FrancophonIA/ELRC3.0 huggingface dataset:
English: The study population included adults with a history of chronic migraine (15 headache days or higher per month).
Croatian: Ispitivana populacija uključivala je odrasle s anamnezom kronične migrene (15 ili više dana s glavoboljom na mjesec).
English: You hear the first “click” (this signals the start of the injection and the blue plunger starts to move).
Croatian: Čut ćete prvi „klik“ (on označava početak ubrizgavanja,
English: There is limited data available on the use of fremanezumab in patients ≥65 years of age (2% of the patients).
Croatian: Dostupni su ograničeni podaci o primjeni fremanezumaba u bolesnika u dobi ≥65 godina (2% bolesnika).
English: The efficacy and safety of fremanezumab was demonstrated regardless of age, gender, race, use of concomitant preventive medicinal products (beta-blockers, calcium channel blocker/benzocycloheptene, antidepressants, anticonvulsants), use of topiramate or onabotulinumtoxin A for migraine in the past, and acute headache medication overuse.
Croatian: Djelotvornost i sigurnost fremanezumaba bila je dokazana bez obzira na dob, spol, rasu, istodobnu primjenu lijekova za preventivnu terapiju (beta-blokatori, blokator kalcijevih kanala/benzociklohepten, antidepresivi, antikonvulzivi), primjenu topiramata ili onabotulinskog toksina A u prošlosti te pretjeranu primjenu lijekova protiv akutne glavobolje.
English: What you need to know before you use AJOVY 3.
Croatian: Što morate znati prije nego počnete primjenjivati AJOVY
English: As fremanezumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been conducted.
Croatian: Budući da je fremanezumab monoklonsko protutijelo, nisu provedena ispitivanja genotoksičnosti ili kancerogenog potencijala.
English: − Choose an injection area from the following areas: Your stomach area (abdomen), avoid about 5 cm around the belly button The front of your thighs, about 5 cm above the knee and 5 cm below the groin The back of your upper arms, in the fleshy areas of the upper back portion
Croatian: Odaberite jedno od sljedećih područja za davanje injekcije: područje trbuha (abdomena), ali izbjegavajte područje koje pokriva približno 5 cm oko pupka prednji dio bedara, područje koje pokriva približno 5 cm iznad koljena i 5 cm ispod prepona stražnji dio nadlaktica, mesnata područja na gornjem stražnjem dijelu
English: AJOVY pre-filled pen (after use)
Croatian: AJOVY napunjena brizgalica (nakon uporabe)
English: − Check the pen label.
Croatian: Provjerite naljepnicu štrcaljke.
English: ADRs from clinical studies are presented according to MedDRA system organ classification.
Croatian: Nuspojave iz kliničkih ispitivanja prikazane su prema MedDRA klasifikaciji organskih sustava.
English: • When injecting AJOVY, hold the pre-filled pen so that your hand does not cover the viewing window.
Croatian: • Tijekom ubrizgavanja lijeka AJOVY držite napunjenu brizgalicu tako da rukom ne prekrivate kontrolni prozorčić.
English: Fremanezumab 675 mg quarterly
Croatian: Fremanezumab 675 mg kvartalno
English: In placebo-controlled studies, 0.4 % of patients (6 out of 1,701) treated with fremanezumab developed anti-drug antibodies (ADA).
Croatian: U placebom kontroliranim ispitivanjima 0,4% bolesnika (6 od 1701) liječenih fremanezumabom razvilo je protutijela protiv lijeka (engl. anti-drug antibodies, ADA).
English: AJOVY pre-filled pen (before use)
Croatian: AJOVY napunjena brizgalica (prije uporabe)
English: Depending on your dose you will need to use 1 pre-filled syringe or 3 pre-filled syringes.
Croatian: Ovisno o Vašoj dozi morat ćete upotrijebiti 1 napunjenu štrcaljku ili 3 napunjene štrcaljke.
English: AJOVY is for subcutaneous injection only.
Croatian: AJOVY je namijenjen samo za supkutanu injekciju.
English: The absolute bioavailability of fremanezumab after subcutaneous administration of 225 mg and 900 mg in healthy subjects was 55% (±SD of 23%) to 66% (±SD of 26%).
Croatian: Apsolutna bioraspoloživost fremanezumaba nakon supkutane primjene 225 mg i 900 mg u zdravih ispitanika bila je 55% (±SD od 23%) do 66% (±SD od 26%).
English: − Do not touch the needle shield area.
Croatian: − Nemojte dirati područje na kojem se nalazi zaštita za iglu.
English: − Check the syringe label.
Croatian: Provjerite naljepnicu brizgalice.
English: Fremanezumab selectively binds the calcitonin gene-related peptide (CGRP) ligand and blocks both CGRP isoforms (α-and β-CGRP) from binding to the CGRP receptor.
Croatian: Fremanezumab se selektivno veže na ligand peptid povezan s kalcitoninskim genom (engl. calcitonin gene-related peptide, CGRP) i blokira vezanje oba izooblika CGRP-a (α- i β-CGRP) na receptor za CGRP.
English: Steady state was achieved by approximately 168 days (about 6 months) following 225 mg monthly and 675 mg quarterly dosing regimens.
Croatian: Stanje dinamičke ravnoteže bilo je postignuto za približno 168 dana (oko 6 mjeseci) nakon režima doziranja od 225 mg mjesečno i 675 mg kvartalno.
English: b) Inject by following the 4 steps below.
Croatian: b) Ubrizgajte lijek slijedeći 4 koraka u nastavku.
English: • AJOVY is injected under your skin (subcutaneous injection).
Croatian: • AJOVY se ubrizgava pod kožu (supkutana injekcija).
English: Before you use the AJOVY pre-filled syringe, read and carefully follow the step-by-step instructions.
Croatian: Prije upotrebe AJOVY napunjene štrcaljke, pročitajte i pažljivo slijedite upute korak po korak.
English: Commonly reported adverse drug reactions (ADRs) were local reactions at the injection site (pain [24%], induration [17%], erythema [16%] and pruritus [2%]).
Croatian: Često prijavljene nuspojave bile su lokalne reakcije na mjestu injekcije (bol [24%], induracija [17%],
English: f) Choose your injection area.
Croatian: f) Odaberite područje za davanje injekcije.
English: − Use a clean, dry cotton ball, or gauze to gently press on the injection site for a few seconds.
Croatian: Upotrijebite čisti, suhi smotuljak vate ili gazu i lagano pritisnite na mjesto primjene injekcije tijekom nekoliko sekundi.
English: The treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine.
Croatian: 4.2. Doziranje i način primjene Liječenje treba započeti liječnik s iskustvom u dijagnosticiranju i liječenju migrene.
English: What AJOVY is and what it is used for What AJOVY is
Croatian: Što je AJOVY i za što se koristi Što je AJOVY
English: AJOVY is used to prevent migraine in adults who have at least 4 migraine days per month.
Croatian: AJOVY se koristi za prevenciju migrene u odraslih koji imaju migrenu najmanje 4 dana na mjesec.
English: This medicine may be removed from the refrigerator and stored at a temperature below 25°C for a maximum period of up to 24 hours.
Croatian: Ovaj lijek se smije ukloniti iz hladnjaka i čuvati na temperaturi ispod 25 °C tijekom jednokratnog razdoblja do maksimalno 24 sata.
English: 79% of patients completed the 12-month treatment period of Study 3.
Croatian: U Ispitivanju 3 je 79% bolesnika dovršilo 12-mjesečno razdoblje liječenja.
English: Before you use the AJOVY pre-filled pen, read and carefully follow the step-by-step instructions.
Croatian: Prije upotrebe AJOVY napunjene brizgalice, pročitajte i pažljivo slijedite upute korak po korak.
English: AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
Croatian: AJOVY je indiciran za profilaksu migrene u odraslih koji imaju migrenu najmanje 4 dana na mjesec.
English: With 12 months of treatment, ADA were detected in 2.3% of the patients (43 out of 1,888) with 0.95% of the patients developing neutralising antibodies.
Croatian: Kod 12-mjesečnog liječenja protutijela protiv lijeka bila su detektirana u 2,3% bolesnika (43 od 1888) uz 0,95% bolesnika u kojih su se razvila neutralizirajuća protutijela.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: AJOVY may be stored unrefrigerated for up to 24 hours at a temperature up to 25°C.
Croatian: AJOVY se može čuvati izvan hladnjaka do 24 sata na temperaturi do 25 °C.
English: Percentage [%] P-value (vs. placebo)
Croatian: postotak [%] p-vrijednost (naspram placeba)
English: − Do not warm up the pre-filled syringe using a microwave or any other heat source.
Croatian: − Nemojte ugrijati napunjenu štrcaljku pomoću mikrovalne pećnice ili bilo kojeg drugog izvora topline.
English: • The blue plunger moves down the viewing window during the injection.
Croatian: • Plavi klip se tijekom ubrizgavanja spušta duž kontrolnog prozorčića.
English: Depending on your dose you will need to use 1 pre-filled pen or 3 pre-filled pens.
Croatian: Ovisno o Vašoj dozi morat ćete upotrijebiti 1 napunjenu brizgalicu ili 3 napunjene brizgalice.
English: Pooled across the two dosing regimens, a reduction of 6.6 monthly migraine days was observed after 15 months relative to Study 1 and Study 2 baseline.
Croatian: Nakon združivanja podataka iz dvaju režima doziranja bilo je uočeno smanjenje za 6,6 mjesečnih dana s migrenom nakon 15 mjeseci u odnosu na početnu vrijednost u Ispitivanju 1 i
English: − Place the pre-filled pen at a 90° angle against your skin at the injection site.
Croatian: Postavite napunjenu brizgalicu na kožu pod kutom od 90° na mjesto primjene injekcije.
English: There is limited data available on the use of fremanezumab in patients ≥65 years of age.
Croatian: Dostupni su ograničeni podaci o primjeni fremanezumaba u bolesnika u dobi od ≥65 godina.
English: − Pull the protective cap straight off. Do not twist.
Croatian: Ravno povucite zaštitnu kapicu.
English: − Do not warm up the pre-filled pen using a microwave or any other heat source.
Croatian: Nemojte ugrijati napunjenu brizgalicu pomoću mikrovalne pećnice ili bilo kojeg drugog izvora topline.
English: − 1 or 3 AJOVY pre-filled syringes to enable 1 or 3 injections depending on your dose
Croatian: − 1 ili 3 AJOVY napunjene štrcaljke tako da možete ubrizgati 1 ili 3 injekcije ovisno o
English: Step 2: How to inject a) Remove the protective cap and do not replace.
Croatian: 2. korak: Kako ubrizgati a) Uklonite zaštitnu kapicu i nemojte je vraćati natrag na brizgalicu.
English: − Do not leave the pre-filled syringe in direct sunlight.
Croatian: Nemojte ostaviti napunjenu brizgalicu na izravnoj sunčevoj svjetlosti.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment or hepatic impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega ili funkcije jetre (vidjeti dio 5.2).
English: There is a limited amount of data from the use of AJOVY in pregnant women.
Croatian: Podaci o primjeni lijeka AJOVY u trudnica su ograničeni.
English: Read the “Instructions for Use” for the pre-filled syringe carefully before using AJOVY.
Croatian: Pažljivo pročitajte „Upute za uporabu“ za napunjenu štrcaljku prije primjene lijeka AJOVY.
English: The medicine must be discarded if it has been out of the refrigerator for longer than 24 hours.
Croatian: Lijek se mora baciti ako je bio izvan hladnjaka dulje od 24 sata.
English: What are the benefits of using AJOVY
Croatian: Koje su prednosti korištenja lijeka AJOVY
English: AJOVY must be discarded if it has been out of the refrigerator for longer than 24 hours.
Croatian: AJOVY se mora baciti ako je bio izvan hladnjaka dulje od 24 sata.
English: If your dose is 675 mg, repeat steps 1 e) to 3 a) with the second and third pre-filled syringe to inject the full dose.
Croatian: Ako primate dozu od 675 mg, ponovite korake od 1. e) do 3. a) s drugom i trećom napunjenom brizgalicom kako biste si ubrizgali cijelu dozu.
English: Within each system organ class, ADRs are ranked by frequency, most frequent reactions first.
Croatian: Unutar svakog organskog sustava nuspojave su poredane prema učestalosti, počevši od najučestalijih reakcija.
English: − Put your used pre-filled syringes (with the needle still attached) in a sharps disposal container right away after use.
Croatian: Odmah nakon primjene odložite upotrijebljenu napunjenu štrcaljku (s još uvijek spojenom iglom) u spremnik za odlaganje oštrih predmeta.
English: Talk to your doctor, pharmacist or nurse if you get any symptoms of an allergic reaction, e.g. trouble breathing, swelling of the lips and tongue, or severe rash, after injecting AJOVY.
Croatian: razvijete bilo koje simptome alergijske reakcije, npr. otežano disanje, oticanje usana i jezika ili jaki osip.
English: − 1 or 3 AJOVY pre-filled pens to enable 1 or 3 injections depending on your dose
Croatian: − 1 ili 3 AJOVY napunjene brizgalice tako da možete ubrizgati 1 ili 3 injekcije ovisno o
English: Demographics and baseline disease characteristics were balanced and comparable between the study arms.
Croatian: Demografske karakteristike i značajke bolesti na početku ispitivanja bile su ravnomjerno raspoređene i usporedive između skupina ispitivanja.
English: − Check that the medicine in the pen viewing window looks clear and is colourless to slightly yellow.
Croatian: Provjerite da lijek u kontrolnom prozorčiću brizgalice izgleda bistro, te da je bezbojan do blijedožute boje.
English: − Do not inject AJOVY into an area that is tender, red, hot, bruised, hardened, tattooed or that has scars or stretch marks.
Croatian: Nemojte ubrizgavati AJOVY u područje koje je osjetljivo, crveno, vruće, natučeno,
English: AJOVY is a solution for injection (injection) in a pre-filled syringe with a fixed injection needle in a blister.
Croatian: AJOVY je otopina za injekciju (injekcija) u napunjenoj štrcaljki s pričvršćenom iglom za injekciju u blisteru.
English: The safety and efficacy of fremanezumab were not affected by ADA development.
Croatian: Sigurnost i djelotvornost fremanezumaba nisu promijenjene uslijed razvoja protutijela protiv lijeka.
English: − 1 alcohol swab per injection
Croatian: − 1 tupfer natopljen alkoholom po injekciji
English: Fremanezumab is a humanised IgG2Δa/kappa monoclonal antibody derived from a murine precursor.
Croatian: Fremanezumab je humanizirano monoklonsko protutijelo IgG2Δa/kapa dobiveno od mišjeg prekursora.
English: AJOVY is given by injection under your skin (subcutaneous injection).
Croatian: AJOVY se daje injekcijom pod kožu (supkutanom injekcijom).
English: Very common (may affect more than 1 in 10 people) Pain, hardening or redness at the injection site
Croatian: vrlo česte (mogu se pojaviti u više od 1 na 10 osoba) bol, otvrdnuće ili crvenilo na mjestu primjene injekcije česte (mogu se pojaviti u do 1 na 10 osoba)
English: − Do not rub the injection site or re-use the pre-filled syringe.
Croatian: − Nemojte trljati mjesto primjene injekcije ili ponovno upotrijebiti napunjenu štrcaljku.
English: AJOVY is a clear, colourless to slightly yellow solution.
Croatian: AJOVY je bistra, bezbojna do blijedožuta otopina.
English: The expiration date has passed or if the pre-filled pen has been out of the refrigerator for longer than 24 hours.
Croatian: Rok valjanosti je istekao ili je napunjena brizgalica bila izvan hladnjaka dulje od 24 sata.
English: The mean headache frequency at baseline was approximately 21 headache days per month (of which 13 headache days were of at least moderate severity).
Croatian: Srednja vrijednost učestalosti glavobolje na početku ispitivanja iznosila je približno 21 dan s glavoboljom na mjesec (od toga je bilo 13 dana s glavoboljom najmanje umjerene težine).
English: e) Inspect your AJOVY pre-filled pen.
Croatian: e) Pregledajte AJOVY napunjenu brizgalicu.
English: Do not use this medicine after the expiry date which is stated on the syringe label and on the outer carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici brizgalice i vanjskoj kutiji iza oznake EXP.
English: You wait another 10 seconds (to make sure all of the medicine is injected).
Croatian: (kako biste osigurali da je sav sadržaj lijeka ubrizgan).
English: Table 3: Key Efficacy Outcomes in Study 2 in Chronic Migraine Efficacy Endpoint
Croatian: Tablica 3: Ključni ishodi djelotvornosti u Ispitivanju 2 za kroničnu migrenu
English: MIDAS total
Croatian: Ukupan MIDAS
English: For all episodic and chronic migraine patients, efficacy was sustained for up to 12 additional months in the long-term study (Study 3), in which patients received 225 mg fremanezumab monthly or 675 mg quarterly.
Croatian: Dugoročno ispitivanje (Ispitivanje 3) U svih bolesnika s epizodnom i kroničnom migrenom, djelotvornost je bila održana do 12 dodatnih mjeseci u dugoročnom ispitivanju (Ispitivanje 3) u kojem su bolesnici primali 225 mg fremanezumaba mjesečno ili 675 mg kvartalno.
English: The efficacy of fremanezumab was assessed in two randomised, 12-week, double-blind, placebocontrolled phase III studies in adult patients with episodic (Study 1) and chronic migraine (Study 2).
Croatian: Djelotvornost fremanezumaba bila je ocijenjena u dva randomizirana, 12-tjedna, dvostruko slijepa, placebom kontrolirana ispitivanja faze III u odraslih bolesnika s epizodnom (Ispitivanje 1) i kroničnom migrenom (Ispitivanje 2).
English: AJOVY is available in packs containing 1 or 3 pre-filled pens.
Croatian: AJOVY je dostupan u pakiranjima koja sadrže 1 ili 3 napunjene brizgalice.
English: AJOVY should not be used if the solution is cloudy or discoloured or contains particles.
Croatian: AJOVY se ne smije primijeniti ako je otopina zamućena ili promijenjene boje ili ako sadrži čestice.
English: − Check that the medicine inside the syringe looks clear and is colourless to slightly yellow.
Croatian: Provjerite da lijek u štrcaljki izgleda bistro i bezbojno do blijedožuto.
English: e) Inspect your AJOVY pre-filled syringe.
Croatian: e) Pregledajte AJOVY napunjenu štrcaljku.
English: If you are breast-feeding or are planning to breast-feed, talk to your doctor or pharmacist before using this medicine.
Croatian: Ako dojite ili planirate dojiti, obratite se svom liječniku ili ljekarniku prije nego primijenite ovaj lijek.
English: The medicine is cloudy, discoloured, or contains particles.
Croatian: Lijek je zamućen, promijenjene boje ili sadrži čestice.
English: Baseline (SD)
Croatian: početna vrijednost (SD)
English: Read the “Instructions for Use” for the pre-filled pen carefully before using AJOVY.
Croatian: Pažljivo pročitajte „Upute za uporabu“ za napunjenu brizgalicu prije primjene lijeka AJOVY.
English: • Carefully read the AJOVY package leaflet to learn more about your medicine.
Croatian: • Za više informacija o lijeku pažljivo pročitajte uputu o lijeku za AJOVY.
English: A total of 791 patients completed the 12-week double-blind treatment period.
Croatian: Dvostruko slijepo, 12-tjedno razdoblje liječenja završio je ukupno 791 bolesnik.
English: 1.5 mL solution in a 2.25 mL Type I glass syringe with plunger stopper (bromobutyl rubber) and needle.
Croatian: I zapremnine 2,25 ml, s čepom klipa (bromobutilna guma) i iglom.
English: If you have missed a dose of AJOVY, inject your missed dose as soon as you can. Do not take a double dose to make up for a forgotten dose.
Croatian: Ako ste propustili dozu lijeka AJOVY, ubrizgajte propuštenu dozu što prije možete.
English: - The other ingredients (excipients) are L-histidine, L-histidine hydrochloride monohydrate, sucrose, disodium ethylenediaminetetraacetic acid (EDTA) dihydrate, polysorbate 80 and water for injections.
Croatian: - Drugi sastojci (pomoćne tvari) su L-histidin, L-histidinklorid hidrat, saharoza, dinatrijeva sol etilendiamintetraacetatne kiseline (EDTA) dihidrat, polisorbat 80, voda za injekcije.
English: − Do not use the pre-filled syringe if you see any of the following: The syringe looks damaged.
Croatian: Nemojte upotrijebiti napunjenu štrcaljku ako vidite išta od sljedećeg:
English: How AJOVY works
Croatian: Kako AJOVY djeluje
English: Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, disodium ethylenediaminetetraacetic acid (EDTA) dihydrate, polysorbate 80, water for injections.
Croatian: Pomoćne tvari: L-histidin, L-histidinklorid hidrat, saharoza, dinatrijeva sol etilendiamintetraacetatne kiseline (EDTA) dihidrat, polisorbat 80, voda za injekcije.
English: − Do not rub the injection site or re-use the pre-filled pen.
Croatian: Nemojte trljati mjesto primjene injekcije ili ponovno upotrijebiti napunjenu brizgalicu.
English: Do not use this medicine if you notice that the outer carton has been tampered with, the syringe is damaged, or the medicine is cloudy, discoloured, or contains particles.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je vanjska kutija oštećena, ako je brizgalica oštećena ili ako je lijek zamućen, promijenjene boje ili sadrži čestice.
English: Mean at baseline (monthly average number of migraine days): Placebo: 9.1, AJOVY Quarterly: 9.2, AJOVY Monthly: 8.9.
Croatian: Srednja vrijednost na početku ispitivanja (prosječan mjesečni broj dana s migrenom): placebo: 9,1; AJOVY kvartalno: 9,2; AJOVY mjesečno: 8,9
English: − Do not recycle used sharps disposal container.
Croatian: − Nemojte reciklirati upotrijebljeni spremnik za odlaganje oštrih predmeta.
English: AJOVY contains sodium
Croatian: AJOVY sadrži natrij
English: Both monthly and quarterly dosing regimens of fremanezumab demonstrated statistically significant and clinically meaningful improvement from baseline compared to placebo for key endpoints (see Table 3).
Croatian: I mjesečni i kvartalni režimi doziranja fremanezumaba pokazali su statistički značajno i klinički značajno poboljšanje od početne vrijednosti u usporedbi s placebom za ključne mjere ishoda (vidjeti Tablicu 3).
English: The pre-filled syringe and the pre-filled pen are for single use only.
Croatian: Napunjena štrcaljka i napunjena brizgalica namijenjene su samo za jednokratnu uporabu.
English: Assuming the model-derived estimated bioavailability of 66% (±SD of 26%) holds for the patient population, central clearance for a typical patient was 0.09 L/day (23.4% CV) following subcutaneous administration of 225 mg, 675 mg and 900 mg of fremanezumab.
Croatian: Pod pretpostavkom da za populaciju bolesnika prema procjeni na temelju modela vrijedi bioraspoloživost od 66% (±SD od 26%), središnji klirens kod tipičnog bolesnika iznosio je 0,09 l na dan (23,4% CV) nakon supkutane primjene 225 mg, 675 mg i 900 mg fremanezumaba.
English: • 225 mg once monthly (monthly dosing) or
Croatian: - jedna injekcija (225 mg) jedanput na mjesec (mjesečno doziranje) ili
English: − 1 sharps disposal or puncture-resistant container b) Place the supplies you have gathered on a clean, flat surface.
Croatian: b) Pribor koji ste prikupili, stavite na čistu, ravnu površinu.
English: Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1).
Croatian: Bolesnici s određenim ozbiljnim kardiovaskularnim bolestima bili su isključeni iz kliničkih ispitivanja
English: Population pharmacokinetic analysis of integrated data from the AJOVY clinical studies did not reveal a difference in the pharmacokinetics of fremanezumab in patients with mild to moderate renal impairment or hepatic impairment relative to those with normal renal or hepatic function (see section 4.2).
Croatian: AJOVY nije otkrila razliku u farmakokinetici fremanezumaba u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega ili jetre u odnosu na bolesnike s normalnom funkcijom bubrega ili jetre
English: The efficacy of fremanezumab was evaluated in episodic migraine in a randomised, multicentre, 12-week, placebo-controlled, double-blind study (Study 1).
Croatian: Djelotvornost fremanezumaba kod epizodne migrene bila je ocijenjena u randomiziranom, multicentričnom, 12-tjednom, placebom kontroliranom, dvostruko slijepom ispitivanju (Ispitivanje 1).
English: − If multiple injections are required, they may be given in the same or different area (abdomen, thigh, upper arm), but you should avoid injecting in exactly the same place.
Croatian: (abdomen, bedro, nadlaktica), ali morate izbjegavati ubrizgavanje u točno isto mjesto.
English: Treatment is intended for patients with at least 4 migraine days per month when initiating treatment with fremanezumab.
Croatian: Liječenje je namijenjeno bolesnicima koji pri započinjanju liječenja fremanezumabom imaju migrenu najmanje 4 dana na mjesec.