natgillin/translations-raw huggingface dataset:
- If the medicine is not used immediately, it should be kept at a temperature of 2 to 8 °C (in the refrigerator) and no longer than 4 hours. 
- Če zdravila ne uporabite takoj, shranjevanje ne sme biti daljše od 4 ur pri temperaturi od 2 do
Savene is supplied as: 
FORMULACIJA Zdravilo je na voljo kot:
Because of the potential for serious adverse reactions in breast-fed infants exposed to dexrazoxane, breast-feeding is contraindicated during Savene therapy (see section 4.3). 
Zaradi potencialno resnih neželenih učinkov pri dojenih dojenčkih, ki so izpostavljeni deksrazoksanu, je dojenje med zdravljenjem z zdravilom
Savene contains the active substance dexrazoxane, which acts as an antidote to anti-cancer medicines called anthracyclines. 
Kaj je zdravilo Savene in za kaj ga uporabljamo Zdravilo Savene vsebuje učinkovino deksrazoksan, ki deluje kot antidot (protistrup) proti antraciklinom, ki se uporabljajo za zdravljenje raka.
Signs and symptoms of overdosage are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea, skin reactions and alopecia. 
Znaki in simptomi prevelikega odmerjanja so verjetno levkopenija, trombocitopenija, slabost,
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after dilution with concentrate. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Intravenska uporaba po redčenju koncentrata v vehiklu.
Note that in these studies dexrazoxane was administered prior to anthracyline administration. 
Upoštevati je potrebno, da so osebe v teh raziskavah prejele deksrazoksan pred antracilinom.
3.1.4 Allow the vial with the concentrate to stand for 5 minutes at room temperature and check if the solution is homogenous and clear. 
3.1.4 Viala s koncentratom naj stoji 5 minut pri sobni temperaturi.
Dizziness, somnolence and syncope have been reported in a few patients included in Savene studies TT01 and TT02 (see section 4.8). 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Pri nekaterih bolnikih, ki so bili vključeni v preučevanje zdravila Savene (študiji TT01 in TT02), so poročali o omotici, somnolenci in sinkopi (glej poglavje 4.8).
Each vial contains 500 mg dexrazoxane as 589 mg dexrazoxane hydrochloride. 
Ena viala vsebuje 500 mg deksrazoksana v obliki 589 mg deksrazoksanovega klorida.
Savene contains potassium and sodium 
Vsebnost kalija in natrija
ALT 
brez
Dyspnoea Pneumonia 
Pljučnica
Contents of the pack and other information 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Savene
Dexrazoxane has been shown to possess mutagenic activity. 
Dokazano je bilo, da je deksrazoksan mutagen.
sudden fainting 
Okvara jeter
• Swelling in arms or legs (oedema) 
• otekanje rok in nog (edem),
Day 2: 1000 mg/m2 
Drugi dan: 1.000 mg/m2 Tretji dan:
Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Sodium gluconate, Sodium hydroxide, Water for injections. 
natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev acetat trihidrat, natrijev glukonat, natrijev hidroksid, voda za injekcije
Superficial thrombophlebitis Venous thrombosis limb 
Pogosti površinski tromboflebitis
You must not breast-feed while you are treated with Savene. 
Med zdravljenjem z zdravilom Savene ne dojite.
STATEMENT OF ACTIVE SUBSTANCE(S) 
SEZNAM POMOŽNIH SNOVI Pomožne snovi - prašek Savene:
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for concentrate for solution for infusion 10 vials of 500 mg dexrazoxane 3 bottles of 500 ml solvent and 3 bottle hangers Emergency kit for the treatment of anthracycline extravasation 
prašek in vehikel za koncentrat za raztopino za infundiranje 10 vial s 500 mg deksrazoksana.
PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion. 
prašek in vehikel za koncentrat za raztopino za infundiranje
There is limited information about the effect of Savene on fertility - if you have a concern about this speak to you doctor. 
Na voljo so omejeni podatki o učinku zdravila Savene na plodnost.
• Inflammation in the mouth 
• krvavitev iz nožnice,
Very common 
Zelo pogosti slabost
Savene will be given by infusion into one of your veins. 
Zdravilo Savene se daje z infuzijo v veno.
Previous history of allergy to dexrazoxane should be carefully considered prior to administration (see section 4.3). 
Pred uporabo deksrazoksana je treba skrbno preveriti, ali ima bolnik alergijo na deksrazoksan v anamnezi (glejte poglavje 4.3).
Hepatic and renal-function monitoring 
Spremljanje delovanja jeter in ledvic.
Keep vials and bottles in the outer carton in order to protect from light. 
Viale in steklenice shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Marketing Authorisation Holder and Manufacturer 
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilo
Savene is an anti-cancer agent and the normal procedures for proper handling and disposal of anticancer medicines should be adopted, namely: - Personnel should be trained to reconstitute the medicine - Pregnant staff should be excluded from working with this medicine - Personnel handling this medicine during reconstitution should wear protective clothing including mask, goggles and gloves - Accidental contact with the skin or eyes should be treated immediately and thoroughly with copious amounts of water 
- Noseče zdravstvene delavke ne smejo delati s tem zdravilom - Osebe, ki pripravljajo zdravilo, morajo nositi zaščitna oblačila, vključno z zaščitno masko,
Injection site induration Injection site swelling Peripheral oedema Somnolence 
Pireksija flebitis na mestu injiciranja eritem na mestu injiciranja, utrujenost induracija na mestu injiciranja, oteklina na mestu injiciranja, periferni edem, somnolenca
respectively. 
Savene.
Excipients Savene powder: None 
Viala s praškom brez
Anaphylactic reaction including angioedema, skin reactions, bronchospasm, respiratory distress, hypotension and loss of consciousness have been observed in patients treated with dexrazoxane and anthracyclines (see section 4.8). 
Pri bolnikih, zdravljenih deksrazoksanom in antraciklini, so opazili anafilaktične reakcije, vključno z angioedemom, kožnimi reakcijami, bronhospazmom, dihalno stisko, hipotenzijo in izgubo zavesti
Do not use Savene: - If you are allergic to dexrazoxane or any of the other ingredients of this medicine (listed in section 6) - If you are planning to become pregnant and do not use adequate contraceptive measures - If you are breast-feeding - If you are given yellow-fever vaccine 
- če načrtujete zanositev in ne uporabljate ustrezne kontracepcije - če dojite - če ste prejeli cepivo proti rumeni mrzlici
Injection site pain 
Zelo pogosti bolečine na mestu injiciranja
Dexrazoxane may cause foetal harm when administered to pregnant women. 
Uporaba deksrazoksana pri nosečnicah lahko škoduje plodu.
Savene is indicated in adults for the treatment of anthracycline extravasation. 
4.1 Terapevtske indikacije Zdravilo Savene je indicirano za zdravljenje antraciklinske ekstravazacije pri odraslih.
- Keep the powder vials and solvent bottles in the outer carton in order to protect from light. 
- Viale s praškom in steklenice z vehiklom shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Preparation guide for use with Savene 20 mg/ml powder and solvent for concentrate for solution for infusion 
Navodilo za pripravo zdravila Savene 20 mg/ml prašek in vehikel za koncentrat za raztopino za infundiranje
Chemical and physical in-use stability has been demonstrated for 4 hours when stored at 2 to 8 °C. 
Dokazana je bilo da, je pripravljena raztopina pri temperaturi 2 do 8 °C kemijsko in fizikalno stabilna 4 ure.
PHARMACEUTICAL FORM AND CONTENTS 500 ml solvent 
500 ml vehikla
Keep the powder vials and solvent bottles in the outer carton in order to protect from light. 
Viale s praškom in steklenice z vehiklom shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
The concentrate contains 20 mg dexrazoxane per ml and should be used immediately for further dilution. 
Koncentrat vsebuje 20 mg deksrazoksana na ml.
NAME OF THE MEDICINAL PRODUCT Solvent for Savene 
Vehikel zdravila Savene
• Dexrazoxane may add to the toxicity induced by the chemotherapy cycle during which the accident took place, requiring careful monitoring of haematological parameters (see section 4.4). 
• Deksrazoksan lahko prispeva k toksičnim učinkom, ki jih sproži cikel kemoterapije, med katerim je prišlo do dogodka.
4.1 Before reconstitution and dilution: - Store below 25 °C. 
SHRANJEVANJE 4.1 Pred rekonstitucijo in redčenjem:
Savene 20 mg/ml powder and solvent for concentrate for solution for infusion Dexrazoxane 
Savene 20 mg/ml praška za koncentrat deksrazoksan
Most common adverse reactions are nausea/vomiting, bone marrow suppression (neutropenia, thrombocytopenia), injection site reactions, diarrhoea, stomatitis and increase in hepatic transaminases (ALT/AST). 
supresija kostnega mozga (nevtropenija, trombocitopenija), reakcije na mestu injiciranja, driska,
STORAGE 
Starostniki
Batch 
Trombociti
Decreased appetite 
Presnovne in prehranske motnje Pogosti zmanjšan apetit
Vascular disorders 
Organski sistemi
< PC: {number} [product code] 
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI <PC: {številka}
Dizziness, tiredness and sudden fainting have been reported in a few patients treated with Savene. 
Vpliv na sposobnost upravljanja vozil in strojev Pri nekaterih bolnikih, zdravljenih z zdravilom Savene, so poročali o omotici, utrujenosti in nenadni omedlevici.
Your doctor may reduce your dose if you have kidney problems. 
Če imate težave z ledvicami, vam lahko zdravnik zniža odmerek.
Vaginal haemorrhage 
Hemoglobin Levkociti Nevtrofilci
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SOLVENT BOTTLE 
Izgled zdravila Savene in vsebina pakiranja kompleta za nujno uporabo
NAME OF THE MEDICINAL PRODUCT Savene 20 mg/ml powder and solvent for concentrate for solution for infusion dexrazoxane 
Navodilo za uporabo Savene 20 mg/ml prašek in vehikel za koncentrat za raztopino za infundiranje deksrazoksan
Wound complication 
Pogosti zapleti ran
NAME OF THE MEDICINAL PRODUCT Savene 20 mg/ml powder and solvent for concentrate for solution for infusion. 
Savene 20 mg/ml prašek in vehikel za koncentrat za raztopino za infundiranje.
Pregnancy, breast-feeding and fertility 
bruhanje, driska, kožne reakcije in alopecija.
Haemoglobin WBC 
1118BJ Schiphol Nizozemska
EU (MA) number Invented name Strength Pharmaceutical form Target species Route of administration Packaging Content Package size Withdrawal period 
EU (MA) številka Izmišljeno ime Jakost Farmacevtska oblika Ciljna živalska vrsta Način uporabe Pakiranje Vsebina Velikost pakiranja Karenca
More about Semler 
Več o družbi Semler
More about the medicines covered by this review 
Več o zdravilih, ki so zajeta v ta pregled
Therefore national authorities can temporarily postpone the suspension in the interest of patients. 
Zato lahko nacionalni organi začasni umik začasno preložijo, saj je to v interesu bolnikov.
The review of Semler was initiated on 28 April 2016 at the request of Denmark, Germany, the Netherlands, Spain and the United Kingdom under Article 31 of Directive 2001/83/EC. 
Pregled družbe Semler se je začel 28. aprila 2016 na zahtevo Danske, Nemčije, Nizozemske, Španije in Združenega kraljestva v skladu s členom 31 Direktive 2001/83/ES.
Thus, no medicines can be approved on the basis of these studies. 
Zato na podlagi teh študij ni mogoče odobriti nobenega zdravila.
Member States should also decide whether recalls of the affected medicines are needed in their territories. 
Države članice se morajo odločiti tudi, ali je na njihovem ozemlju potreben odpoklic zadevnih zdravil.
• Patients should continue to take their medicines as prescribed and contact their doctors in case of questions or concerns. 
• Bolniki morajo še naprej jemati svoja zdravila, kot jim je bilo predpisano, in se posvetovati z zdravnikom, če imajo kakršna koli vprašanja ali pomisleke.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 22 September 2016. 
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 22. septembra 2016 izdala končni pravno zavezujoč sklep, ki velja za vse države članice EU.
• National authorities in the EU will consider how critical individual medicines are in their countries and make final decisions on whether to suspend or allow them to remain available, while new data are generated. 
• Nacionalni organi v EU bodo presodili, kako kritično pomembna so posamezna zdravila v njihovih državah, in podali končne odločitve o začasnem umiku ali ohranitvi dovoljenja za promet z zdravilom, medtem ko bo potekalo pridobivanje novih podatkov.
Some of the medicines which have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in a given EU Member State. 
Nekatera zdravila s priporočilom za začasni umik dovoljenja za promet so v določenih državah članicah EU morda kritičnega pomena (npr. zaradi pomanjkanja drugih razpoložljivih možnosti).
The list of medicines recommended to remain on the market can be found here. 
Seznam zdravil, ki po priporočilu lahko ostanejo na trgu, je na voljo tukaj.
During the evaluation, alternative studies were provided for some of these medicines. 
Med vrednotenjem so bile za nekatera od teh zdravil predložene druge študije.
The CHMP's recommendation concerning these medicines was sent to the European Commission for a legally binding decision valid throughout the EU. 
Priporočilo odbora CHMP o teh zdravilih je bilo poslano Evropski komisiji v sprejetje pravno zavezujočega sklepa, ki bo veljal v vsej EU.
These studies show bioequivalence, and therefore, the CHMP recommended that these medicines can remain on the market. 
Te študije dokazujejo biološko enakovrednost, zato je odbor CHMP priporočil, da ta zdravila lahko ostanejo na trgu.
• There is currently no evidence of unexpected harm or lack of effectiveness with any medicine approved on the basis of studies conducted at Semler. 
• Trenutno ni dokazov o nepričakovani škodljivosti ali pomanjkanju učinkovitosti za katero koli od zdravil, odobrenih na podlagi študij, opravljenih v družbi Semler.
Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu http://www.who.int/prequal 
Tel. +44 (0)20 3660 8427 E-naslov: press@ema.europa.eu http://www.who.int/prequal
The review covered medicines authorised via national procedures in individual EU Member States, whose marketing authorisation applications included data from Semler's bioanalytical site (Semler Research Center Private Ltd, 75A, 15th Cross, 1st Phase, JP Nagar, Bangalore 560 078, Karnataka, India) and from Semler's clinical site (PA Arcade, #21, 22, 23, Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, India). 
Pregled je zajel zdravila, ki so dovoljenje za promet prejela po nacionalnem postopku v posameznih državah članicah EU, njihove vloge za pridobitev dovoljenja za promet pa so vključevale podatke z bioanalitskega mesta družbe Semler (Semler Research Center Private Ltd, 75A, 15th Cross, 1st Phase, JP Nagar, Bangalore 560 078, Karnataka, Indija) in s kliničnega mesta družbe Semler (PA Arcade, #21, 22, 23, Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, Indija).
This is because during this review, alternative studies from different sources were provided that show bioequivalence. 
Med tem pregledom so bile namreč predložene druge študije iz različnih virov, ki dokazujejo biološko enakovrednost.
Semler is a contract research organisation (CRO) with an analytical and a clinical site located in Bangalore, India. 
Družba Semler je pogodbena raziskovalna organizacija z analitskim in kliničnim mestom v Bangaloreju v Indiji.
• Generic medicines containing abacavir/lamivudine (used to treat HIV), which were approved on the basis of studies conducted at Semler, can remain on the market in the EU. 
• Generična zdravila, ki vsebujejo abakavir/lamivudin (ki se uporabljajo za zdravljenje okužbe z virusom HIV), odobrena na podlagi študij, opravljenih v družbi Semler, lahko ostanejo na trgu v EU.
The Agency also recommended that medicines being evaluated for authorisation and which rely only on bioequivalence studies from this site should not be authorised until bioequivalence is demonstrated using alternative data. 
Agencija je priporočila tudi, da zdravila, ki so trenutno v postopku vrednotenja za pridobitev dovoljenja za promet in so podprta samo s študijami biološke enakovrednosti, opravljenimi na tem mestu, ne smejo pridobiti dovoljenja za promet, dokler se biološka enakovrednost ne dokaže z drugimi podatki.
The findings from FDA and WHO inspections called into question the quality management system in place at Semler, and thus the reliability of the data of all bioequivalence studies, including those used to support marketing authorisation applications in the EU. 
Izsledki inšpekcijskih pregledov agencije FDA in organizacije SZO so pod vprašaj postavili vzpostavljeni sistem za upravljanje kakovosti v družbi Semler in posledično zanesljivost podatkov vseh študij biološke enakovrednosti, vključno s tistimi, ki podpirajo vloge za pridobitev dovoljenj za promet z zdravili v EU.
On 21 July 2016, the European Medicines Agency (EMA) recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India. 
Evropska agencija za zdravila (EMA) je 21. julija 2016 priporočila začasni umik dovoljenj za promet z več zdravili, ki so dovoljenje pridobila po nacionalnem postopku, pri katerih so bile študije biološke enakovrednosti opravljene v družbi Semler Research Centre Private Ltd v Bangaloreju v Indiji.
EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that the studies conducted at Semler cannot be accepted in marketing authorisation applications in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA je zaključil, da študije, opravljene v družbi Semler, pri vlogah za pridobitev dovoljenj za promet z zdravili v EU niso sprejemljive.
Bioequivalence studies performed at the site cannot be used to support medicines approval in the EU 
Študij biološke enakovrednosti, opravljenih na tem mestu, ni mogoče uporabiti v podporo odobritvam zdravil v EU
These sites conduct the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU. 
Na teh mestih opravljajo analitski in klinični del študij biološke enakovrednosti, od katerih so nekatere uporabljene v podporo vlogam za pridobitev dovoljenj za promet z zdravili v EU.
• A number of medicines for use in the EU rely on studies carried out at the Semler site in India. 
• Številna zdravila, ki se uporabljajo v EU, so podprta s študijami, opravljenimi v družbi Semler v Indiji.
The Semler site also performs bioequivalence studies for some medicines authorised in the US and medicines included in the WHO prequalification programme3. 
Družba Semler opravlja tudi študije biološke enakovrednosti za nekatera zdravila, ki imajo dovoljenje za promet v ZDA, in zdravila, vključena v prekvalifikacijski program SZO3.
• Medicines that have been suspended can have their suspension lifted if the companies provide alternative data demonstrating bioequivalence. 
• Za preklic začasnega umika dovoljenja za promet z zdravili, katerih dovoljenje za promet je bilo začasno umaknjeno, morajo družbe predložiti druge podatke, ki dokazujejo biološko enakovrednost.
EMA's review followed an FDA inspection1 that identified several issues at Semler's bioanalytical site, including the substitution and manipulation of subjects' clinical samples. 
Pregled agencije EMA je sledil inšpekcijskemu pregledu agencije FDA1, s katerim so na bioanalitskem mestu družbe ugotovili več pomanjkljivosti, vključno z zamenjevanjem in manipulacijo kliničnih vzorcev preiskovancev.
It also included ongoing marketing authorisation applications for medicines which use study data from these sites. 
Pregled je vključeval tudi trenutno obravnavane vloge za pridobitev dovoljenj za promet z zdravili, v katerih so uporabljeni podatki z omenjenih mest.
No generic medicine authorised centrally via EMA was tested in these sites. 
Na teh mestih ni bilo preskušeno nobeno generično zdravilo, ki je dovoljenje za promet pridobilo po centraliziranem postopku prek agencije EMA.
The studies, called ‘bioequivalence' studies, are usually the basis for approving generic medicines. 
Te študije, imenovane študije „biološke enakovrednosti“, so običajno podlaga za pridobitev dovoljenja za promet za generična zdravila.
Bioequivalence studies usually form the basis for approval of generic medicines. 
Študije biološke enakovrednosti so običajno podlaga za pridobitev dovoljenja za promet za generična zdravila.
The World Health Organization (WHO) also raised serious concerns2 regarding data integrity and manipulation of study samples following its own inspections of Semler's bioanalytical and clinical sites. 
Svetovna zdravstvena organizacija (SZO) je po lastnem inšpekcijskem pregledu bioanalitskih in kliničnih mest družbe Semler prav tako izpostavila resne pomisleke2 o integriteti podatkov in manipulaciji vzorcev iz študij.
• The bioequivalence studies performed at the Semler site have been found to be flawed, so they cannot be relied on. As a result, several medicines approved in the EU have been suspended. 
• Ugotovljeno je bilo, da so študije biološke enakovrednosti, opravljene v družbi Semler, prirejene, zato niso zanesljive.
• Medicines still under evaluation cannot be granted authorisation in the EU on the basis of studies conducted at Semler; further data would have to be provided to support authorisation. 
• Zdravila v postopku vrednotenja ne morejo pridobiti dovoljenja za promet v EU na podlagi študij, opravljenih v družbi Semler.
The application was withdrawn in Germany, Norway and Spain, but the procedure was positively ended in all other Member States on 7 March 2003. 
Prijava je bila umaknjena v Nemčiji, na Norveškem in v Španiji, vendar je bil postopek pozitivno izpeljan v vseh drugih državah članicah, dne 7. marca 2003.
09 August 2005 EMEA/CHMP/145829/2005 
9. avgust 2005 EMEA/CHMP/145829/2005
The final opinion was converted into a Decision by the European Commission on 09 August 2005. 
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 9. avgusta 2005.
OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Crestor 5 mg 
MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2)1 ZA Crestor 5 mg
The Rapporteur and Co-Rapporteur appointed were Dr P. Nilsson and Dr. G. Calvo, respectively. 
Poročevalec je bil Dr. P Nilsson in soporočevalec Dr. G. Calvo.
Written explanations were provided by the Marketing Authorisation Holder on 07 February 2005. 
Pisna pojasnila je predložil imetnik dovoljenja za promet, dne 7. februarja
The arbitration procedure started on 18 November 2004. 
Postopek obravnave se je pričel 18. novembra 2004.
International Non-Proprietary Name (INN): Rosuvastatin calcium 
Mednarodno nelastniško ime (INN): Rosuvastatin v obliki kalcijeve soli
On the basis of the marketing authorisation for Crestor (5 mg) granted by The Netherlands, on 21 July 2004 the applicant submitted an application for Mutual Recognition to 13 Concerned Member States. 
Na osnovi dovoljenja za promet za zdravilo Crestor (5 mg), ki ga je dodelila Nizozemska dne 21. julija 2004, je prosilec trinajstim zadevnim državam članicam vložil prošnjo za medsebojno priznavanje.
The main issue during the procedure was whether the 5 mg strength should be the recommended start dose for all patients. 
Glavno vprašanje v toku postopka je bilo, ali naj bi bila jakost 5 mg priporočeni začetni odmerek za vse bolnike.