natgillin/translations-raw huggingface dataset:
In patients tolerating empagliflozin whose eGFR is persistently below 60 ml/min/1.73 m2 or CrCl <60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily. 
U bolesnika koji podnose empagliflozin i čiji je eGFR perzistentno ispod 60 ml/min/1,73 m2 ili klirens kreatinina <60 ml/min, potrebno je prilagoditi ili zadržati dozu empagliflozina na 10 mg jedanput dnevno.
There is no experience with doses above 800 mg in humans. 
Ne postoje iskustva s dozama višim od
The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness. 
iznenadnog smanjenja doze inzulina ili povećane potrebe za inzulinom zbog velikog kirurškog zahvata ili ozbiljne bolesti.
The overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) was similar in patients treated with empagliflozin (empagliflozin 10 mg: 0.5%, empagliflozin 25 mg: 0.3%) and placebo (0.3%). 
Deplecija volumena Sveukupna učestalost deplecije volumena (uključujući prethodno definirane pojmove sniženi krvni tlak (izmjeren ambulantno ), sniženi sistolički krvni tlak, dehidraciju, hipotenziju, hipovolemiju, ortostatsku hipotenziju i sinkopu) bila je slična u bolesnika liječenih empagliflozinom (empagliflozin
Each tablet contains 25 mg empagliflozin. 
TVARI Svaka tableta sadrži 25 mg empagliflozina.
A total of 11,250 patients with type 2 diabetes were treated in 10 double-blind, placebo- and active-controlled clinical studies, of which 7,015 received empagliflozin (empagliflozin 10 mg: 3021 patients; empagliflozin 25 mg: 3994 patients). 
placebom i aktivno kontroliranih kliničkih ispitivanja od kojih je 7015 primalo empagliflozin (empagliflozin 10 mg: 3021 bolesnik; empagliflozin 25 mg: 3994 bolesnika).
HbA1c ≥7%2 
HbA1c ≥7% u 52. tjednu
In male rats, treatment-related benign vascular proliferative lesions (haemangiomas) of the mesenteric lymph node were observed at the highest dose, but not at 300 mg/kg/day, which corresponds to approximately 26-times the maximal clinical exposure to empagliflozin. 
(hemangiomi) mezenterijalnih limfnih čvorova koje su povezane s liječenjem, bile su opažene pri najvišoj dozi, ali ne pri dozi od 300 mg/kg/dan, što približno odgovara 26-strukom iznosu maksimalne kliničke izloženosti empagliflozinu.
• passing more urine than usual or needing to pass urine more often 
• pojačano mokrenje ili češća potreba za mokrenjem
Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives. 
Ispitivanja interakcija provedena na zdravim dobrovoljcima sugeriraju da empagliflozin nije imao klinički značajan učinak na farmakokinetiku metformina, glimepiridina, pioglitazona, sitagliptina,
However, temporary interruption of empagliflozin should be considered in patients with complicated urinary tract infections. 
Međutim, u bolesnika s kompliciranim infekcijama mokraćnog sustava potrebno je razmotriti privremeni prekid terapije empagliflozinom.
2 Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure 
Srednja vrijednost prilagođena za početnu vrijednost 2 Statistička značajnost nije ocjenjivana zbog provođenja naknadnog testa kao potvrde
Interstitial cell tumours in the testes were observed with a higher incidence in rats at 300 mg/kg/day and above, but not at 100 mg/kg/day which corresponds to approximately 18-times the maximal clinical exposure to empagliflozin. 
Tumori intersticijskih stanica testisa opaženi su s višom incidencijom u štakora pri 300 mg/kg/dan i više, ali ne pri 100 mg/kg/dan što odgovara približno
HbA1c (%) at week 522 
HbA1c (%) u 52. tjednu2
Empagliflozin should not be used in patients with ESRD or in patients on dialysis as it is not expected to be effective in these patients (see sections 4.2 and 5.2). 
Empagliflozin se ne smije koristiti u bolesnika u završnom stadiju bolesti bubrega ili u bolesnika na dijalizi budući da se ne očekuje da empagliflozin bude učinkovit u tih bolesnika (vidjeti dijelove 4.2 i
Add-on combination therapy 
Dodatak kombiniranoj terapiji
Add-on to insulin therapy 
Dodatak terapiji inzulinom
N HbA1c (%) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2 N Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N SBP (mmHg)2 Baseline (mean) Change from baseline1 Difference from placebo1 (95% CI) 
Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5% CI) N Bolesnici (%) s postignutim HbA1c <7% s početnom vrijednošću HbA1c ≥7%2
No dose adjustment is required for patients with hepatic impairment. 
Oštećenje jetrene funkcijeNije potrebno prilagođavanje doze u bolesnika s oštećenjem jetre.
Other side effects while taking Jardiance: 
• nesvjesticu ili gubitak svijesti Druge nuspojave tijekom uzimanja lijeka Jardiance:
During the initial 18 weeks and the last 12 weeks, the insulin dose was kept stable, but was adjusted to achieve pre-prandial glucose levels <100 mg/dl [5.5 mmol/l], and post-prandial glucose levels <140 mg/dl [7.8 mmol/l] between Weeks 19 and 40. 
Tijekom početnih 18 tjedana i posljednjih 12 tjedana doza inzulina je bila stalna, ali se između 19. i 40. tjedna prilagođavala u cilju postizanja razine glukoze <100 mg/dl
How to store Jardiance 6. 
Moguće nuspojave 5. Kako čuvati Jardiance
Empagliflozin does not inhibit P-gp at therapeutic doses. 
P-gp pri terapijskim dozama.
Jardiance 10 mg film-coated tablets 
Jardiance 10 mg filmom obložene tablete
Table 7 Results at 24 week in a placebo-controlled study of empagliflozin in renally impaired type 2 diabetes patientsa 
Rezultati u 24. tjednu u placebom kontroliranom ispitivanju empagliflozina u bolesnika s oštećenjem bubrežne funkcije i šećernom bolešću tipa 2a
What Jardiance looks like and contents of the pack Jardiance 10 mg film-coated tablets are round, pale yellow, biconvex and bevel-edged. 
Jardiance 10 mg filmom obložene tablete su okrugle, blijedožute, bikonveksne i ukošenih rubova.
Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2, ‘Warnings and precautions'): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat. 
- bol u trbuhu - prekomjerna žeđ - ubrzano i duboko disanje - smetenost - neuobičajena pospanost ili umor - zadah slatkog mirisa, slatki ili metalni okus u ustima ili drugačiji miris mokraće ili znoja.
Jardiance 25 mg film-coated tablets 
Jardiance 25 mg filmom obložene tablete
It is unknown if Jardiance is harmful to the unborn child. Do not use Jardiance if you are breast-feeding. 
Nije poznato je li Jardiance štetan za nerođeno dijete.
Film coating Hypromellose 
Empagliflozin ne inhibira
SBP (mmHg)4 
Sistolički krvni tlak (mmHg)4
Empagliflozin should not be initiated in patients with an eGFR <60 ml/min/1.73 m or 
Terapija empagliflozinom ne smije se započeti u bolesnika s eGFR<60 ml/min/1,73 m2 ili klirensom kreatinina <60 ml/min.
(add-on to metformin: placebo +5.9 mg/dl, empagliflozin 10 mg: -46.0 mg/dl, empagliflozin 25 mg: -44.6 mg/dl, add-on to metformin and a sulphonylurea: placebo -2.3 mg/dl, empagliflozin 10 mg: -35.7 mg/dl, empagliflozin 25 mg: -36.6 mg/dl). 
Liječenje empagliflozinom kao dodatnom terapijom uz metformin ili metformin i sulfonilureju rezultiralo je klinički značajnim smanjenjem vrijednosti glukoze 2 sata nakon obroka (test tolerancije nakon obroka) u 24. tjednu (dodatak uz metformin: placebo +5,9 mg/dl, empagliflozin 10 mg: -46,0 mg/dl, empagliflozin 25 mg: -44,6 mg/dl, dodatak uz metformin i sulfonilureju: placebo -2,3 mg/dl, empagliflozin 10 mg: -35,7 mg/dl, empagliflozin 25 mg: -36,6 mg/dl).
1 Mean adjusted for baseline value 
1 Srednja vrijednost prilagođena za početnu vrijednost
Jardiance should not be initiated in patients with an eGFR below 60 ml/min/1.73 m2 or 
Terapija lijekom Jardiance ne smije se započeti u bolesnika s eGFR ispod 60 ml/min/1,73 m2 ili klirensom kreatinina <60 ml/min.
Boehringer Ingelheim International GmbH Binger Str. 173 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Boehringer Ingelheim International GmbH Binger Str. 173
Increased urinationa 
Pojačano mokrenjea
SBP (mmHg)2 
Sistolički krvni tlak (mmHg)2
The efficacy and safety of empagliflozin as add-on to multiple daily insulin with or without concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 52 weeks duration. 
Empagliflozin kao dodatak inzulinu koji se primjenjuje više puta dnevno Djelotvornost i sigurnost empagliflozina kao dodatka inzulinu koji se primjenjuje više puta dnevno sa ili bez istodobne terapije metforminom ocijenjena je u dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 52 tjedna.
The frequency of volume depletion events was increased in patients 75 years and older treated with empagliflozin 10 mg (2.3%) or empagliflozin 25 mg (4.4%) compared to placebo (2.1%). 
(2,3%) ili empagliflozinom od 25 mg (4,4%) u usporedbi s placebom (2,1%).
Boehringer Ingelheim International GmbH Binger Strasse 173 
Nositelj odobrenja za stavljanje lijeka u promet Boehringer Ingelheim International GmbH Binger Strasse 173
In a pre-specified pooled analysis of 4 placebo-controlled studies, treatment with empagliflozin resulted in a reduction in systolic blood pressure (empagliflozin 10 mg: -3.9 mmHg; empagliflozin 25 mg: -4.3 mmHg) compared with placebo (-0.5 mmHg) and in diastolic blood pressure (empagliflozin 10 mg: -1.8 mmHg; empagliflozin 25 mg: -2.0 mmHg) compared with placebo (-0.5 mmHg) at week 24 that were maintained up to week 52. 
empagliflozin 25 mg: -4,3 mmHg) u usporedbi s placebom (-0,5 mmHg) i dijastoličkog krvnog tlaka (empagliflozin 10 mg: -1,8 mmHg; empagliflozin 25 mg: -2,0 mmHg) u usporedbi s placebom (-0,5 mmHg) u 24. tjednu koje se održalo do 52. tjedna.
Empagliflozin improves both fasting and post-prandial plasma glucose levels. 
Empagliflozin snižava razinu glukoze natašte i nakon jela.
NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg film-coated tablets Jardiance 25 mg film-coated tablets 
Jardiance 10 mg filmom obložene tablete Jardiance 25 mg filmom obložene tablete
Table 3: Efficacy results of 24 week placebo-controlled studiesa Add-on to metformin therapy Placebo 
Tablica 3: Rezultati djelotvornosti 24-tjednih placebom kontroliranih ispitivanjaa
1 LOCF, values after taking antidiabetic rescue therapy censored 
4 LOCF, cenzurirane vrijednosti nakon dodavanja terapije za postizanje zadovoljavajućeg krvnog tlaka
Patients with renal impairment, 52 week placebo controlled data The efficacy and safety of empagliflozin as add on to antidiabetic therapy was evaluated in patients with renal impairment in a double-blind, placebo-controlled study for 52 weeks. 
Djelotvornost i sigurnost empagliflozina kao dodatka antidijabetičkoj terapiji ocijenjeni su u bolesnika s oštećenjem bubrežne funkcije u dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 52 tjedna.
Therapy 
Terapija
<7% with baseline 
<7% s početnom vrijednošću HbA1c
An interaction study with gemfibrozil, an in vitro inhibitor of OAT3 and OATP1B1/1B3 transporters, showed that empagliflozin Cmax increased by 15% and AUC increased by 59% following coadministration. 
Ispitivanje interakcija s gemfibrozilom, in vitro inhibitorom prijenosnika OAT3 i OATP1B1/1B3,
Baseline (mean) Change from baseline1 Difference from placebo1 
Promjena od početne vrijednosti1 Razlika od placeba1
Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1 
Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1
An increased frequency was noted when given as add-on to metformin and a sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5%, placebo: 8.4%), and as add-on to insulin with or without metformin and with or without a sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 27.1%, placebo: 20.6% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 36.1%, empagliflozin 25 mg: 34.8%, placebo 35.3% over the 78-week trial). 
Povećana učestalost je zabilježena kada je lijek primjenjivan kao dodatak uz metformin i sulfonilureju (empagliflozin 10 mg: 16,1%, empagliflozin 25 mg: 11,5%, placebo: 8,4%) i kao dodatak uz inzulin sa ili bez metformina te sa ili bez sulfonilureje (empagliflozin 10 mg: 19,5%,
Boehringer Ingelheim Ltd. Tel: +44 1344 424 600 
Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600
* p-value <0.0001 
* p-vrijednost<0,0001 ** p-vrijednost <0,001
Urinary tract infection 
Infekcija mokraćnog sustavaa
At Week 52, treatment with empagliflozin resulted in a statistically significant decrease in HbA1c and insulin sparing compared with placebo and a reduction in FPG and body weight. 
HbA1c i uštedom inzulina u usporedbi s placebom te sniženjem vrijednosti FPG i tjelesne težine.
In patients tolerating empagliflozin whose eGFR falls persistently below 60 ml/min/1.73 m2 or CrCl below 60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily. 
60 ml/min/1,73 m2 ili klirens kreatinina ispod 60 ml/min, potrebno je prilagoditi ili zadržati dozu empagliflozina na 10 mg jedanput dnevno.
QUALITATIVE AND QUANTITATIVE COMPOSITION Jardiance 10 mg film-coated tablets 
KVALITATIVNI I KVANTITATIVNI SASTAV Jardiance 10 mg filmom obložene tablete Svaka tableta sadrži 10 mg empagliflozina.
NAME OF THE MEDICINAL PRODUCT Jardiance 25 mg film-coated tablets Empagliflozin 
Jardiance 25 mg filmom obložene tablete empagliflozin
N HbA1c (%) at week 18 Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N HbA1c (%) at week 78 Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N Basal insulin dose (IU/day) at week 78 Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) a Full analysis set (FAS) - Completers using last observation carried forward (LOCF) prior to glycaemic rescue therapy 1 mean adjusted for baseline value * p-value <0.0001 ** p-value <0.025 
Početna vrijednost (prosječna) Promjena od početne vrijednosti1 Razlika od placeba1 (97,5% CI) N Doza bazalnog inzulina (IU/dan) u 78. Tjednu
At exposures sufficiently in excess of exposure in humans after therapeutic doses, empagliflozin had no adverse effects on fertility or early embryonic development. 
Pri izloženostima koje su bile dostatno više od izloženosti u ljudi nakon terapijskih doza,
NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg film-coated tablets Empagliflozin 
Jardiance 10 mg filmom obložene tablete empagliflozin
Treatment with empagliflozin provided reductions in seated SBP and DBP. 
Liječenje empagliflozinom dovelo je do sniženja sistoličkog (SKT) i dijastoličkog (DKT) krvnog tlaka mjerenog u sjedećem položaju.
Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620 
Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 111
FPG of -20.5 mg/dl [-1.14 mmol/l] for empagliflozin 10 mg and -23.2 mg/dl [-1.29 mmol/l] for empagliflozin 25 mg compared to placebo (7.4 mg/dl [0.41 mmol/l]). 
U četiri placebom kontroliranih ispitivanja, liječenje empagliflozinom u obliku monoterapije ili kao dodatna terapija uz metformin, pioglitazon ili metformin plus sulfonilureja rezultiralo je srednjom promjenom početne vrijednosti FPG-a u iznosu -20,5 mg/dl [-1,14 mmol/l] za empagliflozin od 10 mg i -23,2 mg/dl [-1,29 mmol/l] za empagliflozin od 25 mg u usporedbi s placebom (7,4 mg/dl [0,41 mmol/l]).
1 Mean adjusted for baseline value 2 LOCF, values after antihypertensive rescue censored 
Razlika od placeba CI) a Potpuni skup za analizu (Full analysis set, FAS) 1 LOCF, cenzurirane vrijednosti nakon uzimanja pomoćne antidijabetičke terapije (engl. antidiabetic rescue therapy)
Hepatic injury 
Oštećenje jetre
Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis. 
Na osnovi farmakokinetičke analize populacije, indeks tjelesne mase (BMI) nije imao klinički značajan učinak na farmakokinetiku empagliflozina.
2 Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure 3 LOCF, values after antihypertensive rescue censored 
1 Srednja vrijednost prilagođena za početnu vrijednost 2 Statistička značajnost nije ocjenjivana zbog provođenja naknadnog testa kao potvrde
5 Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001 
Srednja vrijednost prilagođena za početnu vrijednost dijastoličkog krvnog tlaka (DKT), početnu vrijednost HbA1c, početnu vrijednost eGFR, zemljopisno područje i broj antihipertenzivnih lijekova
In a pre-specified pooled analysis of three phase 3 studies, treatment with open-label empagliflozin 25 mg in patients with severe hyperglycaemia (N=184, mean baseline HbA1c 11.15%) resulted in a clinically meaningful reduction in HbA1c from baseline of 3.27% at week 24; no placebo or empagliflozin 10 mg arms were included in these studies. 
U prethodno specificiranoj združenoj analizi triju otvorenih ispitivanja faze 3, liječenje empagliflozinom od 25 mg u bolesnika s teškom hiperglikemijom (N=184, srednja početna vrijednost
*, b 
CI) N
(95% CI) 24 hour SBP at week 123 
24-satni SKT u 12. tjednu3 Početna vrijednost
Increased urination 
Pojačano mokrenje
The study was conducted in North America, Latin America, Asia Pacific and Europe. 
Ispitivanje je provedeno u Sjevernoj Americi, Latinskoj Americi, Aziji, Pacifiku i Europi.
• allergic reactions. 
• alergijske reakcije.
If you are between 9 and 14 years old 
Ako imate između 9 i 14 godina
See sections 4.4 and 5.1 for important information on the data that support this indication. 
Vidjeti dijelove 4.4 i 5.1 za važne informacije o podacima koji podržavaju ovu indikaciju.
If necessary, the vaccination schedule can be more flexible. 
Po potrebi raspored cijepljenja može biti i fleksibilniji.
These reactions will usually occur before leaving the doctor's surgery. 
Ove reakcije će se obično pojaviti prije napuštanja liječničke ordinacije.
This does not constitute a sign of deterioration. 
To ne predstavlja znak kvarenja.
- This medicine has been prescribed for you only. 
Ovo cjepivo je propisano samo Vama.
Duration of protection has not fully been established. 
Trajanje zaštite nije u potpunosti definirano.
Date of latest renewal: 17 September 2012. 
Datum posljednje obnove odobrenja: 17. rujna 2012.
If you miss a dose 
Ako propustite dozu
When the value zero is included, i.e. when the lower limit of the CI is <0, the efficacy is not considered statistically significant. 
Kada je uključena nulta vrijednost, odnosno kada je donja granica CI <0, djelotvornost se ne smatra statistički značajnom.
The total number of injections you will receive depends on your age at the time of the first injection. 
Ukupan broj injekcija koje ćete primiti ovisi o Vašoj dobi u trenutku primjene prve injekcije.
Read all of this leaflet carefully before you start receiving this vaccine because it contains important information for you. 
Pažljivo pročitajte cijelu uputu prije nego primite ovo cjepivo jer sadrži Vama važne podatke.
Therefore tell the doctor or nurse if you or your child fainted with a previous injection. 
Stoga recite liječniku ili sestri ukoliko ste se Vi ili Vaše dijete onesvijestili prilikom prijašnjih injekcija.
Tell your doctor if you are taking, have recently taken, might take any other medicines, or have recently received any other vaccine. 
Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, ili ako ste nedavno primili bilo koje drugo cjepivo.
For storage after first opening, see section 6.3. 
Za čuvanje nakon prvog otvaranja, vidjeti dio 6.3.
B-1330 Rixensart, Belgium 
B-1330 Rixensart, Belgija
However, do not drive or use any machines if you are feeling unwell. 
Međutim, nemojte upravljati vozilima i strojevima ako se ne osjećate dobro.
Use with hormonal contraceptive 
Primjena s hormonskom kontracepcijom
Immunization and schedule 
Imunizacija i raspored
HPV type 
HPV tip
Functional antibodies were not determined. 
Funkcionalna protutijela nisu određivana.
It is important that you follow the instructions of your doctor or nurse regarding return visits. 
Važno je da slijedite upute svog liječnika ili medicinske sestre u vezi ponovnog dolaska radi cijepljenja.
The vaccine should never be given into a vein. 
Cjepivo se nikada ne smije dati u venu.
In clinical studies, approximately 60% of women who received Cervarix used hormonal contraceptives. 
U kliničkim ispitivanjima, otprilike 60% žena koje su primile Cervarix koristilo je hormonske kontraceptive.
You will receive 2 injections: 
Primit ćete 2 injekcije:
20 micrograms 
20 mikrograma
The GMTs appeared to be lower in the HIV infected group (non overlapping 95% confidence interval). 
Činilo se da su GMT-i bili niži u HIV zaraženoj grupi (bez preklapanja 95% interval pouzdanosti).
In accordance with Article 114 of Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. 
Sukladno članku 114 Direktive 2001/83/EC, službeno puštanje serije lijeka u promet preuzet će državni laboratoriji ili laboratorij određen za tu svrhu.
However, the presence of a minor infection, such as a cold, is not a contraindication for immunisation. 
Međutim, prisutnost manje infekcije, poput prehlade, nije kontraindikacija za imunizaciju.
You will receive 3 injections: 
Primit ćete 3 injekcije:
EXP After first opening, use immediately or within 6 hours if stored in a refrigerator 
Nakon prvog otvaranja, upotrijebiti odmah ili unutar 6 sati ako je čuvano u hladnjaku.
• if you have a severe infection with a high temperature. 
• ako bolujete od teške infekcije praćene visokom temperaturom.
Cross protective efficacy 
Križna zaštitna djelotvornost
The majority of these reactions were of mild to moderate severity and were not long lasting. 
Većina ovih reakcija je bila blaga do umjerena po težini i kratkotrajna.
Duration of the immune response in women aged 26 years and older 
Trajanje imunološkog odgovora u žena u dobi od 26 godina i više
Immunogenicity in HIV infected women 
Imunogenost u žena zaraženih HIV-om
What Cervarix is and what it is used for 
Što je Cervarix i za što se koristi
It might be necessary to postpone the vaccination until recovery. 
Cijepljenje će možda trebati odgoditi do oporavka.
50 micrograms 
50 mikrograma
The need for a booster dose has not been established (see section 5.1). 
Potreba za dozom docjepljivanja nije utvrđena (vidjeti dio 5.1).
• if you are allergic to any of the active substances or any of the other ingredients of this vaccine (listed in section 6). 
• ako ste alergični na djelatne tvari ili neki drugi sastojak ovog cjepiva (naveden u dijelu 6).
Other medicines and Cervarix 
Drugi lijekovi i Cervarix
• if you have any disease which reduces your resistance to infection such as HIV infection. 
• ako bolujete od neke bolesti koja smanjuje Vašu otpornost na infekciju (npr. HIV infekciju)
For adjuvants, see section 2. 
Za adjuvanse, vidjeti dio 2.
The vaccine has not been shown to have a therapeutic effect. 
Cjepivo nije pokazalo terapijski učinak.
A minor infection such as a cold should not be a problem, but talk to the doctor first. 
Manja infekcija, poput prehlade, ne bi trebala predstavljati problem, ali najprije porazgovarajte s liječnikom.