natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the European Union for Plavix to Sanofi Pharma Bristol-Myers Squibb SNC on 15 July 1998.
Evropska komisija je dovoljenje za promet z zdravilom Plavix, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pharma Bristol-Myers Squibb SNC dne 15. julija 1998.
Plavix is used to prevent problems caused by blood clots in adults who have:
Zdravilo Plavix se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki, pri odraslih, ki:
The full EPAR for Plavix 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 Plavix je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Plavix is converted into its active form in the body.
Zdravilo Plavix se v svojo aktivno obliko pretvori v telesu.
For more information about treatment with Plavix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Plavix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
For genetic reasons, some patients may not be able to convert Plavix as effectively as others, which could reduce their response to the medicine.
Zaradi genetskih razlogov nekateri bolniki zdravila Plavix morda ne morejo tako učinkovito pretvarjati, kar lahko zmanjša njihov odziv na zdravilo.
There was also a reduction in the patients who had a stent inserted.
Do zmanjšanja tveganja je prišlo tudi pri bolnikih, ki so imeli vstavljen stent.
This is a summary of the European public assessment report (EPAR) for Plavix.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Plavix.
Plavix can be started between a few days and 35 days after the attack;
Zdravilo Plavix se lahko začne dajati od nekaj dni po napadu do 35 dni po njem;
This showed that Plavix reduces the risk of an event.
To je dokaz, da zdravilo Plavix znižuje tveganje za pojav dogodka.
In other words, about 10 patients in 1,000 will avoid having a new ischaemic event two years after starting Plavix instead of aspirin.
Z drugimi besedami, približno 10 bolnikov od 1000 se bo izognilo novemu ishemičnemu napadu v dveh letih po pričetku prejemanja zdravila Plavix namesto aspirina.
The CHMP decided that Plavix's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Plavix večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
What benefit has Plavix shown during the studies?
Kakšne koristi je zdravilo Plavix izkazalo med študijami?
In CAPRIE, there were 939 events in the Plavix group, and 1,020 in the aspirin group.
V študiji CAPRIE, je bilo v skupini, ki je prejemala zdravilo Plavix, 939 dogodkov, v skupini, zdravljeni z aspirinom, pa 1 020.
Plavix should not be used in people who may be hypersensitive (allergic) to clopidogrel or any of the other ingredients.
Zdravila Plavix ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) klopidogrel ali katero koli drugo sestavino zdravila.
The standard dose of Plavix is one 75-mg tablet once a day.
Priporočeni odmerek zdravila Plavix je ena 75-miligramska tableta enkrat dnevno.
Plavix was more effective than aspirin at preventing new ischaemic events.
Zdravilo Plavix je bilo pri preprečevanju novih ishemičnih dogodkov učinkovitejše od aspirina.
In acute coronary syndrome, treatment generally starts with a loading dose of one 300-mg tablet or four 75-mg tablets.
Pri akutnem koronarnem sindromu se zdravljenje na splošno začne z udarnim odmerkom ene 300-miligramske tablete ali štirih 75-miligramskih tablet.
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 Plavix.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Plavix, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Some of these patients may have had a stent (a short tube) placed in an artery to prevent it from closing up.
Nekaterim bolnikom je bil morda v arterijo vstavljen stent (kratka cevka), da prepreči njeno zamašitev.
It must not be used in patients who have severe liver disease or a disease that may cause bleeding such as a stomach ulcer or bleeding in the brain.
Ne sme se uporabljati pri bolnikih, ki imajo resno obolenje jeter ali bolezen, ki povzroča krvavitev, kot je želodčna razjeda ali možganska krvavitev.
In acute coronary syndrome and atrial fibrillation, Plavix is used together with aspirin, the dose of which should not be higher than 100 mg.
Pri akutnem koronarnem sindromu in atrijski fibrilaciji se zdravilo Plavix uporablja skupaj z aspirinom, katerega odmerek ne sme biti višji od 100 mg.
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
To preprečuje, da bi trombociti postali lepljivi, zmanjšuje tveganje za nastanek krvnih strdkov ter prispeva k preprečitvi novega srčnega napada ali kapi.
This means that fewer patients will have new ischaemic events if they receive Plavix than if they receive aspirin.
To pomeni, da bo manj bolnikov doživelo nov ishemični napad, če bodo jemali zdravilo Plavix, kot pa če bodo jemali aspirin.
Other information about Plavix
Druge informacije o zdravilu Plavix:
Plavix can be started between seven days and six months after the stroke;
Zdravilo Plavix se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
The most common side effects with Plavix (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured.
Najpogostejši neželeni učinki zdravila Plavix (opaženi pri 1 do 10 bolnikih izmed 100) so hematomi (kopičenje krvi pod kožo), epistaksa (krvavitve iz nosu), gastrointestinalna hemoragija (krvavitve v želodcu ali črevesju), driska, bolečine v trebuhu, dispepsija (zgaga), podplutbe in krvavitve na mestu predrte kože.
What is the risk associated with Plavix?
Kakšna tveganja so povezana z zdravilom Plavix?
It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Uporablja se pri bolnikih, pri katerih obstaja vsaj en dejavnik tveganja za vaskularni dogodek, kot je srčni napad ali kap, ki ne morejo jemati antagonistov vitamina K (drugega zdravila, ki preprečuje krvne strdke) in pri katerih obstaja nizko tveganje za krvavitve.
Plavix is a medicine that contains the active substance clopidogrel.
Plavix je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
In non-ST segment elevation acute coronary syndrome, the overall relative reduction in the risk of an event compared with placebo was 20%.
Pri akutnem koronarnem sindromu brez dviga spojnice ST je znašalo celotno relativno zmanjšanje tveganja za pojav dogodka v primerjavi s placebom 20 %.
In the studies of acute coronary syndrome, all of the patients also took aspirin and the main measure of effectiveness was the number of patients who experienced an ‘event' such as a blocked artery, another heart attack or death during the study.
V študijah akutnega koronarnega sindroma so vsi bolniki jemali aspirin, glavno merilo učinkovitosti pa je bilo število bolnikov z „dogodkom“, kot je blokirana arterija, ponovni srčni napad ali smrt med samo študijo.
Why has Plavix been approved?
Zakaj je bilo zdravilo Plavix odobreno?
In the study in atrial fibrillation patients, Plavix taken together with aspirin reduced the risk of new events by 11% compared with placebo taken with aspirin, with the largest reduction (28%) seen for stroke.
V študiji atrijske fibrilacije so bolniki zdravilo Plavix jemali skupaj z aspirinom, kar je zmanjšalo tveganje za nove dogodke za 11 % v primerjavi s placebom, jemanim skupaj z aspirinom, kjer je bilo največje zmanjšanje opaženo glede kapi (28 %).
• recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
• so nedavno utrpeli ishemično kap (kap, ki jo povzroči neoskrba določenega dela možganov s krvjo).
Plavix has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral arterial disease.
Zdravilo Plavix so primerjali z aspirinom v študiji CAPRIE, v katero je bilo vključenih okoli 19 000 bolnikov, ki so nedavno doživeli srčni napad ali ishemično kap ali pri katerih je bilo ugotovljeno periferno arterijsko obolenje.
For the full list of all side effects reported with Plavix, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Plavix, glejte navodilo za uporabo.
• atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
• trpijo za atrijsko fibrilacijo (neredno hitro krčenje srčnih preddvorov), kjer se mora dajati skupaj z aspirinom.
In ST segment elevation myocardial infarction, fewer patients on Plavix had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Pri miokardnem infarktu z dvigom spojnice ST je bilo število bolnikov, pri katerih so se pojavili dogodki, manjše med bolniki, ki so jemali zdravilo Plavix, kot med bolniki, ki so prejemali placebo (262 v primerjavi s 377 v študiji CLARITY ter 2 121 v primerjavi z 2 310 v študiji COMMIT).
The active substance in Plavix, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Plavix, klopidogrel, je zaviralec agregacije trombocitov.
• a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
• imajo akutni koronarni sindrom, pri katerih se mora zdravilo dajati skupaj z aspirinom (drugim zdravilom za preprečevanje krvnih strdkov).
Plavix has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Plavix with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks.
Zdravilo Plavix so primerjali tudi s placebom v dveh študijah z bolniki z dvigom spojnice ST: študija CLARITY je vključevala 3 000 bolnikov in je trajala do osem dni, študija COMMIT pa je vključevala skoraj 46 000 bolnikov, ki so do štiri tedne prejemali zdravilo Plavix z metoprololom (drugim zdravilom za težave s srcem ali visok krvni tlak) ali brez njega.
In acute coronary syndrome, Plavix has been compared with placebo (a dummy treatment) in one study involving over 12,000 patients with non-ST segment elevation, 2,172 of whom had a stent inserted during the study (CURE study, lasting up to a year).
Pri akutnem koronarnem sindromu so zdravilo Plavix primerjali s placebom (zdravilom brez zdravilne učinkovine) v eni študiji z 12 000 bolniki brez dviga spojnice ST, od katerih so 2 172 bolnikom med študijo vstavili stent (študija CURE, ki je trajala do enega leta).
How has Plavix been studied?
Kako je bilo zdravilo Plavix raziskano?
What is Plavix used for?
Za kaj se zdravilo Plavix uporablja?
What is Plavix?
Kaj je zdravilo Plavix?
How is Plavix used?
Kako se zdravilo Plavix uporablja?
In atrial fibrillation, Plavix has been compared with placebo (both taken together with aspirin) in one main study involving around 7,500 patients who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy.
Pri atrijski fibrilaciji je bilo zdravilo Plavix primerjano s placebom (oba dajana skupaj z aspirinom) v eni glavni študiji, v kateri je sodelovalo okoli 7 500 bolnikov, ki so imeli vsaj en dejavnik tveganja za vaskularni dogodek in ki ne morejo prejemati zdravljenja z antagonistom vitamina K. Bolniki so bili zdravljeni povprečno tri leta, glavno merilo učinkovitosti pa je bilo število bolnikov, ki so doživeli bodisi srčni napad, ishemično kap ali so umrli.
How does Plavix work?
Kako zdravilo Plavix deluje?
London, 25 September 2008 Doc.
London, 25. september 2008 Sklic na dok.
International non-proprietary name (INN): satraplatin
Mednarodno nelastniško ime (INN): satraplatin
These compounds are made from the metal platinum.
Te spojine so narejene iz kovine platina.
This means that the cancer does not respond to hormonal treatment.
To pomeni, da se rak ne odziva na hormonsko zdravljenje.
It was to be available as capsules to be taken by mouth containing 10 or 50 mg satraplatin.
Na voljo naj bi bilo v obliki kapsul, ki se jemljejo peroralno in vsebujejo 10 ali 50 mg satraplatina.
Questions and answers on the withdrawal of the marketing application for Orplatna
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Orplatna
The effects of Orplatna were first tested in experimental models before being studied in humans.
Učinki zdravila Orplatna so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
In this instance, progression could be measured as the appearance of new tumours as detected during a scan, the appearance of new bone problems, the progression of symptoms (such as pain, weight loss or problems with urination), or death.
V tem primeru so napredek lahko merili glede na pojav novih tumorjev, ki so jih zaznali s slikanjem, pojav novih težav s kostmi, napredek simptomov (kot so bolečina, zmanjšanje telesne mase ali težave z uriniranjem) ali smrt.
In the body, satraplatin is expected to attach itself to the DNA within cells, stopping them reproducing.
V telesu naj bi se satraplatin vezal na DNK v celicah in preprečil njihovo razmnoževanje.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Orplatna?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe z zdravilom Orplatna?
This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen.
To je rak, ki prizadene prostato, žlezo pod mehurjem pri moških, ki proizvaja semensko tekočino.
Orplatna was expected to be used to treat prostate cancer.
Zdravilo Orplatna naj bi se uporabljalo za zdravljenje raka prostate.
As a result, it is expected to stop the growth of tumour cells, which eventually die.
Posledica tega je, da zavira rast tumorskih celic in jih v končni fazi tudi ubije.
The CHMP was concerned that the effectiveness of Orplatna had not been sufficiently shown.
CHMP je imel zadržke, da učinkovitost zdravila Orplatna ni bila zadovoljivo dokazana.
The main measure of effectiveness was ‘progression-free survival' (the time taken for the disease to get worse) as well as overall survival time.
Glavno merilo učinkovitosti je bil čas preživetja, v katerem bolezen ni napredovala (čas do poslabšanja bolezni) kot tudi skupni čas preživetja.
What is Orplatna?
Kaj je zdravilo Orplatna?
Based on the review of the data and the company's response to the CHMP's list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Orplatna could not have been approved for the treatment of metastatic hormone-refractory prostate cancer.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP v času umika vloge, je imel Odbor zadržke in začasno menil, da zdravila Orplatna ni mogoče odobriti za zdravljenje hormonsko neodzivnega metastatskega raka prostate.
The active substance in Orplatna, satraplatin, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘platinum compounds'.
Zdravilna učinkovina zdravila Orplatna, satraplatin, je citotoksik (zdravilo, ki ubija celice, ki se delijo, kot na primer rakave celice) iz skupine spojin, ki vsebujejo platino.
Orplatna is a medicine that contains satraplatin as the active substance.
Orplatna je zdravilo, ki vsebuje zdravilno učinkovino satraplatin.
One main study compared the effectiveness of adding Orplatna or placebo (a dummy treatment) to prednisone in 950 patients with metastatic hormone-refractory prostate cancer in whom at least one previous treatment had failed.
V eni glavni študiji so primerjali učinkovitost dodajanja zdravila Orplatna ali placeba (zdravila brez zdravilne učinkovine) prednizonu pri 950 bolnikih s hormonsko neodzivnim metastatskim rakom prostate, pri katerih je bilo neučinkovito najmanj eno predhodno zdravljenje.
On 1 August 2008, Pharmion Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Orplatna, for the treatment of patients with metastatic hormone-refractory prostate cancer who have failed prior chemotherapy.
Družba Pharmion Ltd. je dne 1. avgusta 2007 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za izdajo dovoljenja za promet z zdravilom Orplatna, namenjenim zdravljenju bolnikov s hormonsko neodzivnim rakom prostate, pri katerih je bilo predhodno zdravljenje s kemoterapijo neuspešno.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Orplatna had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je zato v času umika menil, da koristi zdravila Orplatna niso bile zadostno dokazane in da kakršne koli koristi ne odtehtajo znanih tveganj.
The medicine was to be used with prednisone or prednisolone (anti-inflammatory medicines) in patients who had failed to respond to other anti-cancer medicines, when their cancer had spread from the original site to other parts of the body (metastatic) and had been shown to be ‘hormone-refractory'.
Zdravilo naj bi se uporabljalo s prednizonom ali prednizolonom (protivnetni zdravili) pri bolnikih, ki se niso odzvali na druga zdravila proti raku in pri katerih se je rak razširil iz izvornega mesta na druge dele telesa (metastatski) in se je izkazal kot hormonsko neodziven.
Progression-free survival was measured using a ‘composite' method, which means that there was more than one symptom that could be used as a measure.
Čas preživetja, v katerem bolezen ni napredovala, so merili s kombinirano metodo, kar pomeni, da so kot merilo uporabljali več kot en simptom.
The company informed the CHMP that Orplatna will continue to be made available for patients included in ongoing clinical trials.
Družba je CHMP obvestila, da bo zdravilo Orplatna še naprej na voljo bolnikom in da namerava nadaljevati klinična preskušanja, ki trenutno potekajo.
However, the Committee was concerned that the patients in the main study who had previously treated been with docetaxel had more side effects when taking Orplatna than the patients who had received other medicines for their cancer before the study.
Vendar je Odbor izrazil zadržke, da se bo pri bolnikih, vključenih v glavno študijo, ki so bili predhodno zdravljeni z docetakselom, ob jemanju zdravila Orplatna pojavilo več neželenih učinkov kot pri bolnikih, ki so pred študijo jemali druga zdravila proti raku.
Compared with placebo, Orplatna did not increase overall survival time, and the small improvement seen in progression-free survival was not considered relevant in the absence of a benefit in terms of overall survival time.
V primerjavi s placebom se pri jemanju zdravila Orplatna skupni čas preživetja ni podaljšal, kratkotrajno podaljšanje časa, v katerem bolezen ni napredovala, pa ni štelo kot pomembno zaradi odsotnosti koristnih učinkov pri skupnem času preživetja.
In addition, the CHMP had concerns over the composite measure of progression-free survival which the Committed noted had not been sufficiently justified.
Poleg tega je imel CHMP pomisleke o kombiniranem ukrepu časa preživetja brez napredovanja bolezni, za katerega je Odbor menil, da ni zadostno utemeljen.
The Committee also noted that docetaxel is the standard first-line treatment for hormone-refractory prostate cancer, and that it is likely that most patients who would benefit from Orplatna treatment would have failed docetaxel treatment.
Odbor je tudi opozoril, da je docetaksel standardno zdravljenje prve izbire za hormonsko neodzivnega raka prostate in da je verjetno, da bi se pri večini bolnikov, pri katerih zdravljenje z docetakselom ne bi bilo učinkovito, zdravljenje z zdravilom Orplatna izkazalo za učinkovito.
What was Orplatna expected to be used for?
Za kaj naj bi se zdravilo Orplatna uporabljalo?
How is Orplatna expected to work?
Kako naj bi zdravilo Orplatna delovalo?
Bottle (HDPE)
Steklenica (HDPE)
7.32 g 1 pre-filled syringe
7,32 g 1 brizga Meso in organi : 26 dni
Invented Name Strength Pharmaceutical Form
Jakost Farmacevtska oblika
One vial
Karenca
6 vials
6 stekleničk Meso in organi: 26 dni
(Invented) name Strength Pharmaceutical Form
Izmišljeno ime Jakost
MA (EU) number
Številka EU dovoljenja za promet
France considered that the dosing regime of the product is not correct.
Francija meni, da urnik odmerjanja zdravila ni pravilen.
It considered this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
To lahko privede do pomanjkljive učinkovitosti in nadaljnjega razvoja odpornosti ciljnih patogenih organizmov, kar bi lahko v primeru zoonoznih bakterij povzročilo tudi tveganje za človeško zdravje.
The CVMP started the referral procedure during its meeting of 6-8 November 2007.
Odbor CVMP je s postopkom začel dne 6. novembra 2007.
BACKGROUND INFORMATION
ZNANSTVENI ZAKLJUČKI
CVMP agreed that Equibactin vet. proved to be essentially similar to reference product Tribrissen Oral Paste.
Zdravilo Equibactin vet. peroralna pasta se je izkazalo za bistveno podobno referenčnemu zdravilu Tribrissen peroralna pasta.
European Medicines Agency Veterinary Medicines and Inspections
Predlagatelj ali imetnik dovoljenja za promet z zdravilom
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP.
fazo ocenjevanja in napotitvenega postopka v CMD(v) za tem.
In response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of compositions and pharmacokinetic data, that there are no differences between Equibactin vet. and the reference product that would justify different conclusions on the safety and efficacy for the two products.
V odgovor na 2. vprašanje je predlagatelj poudaril, da ni nikakršnih razlik, ki bi utemeljile različne zaključke o varnosti in učinkovitosti obeh zdravil.
The Marketing Authorisation Holder was requested to provide a copy of the dossier and, in view of the concerns raised by France, to indicate and to substantiate where necessary, any differences between Equibactin vet. and the reference product Tribrissen Oral Paste that could justify different conclusions on the safety or efficacy.
Glede na zadržke, ki jih je imela Francija, prikaz in po potrebi utemeljitev morebitnih razlik med zdravilom Equibactin vet. (333 mg/g + 67 mg/g) peroralna pasta za konje in referenčnim zdravilom Tribrissen peroralna pasta (odobreno na Nizozemskem), s katerimi bi lahko utemeljili različne zaključke glede varnosti ali učinkovitosti obeh zdravil.