natgillin/translations-raw huggingface dataset:
trastuzumab and docetaxel-treated group (7.5%) compared to the trastuzumab and docetaxel-treated group (1.9%).
TRYPHAENA; 7,6 % v preskušanju APHINITY), od tega je bilo 2,6 % (TRYPHAENA) in 1,3 % (APHINITY) dogodkov stopnje 3-4 po merilih NCI-CTCAE.
In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was balanced in the two treatment groups (86.3% of Perjeta-treated patients and 86.6% of placebo-treated patients, including 60.7% and 64.8% Grade 4 neutropenia, respectively).
(86,3 % v skupini, ki je prejemala zdravilo Perjeta, in 86,6 % v skupini, ki je prejemala placebo; vključno z nevtropenijo stopnje 4 pri 60,7 % v skupini, ki je prejemala zdravilo Perjeta, in 64,8 % v skupini, ki je prejemala placebo).
Perjeta contains the active substance pertuzumab and is used to treat adult patients with breast cancer when:
Pet študij je ocenjevalo vpliv pertuzumaba na farmakokinetiko sočasno danih citotoksičnih zdravil:
80.6% of placebo-treated patients had recovered at the data cutoff.
bolnikov, ki so prejemali zdravilo Perjeta, v primerjavi s 38,9 % bolnikov, ki so prejemali placebo.
This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
To pomeni, da je CHMP takrat ocenjeval začetno dokumentacijo, ki jo je predložila družba, in pripravil seznam vprašanj.
The company had not yet responded to the questions at the time of the withdrawal.
Družba se ob umiku vloge še ni odzvala na vprašanja.
It was to be used on its own or with other anticancer medicines.
Uporabljalo naj bi se samostojno ali v kombinaciji z drugimi zdravili proti raku.
The application was withdrawn at ‘day 120'.
Družba je vlogo umaknila na 120. dan postopka.
On 8 March 2010, Mylan S.A.S.
Družba Mylan S.A.S.
With the skeleton still in place, the cells cannot divide and they eventually die.
Če je skelet še vedno zdrav, se celice ne morejo deliti in sčasoma odmrejo.
The company provided data on docetaxel from the published literature.
Družba je predstavila podatke o docetakselu iz objavljene literature.
Other substances are added to docetaxel to help it form small spherical structures called ‘micelles' that are suitable for injection.
Docetakselu se dodajajo druge snovi, s pomočjo katerih se tvorijo majhne okrogle strukture, imenovane „micele“, ki so primerne za injiciranje.
Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Docetaksel zavira sposobnost celic, da uničijo notranji „skelet“, ki celicam omogoča deljenje in razmnoževanje.
However, the substances added in Docetaxel Mylan and Taxotere to form the micelles are not the same.
Vendar snovi, ki se dodajajo zdraviloma Docetaxel Mylan in Taxotere za tvorbo micel, niso enake.
This means that Docetaxel Mylan was intended to be similar to a ‘reference medicine' already authorised in the European Union called Taxotere.
To pomeni, da je zdravilo Docetaxel Mylan podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Taxotere.
Because of this and the complex nature of micelles themselves, the Committee had concluded that additional studies on Docetaxel Mylan were necessary, including studies on how the medicine would be treated by the body and its safety.
Zaradi omenjenega in zapletene narave micel je odbor zaključil, da bi bile za zdravilo Docetaxel Mylan potrebne dodatne študije, vključno s študijami o varnosti zdravila in o tem, kako bi se telo odzvalo na zdravilo.
Because Docetaxel Mylan contains the same active substance as Taxotere and was to be given directly into a vein, the company did not consider additional studies on the Docetaxel Mylan to be necessary according to EU rules.
Ker zdravilo Docetaxel Mylan vsebuje enako zdravilno učinkovino kot zdravilo Taxotere in naj bi se dajalo neposredno v veno, je družba menila, da v skladu s pravili EU dodatne študije za zdravilo Docetaxel Mylan niso potrebne.
Docetaxel Mylan was developed as a ‘generic medicine'.
Zdravilo Docetaxel Mylan je bilo razvito kot „generično zdravilo“.
It was to be available as a powder and solvent to be made up into a solution for infusion (drip into a vein).
Na voljo naj bi bilo v obliki praška in vehikla za pripravo raztopine za infundiranje (kapalne infuzije v veno).
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Docetaxel Mylan.
Zato je CHMP v času umika vloge menil, da družba ni predložila dovolj podatkov v podporo vlogi za zdravilo Docetaxel Mylan.
Docetaxel Mylan was expected to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer) and head and neck cancer.
Zdravilo Docetaxel Mylan naj bi se uporabljalo za zdravljenje bolnikov z rakom dojke, nedrobnoceličnim pljučnim rakom, rakom prostate, adenokarcinomom želodca (vrsto želodčnega raka) in rakom glave in vratu.
officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Mylan intended to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
je 8. marca 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Docetaxel Mylan, namenjenim zdravljenju bolnikov z rakom dojke, nedrobnoceličnim pljučnim rakom, rakom prostate, adenokarcinomom želodca ter rakom glave in vratu.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Docetaxel Mylan could not have been approved.
Na podlagi pregleda podatkov je CHMP v času umika vloge izrazil določene zadržke in je začasno menil, da zdravila Docetaxel Mylan ni mogoče odobriti.
What is Docetaxel Mylan?
Kaj je zdravilo Docetaxel Mylan?
Docetaxel Mylan is a medicine that contains the active substance docetaxel.
Docetaxel Mylan je zdravilo, ki vsebuje zdravilno učinkovino docetaksel.
The active substance in Docetaxel Mylan, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Zdravilna učinkovina zdravila Docetaxel Mylan, docetaksel, spada v skupino zdravil proti raku, imenovanih taksani.
What was Docetaxel Mylan expected to be used for?
Za kaj naj bi se zdravilo Docetaxel Mylan uporabljalo?
How is Docetaxel Mylan expected to work?
Kako naj bi zdravilo Docetaxel Mylan delovalo?
The full European Public Assessment Report for Javlor 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 Javlor je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Javlor is a cancer medicine that has been authorised in the EU since September 2009.
Javlor je zdravilo proti raku, ki je v Evropski uniji odobreno od septembra 2009.
It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Podjetje lahko v 15 dneh od prejema obvestila o tem negativnem mnenju zahteva ponovno presojo mnenja.
‘Metastatic' means that the cancer has spread to other parts of the body.
„Metastatski“ pomeni, da se je rak razširil na druge dele telesa.
In addition, there was no benefit in terms of other important measures of effectiveness, including overall survival (how long patients lived).
Poleg tega niso ugotovili nobenih koristi, kar zadeva pomembna merila učinkovitosti, vključno s skupnim preživetjem (koliko časa so bolniki živeli).
Compared with patients given capecitabine alone, more patients receiving Javlor plus capecitabine experienced side effects including neutropenia (abnormally low blood levels of white blood cells), gastrointestinal events such as constipation, nausea and vomiting and stomach ache, fatigue and nervous system disorders such as damage to the nerves in the extremities.
V primerjavi s kapecitabinom kot samostojnim zdravilom so pri več bolnikih, ki so prejemali zdravilo Javlor v kombinaciji s kapecitabinom, zabeležili neželene učinke, kot so nevtropenija (neobičajno nizko število belih krvnih celic), prebavne težave, kot so zaprtje, navzea, bruhanje in bolečine v trebuhu, utrujenost in motnje živčnega sistema, kot so poškodba živcev v okončinah.
The main measure of effectiveness was progression-free survival (how long patients lived without their disease getting worse).
Glavno merilo učinkovitosti je bil čas preživetja brez napredovanja bolezni (čas, ki so ga bolniki preživeli brez poslabšanja bolezni).
Refusal of a change to the marketing authorisation for Javlor (vinflunine) EMA/587197/2014
Zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Javlor (vinflunin) EMA/587197/2014
What is Javlor?
Kaj je zdravilo Javlor?
On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Javlor.
Odbor za zdravila za uporabo v humani medicini (CHMP) je 25. septembra 2014 sprejel negativno mnenje in priporočil zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Javlor.
The CHMP noted that the effectiveness of Javlor in combination with capecitabine had not been sufficiently demonstrated.
CHMP je ugotovil, da učinkovitost zdravila Javlor v kombinaciji s kapecitabinom ni bila zadostno dokazana.
Although there was an improvement in progression-free survival, this was considered to be small.
Čeprav je prišlo do izboljšanja časa preživetja brez napredovanja bolezni, je bilo to izboljšanje majhno.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Javlor.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Javlor.
The company that applied for the change to the authorisation is Pierre Fabre Médicament.
Vlogo za spremembo dovoljenja je predložila družba Pierre Fabre Médicament.
Refusal of a change to the marketing authorisation for Javlor (vinflunine)
Zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Javlor (vinflunin)
The change concerned an extension of indication to add treatment of breast cancer.
Sprememba se je nanašala na razširitev indikacije, tako da bi se zdravilo uporabljalo tudi za zdravljenje raka dojke.
It attaches to a cell protein called tubulin, which is important in the formation of the internal ‘skeleton' that cells need to allow them to divide.
Veže se na beljakovino v celicah, imenovano tubulin, ki ima pomembno vlogo pri tvorjenju notranjega „ogrodja“, ki ga morajo celice zgraditi, da se lahko delijo.
There are no consequences on the use of Javlor in its authorised indication.
Umik nima nobenih posledic za uporabo zdravila Javlor pri odobrenih indikacijah.
The company presented the results of a main study involving 770 patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant.
Družba je predstavila rezultate glavne študije, v katero je bilo vključenih 770 bolnikov z napredovalim rakom dojke, ki so že prejemali zdravljenje z antraciklinom oz. so nanj odporni in ki so hkrati odporni na taksan.
Javlor was also expected to be used in combination with the cancer medicine capecitabine for the treatment of adult patients with locally advanced or metastatic breast cancer.
Zdravilo Javlor naj bi se uporabljalo v kombinaciji z zdravilom proti raku kapecitabin za zdravljenje odraslih bolnikov z lokalno napredovalim ali metastatskim rakom dojke.
The active substance in Javlor, vinflunine, belongs to the group of cancer medicines known as ‘vinca alkaloids'.
Zdravilna učinkovina v zdravilu Javlor, vinflunin, spada v skupino zdravil proti raku, ki se imenujejo „vinka alkaloidi“.
By attaching to tubulin in cancer cells, vinflunine stops the formation of the skeleton, preventing the division and spread of the cancer cells.
Ko se vinflunin veže na tubulin v rakavih celicah, zaustavi tvorbo ogrodja in s tem prepreči delitev in širjenje rakavih celic.
What were the CHMP's main concerns that led to the refusal of the change to the marketing authorisation?
Kateri so bili glavni zadržki, zaradi katerih je CHMP predlagal zavrnitev vloge za spremembo dovoljenja za promet z zdravilom?
Javlor contains the active substance vinflunine and is available as a concentrate for solution for infusion (drip) into a vein.
Zdravilo Javlor vsebuje zdravilno učinkovino vinflunin in je na voljo v obliki koncentrata za raztopino za infundiranje (kapalne infuzije) v veno.
What was Javlor expected to be used for?
Za kaj naj bi se zdravilo Javlor uporabljalo?
It was to be used in patients previously treated with, or resistant to, another type of cancer medicine called an anthracycline and who are also resistant to a third type of cancer medicines called taxanes.
Uporabljalo naj bi se pri bolnikih, ki so se že zdravili z drugo vrsto zdravila proti raku, ki se imenuje antraciklin, oz. so nanj odporni in ki so hkrati odporni na tretjo vrsto zdravil proti raku, ki se imenujejo taksani.
It is already used to treat adults with advanced or metastatic ‘transitional-cell carcinoma of the urothelial tract' (a cancer that affects the lining of the bladder and the rest of the urinary tract).
Zdravilo se že uporablja za zdravljenje odraslih z napredovalim ali metastatskim „urotelnim prehodnoceličnim karcinomom“ (rakom, ki prizadene sluznico sečnega mehurja in ostalih sečil).
How is Javlor expected to work?
Kako naj bi zdravilo Javlor delovalo?
In the study, Javlor given together with capecitabine was compared with capecitabine alone.
V študiji so kombinacijo zdravila Javlor in kapecitabina primerjali s kapecitabinom kot samostojnim zdravilom.
What is happening with Javlor for the treatment of transitional-cell carcinoma of the urothelial tract?
Kako je z uporabo zdravila Javlor za zdravljenje urotelnega prehodnoceličnega karcinomoma?
Therefore, at that point in time, the CHMP was of the opinion that the modest effect of Javlor in the treatment of breast cancer did not outweigh the additional risks observed.
Posledično je CHMP tedaj menil, da zmerni učinek zdravila Javlor pri zdravljenju raka dojke ne odtehta dodatnih ugotovljenih tveganj, zato je priporočil zavrnitev vloge za spremembo dovoljenja za promet z zdravilom.
1 Previously known as DuoCover.
1 Prej znano kot DuoCover.
The European Commission granted a marketing authorisation valid throughout the EU for DuoCover on 15 March 2010.
Evropska komisija je dovoljenje za promet z zdravilom DuoCover, veljavno po vsej Evropski uniji, izdala 15. marca 2010.
It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome':
Uporablja se lahko pri naslednjih skupinah bolnikov z „akutnim koronarnim sindromom“:
It also presented the results of 3 previous studies involving over 61,000 patients with unstable angina or who had had a heart attack.
Predstavila je tudi rezultate treh predhodnih študij, ki so vključevale 61 000 bolnikov z nestabilno angino pektoris ali bolnikov, ki so doživeli srčni napad.
It is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
Na voljo je v obliki tablet, ki vsebujejo 75 mg klopidogrela ter 75 mg ali 100 mg acetilsalicilne kisline.
Acetylsalicylic acid has been available for over 100 years.
Acetilsalicilna kislina je na voljo že več kot 100 let.
• patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from treatment to dissolve blood clots.
• pri bolnikih, ki se zdravijo zaradi srčnega napada z elevacijo spojnice ST, kadar zdravnik meni, da jim bo zdravljenje s ciljem razgradnje krvnih strdkov koristilo.
The full EPAR for Clopidogrel/Acetylsalicylic acid Zentiva 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 Klopidogrel/acetilsalicilna kislina Zentiva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Clopidogrel/Acetylsalicylic acid Zentiva must not be used during the last three months of pregnancy.
Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva se ne sme uporabljati v zadnjih treh mesecih nosečnosti.
Clopidogrel has been authorised since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid.
Klopidogrel je od leta 1998 odobren za zmanjšanje agregacije trombocitov in se pogosto uporablja v kombinaciji z acetilsalicilno kislino.
The Committee therefore decided that Clopidogrel/Acetylsalicylic acid Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zato zaključil, da so koristi zdravila Klopidogrel/acetilsalicilna kislina Zentiva večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The combination of the two active substances has an additive effect, reducing the risk of blood clots forming more than either medicine alone.
Kombinacija obeh zdravilnih učinkovin ima aditiven učinek, saj zmanjša tveganje za nastanek krvnih strdkov bolj kot vsako posamezno zdravilo.
This means that they help to prevent blood cells called platelets from sticking together and forming clots, thus helping to prevent another heart attack.
To pomeni, da pomagata preprečevati zlepljanje krvnih celic, imenovanih trombociti, in tvorbo strdkov, kar prispeva k preprečitvi novega srčnega napada.
This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel/Acetylsalicylic acid Zentiva.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Klopidogrel/acetilsalicilna kislina Zentiva.
The name of the medicine was changed to Clopidogrel/Acetylsalicylic acid Zentiva on 15 January 2016.
Ime zdravila je bilo 15. januarja 2016 spremenjeno v Klopidogrel/acetilsalicilna kislina Zentiva.
For more information about treatment with Clopidogrel/Acetylsalicylic acid Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Klopidogrel/acetilsalicilna kislina Zentiva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Clopidogrel/Acetylsalicylic acid Zentiva (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 Klopidogrel/acetilsalicilna kislina Zentiva (opaženi pri 1 do 10 bolnikih od 100) so hematomi (kopičenje krvi pod kožo), epistaksa (krvavitve iz nosu), gastrointestinalna hemoragija (krvavitve v želodcu ali črevesju), driska, bolečine v trebuhu, dispepsija (zgaga), modrice in krvavitve na mestu vboda v kožo.
This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together.
S tem se zmanjša nastajanje snovi, imenovane tromboksan, ki običajno sodeluje pri tvorbi strdkov z zlepljanjem trombocitov.
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming.
Zaradi tega trombociti ne postanejo „lepljivi“, kar zmanjša tveganje za nastanek krvnih strdkov.
It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain, or in patients with mastocytosis (high blood levels of certain white blood cells called mast cells).
Ne sme se uporabljati pri bolnikih z obolenji, ki povzročajo krvavitve, kot so želodčne razjede ali možganska krvavitev, ali pri bolnikih z mastocitozo (visokimi ravnmi določenih belih krvničk, imenovanih mastociti).
Because the two active substances have been used together for a number of years, the company presented the results of studies showing that the active substances in Clopidogrel/Acetylsalicylic acid Zentiva are absorbed in the body in the same way when taken in a single tablet as when the two medicines are taken separately.
Ker se obe zdravilni učinkovini že vrsto let uporabljata sočasno, je družba predstavila rezultate študij, ki kažejo, da se zdravilni učinkovini zdravila Klopidogrel/acetilsalicilna kislina Zentiva v eni tableti v telesu absorbirata enako, kot če ju bolnik jemlje ločeno.
• patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
• pri bolnikih, ki imajo nestabilno angino pektoris (hudo vrsto bolečine v prsih) ali so imeli srčni napad brez „elevacije ST-spojnice“ (nenormalnega odčitka na elektrokardiogramu ali EKG-ju), ter pri tistih, ki jim je bil v arterijo vstavljen stent (kratka cevka), ki preprečuje, da bi se arterija zamašila;
Clopidogrel stops the platelets sticking together by blocking a substance called ADP from attaching to a special receptor on their surface.
Klopidogrel njihovo zlepljanje zavira tako, da snovi, imenovani ADP, prepreči, da bi se vezala na posebne receptorje na njihovi površini.
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 Clopidogrel/Acetylsalicylic acid Zentiva.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Results from the 3 studies in patients with unstable angina or who had had a heart attack showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was more effective at preventing events such as heart attacks than acetylsalicylic acid alone.
Rezultati treh študij pri bolnikih z nestabilno angino pektoris ali tistih, ki so doživeli srčni napad, so pokazali, da je bila kombinacija klopidogrela in acetilsalicilne kisline, vzetima v obliki ločenih tablet, učinkovitejša pri preprečevanju dogodkov, kot so srčni napadi, kot acetilsalicilna kislina, vzeta samostojno.
Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase.
Acetilsalicilna kislina zaustavi zlepljanje trombocitov z zaviranjem encima, imenovanega prostaglandin ciklooksigenaza.
Clopidogrel/Acetylsalicylic acid Zentiva is used to prevent problems caused by blood clots, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Zdravilo Klopidogrel/acetilsalicilna kislina Zentiva se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki, kot je srčni napad, pri odraslih, ki že jemljejo klopidogrel in acetilsalicilno kislino kot ločeni tableti.
Clopidogrel/Acetylsalicylic acid Zentiva must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in Clopidogrel/Acetylsalicylic acid Zentiva.
Zdravila Klopidogrel/acetilsalicilna kislina Zentiva ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) klopidogrel, nesteroidna protivnetna zdravila (kot je acetilsalicilna kislina) ali katero koli drugo sestavino zdravila Klopidogrel/acetilsalicilna kislina Zentiva.