FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the evaluation of the available data, the CVMP considered that the benefit-risk balance for the concerned veterinary medicinal products was negative as, following treatment at recommended doses, barium selenate remains at injection sites for long time periods after treatment and, consequently, consumption of injection-site residues could pose a significant risk to human health.
Croatian: Na temelju ocjene dostupnih podataka, CVMP je zaključio kako je omjer koristi i rizika za predmetne veterinarsko-medicinske proizvode negativan, budući da se, nakon liječenja u preporučenim dozama, barij selenat zadržava u mjestima injekcije tijekom duljih razdoblja nakon liječenja i, posljedično, potrošnja rezidua u mjestu ubrizgavanja može predstavljati značajan rizik za ljudsko zdravlje.
English: The Committee appointed C. Ibrahim as rapporteur and H. Jukes as co-rapporteur.
Croatian: Povjerenstvo je imenovalo C.
English: On 6 November 2013, the CVMP adopted by majority a revised opinion confirming the recommendation included in its opinion of 17 July 2013, that the benefit-risk balance for the concerned veterinary medicinal products was negative and therefore the CVMP recommended the refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisations for the products concerned.
Croatian: Dana 6. studenog 2013., CVMP je većinom usvojio revidirano mišljenje kojim se potvrđuje preporuka uključena u njegovo mišljenje od 17. srpnja 2013., da je omjer koristi i rizika za predmetne veterinarsko-medicinske proizvode negativan, te je stoga CVMP preporučio odbijanje izdavanja odobrenja za stavljanje VMP-a u promet i suspenziju postojećih odobrenja za stavljanje VMP-a u promet za predmetne proizvode.
English: Germany referred the matter to the CVMP due to serious human health concerns related to exposure to injection site residues from the use of long-acting barium selenatecontaining injectable veterinary medicinal products.
Croatian: Njemačka je uputila predmet CVMP-u zbog ozbiljne zabrinutosti za ljudsko zdravlje povezano s izlaganjem reziduima u mjestu injekcije uslijed primjene injektabilno veterinarsko-medicinskih proizvoda koji sadrže dugodjelujući barij selenat.
English: On 17 July 2013, the CVMP adopted by majority an opinion confirming the recommendation for suspension of the marketing authorisations for the concerned veterinary medicinal products.
Croatian: Dana 17. srpnja 2013., CVMP je većinom usvojio mišljenje kojim se potvrđuje preporuka za suspenziju odobrenja za stavljanje VMP-a u promet za predmetne veterinarsko-medicinske proizvode.
English: Selenium is an essential micronutrient for both animals and man. Barium selenate has been used in slow-release injectable veterinary medicinal products for therapeutic and prophylactic use against selenium deficiencies in cattle and sheep.
Croatian: Barij selenat korišten je u injektabilnim veterinarsko-medicinskim proizvodima sa sporim otpuštanjem za terapijsku i profilaktičku uporabu kod nedostatka selena u goveda i ovaca.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the condition to lift the suspension of the marketing authorisations in Annex III.
Croatian: Znanstveni su zaključci navedeni u Dodatku II, zajedno s uvjetom za ukidanje suspenzije za odobrenja za stavljanje VMP-a u promet koji je naveden u Dodatku III.
English: Opinion following an Article 351 referral for long-acting formulations for injection containing barium selenate for all food producing species
Croatian: Mišljenje nakon provedenog postupka upućivanja sukladno članku 35.1 za dugodjelujuće formulacije za injekcije koje sadrže barijev selenat za sve vrste koje se koriste u proizvodnji hrane
English: The Committee therefore adopted by majority a negative opinion on 10 April 2013, recommending suspension of the marketing authorisations for all concerned products.
Croatian: Direktive 2001/82/EC, s dopunama dana 10. travnja 2013. godine, Povjerenstvo je većinom usvojilo negativno mišljenje, te preporučilo suspenziju odobrenja za stavljanje VMP-a u promet za sve predmetne proizvode.
English: On 14 September 2011, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all long-acting formulations for injection containing barium selenate for all food producing species.
Croatian: Direktive 2011/82/EZ, u vezi s dugodjelujućim formulacijama za injekcije koje sadrže barijev selenat za sve vrste koje se koriste u proizvodnji hrane.
English: An oral explanation was given by the applicant/marketing authorisation holders on 6 March 2013.
Croatian: Podnositelj zahtjeva/nositelji odobrenja za stavljanje VMP-a u promet iznijeli su usmeno pojašnjenje dana 6. ožujka
English: 29 January 2016
Croatian: 04. travnja 2016.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Lithuania) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Bulgaria, Estonia, Hungary, Latvia, Poland and Romania).
Croatian: To je postupak kojim jedna država članica („referenta država članica”, u ovom slučaju Litva) ocjenjuje lijek radi izdavanja odobrenja za stavljanje lijeka u promet koje će biti na snazi u toj zemlji te u drugim državama članicama („članicama sudionicama u postupku”, u ovom slučaju Bugarskoj, Estoniji, Mađarskoj, Latviji, Poljskoj i Rumunjskoj).
English: On 28 January 2015, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Tobramycin VVB.
Croatian: Europska agencija za lijekove završila je 28. siječnja 2015. arbitražni postupak koji je pokrenut zbog neslaganja među državama članicama Europske unije (EU) u vezi s odobrenjem za lijek Tobramycin VVB.
English: EMEA/H/A-29/1428
Croatian: EMA/55653/2016 Rev.1 EMEA/H/A-29/1428
English: However, the Member States were not able to reach an agreement and the Lithuanian medicines regulatory agency referred the matter to the CHMP for arbitration on 14 October 2015.
Croatian: Međutim, države članice nisu uspjele postići dogovor i stoga je litavska regulatorna agencija za lijekove uputila predmet CHMP-u na arbitražu 14. listopada 2015.
English: What is Tobramycin VVB?
Croatian: Što je Tobramycin VVB?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Tobramycin VVB can be granted marketing authorisation in Lithuania and in the following Member States of the EU: Bulgaria, Estonia, Hungary, Latvia, Poland and Romania.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da se odobrenje za stavljanje u promet lijeka Tobramycin VVB može izdati u Litvi te u sljedećim državama članicama EUa: Bugarskoj, Estoniji, Mađarskoj, Latviji, Poljskoj i Rumunjskoj.
English: UAB VVB submitted Tobramycin VVB to the Lithuanian medicines regulatory agency for a decentralised procedure.
Croatian: Tvrtka UAB VVB dostavila je lijek Tobramycin VVB litavskoj regulatornoj agenciji za lijekove radi decentraliziranog postupka.
English: Demonstration of clinical superiority is required because Tobi Podhaler is an orphan medicine and was granted market exclusivity in the EU at the time of its market authorisation in July 2011.
Croatian: Dokazivanje kliničke nadređenosti potrebno je jer je Tobi Podhaler lijek za liječenje rijetkih bolesti za koji je odobrena tržišna ekskluzivnost u EU-u trenutku izdavanja odobrenja za njegovo stavljanje u promet u srpnju 2011.
English: Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily and cause infections.
Croatian: Cistična fibroza nasljedna je bolest pri kojoj dolazi do nakupljanja guste sluzi u plućima što omogućuje brži rast bakterija i prouzročuje infekcije.
English: It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria which eventually kills them.
Croatian: Djeluje tako da ometa proizvodnju proteina koji su bakterijama P. aeruginosa potrebni za izgradnju staničnih stijenki, čime prouzročuje oštećivanje bakterija, a u konačnici i njihovo uništavanje.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Tobramycin VVB is clinically superior to Tobi Podhaler because a substantial proportion of patients are intolerant to Tobi Podhaler but can be treated with Tobramycin VVB.
Croatian: Na temelju procjene trenutačno dostupnih podataka i znanstvenih rasprava vođenih u Odboru, CHMP je zaključio da je lijek Tobramycin VVB klinički nadređen lijeku Tobi Podhaler jer znatan broj bolesnika ne podnosi Tobi Podhaler, ali se mogu liječiti lijekom Tobramycin VVB.
English: Tobramycin VVB is an antibiotic for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged 6 years and older who have cystic fibrosis.
Croatian: Tobramycin VVB je antibiotik za liječenje dugoročne upale pluća prouzročene bakterijom Pseudomonas aeruginosa u bolesnika u dobi od 6 godina i starijih koji imaju cističnu fibrozu.
English: A European Commission decision on this opinion will be issued in due course.
Croatian: Europska je komisija odluku o tom mišljenju objavila 04. travnja 2016.
English: Why was Tobramycin VVB reviewed?
Croatian: Zašto je lijek Tobramycin VVB ponovno ocjenjivan?
English: The active substance in Tobramycin VVB, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Croatian: Djelatna tvar u lijeku Tobramycin VVB, tobramicin, ubraja se u skupinu antibiotika poznatih pod nazivom „aminoglikozidi”.
English: Tobramycin VVB is to be available as a nebuliser solution (300 mg/5 ml) to be inhaled.
Croatian: Lijek Tobramycin VVB dostupan je kao otopina za nebulizator (300 mg/5 ml) koja se inhalira.
English: Tobramycin VVB is a ‘hybrid medicine' that has been developed to be comparable to a ‘reference medicine' containing tobramycin called Tobi (300 mg/5 ml nebuliser solution).
Croatian: Tobramycin VVB je „hibridni lijek” koji je razvijen kako bi bio usporediv s „referentnim lijekom” koji sadržava tobramicin, a koji se naziva Tobi (otopina za nebulizator 300 mg/5 ml).
English: The CHMP therefore recommended that Tobramycin VVB be granted marketing authorisation in Lithuania as well as in the other concerned Member States.
Croatian: CHMP je stoga preporučio izdavanje odobrenja za stavljanje lijeka Tobramycin VVB u promet u Litvi te u drugim članicama sudionicama u postupku.
English: The reason for the referral was a disagreement over whether Tobramycin VVB is clinically superior to Tobi Podhaler, another medicine containing tobramycin.
Croatian: Predmet je upućen na arbitražu zbog neslaganja u vezi oko pitanja je li lijek Tobramycin VVB klinički nadređen lijeku Tobi Podhaler, drugom lijeku koji sadržava tobramicin.
English: This means that during the period of market exclusivity similar products, such as Tobramycin VVB, cannot be placed on the market; there are, however, exceptions such as where clinically superiority over Tobi Podhaler can be shown.
Croatian: To znači da se u razdoblju kada je na snazi odobrenje za tržišnu ekskluzivnost slični proizvodi, kao što je Tobramycin VVB, ne smiju stavljati u promet.
English: budesonide / formoterol
Croatian: budezonid / formoterol
English: The full EPAR and risk management plan summary for Budesonide/Formoterol Teva Pharma B.V. can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i plan upravljanja rizicima za lijek Budesonide/Formoterol Teva Pharma B.V. nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva Pharma B.V. 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je potvrđeno da Budesonide/Formoterol Teva Pharma B.V. od 160/4.5 mikrograma i 320/9 mikrograma posjeduje usporedivu kvalitetu te je bioekvivalentan lijeku Symbicort Turbohaler odgovarajuće jačine.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Budesonide/Formoterol Teva Pharma B.V. is given using a different inhaler.
Croatian: To znači da je sličan „referentom lijeku” koji sadrži iste djelatne tvari, no Budesonide/Formoterol Teva Pharma B.V. primjenjuje se pomoću drugog inhalatora.
English: The two active substances in Budesonide/Formoterol Teva Pharma B.V. are well known and are present in several medicines used to treat asthma, either alone or in combination with other medicines.
Croatian: Dvije djelatne tvari lijeka Budesonide/Formoterol Teva Pharma B.V. dobro su poznate i prisutne u nekoliko lijekova koji se koriste za liječenje astme, samostalno ili u kombinaciji s drugim lijekovima.
English: Studies were carried out to show that Budesonide/Formoterol Teva Pharma B.V. is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way.
Croatian: Provedena su ispitivanja kako bi se dokazalo da je lijek Budesonide/Formoterol Teva Pharma B.V. bioekvivalentan referentnom lijeku (odnosno da stvara iste razine djelatne tvari u organizmu) te da dva lijeka djeluju na isti način.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Budesonide/Formoterol Teva Pharma B.V., including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Budesonide/Formoterol Teva Pharma B.V. nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Budesonide/Formoterol Teva Pharma B.V. on 19 November 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Budesonide/Formoterol Teva Pharma B.V. na snazi u Europskoj uniji od 19. studenoga 2014.
English: Budesonide/Formoterol Teva Pharma B.V. can be used for the regular treatment of asthma.
Croatian: Budesonide/Formoterol Teva Pharma B.V. može se koristiti za redovito liječenje astme.
English: For more information about treatment with Budesonide/Formoterol Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Budesonide/Formoterol Teva Pharma B.V. pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: This is a summary of the European public assessment report (EPAR) for Budesonide/Formoterol Teva Pharma B.V.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Budesonide/Formoterol Teva Pharma B.V.
English: The reference medicine for Budesonide/Formoterol Teva Pharma B.V. is Symbicort Turbohaler.
Croatian: Referentni lijek za Budesonide/Formoterol Teva Pharma B.V. je Symbicort Turbohaler.
English: What measures are being taken to ensure the safe and effective use of Budesonide/Formoterol Teva Pharma B.V.?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Budesonide/Formoterol Teva Pharma B.V.?
English: It is not intended to provide practical advice on how to use Budesonide/Formoterol Teva Pharma B.V.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Budesonide/Formoterol Teva Pharma B.V.
English: Budesonide/Formoterol Teva Pharma B.V. is a medicine that contains the active substances budesonide and formoterol.
Croatian: Budesonide/Formoterol Teva Pharma B.V. je lijek koji sadrži djelatne tvari budezonid i formoterol.
English: For practical information about using Budesonide/Formoterol Teva Pharma B.V., patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Budesonide/Formoterol Teva Pharma B.V. pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: What is Budesonide/Formoterol Teva Pharma B.V. and what is it used for?
Croatian: Što je Budesonide/Formoterol Teva Pharma B.V. i za što se koristi?
English: Budesonide/Formoterol Teva Pharma B.V. is a ‘hybrid medicine'.
Croatian: Budesonide/Formoterol Teva Pharma B.V. je „hibridni lijek”.
English: What are the benefits and risks of Budesonide/Formoterol Teva Pharma B.V.?
Croatian: Koje su koristi i rizici lijeka Budesonide/Formoterol Teva Pharma B.V.?
English: A risk management plan has been developed to ensure that Budesonide/Formoterol Teva Pharma B.V. is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Budesonide/Formoterol Teva Pharma B.V.
English: The Committee recommended that Budesonide/Formoterol Teva Pharma B.V. be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Budesonide/Formoterol Teva Pharma B.V.
English: Other information about Budesonide/Formoterol Teva Pharma B.V.
Croatian: Ostale informacije o lijeku Budesonide/Formoterol Teva Pharma B.V.
English: The benefits and risks of Budesonide/Formoterol Teva Pharma B.V. are therefore taken to be the same as those of the reference medicine.
Croatian: Pretpostavlja se stoga da su koristi i rizici lijeka Budesonide/Formoterol Teva Pharma B.V. isti kao i rizici i koristi referentnog lijeka.
English: Why is Budesonide/Formoterol Teva Pharma B.V. approved?
Croatian: Zašto je Budesonide/Formoterol Teva Pharma B.V. odobren?
English: How is Budesonide/Formoterol Teva Pharma B.V. used?
Croatian: Kako se Budesonide/Formoterol Teva Pharma B.V. koristi?
English: How does Budesonide/Formoterol Teva Pharma B.V. work?
Croatian: Kako Budesonide/Formoterol Teva Pharma B.V. djeluje?
English: - You should not go home unaccompanied.
Croatian: - Ne smijete ići kući bez pratnje.
English: However, the majority were within 12 hours.
Croatian: Većina se, međutim, oporavila u roku od 12 sati.
English: Dexdor is diluted and it is given to you as an infusion (drip) into your veins.
Croatian: Dexdor se razrjeđuje te vam se daje u obliku infuzije (ukapavanja) u venu.
English: Data on treatment for > 24 hours is not available.
Croatian: Podaci o liječenju >24 sata nisu dostupni.
English: Date of latest renewal: 26 May 2016
Croatian: Datum posljednje obnove: 26 svibnja 2016
English: Under 1 month 1 to < 6 months 6 to < 12 months 12 to < 24 months 2 to < 6 years 6 to < 17 years
Croatian: Ispod 1 mjeseca 1do < 6 mjeseci 6 do < 12 mjeseci 12 do < 24 mjeseci 2 do < 6 godina 6 do < 17 godina
English: Adequate data is not available.
Croatian: Nisu dostupni adekvatni podaci.
English: - The doctor will keep you under medical supervision for some hours after the sedation to make sure that you feel well.
Croatian: - Liječnik će vas držati pod medicinskim nadzorom još nekoliko sati nakon sedacije da bi bio siguran da se osjećate dobro.
English: A risk to infants cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenčad.
English: Ask your doctor when you can start doing these activities again and when you can go back to this kind of work.
Croatian: Pitajte svojeg liječnika kada možete ponovno nastaviti s tim aktivnostima i vratiti se na takva radna mjesta.
English: A dose reduction should be considered.
Croatian: Potrebno je razmotriti smanjenje doze.
English: The clinical significance is unknown.
Croatian: Klinički značaj nije poznat.
English: The available data is summarised in the following table;
Croatian: Dostupni podaci sažeti su u sljedećoj tablici;
English: The safety and efficacy of Dexdor in children aged 0 to 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Dexdor u djece u dobi od 0 do 18 godina nisu još ustanovljene.
English: Uncontrolled hypotension.
Croatian: Nekontrolirana hipotenzija.
English: Mean (95% CI)
Croatian: Srednja vrijednost (95% CI)
English: Not known (frequency cannot be estimated from the available data) - increased need to pass urine
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka) - pojačana potreba za mokrenjem
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2 međutim nije moguće dati preporuku o doziranju.
English: The use in other environments is not recommended.
Croatian: Upotreba u drugim uvijetima se ne preporučuje.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primati ovaj lijek jer sadrži vama važne podatke.
English: For hospital use only.
Croatian: Samo za primjenu u bolnici.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se treba upotrijebiti odmah.
English: Other medicines and Dexdor
Croatian: Drugi lijekovi i Dexdor
English: Talk to your doctor about the use of these medicines and about the use of alcohol.
Croatian: S liječnikom razgovarajte o upotrebi tih lijekova i uzimanju alkohola.
English: Supplemental oxygen should be immediately available and provided when indicated.
Croatian: Dopunski kisik mora biti odmah dostupan i primijenjen kada je indicirano.
English: These metabolites have negligible pharmacological activity.
Croatian: Ovi metaboliti imaju zanemarivo farmakološko djelovanje.
English: - if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na deksmedetomidin ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6)
English: These effects were associated with clear maternal toxicity.
Croatian: Ti su učinci povezani s očitom toksičnošću za majke.
English: After dose adjustment, a new steady state sedation level may not be reached for up to one hour.
Croatian: Nakon prilagođavanja doze, možda nova stabilna razina sedacije možda neće biti postignuta do sat vremena.
English: A reduced maintenance dose may be considered (see sections 4.4 and 5.2).
Croatian: Može se razmotriti smanjena doza održavanja (vidjeti dio 4.4 i 5.2).
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Croatian: Kemijska i fizikalna stabilnost u upotrebi dokazana je u trajanju od 24 sata pri 25°C.
English: In healthy volunteers it exhibits a rapid distribution phase with a central estimate of the distribution half-life (t1/2α) of about 6 minutes.
Croatian: Kod zdravih dobrovoljaca on pokazuje brzu fazu distribucije s centralnom procjenom poluvremena distribucije (t1/2α) od približno 6 minuta.
English: Your doctor will know how to treat you based on your condition.
Croatian: Vaš će liječnik znati kako vas, s obzirom na vaše stanje, liječiti.
English: Acute cerebrovascular conditions.
Croatian: Akutna cerebrovaskularna stanja.
English: - if you have recently had a stroke or other serious condition affecting blood supply to the brain.
Croatian: - ako ste nedavno imali moždani udar ili drugo teško stanje koje je utjecalo na dotok krvi u mozak.
English: Your doctor will decide on a suitable dose for you.
Croatian: Vaš će liječnik odrediti koja vam doza odgovara.
English: Ask your doctor for advice before having this medicine
Croatian: Obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.