FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: 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).
English: 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).
Croatian: Klinički značajne nuspojave (uključujući nuspojave ≥ 3. stupnja) povezane s antiangiogenom terapijom primijećene u bolesnika liječenih ramucirumabom u svim kliničkim ispitivanjima bile su:
English: Hazard ratio (95% CI) Stratified log-rank p-value 12-week PFS rate% (95% CI) Abbreviations: CI = confidence interval
Croatian: Stratificirana log-rang p-vrijednost 12-tjedna stopa PFS-a (95% CI)
English: Gastrointestinal perforations (see section 4.4).
Croatian: Perforacija u probavnom sustavu (vidjeti dio 4.4).
English: A second dose reduction is recommended if a urine protein level ≥2 g/24 hours reoccurs.
Croatian: Ako razina proteina u mokraći ponovno poraste na ≥ 2 g/24 sata, preporučuje se još jedno smanjenje doze.
English: This is equivalent to approximately 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: 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.
English: 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).
Croatian: 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).
English: 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).
Croatian: FOLFIRI u odnosu na one koji su primali placebo plus FOLFIRI (HR 0,844; 95% CI: 0,730 do 0,976;
English: Ramucirumab should be permanently discontinued in patients who experience Grade 3 or 4 bleeding (see section 4.2).
Croatian: U bolesnika u kojih dođe do krvarenja 3. ili 4. stupnja, liječenje ramucirumabom mora se trajno obustaviti (vidjeti dio 4.2).
English: b Based on study RAINBOW (ramucirumab plus paclitaxel).
Croatian: Na temelju podataka iz ispitivanja RAINBOW (ramucirumab plus paklitaksel).
English: Objective response rate (CR + PR)
Croatian: Stratificirana log-rang p-vrijednost Stopa objektivnog odgovora (CR + PR) Stopa - postotak (95% CI)
English: 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
Croatian: 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.
English: 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).
Croatian: 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.
English: Median (95% CI) Hazard ratio (95% CI) Stratified log-rank p-value
Croatian: Omjer hazarda (95% CI) Stratificirana log-rank p-vrijednost Stopa objektivnog odgovora (CR + PR) Stopa - postotak (95% CI) Stratificirana CMH p-vrijednost
English: 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)
Croatian: - umor ili slabost - proljev - krvarenje iz nosa - upala sluznice usne šupljine - oticanje šaka, stopala i nogu zbog zadržavanja tekućine - visok krvni tlak
English: Abdominal paina,e Diarrhoea
Croatian: Poremećaji probavnog sustava bol u abdomenua,e proljev opstrukcija crijevaa perforacija u probavnom sustavua
English: Tel: + 44-(0) 1256 315000
Croatian: United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
English: Gastrointestinal haemorrhage eventsa,f Gastrointestinal perforationa
Croatian: Poremećaji probavnog sustava stomatitis proljev epizode krvarenja u probavnom sustavua,f perforacija u probavnom sustavua
English: Rate- percent (95% CI)
Croatian: ORR % (95% CI) p-vrijednost
English: Vascular disorders Hypertensiona,d
Croatian: Poremećaji bubrega i mokraćnog sustava proteinurijaa,h
English: Ramucirumab therapy should be temporarily discontinued if the urine protein level is ≥2 g/24 hours.
Croatian: Ako je razina proteina u mokraći ≥ 2 g/24 sata, liječenje ramucirumabom mora se privremeno prekinuti.
English: FOLFIRI treatment over placebo plus FOLFIRI.
Croatian: 46,0% onih koji su primali placebo plus paklitaksel.
English: The most common adverse reactions observed in ramucirumab-treated patients are: neutropenia, fatigue/asthenia, leukopenia, epistaxis, diarrhoea and stomatitis.
Croatian: arterijski tromboembolijski događaji (vidjeti dio 4.4) Najčešće nuspojave primijećene u bolesnika liječenih ramucirumabom su: neutropenija, umor/astenija,
English: 4.7 Effects on ability to drive and use machines
Croatian: 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.
English: The following convention has been used for classification of frequency:
Croatian: Za određivanje učestalosti korištene su sljedeće kategorije: vrlo često (≥ 1/10)
English: Gastrointestinal perforations
Croatian: Prijavljivanje nuspojava
English: Blister: 5 years.
Croatian: Blister: 5 godina.
English: • Wash your hands thoroughly with soap and water.
Croatian: • Temeljjito operite ruke sapunom i vodom.
English: Bottle: 5 years.
Croatian: Boca: 5 godina.
English: Date of latest renewal: 23 September 2009
Croatian: Datum posljednje obnove odobrenja: 23. rujna 2009.
English: Your doctor will tell you how much Mimpara you must take.
Croatian: Vaš liječnik će vam reći koliko lijeka Mimpara morate uzeti.
English: Mimpara is used in adults:
Croatian: Mimpara se koristi u odraslih:
English: The amount of food you use will depend on how many capsules you need to use every day:
Croatian: Količina hrane ovisi o broju kapsula koje je potrebno uzimati svaki dan:
English: For patients that can swallow you will need:
Croatian: Za bolesnike koji mogu gutati potrebni su:
English: What Mimpara is and what it is used for
Croatian: Što je Mimpara i za što se koristi
English: Mimpara has not been tested in pregnant women.
Croatian: Mimpara nije ispitivana u trudnica.
English: Aclar/PVC/PVAc/Aluminium blister containing 14 tablets.
Croatian: Aclar/PVC/PVAc/aluminij blister sadrži 14 tableta.
English: • Check that you have the correct strength of capsules.
Croatian: • Provjerite imate li ispravnu jačinu kapsula.
English: Cinacalcet did not show any genotoxic or carcinogenic potential.
Croatian: Cinakalcet nije pokazao genotoksični ili karcinogeni potencijal.
English: Before you start taking Mimpara, tell your doctor if you have or have ever had:
Croatian: Prije nego što počnete uzimati lijek Mimpara, obavijestite svojeg liječnika o tome imate li ili ste bilo kada imali:
English: During treatment with Mimpara, tell your doctor:
Croatian: Tijekom liječenja lijekom Mimpara obavijestite svojeg liječnika:
English: It is important that you take your dose of Mimpara as advised by your doctor.
Croatian: Važno je da uzmete dozu lijeka Mimpara koju Vam je preporučio Vaš liječnik.
English: Mimpara is used in children aged 3 years to less than 18 years of age:
Croatian: Mimpara se koristi u djece u dobi od 3 do manje od 18 godina:
English: Not known: frequency cannot be estimated from available data
Croatian: Nepoznato: učestalost se ne može utvrditi na temelju dostupnih podataka
English: Cinacalcet is approximately 97% bound to plasma proteins and distributes minimally into red blood cells.
Croatian: Cinakalcet je oko 97 % vezan za proteine plazme i minimalno se distribuira u crvene krvne stanice.
English: To open the capsule:
Croatian: Za otvaranje kapsule:
English: In case of pregnancy, your doctor may decide to modify your treatment, as Mimpara might harm the unborn baby.
Croatian: U slučaju trudnoće, vaš liječnik može promijeniti terapiju jer Mimpara može biti štetna za vaše nerođeno dijete.
English: If you take more Mimpara than you should you must contact your doctor immediately.
Croatian: Ako uzmete više lijeka Mimpara nego što ste trebali, morate odmah kontaktirati liječnika.
English: The dose should be increased sequentially through available dose levels (see table 1) no more frequently than every 4 weeks.
Croatian: Dozu je potrebno sekvencijalno povećavati dostupnim dozama (vidjeti Tablicu 1) ne češće od svaka 4 tjedna.
English: Other medicines and Mimpara
Croatian: Drugi lijekovi i Mimpara
English: (Hypromellose, macrogol)
Croatian: (hipromeloza, makrogol)
English: The dose can be increased to achieve a desired target iPTH range.
Croatian: Dozu je moguće povećavati za postizanje željenog ciljnog raspona iPTH-a.
English: Gender: Clearance of cinacalcet may be lower in women than in men.
Croatian: Spol: Klirens cinakalceta može biti manji u žena nego u muškaraca.
English: EU/1/04/292/001 - 30 mg carton with 14 tablets EU/1/04/292/002 - 30 mg carton with 28 tablets EU/1/04/292/003 - 30 mg carton with 84 tablets EU/1/04/292/004 - 30 mg bottle with 30 tablets EU/1/04/292/005 - 60 mg carton with 14 tablets EU/1/04/292/006 - 60 mg carton with 28 tablets EU/1/04/292/007 - 60 mg carton with 84 tablets EU/1/04/292/008 - 60 mg bottle with 30 tablets EU/1/04/292/009 - 90 mg carton with 14 tablets EU/1/04/292/010 - 90 mg carton with 28 tablets EU/1/04/292/011 - 90 mg carton with 84 tablets EU/1/04/292/012 - 90 mg bottle with 30 tablets
Croatian: EU/1/04/292/001 - 30 mg - kutija s 14 tableta EU/1/04/292/002 - 30 mg - kutija s 28 tableta EU/1/04/292/003 - 30 mg - kutija s 84 tablete EU/1/04/292/004 - 30 mg - boca s 30 tableta EU/1/04/292/005 - 60 mg - kutija s 14 tableta EU/1/04/292/006 - 60 mg - kutija s 28 tableta EU/1/04/292/007 - 60 mg - kutija s 84 tablete EU/1/04/292/008 - 60 mg - boca s 30 tableta EU/1/04/292/009 - 90 mg - kutija s 14 tableta EU/1/04/292/010 - 90 mg - kutija s 28 tableta EU/1/04/292/011 - 90 mg - kutija s 84 tablete EU/1/04/292/012 - 90 mg - boca s 30 tableta
English: You must open the capsules and administer the entire content of granules.
Croatian: Morate otvoriti kapsule i primijeniti cijeli sadržaj granula.
English: 10 to < 12.5
Croatian: 10 do < 12,5
English: The dose should be adjusted based on iPTH as shown below:
Croatian: Dozu treba prilagoditi na temelju iPTH-a kako je prikazano niže:
English: Talk to your doctor, pharmacist or nurse before taking Mimpara.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek Mimpara.
English: Very common: may affect more than 1 in 10 people • nausea and vomiting, these side effects are normally quite mild and do not last for long.
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba • mučnina i povraćanje; ove nuspojave su uglavnom blage i ne traju dugo.
English: Do not take Mimpara if you have low levels of calcium in your blood.
Croatian: Nemojte uzimati lijek Mimpara ako imate niske vrijednosti kalcija u krvi.
English: • if you start or stop smoking, as this may affect the way Mimpara works.
Croatian: • ako ste počeli ili prestali pušiti, jer to može utjecati na djelovanje lijeka Mimpara.
English: This analysis showed no significant impact of age, sex, race, body surface area, and body weight on cinacalcet pharmacokinetics.
Croatian: Ova analiza je pokazala da ne postoji značajan utjecaj dobi, spola, rase, tjelesne površine i tjelesne težine na farmakokinetiku cinakalceta.
English: • Opadry clear (containing hypromellose, macrogol)
Croatian: • Opadry clear (sadrži hipromelozu, makrogol)
English: Do not initiate cinacalcet or increase the dose if non-compliance is suspected.
Croatian: Nemojte započeti liječenje cinakalcetom ili povisiti dozu ako se sumnja na nesuradljivost.
English: Available sequential dose levels (mg)
Croatian: Dostupne sekvencijalne doze (mg)
English: - The other ingredients of the granules are:
Croatian: - Drugi sastojci granula su:
English: Take all food or liquid immediately.
Croatian: Hranu ili tekućinu uzmite odmah.
English: The granules are not compatible with tubes made of polyurethane and silicone.
Croatian: Granule nisu kompatibilne s cjevčicama od poliuretana i silikona.
English: In order to avoid dosing errors, capsules of different strengths (1, 2.5, or 5 mg) should not be mixed to achieve the desired dose.
Croatian: Kako bi se izbjeglo pogrešno doziranje, ne smiju se miješati kapsule različite jačine (1, 2,5, ili 5 mg) kako bi se postigla željena doza.
English: What Mimpara is and what it is used for What you need to know before you take Mimpara How to take Mimpara
Croatian: Što je Mimpara i za što se koristi Što morate znati prije nego počnete uzimati lijek Mimpara
English: - The tablets are coated with:
Croatian: - Tablete su obložene s:
English: If you take more Mimpara than you should
Croatian: Ako uzmete više lijeka Mimpara nego što ste trebali
English: In pregnant rats, there were slight decreases in body weight and food consumption at the highest dose.
Croatian: U oplođenih štakora došlo je do lagana smanjenja tjelesne težine i potrošnje hrane pri najvećoj dozi.
English: Each blister pack contains either 14, 28 or 84 tablets in a carton.
Croatian: Svako blister pakiranje sadrži 14, 28 ili 84 tableta u kutiji.
English: Mimpara should be used in paediatric patients only if the potential benefit justifies the potential risk.
Croatian: Mimpara se smije koristiti kod pedijatrijskih bolesnika samo ako potencijalna korist opravdava potencijalan rizik.
English: Increases in plasma cinacalcet concentration are similar, regardless of the fat content of the meal.
Croatian: Povećanje koncentracije cinakalceta u plazmi slično je bez obzira na količinu masti u obroku.
English: Restart at the next lower dose.
Croatian: Započnite liječenje sljedećom nižom dozom.
English: The clinical relevance is unknown, however, the potential for cinacalcet to act on these secondary targets cannot be fully excluded.
Croatian: Klinički značaj nije poznat, ali mogućnost da cinakalcet djeluje na te sekundarne ciljeve ne može se potpuno isključiti.
English: If 1-3 capsules are used per day use at least 15 mL food; if 4-6 capsules are used per day use at least 30 mL food.
Croatian: Ako se dnevno uzima 1-3 kapsule, potrebno je najmanje 15 ml hrane; ako se dnevno uzima 4-6 kapsula, potrebno je najmanje 30 ml hrane.
English: Insufficient data are available.
Croatian: Nema dostatnih podataka.
English: • Do not mix granules of different strengths to avoid incorrect dosing.
Croatian: • Nemojte miješati granule različite jačine kako biste izbjegli pogrešno doziranje.
English: If a patient stops or starts smoking, cinacalcet plasma levels may change and dose adjustment may be necessary.
Croatian: Ako bolesnik prestane ili počne pušiti, može se promijeniti razina cinakalceta u plazmi i možda će biti potrebno prilagoditi dozu.
English: Your doctor will discuss with you if you should discontinue either breast-feeding or treatment with Mimpara.
Croatian: Vaš liječnik će raspraviti s vama trebate li prestati dojiti ili prekinuti liječenje lijekom Mimpara.
English: Treatment should be reinitiated using the next lowest dose of Mimpara.
Croatian: Liječenje treba ponovno započeti primjenjujući sljedeću najnižu dozu lijeka Mimpara.
English: What Mimpara contains
Croatian: Što Mimpara sadrži
English: Starting dose (mg)
Croatian: Početna doza (mg)
English: Different strengths of granules should not be mixed, in order to avoid dosing errors.
Croatian: Različite jačine granula ne smiju se miješati kako bi se izbjegle pogreške u doziranju.
English: Granules mixed with soft food or liquid should be administered immediately.
Croatian: Granule pomiješane s mekanom hranom ili tekućinom trebaju se odmah primijeniti.
English: After adjusting for baseline characteristics in a secondary analysis, the HR for the primary composite endpoint was 0.88; 95% CI: 0.79, 0.97.
Croatian: Nakon prilagodbe za početne značajke u sekundarnoj analizi, HR za primarni kompozitni ishod iznosio je 0,88; 95 % CI: 0,79, 0,97.
English: If patient was receiving the lowest dose (1 mg/day) prior to discontinuation, restart at the same dose (1 mg/day).
Croatian: Ako je bolesnik primao najnižu dozu (1 mg/dan) prije prekida liječenja, započnite istom dozom (1 mg/dan).
English: See section 6.1
Croatian: Vidjeti dio 6.1.
English: The dose can be increased up to a maximum dose of 2.5 mg/kg/day, not to exceed a total daily dose of 180 mg.
Croatian: Dozu je moguće povećati do maksimalne doze od 2,5 mg/kg/dan, ali da ne prelazi ukupnu dnevnu dozu od 180 mg.
English: Pack sizes of 1 blister (14 tablets), 2 blisters (28 tablets), 6 blisters (84 tablets) per carton.
Croatian: Pakiranje sa 1 blisterom (14 tableta), 2 blistera (28 tableta), 6 blistera (84 tableta) u kutiji.
English: An open-label extension of this study showed no further reductions in free and total testosterone concentrations over a period of 3 years in Mimpara-treated patients.
Croatian: Otvoreni nastavak ovog ispitivanja nije pokazao daljnje sniženje koncentracije slobodnog i ukupnog testosterona u bolesnika liječenih lijekom Mimpara u razdoblju od 3 godine.
English: - The capsule shell contains:
Croatian: - Ovojnica kapsule sadrži:
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Croatian: Prema smjernici CHMP-a o sustavima upravljanja rizicima lijekova za primjenu kod ljudi, ažurirani RMP trebao bi biti podnesen istodobno sa sljedećim periodičkim izvješćem o neškodljivosti lijeka (PSUR).
English: Only the granules should be administered.
Croatian: Smiju se primjeniti samo granule.
English: After administration of a 75 mg radiolabelled dose to healthy volunteers, cinacalcet was rapidly and extensively metabolised by oxidation followed by conjugation.
Croatian: Nakon primjene radioaktivno obilježene doze od 75 mg zdravim dobrovoljcima, cinakalcet se brzo i ekstenzivno metabolizira oksidacijom, a nakon toga konjugacijom.
English: Smoking induces CYP1A2; the clearance of cinacalcet was observed to be 36-38% higher in smokers than non-smokers.
Croatian: Pušenje inducira CYP1A2; opažen je 36 do 38 % veći klirens cinakalceta kod pušača u odnosu na nepušače.
English: • a medicine used to treat HIV infection and AIDS (ritonavir);
Croatian: • lijek koji se koristi za liječenje HIV infekcija i AIDS (ritonavir);
English: Tell your doctor if you experience an unusually fast or pounding heartbeat, if you have heart rhythm problems, or if you take medicines known to cause heart rhythm problems, while taking Mimpara.
Croatian: Obavijestite svog liječnika ako osjetite neobično ubrzano ili jako lupanje srca, ako imate tegobe sa srčanim ritmom ili ako uzimate lijekove za koje se zna da uzrokuju tegobe sa srčanim ritmom, dok uzimate lijek Mimpara.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, particularly etelcalcetide or any other medicines that lower the level of calcium in your blood.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, osobito etelkalcetid ili bilo koje druge lijekove koji snižavaju vrijednost kalcija u krvi.
English: For instructions on how to use Mimpara granules, read the section at the end of this leaflet.
Croatian: Za upute kako koristiti Mimpara granule, pročitajte zadnji dio ove upute o lijeku.
English: The study did not meet its primary objective of demonstrating a reduction in risk of all-cause mortality or cardiovascular events including myocardial infarction, hospitalisation for unstable angina, heart failure or peripheral vascular event (HR 0.93; 95% CI: 0.85, 1.02; p = 0.112).
Croatian: Ispitivanje nije postiglo primarni cilj da pokaže smanjenje rizika od mortaliteta svih uzroka ili kardiovaskularnih događaja uključujući infarkt miokarda, hospitalizaciju zbog nestabilne angine, zatajenje srca ili periferni krvožilni događaj (HR 0,93; 95 % CI: 0,85, 1,02; p = 0,112).
English: Mimpara works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Croatian: Mimpara kontrolira vrijednosti paratireoidnog hormona (PTH), kalcija i fosfora u vašem organizmu.
English: Symptoms of hypocalcaemia have resolved.
Croatian: Simptomi hipokalcemije su se povukli.
English: Adverse reactions, considered at least possibly attributable to cinacalcet treatment in the placebo-controlled studies and single-arm studies based on best-evidence assessment of causality are listed below using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Croatian: Nuspojave, za koje se smatra da postoji barem mogućnost da se mogu pripisati liječenju cinakalcetom u placebom kontroliranim ispitivanjima i ispitivanjima na jednoj skupini prema procjeni uzročno-posljedične veze na temelju najboljih dokaza navedene su niže prema sljedećoj konvenciji: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000).
English: Using water is not recommended as it may make the medicine taste bitter.
Croatian: Uzimanje s vodom nije preporučljivo jer može ostaviti gorak okus lijeka.
English: • Hold each capsule upright (with the coloured cap on top).
Croatian: • Držite kapsulu uspravno (s obojenom kapicom prema gore).
English: Mimpara reduces calcium levels.
Croatian: Mimpara snižava vrijednosti kalcija.
English: Do not store Mimpara mixed with food or liquid.
Croatian: Nemojte čuvati lijek Mimpara pomiješan s hranom ili tekućinom.
English: Reduce or withhold dose of Mimpara.
Croatian: Smanjite ili privremeno prekinite dozu lijeka Mimpara.
English: While opening it is recommended to hold the capsule upright over the small amount of soft food or liquid.
Croatian: Prilikom otvaranja kapsule preporučuje se držati kapsulu uspravno iznad male količine mekane hrane ili tekućine.
English: *If the dose has been stopped, corrected serum calcium should be measured within 5 to 7 days
Croatian: *Ako je doza prekinuta, korigirana vrijednost serumskog kalcija treba se mjeriti unutar 5 do 7 dana