FrancophonIA/ELRC3.0 huggingface dataset:
English: There have also been reports of fluid accumulation, including peripheral oedema, lymphoedema, pleural effusion and pericardial effusions (including haemodynamically significant effusions in children and adults), in patients receiving Rapamune.
Croatian: U bolesnika koji su koristili Rapamune zabilježeni su slučajevi nakupljanja tekućine, uključujući periferni edem, limfedem, pleuralni i perikardijalni izljev (uključujući hemodinamički značajne izljeve u djece i odraslih).
English: Protein in the urine, occasionally severe and associated with side effects, such as swelling Scarring in the kidney that may reduce kidney function Too much fluid collecting in the tissues due to irregular lymph function Low blood platelets, with or without rash (thrombocytopaenic purpura) Serious allergic reactions that can cause peeling of the skin Tuberculosis
Croatian: Manje često: mogu se javiti u manje od 1 na 100 osoba rak limfnog tkiva (limfom/posttransplantacijski limfoproliferativni poremećaj), kombinirano sniženje broja crvenih krvnih stanica, bijelih krvnih stanica i krvnih pločica krvarenje iz pluća proteini u mokraći, povremeno u velikoj količini i povezani s nuspojavama kao što je oticanje ožiljkaste promjene na bubregu koje mogu smanjiti funkciju bubrega preobilno nakupljanje tekućine u tkivima zbog nepravilnog protoka limfe nizak broj trombocita, sa ili bez osipa (trombocitopenična purpura) ozbiljne alergijske reakcije koje mogu uzrokovati guljenje kože tuberkuloza infekcija Epstein-Barrovim virusom proljev uzrokovan infekcijom bakterijom Clostridium difficile ozbiljno oštećenje jetre
English: Posterior reversible encephalopathy syndrome
Croatian: Poremećaji živčanog sustava glavobolja sindrom posteriorne reverzibilne encefalopatije
English: Rapamune 0.5 mg coated tablets Rapamune 1 mg coated tablets Rapamune 2 mg coated tablets sirolimus
Croatian: Rapamune 0,5 mg obložene tablete Rapamune 1 mg obložene tablete Rapamune 2 mg obložene tablete sirolimus
English: Neutropaenia
Croatian: Cijepljenje
English: MARKETING AUTHORISATION NUMBER(S) Rapamune 0.5 mg coated tablets EU/1/01/171/013-14
Croatian: Rapamune 0,5 mg obložene tablete EU/1/01/171/013-14
English: Ciclosporin (CYP3A4 substrate)
Croatian: Ciklosporin (supstrat CYP3A4)
English: Verapamil (CYP3A4 inhibitor)
Croatian: Verapamil (inhibitor CYP3A4)
English: Each Rapamune 1 mg coated tablet contains 1 mg of sirolimus.
Croatian: Jedna Rapamune 1mg obložena tableta sadrži 1mg sirolimusa.
English: To minimise variability, Rapamune should consistently be taken either with or without food.
Croatian: Kako bi se promjene koncentracije lijeka svele na najmanju moguću mjeru, Rapamune treba dosljedno uzimati ili s hranom ili bez nje.
English: INFORMATION IN BRAILLE Rapamune 1 mg
Croatian: Rapamune 1 mg
English: The Cmax, tmax, and AUC of plasma erythromycin base were increased 1.6-fold, 1.3-fold, and 1.7-fold, respectively.
Croatian: Cmax eritromicina u plazmi povećana je 1,6 puta, tmax 1,3 puta, a AUC 1,7 puta.
English: You must use an effective method of contraception during treatment with Rapamune and for 12 weeks after treatment has stopped.
Croatian: Za vrijeme liječenja lijekom Rapamune, kao i tijekom 12 tjedana nakon prestanka liječenja, morate koristiti učinkovitu metodu kontracepcije.
English: Co-administration of sirolimus and voriconazole is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena sirolimusa i vorikonazola (vidjeti dio 4.4).
English: Cancer of the lymph tissue (lymphoma/post-transplant lympho-proliferative disorder), combined lowering of red blood cells, white blood cells and blood platelets Bleeding from the lung
Croatian: limfom*, maligni melanom*, posttransplantacijski limfoproliferativni poremećaj neuroendokrin i karcinom kože*
English: Lung and liver transplant populations
Croatian: Bolesnici s presadcima pluća i jetre
English: Whole blood sirolimus Cmax, tmax, and AUC were increased 2.3-fold, 1.1-fold, and 2.2-fold, respectively.
Croatian: Cmax sirolimusa u krvi bila je povećana 2,3 puta, tmax 1,1 puta, a AUC 2,2 puta.
English: Rapamune 0.5 mg coated tablets sirolimus
Croatian: Rapamune 0,5 mg obložene tablete sirolimus
English: Pericardial effusion
Croatian: Oralna otopina
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Podrobnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Appropriate adjustment of the immunosuppression regimen should be considered in patients with elevated serum creatinine levels.
Croatian: U bolesnika s povišenom razinom kreatinina u serumu, potrebno je razmotriti odgovarajuću prilagodbu protokola imunosupresije.
English: Each 60 mL bottle of Rapamune contains 60 mg sirolimus.
Croatian: Jedna boca od 60 ml lijeka Rapamune sadrži 60 mg sirolimusa.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip, akne eksfolijativni dermatitis hipersenzitivni vaskulitis
English: Leucopenia
Croatian: limfedem
English: Rapamune 1 mg is supplied to you as white-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 1 mg” on one side.
Croatian: Rapamune 1 mg je dostupan u obliku obloženih tableta bijele boje i trokutastog oblika s oznakom „RAPAMUNE 1 mg“ na jednoj strani.
English: The other ingredients are:
Croatian: Što se nalazi u ovoj uputi:
English: Diltiazem (CYP3A4 inhibitor)
Croatian: Diltiazem (inhibitor CYP3A4)
English: Rapamune 2 mg is supplied to you as yellow to beige-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 2 mg” on one side.
Croatian: Rapamune 2 mg je dostupan u obliku obloženih tableta žute do bež boje i trokutastog oblika s oznakom „RAPAMUNE 2 mg“ na jednoj strani.
English: Each mL of Rapamune contains 1 mg sirolimus.
Croatian: Jedan ml lijeka Rapamune sadrži 1 mg sirolimusa.
English: The use of live vaccines should be avoided with the use of Rapamune.
Croatian: Tijekom uzimanja lijeka Rapamune treba izbjegavati cijepljenje živim cjepivima.
English: Rapamune 2 mg coated tablets
Croatian: Rapamune 2 mg obložene tablete sirolimus
English: Ketoconazole (CYP3A4 inhibitor)
Croatian: Ketokonazol (inhibitor CYP3A4)
English: Controlled clinical studies with posology comparable to that currently indicated for the use of Rapamune in adults have not been conducted in children or adolescents below 18 years of age.
Croatian: U djece ili adolescenata u dobi ispod 18 godina nisu provedena kontrolirana klinička ispitivanja određivanja doze usporediva s onom koja je trenutno indicirana u liječenju odraslih s Rapamuneom.
English: Stomach pain, diarrhoea, constipation, nausea
Croatian: Poremećaji probavnog sustava bol u abdomenu, konstipacija, proljev, mučnina pankreatitis, stomatitis, ascites
English: Controlled clinical studies with posology comparable to that currently indicated for the use of Rapamune in adults have not been conducted in children or adolescents below 18 years of age).
Croatian: U djece ili adolescenata (u dobi ispod 18 godina) nisu provedena kontrolirana klinička ispitivanja određivanja doze usporedive s onom koja je trenutno indicirana u liječenju odraslih s Rapamuneom.
English: Blood creatinine increased *See section below.
Croatian: *Vidjeti dio ispod.
English: Sirolimus has been administered concurrently with the following agents in clinical studies: tacrolimus, ciclosporin, azathioprine, mycophenolate mofetil, corticosteroids and cytotoxic antibodies.
Croatian: U kliničkim se ispitivanjima sirolimus istodobno primjenjivao sa slijedećim lijekovima: takrolimus, ciklosporin, azatioprin, mofetilmikofenolat, kortikosteroidi i citotoksična protutijela.
English: Each mL of Rapamune oral solution contains 1 mg of sirolimus.
Croatian: Jedan ml oralne otopine Rapamune sadrži 1 mg sirolimusa.
English: Erythromycin (CYP3A4 inhibitor)
Croatian: Eritromicin (inhibitor CYP3A4)
English: Protein build-up in the air sacs of the lungs that may interfere with breathing Serious allergic reactions that can affect blood vessels (see above paragraph on allergic reactions) Not known: frequency cannot be estimated from the available data Posterior reversible encephalopathy syndrome (PRES), a serious nervous system syndrome that has the following symptoms: headache, nausea, vomiting, confusion, seizures, and visual loss.
Croatian: Nepoznato: učestalostse ne može procijeniti iz dostupnih podataka sindrom posteriorne reverzibilne encefalopatije, ozbiljan sindrom živčanog sustava koji ima sljedeće simptome: glavobolja, mučnina, povraćanje, smetenost, napadaji i gubitak vida.
English: Rapamune 0.5 mg coated tablets
Croatian: Rapamune 0,5 mg tablete sirolimus
English: Rapamune 1 mg coated tablets
Croatian: Rapamune 1 mg obložene tablete sirolimus
English: Sirolimus whole blood trough concentrations should be measured in 10 to 20 days, with dosage adjustment to maintain concentrations between 5 to 15 ng/mL.
Croatian: Kako bi se održale koncentracije između 5 i 15 ng/ml potrebno je mjeriti najniže koncentracije sirolimusa u punoj krvi za 10 do 20 dana uz prilagodbu doziranja.
English: Renal function should be monitored during concomitant administration of Rapamune and ciclosporin.
Croatian: Tijekom istodobne primjene Rapamunea i ciklosporina mora se pratiti funkcija bubrega.
English: The bottle should remain in an upright position when withdrawing the solution.
Croatian: Dok izvlačite otopinu, boca treba biti u uspravnom položaju.
English: Oral tablet
Croatian: Tablete za peroralnu primjenu
English: Voriconazole (CYP3A4 inhibitor)
Croatian: Vorikonazol (inhibitor CYP3A4)
English: NAME OF THE MEDICINAL PRODUCT Rapamune 0.5 mg coated tablets Rapamune 1 mg coated tablets Rapamune 2 mg coated tablets
Croatian: Rapamune 0,5 mg obložene tablete Rapamune 1 mg obložene tablete Rapamune 2 mg obložene tablete
English: There was a higher rate of serious adverse events, including pneumonia, acute rejection, graft loss and death, in this sirolimus treatment arm (n=60, median time post-transplant 36 months).
Croatian: U ovoj podskupini liječenoj sirolimusom (n=60, medijan vremena nakon transplantacije bilo je 36 mjeseci) uočena je veća stopa ozbiljnih nuspojava uključujući pneumoniju, akutno odbacivanje, propadanje presatka i smrt.
English: Bioavailability has not been determined for tablets after they have been crushed, chewed or split, and therefore this cannot be recommended.
Croatian: Ne preporučuje se drobljenje, žvakanje ili lomljenje tableta, budući da za takve tablete nije određena bioraspoloživost.
English: 4.1 ng/mL (14 to 24 ng/mL) and 8.2  4.2 mg (3.6 to 13.6 mg), respectively (see section 4.2).
Croatian: Terapija održavanja: Od 3. do 12. mjeseca, nakon ukidanja ciklosporina, srednje vrijednosti (10. i 90. percentila) najniže koncentracije (izraženo u vrijednostima kromatografske metode) iznosile su 19  4,1 ng/ml (14 do 24 ng/ml), a dnevne doze 8,2  4,2 mg (3,6 do 13,6 mg) (vidjeti dio 4.2).
English: Urinary tract infection
Croatian: Sirolimus inhibira aktivaciju
English: You should contact your doctor if you experience symptoms that are serious, unusual, or prolonged.
Croatian: Ako dobijete ozbiljne, neobične ili dugotrajne simptome, obratite se svom liječniku.
English: Pancytopaenia; Thrombotic thrombocytopaenic purpura
Croatian: Srčani poremećaji tahikardija perikardijalni izljev
English: Each tablet contains 86.4 mg of lactose monohydrate and 214.4 mg of sucrose.
Croatian: Rapamune 2 mg obložene tablete Jedna tableta sadrži 86,4 mg laktoze hidrata i 214,4 mg saharoze.
English: Yellow to beige-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 2 mg” on one side.
Croatian: Rapamune 2 mg obložene tablete Obložena tableta žute do bež boje, trokutastog oblika s oznakom „RAPAMUNE 2 mg“ s jedne strane.
English: Infectious diarrhoea with Clostridium difficile
Croatian: Tijekom terapije Rapamuneom s ciklosporinom
English: Each tablet contains 86.4 mg of lactose monohydrate and 215.7 mg of sucrose.
Croatian: Rapamune 0,5 mg obložene tablete Jedna tableta sadrži 86,4 mg laktoze hidrata i 215,7 mg saharoze.
English: Venous thrombosis (including deep vein thrombosis)
Croatian: Krvožilni poremećaji hipertenzija, limfokela venska tromboza (uključujući duboku vensku trombozu)
English: GENERAL CLASSIFICATION FOR SUPPLY INSTRUCTIONS ON USE INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU
English: Each tablet contains 86.4 mg of lactose monohydrate and 215.8 mg of sucrose.
Croatian: Rapamune 1 mg obložene tablete Jedna tableta sadrži 86,4 mg laktoze hidrata i 215,8 mg saharoze.
English: Hepatic failure*
Croatian: zatajenje jetre*
English: bromocriptine (used in the treatment of Parkinson's disease and various hormonal disorders), danazol (used in the treatment of gynaecological disorders), or protease inhibitors (e.g., for HIV and hepatitis C such as ritonavir, indinavir, boceprevir, and telaprevir).
Croatian: Ne preporučuje se uzimati Rapamune s rifampicinom, ketokonazolom ili vorikonazolom. bilo koje lijekove protiv povišenog krvnog tlaka ili lijekove zbog srčanih tegoba uključujući nikardipin, verapamil i diltiazem. antiepileptike, uključujući karbamazepin, fenobarbital, fenitoin lijekove za liječenje vrijeda ili drugih probavnih poremećaja, kao što su cisaprid, cimetidin, metoklopramid bromokriptin (primjenjuje se u liječenju Parkinsonove bolesti i raznih hormonskih poremećaja), danazol (primjenjuje se u liječenju ginekoloških poremećaja) ili inhibitore proteaze (npr. za HIV i hepatitis C kao što su ritonavir, indinavir, boceprevir i telaprevir) gospinu travu (Hypericum perforatum)
English: Fever
Croatian: BLISTER
English: Inflammation of the pancreas
Croatian: Učinak ciklosporina
English: 3.0 ng/mL (5.0 to 13 ng/mL) and 2.1  0.70 mg (1.5 to 2.7 mg), respectively (see section 4.2).
Croatian: Na temelju praćenja svih bolesnika tijekom razdoblja istodobne terapije ciklosporinom, srednje vrijednosti (10. i 90. percentila) najniže koncentracije (izraženo u vrijednostima kromatografske metode) iznosile su 8,6  3,0 ng/ml (5,0 do 13 ng/ml), a dnevne doze 2,1  0,70 mg (1,5 do 2,7 mg) (vidjeti dio 4.2).
English: White-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 1 mg” on one side.
Croatian: Rapamune 1 mg obložene tablete Obložena tableta bijele boje, trokutastog oblika s oznakom „RAPAMUNE 1 mg“ s jedne strane.
English: PHARMACEUTICAL FORM Oral solution.
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: bromocriptine (used in the treatment of Parkinson's disease and various hormonal disorders), danazol (used in the treatment of gynaecological disorders), or protease inhibitors (e.g. for HIV and hepatitis C such as ritonavir, indinavir, boceprevir, and telaprevir).
Croatian: Ne preporučuje se uzimati Rapamune s rifampicinom, ketokonazolom ili vorikonazolom. bilo koje lijekove protiv povišenog krvnog tlaka ili lijekove zbog srčanih tegoba uključujući nikardipin, verapamil i diltiazem. antiepileptike, uključujući karbamazepin, fenobarbital, fenitoin. lijekove za liječenje vrijeda ili drugih probavnih poremećaja, kao što su cisaprid, cimetidin, metoklopramid. bromokriptin (primjenjuje se u liječenju Parkinsonove bolesti i raznih hormonskih poremećaja), danazol (primjenjuje se u liječenju ginekoloških poremećaja) ili inhibitore proteaze (npr. za HIV i hepatitis C kao što su ritonavir, indinavir, boceprevir i telaprevir). gospinu travu (Hypericum perforatum).
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika,ili ljekarnika.
English: What you need to know before you use <product>
Croatian: Što morate znati prije nego počnete primjenjivati<lijek>
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Informacije o lijeku mogu naknadno ažurirati nadležna tijela države članice, u suradnji s referentnom državom članicom, ako je potrebno, u skladu s postupcima propisanim u 4. poglavlju glave III.
English: The use of <product> in the prevention of pneumonia is not recommended, as no data from clinical studies are available to demonstrate such effect.
Croatian: Ne preporučuje se uporaba <lijeka> u prevenciji upale pluća, s obzirom na to da nisu dostupni podatci kliničkih ispitivanja kojima bi se dokazao takav učinak.
English: [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Croatian: [Za sve lijekove u Prilogu I., postojeće informacije o lijeku izmijenit će se (umetanje, zamjena ili brisanje teksta, kako je prikladno) kako bi odgovarale dogovorenom tekstu navedenom u nastavku]
English: No data from clinical studies are available to demonstrate that the use of <product> can prevent pneumonia.
Croatian: Ne postoje dostupni podatci kliničkih ispitivanja kojima bi se dokazalo da se uporabom <lijeka> može spriječiti nastanak upale pluća.
English: Prophylaxis of recurrent upper respiratory tract infections (RTI) in <age group>.
Croatian: Profilaksa recidivirajućih infekcija gornjih dišnih puteva (engl. respiratory tract infections, RTI) u <dobna skupina>.
English: Therefore, the administration of <product> to prevent pneumonia is not recommended.
Croatian: Stoga se primjena <lijeka> u sprječavanju upale pluća ne preporučuje.
English: [With regards to the age group, minimal age should be reflected as follows: Luivac and associated names: children from 4 years of age Buccalin and associated names: children from 2 years of age For Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum and their associated names no change is needed to the minimal age currently authorised; however the age cut off should also be reflected in the indication] [Related changes should be implemented as needed throughout the PL]
Croatian: Buccalin i povezani nazivi: djeca u dobi od 2 godine Za Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum i povezane nazive, nije potrebna promjena trenutno odobrene minimalne dobi; no dobna granica jednako se tako treba reflektirati i u indikaciji] [Povezane promjene potrebno je implementirati kako je prikladno, kroz cijelu uputu o lijeku]
English: [For products authorised in the prophylaxis of unspecified recurrent RTI a warning should be added as follows and related changes should be implemented as needed throughout the PL]
Croatian: [Za lijekove odobrene za profilaksu neodređenih recidivirajućih infekcija dišnih puteva, potrebno je dodati upozorenje na sljedeći način, a povezane je promjene potrebno implementirati, kako je prikladno, kroz cijelu uputu o lijeku]
English: [With regards to the age group, minimal age should be reflected as follows: Luivac and associated names: children from 4 years of age Buccalin and associated names: children from 2 years of age For Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum and their associated names no change is needed to the minimal age currently authorised; however the age cut off should also be reflected in the indication, in line with the SmPC guideline.]
Croatian: Buccalin i povezani nazivi: djeca u dobi od 2 godine Za Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum i povezane nazive, nije potrebna promjena trenutno odobrene minimalne dobi; no dobna granica jednako se tako treba reflektirati u indikaciji, u skladu sa smjernicom o sažetku opisa svojstava lijeka.] [Povezane promjene potrebno je implementirati kako je prikladno, kroz cijeli sažetak opisa svojstava lijeka]
English: 4.1 Therapeutic indications [For all products, indications in respiratory tract conditions should be replaced by the below ones for adults and for children]
Croatian: [Za sve lijekove, indikacije za bolesti dišnih puteva potrebno je zamijeniti onima navedenim u nastavku, za odrasle i djecu]
English: Results for study 004 were similar.
Croatian: Rezultati ispitivanja 004 bili su slični.
English: After first use:
Croatian: Nakon prve uporabe:
English: Based on a 5-year duration of protection.
Croatian: Na temelju 5-godišnjeg trajanja zaštite.
English: Canada (Quebec)
Croatian: Kanada (Quebec)
English: For the most recent epidemiological information in your country you should consult with the relevant national organisation.
Croatian: Za najnovije epidemiološke informacije u Vašoj zemlji potrebno je obratiti se nadležnoj nacionalnoj organizaciji.
English: Per 100,000 person-years of observation.
Croatian: Na 100 000 osoba-godina promatranja.
English: Do not use if the content appears otherwise.
Croatian: Nemojte primijeniti cjepivo ako sadržaj izgleda drugačije.
English: • if you or your child has a severe infection with a high temperature (over 38°C).
Croatian: • ako Vi ili Vaše dijete imate tešku infekciju s visokom tjelesnom temperaturom (iznad 38°C).
English: ** p<0.005 to cover 6A where p=0.002
Croatian: ** p<0,005 koji pokriva 6A, pri čemu je p=0,002
English: For adjuvant, see section 2.
Croatian: Za adjuvans, vidjeti dio 2.
English: HIV infection
Croatian: HIV infekcija
English: UK (England & Wales)
Croatian: Ujedinjeno Kraljevstvo (Engleska i Wales)
English: Convulsions (including febrile convulsions)
Croatian: konvulzije (uključujući febrilne konvulzije)
English: The vaccine works by helping the body to make its own antibodies, which protect you or your child against these diseases.
Croatian: Cjepivo djeluje tako što pomaže tijelu da stvori vlastita protutijela, koja Vas ili Vaše dijete štite od tih bolesti.
English: Preterm infants (<37 weeks gestation)
Croatian: Prijevremeno rođena dojenčad (< 37 tjedana gestacije)
English: The study was not designed to demonstrate efficacy in subgroups, and the number of subjects ≥ 85 years of age was not sufficient to demonstrate efficacy in this age group.
Croatian: Ispitivanje nije osmišljeno kako bi se pokazala djelotvornost u podskupinama, a broj ispitanika u dobi od ≥ 85 godina nije bio dovoljan kako bi se pokazala djelotvornost u toj dobnoj skupini.
English: • You will be told when your child should come back for the next injection.
Croatian: • Reći će Vam kad trebate dovesti dijete na sljedeću injekciju.
English: In accordance with Article 114 Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Croatian: Sukladno članku 114 Direktive 2001/83/EZ, službeno puštanje serije lijeka u promet preuzet će državni laboratoriji ili laboratorij određen za tu svrhu.
English: These reactions were mostly moderate (less than or equal to 39°C) and transient.
Croatian: Ove nuspojave su bile uglavnom umjerene (manje ili jednako 39°C) i prolazne.
English: A minor infection, such as a cold, should not be a problem.
Croatian: Lakša infekcija, kao što je prehlada, ne bi trebala predstavljati problem.
English: Adults should receive one injection.
Croatian: Odrasli trebaju primiti jednu injekciju.
English: 2005 data.
Croatian: Podaci iz 2005. g.
English: Prevenar 13 is stable at temperatures up to 25°C for four days.
Croatian: Prevenar 13 je stabilan četiri dana pri temperaturi do 25C.
English: Local reactions and systemic events were solicited daily after each vaccination for 14 days in 6 studies and 7 days in the remaining study.
Croatian: Podaci o lokalnim reakcijama i sistemskim događajima prikupljali su se svakodnevno nakon svakog cijepljenja tijekom 14 dana u 6 ispitivanja i 7 dana u preostalom ispitivanju.
English: These measures will help protect the environment.
Croatian: Ove mjere pomoći će u očuvanju okoliša.
English: Individuals with the conditions described below have an increased risk of pneumococcal disease.
Croatian: Pojedinci s uvjetima opisanim u nastavku imaju povišeni rizik od pneumokokne bolesti.
English: Calculated vaccine effectiveness as of June 2008 (Broome method).
Croatian: Izračunata djelotvornost cjepiva završno s lipnjem 2008. g. (Broomeova metoda).
English: Date of first authorisation: 09 December 2009 Date of latest renewal: 18 September 2014
Croatian: Datum posljednje obnove odobrenja: 18. rujna 2014.