natgillin/translations-raw huggingface dataset:
Orkambi contains the active substances lumacaftor and ivacaftor.
Zdravilo Orkambi vsebuje učinkovini lumakaftor in ivakaftor.
22 March 2013 EMA/402540/2013
22. marec 2013 EMA/402540/2013
Contact our press officers Monika Benstetter or Martin Harvey Allchurch
Stopite v stik z našimi tiskovnimi predstavniki Monika Benstetter ali Martin Harvey Allchurch
Patients were followed for a median of 3.9 years.
Mediani čas spremljanja bolnikov je bil 3,9 leta;
Of those enrolled, 14,741 were from Europe and 10,932 were from China.
14 741 sodelujočih je bilo iz Evrope, 10 932 pa s Kitajske.
Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Tel: +44 (0)20 7418 8427 Elektronski naslov: press@ema.europa.eu
Healthcare professionals should follow these recommendations:
Zdravstveni delavci naj upoštevajo naslednja priporočila:
Further information on the PRAC recommendation and the background to this review can be found on Agency's website.
Podrobnejše informacije o priporočilu odbora PRAC in ozadju tega pregleda so na voljo na spletni strani agencije.
The medicine has been marketed under one of these trade names by Merck Sharp & Dohme Ltd in all EU Member States, except Bulgaria, France and Romania.
Zdravilo je pod enim od naštetih trgovskih imen tržila družba Merck Sharp & Dohme Ltd v vseh državah članicah EU, razen v Bolgariji, Franciji in Romuniji.
• A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
• Pregled teh podatkov je najprej izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC).
• The review of Tredaptive, Pelzont and Trevaclyn was initiated at the request of the European Commission on 19 December 2012, under Article 20 of Regulation (EC) No 726/2004 following the procedural steps laid out in Article 107j and 107k of Directive 2001/83/EC.
• Pregled zdravil Tredaptive, Pelzont in Trevaclyn se je začel na zahtevo Evropske komisije dne 19. decembra 2012 v skladu s členom 20 Uredbe (ES) št. 726/2004 in po postopkovnih pravilih, opredeljenih v členih 107(j) in 107(k) Direktive 2001/83/ES.
The European Commission asked the Agency to assess the impact of the new data from the HPS2-THRIVE study, and to issue an opinion on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Evropska komisija je zahtevala, da agencija oceni vpliv novih podatkov iz študije HPS2-THRIVE in poda mnenje o tem, ali je treba dovoljenja za promet s temi zdravili v EU ohraniti, spremeniti, začasno umakniti ali preklicati.
These included bleeding (intracranial and gastro-intestinal), myopathy, infections and new-onset diabetes.
Med njimi so bile krvavitve (intrakranialne in gastrointestinalne), miopatija, okužbe in novonastala sladkorna bolezen.
They were available as modified release tablets (meaning that the two active substances are released at different rates over a few hours).
Na voljo so bila v obliki tablet s prirejenim sproščanjem (to pomeni, da se zdravilni učinkovini sproščata z različno hitrostjo v obdobju nekaj ur).
The review of Tredaptive, Pelzont and Trevaclyn was initiated in December 2012 after new data from a large, long-term study called HPS2-THRIVE became available.
Pregled zdravil Tredaptive, Pelzont in Trevaclyn se je začel decembra 2012, potem ko so postali na voljo novi podatki iz obsežne dolgoročne študije z imenom HPS2-THRIVE.
The Agency's recommendations are based on the new data from the HPS2-THRIVE study:
Priporočila agencije temeljijo na novih podatkih iz študije HPS2-THRIVE:
It was first used as a medicine to modify blood fat levels in the mid-1950s, but its use has been limited because of its side effects, particularly flushing (reddening of the skin).
Kot zdravilo za zmanjševanje koncentracij maščob v krvi so jo prvič uporabili sredi 50. let prejšnjega stoletja, vendar so uporabo omejili zaradi njenih neželenih učinkov, še zlasti zardevanja (pordelosti kože).
• The HPS2-THRIVE study was a large, long-term study involving 25,673 patients considered to be at high risk for cardiovascular events due to a history of occlusive vascular disease.
• študija HPS2-THRIVE je bila obsežna dolgoročna študija, v katero je bilo vključenih 25 673 bolnikov, pri katerih naj bi zaradi okluzivne žilne bolezni v preteklosti obstajalo visoko tveganje za kardiovaskularne dogodke.
• The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 22 March 2013.
• Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 22. marca 2013 izdala končno pravno zavezujočo odločbo.
More information on the HPS2-THRIVE study is available below.
Podrobnejše informacije o študiji HPS2-THRIVE so na voljo v nadaljevanju.
Such treatment is ultimately aimed to reduce the risk of heart attacks, strokes and other conditions affecting the heart and blood vessels.
Končni cilj zdravljenja je zmanjšati tveganje za srčno in možgansko kap ter druge bolezni, ki prizadenejo srce in krvne žile.
Patients were treated with simvastatin 40 mg or simvastatin 40 mg plus ezetimibe 10 mg to achieve a total cholesterol level of less than 3.5 mmol/l, and were then randomised to nicotinic acid / laropiprant or placebo.
Bolnike so zdravili s simvastatinom 40 mg ali simvastatinom 40 mg v kombinaciji z ezetimibom 10 mg, da bi raven skupnega holesterola znižali na manj kot 3,5 mmol/l, nato pa so jih randomizirali v skupino z nikotinsko kislino/laropiprantom ali s placebom;
The CHMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 22 March 2013.
CHMP je mnenje posredoval Evropski komisiji, ki se je z njim strinjala in dne 22. marca 2013 izdala končno pravno zavezujočo odločbo.
• The two active substances, nicotinic acid and laropiprant, have different functions.
• Zdravilni učinkovini, nikotinska kislina in laropiprant, imata različni funkciji.
• You should make a non-urgent appointment with your doctor to review your treatment.
• Naročite se na nenujen obisk pri zdravniku, ki bo ponovno ocenil vaše zdravljenje.
• Tredaptive, Pelzont and Trevaclyn are identical medicines authorised throughout the EU on 3 July 2008 for the treatment of dyslipidaemia in combination with a statin when statin treatment alone is not sufficient, or alone in patients unable to take statins.
• Tredaptive, Pelzont in Trevaclyn so identična zdravila, ki so bila dne 3. julija 2008 po vsej EU odobrena za zdravljenje dislipidemije bodisi v kombinaciji s statini, kadar monoterapija s statini ni dovolj učinkovita, bodisi samostojno pri bolnikih, ki ne smejo jemati statinov.
Laropiprant has no effect on cholesterol but it reduces flushing, by blocking the receptors for a substance called ‘prostaglandin D2' which is released when nicotinic acid is taken and which dilates (widens) the blood vessels in the skin.
Laropiprant nima učinka na holesterol, vendar pa zmanjšuje zardevanje, tako da zavira receptorje za snov, imenovano „prostaglandin D2“, ki se sprosti ob zaužitju nikotinske kisline in razširi krvne žile v koži.
• Tredaptive, Pelzont and Trevaclyn contain two active substances: nicotinic acid (1,000 mg) and laropiprant (20 mg).
• Zdravila Tredaptive, Pelzont in Trevaclyn vsebujejo dve zdravilni učinkovini: nikotinsko kislino (1 000 mg) in laropiprant (20 mg).
• Doctors should review their patients' treatment in order to discontinue treatment with these medicines, which are no longer available in the EU.
• zdravniki morajo zdravljenje bolnikov ponovno oceniti in prekiniti zdravljenje s temi zdravili, ki v EU niso več na voljo;
The CHMP encouraged patients currently taking these medicines to make a non-urgent appointment with their doctor to discuss their treatment.
CHMP je bolnikom, ki jemljejo ta zdravila, svetoval, naj se naročijo na nenujen obisk pri zdravniku in se z njim pogovorijo o zdravljenju.
Having reviewed the results of the study, the CHMP concluded that the benefits of Tredaptive, Pelzont and Trevaclyn no longer outweigh the risks and that their marketing authorisations should be suspended.
Potem ko je pregledal rezultate študije, je CHMP zaključil, da koristi zdravil Tredaptive, Pelzont in Trevaclyn niso več večje od tveganj in da je treba dovoljenja za promet z njimi začasno umakniti.
On 17 January 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed the recommendation to suspend the marketing authorisations of Tredaptive, Pelzont and Trevaclyn (nicotinic acid / laropiprant) used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol).
Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je 17. januarja 2013 potrdil priporočilo o začasnem umiku dovoljenj za promet z zdravili Tredaptive, Pelzont in Trevaclyn (nikotinska kislina/laropiprant), ki se uporabljajo za zdravljenje odraslih z dislipidemijo (nenormalno visokimi koncentracijami maščob, kot so trigliceridi in holesterol, v krvi).
• If you are taking Tredaptive, Pelzont or Trevaclyn you will have to discontinue treatment, as these medicines are no longer available in the EU.
• Če jemljete zdravilo Tredaptive, Pelzont ali Trevaclyn, boste morali prekiniti zdravljenje, saj ta zdravila v EU niso več na voljo.
Doctors should no longer prescribe these medicines and should review patients' treatment options
Zdravniki ne smejo več predpisovati teh zdravil in morajo ponovno proučiti možnosti zdravljenja bolnikov.
• Tredaptive, Pelzont and Trevaclyn are identical medicines used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol).
• Tredaptive, Pelzont in Trevaclyn so identična zdravila, ki se uporabljajo za zdravljenje odraslih z dislipidemijo (nenormalno visokimi koncentracijami maščob, kot so trigliceridi in holesterol, v krvi).
• Pharmacists should refer patients on new or repeated prescriptions for Tredaptive, Pelzont and Trevaclyn to the treating doctor.
• farmacevti morajo bolnike z novimi ali obnovljivimi recepti za zdravila Tredaptive, Pelzont in Trevaclyn napotiti k lečečemu zdravniku.
Tredaptive, Pelzont and Trevaclyn suspended across the EU
Zdravila Tredaptive, Pelzont in Trevaclyn začasno umaknjena s trgov EU
As taking Tredaptive, Pelzont and Trevaclyn together with a statin has no additional benefit in reducing the risk of major vascular events compared with statin therapy alone and taking into account the increased risk of serious side effects, the CHMP recommended the suspension of these medicines.
Ker jemanje zdravil Tredaptive, Pelzont in Trevaclyn v kombinaciji s statini ni prineslo dodatnih koristi v smislu zmanjšanja tveganja za pomembnejše vaskularne dogodke v primerjavi z monoterapijo s statini in ob upoštevanju povečanega tveganja za resne neželene učinke, je CHMP priporočil, da se ta zdravila začasno umaknejo s trga.
• An increase in the incidence of non-fatal but serious adverse events was seen.
• opazili so večjo pojavnost neželenih učinkov, ki so se končali brez smrtnega izida, vendar so bili resni.
The CHMP opinion was based on a recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend these medicines.
Mnenje odbora CHMP je temeljilo na priporočilu o začasnem umiku teh zdravil, ki ga je izdal Odbor za oceno tveganja na področju farmakovigilance (PRAC).
Doctors should no longer prescribe Tredaptive, Pelzont or Trevaclyn and should review patients' treatment options.
Zdravniki ne smejo več predpisovati zdravil Tredaptive, Pelzont in Trevaclyn ter morajo možnosti zdravljenja bolnikov ponovno proučiti.
• In light of the unfavourable benefit-risk balance of Tredaptive, Pelzont and Trevaclyn, doctors should no longer prescribe these medicines to their patients.
• zaradi neugodnega razmerja med tveganji in koristmi zdravil Tredaptive, Pelzont in Trevaclyn jih zdravniki bolnikom ne smejo več predpisovati;
The results of the study, which are still preliminary, indicated that taking nicotinic acid / laropiprant together with a statin has no significant additional benefit in reducing the risk of major vascular events such as heart attack and stroke, compared with statin therapy alone.
Rezultati študije, ki so še vedno preliminarni, so pokazali, da jemanje nikotinske kisline/laropipranta skupaj s statini ne prinese pomembnih dodatnih koristi v smislu zmanjšanja tveganja za pomembnejše vaskularne dogodke, kot sta srčna in možganska kap, v primerjavi z monoterapijo s statini.
• The study was designed to assess the effect of adding nicotinic acid / laropiprant to statins on a composite endpoint of major vascular events, which included the combination of coronary death, non-fatal heart attack, stroke and revascularisation.
• študija je bila zasnovana za oceno učinka nikotinske kisline/laropipranta kot dodatnega zdravljenja k statinom na sestavljen opazovani dogodek, tj. pomembnejše vaskularne dogodke, ki so vključevali koronarno smrt, srčno kap brez smrtnega izida, možgansko kap in revaskularizacijo.
In addition, a higher frequency of non-fatal but serious side effects was seen in patients taking these medicines.
Poleg tega so pri bolnikih, ki so jemali ta zdravila, pogosteje opazili neželene učinke, ki so se končali brez smrtnega izida, vendar so bili resni.
In higher doses, it reduces the levels of fat in the blood via a mechanism that is not fully understood.
Pri večjih odmerkih prek mehanizma, ki še ni povsem pojasnjen, zmanjšuje koncentracije maščobe v krvi.
• Treatment with nicotinic acid / laropiprant together with a statin did not result in a statistically significant reduction in major vascular events such as heart attack and stroke compared with statin therapy alone.
• zdravljenje z nikotinsko kislino/laropiprantom v kombinaciji s statini ni povzročilo statistično pomembnega zmanjšanja pomembnejših vaskularnih dogodkov, kot sta srčna in možganska kap, v primerjavi z monoterapijo s statini;
• The Agency recommended the suspension of Tredaptive, Pelzont or Trevaclyn following the review of new evidence which indicated that the benefits of these medicines no longer outweigh their risks for patients.
• Agencija je po pregledu novih dokazov, ki so pokazali, da koristi teh zdravil niso več večje od z njimi povezanih tveganj za bolnike, priporočila začasen umik zdravil Tredaptive, Pelzont in Trevaclyn.
Avenida de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
Avenida de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Španija
92931 Paris La Défense Cedex France
92931 Paris La Défense Cedex Francija
Pfizer Europe MA EEIG Ramsgate Road CT13 9 NJ Kent, Sandwich United Kingdom
Pfizer Europe MA EEIG Ramsgate Road CT13 9 NJ Kent, Sandwich Velika Britanija
Industriestrasse 25, D-83607 Holzkirchen, Germany
Industriestrasse 25, D-83607 Holzkirchen, Nemčija
B-dul Theodor Pallady nr. 44C Sector 3, Bucureşti, Romania
B-dul Theodor Pallady nr. 44C Sector 3, Bucureşti, Romunija
S.C. LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44 B, sector 3, Bucureşti, Romania
S.C. LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44 B, sector 3, Bucureşti, Romunija
SERMION 5 mg, poudre pour solution pour perfusion powder for solution for infusion intravenous use
SERMION 5 mg, poudre pour solution pour perfusion prašek za raztopino za infundiranje intravenska uporaba
s r.o., Praha Stroupežnického 17
s r.o., Praha Stroupežnického 17 150 00 Prague 5
Sandoz d.d.,Verovškova 57, 1000 Ljubljana, Slovenia
Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenija
4 mg/4 ml powder and solvent for solution for injection intramuscular and intravenous use
4 mg/4 ml prašek in vehikel za raztopino za injiciranje intramuskularna in intravenska uporaba
Nicergolin powder and solvent for solution for injection intramuscular use intravenous use
Nicergolin prašek in vehikel za raztopino za injiciranje intramuskularna uporaba intravenska uporaba
NICERGOLINA SANDOZ 30 mg effervescent tablet oral use
NICERGOLINA SANDOZ 30 mg šumeča tableta peroralna uporaba
Pfizer Italia srl Via Isonzo, 71 04100 Latina Italy soluble tablet
Pfizer Italia srl Via Isonzo, 71 04100 Latina Italija tableta za peroralno raztopino
10 mg/ml powder and solvente per oral solution
10 mg/ml prašek in vehikel za peroralno raztopino
Modifiedrelease capsule, hard
NICERIUM® 30 UNO 30 mg kapsula s prirejenim sproščanjem, trda
25 October 2013 EMA/565019/2013
23. oktober 2013 EMA/565019/2013
Healthcare professionals will be informed in writing of the updated recommendations.
Zdravstvene delavce bodo o posodobljenih priporočilih obvestili v pisni obliki.
A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Te podatke je najprej pregledal Odbor za oceno tveganja na področju farmakovigilance (PRAC).
The review of short-acting beta-agonists was initiated in November 2012 at the request of the Hungarian medicines agency, under Article 31 of Directive 2001/83/EC.
Pregled kratkodelujočih agonistov beta-adrenergičnih receptorjev je bil sprožen novembra 2012 na zahtevo madžarske agencije za zdravila v skladu s členom 31 Direktive 2001/83/ES.
The medicines are called ‘short acting' because they work quickly, usually having an effect in less than five minutes, which lasts for several hours.
Zdravila se imenujejo „kratkodelujoča“, ker delujejo hitro, saj se učinek navadno pojavi po manj kot petih minutah, traja pa več ur.
It proposed revising their prescribing information, with reinforced warnings on the cardiovascular risks.
Predlagal je ponovni pregled informacij za predpisovanje, s poudarkom na opozorilih glede kardiovaskularnih tveganj.
This timeframe can allow healthcare professionals to take other measures known to improve the health of the baby around the time of birth.
Ta časovni okvir zdravstvenim delavcem omogoča, da uvedejo druge ukrepe, za katere je znano, da izboljšajo zdravje otroka ob času poroda.
The reviewed data originated from clinical studies, post-marketing reports and the published literature.
Pregledani podatki izvirajo iz kliničnih študij, poročil v obdobju trženja in objavljene literature.
Short-acting beta-agonists have been authorised by national procedures in several European Union (EU) Member States, and have been marketed for many years under various trade names.
Kratkodelujoči agonisti beta-adrenergičnih receptorjev so bili z nacionalnimi postopki odobreni v več državah članicah Evropske unije (EU) in so na trgu že mnoga leta pod različnimi trgovskimi imeni.
The available data showed that injectable forms are effective at supressing labour contractions in the short term (up to 48 hours).
Razpoložljivi podatki kažejo, da so oblike za injiciranje učinkovite pri kratkotrajnem zaviranju porodnih popadkov (do 48 ur).
• If you are given these medicines for premature labour in this way, your doctor will monitor you and your baby during treatment and stop treatment if there are any signs of heart problems.
• Če ta zdravila prejmete za zaviranje prezgodnjega poroda na ta način, bo zdravnik med zdravljenjem spremljal vas in vašega otroka ter prekinil zdravljenje, če se pojavijo kakršni koli znaki srčnih težav.
Oral and suppository formulations which are only authorised in obstetric indications will have their marketing authorisations revoked and shall be removed from the market by the Marketing Authorisation Holders by 25th November 2013 at the latest.
Dovoljenja za promet s peroralnimi formulacijami in svečkami, ki so trenutno odobrene samo za porodniške indikacije, bodo preklicana, ta zdravila pa bodo imetniki dovoljenj za promet z zdravili umaknili s tržišča najpozneje do 25. novembra 2013.
However, injectable forms of these medicines can still be given for short-term obstetric use under specific conditions.
Oblike teh zdravil za injiciranje pa so še vedno dovoljene za kratkotrajno porodniško uporabo pod posebnimi pogoji.
However, their use should be limited to pregnant women between 22 and 37 weeks of gestation and women receiving these medicines should be kept under specialist supervision for the duration of treatment, which is limited to a maximum of 48 hours.
Vendar pa je treba njihovo uporabo omejiti na obdobje med 22. in 37. tednom nosečnosti, ženske, ki prejemajo ta zdravila, pa morajo biti pod specialističnim nadzorom celotno zdravljenje, ki je omejeno na največ 48 ur.
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1 has endorsed by consensus new recommendations to restrict the use of medicines called ‘short-acting beta-agonists'.
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh)1 je soglasno podprla nova priporočila za omejitev uporabe zdravil, imenovanih „kratkodelujoči agonisti beta-adrenergičnih receptorjev“.
As short-acting beta-agonists are all authorised nationally, the PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Ker so vsi kratkodelujoči agonisti beta-adrenergičnih receptorjev odobreni na nacionalni ravni, so bila priporočila odbora PRAC poslana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh).
As the CMDh position was adopted by consensus, it will be directly implemented by the Member States where these medicines are authorised.
Ker je skupina CMDh soglasno sprejela sklep, ga bodo neposredno izvajale države članice, v katerih so ta zdravila odobrena.
Smooth muscle is found in many organs, including on the inner linings of the airways, blood vessels, stomach and gut, and womb.
Gladke mišice so v mnogih organih, vključno z notranjimi plastmi dihal, krvnimi žilami, želodcem, črevesjem in maternico.
• These medicines can still be given intravenously (into a vein) to suppress premature labour, but their use is limited to a maximum of 48 hours, and only in women between the 22nd and the 37th weeks of pregnancy.
• Ta zdravila se še vedno lahko dajejo intravensko (v veno) za zaviranje prezgodnjega poroda, vendar je njihova uporaba omejena na največ 48 ur in samo med 22. ter 37. tednom nosečnosti.
As the PRAC recommendations have been endorsed by consensus by the CMDh, they will now be implemented directly in all Member States, according to an agreed timetable.
Ker je skupina CMDh soglasno podprla priporočilo odbora PRAC, ga bodo odslej neposredno izvajale vse države članice v skladu z dogovorjenim časovnim razporedom.
Therefore, the PRAC concluded that the benefits of injectable forms of these medicines continue to outweigh their risks when used under specific conditions: these medicines should only be used to suppress premature labour for up to 48 hours, between the 22nd and the 37th weeks of pregnancy and under specialist supervision with continuous monitoring of the mother and the unborn baby.
Odbor PRAC je zato sklenil, da so koristi teh oblik za injiciranje še vedno večje od tveganj, če se uporabljajo pod posebnimi pogoji: ta zdravila se smejo uporabljati samo za zaviranje prezgodnjega poroda do 48 ur, med 22. in 37. tednom nosečnosti in pod specialističnim nadzorom s stalnim spremljanjem matere ter nerojenega otroka.
These medicines should no longer be used in oral or suppository forms in obstetric indications (for the care of pregnant women), such as for suppressing premature labour or excessive labour contractions.
Ta zdravila se v peroralnih oblikah ali svečkah ne smejo več uporabljati pri porodniških indikacijah (za oskrbo nosečnic), kot je zaviranje prezgodnjega poroda ali čezmernih porodnih popadkov.
The medicines included in the EU review are: fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol and terbutaline, which have been authorised for tocolytic treatment (to suppress labour contractions).
Zdravila, vključena v pregled EU, so: fenoterol, heksoprenalin, izoksuprin, ritodrin, salbutamol in terbutalin, ki so bila odobrena za tokolitično zdravljenje (za zaviranje porodnih popadkov).