FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people) - headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.
Croatian: Često (mogu se javiti u do 1 na 10 osoba) - glavobolja, bol u leđima, bol u mišićima, bol u rukama i nogama, navale crvenila lica,
English: The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil.
Croatian: U muškaraca u dobi iznad 75 godina koji su uzimali tadalafil češće je prijavljivana nuspojava omaglice.
English: Angioedema
Croatian: Antidijabetici
English: What you need to know before you take Tadalafil Mylan 3.
Croatian: Što je Tadalafil Mylan i za što se koristi Što morate znati prije nego počnete uzimati Tadalafil Mylan Kako uzimati Tadalafil Mylan Moguće nuspojave
English: What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 10 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL3' on the other side.
Croatian: Tadalafil Mylan 10 mg je svijetložuta, filmom obložena, okrugla,bikonveksna tableta s oznakom „M” na jednoj strani tablete i „TL3” na drugoj strani tablete.
English: If tadalafil is prescribed once-a-day, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Croatian: Ako je propisana primjena tadalafila jedanput na dan, liječnik koji propisuje lijek mora pažljivo procijeniti omjer koristi i rizika liječenja za svakog pojedinog bolesnika.
English: A light yellow, film-coated, round, biconvex tablet (10.7 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL4' on the other side.
Croatian: Svijetložuta, filmom obložena okrugla bikonveksna tableta (10,7 ± 0,3 mm) s utisnutom oznakom „M” na jednoj strani tablete i „TL4” na drugoj strani tablete.
English: If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Croatian: Ako se propisuje tadalafil, liječnik koji ga propisuje mora pažljivo procijeniti omjer koristi i rizika liječenja za svakog pojedinog bolesnika.
English: Transient amnesia
Croatian: Acetilsalicilatna kiselina
English: What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 20 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL4' on the other side.
Croatian: Tadalafil Mylan 20 mg je svijetložuta, filmom obložena, okrugla, bikonveksna tableta s oznakom „M” na jednoj strani tablete i „TL4” na drugoj strani tablete.
English: Tadalafil Mylan 10 mg film-coated tablets
Croatian: Tadalafil Mylan 10 mg filmom obložene tablete
English: Tadalafil Mylan 20 mg film-coated tablets
Croatian: Tadalafil Mylan 20 mg filmom obložene tablete
English: Tadalafil Mylan 5 mg film-coated tablets
Croatian: Tadalafil Mylan 5 mg filmom obložene tablete
English: Tadalafil Mylan 2.5 mg film-coated tablets
Croatian: Tadalafil Mylan 2,5 mg filmom obložene tablete
English: Tadalafil Mylan 10 mg film-coated tablets tadalafil
Croatian: Tadalafil Mylan 10 mg filmom obložene tablete tadalafil
English: Tadalafil Mylan 20 mg film-coated tablets tadalafil
Croatian: Tadalafil Mylan 20 mg filmom obložene tablete tadalafil
English: Pack sizes of 2, 4, 8,12 and 24 tablets
Croatian: Tadalafil Mylan 20 mg filmom obložene tablete Veličine pakiranja od 2, 4, 8,12 i 24 tablete
English: Tadalafil Mylan 5 mg film-coated tablets tadalafil
Croatian: Tadalafil Mylan 5 mg filmom obložene tablete tadalafil
English: Tadalafil Mylan 2.5 mg film-coated tablets tadalafil
Croatian: Tadalafil Mylan 2,5 mg filmom obložene tablete tadalafil
English: EXP
Croatian: PC:
English: Facial oedema Sudden cardiac death
Croatian: Poremećaji uha i labirinta tinitus iznenadan gubitak sluha
English: Common Uncommon
Croatian: Ujedinjeno Kraljevstvo
English: serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
Croatian: Opći poremećaji i reakcije na mjestu primjene bol u prsnom košu periferni edem, umor edem lica iznenadna srčana smrt
English: 1 bottle + 1 oral syringe of 5 ml + 1 oral syringe of 10 ml + 1 bottle adaptor
Croatian: 1 boca + 1 oralna štrcaljka od 5 ml + 1 oralna štrcaljka od 10 ml + 1 adapter za bocu
English: Solution for injection
Croatian: Otopina za injekciju/infuziju
English: Oral use bottle (glass)
Croatian: Oralna otopina boca (staklo)
English: Intravenous use vial (glass)
Croatian: U venu bočica (staklo)
English: The medicine can only be obtained with a prescription and is available as capsules (25, 50 and 100 mg).
Croatian: Lijek se izdaje samo na recept i dostupan je u obliku kapsula (25, 50 i 100 mg).
English: The full EPAR for Zonisamide Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Zonisamid Mylan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This may help to stabilise electrical activity in the brain.
Croatian: To pomaže u stabilizaciji električne aktivnosti u mozgu.
English: It is used on its own in newly diagnosed adults and as an ‘add-on' therapy in adults and children aged six years and above already receiving other anti-epilepsy medicines.
Croatian: Primjenjuje se sam u novodijagnosticiranih odraslih bolesnika i kao dodatak terapiji u odraslih i djece u dobi od šest godina i više koji već primjenjuju druge lijekove protiv epilepsije.
English: The usual maintenance dose is between 300 and 500 mg a day for children weighing more than 55 kg and 6 to 8 mg per kg of body weight in children weighing less than 55 kg.
Croatian: Uobičajena doza održavanja iznosi od 300 do 500 mg na dan za djecu koja imaju više od 55 kg te od 6 do 8 mg po kilogramu tjelesne težine u djece koja imaju manje od 55 kg.
English: The usual maintenance dose is 300 mg a day.
Croatian: Uobičajena doza održavanja jest 300 mg na dan.
English: When calcium and sodium enter nerve cells, electrical impulses can be transmitted between the nerve cells.
Croatian: Kad kalcij i natrij uđu u živčane stanice, električni impulsi mogu se prenijeti među živčanim stanicama.
English: Epileptic fits are caused by abnormal electrical activity in the brain.
Croatian: Epileptički napadaj uzrokovan je abnormalnom električnom aktivnošću u mozgu.
English: Dose increases may need to be made less frequently in patients with liver or kidney problems or those taking certain other medicines.
Croatian: Povećavanje doze možda će morati biti rjeđe u pacijenata koji imaju problema s jetrom ili bubrezima ili u onih koji uzimaju neke druge lijekove.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva su lijeka bioekvivalentna ako u tijelu proizvode iste razine djelatne tvari.
English: Zonisamide Mylan can be given once or twice a day after an appropriate dose is reached.
Croatian: Zonisamid Mylan može se davati jedanput ili dvaput na dan nakon što se dosegne odgovarajuća doza.
English: By blocking these channels, zonisamide is expected to prevent abnormal electrical activity spreading through the brain, thereby reducing the chances of an epileptic fit.
Croatian: Blokirajući te kanale zonisamid sprečava abnormalnu električnu aktivnost koja se širi kroz mozak, smanjujući time mogućnost epileptičkog napadaja.
English: Zonisamide is thought to work by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels, through which sodium or calcium normally enter nerve cells.
Croatian: Smatra se da zonisamid djeluje na način da blokira posebne pore na površini živčanih stanica koje se zovu natrijevi kanali i kalcijevi kanali, kroz koje natrij ili kalij normalno ulaze u živčane stanice.
English: Zonisamide Mylan is a medicine used to treat patients with partial seizures (epileptic fits starting in one part of the brain), including those who have secondary generalisation (where the seizure subsequently spreads to the whole brain).
Croatian: Zonisamid Mylan lijek je koji se koristi za liječenje bolesnika s parcijalnim napadajima (epileptički napadaji koji počinju u jednom dijelu mozga), uključujući napadaje sa sekundarnom generalizacijom (kad se napadaj širi na cijeli mozak).
English: Before stopping Zonisamide Mylan, the dose should be decreased gradually.
Croatian: Prije prekida terapije lijekom Zonisamid Mylan trebalo bi postupno smanjivati dozu.
English: This is a summary of the European public assessment report (EPAR) for Zonisamide Mylan.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Zonisamid Mylan.
English: After one or two weeks, the dose may be increased to 50 mg twice a day and then further increased in steps of 100 mg every week or every other week, depending on the patient's response.
Croatian: Nakon tjedan ili dva doza se može povećati na 50 mg dvaput na dan, a zatim postupno dodatno povećavati za 100 mg svaki tjedan ili svaki drugi tjedan, ovisno o odgovoru pacijenta.
English: Zonisamide Mylan also acts on the neurotransmitter gamma‑aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other).
Croatian: Zonisamid Mylan također djeluje na neurotransmiter gama - aminomaslačnu kiselinu (GABA, kemikalija kojom se omogućuje da živčane stanice komuniciraju jedna s drugom).
English: This means that Zonisamide Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zonegran.
Croatian: To znači da je Zonisamid Mylan sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Zonegran.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zonisamide Mylan has been shown to have comparable quality and to be bioequivalent to Zonegran.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Zonisamid Mylan posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Zonegran.
English: What measures are being taken to ensure the safe and effective use of Zonisamide Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zonisamid Mylan?
English: Because Zonisamide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Zonisamid Mylan generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: After one or two weeks, the daily dose may be increased in steps of 1 mg per kilogram every one or two weeks until an appropriate dose is reached.
Croatian: Nakon tjedan ili dva dnevna doza može se postupno povećavati za 1 mg po kilogramu svaki tjedan ili svaka dva tjedna dok se ne dosegne odgovarajuća doza.
English: A risk management plan has been developed to ensure that Zonisamide Mylan is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Zonisamid Mylan.
English: Zonisamide Mylan zonisamide
Croatian: Zonisamid Mylan zonisamid
English: What is Zonisamide Mylan and what is it used for?
Croatian: Što je Zonisamid Mylan i za što se koristi?
English: When Zonisamide Mylan is used on its own in newly diagnosed adults, the recommended starting dose is 100 mg once a day for two weeks, which may be increased by 100 mg at intervals of two weeks.
Croatian: Kad se Zonisamid Mylan primjenjuje sam u novodijagnosticiranih odraslih bolesnika, preporučena početna doza jest 100 mg jedanput na dan tijekom dva tjedna, koja se može povećati za 100 mg u intervalima od dva tjedna.
English: For more information about treatment with Zonisamide Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Zonisamid Mylan pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: It is not intended to provide practical advice on how to use Zonisamide Mylan.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Zonisamid Mylan.
English: The usual maintenance dose is between 300 and 500 mg a day.
Croatian: Raspon uobičajene doze iznosi od 300 do 500 mg na dan.
English: The Committee recommended that Zonisamide Mylan be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Zonisamid Mylan u EU-u.
English: The active substance in Zonisamide Mylan, zonisamide, is an anti‑epileptic.
Croatian: Djelatna tvar u lijeku Zonisamid Mylan, zonisamid, jest lijek protiv epilepsije.
English: Zonisamide Mylan is a ‘generic medicine'.
Croatian: Zonisamid HCS je „generički lijek”.
English: When Zonisamide Mylan is used as an ‘add-on' to existing treatment in children aged six years and above, the dose depends on body weight; the recommended starting dose is 1 mg per kg of body weight daily.
Croatian: Kad se Zonisamid Mylan upotrebljava kao dodatak postojećoj terapiji u djece u dobi od šest godina i više, doza ovisi o tjelesnoj težini; preporučena je početna doza 1 mg po kilogramu tjelesne težine na dan.
English: What are the benefits and risks of Zonisamide Mylan?
Croatian: Koje su koristi i rizici lijeka Zonisamid Mylan?
English: Other information about Zonisamide Mylan
Croatian: Ostale informacije o lijeku Zonisamid Mylan
English: When Zonisamide Mylan is used as an ‘add-on' to existing treatment in adults, the recommended starting dose is 25 mg twice a day.
Croatian: Kad se Zonisamid Mylan primjenjuje kao dodatak postojećoj terapiji u odraslih, preporučena početna doza jest 25 mg dvaput na dan.
English: Because Zonisamide Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Zonegran.
Croatian: Budući da je Zonisamid Mylan generički lijek, ispitivanja na bolesnicima bila su ograničena na utvrđivanje činjenice je li on bioekvivalentan referentnom lijeku Zonegran.
English: For practical information about using Zonisamide Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Zonisamid Mylan pročitajte u uputi o lijeku ili se obratite svom liječniku ili ljekarniku.
English: Why is Zonisamide Mylan approved?
Croatian: Zašto je lijek Zonisamid Mylan odobren?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zonisamide Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Mylan, nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Zonisamide Mylan contains the active substance zonisamide.
Croatian: Zonisamid Mylan sadrži djelatnu tvar zonisamid.
English: Therefore, the CHMP's view was that, as for Zonegran, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđeni rizik, kao i kod lijeka Zonegran.
English: How does Zonisamide Mylan work?
Croatian: Kako djeluje Zonisamid Mylan?
English: How is Zonisamide Mylan used?
Croatian: Kako se Zonisamid Mylan koristi?
English: How has Zonisamide Mylan been studied?
Croatian: Kako je Zonisamid Mylan ispitivan?
English: 1 bottle + 1 bottle adaptor + 1 dosing syringe 10 ml
Croatian: 1 bočica + 1 adapter za bočicu + 1 štrcaljka za doziranje od 10 ml
English: (Invented) name Strength Pharmaceutical Form
Croatian: Jačina Farmaceutski oblik
English: 60 ml
Croatian: Bočica (staklena) 60 ml
English: Oral solution
Croatian: Peroralna primjena
English: Oral use bottle (glass)
Croatian: Oralna otopina
English: Talk to your doctor if you are not sure.
Croatian: Razgovarajte sa svojim liječnikom ako niste sigurni.
English: Date of first authorisation: 19 June 2015
Croatian: Datum prvog odobrenja: 19. lipnja 2015.
English: These complications can be severe and can lead to death.
Croatian: Te komplikacije mogu biti teške i dovesti do smrti.
English: OPDIVO should not be frozen.
Croatian: OPDIVO se ne smije zamrzavati.
English: • Details on how to minimise the safety concern through appropriate monitoring and management
Croatian: • Pojedinosti o tome kako minimizirati sigurnosni problem odgovarajućim nadzorom i zbrinjavanjem
English: These changes were not considered clinically relevant.
Croatian: Te se promjene nisu smatrale klinički značajnima.
English: • subjects under the age of 18 years.
Croatian: • u osoba mlađih od 18 godina.
English: 3.6 (Not available)
Croatian: 3,6 (nije dostupan)
English: With a minimum of 63 months follow-up in NSCLC, no new safety signals were identified.
Croatian: Uz praćenje od minimalno63 mjeseca kod NSCLC-a, nisu utvrđeni novi sigurnosni signali.
English: a median follow-up 11.5 months.
Croatian: a Medijan praćenja 11,5 mjeseci.
English: Grade 3 (first occurrence)
Croatian: 3. stupnja (prvi nastup)
English: Unopened vial 3 years
Croatian: Neotvorena bočica 3 godine
English: Number (n)/ minimum follow-up (months)
Croatian: Broj (n) / minimalno praćenje (mjeseci)
English: Seventy-nine percent of patients were former/current smokers.
Croatian: Sedamdeset i devet posto bolesnika bili su bivši/ aktivni pušači.
English: Children and adolescents OPDIVO should not be used in children and adolescents below 18 years of age.
Croatian: Djeca i adolescenti OPDIVO se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: the total volume of infusion must not exceed 160 mL.
Croatian: Ukupni volumen infuzije ne smije biti veći od 160 ml.
English: ≥ 75 years
Croatian: ≥ 75 godina
English: Events (%)
Croatian: Događaji (%)
English: This study should be conducted according to an agreed protocol.
Croatian: Ovo ispitivanje treba provesti u skladu s dogovorenim planom ispitivanja.
English: The diagnosis of myocarditis requires a high index of suspicion.
Croatian: Za postavljanje dijagnoze miokarditisa potreban je visok indeks sumnje.
English: What OPDIVO is and what it is used for 2.
Croatian: Što je OPDIVO i za što se koristi 2.
English: Investigator's choice
Croatian: Izbor ispitivača
English: 101 International Drive Portsmouth, New Hampshire 03801 USA
Croatian: 101 International Drive Portsmouth, New Hampshire 03801 SAD
English: You should not be given OPDIVO if you are allergic to nivolumab or any of the other ingredients of this medicine (listed in section 6 "Contents of the pack and other information").
Croatian: Ne smijete primiti OPDIVO ako ste alergični na nivolumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6. 'Sadržaj pakiranja i druge informacije').
English: Based on the stratified DerSimonian-Laird test.
Croatian: Na temelju stratificiranog DerSimonian-Lairdova testa.
English: The safety and efficacy of OPDIVO in children below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka OPDIVO u djece mlađe od 18 godina nisu ustanovljene.
English: The physician educational material should contain:
Croatian: Edukacijski materijal za liječnike mora sadržavati:
English: Effective contraception should be used for at least 5 months following the last dose of nivolumab.
Croatian: Učinkovitu kontracepciju treba koristiti najmanje 5 mjeseci nakon posljednje doze nivolumaba.
English: Indication*
Croatian: Indikacija*
English: One of the Grade 3 pneumonitis cases worsened over 11 days with a fatal outcome.
Croatian: Jedan slučaj pneumonitisa 3. stupnja pogoršavao se tijekom 11 dana i završio smrtnim ishodom.
English: OS was not mature at the time of this analysis.
Croatian: Podaci o OS-u nisu bili zreli u trenutku provođenja ove analize.
English: Not available as median unstable due to low number of patients and censoring with 24 months of follow-up
Croatian: Nije dostupno jer je medijan nestabilan zbog malog broja bolesnika i cenzuriranja nakon 24 mjeseca praćenja.
English: Minimum follow-up for the analysis of ORR was 28 months.
Croatian: Minimalno praćenje za analizu ORR-a iznosilo je 28 mjeseci.
English: These patients were not evaluated as part of the primary efficacy population.
Croatian: Ti bolesnici nisu ocijenjeni u sklopu populacije za primarnu ocjenu djelotvornosti.
English: No new safety signals were identified in all treated patients and the overall safety profile of nivolumab was similar across subgroups.
Croatian: Ni u jednog liječenog bolesnika nisu pronađeni novi sigurnosni signali, a cjelokupan sigurnosni profil nivolumaba bio je sličan u svim podskupinama.
English: Confirmed objective response
Croatian: Potvrđen objektivan odgovor
English: Minimum follow-up was approximately 24 months.
Croatian: Minimalno razdoblje praćenja iznosilo je približno 24 mjeseca.
English: This will be provided for the approved indications:
Croatian: Te je podatke potrebno dostaviti za sljedeće odobrene indikacije:
English: Hazard ratio in each subgroup derived from a Cox proportional hazards model with treatment as the only covariate.
Croatian: Omjer hazarda u svakoj podskupini dobiven je iz Coxova modela proporcionalnih hazarda, uz liječenje kao jedinu kovarijantu.
English: Thus, the effect of nivolumab on male and female fertility is unknown.
Croatian: Stoga je učinak nivolumaba na plodnost muškaraca i žena nepoznat.
English: These results should be interpreted with caution due to the small sample size within the subgroups.
Croatian: Ove rezultate treba tumačiti uz oprez zbog male veličine uzoraka unutar podskupina.
English: What you need to know before you use OPDIVO
Croatian: Što morate znati prije nego počnete primati OPDIVO
English: You will receive treatment with OPDIVO in a hospital or clinic, under the supervision of an experienced doctor.
Croatian: Kako se primjenjuje OPDIVO OPDIVO ćete primati u bolnici ili klinici, pod nadzorom iskusna liječnika.
English: These subgroup analyses should be interpreted with caution given the small size of the subgroups and lack of statistically significant difference in OS in the all randomised population.
Croatian: Ove analize podskupina treba interpretirati uz oprez s obzirom na male veličine podskupina i nepostojanje statistički značajne razlike za OS u cijeloj randomiziranoj populaciji.
English: Data unstable due to the limited duration of response for Cohort B resulting from censoring.
Croatian: b Podaci nestabilni zbog ograničenog trajanja odgovora za kohortu B kao posljedice cenzuriranja.
English: Nine of 49 patients (18.4%) died from complications of allogeneic HSCT after nivolumab.
Croatian: Devet od 49 bolesnika (18,4%) umrlo je zbog komplikacija alogenog HSCT-a nakon liječenja nivolumabom.
English: Permanently discontinue treatment
Croatian: Trajno prekinuti liječenje
English: Other medicines and OPDIVO
Croatian: Drugi lijekovi i OPDIVO
English: Ask your doctor if you can breast-feed during or after treatment with OPDIVO.
Croatian: Pitajte svog liječnika smijete li dojiti tijekom ili nakon liječenja lijekom OPDIVO.
English: Rare (may affect up to 1 in 1000 people) Severe and possibly fatal peeling of the skin (toxic epidermal necrolysis)
Croatian: Rijetke (mogu se javiti u do 1 na 1000 osoba) teško i moguće smrtonosno ljuštenje kože (toksična epidermalna nekroliza)
English: Follow-up was ongoing at the time of data submission.
Croatian: Praćenje je bilo u tijeku u vrijeme predaje podataka.
English: With available safety data, these decreases in CL were not clinically meaningful.
Croatian: S obzirom na dostupne podatke o sigurnosti, navedena smanjenja klirensa nisu bila klinički značajna.
English: OPDIVO infusion must be completed within 24 hours of preparation.
Croatian: Infuzija lijeka OPDIVO mora se dovršiti unutar 24 sata nakon pripreme.
English: What OPDIVO is and what it is used for
Croatian: Što je OPDIVO i za što se koristi
English: For patients weighing less than 40 kg, the total volume of infusion must not exceed 4 mL per kilogram of patient weight.
Croatian: Za bolesnike tjelesne težine manje od 40 kg, ukupni volumen infuzije ne smije biti veći od 4 ml po kilogramu bolesnikove težine.