FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy was sustained for up to 1 year in an open-label study in which patients with either episodic or chronic migraine (with an average baseline of 10.6 monthly MHDs) received galcanezumab 120 mg/month (with an initial loading dose of 240 mg for the first month) or galcanezumab 240 mg/month.
Croatian: Djelotvornost se održala do godinu dana u otvorenom ispitivanju u kojem su bolesnici s epizodnom ili kroničnom migrenom (s prosječno 10,6 dana s migrenskom glavoboljom mjesečno na početku ispitivanja) primali galkanezumab u dozi od 120 mg mjesečno (uz početnu udarnu dozu od 240 mg primijenjenu prvog mjeseca) ili u dozi od 240 mg mjesečno.
English: The galcanezumab Cmax, ss at monthly doses of 120 mg is achieved after the 240 mg loading dose.
Croatian: Cmax,ss galkanezumaba kod primjene mjesečnih doza od 120 mg postiže se nakon udarne doze od 240 mg.
English: The chronic migraine study (REGAIN) enrolled patients who met ICHD criteria for chronic migraine with ≥ 15 headache days per month, of which at least 8 had the features of migraine.
Croatian: ICHD kriterije za kroničnu migrenu i koji su ≥ 15 dana mjesečno imali glavobolju, koja je najmanje 8 dana imala obilježja migrene.
English: A. It is okay to see a drop of liquid on the tip of the needle.
Croatian: O. U redu je ako vidite kapljicu tekućine na vrhu igle.
English: If you have injected more Emgality than you should, e.g. if after the first dose of 240 mg, you have injected it twice in a single month, or if anyone else has accidentally used Emgality, contact your doctor immediately.
Croatian: 240 mg lijek injicirali dvaput unutar mjesec dana, ili ako je netko drugi slučajno primijenio Emgality, odmah se obratite svom liječniku.
English: Do not use this medicine if you notice that the syringe is damaged, or the medicine is cloudy or has particles in it.
Croatian: Nemojte primijeniti lijek ako primijetite da je brizgalica oštećena ili ako vidite da je lijek mutan ili da sadrži čestice.
English: Read the full Package Leaflet for Emgality inside this box to learn more about your medicine.
Croatian: Za više informacija o ovom lijeku pročitajte cjelovitu uputu o lijeku Emgality koja se nalazi u ovoj kutiji.
English: More patients treated with galcanezumab achieved clinically significant levels of improvement in functioning (responder rate based on MSQ Role Function Restrictive domain) compared with those treated with placebo.
Croatian: Veći broj bolesnika liječenih galkanezumabom ostvario je klinički značajnu razinu poboljšanja funkcioniranja (stopa odgovora prema MSQ rezultatu za funkcionalna ograničenja) u usporedbi s onima koji su primali placebo.
English: • Do not put the needle cap back on the syringe.
Croatian: • Nemojte vraćati zatvarač igle na štrcaljku.
English: While urticaria is uncommon, serious cases of urticaria have been reported in galcanezumab clinical studies.
Croatian: Iako je urtikarija manje česta, u kliničkim su ispitivanjima galkanezumaba prijavljeni ozbiljni slučajevi urtikarije.
English: Most frequently reported terms (≥ 1 %) were: Injection site reaction, Injection site erythema, Injection site pruritus, Injection site bruising, Injection site swelling.
Croatian: Opći poremećaji i reakcije na mjestu primjene bol na mjestu injiciranja reakcije na mjestu injiciranjaa a Najčešće prijavljeni pojmovi (≥ 1%) bili su: reakcija na mjestu injiciranja, eritem na mjestu injiciranja, pruritus na mjestu injiciranja, stvaranje modrica na mjestu injiciranja, oticanje na mjestu injiciranja.
English: List of adverse reactions in clinical studies and post-marketing reports
Croatian: Tablica 1: Popis nuspojava iz kliničkih ispitivanja i ispitivanja nakon stavljanja lijeka u promet
English: Emgality is given by injection under your skin (subcutaneous injection).
Croatian: Emgality se primjenjuje injekcijom pod kožu (supkutanom injekcijom).
English: For subcutaneous use
Croatian: Za supkutanu primjenu
English: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.
Croatian: Preporučena doza je 120 mg galkanezumaba primijenjena supkutanom injekcijom jednom mjesečno, uz početnu udarnu dozu od 240 mg.
English: Ask your doctor, nurse or pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte svog liječnika, medicinsku sestru ili ljekarnika kako baciti lijekove koje više ne koristite.
English: Leave the base cap on until you are ready to inject.
Croatian: Nemojte skinuti zatvarač baze dok ne budete spremni injicirati lijek.
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Upute za uporabu
English: • Keep holding the clear base firmly against your skin.
Croatian: • Nastavite držati prozirnu bazu čvrsto priljubljenom uz kožu.
English: Emgality pre-filled pen is for single use only and contains one dose of Emgality (120 mg).
Croatian: Napunjena brizgalica s lijekom Emgality namijenjena je samo za jednokratnu uporabu i sadrži jednu dozu lijeka Emgality (120 mg).
English: Skin and Subcutaneous Tissue
Croatian: Poremećaji kože i potkožnog tkiva pruritus osip urtikarija
English: The 2 episodic migraine studies (EVOLVE-1 and EVOLVE-2) enrolled patients who met International Classification of Headache Disorders (ICHD) criteria for a diagnosis of migraine with or without aura with 4-14 migraine headache days per month.
Croatian: International Classification of Headache Disorders, ICHD) za dijagnozu migrene s aurom ili bez nje i koji su imali migrensku glavobolju 4 do 14 dana mjesečno.
English: MSQ Role Function Restrictive Domain Responders
Croatian: MSQ rezultat za funkcionalna ograničenja
English: Efficacy and patient reported outcome measures
Croatian: Tablica 3: Djelotvornost i mjere ishoda koje su prijavili bolesnici
English: Injection Button
Croatian: Tirkizni gumb za injiciranje
English: If you drop it on a hard surface, do not use it. Use a new pen for your injection.
Croatian: Ako Vam padne na tvrdu površinu, nemojte je upotrijebiti.
English: eNot adjusted for multiple comparisons.
Croatian: eNije prilagođeno za višestruke usporedbe.
English: Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
Croatian: 4.1 Terapijske indikacije Emgality je indiciran za profilaksu migrene u odraslih osoba koje imaju migrenu najmanje 4 dana mjesečno.
English: Base Cap
Croatian: Zatvarač baze
English: dStatistically significant after adjustment for multiple comparisons.
Croatian: dStatistički značajno nakon prilagodbe za višestruke usporedbe.
English: At Gestational Day 29, in rabbit embryo-foetal development toxicity study skull anomaly was found in one male foetus from mother treated with galcanezumab at an exposure approximately 33 times the human exposure at 240 mg.
Croatian: U ispitivanju toksičnih učinaka na embriofetalni razvoj kunića, 29. dana gestacije, u jednog je fetusa muškog spola čija je majka dobivala galkanezumab, zabilježena anomalija lubanje pri izloženosti približno 33 puta većoj od one u ljudi nakon primjene doze od 240 mg.
English: DO NOT put the base cap back on.
Croatian: NEMOJTE vraćati zatvarač na bazu.
English: Monthly doses of 120 mg or 240 mg achieved a steady-state Cmax (Cmax, ss) of approximately 28 μg/mL (35 % CV) or 54 μg/mL (31 % CV), respectively.
Croatian: iznosio je približno 28 μg/ml (CV 35%) odnosno 54 μg/ml (CV 31%).
English: The overall mean reduction from baseline in the number of monthly MHDs averaged over the treatment phase was 5.6 days for the 120 mg dose group and 6.5 days for the 240 mg dose group.
Croatian: Ukupna srednja vrijednost smanjenja prosječnog broja dana s migrenskom glavoboljom mjesečno tijekom razdoblja liječenja u odnosu na početak ispitivanja iznosila je 5,6 dana u skupini koja je primala dozu od 120 mg te 6,5 dana u skupini koja je primala dozu od 240 mg.
English: The instructions for using the syringe included with the Package Leaflet, must be followed carefully.
Croatian: Moraju se pažljivo slijediti upute za uporabu brizgalice koje se nalaze u uputi o lijeku.
English: • the medicine is cloudy, is discolored, or has small particles
Croatian: • ako je lijek mutan, ako je promijenio boju ili ako sadrži male čestice
English: seconds
Croatian: sekundi
English: Emgality is a solution for injection in a clear glass syringe.
Croatian: Emgality je otopina za injekciju u prozirnoj staklenoj štrcaljki.
English: How to store Emgality
Croatian: Kako primjenjivati Emgality
English: What if there is a drop of liquid on the tip of the needle when I remove the needle cap?
Croatian: Što ako se na vrhu igle nalazi kapljica tekućine nakon što skinem zatvarač igle?
English: • Gently pinch and hold a fold of skin where you will inject.
Croatian: • Nježno uhvatite nabor kože na mjestu gdje ćete injicirati lijek.
English: Packs of 1, 2 or 3 pre-filled pens.
Croatian: Pakiranja od 1, 2 ili 3 napunjene brizgalice.
English: Based on a population pharmacokinetic (PK) analysis, following a loading dose of 240 mg the maximum serum concentration (Cmax) of galcanezumab was approximately 30 μg/mL (27 % coefficient of variation, (CV)) and the time to Cmax was 5 days postdose.
Croatian: galkanezumaba nakon primjene udarne doze od 240 mg iznosila je približno 30 μg/ml (koeficijent varijacije [engl. coefficient of variation, CV] 27 %), a vrijeme do postizanja Cmax iznosilo je 5 dana od primjene doze.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE - NAPUNJENA ŠTRCALJKA
English: A. Do not remove the base cap.
Croatian: Nemojte skinuti zatvarač baze.
English: A. Do not touch the needle or replace the base cap. Store in a safe place to avoid an accidental needlestick.
Croatian: Brizgalicu odložite na sigurno mjesto kako biste izbjegli slučajan ubod iglom.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Sjedinjene Američke Države Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: The medicine inside should be clear.
Croatian: Lijek u brizgalici mora biti bistar.
English: • Each syringe is for ONE-TIME USE ONLY.
Croatian: • Jedna je brizgalica namijenjena SAMO ZA JEDNOKRATNU UPORABU.
English: Eli Lilly Nederland B. V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Eli Lilly Nederland B. V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska.
English: Dispose of the pen
Croatian: Odložite brizgalicu
English: Emgality may be stored unrefrigerated for up to 7 days when stored at temperatures up to 30 °C.
Croatian: Emgality se može čuvati izvan hladnjaka tijekom najviše 7 dana na temperaturi do 30°C.
English: Store in a refrigerator (2 ºC - 8 ºC).
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati u hladnjaku (2ºC - 8ºC).
English: Do not use the syringe, and dispose of as directed by your doctor, pharmacist or nurse if:
Croatian: Nemojte upotrijebiti štrcaljku i zbrinite je sukladno uputama koje ste dobili od liječnika, ljekarnika ili medicinske sestre:
English: In pooled data from studies EVOLVE-1 and EVOLVE-2, more than 19 % of the patients treated with galcanezumab maintained a ≥ 50 % response from Month 1 to Month 6 versus 8 % of the patients on placebo (p < 0.001).
Croatian: Na temelju objedinjenih podataka iz ispitivanja EVOLVE-1 i EVOLVE-2, odgovor u smislu smanjenja broja dana s migrenskom glavoboljom za ≥ 50% održao se od 1. do 6. mjeseca u više od 19% bolesnika liječenih galkanezumabom naspram 8% bolesnika koji su primali placebo (p < 0,001).
English: dNot statistically significant after adjustment for multiple comparisons.
Croatian: dNije statistički značajno nakon prilagodbe za višestruke usporedbe.
English: 1 mL of solution in a type I clear glass syringe.
Croatian: 1 ml otopine u prozirnoj staklenoj štrcaljki (staklo tipa I).
English: Emgality may be stored unrefrigerated for single period up to 7 days when stored at temperatures up to 30 °C.
Croatian: Emgality se može čuvati izvan hladnjaka tijekom jednokratnog razdoblja od najviše 7 dana na temperaturi do 30°C.
English: aEfficacy outcomes were evaluated across Months 1-6. bEvaluated across Months 4-6. cDefined as those with an improvement of ≥ 25 points for Episodic Migraine at Months 4-6 average.
Croatian: cDefinirani kao bolesnici s prosječnim poboljšanjem rezultata za epizodnu migrenu za ≥ 25 bodova tijekom razdoblja od 4. do 6. mjeseca.
English: Pack sizes of 1, 2 or 3 pre-filled syringes.
Croatian: Pakiranja od 1, 2 ili 3 napunjene štrcaljke.
English: MSQ role function restrictive domain responders were defined as those with an improvement of ≥ 17.14 points for Chronic Migraine at Month 3. cStatistically significant after adjustment for multiple comparisons.
Croatian: Bolesnici s odgovorom prema MSQ rezultatu za funkcionalna ograničenja definirali su se kao bolesnici koji su ostvarili poboljšanje rezultata za kroničnu migrenu za ≥ 17,14 bodova tijekom 3 mjeseca.
English: Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the PK of galcanezumab have not been conducted.
Croatian: Nisu provedena posebna ispitivanja kliničke farmakologije kojima bi se ocijenili učinci oštećenja bubrežne i jetrene funkcije na farmakokinetiku galkanezumaba.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED PEN
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE - NAPUNJENA BRIZGALICA
English: Read the “Instructions for Use” for the syringe carefully before using Emgality.
Croatian: "Upute za uporabu" brizgalice prije nego što primijenite Emgality.
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, Nizozemska
English: • Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.
Croatian: • Pitajte svog liječnika, ljekarnika ili medicinsku sestru kako baciti lijekove koje više ne koristite.
English: Dispose of the syringe in a sharps disposal container or as directed by your doctor, pharmacist or nurse.
Croatian: Brizgalicu odložite u spremnik za odlaganje oštrih predmeta ili je zbrinite sukladno uputama liječnika, ljekarnika ili medicinske sestre.
English: Q. What if I see air bubbles in my pen?
Croatian: Što ako vidim mjehuriće zraka u brizgalici?
English: Excipients: L-histidine, L-histidine hydrochloride monohydrate, sodium chloride, polysorbate 80, water for injections.
Croatian: Pomoćne tvari: L-histidin, L-histidinklorid hidrat, natrijev klorid, polisorbat 80,
English: DO NOT put the needle cap back on.
Croatian: NEMOJTE vraćati zatvarač igle na štrcaljku.
English: Talk to your doctor, pharmacist or nurse before or during treatment with Emgality if: - you have a serious cardiovascular disease.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije ili tijekom liječenja lijekom
English: Leave the needle cap on until you are ready to inject.
Croatian: Nemojte skinuti zatvarač igle dok ne budete spremni injicirati lijek.
English: Patients with recent acute cardiovascular events (including MI, unstable angina, CABG, stroke, DVT) and/or those deemed to be at serious cardiovascular risk were excluded from the galcanezumab clinical trials.
Croatian: premoštenje koronarne arterije presatkom, moždani udar i duboku vensku trombozu) i/ili oni za koje se smatralo da su izloženi ozbiljnom kardiovaskularnom riziku.
English: Over 1400 patients were exposed to galcanezumab during the double-blind treatment phase of the placebocontrolled phase 3 studies.
Croatian: Tijekom dvostruko slijepog razdoblja liječenja u sklopu placebom kontroliranih ispitivanja faze 3 galkanezumabu je bilo izloženo više od 1400 bolesnika.
English: Mean Change
Croatian: Srednja vrijednost promjene
English: Back of arm
Croatian: Stražnjica Bedro
English: Based on a population PK analysis that included doses ranging from 5 - 300 mg, the rate of absorption, apparent clearance and apparent volume of distribution was independent of dose.
Croatian: Na temelju populacijske farmakokinetičke analize koja je obuhvatila doze u rasponu od 5 do 300 mg,
English: The solution is clear and colourless to slightly yellow.
Croatian: Otopina je bistra te bezbojna do žućkasta.
English: Uncommon side effects (may affect up to 1 in 100 people): - Hives (raised itchy areas of skin)
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba):
English: • Remove the pen from your skin.
Croatian: • Dignite brizgalicu s kože.
English: In all 3 studies, the overall mean change from baseline in number of monthly Migraine Headache Days (MHDs) was the primary efficacy measure.
Croatian: Primarna mjera ishoda za djelotvornost u svim je trima ispitivanjima bila ukupna srednja vrijednost promjene broja dana s migrenskom glavoboljom mjesečno (engl.
English: Q. What if there is a drop of liquid on the tip of the needle when I remove the base cap?
Croatian: Što ako se na vrhu igle nalazi kapljica tekućine nakon što skinem zatvarač baze?
English: • Leave the needle cap on until you are ready to inject.
Croatian: • Nemojte skinuti zatvarač igle dok ne budete spremni injicirati lijek.
English: The syringe is encased in a disposable, single-dose pen.
Croatian: Štrcaljka je uložena u jednodoznu brizgalicu za jednokratnu uporabu.
English: In pooled data from studies EVOLVE-1 and EVOLVE-2, in patients who failed one or more prophylactic treatments for efficacy reasons, the treatment difference for the reduction of mean monthly MHDs observed between galcanezumab 120 mg and placebo was -2.69 days (p < 0.001) and between galcanezumab 240 mg and placebo -2.78 days (p < 0.001).
Croatian: Na temelju objedinjenih podataka iz ispitivanja EVOLVE-1 i EVOLVE-2, u bolesnika koji nisu uspješno odgovorili na jedno ili više profilaktičkih liječenja zbog razloga povezanih s djelotvornošću, razlika između liječenja s obzirom na smanjenje srednje vrijednosti broja dana s migrenskom glavoboljom mjesečno iznosila je -2,69 dana (p < 0,001) za galkanezumab 120 mg u odnosu na placebo te -2,78 dana (p < 0,001) za galkanezumab 240 mg u odnosu na placebo.
English: At Gestational Day 20, an increase in the number of foetuses and litters with short ribs and a decrease in the mean number of ossified caudal vertebrae occurred in the rat embryo-foetal toxicity development study at an exposure approximately 20 times the human exposure at 240 mg.
Croatian: U ispitivanju toksičnih učinaka na embriofetalni razvoj štakora, 20. dana gestacije zabilježeno je povećanje broja fetusa i mladunaca s kratkim rebrima te smanjenje srednje vrijednosti broja osificiranih repnih kralježaka pri izloženosti približno 20 puta većoj od one u ljudi nakon primjene doze od 240 mg.
English: Grey Syringe Plunger
Croatian: Sivi klip štrcaljke
English: Patients treated with galcanezumab had greater response rates and greater reductions in the number of monthly MHDs that acute medication was taken compared with placebo-treated patients.
Croatian: U odnosu na bolesnike koji su primali placebo, u bolesnika liječenih galkanezumabom zabilježena je veća stopa odgovora i veće smanjenje broja dana primjene akutne terapije za migrensku glavobolju mjesečno.
English: Thumb Pad
Croatian: Oslonac za palac
English: EU/1/18/1330/003 (1 pre-filled syringe) EU/1/18/1330/004 (3 pre-filled syringes) EU/1/18/1330/006 (2 pre-filled syringes)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1330/003 (1 napunjena štrcaljka) EU/1/18/1330/004 (3 napunjene štrcaljke) EU/1/18/1330/006 (2 napunjene štrcaljke)
English: Comprehensive instructions for administration are given in the Package Leaflet.
Croatian: Sveobuhvatne upute za primjenu navode se u uputi o lijeku.
English: There is no evidence to suggest that chronic treatment with galcanezumab would increase the risk of carcinogenesis based on data from pharmacology and chronic toxicology studies with galcanezumab, as well as an assessment of the literature regarding CGRP.
Croatian: Na temelju podataka iz ispitivanja farmakologije i kronične toksičnosti galkanezumaba, kao i ocjene literature o CGRP-u, nema dokaza koji bi ukazivali na to da bi kronično liječenje galkanezumabom moglo povećati rizik od kancerogeneze.
English: Wash your hands with soap and water before you inject Emgality.
Croatian: Prije nego što injicirate Emgality, operite ruke sapunom i vodom.
English: Immune system disorders
Croatian: Poremećaji probavnog sustava konstipacija
English: Both galcanezumab 120 mg and 240 mg treatment groups demonstrated statistically significant and clinically meaningful improvements from baseline compared to placebo on mean change in MHD (see Table 2).
Croatian: I u skupini koja je primala galkanezumab u dozi od 120 mg i u onoj liječenoj galkanezumabom u dozi od 240 mg opaženo je statistički značajno i klinički važno poboljšanje od početka ispitivanja u usporedbi s placebom s obzirom na srednju vrijednost promjene broja dana s migrenskom glavoboljom (vidjeti Tablicu 2).
English: Galcanezumab-treated patients had a greater improvement in functioning (as measured by the MSQ Role Function-Restrictive domain score) compared with placebo-treated patients, beginning at month 1.
Croatian: U usporedbi s bolesnicima koji su primali placebo, oni liječeni galkanezumabom ostvarili su veće poboljšanje funkcioniranja (mjereno MSQ rezultatom za funkcionalna ograničenja), koje je opaženo već u 1. mjesecu.
English: EU/1/18/1330/001 EU/1/18/1330/002 EU/1/18/1330/005
Croatian: EU/1/18/1330/005
English: • Your doctor or nurse should show you how to prepare and inject Emgality using the syringe.
Croatian: Vam pokazati kako pripremiti i injicirati Emgality uz pomoć brizgalice.
English: Galcanezumab may have a minor influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Galkanezumab može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Anaphylaxis Angioedema
Croatian: Poremećaji imunološkog sustava anafilaksija angioedem
English: Sixty-four percent of the patients had acute headache medication overuse at baseline.
Croatian: U 64% bolesnika zabilježena je prekomjerna uporaba lijekova za akutno liječenje migrene na početku ispitivanja.
English: 2 Place and Unlock
Croatian: Namjestite i otključajte
English: Ear and Labyrinth System
Croatian: Poremećaji uha i labirinta vrtoglavica
English: Each pre-filled syringe contains 120 mg of galcanezumab
Croatian: Jedna napunjena štrcaljka sadrži 120 mg galkanezumaba
English: In patients who failed one or more prophylactic treatments for efficacy reasons, the treatment difference for the reduction of mean monthly MHDs observed between galcanezumab 120 mg and placebo was -3.54 days (p < 0.001) and between galcanezumab 240 mg and placebo -1.37 days (p < 0.05).
Croatian: U bolesnika koji nisu uspješno odgovorili na jedno ili više profilaktičkih liječenja zbog razloga povezanih s djelotvornošću, razlika između liječenja s obzirom na smanjenje srednje vrijednosti broja dana s migrenskom glavoboljom mjesečno iznosila je -3,54 dana (p < 0,001) za galkanezumab 120 mg u odnosu na placebo te -1,37 dana (p < 0,05) za galkanezumab 240 mg u odnosu na placebo.
English: L-histidine hydrochloride monohydrate Polysorbate 80
Croatian: L-histidinklorid hidrat polisorbat 80 natrijev klorid voda za injekcije
English: A signal for hypersensitivity reactions, based on cases reported from post-marketing spontaneous data sources was reviewed by the MAH in the PSUR.
Croatian: (PSUR) za galkanezumab, znanstveni zaključci CHMP-a su sljedeći: Nositelj odobrenja je u PSUR-u analizirao signal vezan uz reakcije preosjetljivosti, baziran na slučajevima prijavljenima iz spontanih izvora nakon stavljanja lijeka u promet.
English: Bottom/ Needle end
Croatian: Donji dio/dio s iglom
English: EU/1/18/1330/003 EU/1/18/1330/004 EU/1/18/1330/006
Croatian: EU/1/18/1330/006