natgillin/translations-raw huggingface dataset:
The MAHs disagreed with the CHMP that the evidence that supported the authorisation of omega-3 in secondary prevention after MI suffered from some methodological limitations and was weak and that the efficacy in this indication was not demonstrated in subsequent and more robust clinical trials.
Nositelji odobrenja za stavljanje u promet nisu se složili s CHMP-om da dokaz na koji se oslanja dano odobrenje za primjenu omega-3 u sekundarnoj prevenciji nakon infarkta miokarda ima stanovita metodološka ograničenja, da je dokaz slab i da djelotvornost u toj indikaciji nije dokazana kasnijim robusnijim kliničkim ispitivanjima.
The results of the meta-analyses by Aung et al. and the recent Cochrane review, even though they include trials with products, doses and populations not exactly representing the approved secondary prevention indication, are considered relevant as all studies include patients with cardiovascular disease and therefore are supportive of lack of efficacy.
Rezultati metaanaliza koje su proveli Aung et al. te pregled novije Cochraneove baze podataka, iako se odnose na ispitivanja u kojima lijekovi, doze i populacije nisu točno reprezentativni za indikaciju sekundarne prevencije, smatraju se važnima jer sva ispitivanja uključuju bolesnike s kardiovaskularnim bolestima i stoga podržavaju nedostatak djelotvornosti.
The results of the recently published REDUCE-IT trial are of limited relevance since the daily dose was much higher than the dose of the indication under review (4 g vs. 1 g) and the active substance was icosapent ethyl, a highly purified EPA ethyl ester, instead of a mixture of EPA and DHA.
Rezultati nedavno objavljenog ispitivanja REDUCE-IT ograničenog su značaja jer je dnevna doza mnogo viša od one za razmatranu indikaciju (4 g naspram 1 g), a djelatna je tvar bila ikosapent etil, visoko pročišćen EPA etilni ester umjesto mješavine kiselina EPA i DHA.
A meta-analysis using individual participant data (IPD), selecting patients with a history of MI and treated with the same dose as for the indication under review (1 g) would have been more appropriate.
Bila bi prikladnija metaanaliza podataka pojedinačnih ispitanika izborom bolesnika s infarktom miokarda u povijesti bolesti i liječenih dozom jednakom onoj određenoj za indikaciju koja se razmatra (1 g).
The issue is highlighted by the fact that omega-3 acid ethyl esters had little effect when compared to the Vitamin E arm in the same trial.
Tome se dodaje i činjenica da je učinak etilnih estera omega-3 kiselina bio mali u usporedbi sa skupinom koja je u istom ispitivanju primala vitamin E.
The results of RECUCE-IT study results are of limited relevance since the daily dose was much higher than the dose of the indication under review (4 g vs 1 g) and the active substance was icosapent ethyl, a highly purified EPA ethyl ester, instead of a mixture of EPA and DHA.
Rezultati ispitivanja REDUCE-IT ograničene su važnosti jer je dnevna doza bila mnogo viša od one za razmatranu indikaciju (4 g naspram 1 g), a djelatna je tvar bila ikosapent etil, visoko pročišćen EPA etilni ester umjesto mješavine kiselina EPA i DHA.
Treatment with icosapent ethyl 4g/day was associated with an increase in hospitalization for atrial fibrillation of flutter in the REDUCE-IT trial.
U ispitivanju REDUCE-IT liječenje ikosapent etilom, u dozi od 4 g dnevno, bilo je povezano s većim brojem hospitalizacija zbog fibrilacije atrija ili nepravilnog ritma.
The latter concern also applies to post-hoc analyses in patients with or without anti-platelet medicinal products, betablockers or ACE-inhibitors.
To pitanje odnosi se i na post hoc analize podataka bolesnika koji su primali ili nisu primali antitrombotike, beta-blokatore ili ACE inhibitore.
In addition, in other prospective randomised trials performed after the original approval (GISSI-HF, ORIGIN study and SU.FOL.OM3 performed between 2003 and 2012), as well as in meta-analyses (e.g. by Aung et al. 20184), the results from the GISSI-P study could also not be reproduced.
Osim toga, rezultati ispitivanja GISSI-P nisu mogli biti ponovljeni ni drugim prospektivnim randomiziranim ispitivanjima provedenima nakon prvobitnog odobrenja (ispitivanja GISSI-HF, ORIGIN i SU.FOL.OM3 provedena su između 2003. i 2012. godine), kao ni metaanalizama (npr. one koju su proveli Aung et al.
The provided meta-analyses showed both positive and negative effects of omega-3 fatty acid treatment on the risk of cardiovascular events.
Provedene metaanalize pokazale su da terapija omega-3 masnim kiselinama ima i pozitivne i negativne učinke na rizik od kardiovaskularnih događaja.
The key concern of this study is that standard of care for the treatment of MI has evolved since the outcome of the GISSI-P trial in particular statin therapy, beta-blocker therapy and invasive treatment.
Ključno sporno pitanje u odnosu na to ispitivanje bio je razvoj standardne skrbi za liječenje infarkta miokarda koji je uslijedio nakon rezultata ispitivanja GISSI-P, posebice terapija statinima, terapija beta-blokatorima i invazivno liječenje.
PLoS One.
Prilog II.
Raitt MH, Connor WE, Morris C, Kron J, Halperin B, Chugh SS, McClelland J, Cook J, MacMurdy K, Swenson R, Connor SL, Gerhard G, Kraemer DF, Oseran D, Marchant C, Calhoun D, Shnider R, McAnulty J. Fish oil supplementation and risk of ventricular tachycardia and ventricular fibrillation in patients with implantable defibrillators: a randomized controlled trial.
Raitt MH, Connor WE, Morris C, Kron J, Halperin B, Chugh SS, McClelland J, Cook J, MacMurdy K, Swenson R, Connor SL, Gerhard G, Kraemer DF, Oseran D, Marchant C, Calhoun D, Shnider R, McAnulty J.
Grounds for re-examination have been submitted by BASF AF and ALFASIGMA S.p.A, representing eleven MAHs.
Razloge za preispitivanje mišljenja dostavile su tvrtke BASF AF i ALFASIGMA
This included the responses submitted by the marketing authorisation holders in writing and during an Oral Explanation, as well as the outcome of the consultation with the Cardiovascular Scientific Advisory Group on the 10 of October 2018.
To je uključivalo odgovore nositelja odobrenja za stavljanje lijeka u promet, dostavljene u pisanom obliku i iznesene tijekom usmenog obrazloženja, kao i rezultat konzultacija sa Znanstvenom savjetodavnom skupinom za kardiovaskularna pitanja 10. listopada 2018. CHMP je također razmotrio razloge koje su dostavili nositelji odobrenja kao temelj zahtjeva za preispitivanje preporuka CHMP-a kao i mišljenja Znanstvene savjetodavne skupine iznesena na drugom sastanku 19. ožujka 2019.
beneficial effect of omega-3 for secondary prevention after myocardial infarction at the dose of 1 g/day is weak.
Konačno, dokazi koji proizlaze iz ispitivanja GISSI-P i podržavaju koristan učinak omega-3 za sekundarnu prevenciju nakon infarkta miokarda u dozi od 1 g na dan, slabe su razine.
Therefore, these results do not support an effect in secondary prevention after MI.
Stoga ti rezultati ne podržavaju učinak u sekundarnoj prevenciji nakon infarkta miokarda.
The MAHs have described the results from different RCTs to support the beneficial effect of omega-3 fatty acids in secondary prevention after an MI.
Nositelji odobrenja za stavljanje u promet opisali su rezultate različitih randomiziranih kliničkih ispitivanja kako bi potkrijepili koristan učinak omega-3 masnih kiselina u sekundarnoj prevenciji nakon infarkta miokarda.
In the MAHs' view, GISSI‐P represented the mainstay of evidence in favour of the use of omega-3 fatty acids in the secondary prevention after MI and it is a valid and robust study.
Prema mišljenju nositelja odobrenja, ispitivanje GISSI-P glavno je uporište dokaza u prilog primjene omega-3 masnih kiselina za sekundarnu prevenciju nakon infarkta miokarda, a to je valjano i robusno ispitivanje.
In particular the GISSI-P and OMEGA trials, which were considered most relevant, have been extensively discussed by the MAHs.
Nositelji odobrenja za stavljanje u promet osobito su opsežno razmatrali ispitivanja GISSI-P i OMEGA, koja su se smatrala najvažnijima.
The MAHs proposed, as part of their grounds for re-examination, a modification of the indication for use in high-risk patients, i.e. type 2 diabetes, no acute PCI after MI, impaired systolic function (EF < 50%), known intolerance to one or more guideline recommended cardiovascular medications.
Nositelji odobrenja za stavljanje u promet predložili su, u razlozima za preispitivanje mišljenja, promjenu indikacije za upotrebu u visokorizičnih bolesnika, tj. bolesnika s dijabetesom tipa 2, bez akutne perkutane koronarne intervencije nakon infarkta miokarda, s oštećenom sistoličkom funkcijom
However, some experts in the SAG saw a place in therapy for omega-3containing medicinal products in secondary prevention after MI.
Ipak, neki stručnjaci iz Znanstvene savjetodavne skupine smatrali su da i za lijekove koji sadrže omega-3 ima mjesta u terapiji sekundarne prevencije nakon infarkta miokarda.
The Committee, as a consequence, considers that the benefit-risk balance of Omega-3 acid ethyl esters medicinal products for oral use in secondary prevention after myocardial infarction is not favourable.
Odbor posljedično smatra da omjer koristi i rizika lijekova koji sadrže etilne estere omega-3 kiselina za peroralnu primjenu u sekundarnoj prevenciji nakon infarkta miokarda nije povoljan.
Therefore, the key concern that standard of care after MI has intensified since the time of the GISSI-P study, in particular statin therapy, beta-blockers and PCI, still remains.
Prema tome, i dalje kao ključno pitanje ostaje to što se od vremena kad je provedeno ispitivanje GISSI-P standardna skrb bolesnika nakon infarkta miokarda pojačala, a posebice terapija statinima, beta-blokatorima i perkutana koronarna intervencija.
The ASCEND and VITAL studies did not show an effect of omega3 fatty acids on the primary or secondary cardiovascular endpoints and, as such, were considered as negative studies.
Ispitivanja ASCEND i VITAL nisu pokazala učinak omega-3 masnih kiselina na mjere primarnog i sekundarnog kardiovaskularnog ishoda
Rizos EC, Ntzani EE, Bika E, Kostapanos MS, Elisaf MS. Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systematic review and meta-analysis.
Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systematic review and meta-analysis.
In addition to MI, ACS is also associated with unstable angina.
Osim s infarktom miokarda, akutni koronarni sindrom povezan je s nestabilnom anginom pektoris.
• Based on the totality of the data emerging after the original approval as well as the limitations of the GISSI-P trial, the CHMP concluded that efficacy is not established in secondary prevention after myocardial infarction at the dose of 1 g/day and, although the safety profile of omega-3 -acid ethyl esters is unchanged, the CHMP concluded that the benefit-risk balance in this indication is no longer favourable.
• Na temelju ukupnih podataka koji su se pojavili nakon prvobitnog davanja odobrenja, kao i zbog ograničenja ispitivanja GISSI-P, CHMP je zaključio da nije utvrđena djelotvornost za sekundarnu prevenciju nakon infarkta miokarda u dozi od 1 g na dan.
Based on the totality of the data emerging after the original approval as well as the serious limitations of the GISSI-P trial, the CHMP concluded that efficacy is not established in secondary cardiovascular prevention at the dose of 1 g/day and whereas the safety profile of omega-3 -acid ethyl esters is unchanged, the CHMP concluded that the benefit-risk balance in this indication is no longer favourable.
Na temelju ukupnih podataka koji su se pojavili nakon prvobitnog odobrenja, kao i ozbiljnih ograničenja ispitivanja GISSI-P, CHMP je zaključio da djelotvornost nije utvrđena u sekundarnoj kardiovaskularnoj prevenciji u dozi od 1 g na dan.
Based on the results of studies available today the experts did not see a place for therapy with Omega-3 containing medicinal products at a dose of 1 g/day in the context of secondary cardiovascular prevention after MI given the considerations regarding RCTs (particularly OMEGA and GISSI-P studies), meta-analysis and retrospective cohort studies.
Na temelju rezultata danas dostupnih ispitivanja te s obzirom na razmatranja o randomiziranim kliničkim ispitivanjima (posebice ispitivanjima OMEGA i GISSI-P), metaanalizu i retrospektivna kohortna ispitivanja, stručnjaci su zaključili da terapija lijekovima koji sadrže omega-3 u dozi od 1 g na dan nije prikladna u kontekstu sekundarne kardiovaskularne prevencije nakon infarkta miokarda.
Deepak L. Bhatt, P. Gabriel Steg, Michael Miller, Eliot A. Brinton, Terry A. Jacobson, Steven B. Ketchum, Ralph T. Doyle, Jr., Rebecca A. Juliano, Lixia Jiao, Craig Granowitz, Jean‑Claude Tardif, and Christie M. Ballantyne, for the REDUCE-IT Investigators.
Doyle, Jr., Rebecca A. Juliano, Lixia Jiao, Craig Granowitz, Jean‑Claude Tardif, and Christie M.
JoAnn E. Manson, Nancy R. Cook, I‑Min Lee, William Christen, Shari S. Bassuk, Samia Mora, Heike Gibson, Christine M. Albert, David Gordon, Trisha Copeland, Denise D'Agostino, Georgina Friedenberg, Claire Ridge, Vadim Bubes, Edward L. Giovannucci, Walter C. Willett, and Julie E. Buring, for the VITAL Research Group.
Albert, David Gordon, Trisha Copeland, Denise D'Agostino, Georgina Friedenberg, Claire Ridge, Vadim Bubes, Edward L.
11 Weisman D, Beinart R, Erez A, Koren-Morag N, Goldenberg I, Eldar M, Glikson M, Luria D. Effect of supplemented intake of omega-3 fatty acids on arrhythmias in patients with ICD: fish oil therapy may reduce ventricular arrhythmia.
11 Weisman D, Beinart R, Erez A, Koren-Morag N, Goldenberg I, Eldar M, Glikson M, Luria D.
Recently published RCTs (ASCEND by Bowman et al. 201812, VITAL by Manson et al. 201913, REDUCEIT by Bhatt et al. 201914) do not provide evidence for the efficacy of omega-3 administration (1 g daily) for the indication under review.
201914) ne pružaju dokaze o djelotvornosti primjene omega-3 (1 g dnevno) za indikaciju koja se razmatra.
7 Poole CD, Halcox JP, Jenkins-Jones S, Carr ES, Schifflers MG, Ray KK, et al. Omega-3 Fatty acids and mortality outcome in patients with and without type 2 diabetes after myocardial infarction: a retrospective, matched-cohort study.
Omega-3 Fatty acids and mortality outcome in patients with and without type 2 diabetes after myocardial infarction: a retrospective, matched-cohort study.
Your healthcare professional will give you this information.
Te će vam informacije pružiti vaš zdravstveni djelatnik.
• If you have any questions about your treatment speak to your healthcare professional.
• Ako imate pitanja o liječenju, obratite se svojem zdravstvenom djelatniku.
• During the switch to this type of combination medicine and in the weeks after the switch you should measure your blood sugar levels more frequently.
• Tijekom prijelaza na tu vrstu kombiniranog lijeka i u tjednima nakon prijelaza trebali biste češće mjeriti razinu šećera u krvi.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27. studenoga 2015. EMA/134144/2015
These types of combination medicines are advantageous to patients since they reduce the number of injections they need to have and may help them keep to their treatment.
Te vrste kombiniranih lijekova povoljnije su za bolesnike jer smanjuju broj injekcija koje trebaju primiti te im mogu pomoći pri pridržavanju liječenja.
Further information on the safe use of these medicines and other ways to minimise the possible risk of medication errors, can be found in the guidance on risk minimisation strategies for high strength and fixed combination insulin products.
Dodatne informacije o sigurnoj uporabi tih lijekova i drugim načinima smanjenja mogućih rizika od pogrešaka pri propisivanju lijekova mogu se pronaći u smjernicama za strategije smanjenja rizika za inzulinske proizvode velike jačine i određene kombinacije.
• Ensure that your patients are adequately informed on how to use their medicine.
• Pobrinite se da bolesnici budu odgovarajuće obaviješteni o tome kako se koristiti svojim lijekom.
However, there is a potential risk of patients receiving too little or too much of their medicine because of confusion that may arise over the way the doses are expressed for the individual components − the dose of the insulin is expressed in units while the dose of the non-insulin medicine may be expressed in other units such as mg.
Međutim, postoji mogući rizik da bolesnici dobiju premalo ili previše lijeka zbog zabune koja može nastati u vezi s načinom izražavanja doza za pojedinačne sastojke − doza inzulina izražava se u jedinicama, a doza neinzulinskog lijeka može biti izražena u drugim jedinicama, kao što je mg.
An example of a diabetes medicine that contains insulin in combination with a non-insulin active substance is Xultophy (100 units/ml insulin degludec and 3.6 mg/ml liraglutide) which was authorised in the EU on.
Primjer lijeka za dijabetes koji sadržava inzulin u kombinaciji s neinzulinskom aktivnom tvari jest Xultophy (100 jedinica/ml degludek inzulina i 3,6 mg/ml liraglutida), koji je odobren u EU-u.
• Patients who are blind or with poor vision must be instructed to always get assistance from another person who has good vision and is trained in using the insulin pen device.
• Slijepe ili slabovidne bolesnike mora se uputiti da uvijek zatraže pomoć druge osobe koja ima dobar vid i koja se zna koristiti uređajem s inzulinskom olovkom.
Patients and healthcare professionals are therefore advised to take extra care when using these medicines and carefully follow the recommendations given below.
Stoga se bolesnicima i zdravstvenim djelatnicima savjetuje da posebno pripaze pri uporabi tih lijekova te da pozorno slijede preporuke navedene u nastavku.
Before you use your medicine be clear on how many dose steps you require.
Prije uporabe lijeka provjerite koliko vam je prirasta doze potrebno.
• If the patient has been transferred from another pen device, highlight the differences in design between the two devices.
• Ako se bolesnik prethodno koristio drugim uređajem s olovkom, istaknite razlike u dizajnu između dvaju uređaja.
• Tell patients to closely monitor their blood sugar levels when starting a medicine containing insulin and a non-insulin active substance and in the weeks after.
• Uputite bolesnike da pozorno prate razine šećera u krvi u početku primjene lijeka koji sadržava inzulin i neinzulinsku aktivnu tvar te u tjednima nakon toga.
• One dose step contains a set number of units of insulin plus a fixed amount of the non-insulin medicine.
• Prirast jedne doze sadržava određeni broj jedinica inzulina i utvrđenu količinu neinzulinskog lijeka.
• Read the instructions in your package leaflet carefully before using your medicine.
• Pozorno pročitajte upute o lijeku prije uporabe lijeka.
• Pharmacists are encouraged to check that patients and carers are able to read the dose counter of the pen device before dispensing the medicine.
• Ljekarnicima se preporučuje da provjere mogu li bolesnici i njegovatelji očitati brojač doza uređaja s olovkom prije doziranja lijeka.
• Your healthcare professional will explain the design and features of your pen, including how the dose counter of the pen device shows the number of dose steps to be injected.
• Zdravstveni djelatnik objasnit će vam dizajn i značajke olovke, uključujući i kako brojač doza uređaja s olovkom prikazuje broj prirasta doza koje je potrebno injektirati.
In addition, healthcare professionals are encouraged to take the following precautions when storing, prescribing and dispensing diabetes medicines that contain insulin in combination with a non-insulin active substance:
Osim toga, zdravstvenim djelatnicima preporučuje se da pri pohranjivanju, propisivanju i doziranju lijekova za dijabetes koji sadržavaju inzulin u kombinaciji s neinzulinskom aktivnom tvari poduzmu sljedeće mjere opreza:
• Explain to your patient that the dose counter of the pen device shows the number of dose steps to be injected.
• Objasnite bolesnicima da brojač doza uređaja s olovkom prikazuje broj prirasta doza koje je potrebno injektirati.
Always prescribe the dose of insulin and the dose of non-insulin to be injected as well as the dose frequency.
Uvijek propišite dozu inzulina i dozu neinzulinskog lijeka koje je potrebno injektirati te učestalost primjene doze.
Recently, diabetes medicines that contain insulin in combination with a non-insulin active substance have been approved in the EU.
U posljednje su vrijeme u EU-u odobreni lijekovi za dijabetes koji sadržavaju inzulin u kombinaciji s neinzulinskom aktivnom tvari.
27 November 2015 EMA/134144/2015
Smjernice za prevenciju pogrešaka pri propisivanju lijekova za dijabetes koji sadržavaju inzulin i neinzulinsku aktivnu tvar EMA/134144/2015
Content Package size
Sadržaj Veličina pakiranja
Packaging
Ambalaža
EU Number Invented Name
Izmišljeni naziv
Date of first authorisation: 14/04/2003 Date of last renewal: 11/03/2008
Datum prvog odobrenja: 14/04/2003 Datum posljednjeg produljenja odobrenja: 11/03/2008
ATC vet code: QI09AB02
ATC Vet kod: QI09AB02
Manufacturing authorisation issued by the French Ministère des Affaires Sociales, Ministère délégué à la Santé, and the Ministère de l'Agriculture et de la Forêt on 31 March 1992.
Odobrenje za proizvodnju izdano od strane French Ministère des Affaires Sociales, Ministère délégué à la Santé, i Ministère de l'Agriculture et de la Forêt 31. ožujka 1992.
EXP {month/year}
EXP {mjesec/godina}>
No special precautions.
Nema posebnih mjera predostrožnosti.
- Vaccinate only healthy animals.
- Cijepiti samo zdrave životinje.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu/
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/
5 to 7 weeks before farrowing
5 do 7 tjedana prije prasenja
Laboratoire de Toulouse 4 Chemin du Calquet 31300 TOULOUSE FRANCE
Laboratoire de Toulouse 4 Chemin du Calquet 31300 TOULOUSE FRANCUSKA
Administer using aseptic procedures.
Primijenite koristeći uobičajene aseptičke postupke.
Wash and disinfect hands after use.
Nakon upotrebe operite i dezinficirajte ruke.
Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours).
Cijepljenje može izazvati blago povišenje tjelesne temperature (manje od 1,5 °C u razdoblju od najviše 24 sata).
No undesirable effects have been observed after the administration of twice the recommended dosage.
Nisu primijećene nikakve druge nuspojave nakon primjene dvostruke preporučene doze.
2 weeks before farrowing.
2 tjedna prije prasenja.
Shelf-life: 18 months at 2 - 8 °C.
Rok valjanosti: 18 mjeseci na 2 - 8 °C.
Intramuscular injection in the neck in the area behind the ear.
Intramuskularna injekcija u području vrata iza uha.
- Do not administer in conjunction with other medicinal products.
- Ne primjenjivati zajedno s drugim medicinskim proizvodima.
Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
Stoga, neškodljivost i djelotvornost ovog proizvoda nije ustanovljena kada se koristi s nekim drugim bilo da je primijenjeno istog dana ili u drugo vrijeme).
Per dose of 2 ml:
po dozi od 2 ml:
- Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a sufficient quantity of colostrum within 6 hours of birth.
- Budući da se zaštita prasadi postiže putem kolostruma, svako prase treba posisati dovoljnu količinu kolostruma unutar 6 sati od rođenja.
Use sterile syringe and needles.
Upotrijebite sterilnu štrcaljku i igle.
No information is available on the compatibility of this vaccine with any other.
Ne postoje dostupni podaci o kompatibilnosti ovog cjepiva s bilo kojim drugim veterinarskomedicinskim proizvodom.
All food producing species For use only as a preservative in multidose vaccines at a concentration not exceeding 0.02%
Za upotrebu samo kao konzervans u višedoznim cjepivima u koncentraciji koja ne prelazi 0,02 %