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.
Slovenian: Učinkovitost se je v odprti študiji, v kateri so bolniki z bodisi epizodno ali kronično migreno (s povprečnim mesečnim številom MHD ob izhodišču 10,6 na mesec), prejemali 120 mg galkanezumaba/mesec (z začetnim polnilnim odmerkom 240 mg v prvem mesecu) ali 240 mg galkanezumaba/mesec, ohranila do 1 leta.
English: Injection site pain or reactions
Slovenian: Bolečina ali reakcije na mestu injiciranja
English: Dispose of the pen
Slovenian: 1 Snemite pokrovček
English: DO NOT put the needle cap back on.
Slovenian: Pokrovčka igle NE nameščajte nazaj.
English: Table 2.
Slovenian: Slika 2.
English: If these conditions are exceeded, the pre-filled pen must be discarded.
Slovenian: Če te pogoje presežete, morate napolnjeni injekcijski peresnik zavreči.
English: Before you use the EMGALITY pen, read and carefully follow all the step-by-step instructions.
Slovenian: Pred uporabo injekcijskega peresnika EMGALITY preberite in skrbno upoštevajte vsa navodila po korakih.
English: Comprehensive instructions for administration are given in the Package Leaflet.
Slovenian: Celovita navodila za dajanje so podana v navodilu za uporabo.
English: Emgality contains galcanezumab, a medicine that stops the activity of a naturally occurring substance in the body called calcitonin gene-related peptide (CGRP).
Slovenian: Kaj je zdravilo Emgality in za kaj ga uporabljamo Zdravilo Emgality vsebuje galkanezumab, zdravilo, ki zaustavi aktivnost naravne snovi v telesu, imenovane peptid, povezan z genom za kalcitonin (CGRP - calcitonin gene-related peptide).
English: 1 pre-filled syringe 3 pre-filled syringes 2 pre-filled syringes
Slovenian: raztopina za injiciranje 1 napolnjen injekcijski peresnik 3 napolnjeni injekcijski peresniki 2 napolnjena injekcijska peresnika
English: • Dispose of the syringe and get a new one
Slovenian: • Injekcijsko brizgo zavrzite in vzemite novo.
English: Most frequently reported terms (≥ 1 %) were: Injection site reaction, Injection site erythema, Injection site pruritus, Injection site bruising, Injection site swelling.
Slovenian: Splošne težave in spremembe na mestu aplikacije bolečina na mestu injiciranja reakcije na mestu injiciranjaa a Najpogosteje (≥ 1 %) so poročali o naslednjem: reakcija na mestu injiciranja, eritem na mestu injiciranja, pruritus na mestu injiciranja, podplutbe na mestu injiciranja, oteklina na mestu injiciranja.
English: BATCH NUMBER
Slovenian: Število MHD
English: Dispose of the pen and get a new one.
Slovenian: Injekcijski peresnik zavrzite in vzemite novega.
English: • Do not put the needle cap back on the syringe.
Slovenian: • Pokrovčka igle ne nameščajte ponovno nazaj na injekcijsko brizgo.
English: DO NOT put the base cap back on.
Slovenian: Pokrovčka podnožja NE nameščajte nazaj.
English: What if there is a drop of liquid or blood on my skin after my injection?
Slovenian: Kaj če po injiciranju opazim kapljico tekočine ali krvi na koži?
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.
Slovenian: Bolniki, zdravljeni z galkanezumabom, so imeli boljše stopnje odziva in večja zmanjšanja mesečnega MHD, ko so morali vzeti akutno zdravilo, v primerjavi z bolniki, zdravljenimi s placebom.
English: Do not use this medicine if you notice that the syringe is damaged, or the medicine is cloudy or has particles in it.
Slovenian: Ne uporabljajte zdravila, če opazite, da je injekcijska brizga poškodovana ali če je zdravilo motno ali vsebuje delce.
English: Q. What if there is a drop of liquid or blood on my skin after my injection?
Slovenian: V. Kaj če po injiciranju opazim kapljico tekočine ali krvi na koži?
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.
Slovenian: Neklinični podatki na osnovi študij toksičnosti pri ponavljajočih odmerkih, opravljenih pri podganah in opicah vrste javanski makak (Cynomolgus), ter na osnovi študij farmakološke varnosti, opravljenih pri opicah vrste javanski makak pri izpostavljenostih, ki so bile približno za 10- do 80-krat večje od kliničnih izpostavljenosti pri bolnikih, ki prejemajo 240 mg odmerek, ne kažejo posebnega tveganja za človeka.
English: A. Do not remove the base cap.
Slovenian: O. Pokrovčka podnožja ne odstranjujte.
English: If you drop it on a hard surface, do not use it. Use a new pen for your injection.
Slovenian: Če vam pade na trdo podlago, ga ne uporabite.
English: • Your doctor or nurse should show you how to prepare and inject Emgality using the pen.
Slovenian: • Zdravnik ali medicinska sestra vam bo pokazal/-a, kako pripraviti in injicirati zdravilo Emgality z injekcijskim peresnikom.
English: • Place and hold the clear base flat and firmly against your skin.
Slovenian: • Prozorno podnožje plosko in trdno namestite in držite na koži.
English: You and your doctor should decide if you should breast feed and use Emgality .
Slovenian: Skupaj z zdravnikom se boste odločili, ali boste dojili in uporabljali zdravilo Emgality.
English: Grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: Podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Navodila za uporabo
English: Patient-reported Outcome Measuresb MSQ Role Function-Restrictive Domain N Baseline Mean Change Treatment Difference
Slovenian: Merila izidov po navedbah bolnikov Področje omejevanja funkcioniranja v sklopu MSQb n izhodišče povprečna sprememba razlika med zdravljenjema
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.
Slovenian: Odzivni bolniki na področju omejevanja funkcioniranja v sklopu MSQ so bili opredeljeni kot bolniki z izboljšanjem za ≥ 17,14 točke pri kronični migreni po treh mesecih.
English: Q. What if there is a drop of liquid on the tip of the needle when I remove the base cap?
Slovenian: V. Kaj če opazim kapljico tekočine na konici igle, ko odstranim pokrovček podnožja?
English: You must look out for signs of these reactions while you are using Emgality.
Slovenian: Med uporabo zdravila Emgality bodite pozorni na znake teh reakcij.
English: A. It is okay to see a drop of liquid on the tip of the needle.
Slovenian: O. Nič ni narobe, če opazite kapljico tekočine na konici igle.
English: Inspect the pen and the medicine
Slovenian: Preglejte injekcijsko brizgo in zdravilo
English: Additionally, in month 1, patients treated with galcanezumab (loading dose of 240 mg) demonstrated significantly fewer weekly MHDs compared with placebo-treated patients, at week 1 and each subsequent week.
Slovenian: Poleg tega so v prvem mesecu pri bolnikih, zdravljenih z galkanezumabom (polnilni odmerek 240 mg), dokazali značilno manjše število MHD na teden v primerjavi z bolniki, zdravljenimi s placebom, in sicer po enem tednu in vseh naslednjih tednih.
English: Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy or has particles in it.
Slovenian: Ne uporabljajte zdravila, če opazite, da je injekcijski peresnik poškodovan ali če je zdravilo motno ali vsebuje delce.
English: Do not use the syringe, and dispose of as directed by your doctor, pharmacist or nurse if:
Slovenian: Ne uporabite injekcijske brizge in jo zavrzite po navodilih zdravnika, farmacevta ali medicinske sestre, če:
English: Leave the needle cap on until you are ready to inject.
Slovenian: Pokrovček igle pustite nameščen, dokler niste pripravljeni za injiciranje.
English: • Each pen is for ONE-TIME USE ONLY.
Slovenian: • Vsak injekcijski peresnik je namenjen LE ZA ENKRATNO UPORABO.
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.
Slovenian: Več bolnikov, zdravljenih z galkanezumabom, je doseglo klinično pomembno raven izboljšanja v funkcioniranju (stopnja odziva na podlagi področja omejevanja funkcioniranja v sklopu MSQ) v primerjavi z bolniki, zdravljenimi s placebom.
English: It is okay to see a drop of liquid on the tip of the needle.
Slovenian: Nič ni narobe, če opazite kapljico tekočine na konici igle.
English: If you are a woman able to have children, you are advised to avoid becoming pregnant while using Emgality.
Slovenian: Nosečnost in dojenje Če ste ženska v rodni dobi, vam svetujemo, da med uporabo zdravila Emgality ne zanosite.
English: Do not use the pen, and dispose of as directed by your doctor, pharmacist or nurse if:
Slovenian: Ne uporabite injekcijskega peresnika in ga zavrzite po navodilih zdravnika, farmacevta ali medicinske sestre, če:
English: If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
Slovenian: Če dojite ali načrtujete, da boste dojili, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: dStatistically significant after adjustment for multiple comparisons.
Slovenian: cStatistično značilno po prilagajanju po metodi večkratnih primerjav.
English: Placebo
Slovenian: Emgality placebo
English: Lock Ring
Slovenian: Zaklepni obroč
English: ≥ 75 % MHD Responders Percentage, % P-value
Slovenian: Bolniki z ≥ 75- odstotnim odzivom števila MHD odstotek, % p-vrednost
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.
Slovenian: V študiji toksičnosti za embriofetalni razvoj podgan so 20. dan gestacije opazili povečanje števila plodov in mladičev s kratkimi rebri in zmanjšanja povprečnega števila okostenelih kavdalnih vretenc pri izpostavljenosti, približno 20-krat večji od izpostavljenosti pri človeku pri 240 mg odmerku.
English: > .05e
Slovenian: >0,05d
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.
Slovenian: Na osnovi podatkov iz farmakoloških študij in študij kronične toksičnosti galkanezumaba ter ocene iz literature glede peptida CGRP ni dokazov, ki bi kazali, da kronično zdravljenje z galkanezumabom poveča tveganje za kancerogenezo.
English: eEvaluated at Month 6. fNot adjusted for multiple comparisons.
Slovenian: 6. mesecem dstatistično značilno po prilagajanju po metodi večkratnih primerjav eovrednoteno po 6 mesecih fni prilagojeno na večkratnost primerjav
English: INSTRUCTIONS FOR USE
Slovenian: Navodila za uporabo
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.
Slovenian: Bolniki, zdravljeni z galkanezumabom, so imeli boljše izboljšanje v funkcioniranju (izmerjeno z rezultatom področja omejevanja funkcioniranja v sklopu MSQ) v primerjavi z bolniki, zdravljenimi s placebom, kar se je začelo v 1. mesecu.
English: • Leave the needle cap on until you are ready to inject.
Slovenian: • Pokrovček igle pustite nameščen, dokler niste pripravljeni za injiciranje.
English: The majority of events related to the injection site were mild to moderate and less than 0.5 % of patients exposed to galcanezumab during the phase 3 studies discontinued the treatment due to an injection site reaction.
Slovenian: 3. faze pa je zaradi reakcije na mestu injiciranja prekinilo manj kot 0,5 % bolnikov, izpostavljenih galkanezumabu.
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).
Slovenian: V združenih podatkih iz študije EVOLVE-1 in EVOLVE-2 pri bolnikih, ki so se neuspešno zdravili z enim ali več profilaktičnimi zdravili zaradi neučinkovitosti, je bila razlika med zdravljenjema glede zmanjšanja povprečnega mesečnega števila MHD med 120 mg galkanezumaba in placebom2,69 dneva (p < 0,001) ter med 240 mg galkanezumaba in placebom -2,78 dneva (p < 0,001).
English: Anaphylaxis Angioedema
Slovenian: Bolezni imunskega sistema anafilaksija angioedem
English: Finger Grips
Slovenian: Ploščica za palec
English: Pack sizes of 1, 2 or 3 pre-filled syringes.
Slovenian: Pakiranja po 1, 2 ali 3 napolnjene injekcijske brizge.
English: Emgality is used to prevent migraine in adult patients who have at least 4 migraines days per month.
Slovenian: Zdravilo Emgality se uporablja za preprečevanje migrene pri odraslih bolnikih, ki imajo vsaj
English: Over 1400 patients were exposed to galcanezumab during the double-blind treatment phase of the placebocontrolled phase 3 studies.
Slovenian: V dvojno slepi fazi zdravljenja s placebom nadzorovanih študijah 3. faze je bilo galkanezumabu izpostavljenih več kot 1.400 bolnikov.
English: Emgality is a solution for injection in a clear glass single-dose syringe.
Slovenian: Zdravilo Emgality je raztopina za injiciranje v enoodmerni injekcijski brizgi iz prozornega stekla.
English: MSQ Role Function Restrictive Domain Respondersc N Percentage, % P-value
Slovenian: Odzivni bolniki na področju omejevanja funkcioniranja v sklopu MSQc n odstotek, % p-vrednost
English: In this patients, the treatment difference observed between galcanezumab 120 mg and placebo and between galcanezumab 240 mg and placebo for the reduction of MHDs in these patients was respectively2.53 days (p < 0.001) and -2.26 days (p < 0.001).
Slovenian: Pri teh bolnikih je razlika med 120 mg galkanezumaba in placebom ter med 240 mg galkanezumaba in placebom glede zmanjšanja mesečnega števila dni migrenskega glavobola znašala -2,53 dneva (p < 0,001) oziroma2,26 dneva (p < 0,001).
English: Emgality is a solution for injection in a clear glass syringe.
Slovenian: Zdravilo Emgality je raztopina za injiciranje v injekcijski brizgi iz prozornega stekla.
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.
Slovenian: V juvenilni toksikološki študiji, v kateri so podgane prejemale galkanezumab dvakrat tedensko postnatalno v obdobju od 21. do 90. dne, so bili sistemski učinki omejeni na reverzibilna, minimalna,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - NAPOLNJENA INJEKCIJSKA BRIZGA
English: dNot statistically significant after adjustment for multiple comparisons.
Slovenian: dNi statistično značilno po prilagajanju po metodi večkratnih primerjav.
English: The pre-filled pen should be inspected visually prior to administration.
Slovenian: Napolnjeni injekcijski peresnik morate pred uporabo vizualno pregledati.
English: Do not inject yourself or someone else until you have been shown how to inject Emgality.
Slovenian: Dokler vam ne pokažejo, kako morate injicirati zdravilo Emgality, ga ne injicirajte ne sebi ne komu drugemu.
English: In male fertility study, right testis weight was significantly reduced at exposures to 4 times the human exposure at 240 mg.
Slovenian: V študiji plodnosti pri samcih je bila masa desnega moda pri izpostavljenostih, do 4-krat večjih od izpostavljenosti pri človeku pri
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, Nizozemska
English: Lilly S.A. Tel: + 34-91 663 50 00
Slovenian: Tel: + 34-91 663 50 00
English: Compared with placebo-treated patients, patients treated with galcanezumab 120 mg or 240 mg had significantly greater mean decreases from baseline in the number of monthly MHDs at month 1 and at all subsequent months up to month 6 (see Figure 1).
Slovenian: V primerjavi z bolniki, zdravljenimi s placebom, so imeli bolniki, zdravljeni s 120 mg ali 240 mg galkanezumaba, značilno večje povprečno zmanjšanje mesečnega MHD po 1. mesecu in vseh nadaljnjih mesecih do 6. meseca (glejte sliko 1).
English: • Gently pinch and hold a fold of skin where you will inject.
Slovenian: • Nežno stisnite in držite kožno gubo na mestu injiciranja.
English: Skin and Subcutaneous Tissue
Slovenian: Bolezni kože in podkožja pruritus izpuščaj urtikarija
English: Dispose of the syringe in a sharps disposal container or as directed by your doctor, pharmacist or nurse.
Slovenian: Injekcijsko brizgo odložite v ustrezen vsebnik za odstranjevanje ostrih odpadkov oz. skladno z navodili zdravnika, farmacevta ali medicinske sestre.
English: Q. What if I see air bubbles in my pen?
Slovenian: V. Kaj moram narediti, če v svojem injekcijskem peresniku opazim zračne mehurčke?
English: Wash your hands with soap and water before you inject Emgality.
Slovenian: Pred injiciranjem zdravila Emgality si umijte roke z milom in vodo.
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.
Slovenian: <0,001f n = število bolnikov; IZ95 % = 95-odstotni interval zaupanja aizidi učinkovitosti so bili ovrednoteni v času od 1. do 6. meseca bovrednoteno v času od 4. do 6. meseca copredeljeni kot bolniki s povprečnim izboljšanjem za ≥ 25 točk pri epizodni migreni v obdobju med 4. in
English: Leave the base cap on until you are ready to inject.
Slovenian: Pokrovček podnožja pustite nameščen, dokler niste pripravljeni za injiciranje.
English: ≥ 50 % MHD Responders Percentage, % P-value
Slovenian: Bolniki z ≥ 50-odstotnim odzivom števila MHD odstotek, % p-vrednost
English: Before using your pre-filled pen (pen):
Slovenian: Pred uporabo napolnjenega injekcijskega peresnika (injekcijskega peresnika):
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.
Slovenian: Stopnja odziva je povprečen odstotek bolnikov, ki dosegajo opredeljeno mejno vrednost zmanjšanja števila dni migrenskih glavobolov na mesec (≥ 50 %, ≥ 75 % in 100 %) v dvojno slepem obdobju zdravljenja.Vpliv migrene na funkcioniranje so ocenjevali s področjem omejevanja funkcioniranja v okviru vprašalnika za kakovost življenja pri migreni (MSQ - Migraine-Specific Quality of Life Questionnaire), različica 2.1, in z vprašalnikom za oceno zmanjšane opravilne sposobnosti pri migreni (MIDAS - Migraine Disability Assessment).
English: Tell your doctor or get emergency medical help straight away if you notice any of those signs.
Slovenian: Če opazite katerega koli izmed teh znakov, se nemudoma posvetujte z zdravnikom ali poiščite nujno medicinsko pomoč.
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 3).
Slovenian: V skupinah, ki sta se zdravili s 120 mg in 240 mg galkanezumaba, je prišlo do statistično značilnih in klinično pomembnih izboljšanj od izhodišča pri povprečni spremembi mesečnega števila MHD v primerjavi s placebom (glejte preglednico 3).
English: In patients failing two or more prophylactic treatments, the treatment difference was4.48 days (p < 0.001) between 120 mg and placebo and -1.86 days (p < 0.01) between 240 mg and placebo.
Slovenian: Pri bolnikih, ki so se neuspešno zdravili z dvema ali več profilaktičnimi zdravili, je bila razlika med zdravljenjema med 120 mg odmerkom in placebom -4,48 dneva (p < 0,001) ter -1,86 dneva (p < 0,01) med 240 mg odmerkom in placebom.
English: Common side effects (may affect up to 1 in 10 people): - Vertigo (a feeling of dizziness or “spinning”) - Constipation - Itching - Rash
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - vrtoglavica (občutek omotice ali „vrtenja v glavi“)
English: Emgality contains sodium
Slovenian: Zdravilo Emgality vsebuje natrij.
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).
Slovenian: 4,8 % pri bolnikih, ki so prejemali galkanezumab enkrat mesečno (vsi razen enega od teh so imeli nevtralizirajočo aktivnost in vitro).
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).
Slovenian: V skupinah, ki sta se zdravili s 120 mg in 240 mg galkanezumaba, je prišlo do statistično značilnih in klinično pomembnih izboljšanj od izhodišča pri povprečni spremembi MHD v primerjavi s placebom
English: • The teal plunger rod should show through the body of the syringe.
Slovenian: • Modro zeleni potisni bat morate videti skozi telo brizge,
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED PEN
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - NAPOLNJEN INJEKCIJSKI PERESNIK
English: Galcanezumab is a recombinant humanised monoclonal antibody produced in Chinese Hamster Ovary cells.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 120 mg galkanezumaba v 1 ml. Galkanezumab je rekombinantno humanizirano monoklonsko protitelo, izdelano v ovarijskih celicah kitajskega hrčka.
English: Press a cotton ball or gauze over the injection site.
Slovenian: Na injekcijsko mesto položite kosem vate ali gazo.
English: In patients failing two or more prophylactic treatments, the treatment difference was -2.64 days (p < 0.001) between 120 mg and placebo and -3.04 days (p < 0.001) between 240 mg and placebo.
Slovenian: Pri bolnikih, ki so se neuspešno zdravili z dvema ali več profilaktičnimi zdravili, je bila razlika med zdravljenjema med 120 mg odmerkom in placebom -2,64 dneva ter -3,04 dneva (p < 0,001) med 240 mg odmerkom in placebom.
English: Parts of the Emgality pen
Slovenian: PODATKI V BRAILLOVI PISAVI Emgality
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.
Slovenian: V 12 mesecih zdravljenja so se protitelesa proti zdravilu razvila pri največ 12,5 % bolnikov, zdravljenih z galkanezumabom.
English: Emgality may be stored unrefrigerated for up to 7 days when stored at temperatures up to 30 °C.
Slovenian: Zdravilo Emgality lahko hranite zunaj hladilnika največ 7 dni pri temperaturah do 30 °C.
English: The syringe must not be shaken.
Slovenian: Injekcijske brizge ne smete stresati.
English: Back of arm
Slovenian: Hrbtna stran nadlakti