natgillin/translations-raw huggingface dataset:
The grounds for the referral were concerns raised by Germany that the data provided by the company were not enough to demonstrate the safety and effectiveness of Diotop.
Razlog za napotitev so bili pomisleki Nemčije, da podatki, ki jih je zagotovila družba, niso bili dovolj za potrditev varnosti in učinkovitosti zdravila Diotop.
The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Opravil ga je Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA, pristojen za vprašanja v zvezi z zdravili za uporabo v humani medicini.
The two active substances in Diotop have different effects.
Učinkovini zdravila Diotop imata različne učinke.
Temmler Pharma GmbH requested that the marketing authorisation for Diotop granted by the UK and Austria in 2016 be recognised in Germany (the ‘concerned Member State').
Družba Temmler Pharma GmbH je zahtevala, da se dovoljenje za promet z zdravilom Diotop, izdano leta 2016 v Združenem kraljestvu in Avstriji, prizna tudi v Nemčiji („zadevni državi članici“).
Both diclofenac and omeprazole have been authorised in the EU for many years.
Diklofenak in omeprazol sta v EU odobrena že več let.
EMA completes review following disagreement among EU Member States
Evropska agencija za zdravila zaključila pregled po nesoglasju med državami članicami EU
However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 28 September 2018.
Ker pa države članice niso dosegle soglasja, je britanska regulativna agencija za zdravila dne 28. septembra 2018 zadevo napotila na Evropsko agencijo za zdravila v arbitražo.
The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Diotop on 31/01/2019.
Evropska komisija je na ravni EU 31/01/2019 izdala končno pravno zavezujočo odločbo o izdaji dovoljenja za promet z zdravilom Diotop.
The Agency considered that, although the particular combination in Diotop (diclofenac 75 mg / omeprazole 20 mg) has never been tested in any published study, the data from studies of higher doses of diclofenac or other NSAIDs taken with omeprazole are enough to support the use of the specific combination in Diotop.
Agencija je menila, da čeprav posebna kombinacija v zdravilu Diotop (diklofenak 75 mg/omeprazol 20 mg) ni bila nikoli preskušena v nobeni objavljeni študiji, podatki iz študij višjih odmerkov diklofenaka ali drugih nesteroidnih protivnetnih zdravil, ki se uporabljajo z omeprazolom, zadostujejo za podporo uporabi posebne kombinacije v zdravilu Diotop.
On 15 November 2018, the European Medicines Agency completed a review of Diotop following a disagreement among EU Member States regarding its authorisation.
Evropska agencija za zdravila je 15. novembra 2018 zaključila pregled v zvezi z izdajo dovoljenja za promet z zdravilom Diotop po nesoglasju med državami članicami EU.
The company submitted data from the published literature on the use of several NSAIDs (including diclofenac at the dose of 50 to 150 mg a day) and omeprazole in combination.
Družba je predložila podatke iz objavljene literature o uporabi več nesteroidnih protivnetnih zdravil (vključno z diklofenakom v odmerku 50-150 mg na dan) v kombinaciji z omeprazolom.
Diotop is a medicine used to relieve symptoms such as swelling and pain caused by the joint disorders rheumatoid arthritis, osteoarthritis or ankylosing spondylitis.
Diotop je zdravilo, ki se uporablja za lajšanje simptomov, kot so otekanje in bolečina zaradi skupnih motenj revmatoidnega artritisa, osteoartritisa ali ankilozirajočega spondilitisa.
The Agency concluded that the benefits of Diotop outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Agencija je zaključila, da koristi zdravila Diotop odtehtajo z njim povezana tveganja in da se dovoljenje za promet z njim, izdano v Združenem kraljestvu, lahko prizna tudi v drugih državah članicah EU, v katerih je družba zanj zaprosila.
EMA recommends authorisation of Diotop (diclofenac / omeprazole capsules) in the EU
Evropska agencija za zdravila priporoča izdajo dovoljenja za promet z zdravilom Diotop (diklofenak/omeprazol kapsule) v EU
Diclofenac is a nonsteroidal antiinflammatory drug (NSAID) used for the relief of pain and inflammation in a wide range of conditions.
Diklofenak je nesteroidno protivnetno zdravilo (NSAID), ki se uporablja za lajšanje bolečine in vnetja pri različnih obolenjih.
The Agency therefore concluded that the benefits of Diotop outweigh its risks, and therefore the marketing authorisation for Diotop should be granted in Germany.
Agencija je zato zaključila, da koristi zdravila Diotop odtehtajo z njim povezana tveganja, zato se dovoljenje za promet z njim lahko izda tudi v Nemčiji.
Omeprazole is a widely-used treatment for indigestion and acid reflux that acts by reducing the amount of acid the stomach makes.
Omeprazol se pogosto uporablja za zdravljenje prebavnih motenj in kislinskega refluksa in deluje tako, da zmanjšuje količino kisline v želodcu.
Diotop is used in adult patients who are at risk of developing stomach ulcers and whose disease is already controlled by diclofenac and omeprazole, the two active substances in Diotop, taken separately.
Zdravilo Diotop se uporablja pri odraslih bolnikih, pri katerih obstaja tveganje za nastanek želodčnih razjed in pri katerih je bolezen že nadzorovana z ločenim jemanjem diklofenaka in omeprazola, ki sta učinkovini zdravila Diotop.
This summary was last updated in April 2013.
Povzetek je bil nazadnje posodobljen 04-2013.
This will help them to protect against the disease.
Ta mu bodo pomagala pri obrambi pred boleznijo.
It is available as a suspension for injection.
Na voljo je v obliki suspenzije za injiciranje.
Protection starts 25 days after the last injection and lasts for at least a year.
Zaščita je učinkovita od 25. dne po zadnji injekciji in traja vsaj eno leto.
The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Cepivo vsebuje tudi „adjuvansa“ (aluminijev hidroksid in saponin) za povečanje imunskega odziva.
The first injection is given from one and a half months of age and the second injection is given three weeks later.
Prva injekcija se daje od starosti enega meseca in pol, druga pa tri tedne pozneje.
The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or milk used for human consumption.
Obdobje karence je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso ali mleko uporabi za prehrano ljudi.
Results from a series of laboratory safety trials performed with vaccines of similar composition but containing different serotypes of the virus were also presented.
Predstavljeni so bili tudi rezultati niza laboratorijskih študij varnosti, opravljenih s cepivi s podobno sestavo, ki pa so vsebovali drugačne serotipe virusa.
The studies also showed that the vaccine can be used in pregnant sheep.
Študije so pokazale tudi, da se cepivo lahko uporablja pri brejih ovcah.
The vaccine is given to animals as an injection under the skin.
Cepivo se živalim injicira pod kožo.
There may also be a local reaction at the injection site, such as swelling (generally lasting less than a week) or ‘nodules' (hardening under the skin) that may last for more than 6 or 7 weeks.
Po cepljenju se lahko pri živalih pojavi lokalna reakcija na mestu injiciranja, kot je oteklina (ki ne traja več kot en teden), ali otipljivi „noduli“ (zatrdline pod kožo), ki lahko trajajo več kot 6 ali 7 tednov.
In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 8 Ovis to convert to a normal status.
Leta 2013 je CVMP menil, da predloženi podatki zadostujejo, da dovoljenje za promet s cepivom ZULVAC 8 Ovis dobi običajen status.
ZULVAC 8 Ovis was initially authorised under ‘exceptional circumstances'.
Cepivo ZULVAC 8 Ovis je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
Sheep may show a temporary increase in body temperature, no more than 1.2°C, in the 24 hours after vaccination.
Do 24 ur po cepljenju se lahko pri ovcah pojavi prehodno povišanje telesne temperature, ki ne presega 1,2 °C.
The company also presented results from a series of studies with other vaccines that contain other serotypes of the bluetongue virus, as well as preliminary results from a study in sheep investigating how long the immunity produced by the vaccine lasted after vaccination.
Družba je predstavila tudi rezultate iz niza študij z drugimi cepivi, ki vsebujejo druge serotipe bolezni modrikastega jezika, ter predhodne rezultate študije, opravljene na ovcah, v kateri so raziskovali, kako dolgo po cepljenju traja odpornost, ki nastane s cepivom.
The European Commission granted a marketing authorisation valid throughout the EU for ZULVAC 8 Ovis on 15 January 2010.
Evropska komisija je dovoljenje za promet s cepivom ZULVAC 8 Ovis, veljavno po vsej Evropski uniji, odobrila dne 15. januarja 2010.
The European Medicines Agency (EMA) reviewed additional information submitted according to an agreed timetable on the quality, safety and efficacy of the vaccine.
Evropska agencija za zdravila (EMA) je pregledala vse nove podatke o kakovosti, varnosti in učinkovitosti cepiva, ki so bili predloženi po dogovorjenem časovnem razporedu.
Information on the prescription status of this product may be found on the label/outer package.
Podatki o predpisovanju tega cepiva so navedeni na nalepki/zunanji ovojnini.
In the future, if the animals are exposed to the bluetongue virus, the immune system will be able to produce antibodies more quickly.
Ob ponovni izpostavitvi virusu bolezni modrikastega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
When it is given to sheep, the immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Ko ovca prejme cepivo, imunski sistem viruse prepozna kot „tujke“ in proti njim razvije protitelesa.
The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Za razmerje med koristmi in tveganji glejte modul o znanstveni razpravi tega evropskega javnega poročila o oceni zdravila (EPAR).
What is the withdrawal period?
Kaj je obdobje karence?
The studies showed that the vaccine is safe for sheep and that it prevents viraemia in animals from one and a half months of age that are infected with bluetongue virus serotype 8.
Študije so pokazale, da je cepivo varno za uporabo pri ovcah in preprečuje viremijo pri živalih, starejših od enega meseca in pol, ki so okužene z virusom bolezni modrikastega jezika, serotip 8.
The vaccine is used to prevent viraemia (the presence of the virus in the blood) in sheep from one and a half months of age.
Cepivo se uporablja za preprečevanje viremije (prisotnosti virusa v krvi) pri ovcah, starejših od enega meseca in pol.
The effectiveness of the vaccine in preventing viraemia in sheep was studied in a laboratory trial using the vaccine in sheep from one month of age.
Učinkovitost cepiva pri preprečevanju viremije pri ovcah so raziskovali v laboratorijski študiji, v kateri so cepili ovce, starejše od enega meseca.
Other information about ZULVAC 8 Ovis:
Druge informacije o zdravilu ZULVAC 8 Ovis:
ZULVAC 8 Ovis is a vaccine.
Zdravilo ZULVAC 8 Ovis je cepivo.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ZULVAC 8 Ovis exceed the risks in the prevention of viraemia caused by the bluetongue virus serotype 8 in sheep from one and a half months of age.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so pri ovcah, starejših od enega meseca in pol, koristi cepiva ZULVAC 8 Ovis pri preprečevanju viremije, ki jo povzroča serotip 8 virusa bolezni modrikastega jezika, večje od z njim povezanih tveganj.
What benefit has ZULVAC 8 Ovis shown during the studies?
Kakšne koristi je zdravilo ZULVAC 8 Ovis izkazalo med študijami?
The safety of the vaccine was studied in laboratory safety studies carried out with ZULVAC 8 Ovis in sheep.
Varnost cepiva ZULVAC 8 Ovis je bila raziskana v laboratorijskih študijah varnosti z njegovo uporabo na ovcah.
The withdrawal period for ZULVAC 8 Ovis for meat and milk is zero days.
Karenca za cepivo ZULVAC 8 Ovis za meso in mleko je nič dni.
ZULVAC 8 Ovis is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Cepivo ZULVAC 8 Ovis se uporablja pri ovcah za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo povzroča virus bolezni modrikastega jezika, prenašajo pa jo trzače.
What is the risk associated with ZULVAC 8 Ovis?
Kakšna tveganja so povezana z zdravilom ZULVAC 8 Ovis?
ZULVAC 8 Ovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Cepivo ZULVAC 8 Ovis vsebuje inaktivirane viruse bolezni modrikastega jezika, ki ne povzročajo bolezni.
The virus exists in several forms (serotypes) throughout the world; the type used in ZULVAC 8 Ovis is serotype 8.
Virus obstaja v različnih oblikah (serotipih) po vsem svetu.
Why has ZULVAC 8 Ovis been approved?
Zakaj je bilo zdravilo ZULVAC 8 Ovis odobreno?
Inactivated vaccine against Bluetongue disease virus, serotype 8
ZULVAC 8 Ovis inaktivirano cepivo proti virusu modrikastega jezika, serotip 8
ZULVAC 8 Ovis is a vaccine that contains inactivated (killed) bluetongue serotype 8 virus as the active substance.
Zdravilo ZULVAC 8 Ovis je cepivo, ki kot zdravilno učinkovino vsebuje inaktiviran (uničen) virus bolezni modrikastega jezika, serotip 8.
What is ZULVAC 8 Ovis?
Kaj je zdravilo ZULVAC 8 Ovis?
How has ZULVAC 8 Ovis been studied?
Kako je bilo zdravilo ZULVAC 8 Ovis raziskano?
What is ZULVAC 8 Ovis used for?
Za kaj se zdravilo ZULVAC 8 Ovis uporablja?
How does ZULVAC 8 Ovis work?
Kako zdravilo ZULVAC 8 Ovis deluje?
This means that it was not possible to obtain complete information about ZULVAC 8 Ovis at the time of the initial authorisation.
To pomeni, da ob prvotni izdaji dovoljenja za promet ni bilo mogoče pridobiti vseh podatkov o tem cepivu.
Information for patients and for healthcare professionals
Informacije za bolnike in zdravstvene delavce
The specific recommendations of the CHMP are as follows:
Konkretna priporočila odbora CHMP so:
• Patients should continue to take their medicines as prescribed.
• Bolniki naj svoja zdravila jemljejo, kot jim je bilo predpisano.
More about the medicines
Več o zdravilih
So far no alternative studies from other sources have been provided.
Do zdaj niso bile predložene druge študije iz drugih virov;
Its suspension is therefore not expected to have any impact on patients in the EU.
Tako torej ni pričakovati, da bi imel začasni umik dovoljenja za promet vpliv na bolnike v EU.
The findings cast doubts on the quality management system in place at the site, and thus on the reliability of the data of bioequivalence studies conducted between March 2013 and March 2015.
Ti izsledki vzbujajo dvome o vzpostavljenem sistemu za upravljanje kakovosti na tem mestu in s tem o zanesljivosti podatkov iz študij biološke enakovrednosti, opravljenih med marcem 2013 in marcem 2015.
The review of Alkem was initiated on 1 April 2016 at the request of the German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.
Pregled družbe Alkem se je začel 1. aprila 2016 na zahtevo nemške agencije za zdravila (BfArM) v skladu s členom 31 Direktive 2001/83/ES.
The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion.
Pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP), odgovoren za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel mnenje agencije.
Other riluzole-containing medicines remain available.
Druga zdravila, ki vsebujejo riluzol, ostajajo na voljo.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 8 September 2016.
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 8. septembra 2016 izdala končni pravno zavezujoč sklep, ki velja za vse države članice EU.
The review covered medicines authorised via national procedures in individual EU Member States, whose marketing authorisation applications included data from studies conducted by Alkem Laboratories Ltd, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad410208 India.
Pregled je zajel zdravila, ki so dovoljenje za promet prejela po nacionalnem postopku v posameznih državah članicah EU, njihove vloge za pridobitev dovoljenja za promet pa so vključevale podatke iz študij, opravljenih v družbi Alkem Laboratories Ltd, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410208 Indija.
The CHMP's recommendations concerning these medicines were sent to the European Commission, which issued a legally binding decision valid throughout the EU.
Priporočila odbora CHMP v zvezi s temi zdravili so bila nato posredovana Evropski komisiji, ki je izdala pravno zavezujoč sklep, veljaven v vsej EU.
EMA will continue to work closely with national authorities and international partners to ensure that studies underpinning marketing authorisations in the EU are carried out to the highest standards and that companies continue to comply fully with all aspects of Good Clinical Practice (GCP).
Agencija EMA bo še naprej tesno sodelovala z nacionalnimi organi in mednarodnimi partnerji, s čimer bo zagotovila, da se študije, ki podpirajo dovoljenja za promet z zdravili v EU, izvajajo skladno z najvišjimi standardi, in da vpletene družbe delujejo skladno z vsemi vidiki dobre klinične prakse.
The recommendations followed a joint routine inspection by German and Dutch authorities in March 2015, which revealed misrepresentation of data during the conduct of two different trials performed in 2013 and 2014 at the Taloja site.
Priporočila so sledila skupnemu rutinskemu inšpekcijskemu pregledu, ki sta ga marca 2015 opravila nemški in nizozemski organ, med katerim so odkrili napačno prikazovanje podatkov v času izvajanja dveh različnih preskušanj, ki so ju leta 2013 in 2014 opravili v Taloji.
EMA recommends suspension of one medicine
Agencija EMA priporoča začasen umik dovoljenja za promet z enim zdravilom
Therefore, the Committee recommended that medicines authorised or being evaluated on the basis of these studies should be suspended or refused authorisation, unless alternative data are available from other sources.
Zato je odbor priporočil, da se za zdravila, ki so dovoljenje za promet prejela na podlagi teh študij, oziroma za zdravila v postopku vrednotenja dovoljenje za promet začasno umakne oziroma se zavrne, razen če so na voljo drugi podatki iz drugih virov.
• Cefuroxime Alkem and Cefuroxime Krka (antibiotics) can remain on the market in the EU, as alternative studies have been provided that support a positive benefit-risk balance.
• zdravili Cefuroxime Alkem in Cefuroxime Krka (antibiotika) lahko ostaneta na trgu v EU, ker so bile predložene druge študije, ki podpirajo pozitivno razmerje med tveganji in koristmi.
On 23 June 2016, the European Medicines Agency (EMA) recommended the suspension of a medicine (Riluzole Alkem), for which studies were conducted at the Alkem Laboratories Ltd site in Taloja, India, and has required companies to provide new data for another medicine before it can be authorised in the EU.
Evropska agencija za zdravila (EMA) je 23. junija 2016 priporočila začasen umik dovoljenja za promet z zdravilom (Riluzole Alkem), za katerega so bile študije opravljene v družbi Alkem Laboratories Ltd v Taloji v Indiji, za drugo zdravilo pa je od družb zahtevala, naj zanj predložijo nove podatke, šele nato bo lahko prejelo dovoljenje za promet v EU.
EMA's Committee for Medicinal Products for Human Use (CHMP) noted that, although there is no evidence of harm or lack of effectiveness linked to the conduct of studies by Alkem Laboratories Ltd, the studies cannot be accepted in marketing authorisation applications in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA je ugotovil, da kljub odsotnosti dokazov o škodljivosti in pomanjkanju učinkovitosti, povezanih s študijami, ki jih je opravila družba Alkem Laboratories Ltd, te študije v okviru vlog za pridobitev dovoljenja za promet z zdravilom v EU niso sprejemljive.
• Cefuroxime Ingen Pharma, currently under evaluation by national authorities, can still be considered for authorisation, as studies from other sources have been provided.
• zdravilo Cefuroxime Ingen Pharma, ki je trenutno v postopku vrednotenja pri nacionalnih organih, še vedno lahko pridobi dovoljenje za promet, ker so bile predložene študije iz drugih virov;
It also included ongoing marketing authorisation applications for medicines which use study data from the site.
Pregled je vključeval tudi postopke za pridobitev dovoljenja za promet z zdravili, ki še potekajo in pri katerih so uporabljeni podatki iz študij s tega mesta.
• The medicine being suspended, Riluzole Alkem, contains riluzole and is not yet on the market in the EU.
• Zdravilo Riluzole Alkem, katerega dovoljenje za promet je bilo začasno umaknjeno, vsebuje riluzol in še ni na trgu v EU.
As a result, a medicine is being suspended.
Zato je dovoljenje za promet z enim zdravilom začasno umaknjeno.
• Ibuprofen Orion, a painkiller currently under evaluation by national authorities, cannot be authorised on the basis of studies carried out at Alkem Laboratories Ltd.
• protibolečinsko zdravilo Ibuprofen Orion, ki je trenutno v postopku vrednotenja pri nacionalnih organih, na podlagi študij, opravljenih v družbi Alkem Laboratories Ltd, ne more prejeti dovoljenja za promet.
• Some studies carried out at the Alkem Laboratories Ltd site have been found to be flawed.
• Ugotovljeno je bilo, da so nekatere študije, opravljene v družbi Alkem Laboratories Ltd, prirejene.
• Riluzole Alkem, a medicine for amyotrophic lateral sclerosis (ALS) which has yet to be marketed in the EU, should now be suspended.
• dovoljenje za promet z zdravilom Riluzole Alkem, zdravilom za amiotrofično lateralno sklerozo (ALS), ki se v EU še ne trži, se začasno umakne;
Medicines under evaluation cannot be granted authorisation on the basis of these studies; further data would have to be provided to support authorisation.
Zdravila v postopku vrednotenja na podlagi teh študij ne morejo prejeti dovoljenja za promet.
• There is no evidence of harm or lack of effectiveness with any of the medicines linked to studies conducted by Alkem Laboratories Ltd.
• Pri nobenih zdravilih, povezanih s študijami, izvedenimi v družbi Alkem Laboratories Ltd, ni dokazov o škodljivosti ali pomanjkanju učinkovitosti.
The European Commission issued a decision on 28 September 2017.
Evropska komisija je sklep izdala 28. septembra 2017.
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/124)
Izid napotitvenega postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/124)
Which data has the CVMP reviewed?
Katere podatke je odbor CVMP pregledal?
Consequently, on 1 September 2016, France initiated a procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products.
Zato je Francija 1. septembra 2016 v skladu s členom 35 Direktive 2001/82/ES sprožila postopek za zgoraj navedena zdravila za uporabo v veterinarski medicini.
On 13 July 2017, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat, milk and offal) for cattle, sheep and goats for Zanil and associated names, and generic products thereof.
Evropska agencija za zdravila (agencija) je 13. julija 2017 zaključila pregled varnosti potrošnikov glede karenc (mesa, mleka in organov) za govedo, ovce in koze za zdravilo Zanil in povezana imena ter njegova generična zdravila.