FrancophonIA/ELRC3.0 huggingface dataset:
English: high liver function test results hepatitis B or C infection you are at increased risk of severe and potentially fatal liver damage while taking Aptivus.
Croatian: Bolesnici s kroničnim hepatitisom B ili C liječeni kombiniranom antiretrovirusnom terapijom imaju povećan rizik teških i potencijalno fatalnih nuspojava od strane jetre.
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with amiodarone, bepridil or quinidine is contraindicated due to potential serious and/or life threatening events (see section 4.3)
Croatian: Istodobna primjena Aptivusa s niskom dozom ritonavira i amiodarona, bepridila ili kinidina je kontraindicirana zbog potencijalnih teških i/ili fatalnih događaja (vidjeti dio 4.3)
English: Analyses were conducted to assess virological outcome by the number of primary PI mutations (any change at protease codons 30, 32, 36, 46, 47, 48, 50, 53, 54, 82, 84, 88 and 90) present at baseline.
Croatian: Analiza virološkog odgovora u odnosu na broj primarnih mutacija IP (bilo koja promjena u proteaznim kodonima 30, 32, 36, 46, 47, 48, 50, 53, 54, 82, 84, 88 i 90) prisutnih na početku pokazala je da je stopa odgovora na tipranavir s ritonavirom bila veća nego na kontrolni tretman i u bolesnika s novouvedenim enfuvirtidom i u onih bez njega.
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with cisapride is contraindicated due to potential serious and/or life threatening events (see section 4.3)
Croatian: Istodobna primjena Aptivusa s niskom dozom ritonavira i cisaprida je kontraindicirana zbog potencijalnih teških i/ili fatalnih događaja (vidjeti dio 4.3)
English: Zidovudine 300 mg BID (TPV/r 750/100 mg BID)
Croatian: Zidovudin 300 mg BID (TPV/r 750/100 mg BID)
English: - bosentan (used to treat pulmonary artery hypertension) - halofantrine or lumefantrine (used to treat malaria) - tolterodine (used to treat overactive bladder (with symptoms of urinary frequency, urgency, or urge incontinence)) - boceprevir and telaprevir (used to treat hepatitis C) - cobicistat and products containing cobicistat (used to increase effectiveness of HIV medicines).
Croatian: hitnosti mokrenja, ili hitnosti mokrenja s nemogućnosti zadržavanja mokraće)) - boceprevir i telaprevir (koji se primjenjuju u liječenju hepatitisa C) - kobicistat i lijekovi koji sadrže kobicistat (koji se primjenjuju za povećanje učinkovitosti lijekova protiv HIV-a).
English: Dosing of enteric-coated didanosine and Aptivus soft capsules, coadministered with low dose ritonavir, should be separated by at
Croatian: Primjena želučano otporne formulacije didanozina i Aptivus mekih kapsula s niskom dozom ritonavira mora biti odvojena najmanje 2 sata radi izbjegavanja inkompatibilnosti formulacija.
English: Anaemia
Croatian: Hemofilija
English: Antibiotics
Croatian: Antiepileptici
English: Salmeterol
Croatian: Metoprolol
English: When Aptivus/ritonavir is co-administered with telaprevir, a decrease or an increase of telaprevir exposure could be expected.
Croatian: istodobno s telaprevirom,može se očekivati smanjena ili povećana izloženost telapreviru.
English: Limited data are currently available for the use of Aptivus, co-administered with low dose ritonavir, in patients co-infected with hepatitis B or C. Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reaction.
Croatian: Podaci o primjeni Aptivusa i niske doze ritonavira, u bolesnika s istodobnom infekcijom virusom hepatitisa B ili C trenutno su ograničeni.
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase triazolam concentrations.
Croatian: Temeljem teoretskih razmatranja očekuje se da tipranavir s niskom dozom ritonavira povećava koncentracije triazolama.
English: Be sure your child's doctor clearly informs you what the correct dose for your child should be. You should measure the exact dose using the supplied measuring syringe and adapter, as follows:
Croatian: Vas je djetetov liječnik jasno obavijestio koja je ispravna doza za Vaše dijete.
English: NNRTIs
Croatian: Antacidi
English: The concomitant use of Aptivus, coadministered with low dose ritonavir, with amprenavir/ritonavir is not recommended.
Croatian: Istodobna primjena Aptivusa s niskom dozom ritonavira i amprenavira/ritonavira se ne preporučuje.
English: Tell your doctor if you have: - type A or B haemophilia - diabetes - liver disease.
Croatian: A ili B - dijabetes - bolest jetre.
English: This may be in the skin or joints.
Croatian: A i B, možete imati pojačano krvarenje, koje može biti u koži ili zglobovima.
English: Inhibition of CYP 3A4 by tipranavir/r
Croatian: Inhibicija CYP 3A4 putem tipranavira/r
English: In order to achieve effective tipranavir plasma concentrations and a twice daily dosing regimen, coadministration of tipranavir with low dose ritonavir twice daily is essential (see section 4.2).
Croatian: Tipranavir se mora primijeniti s niskom dozom ritonavira kako bi se osigurale djelotvorne koncentracije u plazmi i mogućnost doziranja dva puta dnevno (vidjeti dio 4.2).
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with triazolam is contraindicated due to potential serious and/or life threatening events (see section 4.3)
Croatian: Istodobna primjena Aptivusa s niskom dozom ritonavira i triazolama je kontraindicirana zbog potencijalno teških i/ili fatalnih događaja (vidjeti dio 4.3)
English: Anti-HCV agents Boceprevir No interaction study performed
Croatian: Lijekovi protiv HCV-a Boceprevir
English: The concomitant use of Aptivus, coadministered with low dose ritonavir, with lopinavir/ritonavir is not recommended.
Croatian: Istodobna primjena Aptivusa s niskom dozom ritonavira i lopinavira/ritonavira se ne preporučuje.
English: The concomitant use of Aptivus, coadministered with low dose ritonavir, with saquinavir/ritonavir is not recommended.
Croatian: Istodobna primjena Aptivusa s niskom dozom ritonavira i sakvinavira/ritonavira se ne preporučuje.
English: BSA Range (m
Croatian: Površina tijela raspon (m
English: The comparator regimen included a ritonavir-boosted PI (also individually defined) plus an OBR.
Croatian: Kontrolni tretman se sastojao od individualno odabranog inhibitora proteaze (IP) s ritonavirom dodanih uz OBR.
English: Inhibition of CYP 3A4 by atazanavir/ritonavir and induction by tipranavir/r.
Croatian: Inhibicija CYP 3A4 putem atazanavir/ritonavira te indukcija putem tipranavira/r.
English: 1184 cells/mm
Croatian: stanica/mm
English: An interaction study in women between tipranavir, co-administered with low dose ritonavir, and ethinyl oestradiol/norethindrone demonstrated a high frequency of non-serious rash.
Croatian: U ispitivanju interakcija s etinilestradiolom/noretindronom u žena, uz istodobnu primjenu tipranavira s niskom dozom ritonovira, povećala se učestalost blagog do umjereno teškog osipa.
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase cisapride concentrations.
Croatian: Temeljem teoretskih razmatranja, očekuje se da tipranavir s niskom dozom ritonavira povećava koncentracije cisaprida.
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase amiodarone, bepridil and quinidine concentrations.
Croatian: Temeljem teoretskih razmatranja, očekuje se da tipranavir s niskom dozom ritonavira povećava koncentracije amiodarona, bepridila i kinidina.
English: Dosing of enteric-coated didanosine and Aptivus soft capsules, co
Croatian: Prijelaz s Aptivus kapsula na oralnu otopinu
English: The following medicines are not recommended: - fluticasone (used to treat asthma) - atorvastatin (used to lower blood cholesterol) - salmeterol (used to achieve long-term asthma control, bronchospasm prevention with COPD)
Croatian: Ne preporučuju se sljedeći lijekovi: - flutikazon (primjenjuje se u liječenju astme)
English: recommended when coadministered with Aptivus/ritonavir.
Croatian: Kada se Aptivus/ritonavir primjenjuje
English: Pyrexia
Croatian: Rilpivirin
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase tolterodine concentrations.
Croatian: Temeljem teoretskih razmatranja, očekuje se da tipranavir u primjeni s niskom dozom ritonavira povećava koncentracije tolterodina.
English: Package leaflet: Information for the user Aptivus 250 mg soft capsules tipranavir
Croatian: Aptivus 250 mg meke kapsule tipranavir
English: Breastfeeding
Croatian: Kvetiapin
English: - Vomiting and/or jaundice which may be symptoms of abnormal liver function - Bleeding - *Bleeding in the brain.
Croatian: Potrebno je obavijestiti liječnika ako imate: - gubitak apetita - mučninu - povraćanje i/ili žuticu koji mogu biti simptomi abnormalne funkcije jetre - Krvarenje - * krvarenje u mozgu, što može dovesti do trajnog invaliditeta ili smrti, a pojavilo se u nekih bolesnika koji su se liječili Aptivusom u kliničkim ispitivanjima.
English: PP
Croatian: C
English: Abdominal pain Rash
Croatian: Bol u abdomenu Pireksija
English: Tell your child's doctor if they have: - type A or B haemophilia - diabetes - liver disease.
Croatian: Obavijestite djetetovog liječnika ako Vaše dijete boluje od sljedećeg: - hemofilija tipa
English: Propylene glycol
Croatian: Lijekovi protiv gihta Kolhicin
English: In case of acute crisis, it is recommended that the tablets are taken before meals.'
Croatian: U slučaju akutne krize, preporučuje se da se tablete uzimaju prije jela.”
English: Limited within study comparisons are available.
Croatian: Dostupne su ograničene usporedbe u okviru ispitivanja.
English: The CHMP endorsed the PKWP's advice.
Croatian: CHMP je prihvatio savjet PKWP-a.
English: During the CMDh referral procedure that followed, no consensus could be reached as the objecting EU Member States maintained their objections, which were considered to represent a potential serious risk to public health.
Croatian: Tijekom postupka upućivanja CMDh-u koji je uslijedio nije postignut konsenzus jer su države članice koje su uložile prigovor ostale pri svom prigovoru, smatrajući da lijek predstavlja potencijalno ozbiljan rizik za javno zdravstvo.
English: The potential serious risk to public health (PSRPH) concern was maintained, and the procedure was referred by the RMS to the CMDh.
Croatian: Ostao je problem potencijalnog ozbiljnog rizika za javno zdravstvo (PSRPH), a postupak je CMDh-u uputila referentna država članica.
English: The mean Cmax reduction observed with food ranges from 21% to 69%.
Croatian: Prosječno smanjenje vrijednosti Cmax promatrano s hranom u rasponu je od 21 % do 69 %.
English: As requested by the CHMP, the applicant also performed a bibliographic search on the databases Medline and Embase.
Croatian: Kao što je CHMP zatražio, podnositelj zahtjeva također je proveo pretraživanje bibliografije u bazama podataka Medline i Embase.
English: The pre-defined criteria for bioequivalence were met for both Cmax and AUC.
Croatian: Unaprijed utvrđeni kriteriji za bioekvivalenciju bili su ispunjeni za Cmax i AUC.
English: Therefore, the CHMP is of the view that the benefit-risk is negative.
Croatian: Dakle, CHMP smatra da je omjer koristi i rizika negativan.
English: The CMDh therefore referred the matter to the CHMP through an Article 29(4) referral procedure.
Croatian: Zbog toga je CMDh predmet uputio CHMP-u u okviru postupka upućivanja u skladu s člankom 29. stavkom 4.
English: During the CHMP meeting the applicant presented their view in an oral explanation.
Croatian: Tijekom sastanka CHMP-a podnositelj zahtjeva predstavio je svoj stav u usmenom obrazloženju.
English: Given the strong evidence of a food effect on the Cmax and Tmax, this effect is concluded to be both drug substance and formulation dependent.
Croatian: S obzirom na snažne dokaze o učinku hrane na Cmax i Tmax, zaključeno je da taj učinak ovisi o ljekovitoj tvari i formulaciji.
English: The results of the comparative bioavailability study under fasting conditions demonstrate bioequivalence between reference and test products for all pharmacokinetic parameters.
Croatian: Rezultati komparativnog ispitivanja bioraspoloživosti u stanju gladovanja pokazuju bioekvivalenciju između referentnog i ispitivanog lijeka za sve farmakokinetičke parametre.
English: Furthermore, comparative dissolution testing at pH 5.5 demonstrated immediate release from test and reference product, which was used to support the comparative rate and extent of absorption in vivo in the fed state.
Croatian: Osim toga, ispitivanje komparativne otopine pri pH od 5,5 ukazalo je na trenutačno otpuštanje iz ispitivanog i referentnog lijeka, koji se upotrijebio radi potpore komparativnoj brzini i opsegu apsorpcije in vivo u stanju sitosti.
English: The marketing authorisation application (MAA) for Diclofenac (epolamine) 50 mg immediate release tablets was submitted according to Article 10(1) of Directive 2001/83/EC.
Croatian: Zahtjev za odobrenje za stavljanje u promet lijeka Diclofenac (epolamin) 50 mg s trenutačnim otpuštanjem podnesen je u skladu s člankom 10. stavkom 1. Direktive 2001/83/EZ.
English: In summary this review of literature by the applicant about the magnitude of the food-effect on the rate of absorption with diclofenac immediate release formulations, allowed to conclude that it reached on average, 50% decrease on Cmax and various delays on tmax, without any loss in the amount of systemic exposure.
Croatian: Ukratko, ovaj pregled literature podnositelja zahtjeva o razmjerima učinka hrane na brzinu apsorpcije s formulacijama diklofenaka s trenutačnim otpuštanjem omogućio je da se dođe do zaključka da je postignuto prosječno smanjenje od 50 % za Cmax i različite odgode za Tmax bez ikakvih gubitaka u količini sustavne izloženosti.
English: For the sodium and potassium salt, and the acid, a food effect is evident in most studies.
Croatian: Za natrijevu i kalijevu sol te kiselinu učinak hrane očit je u većini ispitivanja.
English: However the objecting EU Member States argued that the effect of food on Cmax may be formulationdependent in the case of diclofenac, and that from the available evidence the potential difference in bioavailability (Cmax decrease of up to 70%) may reach such a high level so as to compromise the safe and effective use of the drug.
Croatian: Međutim, države članice EU-a koje su podnijele prigovor tvrdile su da učinak hrane na najveću koncentraciju lijeka (Cmax) može ovisiti o formulaciji u slučaju diklofenaka te da na temelju dostupnih dokaza potencijalna razlika u bioraspoloživosti (smanjenje najveće koncentracije lijeka do 70 %) može doseći tako visoku razinu da ugrozi sigurnu i učinkovitu uporabu lijeka.
English: • The Committee therefore concluded that there was a lack of appropriate data to support the positive benefit-risk of this medicinal product Diclofenac 50mg tablets.
Croatian: • Odbor je stoga zaključio da postoji manjak odgovarajućih podataka koji bi išli u prilog pozitivnom omjeru koristi i rizika ovog lijeka, tj. tableta Diclofenac 50 mg.
English: • The Committee reviewed the data submitted by the applicant in support of this particular medicinal product Diclofenac (Altergon) 50mg tablets;
Croatian: • Odbor je pregledao podatke koje je dostavio podnositelj zahtjeva u prilog ovom lijeku, tj. tabletama Diclofenac (Altergon) 50 mg ;
English: No food-effect study was identified with Diclofenac epolamine.
Croatian: Nije pronađeno nijedno ispitivanje o utjecaju hrane na diklofenak epolamin.
English: Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis via inhibition of both COX-1 and COX-2 isoenzymes of the arachidonic acid pathway.
Croatian: Diklofenak je nesteroidni protuupalni lijek (NSAID) koji inhibira sintezu prostaglandina putem inhibicije izoenzima COX-1 i COX-2 na putu arahidonske kiseline.
English: Section 4.2 of the proposed SmPC for Diclofenac (epolamine) 50 mg immediate release tablets is in line with the reference product, and recommends that: '… tablets should be swallowed whole with a glass of water, preferably during or after meals.
Croatian: Odjeljak 4.2. predloženog sažetka opisa svojstava lijeka za tablete Diclofenac (epolamin) 50 mg s trenutačnim otpuštanjem u skladu je s referentnim lijekom te se u njemu preporučuje sljedeće: „...tablete treba progutati cijele uz čašu vode, po mogućnosti tijekom ili nakon obroka.
English: The CHMP agreed with the applicant that the food effect on Cmax of diclofenac is both drug substance and formulation dependent, based on the review of the literature, which includes potassium and sodium salts, and the acid.
Croatian: CHMP se složio s podnositeljem zahtjeva da učinak hrane na Cmax diklofenaka ovisi o djelatnoj tvari i formulaciji, na temelju pregleda literature, koja uključuje kalijeve i natrijeve soli te kiselinu.
English: Therefore, the Committee recommends the refusal of the marketing authorisation of Diclofenac (Altergon) in the reference and concerned Member States.
Croatian: Stoga Odbor predlaže odbijanje izdavanja odobrenja za stavljanje lijeka Diclofenac (Altergon) u promet u referentnim državama članicama i državama članicama sudionicama u postupku.
English: • The Committee was of the view that in this case bioequivalence of Diclofenac 50 mg tablets vs. the reference product Flector granules for oral solution should be demonstrated in fed conditions as well, in view of the available literature demonstrating that the Cmax of different formulations of diclofenac is affected differently in fed conditions;
Croatian: • Odbor je mišljenja da se u ovom slučaju bioekvivalencija tableta Diclofenac 50 mg i granula referentnog lijeka Flector za oralnu otopinu treba dokazati i u uvjetima sitosti uzimajući u obzir dostupnu literaturu koja pokazuje da je učinak na Cmax različitih formulacija diklofenaka različit u uvjetima sitosti;
English: A summary of the bioequivalence study in the fasted state was presented as well as a review of the literature submitted.
Croatian: Predstavljen je sažetak ispitivanja bioekvivalencije u stanju gladovanja, kao i podneseni pregled literature.
English: Considering this, it was argued that it was necessary to request a fed study in order to rule out any risk of bio-in-equivalence under fed conditions.
Croatian: Uzevši to u obzir, istaknuto je da se treba zatražiti ispitivanje u stanju sitosti kako bi se isključila mogućnost rizika od bio(ne)ekvivalencije u uvjetima sitosti.
English: According to Desjardins et al (2015)1, there was 60% decrease in Cmax for a diclofenac acid capsule, compared to a 43% decrease in Cmax for a potassium tablet, in the fed state vs fasted.
Croatian: Prema razmatranjima Desjardinsa i drugih (2015.)1, došlo je do smanjenja od 60 % za Cmax za kapsule kiseline diklofenaka, u odnosu na smanjenje od 43 % za Cmax za tablete kalija u stanju sitosti naspram stanja gladovanja.
English: However no data was submitted to show the food effect between test and reference product to support this application, given that the SmPC recommendation in section 4.2 is that Diclofenac epolamine tablets should be swallowed whole with a glass of water, preferably during or after meals.
Croatian: Međutim, nisu dostavljeni nikakvi podaci koji bi pokazali utjecaj hrane u usporedbi ispitivanog i referentnog lijeka i išli u korist ovog zahtjeva, uzevši u obzir da je preporuka u sažetku opisa svojstava lijeka u poglavlju 4.2. da tablete diklofenak epolamin treba progutati cijele uz čašu vode, po mogućnosti tijekom ili nakon obroka.
English: Although it was argued by the applicant that a failure of bioequivalence under fasting state is predictive of a failure of bioequivalence under fed state based on the submitted literature, the CHMP was of the view that the reverse argument could not be upheld i.e that bioequivalence under fasting state is predictive of bioequivalence under fed state, without any evidence to support it.
Croatian: Iako je podnositelj zahtjeva tvrdio da nepostojanje bioekvivalencije u stanju gladovanja pretkazuje nepostojanje bioekvivalencije u stanju sitosti, na temelju podnesene literature, CHMP je smatrao da obrnuta tvrdnja ne može biti potvrđena, odnosno da bioekvivalencija u stanju gladovanja pretkazuje bioekvivalenciju u stanju sitosti, bez ikakvog dokaza koji bi to podržao.
English: Chen et al (2015)2 reported a 69% reduction in Cmax for a buffered potassium solution vs a 28% reduction for a potassium tablet, in the fed state vs. fasted state.
Croatian: Chen i drugi (2015.)2 izvijestili su o smanjenju od 69 % za Cmax za ublaženu otopinu kalija naspram smanjenja od 28 % za tablete kalija u stanju sitosti naspram stanja gladovanja.
English: Diclofenac 50 mg Tablets contain diclofenac epolamine, a salt of diclofenac, formed by the combination of diclofenamic acid with the tertiary amine N-(2-hydroxyethyl)-pyrrolidine.
Croatian: Tablete Diclofenac 50 mg sadrže diklofenak epolamin, sol diklofenaka nastalu kombinacijom kiseline diklofenaka s tercijarnim aminom N-(2-hidroksietil)-pirolidin.
English: Therefore as Diclofenac epolamine tablets and the reference product diclofenac epolamine granules for solution are different oral pharmaceutical formulations, and because literature data show that the food effect on Cmax of diclofenac is not only dependent on the drug substance but also on the formulation, in this case, bioequivalence can only be concluded if bioequivalence is shown under fed as well as fasted conditions.
Croatian: Stoga, budući da su tablete diklofenak epolamin i granule referentnog lijeka diklofenak epolamin za otopinu različite oralne farmaceutske formulacije i budući da podaci u literaturi pokazuju da učinak hrane na Cmax diklofenaka ne ovisi samo o djelatnoj tvari nego i o formulaciji, u ovom slučaju bioekvivalencija se može potvrditi samo ako je bioekvivalencija dokazana u uvjetima sitosti i gladovanja.
English: The advice of PKWP was also sought during this procedure.
Croatian: Tijekom ovog postupka tražio se i savjet Radne skupine za farmakokinetiku (PKWP).
English: Therefore the CHMP is of the opinion that the bioequivalence of Diclofenac epolamine tablets and the reference product diclofenac epolamine granules for solution has not been demonstrated for this Article 10(1) marketing authorisation application, since bioequivalence cannot be concluded in the absence of a bioequivalence study in the fed state.
Croatian: Stoga CHMP smatra da bioekvivalencija tableta diklofenak epolamin i granula referentnog lijeka diklofenak epolamin za otopinu nije dokazana za ovaj zahtjev za odobrenje za stavljanje lijeka u promet iz članka 10. stavka 1. jer se bioekvivalencija ne može potvrditi bez ispitivanja bioekvivalencije u stanju sitosti.
English: In summary, the view of the PKWP was that under fed conditions the Cmax is highly variable; Cmax ratio fed/fasted ranged from 26-73% for the different formulations, and formulations that are bioequivalent in the fasted state may not be bioequivalent in the fed state, especially if the dosage form is different.
Croatian: Omjer Cmax na pun/prazan želudac bio je u rasponu od 26 - 73 % za različite formulacije, a formulacije koje su bioekvivalentne u stanju gladovanja ne moraju biti bioekvivalentne u stanju sitosti, posebice ako se razlikuje način doziranja.
English: The Committee, as a consequence, considers that the benefit-risk balance of Diclofenac is not favourable.
Croatian: Slijedom toga, Odbor smatra da omjer koristi i rizika za lijek Diclofenac nije povoljan.
English: • The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of Directive 2001/83/EC where France and the Slovakia raised objections that were considered to be a potential serious risk to public health;
Croatian: • Odbor je razmotrio obavijest o postupku upućivanja koji je pokrenula Ujedinjena Kraljevina u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ.
English: 1 Desjardins PJ, Olugemo K, Solorio D, Young CL. Pharmaocokinetic propertiesand tolerability of low-dose SoluMatrix diclofenac.
Croatian: 1 Desjardins PJ, Olugemo K, Solorio D, Young CL.