natgillin/translations-raw huggingface dataset:
A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe. 
Tijekom čuvanja štrcaljke može se opaziti fini bijeli talog s bistrim bezbojnim supernatantom.
CIN2+ associated with HPV-16 and HPV-18 individually was demonstrated. 
Dodatno, statistički značajna djelotvornost cjepiva za CIN2+ povezana sa HPV-16 i HPV-18 je individualno dokazana.
Twelve-month persistent infection was evaluated as additional efficacy endpoint. 
Kao dodatna mjera ishoda djelotvornosti procjenjivana je perzistentna infekcija tijekom 12 mjeseci.
In the placebo group, there were 4 cases of 6-month persistent infection and 1 case of 12-month persistent infection. 
6-mjesečne perzistentne infekcije i 1 slučaj 12-mjesečne perzistentne infekcije.
(2) mean follow-up of 44 months post dose 1 
(2) prosječni period praćenja od 44 mjeseca nakon 1. doze
Cervical Intraepithelial Neoplasia (CIN) grade 2 and 3 (CIN2/3) and cervical adenocarcinoma in situ (AIS) were used in the clinical trials as surrogate markers for cervical cancer. 
Cervikalna intraepitelna neoplazija (CIN) stupnja 2 i 3 (CIN 2/3) i cervikalni adenokarcinom in situ
Human Papillomavirus1 type 18 L1 protein2,3,4 
20 mikrograma humani papilomavirus1 tip 18 L1 protein2,3,4
(3) mean follow-up of 40 months post dose 3 
(3) prosječni period praćenja od 40 mjeseci nakon 3. doze
(96.1% CI: 0.3;98.1) against CIN3+. 
(95% CI: 80,5; 100).
GlaxoSmithKline s.r.o. 
GlaxoSmithKline S.p.A.
Vaccine efficacy against virological endpoints (6-month and 12-month persistent infection) associated with HPV-16/18 observed in the ATP cohort at the end of study is presented in Table 2. 
Djelotvornost cjepiva protiv viroloških ishoda (6-mjesečna i 12-mjesečna perzistentna infekcija) povezana sa HPV-16/18, uočena u ATP kohorti na kraju ispitivanja, prikazana je u Tablici 2.
1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl). 
Višedozna bočica 1 ml suspenzije u bočici (staklo tip I) za 2 doze sa čepom (butilna guma).
In the event-triggered analysis, vaccine efficacy against CIN1 associated with HPV 16/18 observed in the ATP cohort was 94.1% (96.1% CI: 83.4;98.5). 
U događajem potaknutoj analizi, djelotvornost cjepiva protiv CIN1 povezanim sa HPV 16/18, uočena u ATP kohorti, bila je 94,1% (96,1% CI: 83,4; 98,5).
Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) Water for injections 
6.1 Popis pomoćnih tvari natrijev klorid (NaCl) natrijev dihidrogenfosfat dihidrat (NaH2PO4×2 H2O) voda za injekcije
Animal studies have shown that the efficacy of L1 VLP vaccines is largely mediated by the development of a humoral immune response. 
Ispitivanja provedena na životinjama pokazala su da je djelotvornost cjepiva s L1
The efficacy results at the event-triggered analysis were 94.3% (96.1% CI: 91.5;96.3) against 6-month persistent infection and 91.4% (96.1% CI: 89.4;95.4) against 12-month persistent infection. 
6-mjesečne perzistentne infekcije, odnosno 91,4% (96,1% CI: 89,4 ; 95,4) kod 12-mjesečne perzistentne infekcije.
Tel.: + 48 (22) 576 9000 
GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9000
(3) mean follow-up of 44 months post dose 1 
(3) prosječni period praćenja od 44 mjeseci nakon 1. doze
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. 
Djelotvornost cjepiva na virološke ishode (6-mjesečne i 12-mjesečne perzistentne infekcije) povezane sa HPV-16/18 uočene u TVC na kraju ispitivanja prikazana je u Tablici 4.
Vaccine efficacy against CIN1+ associated with HPV 16/18 observed in the ATP cohort was 91.7% (96.1% CI: 82.4;96.7). 
Djelotvornost cjepiva protiv CIN1+ povezanim sa HPV 16/18, uočena u ATP kohorti, bila je 91,7% (96,1%-tni CI: 82,4;96,7).
Fever (≥38°C) Uncommon Other injection site reactions such as induration, local paraesthesia 
manje često druge reakcije na mjestu injiciranja, poput otvrdnuća i lokalne parestezije
What Cervarix looks like and contents of the pack Suspension for injection. 
Kako Cervarix izgleda i sadržaj pakiranja
Instructions for administration of the vaccine in pre-filled syringe 
Upute za upotrebu cjepiva u napunjenoj štrcaljki
In clinical trials, more than 99% of initially seronegative subjects had seroconverted to both HPV types 16 and 18 one month after the third dose. 
U kliničkim ispitivanjima je u više od 99% početno seronegativnih ispitanica, mjesec dana nakon treće doze cjepiva, došlo do serokonverzije i na HPV-16 i na HPV-18.
Table 1: Vaccine efficacy against high grade cervical lesions associated with HPV-16/18 (ATP cohort) 
Tablica 1: Djelotvornost cjepiva na cervikalne lezije visokog stupnja povezane sa HPV-16/18 (ATP kohorta)
In a pooled analysis (HPV-029,-30 & -48), 99.7% and 100% of females aged 9 years seroconverted to HPV types 16 and 18, respectively after the third dose (at month 7) with GMTs at least 1.4-fold and 2.4-fold higher as compared to females aged 10-14 years and 15 to 25 years, respectively. 
U udruženoj analizi (HPV-029, -30 i -48), u djevojčica u dobi od 9 godina došlo je od serokonverzije na HPV tip 16 u 99,7%, odnosno na HPV tip 18 u 100% djevojčica nakon treće doze (u mjesecu 7).
These can be recognised by: itchy rash of the hands and feet, swelling of the eyes and face, difficulty in breathing or swallowing, sudden drop in blood pressure and loss of consciousness. 
oticanju očiju i lica, poteškoćama u disanju i gutanju,
At the end of study analysis, vaccine efficacy against CIN1 associated with HPV 16/18 observed in the ATP cohort was 92.8% (95% CI: 87.1;96.4). 
U analizi na kraju ispitivanja, djelotvornost cjepiva na CIN1 povezanim sa HPV 16/18, uočena u ATP kohorti, bila je 92,8% (95% CI: 87,1: 96,4).
HPV-16 and HPV-18 are estimated to be responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related high grade vulvar and vaginal intraepithelial neoplasia and 78% of HPV related high-grade anal (AIN 2/3) intraepithelial neoplasia. 
90% slučajeva karcinoma anusa, 70% vulvarnih i vaginalnih intraepitelnih neoplazija visokog stupnja povezanih s HPV-om te 78% analnih intraepitelnih neoplazija visokog stupnja (AIN 2/3) povezanih s HPV-om.
Table 2: Vaccine efficacy against virological endpoints associated with HPV-16/18 (ATP cohort) HPV-16/18 endpoint 
Tablica 2: Djelotvornost cjepiva protiv viroloških ishoda povezanih s HPV-16/18 (ATP kohorta) HPV-16/18 ishod
Intramuscular use Shake before use 
Za intramuskularnu primjenu Protresti prije primjene
Suspension for injection in pre-filled syringe 
Suspenzija za injekciju u napunjenoj štrcaljki.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V*.
The second dose given between 5 and 13 months after the first dose 
1 i 2,5 mjeseci nakon prve doze, a treća doza između 5 i 12 mjeseci nakon prve doze.
Prophylactic efficacy against HPV-16/18 in women naïve to HPV-16 and/or HPV-18 
Djelotvornost profilakse protiv HPV-16/18 u žena bez prethodne infekcije s HPV-16 i/ili HPV-18
• fever (≥38°C) 
crvenilo, oticanje, umor često vrućica (≥ 38°C)
Second injection: given between 5 and 13 months after first injection If you are 15 years old or above 
Prva injekcija: odabranoga dana Druga injekcija: primjenjuje se između 5 i 13 mjeseci nakon prve injekcije
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU
NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in a vial 
Cervarix suspenzija za injekciju u bočici
Itching/pruritus, rash, urticaria 
Poremećaji kože i potkožnog tkiva često svrbež/pruritus, osip, urtikarija
9 to and including 14 years* Two doses each of 0.5 ml. 
9 do uključivo 14 godina*
The phase III trial (study 008) enrolled women without pre-screening for the presence of HPV infection, i.e. regardless of baseline cytology and HPV serological and DNA status. 
U ispitivanje faze III (ispitivanje 008) uključene su žene bez prethodnog probira na prisutnost HPV
MARKETING AUTHORISATION NUMBER(S) EU/1/07/419/001 - pack of 1 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/419/001 - pakiranje od 1
Table 3: Vaccine efficacy against high grade cervical lesions associated with HPV-16/18 (TVC) HPV 
Tablica 3: Djelotvornost cjepiva protiv cervikalnih lezija visokog stupnja povezanih sa HPV-16/18 (TVC)
Tel: + 420 2 22 00 11 11 cz.info@gsk.com 
GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 11 cz.info@gsk.com
Multidose vial EU/1/07/419/010 EU/1/07/419/011 EU/1/07/419/012 
EU/1/07/419/010 EU/1/07/419/011 EU/1/07/419/012
Tel.: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com 
Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
100 multidose vials 100 x 2 doses (1 ml) 
100 višedoznih bočica 100 x 2 doze (1 ml)
Remove the needle protector, which on occasion can be a little stiff. 
koji katkad može biti jače pričvršćen.
Tel: + 386 (0) 1 280 25 00 medical.x.si@gsk.com 
GlaxoSmithKline d.o.o. Tel: + 386 (0) 1 280 25 00 medical.x.si@gsk.com
**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. 
**Ako je potrebna fleksibilnost u rasporedu cijepljenja, druga se doza može primijeniti između
MARKETING AUTHORISATION NUMBER(S) EU/1/07/419/010 - pack of 1 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/419/010 - pakiranje od 1
No efficacy study against anal premalignant lesions has been conducted with Cervarix. 
Nije provedeno ispitivanje djelotvornosti cjepiva Cervarix s obzirom na premaligne analne lezije.
Case counting for the TVC started on day 1 after the first dose. 
je počelo prvog dana nakon prve primljene doze.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MONODOSE VIAL LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA JEDNODOZNU BOČICU
1 pre-filled syringe + 2 needles 1 dose (0.5 ml) 
1 napunjena štrcaljka + 2 igle 1 doza (0,5 ml)
In study 007 the efficacy of Cervarix against 12-month persistent HPV-16/18 infection was 100% (95% CI: 80.5; 100). 
U ispitivanju 007 djelotvornost cjepiva Cervarix protiv 12-mjesečne perzistentne infekcije HPV-16/18 iznosila je 100%
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). 
U drugom kliničkom ispitivanju (ispitivanje 014), provedenom u žena u dobi od 15 do 55 godina, nakon treće doze cjepiva (u 7. mjesecu) sve su ispitanice imale serokonverziju na oba tipa HPV (HPV
Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) 
Cjepivo protiv humanog papilomavirusa [tipova 16, 18] (rekombinantno, adsorbirano, s adjuvansom)
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. 
Atypical Cells of Undetermined Significance) (abnormalan citološki nalaz) (1) 3 doze cjepiva, DNA negativne i seronegativne u nultom mjesecu (osim ako nije posebno navedeno) i DNA negativne u 6. mjesecu za relevantni tip HPV-a (HPV-16 i/ili HPV-18) (2) najmanje jedna doza cjepiva, bez obzira na status HPV DNA i serološki status (osim ako nije posebno navedeno) u nultom mjesecu.
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 
(1) ATP: uključuje žene koje su primile 3 doze cjepiva, bile DNA negativne u nultom mjesecu i 6. mjesecu na relevantne tipove HPV-a.
EU/1/07/419/011 - pack of 10 
EU/1/07/419/011 - pakiranje od 10
EU/1/07/419/012 - pack of 100 
EU/1/07/419/012 - pakiranje od 100
% Efficacy (96.2% CI) 
Cervarix Kontrola % djelotvornosti (96,2% CI)
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. 
U dva klinička ispitivanja (HPV-012 i -013) provedena u djevojčica u dobi od 10 do 14 godina, u svih je ispitanica nakon treće doze cjepiva (u 7. mjesecu) došlo do serokonverzije i na HPV-16 i na HPV-18.
EU/1/07/419/003 - pack of 100 
EU/1/07/419/003 - pakiranje od 100
♦ Very common (side effects which may occur in more than 1 per 10 doses of vaccine): 
U kliničkim ispitivanjima s cjepivom Cervarix zabilježene su sljedeće nuspojave: ♦ Vrlo česte (nuspojave koje se mogu javiti kod više od 1 na 10 doza cjepiva):
HPV-16 related types (A9 species) HPV-31 HPV-33 HPV-35 HPV-52 HPV-58 HPV-18 related types (A7 species) HPV-39 HPV-45 HPV-59 HPV-68 Other types HPV-51 HPV-56 HPV-66 n= number of cases (1) ATP: includes women who received 3 doses of vaccine, were DNA negative at month 0 and at month 6 to the relevant HPV type. 
HPV-31 6M PI HPV-45 6M PI HPV-31 ASC-US+ HPV-45 ASC-US+ N = broj ispitanica uključenih u pojedinu skupinu n = broj ispitanica u pojedinoj skupini koji su prijavili najmanje jedan događaj 6M PI =
1 pre-filled syringe + 1 needle 1 dose (0.5 ml) 
1 napunjena štrcaljka + 1 igla 1 doza (0,5 ml)
DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni. - The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate 
DNA sustavom ekspresije bakulovirusa koji koristi Hi-5 Rix4446 stanice dobivene iz vrste Trichoplusia ni.
Since no vaccine is 100% effective and Cervarix will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations. 
učinkovito i Cervarix ne štiti od svakog HPV tipa, niti djeluje kod već postojećih HPV infekcija,
Very common Injection site reactions including pain, redness, swelling, fatigue 
Opći poremećaji i reakcije na mjestu primjene vrlo često reakcije na mjestu injiciranja, uključujući bol,
10 pre-filled syringes 10 x 1 dose (0.5 ml) 
10 napunjenih štrcaljki 10 x 1 doza (0,5 ml)
10 multidose vials 10 x 2 doses (1 ml) 
10 višedoznih bočica 10 x 2 doze (1 ml)
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription. 
PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
Vaccine-induced IgG GMTs for both HPV-16 and HPV-18 peaked at month 7 and then declined to reach a plateau from month 18 up to the [M107-M113] interval with ELISA GMTs for both HPV-16 and HPV-18 at least still 10-fold higher than the ELISA GMTs observed in women who cleared a natural HPV infection. 
Tijekom razdoblja od 107. do 113. mjeseca, ELISA GMT-i oba tipa (HPV-16 i HPV-18) bili su najmanje 10 puta viši od titara u žena koje su imale prirodnu infekciju HPV, koja se povukla.
Cervarix may be administered concomitantly with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa-IPV vaccines), with no clinically relevant interference with antibody response to any of the components of either vaccine. 
Cervarix se može primijeniti istodobno uz kombinirano cjepivo za docjepljivanje protiv difterije (d), tetanusa (T), pertusisa [acelularnog] (pa), sa ili bez inaktiviranog poliomijelitisa (IPV), (cjepiva dTpa,
Posology 
Bočica
2adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 
50 mikrograma 2 adsorbiran na aluminijev hidroksid, hidratizirani (Al(OH)3) ukupno 0,5 mg Al3+
10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml) 
10 napunjenih štrcaljki + 20 igala 10 x 1 doza (0,5 ml)
Musculoskeletal and connective tissue disorders 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često mialgija često artralgija
100 vials 100 x 1 dose (0.5 ml) 
100 x 1 doza (0,5 ml)
Very common Headache Uncommon Dizziness 
Poremećaji živčanog sustava vrlo često glavobolja manje često omaglica
Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 10 85 52 00
If you get any side effects , talk to your doctor or pharmacist. 
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
Uncommon Upper respiratory tract infection 
Infekcije i infestacije manje često infekcija gornjih dišnih putova
No minimal antibody level associated with protection against CIN of grade 2 or 3 or against persistent infection associated with vaccine HPV types has been identified for HPV vaccines. 
Za HPV cjepiva nije određena minimalna razina protutijela povezanih sa zaštitom od CIN-a stupnja 2
How the vaccine is given 
NAČIN PRIMJENE LIJEKA
Vial 
Nuspojave
10 vials 10 x 1 dose (0.5 ml) 
10 x 1 doza (0,5 ml)
10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml) 
10 napunjenih štrcaljki + 10 igala 10 x 1 doza (0,5 ml)
Table 4: Vaccine efficacy against virological endpoints associated with HPV-16/18 (TVC) 
Tablica 4: Djelotvornost cjepiva protiv viroloških ishoda povezanih s HPV-16/18 (TVC) HPV-16/18 ishod
EU/1/07/419/002 - pack of 10 
EU/1/07/419/002 - pakiranje od 10
Cervarix suspension for injection, multidose container Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) 
Cervarix suspenzija za injekciju, višedozni spremnik Cjepivo protiv humanog papilomavirusa [tipova 16, 18] (rekombinantno, adsorbirano, s adjuvansom)
Tel.: + 385 (0)1 6051999 
GlaxoSmithKline d.o.o. Tel.: + 385 (0)1 6051999
Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) 
Cervarix suspenzija za injekciju u napunjenoj štrcaljki Cjepivo protiv humanog papilomavirusa [tipova 16, 18] (rekombinantno, adsorbirano, s adjuvansom)
Cervarix suspension for injection in multidose container Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed) 
Cervarix suspenzija za injekciju u višedoznom spremniku Cjepivo protiv humanog papilomavirusa [tipova 16, 18] (rekombinantno, adsorbirano, s adjuvansom)
Slovenská republika GlaxoSmithKline Slovakia s.r.o. 
Latvija GlaxoSmithKline Latvia SIA
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
GlaxoSmithKline Pharma GmbH.
• dizziness 
• umor
It starts working in about a week. 
Počinje djelovati nakon približno tjedan dana.
Before You Get Started 
Prije nego što počnete
• it looks damaged 
• ako izgleda oštećeno
Elderly (> 65 years) 
Starije osobe (> 65 godina)
Make sure you have the right medicine. 
Uvjerite se da imate pravi lijek.
You will hear a second click in about 5 to 10 seconds after the first one. 
Čut ćete drugi glasan klik približno 5 - 10 sekundi nakon prvoga.
Date of first authorisation: 14 November 2018 
Datum prvog odobrenja: 14. studeni 2018.
N = number of patients; CI95 % = 95 % confidence interval. 
N = broj bolesnika; CI95% = 95% interval pouzdanosti.
Sesto Fiorentino (FI) Italy 
Sesto Fiorentino (FI) Italija
Handle it carefully. 
Rukujte njome oprezno.
279 patients were exposed for 12 months. 
279 bolesnika lijeku je bilo izloženo 12 mjeseci.
• the medicine is frozen 
• ako je lijek zamrznut
If the plunger is stuck or damaged: 
Ako je klip zapeo ili je oštećen:
• The pen contains glass parts. 
• Brizgalica sadrži staklene dijelove.
Do not remove the pen from your skin until you hear the second loud click. 
Nemojte odvajati brizgalicu od kože dok ne čujete drugi glasni klik.
A. Some patients may hear a soft click right before the second loud click. 
Neki bolesnici mogu čuti tiši klik neposredno prije drugog glasnog klika.
What if I cannot push in the plunger? 
Što ako ne mogu pritisnuti klip?
Age, sex, weight, race, ethnicity 
Dob, spol, tjelesna težina, rasa, etničko podrijetlo
Q. What if I hear more than 2 clicks during my injection - 2 loud clicks and a soft one. 
Što ako čujem više od 2 klika tijekom injekcije - 2 glasna klika i jedan tiši?
Important Information 
Važne informacije
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. 
Ovaj se lijek ne smije davati djeci i adolescentima mlađima od 18 godina jer se lijek nije ispitivao u toj dobnoj skupini.
You must look out for signs of these reactions while you are using Emgality. 
Morate pripaziti na znakove tih reakcija dok primjenjujete Emgality.
Most of the reactions were mild or moderate in severity. 
Većina je reakcija bila blage ili umjerene težine.
The MSQ measures impact of migraine on work or daily activities, relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness. 
MSQ mjeri utjecaj migrene na posao ili svakodnevne aktivnosti, odnose s obitelji i prijateljima, slobodno vrijeme, produktivnost, koncentraciju, energiju i umor.
Commonly Asked Questions 
Česta pitanja
Such signs are listed under “Serious side effects” in section 4. 
Takvi znakovi opisani su u dijelu 4 „Ozbiljne nuspojave“.
You will know your injection is complete when you can see the grey plunger. 
Znat ćete da je injekcija završena kad vidite sivi klip
When your injection is complete: 
Kada je injekcija završena:
You will also see the grey plunger at the top of the clear base. 
Vidjet ćete i sivi klip na vrhu prozirne baze.
The safety and efficacy of galcanezumab in children aged 6 to 18 years have not yet been established. 
Sigurnost i djelotvornost galkanezumaba u djece u dobi od 6 do 18 godina nisu još ustanovljene.
77.8 % of patients completed the treatment period. 
Liječenje je dovršilo 77,8% bolesnika.
Emgality can reduce the frequency of migraine headache and improve your quality of life. 
Emgality može smanjiti učestalost migrenskih glavobolja i poboljšati kvalitetu života.
- if you are allergic to galcanezumab or any of the other ingredients of this medicine (listed in section 6). 
- ako ste alergični na galkanezumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
• Insert the needle at a 45 degree angle. 
• Ubodite iglu pod kutom od 45 stupnjeva.
Stop using Emgality and tell your doctor or seek medical help immediately if you notice any signs of a serious allergic reaction. 
Prestanite koristiti Emgality i recite svom liječniku ili odmah potražite medicinsku pomoć ako primijetite bilo kakve znakove ozbiljne alergijske reakcije.
The treatment benefit should be assessed within 3 months after initiation of treatment. 
Korisne učinke liječenja treba ocijeniti unutar 3 mjeseca nakon početka liječenja.
• Keep these instructions and refer to them as needed. 
• Sačuvajte ove upute za uporabu i pročitajte ih prema potrebi.
Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine. 
Liječenje moraju započeti liječnici s iskustvom u dijagnosticiranju i liječenju migrene.
For example, if your first injection was in your abdomen, your next injection could be in another area of your abdomen. 
Primjerice, ako ste prvu injekciju primijenili u abdomen, sljedeću možete primijeniti u drugi dio abdomena.
People with migraine may have increased levels of CGRP. 
Osobe koje boluju od migrene mogu imati povišene razine CGRP-a.
After You Inject Your Medicine 
Nakon što ste injicirali lijek
Store in a refrigerator (2 °C to 8 °C). 
Čuvati u hladnjaku (2°C - 8°C).
For the MIDAS, higher scores indicate more disability. 
Kod MIDAS-a veći rezultat ukazuje na veću onesposobljenost.
Percentage, % 
Postotak, %
Make sure the pen is locked. 
Provjerite je li brizgalica zaključana.