natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the European Union for Angiox on 20 September 2004.
Evropska komisija je dovoljenje za promet z zdravilom Angiox, veljavno po vsej Evropski uniji, odobrila dne 20. septembra 2004.
The full EPAR for Angiox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Angiox je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It was most effective in patients who also took aspirin and clopidogrel.
Najučinkovitejše je bilo pri bolnikih, ki so jemali tudi aspirin in klopidogrel.
The studies also looked at the number of patients who had major bleeding.
V študijah so beležili tudi število bolnikov, ki so doživeli močnejšo krvavitev.
The dose of Angiox and the duration of treatment depend on why it is being used.
Odmerek zdravila Angiox in trajanje zdravljenja sta odvisna od tega, zakaj se zdravilo uporablja.
This is a summary of the European public assessment report (EPAR) for Angiox.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Angiox.
It decided that Angiox's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Angiox večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
In all three studies, the patients also received other medicines to prevent blood clots, such as aspirin and clopidogrel.
V vseh študijah so bolniki prejemali tudi druga zdravila za preprečevanje nastajanja krvnih strdkov, kot sta aspirin in klopidogrel.
It must also not be used in patients who have recently been bleeding, or who have severe high blood pressure, severe kidney problems or a heart infection.
Prav tako ga ne smejo uporabljati bolniki, ki so nedavno krvaveli, ki imajo močno povišan krvni tlak, resno ledvično obolenje ali okužbo srca.
The most common side effect with Angiox (seen in more than 1 patient in 10) is minor bleeding.
Najpogostejši neželeni učinki zdravila Angiox (opaženi pri več kot 1 bolniku od 10) so manjše krvavitve.
What measures are being taken to ensure the safe use of Angiox?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Angiox?
The company that makes Angiox will provide all doctors who are expected to prescribe the medicine with training and educational materials on how to use it correctly, including dosing instructions.
Družba, ki izdeluje zdravilo Angiox, bo vsem zdravnikom, ki naj bi predpisovali zdravilo Angiox zagotovila usposabljanje in izobraževalno gradivo o njegovi pravilni uporabi, vključno z informacijami o odmerjanju.
What benefit has Angiox shown during the studies?
Kakšne koristi je zdravilo Angiox izkazalo med študijami?
The first dose is given by injection into a vein, which must be followed immediately by an infusion for at least the duration of the procedure.
Prvi odmerek se injicira v veno, temu pa takoj sledi infundiranje vsaj tako dolgo kot traja postopek.
Blood clotting can be a problem when blood clots develop inside blood vessels and restrict the blood flow to major organs such as the heart and the brain.
Strjevanje krvi lahko predstavlja resno težavo, če se v žilah tvorijo krvni strdki in ovirajo pretok krvi do osnovnih organov, kot so srce in možgani.
The main measure of effectiveness was the reduction in the number of patients who had an ‘ischaemic event' (a problem caused by reduced blood flow) including death, a heart attack, urgent revascularisation (restoration of blood flow to the heart) or stroke after 30 days.
Glavno merilo učinkovitosti je bilo zmanjšanje števila bolnikov, ki so po 30 dneh doživeli „ishemični dogodek“ (težavo, ki jo povzroči zmanjšan pretok krvi), vključno s smrtjo, srčnim napadom, nujno revaskularizacijo (ponovno vzpostavitvijo krvnega pretoka do srca).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Angiox.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Angiox, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Angiox should be given by a doctor who has experience in the emergency care of patients with heart problems or in carrying out procedures on the heart.
Zdravilo Angiox mora dajati zdravnik, ki ima izkušnje z nujno oskrbo bolnikov z obolenji srca ali izvedbo posegov na srcu.
This can improve the effectiveness of PCI and help to maintain the flow of blood to the heart in patients with angina or myocardial infarction.
S tem se lahko izboljša učinkovitost postopka PCI in pomaga ohraniti pretok krvi v srce pri bolnikih z angino pektoris ali miokardnim infarktom.
For more information about treatment with Angiox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Angiox preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Using Angiox greatly reduces the risk of a blood clot forming.
Uporaba zdravila Angiox močno zmanjša tveganje za nastanek krvnih strdkov.
Angiox is a medicine that contains the active substance bivalirudin.
Angiox je zdravilo, ki vsebuje zdravilno učinkovino bivalirudin.
Angiox must not be used in people whoare hypersensitive (allergic) to bivalirudin, other hirudins, or any of the other ingredients.
Zdravila Angiox ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) bivalirudin, druge hirudine ali katero koli drugo sestavino zdravila.
This includes patients who are having myocardial infarction (a heart attack) with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG).
To vključuje tudi bolnike, ki so imeli miokardni infarkt (srčni napad) z dvigom spojnice ST (nenormalnim zapisom na elektrokardiogramu ali EKG).
Angiox is an anticoagulant, which means that it prevents the blood from clotting.
Zdravilo Angiox je antikoagulant, kar pomeni, da preprečuje strjevanje krvi.
Angiox is used together with aspirin and clopidogrel (other medicines that help to prevent blood clots).
Zdravilo se uporablja tudi skupaj z aspirinom in klopidogrelom (drugima zdraviloma, ki pomagata preprečevati nastajanje krvnih strdkov).
It is available as a powder that is made up into a solution for injection or infusion (drip) into a vein.
Na voljo je v obliki praška za pripravo raztopine za injiciranje ali infundiranje (kapalne infuzije v veno).
Other information about Angiox
Druge informacije o zdravilu Angiox:
The active substance in Angiox, bivalirudin, is a synthetic substance originally derived from hirudin, the anticoagulant substance produced by leeches.
Zdravilna učinkovina v zdravilu Angiox, bivalirudin, je sintetična snov, prvotno pridobljena iz hirudina, tj. antikoagulacijske snovi, ki jo proizvajajo pijavke.
Almost 4,000 of the patients were having PCI to treat myocardial infarction with ST segment elevation.
Pri skoraj 4 000 bolnikov je bila opravljen postopek PCI za zdravljenje miokardnega infarkta z dvigom spojnice ST.
For the full list of all side effects reported with Angiox, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Angiox, glejte navodilo za uporabo.
What is the risk associated with Angiox?
Kakšna tveganja so povezana z zdravilom Angiox?
Thrombin is central to the processes involved in blood clotting.
Trombin ima osrednjo vlogo pri strjevanju krvi.
The CHMP concluded that Angiox is an acceptable substitute for heparin during PCI and in the treatment of unstable angina and myocardial infarction.
CHMP je sklenil, da je zdravilo Angiox sprejemljiv nadomestek za kombinacijo heparina med postopkom perkutane koronarne intervencije (PCI) ter pri zdravljenju nestabilne angine pektoris in miokardnega infarkta.
In patients with unstable angina or myocardial infarction without ST segment elevation waiting for further treatment, the main study involved almost 14,000 adults and compared Angiox taken alone or with a GPI, with the combination of heparin and a GPI.
Pri bolnikih z nestabilno angino pektoris ali miokardnim infarktom brez dviga spojnice ST, ki so čakali na nadaljnje zdravljenje,je glavna študija zajemala skoraj 14 000 odraslih, v njej pa so primerjali zdravilo Angiox kot samostojno ali skupaj z GPI, s kombinacijo heparina in GPI.
Angiox is used to prevent blood clots in adults who are undergoing percutaneous coronary intervention (PCI), a non-surgical procedure used to unblock the heart's blood vessels.
Zdravilo Angiox se uporablja za preprečevanje nastajanja krvnih strdkov pri odraslih, pri katerih je bila opravljena perkutana koronarna intervencija (PCI), tj. nekirurški poseg za odpravo blokad v srčnih krvnih žilah.
In patients being treated for angina or myocardial infarction without ST segment elevation, the duration of the infusion depends on how the patient is going to be treated.
Pri bolnikih, ki se zdravijo zaradi angine pektoris ali miokardnega infarkta brez dviga spojnice ST, je trajanje infundiranja odvisno od zdravljenja, ki ga bo bolnik prejemal potem.
Why has Angiox been approved?
Zakaj je bilo zdravilo Angiox odobreno?
Major bleeding was less common with Angiox alone than with heparin plus GPI.
Večje krvavitve so bile manj pogoste ob jemanju zdravila Angiox samostojno kot pri jemanju heparina v kombinaciji z GPI.
In both studies of patients undergoing PCI, Angiox (alone or with a GPI where appropriate) was as effective as heparin in combination with a GPI at preventing new ischaemic events.
V obeh študijah z bolniki, pri katerih je bila opravljen postopek PCI, se je zdravilo Angiox (uporabljeno samostojno ali po potrebi skupaj z GPI) pri preprečevanju ishemičnih dogodkov izkazalo za enako učinkovito kot heparin v kombinaciji s GPI.
Angiox is also used to treat adults with unstable angina (a type of chest pain that varies in severity) or myocardial infarction without ST segment elevation, who are waiting for further treatment such as PCI, a heart bypass or using other medicines.
Zdravilo Angiox se uporablja tudi za zdravljenje odraslih z nestabilno angino pektoris (vrsto bolečine v prsih, katere jakost se spreminja) ali miokardnim infarktom brez dviga spojnice ST, pri katerih bo opravljena perkutana koronarna intervencija (PCI) ali operacija srčnega obvoda oziroma pri katerih bodo začeli uporabljati druga zdravila.
When used to treat unstable angina or myocardial infarction without ST segment elevation, Angiox, given with or without a GPI, was as effective as the combination of heparin and a GPI in preventing deaths, heart attacks and revascularisations.
Pri uporabi za zdravljenje nestabilne angine pektoris ali miokardnega infarkta brez dviga spojnice ST je bilo zdravilo Angiox v kombinaciji z GPI ali brez njega pri preprečevanju smrti, srčnih napadov in revaskularizacije enako učinkovito kot kombinacija heparina in GPI.
What is Angiox used for?
Za kaj se zdravilo Angiox uporablja?
In PCI, Angiox has been compared withanother type of anticoagulant, a heparin, in two studies involving a total of almost 10,000 adults.
Pri postopku PCI so zdravilo Angiox v dveh študijah s skupaj skoraj 10 000 odraslimi bolniki primerjali z drugim antikoagulacijskim sredstvom, heparinom.
How has Angiox been studied?
Kako je bilo zdravilo Angiox raziskano?
Heparin was given in combination with a glycoprotein IIb/IIIa inhibitor (GPI, another type of medicine that helps to prevent blood clots) and some patients receiving Angiox were also given a GPI where appropriate.
Heparin so dajali v kombinaciji z zaviralcem glikoproteina IIb/IIIa (GPI, drugo vrsto zdravila, ki pomaga preprečevati krvne strdke.).
What is Angiox?
Kaj je zdravilo Angiox?
It specifically blocks one of the substances involved in the clotting process called thrombin.
Ta zlasti zavira delovanje trombina, ene izmed snovi, ki sodelujejo pri strjevanju krvi.
How is Angiox used?
Kako se zdravilo Angiox uporablja?
The rate of the infusion needs to be reduced in patients with moderate kidney problems who are undergoing PCI.
Pri bolnikih z zmernimi ledvičnimi težavami, pri katerih se opravi perkutana koronarna intervencija, mora biti hitrost infundiranja manjša.
How does Angiox work?
Kako zdravilo Angiox deluje?
What are the benefits and risks of Prevomax?
Kakšne so koristi in tveganja, povezani z zdravilom Prevomax?
The full EPAR for Prevomax can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Prevomax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
To prevent vomiting Prevomax should be given more than one hour in advance of the event that might cause vomiting.
Za preprečevanje bruhanja je treba zdravilo Prevomax dati več kot eno uro pred dogodkom, ki bi lahko sprožil bruhanje.
It is not intended to provide practical advice on how to use Prevomax.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What is Prevomax and what is it used for?
Kaj je zdravilo Prevomax in za kaj se uporablja?
As for every medicine, the company provided studies on the quality of Prevomax.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Prevomax.
Prevomax is injected once daily under the skin or into a vein (1 mg/per kg bodyweight) for up to five days.
Zdravilo Prevomax se injicira v podkožje ali v veno (1 mg/kg telesne mase) enkrat na dan največ pet dni.
The active substance in Prevomax, maropitant, stops a chemical in the body (substance P) from attaching to certain targets called neurokinin-1 (NK1) receptors, which are found on the surface of cells in the part of the brain that controls nausea and vomiting.
Zdravilna učinkovina zdravila Prevomax, maropitant, kemični snovi v telesu (substanci P) prepreči vezavo na določene tarče, imenovane receptorji za nevrokinin 1 (NK1), ki se nahajajo na površini celic v predelu možganov, ki nadzoruje navzejo in bruhanje.
The European Commission granted a marketing authorisation valid throughout the EU for Prevomax on 19 June 2017.
Evropska komisija je dovoljenje za promet z zdravilom Prevomax, veljavno po vsej Evropski uniji, izdala 19/06/2017.
This is a summary of the European public assessment report (EPAR) for Prevomax.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prevomax.
The Committee recommended that Prevomax be approved for use in the EU.
Priporočil je, da se zdravilo Prevomax odobri za uporabo v EU.
Prevomax is a veterinary medicine used in dogs and cats to treat vomiting, in combination with other supportive measures, or to prevent vomiting (except travel sickness).
Prevomax je zdravilo za uporabo v veterinarski medicini, ki se uporablja pri psih in mačkah za zdravljenje bruhanja v kombinaciji z ostalimi podpornimi ukrepi ali za preprečevanje bruhanja (razen potovalne slabosti).
When substance P attaches to these receptors it triggers nausea and vomiting.
Če se substanca P veže na te receptorje, to povzroči navzejo in bruhanje.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Prevomax has been shown to have comparable quality and to be bioequivalent to Cerenia, solution for injection.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Prevomax primerljivo raven kakovosti kot zdravilo Cerenia raztopina za injiciranje ter da mu je bioekvivalentno.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Cerenia, and do not need to be repeated for Prevomax.
Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Cerenia, zato jih ni treba ponoviti za zdravilo Prevomax.
Why is Prevomax approved?
Zakaj je bilo zdravilo Prevomax odobreno?
Prevomax is a ‘generic medicine'.
Zdravilo Prevomax je „generično zdravilo“.
Because Prevomax is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Prevomax generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
In dogs Prevomax can also be used both to prevent nausea and vomiting before and after an operation and to improve recovery from general anaesthesia after use of morphine.
Pri psih se zdravilo Prevomax uporablja tudi za preprečevanje navzeje in bruhanja pred operacijo in po njej ter za hitrejše okrevanje po splošni anesteziji, pri kateri je bil uporabljen morfin.
In cats Prevomax is also used to reduce nausea (signs of feeling sick).
Pri mačkah se zdravilo Prevomax uporablja tudi za zmanjševanje navzeje (znakov siljenja na bruhanje).
This means that Prevomax contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Cerenia.
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Cerenia, ki je že odobreno v EU.
Other information about Prevomax?
Druge informacije o zdravilu Prevomax
The precautions are the same as for the reference medicine since Prevomax is a generic medicine.
Previdnostni ukrepi so enaki kot pri referenčnem zdravilu, saj je zdravilo Prevomax generično zdravilo.
The medicine can only be obtained with a prescription and is available as a solution for injection.
Predpisovanje in izdaja zdravila je le na recept, na voljo pa je v obliki raztopine za injiciranje.
By blocking the receptors, maropitant can prevent nausea and vomiting.
Maropitant lahko z zaviranjem receptorjev prepreči navzejo in bruhanje.
There was no need for ‘bioequivalence' studies to investigate whether Prevomax is absorbed similarly to the reference medicine, Cerenia solution for injection, to produce the same level of the active substance in the blood.
Izvedba študij bioekvivalenosti, s katerimi se proučuje, ali se zdravilo Prevomax absorbira podobno kot referenčno zdravilo Cerenia raztopina za injiciranje in tako ustvari enake ravni zdravilne učinkovine v krvi, ni bila potrebna.
Prevomax contains the active substance maropitant.
Zdravilo Prevomax vsebuje zdravilno učinkovino maropitant.
When given by injection under the skin, the active substance in Prevomax is expected to be absorbed in the same way as the reference medicine.
Kadar se daje s podkožno injekcijo, se pričakuje, da se bo zdravilna učinkovina zdravila Prevomax absorbirala enako kot referenčno zdravilo.
Therefore, the CVMP's view was that, as for Cerenia, the benefits outweigh the identified risks.
Zato je menil, da njegove koristi, enako kot pri zdravilu Cerenia, odtehtajo znana tveganja.
Prevomax is also used to prevent and treat nausea caused by chemotherapy in dogs.
Zdravilo Prevomax se pri psih uporablja tudi za preprečevanje in zdravljenje navzeje, ki jo povzroča kemoterapija.
Safety information has been included in the summary of product characteristics and the package leaflet for Prevomax, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
This is because when given by injection into a vein, the active substance in Prevomax is delivered straight into the bloodstream.
Razlog za to je dejstvo, da se zdravilo Prevomax daje z infundiranjem v veno, zato zdravilna učinkovina vstopi neposredno v krvni obtok.
For more information about treatment with Prevomax, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Prevomax naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For practical information about using Prevomax, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Prevomax naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
How is Prevomax used?
Kako se zdravilo Prevomax uporablja?
How has Prevomax been studied?
Kako je bilo zdravilo Prevomax raziskano?
How does Prevomax work?
Kako zdravilo Prevomax deluje?
Intravenous use, Subcutaneous use
Bortezomib Accord 3,5 mg prašek za raztopino za injiciranje Intravenska uporaba, Subkutana uporaba
Intravenous use
Pot uporabe
14 June 2012
14. junij 2012
The referral started on 5 May 2011.
Napotitveni postopek se je začel 5. maja 2011.
The final opinion was converted into a Decision by the European Commission on 14 June 2012.
Končno mnenje je bilo spremenjeno v sklep Evropske komisije dne 14. junija 2012.
Article 35 of Directive 2001/82/EC, as amended
Člen 35 Direktive 2001/82/ES, kakor je bila spremenjena.
The Committee appointed Dr Cristina Muñoz Madero as rapporteur and Dr Petras Mačiulskis as co-rapporteur.
Odbor je imenoval dr. Cristino Muñoz Madero kot poročevalko, dr. Petrasa Mačiulskisa pa kot soporočevalca.
Written explanations were provided by the marketing authorisation holders on 31 August 2011 and 20 January 2012.
Imetniki dovoljenja za promet z zdravilom so pisna pojasnila predložili dne 31. avgusta 2011 in 20. januarja 2012.
Tilmicosin is a semi-synthetic antibiotic of the macrolide group.
Tilmikozin je polsintetični antibiotik iz skupine makrolidov.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summary of product characteristics, labelling in Annex III and the conditions of the marketing authorisations in Annex IV.
Seznam zadevnih imen zdravil je naveden v Prilogi I. Znanstveni zaključki so skupaj s spremembami povzetka glavnih značilnosti zdravila podani v Prilogi II, označevanje je navedeno v Prilogi III, pogoji dovoljenja za promet z zdravilom pa v Prilogi IV.
The CVMP was requested to give its opinion regarding the recommended dose and inclusion rates in feed for these veterinary medicinal products administered to rabbits.
CVMP je bil pozvan, da poda svoje mnenje glede priporočenega odmerka tega veterinarskega zdravila in njegovih deležev v krmi za uporabo pri kuncih.
Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to recommended changes of the product information and conditions affecting the marketing authorisations for all pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits.
Na podlagi ocene trenutno razpoložljivih podatkov je CVMP menil, da je splošno razmerje med koristmi in tveganji teh zdravil še vedno pozitivno pod pogojem, da se v informacije o zdravilu in pogoje, ki vplivajo na dovoljenja za promet z zdravilom za vse predmešanice za pripravo zdravilne krmne mešanice, ki vsebujejo 40 g, 100 g ali 200 g tilmikozina na kilogram predmešanice in se uporabljajo pri kuncih, vnesejo priporočene spremembe.
On 8 April 2011, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g tilmicosin per kg premix and administered to rabbits.
Evropska komisija je 8. aprila 2011 agenciji predložila obvestilo o napotitvi iz člena 35 Direktive 2001/82/ES v zvezi z vsemi predmešanicami za pripravo zdravilne krmne mešanice, ki vsebujejo 40 g, 100 g ali 200 g tilmikozina na kilogram predmešanice in se uporabljajo pri kuncih.