiegħek
122 Important information about some of the ingredients of Olanzapine Mylan
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'OLANZAPINE MYLAN:
Olanzapine Mylan contains lactose.
L- Olanzapine Mylan fih il- lattożju.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tieħek qallek li għandek intolleranza għal xi tip ta ’ zokkor, kellem lit- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali.
The tablet film-coating contains soya lecithin.
Il- kisja b’ rita tal- pillola fiha l- leċitin tas- soja.