FrancophonIA/ELRC3.0 huggingface dataset:
English: How Myozyme is given
Croatian: Kako primjenjivati Myozyme
English: IOPD Immune Tolerance Induction
Croatian: Indukcija imunološke tolerancije kod infantilnog oblika Pompeove bolesti
English: 11 out of 15 patients had further improved head circumference-for-age percentiles (with individual patient treatment durations ranging from 90 to 130 weeks; mean follow-up period of 110 weeks).
Croatian: 111 tjedana), u 10 od 16 bolesnika došlo je daljnjeg poboljšanja percentila vrijednosti visine s obzirom na dob (trajanje liječenja pojedinih bolesnika kretalo se u rasponu od 90 do 130 tjedana, uz prosječno vrijeme praćenja od 113 tjedana), a u 11 od 15 bolesnika povećala se vrijednost percentila opsega glave s obzirom na dob (trajanje liječenja pojedinih bolesnika kretalo se u rasponu od 90 do 130 tjedana, uz prosječno vrijeme praćenja od 110 tjedana).
English: In clinical trials, 39 infantile-onset patients were treated with Myozyme for more than three years (168 weeks with a median of 121 weeks; see section 5.1).
Croatian: 3 godine (168 tjedana s medijanom od 121 tjedna; vidjeti dio 5.1).
English: The pharmacokinetics of alglucosidase alfa were also evaluated in a separate trial in 21 patients with infantile-onset Pompe disease (all aged between 6 months and 3.5 years at treatment-onset) who received doses of 20 mg/kg of alglucosidase alfa.
Croatian: 21 bolesnika s infantilnim oblikom Pompeove bolesti (svi u dobi između 6 mjeseci i 3,5 godine u trenutku početka liječenja) koji su dobivali doze od 20 mg/kg alglukozidaze alfa.
English: Mean ± s.d.
Croatian: Vistor hf.
English: Sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00
Croatian: T/A SANOFI Tel: +353 (0) 1 403 56 00
English: • Increased heart rate
Croatian: • osip • povećana brzina srčanih otkucaja
English: For single use only Read the package leaflet before use.
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: Excipients:
Croatian: NN:
English: Infantile- and Lateonset Pompe disease
Croatian: Pompeove bolesti2 Infantilni i kasni oblik Pompeove bolesti
English: Any unused product should be discarded.
Croatian: Neupotrijebljeni lijek mora se zbrinuti.
English: It is therefore recommended to perform periodic urinalysis among patients with high IgG antibody titres.
Croatian: Stoga se u bolesnika s visokim titrom IgG protutijela preporučuje povremeno provesti analizu mokraće.
English: In the second year of treatment, 15 out of 17 patients had further improved weight-for-age percentiles (with individual patient treatment durations ranging from 78 to 142 weeks; mean follow-up period of 111 weeks), 10 out of 16 patients had further improved length-for-age percentiles (with individual patient treatment durations ranging from 90 to 130 weeks; mean follow-up period of 113 weeks) and
Croatian: U drugoj je godini liječenja u 15 od 17 bolesnika došlo je daljnjeg poboljšanja percentila vrijednosti težine s obzirom na dob (trajanje liječenja pojedinih bolesnika kretalo se u rasponu od 78 do 142 tjedna, uz prosječno vrijeme praćenja od
English: • Tremor
Croatian: • umor
English: • Increased breathing rate
Croatian: • kašalj • ubrzano disanje
English: Serious adverse reactions reported in 4 patients treated with Myozyme were: angioedema, chest discomfort, throat tightness, non-cardiac chest pain and supraventricular tachycardia.
Croatian: nelagoda u prsištu, stezanje u grlu, nekardijalna bol u prsištu i supraventrikularna tahikardija.
English: • Tiredness
Croatian: • trnci
English: Respiratory distress Bronchospasm Wheezing Pharyngeal oedema Dyspnoea Tachypnoea Throat tightness Stridor
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja vrlo često tahipneja kašalj često stezanje u grlu nepoznato zastoj disanja apneja respiratorni distres bronhospazam piskanje pri disanju faringealni edem dispneja tahipneja stezanje u grlu stridor kašalj
English: Higher mean clearance, lower mean AUC∞, and lower mean Cmax were observed in 5 patients who tested positive for inhibition of cellular uptake of enzyme.
Croatian: U 5 bolesnika čiji je nalaz bio pozitivan na inhibiciju stanične pohrane enzima primijećeni su viši srednji klirens, niži srednji AUC∞ i niži srednji Cmax.
English: A tendency was observed for infantile-onset patients treated with a higher dose (40 mg/kg)
Croatian: U bolesnika s infantilnim oblikom bolesti liječenih većom dozom (40 mg/kg) uočena je sklonost razvoju viših titara IgG protutijela.
English: The risks and benefits of re-administering alglucosidase alfa following an immune-mediated reaction should be considered.
Croatian: Nakon imunološki posredovane reakcije treba razmotriti rizike i koristi ponovne primjene alglukozidaze alfa.
English: • Wheezing
Croatian: • bljedilo
English: • Diarrhoea
Croatian: • zimica
English: If you experience severe ulcerative lesions of your skin, please inform your doctor.
Croatian: Obavijestite svog liječnika ako dobijete teške ojedine na koži.
English: Outcome of a procedure under Article 29(4) of Directive 2001/83/EC
Croatian: Ishod postupka u skladu sa člankom 29. stavkom 4. Direktive 2001/83/EZ
English: The European Commission issued a decision on 28 February 2014.
Croatian: Europska komisija je usvojila odluku dana 28. veljače 2014.
English: The company wanted the authorisation of Nanotop to be recognised in Austria, Finland, France, Italy, Norway, Portugal, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Croatian: Tvrtka je zatražila da se odobrenje za Nanotop prizna u Austriji, Finskoj, Francuskoj, Italiji, Norveškoj, Portugalu, Španjolskoj, Švedskoj i Ujedinjenom Kraljevstvu („države članice učesnice u postupku“).
English: What is Nanotop?
Croatian: Što je Nanotop?
English: Why was Nanotop reviewed?
Croatian: Zašto je Nanotop pregledan?
English: The initial authorisation was based on a well-established-use application, which relied on published data with a similar product named Nanocoll.
Croatian: Prvotno se odobrenje temeljilo na dobro utvrđenoj primjeni, koja se oslanjala na objavljenim podacima za sličan proizvod naziva Nanocoll.
English: On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Nanotop.
Croatian: Dana 19. studenog 2013., Europska agencija za lijekove zaključila je arbitražni postupak nakon neslaganja država članica Europske unije (EU) u vezi s odobrenjem lijeka Nanotop.
English: It contains particles of the human protein albumin which are attached to radioactive technetium (99mTc) before use.
Croatian: Sadrži čestice ljudskog proteina albumin koji se prije primjene veže na radioaktivni tehnecij (99mTc).
English: Nanotop is a kit for the preparation of a radioactive suspension for injection.
Croatian: Nanotop je komplet za pripremu radioaktivne suspenzije za injekciju.
English: ROTOP Pharmaka AG submitted Nanotop for mutual recognition on the basis of the initial authorisation granted by the German medicines regulatory agency on 8 December 2011.
Croatian: ROTOP Pharmaka AG dostavio je lijek Nanotop na međusobno priznavanje na temelju prvotnog odobrenja izdanog od strane njemačke Regulatorne agencije za lijekove dana 8. studenog 2011.
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 26 September 2013.
Croatian: No, države članice nisu uspjele postići sporazum, te je njemačka Regulatorna agencija za lijekove uputila ovaj predmet CHMP-u na arbitražu dana 26. rujna 2013.
English: Questions and answers on Nanotop and associated names (human albumin colloidal particles, kit for radiopharmaceutical preparation) EMA/795874/2013
Croatian: Pitanja i odgovori o lijeku Nanotop i povezanim nazivima (čestice koloida za ljudski albumin, komplet za radiofarmaceutsku pripremu) EMA/795874/2013
English: Particle size is critical for the way the medicine works as it affects how well the medicine is taken up by the lymphatic system.
Croatian: Veličina čestica je kritična za način na koji lijek djeluje s obzirom da utječe na to koliko se dobro lijek apsorbira u limfnom sustavu.
English: During a scan the radioactive technetium can be detected, which help to obtain a clear image of the lymphatic system and to detect whether tumours have spread to the lymph nodes in patients with breast cancer or malignant melanoma (a type of skin cancer).
Croatian: Radioaktivni tehnecij može se otkriti tijekom skeniranja, što pomaže pri dobivanju jasne slike limfnog sustava i otkrivanju jesu li se tumori proširili do limfnih čvorova u bolesnika s rakom dojki ili malignim melanomom (tipom raka kože).
English: When injected, it passes through in the lymphatic system (a network of vessels that transport fluid from tissues through the lymph nodes and into the bloodstream).
Croatian: Prilikom ubrizgavanja prolazi kroz limfni sustav (mrežu krvnih žila koja transportira tekućinu kroz limfne čvorove i u krvotok).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Nanotop outweigh its risks, and that the marketing authorisation granted in Germany can be recognised in other Member States of the EU.
Croatian: Povjerenstvo za lijekove za uporabu u ljudi (CHMP) pri Agenciji zaključilo je da koristi lijeka Nanotop nadmašuju s njim povezane rizike, te odobrenje za stavljanje lijeka u promet izdano u Njemačkoj može biti priznato u drugim državama članicama EU.
English: The grounds for the referral were concerns raised by Sweden that Nanotop could not be considered comparable in quality to Nanocoll, particularly because of supposed differences in particle sizes between the two products.
Croatian: Razlog za postupak upućivanja jest zabrinutost Švedske da se Nanotop ne može smatrati usporedivim u kvaliteti s lijekom Nanocoll, posebice zbog navodne razlike u veličinama čestica između dva proizvoda.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that particle size and its batch variability are similar for Nanotop and Nanocoll.
Croatian: Na temelju evaluacije trenutno dostupnih podataka i znanstvenih zaključaka unutar Povjerenstva, CHMP je zaključio da su veličina čestica kao i varijabilnost serije lijeka bile slične u veličini za lijekove Nanotop i Nanocoll.
English: Nanotop is for diagnostic use.
Croatian: Nanotop je predviđen za dijagnostičku primjenu.
English: The CHMP assessed additional supportive data provided by the company comparing the particle size of Nanotop with that of Nanocoll and the variability in particle size between different batches of each medicine.
Croatian: CHMP je ocijenio dodatne potporne podatke koje je dostavilo društvo uspoređujući veličinu čestica lijeka Nanotop sa česticama lijeka Nanocoll i varijabilnošću u veličini čestica između različitih serija svakog lijeka.
English: The CHMP therefore considered that these medicines can be considered comparable in quality and that the benefits of Nanotop outweigh its risks.
Croatian: Stoga, CHMP smatra da se ovi lijekovi mogu smatrati usporedivima u kvaliteti te da koristi lijeka Nanotop nadmašuju s njim povezane rizike.
English: It recommended that Nanotop be granted marketing authorisation in the concerned Member States.
Croatian: Povjerenstvo je preporučilo da se lijeku Nanotop odobri izdavanje odobrenja za stavljanje lijeka u promet u državama članicama sudionicama u postupku.
English: Questions and answers on Nanotop and associated names (human albumin colloidal particles, kit for radiopharmaceutical preparation)
Croatian: Pitanja i odgovori o lijeku Nanotop i povezanim nazivima
English: Immediate Packaging
Croatian: Veličine pakiranja
English: MA (EU) number (Invented) name
Croatian: Broj odobrenja (Zaštićeno) ime
English: Elderly people (≥ 65 years)
Croatian: Starije osobe (≥ 65 godina)
English: Do not take Varuby more than once every two weeks.
Croatian: Nemojte uzimati Varuby češće od jednom u dva tjedna.
English: Date of first authorisation: 20 April 2017
Croatian: Datum prvog odobrenja: 20. travnja 2017.
English: They will provide appropriate treatment.
Croatian: Oni će započeti odgovarajuće liječenje.
English: Relationship between concentration and effect
Croatian: Odnos između koncentracije i učinka
English: 1114 AB Amsterdam-Duivendrecht Netherlands
Croatian: 1114 AB Amsterdam-Duivendrecht Nizozemska
English: If this happens, do not drive or use any tools or machines.
Croatian: Ako do toga dođe, nemojte upravljati vozilima niti koristiti bilo kakve alate ili strojeve.
English: This is not expected to be clinically relevant.
Croatian: Ne očekuje se da je taj učinak klinički značajan.
English: - You can take Varuby with or without food.
Croatian: - Možete uzimati Varuby s hranom ili bez nje.
English: Complete Response
Croatian: Potpuni odgovor
English: Varuby should not be taken by children and adolescents under 18 years because it has not been studied in this group.
Croatian: Djeca i adolescenti mlađi od 18 godina ne smiju uzimati Varuby jer nije ispitan u toj skupini.
English: Varuby should not be used during pregnancy unless clearly necessary.
Croatian: Varuby se ne smije koristiti tijekom trudnoće ukoliko doista nije nužno.
English: The relevance of convulsions for humans is unknown.
Croatian: Važnost pojave konvulzija za ljude nije poznata.
English: The safety and efficacy of rolapitant in children and adolescents below 18 years of age has not yet been established.
Croatian: Sigurnost i djelotvornost rolapitanta u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: The results were evaluated for each individual study and for the two studies combined.
Croatian: Rezultati su procijenjeni odvojeno za svako ispitivanje i zajedno za oba ispitivanja.
English: Study 1 and 2 Combined
Croatian: Ispitivanje 1 i 2 zajedno
English: NK1 Receptor Occupancy
Croatian: Zaposjednutost NK1 receptora
English: The most common adverse reactions were fatigue (1.9%) and headache (1.5%).
Croatian: Najčešće nuspojave bile su umor (1,9 %) i glavobolja (1,5 %).
English: - if you are allergic to rolapitant or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na rolapitant ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: 8 mg orally twice daily
Croatian: 8 mg peroralno dvaput dnevno
English: If you do not want to take this medicine, discuss this with your doctor.
Croatian: Ako ne želite uzimati ovaj lijek, razgovarajte o tome sa svojim liječnikom.
English: Recent guidance has updated these regimens to highly emetogenic.
Croatian: Nedavne smjernice uvrstile su te režime u jako emetogene.
English: Studies in animals have shown no teratogenic or embryo-foetal effects.
Croatian: Ispitivanja na životinjama nisu pokazala teratogene ili embriofetalne učinke.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, teratogenic potential, and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti, teratogenog potencijala i kancerogenog potencijala.
English: The percentage of patients who received carboplatin in Cycle 1 was 30%.
Croatian: Postotak bolesnika koji su u 1. ciklusu primili karboplatin bio je 30 %.
English: Therefore, the potential interactions associated with the inhibition of these UGT enzymes in the intestine cannot be excluded.
Croatian: Zbog toga se ne mogu isključiti moguće interakcije povezane s inhibicijom ovih UGT enzima u crijevu.
English: The tablets should be swallowed whole, with some water and may be taken with or without food.
Croatian: Tablete treba progutati cijele s nešto vode i mogu se uzeti s hranom ili bez nje.
English: Do not take this medicine in the days after you have chemotherapy - unless you are about to have another chemotherapy cycle.
Croatian: Nemojte uzimati lijek u danima nakon kemoterapije - osim ako trebate primiti još jedan ciklus kemoterapije.
English: No Significant Nausea
Croatian: Bez značajne mučnine
English: N.S. a Primary endpoint was complete response in the delayed phase.
Croatian: a Primarna mjera ishoda bila je potpuni odgovor u odgođenoj fazi.
English: The lowest effective dose of rosuvastatin is to be used.
Croatian: Treba primjenjivati najmanju djelotvornu dozu rosuvastatina.
English: They may be caused by an abnormal muscle breakdown (a condition called rhabdomyolysis).
Croatian: To može biti uzrokovano nenormalnim raspadanjem mišića (stanje koje se naziva rabdomioliza).
English: - The recommended dose is 180 mg (two 90 mg tablets).
Croatian: - Preporučena doza je 180 mg (dvije tablete od 90 mg).
English: The absolute bioavailability of rolapitant is approximately 100%, indicating minimal first pass effect.
Croatian: Apsolutna bioraspoloživost rolapitanta je približno 100 %, što upućuje na minimalan učinak prvog prolaska.
English: If you take more Varuby than you should
Croatian: Ako uzmete više lijeka Varuby nego što ste trebali
English: Wallet card, each containing 2 film-coated tablets - WITH BLUE BOX
Croatian: Ovitak u obliku novčanika, svaki sadrži 2 filmom obložene tablete - S PLAVIM OKVIROM
English: If you think you may have taken more than you should, tell your doctor straight away.
Croatian: Ako mislite da ste uzeli više nego što ste trebali, odmah se obratite liječniku.
English: OATP1B1 and 1B3 substrates
Croatian: Supstrati OATP1B1 i 1B3
English: At Day 6 to 8 following initiation of chemotherapy, patients were asked to recall whether they had any episode of vomiting or retching or nausea that interfered with normal daily life.
Croatian: Od 6. do 8. dana nakon započinjanja kemoterapije bolesnici su zamoljeni da se prisjete jesu li imali bilo kakvu epizodu povraćanja, dizanja želuca ili mučnine koja je ometala njihov normalan svakodnevni život.
English: The tablets are blue, debossed with T0101 on one side and 100 on the other side.
Croatian: Tablete su plave, s utisnutom oznakom T0101 na jednoj strani i 100 na drugoj strani.
English: There is no information on the effects of this medicine if taken during pregnancy.
Croatian: Nema dostupnih podataka o djelovanju ovog lijeka ako se uzima tijekom trudnoće.
English: No dose adjustment is necessary for the elderly.
Croatian: Nije potrebna prilagodba doze u starijih.
English: Varuby may affect how some other medicines work.
Croatian: Varuby može utjecati na djelovanje drugih lijekova.
English: Swallow the tablets whole, with some water.
Croatian: Tablete progutajte cijele s nešto vode.
English: Other medicines and Varuby
Croatian: Drugi lijekovi i Varuby
English: If you stop taking Varuby
Croatian: Ako prestanete uzimati Varuby
English: Day 2 Day 3 Day 4
Croatian: 2. dan 3. dan 4. dan
English: It is not known whether Varuby is present in milk; therefore, breast-feeding is not recommended during treatment with this medicine.
Croatian: Nije poznato je li Varuby prisutan u majčinom mlijeku, te se stoga dojenje ne preporučuje tijekom liječenja ovim lijekom.
English: Rolapitant did not affect the fertility or general reproductive performance of male rats.
Croatian: Rolapitant nije utjecao na plodnost niti na opću reproduktivnu sposobnost mužjaka štakora.
English: Contents of the pack and other information What Varuby contains
Croatian: Sadržaj pakiranja i druge informacije Što Varuby sadrži
English: Effects on offspring at this dose included decreased postnatal survival, and decreased body weights and body weight gain, and may be related to the maternal toxicity observed.
Croatian: Utjecaj na potomke pri ovoj dozi uključivao je smanjeno postnatalno preživljenje, smanjenu tjelesnu težinu i prirast tjelesne težine, a može biti povezan s uočenom maternalnom toksičnošću.
English: Individual results from Studies 1 and 2 as well as a summary of the key results from the combined analysis are shown in Table 1 below.
Croatian: Rezultati iz Ispitivanja 1 i 2 odvojeno, kao i sažetak ključnih rezultata kombinirane analize prikazani su niže u Tablici 1.
English: Complete Response Rolapitant
Croatian: Potpuni odgovor Rolapitant
English: The exposure ratio of M19 to rolapitant was approximately 50% in plasma.
Croatian: Omjer izloženosti M19 prema rolapitantu bio je približno 50 % u plazmi.
English: Rolapitant is slowly eliminated with a mean terminal half-life of approximately 7 days.
Croatian: Rolapitant se sporo eliminira sa srednjom vrijednošću terminalnog poluvijeka od približno 7 dana.
English: Varuby is given as part of a regimen that includes dexamethasone and a 5-HT3 receptor antagonist.
Croatian: Varuby se daje kao dio režima koji uključuje deksametazon i antagonist 5-HT3 receptora.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, other antiemetics, ATC code: A04AD14
Croatian: Farmakoterapijska skupina: antiemetici i pripravci za suzbijanje mučnine, ostali antiemetici, ATK oznaka: A04AD14
English: - Take the tablets within 2 hours before you start your chemotherapy cycle.
Croatian: - Tablete uzmite unutar 2 sata prije početka ciklusa kemoterapije.
English: Dialysis studies have not been performed.
Croatian: Ispitivanja primjene dijalize nisu provedena.
English: Of the 1070 patients, 26% were greater than 65 years of age and 3% were greater than 75 years of age.
Croatian: Od 1070 bolesnika, 26 % bilo je starije od 65 godina, a 3 % starije od 75 godina.
English: What Varuby looks like and contents of the pack
Croatian: Kako Varuby izgleda i sadržaj pakiranja
English: If the combination cannot be avoided, clinical and biological monitoring for adverse reactions related to the concomitant medicinal product must be made.
Croatian: Ako se kombinacija ne može izbjeći, mora se provoditi kliničko i biološko praćenje zbog mogućih nuspojava povezanih s konkomitantnim lijekom.
English: The usual dose is two tablets.
Croatian: Uobičajena doza je dvije tablete.
English: Of these 1332 patients, 629 received non-AC chemotherapy.
Croatian: Također, od ta 1332 bolesnika, 629 ih je primilo drugu kemoterapiju (ne AC).
English: Of these 1332 patients, 28% were greater than 65 years of age and 6% were greater than 75 years of age.
Croatian: Od ta 1332 bolesnika, 28 % bilo je starije od 65 godina, a 6 % starije od 75 godina.
English: Antiemetic activity of rolapitant was maintained throughout repeat cycles for those patients continuing in each of the multiple cycles.
Croatian: Antiemetičko djelovanje rolapitanta održalo se kroz ponovljene cikluse u onih bolesnika koji su nastavili sudjelovati tijekom svakog dodatnog ciklusa.
English: There is no medicinal product interaction between rolapitant and dexamethasone, so no dosage adjustment for dexamethasone is required.
Croatian: Nema interakcije lijekova između rolapitanta i deksametazona tako da nije potrebna prilagodba doze deksametazona.
English: Because of the antiemetic activity of rolapitant, emesis induced by a medicinal product may not be effective.
Croatian: Zbog antiemetskog djelovanja rolapitanta, izazivanje povraćanja lijekovima možda neće biti djelotvorno.
English: Concomitant administration of rifampicin, a strong enzyme inducer significantly decreased the systemic exposure to rolapitant and to its active metabolite.
Croatian: Istodobna primjena rifampicina, jakog induktora enzima, značajno je smanjila sistemsku izloženost rolapitantu i njegovom aktivnom metabolitu.
English: Based on the environmental risk assessment, rolapitant is considered as very persistent, bioaccumulative and not readily biodegradable.
Croatian: Na temelju procjene rizika za okoliš rolapitant se smatra vrlo postojanim, bioakumulativnim i teško biorazgradivim.
English: If you have forgotten to take your dose, tell your doctor straight away.
Croatian: Ako ste zaboravili uzeti dozu, odmah se obratite liječniku.
English: Each dose (two tablets) contains 230 mg of lactose.
Croatian: Jedna doza (dvije tablete) sadrži 230 mg laktoze.
English: If use cannot be avoided, patients should be monitored for adverse reactions to Varuby (see section 4.8).
Croatian: Ako se primjena ne može izbjeći, bolesnike treba nadzirati zbog nuspojava na Varuby (vidjeti dio 4.8).