natgillin/translations-raw huggingface dataset:
Reduce by 1 dose level for 5-FU and irinotecan. 
Smanjiti doze 5-FU i irinotekana za 1 razinu.
If the urine protein is ≥2+ on a dipstick, a 24 hour urine collection should be performed. 
Ako se testnim trakicama utvrdi da je razina proteina u mokraći ≥ 2+, treba prikupiti svu mokraću tijekom 24 sata.
Reduce by 2 dose levels for 5-FU and irinotecan. 
Smanjiti dozu 5-FU i irinotekana za 2 razine.
f Based on study RAINBOW (ramucirumab plus paclitaxel) and study RAISE (ramucirumab plus FOLFIRI). 
f Na temelju podataka iz ispitivanja RAINBOW (ramucirumab plus paklitaksel) i RAISE (ramucirumab plus
The median duration of docetaxel therapy was 14.1 weeks for the ramucirumab plus docetaxel arm (with a median of 4.0 infusions received) and 12.0 weeks for the placebo plus docetaxel arm (with a median of 4.0 infusions received). 
14,1 tjedan u skupini liječenoj ramucirumabom plus docetakselom (medijan primljenih infuzija: 4,0) te
Delay 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 2 levels for 5-FU and irinotecan. 
Odgoditi primjenu 5-FU i irinotekana za najviše 28* dana, dok se nuspojava ne ublaži do ≤ 1. stupnja, a zatim smanjiti dozu 5-FU i irinotekana za 2 razine.
The median relative dose intensity of paclitaxel was 87.7% for the Cyramza plus paclitaxel arm and 93.2% for the placebo plus paclitaxel arm. A similar percentage of patients discontinued treatment due to adverse events: 12% of patients treated with Cyramza plus paclitaxel compared with 11% of patients treated with placebo plus paclitaxel. 
Medijan relativnog intenziteta doze paklitaksela iznosio je 87,7% u skupini koja je primala lijek Cyramza plus paklitaksel te 93,2% u skupini koja je primala placebo plus paklitaksel.
In REVEL, the incidences of Grade ≥3 febrile neutropenia and hypertension were increased with higher ramucirumab exposure. 
U ispitivanju REVEL se s povećanjem izloženosti ramucirumabu povećavala i incidencija febrilne neutropenije i hipertenzije ≥ 3. stupnja.
- Each 50 ml vial contains 500 mg of ramucirumab. 
- Jedna bočica od 50 ml sadrži 500 mg ramucirumaba.
Grade ≤1, then dose reduce by 2 levels for 5-FU. 
dok se nuspojava ne ublaži do ≤ 1. stupnja, a zatim smanjiti dozu 5-FU za 2 razine.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 100 mg/10 ml
Gastrointestinal perforationa 
Tablični prikaz nuspojava
Not known (frequency cannot be estimated from the available data): - an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall 
Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba): - poremećaj zgrušavanja krvi u malim krvnim žilama Nepoznato (ne može se procijeniti iz dostupnih podataka) - proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije).
Patients treated with Cyramza experienced a statistically significant improvement in OS, compared to placebo (Table 12). 
OS-a u odnosu na one koji su primali placebo (Tablica 12).
If diarrhoea has recovered to Grade ≤1, reduce by 2 dose levels for 5-FU and irinotecan. 
Ako se proljev ublaži do ≤ 1. stupnja, smanjiti dozu 5-FU i irinotekana za 2 razine.
Randomisation was stratified by geographic region, gender, prior maintenance, and ECOG PS. Cyramza at 10 mg/kg or placebo and docetaxel at 75 mg/m2 were each administered by intravenous infusion on day 1 of a 21-day cycle. 
Cyramza u dozi od 10 mg/kg ili placebo te docetaksel u dozi od 75 mg/m2 primjenjivali su se svaki intravenskom infuzijom 1. dana 21-dnevnog ciklusa.
In RAISE, the incidence of Grade ≥3 neutropenia was increased with higher ramucirumab exposure. 
U ispitivanju RAISE se s povećanjem izloženosti ramucirumabu povećavala i incidencija neutropenije
Table 10: Summary of efficacy data - ITT population Cyramza plus FOLFIRI N=536 
Tablica 9: Sažetak podataka o djelotvornosti - ITT populacija Cyramza N=238
Patients were also excluded if they had experienced any of: an ATE, Grade 4 hypertension, Grade 3 proteinuria, a grade 3-4 bleeding event, or bowel perforation during first-line bevacizumab therapy. 
U ispitivanje nisu bili uključeni ni bolesnici koji su tijekom prvolinijske terapije bevacizumabom imali bilo što od sljedećega: arterijski tromboembolijski događaj, hipertenziju 4. stupnja, proteinuriju 3. stupnja,
Irinotecan 
Imunogenost
Table 5 provides details of dose delays or dose reductions of components of FOLFIRI at the next cycle based on maximum grade of specific adverse drug reactions. 
Prilagodbe doze svake pojedine sastavnice protokola FOLFIRI treba provoditi neovisno o drugim sastavnicama, sukladno napucima u Tablici 4. U Tablici 5 navode se pojedinosti o odgodi primjene ili smanjenju doze pojedinačnih sastavnica protokola FOLFIRI u sljedećem ciklusu na temelju najvišeg stupnja specifične nuspojave.
If diarrhoea has recovered to Grade ≤1, reduce by 1 dose level for 5-FU and irinotecan. 
Ako se proljev ublaži do ≤ 1. stupnja, smanjiti dozu 5-FU i irinotekana za 1 razinu.
Ramucirumab treatment should be discontinued in patients who develop fistula (see section 4.2). 
U bolesnika u kojih dođe do stvaranja fistule mora se prekinuti liječenje ramucirumabom (vidjeti dio 4.2).
Post discontinuation systemic anti-cancer therapy was given to 47.9% of patients receiving Cyramza plus paclitaxel and 46.0% of patients receiving placebo plus paclitaxel. 
Sistemsku protutumorsku terapiju nakon prekida liječenja primilo je 47,9% bolesnika liječenih lijekom Cyramza plus paklitakselom te
Cyramza 10 mg/ml sterile concentrate ramucirumab 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Cyramza 10 mg/ml sterilni koncentrat ramucirumab
Cyramza treatment will be permanently stopped if you: 
Trajno obustavljanje liječenja Liječenje ramucirumabom mora se trajno obustaviti u slučaju:
Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. 
FOLFIRI naspram placeba plus protokola FOLFIRI, provedeno u bolesnika s metastatskim kolorektalnim rakom koji su doživjeli progresiju bolesti tijekom ili nakon prvolinijske terapije bevacizumabom, oksaliplatinom i fluoropirimidinom.
An increased incidence of proteinuria was reported in patients receiving ramucirumab as compared to placebo. 
U bolesnika koji su primali ramucirumab prijavljena je povećana incidencija proteinurije u odnosu na one koji su primali placebo.
Each 50 ml vial contains 500 mg of ramucirumab. 
Jedna bočica od 50 ml sadrži 500 mg ramucirumaba.
≥65 years old (OS HR 1.10, 95% CI: 0.89, 1.36; median OS [mOS]: 9.2 vs 9.3 months, see section 
Nisu primijećene razlike u djelotvornosti između liječenih skupina u podskupini bolesnika u dobi od ≥ 65 godina (HR za OS 1,10; 95% CI: 0,89; 1,36; medijan OS-a [mOS]: 9,2 naspram
- Inflammation of the mouth (‘stomatitis'): Cyramza, when given in combination with chemotherapy may increase the risk of developing inflammation of the mouth. 
- upala usne šupljine („stomatitis“): Kada se primjenjuje u kombinaciji s kemoterapijom,
Figure 6: Kaplan-Meier curves of overall survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL 
Slika 6: Kaplan-Meierove krivulje ukupnog preživljenja uz primjenu lijeka Cyramza plus docetaksela naspram placeba plus docetaksela u ispitivanju REVEL
Febrile neutropeniad 
Kriterij neutrofili
Figure 3: Kaplan-Meier curves of overall survival for Cyramza versus placebo in REGARD 
Slika 3: Kaplan-Meierove krivulje ukupnog preživljenja uz primjenu lijeka Cyramza naspram placeba u ispitivanju REGARD
The pharmacokinetics of docetaxel were not affected when co-administered with ramucirumab. 
Istodobna primjena ramucirumaba nije utjecala na farmakokinetiku docetaksela.
Cyramza will be permanently stopped if you develop a hole in the wall of your gut. 
Primjena lijeka Cyramza trajno će se obustaviti ako nastane pukotina u stijenci crijeva.
- Each 10 ml vial contains 100 mg of ramucirumab. 
- Jedna bočica od 10 ml sadrži 100 mg ramucirumaba.
An increased incidence of severe hypertension was reported in patients receiving ramucirumab as compared to placebo. 
U bolesnika koji su primali ramucirumab prijavljena je povećana incidencija teške hipertenzije u odnosu na one koji su primali placebo.
Figure 1: Kaplan-Meier curves of overall survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW 
Slika 1: Kaplan-Meierove krivulje ukupnog preživljenja uz primjenu lijeka Cyramza plus paklitaksela naspram placeba plus paklitaksela u ispitivanju RAINBOW
Figure 2: Kaplan-Meier curves of progression-free survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW 
Slika 2: Kaplan-Meierove krivulje preživljenja bez progresije bolesti uz primjenu lijeka Cyramza plus paklitaksela naspram placeba plus paklitaksela u ispitivanju RAINBOW
If you experience an infusion-related reaction during Cyramza therapy, you will be given premedication for all future infusions. 
Ako se tijekom liječenja lijekom Cyramza razvije reakcija na infuziju,
If particulate matter or discolouration is identified, discard the vial. 
Ako primijetite čestice ili promjenu boje, bacite bočicu.
Respiratory, thoracic, and mediastinal disorders 
Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa
Figure 7: Kaplan-Meier curves of progression-free survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL 
Slika 7: Kaplan-Meierove krivulje preživljenja bez progresije bolesti uz primjenu lijeka Cyramza plus docetaksela naspram placeba plus docetaksela u ispitivanju REVEL
61% of patients; 81% of patients had measurable disease and 79% had gastric cancer; 21% had GEJ adenocarcinoma. 
61 godinu; 71% bolesnika bili su muškarci; 61% bolesnika bili su bijelci, a 35% njih Azijati; funkcionalni ECOG status iznosio je 0 u 39% bolesnika, te 1 u 61% bolesnika; 81% bolesnika imalo je mjerljivu bolest; 79% imalo je rak želuca, a 21% adenokarcinom gastroezofagealnog spoja.
c Based on study RAINBOW (ramucirumab plus paclitaxel). 
c Na temelju podataka iz ispitivanja RAINBOW (ramucirumab plus paklitaksel).
Figure 4: Kaplan-Meier curves of overall survival for Cyramza plus FOLFIRI versus placebo plus FOLFIRI in RAISE 
Slika 4: Kaplan-Meierove krivulje ukupnog preživljenja uz primjenu lijeka Cyramza plus protokola FOLFIRI naspram placeba plus protokola FOLFIRI u ispitivanju RAISE
There was an increase in median PFS of 1.2 months in favour of the Cyramza plus FOLFIRI arm: 5.7 months in the Cyramza plus FOLFIRI arm and 4.5 months in the placebo plus FOLFIRI arm. Efficacy results are shown in Table 10 and Figures 4 and 5. 
Primijećeno je produljenje medijana PFS-a za 1,2 mjeseca u korist skupine liječene lijekom Cyramza plus protokolom FOLFIRI: 5,7 mjeseci u skupini koja je primala lijek Cyramza plus FOLFIRI te 4,5 mjeseci u skupini koja je primala placebo plus FOLFIRI.
Pre-specified subgroup analyses for both PFS and OS according to age (<65 and ≥65 years), gender, race, ECOG PS (0 or ≥1), number of organs involved, liver metastases only, site of primary tumour (colon or rectum), carcinoembryonic antigen levels (<200 μg/L, ≥200 μg/L), all showed a treatment effect favouring Cyramza plus 
Sve unaprijed određene analize podskupina za PFS i OS - prema dobi (< 65 i ≥ 65 godina), spolu, rasi, funkcionalnom ECOG statusu
5-FU bolus 
bolus 5-FU 400 mg/m2
In the RAISE study, in mCRC patients treated with ramucirumab plus FOLFIRI, the most frequent (≥1%) ADR that led to the discontinuation of ramucirumab was proteinuria (1.5%). 
Ramucirumab u kombinaciji s FOLFIRI protokolom Najčešća nuspojava (≥ 1%) koja je dovela do prekida primjene ramucirumaba u bolesnika s metastatskim kolorektalnim rakom liječenih ramucirumabom plus protokolom FOLFIRI u ispitivanju
Each 10 ml vial contains 100 mg of ramucirumab. 
Jedna bočica od 10 ml sadrži 100 mg ramucirumaba.
Cyramza plus paclitaxel arm was 27.9% and in the placebo plus paclitaxel arm was 16.1%. 
Stopa objektivnog odgovora (engl. objective response rate, ORR) iznosila je 27,9% u skupini liječenoj lijekom Cyramza plus paklitakselom te 16,1% u skupini koja je primala placebo plus paklitaksel.
A second reduction of 10 mg/m2 is recommended if these toxicities persist or reoccur. 
preporučuje se dodatno smanjiti dozu za 10 mg/m2.
Patients may be at increased risk for the development of fistula when treated with Cyramza. 
Kada se liječe lijekom Cyramza, bolesnici mogu biti izloženi povećanom riziku za nastanak fistule.
Patients with a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders, a recent history of severe (Grade ≥3) bleeding or who had experienced an arterial thrombotic event (ATE) in the 12 months 
U ispitivanje nisu bili uključeni bolesnici koji su u anamnezi imali nekontrolirane nasljedne ili stečene poremećaje krvarenja ili trombotske poremećaje, koji su nedavno imali teško krvarenje
FOLFIRI dose adjustments 
Prilagodba doze protokola FOLFIRI
What Cyramza looks like and contents of the pack 
Što Cyramza sadrži
There was an increase in median survival of 2.3 months in favour of the Cyramza plus paclitaxel arm: 9.63 months in the Cyramza plus paclitaxel arm and 7.36 months in the placebo plus paclitaxel arm. 
9,63 mjeseca u skupini liječenoj lijekom Cyramza plus paklitakselom te 7,36 mjeseci u skupini koja je primala placebo plus paklitaksel.
EU/1/14/957/003 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/957/003
For recurrent Grade 2 diarrhoea, reduce by 1 dose level for 5-FU and irinotecan. 
U slučaju rekurentnog proljeva 2. stupnja, smanjiti dozu 5-FU i irinotekana za 1 razinu.
Proteinuriaa,f 
Poremećaji bubrega i mokraćnog sustava proteinurijaa,f
Figure 5: Kaplan-Meier curves of progression -free survival for Cyramza plus FOLFIRI versus placebo plus FOLFIRI in RAISE 
Slika 5: Kaplan-Meierove krivulje preživljenja bez progresije bolesti uz primjenu lijeka Cyramza plus protokola FOLFIRI naspram placeba plus protokola FOLFIRI u ispitivanju RAISE
There was an increase in median survival of 1.6 months in favour of the Cyramza plus FOLFIRI arm: 13.3 months in the Cyramza plus FOLFIRI arm and 11.7 months in the placebo plus FOLFIRI arm. Progression-free survival was statistically significantly improved in patients receiving Cyramza plus FOLFIRI compared with those receiving placebo plus FOLFIRI (HR 0.793; 95% CI: 0.697 to 0.903; p=0.0005). 
Preživljenje bez progresije bolesti statistički se značajno poboljšalo u bolesnika liječenih lijekom Cyramza plus protokolom FOLFIRI u odnosu na one koji su primali placebo plus FOLFIRI (HR 0,793; 95% CI: 0,697 do 0,903; p=0,0005).
Clinically relevant reactions (including Grade ≥3) associated with antiangiogenic therapy observed in ramucirumab-treated patients across clinical studies were: gastrointestinal perforations, infusionrelated reactions and proteinuria (see sections 4.2 and 4.4). 
Klinički značajne nuspojave (uključujući nuspojave ≥ 3. stupnja) povezane s antiangiogenom terapijom primijećene u bolesnika liječenih ramucirumabom u svim kliničkim ispitivanjima bile su:
Hazard ratio (95% CI) Stratified log-rank p-value 12-week PFS rate% (95% CI) Abbreviations: CI = confidence interval 
Stratificirana log-rang p-vrijednost 12-tjedna stopa PFS-a (95% CI)
Gastrointestinal perforations (see section 4.4). 
Perforacija u probavnom sustavu (vidjeti dio 4.4).
A second dose reduction is recommended if a urine protein level ≥2 g/24 hours reoccurs. 
Ako razina proteina u mokraći ponovno poraste na ≥ 2 g/24 sata, preporučuje se još jedno smanjenje doze.
This is equivalent to approximately 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult. 
Jedna bočica od 50 ml sadrži približno 85 mg natrija, što odgovara približno 4% maksimalnog dnevnog unosa od 2 g natrija prema preporukama Svjetske zdravstvene organizacije za odraslu osobu.
10.5 months in the Cyramza plus docetaxel arm and 9.1 months in the placebo plus docetaxel arm. PFS was statistically significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (HR 0.762; 95% CI: 0.677 to 0.859; p<0.001). 
PFS se statistički značajno poboljšao u bolesnika liječenih lijekom Cyramza plus docetakselom u odnosu na one koji su primali placebo i docetaksel (HR 0,762; 95% CI: 0,677 do 0,859; p<0,001).
Overall survival was statistically significantly improved in patients receiving Cyramza plus FOLFIRI compared with those receiving placebo plus FOLFIRI (HR 0.844; 95% CI: 0.730 to 0.976; p=0.0219). 
FOLFIRI u odnosu na one koji su primali placebo plus FOLFIRI (HR 0,844; 95% CI: 0,730 do 0,976;
Ramucirumab should be permanently discontinued in patients who experience Grade 3 or 4 bleeding (see section 4.2). 
U bolesnika u kojih dođe do krvarenja 3. ili 4. stupnja, liječenje ramucirumabom mora se trajno obustaviti (vidjeti dio 4.2).
b Based on study RAINBOW (ramucirumab plus paclitaxel). 
Na temelju podataka iz ispitivanja RAINBOW (ramucirumab plus paklitaksel).
Objective response rate (CR + PR) 
Stratificirana log-rang p-vrijednost Stopa objektivnog odgovora (CR + PR) Stopa - postotak (95% CI)
Baseline patient demographics and disease characteristics were generally balanced between arms: the median age was 62 years; 67% of patients were male; 82% were Caucasian, 13% Asian; the ECOG PS 
medijan dobi iznosio je 62 godine; 67% bolesnika bili su muškarci; 82% bolesnika bili su bijelci, a 13% Azijci; funkcionalni ECOG status iznosio je 0 u 32% bolesnika te 1 u 67% bolesnika; 73% imalo je neplanocelularni histološki tip, a 26% njih planocelularni histološki tip.
There was an increase in median PFS of 1.5 months in favour of the Cyramza plus docetaxel arm: 4.5 months in the Cyramza plus docetaxel arm and 3 months in the placebo plus docetaxel arm. ORR was significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (22.9% vs. 13.6%, p<0.001). 
Primijećeno je produljenje medijana PFS-a od 1,5 mjeseci u korist skupine liječene lijekom Cyramza plus docetakselom: 4,5 mjeseci u skupini koja je primala lijek Cyramza plus docetaksel te 3 mjeseca u skupini koja je primala placebo plus docetaksel.
Median (95% CI) Hazard ratio (95% CI) Stratified log-rank p-value 
Omjer hazarda (95% CI) Stratificirana log-rank p-vrijednost Stopa objektivnog odgovora (CR + PR) Stopa - postotak (95% CI) Stratificirana CMH p-vrijednost
Very common side effects (may affect more than 1 in 10 people): - low white blood cell counts (may increase the risk of infection) - feeling tired or weak - diarrhoea - nose bleed - inflammation of the lining of the mouth - swelling of hands, feet and legs due to fluid retention - high blood pressure - low platelet count (blood cells that help the blood to clot) - abdominal pain - inflammation of mucous membranes, such as digestive and respiratory tracts - headache - protein in the urine (abnormal urine test) 
- umor ili slabost - proljev - krvarenje iz nosa - upala sluznice usne šupljine - oticanje šaka, stopala i nogu zbog zadržavanja tekućine - visok krvni tlak
Abdominal paina,e Diarrhoea 
Poremećaji probavnog sustava bol u abdomenua,e proljev opstrukcija crijevaa perforacija u probavnom sustavua
Gastrointestinal haemorrhage eventsa,f Gastrointestinal perforationa 
Poremećaji probavnog sustava stomatitis proljev epizode krvarenja u probavnom sustavua,f perforacija u probavnom sustavua
Rate- percent (95% CI) 
ORR % (95% CI) p-vrijednost
Vascular disorders Hypertensiona,d 
Poremećaji bubrega i mokraćnog sustava proteinurijaa,h
Ramucirumab therapy should be temporarily discontinued if the urine protein level is ≥2 g/24 hours. 
Ako je razina proteina u mokraći ≥ 2 g/24 sata, liječenje ramucirumabom mora se privremeno prekinuti.
FOLFIRI treatment over placebo plus FOLFIRI. 
46,0% onih koji su primali placebo plus paklitaksel.
The most common adverse reactions observed in ramucirumab-treated patients are: neutropenia, fatigue/asthenia, leukopenia, epistaxis, diarrhoea and stomatitis. 
arterijski tromboembolijski događaji (vidjeti dio 4.4) Najčešće nuspojave primijećene u bolesnika liječenih ramucirumabom su: neutropenija, umor/astenija,
4.7 Effects on ability to drive and use machines 
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Lijek Cyramza ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
The following convention has been used for classification of frequency: 
Za određivanje učestalosti korištene su sljedeće kategorije: vrlo često (≥ 1/10)
Gastrointestinal perforations 
Prijavljivanje nuspojava
Blister: 5 years. 
Blister: 5 godina.
• Wash your hands thoroughly with soap and water. 
• Temeljjito operite ruke sapunom i vodom.
Bottle: 5 years. 
Boca: 5 godina.
Date of latest renewal: 23 September 2009 
Datum posljednje obnove odobrenja: 23. rujna 2009.
Your doctor will tell you how much Mimpara you must take. 
Vaš liječnik će vam reći koliko lijeka Mimpara morate uzeti.
Mimpara is used in adults: 
Mimpara se koristi u odraslih:
The amount of food you use will depend on how many capsules you need to use every day: 
Količina hrane ovisi o broju kapsula koje je potrebno uzimati svaki dan:
For patients that can swallow you will need: 
Za bolesnike koji mogu gutati potrebni su:
What Mimpara is and what it is used for 
Što je Mimpara i za što se koristi
Mimpara has not been tested in pregnant women. 
Mimpara nije ispitivana u trudnica.
Aclar/PVC/PVAc/Aluminium blister containing 14 tablets. 
Aclar/PVC/PVAc/aluminij blister sadrži 14 tableta.
• Check that you have the correct strength of capsules. 
• Provjerite imate li ispravnu jačinu kapsula.
Cinacalcet did not show any genotoxic or carcinogenic potential. 
Cinakalcet nije pokazao genotoksični ili karcinogeni potencijal.
Before you start taking Mimpara, tell your doctor if you have or have ever had: 
Prije nego što počnete uzimati lijek Mimpara, obavijestite svojeg liječnika o tome imate li ili ste bilo kada imali:
During treatment with Mimpara, tell your doctor: 
Tijekom liječenja lijekom Mimpara obavijestite svojeg liječnika:
It is important that you take your dose of Mimpara as advised by your doctor. 
Važno je da uzmete dozu lijeka Mimpara koju Vam je preporučio Vaš liječnik.
Mimpara is used in children aged 3 years to less than 18 years of age: 
Mimpara se koristi u djece u dobi od 3 do manje od 18 godina:
Not known: frequency cannot be estimated from available data 
Nepoznato: učestalost se ne može utvrditi na temelju dostupnih podataka
Cinacalcet is approximately 97% bound to plasma proteins and distributes minimally into red blood cells. 
Cinakalcet je oko 97 % vezan za proteine plazme i minimalno se distribuira u crvene krvne stanice.
To open the capsule: 
Za otvaranje kapsule:
In case of pregnancy, your doctor may decide to modify your treatment, as Mimpara might harm the unborn baby. 
U slučaju trudnoće, vaš liječnik može promijeniti terapiju jer Mimpara može biti štetna za vaše nerođeno dijete.
If you take more Mimpara than you should you must contact your doctor immediately. 
Ako uzmete više lijeka Mimpara nego što ste trebali, morate odmah kontaktirati liječnika.
The dose should be increased sequentially through available dose levels (see table 1) no more frequently than every 4 weeks. 
Dozu je potrebno sekvencijalno povećavati dostupnim dozama (vidjeti Tablicu 1) ne češće od svaka 4 tjedna.
Other medicines and Mimpara 
Drugi lijekovi i Mimpara
(Hypromellose, macrogol) 
(hipromeloza, makrogol)
The dose can be increased to achieve a desired target iPTH range. 
Dozu je moguće povećavati za postizanje željenog ciljnog raspona iPTH-a.
Gender: Clearance of cinacalcet may be lower in women than in men. 
Spol: Klirens cinakalceta može biti manji u žena nego u muškaraca.