FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Tenofovir disoproxil Zentiva, tenofovir disoproxil, is a ‘prodrug' that is converted into tenofovir in the body.
Croatian: Djelatna tvar u lijeku Tenofovir disoproxil Zentiva, tenofovirdizoproksil, je „prolijek” koji se u tijelu pretvara u tenofovir.
English: Tenofovir disoproxil Zentiva is also used to treat chronic (long-term) hepatitis B virus infection in adults and adolescents aged 12 years and above with liver damage whose liver is still able to work (compensated liver disease).
Croatian: Lijek Tenofovir disoproxil Zentiva upotrebljava se i za liječenje kronične (dugotrajne) infekcije virusom hepatitisa B u odraslih i adolescenata u dobi od 12 godina i starijih s oštećenjem jetre, ali čija jetra i dalje dobro funkcionira (kompenzirana bolest jetre).
English: Because Tenofovir disoproxil Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Tenofovir disoproxil Zentiva generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: For more information about treatment with Tenofovir disoproxil Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Tenofovir disoproxil Zentiva pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: Tenofovir disoproxil Zentiva is used in combination with other HIV medicines.
Croatian: Lijek Tenofovir disoproxil Zentiva upotrebljava se u kombinaciji s drugim lijekovima za liječenje HIV-a.
English: What measures are being taken to ensure the safe and effective use of Tenofovir disoproxil Zentiva?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tenofovir disoproxil Zentiva?
English: Tenofovir disoproxil Zentiva tenofovir disoproxil
Croatian: Tenofovir disoproxil Zentiva tenofovirdizoproksil
English: For more information on how the medicine is taken including doses for adults and adolescents, see the summary of product characteristics (also part of the EPAR).
Croatian: Dodatne informacije o uzimanju lijeka i doziranju za odrasle i adolescente možete potražiti u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: It is not intended to provide practical advice on how to use Tenofovir disoproxil Zentiva.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Tenofovir disoproxil Zentiva.
English: What is Tenofovir disoproxil Zentiva and what is it used for?
Croatian: Što je Tenofovir disoproxil Zentiva i za što se koristi?
English: Because Tenofovir disoproxil Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viread.
Croatian: Budući da je lijek Tenofovir disoproxil Zentiva generički lijek, ispitivanja na ljudima bila su ograničena na ispitivanja za utvrđivanje bioekvivalentnosti s referentnim lijekom Viread.
English: The dose may need to be reduced or the medicine given less often in patients who have moderately or severely reduced kidney function.
Croatian: Bolesnicima s umjerenim ili teškim oštećenjem funkcije bubrega dozu je možda potrebno smanjiti ili rjeđe davati.
English: Other information about Tenofovir disoproxil Zentiva
Croatian: Ostale informacije o lijeku Tenofovir disoproxil Zentiva
English: For practical information about using Tenofovir disoproxil Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Tenofovir disoproxil Zentiva pročitajte u uputi o lijeku ili se obratite svojem liječniku ili ljekarniku.
English: What are the benefits and risks of Tenofovir disoproxil Zentiva?
Croatian: Koje su koristi i rizici lijeka Tenofovir disoproxil Zentiva?
English: Therefore, the CHMP's view was that, as for Viread, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da koristi nadmašuju utvrđene rizike, kao i kod lijeka Viread.
English: Why is Tenofovir disoproxil Zentiva approved?
Croatian: Zašto je lijek Tenofovir disoproxil Zentiva odobren?
English: Tenofovir disoproxil Zentiva contains the active substance tenofovir disoproxil.
Croatian: Lijek Tenofovir disoproxil Zentiva sadrži djelatnu tvar tenofovirdizoproksil.
English: How is Tenofovir disoproxil Zentiva used?
Croatian: Kako se koristi Tenofovir disoproxil Zentiva?
English: Invented name
Croatian: (Zaštićeno) ime Doza
English: Co. Tipperary E91 D768
Croatian: Tipperary E91 D768
English: Annex I List of medicinal products and presentations
Croatian: Popis lijekova i oblika
English: Immediate Packaging
Croatian: Primarno pakiranje
English: 25 June 2015
Croatian: 25. lipnja 2015.
English: Outcome of procedures 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 adopted a decision on this opinion on 25 June 2015.
Croatian: Europska Komisija usvojila je odluku o ovom mišljenju dana 25. lipnja 2015.
English: The company wanted the authorisation to be recognised in Belgium, Germany, Luxembourg and the Netherlands (the ‘concerned Member States').
Croatian: Tvrtka je zatražila priznavanje odobrenja za lijekove u Belgiji, Njemačkoj, Luksemburgu i Nizozemskoj ("državama članicama u postupku").
English: However, the Member States were not able to reach an agreement and the German and Dutch medicines regulatory agencies referred the matter to the CHMP for arbitration on 24 December 2014.
Croatian: No, države članice nisu bile u stanju postići dogovor, te je regulatorne agencije za lijekove Njemačke i Nizozemske uputile predmet CHMP-u na arbitražu dana 24. prosinca 2014. godine.
English: EMA/252261/2015 rev.1 EMEA/H/A-29/1411
Croatian: EMA/252261/2015 EMEA/H/C/-30/1411 EMEA/H/C/-30/1412
English: On 23 April 2015, the European Medicines Agency completed two arbitration procedures following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Merisone and Myoson (tolperisone).
Croatian: Dana 23. travnja 2015., Europska agencija za lijekove završila je dva arbitražna postupka nastavno na neslaganje država članica Europske unije (EU) u vezi s odobrenjem za lijekove Merisone i Myoson (tolperizon).
English: Questions and answers on Merisone and Myoson (tolperisone, 50 and 150 mg tablets) EMA/252261/2015
Croatian: Pitanja i odgovori o lijekovima Merisone i Myoson (tolperizon, tablete od 50 i 150 mg) EMA/252261/2015
English: The exact way tolperisone works is not known, but it is thought to act in the brain and spinal cord to reduce the nerve impulses that make the muscles contract and become rigid.
Croatian: Točan način djelovanja nije poznat, no smatra se da djeluje u mozgu i kralježničnoj moždini kako bi smanjio živčane impulse koji kontrahiraju mišiće i postaju kruti.
English: Why were Merisone and Myoson reviewed?
Croatian: Zašto su lijekovi Merisone i Myoson pregledani?
English: By reducing these impulses, tolperisone is believed to reduce muscle contraction and spacticity.
Croatian: Smanjujući ove impulse, vjeruje se da toplerizon smanjuje kontrakciju mišića i spastičnost.
English: Merisone and Myoson are identical medicines that are used to treat muscle spasms (involuntary contractions) and spasticity.
Croatian: Merisone i Myoson su identični lijekovi koji se koriste za liječenje mišićnih spazama (nevoljnih kontrakcija) i spastičnosti.
English: Merisone and Myoson are generic medicines based on a ‘reference medicine', Mydeton, which is already authorised in the EU.
Croatian: Merisone i Myoson su generički lijekovi koji se temelje na "referentnom lijeku", Mydeton, koji je već odobren u EU.
English: Questions and answers on Merisone and Myoson (tolperisone, 50 and 150 mg tablets)
Croatian: Pitanja i odgovori o lijekovima Merisone i Myoson (tolperizon, tablete od 50 i 150 mg)
English: The CHMP therefore recommended that the marketing authorisation be granted in the concerned Member States.
Croatian: CHMP je stoga preporučio izdavanje odobrenja za stavljanje lijeka u promet u državama članicama u postupku.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Merisone and Myoson outweigh their risks, and the marketing authorisation granted in Hungary can be recognised in other Member States of the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da koristi lijekova Merisone i Myoson nadmašuju njihove rizike, te da odobrenje za stavljanje lijekova u promet izdano u Mađarskoj može biti priznato i u drugom država članicama u EU-u.
English: What are Merisone and Myoson?
Croatian: Što su lijekovi Merisone i Myoson?
English: As the product information for Mydeton was recently updated to say that it should be taken with food, Germany and the Netherlands considered that a bioequivalence study under fed conditions would be required for the granting of a marketing authorisation.
Croatian: Budući da su informacije o lijeku za lijek Mydeton nedavno ažurirane te da se u njima navodi da se lijek treba uzimati sa hranom, Njemačka i Nizozemska su zaključile da treba provesti ispitivanje bioekvivaletnosti u uvjetima unosa hrane kako bi se omogućilo izdavanje odobrenja za stavljanje lijeka u promet.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that because of the characteristics of the active substance of Merisone and Myoson food will affect the absorption of the active substance in the same way as for Mydeton and no further studies are required.
Croatian: Na temelju ocjene trenutno dostupnih podataka i znanstvene rasprave unutar Odbora, CHMP je zaključio da će hrana utjecati na apsorpciju djelatne tvari na isti način kao i u slučaju lijeka Mydeton zbog karakteristika djelatne tvari lijekova Merisone i Myoson te da nisu potrebna daljnja ispitivanja.
English: Meditop Pharmaceutical Co. Ltd. submitted Merisone and Myoson for mutual recognition on the basis of their initial authorisation granted by Hungary on 18 March 2010.
Croatian: Ltd. dostavila je lijekove Merisone i Myoson za zajednički postupak priznavanja na temelju njihovog prvotnog odobrenja za stavljanje lijekova u promet izdanog u Mađarskoj dana 18. ožujka 2010.
English: The grounds for the referral were that the bioequivalence studies had only been performed under fasting conditions.
Croatian: Razlozi za pokretanje postupka upućivanja bila su ispitivanja bioekvivaletnosti koja su provedena samo na tašte.
English: The active substance in Merisone and Myoson, tolperisone, is a centrally acting muscle relaxant.
Croatian: Djelatna tvar u lijekovima Merisone i Myoson, tolperizon, je središnje djelujući mišićni relaksans.
English: Because Merisone and Myoson are generic medicines, studies have been limited to tests to determine that they are bioequivalent to the reference medicine, Mydeton.
Croatian: Budući da su Merisone i Myoson generički lijekovi, ispitivanja su bila ograničena na ispitivanja za utvrđivanje njihove bioekvivalentnosti referentnom lijeku Mydeton.
English: The CHMP therefore concluded that in the case of Merisone and Myoson the bioequivalence study in the fasting state is sufficient to conclude on the bioequivalence in both the fasting and fed states and that the benefits and risks of Merisone and Myoson can be taken to be the same as the reference medicine's.
Croatian: Stoga je CHMP zaključio da je u slučaju lijekova Merisone i Myoson dovoljno ispitivanje bioekvivaletnosti provedeno na tašte kako bi se donijeli zaključci o bioekvivaletnosti u stanju bolesnika na tašte i u stanju hranjenja te da se mogu pretpostaviti isti koristi i rizici za lijekove Merisone i Myoson kao i u slučaju referentnog lijeka.
English: % difference
Croatian: % razlike
English: There were no differences in Cmax.
Croatian: Nije bilo razlika u Cmax.
English: This serious allergic reaction needs immediate medical attention.
Croatian: Ova ozbiljna alergijska reakcija zahtijeva hitnu medicinsku intervenciju.
English: QUALITATIVEAND QUANTITATIVE COMPOSITION
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV
English: A course of treatment usually lasts for 1 to 2 weeks for skin infections.
Croatian: Liječenje obično traje 1 do 2 tjedna za infekcije kože.
English: ** See section 4.4.
Croatian: ** Vidjeti dio 4.4.
English: For blood or heart infections and skin infections your doctor will decide how long you should be treated.
Croatian: Za infekcije krvi ili srca te za infekcije kože Vaš liječnik će odlučiti koliko dugo se trebate liječiti.
English: Detailed instructions for use and handling are given at the end of the leaflet.
Croatian: Detaljne upute za uporabu i rukovanje nalaze se na kraju ove upute.
English: - If you have, or have previously had kidney problems.
Croatian: - Ako imate ili ste ranije imali probleme s bubrezima.
English: After cleaning, do not touch the rubber stopper or allow it to touch any other surface.
Croatian: Nakon čišćenja ne dirajte gumeni čep i pazite da ne dodiruje bilo koju drugu površinu.
English: As the pharmacokinetics (see section 5.2) is comparable, the safety margins for both methods of administration are very similar.
Croatian: Budući da je farmakokinetika usporediva (vidjeti dio 5.2), sigurnosne granice za oba načina primjene su vrlo slične.
English: The duration of therapy should be in accordance with available official recommendations.
Croatian: Trajanje terapije treba biti u skladu s dostupnim službenim preporukama.
English: However, there is currently no evidence that a dose reduction is required (see section 5.2).
Croatian: Za sada, međutim, nema dokaza da je potrebno smanjenje doze (vidjeti dio 5.2).
English: Rates (95% CI)
Croatian: Stope (95% CI)
English: If this happens, tell your doctor who will decide whether you should continue the treatment.
Croatian: Ako se to dogodi, obavijestite svog liječnika, koji će odlučiti trebate li nastaviti liječenje.
English: This mode of administration was only studied in healthy subjects.
Croatian: Ovaj način primjene je ispitivan samo u zdravih ispitanika.
English: The results can suggest poor blood clotting when, in fact, there is no problem.
Croatian: Nalazi mogu pokazati da je zgrušavanje krvi slabo, premda, zapravo, nema problema.
English: This interference led to a false prolongation of PT and elevation of INR.
Croatian: Ta je interferencija dovela do lažnog produljenja PV i povećanja INR.
English: Adults (18 years of age and above)
Croatian: Odrasli (u dobi od 18 godina i stariji)
English: Depending on the study duration, all muscle effects, including microscopic changes, were fully reversible within 1-3 months following cessation of dosing.
Croatian: Ovisno o trajanju ispitivanja, svi učinci na mišiće, uključujući mikroskopske promjene, bili su posve reverzibilni unutar 1-3 mjeseca nakon prekida doziranja.
English: - Do not store above 30°C.
Croatian: - Ne čuvati na temperaturi iznad 30C.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: U obzir je potrebno uzeti službene smjernice o odgovarajućoj primjeni antibakterijskih lijekova.
English: Mitochondrial loss/damage was also observed; however the role and significance of this finding in the overall pathology are unknown.
Croatian: Također je zabilježen gubitak/oštećenje mitohondrija, ali uloga i važnost ovog nalaza u sveukupnoj patologiji nisu poznate.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primite ovaj lijek.
English: UNIQUE IDENTIFIER -HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: Daptomycin is an antibacterial that can stop the growth of certain bacteria.
Croatian: Daptomicin je antibakterijska tvar koji može zaustaviti rast određenih bakterija.
English: - If you are very overweight.
Croatian: - Ako ste vrlo pretili.
English: UNIQUE IDENTIFIER -2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: 2 (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP))
Croatian: 2 (povišenje alanin aminotransferaze (ALT), aspartat aminotransferaze (AST) ili alkalne fosfataze (ALP))
English: The results of these studies show that exposures (AUC) in paediatric patients across all doses are generally lower than those in adults at comparable doses.
Croatian: Rezultati ovih ispitivanja pokazuju da je izloženost (AUC) u pedijatrijskih bolesnika pri svim dozama općenito niža od one u odraslih pri usporedivim dozama.
English: However, from a microbiological point of view the product should be used immediately.
Croatian: Međutim, s mikrobiološkog stajališta lijek treba primijeniti odmah.
English: Children and adolescents (1 to 17 years of age)
Croatian: Djeca i adolescenti (u dobi od 1 do 17 godina)
English: This finding was not associated with an effect on muscle contraction.
Croatian: Navedeni nalaz nije povezan s učinkom na kontrakciju mišića.
English: While the exact incidence of eosinophilic pneumonia associated with daptomycin is unknown, to date the reporting rate of spontaneous reports is very low (< 1/10,000).
Croatian: Iako je točna incidencija eozinofilne pneumonije povezane s daptomicinom nepoznata, do sada je stopa prijavljivanja spontanih izvješća bila vrlo niska (< 1/10 000).
English: If superinfection occurs during therapy, appropriate measures should be taken.
Croatian: Ako se tijekom terapije javi suprainfekcija, potrebno je poduzeti odgovarajuće mjere.
English: Commonly Susceptible Species
Croatian: Uobičajeno osjetljive vrste
English: This medicinal product must not be mixed with other medicinal products except those mentioned above.
Croatian: Ovaj se lijek ne smije miješati s drugim lijekovima, osim onih gore navedenih.
English: This should be taken into account when initiating daptomycin therapy and, if daptomycin is given, these patients should be monitored more frequently than once weekly.
Croatian: To je potrebno uzeti u obzir pri uvođenju terapije daptomicinom, a ako se daptomicin daje, te bolesnike treba kontrolirati češće od jedanput tjedno.
English: - Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements.
Croatian: - Neuobičajeni trnci ili utrnulost ruku ili stopala, gubitak osjeta ili poteškoće pri kretanju.
English: Daptomycin Hospira may interfere with laboratory tests that measure how well your blood is clotting.
Croatian: Daptomicin Hospira može utjecati na laboratorijske pretrage koje određuju koliko se dobro Vaša krv zgrušava.
English: - Patients should be reviewed regularly while on therapy for any signs or symptoms that might represent myopathy.
Croatian: - Bolesnike treba tijekom terapije redovito provjeravati radi pojave bilo kojeg znaka ili simptoma koji može ukazivati na miopatiju.
English: Daptomycin Hospira will usually be given to you by a doctor or a nurse.
Croatian: Lijek Daptomicin Hospira će Vam obično davati liječnik ili medicinska sestra.
English: A light yellow to light brown lyophilised cake or powder.
Croatian: Svijetlo žuti do svijetlo smeđi liofilizirani kolačić ili prašak.
English: The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial.
Croatian: Potpuno rekonstituiran lijek izgledat će bistro i može imati nekoliko malenih mjehurića ili pjenu oko ruba bočice.
English: The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is mainly based on pharmacokinetic modelling data.
Croatian: Sigurnost i djelotvornost prilagođavanja intervala doziranja nisu procijenjeni u kontroliranim kliničkim ispitivanjima, a preporuka se uglavnom temelji na podacima rezultata farmakokinetičkih modela.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Other antibacterials, ATC code: J01XX09
Croatian: Farmakoterapijska skupina: Antibakterijski lijekovi za sustavnu primjenu, Ostali antibakterijski lijekovi, ATK oznaka: J01XX09
English: Anxiety, insomnia
Croatian: Anksioznost, nesanica
English: These may be signs of a rare but serious lung disorder called eosinophilic pneumonia.
Croatian: Ovo mogu biti znakovi rijetkog, ali ozbiljnog plućnog poremećaja koji se zove eozinofilna upala pluća.
English: Preparation of the solution for infusion requires an additional dilution step as detailed below.
Croatian: Priprema otopine za infuziju zahtijeva dodatni korak razrjeđivanja, kao što je niže navedeno.
English: The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Croatian: Prevalencija rezistencije određenih vrsta može se razlikovati zemljopisno i tijekom vremena te je stoga poželjno imati lokalne informacije o rezistenciji, posebno pri liječenju teških infekcija.
English: The following adverse reactions were reported during therapy and during follow-up with frequencies corresponding to very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data):
Croatian: Sljedeće nuspojave zabilježene su tijekom terapije i u razdoblju praćenja s učestalošću koja je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i <1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka):
English: Reproductive toxicity testing showed no evidence of effects on fertility, embryofoetal, or postnatal development.
Croatian: Ispitivanje reproduktivne toksičnosti nije pokazalo učinke na plodnost, embriofetalni ni postnatalni razvoj.
English: The primary objective of Study DAP-PEDS-07-03 was to assess the safety of treatment.
Croatian: Primarni cilj ispitivanja DAP-PEDS-07-03 bio je ocijeniti sigurnost liječenja.
English: Daptomycin Hospira is not usually given to pregnant women.
Croatian: Daptomicin Hospira obično se ne daje trudnim ženama.
English: In vitro studies with human hepatocytes indicate that daptomycin does not inhibit or induce the activities of the following human cytochrome P450 isoforms: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 and 3A4.
Croatian: In vitro ispitivanja na ljudskim hepatocitima pokazala su da daptomicin ne inhibira niti inducira aktivnost sljedećih izoenzima ljudskog sustava citokroma P450: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 i 3A4.
English: These transaminase increases were likely to be related to the skeletal muscle effects.
Croatian: Povišene transaminaze su vjerojatno bile povezane s učinkom na skeletne mišiće.
English: *Mean (Standard Deviation) calculated for patients 2 to 6 years of age, since no patients 1 to <2 years of age were enrolled in the study.
Croatian: * Srednja vrijednost (standardna devijacija) izračunata za bolesnike u dobi od 2 do 6 godina, budući da u ispitivanje nisu bili uključeni bolesnici u dobi od 1 do <2 godine.
English: People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
Croatian: Osobe starije od 65 godina mogu primati jednaku dozu kao i druge odrasle osobe, pod uvjetom da im bubrezi dobro rade.
English: The use of antibacterials may promote the overgrowth of non-susceptible micro-organisms.
Croatian: Primjena antimikrobika može pospješiti prekomjeran rast neosjetljivih mikroorganizama.
English: Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.
Croatian: Budući da se radi o spontano prijavljenim nuspojavama unutar populacije neodređene veličine, nije moguće pouzdano procijeniti učestalost pa se ona stoga definira kao nepoznata.