FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.8 Undesirable effects <Paediatric population>
Croatian: 4.8 Nuspojave <Pedijatrijska populacija>
English: 6.1 List of excipients <None.>
Croatian: 6.1 Popis pomoćnih tvari <Nema.>
English: <The marketing authorisation holder (MAH) shall submit the first PSUR periodic safety update report for this product within 6 months following authorisation.>
Croatian: <Nositelj odobrenja za stavljanje lijeka u promet će prvi PSURo periodičko izvješće o neškodljivosti za ovaj lijek dostaviti unutar 6 mjeseci nakon dobivanja odobrenja.>
English: What X contains - The active substance(s) is (are)… - The other <ingredient(s)> <(excipient(s))> is (are)...
Croatian: Što X sadrži - Djelatna(e) tvar(i) je (su)… - Drugi(a)(e) sastojak(ci) <(pomoćna(e) tvar(i))> je (su)…
English: Slovenská republika {Názov} <{Adresa}
Croatian: Slovenská republika {Názov}
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.> <Paediatric population>
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.>
English: • Periodic Ssafety Uupdate Rreports (PSURs)
Croatian: • Periodička izvješća o neškodljivosti lijeka (PSUR-evi)
English: 4.5 Interaction with other medicinal products and other forms of interaction <No interaction studies have been performed.> <Paediatric population> <Interaction studies have only been performed in adults.> 4.6 Fertility, pregnancy and lactation <Pregnancy> <Breast-feeding> <Fertility>
Croatian: <Pedijatrijska populacija> <Ispitivanja interakcija provedena su samo u odraslih.> 4.6 Plodnost, trudnoća i dojenje <Trudnoća> <Dojenje> <Plodnost>
English: days>.>
Croatian: dana>.>
English: <Post-authorisation efficacy study (PAES):> <Non-interventional post-authorisation safety study (PASS):>>
Croatian: <Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES):> <Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS):>>
English: <If you stop <taking> <using> X> <If you have any further questions on the use of this medicine, ask your <doctor> <,> <or> <pharmacist> <or nurse>.>
Croatian: <Ako prestanete <uzimati> <primjenjivati> X> <U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se <liječniku> <,> <ili> <ljekarniku>
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE <Name and address of the manufacturer(s) of the biological active substance(s) {Name and address}> <Name and address of the manufacturer(s) responsible for batch release> {Name and address} <The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.>
Croatian: ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET <Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari {Naziv i adresa}> <Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet> {Naziv i adresa} <Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet.>
English: <An updated RMP shall be submitted by {CHMP agreed deadline}.> <Not applicable.>
Croatian: <Ažurirani RMP treba dostaviti do {prema dogovorenom vremenskom rasporedu CHMP-a}>.
English: • <Obligation to conduct post-authorisation measures> The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: Opis
English: <This being a conditional marketing authorisation and pursuant to Article 14a(47) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:>
Croatian: <Budući da je ovo uvjetno odobrenje za stavljanje lijeka u promet, sukladno članku 14.-a. stavku 47. Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:>
English: 6.6 Special precautions for disposal <and other handling> <Use in the paediatric population> <No special requirements <for disposal>.> <Any unused medicinal product or waste material should be disposed of in accordance with local requirements.>
Croatian: <i druga rukovanja lijekom> <Primjena u pedijatrijskoj populaciji> <Nema posebnih zahtjeva <za zbrinjavanje>.> <Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.>
English: < This medicine is subject to additional monitoring.
Croatian: Ovaj je lijek pod dodatnim praćenjem.
English: STATEMENT OF ACTIVE SUBSTANCE(S) <This product contains cells of <human> <animal> origin.>
Croatian: NAVOĐENJE DJELATNE(IH) TVARI <Ovaj lijek sadrži stanice <ljudskog><životinjskog> podrijetla.>
English: A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND>
Croatian: <PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I> PROIZVOĐAČ(I)
English: X with <food> <and> <,> <drink> <and> <alcohol> Pregnancy <and> <,> breast-feeding <and fertility> <If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your <doctor> <or> <pharmacist> for advice before taking this medicine.> Driving and using machines <X contains {name the excipient(s)}>
Croatian: Drugi lijekovi i X <Obavijestite svog <liječnika> <ili> <ljekarnika> ako <uzimate> <primjenjujete>, nedavno ste <uzeli> <primijenili> ili biste mogli <uzeti> <primijeniti> bilo koje druge lijekove.> X s <hranom> <i> <,> <pićem> <i> <alkoholom> Trudnoća <i> <,> dojenje <i plodnost> <Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom <liječniku> <ili> <ljekarniku> za savjet prije nego uzmete ovaj lijek.˃
English: <Use in children <and adolescents>> <The score line is only there to help you break the tablet if you have difficulty swallowing it whole.> <The tablet can be divided into equal doses.> <The score line is not intended for breaking the tablet.>
Croatian: <Primjena u djece <i adolescenata>> <Urez služi samo da Vam pomogne prelomiti tabletu ako je ne možete progutati cijelu.>
English: Warnings and precautions Talk to your doctor <or> <,> <pharmacist> <or nurse> before <taking> <using> X
Croatian: Obratite se svom liječniku <ili> <,> <ljekarniku> <ili medicinskoj sestri> prije nego <uzmete> <primijenite> X.
English: {NATURE/TYPE}
Croatian: {VRSTA/TIP}
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE {VRSTA/TIP}
English: QUALITATIVE AND QUANTITATIVE COMPOSITION <2.1 General description> [For advanced therapy products only] <2.2 Qualitative and quantitative composition> [For advanced therapy products only] <Excipient(s) with known effect> <For the full list of excipients, see section 6.1.>
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV <2.1 Opći opis> [Samo za lijek za naprednu terapiju] <2.2 Kvalitativni i kvantitativni sastav>
English: <The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.> <The score line is not intended for breaking the tablet.> <The tablet can be divided into equal doses.>
Croatian: <Urez služi samo kako bi se olakšalo lomljenje tablete radi lakšeg gutanja, a ne da bi se podijelila na jednake doze.>
English: 6.5 Nature and contents of container <and special equipment for use, administration or implantation> <Not all pack sizes may be marketed.>
Croatian: 6.5 Vrsta i sadržaj spremnika <i posebna oprema za uporabu, primjenu ili ugradnju>
English: <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: <PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I> PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: <The European Medicines Agency has deferred the obligation to submit the results of studies with <{(Invented) Nname}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in one or more subsets of the paediatric population in {condition, as per Ppaediatric Iinvestigation Pplan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Croatian: <Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka <{(Novoizumljeno) ime}> [ili za generičke lijekove: <referentni lijek koji sadrži {ime djelatne(ih) tvari}>] u jednoj ili više podskupina pedijatrijske populacije u {uvjeti zadani po Planu istraživanja u pedijatrijskoj populaciji (PIP-u), za odobrenu indikaciju} (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).>
English: 6.2 Incompatibilities <Not applicable.> <In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.> <This medicinal product must not be mixed with other medicinal products except those mentioned in section <6.6> <and> <12>.>
Croatian: <Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu <6.6> <i> <12>.>
English: <Additional side effects in children <and adolescents>> Reporting of side effects
Croatian: <Dodatne nuspojave u djece <i adolescenata>>
English: <The reference medicinal product containing {active substance} has been authorised under ‘exceptional circumstances'.
Croatian: <Referentni lijek koji sadrži {djelatna tvar} odobren je u „iznimnim okolnostima”“.
English: Marketing Authorisation Holder and Manufacturer {Name and address} <{tel}> <{fax}> <{e-mail}>
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač {Naziv i adresa} <{tel}> <{fax}> <{e-mail}>
English: <{tel}> <{fax}> <{e-mail}>
Croatian: <{fax}> <{e-mail}>
English: <The European Medicines Agency has waived the obligation to submit the results of studies with <{(Invented) Nname}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in all subsets of the paediatric population in {condition as per Ppaediatric Iinvestigation Pplan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Croatian: <Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka <{(Novoizumljeno) ime}> [ili za generičke lijekove: <referentni lijek koji sadrži {ime djelatne(ih) tvari}>] u svim podskupinama pedijatrijske populacije u {uvjeti zadani po Planu istraživanja u pedijatrijskoj populaciji (PIP-u), za odobrenu indikaciju} (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).>
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR <THE CONDITIONAL MARKETING AUTHORISATION> <THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES>>
Croatian: POSEBNE OBVEZE ZA PROVEDBEISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA KOD <UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET> <ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA>>
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu<, and on the website of {name of Member StateMS Agency (link)}>.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu<, kao i na internetskoj stranici {naziv nadležnog tijela države članice (poveznica)}>.
English: Hrvatska {Ime} <{Adresa} {Poštanski broj} {grad}> Tel: + {Telefonski broj} <{e-mail}>
Croatian: Hrvatska {Naziv} <{Adresa} {Poštanski broj} {grad}> Tel: + {Telefonski broj} <{e-mail}>
English: Do not <take> <use> X<:> - <if you are allergic to {active substance(s)} or any of the other ingredients of this medicine
Croatian: Što morate znati prije nego počnete <uzimati> <primjenjivati> X Nemojte <uzimati> <primjenjivati> X<:> <ako ste alergični na {djelatnu(e) tvar(i)} ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).>
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.* [*For the printed material, please refer to the guidance of the annotated QRD template.]
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.* [*Za tiskani materijal vidjeti uputu u QRD predlošku s pojašnjenjima.] 4.9 Predoziranje
English: <Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.> <Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.> <Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:> <Environmental Rrisk Aassessment (ERA)>
Croatian: <Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.>
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {Name and address}
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET {Naziv i adresa} <{tel}>
English: SK-000 00 {Mesto}> Tel: + {Telefónne číslo}
Croatian: SK-000 00 {Mesto}> Tel: + {Telefónne číslo} <{e-mail}>
English: Do not use this medicine after the expiry date which is stated on the <label> <carton> <bottle> <…> <after {abbreviation used for expiry date}.> <The expiry date refers to the last day of that month.> <Do not use this medicine if you notice {description of the visible signs of deterioration}.> <Do not throw away any medicines via wastewater <or household waste>.
Croatian: <Ovaj lijek se ne smije upotrijebiti ako primijetite {opis vidljivih znakova odstupanja u kakvoći}.> <Nikada nemojte nikakve lijekove bacati u otpadne vode <ili kućni otpad>.
English: NAME OF THE MARKETING AUTHORISATION HOLDER {Name}
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET {Naziv}
English: - If you have any further questions, ask your <doctor> <,> <or> <pharmacist> <or nurse>.
Croatian: - Ako imate dodatnih pitanja, obratite se <liječniku> <,> <ili> <ljekarniku>
English: What you need to know before you <take> <use> X 3.
Croatian: Što morate znati prije nego počnete <uzimati> <primjenjivati> X 3. Kako <uzimati> <primjenjivati> X 4. Moguće nuspojave
English: Ísland {Nafn} <{Heimilisfang} IS-000 {Borg/Bær}> Sími: + {Símanúmer}
Croatian: <{Heimilisfang} IS-000 {Borg/Bær}> Sími: + {Símanúmer} <{Netfang }>
English: <The <safety> <and> <efficacy> of {X} in children aged {x to y} <months> <years> [or any other relevant subsets, e.g. weight, pubertal age, gender] <has> <have> not <yet> been established.> <No data are available.> <Currently available data are described in section <4.8> <5.1> <5.2> but no recommendation on a posology can be made.>
Croatian: Pedijatrijska populacija <Sigurnost> <i> <djelotvornost> {X} u djece u dobi {od x do y} <mjeseci(a)> <godine(a)> [ili u bilo kojoj drugoj bitnoj podskupini, npr. prema težini, pubertetu, spolu] <nije> <nisu> <još> ustanovljena(e).> <Nema dostupnih podataka.>
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {(Invented) name strength pharmaceutical form} {Aactive substance(s)} {Route of administration}
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA {(Novoizumljeno) ime jačina farmaceutski oblik} {djelatna(e) tvar(i)} {Put primjene}
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS> <Any unused medicinal product or waste material should be disposed of in accordance with local requirements.>
Croatian: <Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.>
English: <{X} is indicated in <adults> <neonates> <infants> <children> <adolescents> <aged {x to y}> <years> <months>.>
Croatian: 4.1 Terapijske indikacije <Ovaj lijek se koristi samo u dijagnostičke svrhe.> <{X} je indiciran(a) u <odraslih> <novorođenčadi> <dojenčadi> <djece> <adolescenata> <u dobi {od x do y}> <godina> <mjeseci>.>
English: METHOD OF ADMINISTRATION
Croatian: <Mehanizam djelovanja>
English: 4.3 Contraindications <Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 <or {name of the residue(s)}>.>
Croatian: <razrjeđivanju> lijeka prije primjene vidjeti dio <6.6> <i> <12>.> 4.3 Kontraindikacije <Preosjetljivost na djelatnu(e) tvar(i) ili neku od pomoćnih tvari navedenih u dijelu 6.1 <ili {naziv ostatne(ih) tvari}>.>
English: <There is no relevant use of {X} <in the paediatric population> <in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...>.>
Croatian: <{X} je kontraindiciran(a) u djece u dobi {od x do y} <godine(a)>, <mjeseci(a)> [ili u bilo kojoj drugoj bitnoj podskupini, npr. prema težini, pubertetu, spolu] <za indikaciju…> (vidjeti dio 4.3).>
English: {(Invented) name strength pharmaceutical form} {Aactive substance(s)}
Croatian: {(Novoizumljeno) ime jačina farmaceutski oblik} {djelatna(e) tvar(i)}
English: <This medicinal product is for diagnostic use only.>
Croatian: <Lijek se izdaje na recept.>
English: NAME OF THE MEDICINAL PRODUCT {(Invented) name strength pharmaceutical form} {Aactive substance(s)}
Croatian: NAZIV LIJEKA {(Novoizumljeno) ime jačina farmaceutski oblik}
English: <Medicinal product subject to medical prescription.> <Medicinal product not subject to medical prescription.> <Medicinal product subject to special medical prescription.> <Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).> <Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).>
Croatian: <Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).>
English: - If you get any side effects, talk to your <doctor> <,> <or> <pharmacist> <or nurse>.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti <liječnika> <,> <ili> <ljekarnika> <ili medicinsku sestru>.
English: Malta {Isem} <{Indirizz}
Croatian: {Isem} <{Indirizz}
English: <{Адрес} {Град} {Пощенски код}> Teл.
Croatian: <{Адрес} {Град} {Пощенски код}> Teл.: + {Телефонен номер}
English: LIST OF EXCIPIENTS
Croatian: Prijavljivanje nuspojava
English: 28 April 2016
Croatian: 28. travnja 2016.
English: Transmission to National Competent Authorities of the translations of the annexes to the position:
Croatian: Dostava prijevoda priloga stajalištu nacionalnim nadležnim tijelima:
English: March 2016 CMDh meeting
Croatian: Sastanak CMDh-a u ožujku 2016.
English: Implementation of the position by the Member States:
Croatian: Direktive 2001/83/EZ,
English: 28 May 2016
Croatian: Datum na koji države članice provode stajalište: 28. svibnja 2016.
English: Date of first authorisation: 31 October 2018
Croatian: Datum prvog odobrenja: 31. listopada 2018.
English: #P value not statistically significant.
Croatian: #P vrijednost nije bila statistički značajna.
English: You may also notice that you do not get ill as often and/or that it is easier to gain weight.
Croatian: Možete također primijetiti da se ne razbolijevate tako često i/ili da Vam je lakše dobiti na tjelesnoj težini.
English: It is important to take this medicine regularly.
Croatian: Važno je da redovito uzimate ovaj lijek.
English: Just wait, and take your next tablet at the usual time.
Croatian: Samo pričekajte i uzmite sljedeću tabletu u uobičajeno vrijeme.
English: Your doctor may need to adjust your dose.
Croatian: Liječnik će Vam možda trebati prilagoditi dozu.
English: †Estimated event rate per year calculated using 48 weeks per year.
Croatian: †Procijenjena stopa događaja godišnje izračunata za razdoblje od 48 tjedana godišnje.
English: Take the tablets about 12 hours apart.
Croatian: Tablete uzmite u razmaku od približno 12 sati.
English: You must keep using all your other medicines, unless your doctor tells you to stop.
Croatian: I dalje morate uzimati sve druge lijekove, osim ako Vam liječnik kaže da prestanete.
English: Do not make changes unless your doctor tells you.
Croatian: Nemojte uvoditi promjene osim ako Vam tako ne kaže liječnik.
English: Talk to your doctor, without taking the tablets, if this applies to you.
Croatian: Obratite se svom liječniku, ne uzimajući tablete, ako to vrijedi za Vas.
English: The next scheduled dose can be taken at the usual time.
Croatian: Sljedeću dozu može uzeti prema rasporedu u uobičajeno vrijeme.
English: These are listed in section 4.
Croatian: Oni su navedeni u dijelu 4.
English: Symkevi with food and drink
Croatian: Symkevi s hranom i pićem
English: • Do not take 2 tablets to make up for a missed dose.
Croatian: • Nemojte uzeti 2 tablete kako biste nadoknadili propuštenu dozu.
English: AUC0-24h or AUC0-12h
Croatian: AUC0-24h ili AUC0-12h
English: Your doctor will tell you how long you need to keep using Symkevi.
Croatian: Liječnik će Vam reći koliko dugo trebate uzimati Symkevi.
English: Other medicines and Symkevi
Croatian: Drugi lijekovi i Symkevi
English: Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to treatment cannot be excluded.
Croatian: Iako su u nekim slučajevima bili prisutni drugi čimbenici rizika (kao što su primjena kortikosteroida i izloženost zračenju), mogući rizik koji bi se mogao pripisati liječenju ne može se isključiti.
English: This is stamped with “V100”.
Croatian: Na njoj je utisnuta oznaka „V100“.
English: • Pregnancy: It may be better to avoid using this medicine during pregnancy.
Croatian: • Trudnoća: Bolje je izbjegavati primjenu ovog lijeka tijekom trudnoće.
English: As efficacy was a secondary objective for Study 3 there was no multiplicity adjustment.
Croatian: Budući da je djelotvornost bila drugi cilj ispitivanja 3, nije bilo prilagodbe zbog višestrukog testiranja.
English: If possible, take your medicine and this leaflet with you.
Croatian: Po mogućnosti, ponesite sa sobom lijek i ovu uputu.
English: • Cheese, whole milk, whole milk dairy products, yogurt, chocolate
Croatian: • sir, punomasno mlijeko, mliječni proizvodi od punomasnog mlijeka, jogurt, čokolada
English: Your doctor will consider the benefit of breast-feeding for the child and the benefit of treatment for you to help you decide whether to stop breast-feeding or to stop treatment.
Croatian: Liječnik će razmotriti korist od dojenja za dijete i korist od liječenja za Vas kako bi Vam pomogao da odlučite hoćete li prestati dojiti ili prestati s liječenjem.
English: Treatment of overdose consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Croatian: Liječenje predoziranja sastoji se od općih potpornih mjera, uključujući praćenje vitalnih znakova i promatranje kliničkog stanja bolesnika.
English: • In the morning, take one yellow Symkevi tablet.
Croatian: • Ujutro uzmite jednu žutu tabletu lijeka Symkevi.
English: These may be a sign of liver problems:
Croatian: Ovo može biti znak problema s jetrom:
English: Effects on sweat chloride
Croatian: Učinci na kloride u znoju
English: Meals or snacks that contain fat include those prepared with butter or oils or those containing eggs.
Croatian: Glavni obroci ili međuobroci koji sadrže masti uključuju one pripremljene s maslacem ili uljem ili one koji sadrže jaja.
English: Children aged less than 12 years
Croatian: Djeca mlađa od 12 godina
English: What Symkevi is and what it is used for 2.
Croatian: Što je Symkevi i za što se koristi 2.
English: • Increased liver enzymes in the blood
Croatian: • povišene vrijednosti jetrenih enzima u krvi
English: You may get side effects, including those mentioned in section 4 below.
Croatian: Možete dobiti nuspojave, uključujući one navedene u dijelu 4 u nastavku.