natgillin/translations-raw huggingface dataset:
Powder for use in drinking water
= .... mg zdravila na l pitne vode
Ref.: EMEA/748861/2009 EMEA/H/C/558/II/29
: EMEA/748861/2009 EMEA/H/C/558/II/29
It is already used to treat the following types of cancer:
Uporablja se že za zdravljenje naslednjih vrst raka:
Erbitux has been authorised since June 2004.
Zdravilo Erbitux je odobreno od junija 2004.
As a result, the tumour cells can no longer receive the messages needed for growth, progression and spread.
Posledica te vezave je, da tumorske celice ne morejo več prejemati sporočil, potrebnih za svojo rast, napredovanje in širjenje.
These ‘subgroup analyses' attempted to identify a group of patients that would benefit from treatment.
Z„analizami podskupin“ so skušali določiti skupino bolnikov, ki bi ji zdravljenje koristilo.
The CHMP was also concerned over discrepancies in the studies' findings between the two main measures of effectiveness.
CHMP je izrazil pomisleke tudi glede neujemanja izsledkov študij med dvema glavnima meriloma učinkovitosti.
The full European Public Assessment Report for Erbitux is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Erbitux je na voljo tukaj.
The company presented the results of two main studies involving a total of 1,801 adults with advanced, metastatic or recurrent non-small cell lung cancer who had not been treated before.
Družba je predstavila rezultate dveh glavnih študij, ki so vključevale skupno 1 801 odraslo osebo z napredovalim, metastatskim ali ponavljajočim se nedrobnoceličnim pljučnim rakom, ki predhodno še ni bil zdravljen.
‘Metastatic' means that the cancer has spread to other parts of the body;
„Metastatski“ pomeni, da se je rakavo obolenje razširilo na druge dele telesa;
In November 2009, following the re-examination, the CHMP added a further concern over the ways in which the studies' results were analysed after they can been completed.
CHMP je novembra 2009 po ponovni proučitvi izrazil dodatni zadržek glede načina analize rezultatov študij po njihovem zaključku.
There are no consequences on the use of Erbitux in its authorised indications, for which the balance of benefits and risks remains unchanged.
Zavrnitev nima nobenih posledic za uporabo zdravila Erbitux za odobrene indikacije, pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
Questions and answers on the recommendation for the refusal of a change to the marketing authorisation for Erbitux cetuximab
Vprašanja in odgovori v zvezi s priporočilom za zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Erbitux cetuksimab
The change concerned an extension of indication to add the treatment of non-small cell lung cancer.
Sprememba se je nanašala na razširitev indikacije z vključitvijo zdravljenja nedrobnoceličnega pljučnega raka.
Erbitux can be used when the cancer is locally advanced (when the tumour has grown but has not spread), recurrent (when it has come back after previous treatment) or metastatic.
Zdravilo Erbitux se lahko uporablja, ko je rak lokalno napredoval (tumor je zrasel, a se ni razširil), je ponavljajoč (se je po prejšnjem zdravljenju ponovil) ali metastatski.
On 23 July 2009, 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 Erbitux.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 23. julija 2009 priporočil zavrnitev vloge za spremembo dovoljenja za promet z zdravilom Erbitux.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Gre za protitelo (vrsto beljakovine), ki je bilo zasnovano tako, da prepozna posebno strukturo (imenovano antigen) v telesu in se veže nanjo.
It was to be used in patients who had not been treated before, when the tumour cells had a protein on their surface called epidermal growth factor receptor (EGFR).
Uporabljalo naj bi se pri predhodno še nezdravljenih bolnikih, pri katerih so tumorske celice imele na površini beljakovino, imenovano receptor za epidermalni rastni dejavnik (EGFR).
The main measures of effectiveness were how long the patientssurvived and how long they lived without their cancer getting worse.
Glavno merilo učinkovitosti je bil čas preživetja in čas do poslabšanja bolezni.
What are the consequences of the refusal for patients in clinical trials using Erbitux?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Erbitux?
In July 2009, the CHMP was concerned that the benefits of adding Erbitux to standard platinum-based chemotherapy were modest in terms of survival times, and that the medicine did not have a convincing effect on how long patients lived without their cancer getting worse.
Julija 2009 je CHMP menil, da so bile koristi dodajanja zdravila Erbitux k standardnemu zdravljenju s kemoterapijo na osnovi platine skromne z vidika časa preživetja in da zdravilo ni imelo prepričljivega učinka na čas do poslabšanja bolezni.
Erbitux was to be used in combination with platinum-based chemotherapy (a combination of anticancer medicines that includes a medicine such as cisplatin or carboplatin).
Zdravilo Erbitux naj bi se uporabljalo v kombinaciji s kemoterapijo na osnovi platine (kombinacijo zdravil proti raku, ki vključuje zdravila, kot sta cisplatin ali karboplatin).
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Erbitux.
Družba je obvestila CHMP, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Erbitux.
• ‘squamous cell' cancers of the head and neck.
• ploščatoceličnega raka glave in vratu.
Therefore, the CHMP was of the opinion that the benefits of Erbitux in the treatment of non-small cell lung cancer did not outweigh its risks.
CHMP je zato menil, da koristi zdravila Erbitux pri zdravljenju nedrobnoceličnega pljučnega raka ne odtehtajo z njim povezanih tveganj.
What is happening with Erbitux for the treatment of cancer of the colon or rectum and cancers of the head and neck?
Kakšne so posledice za zdravilo Erbitux, indicirano za zdravljenje raka debelega črevesa ali danke oziroma raka glave in vratu?
In both studies, the combination of Erbitux with platinum-based chemotherapy was compared with platinum based chemotherapy without Erbitux.
V obeh študijah so kombinacijo zdravila Erbitux s kemoterapijo na osnovi platine primerjali s kombinacijo kemoterapije na osnovi platine brez dodanega zdravila Erbitux.
Hence, the CHMP recommended that the change to the marketing authorisation be refused.
Zato je priporočil zavrnitev spremembe dovoljenja za promet.
What was Erbitux expected to be used for?
Za kaj naj bi se zdravilo Erbitux uporabljalo?
Severe side effects were seen in some lung cancer patients who received Erbitux - these were similar to the side effects seen in patients treated with Erbitux for other types of cancer.
Pri nekaterih bolnikih s pljučnim rakom, ki so prejemali zdravilo Erbitux, so se pojavili resni neželeni učinki, ki so bili podobni neželenim učinkom, opaženim pri bolnikih, zdravljenih z zdravilom Erbitux zaradi drugih vrst raka.
How is Erbitux expected to work?
Kako naj bi zdravilo Erbitux delovalo?
In lung cancer, Erbitux is expected to work in the same way as it does in its existing indications.
Zdravilo Erbitux naj bi pri pljučnem raku delovalo enako kot pri drugih odobrenih indikacijah.
Erbitux is a solution for infusion (drip into a vein) that contains the active substance cetuximab.
Zdravilo Erbitux je raztopina za infuzijo (kapalno infuzijo v veno), ki vsebuje zdravilno učinkovino cetuksimab.
Cetuximab has been designed to attach to EGFR, which can be found on the surface of some tumour cells.
Cetuksimab je bil zasnovan tako, da se veže na receptor za epidermalni rastni faktor, ki je na površini določenih tumorskih celic.
• metastatic cancer of the colon or rectum (large intestine).
• metastatskega raka debelega črevesa ali danke.
Erbitux was also expected to be used to treat ‘non-small cell' lung cancer that was advanced (had started to spread) or metastatic.
Zdravilo naj bi se uporabljalo tudi za zdravljenje napredovalega (ki se je začel širiti) ali metastatskega nedrobnoceličnega pljučnega raka.
Ref.: EMA/756630/2009 EMEA/H/C/264
: EMEA/756630/2009 EMEA/H/C/264
After five years, the marketing authorisation was renewed for a further five years.
Po petih letih je bilo dovoljenje za promet podaljšano za nadaljnjih pet let.
As the company had supplied the additional information requested, the ‘Exceptional Circumstances' ended on 10 March 2004.
Ko je družba predložila dodatne zahtevane podatke, je odobritev „v izjemnih okoliščinah“ prenehala veljati dne 10. marca 2004.
Agenerase amprenavir EPAR summary for the public
Agenerase amprenavir Povzetek EPAR za javnost
The European Commission granted a marketing authorisation valid throughout the European Union for Agenerase to Glaxo Group Limited on 20 October 2000.
Evropska komisija je dovoljenje za promet z zdravilom Agenerase, veljavno po vsej Evropski uniji, odobrila družbi Glaxo Group Limited dne 20. oktobra 2000.
Other information about Agenerase:
Druge informacije o zdravilu Agenerase:
Agenerase was originally authorised under ‘Exceptional Circumstances', because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Agenerase je bilo prvotno odobreno „v izjemnih okoliščinah“, ker podatki zaradi znanstvenih razlogov v času odobritve niso bili na voljo.
It is available as cream capsules (50 and 150 mg) and as an oral solution (15 mg/ml).
Na voljo je v obliki kapsul krem barve (50 in 150 mg) in v obliki peroralne raztopine (15 mg/ml).
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Ko je encim blokiran, se virus ne more več normalno razmnoževati, kar zmanjša hitrost širjenja okužbe.
The Committee recommended that Agenerase be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Agenerase odobri dovoljenje za promet.
This allows a lower dose of amprenavir to be used for the same effect.
Zato lahko uporabimo manjši odmerek amprenavirja za enak protivirusni učinek.
What benefit has Agenerase shown during the studies?
Kakšne koristi je zdravilo Agenerase izkazalo med študijami?
In children aged between four and 12 years and in patients who weigh less than 50 kg, the recommended dose of Agenerase depends on body weight.
Pri otrocih, starih od štiri do 12 let, in bolnikih, ki tehtajo manj kot 50 kg, je višina priporočenega odmerka zdravila Agenerase odvisna od telesne mase bolnika.
If ritonavir is not used, Agenerase is taken at a higher dose (1,200 mg twice a day).
Če bolnik ne prejema ritonavirja, je odmerek zdravila Agenerase višji (1 200 mg dvakrat na dan).
The recommended dose of Agenerase for patients over 12 years of age is 600 mg twice a day, taken with 100 mg ritonavir twice a day and with other antiviral medicines.
Priporočeni odmerek zdravila Agenerase za bolnike, starejše od 12 let, je 600 mg dvakrat na dan skupaj s 100 mg ritonavirja dvakrat na dan in drugimi protivirusnimi zdravili.
Agenerase, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Agenerase v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusov HIV v krvi in jo zadržuje na nizki ravni.
The main measures of effectiveness were the number of patients with undetectable levels of HIV in the blood (viral load) and the change in viral load after treatment.
Glavni merili učinkovitosti sta bili število bolnikov z nezaznavno ravnjo virusa HIV v krvi (virusno obremenitvijo) in sprememba virusne obremenitve po zdravljenju.
What is the risk associated with Agenerase?
Kakšna tveganja so povezana z zdravilom Agenerase?
Agenerase does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Agenerase ne zdravi okužbe z virusom HIV ali aidsa lahko pa podaljša čas do pojava poškodbe imunskega sistema ter razvoja okužb in bolezni, ki so povezane z aidsom.
Agenerase is a medicine that contains the active substance amprenavir.
Agenerase je zdravilo, ki vsebuje zdravilno učinkovino amprenavir.
See the Package Leaflet for the full list of these medicines.
Za celoten seznam teh zdravil glejte navodilo za uporabo.
The oral solution is for patients who cannot swallow the capsules but it cannot be given with ritonavir.
Peroralna raztopina je namenjena bolnikom, ki ne morejo pogoltniti kapsul, vendar se ne sme dajati skupaj z ritonavirjem.
Of these, 43 had HIV that was resistant to four other protease inhibitors.
Med temi bolniki jih je 43 bilo okuženih z virusom HIV, ki je bil odporen na štiri druge zaviralce proteaz.
Agenerase is used in combination with other antiviral medicines to treat patients over four years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Agenerase se uporablja v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje bolnikov, starejših od štirih let, ki so okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
It slows down the rate at which amprenavir is broken down, increasing the levels of amprenavir in the blood.
Učinkuje tako, da upočasni hitrost razgrajevanja amprenavirja in s tem zviša njegove ravni v krvi.
Doctors should prescribe Agenerase after they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
Preden zdravnik predpiše zdravilo Agenerase, se mora seznaniti z vsemi protivirusnimi zdravili, ki jih je bolnik prejemal pred tem, in oceniti verjetnost, da se bo virus odzval na zdravilo.
Treatment with Agenerase should be started by a doctor who has experience in the management of HIV infection.
Zdravljenje z zdravilom Agenerase lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
Agenerase should not be used in people who may be hypersensitive (allergic) to amprenavir or any of the other ingredients.
Zdravila Agenerase ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) amprenavir ali katerokoli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Agenerase benefits are greater than its risks, but noted that the benefit of Agenerase taken with ritonavir has not been demonstrated in patients who have not taken protease inhibitors in the past.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Agenerase večje od z njim povezanih tveganj, vendar je opozoril, da korist zdravila Agenerase v kombinacji z ritonavirjem ni bila dokazana pri bolnikih, ki se v preteklosti še niso zdravili z zaviralci proteaz.
In the studies of adults who had not previously taken protease inhibitors, Agenerase taken without ritonavir was more effective than placebo but less effective than indinavir.
V študijah na odraslih, ki predhodno niso jemali zaviralcev proteaz, je bilo zdravilo Agenerase brez kombinacije ritonavirja učinkovitejše od placeba, vendar manj učinkovito od indinavirja.
For the full list of all side effects reported with Agenerase, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Agenerase, glejte navodilo za uporabo.
Because amprenavir is less easily absorbed with the oral solution than with the capsules, the two formulations are not interchangeable on a milligram-for-milligram basis.
Ker se amprenavir v obliki peroralne raztopine po zaužitju ne absorbira tako lahko kot amprenavir v obliki kapsul, ti obliki zdravila nista medsebojno zamenljivi po načelu „miligram za miligram“.
In adults, Agenerase capsules are usually given with low-dose ritonavir (another antiviral medicine).
Odraslim se morajo kapsule zdravila Agenerase praviloma dajati skupaj z nizkim odmerkom ritonavirja (drugega protivirusnega zdravila).
As with other anti-HIV medicines, patients taking Agenerase may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Enako kot pri drugih zdravilih proti virusu HIV lahko pride tudi pri bolnikih, ki jemljejo zdravilo Agenerase, do lipodistrofije (sprememb v porazdelitvi telesnega maščevja), osteonekroze (odmiranja kostnega tkiva) ali sindroma imunske reaktivacije (simptomov okužbe, ki jih povzroči imunski sistem med okrevanjem).
Agenerase should only be used in patients who have previously been treated with the same type of medicine as Agenerase (protease inhibitors).
Zdravilo Agenerase smejo uporabljati le tisti bolniki, ki so že bili predhodno zdravljeni z isto vrsto zdravila, kot je zdravilo Agenerase (zaviralci proteaz).
The most common side effects with Agenerase (seen in more than 1 patient in 10) are hypercholesterolaemia (high blood cholesterol levels), headache, diarrhoea, flatulence (gas), nausea (feeling sick), vomiting, rash and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Agenerase (opaženi pri več 1 bolniku od 10) so hiperholesterolemija (visoke koncentracije holesterola v krvi), glavobol, driska, flatulenca (vetrovi), navzeja (slabost), bruhanje, izpuščaji in utrujenost.
Why has Agenerase been approved?
Zakaj je bilo zdravilo Agenerase odobreno?
Agenerase without ritonavir has also been compared with placebo (a dummy treatment) and with invirase (another protease inhibitor) in 736 HIV-infected adults who had not previously been treated with protease inhibitors.
Zdravilo Agenerase brez dodanega ritonavirja so primerjali tudi s placebom (zdravilom brez zdravilne učinkovine) in invirazo (drugim zaviralcem proteaz) pri 736 odraslih ljudeh, okuženih z virusom HIV, ki predhodno še niso bili zdravljeni z zaviralci proteaze.
In adults who had taken protease inhibitors in the past, Agenerase boosted with ritonavir was as effective as other protease inhibitors in reducing viral loads after 16 weeks of treatment: around two thirds of the patients in both groups had viral loads below 400 copies/ml.
Zdravilo Agenerase, ojačeno z ritonavirjem, je bilo pri odraslih, ki so v preteklosti jemali zaviralce proteaz, po 16 tednih zdravljenja enako učinkovito pri nižanju virusne obremenitve kot drugi zaviralci proteaz: okoli dve tretjini bolnikov v obeh skupinah je imelo virusno obremenitev pod 400 kopijami/ml.
Agenerase must not be used in patients who are taking St John's wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Agenerase and are harmful at high levels in the blood.
Zdravila Agenerase ne smejo uporabljati bolniki, ki jemljejo šentjanževko (rastlinski pripravek za zdravljenje depresije) ali zdravila, ki se presnavljajo enako kot zdravilo Agenerase in so pri visokih ravneh v krvi škodljiva.
The full EPAR for Agenerase can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Agenerase je na voljo tukaj.
The active substance in Agenerase, amprenavir, is a protease inhibitor.
Zdravilna učinkovina zdravila Agenerase, amprenavir, spada med zaviralce proteaz.
Agenerase boosted with ritonavir must not be taken by patients who have severe problems with their liver, or by patients taking rifampicin (used to treat tuberculosis) or medicines that are broken down in the same way as ritonavir, such as flecainide and propafenone (used to correct irregular heartbeat).
Zdravila Agenerase v kombinaciji z ritonavirjem, ki okrepi učinek zdravila, prav tako ne smejo uporabljati bolniki, ki imajo hude težave z jetri ali jemljejo rifampicin (zdravilo za zdravljenje tuberkuloze) oziroma zdravila, ki se presnavljajo enako kot ritonavir, kot sta flekainid in propafenon (zdravilo za uravnavanje nerednega srčnega ritma).
How has Agenerase been studied?
Kako je bilo zdravilo Agenerase raziskano?
Patients who have problems with their liver may be at an elevated risk of liver damage when taking Agenerase.
Pri bolnikih s težavami z jetri obstaja pri jemanju zdravila Agenerase povečano tveganje za poškodbe jeter.
Taking Agenerase with ritonavir should be avoided in children.
Pri otrocih bi se morali izogibati sočasni uporabi zdravila Agenerase in ritonavirja.
The dose of Agenerase should be reduced in patients who have problems with their liver, and it should be taken without ritonavir by patients who have severe liver problems.
Odmerek zdravila Agenerase je treba zmanjšati pri bolnikih s težavami z jetri, pri bolnikih s hudimi težavami z jetri pa se mora zdravilo Agenerase uporabljati brez ritonavirja.
What is Agenerase used for?
Za kaj se zdravilo Agenerase uporablja?
Agenerase without ritonavir has also been studied in 268 HIV-infected children and adolescents aged between six months and 18 years, all of whom had previously taken treatment for HIV infection, and 135 of whom had been treated with protease inhibitors.
Zdravilo Agenerase brez dodanega ritonavirja so raziskali tudi pri 268 otrocih in mladostnikih, okuženih z virusom HIV, ki so bili stari od šest mesecev do 18 let.
How is Agenerase used?
Kako se zdravilo Agenerase uporablja?
What is Agenerase?
Kaj je zdravilo Agenerase?
Agenerase reduced viral loads in children and adolescents, although very few of those who had taken protease inhibitors in the past responded to treatment and there were very few children aged below four years.
Pri bolnikih z virusom HIV, odpornim na štiri druge zaviralce proteaz, so tisti, ki so jemali kombinacijo zdravila Agenerase in ritonavirja, po štirih tednih pokazali večje znižanje virusne obremenitve kot tisti, ki so še naprej jemali svoje dotedanje zaviralce proteaz: zdravilo Agenerase je znižalo virusno obremenitev pri otrocih in mladostnikih, vendar se je na zdravljenje odzvalo majhno število tistih, ki so v preteklosti že jemali zaviralce proteaz, med njimi pa je bilo zelo majhno število otrok, mlajših od štirih let.
Agenerase boosted with low-dose ritonavir has been compared with other protease inhibitors in 206 adults who had taken protease inhibitors in the past.
Pri 206 odraslih, ki so v preteklosti že prejemali zaviralce proteaz, so učinkovitost zdravila Agenerase, ojačenega z nizkimi odmerki ritonavirja, primerjali tudi z učinkovitostjo drugih zaviralcev proteaz.
How does Agenerase work?
Kako zdravilo Agenerase deluje?
If you are an elderly patient (over 65 years of age), you should take Lyrica normally except if you have problems with your kidneys.
Če ste starejši bolnik (nad 65 let), lahko jemljete zdravilo Lyrica normalno, razen če imate težave z ledvicami.
Do not use this medicine after the expiry date which is stated on the carton or bottle.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali plastenki.
Lyrica should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Zdravila Lyrica se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno (če koristi za mater jasno prevladajo nad možnim tveganjem za plod).
Date of first authorisation: 06 July 2004 Date of latest renewal: 06 July 2009
Datum prve odobritve: 6. julij 2004 Datum zadnjega podaljšanja: 6. julij 2009
Lyrica is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Zdravilo Lyrica ni namenjeno temu, da bi ga jemali samo, temveč ga je vedno treba uporabljati v kombinaciji z drugimi zdravili proti epilepsiji.
Lyrica and certain other medicines may influence each other (interaction).
Zdravilo Lyrica in določena druga zdravila imajo lahko medsebojno delovanje (interakcije).
* Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
* zvišanje alanin aminotransferaze (ALT) in aspartat aminotransferaze (AST)
Lyrica oral solution contains small amounts of ethanol (alcohol), less than 100 mg/ml.
Zdravilo Lyrica peroralna raztopina vsebuje majhne količine etanola (alkohol), in sicer manj kot 100 mg/ml.