FrancophonIA/ELRC3.0 huggingface dataset:
English: N = number of subjects included in each group n = number of cases (1) ATP: includes women who received 3 doses of vaccine, were DNA negative and seronegative at month 0 and DNA negative at month 6 to the relevant HPV type (HPV
Slovenian: N = število oseb, vključenih v vsako skupino n = število primerov (1) PP: vključuje ženske, ki so prejele 3 odmerke cepiva ter so bile ob mesecu 0 DNA-negativne in seronegativne ter ob mesecu 6 DNA-negativne za zadevni tip HPV (HPV-16 ali HPV-18)
English: % Efficacy (96.2% CI)
Slovenian: Cervarix Kontrola % učinkovitosti (96,2 % IZ)
English: 4.4 Special warnings and precautions for use As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Slovenian: Pri cepljenju je, tako kot pri vseh cepivih, ki se jih injicira, treba zagotoviti ustrezno obliko zdravljenja in nadzora, ki morata biti v takšnem primeru nemudoma na voljo.
English: A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe.
Slovenian: Med shranjevanjem napolnjene injekcijske brizge se lahko pojavi fina bela usedlina in bister brezbarven supernatant.
English: Prophylactic efficacy against HPV-16/18 in women naïve to HPV-16 and/or HPV-18
Slovenian: Učinkovitost profilakse proti HPV-16/18 pri ženskah, ki še niso bile izpostavljene HPV-16 in/ali HPV-18
English: In a supplemental analysis, the efficacy of Cervarix was evaluated against HPV-16/18-related CIN3+.
Slovenian: V dodatni analizi so ocenili učinkovitost cepiva Cervarix proti CIN3+, povezanemu s
English: • gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
Slovenian: • prebavni simptomi, vključno s siljenjem na bruhanje, bruhanjem, drisko in bolečinami v trebuhu,
English: Multidose vial EU/1/07/419/010 EU/1/07/419/011 EU/1/07/419/012
Slovenian: EU/1/07/419/010 EU/1/07/419/011 EU/1/07/419/012
English: When Cervarix is given for the first dose, it is recommended that Cervarix (and not another vaccine against HPV) be given for the complete vaccination course.
Slovenian: Cervarix (in ne z drugim cepivom proti HPV).
English: - This medicine has been prescribed for you only.
Slovenian: - Cepivo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: The doctor or nurse will give Cervarix as an injection into the muscle of the upper arm. How much is given
Slovenian: Kako se daje to cepivo Cepivo Cervarix vam bo dal zdravnik ali medicinska sestra v obliki injekcije v mišico nadlakti.
English: Instructions for administration of the vaccine in pre-filled syringe
Slovenian: Navodila za injiciranje cepiva v napolnjeni injekcijski brizgi
English: Needle protector
Slovenian: Ščitnik igle
English: Data in pregnant women collected as part of pregnancy registries, epidemiological studies and inadvertent exposure during clinical trials are insufficient to conclude whether or not vaccination with Cervarix affects the risk of adverse pregnancy outcomes including spontaneous abortion.
Slovenian: Podatkov o nosečnicah, zbranih iz registrov nosečnosti, epidemioloških študij in nenamernih izpostavljenosti med kliničnimi preskušanji,
English: At study completion, there were no cases of infection or histopathological lesions associated with HPV-16 or HPV-18 in the vaccine group in study HPV-023.
Slovenian: Ob dokončanju študije v cepljeni skupini v študiji HPV-023 ni bilo primerov okužbe ali histopatoloških sprememb, povezanih s HPV-16 ali HPV-18.
English: Cervarix does not protect people from diseases caused by infection with HPV types 16 or 18 if they are already infected with Human Papillomavirus type 16 or 18 at the time of vaccination.
Slovenian: Če je okužba z genotipoma 16 ali 18 humanih virusov papiloma v času cepljenja že prisotna, cepivo Cervarix ne more ščititi pred boleznimi, ki so posledica okužbe z genotipoma 16 ali 18 HPV.
English: N Cases
Slovenian: N Primeri
English: ♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine):
Slovenian: ♦ Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 10, vendar več kot 1 od
English: This leaflet was last revised in {month YYYY} Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: 9 to and including 14 years* Two doses each of 0.5 ml.
Slovenian: Cepljenje in shema Od 9 do vključno 14 let* Dva odmerka po 0,5 ml. Cepljenje z drugim odmerkom se opravi od 5 do 13 mesecev po prvem odmerku.
English: HPV type 18 L1 protein1,2
Slovenian: L1 protein genotipa 18 HPV1,2
English: Suspension for injection in pre-filled syringe
Slovenian: Suspenzija za injiciranje v napolnjeni injekcijski brizgi.
English: HPV type 16 L1 protein1,2
Slovenian: L1 protein genotipa 16 HPV1,2
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE WITH OR WITHOUT NEEDLE, PACK OF 1, 10
Slovenian: NAPOLNJENA INJEKCIJSKA BRIZGA Z INJEKCIJSKO IGLO ALI BREZ, PAKIRANJA PO 1, 10
English: Cervarix is not recommended for use in children below 9 years of age due to lack of data on safety and immunogenicity in this age-group.
Slovenian: Zaradi pomanjkanja podatkov o varnosti in imunogenosti uporaba cepiva Cervarix pri otrocih, mlajših od 9 let, ni priporočljiva.
English: These diseases include: - cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb) and anal cancer, - precancerous cervical, vulvar, vaginal and anal lesions (changes in genital or anal cells that have a risk of turning into cancer).
Slovenian: - predrakave cervikalne, vulvarne, vaginalne in analne spremembe (spremembe v celicahspolovila ali zadnjika, iz katerih se lahko razvije rak).
English: 100 vials 100 x 1 dose (0.5 ml)
Slovenian: 100 vial 100 x 1 odmerek (0,5 ml)
English: On the basis of these immunogenicity data, the efficacy of Cervarix is inferred from 9 to 14 years of age.
Slovenian: Na osnovi teh podatkov o imunogenosti, lahko sklepamo o učinkovitosti cepiva Cervarix pri osebah,
English: Vaccine efficacy against virological endpoints (6-month and 12-month persistent infection) associated with HPV-16/18 observed in TVC at end of study is presented in Table 4.
Slovenian: (2) povprečno spremljanje 44 mesecev po 1. odmerku Učinkovitost cepiva proti virološkima opazovanima dogodkoma (6-mesečna in 12-mesečna persistentna okužba), povezana s HPV-16/18, ugotovljena v TVC ob koncu študije, je prikazana v preglednici 4.
English: Gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
Slovenian: Pogosti prebavni simptomi, vključno z navzeo, bruhanjem, drisko in bolečino v trebuhu
English: Not known* Lymphadenopathy
Slovenian: limfadenopatija
English: 10 vials 10 x 1 dose (0.5 ml)
Slovenian: 10 vial 10 x 1 odmerek (0,5 ml)
English: What you need to know before you receive Cervarix
Slovenian: Kaj morate vedeti, preden boste prejeli cepivo Cervarix Cepiva Cervarix ne smete prejeti
English: Very common Headache Uncommon Dizziness
Slovenian: Zelo pogosti glavobol
English: Based on the HPV type assignment post-hoc analysis, there was 1 CIN2+ case in the vaccine group versus 92 cases in the control group (Efficacy 98.9% (95% CI: 93.8;100)) and no CIN3+ case in the vaccine group versus 22 cases in the control group (Efficacy 100% (95% CI: 81.8;100)) at the end of study analysis.
Slovenian: Glede na post hoc analizo razporeditve tipa HPV je bil v cepljeni skupini 1 primer CIN2+, v kontrolni skupini pa je bilo 92 takšnih primerov (učinkovitost 98,9 % (95 % IZ: 93,8; 100)).
English: CIN2+ associated with HPV-16 and HPV-18 individually was demonstrated.
Slovenian: Poleg tega je bila dokazana statistično značilna učinkovitost cepiva proti CIN2+, povezanemu s HPV-16 in HPV-18 posamezno.
English: HPV type assignment analysis (see under Table).
Slovenian: (razporeditev tipa HPV).
English: Frequencies are reported as:
Slovenian: Te bolezni so:
English: In two clinical trials (HPV-012 & -013) performed in girls aged 10 to 14 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7) with GMTs at least 2-fold higher as compared to women aged 15 to 25 years.
Slovenian: V dveh kliničnih preskušanjih (HPV-012 in -013), izvedenih pri deklicah, starih od 10 do 14 let, je po cepljenju s tretjim odmerkom (7. mesec) pri vseh osebah prišlo do serokonverzije na oba genotipa 16 in 18 HPV.
English: Uncommon Upper respiratory tract infection
Slovenian: Infekcijske in parazitske bolezni Občasni okužba zgornjih dihal
English: NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in a vial
Slovenian: Cervarix suspenzija za injiciranje v viali
English: Syringe cap
Slovenian: • glavobol,
English: Frequency Adverse reactions
Slovenian: Neznana pogostnost*
English: Cervarix contains sodium chloride.
Slovenian: pridobljene s cepivom Cervarix.
English: Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types.
Slovenian: Cepivo Cervarix je indicirano za preprečevanje predrakavih anogenitalnih sprememb (cervikalnih, vulvarnih, vaginalnih in analnih) ter raka materničnega vratu in raka anusa, ki so posledica okužbe z določenimi onkogenimi genotipi humanih virusov papiloma (HPV) od starosti 9 let naprej (za pomembne informacije o podatkih, ki podpirajo to indikacijo, glejte poglavji 4.4 in 5.1).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MONODOSE VIAL LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: EU/1/07/419/012 - pack of 100
Slovenian: EU/1/07/419/012 - pakiranje po 100
English: Clinical efficacy in women aged 26 years and older The efficacy of Cervarix was assessed in a double-blind, randomised Phase III clinical trial (HPV-015) that included a total of 5,778 women aged 26-72 years (median: 37.0 years).
Slovenian: (HPV-015), ki je zajela skupno 5.778 žensk, starih od 26 do 72 let (mediana: 37,0 let).
English: EU/1/07/419/011 - pack of 10
Slovenian: EU/1/07/419/011 - pakiranje po 10
English: Cervarix may not have an optimal effect if used with medicines that suppress the immune system.
Slovenian: V primeru uporabe zdravil, ki zavirajo imunski sistem, učinek cepiva Cervarix morda ne bo optimalen.
English: The TVC-naïve is a subset of the TVC that includes women with normal cytology, and who were HPV DNA negative for 14 oncogenic HPV types and seronegative for HPV-16 and HPV-18 at baseline.
Slovenian: DNA-negativne za 14 onkogenih tipov HPV in seronegativne za HPV-16 in HPV-18 ob izhodišču.
English: EU/1/07/419/003 - pack of 100
Slovenian: EU/1/07/419/003 - pakiranje po 100
English: 1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
Slovenian: 1 napolnjena injekcijska brizga + 1 injekcijska igla 1 odmerek (0,5 ml)
English: In another clinical trial (study 014) performed in women aged 15 to 55 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7).
Slovenian: V drugem kliničnem preskušanju (študija 014), izvedenem pri ženskah, starih od 15 do 55 let, se je po cepljenju s tretjim odmerkom cepiva (v 7. mesecu) serokonverzija na oba genotipa HPV, 16 in 18, pojavila pri vseh osebah, vendar pa so bili pri ženskah, starejših od 25 let, geometrijski srednji titri nižji.
English: Itching/pruritus, rash, urticaria
Slovenian: Pogosti srbenje, izpuščaj, urtikarija
English: 1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
Slovenian: 1 napolnjena injekcijska brizga + 2 injekcijski igli 1 odmerek (0,5 ml)
English: - If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: 10 pre-filled syringes 10 x 1 dose (0.5 ml)
Slovenian: 10 napolnjenih injekcijskih brizg 10 x 1 odmerek (0,5 ml)
English: The efficacy of Cervarix was assessed in two controlled, double-blind, randomised Phase II and III clinical trials that included a total of 19,778 women aged 15 to 25 years.
Slovenian: in III. faze, v kateri je bilo skupaj vključenih 19.778 žensk, starih od 15 do 25 let.
English: **If flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose and the third dose between 5 and 12 months after the first dose.
Slovenian: 2,5 meseca po prvem odmerku in cepljenje s tretjim odmerkom od 5 do 12 mesecev po prvem odmerku.
English: I.M.
Slovenian: A.
English: N = number of subjects included in each group n = number of cases (1) ATP: includes women who received 3 doses of vaccine, were DNA negative and seronegative at month 0 and DNA negative at month 6 to the relevant HPV type (HPV-16 or HPV-18) (2) including 4 cases of CIN2+ and 2 cases of CIN3+ in which another oncogenic HPV type was identified in the lesion, concomitantly with HPV-16 or HPV-18.
Slovenian: (1) PP: vključuje ženske, ki so prejele 3 odmerke cepiva ter so bile ob mesecu 0 DNA-negativne in seronegativne ter ob mesecu 6 DNA-negativne za zadevni tip HPV (HPV-16 ali HPV-18)
English: Second injection: 1 month after first injection
Slovenian: Prvi odmerek: na izbrani dan Drugi odmerek: 1 mesec po prvem odmerku Tretji odmerek: 6 mesecev po prvem odmerku
English: In study 024 (a subset of study 001/007), a challenge dose of Cervarix was administered to 65 subjects at a mean interval of 6.8 years after the administration of the first vaccine dose.
Slovenian: V študiji 024 (podštudiji študije 001/007) je bil provokacijski odmerek cepiva Cervarix uporabljen pri
English: GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com
Slovenian: GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00
English: Human Papillomavirus1 type 16 L1 protein2,3,4
Slovenian: L1 protein2,3,4 genotipa 16 humanega virusa papiloma1
English: Pre-filled syringe
Slovenian: Napolnjena injekcijska brizga
English: What Cervarix looks like and contents of the pack Suspension for injection.
Slovenian: Izgled cepiva Cervarix in vsebina pakiranja
English: 10 multidose vials 10 x 2 doses (1 ml)
Slovenian: 10 x 2 odmerka (1 ml)
English: Warnings and precautions Talk to your doctor or pharmacist before you are given Cervarix
Slovenian: Predno prejmete cepivo Cervarix, se posvetujte s svojim zdravnikom ali s farmacevtom, če imate:
English: Suspension for injection in pre-filled syringe 1 pre-filled syringe
Slovenian: Suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga 1 odmerek (0,5 ml)
English: Human Papillomavirus1 type 18 L1 protein2,3,4
Slovenian: L1 protein2,3,4 genotipa 18 humanega virusa papiloma1
English: Table 5: Vaccine efficacy against high-grade cervical lesions irrespective of the HPV DNA type in the lesion
Slovenian: Preglednica 5: Učinkovitost cepiva proti visokostopenjskim spremembam materničnega vratu, ne glede na tip HPV DNA v spremembi analiza ob koncu študije(3)
English: 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
Slovenian: 10 napolnjenih injekcijskih brizg + 20 injekcijskih igel 10 x 1 odmerek (0,5 ml)
English: HPV-31 6M PI HPV-45 6M PI HPV-31 ASC-US+ HPV-45 ASC-US+ N = number of subjects in each group n = number of subjects reporting at least one event in each group 6M PI = 6-month persistent infection CI = Confidence Interval ASC-US= Atypical Cells of Undetermined Significance (abnormal cytology) (1) 3 doses of vaccine, DNA negative and seronegative at month 0 (unless specified) and DNA negative at month 6 for the relevant HPV type (HPV-16 and/or HPV-18) (2) at least one dose of vaccine, irrespective of HPV DNA and serostatus (unless specified) at month 0.
Slovenian: negativnost v mesecu 6 za relevantni tip HPV (HPV-16 in/ali HPV-18) (2) Vsaj en odmerek cepiva, ne glede na HPV DNA in serološko stanje (če ni določeno drugače) v mesecu 0.
English: If you are pregnant, if pregnancy occurs during the course of vaccination or if you are trying to become pregnant it is recommended to postpone or interrupt vaccination until after completion of the pregnancy.
Slovenian: Če ste noseči, če zanosite, preden prejmete vse odmerke cepiva Cervarix, ali če načrtujete nosečnost,
English: HPV DNA status, cytology and serostatus at baseline.
Slovenian: serološki in DNA status.
English: If you get any side effects , talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise.
Slovenian: Z eno roko držite valj brizge (ne bata brizge)
English: Table 4: Vaccine efficacy against virological endpoints associated with HPV-16/18 (TVC)
Slovenian: Preglednica 4: Učinkovitost cepiva proti virološkim opazovanim dogodkom, povezanimi s HPV
English: Cervarix suspension for injection, multidose container Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Slovenian: Cervarix suspenzija za injiciranje, večodmerni vsebnik Adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
English: EU/1/07/419/002 - pack of 10
Slovenian: EU/1/07/419/002 - pakiranje po 10
English: Cervarix is intended for use from 9 years of age onwards.
Slovenian: Koliko cepiva se uporabi Cepivo Cervarix je namenjeno cepljenju oseb, starih 9 let ali več.
English: Other medicines and Cervarix
Slovenian: Shranjevanje cepiva Cervarix
English: Use with hormonal contraceptive
Slovenian: UČINKOVITO UPORABO ZDRAVILA
English: 100 multidose vials 100 x 2 doses (1 ml)
Slovenian: 100 x 2 odmerka (1 ml)
English: In study 007 the efficacy of Cervarix against 12-month persistent HPV-16/18 infection was 100% (95% CI: 80.5; 100).
Slovenian: 16/18 100 % (95 % interval zaupanja: 80,5; 100).
English: Table 2: Vaccine efficacy against virological endpoints associated with HPV-16/18 (ATP cohort) HPV-16/18 endpoint
Slovenian: HPV-16/18 (kohorta PP) Opazovani dogodek HPV-16/18
English: N = number of subjects included in each group n = number of cases (1) TVC: includes all vaccinated subjects (who received at least one dose of vaccine) irrespective of
Slovenian: N = število oseb, vključenih v vsako skupino n = število primerov
English: 6M PI in subjects seropositive at baseline only
Slovenian: 6-mesečna p.o. samo pri preiskovankah , ki so bile seropozitivne ob izhodišču
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cervarix
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Cervarix suspenzija za injiciranje i.m.
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
Slovenian: 10 napolnjenih injekcijskih brizg + 10 injekcijskih igel 10 x 1 odmerek (0,5 ml)
English: Clinical efficacy in women aged 15 to 25 years
Slovenian: 79,2 % žensk starih od 10 do 25 let).
English: Nervous system disorders
Slovenian: Intramuskularna uporaba.
English: Shake before use
Slovenian: Pred uporabo pretresite.
English: Cervarix suspension for injection in multidose container Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Slovenian: Cervarix suspenzija za injiciranje, večodmerni vsebnik adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
English: Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Slovenian: Cervarix suspenzija za injiciranje v napolnjeni injekcijski brizgi Adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
English: • dizziness
Slovenian: • utrujenost.
English: GlaxoSmithKline S.p.A. Tel:+ 39 (0)45 9218 111
Slovenian: Tel: + 39 (0)45 9218 111
English: How the vaccine is given
Slovenian: NAČIN IZDAJANJA ZDRAVILA
English: In clinical studies that enrolled girls and women aged from 10 up to 72 years (of which 79.2% were aged 10-25 years at the time of enrolment), Cervarix was administered to 16,142 females whilst 13,811 females received control.
Slovenian: V klinične študije so bile vključene deklice in ženske, stare od 10 do 72 let (ob vključitvi je bilo
English: NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Slovenian: NAVODILO ZA UPORABO Cervarix suspenzija za injiciranje v napolnjeni injekcijski brizgi adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
English: Sodium chloride (NaCl)
Slovenian: GlaxoSmithKline (Cyprus) Ltd
English: An anamnestic immune response to HPV-16 and HPV-18 (by ELISA) was observed one week and one month after the challenge dose, GMTs one month after the challenge dose exceeded those observed one month after the primary 3-dose vaccination.
Slovenian: Geometrijski srednji titer po provokacijskem odmerku je presegel odziv, ugotovljen en mesec po primarnem cepljenju s tremi odmerki.
English: It starts working in about a week.
Slovenian: Delovati začne približno v enem tednu.
English: Before You Get Started
Slovenian: Preden začnete
English: Date of first authorisation: 14 November 2018
Slovenian: Datum prve odobritve: 14. november 2018
English: 279 patients were exposed for 12 months.
Slovenian: 279 bolnikov je bilo izpostavljenih 12 mesecev.
English: Elderly (> 65 years)
Slovenian: Starejši (> 65 let)
English: Handle it carefully.
Slovenian: Z njim rokujte previdno.
English: • it looks damaged
Slovenian: • je videti poškodovana;
English: Patients > 65 years of age were also excluded.
Slovenian: Izključeni so bili tudi bolniki, stari > 65 let.
English: Make sure you have the right medicine.
Slovenian: Prepričajte se, da imate pravo zdravilo.
English: • Do not inject in the same spot as before.
Slovenian: • Ne injicirajte si na isto točko kot prej.
English: Sesto Fiorentino (FI) Italy
Slovenian: Sesto Fiorentino (FI) Italija
English: What if I cannot push in the plunger?
Slovenian: Kaj če ne morem potisniti bata?
English: • the medicine is frozen
Slovenian: • je zdravilo zamrznjeno.
English: Commonly Asked Questions
Slovenian: Pogosto zastavljena vprašanja
English: Look out for allergic reactions
Slovenian: Bodite pozorni na alergijske reakcije.
English: 77.8 % of patients completed the treatment period.
Slovenian: 77,8 % bolnikov je zaključilo obdobje zdravljenja.
English: The treatment benefit should be assessed within 3 months after initiation of treatment.
Slovenian: Korist zdravljenja je treba oceniti v treh mesecih od začetka zdravljenja.
English: No safety data are available in these patients.
Slovenian: Podatkov o varnosti pri teh bolnikih ni.
English: A. Some patients may hear a soft click right before the second loud click.
Slovenian: O. Nekateri bolniki lahko slišijo tišji klik tik pred drugim glasnim klikom.
English: Do not remove the pen from your skin until you hear the second loud click.
Slovenian: Ne umaknite peresnika s kože, dokler ne slišite drugega glasnega klika.
English: Important Information
Slovenian: Pomembne informacije
English: Percentage, %
Slovenian: odstotek, %
English: Emgality can reduce the frequency of migraine headache and improve your quality of life.
Slovenian: Zdravilo Emgality lahko zmanjšuje pogostnost migrenskih glavobolov in izboljša kakovost življenja.
English: A. This is normal.
Slovenian: O. To je normalno.
English: If the plunger is stuck or damaged:
Slovenian: Če je bat blokiran ali poškodovan:
English: Turn the lock ring to the unlock position.
Slovenian: Zaklepni obroč obrnite v odklenjen položaj.
English: No drug interaction studies were conducted.
Slovenian: Študij medsebojnega delovanja zdravil niso izvedli.
English: Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine.
Slovenian: Zdravljenje morajo uvesti zdravniki, ki imajo izkušnje z diagnostiko in zdravljenjem migrene.
English: The MSQ measures impact of migraine on work or daily activities, relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness.
Slovenian: Vprašalnik MSQ meri vpliv migrene na delo ali vsakodnevne aktivnosti, odnose z družino in prijatelji, prosti čas, produktivnost, koncentracijo, energijo in utrujenost.