FrancophonIA/ELRC3.0 huggingface dataset:
English: It also includes a retrospective observational study to look at any association between exposure to valproate in men and the risk of malformations and developmental disorders including autism in offspring, and an observational study to evaluate and identify the best practice for stopping and switching of valproate treatment.
Croatian: To, nadalje, uključuje retrospektivno opservacijsko ispitivanje kako bi se utvrdila bilo kakva povezanost između izloženosti valproatu u muškaraca i rizika od malformacija i razvojnih poremećaja uključujući autizam u djece te opservacijsko ispitivanje radi procjene i utvrđivanja najbolje prakse za prekid i zamjenu liječenja valproatom.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Croatian: CMDh je regulatorno tijelo za lijekove koje zastupa države članice Europske unije (EU), Island, Lihtenštajn i Norvešku.
English: Because the CMDh position was agreed by majority vote it will now be sent to the European Commission, which will take a final legally binding decision valid across the EU.
Croatian: Budući da je odluka CMDh-a usvojena većinom glasova, poslana je Europskoj komisiji koja je objavila konačnu zakonski obvezujuću odluku koja vrijedi diljem EU-a.
English: This will include surveys of healthcare professionals and patients to assess the reach and effectiveness of the new measures, and use of data from existing registries to further characterise the malformations known as foetal anticonvulsant syndrome in children whose mothers took valproate in pregnancy and how this compares to other anti-epileptic medicines.
Croatian: To će uključivati ankete koje će popunjavati zdravstveni radnici i bolesnici kako bi se ocijenio doseg i učinkovitost ovih novih mjera kao i upotrebu podataka iz postojećih registara kako bi se dodatno utvrdile malformacije poznate kao fetalni antikonvulzivni sindrom u djece čije su majke uzimale valproat u trudnoći te usporedbe s drugim antiepilepticima.
English: • Medicines containing valproate have been available in EU countries for many years to treat epilepsy, bipolar disorder and in some countries migraine.
Croatian: • Lijekovi koji sadržavaju valproat dostupni su u državama EU-a već dugo godina za liječenje epilepsije, bipolarnog poremećaja, a u nekim državama i migrene.
English: Valproate medicines are used to treat epilepsy and bipolar disorder.
Croatian: Lijekovi koji sadržavaju valproat primjenjuju se za liječenje epilepsije i bipolarnog poremećaja.
English: • Valproate medicines are now therefore contraindicated, i.e. must not be used, in girls and women able to have children unless the terms of a special pregnancy prevention programme are followed.
Croatian: • Stoga su lijekovi koji sadržavaju valproat sada kontraindicirani, tj. ne smiju se primjenjivati, u djevojaka i žena koje mogu imati djecu, osim u slučaju kada se slijedi poseban program sprječavanja začeća.
English: The CMDh1 has endorsed new measures to avoid exposure of babies to valproate medicines in the womb, because exposed babies are at high risk of malformations and developmental problems.
Croatian: CMDh1 je, 21. ožujka 2018., odobrio nove mjere za izbjegavanje izloženosti djece u majčinoj utrobi lijekovima koji sadržavaju valproat jer su izložena djeca pod većim rizikom od malformacija i razvojnih problema.
English: • There will be changes to the product information (package leaflet for patients and SmPC for healthcare professionals) to reflect these new conditions and also to the packaging of the medicine, including a visual warning in the form of boxed text which may be accompanied by other elements such as a symbol.
Croatian: • U informacije o lijeku (u uputu o lijeku za bolesnike i u Sažetak opisa svojstava lijeka za zdravstvene radnike) unijet će se promjene kako bi se odrazili ti novi uvjeti kao i na pakiranje lijeka, uključujući vizualno upozorenje u obliku uokvirenog teksta koji može biti popraćen drugim elementima, kao što su znakovi.
English: In addition, there will be a patient alert card attached to the packaging so that pharmacists can go through it with the patient when the medicine is dispensed.
Croatian: Uz to će, uz pakiranje, biti priložena kartica s upozorenjima za bolesnika koju ljekarnik s bolesnikom može pregledati pri isporučivanju lijeka.
English: Valproate-containing medicines have been approved nationally in the EU to treat epilepsy and bipolar disorder and in some countries for prevention of migraine.
Croatian: Lijekovi koji sadržavaju valproat odobreni su na razini država unutar EU-a za liječenje epilepsije i bipolarnog poremećaja, a u nekim državama i za sprječavanje migrene.
English: Companies marketing these medicines are also required to carry out additional studies on the nature and extent of the risks and to monitor valproate use and the long-term effects from affected pregnancies.
Croatian: Tvrtke koje stavljaju te lijekove na tržište također moraju provesti dodatna ispitivanja o prirodi i opsegu rizika te pratiti primjenu valproata i dugoročne učinke povezane s primjenom valproata u trudnoći.
English: As the CMDh position was adopted by majority vote, it will now be sent to the European Commission, which will take an EU-wide legally binding decision.
Croatian: Budući da je CMDh-ovo stajalište usvojeno većinom glasova, ono je poslano Europskoj komisiji, koja je 31. svibnja 2018. objavila odluku koja je zakonski obvezujuća na području cijelog EU-a.
English: The companies that market valproate must carry out further studies to characterise the nature and extent of the risks posed by valproate and monitor ongoing valproate use and the long-term effects from affected pregnancies.
Croatian: Tvrtke koje valproat stavljaju na tržište moraju provesti dodatna ispitivanja s ciljem utvrđivanja prirode i opsega rizika koji valproat predstavlja te moraju pratiti trenutačnu primjenu valproata i dugoročne učinke na temelju primjene lijeka tijekom trudnoća.
English: • In pregnancy, valproate is contraindicated and an alternative treatment should be decided on, with appropriate specialist consultation, for women planning pregnancy; however, there may be a small number of women with epilepsy for whom there is no suitable alternative treatment to valproate and who should be appropriately supported and counselled.
Croatian: • U trudnoći je valproat kontraindiciran te je potrebno, nakon savjetovanja s odgovarajućim specijalistom, odlučiti se za alternativno liječenje za žene koje planiraju trudnoću.
English: The experience in children is limited.
Croatian: Iskustvo u djece je ograničeno.
English: Watch for at least 10 seconds.
Croatian: Motrite je najmanje 10 sekundi.
English: There is no evidence that such an interaction would be harmful.
Croatian: Nema dokaza da bi takva interakcija bila štetna.
English: These symptoms generally develop in a rapid fashion.
Croatian: Ovi simptomi se obično brzo razvijaju.
English: Not working correctly
Croatian: Ne radi ispravno
English: The relevance of these findings for humans is not known.
Croatian: Važnost ovih nalaza za ljude nije poznata.
English: • are planning to have a baby.
Croatian: • ako planirate imati dijete.
English: Step 1: Prepare
Croatian: Korak 1: Priprema
English: • You may hear a series of clicks.
Croatian: • Možda ćete čuti seriju škljocanja.
English: For safety reasons:
Croatian: Zbog sigurnosti:
English: C RELEASE your thumb.
Croatian: C OTPUSTITE palac.
English: Always take Neulasta exactly as your doctor has told you.
Croatian: Uvijek primijenite lijek Neulasta točno onako kako Vam je rekao liječnik.
English: 45 minutes
Croatian: 45 minuta
English: If the dose is complete, go to the next step.
Croatian: Ako je doziranje završeno, prijeđite na sljedeći korak.
English: It may harm them, even if their symptoms of illness are the same as yours.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesi jednaki Vašima.
English: What Neulasta is and what it is used for
Croatian: Što je Neulasta i za što se koristi
English: 0% (empty)
Croatian: 0% (prazno)
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
English: 27 hours
Croatian: 27 sati
English: • nausea and headaches.
Croatian: • mučnina i glavobolje.
English: Latex may be transferred to your skin.
Croatian: Lateks se može prenijeti na Vašu kožu.
English: - This medicine has been prescribed for you only.
Croatian: - Ovaj je lijek propisan Vama.
English: Store in a refrigerator (2°C - 8°C).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: You should talk to your doctor about your risks of developing cancers of the blood.
Croatian: Trebate porazgovarati sa svojim liječnikom o riziku razvoja nekog od oblika raka krvi.
English: • some changes may occur in your blood, but these will be detected by routine blood tests.
Croatian: • moguće su i promjene u krvi, ali one će se otkriti prilikom rutinskih krvnih pretraga.
English: For more information, see section 5.1.
Croatian: Za više informacija vidjeti dio 5.1.
English: Date of first authorisation: 22 August 2002 Date of latest renewal: 16 July 2007
Croatian: Datum posljednje obnove: 16. srpnja 2007.
English: • Any part appears cracked or broken.
Croatian: • Ukoliko bilo koji dio štrcaljke izgleda napuknut ili slomljen.
English: Grab here
Croatian: Uhvatite ovdje
English: Step 2: Get ready A Wash your hands thoroughly.
Croatian: Korak 2: Pripremite se A Temeljito operite ruke.
English: Neulasta has not been tested in pregnant women.
Croatian: Neulasta nije ispitivana u trudnica.
English: • You should see a black line next to the 0% (empty) indicator to confirm you have received a full dose.
Croatian: • Trebate vidjeti crnu liniju indikatora napunjenosti kod 0% (prazno) kako biste potvrdili da ste dobili cijelu dozu.
English: Other medicines and Neulasta
Croatian: Drugi lijekovi i Neulasta
English: Do not reapply it.
Croatian: Ne stavljajte ga ponovno.
English: B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
Croatian: B POGURNITE klip polaganim i postojanim pritiskom dok ne osjetite ili ne čujete „škljoc“.
English: Wash your hands thoroughly.
Croatian: Temeljito operite ruke.
English: Let your skin dry.
Croatian: Pustite da se koža osuši.
English: This means that the delivery is complete.
Croatian: Ovo znači da je doziranje završeno.
English: • when to expect dose delivery to begin
Croatian: • kada očekivati da će primjena doze započeti
English: See also section 4.8.
Croatian: Vidjeti dio 4.8.
English: • Even with a leak, the status light may remain green and the fill indicator may be at 0% (empty).
Croatian: • Čak i uz curenje, svjetlo statusne lampice može ostati zeleno, a indikator punjenja na 0% (prazno).
English: Your doctor or nurse will show you how to inject yourself.
Croatian: Vaš će Vam liječnik ili medicinska sestra pokazati kako ćete si injicirati lijek.
English: • Outer area of upper arm (only if someone else is giving you the injection).
Croatian: • Vanjsko područje nadlaktice (samo ako Vam netko drugi daje injekciju).
English: Puerto Rico 00777-4060 USA
Croatian: Puerto Rico 00777-4060 SAD
English: You should check with your doctor or pharmacist if you are unsure.
Croatian: Provjerite s Vašim liječnikom ili ljekarnikom ako niste sigurni.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Croatian: Kao i kod svih terapijskih proteina, postoji mogućnost izazivanja imunološkog odgovora.
English: • if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine.
Croatian: • ako ste alergični na pegfilgrastim, filgrastim ili neki drugi sastojak ovog lijeka.
English: • Check your status light again.
Croatian: • Ponovno provjerite statusnu lampicu.
English: Electrical equipment
Croatian: Elektronička oprema
English: Median time to recovery from severe neutropenia was estimated as 22 days in both treatment groups.
Croatian: Medijan vremena oporavka od teške neutropenije procijenjen je na 22 dana u obje skupine.
English: Neulasta contains sorbitol.
Croatian: Neulasta sadrži sorbitol.
English: • alcohol wipes or similar.
Croatian: • vatu natopljenu alkoholom ili slično.
English: Wear the on-body injector under your clothing.
Croatian: Nosite on-body injektor ispod Vaše odjeće.
English: Stevens-Johnson syndrome
Croatian: Stevens-Johnsonov sindrom
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Croatian: Zbog toga veličinu slezene treba pažljivo nadzirati (npr. klinički pregled, ultrazvuk).
English: Medication error as a result of device failure
Croatian: Medikacijska pogreška kao rezultat neispravnog uređaja
English: Consider wearing loose clothing and take care when changing clothes.
Croatian: Pokušajte nositi širu odjeću i pažljivo mijenjate odjeću.
English: Stop using Neulasta and seek medical attention immediately if you notice any of the symptoms described in section 4.
Croatian: Prestanite s primjenom lijeka Neulasta i odmah potražite medicinsku pomoć ako primijetite bilo koji od simptoma opisanih u dijelu 4.
English: Do not try to warm the syringe by using a heat source such as hot water or microwave.
Croatian: Ne pokušavajte ugrijati štrcaljku korištenjem izvora topline kao što su vruća voda ili mikrovalovna pećnica.
English: White blood cells are important as they help your body fight infection.
Croatian: Bijele krvne stanice su važne jer pomažu tijelu u borbi protiv infekcija.
English: Before you inject Neulasta you must do the following:
Croatian: Prije injiciranja Neulaste morate učiniti sljedeće:
English: Wash your hands thoroughly with soap and water.
Croatian: Temeljito operite ruke sapunom i vodom.
English: Remove from the refrigerator.
Croatian: Izvadite štrcaljku iz hladnjaka.
English: Before you use a Neulasta pre-filled syringe with automatic needle guard, read this important information:
Croatian: Prije korištenja Neulasta napunjene štrcaljke s automatskim štitnikom za iglu, pročitajte ove važne informacije:
English: • think you may be pregnant; or
Croatian: • ako sumnjate da ste trudni; ili
English: The number of cases is small, but because of the seriousness of the ADR, the PRAC recommends that the Product Information should be updated accordingly.
Croatian: Broj slučajeva je mali, ali zbog ozbiljnosti nuspojave, PRAC preporučuje da se informacije o lijeku odgovarajuće ažuriraju.
English: If there are particles in it, you must not use it.
Croatian: Ako sadrži vidljive čestice, ne smijete je koristiti.
English: The concentration is 10 mg/mL based on protein only**.
Croatian: Koncentracija iznosi 10 mg/ml samo na temelju proteinskog dijela**.
English: The patient alert card shall contain the following key messages:
Croatian: Kartica s upozorenjima za bolesnika treba sadržavati sljedeće ključne informacije:
English: Do not touch the cleaned area of the skin.
Croatian: Ne dirajte očišćeni dio kože.
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factor; ATC Code: L03AA13
Croatian: Farmakoterapijska skupina: imunostimulatori, faktor stimulacije kolonija; ATK oznaka: L03AA13
English: You can now use the pre-filled syringe.
Croatian: Sada možete koristiti napunjenu štrcaljku.
English: 9/L or greater have been observed in less than 1% of patients receiving pegfilgrastim.
Croatian: 9/L ili više primijećen je u manje od 1% bolesnika koji su primali pegfilgrastim.
English: • Avoid activities and places that may interfere with monitoring during the dosing of Neulasta.
Croatian: • Izbjegavajte aktivnosti i mjesta koja mogu ometati praćenje tijekom primanja doze lijeka Neulasta.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: If it is exposed to direct sunlight for more than 1 hour, it may affect your medicine.
Croatian: Izloženost izravnoj sunčevoj svjetlosti dulje od 1 sata može utjecati na Vaš lijek.
English: Get emergency medical help right away.
Croatian: Odmah potražite hitnu medicinsku pomoć.
English: Your doctor may monitor your condition more closely.
Croatian: Vaš liječnik će možda pratiti pobliže Vaše stanje;
English: It is important to tell your doctor if you:
Croatian: Obavezno recite Vašem liječniku:
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Croatian: Vezujuća antitijela pojavljuju se kao što se očekuje kod svih bioloških lijekova, međutim do sada nisu povezana s neutralizirajućom aktivnosti.
English: Avoid vigorous shaking.
Croatian: Izbjegavajte snažno protresanje.
English: Dermatitis contact
Croatian: Kontaktni dermatitis
English: • Only expose the on-body injector to temperatures between 5°C - 40°C.
Croatian: • On-body injektor smije se izlagati temperaturama samo između 5°C - 40°C.
English: If needed, you may cover the injection site with a plaster.
Croatian: Ako je potrebno, možete mjesto injiciranja prekriti flasterom.
English: Apply a plaster if needed.
Croatian: Upotrijebite flaster ako je potrebno.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi trebali uzimati ovaj lijek.
English: Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is similar to that in adults.
Croatian: Ograničeni podaci ukazuju da je farmakokinetika pegfilgrastima u starijih ispitanika (> 65 godina) slična kao i u odraslih.
English: 9/L) have been reported (see section 4.4).
Croatian: 9/l) (vidjeti dio 4.4).
English: Neulasta is for use in adults aged 18 and over.
Croatian: Neulasta se primjenjuje u odraslih osoba starijih od 18 godina.
English: If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Croatian: Ako dođe do ozbiljne alergijske reakcije, treba primijeniti odgovarajuću terapiju te pažljivo pratiti stanje bolesnika kroz nekoliko dana.
English: Long term outcome was not studied (see section 4.4).
Croatian: Dugoročni ishod nije ispitivan (vidjeti dio 4.4).
English: Prepare and clean your injection site.
Croatian: Pripremite i očistite mjesto injiciranja.
English: Do not warm Neulasta in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Ne zagrijavajte lijek Neulasta ni na bilo koji drugi način (primjerice, u mikrovalnoj pećnici ili u vrućoj vodi).
English: This may result in a missed or incomplete dose of Neulasta.
Croatian: Ovo može dovesti do propuštene ili nepotpune doze lijeka Neulasta.
English: Only use each syringe for one injection.
Croatian: Svaku štrcaljku koristite samo za jedno injiciranje.
English: Neulasta is injected subcutaneously via:
Croatian: Neulasta se injicira supkutano putem:
English: • are pregnant;
Croatian: • ako ste trudni;
English: • Serious allergic reactions can happen with Neulasta.
Croatian: • Moguće su teške alergijske reakcije na lijek Neulasta.
English: Important: If at any time you hear beeping, check the status light.
Croatian: Važno: Ako u bilo kojem trenutku čujete zvučni signal, provjerite statusnu lampicu.
English: The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving Neulasta in nine randomised clinical trials.
Croatian: Kategorija učestalosti je procijenjena statističkim izračunom na temelju 1576 bolesnika koji su Neulastu primali u devet randomiziranih kliničkih ispitivanja.
English: Sweet's syndrome (acute febrile dermatosis)1,2
Croatian: Sweetov sindrom (akutna febrilna dermatoza)1,2;
English: Splenomegaly, generally asymptomatic, is uncommon.
Croatian: Splenomegalija, obično asimptomatska, je manje česta.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava upravljanja rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: The potency of this product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class.
Croatian: Potentnost ovog lijeka ne smije se uspoređivati s potentnošću drugih pegiliranih ili nepegiliranih proteina iste terapijske skupine.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet:
English: Remember
Croatian: Zapamtite
English: • a pre-filled syringe for manual administration; or
Croatian: • napunjene štrcaljke za ručnu primjenu; ili
English: Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with pegfilgrastim treatment.
Croatian: Stevens-Johnsonov sindrom, koji može biti životno ugrožavajući ili smrtonosan, rijetko je prijavljen kod liječenja pegfilgrastimom.
English: If you see the status light is flashing red, your on-body injector is not functioning properly.
Croatian: Ako vidite da statusna lampica svijetli crvenim svjetlom, Vaš on-body injektor ne radi ispravno.
English: B Carefully pull the grey needle cap straight out and away from your body.
Croatian: B Pažljivo ravno povucite sivu kapicu s igle i dalje od Vašeg tijela.
English: • Keep the on-body injector at least 10 cm (4 inches) away from electrical equipment such as mobile phones, cordless telephones, microwaves and other common appliances.
Croatian: • Držite on-body injektor najmanje 10 cm udaljenim od elektroničke opreme poput mobilnih uređaja, bežičnih telefona, mikrovalnih pećnica i drugih kućanskih aparata.
English: ** The concentration is 20 mg/mL if the PEG moiety is included.
Croatian: ** Koncentracija iznosi 20 mg/ml ako se uključi i PEG.
English: • Remove any extra adhesive using soap and water.
Croatian: • Uklonite preostalo adhezijsko sredstvo sapunom i vodom.
English: If you forget to inject Neulasta
Croatian: Ako ste zaboravili injicirati lijek Neulasta
English: These elevations are transient and return to baseline.
Croatian: Ta povišenja su prolazna i vraćaju se na početne vrijednosti.
English: How do you, or the person injecting you, use Neulasta pre-filled syringe?
Croatian: Kako ćete Vi ili osoba koja Vam daje injekciju koristiti Neulasta napunjenu štrcaljku?
English: It is important to keep the skin pinched when injecting.
Croatian: Važno je držati nabor kože za vrijeme davanja injekcije.
English: Neulasta left at room temperature for more than 72 hours should be discarded.
Croatian: Neulasta ostavljena na sobnoj temperaturi dulje od 72 sata se mora ukloniti.
English: The most suitable places to inject yourself are:
Croatian: Najpogodnija mjesta za samoprimjenu su:
English: Do not recycle pre-filled syringes or throw them into household waste.
Croatian: Nemojte reciklirati iskorištene štrcaljke ili ih bacati u kućni otpad.
English: Note: It is normal to see a few drops of fluid at the application site, but not normal to see a noticeably wet (saturated) adhesive.
Croatian: Napomena: Normalno je ako vidite nekoliko kapljica tekućine na mjestu primjene lijeka, ali nije normalno ako uočite vidno mokru (natopljenu) ljepljivu podlogu.
English: Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of Neulasta with any other medicinal products.
Croatian: Nisu provedena specifična ispitivanja interakcija ili metabolizma, no klinička ispitivanja nisu upućivala na interakciju Neulaste s bilo kojim drugim lijekovima.
English: This is ok.
Croatian: To je normalno.