FrancophonIA/ELRC3.0 huggingface dataset:
English: • Acute retinopathies of vascular origin
Croatian: • Akutne retinopatije vaskularnog podrijetla
English: A scientific advisory group (SAG) was convened in December 2012 at the request of the CHMP during which the experts discussed, based on their clinical experience, whether this substance plays a role in the symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Croatian: Znanstvena savjetodavna skupina (SAG) sazvana je u prosincu 2012. godine na zahtjev CHMP-a tijekom kojeg su stručnjaci na temelju svog kliničkog iskustva raspravljali igra li tvar ulogu u simptomatskom liječenju kroničnog patološkog, kognitivnog i neurosenzorskog oštećenja u starijih (isključujuči Alzheimerovu bolest i druge vrste demencija).
English: For the indication “ancillary treatment of Raynaud's syndrome”, all the studies submitted in support of this indication were considered by the CHMP of poor methodological quality (i.e. uncontrolled, open designed, with a low number of patients (n=20-37)).
Croatian: Za indikaciju „pomoćno liječenje Raynaudova sindroma”, sva ispitivanja predana kao potpora ovoj indikaciji smatrana se od strane CHMP-a loše kvalitete metodologije (tj. nisu bila kontrolirana, nisu bila slijepog dizajna te je broj bolesnika bio mali (n=20-37)).
English: Dihydroergocryptine is an ergot alkaloid that has an agonist activity on D2 dopaminergic receptors and a partial agonist activity on D1 receptors.
Croatian: • Simptomatsko liječenje venolimfatičke insuficijencije Dihidroergokriptin je alkaloid ergota koje ima agonističku aktivnost na D2 dopaminergičke receptore i parcijalnu agonističku aktivnost na D1 receptorima.
English: Agonism to 5-HT2B receptors induces a proliferative response and mitogenicity of the cells expressing this receptor leading to fibrogenesis.
Croatian: Agonizam na receptore 5-HT2Binducira proliferativni odgovor i mitogeničnost stanica koje eksprimiraju ovaj receptor što uzrokuje fibrogenezu.
English: These included changing the prescription status, limiting treatment duration in certain conditions, contraindicating the product in patients with pre-existing fibrosis or in association with other drugs, the issuing of a DHPC highlighting the risk, a checklist for prescribers, and a pharmacological in vitro study for 5-HT subclass receptors affinity to the product.
Croatian: Oni uključuju ograničeno trajanje liječenja u određenim uvjetima, što čini lijek kontradiktornim u bolesnika s prethodnom fibrozom ili u vezi s drugim lijekovima, izdavanje DHPC-a koje je istaknulo rizik, lista provjere za propisivače te farmakološka i in vitro ispitivanja afiniteta lijeka prema podklasi receptora 5-HT.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations or suspension of the marketing authorisations, as applicable, taking into consideration the approved indications for each product
Croatian: Prilog II Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje u promet lijeka ili suspenziju odobrenja uzimajući u obzir odobrene indikacije za svaki lijek
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Croatian: • Pomoćno liječenje smanjenje oštrine vida i poremećaja vidnog polja prvenstveno vaskularnog podrijetla.
English: Overall summary of the scientific evaluation of dihydroergocryptine/caffeine containing medicinal products (see Annex I)
Croatian: Ukupni sažetak znanstvene procjene lijekova koji sadrže dihidroergokriptin/kofein (vidjeti Prilog I).
English: • The Committee considered that the benefit-risk balance of dihydroergocryptine/caffeine containing products: Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Croatian: • Povjerenstvo je smatralo da omjer dobrobiti i rizika lijekova koji sadrže dihidroergokriptin/kofein: Nije povoljan za simptomatsko liječenje kroničnog patološkog, kognitivnog i neurosenzorskog oštećenja u starijih osoba (isključujući Alzheimerovu bolest i druge demencije).
English: Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Croatian: • Simptomatsko liječenje kroničnog patološkog kognitivnog poremećaja i neurosenzornog poremećaja u starijih (isključujući Alzheimerovu bolest i druge demencije)
English: Therefore, even if it is highly pharmacologically plausible that ergot derivatives acting as 5HT2B receptor agonists may induce "serotonergic" valve disease similar to that induced by carcinoid tumours or fibrotic lesions of other tissues, it must be remembered that some ergot derivatives are not 5-HT2B receptor agonists.
Croatian: Ukupno gledano, promjenjivi afinitet za serotoninergične receptore s različitim derivatima ergota i korištenim terapijskim dozama može objasniti razlike uočene za stupnjeve notifikacije za fibrotičke reakcije Stoga čak i ako je uvelike farmakološki vjerojatno da derivati ergota koji djeluju kao agonisti receptora 5-HT2B mogu potaknuti „serotoninergičnu” bolest zalistaka sličnu onoj izazvanoj karcinoidnim tumorima ili fibrotičkim lezijama drugih tkiva, ne smije se zaboraviti da neki derivati ergota nisu agonisti receptora 5-HT2B.
English: • The variation to the terms of the marketing authorisation for dihydroergocryptine/caffeine containing medicinal products referred to in Annex I, to delete the below indications from the Product Information (specific wording of the indication may vary from product to product and country to country) as well as any relevant reference to these indications in the Product Information, when there are other therapeutic indications approved as part of their marketing authorisation:
Croatian: • Izmjenu odobrenja za stavljanje u promet lijekova koji sadrže dihidroergokriptin/kofein koji su navedeni u Prilogu I. kako bi se izbrisale u nastavku navedene indikacije iz Informacija o lijeku (specifične riječi mogu varirati od lijeka do lijeka i od zemlje do zemlje) kao i bilo koje relevantne reference za ove indikacije u Informacijama o lijeku kada postoje druge terapijske indikacije odobrene kao dio njihova odobrenja za stavljanje lijeka u promet: Simptomatsko liječenje kroničnog patološkog kognitivnog poremećaja i neurosenzornog poremećaja u starijih (isključujući Alzheimerovu bolest i druge demencije) Pomoćno liječenje Raynaudovog sindroma.
English: • Symptomatic treatment of veno-lymphatic insufficiency
Croatian: • Pomoćno liječenje Raynaudovog sindroma
English: Date of first authorisation: 22 November 2018
Croatian: Datum prvog odobrenja: 22 studenog 2018
English: Always use Ziextenzo exactly as your doctor has told you.
Croatian: Uvijek primijenite lijek Ziextenzo točno onako kako Vam je rekao liječnik.
English: What Ziextenzo is and what it is used for
Croatian: Što je Ziextenzo i za što se koristi
English: • The recommended site is the front of your thighs.
Croatian: • Preporučeno mjesto je prednja strana bedara.
English: For more information, see section 5.1
Croatian: Za više informacija vidjeti dio 5.1
English: When you are ready to use the pre-filled syringe, open the blister and wash your hands thoroughly with soap and water.
Croatian: Kada ste spremni upotrijebiti napunjenu štrcaljku, otvorite blister i temeljito operite ruke sapunom i vodom.
English: Stop using Ziextenzo and seek medical attention immediately if you notice any of the symptoms described in section 4.
Croatian: Prestanite s primjenom lijeka Ziextenzo i odmah potražite medicinsku pomoć ako primijetite bilo koji od simptoma opisanih u dijelu 4.
English: To help avoid possible infections and to ensure that you use the medicine correctly, it is important that you follow these instructions.
Croatian: Radi izbjegavanja mogućih infekcija te radi ispravne primjene lijeka važno je da slijedite ove upute.
English: Contents of the pack and other information What Ziextenzo contains
Croatian: Sadržaj pakiranja i druge informacije Što Ziextenzo sadrži
English: Be careful not to touch the needle guard wings before use.
Croatian: Pazite da ne dodirnete krila štitnika za iglu prije uporabe.
English: • if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na pegfilgrastim, filgrastim ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: What you additionally need for your injection:
Croatian: Dodatni pribor potreban za primjenu injekcije:
English: Your doctor may decide that it would be more convenient for you to inject Ziextenzo yourself.
Croatian: Vaš liječnik može odlučiti da će Vama biti pogodnije ako si sami injicirate lijek Ziextenzo.
English: If you use more Ziextenzo than you should
Croatian: Ako primijenite više lijeka Ziextenzo nego što biste trebali
English: Other medicines and Ziextenzo
Croatian: Drugi lijekovi i Ziextenzo
English: What Ziextenzo looks like and contents of the pack
Croatian: Kako Ziextenzo izgleda i sadržaj pakiranja
English: Device ACTIVATED - DO NOT USE
Croatian: Uređaj je AKTIVIRAN - NE
English: Healthcare providers only
Croatian: Samo za zdravstvene radnike
English: If you become pregnant during Ziextenzo treatment, please inform your doctor.
Croatian: Ukoliko zatrudnite tijekom primjene lijeka Ziextenzo, molimo obavijestite liječnika.
English: Ziextenzo may be used if it is accidentally frozen for a single period of less than 24 hours.
Croatian: Ziextenzo se može upotrijebiti ako je bio slučajno zamrznut u jednokratnom razdoblju kraćem od 24 sata.
English: If it has expired, return the entire pack to the pharmacy.
Croatian: Ako je rok valjanosti istekao, vratite cijelo pakiranje u ljekarnu.
English: Ziextenzo is for use in adults aged 18 and over.
Croatian: Ziextenzo se primjenjuje u odraslih osoba starijih od 18 godina.
English: Stop using Ziextenzo if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite koristiti lijek Ziextenzo ako razvijete ove simptome i obratite se liječniku ili odmah potražite medicinsku pomoć.
English: • Do not inject into areas where the skin is tender, bruised, red, scaly or hard.
Croatian: • Ne primjenjujte injekciju na područjima gdje je koža osjetljiva, s modricom, crvena, ljuskava ili tvrda.
English: By touching them, the needle guard may be activated too early.
Croatian: Ako ih dodirnete, štitnik za iglu se može prerano aktivirati.
English: Kolodvorska Cesta 27 1234 Menges Slovenia
Croatian: LEK Pharmaceuticals d.d. Kolodvorska Cesta 27 1234 Menges Slovenija
English: Your doctor will check your blood and urine regularly as pegfilgrastim can harm the tiny filters inside your kidneys (glomerulonephritis).
Croatian: Vaš će liječnik redovito provjeravati Vašu krv i mokraću jer pegfilgrastim može oštetiti sitne filtere unutar Vaših bubrega (glomerulonefritis).
English: Talk to your doctor, pharmacist or nurse before using Ziextenzo:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije primjene lijeka Ziextenzo:
English: Ziextenzo left at room temperature for more than 120 hours should be discarded.
Croatian: Ziextenzo ostavljen na sobnoj temperaturi dulje od 120 sata se mora ukloniti.
English: This can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Croatian: To može biti znak akutnog respiratornog distres sindroma odraslih (ARDS).
English: Do not use if the syringe is broken or activated.
Croatian: Ne upotrebljavajte štrcaljku ako je oštećena ili aktivirana.
English: Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.
Croatian: Držite klip potisnutim u krajnjem položaju dok zadržavate štrcaljku na mjestu tijekom sljedećih 5 sekundi.
English: Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Ziextenzo.
Croatian: Slučajno jednokratno izlaganje temperaturama zamrzavanja u razdoblju kraćem od 24 sata ne utječe nepovoljno na stabilnost lijeka Ziextenzo.
English: The liquid should be clear.
Croatian: Tekućina bi trebala biti prozirna.
English: Holding the pre-filled syringe as shown, slowly depress the plunger as far as it will go so that the plunger head is completely between the needle guard wings.
Croatian: Držeći napunjenu štrcaljku kako je prikazano, polako potiskujte klip do kraja, tako da se glava klipa u potpunosti smjesti između krila štitnika za iglu.
English: Important: Read the package leaflet before handling the pre-filled syringe.
Croatian: Važno: pročitajte uputu o lijeku prije rukovanja napunjenom štrcaljkom.
English: Do not open the carton until you are ready to use the pre-filled syringe.
Croatian: Ne otvarajte pakiranje prije nego što ste spremni za upotrebu napunjene štrcaljke.
English: Do not shake Ziextenzo vigorously as this may affect its activity.
Croatian: Ne tresite snažno lijek Ziextenzo jer to može utjecati na njegovu aktivnost.
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/L) have been reported (see section 4.4).
Croatian: Prijavljeni su česti slučajevi leukocitoze (broj leukocita > 100 x 109/L) (vidjeti dio 4.4).
English: You may see a small air bubble in the liquid.
Croatian: Možda ćete u tekućini vidjeti maleni mjehurić zraka.
English: If you are injecting yourself and have forgotten a dose of Ziextenzo, you should contact your doctor to discuss when you should inject the next dose.
Croatian: Ako sami injicirate i zaboravili ste si dati svoju dozu lijeka Ziextenzo, upitajte liječnika kada biste trebali injicirati sljedeću dozu.
English: After the medicine has been injected, the needle guard will be activated to cover the needle.
Croatian: Nakon ubrizgavanja lijeka aktivirat će se štitnik za iglu, koji će pokriti iglu.
English: If you forget to inject Ziextenzo
Croatian: Ako ste zaboravili injicirati lijek Ziextenzo
English: There may be a small amount of blood at the injection site.
Croatian: Na mjestu injiciranja može se pojaviti malena količina krvi.
English: Pegfilgrastim has not been tested in pregnant women.
Croatian: Pegfilgrastim nije ispitivan u trudnica.
English: Ziextenzo is a biosimilar medicinal product.
Croatian: Ziextenzo je biosličan lijek.
English: The needle guard is intended to protect healthcare professionals, caregivers and patients from accidental needle sticks after the injection.
Croatian: Štitnik za iglu namijenjen je zaštiti zdravstvenih radnika, njegovatelja i bolesnika od slučajnog ubadanja iglom nakon injiciranja.
English: It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.
Croatian: Važno je da ne pokušavate sami sebi dati injekciju ako niste prošli obuku kod svojeg liječnika, medicinske sestre ili ljekarnika.
English: Do not remove the needle cap until just before you give the injection.
Croatian: Ne skidajte kapicu za iglu sve do trenutka neposredno prije primjene injekcije.
English: Device READY TO BE USED
Croatian: Uređaj SPREMAN ZA UPORABU
English: If you develop or are likely to develop cancers of the blood, you should not use Ziextenzo, unless instructed by your doctor.
Croatian: Ukoliko imate ili postoji neposredna opasnost od razvoja oblika raka krvi, ne biste trebali primjenjivati Ziextenzo, osim u slučaju da je to savjet Vašeg liječnika.
English: Take the carton containing the blistered pre-filled syringe out of the refrigerator and leave it unopened for approximately 15-30 minutes so that it reaches room temperature.
Croatian: Izvadite pakiranje s napunjenom štrcaljkom u blisteru iz hladnjaka i ostavite ga neotvorenim približno 15-30 minuta kako bi doseglo sobnu temperaturu.
English: The injection site is the place on the body where you are going to use the pre-filled syringe.
Croatian: Mjesto injiciranja je mjesto na tijelu na kojemu ćete injicirati napunjenu štrcaljku.
English: You may cover the injection site with a small adhesive bandage, if needed.
Croatian: Mjesto injiciranja možete po potrebi prekriti malenim flasterom.
English: If leukocyte counts exceed 50 x 109/L after the expected nadir, this medicine should be discontinued immediately.
Croatian: Ako broj leukocita nakon očekivane najniže vrijednosti prelazi 50 x 109/L, liječenje ovim lijekom treba odmah prekinuti.
English: Clean the injection site with an alcohol swab.
Croatian: Očistite mjesto injiciranja alkoholnim jastučićem.
English: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1% of patients receiving pegfilgrastim.
Croatian: Broj leukocita od 100 x 109/L ili više primijećen je u manje od 1% bolesnika koji su primali pegfilgrastim.
English: Consistent with a self-regulating clearance mechanism, the serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see Figure 1).
Croatian: U skladu sa samoregulirajućim mehanizmom klirensa, koncentracija pegfilgrastima u serumu brzo opada s početkom oporavka neutrofila (vidjeti sliku 1).
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Ziextenzo.
Croatian: Prijavljene su teške kožne reakcije (Stevens-Johnsonov sindrom) povezane s primjenom lijeka
English: Keep the plunger fully depressed while you carefully pull the needle straight out from the injection site and let it go off your skin.
Croatian: Držite klip potisnutim do kraja dok pažljivo i ravno izvlačite iglu iz mjesta injiciranja, te potom otpustite nabor kože.
English: Your doctor has given you Ziextenzo to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Croatian: Liječnik Vam je propisao lijek Ziextenzo za poticanje funkcije koštane srži (dio kosti koji stvara krvne stanice) kako bi stvorila više bijelih krvnih stanica za borbu tijela protiv infekcija.
English: If the transparent needle guard is covering the needle cap (as shown below) the syringe has been activated, DO NOT use this syringe and take a new syringe.
Croatian: Ako prozirni štitnik za iglu pokriva kapicu za iglu (kako prikazuje slika ispod ili u nastavku), štrcaljka je već aktivirana; NE UPOTREBLJVAJTE tu štrcaljku, nego uzmite novu štrcaljku.
English: Inspect the pre-filled syringe.
Croatian: Pregledajte napunjenu štrcaljku.
English: Slowly release the plunger and allow the syringe needle guard to automatically cover the exposed needle.
Croatian: Polako otpustite klip i sačekajte da štitnik za iglu automatski prekrije izloženu iglu.
English: This may be a sign of a problem with your spleen (splenomegaly).
Croatian: To može biti znak problema sa slezenom (povećanje slezene).
English: You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds.
Croatian: Mjesto injiciranja možete pritisnuti kuglicom vate ili gazom, te zadržati na mjestu tijekom 10 sekundi.
English: Gently pinch the skin at the injection site and insert the needle as shown.
Croatian: Nježno uhvatite nabor kože na mjestu injiciranja i umetnite iglu kako je prikazano.
English: In this configuration the needle guard is NOT ACTIVATED and the pre-filled syringe is ready for use
Croatian: Štitnik za iglu u ovom položaju NIJE AKTIVIRAN i napunjena je štrcaljka spremna za uporabu
English: For further instructions on how to inject yourself with Ziextenzo, please read the section at the end of this leaflet.
Croatian: Dodatne upute o tome kako samostalno injicirati lijek Ziextenzo potražite na kraju ove upute o lijeku.
English: Ziextenzo has no or negligible effect on the ability to drive or use machines.
Croatian: Ziextenzo ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Store in the refrigerator between 2 °C and 8 °C.
Croatian: Čuvati u hladnjaku na temperaturi između 2 °C i 8 °C.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER
English: See section 2 “Ziextenzo contains sorbitol (E420) and sodium”.
Croatian: Vidjeti dio 2, „Ziextenzo sadrži sorbitol (E420) i natrij“.
English: You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
Croatian: Primjena je također moguća na donji dio trbuha, ali ne na područje unutar 5 centimetara od pupka.
English: Prior to use‚ remove the pre-filled syringe from the refrigerator and allow Ziextenzo to reach room temperature (up to a maximum of 35 °C) for approximately 15-30 minutes.
Croatian: Prije uporabe izvadite napunjenu štrcaljku iz hladnjaka i pričekajte da lijek Ziextenzo dosegne sobnu temperaturu (do najviše 35 °C), približno 15-30 minuta.
English: The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or healthy donors have not been adequately evaluated.
Croatian: Sigurnost i djelotvornost pegfilgrastima u mobilizaciji krvotvornih matičnih stanica u bolesnika ili zdravih davatelja nisu odgovarajuće ispitane.
English: • Alcohol swab.
Croatian: • Alkoholni jastučić.
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Croatian: Treba uzeti u obzir aditivni učinak istodobno primijenjenih lijekova koji sadrže sorbitol (ili fruktozu) te unos sorbitola
English: Check to ensure the plastic transparent needle guard is situated over the barrel of the glass syringe.
Croatian: Provjerite je li prozirni plastični štitnik za iglu smješten preko spremnika staklene štrcaljke.
English: Dispose of the used syringe in a sharps container (closable, puncture resistant container).
Croatian: Upotrijebljenu štrcaljku odložite u spremnik za oštre predmete (spremnik koji se može zatvoriti, sa stjenkama otpornim na ubod).
English: Do not use the pre-filled syringe if the seal of the blister is broken, as it may not be safe for you to use.
Croatian: Ne upotrebljavajte napunjenu štrcaljku ako je blister oštećen i propušta zrak jer uporaba u tom slučaju možda nije sigurna.
English: versus 17%, p < 0.001).
Croatian: p < 0,001).
English: • if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration).
Croatian: • ako ste nedavno imali ozbiljniju infekciju pluća (upalu pluća), tekućinu u plućima (edem pluća), upalne procese u području pluća (intersticijska bolest pluća) ili neuobičajeni rendgenski nalaz pluća (plućna infiltracija).
English: Ziextenzo therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Croatian: 4.2 Doziranje i način primjene Liječenje lijekom Ziextenzo mora započeti i nadzirati liječnik s iskustvom u onkologiji i/ili hematologiji.
English: Please tell your doctor immediately if you have any of the following or combination of the following side effects:
Croatian: • ako imate znakove jedne od sljedećih ili kombinacije sljedećih nuspojava:
English: Ziextenzo may be exposed to room temperature (not above 35 °C) for a maximum single period of up to 120 hours.
Croatian: Ziextenzo se može izložiti sobnoj temperaturi (ne višoj od 35 °C) jednokratno, tijekom najviše 120 sata.
English: Return the Ziextenzo pre-filled syringe and the package to your pharmacy.
Croatian: Vratite Ziextenzo napunjenu štrcaljku s pakiranjem u ljekarnu.
English: What you need to know before you use Ziextenzo Do not use Ziextenzo
Croatian: Što morate znati prije nego počnete primjenjivati lijek Ziextenzo
English: Once a syringe has been removed from the refrigerator and has reached room temperature (not above 35 °C) it must either be used within 120 hours or disposed of.
Croatian: Kada štrcaljku jednom izvadite iz hladnjaka te ona dosegne sobnu temperaturu (ne višu od 35 °C), mora se upotrijebiti u roku od 120 sata ili baciti.
English: The carton contains the pre-filled syringe individually sealed in a plastic blister.
Croatian: Pakiranje sadrži napunjenu štrcaljku, pojedinačno zapakiranu u plastični blister, zaštićenu od prodora zraka.