FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine should not be given to children and adolescents under 18 years of age because it has not been studied in this age group.
Slovenian: Tega zdravila ne smete dajati otrokom in mladostnikom, mlajšim od 18 let, ker ga v tej starostni skupini niso preučevali.
English: Any further decision to continue treatment should be taken on an individual patient basis.
Slovenian: Katerekoli naslednje odločitve o nadaljevanju zdravljenja je treba sprejeti glede na posameznega bolnika.
English: Emgality can potentially cause serious allergic reactions.
Slovenian: Zdravilo Emgality lahko povzroči resne alergijske reakcije.
English: - if you are allergic to galcanezumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na galkanezumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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.
Slovenian: Znano je, da se humani IgG v prvih dneh po rojstvu izloča v materino mleko, njegove koncentracije pa se nato hitro zmanjšajo, zato tveganja za dojenega otroka v tem kratkem obdobju ni mogoče izključiti.
English: Evaluation of the need to continue treatment is recommended regularly thereafter.
Slovenian: Nato je potrebo po nadaljevanju zdravljenja priporočljivo redno vrednotiti.
English: Across the 3 studies, patients were predominantly female (> 83 %) with a mean age of 41 years, and an average migraine history of 20 to 21 years.
Slovenian: V vseh treh študijah so bili bolniki pretežno ženskega spola (> 83 %), s povprečno starostjo 41 let in povprečno anamnezo migrene od 20 do 21 let.
English: • Insert the needle at a 45 degree angle.
Slovenian: • Iglo vstavite pod kotom 45 stopinj.
English: A. This is not necessary, but it may help you keep the pen steady and firm against your skin.
Slovenian: O. To ni potrebno, vendar vam lahko pomaga, da boste injekcijski peresnik držali bolj mirno in trdno na koži.
English: Did I get my complete injection?
Slovenian: Ali sem prejel/-a celotno injekcijo?
English: 3 Press and Hold
Slovenian: 3 Pritisnite in zadržite
English: • Keep these instructions and refer to them as needed.
Slovenian: • Ta navodila za uporabo shranite in jih po potrebi ponovno preberite.
English: Q. What if I hear more than 2 clicks during my injection - 2 loud clicks and a soft one.
Slovenian: V. Kaj naj storim, če med injiciranjem slišim več kot dva klika - dva glasnejša in enega tišjega?
English: Scoring ranges from 0 to 100, with higher scores indicating less impairment , that is, patients experience fewer restrictions on the performance of day-to-day activities.
Slovenian: Rezultati so v razponu od 0 do 100, pri čemer višji rezultati pomenijo manjšo oviranost, kar pomeni, da imajo bolniki manj omejitev pri opravljanju vsakodnevnih aktivnosti.
English: Efficacy and patient reported outcome measures
Slovenian: Učinkovitost in merila izidov po navedbah bolnikov
English: Less than 2.5 % of patients in these studies discontinued due to adverse events.
Slovenian: Manj kot 2,5 % bolnikov v teh študijah je zdravilo prenehalo jemati zaradi neželenih učinkov.
English: You will hear a second click in about 5 to 10 seconds after the first one.
Slovenian: Približno od 5 do 10 sekund po prvem kliku boste zaslišali drugi klik.
English: • Do not touch the needle.
Slovenian: • Ne dotikajte se igle.
English: It is preferable to avoid the use of Emgality in pregnancy as the effects of this medicine in pregnant women are not known.
Slovenian: Med nosečnostjo se je bolje izogibati zdravilu Emgality, saj učinki tega zdravila pri nosečnicah niso znani.
English: Store in a refrigerator (2 °C to 8 °C).
Slovenian: Shranjujte v hladilniku (2 °C-8 °C).
English: Afterwards, use of galcanezumab could be considered during breast-feeding only if clinically needed.
Slovenian: Kasneje je mogoče razmisliti o uporabi galkanezumaba med dojenjem samo, če je to klinično potrebno.
English: Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1).
Slovenian: Bolniki z določenimi srčno-žilnimi boleznimi so bili izključeni iz kliničnih študij (glejte poglavje 5.1).
English: After training, patients may self-inject galcanezumab if a healthcare professional determines that it is appropriate.
Slovenian: Po usposabljanju si bolniki lahko sami injicirajo galkanezumab, če zdravstveni delavec presodi, da je to primerno.
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.
Slovenian: Lahko tudi preberete razdelek „Izberite svoje mesto injiciranja“ v teh navodilih, ki vam bo v pomoč pri odločanju, kateri predel je za vas najprimernejši.
English: Elevated blood concentrations of CGRP have been associated with migraine attacks.
Slovenian: Povečanje koncentracije CGRP v krvi je povezano z migrenskimi napadi.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: CI95%
Slovenian: IZ95 %
English: People with migraine may have increased levels of CGRP.
Slovenian: Osebe z migreno imajo lahko zvišane ravni peptida CGRP.
English: In 86 % of the patients reporting injection site pain, the event occurred within 1 hour of injection and resolved on average in 1 day.
Slovenian: Pri 86 % bolnikov, ki so poročali o bolečini na mestu injiciranja, se je učinek pojavil v eni uri po injiciranju in je povprečno minil v enem dnevu.
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.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
English: Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Approximately 15 % of the patients continued concurrent treatment with topiramate or propranolol as allowed by the protocol for prophylaxis of migraine.
Slovenian: Približno 15 % bolnikov je nadaljevalo sočasno zdravljenje s topiramatom ali propanololom, kot je dovoljeval protokol za profilakso migrene.
English: Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy.
Slovenian: Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italija.
English: For example, if your first injection was in your abdomen, your next injection could be in another area of your abdomen.
Slovenian: Če je bila na primer prva injekcija v trebuh, si naslednjo injekcijo lahko daste v drug predel trebuha.
English: • You may inject the medicine into your stomach area (abdomen) or thigh.
Slovenian: • Sami si zdravilo lahko injicirate v trebuh (abdomen) ali stegno.
English: • Press and hold the teal injection button; you will hear a loud click.
Slovenian: • Pritisnite in zadržite modro zeleni gumb za injiciranje; slišali boste glasen klik.
English: Allergic reactions with Emgality are usually mild to moderate (such as rash or itching).
Slovenian: Alergijske reakcije pri zdravilu Emgality so običajno blage do zmerne (na primer izpuščaj ali srbenje).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with galcanezumab in one or more subsets of the paediatric population in the prophylaxis of migraine headaches (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z galkanezumabom za eno ali več podskupin pediatrične populacije pri profilaksi migrenskih glavobolov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Prepare for injection
Slovenian: Pripravite se za injiciranje
English: Galcanezumab exposure increases proportionally with dose.
Slovenian: Izpostavljenost galkanezumabu se povečuje sorazmerno z odmerkom.
English: The safety and efficacy of galcanezumab in children aged 6 to 18 years have not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost galkanezumaba pri otrocih, starih od 6 do 18 let, še nista bili dokazani.
English: In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Slovenian: Ob prevelikem odmerjanju je priporočljivo spremljati bolnika glede pojava znakov ali simptomov neželenih učinkov ter nemudoma uvesti ustrezno simptomatsko zdravljenje.
English: What Emgality is and what it is used for 2.
Slovenian: Kaj je zdravilo Emgality in za kaj ga uporabljamo 2.
English: Patients should be instructed to inject a missed dose as soon as possible and then resume monthly dosing.
Slovenian: Bolnike je treba poučiti, da naj si pozabljeni odmerek čim prej injicirajo in nato nadaljujejo odmerjanje enkrat mesečno.
English: Your doctor will decide for how long you should use Emgality.
Slovenian: Zdravnik bo presodil, kako dolgo morate uporabljati zdravilo Emgality.
English: Syringe Body with Medicine
Slovenian: Telo brizge z zdravilom
English: Approximately one-third of patients across the studies had at least 1 prior failure on a migraine prophylactic treatment for efficacy reasons and approximately 16 % of patients across the studies had at least 2 prior failure on a prophylactic treatment for efficacy reasons.
Slovenian: Približno ena tretjina bolnikov v študijah se je predhodno neuspešno zdravila z vsaj enim profilaktičnim zdravilom proti migreni zaradi pomanjkanja učinkovitosti, približno 16 % bolnikov v študijah pa se je predhodno neuspešno zdravilo z vsaj dvema profilaktičnima zdraviloma zaradi pomanjkanja učinkovitosti.
English: • Do not put the needle cap back on - you could damage the needle or injure yourself by accident.
Slovenian: • Pokrovčka igle ne nameščajte ponovno nazaj - lahko poškodujete iglo ali nenamerno poškodujete sebe.
English: When your injection is complete:
Slovenian: Ko je injiciranje končano:
English: Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel:
Slovenian: Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
English: Such signs are listed under “Serious side effects” in section 4.
Slovenian: Ti znaki so navedeni v poglavju 4 pod »Možni neželeni učinki«.
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.
Slovenian: Na podlagi populacijske farmakokinetične analize, ki je vključevala odmerke v razponu od 5 do 300 mg, so bili stopnja absorpcije, navidezni očistek in navidezni volumen porazdelitve neodvisni od odmerka.
English: These findings were noted at no maternal toxicity and were considered to be related to galcanezumab but non-adverse.
Slovenian: Te izsledke so zabeležili pri odsotnosti toksičnosti za mater in so bili ocenjeni kot povezani z galkanezumabom, vendar neškodljivi.
English: You will also see the grey plunger at the top of the clear base.
Slovenian: Prav tako boste na vrhu prozornega podstavka videli siv bat.
English: For a more comfortable injection, leave the syringe at room temperature for 30 minutes before injecting.
Slovenian: Da bo injiciranje udobnejše, pustite injekcijski peresnik na sobni temperaturi 30 minut pred injiciranjem.
English: Choose your injection site
Slovenian: Izberite svoje mesto injiciranja
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: What you need to know before you use Emgality 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Emgality 3.
English: Serious hypersensitivity
Slovenian: Resna preobčutljivost
English: Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000).
Slovenian: Ocena pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100),
English: • The pen contains glass parts.
Slovenian: • Injekcijski peresnik vsebuje steklene dele.
English: Galcanezumab binds to CGRP with high affinity (KD = 31 pM) and high specificity (> 10,000-fold vs related peptides adrenomedullin, amylin, calcitonin and intermedin).
Slovenian: Galkanezumab se veže na CGRP z visoko afiniteto (KD = 31 pM) in visoko specifičnostjo (> 10.000-krat večjo od sorodnih peptidov adrenomedulina, amilina, kalcitonina in intermedina).
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.
Slovenian: Bolniki z nedavnimi akutnimi srčno-žilnimi dogodki (vključno z miokardnim infarktom, nestabilno angino pektoris, CABG, možgansko kapjo, GVT) in/ali bolniki, za katere so presodili, da imajo resno srčnožilno tveganje, so bili izključeni iz kliničnih preskušanj z galkanezumabom.
English: Q. Do I need to hold the injection button down until the injection is complete?
Slovenian: V. Ali moram držati gumb za injiciranje, dokler injiciranje ni končano?
English: The needle included in the pack is only suitable for sub-cutaneous injection.
Slovenian: Igla, priložena v pakiranju, je primerna samo za subkutano injiciranje.
English: The majority of injection site reactions were reported within 1 day and on average resolved within 5 days.
Slovenian: Poročali so, da se je večina reakcij na mestu injiciranja pojavila v enem dnevu, minile pa so povprečno v petih dneh.
English: One percent of the patients exposed to galcanezumab during the phase 3 studies experienced severe pain at the injection site.
Slovenian: En odstotek bolnikov, izpostavljenih galkanezumabu v študijah 3. faze, je občutil hudo bolečino na mestu injiciranja.
English: Pharmacotherapeutic group: analgesics, other antimigraine preparations, ATC code: N02CX08
Slovenian: Farmakoterapevtska skupina: analgetiki, druga zdravila proti migreni, oznaka ATC: N02CX08
English: Emgality has not been studied in patients with serious cardiovascular diseases.
Slovenian: Zdravila Emgality pri bolnikih z resnimi srčno-žilnimi boleznimi niso preučevali.
English: If a serious hypersensitivity reaction occurs, administration of galcanezumab should be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pojavi resna preobčutljivostna reakcija, je treba dajanje galkanezumaba nemudoma prekiniti in uvesti ustrezno zdravljenje.
English: The efficacy and safety of galcanezumab has been studied in 3 phase 3, randomized, placebocontrolled, double-blind studies in adult patients (N = 2886).
Slovenian: Klinična učinkovitost in varnost Učinkovitost in varnost galkanezumaba so preučevali v treh randomiziranih, s placebom nadzorovanih, dvojno slepih študijah 3. faze pri odraslih bolnikih (n = 2.886).
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.
Slovenian: študijo kronične migrene (REGAIN) so vključili bolnike, ki so izpolnjevali merila ICHD za kronično migreno z ≥ 15 dnevi glavobola na mesec, od katerih jih je vsaj 8 imelo značilnosti migrene.
English: P-value
Slovenian: p-vrednost
English: Most of the reactions were mild or moderate in severity.
Slovenian: Večina učinkov je bila blagih do zmernih.
English: There is no relevant use of galcanezumab in children below the age of 6 years for the prevention of migraine.
Slovenian: Galkanezumab ni primeren za uporabo pri otrocih, mlajših od 6 let, za preprečevanje migrene.
English: Click
Slovenian: Klik
English: The second click tells you that your injection is complete.
Slovenian: Drugi klik pomeni, da je injiciranje končano.
English: You should not stop using Emgality without speaking to your doctor first.
Slovenian: Zdravila Emgality ne smete prenehati uporabljati, ne da bi se pred tem posvetovali z zdravnikom.
English: Do not inject within 5 centimeters of the belly button (navel).
Slovenian: Ne injicirajte si v predel 5 centimetrov okrog popka.
English: It is important not to try to inject yourself until you have been trained by your doctor or nurse.
Slovenian: Pomembno je, da si zdravila ne skušate injicirati sami, dokler vas zdravnik ali medicinska sestra primerno ne usposobi za to.
English: Doses up to 600 mg have been administered subcutaneously to humans without dose-limiting toxicity.
Slovenian: Ljudem so subkutano dajali odmerke do 600 mg brez toksičnosti, ki bi omejevala velikost odmerka.
English: Figure 1 Reduction in monthly migraine headache days over time in studies EVOLVE-1 and EVOLVE-2
Slovenian: Zmanjšanje števila dni z migrenskim glavobolom na mesec v časovnem intervalu v študijah EVOLVE-1 in EVOLVE-2
English: • Another person may give you the injection in the back of your upper arm or buttock.
Slovenian: • Druga oseba vam lahko da injekcijo v hrbtno stran nadlakti ali zadnjico.
English: 96 cases describing hypersensitivity reactions, anaphylactic reactions or angioedema were identified (29 serious, 0 fatal outcomes); 18 cases (14 serious, 4 non-serious) qualified under the anaphylactic reaction SMQ, 40 cases qualified under the angioedema SMQ (narrow) and 36 cases described as rash.
Slovenian: Ugotovljenih je bilo 96 neželenih učinkov, pri katerih so opisovali preobčutljivostne reakcije, anafilaktične reakcije ali angioedem (29 resnih, 0 smrtnih izidov); 18 neželenih učinkov (14 resnih, 4 niso bili resni) je bilo po standardizirani poizvedbi MedDRA (SMQ) razvrščenih med anafilaktične reakcije, 40 neželenih učinkov med angioedem (iskanje po najbližjem izrazu), 36 pa je bilo opisanih kot izpuščaj.
English: 3 Inject
Slovenian: 3 Injicirajte
English: Nonclinical studies have not been conducted to evaluate the carcinogenic or mutagenic potential of galcanezumab.
Slovenian: Nekliničnih študij za ovrednotenje kancerogenega ali mutagenega potenciala galkanezumaba niso izvedli.
English: Some patients have had vertigo whilst using Emgality.
Slovenian: Nekateri bolniki so med uporabo zdravila Emgality imeli vrtoglavico.
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.
Slovenian: Starost, spol, telesna masa, rasna in etnična pripadnost Na podlagi starosti (od 18 do 65 let), spola, telesne mase in rasne ali etnične pripadnosti ni potrebno prilagajanje odmerka, saj ni bilo klinično pomembnega učinka teh dejavnikov na navidezni očistek ali navidezni volumen porazdelitve galkanezumaba.
English: However, the presence of anti-drug antibodies did not affect the pharmacokinetics, efficacy, or safety of galcanezumab.
Slovenian: Prisotnost protiteles proti zdravilu ni vplivala na farmakokinetiko, učinkovitost ali varnost galkanezumaba.
English: Otherwise, you may give or get an infection.
Slovenian: Sicer lahko okužite druge ali pa se okužite sami.
English: • Slowly push on the thumb pad to push the plunger all the way in until all the medicine is injected.
Slovenian: • Počasi potiskajte ploščico za palec, da do konca potisnete bat, in injicirate vse zdravilo.
English: Galcanezumab may have a minor influence on the ability to drive and use machines.
Slovenian: Galkanezumab ima lahko manjši vpliv na sposobnost vožnje ali upravljanja strojev.
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.
Slovenian: V dve študiji epizodne migrene (EVOLVE-1 in EVOLVE-2) so bili vključeni bolniki, ki so izpolnjevali merila po mednarodni klasifikaciji glavobolov (ICHD - International Classification of Headache Disorders) za diagnozo migrene z avro ali brez nje ter z od 4 do 14 dnevi migrenskega glavobola na mesec.
English: The reported adverse drug reactions for 120 mg and 240 mg in the migraine clinical trials were injection site pain (10.1 %/11.6 %), injection site reactions (9.9 %/14.5 %), vertigo (0.7 %/1.2 %), constipation (1.0 %/1.5 %), pruritus (0.7 %/1.2 %) and urticaria (0.3 %/0.1 %).
Slovenian: Neželeni učinki zdravila v odmerku 120 mg in 240 mg, o katerih so poročali v kliničnih preskušanjih migrene, so bili bolečina na mestu injiciranja (10,1 %/11,6 %), reakcije na mestu injiciranja (9,9 %/14,5 %), vrtoglavica (0,7 %/1,2 %), obstipacija (1,0 %/1,5 %), pruritus (0,7 %/1,2 %) in urtikarija (0,3 %/0,1 %).
English: A. After you press the teal injection button, you will hear 2 loud clicks.
Slovenian: O. Po pritisku modro zelenega gumba za injiciranje boste slišali dva glasna klika.
English: What you need to know before you use Emgality Do not use Emgality:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Emgality Ne uporabljajte zdravila Emgality:
English: List of adverse reactions in clinical studies and post-marketing reports
Slovenian: Seznam neželenih učinkov v kliničnih študijah in v obdobju po uvedbi zdravila na trg
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
Slovenian: Na podlagi znanstvenih zaključkov za galkanezumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) galkanezumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
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.
Slovenian: Če ste uporabili večji odmerek zdravila Emgality, kot bi smeli Če ste si injicirali večji odmerek zdravila Emgality, kot bi smeli, npr. če ste si ga po prvem odmerku 240 mg injicirali dvakrat v enem mesecu ali če je kdo drug nenamerno uporabil zdravilo Emgality, o tem takoj obvestite zdravnika.
English: Vertigo may occur following the administration of galcanezumab (see section 4.8).
Slovenian: Po dajanju galkanezumaba se lahko pojavi vrtoglavica (glejte poglavje 4.8).
English: There are limited data from the use of galcanezumab in pregnant women.
Slovenian: Podatki o uporabi galkanezumaba pri nosečnicah so omejeni.
English: Similarly, IgG monoclonal antibodies are mainly eliminated via intracellular catabolism and hepatic impairment is not expected to influence the clearance of galcanezumab.
Slovenian: Podobno velja, da se monoklonska protitelesa IgG večinoma izločajo z znotrajceličnim katabolizmom, zato ni pričakovati, da bi okvara jeter vplivala na očistek galkanezumaba.
English: Study REGAIN had a 3 month, double-blind, placebo-controlled treatment period followed by a 9 month open-label extension.
Slovenian: Študija REGAIN je obsegala 3-mesečno, dvojno slepo, s placebom nadzorovano obdobje zdravljenja, ki mu je sledilo 9-mesečno odprto podaljšanje.
English: A patient may self-inject galcanezumab by following the Instructions for Use.
Slovenian: Bolnik si lahko sam injicira galkanezumab po navodilih za uporabo.