natgillin/translations-raw huggingface dataset:
The most common side effects with Incivo (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), nausea (feeling sick), diarrhoea, vomiting, haemorrhoids (piles), proctalgia (anal pain), pruritus (itching) and rash.
Najpogostejši neželeni učinki zdravila Incivo (opaženi pri več kot 1 bolniku od 10) so anemija (nizko število rdečih krvnih celic), navzeja (slabost), driska, bruhanje, hemoroidi, proktalgija (bolečine v zadnjiku), pruritus (srbečica) in izpuščaji.
In all three studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus six months after the end of
V vseh treh študijah je bilo glavno merilo učinkovitosti število bolnikov, pri katerih krvne preiskave šest mesecev po koncu zdravljenja niso pokazale znakov virusa hepatitisa C.
It is used in adults who have compensated liver disease (when the liver is damaged but is still functioning normally) including cirrhosis (scarring of the liver) either in previously untreated patients or in those who have already been treated with interferon alfa.
Uporablja se pri odraslih bolnikih s kompenzirano boleznijo jeter (kadar so jetra poškodovana, vendar še vedno normalno delujejo), vključno s cirozo (brazgotinjenjem jeter), in sicer pri bolnikih, ki še niso bili zdravljeni, ali bolnikih, ki so že bili zdravljeni z interferonom alfa.
Incivo was investigated in three main studies in patients infected with hepatitis C. The first study involved 1,095 previously untreated patients, and the second study involved 663 patients who had already been treated with peginterferon alfa and ribavirin but were still infected.
Zdravilo Incivo so raziskovali v treh glavnih študijah pri bolnikih, okuženih s hepatitisom C. V prvi študiji je sodelovalo 1 095 predhodno nezdravljenih bolnikov, v drugi pa 663 bolnikov, ki so se že zdravili s peginterferonom alfa in ribavirinom, vendar so bili še vedno okuženi.
The active substance in Incivo, telaprevir, is a protease inhibitor.
Zdravilna učinkovina v zdravilu Incivo, telaprevir, je zaviralec proteaze.
A third study in previously untreated patients compared the effects of giving peginterferon alfa and ribavirin for different lengths of time (either six months or one year) together with three months of Incivo treatment.
V tretji študiji so pri predhodno nezdravljenih bolnikih primerjali učinke jemanja peginterferona alfa in ribavirina v različno dolgih obdobjih (šest mesecev ali eno leto) skupaj s tremi meseci zdravljenja z zdravilom Incivo.
Three Incivo tablets should be swallowed whole twice a day with food for a period of 12 weeks.
Tri tablete zdravila Incivo je treba jemati 12 tednov, in sicer jih je treba pogoltniti cele s hrano dvakrat na dan. Druga možnost je jemanje tablet Incivo s hrano vsakih osem ur.
Incivo must not be given in combination with several other medicines, including those which are affected by or affect the CYP3A gene and Class Ia or III antiarrhythmics.
Zdravilo Incivo se ne sme jemati v kombinaciji z več drugimi zdravili, vključno s tistimi, na katera učinkujejo gen CYP3A in antiaritmiki razreda Ia ali III, oziroma tistimi, ki učinkujejo na gen CYP3A in antiaritmike razreda Ia ali III. Za celoten seznam omejitev glejte navodilo
Incivo is a medicine that contains the active substance telaprevir.
Incivo je zdravilo, ki vsebuje zdravilno učinkovino telaprevir.
How does Incivo work?
Kako zdravilo Incivo deluje?
Treatment with Incivo should be started and monitored by a doctor experienced in managing chronic
Zdravljenje z zdravilom Incivo naj uvede in spremlja zdravnik z izkušnjami pri zdravljenju okužb s
Incivo is used to treat chronic (long term) hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in combination with two other medicines, peginterferon alfa and ribavirin.
Zdravilo Incivo se uporablja za zdravljenje kroničnega (dolgotrajnega) hepatitisa C (bolezni jeter zaradi okužbe z virusom hepatitisa C) v kombinaciji z dvema drugima zdraviloma, peginterferonom alfa in
Treatment with ribavirin and peginterferon alfa will continue for a longer period, based on whether the patient has been treated before and test results during their Incivo treatment.
Zdravljenje z ribavirinom in peginterferonom alfa se nadaljuje dlje časa glede na to, ali je bolnik že bil zdravljen, in glede na izvide preiskav med zdravljenjem z zdravilom Incivo.
In the first study, when Incivo was given for three months, 75% of patients tested negative for hepatitis C compared with 44% of patients receiving placebo.
V prvi študiji, v kateri so zdravilo Incivo dajali tri mesece, je bil pri 75 % bolnikov izvid za hepatitis C negativen v primerjavi s 44 % bolnikov, ki so prejemali placebo.
How has Incivo been studied?
Kako je bilo zdravilo Incivo raziskano?
The third study showed that in patients treated with Incivo, giving peginterferon alfa and ribavirin for six months was as effective as giving these medicines for one year, since 92% of patients receiving them for six months tested negative for hepatitis C compared with 88% of patients
Rezultati tretje študije so pokazali, da je bilo zdravljenje bolnikov z zdravilom Incivo, ki so šest mesecev jemali peginterferon alfa in ribavirin, enako učinkovito kot enoletno zdravljenje s tema zdraviloma, saj je bil pri 92 % bolnikov, ki so navedena zdravila prejemali šest mesecev, izvid za hepatitis C negativen v primerjavi z 88 % bolnikov, ki so peginterferon alfa in
Both studies compared Incivo with placebo (a dummy treatment) added to a course of peginterferon alfa and ribavirin.
V obeh študijah so zdravilo Incivo primerjali s placebom (zdravilom brez zdravilne učinkovine), ki so ga dodajali zdravljenju s peginterferonom alfa in ribavirinom.
In the second study, 88% of patients receiving Incivo for three months tested negative for hepatitis C compared with 24% of patients receiving placebo.
V drugi študiji je bil izvid za hepatitis C negativen pri 88 % bolnikov, ki so zdravilo Incivo prejemali tri mesece, v primerjavi s 24 % bolnikov, ki so prejemali placebo.
For the full list of all side effects reported with Incivo, see the
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Incivo, glejte navodilo za uporabo.
The Committee noted that in both previously untreated patients and patients who had already been treated, adding Incivo to standard treatment considerably increased the number showing no sign of infection after six months.
CHMP je menil, da predstavlja dodajanje zdravila Incivo standardnemu zdravljenju velik napredek pri zdravljenju najpogostejšega tipa virusa hepatitisa C. Ugotovil je, da je tako pri predhodno nezdravljenih bolnikih kot pri bolnikih, ki so že bili zdravljeni, dodajanje zdravila Incivo standardnemu zdravljenju pomembno povečalo število bolnikov, ki po šestih mesecih niso več kazali znakov okužbe.
The first European approval was in Sweden on 12 April 1996.
Zdravilo je dovoljenje za promet v Evropi prvič pridobilo 12. aprila 1996 na Švedskem.
The pregnancy section has been revised in line with the relevant guideline[7].
Poglavje o nosečnosti je bilo popravljeno v skladu z ustrezno smernico[7].
• The Committee considered the referral under Article 30 of Directive 2001/83/EC
• odbor je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES;
Cancer Patients 2014, Chapter 15, pp.251-269.
Disease in Cancer Patients 2014, Chapter 15, pp.251-269.
However, the treatment regimen and posology in these paediatric indications should be chosen according to the local standard of care.
Vendar je treba režim zdravljenja in način odmerjanja pri navedenih pediatričnih indikacijah izbrati v skladu z lokalnim standardnim zdravljenjem.
Treatment Reviews 1995;21:33-64.
Cancer Treatment Reviews 1995;21:33-64.
Etoposide is used for the treatment of various neoplastic diseases.
Etopozid se uporablja za zdravljenje različnih neoplastičnih bolezni.
A text to consider preservation of the sperm has been included in this section.
V to poglavje je bilo vključeno besedilo o možnosti shranjevanja sperme.
Paediatric indications were agreed in the following indications:
Pri otrocih so bile dogovorjene naslednje indikacije:
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product, the European Commission therefore notified the CHMP/European Medicines Agency on 14 October 2015 of a referral under Article 30 of Directive 2001/83/EC for Etopophos and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise the product information across the EU.
Zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice v zvezi z izdajo dovoljenja za promet z zgoraj navedenim zdravilom, je Evropska komisija 14. oktobra 2015 obvestila odbor CHMP pri Evropski agenciji za zdravila o napotitvi v skladu s členom 30 Direktive 2001/83/ES za zdravilo Etopophos in povezana imena z namenom odprave neskladij med nacionalno odobrenimi informacijami o zdravilu in uskladitve različnih informacij o zdravilu po vsej EU.
As breastfeeding women could replace breastfeeding by dairy products to feed their child the text has been amended accordingly.
Ker doječe matere lahko nadomestijo dojenje z mlečnimi formulami, je bilo besedilo ustrezno spremenjeno.
In renal impairment (creatinine clearance (CrCl) 15-50 mL/min) a dose reduction of 25% is recommended.
Pri ledvični okvari (očistek kreatinina (CrCl) 15-50 ml/min) se priporoča zmanjšanje odmerka za 25 %.
In relation to lactation, information on the fact that etoposide is excreted in the milk (Medications and Mothers' Milk: Thomas W. Hale) has been added.
V zvezi z dojenjem je bila dodana informacija, da se etopozid izloča v materino mleko (Medications and Mothers' Milk (Zdravila in materino mleko): Thomas W. Hale).
In patients with renal impairment, the CHMP agreed not to recommend a dose reduction when creatinine clearance is > 50 mL/min as supported by available literature[1][2][3][4][5].
Pri bolnikih z ledvično okvaro se je odbor CHMP strinjal, da ne priporoči zmanjšanega odmerka, kadar je očistek kreatinina > 50 ml/min, kot podpira razpoložljiva literatura[1][2][3][4][5].
- Small-cell lung cancer
- drobnocelični pljučni rak;
The revised indications in section 4.1 of the Summary of Product characteristics (SmPC) are:
Revidirane indikacije v poglavju 4.1 povzetka glavnih značilnosti zdravila so naslednje:
The following special warnings and precautions for use have been harmonised in section 4.4 where they were already included in some or most of the national SmPCs: myelosuppression, secondary leukaemia, hypersensitivity, injection site reaction, low serum albumin, impaired renal and hepatic function, tumour lysis syndrome and mutagenic potential.
V poglavju 4.4 so bila usklajena naslednja posebna opozorila in previdnostni ukrepi, ki so bili v nekatera ali večino nacionalnih povzetkov glavnih značilnosti zdravila že vključeni: mielosupresija, sekundarna levkemija, preobčutljivost, reakcija na mestu injiciranja, nizka raven albumina v serumu, oslabljeno delovanje ledvic in jeter, sindrom tumorske lize in mutageni potencial.
Etopophos is currently approved in DE, FR, SE and UK.
Zdravilo Etopophos ima trenutno dovoljenja za promet v Franciji, Nemčiji, na Švedskem in v Združenem kraljestvu.
As immunosuppression is a very common side effect of etoposide, concomitant use of live vaccines has been added as a contraindication, which is in line as well with the guideline on SmPC.
Ker je imunosupresija zelo pogost neželen učinek etopozida, je bila med kontraindikacije dodana tudi sočasna uporaba živih cepiv, kar je prav tako v skladu s smernico za povzetke glavnih značilnosti zdravila.
Etopophos and associated names was included in the list of products for summary of product characteristics (SmPC) harmonisation, drawn up by the CMDh, in accordance with Article 30(2) of Directive 2001/83/EC.
Zdravilo Etopophos in povezana imena so vključena na seznam zdravil, pri katerih je potrebna uskladitev povzetkov glavnih značilnosti zdravila, ki ga je sestavila skupina CMD(h) v skladu s členom 30(2) Direktive 2001/83/ES.
In section 4.5 of the SmPC the interactions that were documented in the majority of current national SmPCs have been retained in the harmonised text.
V poglavju 4.5 povzetka glavnih značilnosti zdravila so bile interakcije, navedene v večini trenutnih nacionalnih povzetkov glavnih značilnosti zdravila, ohranjene tudi v usklajenem besedilu.
In paediatric patients diagnosed with Hodgkin's lymphoma, non-Hodgkin's lymphoma or acute myeloid leukaemia, the CHMP recommended the range of 75 to 150 mg/ m2/day for 2 to 5 days in combination with other antineoplastic agents as supported in studies conducted by major international groups such as The German Society of Paediatric Oncology and Haematology Hodgkin's Disease, The Children's Cancer Group and The European Organization of Research and Treatment of Cancer Children Leukaemia Group among others.
Pri pediatričnih bolnikih z diagnozo Hodgkinovega limfoma, ne-Hodgkinovega limfoma ali akutne mieloične levkemije je odbor CHMP priporočil odmerek v razponu med 75 in 150 mg/m2/dan v obdobju 2 do 5 dni v kombinaciji z drugimi zdravili z delovanjem na novotvorbe, kar so podprle študije, ki so jih opravile večje mednarodne skupine, med drugim Nemško združenje za pediatrično onkologijo in hematološko Hodgkinovo bolezen, Skupina za zdravljenje raka pri otrocih in Evropska organizacija za raziskave in zdravljenje raka ter Skupina za raka in levkemijo pri otrocih.
• The Committee considered the divergences identified in the notification for Etopophos and associated names, as well as the remaining sections of the product information.
• odbor je obravnaval razlike, ugotovljene v obvestilu za zdravilo Etopophos in povezana imena, ter preostala poglavja informacij o zdravilu;
• The committee agreed on a harmonised product information for Etopophos and associated names.
• odbor se je strinjal z usklajenimi informacijami o zdravilu Etopophos in povezanih imenih.
The CHMP as a consequence, concluded that the benefit-risk balance of Etopophos and associated names remains favourable, subject to the agreed changes to the product information.
Posledično je odbor zaključil, da je razmerje med tveganji in koristmi zdravila Etopophos in povezanih imen še naprej ugodno, če se upoštevajo dogovorjene spremembe informacij o zdravilu.
• The scope of the referral was the harmonisation of the product information,
• namen napotitve je bila uskladitev informacij o zdravilu;
- Ovarian cancer: non-epithelial ovarian cancer and platinum-resistant/refractory epithelial ovarian cancer
- rak jajčnikov: neepitelijski rak jajčnikov in proti platini odporen/refraktaren epitelijski rak jajčnikov.
The data in literature for patients with CrCl less than 15 mL/min and on dialysis strongly suggest that further dose reduction is required in these patients as reviewed by Inoue et al. (2004)[6].
Podatki v literaturi za bolnike s CrCl pod 15 ml/min, ki se zdravijo z dializo, jasno kažejo, da je pri teh bolnikih potrebno nadaljnje zmanjšanje odmerka, kot so v preglednem članku objavili Inoue et al. (2004)[6].
The CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Etopophos and associated names (see Annex I).
Odbor CHMP je priporočil spremembo pogojev dovoljenj za promet z zdravilom Etopophos in povezanimi imeni, za katera so v Prilogi III navedene informacije o zdravilu (glejte Prilogo I).
The MAH also discussed a dose reduction for patients with end stage renal disease (CrCl < 15mL/min).
Imetnik dovoljenja za promet z zdravilom je razpravljal tudi o zmanjšanju odmerka pri bolnikih z zadnjim stadijem bolezni ledvic (CrCl < 15 ml/min).
The CHMP also noted that etoposide may decrease male fertility.
Odbor CHMP je opozoril tudi, da etopozid lahko negativno vpliva na plodnost pri moških.
As regards the posology, section 4.2 of the SmPC, the doses were harmonised for all indications and patient populations - adult and paediatric.
Kar zadeva način odmerjanja, poglavje 4.2 povzetka glavnih značilnosti zdravila, so bili odmerki usklajeni za vse indikacije in populacije bolnikov - odrasle in otroke.
Grounds for the CHMP opinion Whereas
Podlaga za mnenje odbora CHMP ob upoštevanju naslednjega:
Etoposide is a semi-synthetic derivative of podophyllotoxin which ruptures double strand DNA by means of an interaction with DNA-topoisomerase II, or by the formation of free radicals.
Etopozid je polsintetični derivat podofilotoksina, ki reagira z DNK-topoizomerazo II ali sproži nastajanje prostih radikalov in tako prekine dvoverižno DNK.
- Gestational trophoblastic neoplasia
- gestacijska trofoblastna neoplazija;
• The Committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
• odbor je pregledal vse podatke, ki jih je v podporo predlagani uskladitvi informacij o zdravilu predložil imetnik dovoljenja za promet z zdravilom;
This has been addressed by a warning in section 4.2 of the SmPC.
To je obravnavano v opozorilu v poglavju 4.2 povzetka glavnih značilnosti zdravila.
With regards to fertility, pregnancy and lactation section 4.6 of the SmPC, information addressed to women of childbearing potential with regards to contraception in males and females was included.
Kar zadeva poglavje 4.6 povzetka glavnih značilnosti zdravila o plodnosti, nosečnosti in dojenju, so bile vključene informacije, namenjene ženskam v rodni dobi, v zvezi s kontracepcijo pri moških in ženskah.
Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally.
označevanje, kadar je bilo to ustrezno, vendar je bilo treba večino poglavij dopolniti na nacionalni ravni.
Finally, lactation has also been included as a contraindication with a reference to section 4.6 of the SmPC where lactation is further described.
Med kontraindikacije je bilo vključeno tudi dojenje, s sklicem na poglavje 4.6 povzetka glavnih značilnosti zdravila, kjer je dojenje podrobneje opisano.
Etopophos contains etoposide phosphate, a pro-drug of etoposide which is rapidly converted to etoposide in vivo.
Zdravilo Etopophos vsebuje etopozid fosfat, predzdravilo etopozida, ki se in vivo hitro pretvori v etopozid.
The recommended dose in adult patients is 50 to 100 mg/m2/day on days 1 to 5 in line with the current clinical practice guidelines, however when administered on three days (e.g. days 1, 3, and 5) the daily dose that is most commonly used can be either 100 to 120 mg/m2 every 3 to 4 weeks in combination with other drugs indicated in the disease to be treated.
Kadar se daje tri dni (npr. 1., 3. in 5. dan), se najpogosteje uporablja dnevni odmerek od 100 do 120 mg/m vsake 3 do 4 tedne v kombinaciji z drugimi zdravili, indiciranimi pri zdravljeni bolezni.
• The product information proposed by the Marketing Authorisation Holder has been assessed based on the documentation submitted and the scientific discussion within the Committee,
• odbor CHMP je na podlagi predložene dokumentacije in znanstvene razprave v odboru ocenil informacije o zdravilu, ki so jih predlagali imetniki dovoljenj za promet z zdravilom;
Etoposide phosphate injection is supplied as a nonpyrogenic lyophilized powder intended for reconstitution and/or dilution with a suitable parenteral vehicle prior to intravenous (IV) administration and is available as 114 mg etoposide phosphate (100 mg etoposide equivalent) single dose sterile vial and 1140 mg etoposide phosphate (1000 mg etoposide equivalent) pharmacy bulk vial (Germany only).
uporabo, in sicer v obliki 114 mg etopozidfosfata (kar ustreza 100 mg etopozida) v sterilni enoodmerni viali in v obliki 1140 mg etopozid fosfata (kar ustreza 1000 mg etopozida) v večji viali za lekarne (samo v Nemčiji).
- Testicular cancer: first line, recurrent or refractory testicular cancer
- rak mod: prva izbira, ponavljajoč se ali refraktarni rak mod;
Hypersensitivity has been added as contraindication in section 4.3 of the SmPC in line with the guideline on SmPC.
V skladu s smernico za povzetke glavnih značilnosti zdravila je bila med kontraindikacije v poglavju 4.3 povzetka glavnih značilnosti zdravila dodana preobčutljivost.
These observations are further supported by data from epidemiological and laboratory studies;
Ta opažanja nadalje podpirajo podatki iz epidemioloških in laboratorijskih študij.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Pregsure BVD AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA Pregsure BVD IN POVEZANIH IMEN (GLEJTE DODATEK I)
The marketing authorisation holder voluntarily stopped the sales of the product from the market in Germany in April 2010 and from all other concerned EU Member States in June 2010.
Imetnik dovoljenja za promet z zdravilom je prostovoljno ustavil prodajo zdravila na nemškem trgu aprila 2010, v vseh drugih zadevnih državah članicah EU pa junija 2010.
Product name Pharmaceutical form
Ime zdravila Farmacevtska oblika
Laboratórios Pfizer Lda Lagoas Park - Edifício
Portugalska Laboratórios Pfizer Lda Lagoas Park - Edifício
The marketing authorisation holder has taken precautionary measures to stop sales of the product in EU.
Imenik dovoljenja za promet z zdravilom je sprejel preventivne ukrepe za ustavitev prodaje zdravila v EU.
therefore, in accordance with Article 83 (1)(a) of Directive 2001/82/EC, the CVMP recommends the suspension of the marketing authorisations for the veterinary medicinal products referred to in Annex I of the CVMP Opinion.
CVMP v skladu s členom 83 (1)(a) Direktive 2001/82/ES priporoča začasni umik dovoljenj za promet z veterinarskimi zdravili iz Dodatka I mnenja CVMP.
In this particular case, for a prophylactic measure such as vaccination this figure was considered unacceptable for a potentially fatal disorder.
V tem primeru - za profilaktični ukrep, npr. za cepljenje - je bil ta rezultat nesprejemljiv za bolezen z možnim smrtnim izidom.
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, imetnikov dovoljenja za promet z zdravilom v državah članicah
The product has also a claim of partial cross protection against BVDV type 2.
Zdravilo zagotavlja tudi delno navzkrižno zaščito pred BVDV tipa 2.
In addition, the CVMP considered that temporary measures are needed and therefore recommends that all batches of the product be recalled at wholesale level.
Poleg tega je CVMP menil, da so potrebni začasni ukrepi, zato priporoča, da se vse serije zdravila odpokličejo na ravni prodaje na debelo.
Benefit-risk evaluation
Ocena koristi in tveganj
Target animal species
Živalska vrsta
Since March 2009, over 400 adverse events of bovine neonatal pancytopenia (involving over 2,000 animals) have been reported within eleven European Union (EU) Member States where the product is authorised.
Od marca 2009 so poročali o več kot 400 neželenih primerih neonatalne pancitopenije pri govedu (pri več kot 2000 živalih) v enajstih državah članicah Evropske unije (EU), v katerih je zdravilo odobreno.
The overall incidence for bovine neonatal pancytopenia at EU level between 2004 and 2009 was estimated to be 0.016% based on a single dose.
Celokupna pogostost neonatalne pancitopenije pri govedu na ravni EU med leti 2004 in 2009 je bila ocenjena na 0,016 % na podlagi enkratnega odmerka.
These reports raised concern over a potential association with the use of Pregsure BVD.
Ta poročila so bila povod za pomisleke glede morebitne povezave z uporabo zdravila Pregsure BVD.