FrancophonIA/ELRC3.0 huggingface dataset:
English: Didanosine is intended to be administrated on en empty stomach as stated in the proposed Summary of Product Characteristics (SmPC): “Didanosine absorption is reduced in the presence of food, and hence Didanosine gastro-resistant capsules should be administrated on an empty stomach (at least 2 hours before or 2 hours after a meal)”.
Croatian: Didanozin je namijenjen za primjenu na prazan želudac kako je to navedeno u predloženom sažetku opisa svojstava lijeka (SmPC): „Apsorpcija didanozina smanjena je u prisutnosti hrane i stoga želučanootporne kapsule didanozina treba primijeniti na prazan želudac (najmanje 2 sata prije ili poslije obroka)”.
English: Didanosine has to be first converted intracellularly to its active metabolite ddATP (responsible for antiviral activity) which has a significantly longer intracellular half-life (about 43 hours) as compared with plasma half-life of didanosine.
Croatian: Didanozin treba prvo konvertirati u stanici u njegov aktivni metabolit ddATP (koji je odgovoran za antivirusnu aktivnost) koja ima znatno dulji unutarstanični poluživot (oko 43 sata) u usporedbi plazmatskim poluživotom didanozina.
English: In addition, the objecting Members States considered that the arguments provided by the applicant did not sufficiently address the consequences of the difference observed in didanosine pharmacokinetics in the fed state between test and reference products.
Croatian: Osim toga, države članice koje su se protivile smatrale su da argumenti koje je podnio predlagatelj nisu dostatni za objašnjenje posljedica razlika uočenih u farmakokinetici didanozina, u stanju kad su bolesnici bili siti između testnih i referentnih lijekova.
English: • The Committee reviewed all the data submitted by the applicant in order to support the bioequivalence between Didanosine and associated names and the reference product.
Croatian: • Povjerenstvo je pregledalo sve predane podatke kako bi poduprlo bioekvivalenciju između didanozina i pridruženih naziva i referentnog lijeka.
English: The Committee acknowledged that the conventional criterion for bioequivalence for maximum plasma concentration (Cmax) was outside the 80-125% acceptability limits.
Croatian: Povjerenstvo je priznalo da su standardni kriteriji za bioekvivalenciju za maksimalnu plazmatsku koncentraciju (Cmax) bili izvan granica prihvatljivosti od 80 do 125 %.
English: Overall summary of the scientific evaluation of didanosine and associated names (see Annex I)
Croatian: Ukupni sažetak znanstvene procjene didanozina i pridruženih naziva (vidjeti Prilog I.)
English: This is attributed to the delay in absorption rate of enteric coated formulation which is reflected in the Tmax which is about 2 hours for the enteric coated formulation compared to 0.67 hours for the buffered tablet.
Croatian: To se pripisuje odgodi u brzini apsorpcije enterički obloženih formulacija što se odražava u Tmax koji iznosi otprilike 2 sata za enterički obloženu formulaciju u usporedbi sa 0,67 sati za puferirane tablete.
English: Both studies were carried out using open label, randomised, two treatment, two sequence, two period, single dose cross-over design.
Croatian: Oba su ispitivanja provedena upotrebom otvorenih, nasumičnih, unakrsnih ispitivanja čiji se dizajn temeljio na dvije terapije, dvije sekvence, dva razdoblja i na pojedinačnoj dozi.
English: didanosine in treatment of HIV infecting were conducted using buffered tablets3,4,5,6,7,8.
Croatian: Početna klinička ispitivanja koja su dokazala djelotvornost didanozina u liječenju infekcije HIV-om provedena su upotrebom puferiranih tableta3,4,5,6,7,8.
English: The pharmacokinetics data reveals that the plasma concentration (Cmax) obtained from enteric-coated capsule formulation of didanosine is about 40% lower as compared to the buffered tablet formulation.
Croatian: Farmakokinetički podaci otkrivaju da su plazmatske koncentracije (Cmax) dobivene iz formulacija enteričko obloženih kapsula didanozina za otprilike 40 % niža u usporedbi s formulacijom puferiranih tableta.
English: Didanosine (2', 3'-dideoxyinosine) is an inhibitor of the in vitro replication of human immunodeficiency virus (HIV) in cultured human cells and cell lines.
Croatian: Didanozin (2', 3'-dideoksididanozin) je inhibitor in vitro replikacije virusa humane imunodeficijencije (HIV) u kulturama humanih stanica i linija stanica.
English: 6 Drusano GL et al.
Croatian: 3 Damle BD et al.
English: the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Didanosine and associated names (see Annex I).
Croatian: CHMP je preporučio izdavanje odobrenja za stavljanje u promet, uz sažetak svojstava proizvoda, označivanje i upute o lijeku koji ostaju kao kod zadnje verzije utvrđene tijekom postupka Skupine za koordinaciju, kao što je spomenuto u Prilogu III. ovog mišljenja za didanozin i pridružene nazive (vidjeti Prilog 1.).
English: During the decentralised procedure France and the Netherlands expressed the opinion that bioequivalence had not been demonstrated in the fed conditions as Cmax was outside the 80-125% acceptability limits1.
Croatian: Tijekom decentraliziranog postupka Francuska i Nizozemska izrazile su mišljenje da bioekvivalencija nije dokazana u uvjetima kad su ispitanici smjeli jesti jer je Cmax bio izvan granica prihvatljivosti od 80-125 %1.
English: Ann Intern Med 1992: 116:562-566
Croatian: Ann Intern Med 1992: 116 (562)-566 7 Perry CM, Balfour JA.
English: The results were satisfactory in terms of extent of absorption (i.e. AUC).
Croatian: Rezultati su bili zadovoljavajući u smislu apsorpcije (tj. AUC).
English: Of note, bioequivalence in fasted state is considered to be the most important as this product is intended to be taken on an empty stomach.
Croatian: Potrebno je zabilježiti da se bioekvivalencija u situaciji kad su bolesnici morali biti natašte smatrala najvažnijom jer je ovaj lijek namijenjen uzimanju na prazan želudac.
English: Didanosine and associated names is indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infected patients.
Croatian: Didanozin i pridruženi nazivi indicirani su u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje bolesnika zaraženih virusom HIV-1.
English: Since the product is to be administrated at least 2 hours before or after food intake, it is unlikely that the product ingested will be exposed to in vivo conditions, prevailing under fed state.
Croatian: S obzirom da će se lijek primijeniti najmanje 2 sata prije ili nakon uzimanja hrane, nije vjerojatno da će se progutani lijek izložiti pod in-vivo uvjetima, ako ga bolesnici uzimaju na pun želudac.
English: • The Committee noted that in the fed study, both formulations were subject to a food effect reducing plasma concentrations.
Croatian: • Povjerenstvo je napomenulo da su u ispitivanju u uvjetima kad su bolesnici smjeli jesti obje formulacije bile podložne utjecaju hrane u smislu smanjivanja plazmatskih koncentracija.
English: The main purpose of conducting bioequivalence fed study is to exclude food related effects, such as dose-dumping (in particular for gastro-resistant formulations) or failure of protection from acid mediated degradation in the stomach.
Croatian: Glavna svrha provođenja studija bioekvivalencije kad su bolesnici smjeli jesti je isključivanje učinaka hrane poput naglog i prekomjernog otpuštanja doze lijeka u krv (posebice za želučanootporne formulacije) ili neuspjeh u zaštiti od kiselinom posredovane razgradnje u želucu.
English: Damle BD et al. Bioequivalence of two formulations of didanosine, encapsulated enteric-coated beads and buffered tablet, in healthy volunteers and HIV-infected subjects.
Croatian: Bioequivalence of two formulations of didanosine, encapsulated enteric-coated beads and buffered tablet, in healthy volunteers and HIV-infected subjects.
English: The Applicant claimed that the significant decrease observed under fed conditions for Cmax for the test product (90% CI outside the standard range) may be attributed to high inter-individual variability with respect to Cmax which was 36% in the study conducted under fed conditions.
Croatian: Predlagatelj je tvrdio da se značajan pad uočen u uvjetima kad su bolesnici smjeli jesti za Cmax za testni lijek (90 % intervala pouzdanosti izvan standardnog raspona) može pripisati visokoj interindividualnoj varijabilnosti s obzirom na Cmax koja je iznosila 36 % u ispitivanju koje je provedeno pod uvjetima kad su ispitanici smjeli jesti.
English: Pharmacokinetics studies conducted on Didanosine formulations reveal that administration of the product with food or immediately after food results in decreased in vivo availability of the drug.
Croatian: Farmakokinetička ispitivanja provedena na formulaciji didanozina otkrivaju da primjena lijeka s hranom ili neposredno nakon uzimanja hrane rezultira smanjenom in-vivo raspoloživosti lijeka.
English: The primary pharmacokinetic parameters (Cmax and AUC) were satisfactory in the fasting study with the 90% confidence interval (CI) falling within the standard criteria of 80.00 - 125.00%.
Croatian: Primarni farmakokinetički parametri (Cmax i AUC) bili su zadovoljavajući u ispitivanjima natašte s 90 %-tnim intervalom pouzdanosti (CI) koji spada unutar standardnih kriterija od 80,00 - 125,00
English: • The Committee is of the opinion that bioequivalence has been demonstrated under fasting conditions which is the recommended state for administration of didanosine.
Croatian: • Povjerenstvo je smatralo da je bioekvivalencija dokazana u uvjetima kad su bolesnici bili natašte što je i preporučeno stanje za primjenu didanozina.
English: In order to demonstrate the safety and efficacy of Didanosine and associated names in combination with other antiretroviral drugs in the treatment of HIV-1 infected patients, the application dossier was based on two single dose bioequivalence studies, one under fasting state and one under fed state.
Croatian: Kako bi se dokazala sigurnost i djelotvornost didanozina i pridruženih naziva u kombinaciji s drugim antiretrovirusnim lijekovima u liječenju bolesnika s infekcijom HIV-1, dosje lijeka za potrebe registracije temeljio se na dvije pojedinačne studije bioekvivalencije, jedna u stanju kad su bolesnici morali biti natašte, a druga kad su bolesnici smjeli jesti.
English: After didanosine enters the cell, it is enzymatically converted to dideoxyadenosine-triphosphate (ddATP), its active metabolite.
Croatian: Nakon što didanozin uđe u stanicu, enzimatski se konvertira u dideoksiadenozin-trifosfat (ddATP), svoj aktivni metabolit.
English: In viral nucleic acid replication, incorporation of this 2', 3'-dideoxynucleoside prevents chain extension, and thereby inhibits viral replication.
Croatian: Kod replikacije nukleinskih kiselina inkorporacija ovog metabolita 2', 3'-dideoksinukleozid sprječava produljenje lanca i tako inhibira replikaciju virusa.
English: In addition, ddATP inhibits HIV-reverse transcriptase by competing with deoxyadenosine-triphosphate (dATP) for binding to the enzyme's active site, preventing proviral DNA synthesis.
Croatian: Osim toga, ddATP inhibira HIV reverznu transkriptazu djelujući s deoksiadenozin-trifosfatom (dATP) za vezanje na aktivno mjesto enzima, sprječavajući sintezu proviralne DNK.
English: Didanosine and associated names (Gastro-resistant capsules 400 mg) was compared to the reference product Videx EC (Gastro-resistant capsules 400 mg) in 60 healthy adults under fasting conditions.
Croatian: Didanozin i pridruženi nazivi (želučanootporne kapsule 400 mg) bili su uspoređeni s referentnim lijekom Videx EX (želučanootporne kapsule 400 mg) kod 60 zdravih dobrovoljaca, u uvjetima kad su bili natašte.
English: This observation is in line with the results presented in the current application where AUC and Cmax of the test product significantly decrease under fed conditions.
Croatian: Ovo opažanje je u skladu s rezultatima prikazanim u postojećoj primjeni gdje su AUC i Cmax testnog lijeka značajno pali u stanju kad su ispitanici smjeli jesti.
English: Hence, both test and reference products can be considered as having similar food effect in terms of reduction in Cmax and AUC.
Croatian: Stoga se može smatrati da i testni i referentni lijek imaju sličan učinak s hranom u smislu Cmax i AUC smanjenja.
English: • Observed food effect for test and reference products As per the current recommendations for modified release formulations1,2, bioequivalence studies in fasted and fed conditions are required.
Croatian: • Uočeni učinci hrane na testne i referentne lijekove Prema trenutačnim preporukama za formulacije s modificiranim oslobađanjem1,2, potrebna su ispitivanja lijeka u uvjetima natašte i kad je dozvoljena konzumacija hrane.
English: The bioequivalence studies confirmed that dose dumping did not occur with Didanosine and associated names.
Croatian: Ispitivanja bioekvivalencije potvrdila su da se prekomjerno i prebrzo otpuštanje doze lijeka u krv nije dogodilo s didanozinom i pridruženim nazivima.
English: Damle BD et al. Pharmacokinetics and gamma scintigraphy evaluation of two enteric coated formulations of didanosine in healthy volunteers.
Croatian: Pharmacokinetics and gamma scintigraphy evaluation of two enteric coated formulations of didanosine in healthy volunteers.
English: The presented data does not give evidence of in vivo dose-dumping from the formulation under fed conditions.
Croatian: Prikazani podaci ne dokazuju in-vivo naglo i prekomjerno otpuštanje doze iz formulacije u uvjetima kad su ispitanici smjeli jesti.
English: 7 Perry CM, Balfour JA. Didanosine: An Update on its Antiviral Activity, Pharmacokinetic Properties and Therapeutic
Croatian: Didanosine: An Update on its Antiviral Activity, Pharmacokinetic Properties and Therapeutic
English: Chicago 2001 La Porte C et al. Pharmacokinetic interaction study of indinavir/ritonavir and the enteric-coated capsule formulation of didanosine in healthy volunteers.
Croatian: Pharmacokinetic interaction study of indinavir/ritonavir and the enteric-coated capsule formulation of didanosine in healthy volunteers.
English: Therefore, for both the test and the reference product in the fed state the absorption of didanosine decreases which indicate that both products possess similar food effect in terms of reduction in Cmax and AUC with no evidence of dose-dumping.
Croatian: Stoga, i za testni i referentni lijek u stanju kad su ispitanici smjeli jesti, apsorpcija didanozina opada što ukazuje da oba lijeka posjeduju slične učinke kad se uzimaju s hranom u smislu redukcije Cmax i AUC bez dokaza naglog i prekomjernog otpuštanja doze.
English: Schrader S et al.
Croatian: Hernandez-novoa B et al.
English: Hernandez-novoa B et al. Effect of food on the antiviral activity of didanosine enteric-coated capsules: A pilot comparative study.
Croatian: Effect of food on the antiviral activity of didanosine enteric-coated capsules: A pilot comparative study.
English: In the fed study, the results were satisfactory in terms of extent of absorption (i.e. AUC) with 90% CI within standard range of 80.00 - 125.00%.
Croatian: U ispitivanju u kojem je bila dozvoljena konzumacija hrane, rezultati su bili zadovoljavajući u smislu stupnja apsorpcije (tj. AUC) s 90 %-tnim CI-em unutar standardnog raspona od 80,00125,00 %.
English: 2005; 45: 211-218 10 Lopez JC et al. A Cohort Study of the Food Effect on Virological Failure and Treatment Discontinuation in
Croatian: 2005; 45: 211; -218: 10 Lopez JC et al.
English: The fed study was conducted during an extended clock-stop.
Croatian: Ispitivanje u uvjetima kad su ispitanici smjeli jesti provedeno je tijekom produljenja obustave procjene dokumentacije.
English: In the current application, the AUC under both fasted and fed conditions was within the acceptance criteria of 80
Croatian: U trenutačnoj primjeni, u situacijama kad je bolesnik natašte i kad je sit, AUC je bila unutar kriterija prihvatljivosti od 80 do 125 %.
English: 13 Stevens RC et al. Effect of food and pharmacokinetic variability on didanosine systemic exposure in HIV-infected children.
Croatian: CID 2008; 47: 1083; -1092: 13 Stevens RC i suradnici Effect of food and pharmacokinetic variability on didanosine systemic exposure in HIV
English: EU-Number
Croatian: EMEA Broj
English: They should both have the same colour.
Croatian: Moraju oboje biti iste boje.
English: Stand up slowly when you get out of chairs or bed.
Croatian: Polako ustajte kada se dižete sa stolca ili iz kreveta.
English: Do not use a facial mask.
Croatian: Nemojte koristiti masku za lice.
English: The following information is intended for healthcare professionals only: Instructions for use and handling
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Upute za uporabu i rukovanje
English: • if you have a heart problem, such as
Croatian: • ako imate problem sa srcem, kao što je
English: Ventavis with food and drink
Croatian: Ventavis s hranom i pićem
English: How much to inhale and for how long
Croatian: Koju količinu inhalirati i koliko dugo
English: Tell your doctor if you are taking:
Croatian: Obavijestite liječnika ako uzimate:
English: • talk to your doctor
Croatian: • obratite se liječniku
English: He/she will look for the cause and take appropriate measures.
Croatian: Liječnik će utvrditi uzrok i poduzeti odgovarajuće mjere.
English: * Life-threatening and/or fatal cases have been reported.
Croatian: * Prijavljeni su slučajevi opasni po život i/ili smrtni slučajevi.
English: System organ class (MedDRA)
Croatian: Klasifikacija organskih sustava (MedDRA)
English: ACE inhibitors.
Croatian: ACE inhibitori.
English: If it does, rinse the skin or your eyes immediately with plenty of water.
Croatian: Ako se to ipak dogodi, odmah isperite kožu ili oči većom količinom vode.
English: These concentrations decline with half-lives between approximately 5 and 25 minutes.
Croatian: Te se koncentracije smanjuju uz poluvijek između približno 5 i 25 minuta.
English: A specific antidote is not known.
Croatian: Nije poznat specifični antidot.
English: Local tolerance, contact sensitising and antigenicity potential
Croatian: Lokalna podnošljivost, kontaktna senzibilizacija i antigeni potencijal
English: Please ask your doctor what you should do.
Croatian: Molimo zatražite savjet liječnika što trebate napraviti.
English: Your blood pressure may drop much further.
Croatian: Krvni tlak mogao bi Vam se sniziti znatno više.
English: When using the I-Neb AAD system the following instructions need to be followed.
Croatian: Za uporabu sustava I-Neb AAD potrebno je slijediti sljedeće upute.
English: − Myocardial infarction within the last six months.
Croatian: - Infarkt miokarda unutar posljednjih šest mjeseci.
English: If you stop or wish to stop treatment, discuss it with your doctor first.
Croatian: Ako prekinete ili želite prekinuti liječenje, najprije o tome porazgovarajte s Vašim liječnikom.
English: No data from controlled clinical trials are available.
Croatian: Podaci iz kontroliranih kliničkih ispitivanja nisu dostupni.
English: Ventavis and certain other medicines may affect each other in the way they work in your body.
Croatian: Ventavis i određeni drugi lijekovi mogu imati međusobni učinak na način njihova djelovanja u Vašem tijelu.
English: This dose should be maintained.
Croatian: Ta se doza mora održavati.
English: PPH is a category of pulmonary hypertension where the cause of the high blood pressure is not known.
Croatian: PPH je vrsta plućne hipertenzije kod koje uzrok povišenog krvnog tlaka nije poznat.
English: Ventavis is used to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Croatian: Ventavis se koristi za poboljšanje tjelesne sposobnosti (mogućnosti obavljanja fizičkih aktivnosti) i simptoma.
English: No unchanged substance is eliminated.
Croatian: Nepromijenjena se supstancija ne izlučuje.
English: The main metabolite is tetranor-iloprost, which is found in the urine in free and conjugated form.
Croatian: Glavni metabolit je tetranoriloprost, koji je pronađen u urinu u slobodnom i konjugiranom obliku.
English: • If you are pregnant, think you might be or are planning to have a baby, tell your doctor straight away.
Croatian: • Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, odmah o tome obavijestite svog liječnika.
English: 3 minutes
Croatian: 3 minute
English: • If you could get pregnant, use reliable contraception from the time you start treatment and during treatment.
Croatian: • Ako biste mogli zatrudnjeti, koristite pouzdanu kontracepciju od početka liječenja i tijekom liječenja.
English: If you feel that the effect of Ventavis is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako osjećate da je učinak lijeka Ventavis presnažan ili preslab, obratite se liječniku ili ljekarniku.
English: Your doctor will monitor you and treat any resulting symptoms.
Croatian: Liječnik će Vas pratiti i liječiti nastale simptome.
English: Date of first authorisation: 16 September 2003 Date of latest renewal: 26 August 2013
Croatian: Datum posljednje obnove odobrenja: 26. kolovoza 2013.
English: The following serious side effects may occur.
Croatian: Mogu se pojaviti sljedeće ozbiljne nuspojave.
English: Below we list other possible side effects by how likely they are:
Croatian: U nastavku se nalazi popis drugih mogućih nuspojava prema vjerojatnosti njihove pojave:
English: Most people will have 6 to 9 inhalation sessions spread throughout the day.
Croatian: Većina osoba će imati 6 do 9 inhalacija raspoređenih tijekom cijelog dana.
English: The following pharmacological effects have been observed in vitro:
Croatian: Sljedeći su farmakološki učinci opaženi in vitro:
English: If you swallow it accidentally, drink plenty of water and tell your doctor.
Croatian: Ako je slučajno progutate, popijte veću količinu vode i obratite se svom liječniku.
English: Contents of the pack and other information What Ventavis contains:
Croatian: Sadržaj pakiranja i druge informacije Što Ventavis sadrži:
English: Stop using Ventavis and tell your doctor immediately.
Croatian: Prestanite uzimati Ventavis i odmah se obratite svom liječniku.
English: If you tend to faint as soon as you get out of bed, it may be helpful to take your first dose of the day while you are still lying down.
Croatian: Ako ste skloni nesvjestici čim ustanete iz kreveta, možda će pomoći uzimanje prve doze u danu dok se još nalazite u ležećem položaju.
English: Elderly Pharmacokinetics in elderly patients have not been investigated.
Croatian: Starije osobe Farmakokinetika u starijih bolesnika nije ispitivana.
English: § see section “Description of selected adverse reactions”
Croatian: § vidjeti dio „Opis odabranih nuspojava“
English: Pharmacokinetics after use with different nebulisers
Croatian: Farmakokinetika nakon primjene s različitim nebulizatorima
English: Interruption of the inhalation session, monitoring and symptomatic measures are recommended.
Croatian: Preporučuju se prekid inhalacije, nadzor i simptomatske mjere.
English: Other nebulising systems
Croatian: Drugi nebulizatorski sustavi
English: • awareness of fast or hard heartbeat (palpitations)
Croatian: • svjesnost o brzim ili jakim otkucajima srca (palpitacije)
English: How to inhale
Croatian: Kako inhalirati
English: The duration of treatment depends on clinical status and is left to the physician's discretion.
Croatian: Trajanje liječenja ovisi o kliničkom statusu i odluka o tome prepuštena je liječniku.
English: A mass-balance study was done using 3H-iloprost in healthy subjects.
Croatian: Ispitivanje masene bilance provedeno je primjenom 3H-iloprosta u zdravih ispitanika.
English: The need to adapt and/or change the therapy should be considered (see section 4.8).
Croatian: U takvim slučajevima potrebno je razmotriti prilagodbu i/ili promjenu terapije (vidjeti dio 4.8).
English: Use dosing intervals of 3 - 4 hours (this corresponds to a maximum of 6 administrations per day).
Croatian: Koristite intervale od 3 - 4 sata (što odgovara primjeni od maksimalno 6 puta na dan).
English: The active substance can be delivered more rapidly to your lungs.
Croatian: Djelatna tvar može brže doprijeti u Vaša pluća.