FrancophonIA/ELRC3.0 huggingface dataset:
English: The 120 mg dose was associated with a statistically significant reduction in disability over placebo.
Croatian: Doza od 120 mg bila je povezana sa statistički značajnim smanjenjem onesposobljenosti u odnosu na placebo.
English: Choose your injection site
Croatian: Odaberite mjesto za injiciranje
English: System Organ Class
Croatian: Klasifikacije organskih sustava
English: Turn the lock ring to the unlock position.
Croatian: Otključajte brizgalicu okretanjem prstena za zaključavanje.
English: Vertigo may occur following the administration of galcanezumab (see section 4.8).
Croatian: Nakon primjene galkanezumaba može se javiti vrtoglavica (vidjeti dio 4.8).
English: The cumulative review of the data, taking into account pharmacological plausibility, temporal association to treatment and a general lack of confounding factors, concluded that anaphylaxis, angioedema, and rash should be added as new adverse drug reactions in the SmPC and package leaflet of galcanezumab.
Croatian: Kumulativnim pregledom podataka, uzimajući u obzir farmakološku vjerojatnost, vremensku povezanost s liječenjem i općeniti nedostatak zbunjujućih čimbenika, zaključeno je da anafilaksiju, angioedem i osip treba dodati kao nove nuspojave lijeka u sažetak opisa svojstava lijeka i uputu o lijeku galkanezumaba.
English: If the syringe is stored at a higher temperature or for a longer period it must be discarded.
Croatian: Ako se štrcaljka čuvala na višoj temperaturi ili tijekom duljeg razdoblja, mora se baciti.
English: Treatment Difference
Croatian: Razlika između liječenja
English: Galcanezumab was associated with a statistically significant reduction in disability over placebo.
Croatian: Galkanezumab je bio povezan sa statistički značajnim smanjenjem onesposobljenosti u odnosu na placebo.
English: • Do not continue to use the syringe
Croatian: • Nemojte nastaviti s uporabom štrcaljke.
English: A caregiver may also give you your Emgality injection after proper training.
Croatian: Injekciju lijeka Emgality može Vam dati i njegovatelj nakon što prođe propisnu obuku.
English: Completion rate of the double-blind treatment phase for patients who received galcanezumab ranged from 82.8 % to 87.7 %.
Croatian: Stopa dovršenja dvostruko slijepog razdoblja liječenja među bolesnicima koji su primali galkanezumab kretala se u rasponu od 82,8% do 87,7%.
English: Response rate is the mean percentage of patients meeting a defined threshold in the reduction of the number of monthly MHDs (≥ 50 %, ≥ 75 % and 100 %) across the double-blind treatment period.
Croatian: Stopa odgovora je srednja vrijednost postotka bolesnika koji su dosegnuli definiranu donju graničnu vrijednost smanjenja broja dana s migrenskom glavoboljom mjesečno (≥ 50%, ≥ 75% i 100%) tijekom dvostruko slijepog razdoblja liječenja.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena ispitivanja interakcija s drugim lijekovima.
English: Did I get my complete injection?
Croatian: Jesam li injicirao cijelu dozu?
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 humani IgG izlučuje u majčino mlijeko tijekom prvih nekoliko dana nakon poroda, a zatim njegova koncentracija ubrzo pada na nisku razinu.
English: Injection site location (abdomen, thigh, buttocks and arm) did not significantly influence the absorption of galcanezumab.
Croatian: Mjesto injiciranja (abdomen, bedro, stražnjica ili nadlaktica) nije značajno utjecalo na apsorpciju galkanezumaba.
English: Q. What if I unlocked the pen and pressed the teal injection button before I twisted off the base cap?
Croatian: Što ako otključam napunjenu brizgalicu i pritisnem tirkizni gumb za injiciranje prije nego što odvrnem i skinem zatvarač baze?
English: Medicinal product subject to restricted medical prescription.
Croatian: Lijek se izdaje na ograničeni recept.
English: No dose adjustment is needed on the basis of age (18 to 65 years), sex, weight, race or ethnicity as there was no clinically meaningful effect of these factors on the apparent clearance or apparent volume of distribution of galcanezumab.
Croatian: Nije potrebno prilagođavati dozu s obzirom na dob (18 - 65 godina), spol, tjelesnu težinu, rasu ili etničko podrijetlo, jer navedeni faktori nisu imali klinički značajnog utjecaja na prividni klirens ni prividni volumen distribucije galkanezumaba.
English: The baseline scores of the MIDAS reflected severe migraine related disability of patients in EVOLVE-1 and EVOLVE-2 (mean of 33.1) and a very severely disabled population (mean of 67.2) in REGAIN.
Croatian: Početni MIDAS rezultati pokazali su tešku onesposobljenost uzrokovanu migrenom u bolesnika u ispitivanjima EVOLVE-1 i EVOLVE-2 (srednja vrijednost 33,1) i izrazito tešku onesposobljenost populacije bolesnika u ispitivanju REGAIN (srednja vrijednost 67,2).
English: Do not take a double dose to make up for forgotten injection If you have forgotten to inject a dose of Emgality, inject the missed dose as soon as possible and then inject the next dose after a month from that date.
Croatian: Ako ste zaboravili primijeniti dozu lijeka Emgality, injicirajte propuštenu dozu što je prije moguće, a zatim sljedeću dozu primijenite mjesec dana od tog datuma.
English: • Place and hold the clear base flat and firmly against your skin.
Croatian: • Položite i držite prozirnu bazu ravno i čvrsto priljubljenom uz kožu.
English: Put the original package with any unused pens back in the refrigerator.
Croatian: Vratite originalno pakiranje s neupotrijebljenim brizgalicama u hladnjak.
English: • Periodic Safety Update Reports (PSURs)
Croatian: • Periodička izvješća o neškodljivosti lijeka (PSUR-evi)
English: You can also read the “Choose your injection site” section of these instructions to help you choose which area can work best for you.
Croatian: Kako biste lakše odabrali mjesto koje Vam najbolje odgovara, možete pročitati i dio ove upute pod nazivom „Odaberite mjesto za injiciranje“.
English: Based on a population PK analysis, bilirubin concentration or Cockcroft-Gault creatinine clearance (range: 24 to 308 mL/min) did not significantly influence the apparent clearance of galcanezumab.
Croatian: Na temelju populacijske farmakokinetičke analize, koncentracija bilirubina i klirens kreatinina izračunat Cockcroft-Gaultovom formulom (raspon: 24 - 308 ml/min) nisu značajno utjecali na prividni klirens galkanezumaba.
English: As a humanised IgG4 monoclonal antibody, galcanezumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Croatian: Budući da je galkanezumab humanizirano IgG4 monoklonsko protutijelo, očekuje se da će se kataboličkim putovima razgraditi na male peptide i aminokiseline na isti način kao i endogeni IgG.
English: Less than 2.5 % of patients in these studies discontinued due to adverse events.
Croatian: U tim je ispitivanjima manje od 2,5% bolesnika prekinulo liječenje zbog nuspojava.
English: • Another person may give you the injection in the back of your upper arm or buttock.
Croatian: • Druga osoba može Vam lijek injicirati u stražnji dio nadlaktice ili stražnjicu.
English: Figure 2 Reduction in monthly migraine headache days over time in study REGAIN
Croatian: Slika 2: Smanjenje broja dana s migrenskom glavoboljom mjesečno tijekom vremena u ispitivanju REGAIN
English: Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1).
Croatian: U klinička ispitivanja nisu bili uključeni bolesnici s određenim značajnim kardiovaskularnim bolestima (vidjeti dio 5.1).
English: Q. How can I tell if my injection is complete?
Croatian: P. Kako ću znati jesam li završio injekciju?
English: The syringe must not be shaken.
Croatian: Štrcaljka se ne smije tresti.
English: Clear Base
Croatian: Prozirna baza
English: Inspect the pen and the medicine
Croatian: Pregledajte brizgalicu i lijek
English: That is the normal operation of the pen.
Croatian: Tako brizgalica normalno funkcionira.
English: Emgality is used to prevent migraine in adult patients who have at least 4 migraines days per month.
Croatian: Emgality se koristi za sprječavanje migrene u odraslih osoba koje imaju migrenu najmanje 4 dana mjesečno.
English: Completion rate of the double-blind treatment phase for patients who received galcanezumab was 95.3 %.
Croatian: Stopa dovršetka dvostruko slijepog razdoblja liječenja među bolesnicima koji su primali galkanezumab iznosila je 95,3%.
English: One percent of the patients exposed to galcanezumab during the phase 3 studies experienced severe pain at the injection site.
Croatian: U jedan posto bolesnika koji su bili izloženi galkanezumabu tijekom ispitivanja faze 3 zabilježena je teška bol na mjestu injiciranja.
English: Water for injections
Croatian: voda za injekcije.
English: What if there is a drop of liquid or blood on my skin after my injection?
Croatian: Što ako mi se nakon injekcije na koži pojavi kapljica tekućine ili krvi?
English: No dose adjustment is required in patients with mild to moderate renal impairment or hepatic impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim do umjerenim oštećenjem bubrežne funkcije ili oštećenjem jetrene funkcije (vidjeti dio 5.2).
English: Emgality should not be used if the solution is cloudy, discoloured or contains particles, or if any part of the device appears to be damaged.
Croatian: Emgality se ne smije primijeniti ako je otopina mutna, ako je promijenila boju, ako sadrži čestice ili ako bilo koji dio pomagala za primjenu izgleda oštećeno.
English: If you are a woman able to have children, you are advised to avoid becoming pregnant while using Emgality.
Croatian: Ako ste žena koja može zatrudnjeti, preporučuje se da izbjegavate trudnoću tijekom liječenja lijekom
English: On the basis of the scientific conclusions for galcanezumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing galcanezumab is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za galkanezumab, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) galkanezumab nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Do not inject yourself or someone else until you have been shown how to inject Emgality.
Croatian: Nemojte injicirati Emgality sebi ili drugoj osobi dok Vam zdravstveni radnik ne pokaže kako se to radi.
English: Emgality contains galcanezumab, a medicine that stops the activity of a naturally occurring substance in the body called calcitonin gene-related peptide (CGRP).
Croatian: Emgality sadrži galkanezumab, lijek koji sprječava djelovanje tvari koja je prirodno prisutna u organizmu, a zove se peptid povezan s kalcitoninskim genom (engl. calcitonin gene-related peptide, CGRP).
English: Non-clinical data revealed no special hazards for humans based on repeat-dose toxicity studies conducted in rats and cynomolgus monkeys and safety pharmacology evaluations conducted in cynomolgus monkeys at exposures approximately 10 to 80 times higher than clinical exposures in patients receiving 240 mg.
Croatian: Neklinički podaci nisu ukazali na poseban rizik za ljude na temelju ispitivanja toksičnosti ponovljenih doza provedenih na štakorima i makaki majmunima te ispitivanja sigurnosne farmakologije provedenih na makaki majmunima pri razinama izloženosti približno 10 - 80 puta većima od kliničkih razina izloženosti u bolesnika nakon primjene doze od 240 mg.
English: Galcanezumab could have a minor effect on your ability to drive and use machines.
Croatian: Galkanezumab može malo utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: The effect of galcanezumab on human fertility has not been evaluated.
Croatian: Nije se ocjenjivao učinak galkanezumaba na plodnost ljudi.
English: In male fertility study, right testis weight was significantly reduced at exposures to 4 times the human exposure at 240 mg.
Croatian: U ispitivanju plodnosti mužjaka zabilježeno je značajno smanjenje težine desnog testisa pri izloženosti 4 puta većoj od one u ljudi nakon primjene doze od 240 mg.
English: Syringe Body with Medicine
Croatian: Tijelo štrcaljke ispunjeno lijekom
English: It may be colourless to slightly yellow.
Croatian: Može biti bezbojan do žućkast.
English: - The first time you receive Emgality your doctor or nurse will inject two syringes (total 240 mg).
Croatian: - Prvi puta kada primite Emgality, liječnik ili medicinska sestra injicirat će Vam sadržaj dviju štrcaljki (ukupno 240 mg).
English: 100 % Responders Percentage, % P-value
Croatian: Postotak, % P-vrijednost
English: It is unknown whether galcanezumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se galkanezumab u majčino mlijeko.
English: Galcanezumab is a humanised IgG4 monoclonal antibody that binds calcitonin gene-related peptide (CGRP) thus preventing its biological activity.
Croatian: Galkanezumab je humanizirano IgG4 monoklonsko protutijelo koje se vezuje za peptid povezan s kalcitoninskim genom (engl. calcitonin gene-related peptide, CGRP) i tako sprječava njegovu biološku aktivnost.
English: Similarly, IgG monoclonal antibodies are mainly eliminated via intracellular catabolism and hepatic impairment is not expected to influence the clearance of galcanezumab.
Croatian: Slično tome, IgG monoklonska protutijela pretežno se eliminiraju unutarstaničnim katabolizmom, pa se ne očekuje da će oštećenje jetrene funkcije utjecati na klirens galkanezumaba.
English: Galcanezumab is to be injected subcutaneously in the abdomen, thigh, back of the upper arm, or in the gluteal region.
Croatian: Galkanezumab se primjenjuje supkutanom injekcijom u abdomen, bedro, stražnji dio nadlaktice ili glutealno područje.
English: Emgality contains sodium
Croatian: Emgality sadrži natrij
English: • Do not inject in the same spot as before.
Croatian: • Nemojte injicirati lijek u isto mjesto u koje ste primijenili prošlu injekciju.
English: If the pen is stored at a higher temperature or for a longer period it must be discarded.
Croatian: Ako se brizgalica čuvala na višoj temperaturi ili tijekom duljeg razdoblja, mora se baciti.
English: - The first time you receive Emgality your doctor or nurse will inject two pens (total 240 mg).
Croatian: - Prvi puta kada primite Emgality, liječnik ili medicinska sestra injicirat će Vam sadržaj dviju brizgalica (ukupno 240 mg).
English: In the clinical studies, the incidence of anti-drug antibody development during the double-blind treatment phase was 4.8 % in patients receiving galcanezumab once monthly (all but one of whom had in vitro neutralizing activity).
Croatian: U kliničkim je ispitivanjima incidencija razvoja protutijela na lijek tijekom dvostruko slijepog razdoblja liječenja iznosila 4,8% u bolesnika koji su primali galkanezumab jednom mjesečno (među tim je bolesnicima kod svih osim jednoga zabilježeno neutralizirajuće djelovanje in vitro).
English: A. It is normal to have air bubbles in the pen.
Croatian: O. Normalno je da se u brizgalici nalaze mjehurići zraka.
English: Approximately 15 % of the patients continued concurrent treatment with topiramate or propranolol as allowed by the protocol for prophylaxis of migraine.
Croatian: Približno 15% bolesnika nastavilo je istodobno primjenjivati topiramat ili propranolol za profilaksu migrene kada je to bilo dopušteno planom ispitivanja.
English: With 12 months of treatment, up to 12.5 % of galcanezumab-treated patients developed anti-drug antibodies, most of which were of low titre and tested positive for neutralising activity in vitro.
Croatian: Nakon 12 mjeseci liječenja u do 12,5% bolesnika liječenih galkanezumabom razvila su se protutijela na lijek, koja su se u većini slučajeva javila u niskim titrima i bila pozitivna na neutralizirajuće djelovanje in vitro.
English: The other ingredients are: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride and water for injections.
Croatian: Drugi sastojci su: L-histidin, L-histidinklorid hidrat, polisorbat 80, natrijev klorid i voda za injekcije.
English: • Dispose of the syringe and get a new one
Croatian: • Zbrinite štrcaljku i uzmite novu.
English: • The grey syringe plunger should be pushed all the way to end of the syringe.
Croatian: • Sivi klip štrcaljke treba potisnuti sve do kraja štrcaljke.
English: In a juvenile toxicology study in which rats were administered galcanezumab twice weekly from Postnatal Day 21 through 90, systemic effects were limited to reversible, minimal, nonadverse decreases in total bone mineral content and bone mineral density at exposures approximately 50 times the human exposure at 240 mg.
Croatian: U toksikološkom ispitivanju na juvenilnim štakorima kojima se galkanezumab primjenjivao dvaput tjedno od 21. do 90. dana nakon okota sistemski su učinci bili ograničeni na reverzibilna, minimalna smanjenja ukupnog mineralnog sadržaja i mineralne gustoće kosti, koja nisu bila štetna i koja su opažena pri izloženosti približno 50 puta većoj od one u ljudi nakon primjene doze od 240 mg.
English: Episodic migraine
Croatian: Epizodna migrena
English: Do not use this medicine after the expiry date which is stated on the label and on the carton after “EXP.” The expiry date refers to the last day of that month.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „EXP“.
English: Take the syringe from the refrigerator
Croatian: Izvadite brizgalicu iz hladnjaka
English: No dose adjustment is required as the pharmacokinetics of galcanezumab are not affected by age.
Croatian: Nije potrebno prilagođavati dozu jer dob ne utječe na farmakokinetiku galkanezumaba.
English: Papendorpseweg 83, 3528 BJ Utrecht The Netherlands
Croatian: Papendorpseweg 83, 3528 BJ Utrecht
English: Do not microwave the syringe, run hot water over it, or leave it in direct sunlight.
Croatian: Nemojte stavljati štrcaljku u mikrovalnu pećnicu ili pod mlaz vruće vode niti je izlagati izravnoj sunčevoj svjetlosti.
English: - After the first dose, you will use one syringe (120 mg) every month.
Croatian: Nakon prve doze, primjenjivat ćete jednu štrcaljku (120 mg) jednom mjesečno.
English: Its colour may vary from colourless to slightly yellow.
Croatian: Boja otopine može se kretati od bezbojne do žućkaste.
English: If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
Croatian: Ako dojite ili planirate dojiti, obratite se svom liječniku prije nego primijenite ovaj lijek.
English: • Remove the needle from your skin
Croatian: • Izvucite iglu iz kože.
English: The pre-filled syringe should be inspected visually prior to administration.
Croatian: Napunjenu štrcaljku treba vizualno pregledati prije uporabe.
English: What you need to know before you use Emgality 3.
Croatian: Što morate znati prije nego počnete primjenjivati Emgality
English: Injection site pain or reactions
Croatian: Opis odabranih nuspojava Bol ili reakcije na mjestu injiciranja
English: Before you use the EMGALITY syringe, read and carefully follow all the step-by-step instructions.
Croatian: Prije nego što upotrijebite štrcaljku s lijekom EMGALITY, pročitajte cjelovite upute za uporabu korak-po-korak i pažljivo ih slijedite.
English: Do not share or reuse your pen.
Croatian: Nemojte dijeliti štrcaljku s drugima niti je ponovno koristiti.
English: Emgality pre-filled syringe is for single use only and contains one dose of Emgality (120 mg).
Croatian: Napunjena štrcaljka s lijekom Emgality namijenjena je samo za jednokratnu uporabu i sadrži jednu dozu lijeka Emgality (120 mg).
English: If these conditions are exceeded, the pre-filled syringe must be discarded.
Croatian: Ako se ti uvjeti prekorače, napunjena brizgalica mora se baciti.
English: Solution for injection (injection).
Croatian: OBLIK Otopina za injekciju (injekcija).
English: It is okay to see a drop of liquid on the tip of the needle.
Croatian: U redu je ako vidite kapljicu tekućine na vrhu igle.
English: - After the first dose, you will use one pen (120 mg) every month.
Croatian: Nakon prve doze, primjenjivat ćete jednu brizgalicu (120 mg) jednom mjesečno.
English: There are limited data from the use of galcanezumab in pregnant women.
Croatian: Podaci o primjeni galkanezumaba u trudnica su ograničeni.
English: aEfficacy outcomes were evaluated across Months 1-3. bPatient-reported outcomes were evaluated at Month 3.
Croatian: aIshodi za djelotvornost ocjenjivali su se tijekom razdoblja od 1. do 3. mjeseca bIshodi koje su prijavili bolesnici ocjenjivali su se u 3. mjesecu.
English: • The teal plunger rod should show through the body of the syringe.
Croatian: • Tirkizni potisnik klipa trebao bi se vidjeti kroz tijelo štrcaljke.
English: • If you have vision problems, do not use Emgality syringe without help from a caregiver.
Croatian: • Ako imate poteškoća s vidom ili sluhom, nemojte koristiti štrcaljku s lijekom Emgality bez pomoći njegovatelja.
English: 3 Press and Hold
Croatian: Pritisnite i držite
English: Before you use the EMGALITY pen, read and carefully follow all the step-by-step instructions.
Croatian: Prije nego što upotrijebite brizgalicu s lijekom EMGALITY, pročitajte cjelovite upute za uporabu korak-po-korak i pažljivo ih slijedite.
English: • You should see the teal plunger rod show through the syringe body when the injection is complete as shown.
Croatian: • Kada injekcija završi, trebali biste vidjeti tirkizni potisnik klipa kroz tijelo štrcaljke, kao što je prikazano na slici.
English: The impact of migraine on functioning was assessed by the Role Function-Restrictive domain of the Migraine-Specific Quality of Life Questionnaire (MSQ) version 2.1, and by the Migraine Disability Assessment (MIDAS) Questionnaire.
Croatian: Utjecaj migrene na funkcioniranje bolesnika ocjenjivao se na temelju rezultata za domenu funkcionalnih ograničenja prema verziji 2.1 Upitnika o kvaliteti života kod migrene (engl.
English: Emgality is injected under your skin (subcutaneous injection).
Croatian: Emgality se injicira pod kožu (supkutana injekcija).
English: Patients received placebo, galcanezumab 120 mg/month (with an initial loading dose of 240 mg for the first month) or galcanezumab 240 mg/month and were allowed to use medication for the acute treatment of migraine.
Croatian: Bolesnici su primali placebo, galkanezumab u dozi od 120 mg mjesečno (uz početnu udarnu dozu od 240 mg primijenjenu prvog mjeseca) ili galkanezumab u dozi od 240 mg mjesečno i mogli su uzimati lijekove za akutno liječenje migrene.
English: REGAIN - Chronic Migraine Emgality
Croatian: REGAIN - kronična migrena
English: Before using your pre-filled pen (pen):
Croatian: Prije nego što upotrijebite napunjenu brizgalicu (brizgalicu):
English: Some patients have had vertigo whilst using Emgality.
Croatian: Neki su bolesnici tijekom primjene lijeka Emgality imali vrtoglavicu.
English: This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say it is essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 120 mg, tj. zanemarive količine natrija.
English: • the expiration date printed on the label has passed
Croatian: • ako je istekao rok valjanosti naveden na naljepnici
English: 1 pre-filled syringe 3 pre-filled syringes 2 pre-filled syringes
Croatian: 1 napunjena brizgalica 3 napunjene brizgalice 2 napunjene brizgalice
English: Chronic Migraine
Croatian: Kronična migrena
English: You and your doctor should decide if you should breast feed and use Emgality .
Croatian: Vi i Vaš liječnik trebate odlučiti hoćete li dojiti i primjenjivati Emgality.
English: Based on a population PK analysis, the apparent volume of distribution of galcanezumab was 7.3 L. Biotransformation
Croatian: Na temelju populacijske farmakokinetičke analize, prividni volumen distribucije galkanezumaba iznosio je 7,3 l.