natgillin/translations-raw huggingface dataset:
a Grade ≥ 2) that represent a worsening from baseline and are considered adverse drug reactions in HCV-infected patients treated with INCIVO combination treatment from the pooled data from the placebo-controlled 
a) iz združenih podatkov s placebo nadzorovanih preskušanj faze II in III, ki predstavljajo poslabšanje od začetka zdravljenja in so obravnavani kot neželeni učinki pri bolnikih, okuženih s HCV, ki se zdravijo s kombinacijo z zdravilom INCIVO
See table 1 for Guidelines for Discontinuation of INCIVO, Peginterferon Alfa, and Ribavirin Treatment. 
Za smernice o ukinitvi zdravljenja z zdravilom INCIVO, peginterferonom alfa in ribavirinom glejte preglednico 1.
3) being treated with efavirenz or atazanavir/ritonavir in combination with tenofovir disoproxil fumarate and emtricitabine or lamivudine. 
3) ali so imeli stabilno, nadzorovano okužbo s HIV (< 50 kopij RNK HIV/ml, število celic CD4 ≥ 300 celic/mm3) in so se zdravili z efavirenzom ali s shemo atazanavir/ritonavir v kombinaciji s dizoproksiltenofovirat fumaratom in emtricitabinom ali lamivudinom.
Table 12 shows SVR rates by extent of liver fibrosis. 
Preglednica 12: stopnje trajnega virološkega odziva glede na obseg jetrne fibroze na začetku
If your treatment is not working, your doctor may stop your medicines. 
Če bo ugotovil, da zdravljenje nima učinka, ga bo lahko prekinil.
INCIVO must be administered with peginterferon alfa and ribavirin. 
Zdravilo INCIVO je treba uporabljati skupaj s peginterferonom alfa in ribavirinom.
There are no clinical data on the use of INCIVO in patients on haemodialysis. 
O uporabi zdravila INCIVO pri bolnikih, ki se zdravijo s hemodializo, ni kliničnih podatkov.
INCIVO must be taken in combination with peginterferon alfa and ribavirin. 
Predpisujete ga lahko samo v kombinaciji s peginterferonom alfa in ribavirinom.
T12/P(2a)R48: INCIVO for 12 weeks in combination with peginterferon alfa-2a and ribavirin for 24 or 48 weeks T12/P(2b)R48: INCIVO for 12 weeks in combination with peginterferon alfa-2b and ribavirin for 24 or 48 weeks 95% confidence interval for the difference was (-10.8, 12.1) Denominator was the number of patients with undetectable HCV RNA (target not detected) at end of treatment 
T12/PR24: Jemanje zdravila INCIVO 12 tednov s peginterferonom alfa-2a in ribavirinom v času 24 tednov; T12/PR48: jemanje zdravila INCIVO 12 tednov s peginterferonom alfa-2a in ribavirinom v času 48 tednov; Postavka »vsi bolniki« zajema 322 bolnikov z nezaznavno HCV RNK (nezaznaven analit) v 4. in 12. tednu in 218 drugih bolnikov, ki so bili zdravljeni v študiji (118 takih, ki niso imeli nemerljive HCV RNK (nezaznaven analit) v 4. tednu in v 12. tednu, in 100 takih, ki so zapustili študijo pred 20. tednom, ko je bila opravljena randomizacija).
It is important to stay hydrated with fluids during INCIVO combination treatment. 
Med kombiniranim zdravljenjem z zdravilom INCIVO je pomembna zadostna hidracija.
Caution is warranted and clinical monitoring is recommended when co-administered with INCIVO. 
Potrebna je previdnost in pri sočasni uporabi antibiotikov z zdravilom INCIVO je priporočljivo klinično spremljanje bolnika.
The 540 enrolled patients had a median age of 51 years (range: 19 to 70); 60% of the patients were male; 32% had a body mass index ≥ 30 kg/m2; 14% were Black; 10% were Hispanic or Latino; 82% had baseline HCV RNA levels > 800,000 IU/ml; 16% had bridging fibrosis; 11% had cirrhosis; 72% had HCV genotype 1a; and 27% had HCV genotype 1b. 
10% je bilo španskega ali latinskoameriškega rodu, 82% je imelo začetno vrednost HCV RNK > 800.000 i.e./ml, 16% je imelo mostno fibrozo, 11% je imelo cirozo, 72% je imelo HCV genotip 1a
Interactions between telaprevir and HIV antiretroviral agents are frequent, and the recommendations in table 2, section 4.5, should be carefully followed. 
Medsebojna delovanja telaprevirja s protiretrovirusnimi zdravili za zdravljenje okužbe s HIV so pogosta.
SVR in patients who did not have undetectable HCV RNA (target not detected) at weeks 4 
SVR pri bolnikih, ki niso dosegli eRVR Koncentracija HCV RNK < 25 i.e./ml ob koncu
SVR rates for patients with or without cirrhosis Patients without cirrhosis 65.5% (38/58) 
Stopnje SVR pri bolnikih s cirozo ali brez ciroze bolniki s cirozo bolniki brez ciroze
Increases in serum uric acid occur very commonly during treatment with INCIVO in combination with peginterferon alfa and ribavirin. 
Med zdravljenjem z zdravilom INCIVO v kombinaciji s peginterferonom alfa in ribavirinom se zelo pogosto pojavlja zvečanje koncentracij sečne kisline v serumu.
Gastrointestinal disorders very common nausea, diarrhoea, vomiting, haemorrhoids, proctalgia common anal pruritus, rectal haemorrhage, anal fissure uncommon proctitis, pancreatitis 
simptomi, napredujoč, hud izpuščaj, sum na ali diagnosticiran bulozni izpuščaj, sindrom
Talk to your doctor or pharmacist before taking INCIVO. 
Pred začetkom jemanja zdravila INCIVO se posvetujte z zdravnikom ali farmacevtom.
The 662 enrolled patients had a median age of 51 years (range: 21 to 70); 70% of the patients were male; 26% had a body mass index ≥ 30 kg/m2; 5% were Black; 11% were Hispanic or Latino; 89% had baseline HCV RNA levels > 800,000 IU/ml; 22% had bridging fibrosis; 26% had cirrhosis; 54% had HCV genotype 1a; and 46% had HCV genotype 1b. 
Skupaj 662 vključenih bolnikov je imelo mediano starost 51 let (razpon: od 21 do 70 let), 70% bolnikov je bilo moškega spola, 26% je imelo indeks telesne mase ≥ 30 kg/m2, 5% je bilo črncev in 11% je bilo španskega ali latinskoameriškega rodu.
You must read the package leaflets for peginterferon alfa and ribavirin for additional information. 
Za dodatne podatke preberite navodili za uporabo peginterferona alfa in ribavirina.
Effect on unbound telaprevir concentrations is unknown (see sections 4.2 and 4.4). 
Učinek na koncentracije nevezanega telaprevirja ni znan (glejte
There is limited pharmacokinetic data on the use of INCIVO in HCV patients aged ≥ 65 years and no data in subjects > 70 years of age. 
Podatkov o uporabi zdravila INCIVO pri bolnikih starih > 70 let ni.
See the package leaflets for peginterferon alfa and ribavirin for a list of their contraindications (e.g. pregnancy precautions for men and women) since INCIVO must be used in combination with peginterferon alfa and ribavirin. 
Zdravilo INCIVO morate uporabljati skupaj s peginterferonom alfa in ribavirinom, zato glejte tudi seznam kontraindikacij (npr. preprečevanje nosečnosti) v navodilih za uporabo teh dveh zdravil.
Contact your doctor immediately if you get a skin rash. 
Če se pri vas pojavi kožni izpuščaj, se takoj obrnite na svojega zdravnika.
Exposure to telaprevir is higher during co-administration of peginterferon alfa and ribavirin than after administration of telaprevir alone. 
Stopnja izpostavljenosti bolnika telaprevirju je večja med sočasnim jemanjem peginterferona alfa in ribavirina
Refer also to the Summary of Product Characteristics for ribavirin for patients with CrCL < 50 ml/min 
Pri bolnikih s CrCl < 50 ml/min glejte tudi Povzetek glavnih značilnosti zdravila ribavirin (glejte tudi
Hepatobiliary disorders common hyperbilirubinaemia 
ANTIKONVULZIVI karbamazepin*
SVR in patients with undetectable HCV RNA (target not detected) at weeks 4 and 12 
Preglednica 9: stopnje odziva: študija 111 Bolniki z nezaznavno HCV RNK (nezaznaven analit) v 4. in 12. tednu
PDE-5 INHIBITORS sildenafil tadalafil vardenafil 
IMUNOSUPRESIVI ciklosporin* takrolimus* sirolimus
Furthermore, high rates of anaemia have been seen when using INCIVO with peginterferon and ribavirin in patients with these characteristics. 
Pri teh bolnikih so ob uporabi zdravila INCIVO v kombinaciji s peginterferonom in ribavirinom opazili tudi večjo pogostnost anemije.
This medicine contains 2.3 mg sodium per tablet, which should be taken into consideration by patients on a controlled sodium diet. Tell your doctor if you have to take care of your salt intake and follow a 
Zdravniku povejte, če morate paziti na vnos soli ali ste na dieti z nadzorovano količino
Concurrent administration of salmeterol and telaprevir is not recommended. 
INHALACIJSKI AGONISTI ADRENERGIČNIH RECEPTORJEV BETA Sočasna uporaba salmeterola in telaprevirja ni priporočljiva.
Treatment Outcome Treatment-Naïve Patients N = 64 % (n/N) 
Zdravljeni bolniki po podskupinah Bolniki s ponovitvijo bolezni N = 29 % (n/N)
to treat some stomach conditions (gastrointestinal motility agents) 
cisaprid za zdravljenje nekaterih želodčnih bolezni (zdravila za urejanje gibljivosti prebavil)
® TaqMan 
Izpuščaj
Manufacturer Janssen-Cilag SpA, Via C. Janssen, 
Janssen-Cilag SpA, Via C. Janssen, 04010 Borgo San Michele, Latina, Italija
Follow usual aseptic procedures. 
Upoštevajte običajna merila aseptičnega dajanja.
Following the second vaccination swelling may persist for at least 35 days. 
Po drugem cepljenju lahko takšna oteklina traja najmanj 35 dni.
According to Article 71 of Directive 2001/82/EC as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programme for the diagnosis, control and eradication of animal disease, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory. 
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da: a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz b) bolezen, za katero se z zdravilom za uporabo v veterinarski medicini pridobi imunost, na
One dose of 0.5 ml should be given at 10 to 14 weeks of age. 
En odmerek po 0,5 ml dajemo pri starosti 10 do 14 tednov.
Triethanolamine (at doses up to 0.25 mg/kg bw) is considered not within the scope of Council 
Trietanolamin (v odmerkih do 0,25 mg/kg telesne mase) ni vključen v Uredbo Sveta (EGS) št.
Intervet International B.V. Wim de Körverstraat 35 5831AN Boxmeer The Netherlands 
Wim de Körverstraat 35 5831AN Boxmeer Nizozemska
Swelling was very common. 
Oteklina je bila zelo pogosta.
EU/2/09/093/001 EU/2/09/093/002 
EU/0/00/000/000
Store and transport refrigerated (2ºC - 8°C). 
Shranjujte in prevažajte v hladilniku (2 C - 8 C).
Accidental injection is dangerous - read package leaflet before use. 
Nenamerno injiciranje je nevarno - pred uporabo preberite navodilo za uporabo.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your 
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za
Vaccination may result in moderate swelling of the breast tissue which will resolve within 30 days. 
Cepljenje lahko povzroči zmerno oteklino tkiva na prsih, ki v 30 dneh mine.
Pharmacotherapeutic group: Immunologicals for aves, ATC vet code: QI01AB08 
Farmakoterapevtska skupina: imunološka zdravila za ptice, oznaka ATCvet: QI01AB08
Annex II of Council Regulation (EEC) 
Dodatek II Uredbe Sveta (EGS) št. 2377/90
The second dose should be administered no later than 6 weeks before the onset of lay. 
Drugega odmerka ne smemo dati pozneje kot 6 tednov pred začetkom obdobja nesnosti.
Do not use after the expiry date stated on the carton. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli.
Vaccine against necrotic enteritis 
Cepivo proti nekrotičnemu enteritisu
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder. 
Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja
No systemic reactions to vaccination were seen following intramuscular vaccination. 
Po intramuskularnem cepljenju niso bile opažene nikakršne sistemske spremembe.
Clostridium perfringens Type A alpha toxoid Not less than 6.8 IU * 
Clostridium perfringens tipa A, toksoid alfa ne manj kot 6,8 i.e.*
Thiomersal 
KARENCA
Netvax emulsion for injection for chickens 
Netvax, emulzija za injiciranje za piščance
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. 
Če vam je bil ta proizvod nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodilo za uporabo.
Clostridium perfringens Type A alpha toxoid: ≥ 6.8 IU* 
Clostridium perfringens tipa A, toksoid alfa: ≥ 6,8 i.e.*
The onset of passive transfer of immunity: 6 weeks following completion of the vaccination procedure 
Prenos pasivne imunosti: 6 tednov po končanem postopku cepljenja.
The vaccine is safe for use in laying and breeding birds. 
Uporaba cepiva je varna pri pticah v obdobju nesnosti in pri vzrejnih pticah.
After administration of a double dose, local reactions may increase slightly. 
Po dajanju dvojnega odmerka se lahko nekoliko povečajo lokalne reakcije (glejte poglavje 4.6).
Name and address of the manufacturer of the biological active substance(s) 
Ime in naslov izdelovalca(izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin)
A second dose of 0.5 ml should be administered 4 to 10 weeks after the first vaccination. 
Drugi odmerek po 0,5 ml dajemo 4 do 10 tednov po prvem.
The duration of passive transfer of immunity: 51 weeks following completion of the vaccination procedure 
Trajanje prenesene pasivne imunosti: 51 tednov po končanem postopku cepljenja.
Shelf-life after first opening the immediate packaging: 8 hours 
Rok uporabnosti po prvem odpiranju vsebnika: 8 ur.
Special precautions to be taken by the person administering the veterinary medicinal product to 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
Pack Sizes 
Velikost pakiranja
500ml high density polyethylene (HDPE) flexible bottle closed with a chlorobutyl rubber closure held in place with an aluminium seal with centre hole. 
Steklenička iz polietilena velike gostote (HDPE) s klorobutilnim gumijastim zamaškom in aluminijasto zaporko z odprtino v sredini.
Vaccinate chickens by the intramuscular route into the breast. 
Piščance cepite intramuskularno v prsno mišico.
Syringes and needles must be sterile before use. 
Uporabljajte sterilne brizge in igle.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH 
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
To reduce mortality and the incidence and severity of lesions caused by Clostridium perfringens Type A induced necrotic enteritis. 
Za zmanjšanje pogina ter pojavnosti in resnosti okvar pri nekrotičnem enteritisu, ki jih povzroča bakterija Clostridium perfringens tipa A. Učinkovitost je dokazana z izzivnim preizkusom pri piščancih približno tri tedne po izvalitvi.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR 
<IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN>IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJE V EGP, ČE STA RAZLIČNA
For the active immunization of chickens to provide passive immunisation against necrotic enteritis to their progeny, during the laying period. 
Za aktivno imunizacijo piščancev proti nekrotičnemu enteritisu v času nesnosti in prenos pasivne
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Pack sizes: 
Namenjeno uporabniku:
To stimulate active immunity in chickens, in order to provide passive protection to the progeny against Clostridium perfringens Type A induced necrotic enteritis. 
Za aktivno imunizacijo piščancev proti nekrotičnemu enteritisu, ki ga povzroča bakterija Clostridium perfringens tipa A, v času nesnosti in prenos pasivne zaščite na njihove potomce.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR 
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
CONDITIONS OR RESTRICTIONS OF THE MARKETING 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION 
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
Keep out of the reach and sight of children. 
Shranjujte nedosegljivo otrokom
This summary was last updated in 08-2011. 
Povzetek je bil nazadnje posodobljen 08-2011.
The European Commission granted a marketing authorisation valid throughout the European Union for Savene on 28 July 2006. 
Evropska komisija je dovoljenje za promet z zdravilom Savene, veljavno po vsej Evropski uniji, odobrila dne 28. julija 2006.
Savene dexrazoxane 
Savene deksrazoksan
Other information about Savene: 
Druge informacije o zdravilu Savene:
Savene was not compared with any other medicines in these studies. 
V teh študijah zdravila Savene niso primerjali z nobenim drugim zdravilom.
The summary of the opinion of the Committee for Orphan Medicinal Products for Savene is available here. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Savene je na voljo tukaj.
Patients will be monitored for these side effects before, during and after treatment. 
Bolnike je treba glede neželenih učinkov nadzorovati pred in med zdravljenjem ter po njem.
The first infusion of Savene is given as soon as possible after the accident, and no later than six hours after it happened. 
Prva infuzija se da čimprej po nehotenem dogodku in ne več kot šest ur po njem.
What benefit has Savene shown during the studies? 
Kakšne koristi je zdravilo Savene izkazalo med študijami?
For more information about treatment with Savene, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Savene preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
It must not be used in women who could become pregnant or who are breastfeeding, or in patients receiving vaccination against yellow fever. 
Ne sme se uporabljati pri ženskah, ki bi utegnile zanositi ali dojijo, ter pri bolnikih, ki prejemajo cepljenje proti rumeni mrzlici.
Patients can also develop low blood levels of white blood cells and platelets. 
Pri bolniku se utegne pojaviti tudi nizka raven belih krvnih telesc in krvnih ploščic.
What is the risk associated with Savene? 
Kakšna tveganja so povezana z zdravilom Savene?
Savene must be used under the supervision of a doctor who has experience in the use of anticancer medicines. 
Zdravilo Savene se mora uporabljati pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil proti raku.
The Committee decided that Savene's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor je zaključil, da so koristi zdravila Savene večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Two further infusions are then given, one on day 2 and another on day 3, at the same time as the first infusion. 
Naslednji dve infuziji je treba nato dati drugi in tretji dan ob istem času, kot je bila dana prva infuzija.
Anthracycline extravasation is a condition that can currently be managed using various methods, but for which there is no standard authorised treatment. 
Antraciklinska ekstravazacija je stanje, za katerega se trenutno uporabljajo različne metode, vendar pa zanj ni standardnega odobrenega zdravljenja.
The most common side effects with Savene (seen in more than 1 patient in 10) are nausea (feeling sick), and pain and infection at the site of the injection. 
Najpogostejši neželeni učinki zdravila Savene (opaženi pri več kot 1 bolniku od 10) so slabost ter bolečina in okužba na mestu injiciranja.
Because the number of patients who have extravasation of anthracyclines is low, the condition is considered ‘rare', and Savene was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 September 2001. 
Ker je število bolnikov, pri katerih se pojavi antraciklinska ekstravazacija, majhno, in je bolezen redka, je bilo zdravilo Savene dne 19. septembra 2001 določeno kot zdravilo sirota (zdravilo, ki se uporablja pri redkih boleznih).
Only one patient among the 54 in whom the effectiveness of Savene could be measured had tissue damage requiring surgery. 
Samo en bolnik od 54, pri katerih je bilo mogoče meriti učinkovitost zdravila Savene, je imel poškodbe tkiv, ki so zahtevale operacijo.
Savene has been tested in two main studies involving a total of 80 patients who had extravasation of anthracyclines such as epirubicin or doxorubicin. 
Zdravilo Savene je bilo preskušeno v dveh glavnih študijah, ki sta vključevali skupaj 80 bolnikov, pri katerih je prišlo do antraciklinske ekstravazacije zaradi zdravil kot sta epirubicin ali doksorubicin.
Together, these effects can reduce the amount of tissue damage caused by anthracycline extravasation. 
Skupaj lahko ti učinki zmanjšajo količino tkiva, poškodovanega zaradi antraciklinske ekstravazacije.
This document is a summary of the European public assessment report (EPAR) for Savene. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Savene.
The way it works is not entirely clear, but may be linked to the way the medicine attaches to iron in the body to form a ‘chelate' and to its effect on some enzymes, such as topoisomerase II. 
Njegov način delovanja ni v celoti znan, vendar utegne biti povezan z načinom, kako se veže na železo v telesu, da tvori kelat, in njegovimi učinki na nekatere encime, kot je topoizomeraza II.
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 Savene. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Savene, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Extravasation happens when an anticancer medicine that is normally injected into a vein leaks or is accidentally injected in the tissue surrounding the vein, where it can cause serious damage. 
Do ekstravazacije pride, če se zdravilo proti raku, ki je bilo normalno injicirano v veno, izlije, ali če je nehote injicirano v tkivo, ki obkroža veno, kjer lahko povzroči resne poškodbe.
Why has Savene been approved? 
Zakaj je bilo zdravilo Savene odobreno?
For the full list of all side effects reported with Savene, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Savene, glejte navodilo za uporabo.
The studies looked at how many patients needed surgery to correct the damage due to the extravasation. 
V študijah so proučevali, koliko bolnikov je potrebovalo operacijo za odpravo posledic ekstravazacije.
Dexrazoxane has been in use since the 1990s as a medicine to help prevent the cardiomyopathy (harm to the heart muscle) associated with the use of anthracyclines. 
Deksrazoksan se uporablja od devetdesetih let prejšnjega stoletja kot zdravilo za preprečevanje kardiomiopatije (poškodb srčne mišice), povezane z uporabo antraciklinov.