natgillin/translations-raw huggingface dataset:
26 In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
V 18- mese ni študiji so asnega zdravljenja pri bolnikih z mani no ali mešano epizodo, stabiliziranih z olanzapinom skupaj s stabilizatorjem razpoloženja (litij ali valproat), dolgotrajno so asno zdravljenje z olanzapinom skupaj z litijem ali valproatom ni bilo statisti no zna ilno bolj ugodno kot zdravljenje samo z litijem ali samo valproatom pri odlogu ponovnega pojava bipolarne motnje, dolo ene po sindromnih (diagnosti nih) merilih.
In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
28 44 bolnikih s shizofrenijo, starejših od 65 let, odmerjanje od 5 do 20 mg/ dan ni bilo povezano s kakim razlo evalnim profilom neželenih u inkov.
27 smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Vendar pa je vpliv starosti, spola ali kajenja na o istek in razpolovni as olanzapina majhen v primerjavi s povpre no variabilnostjo med posamezniki.
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.
29 Hematološka toksi nost Pri vsaki vrsti so odkrili u inke na hematološke parametre, vklju no z z odmerkom povezanimi znižanji koncentracij levkocitov v obtoku pri miših in nespecifi nim znižanjem koncentracije levkocitov v obtoku pri podganah; vendar pa niso našli dokazov citotoksi nosti za kostni mozeg.
Aluminium blister strips in cartons of 28, 35 56, or 70 orodispersible tablets per carton.
Aluminijasti pretisni omoti v škatlah po 28, 35, 56 ali 70 orodisperzibilnih tablet.
6.6 Special precautions for disposal
30 6. 6 Posebni varnostni ukrepi za odstranjevanje
ZYPREXA VELOTAB 15 mg orodispersible tablets
ZYPREXA VELOTAB 15 mg orodisperzibilne tablete
For a full list of excipients, see section 6.1.
Vsaka orodisperzibilna tableta vsebuje 1, 20 mg aspartama 0, 225 mg natrijevega metilparahidroksibenzoata 0, 075 mg natrijevega propilparahidroksibenzoata Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
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.
32 Med zdravljenjem shizofrenije, mani ne epizode in prepre evanjem ponovnega pojava bipolarne motnje se lahko dnevni odmerek na podlagi individualnega klini nega stanja kasneje prilagodi v razponu 5 do 20 mg na dan.
Elderly patients A lower starting dose (5 mg/ day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Starejši Nižji za etni odmerek (5 mg na dan) ni rutinsko priporo en, vendar ga je treba upoštevati pri bolnikih, starih 65 let in ve, kadar to upravi ujejo klini ni dejavniki (glejte tudi poglavje 4. 4).
4.4 Special warnings and precautions for use
33 4. 4 Posebna opozorila in previdnostni ukrepi
31 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Psihoza povezana z demenco in/ ali vedenjske motnje Olanzapin ni odobren za zdravljenje bolnikov s psihozo, povezano z demenco in/ ali vedenjskimi motnjami ter ni priporo ljiv za uporabo pri teh skupinah bolnikov zaradi pove ane umrljivosti in tveganja za cerebrovaskularne dogodke.
Appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus for which regular glucose control is recommended.
34 sladkorne bolezni, za katero je priporo en reden nadzor glukoze, je priporo eno ustrezno klini no spremljanje.
32 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Antiholinergi no delovanje Medtem ko je olanzapin pokazal antiholinergi no delovanje v pogojih in vitro, so izkušnje klini nih preskušanj razkrile majhno incidenco s tem povezanih dogodkov.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
35 Splošno delovanje na osrednje živ evje Glede na primarne u inke olanzapina na osrednje živ evje je potrebna previdnost, kadar se ga jemlje v kombinaciji z drugimi osrednje delujo imi zdravili in alkoholom.
33 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Tardivne diskinezije V primerjalnih študijah, ki so trajale eno leto ali manj, so olanzapin povezovali s statisti no zna ilno manjšo incidenco diskinezij, ki se pojavijo ob zdravljenju.
Inhibition of CYP1A2 Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
36 Zaviranje CYP1A2 Fluvoksamin, specifi ni zaviralec CYP1A2, je pokazal pomembno zaviranje presnove olanzapina.
34 Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Za fluoksetin (zaviralec CYP2D6), posamezne odmerke antacida (aluminij, magnezij) ali cimetidina niso ugotovili, da bi zna ilno vplivali na farmakokinetiko olanzapina.
Vascular disorders
38 Sr ne bolezni Žilne bolezni
36 Hepato-biliary disorders
Bolezni jeter, žol nika in žol evodov Bolezni kože in podkožja
3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (6.2 mmol/ l).
39 3 Opazovano pri osnovnih normalnih ravneh na teš e (< 5, 17 mmol/ l), ki so se povišale na visoke (6, 2 mmol/ l).
37 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 Pri nenadni prekinitvi zdravljenja z olanzapinom so poro ali o akutnih simptomih kot so znojenje, nespe nost, tresenje, tesnoba, slabost in bruhanje.
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.
40 Naslednja tabela vklju uje neželene u inke, ki so jih poro ali z višjo pogostnostjo pri mladostnikih (starih 13- 17 let) kot pri odraslih bolnikih ali neželene u inke, ki so jih ugotovili samo v kratkoro nih klini nih preskušanjih pri mladostnikih.
38 Metabolism and nutrition disorders Very common:
Presnovne in prehranske motnje Zelo pogosti:
Management of overdose There is no specific antidote for olanzapine.
41 Ravnanje v primeru prevelikega odmerjanja Za olanzapin ni specifi nega antidota.
In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
42 Pri bolnikih z mani no ali mešano epizodo bipolarne motnje je olanzapin pokazal ve jo u inkovitost kot placebo in seminatrijev valproat (divalproeks) pri znižanju mani nih simptomov v treh tednih.
40 In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
V 18- mese ni študiji so asnega zdravljenja pri bolnikih z mani no ali mešano epizodo, stabiliziranih z olanzapinom skupaj s stabilizatorjem razpoloženja (litij ali valproat), dolgotrajno so asno zdravljenje z olanzapinom skupaj z litijem ali valproatom ni bilo statisti no zna ilno bolj ugodno kot zdravljenje samo z litijem ali samo valproatom pri odlogu ponovnega pojava bipolarne motnje, dolo ene po sindromnih (diagnosti nih) merilih.
In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
43 44 bolnikih s shizofrenijo, starejših od 65 let, odmerjanje od 5 do 20 mg/ dan ni bilo povezano s kakim razlo evalnim profilom neželenih u inkov.
41 The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Plazemski o istek olanzapina je manjši pri starejših v primerjavi z mlajšimi, pri ženskah v primerjavi z moškimi in pri nekadilcih v primerjavi s kadilci.
However, the magnitude of the impact of age, gender, or smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Vendar pa je vpliv starosti, spola ali kajenja na o istek in razpolovni as olanzapina majhen v primerjavi s povpre no variabilnostjo med posamezniki.
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.
44 Hematološka toksi nost Pri vsaki vrsti so odkrili u inke na hematološke parametre, vklju no z z odmerkom povezanimi znižanji koncentracij levkocitov v obtoku pri miših in nespecifi nim znižanjem koncentracije levkocitov v obtoku pri podganah; vendar pa niso našli dokazov citotoksi nosti za kostni mozeg.
6.6 Special precautions for disposal
45 6. 6 Posebni varnostni ukrepi za odstranjevanje
ZYPREXA VELOTAB 20 mg orodispersible tablets
ZYPREXA VELOTAB 20 mg orodisperzibilne tablete
For a full list of excipients, see section 6.1.
Vsaka orodisperzibilna tableta vsebuje 1, 60 mg aspartama 0, 30 mg natrijevega metilparahidroksibenzoata 0, 10 mg natrijevega propilparahidroksibenzoata Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
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.
47 Med zdravljenjem shizofrenije, mani ne epizode in prepre evanjem ponovnega pojava bipolarne motnje se lahko dnevni odmerek na podlagi individualnega klini nega stanja kasneje prilagodi v razponu 5 do 20 mg na dan.
4.4 Special warnings and precautions for use
48 4. 4 Posebna opozorila in previdnostni ukrepi
45 Dementia-related psychosis and/ or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/ or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Psihoza povezana z demenco in/ ali vedenjske motnje Olanzapin ni odobren za zdravljenje bolnikov s psihozo, povezano z demenco in/ ali vedenjskimi motnjami ter ni priporo ljiv za uporabo pri teh skupinah bolnikov zaradi pove ane umrljivosti in tveganja za cerebrovaskularne dogodke.
Appropriate clinical monitoring is advisable particularly in diabetic patients and in patients with risk factors for the development of diabetes mellitus for which regular glucose control is recommended.
49 sladkorne bolezni, za katero je priporo en reden nadzor glukoze, je priporo eno ustrezno klini no spremljanje.
46 Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Antiholinergi no delovanje Medtem ko je olanzapin pokazal antiholinergi no delovanje v pogojih in vitro, so izkušnje klini nih preskušanj razkrile majhno incidenco s tem povezanih dogodkov.
General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol.
50 Splošno delovanje na osrednje živ evje Glede na primarne u inke olanzapina na osrednje živ evje je potrebna previdnost, kadar se ga jemlje v kombinaciji z drugimi osrednje delujo imi zdravili in alkoholom.
47 Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Tardivne diskinezije V primerjalnih študijah, ki so trajale eno leto ali manj, so olanzapin povezovali s statisti no zna ilno manjšo incidenco diskinezij, ki se pojavijo ob zdravljenju.
Inhibition of CYP1A2 Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine.
51 Zaviranje CYP1A2 Fluvoksamin, specifi ni zaviralec CYP1A2, je pokazal pomembno zaviranje presnove olanzapina.
48 Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Za fluoksetin (zaviralec CYP2D6), posamezne odmerke antacida (aluminij, magnezij) ali cimetidina niso ugotovili, da bi zna ilno vplivali na farmakokinetiko olanzapina.
4.7 Effects on ability to drive and use machines
52 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Vascular disorders
53 Sr ne bolezni Žilne bolezni
50 Hepato-biliary disorders
Bolezni jeter, žol nika in žol evodov Bolezni kože in podkožja
3 Observed for fasting normal levels at baseline (< 5.17 mmol/ l) which increased to high (6.2 mmol/ l).
54 3 Opazovano pri osnovnih normalnih ravneh na teš e (< 5, 17 mmol/ l), ki so se povišale na visoke (6, 2 mmol/ l).
51 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
7 Pri nenadni prekinitvi zdravljenja z olanzapinom so poro ali o akutnih simptomih kot so znojenje, nespe nost, tresenje, tesnoba, slabost in bruhanje.
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.
55 Naslednja tabela vklju uje neželene u inke, ki so jih poro ali z višjo pogostnostjo pri mladostnikih (starih 13- 17 let) kot pri odraslih bolnikih ali neželene u inke, ki so jih ugotovili samo v kratkoro nih klini nih preskušanjih pri mladostnikih.
52 Metabolism and nutrition disorders Very common:
Presnovne in prehranske motnje Zelo pogosti:
Management of overdose There is no specific antidote for olanzapine.
56 Ravnanje v primeru prevelikega odmerjanja Za olanzapin ni specifi nega antidota.
In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium (divalproex) in reduction of manic symptoms over 3 weeks.
57 Pri bolnikih z mani no ali mešano epizodo bipolarne motnje je olanzapin pokazal ve jo u inkovitost kot placebo in seminatrijev valproat (divalproeks) pri znižanju mani nih simptomov v treh tednih.
54 In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
V 18- mese ni študiji so asnega zdravljenja pri bolnikih z mani no ali mešano epizodo, stabiliziranih z olanzapinom skupaj s stabilizatorjem razpoloženja (litij ali valproat), dolgotrajno so asno zdravljenje z olanzapinom skupaj z litijem ali valproatom ni bilo statisti no zna ilno bolj ugodno kot zdravljenje samo z litijem ali samo valproatom pri odlogu ponovnega pojava bipolarne motnje, dolo ene po sindromnih (diagnosti nih) merilih.
In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/ day was not associated with any distinguishing profile of adverse events.
58 44 bolnikih s shizofrenijo, starejših od 65 let, odmerjanje od 5 do 20 mg/ dan ni bilo povezano s kakim razlo evalnim profilom neželenih u inkov.
55 smoking on olanzapine clearance and half-life is small in comparison to the overall variability between individuals.
Vendar pa je vpliv starosti, spola ali kajenja na o istek in razpolovni as olanzapina majhen v primerjavi s povpre no variabilnostjo med posamezniki.
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.
59 Hematološka toksi nost Pri vsaki vrsti so odkrili u inke na hematološke parametre, vklju no z z odmerkom povezanimi znižanji koncentracij levkocitov v obtoku pri miših in nespecifi nim znižanjem koncentracije levkocitov v obtoku pri podganah; vendar pa niso našli dokazov citotoksi nosti za kostni mozeg.
6.6 Special precautions for disposal
60 6. 6 Posebni varnostni ukrepi za odstranjevanje
57 ANNEX II
61 DODATEK II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠ ANJE SERIJE
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠ ANJE SERIJE
Name and address of the manufacturers responsible for batch release in the EEA
Ime in naslov izdelovalcev, odgovornih za sproš anje serije
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN U INKOVITO UPORABO • ZDRAVILA
The Marketing Authorisation Holder will provide the PSUR annually.
Imetnik dovoljenja za promet bo predajal z zadnjimi podatki dopolnjena redna poro ila o varnosti zdravila (PSUR - Periodic Safety Update Report) na 1 leto.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1, of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Na rt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel dodatne farmakovigilan ne aktivnosti, podrobno opisane v na rtu farmakovigilance, ki je bil sprejet v razli ici 1. 1 na rta z obvadovanje tveganja (RMP), predstavljenega v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim poro ilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljen RMP predložiti: • kadar imetnik dovoljenja za uporabo z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije, na rt farmakovigilance ali na dejavnosti za zmanjševanje tveganja • v 60 dneh po dosegu pomembnega mejnika (pri farmakovigilanci ali zmanjševanju tveganja) • na zahtevo Evropske agencije za zdravila (EMEA)
59 ANNEX III
63 DODATEK III
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
65 PODATKI NA ZUNANJI OVOJNINI
28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets
28 orodisperzibilnih tablet 35 orodisperzibilnih tablet 56 orodisperzibilnih tablet 70 orodisperzibilnih tablet
Separate one blister cell from the strip.
Lo ite en pretisni razdelek od ostalih razdelkov pretisnega omota.
EU/ 1/ 99/ 125/ 001 28 orodispersible tablets EU/ 1/ 99/ 125/ 009 35 orodispersible tablets EU/ 1/ 99/ 125/ 005 56 orodispersible tablets EU/ 1/ 99/ 125/ 013 70 orodispersible tablets
EU/ 1/ 99/ 125/ 001 28 orodispersibilnih tablet EU/ 1/ 99/ 125/ 009 35 orodispersibilnih tablet EU/ 1/ 99/ 125/ 005 56 orodispersibilnih tablet EU/ 1/ 99/ 125/ 013 70 orodispersibilnih tablet
63 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
67 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNIH TRAKOVIH
ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 5 mg ORODISPERZIBILNE TABLETE:
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
68 PODATKI NA ZUNANJI OVOJNINI
EU/ 1/ 99/ 125/ 002 28 orodispersible tablets EU/ 1/ 99/ 125/ 010 35 orodispersible tablets EU/ 1/ 99/ 125/ 006 56 orodispersible tablets EU/ 1/ 99/ 125/ 014 70 orodispersible tablets
EU/ 1/ 99/ 125/ 002 28 orodispersibilnih tablet EU/ 1/ 99/ 125/ 010 35 orodispersibilnih tablet EU/ 1/ 99/ 125/ 006 56 orodispersibilnih tablet EU/ 1/ 99/ 125/ 014 70 orodispersibilnih tablet
66 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
70 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNIH TRAKOVIH
ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 10 mg ORODISPERZIBILNE TABLETE:
Each tablet contains 15 mg olanzapine
Ena orodisperzibilna tableta vsebuje 15 mg olanzapina.
EU/ 1/ 99/ 125/ 003 28 orodispersible tablets EU/ 1/ 99/ 125/ 011 35 orodispersible tablets EU/ 1/ 99/ 125/ 007 56 orodispersible tablets EU/ 1/ 99/ 125/ 015 70 orodispersible tablets
EU/ 1/ 99/ 125/ 003 28 orodispersibilnih tablet EU/ 1/ 99/ 125/ 011 35 orodispersibilnih tablet EU/ 1/ 99/ 125/ 007 56 orodispersibilnih tablet EU/ 1/ 99/ 125/ 015 70 orodispersibilnih tablet
69 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
73 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNIH TRAKOVIH
ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 15 mg ORODISPERZIBILNE TABLETE:
Store in the original package in order to protect from light and moisture
Shranjujte v originalni ovojnini za zagotovitev zaš ite pred svetlobo in vlago.
EU/ 1/ 99/ 125/ 004 28 orodispersible tablets EU/ 1/ 99/ 125/ 012 35 orodispersible tablets EU/ 1/ 99/ 125/ 008 56 orodispersible tablets EU/ 1/ 99/ 125/ 016 70 orodispersible tablets
EU/ 1/ 99/ 125/ 004 28 orodispersibilnih tablet EU/ 1/ 99/ 125/ 012 35 orodispersibilnih tablet EU/ 1/ 99/ 125/ 008 56 orodispersibilnih tablet EU/ 1/ 99/ 125/ 016 70 orodispersibilnih tablet
72 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
76 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNIH TRAKOVIH
ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS:
ZYPREXA VELOTAB 20 mg ORODISPERZIBILNE TABLETE:
ZYPREXA VELOTAB 5 mg orodispersible tablets ZYPREXA VELOTAB 10 mg orodispersible tablets ZYPREXA VELOTAB 15 mg orodispersible tablets ZYPREXA VELOTAB 20 mg orodispersible tablets olanzapine
ZYPREXA VELOTAB 5 mg orodisperzibilne tablete ZYPREXA VELOTAB 10 mg orodisperzibilne tablete ZYPREXA VELOTAB 15 mg orodisperzibilne tablete ZYPREXA VELOTAB 20 mg orodisperzibilne tablete olanzapin
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
- e imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you.
Njim bi lahko celo
Do not pass it on to others.
škodovalo, eprav imajo znake bolezni, podobne vašim.