FrancophonIA/ELRC3.0 huggingface dataset:
English: Constipation Dyspepsia Nausea Salivary hypersecretion Vomiting
Croatian: Poremećaji probavnog sustava konstipacija dispepsija mučnina hipersekrecija pankreatitis disfagija proljev nelagoda u abdomenu
English: 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)
Croatian: 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)
English: 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 %),
Croatian: I bile su slične onima u odraslih bolesnika, osim sljedećih nuspojava: vrlo često (≥ 1/10) somnolencija (23,0 %),
English: 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)
Croatian: 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)
English: Each tablet contains 15 mg of aripiprazole.
Croatian: Jedna tableta sadrži 15 mg aripiprazola.
English: 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)
Croatian: 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)
English: Akathisia Extrapyramidal disorder Tremor
Croatian: Nepoznato poriomanija agresija agitacija nervoza
English: If continued treatment is indicated with oral aripiprazole, see the Summary of Product Characteristics for ABILIFY tablets, ABILIFY orodispersible tablets, or ABILIFY oral solution.
Croatian: Ako je indiciran nastavak liječenja oralnim aripiprazolom, vidjeti Sažetak opisa svojstava lijeka za
English: 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)
Croatian: 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)
English: No cases of overdose associated with adverse reactions were reported in clinical studies with ABILIFY solution for injection.
Croatian: U kliničkim ispitivanjima lijeka ABILIFY otopina za injekciju nije zabilježen nijedan slučaj predoziranja povezanog s nuspojavama.
English: 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)
Croatian: 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)
English: • diabetes mellitus,
Croatian: • šećerna bolest,
English: See package leaflet for further information.
Croatian: Za dodatne informacije vidjeti Uputu o lijeku.
English: 3 mg aspartame (E 951) and 0.1125 mg lactose per orodispersible tablet
Croatian: 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.
English: ABILIFY 30 mg orodispersible tablets
Croatian: ABILIFY 30 mg raspadljive tablete za usta
English: ABILIFY contains sodium
Croatian: ABILIFY sadrži natrij
English: • slower heartbeat,
Croatian: • štucavica, • suha usta.
English: ABILIFY 30 mg orodispersible tablets aripiprazole
Croatian: ABILIFY 30 mg raspadljive tablete za usta aripiprazol
English: ABILIFY 10 mg orodispersible tablets aripiprazole
Croatian: ABILIFY 10 mg raspadljive tablete za usta aripiprazol
English: Rhabdomyolysis Myalgia
Croatian: Točkovna procjena omjera hazarda
English: ABILIFY 15 mg orodispersible tablets
Croatian: ABILIFY 15 mg raspadljive tablete za usta
English: Excipient with known effect 62.18 mg lactose (as monohydrate) per tablet
Croatian: 62,18 mg laktoze (u obliku laktoza hidrata) po tableti ABILIFY 15 mg tablete
English: Excipient with known effect 67 mg lactose (as monohydrate) per tablet
Croatian: 67 mg laktoze (u obliku laktoza hidrata) po tableti ABILIFY 10 mg tablete
English: Stiffness
Croatian: Doziranje
English: Hepatic failure
Croatian: moždani udar.
English: • baldness,
Croatian: • mučnina,
English: ABILIFY 10 mg orodispersible tablets
Croatian: ABILIFY 10 mg raspadljive tablete za usta
English: Otsuka Pharmaceuticals (UK) Ltd. Tel: +44 (0) 203 747 5300
Croatian: Otsuka Pharmaceutical Italy S.r.l. Tel: +39 (0) 2 0063 2710
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva rabdomioliza mialgija ukočenost
English: ABILIFY orodispersible tablets contain sodium.
Croatian: ABILIFY raspadljive tablete za usta sadrže natrij.
English: This medicine contains 200 mg of fructose and 400 mg of sucrose in each mL.
Croatian: 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.
English: 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).
Croatian: I u adolescenata u dobi od 13 godina i starijih tijekom najdulje 12 tjedana (vidjeti dio 5.1).
English: ABILIFY 30 mg orodispersible tablets 30 mg: Round and pink, marked with "A" over "643" on one side and "30" on the other.
Croatian: 30 mg: Okrugla i ružičasta s oznakom "A" iznad "643" na jednoj strani i "30" na drugoj.
English: 2 mg aspartame (E 951) and 0.075 mg lactose per orodispersible tablet
Croatian: 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.
English: ABILIFY 15 mg orodispersible tablets aripiprazole
Croatian: ABILIFY 15 mg raspadljive tablete za usta aripiprazol
English: Hepatobiliary
Croatian: fenobarbital)
English: • trembling,
Croatian: • proljev,
English: Diastolic blood pressure increased
Croatian: moždanog udara, abnormalnog krvnog tlaka
English: The oral solution contains sodium.
Croatian: Natrij Oralna otopina sadrži natrij.
English: • liver failure,
Croatian: • upala jetre,
English: Drug withdrawal syndrome neonatal (see section 4.6)
Croatian: Stanja vezana uz trudnoću, babinje i perinatalno razdoblje sindrom ustezanja od lijeka u novorođenčadi (vidjeti dio 4.6)
English: Tell the doctor or nurse if you feel dizzy or faint after the injection.
Croatian: Ako nakon injekcije osjećate omaglicu ili nesvjesticu, obavijestite o tome liječnika ili medicinsku sestru.
English: 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.
Croatian: receptorima i antagonizma sa serotoninskim 5-HT2A receptorima.
English: Prolactin
Croatian: Distonija
English: 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).
Croatian: Tikovi povezani s Touretteovim poremećajem u pedijatrijskih bolesnika (vidjeti dio 4.2)
English: Orthostatic hypotension
Croatian: Krvožilni poremećaji ortostatska hipotenzija venska tromboembolija
English: ABILIFY 10 mg orodispersible tablets 10 mg: Round and pink, marked with "A" over "640" on one side and "10" on the other.
Croatian: 10 mg: Okrugla i ružičasta s oznakom "A" iznad "640" na jednoj strani i "10" na drugoj.
English: Additionally,
Croatian: U ovom ispitivanju,
English: Diabetes mellitus Hyperglycaemia
Croatian: Poremećaji metabolizma i prehrane šećerna bolest hiperglikemija hiponatremija anoreksija
English: • chest pain,
Croatian: • upala gušterače,
English: Fructose and sucrose
Croatian: Fruktoza i saharoza
English: • weight gain,
Croatian: • povećanje tjelesne težine,
English: • sleepiness,
Croatian: • pospanost,
English: This can lead to symptoms such as:
Croatian: To može dovesti do simptoma kao što su:
English: TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
Croatian: TTP = vrijeme do progresije; „np“ označava da nije bilo moguće procijeniti ili da još nije dostignuto.
English: Therefore, your doctor may decide to continue to check your heart functions, even after you finish treatment.
Croatian: Stoga će liječnik možda odlučiti nastaviti kontrolirati Vašu srčanu funkciju čak i nakon završetka liječenja.
English: Children and adolescents Ogivri is not recommended for anyone under the age of 18 years.
Croatian: Ogivri se ne preporučuje osobama mlađima od 18 godina.
English: All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule).
Croatian: Svaku dozu treba primijeniti u odgovarajuće vrijeme svaki tjedan ili svaka tri tjedna (ovisno o Vašem rasporedu doziranja).
English: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati ni razrjeđivati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
English: What Ogivri is and what it is used for
Croatian: Što je Ogivri i za što se koristi
English: • breathlessness (including breathlessness at night),
Croatian: • nedostatak zraka (uključujući nedostatak zraka tijekom noći),
English: Ogivri may also be given once a week for metastatic breast cancer.
Croatian: Ogivri se također može davati jednom tjedno za metastatski rak dojke.
English: Ogivri can cause breathing difficulties, especially when it is first given.
Croatian: Ogivri može izazvati poteškoće u disanju, osobito prilikom prve primjene.
English: Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Croatian: Neki od ovih simptoma mogu biti ozbiljni, a neke su bolesnice preminule (pogledajte dio 2, „Upozorenja i mjere opreza“).
English: Ogivri should only be given by a doctor or nurse.
Croatian: Ogivri smije primijeniti samo liječnik ili medicinska sestra.
English: The dose of Ogivri depends on your body weight.
Croatian: Potrebna doza lijeka Ogivri ovisi o Vašoj tjelesnoj težini.
English: Study M77001: Full analysis set (intent-to-treat), 24 months results
Croatian: 3 Ispitivanje M77001: potpuni skup analiza (bolesnice predviđene za liječenje), rezultati nakon 24 mjeseca
English: Regardless of the regimen used, most symptomatic cardiac events occurred within the first 18 months.
Croatian: Bez obzira na kemoterapijski protokol većina simptomatskih srčanih događaja zabilježena je u prvih 18 mjeseci.
English: If diluted aseptically, it may be stored for 24 hours (do not store above 30°C).
Croatian: Ako je razrijeđena u aseptičkim uvjetima, može se čuvati 24 sata (ne čuvati na temperaturi iznad 30 °C).
English: 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).
Croatian: 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).
English: Special Economic Zone Plot Nos. 2, 3, 4 & 5 Phase-IV-Bommasandra-Jigani Link Road-Bommasandra Post 560 099 Bangalore
Croatian: 2, 3, 4 & 5 Phase-IV-Bommasandra-Jigani Link Road-Bommasandra Post 560 099 Bangalore
English: • shock (a dangerous decrease of blood pressure causing symptoms like rapid, shallow breathing,
Croatian: • šok (opasno sniženje krvnog tlaka koje uzrokuje simptome kao što su ubrzano, plitko disanje,
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2018
Croatian: Datum prvog odobrenja: 12. prosinca 2018.
English: - The active substance is trastuzumab.
Croatian: - Djelatna tvar je trastuzumab.
English: • Your doctor will advise you of the risks and benefits of taking Ogivri during pregnancy.
Croatian: • Liječnik će Vam objasniti rizike i koristi primjene lijeka Ogivri tijekom trudnoće.
English: Study MO16419
Croatian: 4 Ispitivanje MO16419
English: What Ogivri looks like and contents of the pack
Croatian: Kako Ogivri izgleda i sadržaj pakiranja
English: Side effects of not known frequency: frequency cannot be estimated from the available data
Croatian: Nuspojave nepoznate učestalosti: učestalost se ne može procijeniti iz dostupnih podataka
English: 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.
Croatian: 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.
English: Trastuzumab loading dose should be administered as a 90-minute intravenous infusion.
Croatian: Udarnu dozu trastuzumaba potrebno je primijeniti u 90-minutnoj intravenskoj infuziji.
English: Ogivri may affect your ability to drive a car or operate machines.
Croatian: Ogivri može utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Croatian: Čuvanje lijeka nakon rekonstitucije i razrjeđivanja nije predviđeno, osim ukoliko ono nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: Approximately 17 % of cardiac dysfunction related events occurred after completion of trastuzumab.
Croatian: Približno 17% događaja povezanih s disfunkcijom srca nastupilo je nakon završetka liječenja trastuzumabom.
English: Overexpression of HER2 is observed in 20 %-30 % of primary breast cancers.
Croatian: Povećana ekspresija HER2 uočena je u 20% - 30% primarnih karcinoma dojke.
English: Observation N = 1697***
Croatian: Opservacija N=1697***
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se lijek ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika.
English: 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.
Croatian: 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.
English: Paediatric population There is no relevant use of trastuzumab in the paediatric population.
Croatian: Pedijatrijska populacija Nema relevantne primjene trastuzumaba u pedijatrijskoj populaciji.
English: • if you are allergic to trastuzumab, murine (mouse) proteins, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na trastuzumab, mišje proteine ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: Trastuzumab 1 Year N = 1702***
Croatian: Trastuzumab tijekom 1 godine N=1702***
English: Ogivri is a biosimilar medicinal product.
Croatian: Ogivri je biosličan lijek.
English: 1 Denotes adverse reactions that are reported largely in association with Infusion-related reactions.
Croatian: 1 Označava nuspojave koje su uglavnom prijavljivane u vezi s reakcijama povezanih s infuzijom.
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D).
Croatian: Međutim, trastuzumab može povećati ukupnu izloženost jednom od metabolita doksorubicina (7-deoksi-13-dihidro-doksorubicinon, D7D).
English: The efficacy results from the BCIRG 006 are summarized in Tables 9 and 10.
Croatian: Rezultati djelotvornosti iz ispitivanja BCIRG 006 sažeto su prikazani u Tablicama 9. i 10.
English: 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.
Croatian: Liječnik će Vam tijekom i nakon liječenja redovito kontrolirati srce, ali ako primijetite neki od gore navedenih simptoma o tome odmah obavijeste svog liječnika.
English: Greater than 70 % of patients enrolled exhibited 3+ overexpression.
Croatian: Više od 70% uključenih bolesnica imalo je povećanu ekspresiju razine 3+.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Croatian: Uvijek čuvajte ovaj lijek u zatvorenom originalnom pakiranju u hladnjaku na temperaturi od 2 °C do 8 °C.
English: Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g. every 6 - 8 weeks).
Croatian: Bolesnicima koji razviju asimptomatsku disfunkciju srca mogli bi koristiti češći pregledi (primjerice, svakih 6 do 8 tjedana).
English: What Ogivri contains
Croatian: Što Ogivri sadrži
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Ogivri.
Croatian: Ti lijekovi (ili neki drugi antraciklini) mogu oštetiti srčani mišić i povećati rizik od srčanih problema pri primjeni lijeka Ogivri.
English: Chemo + Trastuzumab (n = 115)
Croatian: Kemoterapija + trastuzumab (n = 115)
English: In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50 % of tumour cells.
Croatian: Općenito, CISH se smatra pozitivnim ako postoji više od pet kopija HER2 gena po jezgri u više od 50% tumorskih stanica.
English: If you receive Ogivri in combination with chemotherapy, some of them may also be due to the chemotherapy.
Croatian: Ako primate lijek Ogivri u kombinaciji s kemoterapijom, neke od njih mogu biti i posljedica primljene kemoterapije.
English: The results of these simulations indicate that at least 95 % of patients will reach concentrations that are < 1 mcg/mL (approximately 3 % of the population predicted Cmin,ss, or about 97 % washout) by 7 months.
Croatian: Rezultati tih simulacija ukazuju da će najmanje 95% bolesnika postići koncentracije < 1 µg/ml (približno 3% vrijednosti Cmin ss predviđene za populaciju ili ispiranje od približno 97%) do 7. mjeseca.
English: AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)*
Croatian: AC→PH (naspram AC→P) (NSABP B-31 i NCCTG N9831)*
English: Do not throw away any medicines via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode.
English: Talk to your doctor, pharmacist or nurse before you are given Ogivri if:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Ogivri:
English: 47.3 (32-ne)
Croatian: 47,3 (32-np)
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, beta agonists, and corticosteroids.
Croatian: Ozbiljne reakcije uspješno su liječene potpornom terapijom, primjerice kisikom, beta-agonistima i kortikosteroidima.
English: If during treatment you experience symptoms, such as chills or fever, you should not drive or use machines until these symptoms disappear.
Croatian: Ako tijekom liječenja primijetite simptome poput zimice ili vrućice, ne smijete upravljati vozilima niti rukovati strojevima sve dok se ti simptomi ne povuku.
English: A careful risk-benefit assessment should be made before deciding to treat with trastuzumab.
Croatian: Potrebna je pomna procjena rizika i koristi liječenja prije donošenja odluke o liječenju trastuzumabom.
English: What Ogivri is and what it is used for What you need to know before you are given Ogivri How Ogivri is given
Croatian: Što je Ogivri i za što se koristi Što morate znati prije nego počnete primati Ogivri
English: When Ogivri binds to HER2 it stops the growth of such cells and causes them to die.
Croatian: Kada se Ogivri veže na HER2, zaustavlja rast tih stanica i uzrokuje njihovo odumiranje.
English: Ogivri contains sorbitol
Croatian: Ogivri sadrži sorbitol
English: As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during trastuzumab therapy and for 7 months after the last dose.
Croatian: Budući da se humani IgG1 izlučuje u majčino mlijeko u ljudi, a nema spoznaja o mogućem štetnom učinku na novorođenče, žene ne bi smjele dojiti tijekom liječenja trastuzumabom ni 7 mjeseci nakon posljednje doze lijeka.
English: • fluid retention (swelling) in the legs or arms,
Croatian: • zadržavanje tekućine (oticanje) u nogama ili rukama,
English: You must tell your doctor before receiving this medicine if you have HFI or if you can no longer take sweet foods or drinks because you feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Croatian: Morate reći svom liječniku prije nego primite ovaj lijek ako imate nasljedno nepodnošenje fruktoze ili ako više ne možete konzumirati slatku hranu ili piće zbog pojave mučnine, povraćanja ili neugodnih nuspojava poput nadutosti, grčeva u trbuhu ili proljeva.
English: FP + H: Fluoropyrimidine/cisplatin + Trastuzumab FP: Fluoropyrimidine/cisplatin a Odds ratio
Croatian: FP + H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin a Omjer šansi
English: Switching treatment between trastuzumab intravenous and trastuzumab subcutaneous formulation and vice versa.
Croatian: Prelazak s liječenja intravenskom formulacijom trastuzumaba na supkutanu formulaciju trastuzumaba i obrnuto
English: Women of childbearing potential should be advised to use effective contraception during treatment with trastuzumab and for 7 months after treatment has concluded (see section 5.2).
Croatian: Ženama reproduktivne dobi potrebno je preporučiti učinkovitu kontracepciju tijekom terapije trastuzumabom i 7 mjeseci nakon prestanka liječenja (vidjeti dio 5.2).
English: For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Ogivri is given every 3 weeks.
Croatian: Za rani rak dojke, metastatski rak dojke i metastatski rak želuca, Ogivri se primjenjuje svaka 3 tjedna.
English: 4.4 Special warnings and precautions for use Traceability
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi
English: p-value versus AC→P
Croatian: p-vrijednost naspram AC P
English: For monotherapy, the rate was 6 % - 9 %.
Croatian: Kod primjene u monoterapiji stopa je iznosila 6% do 9%.
English: Other medicines and Ogivri
Croatian: Drugi lijekovi i Ogivri
English: Ogivri contains the active substance trastuzumab, which is a monoclonal antibody.
Croatian: Ogivri sadrži djelatnu tvar trastuzumab, koji je monoklonsko protutijelo.
English: Trastuzumab 1 Year N = 1693
Croatian: Trastuzumab tijekom 1 godine N=1693
English: If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Warnings and precautions”).
Croatian: U slučaju dobrog podnošenja prve doze, sljedeće se doze mogu primijeniti u infuziji trajanja 30 minuta (pogledajte dio 2., „Upozorenja i mjere opreza“).