FrancophonIA/ELRC3.0 huggingface dataset:
English: • Moderate to severe major depressive disorder, if the depression does not respond to psychological therapy after 4-6 sessions.
Slovenian: • zmerne do hude velike depresivne epizode, če je depresija neodzivna na psihološko terapijo po
English: Eli Lilly and Co Ltd, Kingsclere road, Basingstoke, Hampshire RG21 6XA,
Slovenian: Kingsclere Road, Basingstoke, Hampshire RG21 6XA,
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <[To be completed nationally]>
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET <[Dopolnjeno nacionalno]>
English: • Do not store your capsules above 25°C.
Slovenian: Kapsule shranjujte pri temperaturi do 25 oC!
English: PHARMACEUTICAL FORM Oral liquid.
Slovenian: FARMACEVTSKA OBLIKA Peroralna raztopina.
English: Belgium Eli Lilly Benelux S.A. rue de l'Etuve 52 Stoofstraat 1000 Brussels
Slovenian: Eli Lilly Benelux S.A. rue de l'Etuve 52 Stoofstraat 1000 Brussels Belgija
English: Belgium Eli Lilly Benelux S.A. rue de l'Etuve 52 Stoofstraat B-1000 Brussels
Slovenian: Eli Lilly Benelux S.A. rue de l'Etuve 52 Stoofstraat B-1000 Brussels Belgija
English: Dose adjustments should be made carefully, on an individual basis, to maintain the patient at the lowest effective dose.
Slovenian: Prilagoditve odmerka je treba opraviti pazljivo, na individualni osnovi, da bi bolnika ohranili na najmanjšem učinkovitem odmerku.
English: Isolated cases of adverse events potentially indicating delayed sexual maturation or sexual dysfunction have been reported from paediatric clinical use.
Slovenian: V pediatrični klinični uporabi so poročali o osamljenih primerih neželenih učinkov, ki lahko nakazujejo zapoznelo spolno dozorevanje ali spolno disfunkcijo (glejte tudi poglavje 5.3).
English: Haemorrhage: There have been reports of cutaneous bleeding abnormalities such as ecchymosis and purpura with SSRI's.
Slovenian: Krvavitve: Pri uporabi selektivnih zaviralcev prevzema serotonina so poročali o nenormalnih kožnih krvavitvah, kot so ekhimoze in purpure.
English: Urogenital system: Urinary retention, urinary frequency
Slovenian: Sečila in spolovila: Retenca urina, večja pogostnost odvajanja urina.
English: Treatment with fluoxetine can be initiated the following day after discontinuation of a reversible MAOI.
Slovenian: Vendar pa lahko zdravljenje s fluoksetinom uvedemo naslednji dan po prenehanju zdravljenja z reverzibilnim zaviralcem monoaminooksidaze.
English: A lower or less frequent dose (e.g. 20 mg every second day) should be considered in patients with hepatic impairment (see 5.2 Pharmacokinetic properties), or in patients where concomitant medication has the potential for interaction with (Invented name)® (see 4.5 Interactions).
Slovenian: Pri bolnikih z okvarjenim delovanjem jeter (glejte poglavje 5.2 Farmakokinetične lastnosti) ali pri bolnikih, ki sočasno jemljejo zdravila, ki bi lahko medsebojno delovala s (Izmišljeno ime)® (glejte poglavje 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij), je treba razmisliti o nižjem odmerku ali manj pogostem odmerjanju (npr. 20 mg vsak drugi dan).
English: Pharmaceutical form Route of administration
Slovenian: Farmacevtska oblika
English: Half-life: The long elimination half-lives of both fluoxetine and norfluoxetine should be borne in mind (see 'Pharmacokinetic properties') when considering pharmacodynamic or pharmacokinetic drug interactions (e.g. when switching from fluoxetine to other antidepressants).
Slovenian: Razpolovni čas: Ob ocenjevanju farmakodinamičnega ali farmakokinetičnega medsebojnega delovanja zdravil (npr. ob prevedbi s fluoksetina na druge antidepresive) je treba upoštevati dolga razpolovna časa izločanja tako fluoksetina kot tudi norfluoksetina (glejte poglavje 5.2 Farmakokinetične lastnosti).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka kapsula vsebuje fluoksetinijev klorid v količini, enaki 20 mg fluoksetina.
English: (Invented name)®, at a dose of 20mg, has been shown to be significantly more effective than placebo in two short-term pivotal studies, as measured by the reduction of Childhood Depression Rating Scale-Revised (CDRS-R) total scores and Clinical Global Impression of Improvement (CGI-I) scores.
Slovenian: V dveh kratkotrajnih vodilnih študijah so z oceno zmanjšanja skupne vrednosti na revidirani ocenjevalni lestvici depresije v otroštvu (Childhood Depression Rating Scale-Revised, CDRS-R) in vrednosti na lestvici kliničnega vtisa o izboljšanju (Clinical Global Impression of Improvement, CGI-I) pokazali, da je (Izmišljeno ime)® v odmerku 20 mg značilno bolj učinkovit v primerjavi s placebom.
English: Not recommended combinations: MAOI-A (see section 4.3)
Slovenian: Odsvetovane kombinacije: Zaviralec monoaminooksidaze-A (glejte poglavje 4.3 Kontraindikacije).
English: 13 rue Pagès 92158 Suresnes Cedex France
Slovenian: 92158 Suresnes Cedex, FRANCIJA
English: Symptoms of overdose have included nausea, vomiting, seizures, cardiovascular dysfunction ranging from asymptomatic arrhythmias to cardiac arrest, pulmonary dysfunction, and signs of altered CNS status ranging from excitation to coma.
Slovenian: Simptomi prevelikega odmerjanja so vključevali slabost, bruhanje, krče, motnje delovanja srčnožilnega sistema z razponom od asimptomatskih motenj ritma do srčnega zastoja, motnje dihal in znake spremenjenega stanja osrednjega živčevja z razponom od razdraženja do kome.
English: Not all pack sizes may be marketed 6.6.
Slovenian: Na trgu ni vseh navedenih pakiranj.
English: • feelings of weakness, drowsiness or confusion mostly in elderly people and in (elderly) people on diuretics (water tablets);
Slovenian: občutek oslabelosti, zaspanosti ali zmedenosti, večinoma pri starejših in pri (starejših) ljudeh, ki so jemali diuretike (tablete za odvajanje vode), podaljšano in bolečo erekcijo, razdražljivost in hudo vznemirjenost.
English: Significantly more patients (twice as many) relapsed on placebo compared to fluoxetine.
Slovenian: V primerjavi s fluoksetinom je pri tistih bolnikih, ki so prejemali placebo, do ponovitve prišlo pri znatno večjem številu (dvakrat tolikšnem).
English: Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose.
Slovenian: Prilagajanje odmerkov naj bo skrbno in prilagojeno posamezniku, z namenom vzdrževanja bolnikov na najnižjem učinkovitem odmerku.
English: • If you miss a dose, do not worry.
Slovenian: • Ne bodite v skrbeh, če ste pozabili vzeti odmerek.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of oral liquid contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsakih 5 ml raztopine vsebuje fluoksetinijev klorid v količini, enaki 20 mg fluoksetina.
English: ENGLAND
Slovenian: Velika Britanija
English: Fluoxetine ‘Lilly' 20 mg
Slovenian: Fluoxetine ‘Lilly'
English: BEFORE YOU TAKE (Invented name)®
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI (IZMIŠLJENO IME)®
English: NAME OF THE MEDICINAL PRODUCT (Invented name)® 20 mg per 5 ml oral liquid <[See Annex I - To be completed nationally]> fluoxetine hydrochloride
Slovenian: IME ZDRAVILA (Izmišljeno ime)® 20 mg na 5 ml peroralne raztopine <[Glejte Dodatek I - Dopolnjeno nacionalno]> fluoksetinijev klorid
English: Ecchymosis has been reported as an infrequent event during treatment with fluoxetine.
Slovenian: Med zdravljenjem s fluoksetinom so o ekhimozah poročali kot o nepogostih dogodkih.
English: Mint flavour (containing 0.23% alcohol) Purified Water
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi benzojska kislina saharoza glicerol aroma poprove mete (vsebuje 0,23 % alkohola) prečiščena voda
English: 20 mg
Slovenian: 20 mg trde kapsule
English: MARKETING AUTHORISATION NUMBER(S) <[See Annex I - To be completed nationally]>
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET <[Glejte Dodatek I - Dopolnjeno nacionalno]>
English: SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE MEDICAL PRODUCT (Invented name)® 20 mg hard capsules <[See Annex I - To be completed nationally]>
Slovenian: IME ZDRAVILA (Izmišljeno ime)® 20 mg trde kapsule <[Glejte Dodatek I - Dopolnjeno nacionalno]>
English: • If you get a rash or allergic reaction such as itching, swollen lips/tongue or wheezing/shortness of breath, stop taking the capsules straight away and tell your doctor immediately.
Slovenian: • Če dobite izpuščaj ali alergijsko reakcijo kot je srbenje, otečene ustnice ali jezik, ali sopete in imate težave z dihanjem, takoj prenehajte jemati kapsule in nemudoma povejte svojemu zdravniku.
English: 20mg/5ml
Slovenian: Fluctine 20mg/5ml-orale Lösung
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]>
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM <[Glejte Dodatek I - Dopolnjeno nacionalno]>
English: MARKETING AUTHORIZATION NUMBER <[To be completed nationally]>
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET <[Dopolnjeno nacionalno]>
English: Nature and contents of container <[To be completed nationally]> Not all pack sizes may be marketed 6.6.
Slovenian: <[Dopolnjeno nacionalno]> Na trgu ni vseh navedenih pakiranj.
English: Luxembourg Eli Lilly Benelux S.A, Rue de l'Etuve 52 Stoofstraat, 1000
Slovenian: Eli Lilly Benelux S.A, Rue de l'Etuve 52 Stoofstraat, 1000 Brussels, BELGIJA
English: What (Invented name)® looks like and contents of the pack <[To be completed nationally]>
Slovenian: Izgled zdravila (Izmišljeno ime)® in vsebina pakiranja <[Glejte Dodatek I - Dopolnjeno nacionalno]>
English: NAME OF THE MEDICINAL PRODUCT (Invented name)® 20 mg hard capsules <[See Annex I - To be completed nationally]> fluoxetine hydrochloride
Slovenian: IME ZDRAVILA (Izmišljeno ime)® 20 mg trde kapsule <[Glejte Dodatek I - Dopolnjeno nacionalno]> fluoksetinijev klorid
English: • develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), stop taking the capsules straight away and contact your doctor immediately .
Slovenian: • se pri vas pojavi izpuščaj ali druge alergijske reakcije (kot na primer srbenje, otečene ustnice ali obraz ali težave z dihanjem), takoj prenehajte jemati kapsule in se nemudoma obrnite na svojega zdravnika.
English: • If you get a rash or allergic reaction such as itching, swollen lips/tongue or wheezing/shortness of breath, stop taking (Invented name)® straight away and tell your doctor immediately.
Slovenian: • Če dobite izpuščaj ali alergijsko reakcijo kot je srbenje, otečene ustnice ali jezik, ali sopete in imate težave z dihanjem, takoj prenehajte jemati (Izmišljeno ime)® in nemudoma povejte svojemu zdravniku.
English: (Invented name)® 20mg hard capsules <[See Annex I - To be completed nationally]> fluoxetine (as hydrochloride)
Slovenian: (Izmišljeno ime)® 20 mg trde kapsule <[Glejte Dodatek I - Dopolnjeno nacionalno]> fluoksetin (v obliki klorida)
English: Whereas,
Slovenian: Ob upoštevanju naslednjega,
English: (Invented name)® 20mg oral liquid <[See Annex I - To be completed nationally]> fluoxetine (as hydrochloride)
Slovenian: (Izmišljeno ime)® 20 mg peroralna raztopina <[Glejte Dodatek I - Dopolnjeno nacionalno]> fluoksetin (v obliki klorida)
English: Other haemorrhagic manifestations (e.g., gynaecological haemorrhages, gastrointestinal bleedings and other cutaneous or mucous bleedings) have been reported rarely (see ‘Precautions', Haemorrhage).
Slovenian: Redko so poročali o drugih krvavitvah (npr. ginekoloških krvavitvah, krvavitvah v prebavilih in drugih kožnih ali sluzničnih krvavitvah) (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi, Krvavitve).
English: Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose.
Slovenian: Skrbno prilagajamo odmerjanje pri vsakem posamezniku, da bolnika vzdržujemo na najnižjem učinkovitem odmerku.
English: • develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), stop taking (Invented name)® straight away and contact your doctor immediately .
Slovenian: • se pri vas pojavi izpuščaj ali druge alergijske reakcije (kot na primer srbenje, otečene ustnice ali obraz ali težave z dihanjem), takoj prenehajte jemati (Izmišljeno ime)® in se nemudoma obrnite na svojega zdravnika.
English: HOW TO STORE (Invented name)®
Slovenian: SHRANJEVANJE ZDRAVILA (IZMIŠLJENO IME)®
English: MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]>
Slovenian: IMETNIK DOVOLJENJA ZA PROMET <[Glejte Dodatek I - Dopolnjeno nacionalno]>
English: Most of these side effects are likely to go away with continued treatment.
Slovenian: Večina zgoraj naštetih pojavov ni skrb zbujajočih in ob rednem zdravljenju minejo.
English: 20 mg/5 ml
Slovenian: 20 mg/5 ml peroralna raztopina peroralna uporaba
English: Miscellaneous: Alopecia, yawn, abnormal vision (e.g., blurred vision, mydriasis), sweating, vasodilatation, arthralgia, myalgia, postural hypotension, ecchymosis.
Slovenian: Razno: plešavost, zehanje, motnje vida (npr. zamegljen vid, midriaza), znojenje, vazodilatacija, bolečine v sklepih ali mišicah, posturalna hipotenzija, ekhimoze.
English: Black Iron Oxide E172
Slovenian: Sestava 1: šelak propilenglikol amonijev hidroksid črni železov oksid (E172)
English: Patients receiving warfarin therapy should receive careful coagulation monitoring when fluoxetine is initiated or stopped.
Slovenian: Pri bolnikih, ki prejemajo varfarin, je treba ob uvedbi ali ukinitvi zdravljenja s fluoksetinom strjevanje krvi skrbno nadzorovati (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi, Krvavitve).
English: Method of administration:
Slovenian: Pot uporabe:
English: A lower dose, e.g., alternate day dosing, is recommended in patients with significant hepatic dysfunction.
Slovenian: Pri bolnikih s pomembno okvaro delovanja jeter priporočamo nižji odmerek, npr. odmerjanje vsak drugi dan.
English: Marketing Authorisation Holder and Manufacturer <[See Annex I - To be completed nationally]>
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec <[Glejte Dodatek I - Dopolnjeno nacionalno]>
English: Lilly France S.A.S 13 rue Pagès 92158 Suresnes Cedex, FRANCE
Slovenian: Lilly France S.A.S 13 rue Pagès
English: Posology and method of administration
Slovenian: 4.2 Odmerjanje in način uporabe
English: When appropriate the dosage can be gradually increases up to a maximum of 60 mg.
Slovenian: Kadar je to primerno, lahko odmerek postopno povečujemo do največ 60 mg. Odmerek povečujemo previdno, s čimer zagotovimo, da dobite najmanjši učinkoviti odmerek.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka kapsula vsebuje fluoksetinijev klorid v količini, enaki 20 mg fluoksetina.
English: St John's Wort: An increase in serotonergic effects, such as serotonin syndrome, may occur when selective serotonin reuptake inhibitors and herbal preparations containing St John's Wort (Hypericum perforatum) are used together.
Slovenian: Šentjanževka: Ob sočasni uporabi selektivnih zaviralcev prevzema serotonina in zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum), se lahko serotoninergični učinki, denimo, serotoninski sindrom, okrepijo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 5ml of oral liquid contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsakih 5 ml raztopine vsebuje fluoksetinijev klorid v količini, enaki 20 mg fluoksetina.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 20 mg hard capsules
Slovenian: Fluctin Kapseln 20.mg trda kapsula peroralna uporaba
English: What (Invented name)® 20mg capsules contain:
Slovenian: Kaj vsebuje zdravilo (Izmišljeno ime)® 20 mg kapsule Zdravilna učinkovina je fluoksetinijev klorid.
English: NAME OF THE MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]>
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM <[Glejte Dodatek I - Dopolnjeno nacionalno]>
English: SPECIAL STORAGE CONDITIONS Do not store above 25˚C.
Slovenian: Shranjevanje pri temperaturi do 25 °C.
English: Pharmacodynamic properties
Slovenian: 5.1 Farmakodinamične lastnosti
English: Further information on Emgality can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Emgality so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Emgality (galcanezumab)
Slovenian: Emgality (galkanezumab)
English: This will stop the symptoms of migraine.
Slovenian: To prepreči simptome migrene.
English: What measures are being taken to ensure the safe and effective use of Emgality?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Emgality?
English: The European Medicines Agency therefore decided that Emgality's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Emgality večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: It contains the active substance galcanezumab.
Slovenian: Vsebuje učinkovino galkanezumab.
English: Emgality (galcanezumab) EMA/658658/2018
Slovenian: Emgality (galkanezumab) EMA/658658/2018
English: Patients can inject the medicine themselves after being trained.
Slovenian: Bolniki si po ustreznem usposabljanju zdravilo lahko injicirajo sami.
English: Other information about Emgality
Slovenian: Druge informacije o zdravilu Emgality
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emgality have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Emgality upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Doctors should review treatment after 3 months and only continue it if patients benefit from it.
Slovenian: Po treh mesecih morajo zdravniki oceniti zdravljenje in z njim nadaljevati, če bolniku koristi.
English: As for all medicines, data on the use of Emgality are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Emgality stalno spremljajo.
English: The most common side effects with Emgality (which may affect more than 1 in 10 people) are reactions at the site of injection such as pain, redness, itching, bruising or swelling.
Slovenian: Najpogostejši neželeni učinki zdravila Emgality (ki se lahko pojavijo pri največ 1 bolniku od 10) so reakcije na mestu injiciranja, na primer bolečina, rdečina, srbečica, podplutba ali oteklina.
English: Emgality is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.
Slovenian: Emgality je zdravilo, ki se uporablja za preprečevanje migrene pri odraslih, ki imajo migreno vsaj štiri dni na mesec.
English: The active substance of Emgality, galcanezumab, is a monoclonal antibody (a type of protein) designed to attach to and block CGRP, thereby helping blood vessels to return to their normal size.
Slovenian: Učinkovina zdravila Emgality, galkanezumab, je monoklonsko protitelo (vrsta beljakovine), zasnovano tako, da se veže na snov CGRP in zavre njeno delovanje ter tako pripomore, da se krvne žile vrnejo v običajno velikost.
English: Treatment should be started with the injection of the content of 2 syringes (or pens), followed a month later by single injections given every month.
Slovenian: Zdravljenje je treba začeti z injiciranjem vsebine dveh injekcijskih brizg (ali injekcijskih peresnikov), čemur mesec pozneje sledi mesečno injiciranje vsebine ene injekcijske brizge.
English: Side effects reported with Emgality are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Emgality, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefits of Emgality have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Emgality izkazalo v študijah?
English: An overview of Emgality and why it is authorised in the EU
Slovenian: Pregled zdravila Emgality in zakaj je odobreno v EU
English: Why is Emgality authorised in the EU?
Slovenian: Zakaj je zdravilo Emgality odobreno v EU?
English: A substance called CGRP has been shown to be involved in the development of migraine by widening blood vessels in the brain.
Slovenian: Izkazalo se je, da snov, imenovana CGRP, sodeluje pri razvoju migrene, tako da širi krvne žile v možganih.
English: What are the risks associated with Emgality?
Slovenian: Kakšna tveganja so povezana z zdravilom Emgality?
English: For more information about using Emgality, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Emgality glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Emgality and what is it used for?
Slovenian: Kaj je zdravilo Emgality in za kaj se uporablja?
English: Emgality was shown to be more effective than placebo at reducing the number of days of migraine, although the size of the effect is limited particularly for patients with chronic migraine.
Slovenian: Zdravilo Emgality se je pri zmanjševanju števila migrenskih dni izkazalo za učinkovitejše od placeba, čeprav je učinek omejen, zlasti pri bolnikih s kroničnimi migrenami.
English: Emgality can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of migraine.
Slovenian: Predpisovanje in izdaja zdravila Emgality je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem migrene.
English: Emgality is injected under the skin using a pre-filled syringe or pen.
Slovenian: Zdravilo Emgality se injicira pod kožo z uporabo napolnjene injekcijske brizge ali napolnjenega injekcijskega peresnika.
English: The side effects seen with Emgality are considered manageable with most being mild or moderate in severity.
Slovenian: Neželeni učinki, opaženi pri zdravilu Emgality, veljajo za obvladljive, večina je blagih ali zmernih.
English: In a third study of 1,117 patients who had migraines for more than 15 days a month on average (chronic migraine), those treated with Emgality had on average around 5 fewer days with migraines per month compared with around 3 fewer days for patients on placebo.
Slovenian: V tretji študiji, v katero je bilo vključenih 1 117 bolnikov, ki so imeli migreno v povprečju več kot 15 dni na mesec (kronična migrena), so imeli bolniki, zdravljeni z zdravilom Emgality, na mesec približno pet migrenskih dni manj, bolniki, ki so jemali placebo, pa tri migrenske dneve manj.
English: Overall, Emgality led to 2 fewer days with migraines per month compared with placebo (a dummy treatment).
Slovenian: Na splošno je zdravilo Emgality povzročilo dva migrenska dneva manj na mesec v primerjavi s placebom (zdravilom brez zdravilne učinkovine).
English: In two studies involving 1,784 patients who had migraines between 4 and 14 days a month, those treated with Emgality had 4 or 5 fewer days with migraines per month, compared with 2 to 3 fewer days for patients on a placebo injection.
Slovenian: V dveh študijah, pri katerih je sodelovalo 1 784 bolnikov, ki so imeli migreno med štiri in 14 dni na mesec, so tisti, ki so bili zdravljeni z zdravilom Emgality, imeli štiri ali pet migrenskih dni manj na
English: For the full list of side effects and restrictions of Emgality, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Emgality glejte navodilo za uporabo.
English: How does Emgality work?
Slovenian: Kako zdravilo Emgality deluje?
English: How is Emgality used?
Slovenian: Kako se zdravilo Emgality uporablja?