FrancophonIA/ELRC3.0 huggingface dataset:
English: Figure 2: Mean Change from Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity for Study 2
Croatian: Slika 2: Srednja vrijednost promjene od početne vrijednosti u prosječnom mjesečnom broju dana s glavoboljom najmanje umjerene težine za Ispitivanje 2
English: • The AJOVY pre-filled syringe is for single use only.
Croatian: • AJOVY napunjena brizgalica namijenjena je samo za jednokratnu uporabu.
English: Table 2: Key Efficacy Outcomes in Study 1 in Episodic Migraine Efficacy Endpoint
Croatian: Tablica 2: Ključni ishodi djelotvornosti u Ispitivanju 1 za epizodnu migrenu
English: Key secondary endpoints were the achievement of at least 50% reduction from baseline in monthly migraine days (50% responder rate), mean change from baseline in the patient reported MIDAS score, and change from baseline in monthly average number of days of acute headache medicinal product use.
Croatian: Ključne mjere sekundarnog ishoda bile su postizanje najmanje 50%-tnog smanjenja od početne vrijednosti mjesečnih dana s migrenom (50%-tna stopa terapijskog odgovora), srednja vrijednost promjene od početne vrijednosti rezultata na testu MIDAS koji ispunjavaju sami bolesnici i promjena u prosječnom mjesečnom broju dana s primjenom lijeka protiv akutne glavobolje u odnosu na početnu vrijednost.
English: Pack sizes of 1 or 3 pre-filled pens.
Croatian: Veličine pakiranja od 1 ili 3 napunjene brizgalice.
English: Mean at baseline (monthly average number of headache days of at least moderate severity): Placebo: 13.3, AJOVY Quarterly: 13.2, AJOVY Monthly: 12.8.
Croatian: Srednja vrijednost na početku ispitivanja (prosječan mjesečni broj dana s glavoboljom najmanje umjerene težine): placebo: 13,3; AJOVY kvartalno: 13,2; AJOVY mjesečno: 12,8.
English: Fremanezumab is highly specific for CGRP and does not bind to closely related family members (e.g., amylin, calcitonin, intermedin and adrenomedullin).
Croatian: Fremanezumab je visoko specifičan za CGRP i ne veže se na vrlo srodne članove obitelji (npr. amilin,
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 2).
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 2).
English: Mean changea (95% CI) TD (95% CI)b
Croatian: srednja vrijednost promjenea (95% CI) TD (95% CI)b početna vrijednost (SD)
English: b) Inject by following the steps below.
Croatian: b) Ubrizgajte lijek, slijedeći korake u nastavku.
English: AJOVY Syringe
Croatian: štrcaljka AJOVY
English: Keep the pre-filled syringe(s) or pre-filled pen(s) in the outer carton in order to protect from light.
Croatian: Čuvati napunjenu(e) štrcaljku(e) ili napunjenu(e) brizgalicu(e) u vanjskoj kutiji radi zaštite od svjetlosti.
English: What AJOVY is used for
Croatian: Za što se koristi AJOVY
English: − 1 gauze pad or cotton ball per injection
Croatian: − 1 jastučić od gaze ili smotuljak vate po injekciji
English: Available non-clinical data do not suggest an effect on fertility (see section 5.3).
Croatian: Dostupni neklinički podaci ne ukazuju na učinak na plodnost
English: Parts of the AJOVY pre-filled syringe
Croatian: Dijelovi AJOVY napunjene štrcaljke
English: The syringe is for single use only.
Croatian: Brizgalica je namijenjena samo za jednokratnu uporabu.
English: Adults with a history of episodic migraine (less than 15 headache days per month) were included in the study.
Croatian: U ispitivanje su bili uključeni odrasli s anamnezom epizodne migrene (manje od 15 dana s glavoboljom na mjesec).
English: AJOVY is a solution for injection (injection) in a single-dose pre-filled pen.
Croatian: AJOVY je otopina za injekciju (injekcija) u napunjenoj brizgalici s jednokratnom dozom.
English: A total of 875 patients (742 females, 133 males) were randomised into one of three arms: 675 mg fremanezumab every three months (quarterly, n=291), 225 mg fremanezumab once a month (monthly, n=290), or monthly administration of placebo (n=294) administered via subcutaneous injection.
Croatian: Ukupno je bilo randomizirano 875 bolesnika (742 žene, 133 muškarca) u jednu od tri skupine: 675 mg fremanezumaba svaka tri mjeseca (kvartalno, n=291), 225 mg fremanezumaba jedanput na mjesec (mjesečno, n=290) ili mjesečna primjena placeba (n=294) primijenjenog supkutanom injekcijom.
English: Figure 1: Mean Change from Baseline in the Monthly Average Number of Migraine Days for Study 1
Croatian: Slika 1: Srednja vrijednost promjene od početne vrijednosti u prosječnom mjesečnom broju dana s migrenom tijekom Ispitivanja 1
English: If your dose is 675 mg, inject the three injections one after another, each in a different place.
Croatian: - tri injekcije (675 mg) svaka 3 mjeseca (kvartalno doziranje) Ako Vaša doza iznosi 675 mg, ubrizgajte tri injekcije jednu za drugom, svaku na drugo mjesto.
English: Fremanezumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Croatian: Fremanezumab je humanizirano monoklonsko protutijelo proizvedeno u stanicama jajnika kineskog hrčka (engl.
English: The primary efficacy endpoint was the mean change from baseline in the monthly average number of migraine days during the 12-week treatment period.
Croatian: Mjera primarnog ishoda djelotvornosti bila je srednja vrijednost promjene od početne vrijednosti u pogledu prosječnog mjesečnog broja dana s migrenom tijekom 12-tjednog razdoblja liječenja.
English: When switching dosing regimens, the first dose of the new regimen should be administered on the next scheduled dosing date of the prior regimen.
Croatian: • 675 mg svaka tri mjeseca (kvartalno doziranje) Kod prijelaza na drugi režim doziranja, prvu dozu novog režima treba primijeniti na sljedeći datum doziranja prema rasporedu prethodnog režima.
English: The effect also occurred from as early as the first month and sustained over the treatment period (see Figure 1).
Croatian: Učinak je također nastupio već od prvog mjeseca i održao se tijekom razdoblja liječenja
English: The mean migraine frequency at baseline was approximately 9 migraine days per month.
Croatian: Srednja vrijednost učestalosti migrene na početku ispitivanja iznosila je približno 9 dana s migrenom na mjesec.
English: Overall, 30% of the patients had previously used topiramate and 15% onabotulinumtoxin A. A total of 1,034 patients completed the 12-week double-blind treatment period.
Croatian: Sveukupno je 30% bolesnika prethodno uzimalo topiramat, a 15% njih onabotulinski toksin A.
English: • Do not shake the pre-filled pen.
Croatian: • Nemojte protresati napunjenu brizgalicu.
English: Pack sizes of 1 or 3 pre-filled syringes.
Croatian: Veličine pakiranja od 1 ili 3 napunjene štrcaljke.
English: Step 3: Disposal of the pre-filled syringe a) Dispose of your pre-filled syringe right away.
Croatian: 3. korak: Zbrinjavanje napunjene štrcaljke a) Odmah zbrinite svoju napunjenu štrcaljku.
English: (Note: When the blue plunger has filled the viewing window you will still be able to see the grey stopper.)
Croatian: Kada je ubrizgavanje potpuno dovršeno, u kontrolnom se prozorčiću vidi samo plavi klip. (Napomena: Nakon što plavi klip ispuni kontrolni prozorčić, i dalje ćete moći vidjeti sivi čep.)
English: • Do not shake the pre-filled syringe.
Croatian: • Nemojte protresati napunjenu štrcaljku.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - NAPUNJENA ŠTRCALJKA
English: CI = confidence interval; HIT-6 = Headache Impact Test; MAHMD = monthly acute headache medication days; MHD = monthly headache days of at least moderate severity; MMD = monthly migraine days; SD = standard deviation; TD = treatment difference a For all endpoints mean change and CIs are based on the ANCOVA model that included treatment, gender, region, and baseline preventive medication use (yes/no) as fixed effects and corresponding baseline value and years since onset of migraine as covariates.
Croatian: Migraine Disability Assessment); MMD = mjesečni dani s migrenom (engl. monthly migraine days); SD = standardna devijacija; TD = terapijska razlika (engl. treatment difference) a Srednja vrijednost promjene i vrijednosti CI za sve mjere ishoda temelje se na modelu ANCOVA koji je uključivao liječenje, spol, regiju i primjenu lijeka za preventivnu terapiju na početku ispitivanja (da/ne) kao fiksne učinke, a odgovarajuću početnu vrijednost i godine od pojave migrene kao kovarijate.
English: The primary efficacy endpoint was the mean change from baseline in the monthly average number of headache days of at least moderate severity during the 12-week treatment period.
Croatian: Mjera primarnog ishoda djelotvornosti bila je srednja vrijednost promjene od početne vrijednosti u pogledu prosječnog mjesečnog broja dana s glavoboljom najmanje umjerene težine tijekom 12-tjednog razdoblja liječenja.
English: For single use only.
Croatian: Supkutano Samo za jednokratnu uporabu.
English: How to store AJOVY
Croatian: Kako čuvati AJOVY
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED PEN
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - NAPUNJENA BRIZGALICA
English: A total of 1,130 patients (991 females, 139 males) were randomised into one of three arms: 675 mg fremanezumab starting dose followed by 225 mg fremanezumab once a month (monthly, n=379), 675 mg fremanezumab every three months (quarterly, n=376), or monthly administration of placebo (n=375) administered via subcutaneous injection.
Croatian: Ukupno je bilo randomizirano 1130 bolesnika (991 žena, 139 muškaraca) u jednu od tri skupine: 675 mg fremanezumaba početne doze nakon koje je uslijedilo 225 mg fremanezumaba jedanput na mjesec (mjesečno, n=379), 675 mg fremanezumaba svaka tri mjeseca (kvartalno, n=376)
English: b Treatment difference is based on the MMRM analysis with treatment, gender, region, and baseline preventive medication use (yes/no), month, and treatment month as fixed effects and corresponding baseline value and years since onset of migraine as covariates.
Croatian: b Terapijska razlika temelji se na analizi MMRM s liječenjem, spolom, regijom, primjenom lijeka za preventivnu terapiju na početku ispitivanja (da/ne) i mjesecima liječenja kao fiksnim učincima te odgovarajućom početnom vrijednošću i godinama od pojave migrene kao kovarijatama.
English: Patients had a median age of 41 years (range: 18 to 70 years), 88% were female, and 79% were white.
Croatian: 70 godina), 88% njih su bile žene, a 79% bijelci.
English: • Put the carton back in the refrigerator immediately, if you have any unused pre-filled pens in the carton.
Croatian: • Ako u kutiji ima neupotrijebljenih napunjenih brizgalica, kutiju odmah vratite u hladnjak.
English: The patients enrolled had at least a 12-month history of migraine (with and without aura) according to the International Classification of Headache Disorders (ICHD-III) diagnostic criteria.
Croatian: Međunarodne klasifikacije glavobolja (ICHD-III), migrenu (sa ili bez aure) u anamnezi najmanje 12 mjeseci.
English: Disodium ethylenediaminetetraacetic acid (EDTA) dihydrate Polysorbate 80 (E 433)
Croatian: L-histidinklorid hidrat saharoza dinatrijeva sol etilendiamintetraacetatne kiseline (EDTA) dihidrat polisorbat 80 (E 433) voda za injekcije
English: − Do not put the cap back on the needle at any time to avoid injury and infection.
Croatian: Nemojte vraćati kapicu na iglu ni u kojem trenutku radi izbjegavanja ozljede i infekcije.
English: Solution for injection 1 pre-filled syringe of 1.5 mL solution 3 pre-filled syringes of 1.5 mL solution
Croatian: 1 napunjena štrcaljka s 1,5 ml otopine 3 napunjene štrcaljke s 1,5 ml otopine
English: CI = confidence interval; MAHMD = monthly acute headache medication days; MHD = monthly headache days of at least moderate severity; MIDAS = Migraine Disability Assessment; MMD = monthly migraine days; SD = standard deviation; TD = treatment difference a For all endpoints mean change and CIs are based on the ANCOVA model that included treatment, gender,
Croatian: Headache Impact Test); MAHMD = mjesečni dani primjene lijeka protiv akutne glavobolje; MHD = mjesečni dani s glavoboljom od najmanje umjerene težine; MMD = mjesečni dani s migrenom; SD = standardna devijacija; TD = terapijska razlika a
English: 75% Responder Rate MMD
Croatian: 75%-tna stopa terapijskog odgovora za MMD
English: Treatment difference is based on the MMRM analysis with treatment, gender, region, and baseline preventive medication use (yes/no), month, and treatment month as fixed effects and corresponding baseline value and years since onset of migraine as covariates.
Croatian: Terapijska razlika temelji se na analizi MMRM s liječenjem, spolom, regijom, primjenom lijeka za preventivnu terapiju na početku ispitivanja (da/ne) i mjesecima liječenja kao fiksnim učincima te odgovarajućom početnom vrijednošću i godinama od pojave migrene kao kovarijatama.
English: Clear to opalescent, colourless to slightly yellow solution with a pH of 5.5 and an osmolality of 300-450 mOsm/kg.
Croatian: Bistra do opalescentna, bezbojna do blijedožuta otopina s pH od 5,5 i osmolalnošću od
English: AJOVY 225 mg injection fremanezumab SC
Croatian: AJOVY 225 mg injekcija fremanezumab s.c.
English: TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Croatian: 3 89079 Ulm
English: 50% Responder Rate MMD
Croatian: 50%-tna stopa terapijskog odgovora za MMD
English: How to use AJOVY
Croatian: Kako primjenjivati AJOVY
English: P-value (vs. placebo)a p<0.0001
Croatian: p-vrijednost (naspram placeba)a p<0,0001
English: AJOVY 225 mg solution for injection in pre-filled syringe AJOVY 225 mg solution for injection in pre-filled pen
Croatian: AJOVY 225 mg otopina za injekciju u napunjenoj štrcaljki AJOVY 225 mg otopina za injekciju u napunjenoj brizgalici
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Reakcije na mjestu injekcije
English: Mean changea (95% CI) TD (95% CI)
Croatian: srednja vrijednost promjenea (95% CI)
English: Each pre-filled syringe contains 1.5 mL solution.
Croatian: Jedna napunjena štrcaljka sadrži 1,5 ml otopine.
English: Step 3: Disposal of the pre-filled pen a) Dispose of your pre-filled pen right away.
Croatian: 3. korak: Zbrinjavanje napunjene brizgalice a) Odmah zbrinite napunjenu brizgalicu.
English: What AJOVY is and what it is used for 2.
Croatian: Što je AJOVY i za što se koristi
English: Furthermore, concomitant use of acute migraine treatments (specifically analgesics, ergots, and triptans) and migraine preventive medicinal products during the clinical studies did not affect the pharmacokinetics of fremanezumab.
Croatian: i lijekova za prevenciju migrene tijekom kliničkih ispitivanja nije utjecala na farmakokinetiku fremanezumaba.
English: − Do not put the protective cap back on the pre-filled pen, to avoid injury and infection.
Croatian: Nemojte vraćati zaštitnu kapicu na napunjenu brizgalicu, radi izbjegavanja ozljede i infekcije.
English: There are two alternative recommended dosing options: - one injection (225 mg) once a month (monthly dosing) or - three injections (675 mg) every 3 months (quarterly dosing)
Croatian: Dostupne su dvije mogućnosti doziranja: • 225 mg jedanput mjesečno (mjesečno doziranje) ili
English: Teva Nederland B.V. Tel: +31 800 022 8400
Croatian: Tel: +31 800 022 8400
English: − Put your used pre-filled pens in a sharps disposal container right away after use.
Croatian: Odmah nakon primjene odložite upotrijebljenu napunjenu brizgalicu u spremnik za odlaganje oštrih predmeta.
English: − Do not put the needle cap back on the pre-filled syringe, to avoid injury and infection.
Croatian: Nemojte vraćati kapicu igle na napunjenu štrcaljku radi izbjegavanja ozljede i infekcije.
English: Fremanezumab 225 mg monthly with 675 mg starting dose
Croatian: 225 mg mjesečno uz početnu dozu od
English: 75% Responder Rate MHD
Croatian: 75%-tna stopa terapijskog odgovora za MHD
English: Each pre-filled pen contains 1.5 mL solution.
Croatian: Jedna napunjena brizgalica sadrži 1,5 ml otopine.
English: Table 1: Adverse reactions in clinical studies MedDRA System Organ Class Frequency
Croatian: Tablica 1: Nuspojave u kliničkim ispitivanjima
English: 50% Responder Rate MHD
Croatian: 50%-tna stopa terapijskog odgovora za MHD
English: Uncommon (may affect up to 1 in 100 people) Rash at the injection site
Croatian: svrbež na mjestu primjene injekcije manje česte (mogu se pojaviti u do 1 na 100 osoba)
English: Do not inject AJOVY until you or your caregiver have been trained by your doctor or nurse.
Croatian: Vas ili Vašeg njegovatelja tome podučili liječnik ili medicinska sestra.
English: AJOVY Pen
Croatian: brizgalica AJOVY
English: − Do not put the protective cap back on the pre-filled pen at any time to avoid injury and infection.
Croatian: Nemojte ni u kojem trenutku vraćati zaštitnu kapicu na napunjenu brizgalicu, radi izbjegavanja ozljede i infekcije.
English: Keep the pre-filled syringe in the outer carton to protect the medicine from light.
Croatian: Čuvati napunjenu štrcaljku u vanjskoj kutiji radi zaštite lijeka od svjetlosti.
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 007 0
Croatian: Österreich ratiopharm Arzneimittel Vertriebs-GmbH
English: Reporting of side effects
Croatian: Mjera ishoda djelotvornosti
English: Instructions for Use AJOVY 225 mg solution for injection in pre-filled syringe fremanezumab
Croatian: Upute za uporabu AJOVY 225 mg otopina za injekciju u napunjenoj štrcaljki fremanezumab
English: Assuming the model-derived estimated bioavailability of 66% (±SD of 26%) holds for the patient population, the volume of distribution for a typical patient was 3.6 L (35.1% 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%), volumen distribucije kod tipičnog bolesnika iznosio je 3,6 l
English: One pre-filled syringe contains 225 mg fremanezumab.
Croatian: Jedna napunjena štrcaljka sadrži 225 mg fremanezumaba.
English: Month 3
Croatian: PRILOG III.
English: In patients on one other concomitant, migraine preventive medicinal product, the treatment difference for the reduction of monthly headache days (MHD) of at least moderate severity observed between fremanezumab 675 mg quarterly and placebo was -1.3 days (95% CI: -2.66, 0.03) and between fremanezumab 225 mg monthly with 675 mg starting dose and placebo -2.0 days (95% CI: -3.27, -0.67).
Croatian: U bolesnika na istodobnoj primjeni drugog lijeka za preventivnu terapiju migrene, terapijska razlika u smanjenju mjesečnih dana s glavoboljom (MHD) najmanje umjerene težine uočena između fremanezumaba 675 mg kvartalno i placeba bila je -1,3 dana (95% CI: -2,66; 0,03), a između fremanezumaba 225 mg mjesečno uz početnu dozu od 675 mg i placeba bila je -2,0 dana (95% CI: -3,27; -0,67).
English: EU/1/19/1358/001 - 1 pre-filled syringe EU/1/19/1358/002 - 3 pre-filled syringes Pre-filled pen
Croatian: EU/1/19/1358/001 - 1 napunjena štrcaljka EU/1/19/1358/002 - 3 napunjene štrcaljke Napunjena brizgalica
English: In patients who had previously used topiramate the treatment difference for the reduction of monthly headache days (MHD) of at least moderate severity observed between fremanezumab 675 mg quarterly and placebo was -2.7 days (95% CI: -3.88, -1.51) and between fremanezumab 225 mg monthly with 675 mg starting dose and placebo -2.9 days (95% CI: -4.10, -1.78).
Croatian: U bolesnika koji su prethodno uzimali topiramat, terapijska razlika u smanjenju mjesečnih dana s glavoboljom (MHD) najmanje umjerene težine uočena između fremanezumaba 675 mg kvartalno i placeba bila je -2,7 dana (95% CI: -3,88; -1,51), a između fremanezumaba 225 mg mjesečno uz početnu dozu od 675 mg i placeba bila je -2,9 dana (95% CI: -4,10; -1,78).
English: • Each AJOVY pre-filled syringe contains 225 mg of fremanezumab.
Croatian: • Jedna AJOVY napunjena štrcaljka sadrži 225 mg fremanezumaba.
English: Pre-filled pen containing 1.5 mL solution in a 2.25 mL Type I glass syringe with plunger stopper (bromobutyl rubber) and needle.
Croatian: Napunjena brizgalica sadrži 1,5 ml otopine u štrcaljki od stakla tipa
English: Merckle GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Croatian: Merckle GmbH Graf-Arco-Str.
English: Keep the pre-filled pen in the outer carton to protect the medicine from light.
Croatian: Čuvati napunjenu brizgalicu u vanjskoj kutiji radi zaštite lijeka od svjetlosti.
English: Key secondary endpoints were the achievement of at least 50% reduction from baseline in monthly headache days of at least moderate severity (50% responder rate), mean change from baseline in the patient reported HIT-6 score, and change from baseline in monthly average number of days of acute headache medicinal product use.
Croatian: (50%-tna stopa terapijskog odgovora), srednja vrijednost promjene od početne vrijednosti rezultata testa HIT-6 koji ispunjavaju bolesnici i promjena u prosječnom mjesečnom broju dana s primjenom lijeka protiv akutne glavobolje u odnosu na početnu vrijednost.
English: AJOVY 225 mg solution for injection in pre-filled syringe fremanezumab
Croatian: AJOVY 225 mg otopina za injekciju u napunjenoj štrcaljki fremanezumab
English: In patients who had previously used onabotulinumtoxin A the treatment difference for the reduction of monthly headache days (MHD) of at least moderate severity observed between fremanezumab 675 mg quarterly and placebo was -1.3 days (95% CI: -3.01, -0.37) and between fremanezumab 225 mg monthly with 675 mg starting dose and placebo -2.0 days (95% CI: -3.84, -0.22).
Croatian: U bolesnika koji su prethodno primali onabotulinski toksin A, terapijska razlika u smanjenju mjesečnih dana s glavoboljom (MHD) najmanje umjerene težine uočena između fremanezumaba 675 mg kvartalno i placeba bila je -1,3 dana (95% CI: -3,01; -0,37), a između fremanezumaba 225 mg mjesečno uz početnu dozu od 675 mg i placeba bila je -2,0 dana (95% CI: -3,84; -0,22).
English: Instructions for Use AJOVY 225 mg solution for injection in pre-filled pen fremanezumab
Croatian: Upute za uporabu AJOVY 225 mg otopina za injekciju u napunjenoj brizgalici fremanezumab
English: Fremanezumab 225 mg monthly
Croatian: 225 mg mjesečno
English: In patients on one other concomitant, migraine preventive medicinal product, the treatment difference for the reduction of monthly migraine days (MMD) observed between fremanezumab 675 mg quarterly and placebo was -1.8 days (95% CI: -2.95, -0.55) and between fremanezumab 225 mg monthly and placebo -2.0 days (95% CI: -3.21, -0.86).
Croatian: U bolesnika na istodobnoj primjeni drugog lijeka za preventivnu terapiju migrene, terapijska razlika u smanjenju mjesečnih dana s migrenom (MMD) uočena između fremanezumaba 675 mg kvartalno i placeba bila je -1,8 dana (95% CI: -2,95; -0,55), a između fremanezumaba 225 mg mjesečno i placeba
English: No pharmacokinetic drug interactions are expected based on the characteristics of fremanezumab.
Croatian: S obzirom na svojstva fremanezumaba, ne očekuju se farmakokinetičke interakcije s drugim lijekovima.
English: • Each AJOVY pre-filled pen contains 225 mg of fremanezumab.
Croatian: • Jedna AJOVY napunjena brizgalica sadrži 225 mg fremanezumaba.
English: EU/1/19/1358/003 - 1 pre-filled pen EU/1/19/1358/004 - 3 pre-filled pens
Croatian: EU/1/19/1358/003 - 1 napunjena brizgalica EU/1/19/1358/004 - 3 napunjene brizgalice
English: In patients who had previously used topiramate the treatment difference for the reduction of monthly migraine days (MMD) observed between fremanezumab 675 mg quarterly and placebo was -2.3 days (95% CI: -3.64, -1.00) and between fremanezumab 225 mg monthly and placebo -2.4 days (95% CI: -3.61, -1.13).
Croatian: U bolesnika koji su prethodno uzimali topiramat, terapijska razlika u smanjenju mjesečnih dana s migrenom (MMD) uočena između fremanezumaba 675 mg kvartalno i placeba bila je -2,3 dana (95% CI: -3,64; -1,00), a između fremanezumaba 225 mg mjesečno i placeba -2,4 dana