natgillin/translations-raw huggingface dataset:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU VANJSKO PAKIRANJE I NALJEPNICA BOCE
ABILIFY 10 mg tablets: 
ABILIFY 10 mg tablete:
ABILIFY 15 mg orodispersible tablets Yellow iron oxide (E 172) 
ABILIFY 15 mg raspadljive tablete za usta Željezov oksid, žuti (E 172)
• The other ingredients are calcium silicate, croscarmellose sodium, crospovidone, silicon dioxide, xylitol, microcrystalline cellulose, aspartame, acesulfame potassium, vanilla flavour (contains lactose), tartaric acid and magnesium stearate. 
ksilitol, mikrokristalična celuloza, aspartam, acesulfamkalij, aroma vanilije (sadrži laktozu),
Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1, 56 × 1, 98 × 1 tablets. 
Aluminijski perforirani blisteri djeljivi na jedinične doze u kutijama s 14 × 1, 28 × 1, 49 × 1, 56 × 1,
ABILIFY 15 mg orodispersible tablets are round and yellow, marked with ‘"A" over "641"' on one side and ‘15' on the other. 
ABILIFY 15 mg raspadljive tablete za usta su okrugle i žute, s oznakom ‘"A" iznad "641"' na jednoj strani i ‘15' na drugoj.
Read the package leaflet before use. 
koje su priložene u pakiranju.
• feeling aggressive, 
• agresivnost,
In the pooled adolescent schizophrenia population (13 to 17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 29.5 % and 48.3 %, respectively. 
U cjelokupno ispitanoj populaciji adolescenata sa shizofrenijom (u dobi od 13 do 17 godina) koji su primali lijek u trajanju do 2 godine, incidencija niske razine prolaktina u serumu u djevojaka (< 3 ng/ml) bila je 29,5 %, a u mladića (< 2 ng/ml) 48,3 %.
ABILIFY 10 mg tablets 
ABILIFY 10 mg tablete
In a clinical trial of oral aripiprazole in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107 %, while Cmax was unchanged. 
Kinidin i drugi inhibitori CYP2D6 U kliničkom ispitivanju sa zdravim ispitanicima, jaki inhibitor CYP2D6 (kinidin) povećao je površinu ispod krivulje (AUC) aripiprazola za 107 %, dok je maksimalna koncentracija (Cmax) ostala neizmijenjena.
Administration of ABILIFY solution for injection was well tolerated and produced no direct target organ toxicity in rats or monkeys after repeated dosing at systemic exposures (AUC) that were 15 and 5 times, respectively, human exposure at the maximum recommended human dose of 30 mg intramuscular. 
Pimjena ABILIFY otopina za injekciju dobro se podnosila i nije imala nikakve izravne toksične učinke na ciljne organe u štakora i majmuna nakon ponovljene primjene i pri sistemskoj izloženosti
• feeling anxious, 
• osjećaj tjeskobe,
ABILIFY 30 mg orodispersible tablets are round and pink, marked with ‘"A" over "643"' on one side and ‘30' on the other. 
ABILIFY 30 mg raspadljive tablete za usta su okrugle i ružičaste, s oznakom ‘"A" iznad "643"' na jednoj strani i ‘30' na drugoj.
• high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes 
• povišenog šećera u krvi (karakteriziranog simptomima poput pretjerane žeđi, obilnog mokrenja,
ABILIFY 30 mg orodispersible tablets Red iron oxide (E 172) 
ABILIFY 30 mg raspadljive tablete za usta Željezov oksid, crveni (E 172)
ABILIFY 15 mg tablets: 
ABILIFY 15 mg tablete:
Peripheral oedema 
Oralna otopina
ABILIFY 10 mg orodispersible tablets are round and pink, marked with ‘"A" over "640"' on one side and ‘10' on the other. 
ABILIFY 10 mg raspadljive tablete za usta su okrugle i ružičaste, s oznakom ‘"A" iznad "640"' na jednoj strani i ‘10' na drugoj.
ABILIFY 10 mg orodispersible tablets Red iron oxide (E 172) 
ABILIFY 10 mg raspadljive tablete za usta Željezov oksid, crveni (E 172)
Each tablet contains 30 mg of aripiprazole. 
Jedna tableta sadrži 30 mg aripiprazola.
ABILIFY 15 mg tablets 
ABILIFY 15 mg tablete
ABILIFY 5 mg tablets: 
ABILIFY 5 mg tablete:
ABILIFY 30 mg tablets aripiprazole 
ABILIFY 30 mg tablete aripiprazol
The effective dose range of ABILIFY solution for injection is 5.25 mg to 15 mg as a single injection. 
5,25 mg do 15 mg u obliku jednokratne injekcije.
In a 26-week, placebo-controlled trial in adult stabilised patients with chronic schizophrenia, aripiprazole had significantly greater reduction in relapse rate, 34 % in aripiprazole group and 57 % in placebo. 
U placebom kontroliranom ispitivanju u trajanju od 26 tjedana koje je uključilo stabilne odrasle bolesnike s kroničnom shizofrenijom, aripiprazol je imao značajno veće smanjenje stope relapsa, 34 %
The efficacy of aripiprazole in paediatric subjects with Tourette's syndrome (aripiprazole: n = 32, placebo: n = 29) was also evaluated over a flexible dose range of 2 mg/day to 20 mg/day and a starting dose of 2 mg, in a 10 week, randomised, double blind, placebo-controlled study conducted in SouthKorea. 
20 mg na dan uz početnu dozu od 2 mg u pedijatrijskih ispitanika s Touretteovim sindromom (aripiprazol: n = 32, placebo: n = 29) u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 10 tjedana provedenom u Južnoj Koreji.
ABILIFY 10 mg tablets aripiprazole 
ABILIFY 10 mg tablete aripiprazol
EU/1/04/276/016 (30 mg, 14 × 1 tablets) EU/1/04/276/017 (30 mg, 28 × 1 tablets) EU/1/04/276/018 (30 mg, 49 × 1 tablets) EU/1/04/276/019 (30 mg, 56 × 1 tablets) EU/1/04/276/020 (30 mg, 98 × 1 tablets) 
EU/1/04/276/016 (30 mg, 14 × 1 tableta) EU/1/04/276/017 (30 mg, 28 × 1 tableta) EU/1/04/276/018 (30 mg, 49 × 1 tableta) EU/1/04/276/019 (30 mg, 56 × 1 tableta) EU/1/04/276/020 (30 mg, 98 × 1 tableta)
Photosensitivity reaction Alopecia 
Poremećaji kože i potkožnog tkiva osip fotosenzitivna reakcija alopecija hiperhidroza
Each tablet contains 5 mg of aripiprazole. 
Jedna tableta sadrži 5 mg aripiprazola.
ABILIFY 5 mg tablets 
ABILIFY 5 mg tablete
Tardive dyskinesia Dystonia 
Tardivna diskinezija
In the paediatric bipolar population (10 to 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 28.0 % and 53.3 %, respectively. 
U pedijatrijskoj populaciji s bipolarnim poremećajem (10 do 17 godina), koja je lijeku bila izložena tijekom najviše 30 tjedana, incidencija niskih vrijednosti prolaktina u serumu iznosila je 28,0 % u djevojčica (< 3 ng/ml) i 53,3 % u dječaka (< 2 ng/ml).
Manic episodes in Bipolar I Disorder: in a 12-week controlled trial, the incidence of EPS was 23.5 % for aripiprazole-treated patients and 53.3 % for haloperidol-treated patients. 
12 tjedana, incidencija EPS-a bila je 23,5 % u bolesnika liječenih aripiprazolom i 53,3 % u bolesnika liječenih haloperidolom.
EU/1/04/276/030 (30 mg, 14 × 1 orodispersible tablets) EU/1/04/276/031 (30 mg, 28 × 1 orodispersible tablets) EU/1/04/276/032 (30 mg, 49 × 1 orodispersible tablets) 
EU/1/04/276/030 (30 mg, 14 × 1 raspadljiva tableta za usta) EU/1/04/276/031 (30 mg, 28 × 1 raspadljiva tableta za usta) EU/1/04/276/032 (30 mg, 49 × 1 raspadljiva tableta za usta)
Each orodispersible tablet contains 10 mg of aripiprazole. 
Jedna raspadljiva tableta za usta sadrži 10 mg aripiprazola.
Each orodispersible tablet contains 30 mg of aripiprazole. 
Jedna raspadljiva tableta za usta sadrži 30 mg aripiprazola.
Immune system disorders 
Nepoznato limfnog sustava neutropenija trombocitopenija
Pathological gambling Impulse-control disorder Binge eating 
(vidjeti dio 4.4) patološko kockanje poremećaj kontrole nagona kompulzivno prejedanje kompulzivno kupovanje
ABILIFY 5 mg tablets aripiprazole 
ABILIFY 5 mg tablete aripiprazol
The safety and efficacy of ABILIFY in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established. 
Sigurnost i djelotvornost lijeka ABILIFY u liječenju shizofrenije ili maničnih epizoda kod bipolarnog poremećaja tipa
Each orodispersible tablet contains 15 mg of aripiprazole. 
Jedna raspadljiva tableta za usta sadrži 15 mg aripiprazola.
Each tablet contains 10 mg of aripiprazole. 
Jedna tableta sadrži 10 mg aripiprazola.
ABILIFY 15 mg tablets aripiprazole 
ABILIFY 15 mg tablete aripiprazol
Among the patients included in the primary efficacy analysis, 
U dva ispitivanja u zdravih ispitanika,
Methyl parahydroxybenzoate (E 218) Propylene glycol 
6.1 Popis pomoćnih tvari dinatrijev edetat fruktoza glicerin laktatna kiselina metilparahidroksibenzoat (E 218) propilenglikol propilparahidroksibenzoat (E 216) natrijev hidroksid saharoza voda, pročišćena aroma naranče
• dry mouth. 
Primjena kroz usta.
Constipation Dyspepsia Nausea Salivary hypersecretion Vomiting 
Poremećaji probavnog sustava konstipacija dispepsija mučnina hipersekrecija pankreatitis disfagija proljev nelagoda u abdomenu
EU/1/04/276/011 (15 mg, 14 × 1 tablets) EU/1/04/276/012 (15 mg, 28 × 1 tablets) EU/1/04/276/013 (15 mg, 49 × 1 tablets) EU/1/04/276/014 (15 mg, 56 × 1 tablets) EU/1/04/276/015 (15 mg, 98 × 1 tablets) 
EU/1/04/276/011 (15 mg, 14 × 1 tableta) EU/1/04/276/012 (15 mg, 28 × 1 tableta) EU/1/04/276/013 (15 mg, 49 × 1 tableta) EU/1/04/276/014 (15 mg, 56 × 1 tableta) EU/1/04/276/015 (15 mg, 98 × 1 tableta)
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0 %), 
I bile su slične onima u odraslih bolesnika, osim sljedećih nuspojava: vrlo često (≥ 1/10) somnolencija (23,0 %),
EU/1/04/276/024 (10 mg, 14 × 1 orodispersible tablets) EU/1/04/276/025 (10 mg, 28 × 1 orodispersible tablets) EU/1/04/276/026 (10 mg, 49 × 1 orodispersible tablets) 
EU/1/04/276/024 (10 mg, 14 × 1 raspadljiva tableta za usta) EU/1/04/276/025 (10 mg, 28 × 1 raspadljiva tableta za usta) EU/1/04/276/026 (10 mg, 49 × 1 raspadljiva tableta za usta)
Each tablet contains 15 mg of aripiprazole. 
Jedna tableta sadrži 15 mg aripiprazola.
EU/1/04/276/006 (10 mg, 14 × 1 tablets) EU/1/04/276/007 (10 mg, 28 × 1 tablets) EU/1/04/276/008 (10 mg, 49 × 1 tablets) EU/1/04/276/009 (10 mg, 56 × 1 tablets) EU/1/04/276/010 (10 mg, 98 × 1 tablets) 
EU/1/04/276/006 (10 mg, 14 × 1 tableta) EU/1/04/276/007 (10 mg, 28 × 1 tableta) EU/1/04/276/008 (10 mg, 49 × 1 tableta) EU/1/04/276/009 (10 mg, 56 × 1 tableta) EU/1/04/276/010 (10 mg, 98 × 1 tableta)
Akathisia Extrapyramidal disorder Tremor 
Nepoznato poriomanija agresija agitacija nervoza
If continued treatment is indicated with oral aripiprazole, see the Summary of Product Characteristics for ABILIFY tablets, ABILIFY orodispersible tablets, or ABILIFY oral solution. 
Ako je indiciran nastavak liječenja oralnim aripiprazolom, vidjeti Sažetak opisa svojstava lijeka za
EU/1/04/276/001 (5 mg, 14 × 1 tablets) EU/1/04/276/002 (5 mg, 28 × 1 tablets) EU/1/04/276/003 (5 mg, 49 × 1 tablets) EU/1/04/276/004 (5 mg, 56 × 1 tablets) EU/1/04/276/005 (5 mg, 98 × 1 tablets) 
EU/1/04/276/001 (5 mg, 14 × 1 tableta) EU/1/04/276/002 (5 mg, 28 × 1 tableta) EU/1/04/276/003 (5 mg, 49 × 1 tableta) EU/1/04/276/004 (5 mg, 56 × 1 tableta) EU/1/04/276/005 (5 mg, 98 × 1 tableta)
No cases of overdose associated with adverse reactions were reported in clinical studies with ABILIFY solution for injection. 
U kliničkim ispitivanjima lijeka ABILIFY otopina za injekciju nije zabilježen nijedan slučaj predoziranja povezanog s nuspojavama.
EU/1/04/276/027 (15 mg, 14 × 1 orodispersible tablets) EU/1/04/276/028 (15 mg, 28 × 1 orodispersible tablets) EU/1/04/276/029 (15 mg, 49 × 1 orodispersible tablets) 
EU/1/04/276/027 (15 mg, 14 × 1 raspadljiva tableta za usta) EU/1/04/276/028 (15 mg, 28 × 1 raspadljiva tableta za usta) EU/1/04/276/029 (15 mg, 49 × 1 raspadljiva tableta za usta)
• diabetes mellitus, 
• šećerna bolest,
See package leaflet for further information. 
Za dodatne informacije vidjeti Uputu o lijeku.
3 mg aspartame (E 951) and 0.1125 mg lactose per orodispersible tablet 
3 mg aspartama (E 951) i 0,1125 mg laktoze po raspadljivoj tableti za usta ABILIFY 30 mg raspadljive tablete za usta Jedna raspadljiva tableta za usta sadrži 30 mg aripiprazola.
ABILIFY 30 mg orodispersible tablets 
ABILIFY 30 mg raspadljive tablete za usta
ABILIFY contains sodium 
ABILIFY sadrži natrij
• slower heartbeat, 
• štucavica, • suha usta.
ABILIFY 30 mg orodispersible tablets aripiprazole 
ABILIFY 30 mg raspadljive tablete za usta aripiprazol
ABILIFY 10 mg orodispersible tablets aripiprazole 
ABILIFY 10 mg raspadljive tablete za usta aripiprazol
Rhabdomyolysis Myalgia 
Točkovna procjena omjera hazarda
ABILIFY 15 mg orodispersible tablets 
ABILIFY 15 mg raspadljive tablete za usta
Excipient with known effect 62.18 mg lactose (as monohydrate) per tablet 
62,18 mg laktoze (u obliku laktoza hidrata) po tableti ABILIFY 15 mg tablete
Excipient with known effect 67 mg lactose (as monohydrate) per tablet 
67 mg laktoze (u obliku laktoza hidrata) po tableti ABILIFY 10 mg tablete
Stiffness 
Doziranje
Hepatic failure 
moždani udar.
• baldness, 
• mučnina,
ABILIFY 10 mg orodispersible tablets 
ABILIFY 10 mg raspadljive tablete za usta
Otsuka Pharmaceuticals (UK) Ltd. Tel: +44 (0) 203 747 5300 
Otsuka Pharmaceutical Italy S.r.l. Tel: +39 (0) 2 0063 2710
Musculoskeletal and connective tissue disorders 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva rabdomioliza mialgija ukočenost
ABILIFY orodispersible tablets contain sodium. 
ABILIFY raspadljive tablete za usta sadrže natrij.
This medicine contains 200 mg of fructose and 400 mg of sucrose in each mL. 
Ovaj lijek sadrži 200 mg fruktoze i 400 mg saharoze po ml. Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
ABILIFY is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1). 
I u adolescenata u dobi od 13 godina i starijih tijekom najdulje 12 tjedana (vidjeti dio 5.1).
ABILIFY 30 mg orodispersible tablets 30 mg: Round and pink, marked with "A" over "643" on one side and "30" on the other. 
30 mg: Okrugla i ružičasta s oznakom "A" iznad "643" na jednoj strani i "30" na drugoj.
2 mg aspartame (E 951) and 0.075 mg lactose per orodispersible tablet 
Pomoćna tvar s poznatim učinkom2 mg aspartama (E 951) i 0,075 mg laktoze po raspadljivoj tableti za usta ABILIFY 15 mg raspadljive tablete za usta Jedna raspadljiva tableta za usta sadrži 15 mg aripiprazola.
ABILIFY 15 mg orodispersible tablets aripiprazole 
ABILIFY 15 mg raspadljive tablete za usta aripiprazol
Hepatobiliary 
fenobarbital)
• trembling, 
• proljev,
Diastolic blood pressure increased 
moždanog udara, abnormalnog krvnog tlaka
The oral solution contains sodium. 
Natrij Oralna otopina sadrži natrij.
• liver failure, 
• upala jetre,
Drug withdrawal syndrome neonatal (see section 4.6) 
Stanja vezana uz trudnoću, babinje i perinatalno razdoblje sindrom ustezanja od lijeka u novorođenčadi (vidjeti dio 4.6)
Tell the doctor or nurse if you feel dizzy or faint after the injection. 
Ako nakon injekcije osjećate omaglicu ili nesvjesticu, obavijestite o tome liječnika ili medicinsku sestru.
5-HT1A and 5-HT2A receptors and moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha-1 adrenergic and histamine H1 receptors. 
receptorima i antagonizma sa serotoninskim 5-HT2A receptorima.
Prolactin 
Distonija
ABILIFY in one or more subsets of the paediatric population in the treatment of schizophrenia and in the treatment of bipolar affective disorder (see section 4.2 for information on paediatric use). 
Tikovi povezani s Touretteovim poremećajem u pedijatrijskih bolesnika (vidjeti dio 4.2)
Orthostatic hypotension 
Krvožilni poremećaji ortostatska hipotenzija venska tromboembolija
ABILIFY 10 mg orodispersible tablets 10 mg: Round and pink, marked with "A" over "640" on one side and "10" on the other. 
10 mg: Okrugla i ružičasta s oznakom "A" iznad "640" na jednoj strani i "10" na drugoj.
Additionally, 
U ovom ispitivanju,
Diabetes mellitus Hyperglycaemia 
Poremećaji metabolizma i prehrane šećerna bolest hiperglikemija hiponatremija anoreksija
• chest pain, 
• upala gušterače,
Fructose and sucrose 
Fruktoza i saharoza
• weight gain, 
• povećanje tjelesne težine,
• sleepiness, 
• pospanost,
This can lead to symptoms such as: 
To može dovesti do simptoma kao što su:
TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached. 
TTP = vrijeme do progresije; „np“ označava da nije bilo moguće procijeniti ili da još nije dostignuto.
Therefore, your doctor may decide to continue to check your heart functions, even after you finish treatment. 
Stoga će liječnik možda odlučiti nastaviti kontrolirati Vašu srčanu funkciju čak i nakon završetka liječenja.
Children and adolescents Ogivri is not recommended for anyone under the age of 18 years. 
Ogivri se ne preporučuje osobama mlađima od 18 godina.
All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule). 
Svaku dozu treba primijeniti u odgovarajuće vrijeme svaki tjedan ili svaka tri tjedna (ovisno o Vašem rasporedu doziranja).
This medicinal product must not be mixed or diluted with other medicinal products except those mentioned in section 6.6. 
Lijek se ne smije miješati ni razrjeđivati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
What Ogivri is and what it is used for 
Što je Ogivri i za što se koristi
• breathlessness (including breathlessness at night), 
• nedostatak zraka (uključujući nedostatak zraka tijekom noći),
Ogivri may also be given once a week for metastatic breast cancer. 
Ogivri se također može davati jednom tjedno za metastatski rak dojke.
Ogivri can cause breathing difficulties, especially when it is first given. 
Ogivri može izazvati poteškoće u disanju, osobito prilikom prve primjene.
Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”). 
Neki od ovih simptoma mogu biti ozbiljni, a neke su bolesnice preminule (pogledajte dio 2, „Upozorenja i mjere opreza“).
Ogivri should only be given by a doctor or nurse. 
Ogivri smije primijeniti samo liječnik ili medicinska sestra.
The dose of Ogivri depends on your body weight. 
Potrebna doza lijeka Ogivri ovisi o Vašoj tjelesnoj težini.
Study M77001: Full analysis set (intent-to-treat), 24 months results 
3 Ispitivanje M77001: potpuni skup analiza (bolesnice predviđene za liječenje), rezultati nakon 24 mjeseca
Regardless of the regimen used, most symptomatic cardiac events occurred within the first 18 months. 
Bez obzira na kemoterapijski protokol većina simptomatskih srčanih događaja zabilježena je u prvih 18 mjeseci.
If diluted aseptically, it may be stored for 24 hours (do not store above 30°C). 
Ako je razrijeđena u aseptičkim uvjetima, može se čuvati 24 sata (ne čuvati na temperaturi iznad 30 °C).
In this section, the following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). 
U ovom dijelu, za prikaz nuspojava prema učestalosti korišteni su sljedeći kriteriji: vrlo često (≥ 1/10), često (≥ 1/100 i<1/10), manje često (≥ 1/1000 i<1/100), rijetko (≥ 1/10 000 i<1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Special Economic Zone Plot Nos. 2, 3, 4 & 5 Phase-IV-Bommasandra-Jigani Link Road-Bommasandra Post 560 099 Bangalore 
2, 3, 4 & 5 Phase-IV-Bommasandra-Jigani Link Road-Bommasandra Post 560 099 Bangalore
• shock (a dangerous decrease of blood pressure causing symptoms like rapid, shallow breathing, 
• šok (opasno sniženje krvnog tlaka koje uzrokuje simptome kao što su ubrzano, plitko disanje,
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2018 
Datum prvog odobrenja: 12. prosinca 2018.
- The active substance is trastuzumab. 
- Djelatna tvar je trastuzumab.
• Your doctor will advise you of the risks and benefits of taking Ogivri during pregnancy. 
• Liječnik će Vam objasniti rizike i koristi primjene lijeka Ogivri tijekom trudnoće.
Study MO16419 
4 Ispitivanje MO16419
What Ogivri looks like and contents of the pack 
Kako Ogivri izgleda i sadržaj pakiranja
Side effects of not known frequency: frequency cannot be estimated from the available data 
Nuspojave nepoznate učestalosti: učestalost se ne može procijeniti iz dostupnih podataka
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego primite ovaj lijek.
Trastuzumab loading dose should be administered as a 90-minute intravenous infusion. 
Udarnu dozu trastuzumaba potrebno je primijeniti u 90-minutnoj intravenskoj infuziji.
Ogivri may affect your ability to drive a car or operate machines. 
Ogivri može utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions. 
Čuvanje lijeka nakon rekonstitucije i razrjeđivanja nije predviđeno, osim ukoliko ono nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
Approximately 17 % of cardiac dysfunction related events occurred after completion of trastuzumab. 
Približno 17% događaja povezanih s disfunkcijom srca nastupilo je nakon završetka liječenja trastuzumabom.
Overexpression of HER2 is observed in 20 %-30 % of primary breast cancers. 
Povećana ekspresija HER2 uočena je u 20% - 30% primarnih karcinoma dojke.
Observation N = 1697*** 
Opservacija N=1697***
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Ako se lijek ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika.
If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Ogivri treatment. 
Ako se pojave znakovi zatajenja srca (srce nedostatno pumpa krv), možda ćete srčanu funkciju kontrolirati češće (svakih šest do osam tjedana), a možda ćete primati terapiju za zatajenje srca ili ćete morati prekinuti liječenje lijekom Ogivri.
Paediatric population There is no relevant use of trastuzumab in the paediatric population. 
Pedijatrijska populacija Nema relevantne primjene trastuzumaba u pedijatrijskoj populaciji.
• if you are allergic to trastuzumab, murine (mouse) proteins, or any of the other ingredients of this medicine (listed in section 6). 
• ako ste alergični na trastuzumab, mišje proteine ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
Trastuzumab 1 Year N = 1702*** 
Trastuzumab tijekom 1 godine N=1702***
Ogivri is a biosimilar medicinal product. 
Ogivri je biosličan lijek.
1 Denotes adverse reactions that are reported largely in association with Infusion-related reactions. 
1 Označava nuspojave koje su uglavnom prijavljivane u vezi s reakcijama povezanih s infuzijom.
However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D). 
Međutim, trastuzumab može povećati ukupnu izloženost jednom od metabolita doksorubicina (7-deoksi-13-dihidro-doksorubicinon, D7D).
The efficacy results from the BCIRG 006 are summarized in Tables 9 and 10. 
Rezultati djelotvornosti iz ispitivanja BCIRG 006 sažeto su prikazani u Tablicama 9. i 10.
Your doctor will monitor your heart regularly during and after treatment but you should tell your doctor immediately if you notice any of the above symptoms. 
Liječnik će Vam tijekom i nakon liječenja redovito kontrolirati srce, ali ako primijetite neki od gore navedenih simptoma o tome odmah obavijeste svog liječnika.
Greater than 70 % of patients enrolled exhibited 3+ overexpression. 
Više od 70% uključenih bolesnica imalo je povećanu ekspresiju razine 3+.