natgillin/translations-raw huggingface dataset:
In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 4.4). 
U bolesnica s oštećenjem funkcije jetre atosiban treba primjenjivati s oprezom (vidjeti dio 4.2 i 4.4).
OTHER EU/1/13/852/002 
DRUGO EU/1/13/852/002
Intravenous therapy using the initial bolus injection of atosiban 6.75 mg/0.9 ml, solution for injection (see Summary of Product Characteristics of this medicinal product) should be started as soon as possible after diagnosis of pre-term labour. 
Intravensku terapiju primjenom inicijalne bolus injekcije atosibana 6,75 mg/0,9 ml, otopine za injekciju (vidjeti Sažetak opisa svojstava lijeka) potrebno je započeti što je moguće ranije nakon postavljanja dijagnoze prijevremenog poroda.
For storage conditions after first opening of the medicinal product, see section 6.3. 
Uvjete čuvanja nakon prvog otvaranja lijeka, vidjeti u dijelu 6.3
Colourless tubular glass vial (type I) with bromobutyl flange grey rubber stopper and sealed with flip off violet colour aluminium seal. 
Bezbojna cjevasta staklena bočical (tip I) s bromo-butil sivim gumenim čepom s prirubnicom i zatvorena „flip off“ ljubičastom aluminijskom brtvom.
LIST OF EXCIPIENTS Excipients: mannitol, hydrochloric acid 1M, water for injections. 
POPIS POMOĆNIH TVARI Pomoćne tvari: manitol, kloridna kiselina 1M, voda za injekcije.
Do not use Atosiban SUN if you notice particulate matter and discoloration prior to administration. 
Atosiban SUN se ne smije upotrijebiti ako primijetite čestice ili promjenu boje prije primjene.
- The other ingredients are mannitol, hydrochloric acid 1M and water for injections. 
- Pomoćne tvari su manitol, kloridna kiselina 1M i voda za injekcije.
1 vial (6.75 mg/0.9 ml) 
1 bočica (6,75 mg/0,9 ml)
In the case of persistence of uterine contractions during treatment with atosiban, alternative therapy should be considered. 
Ukoliko su kontrakcije maternice i dalje prisutne za vrijeme liječenja lijekom atosiban, potrebno je razmisliti o drugoj terapiji.
Provides 0.75 mg/ml when diluted as recommended. 
1 bočica (7,5 mg/ml) Sadrži 0,75 mg/ml kad se razrijedi kako je preporučeno.
Patients with renal or liver impairment 
Bolesnice s oštećenjima bubrega ili jetre
The atosiban 6.75 mg/0.9 ml solution for injection should be used immediately. 
Atosiban 6,75 mg/0,9 ml otopina za injekciju mora se odmah upotrijebiti.
The intravenous infusion is prepared by diluting Atosiban SUN 37.5 mg/5 ml, concentrate for solution for infusion in sodium chloride 9 mg/ml (0.9%) solution for injection, Ringer's lactate solution or 5% w/v glucose solution. 
Intravenska infuzija priprema se otapanjem Atosiban SUN 37,5 mg/5 ml, koncentrata za otopinu za infuziju u natrijevom kloridu 9 mg/ml (0.9%) otopina za injekciju, otopini Ringerovog laktata ili 5% otopini glukoze.
One pack contains one vial containing 0.9 ml solution. 
Jedno pakiranje sadrži jednu bočicu s 0,9 ml otopine.
Once the bolus has been injected, proceed with the infusion (See Summary of Product Characteristics of Atosiban SUN 37.5 mg/5 ml, concentrate for solution for infusion). 
Nakon injiciranja bolusa, potrebno je nastaviti s infuzijom (vidjeti Sažetak opisa svojstava lijeka Atosiban SUN 37,5 mg/5 ml, koncentrat za otopinu za infuziju).
Once the vial has been opened, the medicinal product must be used immediately. 
Nakon otvaranja bočice lijek se mora odmah upotrijebiti.
In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of atosiban 6.75 mg/0.9 ml, solution for injection followed by infusion with atosiban 37.5 mg/5 ml, concentrate for solution for infusion. 
Ukoliko je potrebno ponovljeno liječenje atosibanom, ono također treba započeti s bolus injekcijom atosibana 6,75 mg/0,9 ml, otopina za injekciju nakon čega slijedi infuzija atosibana 37,5 mg/5 ml, koncentrata za otopinu za infuziju.
Name and address of the manufacturer(s) responsible for batch release Sun Pharmaceutical Industries Europe B.V. 
Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet Sun Pharmaceutical Industries Europe B.V.
02-954 Warszawa Polska tel. +48 22 642 07 75 
+48 22 642 07 75 România
One pack contains one vial containing 5 ml solution. 
Jedno pakiranje sadrži jednu bočicu s 5 ml otopine.
- Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to 
- Zatim druga kontinuirana infuzija (drip) u dozi od 6 mg na sat primjenjuje se u trajanju do 45
NETHERLANDS 
NIZOZEMSKA
- A reaction at the site where the injection was given. 
- reakcije na mjestu primjene injekcije.
If you are not sure, talk to your doctor, midwife or pharmacist before you are given Atosiban SUN. 
obratite se svom liječniku, primalji ili ljekarniku prije primjene Atosiban SUN-a.
Talk to your doctor, midwife or pharmacist before you are given Atosiban SUN - If you think your waters might have broken (premature rupture of your membranes). 
Prije primjene Atosiban SUN-a provjerite s liječnikom, ljekarnikom ili medicinskom sestrom: - Ako mislite da vam je pukao vodenjak (prijevremeno prsnuće plodovih ovoja).
Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other medicinal products with tocolytic activity, like calcium antagonists and betamimetics, and/or in women with multiple pregnancy, have been reported post-marketing. 
U razdoblju nakon stavljanja lijeka u promet bilježe se respiratorni događaji poput dispneje i edema pluća, posebno u slučaju istovremene primjene drugih lijekova s tokolitičkom aktivnosti kao što su kalcijevi antagonisti i beta-mimetici, i/ili višeplodna trudnoća u žena.
Replace it by 10 ml atosiban 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml. 
Zamijenite ga za 10 ml atosibana 37,5 mg/5 ml koncentrata za otopinu za infuziju iz dvije bočice od 5 ml, kako biste dobili koncentraciju od 75 mg atosibana u 100 ml.
- If your waters have broken (premature rupture of your membranes) and you have completed 
- Ako imate prerano prsnuće vodenjaka (prijevremeno prsnuće plodovih ovoja), a navršili ste 30
Atosiban SUN will be given into a vein (intravenously) in three stages: - The first injection of 6.75 mg in 0.9 ml will be slowly injected into your vein over one minute. 
Atosiban SUN se primjenjuje u venu (intravenski) u tri uzastopna koraka: - Početna injekcija od 6,75 mg u 0,9 ml polako se daje u venu u trajanju od jedne minute.
Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation. 
Atosiban se smije primijeniti samo kod dijagnoze prijevremenog poroda između navršenog 24 i 33
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal products subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate). 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica od 5 ml otopine sadrži 37,5 mg atosibana (u obliku atosibanacetata).
- Your womb may be less able to contract after your baby has been born. 
Nakon poroda mogla bi se smanjiti sposobnost kontrakcije vaše maternice.
In human pre-term labour, atosiban at the recommended dose antagonises uterine contractions and induces uterine quiescence. 
U slučaju prijevremenog poroda u žena, atosiban u preporučenoj dozi antagonizira kontrakcije maternice i inducira smirivanje maternice.
Withdraw 0.9 ml of a 0.9 ml labelled vial of atosiban 6.75 mg/0.9 ml, solution for injection and administer slowly as an intravenous bolus dose over one minute, under adequate medical supervision in an obstetric unit. 
Priprema početne intravenske injekcije: Izvucite 0,9 ml iz bočice atosibana 6,75 mg/0,9 ml, otopine za injekciju označene s 0,9 ml i primijenite polako u venu u obliku bolusa tijekom jedne minute, uz prikladni medicinski nadzor na odjelu porodništva.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate). 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica od 0,9 ml otopine sadrži 6,75 mg atosibana (u obliku atosibanacetata).
Atosiban SUN is given intravenously in three successive stages: - The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute. 
Atosiban SUN se daje intravenski u tri uzastopna koraka: - Početna intravenska injekcija od 6,75 mg u 0,9 ml polako se injicira intravenski u trajanju od jedne minute.
Cluj-Napoca, Judeţul Cluj România tel. +40 (264) 501 500 
+40 (264) 501 500 United Kingdom
- Gestational age below 24 or over 33 completed weeks - Premature rupture of the membranes >30 weeks of gestation - Abnormal foetal heart rate - Antepartum uterine haemorrhage requiring immediate delivery - Eclampsia and severe pre-eclampsia requiring delivery - Intrauterine foetal death - Suspected intrauterine infection - Placenta praevia - Abruptio placenta - Any other conditions of the mother or foetus, in which continuation of pregnancy is hazardous - Hypersensitivity to the active substance or any of the excipients listed in section 6.1. 
- Placenta praevia - Abrupcija placente - Bilo koje drugo stanje majke ili fetusa, kod kojeg je nastavak trudnoće opasan - Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1
When atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits of delaying delivery should be balanced against the potential risk of chorioamnionitis. 
Kada se atosiban koristi u bolesnica u kojih se ne može isključiti prijevremena ruptura vodenjaka,
What Atosiban SUN looks like and contents of the pack Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution without particles. 
Atosiban SUN 37,5 mg/5 ml koncentrat za otopinu za infuziju je bistra, bezbojna otopina bez čestica.
- Each vial of Atosiban SUN 6.75 mg/0.9 ml solution for injection contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml. 
- Jedna bočica Atosiban SUN-a 6,75 mg/0,9 ml otopine za injekciju sadrži atosibanacetat što odgovara 6,75 mg atosibana u 0,9 ml.
For storage conditions after first opening and dilution of the medicinal product, see section 6.3. 
Uvjete čuvanja nakon prvog otvaranja i razrjeđivanja lijeka, vidjeti u dijelu 6.3 6.5 Vrsta i sadržaj spremnika
For intravenous infusion, following the bolus dose, atosiban 37.5 mg/5 ml concentrate for solution for infusion should be diluted in one of the following solutions: - sodium chloride 9 mg/ml (0.9%) solution for injection - Ringer's lactate solution - 5% w/v glucose solution. 
Atosiban 37,5 mg/5 ml, koncentrat za otopinu za infuziju, koji se daje kao intravenska infuzija nakon bolus doze, potrebno je razrijediti u jednoj od sljedećih otopina: - natrijev klorid 9 mg/ml (0,9%) otopina za injekciju
Str. Fabricii nr 124 
Fabricii nr 124 Cluj-Napoca, Judeţul Cluj
Atosiban is indicated to delay imminent pre-term birth in pregnant adult women with: - regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes - a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50% - a gestational age from 24 until 33 completed weeks - a normal foetal heart rate 
- dilatacijom cerviksa od 1 do 3 cm (0-3 za nulipare) i skraćenjem za ≥ 50% - gestacijska dob od 24 do 33 navršena tjedna
Common (may affect less than 1 in 10 people) - Headache. 
Često (pojavljuje se u manje od 1 na 10 osoba)
- Each vial of Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml. 
- Jedna bočica Atosiban SUN 37,5 mg/5 ml koncentrata za otopinu za infuziju sadrži atosibanacetat što odgovara 37,5 mg atosibana u 5 ml.
Preparation of the initial intravenous injection: 
Priprema otopine za infuziju u venu:
What Atosiban SUN looks like and contents of the pack Atosiban SUN 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles. 
Atosiban SUN 6,75 mg/0,9 ml otopina za injekciju je bistra, bezbojna otopina bez čestica.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 ml (7.5 mg/ml) 
5 ml (7,5 mg/ml)
If you get any side effects, talk to your doctor, midwife or pharmacist. 
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, primalju ili ljekarnika.
Atosiban SUN 6.75 mg/0.9 ml solution for injection atosiban 
Atosiban SUN 6,75 mg/0,9 ml otopina za injekciju atosiban
Atosiban is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with atosiban 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of atosiban 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of atosiban 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours. 
(infuzija udarne doze 300 mikrograma/min) atosibana 37,5 mg/5 ml koncentrata za otopinu za infuziju tijekom tri sata, te potom niža doza atosibana 37,5 mg/5 ml koncentrata za otopinu za infuziju (naredna infuzija od 100 mikrograma/min) do 45 sati.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.9 ml (6.75 mg/0.9 ml) 
0,9 ml (6,75 mg /0,9 ml)
Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion atosiban 
Atosiban SUN 37,5 mg/5 ml koncentrat za otopinu za infuziju atosiban
The total dose given during a full course of atosiban therapy should preferably not exceed 330.75 mg of atosiban. 
Ukupna primijenjena doza tijekom punog tijeka terapije lijekom atosiban ne bi smjela biti veća od
Pruritis, Rash 
Svrbež, osip
España Sun Pharma Laboratorios, S.L. 
Sun Pharma Laboratorios, S.L. Rambla de Catalunya 53-55
MARKETING AUTHORISATION NUMBER(S) EU/1/13/852/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/852/001
MARKETING AUTHORISATION NUMBER(S) EU/1/13/852/002 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/852/002
NAME OF THE MEDICINAL PRODUCT Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion atosiban 
Atosiban SUN 37,5 mg/5 ml koncentrat za otopinu za infuziju
NAME OF THE MEDICINAL PRODUCT Atosiban SUN 6.75 mg/0.9 ml solution for injection 
Atosiban SUN 6,75 mg/0,9 ml otopina za injekciju
Posology 
Tahikardia
During treatment with Atosiban SUN, your contractions and your unborn baby's heart rate may be monitored. 
Kontrakcije maternice i brzina otkucaja srca nerođenog djeteta trebaju se nadzirati za vrijeme liječenja
Further treatment cycles of Atosiban SUN can be used should contractions recur. 
Ako se kontrakcije ponovno pojave, mogu se primijeniti dodatni ciklusi liječenja Atosiban SUN-om.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 0.9 ml solution contains 6.75 mg of atosiban (as acetate). 
Jedna bočica od 0,9 ml otopine sadrži 6,75 mg atosibana (u obliku atosibanacetata).
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 5 ml solution contains 37.5 mg of atosiban (as acetate). 
Jedna bočica od 5 ml otopine sadrži 37,5 mg atosibana (u obliku atosibanacetata).
- Feeling dizzy. 
- otopini Ringerovog laktata
54 mg infusion Up to 45 hours subsequent 
54 mg
Skin and subcutaneous tissue disorders 
Hipotenzija, navala vrućine Poremećaji probavnog sustava Mučnina Povraćanje Poremećaji kože i potkožnog tkiva
Uncommon (may affect less than 1 in 100 people) - High temperature (fever). 
Manje često (pojavljuje se u manje od 1 na 100 osoba)
PHARMACEUTICAL FORM AND CONTENTS Solution for injection 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
The vials should be inspected visually for particulate matter and discoloration prior to administration. 
Prije primjene, bočice je potrebno vizualno pregledati na moguću prisutnost čestica i promjenu boje.
- If you are pregnant with more than one baby. 
- Ako imate višeplodnu trudnoću.
Rare (may affect less than 1 in 1,000 people) - Your womb may be less able to contract after your baby has been born. 
Rijetko (pojavljuje se u manje od 1 na 1000 osoba)
Uterine haemorrhage, uterine atony 
Krvarenje iz maternice, atonija maternice
Once the vial has been opened, the medicinal product must be used straight away. 
Lijek se mora upotrijebiti odmah nakon otvaranja bočice.
What Atosiban SUN contains - The active substance is atosiban. 
Sadržaj pakiranja i druge informacije Što Atosiban SUN sadrži
Once the vial has been opened, the solution must be used immediately. 
Otopina se mora upotrijebiti odmah nakon otvaranja bočice.
Olanzapine 
Olanzapin
This summary was last updated in 01-2013. 
Sažetak je posljednji put ažuriran 01.2013.
The usual dose range is between 5 and 20 mg per day. 
Uobičajeni raspon doze je između 5 i 20 mg na dan.
Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day. 
Bolesnici stariji od 65 godina koji imaju problema s jetrom ili bubrezima možda će trebati nižu početnu dozu od 5 mg na dan.
It is available as orodispersible tablets (5, 10, 15 and 20 mg). 
Dostupan je u obliku raspadljivih tableta za usta (5, 10, 15 i 20 mg).
It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s. 
Poznat je kao „atipični” antipsihotik jer je različit od starijih antipsihotika koji su dostupni na tržištu od 1950.
Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs). 
Shizofrenija je mentalna bolest koja ima brojne simptome, uključujući neorganizirano razmišljanje i govor, halucinacije (bolesnici čuju ili vide nešto čega nema), sumnjičavost i iluzije (pogrešna uvjerenja).
Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain. 
Točni mehanizam njegovog djelovanja nije poznat, ali vezuje se na različite receptore na površini živčanih stanica u mozgu.
It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness with alternating periods of high mood and depression) who have responded to an initial course of treatment. 
Može se također koristiti za sprječavanje ponovnog pojavljivanja ovih epizoda (ako se simptomi ponovno pojave) u odraslih osoba s bipolarnim poremećajem (mentalnom bolesti s izmjeničnim razdobljima oduševljenja i depresije) koji su reagirali na početni ciklus liječenja.
The full EPAR for the reference medicines can also be found on the Agency's website. 
Cjelovito izvješće EPAR za referentni lijek također se nalazi na internetskim stranicama Agencije.
The recommended starting dose of Olanzapine Glenmark Europe depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day. 
Preporučena početna doza lijeka Olanzapine Glenmark Europe ovisi o bolesti koja se liječi: 10 mg na dan koriste se za liječenje shizofrenije te u prevenciju epizoda manije, a 15 mg na dan u liječenju epizoda manije osim ako se ne koristi s drugim lijekovima pa u tom slučaju početna doza može biti 10 mg na dan.
The dose is adjusted according to how well the patient responds to and tolerates the treatment. 
Doza se prilagođava u skladu s tim kako dobro bolesnik reagira na liječenje te kako ga dobro podnosi.
This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other. 
To prekida signale koji se prenose između stanica mozga putem „neurotransmitera”, kemikalija koje omogućavaju da živčane stanice komuniciraju jedna s drugom.
Since these neurotransmitters are involved in schizophrenia and in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases. 
S obzirom da su ti neurotransmiteri uključeni u shizofreniju i bipolarne poremećaje, olanzapin pomaže pri normalizaciji moždane aktivnost smanjujući simptome ovih bolesti.
Medicines are bioequivalent when they produce the same levels of the active substance in the body. 
Dva su lijeka bioekvivalentna kada u tijelu proizvode iste razine djelatne tvari.
The orodispersible tablets are taken by being placed on the tongue, where they disintegrate in the saliva, or by mixing them in water before swallowing. 
Raspadljive tablete za usta uzimaju se tako što se stave na jezik gdje ih razgradi slina ili se miješaju s vodom prije gutanja.
It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. 
Smatra se da se korist olanzapina uglavnom temelji na inhibiranju receptora za neurotransmitere 5-hidroksitriptamina (također zvan serotonin) i dopamin.
The full EPAR for Olanzapine Glenmark Europe can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku Olanzapine Glenmark Europe (EPAR) nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Olanzapine Glenmark Europe is also effective in maintaining improvement in patients who have responded to an initial course of treatment. 
Olanzapine Glenmark Europe također je djelotvoran u održavanju poboljšanja u bolesnika koji su reagirali na početni ciklus liječenja.
This means that Olanzapine Glenmark Europe is similar to ‘reference medicines' already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotabs. 
To znači da je Olanzapine Glenmark Europe sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Zyprexa i Zyprexa Velotabs.
Olanzapine Glenmark Europe is also used to treat moderate to severe manic episodes (extremely high mood) in adults. 
Olanzapine Glenmark Europe se također koristi za liječenje umjerenih do teških epizoda manije (ekstremno dobrog raspoloženja) u odraslih osoba.
This is a summary of the European public assessment report (EPAR) for Olanzapine Glenmark Europe. 
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Olanzapine Glenmark Europe.
Because Olanzapine Glenmark Europe is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicines. 
Budući da je Olanzapine Glenmark Europe generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Glenmark Europe on 3 December 2009. 
Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Olanzapine Glenmark Europe vrijedi na prostoru Europske unije od 3. prosinca 2009.
Therefore, the CHMP's view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk. 
Stoga je stav CHMP-a kako koristi lijekova Zyprexa i Zyprexa Velotab nadmašuju utvrđene rizike.
For more information about treatment with Olanzapine Glenmark Europe, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Glenmark Europe pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
Olanzapine Glenmark Europe is used to treat adults with schizophrenia. 
Olanzapine Glenmark Europe koristi se za liječenje odraslih bolesnika sa shizofrenijom.
Olanzapine Glenmark Europe is a ‘generic medicine'. 
Olanzapine Glenmark Europe je „generički lijek”.
The active substance in Olanzapine Glenmark Europe, olanzapine, is an antipsychotic medicine. 
Djelatna tvar u lijeku Olanzapine Glenmark Europe, olanzapin, je antipsihotik.