natgillin/translations-raw huggingface dataset:
Each coated tablet contains 242 mg lactose monohydrate
Vsaka obložena tableta vsebuje 242 mg laktoza monohidrat
White, round, biconvex, coated tablets with ‘ OLZ 7.5’ debossing on one side and ‘ NEO’ on the other.
Bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako 'OLZ 7, 5' na eni strani in 'NEO' na drugi.
30 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Izkušenj pri otrocih ni.
Elderly 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).
Nižji začetni odmerek (5 mg dnevno) ni rutinsko priporočen, vendar ga je treba upoštevati pri bolnikih, starih 65 let in več, kadar to upravičujejo klinični dejavniki (glejte tudi poglavje 4. 4).
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
V kliničnih preskušanjih so o poslabšanju parkinsonske simptomatike in halucinacijah poročali zelo pogosto in pogosteje kot pri placebu (glejte poglavje 4. 8),
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
32 QT interval V kliničnih preskušanjih so bila klinično pomembna podaljšanja QTc (QT korekcija Fridericia [QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 msek) pri bolnikih, zdravljenih z olanzapinom, redka (od 0, 1% do 1%), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
Lactose OLANZAPINE NEOPHARMA tablets contain lactose.
Laktoza OLANZAPIN NEOPHARMA tablete vsebujejo laktozo.
33 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Potential interactions affecting olanzapine Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
33 Možna medsebojna delovanja, ki vplivajo na olanzapin Ker se olanzapin presnavlja s CYP1A2, utegnejo snovi, ki lahko specifično inducirajo ali inhibirajo ta izoencim, vplivati na farmakokinetiko olanzapina.
Spontaneous reports have been very rarely received on tremor, hypertonia, lethargy and sleepiness, in infants born to mothers who had used olanzapine during the 3rd trimester.
34 Zelo redko so spontano poročali o tresenju, hipertoniji, letargiji in zaspanosti pri dojenčkih, rojenih materam, ki so uporabljale olanzapin v tretjem trimesečju.
35 Very common
35 Zelo pogosti
Transient, asymptomatic elevations of hepatic transaminases (ALT, AST), especially in early treatment (see section 4.4)
Prehodna asimptomatska zvišanja jetrnih transaminaz (ALT, AST), posebno na začetku zdravljenja (glejte poglavje 4. 4
Skin and subcutaneous tissue disorders
)
36
36 Bolezni kože in podkožja
37 Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
Dolgoročna izpostavljenost (najmanj 48 tednov) Delež bolnikov, ki so imeli neželene, klinično značilne spremembe telesne mase, glukoze,
38 patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
Pri dolgoročni izpostavljenosti (najmanj 24 tednov) je približno polovica mladostnikov pridobila ≥ 15% in skoraj tretjina ≥ 25% od njihove osnovne telesne mase.
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).
38 10 Opazovano pri osnovnih normalnih ravneh na tešče (< 1, 016 mmol/ l), ki so se povišale na visoke (≥ 1, 467 mmol/ l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1, 016 mmol/ l - < 1, 467 mmol/ l) na visoke (≥ 1, 467 mmol/ l).
Olanzapine demonstrated a greater in vitro affinity for serotonin 5HT2 than dopamine D2 receptors and greater
V pogojih in vitro je olanzapin pokazal večjo afiniteto za serotoninske 5- HT2 kot za dopaminske D2 receptorje in večjo 5- HT2 kot D2 aktivnost v modelih in vivo.
39 5 HT2 than D2 activity in vivo, models.
39 motorično delovanje.
Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Olanzapin je zmanjšal pogojeni umaknitveni odziv, test, ki kaže na antipsihotično delovanje, pri odmerkih, nižjih od tistih, ki povzročijo katalepsijo, učinek, ki kaže na motorične neželene učinke.
There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
Podatkov o vzdrževalnem učinku ni in podatki o dolgoročni varnosti so nezadostni (glejte
40 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
41 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
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 Akutna toksičnost (toksičnost po enkratnem odmerku) Znaki toksičnosti po peroralnem dajanju pri glodavcih so bili značilni za močne antipsihotike: hipoaktivnost, koma, tresenje, klonični krči, slinjenje in zmanjšano pridobivanje telesne mase.
Hypromellose (E464) Titanium dioxide (E171) Lactose monohydrate Polyethylene glycol 3000 Glycerol triacetate
Opadry II beli vsebuje: hipromelozo (E464) titanov dioksid (E171) laktozo monohidrat makrogol 3000 gliceriltriacetat
42 6.2 Incompatibilities
42 6. 2 Inkompatibilnosti.
EU/ 1/ 07/ 426/ 005 – Olanzapine Neopharma – 7.5 mg – coated tablets – 28 tablets per box
EU/ 1/ 07/ 426/ 005 - Olanzapine Neopharma – 7. 5 mg – obložene tablete - 28 tablet na škatlo.
EU/ 1/ 07/ 426/ 006 – Olanzapine Neopharma – 7.5 mg – coated tablets – 56 tablets per box
EU/ 1/ 07/ 426/ 006 - Olanzapine Neopharma – 7. 5 mg – obložene tablete - 56 tablet na škatlo.
Olanzapine Neopharma 10 mg coated tablets
Olanzapin Neopharma 10 mg obložene tablete
Each coated tablet contains 322.6 mg lactose monohydrate
Vsaka obložena tableta vsebuje 322. 6 mg laktoza monohidrat
White, round, biconvex, coated tablets with ‘ OLZ 10’ debossing on one side and ‘ NEO’ on the other.
Bele, okrogle, bikonveksne, obložene tablete z vtisnjeno oznako 'OLZ 10' na eni strani in 'NEO' na drugi.
44 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Izkušenj pri otrocih ni.
In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
V teh
In these trials, patients were initially required to be stable on the lowest effective dose of anti-Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
45 preskušanjih je bilo potrebno, da se je zdravstveno stanje bolnikov najprej ustalilo ob prejemanju najnižjega učinkovitega odmerka antiparkinsonskih zdravil (dopaminskih agonistov) ter da so ves čas študije prejemali ista antiparkinsonska zdravila v enakih odmerkih.
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
46 QT interval V kliničnih preskušanjih so bila klinično pomembna podaljšanja QTc (QT korekcija Fridericia [QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 msek) pri bolnikih, zdravljenih z olanzapinom, redka (od 0, 1% do 1%), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
47 4.5 Interaction with other medicinal products and other forms of interaction
47 izoencim, vplivati na farmakokinetiko olanzapina.
48 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
48 V študiji pri doječih zdravih ženskah se je olanzapin izločal v materino mleko.
49 Very common
49 Zelo pogosti
50
50 Bolezni kože in podkožja
51 Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
Dolgoročna izpostavljenost (najmanj 48 tednov) Delež bolnikov, ki so imeli neželene, klinično značilne spremembe telesne mase, glukoze,
52 patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
Pri dolgoročni izpostavljenosti (najmanj 24 tednov) je približno polovica mladostnikov pridobila ≥ 15% in skoraj tretjina ≥ 25% od njihove osnovne telesne mase.
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 Opazovano pri osnovnih normalnih ravneh na tešče (< 1, 016 mmol/ l), ki so se povišale na visoke (≥ 1, 467 mmol/ l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1, 016 mmol/ l - < 1, 467 mmol/ l) na visoke (≥ 1, 467 mmol/ l).
53 5 HT2 than D2 activity in vivo, models.
53 motorično delovanje.
55 5.3 Preclinical safety data
55 5. 3 Predklinični podatki o varnosti
56 6.2 Incompatibilities
56 makrogol 3000 gliceriltriacetat
Cold-formed aluminium blisters in cartons of 7, 28 or 56 tablets per carton.
Hladno- oblikovani aluminijasti pretisni omoti v škatlah po 7, 28 ali 56 tablet.
EU/ 1/ 07/ 426/ 007 – Olanzapine Neopharma – 10 mg – coated tablets – 7 tablets per box
EU/ 1/ 07/ 426/ 007 - Olanzapine Neopharma – 10 mg – obložene tablete - 7 tablet na škatlo.
EU/ 1/ 07/ 426/ 008 – Olanzapine Neopharma – 10 mg – coated tablets – 28 tablets per box
EU/ 1/ 07/ 426/ 008 - Olanzapine Neopharma – 10 mg – obložene tablete - 28 tablet na škatlo.
EU/ 1/ 07/ 426/ 009 – Olanzapine Neopharma – 10 mg – coated tablets – 56 tablets per box
EU/ 1/ 07/ 426/ 009 - Olanzapine Neopharma – 10 mg – obložene tablete - 56 tablet na škatlo.
NAME OF THE MEDICINAL PRODUCT
57 1 IME ZDRAVILA
Olanzapine Neopharma 15 mg coated tablets
Olanzapin Neopharma 15 mg obložene tablete
Each coated tablet contains 315 mg lactose monohydrate
Vsaka obložena tableta vsebuje 315 mg laktoza monohidrat
Blue, elliptical, convex, coated tablets with ‘ NEO’ debossed on one side and plain on the other side.
Modre, eliptične, konveksne, obložene tablete z vtisnjeno oznako 'NEO' na eni in brez oznake na drugi strani.
59 Children and adolescents Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Izkušenj pri otrocih ni..
In these trials, patients were initially required to be stable on the lowest effective dose of anti-Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
59 preskušanjih je bilo potrebno, da se je zdravstveno stanje bolnikov najprej ustalilo ob prejemanju najnižjega učinkovitega odmerka antiparkinsonskih zdravil (dopaminskih agonistov) ter da so ves čas študije prejemali ista antiparkinsonska zdravila v enakih odmerkih.
QT interval In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF < 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
60 QT interval V kliničnih preskušanjih so bila klinično pomembna podaljšanja QTc (QT korekcija Fridericia [QTcF] ≥ 500 milisekund [msek] kadarkoli nad osnovno vrednostjo pri bolnikih z osnovno vrednostjo QTcF < 500 msek) pri bolnikih, zdravljenih z olanzapinom, redka (od 0, 1% do 1%), brez pomembnih razlik v spremljajočih srčnih dogodkih v primerjavi z bolniki, zdravljenimi s placebom.
62 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Potential interactions affecting olanzapine Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine.
Možna medsebojna delovanja, ki vplivajo na olanzapin Ker se olanzapin presnavlja s CYP1A2, utegnejo snovi, ki lahko specifično inducirajo ali inhibirajo ta
63 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
62 V študiji pri doječih zdravih ženskah se je olanzapin izločal v materino mleko.
64 Very common
63 Zelo pogosti
Skin and subcutaneous tissue disorders
64 Bolezni kože in podkožja
66 Long-term exposure (at least 48 weeks) The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/ LDL/ HDL cholesterol or triglycerides increased over time.
Dolgoročna izpostavljenost (najmanj 48 tednov) Delež bolnikov, ki so imeli neželene, klinično značilne spremembe telesne mase, glukoze,
67 patients gained ≥ 15% and almost a third gained ≥ 25% of their baseline body weight.
Pri dolgoročni izpostavljenosti (najmanj 24 tednov) je približno polovica mladostnikov pridobila ≥ 15% in skoraj tretjina ≥ 25% od njihove osnovne telesne mase.
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 Opazovano pri osnovnih normalnih ravneh na tešče (< 1, 016 mmol/ l), ki so se povišale na visoke (≥ 1, 467 mmol/ l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1, 016 mmol/ l - < 1, 467 mmol/ l) na visoke (≥ 1, 467 mmol/ l).
68 5 HT2 than D2 activity in vivo, models.
67 motorično delovanje.
69 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
70 5.3 Preclinical safety data
69 5. 3 Predklinični podatki o varnosti
Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol 6000 Indigo carmine aluminium lake (E132) Brilliant blue FCF aluminium lake (E133)
Obloga tablete Opadry modri vsebuje: hipromelozo (E464) titanov dioksid (E171) makrogol 6000
71 Iron oxide black (E172)
70 barvilo indigotin (E132) barvilo modro FCF (E133) Črni železov oksid (E172)
6.2 Incompatibilities
6. 2 Inkompatibilnosti.
EU/ 1/ 07/ 426/ 010 – Olanzapine Neopharma – 15 mg – coated tablets – 28 tablets per box
EU/ 1/ 07/ 426/ 010 - Olanzapine Neopharma – 15 mg – obložene tablete - 28 tablet na škatlo.
EU/ 1/ 07/ 426/ 011 – Olanzapine Neopharma – 15 mg – coated tablets – 56 tablets per box
EU/ 1/ 07/ 426/ 011 - Olanzapine Neopharma – 15 mg – obložene tablete - 56 tablet na škatlo.
DATE OF REVISION OF THE TEXT
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /
{MM/ YYYY}
71 DODATEK II
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
CONDITIONS OF THE MARKETING AUTHORISATION
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Neolab 57 High Street, Odiham Hants RG29 1LF United Kingdom
Neolab 57 High Street, Odiham Hants RG29 1LF Velika Britanija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3 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.
Farmakovigilančni sistem Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3, ki je predstavljena v Modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje pred prihodom zdravila na trg in dokler je zdravilo na tržišču.
Risk Management Plan Risk Management Plan was not submitted.
Načrt o obvladovanju tveganja Načrt o obvladovanju tveganja ni bil predložen.
The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimization activities have been identified.
Vloga temelji na referenčnem zdravilu, za katerega niso bile ugotovljene nobene nevarnosti, ki bi zahtevale dodatne ukrepe za zmanjševanje tveganj.
PSURs The PSUR submission schedule for Olanzapine Neopharma tablets should follow the PSURs submission schedule for the reference medicinal product Zyprexa.
Periodična poročila o varnosti zdravila (PSUR) Shema predložitve PSUR za tablete "Olanzapin Neopharma" mora slediti shemi predložitve za referenčno zdravilo "Zyprexa".
LABELLING
75 PODATKI NA ZUNANJI OVOJNINI
Olanzapine Neopharma 2.5 mg coated tablets olanzapine
Olanzapin Neopharma 2, 5 mg obložene tablete olanzapin
Each coated tablet contains 2.5 mg olanzapine
Ena obložena tableta vsebuje 2, 5 mg olanzapina.
Contains lactose monohydrate, see package leaflet for further information.
Za nadaljnje informacije glejte navodilo za uporabo.
Neopharma Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, UK Tel: +44 (0)1256 704110 Fax: +44 (0)1256 701144
Neopharma Limited, 57 High Street, Odiham, Hampshire, RG29 1LF, Velika Britanija Tel: +44 (0) 1256 704110 Faks: +44 (0) 1256 701144
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( E) DOVOLJENJA (DOVOLJENJ) ZA PROMET.
EU/ 1/ 07/ 426/ 001, 28 coated tablets EU/ 1/ 07/ 426/ 002, 56 coated tablets
EU/ 1/ 07/ 426/ 001 28 obloženih tablet EU/ 1/ 07/ 426/ 002 56 obloženih tablet
Olanzapine Neopharma 2.5 mg
OlanzapinNeopharma 2, 5 mg
78 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
77 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNI TRAKOVIH
79 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
78 PODATKI NA ZUNANJI OVOJNINI
Olanzapine Neopharma 5 mg coated tablets olanzapine
Olanzapin Neopharma 5 mg obložene tablete olanzapin
Store below 30°C.
79 Shranjujte pri temperaturi do 30°C.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH KADAR SO POTREBNI
EU/ 1/ 07/ 426/ 003, 28 coated tablets EU/ 1/ 07/ 426/ 004, 56 coated tablets
EU/ 1/ 07/ 426/ 003 28 obloženih tablet EU/ 1/ 07/ 426/ 004 56 obloženih tablet
Olanzapine Neopharma 5 mg
Olanzapin Neopharma 5 mg
81 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
80 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNI TRAKOVIH
82 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
81 PODATKI NA ZUNANJI OVOJNINI
Olanzapine Neopharma 7.5 mg coated tablets olanzapine
Olanzapin Neopharma 7, 5 mg obložene tablete olanzapin
Each coated tablet contains 7.5 mg olanzapine
Ena obložena tableta vsebuje 7, 5 mg olanzapina.
EU/ 1/ 07/ 426/ 005, 28 coated tablets EU/ 1/ 07/ 426/ 006, 56 coated tablets
EU/ 1/ 07/ 426/ 005 28 obloženih tablet EU/ 1/ 07/ 426/ 006 56 obloženih tablet
Olanzapine Neopharma 7.5 mg
Olanzapin Neopharma 7, 5 mg
84 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
83 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNI TRAKOVIH
85 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
84 PODATKI NA ZUNANJI OVOJNINI
Olanzapine Neopharma 10 mg coated tablets olanzapine
Olanzapin Neopharma 10 mg obložene tablete olanzapin
EU/ 1/ 07/ 426/ 007, 7 coated tablets EU/ 1/ 07/ 426/ 008, 28 coated tablets EU/ 1/ 07/ 426/ 009, 56 coated tablets
EU/ 1/ 07/ 426/ 007 7 obloženih tablet EU/ 1/ 07/ 426/ 008 28 obloženih tablet EU/ 1/ 07/ 426/ 009 56 obloženih tablet
Olanzapine Neopharma 10 mg
Olanzapin Neopharma 10 mg
87 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
86 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNI TRAKOVIH
88 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
87 PODATKI NA ZUNANJI OVOJNINI
Olanzapine Neopharma 15 mg coated tablets olanzapine
Olanzapin Neopharma 15 mg obložene tablete olanzapin
EU/ 1/ 07/ 426/ 010, 28 coated tablets EU/ 1/ 07/ 426/ 011, 56 coated tablets
EU/ 1/ 07/ 426/ 010 28 obloženih tablet EU/ 1/ 07/ 426/ 011 56 obloženih tablet
Olanzapine Neopharma 15 mg
Olanzapin Neopharma 15 mg
90 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
89 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNI TRAKOVI
PACKAGE LEAFLET
91 NAVODILO ZA UPORABO
OLANZAPINE NEOPHARMA 2.5 mg coated tablets OLANZAPINE NEOPHARMA 5 mg coated tablets OLANZAPINE NEOPHARMA 7.5 mg coated tablets OLANZAPINE NEOPHARMA 10 mg coated tablets OLANZAPINE NEOPHARMA 15 mg coated tablets olanzapine
OLANZAPIN NEOPHARMA 2, 5 mg obložene tablete OLANZAPIN NEOPHARMA 5 mg obložene tablete OLANZAPIN NEOPHARMA 7, 5 mg obložene tablete OLANZAPIN NEOPHARMA 10 mg obložene tablete OLANZAPIN NEOPHARMA 15 mg obložene tablete olanzapin
What OLANZAPINE NEOPHARMA is and what it is used for 2.
Kaj je zdravilo OLANZAPIN NEOPHARMA in za kaj ga uporabljamo 2.
Before you take OLANZAPINE NEOPHARMA 3.
Kaj morate vedeti, preden boste vzeli zdravilo OLANZAPIN NEOPHARMA 3.
How to take OLANZAPINE NEOPHARMA 4.
Kako jemati zdravilo OLANZAPIN NEOPHARMA 4.
How to store OLANZAPINE NEOPHARMA 6.
Možni neželeni učinki 5 Shranjevanje zdravila OLANZAPIN NEOPHARMA 6.
WHAT OLANZAPINE NEOPHARMA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO OLANZAPIN NEOPHARMA IN ZA KAJ GA UPORABLJAMO
OLANZAPINE NEOPHARMA belongs to a group of medicines called antipsychotics.
Zdravilo OLANZAPIN NEOPHARMA spada v skupino zdravil, imenovanih antipsihotiki.
OLANZAPINE NEOPHARMA 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.
Zdravilo OLANZAPIN NEOPHARMA se uporablja za zdravljenje bolezni s simptomi, kot so prisluhi, prividi ali občutki, ki niso povezani z realnostjo, zmotna prepričanja, nenavadna sumničavost in postopno izogibanje socialnim stikom.
OLANZAPINE NEOPHARMA 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.
Zdravilo OLANZAPIN NEOPHARMA se uporablja za zdravljenje stanja s simptomi, kot so » privzdignjeno « počutje, nenormalno veliko energije, manjša potreba po spanju kot sicer, zelo hitro govorjenje z bežečimi idejami in včasih huda razdražljivost.
BEFORE YOU TAKE OLANZAPINE NEOPHARMA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO OLANZAPIN NEOPHARMA
Do not take OLANZAPINE NEOPHARMA
Ne jemljite zdravila OLANZAPIN NEOPHARMA
- if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of
- če ste alergični na (preobčutljivi za) olanzapin ali katerokoli sestavino zdravila OLANZAPIN
- if you have been previously diagnosed with eye problems such as certain kinds of glaucoma
- če so vam v preteklosti ugotovili težave z očmi kot je določena vrsta glavkoma (povišan tlak v
(increased pressure in the eye).
očesu).
Take special care with OLANZAPINE NEOPHARMA
Bodite posebno pozorni pri jemanju zdravila OLANZAPIN NEOPHARMA
If this
Če