natgillin/translations-raw huggingface dataset:
Instructions for administration of the vaccine in pre-filled syringe 
Navodila za injiciranje cepiva v napolnjeni injekcijski brizgi
Needle protector 
Ščitnik igle
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. 
Podatkov o nosečnicah, zbranih iz registrov nosečnosti, epidemioloških študij in nenamernih izpostavljenosti med kliničnimi preskušanji,
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. 
Ob dokončanju študije v cepljeni skupini v študiji HPV-023 ni bilo primerov okužbe ali histopatoloških sprememb, povezanih s HPV-16 ali HPV-18.
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. 
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.
N Cases 
N Primeri
♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine): 
♦ Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 10, vendar več kot 1 od
This leaflet was last revised in {month YYYY} Other sources of information 
Navodilo je bilo nazadnje revidirano dne
9 to and including 14 years* Two doses each of 0.5 ml. 
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.
HPV type 18 L1 protein1,2 
L1 protein genotipa 18 HPV1,2
Suspension for injection in pre-filled syringe 
Suspenzija za injiciranje v napolnjeni injekcijski brizgi.
HPV type 16 L1 protein1,2 
L1 protein genotipa 16 HPV1,2
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE WITH OR WITHOUT NEEDLE, PACK OF 1, 10 
NAPOLNJENA INJEKCIJSKA BRIZGA Z INJEKCIJSKO IGLO ALI BREZ, PAKIRANJA PO 1, 10
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. 
Zaradi pomanjkanja podatkov o varnosti in imunogenosti uporaba cepiva Cervarix pri otrocih, mlajših od 9 let, ni priporočljiva.
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). 
- predrakave cervikalne, vulvarne, vaginalne in analne spremembe (spremembe v celicahspolovila ali zadnjika, iz katerih se lahko razvije rak).
100 vials 100 x 1 dose (0.5 ml) 
100 vial 100 x 1 odmerek (0,5 ml)
On the basis of these immunogenicity data, the efficacy of Cervarix is inferred from 9 to 14 years of age. 
Na osnovi teh podatkov o imunogenosti, lahko sklepamo o učinkovitosti cepiva Cervarix pri osebah,
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. 
(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.
Gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain 
Pogosti prebavni simptomi, vključno z navzeo, bruhanjem, drisko in bolečino v trebuhu
Not known* Lymphadenopathy 
limfadenopatija
10 vials 10 x 1 dose (0.5 ml) 
10 vial 10 x 1 odmerek (0,5 ml)
What you need to know before you receive Cervarix 
Kaj morate vedeti, preden boste prejeli cepivo Cervarix Cepiva Cervarix ne smete prejeti
Very common Headache Uncommon Dizziness 
Zelo pogosti glavobol
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. 
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)).
CIN2+ associated with HPV-16 and HPV-18 individually was demonstrated. 
Poleg tega je bila dokazana statistično značilna učinkovitost cepiva proti CIN2+, povezanemu s HPV-16 in HPV-18 posamezno.
HPV type assignment analysis (see under Table). 
(razporeditev tipa HPV).
Frequencies are reported as: 
Te bolezni so:
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. 
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.
Uncommon Upper respiratory tract infection 
Infekcijske in parazitske bolezni Občasni okužba zgornjih dihal
NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in a vial 
Cervarix suspenzija za injiciranje v viali
Syringe cap 
• glavobol,
Frequency Adverse reactions 
Neznana pogostnost*
Cervarix contains sodium chloride. 
pridobljene s cepivom Cervarix.
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. 
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).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MONODOSE VIAL LABEL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
EU/1/07/419/012 - pack of 100 
EU/1/07/419/012 - pakiranje po 100
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). 
(HPV-015), ki je zajela skupno 5.778 žensk, starih od 26 do 72 let (mediana: 37,0 let).
EU/1/07/419/011 - pack of 10 
EU/1/07/419/011 - pakiranje po 10
Cervarix may not have an optimal effect if used with medicines that suppress the immune system. 
V primeru uporabe zdravil, ki zavirajo imunski sistem, učinek cepiva Cervarix morda ne bo optimalen.
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. 
DNA-negativne za 14 onkogenih tipov HPV in seronegativne za HPV-16 in HPV-18 ob izhodišču.
EU/1/07/419/003 - pack of 100 
EU/1/07/419/003 - pakiranje po 100
1 pre-filled syringe + 1 needle 1 dose (0.5 ml) 
1 napolnjena injekcijska brizga + 1 injekcijska igla 1 odmerek (0,5 ml)
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). 
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.
Itching/pruritus, rash, urticaria 
Pogosti srbenje, izpuščaj, urtikarija
1 pre-filled syringe + 2 needles 1 dose (0.5 ml) 
1 napolnjena injekcijska brizga + 2 injekcijski igli 1 odmerek (0,5 ml)
- If you get any side effects, talk to your doctor or pharmacist. 
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
10 pre-filled syringes 10 x 1 dose (0.5 ml) 
10 napolnjenih injekcijskih brizg 10 x 1 odmerek (0,5 ml)
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. 
in III. faze, v kateri je bilo skupaj vključenih 19.778 žensk, starih od 15 do 25 let.
**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. 
2,5 meseca po prvem odmerku in cepljenje s tretjim odmerkom od 5 do 12 mesecev po prvem odmerku.
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. 
(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)
Second injection: 1 month after first injection 
Prvi odmerek: na izbrani dan Drugi odmerek: 1 mesec po prvem odmerku Tretji odmerek: 6 mesecev po prvem odmerku
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. 
V študiji 024 (podštudiji študije 001/007) je bil provokacijski odmerek cepiva Cervarix uporabljen pri
Human Papillomavirus1 type 16 L1 protein2,3,4 
L1 protein2,3,4 genotipa 16 humanega virusa papiloma1
Pre-filled syringe 
Napolnjena injekcijska brizga
What Cervarix looks like and contents of the pack Suspension for injection. 
Izgled cepiva Cervarix in vsebina pakiranja
10 multidose vials 10 x 2 doses (1 ml) 
10 x 2 odmerka (1 ml)
Warnings and precautions Talk to your doctor or pharmacist before you are given Cervarix 
Predno prejmete cepivo Cervarix, se posvetujte s svojim zdravnikom ali s farmacevtom, če imate:
Suspension for injection in pre-filled syringe 1 pre-filled syringe 
Suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga 1 odmerek (0,5 ml)
Human Papillomavirus1 type 18 L1 protein2,3,4 
L1 protein2,3,4 genotipa 18 humanega virusa papiloma1
Table 5: Vaccine efficacy against high-grade cervical lesions irrespective of the HPV DNA type in the lesion 
Preglednica 5: Učinkovitost cepiva proti visokostopenjskim spremembam materničnega vratu, ne glede na tip HPV DNA v spremembi analiza ob koncu študije(3)
10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml) 
10 napolnjenih injekcijskih brizg + 20 injekcijskih igel 10 x 1 odmerek (0,5 ml)
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. 
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.
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. 
Če ste noseči, če zanosite, preden prejmete vse odmerke cepiva Cervarix, ali če načrtujete nosečnost,
HPV DNA status, cytology and serostatus at baseline. 
serološki in DNA status.
If you get any side effects , talk to your doctor or pharmacist. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise. 
Z eno roko držite valj brizge (ne bata brizge)
Table 4: Vaccine efficacy against virological endpoints associated with HPV-16/18 (TVC) 
Preglednica 4: Učinkovitost cepiva proti virološkim opazovanim dogodkom, povezanimi s HPV
Cervarix suspension for injection, multidose container Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) 
Cervarix suspenzija za injiciranje, večodmerni vsebnik Adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
EU/1/07/419/002 - pack of 10 
EU/1/07/419/002 - pakiranje po 10
Cervarix is intended for use from 9 years of age onwards. 
Koliko cepiva se uporabi Cepivo Cervarix je namenjeno cepljenju oseb, starih 9 let ali več.
Other medicines and Cervarix 
Shranjevanje cepiva Cervarix
Use with hormonal contraceptive 
UČINKOVITO UPORABO ZDRAVILA
100 multidose vials 100 x 2 doses (1 ml) 
100 x 2 odmerka (1 ml)
In study 007 the efficacy of Cervarix against 12-month persistent HPV-16/18 infection was 100% (95% CI: 80.5; 100). 
16/18 100 % (95 % interval zaupanja: 80,5; 100).
Table 2: Vaccine efficacy against virological endpoints associated with HPV-16/18 (ATP cohort) HPV-16/18 endpoint 
HPV-16/18 (kohorta PP) Opazovani dogodek HPV-16/18
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 
N = število oseb, vključenih v vsako skupino n = število primerov
6M PI in subjects seropositive at baseline only 
6-mesečna p.o. samo pri preiskovankah , ki so bile seropozitivne ob izhodišču
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cervarix 
IME ZDRAVILA IN POT(I) UPORABE Cervarix suspenzija za injiciranje i.m.
10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml) 
10 napolnjenih injekcijskih brizg + 10 injekcijskih igel 10 x 1 odmerek (0,5 ml)
Clinical efficacy in women aged 15 to 25 years 
79,2 % žensk starih od 10 do 25 let).
Nervous system disorders 
Intramuskularna uporaba.
Shake before use 
Pred uporabo pretresite.
Cervarix suspension for injection in multidose container Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) 
Cervarix suspenzija za injiciranje, večodmerni vsebnik adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) 
Cervarix suspenzija za injiciranje v napolnjeni injekcijski brizgi Adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
• dizziness 
• utrujenost.
How the vaccine is given 
NAČIN IZDAJANJA ZDRAVILA
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. 
V klinične študije so bile vključene deklice in ženske, stare od 10 do 72 let (ob vključitvi je bilo
NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) 
NAVODILO ZA UPORABO Cervarix suspenzija za injiciranje v napolnjeni injekcijski brizgi adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
Sodium chloride (NaCl) 
GlaxoSmithKline (Cyprus) Ltd
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. 
Geometrijski srednji titer po provokacijskem odmerku je presegel odziv, ugotovljen en mesec po primarnem cepljenju s tremi odmerki.
It starts working in about a week. 
Delovati začne približno v enem tednu.
Before You Get Started 
Preden začnete
Date of first authorisation: 14 November 2018 
Datum prve odobritve: 14. november 2018
279 patients were exposed for 12 months. 
279 bolnikov je bilo izpostavljenih 12 mesecev.
Elderly (> 65 years) 
Starejši (> 65 let)
Handle it carefully. 
Z njim rokujte previdno.
• it looks damaged 
• je videti poškodovana;
Patients > 65 years of age were also excluded. 
Izključeni so bili tudi bolniki, stari > 65 let.
Make sure you have the right medicine. 
Prepričajte se, da imate pravo zdravilo.
• Do not inject in the same spot as before. 
• Ne injicirajte si na isto točko kot prej.
What if I cannot push in the plunger? 
Kaj če ne morem potisniti bata?
• the medicine is frozen 
• je zdravilo zamrznjeno.
Commonly Asked Questions 
Pogosto zastavljena vprašanja
Look out for allergic reactions 
Bodite pozorni na alergijske reakcije.
77.8 % of patients completed the treatment period. 
77,8 % bolnikov je zaključilo obdobje zdravljenja.
The treatment benefit should be assessed within 3 months after initiation of treatment. 
Korist zdravljenja je treba oceniti v treh mesecih od začetka zdravljenja.
No safety data are available in these patients. 
Podatkov o varnosti pri teh bolnikih ni.
A. Some patients may hear a soft click right before the second loud click. 
O. Nekateri bolniki lahko slišijo tišji klik tik pred drugim glasnim klikom.
Do not remove the pen from your skin until you hear the second loud click. 
Ne umaknite peresnika s kože, dokler ne slišite drugega glasnega klika.
Important Information 
Pomembne informacije
Percentage, % 
odstotek, %
Emgality can reduce the frequency of migraine headache and improve your quality of life. 
Zdravilo Emgality lahko zmanjšuje pogostnost migrenskih glavobolov in izboljša kakovost življenja.
A. This is normal. 
O. To je normalno.
If the plunger is stuck or damaged: 
Če je bat blokiran ali poškodovan:
Turn the lock ring to the unlock position. 
Zaklepni obroč obrnite v odklenjen položaj.
No drug interaction studies were conducted. 
Študij medsebojnega delovanja zdravil niso izvedli.
Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine. 
Zdravljenje morajo uvesti zdravniki, ki imajo izkušnje z diagnostiko in zdravljenjem migrene.
The MSQ measures impact of migraine on work or daily activities, relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness. 
Vprašalnik MSQ meri vpliv migrene na delo ali vsakodnevne aktivnosti, odnose z družino in prijatelji, prosti čas, produktivnost, koncentracijo, energijo in utrujenost.
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. 
Tega zdravila ne smete dajati otrokom in mladostnikom, mlajšim od 18 let, ker ga v tej starostni skupini niso preučevali.
Any further decision to continue treatment should be taken on an individual patient basis. 
Katerekoli naslednje odločitve o nadaljevanju zdravljenja je treba sprejeti glede na posameznega bolnika.
Emgality can potentially cause serious allergic reactions. 
Zdravilo Emgality lahko povzroči resne alergijske reakcije.
- if you are allergic to galcanezumab or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na galkanezumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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. 
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.
Evaluation of the need to continue treatment is recommended regularly thereafter. 
Nato je potrebo po nadaljevanju zdravljenja priporočljivo redno vrednotiti.
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. 
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.
• Insert the needle at a 45 degree angle. 
• Iglo vstavite pod kotom 45 stopinj.
A. This is not necessary, but it may help you keep the pen steady and firm against your skin. 
O. To ni potrebno, vendar vam lahko pomaga, da boste injekcijski peresnik držali bolj mirno in trdno na koži.
Did I get my complete injection? 
Ali sem prejel/-a celotno injekcijo?
3 Press and Hold 
3 Pritisnite in zadržite
• Keep these instructions and refer to them as needed. 
• Ta navodila za uporabo shranite in jih po potrebi ponovno preberite.
Q. What if I hear more than 2 clicks during my injection - 2 loud clicks and a soft one. 
V. Kaj naj storim, če med injiciranjem slišim več kot dva klika - dva glasnejša in enega tišjega?
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. 
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.
Efficacy and patient reported outcome measures 
Učinkovitost in merila izidov po navedbah bolnikov
Less than 2.5 % of patients in these studies discontinued due to adverse events. 
Manj kot 2,5 % bolnikov v teh študijah je zdravilo prenehalo jemati zaradi neželenih učinkov.
You will hear a second click in about 5 to 10 seconds after the first one. 
Približno od 5 do 10 sekund po prvem kliku boste zaslišali drugi klik.
• Do not touch the needle. 
• Ne dotikajte se igle.
It is preferable to avoid the use of Emgality in pregnancy as the effects of this medicine in pregnant women are not known. 
Med nosečnostjo se je bolje izogibati zdravilu Emgality, saj učinki tega zdravila pri nosečnicah niso znani.
Store in a refrigerator (2 °C to 8 °C). 
Shranjujte v hladilniku (2 °C-8 °C).
Afterwards, use of galcanezumab could be considered during breast-feeding only if clinically needed. 
Kasneje je mogoče razmisliti o uporabi galkanezumaba med dojenjem samo, če je to klinično potrebno.
Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1). 
Bolniki z določenimi srčno-žilnimi boleznimi so bili izključeni iz kliničnih študij (glejte poglavje 5.1).
After training, patients may self-inject galcanezumab if a healthcare professional determines that it is appropriate. 
Po usposabljanju si bolniki lahko sami injicirajo galkanezumab, če zdravstveni delavec presodi, da je to primerno.
You can also read the “Choose your injection site” section of these instructions to help you choose which area can work best for you. 
Lahko tudi preberete razdelek „Izberite svoje mesto injiciranja“ v teh navodilih, ki vam bo v pomoč pri odločanju, kateri predel je za vas najprimernejši.
Elevated blood concentrations of CGRP have been associated with migraine attacks. 
Povečanje koncentracije CGRP v krvi je povezano z migrenskimi napadi.
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. 
• 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.
CI95% 
IZ95 %