FrancophonIA/ELRC3.0 huggingface dataset:
English: A sixth study in over 2,000 children first vaccinated between 6 and 12 weeks of age showed that Nimenrix (given as 2 doses 2 months apart) was as effective as two other vaccines against N. meningitidis in stimulating an immune response.
Croatian: Šesto ispitivanje kojim je bilo obuhvaćeno više od 2 000 djece koja su prvo cjepivo primila u dobi između 6 i 12 tjedana pokazalo je da je cjepivo Nimenrix (primijenjeno u dvije doze s razmakom od dva mjeseca) bilo jednako učinkovito kao druga dva cjepiva protiv bakterije N. meningitidis u pogledu stimulacije imunosnog odgovora.
English: For children between 6 months and one year of age, the available data allowed to conclude that a single dose of Nimenrix was sufficient to stimulate an immune response against N. meningitidis.
Croatian: Za djecu u dobi od šest tjedana do godine dana, dostupni podatci upućuju na zaključak da je jedna doza cjepiva Nimenrix dostatna za stimulaciju imunosnog odgovora protiv bakterije N. meningitidis.
English: The European Medicines Agency considered that Nimenrix had been shown to be at least as effective as comparable vaccines at stimulating an immune response to the four groups of the N. meningitidis bacterium in people of different age groups.
Croatian: Europska agencija za lijekove smatrala je da se cjepivo Nimenrix pokazalo barem jednako učinkovitim kao usporediva cjepiva u pogledu stimulacije imunosnog odgovora na četiri grupe bakterije N. meningitidis u osoba različitih dobnih skupina.
English: Results showed that a single injection of Nimenrix was as effective as the other vaccines in stimulating an immune response against all four types of N. meningitidis polysaccharides.
Croatian: Rezultati su pokazali da je jedna injekcija cjepiva Nimenrix jednako učinkovita kao i ostala cjepiva u pogledu stimulacije imunosnog odgovora protiv sva četiri tipa polisaharida iz bakterije N. meningitidis.
English: Side effects after booster vaccination with Nimenrix are generally similar to those after initial vaccination, but diarrhoea, vomiting and nausea are also very common.
Croatian: Nimenrix uglavnom su slične onima nakon prvog cijepljenja, no proljev, povraćanje i mučnina također su vrlo česti.
English: What benefits of Nimenrix have been shown in studies?
Croatian: Koje su koristi od cjepiva Nimenrix utvrđene u ispitivanjima?
English: Studies also showed that, in people vaccinated with Nimenrix or another meningococcal vaccine when they were 1 year of age or older, Nimenrix given as a booster several years after they had been vaccinated increased the level of antibodies.
Croatian: Ispitivanja su također pokazala da je u osoba koje su primile cjepivo Nimenrix ili neko drugo meningokokno cjepivo u dobi od godinu dana ili kasnije, docjepljivanje cjepivom Nimenrix nekoliko godina kasnije povećalo razinu protutijela.
English: How does Nimenrix work?
Croatian: Kako djeluje Nimenrix?
English: Children from 6 months of age, adolescents and adults should be given one dose of Nimenrix, but an additional dose may be considered for some children at high risk of invasive meningococcal disease (at least 2 months after the last dose of Nimenrix).
Croatian: Djeca starija od šest mjeseci, adolescenti i odrasli trebaju primiti jednu dozu cjepiva Nimenrix, ali u djece u koje postoji visok rizik od invazivne meningokokne bolesti može se razmotriti i dodatna doza (najmanje dva mjeseca nakon prethodne doze cjepiva Nimenrix).
English: Children who received the initial dose (or doses) of Nimenrix between 6 weeks and one year of age should receive a booster dose at 1 year of age, at least 2 months after the last dose of Nimenrix.
Croatian: Djeca koja su primila početnu dozu (ili početne doze) cjepiva Nimenrix u dobi između šest tjedana i godinu dana trebaju primiti dozu docjepljivanja u dobi od godinu dana, najmanje dva mjeseca nakon prethodne doze cjepiva Nimenrix.
English: In infants from 6 weeks to less than 6 months of age, two doses of Nimenrix are recommended (the first dose is given from 6 weeks of age, the second dose 2 months afterwards).
Croatian: U dojenčadi starije od šest tjedana i mlađe od šest mjeseci preporučuju se dvije doze cjepiva Nimenrix (prva se doza daje u dobi od šest tjedana ili kasnije, a druga doza dva mjeseca nakon toga).
English: For the full list of side effects and restrictions of Nimenrix, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s cjepivom Nimenrix potražite u uputi o lijeku.
English: Nimenrix contains small amounts of capsular polysaccharides (sugars from the outer coat) extracted from the four groups of the N. meningitidis bacterium: A, C, W135 and Y. These have been purified and then ‘conjugated' (attached) to a protein carrier called tetanus toxoid (a weakened toxin of tetanus which does not cause disease, also used in tetanus vaccine), because this improves the immune response to the vaccine.
Croatian: Oni su pročišćeni i potom „konjugirani” (vezani) na proteinski nosač naziva tetanusni toksoid (oslabljeni toksin tetanusa koji ne uzrokuje bolest, koristi se i u cjepivu protiv tetanusa) jer se na taj način poboljšava imunosni odgovor na cjepivo.
English: Nimenrix was compared with several other similar vaccines against N. meningitidis.
Croatian: Cjepivo Nimenrix uspoređeno je s nekoliko sličnih cjepiva protiv bakterijeN. meningitidis.
English: How is Nimenrix used?
Croatian: Kako se Nimenrix primjenjuje?
English: Nimenrix is a vaccine used to protect adults, adolescents and children from the age of 6 weeks against invasive meningococcal disease caused by four groups of the bacterium Neisseria meningitidis (group A, C, W-135, and Y).
Croatian: Nimenrix je cjepivo koje se koristi za zaštitu odraslih osoba, adolescenata i djece nakon navršenih 6 tjedana od invazivne meningokokne bolesti uzrokovane četirima grupama bakterije
English: Strength Pharmaceutical form
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik
English: You will need:
Croatian: Trebat će Vam:
English: Take them at the same time every day.
Croatian: Uzimajte ih svakoga dana u isto vrijeme.
English: Combination should be avoided.
Croatian: Kombinaciju je potrebno izbjegavati.
English: Wash and dry your hands.
Croatian: Operite i osušite ruke.
English: You can take them either with or without food, but you need to do this in the same way each day.
Croatian: Možete ih uzimati uz obrok ili bez njega, ali to morate činiti na isti način svaki dan.
English: if you have an infection.
Croatian: ako imate infekciju.
English: Urgent treatment may be necessary.
Croatian: Može biti potrebno hitno liječenje.
English: Do not swallow them whole.
Croatian: Nemojte ih gutati cijele.
English: Do not use juice or any other liquids.
Croatian: Nemojte koristiti sok ili druge tekućine.
English: No change Increase
Croatian: Bez promjene Porast
English: Reported experience with overdose in humans is very limited.
Croatian: Prijavljeno iskustvo s predoziranjem u ljudi je vrlo ograničeno.
English: Diltiazem Dronedarone
Croatian: Diltiazem Dronedaron
English: Adding water
Croatian: Dodavanje vode
English: Using a small glass
Croatian: Uporaba male čaše
English: How to prepare and take the oral suspension
Croatian: Kako pripremiti i uzeti oralnu suspenziju
English: Food effect
Croatian: Učinak hrane
English: Discontinue treatment if failure to recover within 4 weeks.
Croatian: Prekinuti liječenje ako nema oporavka u roku od 4 tjedna.
English: They may differ from the general information contained in this leaflet.
Croatian: One se mogu razlikovati od općenitih informacija sadržanih u ovoj Uputi.
English: Follow all the doctor's instructions carefully.
Croatian: Pažljivo slijedite upute svog liječnika.
English: Tell your doctor if you are pregnant or think that you may be pregnant.
Croatian: Obavijestite svog liječnika ako ste trudni ili mislite da biste mogli biti trudni.
English: Stomatitis mostly occurs within the first 8 weeks of treatment.
Croatian: Stomatitis se većinom javlja unutar prvih 8 tjedana liječenja.
English: Exact 95% CI obtained using Clopper-Pearson method b
Croatian: Točan 95% CI dobiven pomoću Clopper-Pearsonove metode b
English: The median duration of the double-blind period was 18 weeks.
Croatian: Medijan trajanja dvostruko slijepog razdoblja bio je 18 tjedana.
English: Laboratory tests and monitoring
Croatian: Laboratorijski testovi i praćenje
English: If you take more Votubia than you should
Croatian: Ako uzmete više Votubie nego što ste trebali
English: if you have had recent major surgery, or if you still have an unhealed wound following surgery.
Croatian: ako ste nedavno imali veći kirurški zahvat, ili ako imate nezacijeljenu ranu nakon kirurškog zahvata.
English: What Votubia is and what it is used for
Croatian: Što je Votubia i za što se koristi
English: STOP taking Votubia and seek medical help immediately if you or your child experiences any of the following signs of an allergic reaction:
Croatian: PRESTANITE uzimati Votubiu i odmah potražite liječničku pomoć ako Vi ili Vaše dijete osjetite bilo koji od sljedećih znakova alergijske rekacije:
English: Nonclinical studies in rats indicate:
Croatian: Neklinička ispitivanja na štakorima ukazuju:
English: The grades follow CTCAE Version 3.0 and 4.03.
Croatian: Stupnjevi slijede CTCAE Verziju 3.0 i 4.03.
English: • 1 small glass (maximum size 100 ml)
Croatian: • 1 mala čaša (maksimalne veličine 100 ml)
English: Increased exposure expected (the effect varies widely).
Croatian: Očekuje se povećana izloženost (učinak znatno varira).
English: Partial seizures start by only affecting one side of the brain but can spread and extend to larger areas on both sides of the brain (called a “secondary generalisation”).
Croatian: Parcijalni napadaji započinju samo zahvaćanjem jedne strane mozga, ali se mogu proširiti i zahvatiti veća područja na obje strane mozga (pod nazivom „sekundarna generalizacija“).
English: No efficacy data available in elderly patients
Croatian: Nema podataka o djelotvornosti u starijih bolesnika
English: Further clinical benefit, such as improvement in disease-related symptoms, has not been demonstrated.
Croatian: Dodatna klinička korist, poput poboljšanja simptoma povezanih s bolešću, nije dokazana.
English: Relative bioavailability/bioequivalence
Croatian: Relativna bioraspoloživost/bioekvivalencija
English: Other non-haematological toxicities (excluding metabolic events)
Croatian: Druge nehematološke toksičnosti (isključujući metaboličke događaje)
English: There are currently not sufficient data to allow dosing recommendations in this situation.
Croatian: Za sada nema dovoljno podataka iz kojih bi se moglo preporučiti doziranje u ovoj situaciji.
English: Male patients should not be prohibited from attempting to father children.
Croatian: Bolesnicima muškoga spola ne treba zabraniti da pokušaju postati očevi.
English: if you have diabetes (high level of sugar in your blood).
Croatian: ako imate šećernu bolest (visoke razine šećera u krvi).
English: A complete and illustrated set of instructions for use is provided at the end of the package leaflet “Instructions for use”.
Croatian: Potpuni i ilustrirani skup uputa za uporabu nalazi se na kraju upute o lijeku „Upute za uporabu“.
English: Family-wise error rate of 2.5% one-sided
Croatian: I (engl. family-wise error rate) od 2,5% jednostrano
English: Store them in a dry and clean place until next time.
Croatian: Spremite ih na suho i čisto mjesto do sljedeće uporabe.
English: Votubia could harm an unborn baby and is not recommended during pregnancy.
Croatian: Votubia može naštetiti nerođenom djetetu te se ne preporučuje tijekom trudnoće.
English: 25 ml of water
Croatian: 25 ml vode
English: Efavirenz, nevirapine
Croatian: Efavirenz, nevirapin
English: These metabolites were also identified in animal species used in toxicity studies, and showed approximately 100 times less activity than everolimus itself.
Croatian: Ovi metaboliti nađeni su i u životinjskih vrsta korištenih u ispitivanjima toksičnosti, a pokazali su se približno 100 puta manje aktivnima od samoga everolimusa.
English: Frequency based upon number of women from 10 to 55 years of age while on treatment in the pooled data
Croatian: Učestalost temeljena na broju žena od 10 do 55 godina tijekom liječenja u objedinjenim podacima
English: Concomitant ketogenic diet
Croatian: Istodobna ketogena dijeta
English: How to take this medicine
Croatian: Kako uzimati ovaj lijek
English: Non-infectious pneumonitis
Croatian: Neinfektivni pneumonitis
English: The amount of water added does not need to be exact.
Croatian: Količina vode ne mora biti precizno izmjerena.
English: No signs of acute toxicity have been reported in these cases.
Croatian: U ovim slučajevima nisu prijavljeni nikakvi znaci akutne toksičnosti.
English: Other medicines and Votubia
Croatian: Drugi lijekovi i Votubia
English: Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Croatian: Liječenje treba nastaviti dok god se uočava klinička korist ili do pojave neprihvatljive toksičnosti.
English: If necessary, drink additional water to wash out any residues in your mouth.
Croatian: Po potrebi popijte još vode kako biste iz usne šupljine isprali ostatke lijeka.
English: Clinical study results did not show an impact of Votubia on growth and pubertal development.
Croatian: Rezultati kliničkih ispitivanja nisu pokazali utjecaj Votubie na rast i pubertetski razvoj.
English: Proportion of patients (%)
Croatian: Udio bolesnika (%)
English: This was manifested as mortality and reduced foetal weight.
Croatian: Ovo se očitovalo smrtnošću i smanjenjem težine ploda.
English: Reduction in seizure frequency was sustained over an evaluation period of approximately 2 years.
Croatian: Smanjenje učestalosti napadaja održalo se tijekom razdoblja ocjenjivanja od otprilike 2 godine.
English: Talk to your doctor before taking Votubia: if you have any problems with your liver or if you have ever had any disease which may have affected your liver.
Croatian: Obratite se svom liječniku prije nego uzmete Votubiu: ako imate bilo kakvih problema s jetrom ili ako ste ikada imali neku bolest kojom je mogla biti zahvaćena jetra.
English: Please read the detailed instructions at the end of this leaflet to find out how to do this.
Croatian: Molimo pročitajte detaljne upute o primjeni lijeka na kraju ove upute da biste saznali kako to učiniti.
English: Statistic
Croatian: Statistički
English: Pale stools or dark urine may also be signs of hepatitis.
Croatian: Blijeda stolica ili tamna mokraća također mogu biti znakovi hepatitisa.
English: Single doses of up to 70 mg have been given with acceptable acute tolerability in the adult population.
Croatian: Jednokratne doze do 70 mg su davane uz prihvatljivu akutnu podnošljivost u odrasloj populaciji.
English: Care should be taken to ensure the entire dose is ingested.
Croatian: Potrebno je pobrinuti se da se uzme cijela doza.
English: Re-initiate Votubia at same dose.
Croatian: Ponovno započeti primjenu Votubie u istoj dozi.
English: Most of the side effects are mild to moderate and will generally disappear if your treatment is interrupted for a few days.
Croatian: Većina nuspojava su blage do umjerene te će općenito nestati ako se Vaše liječenje prekine na par dana.
English: Final analysis
Croatian: Završna analiza
English: Primary analysis
Croatian: Primarna analiza
English: Date of first authorisation: 02 September 2011 Date of latest renewal: 28 July 2015
Croatian: Datum posljednje obnove odobrenja: 28. srpnja 2015.
English: Mean (standard deviation) Median
Croatian: Srednja vrijednost (standardno odstupanje) Medijan
English: Some cases were severe and on rare occasions, a fatal outcome was observed.
Croatian: Neki su slučajevi bili teški i rijetko doveli do smrtnog ishoda.
English: However, the exact mechanism of action in the reduction of seizures associated with TSC is not fully elucidated.
Croatian: Međutim, točni mehanizam djelovanja u smanjenju napadaja povezanih s KTS-om nije potpuno razjašnjen.
English: • Approximately 50 ml of water to prepare the suspension
Croatian: • Otprilike 50 ml vode za pripremu suspenzije
English: Large increase in everolimus concentration is expected.
Croatian: Očekuje se veliko povećanje koncentracije everolimusa.
English: It is reported, however, that CYP3A4 activity is reduced at birth and increases during the first year of life, which could affect the clearance in this patient population.
Croatian: Zabilježeno je, međutim, da je CYP3A4 aktivnost smanjena pri rođenju te da raste tijekom prve godine života, što može utjecati na klirens u toj populaciji bolesnika.
English: Hands should be washed thoroughly before and after preparation of the suspension.
Croatian: Ruke treba temeljito oprati prije i nakon pripreme suspenzije.
English: A higher or lower dose may be recommended by your doctor based on your individual treatment needs, for example if you have problems with your liver or if you are taking certain other medicines in addition to Votubia.
Croatian: Liječnik će Vam možda preporučiti višu ili nižu dozu na temelju Vaših individualnih potreba u liječenju, primjerice ako imate problema s jetrom ili ako uzimate određene druge lijekove uz Votubiu.
English: Three minutes must be allowed for suspension to occur.
Croatian: Pričekati tri minute za suspendiranje.
English: Votubia contains lactose (milk sugar).
Croatian: Votubia sadrži laktozu (mliječni šećer).
English: Haematological parameters
Croatian: Hematološki parametri
English: Fill a small glass with water (drinkable tap water or non-sparkling bottled water).
Croatian: Napunite malu čašu vodom (vodom za piće iz slavine ili negaziranom buteljiranom vodom).
English: For dose reductions below the lowest available strength, alternate day dosing should be considered.
Croatian: Za smanjenja doze niža od najniže dostupne jačine, potrebno je razmotriti alternativno dnevno doziranje.
English: There are no clinical data on the distribution of everolimus in the human brain.
Croatian: Nema kliničkih podataka o distribuciji everolimusa u ljudskom mozgu.
English: Note: The amount of water in the oral syringe does not need to be exact but all the tablets should be covered.
Croatian: Napomena: Količina vode u štrcaljki za usta ne mora biti precizno određena, ali treba prekriti sve tablete koje se nalaze u štrcaljki.
English: SEGA volume (cm
Croatian: SEGA volumen (cm3)
English: Active substance by interaction
Croatian: Djelatna tvar po interakciji
English: Votubia is not recommended for use in patients:
Croatian: Votubia se ne preporučuje za primjenu u bolesnika:
English: Statistically significant per Bonferroni-Holm procedure d
Croatian: Statistički značajno prema BonferroniHolmovom postupku d
English: No change >-25 to <25
Croatian: Bez promjene >-25 do <25
English: High level of an enzyme called blood lactate dehydrogenase that gives information about the health of certain organs
Croatian: Visoka razina enzima u krvi koji se naziva laktat dehidrogenaza i koji pruža informaciju o zdravlju određenih organa
English: ≤5 ng/ml >5 ng/ml Difference Difference is “≤5 ng/ml” minus “>5 ng/ml”
Croatian: ≤5 ng/ml >5 ng/ml Razlika Razlika je „≤5 ng/ml” minus „>5 ng/ml”
English: Reactivation of infection is an expected reaction during periods of immunosuppression.
Croatian: Reaktivacija infekcije je očekivani događaj tijekom razdoblja imunosupresije.
English: Tell your doctor immediately if you experience these symptoms.
Croatian: Odmah obavijestite svog liječnika ako primjetite navedene simptome.
English: However, there are no clinical data with this dose adjustment.
Croatian: Međutim, ne postoje klinički podaci uz tu prilagodbu doze.
English: Patients should be advised to report promptly any new or worsening respiratory symptoms.
Croatian: Bolesnike se mora savjetovati da odmah prijave nove respiratorne simptome ili pogoršanje postojećih simptoma.
English: No patient required surgical intervention for SEGA during the entire course of the study.
Croatian: Nijedan bolesnik nije trebao kiruršku intervenciju zbog SEGA-e tijekom cjelokupnog trajanja ovog ispitivanja.
English: Patients were treated with concomitant and stable dose of 1 to 3 antiepileptics prior to study entry.
Croatian: Bolesnici su bili liječeni istodobnom i stabilnom dozom 1 do 3 antiepileptika prije uključivanja u ispitivanje.
English: Long-term monitoring
Croatian: Dugoročno praćenje
English: Votubia tablets are to be swallowed whole with a glass of water.
Croatian: Votubia tablete moraju se progutati cijele sa čašom vode.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • priikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: What Votubia is and what it is used for What you need to know before you take Votubia How to take Votubia
Croatian: Što je Votubia i za što se koristi Što morate znati prije nego počnete uzimati Votubiu Kako uzimati Votubiu
English: Refill the glass with the same amount of water (approximately 30 ml), gently stir the remaining content and drink the whole amount to make sure that you get the full dose of Votubia tablets.
Croatian: Čašu iznova napunite istom količinom vode (približno 30 ml), lagano izmiješajte ostatke sadržaja i popijte cijelu količinu, kako biste bili sigurni da ste uzeli punu dozu Votubia tableta.
English: The pharmacokinetics of everolimus have not been studied in patients younger than 1 year of age.
Croatian: Farmakokinetika everolimusa nije ispitivana u bolesnika mlađih od 1 godine.
English: Gently stir the contents of the glass with a spoon and then proceed immediately to step 8.
Croatian: Nježno žlicom promiješajte sadržaj čaše i zatim odmah nastavite s korakom 8.
English: Management of severe and/or intolerable suspected adverse reactions may require dose reduction and/or temporary interruption of Votubia therapy.
Croatian: Zbrinjavanje teških i/ili nepodnošljivih suspektnih nuspojava moglo bi zahtijevati smanjenje doze i/ili privremeni prekid terapije Votubiom.
English: The same pharmaceutical form must be used consistently, as appropriate for the indication being treated.
Croatian: Isti farmaceutski oblik mora se dosljedno uzimati, kako je primjereno indikaciji za koju se primjenjuje.
English: Non-responders - n (%)
Croatian: Osobe bez odgovora - n (%)
English: However products containing alcohol, hydrogen peroxide, iodine and thyme derivatives should be avoided as they may exacerbate the condition.
Croatian: Međutim, proizvodi koji sadrže alkohol, vodikov peroksid, jod i derivate majčine dušice moraju se izbjegavati, jer mogu dovesti do pogoršanja stanja.
English: If you have fever or other signs of an infection, consult with your doctor.
Croatian: Dobijete li vrućicu ili druge znakove infekcije, posavjetujte se sa svojim liječnikom.
English: Ask your doctor or pharmacist if you are not sure.
Croatian: Upitajte svog liječnika ili ljekarnika ako niste sigurni.
English: Manufacturer Novartis Pharma GmbH Roonstrasse 25
Croatian: Novartis Pharma GmbH Roonstrasse 25
English: Only water should be used as the vehicle.
Croatian: Kao disperzno sredstvo se treba koristiti samo voda.
English: Due to between subject variability the recommended dose adjustments may not be optimal in all individuals, therefore close monitoring of side effects is recommended.
Croatian: Zbog varijabilnosti između ispitanika preporučene prilagodbe doze možda nisu optimalne u svih pojedinaca, stoga se preporučuje pažljivo praćenje nuspojava.
English: Two primary regulators of mTORC1 signalling are the oncogene suppressors tuberin-sclerosis complexes 1 & 2 (TSC1, TSC2).
Croatian: Dva glavna regulatora signalnih putova mTORC1 su onkogeni supresori kompleksi tuberozne skleroze 1 & 2 (TSC1, TSC2).
English: Read and follow these instructions carefully so that you know how to correctly prepare the medicine.
Croatian: Pažljivo pročitajte i slijedite ove upute da biste znali pravilno pripremiti lijek za uporabu.