FrancophonIA/ELRC3.0 huggingface dataset:
English: • gastrointestinal bleeding, inflammation of the colon, inflammation of the gullet, inflammation of the anus, mouth ulcer
Croatian: • gastrointestinalno krvarenje, upala debelog crijeva, upala jednjaka, upala anusa, afte u ustima
English: • Thiotepa (intensified regimen5 mg/kg twice a day), given as two intravenous infusions over 2
Croatian: • Tiotepa (intenzivni režim 5 mg/kg dvaput na dan) daje se kao dvije intravenske infuzije tijekom2 - 4 sata na -2. dan prije infuzije matičnih stanica (0. dan).
English: Conjunctival haemorrhage, dry eye
Croatian: Nepoznato hemoragija konjunktive, suho oko
English: Dysphagia, diarrhoea, vomiting, abdominal pain
Croatian: proljev, mučnina, povraćanje, bol u trbuhu (abdomenu)
English: • Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -6, -5, -4, -3, -2) before stem cell infusion (day 0).
Croatian: • Fludarabin 30 mg/m² tjelesne površine po danu kao polusatna intravenska infuzija daje se tijekom pet uzastopnih dana (-6., -5., -4., -3., -2. dan) prije infuzije matičnih stanica (0. dan).
English: Vascular disorders Common Hypertension, flushing
Croatian: Krvožilni poremećaji Često hipertenzija, navale crvenila
English: * See detailed sections below a Case reports (> 1) after treosulfan-based conditioning obtained from other sources b Bronze pigmentation c Fever in the absence of neutropenia where neutropenia is defined as ANC < 1.0 x 109/L
Croatian: c Vrućica u odsutnosti neutropenije, pri čemu je neutropenija definirana kao ABN < 1,0 x 10
English: NAME OF THE MEDICINAL PRODUCT Trecondi 1 g powder for solution for infusion Trecondi 5 g powder for solution for infusion
Croatian: Trecondi 1 g prašak za otopinu za infuziju Trecondi 5 g prašak za otopinu za infuziju
English: * See detailed sections below a Clinically or microbiologically documented infection with grade 3 or 4 neutropenia (absolute neutrophil count [ANC] < 1.0 x 109/L) and sepsis b Acidosis might be a consequence of the release of methanesulfonic acid through treosulfan activation/cleavage in the plasma c Case reports (> 2) after treosulfan-based conditioning obtained from other sources d Bronze pigmentation e Fever in the absence of neutropenia where neutropenia is defined as ANC < 1.0 x 109/L
Croatian: a Klinički ili mikrobiološki dokumentirana infekcija s neutropenijom III. ili IV. stupnja (apsolutni broj neutrofila [ABN] < 1,0 x 10
English: Vomiting, oral pain, dysphagia, mouth haemorrhage, oesophageal or gastrointestinal pain
Croatian: Često oralni bol, gastritis, dispepsija, konstipacija, disfagija Manje često krvarenje u ustima, distenzija abdomena, ezofagealni ili gastrointestinalni bol, suha usta
English: • Treosulfan 10-14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, -4) before stem cell infusion (day 0).
Croatian: • Treosulfan 10 - 14 g/m² tjelesne površine po danu kao dvosatna intravenska infuzija daje se tijekom tri uzastopna dana (-6., -5., -4. dan) prije infuzije matičnih stanica (0. dan).
English: • Treosulfan 14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, -4) before stem cell infusion (day 0).
Croatian: • Treosulfan 14 g/m² tjelesne površine po danu kao dvosatna intravenska infuzija daje se tijekom tri uzastopna dana (-6., -5., -4. dan) prije infuzije matičnih stanica (0. dan).
English: Common Dyspnoea, epistaxis
Croatian: Često dispneja, epistaksa
English: Common Oedema, pyrexiae, chills
Croatian: Često edem, pireksijae, zimica
English: • chest pain, pain
Croatian: • bol u prsnom košu, bol
English: • restlessness
Croatian: • nemir
English: Uncommon Hyperglycaemia
Croatian: Manje često hiperglikemija
English: Maculo-papular rash, purpura, erythema
Croatian: Manje često makulopapularni osip, purpura,
English: Elderly
Croatian: eritem
English: Dyspnoea, pleural effusion, pharyngeal or laryngeal inflammation
Croatian: Manje često dispneja, pleuralni izljev, upala farinksa ili larinksa
English: The lowest frequency of cardiac disorders was seen with the dose regimen of 10 g/m²/day, day -4 to -2 (2.7%).
Croatian: Najniža učestalost srčanih poremećaja opažena je pri režimu doziranja od 10 g/m²
English: Renal and urinary disorders Not known Acute kidney injury, renal failure, noninfective cystitis
Croatian: Nepoznato akutno oštećenje bubrega, zatajenje bubrega, neinfektivni cistitis
English: Posology
Croatian: Događaji
English: Very common Pyrexiac
Croatian: Vrlo često pireksijac
English: • inflammation of the lining of various parts of the body, especially in the mouth (which can cause ulcers), diarrhoea, nausea, vomiting, belly (abdominal) pain
Croatian: • upala sluznica u različitim dijelovima tijela, posebice u ustima (što može prouzročiti ranice),
English: All Adverse Reactions / Frequency
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: Dermatitis exfoliative, maculo-papular rash, erythema
Croatian: Često eksfolijativni dermatitis, makulopapularni osip, eritem
English: Uncommon Haematoma, hypotension
Croatian: Manje često hematom, hipotenzija
English: Hepatic failure, hepatomegaly, hepatic pain
Croatian: Nepoznato zatajenje jetre, hepatomegalija, bol u jetri
English: • difficulty in swallowing, mouth pain
Croatian: • otežano gutanje, bol u ustima
English: 16 March 2019
Croatian: 16. ožujka 2019.
English: 15 May 2019
Croatian: 15. svibnja 2019.
English: Adoption of CMDh position:
Croatian: Usvajanje stajališta CMDh-a:
English: The CMDh agrees with the scientific conclusions made by the PRAC.
Croatian: CMDh je suglasan sa znanstvenim zaključcima koje je donio PRAC.
English: The study shall be conducted in more than one Member State and the protocol shall be submitted to the PRAC within 3 months of the commission decision for this procedure.
Croatian: Ispitivanje se mora provesti u više od jedne države članice, a plan ispitivanja mora biti dostavljen PRAC-u u roku od tri mjeseca od odluke Europske komisije u pogledu ovog postupka.
English: Timetable for the implementation of the position
Croatian: Raspored provedbe ovog stajališta
English: January 2019 CMDh meeting
Croatian: Sastanak CMDh-a u siječnju 2019.
English: The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through)
Croatian: Nositelj(i) odobrenja za stavljanje lijeka u promet uklonit će sljedeći(e) uvjet(e) (novi tekst je podcrtan i podebljan, obrisani tekst je precrtan):
English: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder):
Croatian: Provedba stajališta u državama članicama (nositelj odobrenja za stavljanje lijeka u promet predaje izmjenu):
English: The Marketing Authorisation Holders shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to monitor off-label use.
Croatian: Nositelji odobrenja za stavljanje lijeka u promet moraju provesti ispitivanje potrošnje lijeka u svrhu ocjene djelotvornosti mjera minimizacije rizika te radi praćenja primjene lijeka izvan odobrene indikacije.
English: The joint database drug utilisation final study report submitted by the MAHs, together with the joint PASS (physician survey) final study report submitted by the MAHs as a separate procedure (EMEA/H/N/PSR/J/0010), comply with their obligation to conduct a drug utilisation study to assess the effectiveness of the risk minimisation measures and to monitor the off-label use of the drug as imposed during the referral under Article 31 of Directive 2001/83/EC for domperidone containing products.
Croatian: Završno izvješće ispitivanja potrošnje lijeka (engl. drug utilisation study) koje je provedeno na temelju zajedničke baze podataka i koje su podnijeli nositelji odobrenja za stavljanje lijeka u promet te završno izvješće ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet (PASS), (provedeno anketom u liječnika), koje su nositelji odobrenja podnijeli u zasebnom postupku (EMEA/H/N/PSR/J/0010) ispunjavaju njihovu obavezu provedbe ispitivanja potrošnje lijeka u svrhu ocjene djelotvornosti mjera minimizacije rizika, kao i obavezu praćenja primjene lijeka izvan odobrene indikacije (engl. off-label use), kako je zatraženo tijekom arbitražnog postupka prema članku 31. Direktive 2001/83/EZ za lijekove koji sadrže domperidon.
English: Transmission to National Competent Authorities of the translations of the annexes to the position:
Croatian: Dostava prijevoda priloga stajalištu nadležnim nacionalnim tijelima:
English: Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Croatian: Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance domperidone and concerned by the PASS final report, the scientific conclusions are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni završnog izvješća zatraženog neintervencijskog ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet (engl. post-authorization safety study, PASS) za lijek(ove) koji sadrži(e) djelatnu tvar domperidon, a koja je obuhvaćena završnim izvješćem PASS-a, znanstveni zaključci su sljedeći:
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance domperidone and concerned by the PASS final report, the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka o rezultatima ispitivanja za lijek(ove) koji sadrži(e) djelatnu tvar domperidon, a koja je obuhvaćena završnim izvješćem PASS-a, CMDh smatra da je omjer koristi i rizika prethodno navedenog(ih) lijeka(ova) nepromijenjen, uz predložene izmjene informacija o lijeku.
English: The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Croatian: Stajalište je CMDh-a da je potrebna izmjena odobrenja za stavljanje u promet za lijek(ove) obuhvaćen(e) ovim završnim izvješćem PASS-a.
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance domperidone concerned by the noninterventional imposed PASS final report
Croatian: Izmjene uvjeta odobrenja za stavljanje lijeka u promet za lijek(ove) koji sadrži(e) djelatnu tvar domperidon, a koja je obuhvaćena završnim izvješćem zatraženog neintervencijskog PASS-a
English: Therefore, in view of available data regarding the joint database drug utilisation final study report, together with the joint PASS (physician survey) final study report submitted as a separate procedure (EMEA/H/N/PSR/J/0010), the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Croatian: S obzirom na dostupne podatke završnog izvješća ispitivanja potrošnje lijeka provedenog na temelju zajedničke baze podataka te završnog izvješća ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet (provedeno anketom u liječnika), koje je podneseno u zasebnom postupku (EMEA/H/N/PSR/J/0010), PRAC smatra da su izmjene uvjeta odobrenja za stavljanje lijeka u promet opravdane.
English: Annex II Conditions to the Marketing Authorisation(s)
Croatian: Uvjeti odobrenja za stavljanje lijeka u promet
English: Page 1 of 1
Croatian: Stranica 1 od 1
English: Strength Pharmaceutical Form Route of Administration
Croatian: Jačina Farmaceutski oblik Put primjene
English: Zonisamide
Croatian: Zonisamid
English: Confidential
Croatian: Povjerljivo
English: 1.2 Application Form - Annex A
Croatian: Obrazac prijave - Prilog A
English: EU Number Invented name
Croatian: Broj EU odobrenja
English: Pack size
Croatian: Unutarnje pakiranje
English: Some patients have committed suicide.
Croatian: Neki su bolesnici počinili samoubojstvo.
English: - if you are over 65.
Croatian: Ako ste stariji od 65 godina.
English: - Tell your doctor:
Croatian: - Obavijestite svog liječnika:
English: • disturbances of coordination and balance
Croatian: • poremećaji koordinacije i ravnoteže
English: Effect of food
Croatian: Učinak hrane
English: Keep the tablet bottle with you so that you can easily describe what you have taken.
Croatian: Ponesite sa sobom bocu s tabletama, tako da možete lakše opisati što ste uzeli.
English: *lower than recommended doses; similar findings are expected with recommended doses.
Croatian: *manje od preporučenih doza; slični rezultati očekuju se s preporučenim dozama.
English: • feeling worried or depressed
Croatian: • osjećaj brige ili depresije
English: Atripla must be taken every day.
Croatian: Atripla se mora uzimati svaki dan.
English: M=Failure
Croatian: N=neuspjeh
English: ** based on historical comparison.
Croatian: ** temeljeno na usporedbi prijašnjih podataka.
English: - if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
Croatian: - ako je bilo koji član Vaše obitelji (roditelji ili njihovi roditelji, braća ili sestre) iznenada umro uslijed srčanih problema ili je rođen sa srčanim problemom
English: - any signs of inflammation or infection.
Croatian: bilo kakvi znakovi upale ili infekcije.
English: Parameters Test Reference
Croatian: Parametri test referenca
English: Tell your doctor immediately if you are pregnant or intend to become pregnant.
Croatian: Odmah obavijestite liječnika ako ste trudni ili namjeravate zatrudnjeti.
English: If you take more Atripla than you should
Croatian: Ako uzmete više Atriple nego što ste trebali
English: Wait and take the next dose at the regular time.
Croatian: Pričekajte, pa sljedeću dozu uzmite u redovito vrijeme.
English: Also, tell your doctor if you are taking maraviroc.
Croatian: Također, obavijestite liječnika ako uzimate maravirok.
English: If you are over 65 years of age and are prescribed Atripla, your doctor will monitor you carefully.
Croatian: Ako ste stariji od 65 godina, a propisana Vam je Atripla, liječnik će Vas pažljivo nadzirati.
English: This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time.
Croatian: To je vrlo važno jer se količina virusa može početi povećavati čak i ako prestanete uzimati lijek samo nakratko.
English: What Atripla is and what it is used for
Croatian: Što je Atripla i za što se koristi
English: A risk to the infants cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenčad.
English: The virus may then become harder to treat.
Croatian: Virus tada može postati otporniji na liječenje.
English: Values for Test and Reference are mean (% coefficient of variation).
Croatian: Vrijednosti za test i referencu su srednje vrijednosti (% koeficijenta varijabilnosti).
English: Adverse reactions were generally consistent with those seen in previous studies of the individual components.
Croatian: Nuspojave su općenito bile konzistentne s onima koje su zabilježene u prethodnim ispitivanjima pojedinačnih komponenti.
English: Based on the different elimination pathways, no interaction is expected.
Croatian: Zbog različitih puteva eliminacije ne očekuje se nikakva interakcija.
English: • increased appetite
Croatian: • povećani apetit
English: PC: {number} SN: {number} NN: {number} [outer packaging only]
Croatian: PC: {broj} SN: {broj} NN: {broj}
English: These metabolites are essentially inactive against HIV-1.
Croatian: Ti su metaboliti u osnovi neaktivni protiv virusa HIV-1.
English: Interaction studies with these agents have only been performed in adults.
Croatian: Ispitivanja interakcija s ovim tvarima provedena su samo u odraslih.
English: If you are affected, do not drive and do not use any tools or machines.
Croatian: Osjećate li te simptome, nemojte voziti niti koristiti bilo kakve alate ili strojeve.
English: Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Croatian: Liječnika odmah obavijestite o novim ili neobičnim simptomima nakon što se prestanete liječiti, osobito o simptomima koje dovodite u vezu s infekcijom hepatitisom B.
English: EU/1/07/430/001 EU/1/07/430/002
Croatian: EU/1/07/430/002
English: M=Excluded
Croatian: N=isključeno
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Croatian: Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100) ili rijetko (≥ 1/10 000 do < 1/1000).
English: Date of first authorisation: 13 December 2007 Date of latest renewal: 17 September 2012
Croatian: Datum posljednje obnove odobrenja: 17. rujna 2012.
English: Atripla tablets should be swallowed whole with water, once daily.
Croatian: Tablete Atriple treba cijele progutati s vodom, jednom dnevno.
English: • decreased sexual drive
Croatian: • smanjen spolni nagon
English: Patients should be monitored for seizure control.
Croatian: Bolesnike treba nadzirati radi kontrole napadaja.
English: Autoimmune disorders may occur many months after the start of treatment.
Croatian: Autoimuni poremećaji mogu se pojaviti puno mjeseci kasnije nakon početka liječenja.
English: The clinical significance of these effects is not known.
Croatian: Klinički značaj ovih učinaka nije poznat.
English: GMR (%) (90%CI) Test Reference
Croatian: GMR (%) (90%CI) test referenca
English: A summary of resistance mutation development is shown in Table 3.
Croatian: Sažetak pojava mutacija za razvoj rezistencije prikazan je u Tablici 3.
English: This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir.
Croatian: Ovo smanjenje vrijednosti Cmin atazanavira moglo bi negativno utjecati na djelotvornost atazanavira.
English: Table 6: Summary of pharmacokinetic data from study GS-US-177-0105
Croatian: Tablica 6: Sažetak farmakokinetičkih podataka iz istraživanja GS-US-177-0105
English: Total active HMG Co-A reductase inhibitors:
Croatian: Ukupni aktivni inhibitori HMG Co-A reduktaze:
English: If this is unavoidable, your doctor will monitor your kidney function once a week.
Croatian: Ako se to ne može izbjeći, liječnik će jednom tjedno pratiti funkciju Vaših bubrega.
English: Atripla contains three active substances that are used to treat human immunodeficiency virus (HIV) infection:
Croatian: Atripla sadržava tri djelatne tvari koje se koriste za liječenje infekcije virusom humane imunodeficijencije (HIV):
English: Increases in bupropion dosage should be guided by clinical response, but the maximum recommended dose of bupropion should not be exceeded.
Croatian: Povećanja doze bupropiona treba usklađivati s kliničkim odgovorom, ali ne smije se prekoračiti maksimalna preporučena doza bupropiona.
English: Lopinavir concentrations: ↓ 30-40%
Croatian: Koncentracije lopinavira: ↓ 30-40%
English: Tell your doctor if you are taking other medicines which may damage your kidneys.
Croatian: Obavijestite svog liječnika ako uzimate druge lijekove koji bi mogli naškoditi Vašim bubrezima.
English: This is equivalent to 1.2% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 1,2% preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: Atripla has not been evaluated in the presence of food.
Croatian: Atripla nije istraživana uz prisutnost hrane.
English: - You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Croatian: - HIV virus možete prenijeti čak i dok uzimate ovaj lijek, iako je tada rizik od prijenosa manji zbog učinkovite antiretrovirusne terapije.
English: abnormal dreams, insomnia
Croatian: abnormalni snovi, nesanica
English: It is believed that these symptoms are due to improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Croatian: Vjeruje se da je uzrok tih simptoma poboljšanje imunološkog odgovora tijela koje tijelu omogućava da se bori protiv infekcija koje su možda bile prisutne bez pojave očitih simptoma.
English: - if you have or have had kidney disease, or if tests have shown problems with your kidneys.
Croatian: ako imate ili ste imali bolest bubrega, ili su testovi ukazivali na probleme s bubrezima.
English: Atripla comes in bottles of 30 tablets (with a silica gel sachet that must be kept in the bottle to help protect your tablets).
Croatian: Atripla dolazi u bocama od 30 tableta (s vrećicom silikagela koja mora biti u boci da bi se zaštitile tablete).
English: Table 1: Interactions between Atripla or its individual components and other medicinal products
Croatian: Tablica 1: Interakcije između Atriple ili njenih pojedinačnih komponenti i drugih lijekova
English: Your doctor will carefully consider whether to treat you with medicines containing tenofovir and didanosine.
Croatian: Liječnik će pažljivo razmotriti hoće li Vas liječiti lijekovima koji sadržavaju tenofovir i didanozin.
English: Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N.
Croatian: Supstitucije na RT na položajima 98, 100, 101, 108, 138, 188, 190 ili 225 također su opažene, ali rjeđe i često samo u kombinaciji s K103N.
English: Atripla should be taken on an empty stomach (commonly defined as 1 hour before or 2 hours after a meal) preferably at bedtime.
Croatian: Atripla se treba uzimati na prazan želudac (stanje koje se obično definira kao 1 sat prije ili 2 sata nakon jela), po mogućnosti prije spavanja.
English: Psychiatric side effects in addition to those listed above include delusions (false beliefs), neurosis.
Croatian: Psihijatrijske nuspojave osim onih navedenih iznad uključuju deluzije (lažna uvjerenja) i neurozu.
English: • increased fatty acids (triglycerides), bilirubin or sugar levels in the blood
Croatian: • povišene trigliceride (masne kiseline), bilirubin ili šećer u krvi
English: If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
Croatian: Ako ste zaraženi hepatitisom B, liječnik će pažljivo razmisliti o najboljem režimu liječenja za Vas.
English: - if you have a history of liver disease, including chronic active hepatitis.
Croatian: ako ste nekada imali bolest jetre, uključujući kronični aktivni hepatitis.
English: Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving and operating machinery.
Croatian: Bolesnike treba uputiti da u slučaju da osjete te simptome trebaju izbjegavati potencijalno opasne radnje poput vožnje i rukovanja strojevima.
English: If you are pregnant, you should take Atripla only if you and your doctor decide it is clearly needed.
Croatian: Ako ste trudni, Atriplu smijete uzimati isključivo ako Vi i Vaš liječnik odlučite da je njezino uzimanje nužno.
English: What Atripla looks like and contents of the pack
Croatian: Kako Atripla izgleda i sadržaj pakiranja
English: Efavirenz does not bind to cannabinoid receptors.
Croatian: Efavirenz se ne vezuje za kanabinoidne receptore.
English: Stopping Atripla can seriously affect your response to future treatment.
Croatian: Prestanak uzimanja Atriple može ozbiljno ugroziti Vašu reakciju na buduće liječenje.
English: The methadone dose was increased by a mean of 22% to alleviate withdrawal symptoms.
Croatian: Doza metadona povećana je za prosječno 22% da bi se ublažili simptomi apstinencijske krize.
English: [outer packaging only]
Croatian: [samo vanjsko pakiranje]
English: Decreases in bone mineral density of the hip were significantly greater in this group until 96 weeks.
Croatian: Smanjenje mineralne gustoće kosti kuka bilo je značajno veće u toj skupini do 96-og tjedna.