FrancophonIA/ELRC3.0 huggingface dataset:
English: Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period.
Croatian: Poznato je da se ljudski IgG izlučuje u majčino mlijeko tijekom prvih dana nakon porođaja i ubrzo nakon toga smanjuje na niske koncentracije; posljedično tome, ne može se isključiti rizik za dojenčad tijekom tog kratkog razdoblja.
English: ATC code: Not yet assigned.
Croatian: ATK oznaka: Nije još dodijeljena.
English: It should not be administered by the intravenous or intramuscular route.
Croatian: Ne smije biti primijenjen intravenskim ili intramuskularnim putem.
English: − After you have injected all of the medicine, pull the needle straight out.
Croatian: Nakon što ste ubrizgali sav lijek, ravno izvucite iglu.
English: OPEN HERE LIFT HERE
Croatian: OVDJE PODIĆI
English: HIT-6 total
Croatian: Ukupan HIT-6
English: Other medicines and AJOVY
Croatian: Drugi lijekovi i AJOVY
English: More than 1,400 patients were treated for at least 12 months.
Croatian: Više od 1400 bolesnika bilo je liječeno tijekom najmanje 12 mjeseci.
English: No data on exposure-efficacy relationship in subjects with body weight >132 kg is available.
Croatian: Nema dostupnih podataka o odnosu izloženosti i djelotvornosti u ispitanika tjelesne težine >132 kg.
English: Contents of the pack and other information What AJOVY contains
Croatian: Sadržaj pakiranja i druge informacije Što AJOVY sadrži
English: Fremanezumab has an estimated half-life of 30 days.
Croatian: Fremanezumab ima procijenjeni poluvijek od 30 dana.
English: This medicine also decreases the disability associated with migraine and it reduces the need for medicines used to treat migraine attacks.
Croatian: Ovaj lijek ujedno smanjuje onesposobljenost povezanu s migrenom i smanjuje potrebu za lijekovima koji se primjenjuju za liječenje napadaja migrene.
English: If you have used more AJOVY than you should, tell your doctor.
Croatian: Ako ste primijenili više lijeka AJOVY nego što ste trebali, obavijestite svog liječnika.
English: Overall, 19% of the patients had previously used topiramate.
Croatian: Sveukupno je 19% bolesnika prethodno uzimalo topiramat.
English: A population pharmacokinetic analysis looking at age, race, gender, and weight was conducted on data from 2,546 subjects.
Croatian: Analiza populacijske farmakokinetike s osvrtom na dob, rasu, spol i težinu bila je provedena na podacima 2546 ispitanika.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment if necessary.
Croatian: U slučaju predoziranja preporučuje se nadzirati bolesnika u pogledu pojave bilo kojih znakova ili simptoma nuspojava i provesti odgovarajuće simptomatsko liječenje ako je potrebno.
English: Your doctor or nurse will explain to you or your caregiver how to give the injection.
Croatian: Liječnik ili medicinska sestra objasnit će Vama ili Vašem njegovatelju kako dati injekciju.
English: Pain, induration and erythema were typically observed immediately after injection while pruritus and rash appeared within a median of 24 and 48 hours, respectively.
Croatian: Bol, induracija i eritem su obično bili uočeni odmah nakon injekcije, dok su se pruritus i osip pojavili unutar medijana od 24 odnosno 48 sati.
English: Push the plunger all the way down as far as it will go to inject all of the medicine.
Croatian: Potisnite klip do kraja sve dok ide kako biste ubrizgali sav lijek.
English: All injection site reactions resolved, mostly within a few hours or days.
Croatian: Sve reakcije na mjestu injekcije nestale su većinom unutar nekoliko sati ili dana.
English: Major cardiovascular diseases
Croatian: Ozbiljne kardiovaskularne bolesti
English: This reduction in CGRP's activity reduces migraine attacks.
Croatian: To smanjenje aktivnosti CGRP-a smanjuje napadaje migrene.
English: Slowly push the plunger in.
Croatian: Polako potiskujte klip.
English: Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Croatian: Reakcije na mjestu injekcije uglavnom nisu zahtijevale prekid primjene lijeka.
English: For multiple injections, injection sites should be alternated.
Croatian: Za višestruke injekcije, potrebno je mijenjati mjesta primjene injekcije.
English: What AJOVY looks like and contents of the pack
Croatian: Kako AJOVY izgleda i sadržaj pakiranja
English: The most frequently observed local reactions at the injection site were pain, induration and erythema.
Croatian: Najčešće uočene lokalne reakcije na mjestu injekcije bile su bol, induracija i eritem.
English: If a fremanezumab injection is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen.
Croatian: Ako je injekcija fremanezumaba propuštena na planirani datum, doziranje je potrebno nastaviti što je prije moguće prema indiciranoj dozi i režimu.
English: Gently pinch up at least 2.5 cm of the skin that you have cleaned.
Croatian: Nježno uhvatite palcem i kažiprstom najmanje 2,5 cm kože koju ste očistili.
English: Hypersensitivity reactions were reported with fremanezumab in less than 1% of patients in clinical trials.
Croatian: Reakcije preosjetljivosti uz fremanezumab bile su prijavljene u manje od 1% bolesnika u kliničkim ispitivanjima.
English: Evaluation of the need to continue treatment is recommended regularly thereafter.
Croatian: Nakon toga preporučuje se redovito procjenjivati potrebu za nastavkom liječenja.
English: Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) have not been studied.
Croatian: Bolesnici s teškim oštećenjem funkcije bubrega (eGFR <30 ml/min/1,73 m2) nisu ispitani.
English: Pharmacotherapeutic group: Not yet assigned.
Croatian: Farmakoterapijska skupina: Nije još dodijeljena.
English: A total of over 2,500 patients (more than 1,900 patient years) have been treated with AJOVY in registration studies.
Croatian: Ukupno je više od 2500 bolesnika (više od 1900 bolesnik-godina) bilo liječeno lijekom AJOVY u registracijskim ispitivanjima.
English: A double dose must not be administered to make up for a missed dose.
Croatian: Ne smije se primijeniti dvostruka doza kako bi se nadoknadila propuštena doza.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with AJOVY in one or more subsets of the paediatric population in prevention of migraine headaches (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka AJOVY u jednoj ili više podskupina pedijatrijske populacije za prevenciju migrenskih glavobolja (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: b) Ask your doctor, pharmacist or nurse how to throw away the container.
Croatian: b) Pitajte svog liječnika, ljekarnika ili medicinsku sestru kako baciti spremnik.
English: The formed small peptides and amino acids may be re-used in the body for de novo synthesis of proteins or are excreted by the kidney.
Croatian: Nastali mali peptidi i aminokiseline mogu biti ponovno upotrijebljeni u tijelu za de novo sintezu proteina ili se izlučuju putem bubrega.
English: The antibody responses were of low titer.
Croatian: Protutijela su imala nizak titar.
English: While the precise mechanism of action by which fremanezumab prevents migraine attacks is unknown, it is believed that prevention of migraine is obtained by its effect modulating the trigeminal system.
Croatian: Iako nije poznat točan mehanizam djelovanja kojim fremanezumab sprečava napadaje migrene, vjeruje se da se prevencija migrene postiže njegovim učinkom na modulaciju trigeminalnog sustava.
English: This medicine is not expected to have any effect on your ability to drive or use machines.
Croatian: Ne očekuje se da će ovaj lijek utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Approximately twice as much exposure is expected in the lowest body weight quartile (43.5 to 60.5 kg) compared to the highest body weight quartile (84.4 to131.8 kg).
Croatian: Očekuje se približno dvostruko veća izloženost u najnižem kvartilu tjelesne težine (43,5 do 60,5 kg) u usporedbi s najvišim kvartilom tjelesne težine (84,4 do 131,8 kg).
English: No safety data are available in these patients.
Croatian: Nema dostupnih podataka o sigurnosti primjene u tih bolesnika.
English: Any further decision to continue treatment should be taken on an individual patient basis.
Croatian: Sve daljnje odluke o nastavku liječenja donose se ovisno o slučaju pojedinog bolesnika.
English: Elderly patients (>70 years), patients using opioids or barbiturates on more than 4 days per month, and patients with pre-existing myocardial infarction, cerebrovascular accident, and thromboembolic events were excluded.
Croatian: Stariji bolesnici (>70 godina), bolesnici koji koriste opioide ili barbiturate više od 4 dana na mjesec te bolesnici koji su imali infarkt miokarda, cerebrovaskularni inzult i tromboembolijske događaje bili su isključeni.
English: If you use more AJOVY than you should
Croatian: Ako primijenite više lijeka AJOVY nego što ste trebali
English: AJOVY should not be used if the solution has been frozen.
Croatian: AJOVY se ne smije primijeniti ako je otopina bila zamrznuta.
English: For further instructions on administration, see section 6.6.
Croatian: Za daljnje upute o primjeni, vidjeti dio 6.6.
English: CGRP levels have been shown to increase significantly during migraine and return to normal with headache relief.
Croatian: Pokazano je da se razine CGRP-a značajno povisuju tijekom migrene i vraćaju na normalu pri nestanku glavobolje.
English: If a hypersensitivity reaction occurs, discontinuation of fremanezumab administration should be considered and appropriate therapy should be initiated.
Croatian: Ako nastupi reakcija preosjetljivosti, potrebno je razmotriti prekid primjene fremanezumaba i započeti odgovarajuću terapiju.
English: As a precautionary measure, it is preferable to avoid the use of AJOVY during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka AJOVY tijekom trudnoće.
English: AJOVY has no or negligible influence on the ability to drive and use machines.
Croatian: AJOVY ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Tell your doctor if you have or have had cardiovascular disease (problems affecting the heart and blood vessels) before using this medicine, because AJOVY has not been studied in patients with certain cardiovascular diseases.
Croatian: Obavijestite liječnika ako imate ili ste imali bolest srca i krvnih žila (kardiovaskularne tegobe) prije primjene ovog lijeka, jer AJOVY nije ispitan u bolesnika s određenim bolestima srca i krvnih žila.
English: Median accumulation ratio, based on once monthly and once quarterly dosing regimens, is approximately 2.4 and 1.2, respectively.
Croatian: Medijan omjera nakupljanja na temelju režima doziranja jedanput mjesečno i jedanput kvartalno iznosi približno 2,4 odnosno 1,2.
English: The expiration date has passed.
Croatian: Rok valjanosti je istekao.
English: − Do not touch the needle.
Croatian: Nemojte dirati iglu.
English: Approximately 52% of the patients in the study had acute headache medication overuse.
Croatian: Približno 52% bolesnika u ispitivanju uzimalo je prekomjernu količinu lijekova za akutnu glavobolju.
English: Based on the results of population pharmacokinetic analysis, no dose adjustment is required (see section 5.2).
Croatian: Na temelju rezultata analize populacijske farmakokinetike, nije potrebna prilagodba doze (vidjeti dio 5.2).
English: Dose proportionality, based on population pharmacokinetics, was observed between 225 mg to 675 mg.
Croatian: Proporcionalnost doze na temelju populacijske farmakokinetike bila je uočena između 225 mg i 675 mg.
English: c) Check that the blue plunger has filled the viewing window and remove the pre-filled pen from your skin.
Croatian: c) Provjerite da je plavi klip ispunio kontrolni prozorčić i uklonite napunjenu brizgalicu s kože.
English: If you forget or miss to use AJOVY
Croatian: Ako ste zaboravili ili propustili primijeniti AJOVY
English: When initiating treatment with fremanezumab, concomitant migraine preventive treatment may be continued if considered necessary by the prescriber (see section 5.1).
Croatian: Kad se započinje s liječenjem fremanezumabom, može se istodobno nastaviti s preventivnim liječenjem migrene ako liječnik koji propisuje lijek to smatra potrebnim (vidjeti dio 5.1).
English: Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you do not miss a dose or have a dose too soon after the last one.
Croatian: Koristite podsjetnike poput napomena u kalendaru ili u dnevniku jer će Vam to pomoći da se prisjetite termina sljedeće doze tako da ne propustite dozu ili je ne primijenite prerano nakon prethodne doze.
English: A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine.
Croatian: Tvar u tijelu pod nazivom peptid povezan s kalcitoninskim genom (engl. calcitonin gene-related peptide, CGRP) ima važnu ulogu u migreni.
English: c) Wait for 30 minutes to let AJOVY reach room temperature (<30°C) to reduce discomfort during injection.
Croatian: c) Pričekajte 30 minuta kako bi AJOVY postigao sobnu temperaturu (<30 °C) radi smanjenja nelagode tijekom davanja injekcije.
English: AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises and attaches to a specific target in the body.
Croatian: AJOVY je lijek koji sadrži djelatnu tvar fremanezumab, monoklonsko protutijelo, vrstu proteina koji prepoznaje i veže se na specifičan cilj u tijelu.
English: You and your doctor should decide if you will use AJOVY while breast-feeding.
Croatian: Potrebno je da Vi i Vaš liječnik odlučite hoćete li primjenjivati AJOVY tijekom dojenja.
English: − After you have injected all of the medicine, i.e. the blue plunger has filled the viewing window and you are able to see the grey stopper, remove the pre-filled pen from the skin by lifting the pre-filled pen straight up and dispose straightaway into a sharp disposal container (see step 3).
Croatian: Nakon što ste ubrizgali sav sadržaj lijeka, tj. plavi klip je ispunio kontrolni prozorčić i možete vidjeti sivi čep, uklonite napunjenu brizgalicu s kože tako da podignete napunjenu brizgalicu ravno prema gore i odmah je odložite u spremnik za odlaganje oštrih predmeta (pogledajte 3. korak).
English: The marketing authorisation holder shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
English: Step 1: Getting ready for an injection a) Gather the following supplies for your injection:
Croatian: 1. korak: priprema za ubrizgavanje injekcije a) Pripremite sljedeći pribor za ubrizgavanje injekcije:
English: No formal clinical drug interaction studies have been performed with AJOVY.
Croatian: Nisu provedena formalna klinička ispitivanja interakcija lijeka AJOVY s drugim lijekovima.
English: AJOVY can be injected into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated.
Croatian: AJOVY se može ubrizgati u područja abdomena, bedra ili nadlaktice koja nisu osjetljiva, natučena, crvena ili otvrdnula.
English: The pre-filled syringe and the pre-filled pen should not be shaken.
Croatian: Napunjena štrcaljka i napunjena brizgalica ne smiju se protresati.
English: The effect also occurred from as early as the first month and sustained over the treatment period (see Figure 2).
Croatian: Učinak je također nastupio već od prvog mjeseca i održao se tijekom razdoblja liječenja (vidjeti sliku 2).
English: Similar to other monoclonal antibodies, fremanezumab is expected to be degraded by enzymatic proteolysis into small peptides and amino acids.
Croatian: Slično drugim monoklonskim protutijelima, očekuje se da će fremanezumab biti razgrađen enzimskom proteolizom na male peptide i aminokiseline.
English: Frequency categories are based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Croatian: manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000).
English: A sub-set of patients (21%) was also allowed to use one commonly used concomitant, preventive medicinal product (beta-blockers, calcium channel blocker/benzocycloheptene, antidepressants, anticonvulsants).
Croatian: Podskupini bolesnika (21%) također je bilo dozvoljeno istodobno primijeniti jedan od uobičajeno korištenih lijekova za preventivnu terapiju (beta-blokatori, blokator kalcijevih kanala/benzociklohepten, antidepresivi, antikonvulzivi).
English: - The active substance is fremanezumab.
Croatian: - Djelatna tvar je fremanezumab.
English: 61% of patients completing Study 3 achieved a 50% response in the last month of the study.
Croatian: 2. Od bolesnika koji su završili Ispitivanje 3, njih 61% postiglo je 50%-tni odgovor u posljednjem mjesecu ispitivanja.
English: You hear a second “click” (about 15 seconds after the first “click”; the plunger will be moving to the bottom of the viewing window as the medicine is being injected).
Croatian: (približno 15 sekundi nakon prvog „klika“, klip će se i dalje kretati prema dnu kontrolnog prozorčića kako se lijek ubrizgava).
English: − As the pre-filled pen is lifted from the skin, the needle shield returns to the original position and locks into place, covering the needle.
Croatian: Kako se napunjena brizgalice podiže s kože, zaštita za iglu vraća se u svoj početni položaj i zaključava, prekrivajući iglu.
English: Afterwards, use of fremanezumab could be considered during breast-feeding only if clinically needed.
Croatian: Nakon toga, primjena fremanezumaba tijekom dojenja može se razmotriti samo ako je to klinički potrebno.
English: − Clean the chosen injection area using a new alcohol swab.
Croatian: − Očistite odabrano područje za davanje injekcije pomoću novog tupfera natopljenog alkoholom.
English: Fremanezumab attaches to CGRP and prevents it from working.
Croatian: Fremanezumab se veže za CGRP i sprječava njegovo djelovanje.
English: AJOVY reduces the frequency of migraine attacks and days with headache.
Croatian: AJOVY smanjuje učestalost napadaja migrene i dana s glavoboljom.
English: Episodic migraine study (Study 1)
Croatian: Ispitivanje epizodne migrene (Ispitivanje 1)
English: No safety signal was observed during the 15-month combined treatment period.
Croatian: Tijekom 15-mjesečnog združenog razdoblja liječenja nije uočen sigurnosni signal.
English: No dose adjustments are required for fremanezumab.
Croatian: Nisu potrebne prilagodbe doze fremanezumaba.
English: It is unknown whether fremanezumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se fremanezumab u majčino mlijeko.
English: c) Wait for 30 minutes to let AJOVY reach room temperature to reduce discomfort during injection.
Croatian: c) Pričekajte 30 minuta kako bi AJOVY postigao sobnu temperaturu radi smanjenja nelagode tijekom davanja injekcije.
English: The following mild to moderate, short-lasting skin reactions around the injection area can occur:
Croatian: Mogu se pojaviti sljedeće blage do umjerene, kratkotrajne kožne reakcije oko mjesta primjene injekcije:
English: Insert the needle into the pinched skin at a 45° to 90° angle.
Croatian: Ubodite iglu u nabor kože koji držite prstima pod kutem od 45° do 90°.
English: The detailed instructions for use provided at the end of the package leaflet must be followed step-bystep carefully.
Croatian: Detaljne upute za primjenu sadržane na kraju upute o lijeku moraju se pažljivo slijediti korak po korak.
English: Patients had a median age of 42 years (range: 18 to 70 years), 85% were female, and 80% were white.
Croatian: Bolesnici su imali medijan dobi od 42 godine (raspon: od 18 do 70 godina), 85% njih su bile žene, a 80% bijelci.
English: Doses up to 2,000 mg have been administered intravenously in clinical trials without dose-limiting toxicity.
Croatian: U kliničkim ispitivanjima intravenski su bile primijenjene doze do 2000 mg bez toksičnosti koja ograničuje dozu (engl. dose-limiting toxicity).
English: After single subcutaneous administrations of 225 mg and 675 mg fremanezumab, median time to maximum concentrations (tmax) in healthy subjects was 5 to 7 days.
Croatian: Nakon jednokratnih supkutanih primjena 225 mg i 675 mg fremanezumaba, medijan vremena do maksimalnih koncentracija (tmax) u zdravih ispitanika iznosio je 5 do 7 dana.
English: − Press down on the pre-filled pen and keep pressed down against the skin for about 30 seconds.
Croatian: Pritisnite napunjenu brizgalicu o kožu i držite je tako približno 30 sekundi.
English: It is preferable to avoid the use of AJOVY during pregnancy as the effects of this medicine in pregnant women are not known.
Croatian: tijekom trudnoće jer učinci ovog lijeka u trudnica nisu poznati.
English: However, body weight did not have an observed effect on the clinical efficacy based on the exposure-response analyses in episodic and chronic migraine patients.
Croatian: tjelesna težina nije vidljivo utjecala na kliničku djelotvornost na temelju analiza izloženosti i odgovora u bolesnika s epizodnom i kroničnom migrenom.
English: g) Clean your injection area.
Croatian: g) Očistite područje za davanje injekcije.
English: Patients may self-inject if instructed in subcutaneous self-injection technique by a healthcare professional.
Croatian: Bolesnici mogu davati injekcije sami sebi ako su im zdravstveni radnici pokazali tehniku samoprimjene supkutane injekcije.
English: Patients were allowed to use acute headache treatments during the study.
Croatian: Bolesnicima je tijekom ispitivanja bilo dozvoljeno uzimati terapiju za akutne glavobolje.
English: Step 2: How to inject a) Pull the needle cap straight off and throw it away.
Croatian: 2. korak: Kako ubrizgati a) Ravno povucite kapicu igle i bacite je.
English: All local injection site reactions were transient and predominantly mild to moderate in severity.
Croatian: Sve lokalne reakcije na mjestu injekcije bile su prolazne i većinom blage do umjerene težine.
English: Within each frequency grouping, ADRs are presented in the order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
English: − You may see small air bubbles in the pre-filled syringe.
Croatian: Možda ćete vidjeti male mjehuriće zraka u napunjenoj brizgalici.
English: Do not use this medicine if you are allergic to fremanezumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati ovaj lijek ako ste alergični na fremanezumab ili neki drugi sastojak ovog lijeka
English: • Do not pull back on the plunger at any time as this can break the pre-filled syringe.
Croatian: • Nemojte ni u kojem trenutku povući klip unazad, jer to može slomiti napunjenu štrcaljku.
English: The following ADRs have been identified in the AJOVY clinical development programme (Table 1).
Croatian: U kliničkom programu razvoja lijeka AJOVY utvrđene su sljedeće nuspojave (tablica 1).
English: Since monoclonal antibodies are not known to be eliminated via renal pathways or metabolised in the liver, renal and hepatic impairment are not expected to impact the pharmacokinetics of fremanezumab.
Croatian: Budući da za monoklonska protutijela nije poznato da se izlučuju putem bubrega ili metaboliziraju u jetri, ne očekuje se da će oštećenje funkcije bubrega i jetre utjecati na farmakokinetiku fremanezumaba.
English: d) Apply pressure at the injection site.
Croatian: d) Primijenite pritisak na mjesto primjene injekcije.