FrancophonIA/ELRC3.0 huggingface dataset:
English: If either of these symptoms occur, stop using Budesonide/Formoterol Teva Pharma B.V. straightaway and use your ‘reliever inhaler'.
Croatian: Ako se pojavi bilo koji od ovih simptoma odmah prekinite s primjenom lijeka Budezonid/Formoterol Teva Pharma B.V. i primijenite svoj „inhalator za brzo ublažavanje simptoma“.
English: Side panel: Each delivered dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Croatian: Bočna strana: Svaka primijenjena doza sadrži 320 mikrograma budezonida i 9 mikrograma formoterol fumarat dihidrata.
English: THE SIGHT AND REACH OF CHILDREN
Croatian: Djeca i adolescenti
English: Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht The Netherlands
Croatian: Computerweg 10, 3542 DR Utrecht Nizozemska
English: Side panel: Each delivered dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Croatian: Bočna strana: Svaka primijenjena doza sadrži 160 mikrograma budezonida i 4,5 mikrograma formoterolfumarat dihidrata.
English: • Medicines for thyroid problems (such as levothyroxine).
Croatian: • lijekove za liječenje tegoba sa štitnjačom (poput levotiroksina).
English: Patients should be reassessed regularly by their prescriber/health care provider so that the dose of Budesonide/Formoterol Teva Pharma B.V. remains optimal.
Croatian: Bolesnike mora redovito procijenjivati liječnik koji im propisuje lijekove/pružatelj zdravstvene skrbi kako bi doza inhalatora Budezonid/Formoterol Teva Pharma B.V. ostala optimalna.
English: • Use Budesonide/Formoterol Teva Pharma B.V. every day.
Croatian: • Svakodnevno koristite Budezonid/Formoterol Teva Pharma B.V.
English: Budesonide/Formoterol Teva Pharma B.V. contains two different active substances: budesonide and formoterol fumarate dihydrate.
Croatian: Što je Budezonid/Formoterol Teva Pharma B.V. i za što se koristi Budezonid/Formoterol Teva Pharma B.V. sadrži dvije različite djelatne tvari: budezonid i formoterolfumarat dihidrat.
English: If any of the above applies to you, or if you are not sure, talk to your doctor, pharmacist or nurse before using Budesonide/Formoterol Teva Pharma B.V.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas ili niste sigurni, prije uporabe lijeka Budezonid/Formoterol Teva Pharma B.V. razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom.
English: If you forget to use Budesonide/Formoterol Teva Pharma B.V.
Croatian: Ako ste zaboravili primijeniti Budezonid/Formoterol Teva Pharma B.V.
English: If you stop using Budesonide/Formoterol Teva Pharma B.V.
Croatian: Ako prestanete primjenjivati Budezonid/Formoterol Teva Pharma B.V.
English: Preparing your new Budesonide/Formoterol Teva Pharma B.V.
Croatian: Priprema Vašeg novog inhalatora Budezonid/Formoterol Teva Pharma B.V.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Inhalation use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: The inhaler is white with a semi-transparent wine red mouthpiece cover.
Croatian: Inhalator je bijele boje s poluprozirnim poklopac nastavka za usta koji je boje crvenog vina.
English: Use your Budesonide/Formoterol Teva Pharma B.V. every day.
Croatian: Svakodnevno koristite Budezonid/Formoterol Teva Pharma B.V.
English: Front panel: This delivered dose is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
Croatian: Prednja strana: Ova primijenjena doza odgovara odmjerenoj dozi od 400 mikrograma budezonida i 12 mikrograma formoterolfumarat dihidrata.
English: Front panel: This delivered dose is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
Croatian: Prednja strana: Ova primijenjena doza odgovara odmjerenoj dozi od 200 mikrograma budezonida i 6 mikrograma formoterolfumarat dihidrata.
English: Oral infections
Croatian: Infekcije usta
English: This is not likely to be relevant for humans given recommended doses.
Croatian: Kod čovjeka pri preporučenim dozama taj učinak vjerojatno nije relevantan.
English: Close your lips around the mouthpiece.
Croatian: Nastavak za usta obavijte usnama.
English: Using Budesonide/Formoterol Teva Pharma B.V. and a separate ‘reliever inhaler'
Croatian: Primjena lijeka Budezonid/Formoterol Teva Pharma B.V. i zasebnog 'inhalatora za brzo ublažavanje simptoma'
English: Tel: +39 028 917 981
Croatian: Teva Italia S.r.l. Tel: +39 028 917 981
English: Excipient(s) with known effect: Each dose contains approximately 10 milligrams of lactose (as monohydrate) .
Croatian: Jedna doza sadrži oko 10 miligrama laktoze (u obliku hidrata).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Lactose monohydrate.
Croatian: 6.1 Popis pomoćnih tvari laktoza hidrat 6.2 Inkompatibilnosti
English: Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery.
Croatian: Stoga se u razdobljima stresa, poput teških infekcija ili elektivnih kirurških zahvata, mora razmotriti uvođenje dodatnog sistemskog kortikosteroida.
English: White inhaler with a semi-transparent wine red mouthpiece cover.
Croatian: Bijeli inhalator s poluprozirnim poklopcem nastavka za usta boje crvenog vina.
English: The most common symptoms that may occur after if you use more Budesonide/Formoterol Teva Pharma B.V. than you should are trembling, headache or a rapid heartbeat.
Croatian: Teva Pharma B.V. nego biste trebali, su drhtanje, glavobolja ili brzi otkucaji srca.
English: Marketing Authorisation Holder Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nizozemska.
English: Teva Pharmaceuticals Europe B.V. Swensweg 5
Croatian: Teva Pharmaceuticals Europe B.V.
English: • Mild sore throat, coughing and a hoarse voice.
Croatian: • Blaga grlobolja, kašalj i promuklost.
English: Candida infection in the oropharynx is due to active substance deposition.
Croatian: Opis odabranih nuspojava Kandidijaza orofarinksa uzrokovana je odlaganjem djelatne tvari.
English: Budesonide/Formoterol Teva Pharma B.V.is indicated in adults 18 years of age and older only.
Croatian: Budezonid/Formoterol Teva Pharma B.V. indiciran je samo u odraslih u dobi od 18 godina i više.
English: If either of these symptoms occur, stop using Budesonide/Formoterol Teva Pharma B.V. straightaway and use your 'reliever inhaler' Contact your doctor immediately as you may need to have your treatment changed.
Croatian: Ako se pojavi bilo koji od ovih simptoma odmah prekinite s primjenom lijeka Budezonid/Formoterol Teva Pharma B.V. i primijenite svoj “inhalator za brzo ublažavanje simptoma“.
English: Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.
Croatian: Budezonid/Formoterol Teva Pharma B.V. indiciran je samo u odraslih u dobi od 18 godina i starijih.
English: Budesonide/Formoterol Teva Pharma B.V.is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Croatian: Budezonid/Formoterol Teva Pharma B.V. nije indiciran za primjenu u djece, u dobi od 12 godina i mlađe, niti za adolescente u dobi od 13 do 17 godina.
English: How to store Budesonide/Formoterol Teva Pharma B.V.
Croatian: Kako čuvati Budezonid/Formoterol Teva Pharma B.V.
English: Mogilska 80
Croatian: 4.8 Nuspojave
English: How to use Budesonide/Formoterol Teva Pharma B.V.
Croatian: Kako primjenjivati Budezonid/Formoterol Teva Pharma B.V.
English: Dizziness
Croatian: Nuspojava
English: NAME OF THE MEDICINAL PRODUCT Budesonide/Formoterol Teva Pharma B.V. 320 micrograms/9 micrograms inhalation powder.
Croatian: NAZIV LIJEKA Budezonid/Formoterol Teva Pharma B.V. 320 mikrograma/9 mikrograma prašak inhalata
English: See leaflet for further information
Croatian: Vidjeti uputu o lijeku za dodatne informacije.
English: For a fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate or the concomitant treatment with formoterol and budesonide, no clinical data on exposed pregnancies are available.
Croatian: Trudnoća Nema dostupnih kliničkih podataka o trudnoćama izloženim terapiji kombinacijom fiksne doze budezonida i formoterolfumarat dihidrata ili istodobnom liječenju formoterolom i budezonidom.
English: Budesonide/Formoterol Teva Pharma B.V. is indicated for use in adults 18 years of age and older only.
Croatian: Primjena lijeka Budezonid/Formoterol Teva Pharma B.V. indicirana je samo za odrasle u dobi od 18 i više godina.
English: NAME OF THE MEDICINAL PRODUCT Budesonide/Formoterol Teva Pharma B.V. 160 micrograms / 4.5 micrograms inhalation powder.
Croatian: NAZIV LIJEKA Budezonid/Formoterol Teva Pharma B.V. 160 mikrograma/4,5 mikrograma prašak inhalata
English: Budesonide/Formoterol Teva Pharma B.V. 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
Croatian: Budezonid/Formoterol Teva Pharma B.V. 160 mikrograma/4,5 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat
English: This is equivalent to a metered dose of 400 micrograms budesonide and 12 micrograms of formoterol fumarate dihydrate.
Croatian: To odgovara odmjerenoj dozi od 400 mikrograma budezonida i 12 mikrograma formoterol fumarat dihidrata.
English: This is equivalent to a metered dose of 200 micrograms budesonide and 6 micrograms of formoterol fumarate dihydrate.
Croatian: To odgovara odmjerenoj dozi od 200 mikrograma budezonida i 6 mikrograma formoterolfumarat dihidrata.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna primijenjena doza (doza koja izlazi iz nastavka za usta inhalatora Spiromax) sadrži 320 mikrograma budezonida i 9 mikrograma formoterol fumarat dihidrata.
English: Immediate and delayed hypersensitivity reactions, e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction
Croatian: Istodobno liječenje s kinidinom, dizopiramidom, prokainamidom, fenotiazinima, antihistaminicima
English: Budesonide/Formoterol Teva Pharma B.V. contains lactose Lactose is a type of sugar found in milk.
Croatian: Budezonid/Formoterol Teva Pharma B.V. sadrži laktozu
English: dosing averages 4 hours.
Croatian: u 24 sata i češće od svaka 4 sata.
English: 6.2 Incompatibilities Not applicable.
Croatian: 6.1 Popis pomoćnih tvari laktoza hidrat 6.2 Inkompatibilnosti Nije primjenjivo.
English: Budesonide/Formoterol Teva Pharma B.V. pharmacokinetic profile
Croatian: Farmakokinetički profil lijeka Budezonid/Formoterol Teva Pharma B.V.
English: If patients find the treatment ineffective, or exceed the highest recommended dose of Budesonide/Formoterol Teva Pharma B.V., medical attention must be sought (see section 4.2).
Croatian: Budezonid/Formoterol Teva Pharma B.V., moraju zatražiti liječničku pomoć (vidjeti dio 4.2).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Budesonide/Formoterol Teva Pharma B.V. 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Budezonid/Formoterol Teva Pharma B.V. 160 mikrograma/4,5 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat
English: How to use Budesonide/Formoterol Teva Pharma B.V. (page 8) 4.
Croatian: (stranica 5) Kako primjenjivati Budezonid/Formoterol Teva Pharma B.V. (stranica 8)
English: • Muscle cramps.
Croatian: • Grčevi mišića.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Budesonide/Formoterol Teva Pharma B.V.320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Budezonid/Formoterol Teva Pharma B.V. 320 mikrograma/9 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat
English: Bruises
Croatian: Modrice
English: Budesonide/Formoterol Teva Pharma B.V. 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Croatian: Budezonid/Formoterol Teva Pharma B.V. 320 mikrograma/9 mikrograma prašak inhalata budezonid/ formoterolfumarat dihidrat.
English: Other medicines and Budesonide/Formoterol Teva Pharma B.V. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Do not use Budesonide/Formoterol Teva Pharma B.V. if:
Croatian: Budezonid/Formoterol Teva Pharma B.V. ako:
English: Lactose contains small amounts of milk protein which may cause allergic reactions.If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
English: How to use Budesonide/Formoterol Teva Pharma B.V. (page 9) 4.
Croatian: (stranica 5) Kako primjenjivati Budezonid/Formoterol Teva Pharma B.V. (stranica 9)
English: If you feel you are getting breathless or wheezy while using Budesonide/Formoterol Teva Pharma B.V., you should continue to use Budesonide/Formoterol Teva Pharma B.V. but go to see your doctor as soon as possible, as you may need additional treatment.
Croatian: Ako osjećate da Vam nedostaje zraka ili da Vam zviždi u plućima tijekom primjene inhalatora Budezonid/Formoterol Teva Pharma B.V., trebate nastaviti s primjenom inhalatora
English: Use your separate ‘reliever inhaler' to treat asthma symptoms when they happen.
Croatian: • Koristite svoj „inhalator za brzo ublažavanje simptoma” kad nastupe simptomi astme, kako biste olakšali ponovno disanje.
English: How to store Budesonide/Formoterol Teva Pharma B.V. (page 21) 6.
Croatian: Kako čuvati Budezonid/Formoterol Teva Pharma B.V. (stranica 21) Sadržaj pakiranja i druge informacije (stranica 22)
English: Do not use Budesonide/Formoterol Teva Pharma B.V. just before exercise to stop asthma symptoms from occurring, use your separate ‘reliever inhaler'.
Croatian: B.V. neposredno prije tjelovježbe kako biste spriječili pojavu simptoma astme, primijenite zasebni
English: Adrenal function
Croatian: Funkcija nadbubrežne žlijezde
English: If you get any side effects, talk to your doctor,pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: How to store Budesonide/Formoterol Teva Pharma B.V. (page 19) 6.
Croatian: Kako čuvati Budezonid/Formoterol Teva Pharma B.V. (stranica 19) Sadržaj pakiranja i druge informacije (stranica 19)
English: Description of selected adverse reactions
Croatian: Neposredne i odgođene reakcije preosjetljivosti,
English: Patients should be reminded to take their Budesonide/Formoterol Teva Pharma B.V. maintenance dose as prescribed, even when asymptomatic.
Croatian: Bolesnike se mora podsjetiti da svoju dozu održavanja lijekom Budezonid/Formoterol Teva Pharma
English: Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Croatian: Jedna primijenjena (inhalirana) doza sadrži 320 mikrograma budezonida i 9 mikrograma formoterolfumarat dihidrataTo odgovara odmjerenoj dozi od 400 mikrograma budezonida i 12 mikrograma formoterolfumarat dihidrata.
English: • Feeling dizzy.
Croatian: • Osjećaj omaglice.
English: Budesonide/Formoterol Teva Pharma B.V.320 micrograms/9 micrograms, inhalation powder (budesonide/formoterol fumarate dihydrate)
Croatian: Uputa o lijeku: Informacija za bolesnika Budezonid/Formoterol Teva Pharma B.V. 320 mikrograma/9 mikrograma prašak inhalata (budezonid/ formoterolfumarat dihidrat)
English: Budesonide/Formoterol Teva Pharma B.V. 160 micrograms/4.5 micrograms, inhalation powder (budesonide/formoterol fumarate dihydrate)
Croatian: Uputa o lijeku: Informacija za bolesnika Budezonid/Formoterol Teva Pharma B.V. 160 mikrograma/4,5 mikrograma prašak inhalata (budezonid/ formoterolfumarat dihidrat)
English: Each delivered (inhaled) dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Croatian: Jedna primijenjena (inhalirana) doza sadrži 160 mikrograma budezonida i 4,5 mikrograma formoterolfumarat dihidrata.To odgovara odmjerenoj dozi od 200 mikrograma budezonida i 6 mikrograma formoterolfumarat dihidrata.
English: Serious asthma-related adverse reactions and exacerbations may occur during treatment with Budesonide/Formoterol Teva Pharma B.V.
Croatian: Ozbiljne nuspojave povezane s astmom i egzacerbacije mogu se pojaviti tijekom liječenja lijekom
English: The treatment will be repeated every two weeks.
Croatian: Liječenje će se ponoviti svaka dva tjedna.
English: It must be protected from light, and it must not be frozen.
Croatian: Mora biti zaštićena od svjetlosti i ne smije se zamrzavati.
English: Volume (V)
Croatian: Volumen (V)
English: SD= standard deviation
Croatian: SD= standardna devijacija
English: Results are shown in Table 4.
Croatian: Rezultati su prikazani u Tablici 4.
English: What to do in case of diarrhoea
Croatian: Što učiniti u slučaju proljeva
English: It is especially important that you tell your doctor if you have been given irinotecan in any form earlier.
Croatian: Posebno je važno da svom liječniku kažete ako ste ranije primili irinotekan u bilo kojem obliku.
English: They may differ from the general information contained in this leaflet.
Croatian: One se mogu razlikovati od općih informacija sadržanih u ovoj uputi.
English: You should avoid driving, using machines or performing other tasks that need full attention if you feel sleepy, dizzy and exhausted.
Croatian: Trebate izbjegavati upravljanje vozilima, rad sa strojevima ili obavljanje drugih zadataka koji trebaju punu pozornost ako se osjećate pospano, ošamućeno i iscrpljeno.
English: Contact your doctor immediately to give you a suitable treatment.
Croatian: Javite se odmah svom liječniku kako biste dobili odgovarajuće liječenje.
English: Genotoxic and carcinogenic potential
Croatian: Genotoksični i kancerogeni potencijal
English: Unstratified log-rank test
Croatian: Nestratificirani log-rang test
English: Your doctor may need to adjust the dose or stop treatment.
Croatian: Vaš liječnik će možda trebati prilagoditi dozu ili prekinuti liječenje.
English: Due to its mechanism of action, irinotecan is considered a potential carcinogen.
Croatian: Zbog svog mehanizma djelovanja, irinotekan se smatra potencijalno kancerogenim.
English: Grade 3 or 4 (despite antiemetic therapy)
Croatian: Stupanj 3 ili 4 (unatoč antiemetskoj terapiji)
English: Blood tests and medical examinations
Croatian: Krvne pretrage i liječnički pregledi
English: Do not throw away this medicine via wastewater or household waste.
Croatian: Nikada nemojte ovaj lijek bacati u otpadne vode ili kućni otpad.
English: Your doctor may give you a medicine which contains loperamide to begin treatment at home but it must not be used for longer than 48 consecutive hours.
Croatian: Liječnik vam može dati lijek koji sadrži loperamid kako biste započeli liječenje kod kuće, ali se on ne smije koristiti duže od 48 sati neprekidno.
English: In certain cases, lower doses or longer dosing intervals may be required.
Croatian: U nekim slučajevima mogu biti potrebne manje doze ili duži intervali doziranja.
English: Asian population
Croatian: Azijska populacija
English: Cox model analysis
Croatian: Analiza Coxovim modelom
English: Prior Whipple procedure
Croatian: Prethodni Whippleov postupak
English: You will need to have further (blood or other) tests during treatment so that your doctor can monitor your blood cells and assess how you are responding to the treatment.
Croatian: Morat ćete imati daljnje pretrage (krvi ili druge) tijekom liječenja tako da liječnik može pratiti Vaše krvne stanice i procijeniti kako reagirate na liječenje.
English: Your doctor will decide upon the doses you will receive.
Croatian: Vaš liječnik će odlučiti koju dozu lijeka ćete primiti.
English: Ask your doctor for advice if you are planning to have a baby.
Croatian: Obratite se svom liječniku za savjet ako planirate imati dijete.
English: It is important that you are aware of what these side effects may be.
Croatian: Važno je da ste svjesni kakve te nuspojave mogu biti.
English: The appropriate starting dose for patients taking these anticonvulsants or other strong inducers has not been defined.
Croatian: Odgovarajuća početna doza za bolesnike koji primaju te antikonvulzive ili druge snažne induktore nije definirana.
English: Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Croatian: Mrtva ili inaktivirana cjepiva mogu se primjenjivati; međutim, odgovor na ta cjepiva može biti oslabljen.
English: Carefully follow all instructions given to you by your doctor or nurse.
Croatian: Pažljivo slijedite sve upute koje Vam je dao liječnik ili medicinska sestra.
English: Patients received treatment until disease progression or unacceptable toxicity.
Croatian: Bolesnici su primali liječenje sve do progresije bolesti ili do neprihvatljive toksičnosti.
English: However, in other studies with irinotecan they have been shown to be devoid of any mutagenic potential in the Ames test.
Croatian: Međutim, u drugim ispitivanjima s irinotekanom pokazalo se da nemaju nikakav mutageni potencijal u Amesovom testu.
English: Grade 3 or 4
Croatian: Stupanj 3 ili 4
English: Loperamide should not be used for more than 48 consecutive hours due to risk of paralytic ileus.
Croatian: Loperamid se ne smije koristiti dulje od 48 uzastopnih sati zbog rizika od paralitičkog ileusa.
English: The adverse reactions in these patients were similar to those reported with the recommended dosage and regimen.
Croatian: Nuspojave u tih bolesnika bile su slične onima prijavljenim uz preporučenu dozu i režim liječenja.
English: Tell your doctor or nurse about any of the following serious side effects straight away:
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru o bilo kojoj od sljedećih ozbiljnih nuspojava:
English: If the solution contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Croatian: Ako otopina dođe u doticaj s kožom, kožu treba odmah temeljito oprati sapunom i vodom.
English: During treatment patients should observe caution when driving or using machines.
Croatian: Tijekom liječenja bolesnici trebaju biti oprezni kad upravljaju vozilima ili rade sa strojevima.
English: Very common: Alopecia
Croatian: Vrlo često: alopecija
English: Tell your doctor if you are or think you may be pregnant.
Croatian: Obavijestite svog liječnika ako ste trudni ili mislite da biste mogli biti trudni.
English: The following side effects may occur:
Croatian: Mogu se pojaviti sljedeće nuspojave:
English: All dose modifications should be based on the worst preceding toxicity.
Croatian: Prilagodba doziranja Sve modifikacije doze treba temeljiti na najgoroj prethodnoj toksičnosti.
English: Patients should be monitored for signs of infections.
Croatian: Bolesnike je potrebno pratiti radi znakova infekcije.
English: For more details see section 6.6.
Croatian: Za dodatne detalje, vidjeti dio 6.6.
English: What you need to know before you use ONIVYDE pegylated liposomal Follow carefully all instructions given to you by your doctor.
Croatian: Što morate znati prije nego počnete primjenjivati ONIVYDE pegilirani liposomalni Pažljivo slijedite sve upute koje vam je dao liječnik.
English: The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby allowing it to act for longer.
Croatian: Očekuje se da će se liposomi akumulirati unutar tumora i polako tijekom vremena ispuštati lijek, omogućujući mu time da djeluje duže.
English: * MedDRA version 14.1 ** Rare occurrence cannot be estimated from the NAPOLI-1study due to the small sample size
Croatian: * MedDRA verzija 14.1 ** Rijetka pojava ne može se ustanoviti iz ispitivanja NAPOLI-1 zbog male veličine uzorka
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 October 2016
Croatian: Datum prvog odobrenja: 14. listopada 2016