qanastek/EMEA-V3 huggingface dataset:
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of 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.
87 iż ieda ta '10 mg ta' olanzapine (ko- terapija bil- litju jew b’ valproate) wasslet għ tnaqqis ikbar fis - - ż al sintomi tal- manija meta mqabbel mal- litju jew ma ’ valproate wara 6 ġ at. imgħ
Olanzapine orodispersible tablet is bioequivalent to olanzapine tablets, with a similar rate and extent of absorption.
Olanzapine jiġ assorbit tajjeb wara li jingħ oralment, u jilħ konċ
Olanzapine orodispersible tablets may be used as an alternative to olanzapine tablets.
entrazzjonijiet massimi fil- plażma
96 In healthy elderly (65 and over) versus non-elderly subjects, 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).
ħ Meta tqabblu anzjani (ta '65 sena jew iktar) f' saħithom ma' persuni mhux anzjani, il - half- life ta 'l - ħ eliminazzjoni terminali medja ttawlet (51. 8 u 33. 8 siegħ rispettivament) u r- rata ta' tneħija tnaqqset a (17. 5 u 18. 2 litru fis- siegħ rispettivament).
In renally impaired patients (creatinine clearance < 10 ml/ min) versus healthy subjects, 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).
88 ħ Meta tqabblu pazjenti bi problemi fil- kliewi (b' rata ta 'tneħija tal- kreatinina ta ’ inqas minn 10 ml/ min) ħ ma ’ persuni f' saħithom, ma kienx hemm differenza sinjifikanti fil- half- life ta' l- eliminazzjoni ħ terminali medja (37. 7 siegħ u 32. 4 siegħ rispettivament) jew fir- rata ta 'tneħija (21. 2 u 25. 0 litru fis -
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' persuni jpejpu bi problemi ħ tal- fwied, il - half- life ta 'l - eliminazzjoni terminali medja (39. 3 fief ħ siegħ kienet itwal u r - rata ta' tneħ ija (18. 0- il litru fis- siegħ tnaqqset meta mqabbla ma 'persuni
97 Haematologic toxicity:
ġ rieden u tnaqqis mhux speċ
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.
mutazzjonijiet batteriċu testijiet tal- mammiferi in vitro u in vivo. i
6.1 List of excipients
li
Mannitol Microcrystalline cellulose Crospovidone Low-substituted hydroxypropylcellulose Aspartame Calcium silicate Magnesium stearate
idx
6.3 Shelf life
Lactose monohydrate Powdered cellulose Pregelatinised maize starch Maize starch Colloidal anhydrous silica Magnesium stearate
Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blister packs (Al/ OPA/ Al/ PVC).
14, 28, 35, 56 jew 70 pillola f' kaxxa.
98 7.
jali.
Zalasta 7.5 mg orodispersible tablets
Zalasta 5 mg pilloli li jinħ fil- ħ
Each orodispersible tablet contains 7.5 mg olanzapine.
Kull pillola li tinħ fil- ħ fiha 5 mg olanzapine.
Each orodispersible tablet contains 0.75 mg aspartame.
Kull pillola fiha 0. 50 mg aspartame.
Orodispersible tablet.
Pillola li tinħ fil- ħ
Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
Il- pilloli huma tondi, kemxejn konvessi, isfar irħ amati bil- possibbiltà ta 'tikek individwali.
100 Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapine jista 'jittieħ ma' l- ikel jew fuq stonku vojt għ l- assorbiment tiegħ ma jiġ affettwat mill -
During antipsychotic treatment, improvement in the patient's clinical condition may take severa l days to some weeks.
Waqt trattament bl- antipsikotiċ titjib fil- kundizzjoni klinika tal- pazjent għ
101 duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
), fuq pazjenti anzjani (età medja 78 sena) li kellhom psikożrelatata mad - a i
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and relat ed conditions.
jippreskrivi għ pazjenti bi prostata kbira, jew paralytic ileus u kundizzjonijiet relatati. al
102 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Għ
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
95 Diskajneż Tardiva ja Fi studji ta ’ tqabbil li damu sena jew inqas, olanzapine kien assoċ ma 'inċ
103 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Il- pressjoni baxxa relatata mat- tibdil tal- poż izzjoni kienet osservata mhux frekwentement fl- anzjani fi studji kliniċb' olanzapine.
Aspartame Zalasta orodispersible tablets contain aspartame, a source of phenylalanine.
alq andha l- aspartame, li hija sors ta ’ phenylalanine.
May be harmful for people with phenylketonuria.
Tista ’ tkun ta ’ periklu għ nies b’ phenylketonuria. al
Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Ma ntweriex li l- farmakokinetika ta 'olanzapine tiġ affettwata minn fluoxetine (inibitur tas- CYP2D6), i dożwaħ i danin ta' sustanzi kontra l- aċ (aluminju, manjeż jew cimetidine.
104 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
tieġ ġ Is- sorveljanza terapewtika tal- livelli ta ’ valproate fil- plaż ma indikatx li hu meħ aġustament fid - ma doż ta 'valproate wara l- introduzzjoni ta' olanzapine fl- istess ħ a in.
Adults The most frequently (seen in ≥ 1% of patients) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases (see section 4.4), rash, asthenia, fatigue and oedema.
Adulti Fi studji kliniċ l- aktar reazzjonijiet avversi li ġ irrapportati b' mod frekwenti (jidhru f '> 1% tal -
The following table lists the adverse reactions and laboratory investigations observed from spontaneous reporting and in clinical trials.
pazjenti) u li huma assoċ ma 'l- uż ta' l- olanzapine kienu sonnolenza, ż fil- piżeosinofilja, livelli
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
eridi (ara sezzjoni 4. 4), glukosurja, ż fl- aptit, għ ta 'prolactin, kolesterol, glucose u trigliċ
Very common (≥
sturdament, akatiż parkinsoniż (ara sezzjoni 4. 4), diskineż pressjoni baxxa mal- waqfien, effetti
10%), common (≥ 1% and < 10%), uncommon (≥ 0.1% and < 1%), rare (≥ 0.01% and
It- termini ta 'frekwenza elenkati huma mfissra kif ġ Komuni ħ (> 10%), komuni (> 1% u <
< 0.1%), very rare (< 0.01%), not known (cannot be estimated from the data available).
10%), mhux komuni (> 0. 1% u < 1%), rari (> 0. 01% u < 0. 1%), rari ħ (< 0. 01%), mhux magħ (ma jistgħ jiġ stmati mill- informazzjoni li hemm disponibbli). ux u
Very common
afna
Common
rufa
Uncommon
Mhux magħrufa
Not known
olja
105 Metabolism and nutrition disorders Weight gain1
eridi Glikosurja Ż ieda fl- aptit
Nervous system disorders Somnolence
Aċessjonijiet li fil - ġ
Dizziness Akathisia6
maġoranza tagħ hom
6
6 mu 6
seizures or risk factors
kien rrappurtat passat
Dyskinesia
Diskineż ja
Orthostatic hypotension
Pressjoni baxxa mal -
Thromboembolism (including pulmonary embolism and deep vein thrombosis)
(inklużl- emboliż mu pulmonari u t- tromboż i
106 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
ma
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
99 Innotat għ livelli normali waqt is- sawm fil- linja baż (< 1. 69 mmol/ l) li ż 5
107 In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels.
Fi studju kliniku wieħ f' pazjenti b' manija bipolari, terapija b’ valproate flimkien ma 'olanzapine rriż
108 Signs and symptoms Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
aġitazzjoni/ agressività, dysarthria, diversi sintomi estrapiramidali, u tnaqqis fil- livell ta 'konoxxenza tal - pazjent li tvarja minn sedazzjoni għ koma. al
109 In a multinationational, 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).
l- iskala tad- dipressjoni Montgomery- Asberg), saret analiżsekondarja prospettiva tat- tibdil fil- punteġ tal - i ħ burdati mill- bażsa l- aħar u din uriet li kien hemm titjib statistikament sinjifikant (p=0. 001) favur i olanzapine (- 6. 0) meta mqabbel ma 'haloperidol (- 3. 1).
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of 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.
102 iż ieda ta '10 mg ta' olanzapine (ko- terapija bil- litju jew b’ valproate) wasslet għ tnaqqis ikbar fis - - ż al sintomi tal- manija meta mqabbel mal- litju jew ma ’ valproate wara 6 ġ at. imgħ
110 In healthy elderly (65 and over) versus non-elderly subjects, 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).
ħ Meta tqabblu anzjani (ta '65 sena jew iktar) f' saħithom ma' persuni mhux anzjani, il - half- life ta 'l - ħ elimi nazzjoni terminali medja ttawlet (51. 8 u 33. 8 siegħ rispettivament) u r- rata ta' tneħija tnaqqset a (17. 5 u 18. 2 litru fis- siegħ rispettivament).
In renally impaired patients (creatinine clearance < 10 ml/ min) versus healthy subjects, 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).
103 ħ Meta tqabblu pazjenti bi problemi fil- kliewi (b' rata ta 'tneħija tal- kreatinina ta ’ inqas minn 10 ml/ min) ħ ma ’ persuni f' saħithom, ma kienx hemm differenza sinjifikanti fil- half- life ta' l- eliminazzjoni ħ terminali medja (37. 7 siegħ u 32. 4 siegħ rispettivament) jew fir- rata ta 'tneħija (21. 2 u 25. 0 litru fis -
111 Haematologic toxicity:
ġ rieden u tnaqqis mhux speċ
6.3 Shelf life
Mannitol Microcrystalline cellulose Crospovidone Low- substituted hydroxypropylcellulose Aspartame Calcium silicate Magnesium stearate
Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blister packs (Al/ OPA/ Al/ PVC).
Zalasta pilloli li jinħ fil- ħ huma disponibbli f’ kaxxi ta ’ 14, 28, 35, 56 jew 70 pillola f’ pakketti ta ’ allu alq folji (Al/ OPA/ Al/ PVC).
112 7.
jali.
MARKETING AUTHORISATION HOLDER
105
Zalasta 10 mg orodispersible tablets
Zalasta 7. 5 mg pilloli li jinħ fil- ħ allu alq
Each orodispersible tablet contains 10 mg olanzapine.
Kull pillola li tinħ fil- ħ fiha 7. 5 mg olanzapine.
Each orodispersible tablet contains 1.00 mg aspartame.
Kull pillola fiha 0. 75 mg aspartame.
Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapine jista 'jittieħ ma' l- ikel jew fuq stonku vojt għ l- assorbiment tiegħ ma jiġ affettwat mill -
114 Zalasta orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Meta jkun sa jitwaqqaf it- trattament, wieħ għed andu jikkunsidra t- tnaqqis tad- doż bil- mod il- mod. a
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients
), fuq pazjenti anzjani (età medja 78 sena) li kellhom psikożrelatata mad - a i
115 compared to patients treated with placebo (3.5% vs.
demenzja u/ jew disturbi fil- komportament, kien hemm ż ta ’ darbtejn akbar fl- inċ
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and relat ed conditions.
jippre skrivi għ pazjenti bi prostata kbira, jew paralytic ileus u kundizzjonijiet relatati. al
116 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Għ
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
110 Diskajneż Tardiva ja Fi studji ta ’ tqabbil li damu sena jew inqas, olanzapine kien assoċ ma 'inċ
117 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Il- pressjoni baxxa relatata mat- tibdil tal- poż izzjoni kienet osservata mhux frekwentement fl- anzjani fi studji kliniċb' olanzapine.
118 General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Attività tas- CNS ġenerali Għ andha tittieħ kawtela f' pazjenti li jixorbu l- alkoħ jew li jieħ prodotti mediċ li jistgħ
Not known
Eosinofilja Lewkopenja Newtropenja Disturbi fis- sistema immuni Disturbi fil- metaboliż u n- nutrizzjoni mu
Blood and the lymphatic system disorders Immune system disorders
Tromboċitopenja Reazzjoni allerġika
Eosinophilia
Ż 1 ieda fil- piż Livelli għ ta '
Leukopenia Neutropenia
vilupp jew iggravar
Thrombocytopenia Allergic reaction
kolesterol2, 3 Livelli għ ta '
Metabolism and nutrition
tad- dijabete, xi kultant
disorders
olja
Weight gain1
assoċ ma ’ jata
Elevated cholesterol
ketoaċ i jew koma idoż
Development or
olja trigliċ 2, 5
119
eridi Glikosurja Ż ieda fl- aptit
levels 2,3 Elevated glucose levels 4 Elevated triglyceride levels 2,5 Glucosuria Increased appetite
(ara sezzjoni 4. 4) Ipotermija
exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4) Hypothermia
Disturbi fis- sistema nervuż a ċ Sonnolenza
Nervous system disorders
Aċessjonijiet li fil - ġ
Somnolence Cardiac disorders
maġoranza tagħ hom
Dizziness Akathisia6 Parkinsonism6 Dyskinesia 6
kien rrappurtat passat
Seizures where in most cases a history of seizures or risk factors for seizures were reported Neuroleptic malignant syndrome (see section 4.4) Dystonia (including oculogyration) Tardive dyskinesia Discontinuation symptoms7
mediku ta 'ċ aċessjonijiet jew fatturi tar- riskju għall - ċ aċessjonijiet Sindromu Newrolettiku Malinn (ara sezzjoni 4. 4) Distonja (tinkludi okuloġ irazzjoni) Diskineż tardiva ja Sintomi ta' twaqqif tal - kura 7
Musculoskeletal and connective tissue disorders Rhabdomyolysis Renal and urinary disorders Urinary hesitation Reproductive system and breast disorders Priapism General disorders and administration site conditions
Disturbi muskolu- skeltrali u tal- connective tissue Rabdomijoliż i Disturbi fil- kliewi u fis- sistema urinarja Eż itazzjoni urinarja Disturbi fis- sistema riproduttiva u fis- sider Prijapiżmu Disturbi ġ enerali u kondizzjonijiet ta 'mnejn jingħ ata Astenja Għ eja Edima Investigazzjonijiet Ż Livelli elevati ta' prolactin fil- plaż 8
120 Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
ma
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
114 Innotat għ livelli normali waqt is- sawm fil- linja baż (< 1. 69 mmol/ l) li ż 5
In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma
Parkinson, id- deterjorament fis- sintomi tal- marda ta ’ Parkinson u fl- alluċ inazzjonijiet, kienu rrapportati b' mod komuni ħ
121 valproate levels.
afna u aktar ta ’ spiss milli bil- plaċ ebo.
Signs and symptoms
afna fil- każ doż eċessiva (inċ
122 Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
aġitazzjoni/ agressività, dysarthria, diversi sintomi estrapiramidali, u tnaqqis fil- livell ta 'konoxxenza tal - pazjent li tvarja minn sedazzjoni għ koma. al
In two of two placebo and two of three comparator controlled trials with 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 tnejn miż ewġ - ż studji kontrollati bil- plaċ u fi tnejn minn tliet studji ta ’ tqabbil ikkontrollati bis - ebo sehem ta ’ 2, 900 pazjent skiż
In a multinationational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms
Fi studju multinazzjonali double- blind komparattiv ta 'l- iskiż ofrenija, mard skiż oaffettiv u mard ieħor relatat li fih ħ sehem 1, 481 pazjent bi gradi varji ta' sintomi dipressivi assoċ (medja bażta '16. 6 fuq
123 (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).
l- iskala tad- dipressjoni Montgomery- Asberg), saret analiżsekondarja prospettiva tat- tibdil fil- punteġ tal - i ħ burdati mill- bażsa l- aħar u din uriet li kien hemm titjib statistikament sinjifikant (p=0. 001) favur i olanzapine (- 6. 0) meta mqabbel ma 'haloperidol (- 3. 1).
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of 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.
117 iż ieda ta '10 mg ta' olanzapine (ko- terapija bil- litju jew b’ valproate) wasslet għ tnaqqis ikbar fis - - ż al sintomi tal- manija meta mqabbel mal- litju jew ma ’ valproate wara 6 ġ at. imgħ
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
Il- varjabilità farmakokinetika osservata ma kinitx tvarja iktar a minn dik tal- persuni mhux anzjani.
In 44
F' 44 pazjent bl- iskiż
124 patients with schizophrenia 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
ofrenija ta 'iktar minn 65 sena, dożta' bejn 5 u 20 i
In renally impaired patients (creatinine clearance < 10 ml/ min) versus healthy subjects, 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).
118 ħ Meta tqabblu pazjenti bi problemi fil- kliewi (b' rata ta 'tneħija tal- kreatinina ta ’ inqas minn 10 ml/ min) ħ ma ’ persuni f' saħithom, ma kienx hemm differenza sinjifikanti fil- half- life ta' l- eliminazzjoni ħ terminali medja (37. 7 siegħ u 32. 4 siegħ rispettivament) jew fir- rata ta 'tneħija (21. 2 u 25. 0 litru fis -
Reversible
adam.
125 neutropenia, thrombocytopenia, or anemia 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).
Fi klieb ċ
126 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovenja ka
127 1.
121 1.
Zalasta 15 mg orodispersible tablets
Zalasta 10 mg pilloli li jinħ fil- ħ allu alq
Each orodispersible tablet contains 15 mg olanzapine.
Kull pillola li tinħ fil- ħ fiha 10 mg olanzapine.
Each orodispersible tablet contains 1.50 mg aspartame.
Kull pillola fiha 1. 00 mg aspartame.
128 Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapine jista 'jittieħ ma' l- ikel jew fuq stonku vojt għ l- assorbiment tiegħ ma jiġ affettwat mill -
129 duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
), fuq pazjenti anzjani (età medja 78 sena) li kellhom psikożrelatata mad - a i
Hyperglycaemia and diabetes Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.
għ andhom jitwaqqfu l- mediċ antipsikotiċkollha, inkluż
8).
koma kienu rrappurtati b’ mod rari, inklużxi każ fatali (ara sezzjoni 4. 8).
130 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Għ
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
125 Diskajneż Tardiva ja Fi studji ta ’ tqabbil li damu sena jew inqas, olanzapine kien assoċ ma 'inċ
131 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Il- pressjoni baxxa relatata mat- tibdil tal- poż izzjoni kienet osservata mhux frekwentement fl- anzjani fi studji kliniċb' olanzapine.
132 Therapeutic monitoring of valproate plasma levels did not indicate that valproate dosage adjustment is required after the introduction of concomitant olanzapine.
tieġ ġ Is- sorveljanza terapewtika tal- livelli ta ’ valproate fil- plaż ma indikatx li hu meħ aġustament fid - ma doż ta 'valproate wara l- introduzzjoni ta' olanzapine fl- istess ħ a in.
133 Metabolism and nutrition disorders Weight gain1
eridi Glikosurja Ż ieda fl- aptit
134 Priapism General disorders and administration site conditions Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
ma
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
129 Innotat għ livelli normali waqt is- sawm fil- linja baż (< 1. 69 mmol/ l) li ż 5
135 In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma valproate levels.
Fi studju kliniku wieħ f' pazjenti b' manija bipolari, terapija b’ valproate flimkien ma 'olanzapine rriż
136 Signs and symptoms Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
aġitazzjoni/ agressività, dysarthria, diversi sintomi estrapiramidali, u tnaqqis fil- livell ta 'konoxxenza tal - pazjent li tvarja minn sedazzjoni għ koma. al
137 In a multinationational, 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).
l- iskala tad- dipressjoni Montgomery- Asberg), saret analiżsekondarja prospettiva tat- tibdil fil- punteġ tal - i ħ burdati mill- bażsa l- aħar u din uriet li kien hemm titjib statistikament sinjifikant (p=0. 001) favur i olanzapine (- 6. 0) meta mqabbel ma 'haloperidol (- 3. 1).
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of 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.
132 iż ieda ta '10 mg ta' olanzapine (ko- terapija bil- litju jew b’ valproate) wasslet għ tnaqqis ikbar fis - - ż al sintomi tal- manija meta mqabbel mal- litju jew ma ’ valproate wara 6 ġ at. imgħ
138 In healthy elderly (65 and over) versus non-elderly subjects, 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).
ħ Meta tqabblu anzjani (ta '65 sena jew iktar) f' saħithom ma' persuni mhux anzjani, il - half- life ta 'l - ħ eliminazzjoni terminali medja ttawlet (51. 8 u 33. 8 siegħ rispettivament) u r- rata ta' tneħija tnaqqset a (17. 5 u 18. 2 litru fis- siegħ rispettivament).
In renally impaired patients (creatinine clearance < 10 ml/ min) versus healthy subjects, 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).
133 ħ Meta tqabblu pazjenti bi problemi fil- kliewi (b' rata ta 'tneħija tal- kreatinina ta ’ inqas minn 10 ml/ min) ħ ma ’ persuni f' saħithom, ma kienx hemm differenza sinjifikanti fil- half- life ta' l- eliminazzjoni ħ terminali medja (37. 7 siegħ u 32. 4 siegħ rispettivament) jew fir- rata ta 'tneħija (21. 2 u 25. 0 litru fis -
139 Haematologic toxicity:
ġ rieden u tnaqqis mhux speċ
140 7.
jali.
MARKETING AUTHORISATION HOLDER
135
141 1.
136 1.
Zalasta 20 mg orodispersible tablets
Zalasta 15 mg pilloli li jinħ fil- ħ allu alq
Each orodispersible tablet contains 20 mg olanzapine.
Kull pillola li tinħ fil- ħ fiha 15 mg olanzapine.
Each orodispersible tablet contains 2.00 mg aspartame.
Kull pillola fiha 1. 50 mg aspartame.
142 Olanzapine can be given without regards for meals as absorption is not affected by food.
Olanzapine jista 'jittieħ ma' l- ikel jew fuq stonku vojt għ l- assorbiment tiegħ ma jiġ affettwat mill -
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/ or disturbed
), fuq pazjenti anzjani (età medja 78 sena) li kellhom psikożrelatata mad - a i
143 behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5% vs.
demenzja u/ jew disturbi fil- komportament, kien hemm ż ta ’ darbtejn akbar fl- inċ
144 Hepatic function Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen commonly, especially in early treatment.
Għ
Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
140 Diskajneż Tardiva ja Fi studji ta ’ tqabbil li damu sena jew inqas, olanzapine kien assoċ ma 'inċ
145 Postural hypotension Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Il- pressjoni baxxa relatata mat- tibdil tal- poż izzjoni kienet osservata mhux frekwentement fl- anzjani fi studji kliniċb' olanzapine.
146 General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Attività tas- CNS ġenerali Għ andha tittieħ kawtela f' pazjenti li jixorbu l- alkoħ jew li jieħ prodotti mediċ li jistgħ
147
eridi Glikosurja Ż ieda fl- aptit
148 Asthenia Fatigue Oedema Investigations Elevated plasma prolactin levels 8 1
ma
5 Observed for fasting normal levels at baseline (< 1.69 mmol/ l) which increased to high (≥ 2.26 mmol/ l).
144 Innotat għ livelli normali waqt is- sawm fil- linja baż (< 1. 69 mmol/ l) li ż 5
149 valproate levels.
afna u aktar ta ’ spiss milli bil- plaċ ebo.
150 Very common symptoms in overdose (> 10% incidence) include tachycardia, agitation/ aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
aġitazzjoni/ agressività, dysarthria, diversi sintomi estrapiramidali, u tnaqqis fil- livell ta 'konoxxenza tal - pazjent li tvarja minn sedazzjoni għ koma. al
151 (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).
l- iskala tad- dipressjoni Montgomery- Asberg), saret analiżsekondarja prospettiva tat- tibdil fil- punteġ tal - i ħ burdati mill- bażsa l- aħar u din uriet li kien hemm titjib statistikament sinjifikant (p=0. 001) favur i olanzapine (- 6. 0) meta mqabbel ma 'haloperidol (- 3. 1).
In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of 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.
147 iż ieda ta '10 mg ta' olanzapine (ko- terapija bil- litju jew b’ valproate) wasslet għ tnaqqis ikbar fis - - ż al sintomi tal- manija meta mqabbel mal- litju jew ma ’ valproate wara 6 ġ at. imgħ
152 patients with schizophrenia 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
ofrenija ta 'iktar minn 65 sena, dożta' bejn 5 u 20 i
In female versus male subjects the mean elimination half life was somewhat prolonged (36.7 versus 32.3 hr) and the clearance was reduced (18.9 versus 27.3 l/ hr).
Meta tqabblu n- nisa ma 'l- irġ il- half - life ta' l- eliminazzjoni terminali medja kienet ftit jew iel, ħ wisq itwal fin - nisa (36. 7 siegħ u 32. 3 siegħ rispettivament) u r- rata ta 'tneħija tnaqqset (18. 9 u 27. 3
In renally impaired patients (creatinine clearance < 10 ml/ min) versus healthy subjects, 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).
148 ħ Meta tqabblu pazjenti bi problemi fil- kliewi (b' rata ta 'tneħija tal- kreatinina ta ’ inqas minn 10 ml/ min) ħ ma ’ persuni f' saħithom, ma kienx hemm differenza sinjifikanti fil- half- life ta' l- eliminazzjoni ħ terminali medja (37. 7 siegħ u 32. 4 siegħ rispettivament) jew fir- rata ta 'tneħija (21. 2 u 25. 0 litru fis -
Such factors possibly contribute to the higher average exposure observed in adolescents.
Fatturi bħ dawn x' aktarx li jikkontribwixxu għ
5.3 Preclinical safety data
osservata fl- adolexxenti. la
Haematologic toxicity:
ġrieden u tnaqqis mhux speċ
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.
ifiku fil- lewkoċ fil- firien; madankollu ma nstabet ebda evidenza ta 'effett iti
153 neutropenia, thrombocytopenia, or anemia 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).
Fi klieb ċ
Mannitol Microcrystalline cellulose Crospovidone Low-substituted hydroxypropylcellulose Aspartame Calcium silicate Magnesium stearate
Mannitol Microcrystalline cellulose Crospovidone Low- substituted hydroxypropylcellulose Aspartame Calcium silicate Magnesium stearate
Not applicable.
jali.
6.3 Shelf life
andu jintrema kif
6.4 Special precautions for storage
Kull pillola fiha 2. 00 mg aspartame.
This medicinal product does not require any special storage conditions.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
6.5 Nature and contents of container
GĦAMLA FARMAĊEWTIKA
Zalasta orodispersible tablets are available in boxes of 14, 28, 35, 56 or 70 tablets in blister packs (Al/ OPA/ Al/ PVC).
Il- pilloli huma tondi, kemxejn konvessi, isfar irħ amati bil- possibbiltà ta 'tikek individwali.
6.6 Special precautions for disposal
4. 1 Indikazzjonijiet terapewtiċ i
Any unused product or waste material should be disposed of in accordance with local requirements.
Olanzapine hu indikat għ at- trattament ta 'episodji ta' manija minn moderati sa severi.
7.
ta '
MARKETING AUTHORISATION HOLDER
at- trattament b' olanzapine,
154 KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
olanzapine hu indikat għall- prevenzjoni tar- rikorrenza f' pazjenti bid- disturb bipolari (ara sezzjoni 5. 1).
8.
oloġ
MARKETING AUTHORISATION NUMBER(S)
Id- doż inizjali rrakkomandata għ olanzapine hi 10 mg kuljum.
EU/ 1/ 07/ 415/ 052-056
Episodji ta 'manija:
9.
da
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
b' olanzapine biss jew 10 mg kuljum fil- każ terapija b' olanzapine flimkien ma 'mediċ oħ (ara sezzjoni 5. 1).
Date of first authorisation:
Prevenzjoni tar- rikorrenzata ’ disturb bipolari:
27 September 2007.
Jekk ikun hemm episodju ġ ta 'manija,
10.
lita
DATE OF REVISION OF THE TEXT
152 Waqt it- trattament għ
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Id - i andhiex tiż għ waħ ikbar mid- doż inizjali rakkomandata ħ jekk issir valutazzjoni doż m' għ
155 ANNEX II
a died al da a
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Olanzapine jista 'jittieħ ma' l- ikel jew fuq stonku vojt għ l- assorbiment tiegħ ma jiġ affettwat mill -
B.
ix
CONDITIONS OF THE MARKETING AUTHORISATION
Tfal u adolexxenti Olanzapine mhux irrakkomandat għ
156 A.
all- uż
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
fit- tfal u fl- adolexxenti ta ’ taħit- 18- il sena peress li u t
Name and address of the manufacturers responsible for batch release
mijiet u prolactin f’ pazjenti adolexxenti milli fl- istudji ta ’ pazjenti
KRKA, d. d., Novo mesto Š marješ cesta 6, 8501 Novo mesto ka Slovenia
adulti (ara sezzjonijiet 4. 4, 4. 8, 5. 1 u 5. 2).
KRKA Polska Sp. z o. o.
F' każ ta 'insuffiċ
Ul.
ijiet
Równoległ 5, Warszawa a Poland
andha tkun ta '5
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.
Għ dawn il- pazjenti, meta jkun indikat, id- doż għ a andha tiż b' moderazzjoni. died
B.
al
CONDITIONS OF THE MARKETING AUTHORISATION
4. 4 Twissijiet speċ u prekawzjonijiet għ
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Waqt trattament bl- antipsikotiċ titjib fil- kundizzjoni klinika tal- pazjent għ
Medicinal product subject to medical prescription.
andhom jiġ monitorjati sew waqt dan il- perjodu. u
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Psikożrelatata mad- demenzja u/ jew disturbi fil- komportament i Olanzapine mhux approvat għ
Not aplicable.
erebro- vaskulari.
 OTHER CONDITIONS
idenza ta ’ mwiet fil -
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2 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.
L- inċ
PSURs The PSUR submission schedule for Zalasta tablets and orodispersible tablets should follow PSURs submission schedule for the reference medicinal product.
Il- fatturi ta ’ riskju li jistgħ jippredisponu dan il - u grupp ta ’ pazjenti għ ż fil- mortalità jinkludu l- età ta ’ > 65 sena, id- diffikulta biex wieħ jibla ’, is -
157 ANNEX III
al ieda
LABELLING AND PACKAGE LEAFLET
pulmonite, bil - jew fl- assenza
158 A.
ebo,
LABELLING
puplesija,
159 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
attakki iskemiċmomentanji) inklużl- imwiet.
CARTON FOR ZALASTA 2.5 mg TABLETS
istu ta ’ riskju għ CVAE f’ assoċ
1.
al
NAME OF THE MEDICINAL PRODUCT
L -
Zalasta 2.5 mg tablets Olanzapine
Olanzapine inbeda b '2. 5 mg/ ġ
2.
i,
STATEMENT OF ACTIVE SUBSTANCE(S)
qalb irregolari).
Each tablet contains 2.5 mg olanzapine.
olanzapine.
3.
oli
LIST OF EXCIPIENTS
kultant assoċ ma 'ketoaċ jati
Contains lactose monohydrate.
koma kienu rrappurtati b’ mod rari, inklużxi każ fatali (ara sezzjoni 4. 8).
See package leaflet for further information.
Għ i
4.
li
PHARMACEUTICAL FORM AND CONTENTS
andu jingħ parir ata
14 tablets 28 tablets 35 tablets 56 tablets 70 tablets
Tibdil fil- livell tal- lipidi għ
5.
ebo
METHOD AND ROUTE(S) OF ADMINISTRATION
għ andhom fatturi ta ’ riskju għ
Read the package leaflet before use.
all- iż vilupp ta ’ disturbi fil- lipidi.
Oral use.
inċ idenza ta 'avvenimenti relatati.
6.
od
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
jippreskrivi għ pazjenti bi prostata kbira, jew paralytic ileus u kundizzjonijiet relatati. al
Keep out of the reach and sight of children.
potenzjalment tossiċgħ i all- fwied.
OTHER SPECIAL WARNING(S), IF NECESSARY
(inkluż epatoċ ellulari, kolestatika jew korriment imħ tal- fwied), it- trattament b' olanzapine għ jitwaqqaf.
8.
andu
EXPIRY DATE
Newtropenja
EXP:
add
9.
iti
SPECIAL STORAGE CONDITIONS
kwalunkwe raġ f' pazjenti li jkunu ngħ
10.
uni,
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
storja ta 'dipressjoni/ tossiċ fil- mudullun ikkawż minn mediċ f' pazjenti b' dipressjoni fil- mudullun
160 11.
ini,
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Twaqqif tal- kura B’ mod rari ħ ġ irrappurtati (< 0. 01%) sintomi akuti bħ għ
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
al araq, insomnja, rogħ ansjetà, tqalligħ da,,
12.
idu
MARKETING AUTHORISATION NUMBER(S)
B’ mod rari ħ (< 0. 01%) ġ irrapportata assoċ
EU/ 1/ 07/ 415/ 001 (14 tablets) EU/ 1/ 07/ 415/ 002 (28 tablets) EU/ 1/ 07/ 415/ 003 (35 tablets) EU/ 1/ 07/ 415/ 004 (56 tablets) EU/ 1/ 07/ 415/ 005 (70 tablets)
Relazzjoni kawż bejn l- okkorrenza ta ’ tromboemboliż fil- vini u l- kura
13.
ali
BATCH NUMBER
ietx akkwiż għ
Batch:
entaw
14.
uri
GENERAL CLASSIFICATION FOR SUPPLY
Attività tas- CNS ġ
Medicinal product subject to medical prescription.
entralment u meta jittieħ ma 'l- alkoħ Minħ ed ol.
15.
ġ
INSTRUCTIONS ON USE
Olanzapine għ
16.
al
INFORMATION IN BRAILLE
all- aċessjonijiet.
Zalasta 2.5 mg tablets
f' pazjenti ttrattati b' olanzapine.
161 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
all- aċessjonijiet
BLISTER FOR ZALASTA 2.5 mg TABLETS
jew storja ta 'aċessjonijiet.
1.
jat
NAME OF THE MEDICINAL PRODUCT
idenza statistikament iktar
Zalasta 2.5 mg tablets Olanzapine
baxxa ta 'diskajneż emerġ mit- trattament.
NAME OF THE MARKETING AUTHORISATION HOLDER
jiddeterjoraw temporanjament jew saħ
KRKA
i ra,
3.
t
EXPIRY DATE
all- uż
EXP:
ieda
4.
,
BATCH NUMBER
prolactin.
Batch:
jati
5.
ewx
OTHER
rufa
162 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Aspartame Zalasta pillola li tinħ fil- ħ għ
CARTON FOR ZALASTA 5 mgTABLETS
4. 5 Prodotti mediċinali oħ li ma jaqblux ma ’ dan il- prodott u affarijiet oħ li jistgħ jibdlu l -
NAME OF THE MEDICINAL PRODUCT
ewtiku tal- prodott saru fl- adulti
Zalasta 5 mg tablets Olanzapine
entrazzjoni ta 'olanzapine.
2.
ħ
STATEMENT OF ACTIVE SUBSTANCE(S)
ieda afifa jew moderata fit- tneħija ta '
Each tablet contains 5 mg olanzapine.
Il- konsegwenzi kliniċaktarx li huma limitati, iż hu rakkomandat li ssir sorveljanza klinika
3.
a a
LIST OF EXCIPIENTS
tieġ( ara sezzjoni 4. 2).
Contains lactose monohydrate.
kinux ipejpu u 77% f' irġ li ma kinux ipejpu.
See package leaflet for further information.
rispettivament.
4.
am
PHARMACEUTICAL FORM AND CONTENTS
anqas sagħ qabel jew wara olanzapine. tejn
14 tablets 28 tablets 35 tablets 56 tablets 70 tablets
156 Il- potenzjal ta 'olanzapine li jaffettwa prodotti mediċ
5.
ra
METHOD AND ROUTE(S) OF ADMINISTRATION
jirrappreżentaw s- sekwenza CYP2D6), warfarin (CYP2C9), theophylline (CYP1A2) jew diazepam (CYP3A4 u 2C19).
Read the package leaflet before use.
Olanzapine ma wera l- ebda interazzjoni meta ngħ flimkien mal- litju jew biperiden. ata
Oral use.
a entrali.
6.
ed
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Il- pazjenti għ andhom jingħataw parir hom jekk joħ u tqal jew jekk ikun fi ħ biex jgħarrfu lit- tabib tagħ
Keep out of the reach and sight of children.
Madankollu, billi l- esperjenza fil- bniedem hi limitata, fit- tqala, olanzapine għ andu jintuż a
7.
ġ
OTHER SPECIAL WARNING(S), IF NECESSARY
evuti rapporti spontanji ħ ta 'rogħ ipertonija, letarġ u ngħ qawwi, fi tfal ż ar Kienu riċ
8.
ħ
EXPIRY DATE
adda ġ alib tas -
EXP:
:
9.
or
SPECIAL STORAGE CONDITIONS
ataw parir biex ma jreddgħ
10.
ila
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Billi olanzapine jista 'jikkawż ngħ u sturdament, il- pazjenti għ
163 11.
as
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
andhom jitwissew fuq it- tħ addim ta '
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
makkinarju, inkluż
12.
ew
MARKETING AUTHORISATION NUMBER(S)
pazjenti) u li huma assoċ ma 'l- uż ta' l- olanzapine kienu sonnolenza, ż fil- piżeosinofilja, livelli
EU/ 1/ 07/ 415/ 006 EU/ 1/ 07/ 415/ 007 EU/ 1/ 07/ 415/ 008 EU/ 1/ 07/ 415/ 009 EU/ 1/ 07/ 415/ 010
eridi (ara sezzjoni 4. 4), glukosurja, ż fl- aptit, għ ta 'prolactin, kolesterol, glucose u trigliċ
(14 tablets) (28 tablets) (35 tablets) (56 tablets) (70 tablets)
sturdament, akatiż parkinsoniż (ara sezzjoni 4. 4), diskineż pressjoni baxxa mal- waqfien, effetti
13.
ja,
BATCH NUMBER
ja,
Batch:
ej:
14.
rufa
GENERAL CLASSIFICATION FOR SUPPLY
Tromboċitopenja Reazzjoni allerġika
Medicinal product subject to medical prescription.
Ż 1 ieda fil- piż Livelli għ ta '
15.
olja
INSTRUCTIONS ON USE
vilupp jew iggravar
16.
olja
INFORMATION IN BRAILLE
ketoaċ i jew koma idoż
Zalasta 5 mg tablets
olja trigliċ 2, 5
164 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Disturbi fis- sistema nervuż a ċ Sonnolenza
BLISTER FOR ZALASTA 5 mg TABLETS
Aċessjonijiet li fil - ġ
1.
6 mu 6
NAME OF THE MEDICINAL PRODUCT
kien rrappurtat passat
Zalasta 5 mg tablets Olanzapine
Bradikardija QT c imtawwal (ara sezzjoni 4. 4)
2.
mu
NAME OF THE MARKETING AUTHORISATION HOLDER
(inklużl- emboliż mu pulmonari u t- tromboż i
KRKA
158
EXPIRY DATE
Epatite inkluż
EXP:
mard
4.
addi
BATCH NUMBER
epatoċ ellulari,
Batch:
jalmet fil - (ara
5.
ilda
OTHER
Raxx
165 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
ilda Reazzjoni ta 'fotosensittività Alopeċ ja
CARTON FOR ZALASTA 7.5 mg TABLETS
ieda f' alkaline
NAME OF THE MEDICINAL PRODUCT
phosphokinase għ
Zalasta 7.5 mg tablets Olanzapine
Ż ieda fil- bilirubin totali
2.
, i i
STATEMENT OF ACTIVE SUBSTANCE(S)
Mass Index - BMI), fil- kategoriji kollha.
Each tablet contains 7.5 mg olanzapine.
Kien komuni ħ
LIST OF EXCIPIENTS
afna li wara
Contains lactose monohydrate.
mijiet.
See package leaflet for further information.
Innotat għ livelli normali waqt is- sawm fil- linja baż (< 5. 17 mmol/ l) li ż 3
PHARMACEUTICAL FORM AND CONTENTS
diedu għ għ al oljin (≥
14 tablets 28 tablets 35 tablets 56 tablets 70 tablets
Innotat għ livelli normali waqt is- sawm fil- linja baż (< 5. 56 mmol/ l) li ż 4
5.
al i
METHOD AND ROUTE(S) OF ADMINISTRATION
159 Innotat għ livelli normali waqt is- sawm fil- linja baż (< 1. 69 mmol/ l) li ż 5
Read the package leaflet before use.
2. 26 mmol/ l).
Oral use.
afna.
6.
i,
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
numerikament ogħ imma statistikament mhux differenti b’ mod sinifikattiv mill- plaċ Pazjenti
Keep out of the reach and sight of children.
ikkumparata ma 'dożtitrati ta ’ haloperidol.
OTHER SPECIAL WARNING(S), IF NECESSARY
Fil -
8.
ċ
EXPIRY DATE
allinqas 48
EXP:
- ż
SPECIAL STORAGE CONDITIONS
eridi ż ma ż mien.
10.
- ż
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
terapija, ir- rata taż ieda fil- medja tal- glucose fid- demm naqset wara kważ4- 6 xhur.
166 11.
- ż
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Tagħ addizzjonali dwar popolazzjonijiet speċ
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
mhux normali u waqgħ Il- pulmonite, iż ieda fit- temperatura tal- ġ
12.
- ż
MARKETING AUTHORISATION NUMBER(S)
isem, il- letarġ l- eritema, l - ija,
EU/ 1/ 07/ 415/ 011 EU/ 1/ 07/ 415/ 012 EU/ 1/ 07/ 415/ 013 EU/ 1/ 07/ 415/ 014 EU/ 1/ 07/ 415/ 015
alluċinazzjonijiet viż u l- inkontinenza ta ’ l- awrina kienu komunement osservati. ivi
(14 tablets) (28 tablets) (35 tablets) (56 tablets) (70 tablets)
Fi studji kliniċf’ pazjenti b’ psikożdovuta għ mediċ (agonist ta 'dopamine) assoċ mal- marda ta ’
13.
ina
BATCH NUMBER
jata
Batch:
ultat
14.
ma.
GENERAL CLASSIFICATION FOR SUPPLY
ulta ieda
Medicinal product subject to medical prescription.
rogħ nixfa fil- ħ ż fl- aptit, u ż fil- piżDisturb fid- diskors kien ukoll komunement rappurtat.
15.
da,
INSTRUCTIONS ON USE
ieda ieda
16.
ieda
INFORMATION IN BRAILLE
Trattament b’ olanzapine għ ħ tal- ġ
Zalasta 7.5 mg tablets
imgħ
167 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
ż mien twil (sa 12- il xahar) bl- għ ta 'prevenzjoni ta' episodju ieħ f' pazjenti b' mard bipolari kien
BLISTER FOR ZALASTA 7.5 mg TABLETS
assoċ ma 'ż ta' ≥7% mil- linja bażtal- piż
NAME OF THE MEDICINAL PRODUCT
tal- ġisem f '39. 9% tal- pazjenti.
Zalasta 7.5 mg tablets Olanzapine
Għ imwettqa studji kliniċmagħ
2.
Ż
NAME OF THE MARKETING AUTHORISATION HOLDER
ieda fil- piżklinikament sinifikanti (≥7%)
KRKA
ieda
EXPIRY DATE
160 adolexxenti li kellhom ż fil- piż
BATCH NUMBER
ta ’ ż allinqas 24 ġ
Batch:
mien (għ
5.
mien..
OTHER
ż
168 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
It- termini ta 'frekwenza elenkati huma mfissra kif ġ Komuni ħ
CARTON FOR ZALASTA 10 mg TABLETS
afna (≥10%), komuni (≥1% u < 10%).
NAME OF THE MEDICINAL PRODUCT
Disturbi fil- metaboliż u n- nutrizzjoni mu Komuni ħ afna:
Zalasta 10 mg tablets Olanzapine
9
2.
al
STATEMENT OF ACTIVE SUBSTANCE(S)
għoljin (≥5. 17 mmol/ l) kienu komuni.
Each tablet contains 10 mg olanzapine.
idenza ta 'iktar minn 10%) jinkludu t- takikardija,
LIST OF EXCIPIENTS
joni, koma,
Contains lactose monohydrate.
iċ Il- ġestjoni ta 'dożeċessivi Ma hemm l- ebda antidotu speċ għ olanzapine.
See package leaflet for further information.
Jistgħ
4.
iċ
PHARMACEUTICAL FORM AND CONTENTS
ifieri ħ ta 'l- istonku,
7 tablets 14 tablets 28 tablets 35 tablets 56 tablets 70 tablets
jkunu indikati l- proċ eduri standard għ estjoni ta ’ dożeċessivi (jiġ
5.
asil
METHOD AND ROUTE(S) OF ADMINISTRATION
amministrazzjoni ta 'faħ attivat).
Read the package leaflet before use.
bijodisponibilità orali b' bejn 50 u 60%.
Oral use.
funzjoni respiratorja.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Għ
Keep out of the reach and sight of children.
kardjovaskulari biex jintgħ r- ritmi abnormali li jista 'jkun hemm.
7.
joni
OTHER SPECIAL WARNING(S), IF NECESSARY
medika stretta għ andha titkompla sakemm jirkupra l- pazjent.
EXPIRY DATE
N05AH03.
EXP:
i:
SPECIAL STORAGE CONDITIONS
Fl- istudji ta ’ qabel l- uż kliniku, olanzapine wera varjetà ta 'affinitajiet għ riċ
10.
u
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
għ as- serotonin 5 HT2A/ 2C, 5 HT3, 5 HT6; dopamina D1, D2, D3, D4, D5; riċ koliner ġ i m1- m5; α adrenerġ i; u riċ
169 11.
1 iċ
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
L- istudji dwar l- imġ f’ annimali li iba
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
ngħ ataw olanzapine wrew affinità in vitro ikbar għ serotonin 5HT2 milli għ riċ
12.
al
MARKETING AUTHORISATION NUMBER(S)
olimbiċ( A10), waqt li ftit kellu i