FrancophonIA/ELRC3.0 huggingface dataset:
English: Avelumab should be permanently discontinued if immune-related myocarditis is confirmed (see section 4.2).
Croatian: Ako se imunološki posredovan miokarditis potvrdi, primjenu avelumaba potrebno je trajno prekinuti (vidjeti dio 4.2).
English: • Dryness in the mouth
Croatian: • suhoća usta
English: Package leaflet: Information for the patient Bavencio 20 mg/mL concentrate for solution for infusion avelumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Bavencio 20 mg/ml koncentrat za otopinu za infuziju avelumab
English: Pneumonitis*
Croatian: Često pneumonitis*
English: There was no evidence to suggest a clinically relevant change of avelumab clearance over time in patients with advanced RCC.
Croatian: U bolesnika s uznapredovalim karcinomom bubrežnih stanica nije bilo dokaza koji bi ukazivali na klinički važnu promjenu klirensa avelumaba tijekom vremena.
English: • Inflammation of the eye
Croatian: • začepljenje crijeva
English: In patients treated with avelumab in combination with axitinib, 0.6% (3/489) of patients developed immune-related pneumonitis.
Croatian: U bolesnika liječenih avelumabom u kombinaciji s aksitinibom, 0,6 % (3/489) bolesnika razvilo je imunološki posredovan pneumonitis.
English: The median time to onset of immune-related colitis was 5.1 months (range: 2.3 weeks to 14 months).
Croatian: Medijan vremena do nastupa imunološki posredovanog kolitisa iznosio je 5,1 mjesec (raspon: od 2,3 tjedna do 14 mjeseci).
English: The other ingredients are mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injections (see section 2 “Bavencio has a low sodium content”).
Croatian: Drugi sastojci su manitol, ledena acetatna kiselina, polisorbat 20, natrijev hidroksid, voda za injekcije
English: Avelumab should be permanently discontinued if immune-related pancreatitis is confirmed (see section 4.2).
Croatian: Ako se imunološki posredovan pankreatitis potvrdi, primjenu avelumaba potrebno je trajno prekinuti (vidjeti dio 4.2).
English: Improvement of PFS was observed across pre-specified subgroups.
Croatian: U unaprijed definiranim podskupinama opaženo je poboljšanje preživljenja bez progresije bolesti.
English: Of these patients, there were 7 (0.4%) patients with Grade 3 immune-related colitis.
Croatian: Među tim bolesnicima, njih 7 (0,4 %) imalo je imunološki posredovan kolitis 3. stupnja.
English: Rash pruritic, rash maculo-papular, pruritus generalized, dermatitis acneiform, erythema, rash macular, rash papular, rash erythematous, dermatitis, eczema, rash generalized
Croatian: Često pruritični osip, makulopapulozni osip, generalizirani pruritus, akneiformni dermatitis, eritem, makulozni osip, papulozni osip, eritematozni osip, dermatitis, ekcem, generalizirani osip
English: Hyperthyroidism, adrenal insufficiency, thyroiditis
Croatian: Često hipertireoza, adrenalna insuficijencija, tiroiditis Manje često autoimuni tiroiditis, hipofizitis
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava Vrlo često anemija
English: The median time to onset of immune-related colitis was 2.1 months (range: 2 days to 11 months).
Croatian: Medijan vremena do nastupa imunološki posredovanog kolitisa iznosio je 2,1 mjesec (raspon: od 2 dana do 11 mjeseci).
English: In patients treated with avelumab as monotherapy, 0.9% (16/1,738) of patients developed immune-related hepatitis.
Croatian: Imunološki posredovan hepatitis U bolesnika liječenih avelumabom kao monoterapijom, 0,9 % (16/1738) bolesnika razvilo je imunološki posredovan hepatitis.
English: • problems with your hormone producing glands (the thyroid, adrenal and pituitary glands) that may affect how these glands work;
Croatian: • problemi sa žlijezdama koje stvaraju hormone (štitna žlijezda, nadbubrežna žlijezda i hipofiza)
English: Avelumab should be withheld for Grade 3 or Grade 4 thyroid disorders (see section 4.2).
Croatian: Primjenu avelumaba treba privremeno obustaviti kod poremećaja štitne žlijezde 3. ili 4. stupnja (vidjeti dio 4.2).
English: When avelumab 10 mg/kg was administered in combination with axitinib 5 mg, the respective exposures of avelumab and axitinib were unchanged compared to the single agents.
Croatian: Kad se avelumab u dozi od 10 mg/kg primjenjivao u kombinaciji s aksitinibom u dozi od 5 mg,
English: Median PFS, months (95% CI) 3-month PFS rate by K-M, (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier * Efficacy data with a minimum follow-up of 7 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR)
Croatian: Medijan PFS-a, mjeseci (95 % CI) 3-mjesečna stopa PFS-a prema K-M, (95 % CI) 6-mjesečna stopa PFS-a prema K-M, (95 % CI) 12-mjesečna stopa PFS-a prema K-M, (95 % CI) CI: interval pouzdanosti; RECIST: Kriteriji za ocjenu odgovora kod solidnih tumora (engl.
English: Avelumab should be withheld for Grade 2 or Grade 3 immune-related colitis until resolution, and permanently discontinued for Grade 4 or recurrent Grade 3 immune-related colitis (see section 4.2).
Croatian: Kod imunološki posredovanog kolitisa 2. ili 3. stupnja potrebno je privremeno obustaviti primjenu avelumaba do njegova povlačenja, a trajno prekinuti kod imunološki posredovanog kolitisa 4. stupnja ili rekurentnog imunološki posredovanog kolitisa 3. stupnja (vidjeti dio 4.2).
English: Hyperglycaemia
Croatian: Često hiperglikemija
English: Other immune-related adverse reactions
Croatian: Druge imunološki posredovane nuspojave
English: Table 2: Adverse reactions in patients treated with avelumab as monotherapy in clinical study EMR100070-003 and adverse reactions from a phase I study (EMR100070-001) in solid tumours
Croatian: EMR100070-003 i nuspojave u ispitivanju faze I (EMR100070-001) kod solidnih tumora
English: Median PFS, months (95% CI) 6-month PFS rate by K-M, (95% CI) 12-month PFS rate by K-M, (95% CI) 24-month PFS rate by K-M, (95% CI) 36-month PFS rate by K-M, (95% CI) CI: Confidence interval; RECIST: Response Evaluation Criteria in Solid Tumours; IERC: Independent Endpoint Review Committee; K-M: Kaplan-Meier; +denotes a censored value * Efficacy data with a minimum follow-up of 36 months (cut-off date 14 September 2018) ** CR or PR was confirmed at a subsequent tumour assessment a Based on number of patients with confirmed response (CR or PR)
Croatian: 6-mjesečna stopa PFS-a prema K-M, (95 % CI) 12-mjesečna stopa PFS-a prema K-M, (95 % CI) 24-mjesečna stopa PFS-a prema K-M, (95 % CI) 36-mjesečna stopa PFS-a prema K-M, (95 % CI) CI: interval pouzdanosti; RECIST: Kriteriji za ocjenu odgovora kod solidnih tumora (engl.
English: Avelumab should be withheld for Grade 3 or Grade 4 endocrinopathies until resolution (see section 4.2).
Croatian: Kod endokrinopatija 3. ili 4. stupnja potrebno je privremeno obustaviti primjenu avelumaba do njihovog povlačenja (vidjeti dio 4.2).
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related adrenal insufficiency.
Croatian: Od tih je bolesnika njih 2 (0,4 %) imalo imunološki posredovanu adrenalnu insuficijenciju 3. stupnja.
English: In patients treated with avelumab as monotherapy, 1.5% (26/1,738) of patients developed immune-related colitis.
Croatian: Imunološki posredovan kolitis U bolesnika liječenih avelumabom kao monoterapijom, 1,5 % (26/1738) bolesnika razvilo je imunološki posredovan kolitis.
English: The Patient Information brochure shall contain the following key messages:
Croatian: Brošura s informacijama za bolesnika sadržavat će sljedeće ključne poruke: • Kratak uvod u brošuru i njezinu svrhu
English: • Loose stools, nausea, constipation, vomiting
Croatian: • mekane stolice, mučnina, zatvor, povraćanje
English: Avelumab was discontinued in 0.4% (2/489) of patients due to immune-related colitis.
Croatian: Primjena avelumaba prekinuta je zbog imunološki posredovanog kolitisa u 0,4 % (2/489) bolesnika.
English: Immune-related colitis Immune-related colitis has been reported in patients receiving avelumab (see section 4.8).
Croatian: U bolesnika koji primaju avelumab zabilježen je imunološki posredovan kolitis (vidjeti dio 4.8).
English: • Muscle pain
Croatian: Memorial Sloan
English: In both studies, avelumab was administered at 10 mg/kg every 2 weeks.
Croatian: 10 mg/kg avelumaba svaka 2 tjedna.
English: Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related hepatitis.
Croatian: Primjena avelumaba prekinuta je zbog imunološki posredovanog hepatitisa u 0,5 % (9/1738) bolesnika.
English: 12-month PFS rate by K-M, (95% CI)** 52.4% (47.4, 57.2) 18-month PFS rate by K-M, (95% CI)** 43.9% (38.8, 49.0)
Croatian: Sunitinib: (N=444, događaja=258, medijan=8,0 mjeseci, 95% CI (6,7; 9,8.))
English: Fatigue, pyrexia, oedema peripheral
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često umor, pireksija, periferni edem
English: An updated RMP should be submitted:
Croatian: MSKCC prognostički kriteriji:
English: Fatigue has been reported following administration of avelumab (see section 4.8).
Croatian: Nakon primjene avelumaba zabilježen je umor (vidjeti dio 4.8).
English: PD-L1 expression at cut-off of 1%
Croatian: Smatra se da je put PD-1/PD-L1
English: Immune-related pancreatitis has been reported in patients receiving avelumab.
Croatian: U bolesnika koji primaju avelumab zabilježen je imunološki posredovan pankreatitis.
English: Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related adrenal insufficiency.
Croatian: Primjena avelumaba prekinuta je zbog imunološki posredovane adrenalne insuficijencije u 0,1 % (2/1738) bolesnika.
English: Objective response rate (ORR) n (%) (95% CI)
Croatian: Stopa odgovora CR+PR** n (%) (95 % CI)
English: Of these patients, there were 2 (0.4%) patients with Grade 3 immune-related nephritis.
Croatian: Od tih je bolesnika njih 2 (0,4 %) imalo imunološki posredovan nefritis 3. stupnja.
English: Hypotension, flushing
Croatian: Često hipotenzija, navale crvenila
English: Avelumab should be withheld and antihyperglycaemics in patients with Grade ≥ 3 hyperglycaemia should be administered.
Croatian: ≥ 3. stupnja treba privremeno obustaviti primjenu avelumaba i primijeniti antihiperglikemike.
English: Immune-related myocarditis has been reported in patients receiving avelumab.
Croatian: U bolesnika koji primaju avelumab zabilježen je imunološki posredovan miokarditis.
English: • Signs of liver problems, including inflammation of the liver (hepatitis) may include yellowing of your skin (jaundice) or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea coloured), bleeding or bruising more easily than normal, feeling less hungry than usual, tiredness or abnormal liver function tests.
Croatian: • Znakovi problema s jetrom, uključujući upalu jetre (hepatitis), mogu uključivati žutu boju kože (žuticu) ili bjeloočnica, jaku mučninu ili povraćanje, bol na desnoj strani trbuha
English: The following side effects have been reported in clinical trials with avelumab in combination with axitinib:
Croatian: Sljedeće nuspojave zabilježene su u kliničkim ispitivanjima avelumaba u kombinaciji s aksitinibom: Vrlo često (mogu se javiti u više od 1 na 10 osoba)
English: Immune-related pneumonitis occurred in patients treated with avelumab.
Croatian: U bolesnika liječenih avelumabom javljao se imunološki posredovan pneumonitis.
English: The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy.
Croatian: uključen u održavanje tolerancije na fetus tijekom trajanja trudnoće.
English: This is very common for thyroid gland, common for adrenal glands, and uncommon for pituitary gland.
Croatian: Ovo je vrlo često kod upale štitne žlijezde, često kod upale nadbubrežne žlijezde i manje često kod upale hipofize.
English: Product-Limit Survival Estimate (N=116)
Croatian: Procjena preživljenja Kaplan-Meierovom metodom (N=116)
English: Grade 2 or Grade 3 colitis or diarrhoea Withhold until adverse reactions recover to
Croatian: Kod nefritisa 2. ili 3. stupnja treba privremeno obustaviti primjenu avelumaba do njegovog povlačenja na
English: Avelumab was discontinued in 0.1% (2/1,738) of patients due to immune-related thyroid disorders.
Croatian: Primjena avelumaba prekinuta je zbog imunološki posredovanih poremećaja štitne žlijezde u 0,1 % (2/1738) bolesnika.
English: Corticosteroids should be administered for immune-related pancreatitis (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper).
Croatian: Kod imunološki posredovanog pankreatitisa potrebno je primijeniti kortikosteroide (početnu dozu prednizona od 1 do 2 mg/kg na dan ili ekvivalentni lijek te nakon toga postupno snižavati dozu kortikosteroida).
English: Positive (n=58) Negative (n=16)
Croatian: Ekspresija PD-L1 uz graničnu vrijednost od 1 % N=74a pozitivna (n=58) negativna (n=16)
English: The median time to onset of thyroid disorders was 2.8 months (range: 2 weeks to 13 months).
Croatian: Medijan vremena do nastupa poremećaja štitne žlijezde iznosio je 2,8 mjeseci (raspon: od 2 tjedna do
English: Immune-related hepatitis occurred in patients treated with avelumab.
Croatian: U bolesnika liječenih avelumabom javljao se imunološki posredovan hepatitis.
English: Colitis*, autoimmune colitis*, enterocolitis*, ileus
Croatian: Manje često kolitis*, autoimuni kolitis*, enterokolitis*, ileus Rijetko pankreatitis*
English: Avelumab was discontinued in 0.5% (9/1,738) of patients due to immune-related colitis.
Croatian: Primjena avelumaba prekinuta je zbog imunološki posredovanog kolitisa u 0,5 % (9/1738) bolesnika.
English: Infusion-related reactions Grade 1 infusion-related reaction
Croatian: Reakcija 1. stupnja povezana s infuzijom Smanjiti brzinu infuzije za
English: Common
Croatian: Independent
English: Adverse reactions Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava Često anemija, trombocitopenija
English: Of these patients, there were 3 (0.2%) patients with Grade 3 immune-related thyroid disorders.
Croatian: Od tih je bolesnika njih 3 (0,2 %) imalo imunološki posredovane poremećaje štitne žlijezde 3. stupnja.
English: • Increased pancreatic enzymes in the blood
Croatian: • povišeni enzimi gušterače u krvi
English: bumpy rash or skin wheals, flushing, low blood pressure (dizziness, fatigue, nausea) fever,
Croatian: zimica ili drhtavica, izdignuti osip ili koprivnjača, navale crvenila, nizak krvni tlak (omaglica, umor, mučnina), vrućica, bol u leđima i bol u trbuhu.
English: Guillain-Barré Syndrome*
Croatian: uveitis i Guillain-Barreov sindrom o reakcije povezane s infuzijom
English: Avelumab should be withheld in the event of suspected immune-related pancreatitis.
Croatian: Kod sumnje na imunološki posredovan pankreatitis potrebno je privremeno obustaviti primjenu avelumaba.
English: Mannitol
Croatian: Bavencio.
English: Grade 3 or Grade 4 endocrinopathies Withhold until adverse reactions recover to
Croatian: Endokrinopatije 3. ili 4. stupnja
English: Glacial acetic acid Polysorbate 20
Croatian: 6.1 Popis pomoćnih tvari manitol ledena acetatna kiselina polisorbat 20 natrijev hidroksid voda za injekcije
English: Rare
Croatian: Blinded
English: Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a corticosteroid taper).
Croatian: Kod događaja ≥ 2. stupnja potrebno je primijeniti kortikosteroide (početnu dozu prednizona od 1 do 2 mg/kg na dan ili ekvivalentni lijek te nakon toga postupno snižavanje doze kortikosteroida).
English: Myalgia
Croatian: Nuspojave
English: Adverse reactions Respiratory, thoracic and mediastinal disorders
Croatian: Imunološki posredovan nefritis i poremećaj funkcije bubrega
English: Positive (n=19) Negative (n=55)
Croatian: Ekspresija PD-L1 uz graničnu vrijednost od 5 % N=74a pozitivna (n=19) negativna (n=55)
English: Hazard ratio (95% CI) p-value*
Croatian: medijan u mjesecima (95% CI) omjer hazarda (95% CI) p-vrijednost*
English: Diabetes mellitus, Type 1 diabetes mellitus
Croatian: PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Lymphopenia
Croatian: Kolitis
English: Of the 88 patients, 65 (74%) were male, the median age was 73 years (range 33 years to 88 years), 81 (92%) patients were Caucasian, and 49 (56%) patients and 39 (44%) patients with an Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1, respectively.
Croatian: 33 godine do 88 godina), 81 (92 %) bolesnik bio je bijelac, a ocjena općeg stanja prema ljestvici Istočne kooperativne onkološke skupine (engl.
English: Thrombocytopenia, eosinophilia§
Croatian: Često limfopenija Manje često trombocitopenija, eozinofilija§
English: In most cases you will need a doctor.
Croatian: U većini slučajeva ćete trebati pomoć liječnika.
English: Open here
Croatian: Otvoriti ovdje
English: • At the request of the European Medicines Agency
Croatian: • Na zahtjev Europske agencije za lijekove;
English: Change the needle and try again.
Croatian: Promijenite iglu i pokušajte ponovno.
English: No evidence of toxic effects was found.
Croatian: Nisu pronađeni dokazi toksičnih učinaka.
English: Always carry some sugar (at least 20 grams) with you.
Croatian: Uvijek sa sobom nosite malo šećera (barem 20 grama).
English: • Severe allergic reaction with low blood pressure (shock)
Croatian: • teška alergijska reakcija praćena niskim krvnim tlakom (šok)
English: Be careful when you start or stop taking another medicine.
Croatian: Budite oprezni kada započinjete ili prestajete uzimati neki drugi lijek.
English: This helps prevent:
Croatian: Tako ćete spriječiti:
English: It should be handled with care.
Croatian: Njime treba rukovati oprezno.
English: • This pen is only for your use.
Croatian: • Ova brizgalica je samo za Vašu uporabu.
English: Inform your doctor if you are planning to become pregnant, or if you are already pregnant.
Croatian: Obavijestite svog liječnika ako planirate trudnoću ili ste već trudni.
English: This leaflet was last revised in {date}
Croatian: Ova uputa je zadnji puta revidirana u {datum}
English: Special populations Elderly population (≧65 years old)
Croatian: Stariji bolesnici (≧ 65 godina)
English: Always tell people who are caring for you or treating you that you require insulin.
Croatian: Uvijek recite osobama koje skrbe o Vama ili Vas liječe da Vam je potreban inzulin.
English: Illnesses and injuries
Croatian: Bolesti i ozljede
English: These symptoms often develop before the symptoms of a low sugar level in the brain.
Croatian: Ovi simptomi obično se razvijaju prije simptoma niske razine šećera u mozgu.
English: Other source of information
Croatian: Drugi izvori informacija
English: If the hypoglycaemia comes back again take another 10 to 20 g sugar.
Croatian: Ako se hipoglikemija ponovno javi, opet uzmite 10 do 20 g šećera.
English: Slowly count to 10 before you withdraw the needle from the skin.
Croatian: Polako brojite do 10 prije nego iglu izvučete iz kože.
English: - In your body
Croatian: U tijelu
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
English: For these reasons, it must be done in a clinic or a similar setting.
Croatian: Zbog toga se mora provoditi u klinici ili sličnom okruženju.
English: This is because the insulin may have lost some of its effectiveness.
Croatian: To je zbog toga što je inzulin možda izgubio na učinkovitosti.
English: These injections are justified even if it is not certain that you have hypoglycaemia.
Croatian: Te su injekcije opravdane i onda kad nije sigurno da imate hipoglikemiju.
English: Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Croatian: Neki lijekovi uzrokuju promjene u razini šećera u krvi (smanjenje, povišenje ili oboje, ovisno o situaciji).
English: Do not use this SoloStar.
Croatian: Nemojte koristiti taj SoloStar.
English: • Skin and allergic reactions
Croatian: • kožne i alergijske reakcije
English: The basal metabolic requirement is 40% to 60% of the total daily requirement.
Croatian: Bazalna metabolička potreba iznosi 40% do 60% ukupne dnevne potrebe.
English: Do not share it with anyone else.
Croatian: Nemojte je dijeliti s drugim osobama.
English: The dose can then be selected.
Croatian: Tada se može odabrati doza.
English: Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Croatian: Općenito, što je veći i brži pad razine glukoze u krvi, to je izraženiji fenomen proturegulacije i njegovi simptomi.
English: Instructions for Use.
Croatian: Upute za uporabu.
English: 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 uzimali ili biste mogli uzeti bilo koje druge lijekove.
English: The insulin requirement is often increased.
Croatian: Potreba za inzulinom često je povećana.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: • Contamination and/or infection
Croatian: • onečišćenje i/ili infekciju
English: Carry some information with you to show you are diabetic.
Croatian: Nosite sa sobom neku informaciju o tome da ste dijabetičar.
English: To prevent the possible transmission of disease, each pen must be used by one patient only.
Croatian: Kako bi se spriječio mogući prijenos bolesti, istu brizgalicu smije koristiti samo jedan bolesnik.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Croatian: To može predstavljati rizik u situacijama u kojima su takve sposobnosti posebno važne (primjerice, upravljanje vozilom ili rukovanje strojevima).
English: Your blood sugar levels may either rise or fall if you drink alcohol.
Croatian: Razina šećera u krvi može porasti ili pasti ako pijete alkohol.
English: Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.
Croatian: Odmah razgovarajte s liječnikom ako niste u stanju kontrolirati hipoglikemiju ili ako se ona ponavlja.
English: Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta).
Croatian: Zatim pojedite neki obrok koji ima dugotrajno djelovanje na povišenje razine šećera u krvi (primjerice kruh ili tjesteninu).
English: • If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
Croatian: • Ako inzulin ne izlazi, pogledajte ima li mjehurića zraka i ponovite test sigurnosti još dva puta da biste ih uklonili.
English: Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
Croatian: Potrebe za inzulinom mogu se smanjiti tijekom prvog tromjesečja, a u pravilu se povećavaju u drugom i trećem tromjesečju trudnoće.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: It should be considered whether it is advisable to drive or use machines in these circumstances.
Croatian: Treba razmotriti je li preporučljivo u takvim okolnostima upravljati vozilom ili rukovati strojevima.