natgillin/translations-raw huggingface dataset:
The animals were challenged with bluetongue virus serotype 1, after receiving Zulvac 1 Bovis vaccine containing different amounts of virus. 
Živali so izpostavili serotipu 1 virusa bolezni modrega jezika po tem, ko so bile cepljene s cepivom Zulvac 1 Ovis, ki je vsebovalo različne količine virusa.
Other information about Zulvac 1 Ovis: 
Druge informacije o zdravilu Zulvac 1 Ovis:
Zulvac 1 Ovis is a vaccine. 
Zdravilo Zulvac 1 Ovis je cepivo.
What benefit has Zulvac 1 Ovis shown during the studies? 
Kakšne koristi je zdravilo Zulvac 1 Ovis izkazalo med študijami?
The withdrawal period for Zulvac 1 Ovis for meat and milk is zero days. 
Karenca za cepivo Zulvac 1 Ovis za meso in mleko je nič dni.
Zulvac 1 Bovis contains bluetongue virus of one serotype (serotype 1). 
Cepivo Zulvac 1 Ovis vsebuje virus bolezni modrega jezika enega tipa (serotip 1).
Zulvac 1 Ovis is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges. 
Zdravilo Zulvac 1 Ovis se uporablja pri ovcah za zaščito pred boleznijo modrega jezika, tj. okužbo, ki jo povzroča virus modrega jezika, prenašajo pa jo trzače.
This means that it was not possible to obtain complete information about Zulvac 1 Ovis at the time of the initial authorisation. 
To pomeni, da ob prvotni izdaji dovoljenja za promet ni bilo mogoče pridobiti vseh podatkov o cepivu Zulvac 1
What is the risk associated with Zulvac 1 Ovis? 
Kakšna tveganja so povezana z zdravilom Zulvac 1 Ovis?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zulvac 1 Ovis exceed the risks in the prevention of viraemia caused by Bluetongue Virus, serotype 1 in sheep from one and a half months of age. 
CVMP je zaključil, da so pri ovcah, starejših od enega meseca in pol, koristi cepiva Zulvac 1 Ovis pri preprečevanju viremije, ki jo povzroča serotip 1 virusa bolezni modrega jezika, večje od z njim povezanih tveganj.
Why has Zulvac 1 Ovis been approved? 
Zakaj je bilo zdravilo Zulvac 1 Ovis odobreno?
Zulvac 1 Ovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease. 
Cepivo Zulvac 1 Ovis vsebuje inaktiviran virus bolezni modrega jezika, ki ne povzroča bolezni.
The vaccine is used to prevent viraemia (the presence of the viruses in the blood) in sheep from one and a half months of age. 
Cepivo se uporablja za preprečevanje viremije (prisotnosti virusov v krvi) pri ovcah, starejših od enega meseca in pol. Cepivo se mladičem injicira pod kožo v dveh odmerkih.
Inactivated vaccine against Bluetongue disease virus, serotype 1 
Zulvac 1 Ovis inaktivirano cepivo proti virusu modrega jezika, serotip 1
What is Zulvac 1 Ovis? 
Kaj je zdravilo Zulvac 1 Ovis?
How has Zulvac 1 Ovis been studied? 
Kako je bilo zdravilo Zulvac 1 Ovis raziskano?
What is ZULVAC 1 Ovis used for? 
Za kaj se zdravilo Zulvac 1 Ovis uporablja?
How does Zulvac 1 Ovis work? 
Kako zdravilo Zulvac 1 Ovis deluje?
Animals should be re-examined every 6 months during treatment. 
Živali je treba med zdravljenjem vsakih 6 mesecev pregledati.
Dogs (bitches). 
Psi (psice)
See also 4.3 Contraindications. 
Glejte tudi 4.3 Kontraindikacije.
The incidence is about 59 %. 
Pogostnost teh pojavov je približno 5 do 9 %.
Pharmacotherapeutic group: estrogens, ATCvet code: QG03CA04. 
Farmakoterapevtska skupina: estrogeni, oznaka ATCvet: QG03CA04.
SPECIAL WARNINGS, IF NECESSARY Not applicable. 
POSEBNA OPOZORILA, ČE SO POTREBNA Ni smiselno.
11 PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno.
Nearly the whole Estriol is bound to Albumin in Plasma. 
Skoraj ves estriol se veže na albumin v plazmi.
MARKETING AUTHORISATION NUMBER(S) EU/2/00/018/001 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/00/018/001
Date of last renewal: March 2010 
Datum podaljšanja: marec 2010
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 
Če opazite kakršne koli resne neželene učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
B.V. Kloosterstraat 6 5349 AB Oss The Netherlands 
Kloosterstraat 6 5349 AB Oss Nizozemska
The minimum dose given should not be less than 0.5 mg per dog per day. 
Najmanjši odmerek ne sme biti manjši od 0,5 mg na dan na psico.
9 DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: March 2000 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: marec 2000
In the target animal safety study and the clinical trials, including long-term treatment, no signs of bone marrow suppression were observed. 
V študijah varnosti pri ciljni živalski vrsti in kliničnih preskušanjih, tudi pri dolgotrajnem zdravljenju, niso zasledili znakov supresije kostnega mozga.
The dose has to be fixed for each dog on an individual basis. 
Odmerek je treba psicam določiti individualno.
If no response to treatment is obtained the diagnosis should be reconsidered in order to investigate other causes for the incontinence such as neurological disorders, bladder neoplasia, etc. 
Če na zdravljenje ni odziva, moramo ponovno presoditi o diagnozi, da bi odkrili morebitne druge vzroke inkontinence, kot so nevrološke motnje, neoplazija mehurja in druge.
Amylopectin Potato starch Magnesium stearate Lactose 
Amilopektin Krompirjev škrob Magnezijev stearat Laktoza
Do not use after the expiry date which is stated on the label after Exp. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po Exp.
Incurin is intended for once daily oral administration. 
Incurin dajemo enkrat na dan peroralno.
The use of Incurin is contraindicated during pregnancy, lactation and in animals younger than 1 year. 
Uporaba Incurina je kontraindicirana v obdobju brejosti, laktacije in pri živalih, mlajših od 1 leta.
NAME OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V. 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International B.V.
For oral administration. 
Za peroralno dajanje.
Animals showing a polyuria-polydipsia should not be treated with Incurin. 
Živali s sindromom poliurije-polidipsije ne smemo zdraviti z Incurinom.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 
Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
Further, in some dogs, symptoms of nausea were observed. 
Pri nekaterih psicah so se pojavili simptomi slabosti.
In rare cases development of alopecia has also been observed. 
Zasledili so še redke primere razvoja alopecije.
PHARMACEUTICAL FORM Tablet. 
FARMACEVTSKA OBLIKA Tableta
Ensure the dose used to achieve the therapeutic effect is as low as possible. 
Terapevtski učinek je treba doseči s čim manjšim odmerkom.
Estriol is excreted in conjugated from via the urine. 
Estriol se izloča v konjugirani obliki z urinom.
A relationship between final effective dose and body weight has not been established and therefore the dose has to be determined for each dog on an individual basis. 
Razmerje med končnim učinkovitim odmerkom in telesno maso ni določeno, zato moramo ustrezen odmerek določiti individualno.
Since there exists no relation between the final effective dose and the body weight, a fixed dose per kg body weight is not feasible. 
Ker med končnim učinkovitim odmerkom in telesno maso ni povezave, fiksnega odmerka na kilogram telesne mase ne moremo določiti.
High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary glands). 
Veliki odmerki estrogena lahko spodbudijo rast tumorja na ciljnih organih z estrogenskimi receptorji (mlečna žleza).
One blister contains 30 tablets. 
En pretisni omot vsebuje 30 tablet.
Dog. 
Pes
Estriol is a short-acting natural oestrogen. 
Estriol je kratkodelujoči naravni estrogen.
ADVICE ON CORRECT ADMINISTRATION Not applicable. 
NASVET O PRAVILNI UPORABI ZDRAVILA Navedba ni smiselna.
This is probably due to the short-acting oestrogenic character of estriol. 
To je verjetno posledica kratkotrajnega estrogenega učinka estriola.
Name and address of the manufacturer(s) of the biological active substance(s) 
Ime in naslov izdelovalca(izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin).
The following dosing schedule is advised: start treatment with 1 tablet (1 mg estriol) every day. 
Priporočena shema odmerjanja: zdravljenje začnemo z 1 tableto (1 mg estriola) na dan.
MANUFACTURER'S BATCH NUMBER Batch number. 
IZDELOVALČEVA ŠTEVILKA SERIJE Številka serije
The following dosing schedule is advised: start treatment with 1 tablet every day. 
Priporočena shema odmerjanja: zdravljenje začnemo z 1 tableto na dan.
6.5 Nature and composition of immediate packaging Blister package of clear PVC film backed by aluminium foil provided with heat seal coating (vinyl copolymer) on the side in contact with the tablets. 
Pretisni omot iz prozornega filma iz pvc in aluminijaste folije s toplotno zavarjeno oblogo (kopolimer vinila) na strani, ki je v stiku s tabletami.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ, ČE STA RAZLIČNA
Do not use more than 2 tablets per dog per day. 
Dnevni odmerek naj ne prekorači 2 tablet na dan na psico.
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only - to be supplied only on veterinary prescription. 
BESEDILO “SAMO ZA ŽIVALI” Samo za živali - na veterinarski recept.
Each strip is packed in a carton box. 
Po en trak je pakiran v zloženki.
In rare cases vaginal bleeding occurred. 
Redko se je pojavila krvavitev iz nožnice.
PACKAGE SIZE Carton box with 1 blister. 
VELIKOST PAKIRANJA Zloženka z 1 pretisnim omotom.
Some dogs do not need daily treatment; treatment every other day may be tried once the effective daily dose has been established. 
Nekatere psice zdravila ne potrebujejo vsak dan; ko določimo učinkovit dnevni odmerek, lahko zdravilo poskusimo dajati vsak drugi dan.
These effects are reversible after lowering the dose. 
Ti učinki minejo, če odmerek zmanjšamo.
STATEMENT OF ACTIVE AND OTHER SUBTANCES Active substance: estriol 1 mg/tablet 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Zdravilna učinkovina: estriol, 1 mg v 1 tableti
EXPIRY DATE (Month / year) 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA (Mesec/leto)
In ovarioectomised female dogs it has a beneficial effect on urinary incontinence. 
Pri psicah po ovariohisterektomiji ima ugoden učinek na urinsko inkontinenco.
After oral administration of multiple doses no accumulation occurs. 
Po večkratnem peroralnem dajanju ne prihaja do kopičenja.
In the incontinent female dog it has a beneficial effect on the urinary incontinence. 
Pri psicah z inkontinenco ima ugoden učinek na urinsko inkontinenco.
EXPIRY DATE Exp (Month / year) 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Exp {mesec/leto}
Do not use in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches. 
Zdravila ne smemo uporabljati pri psicah, pri katerih ovariohisterektomija ni bila opravljena, ker je učinkovitost zdravila dokazana samo pri psicah po ovariohisterektomiji.
4.7 Use during pregnancy, lactation or lay 
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Zdravila ne uporabite v obdobju brejosti ali laktacije.
4.2 Indications for use, specifying the target species The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches. 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zdravljenje hormonsko odvisne urinske inkontinence, ki je posledica nepravilnega delovanja sfinkterskega mehanizma pri psicah po ovariohisterektomiji.
Name and address of the manufacturer(s) responsible for batch release 
Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega za sproščanje serije
In case of overdose typical oestrogen effects may occur. 
Preveliki odmerki lahko imajo značilne estrogene učinke.
4.9 Amount(s) to be administered and administration route 
4.9 Odmerjanje in pot uporabe
After oral administration Estriol is nearly completely absorbed from gastrointestinal tract. 
Estriol se po peroralnem dajanju iz prebavil skoraj povsem absorbira.
1 mg/tablet For a full list of excipients, see section 6.1 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna učinkovina: estriol, 1 mg v eni tableti Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Incurin is indicated for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs. 
Incurin je indiciran za zdravljenje hormonsko odvisne urinske inkontinence, ki je posledica nepravilnega delovanja sfinkterskega mehanizma pri psicah.
If treatment is not successful, increase the dose to 2 tablets a day to be given in one dose. 
Če zdravljenje ni uspešno, odmerek povečamo na 2 tableti na dan, ki ju dajemo hkrati.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
PACKAGE LEAFLET INCURIN 1 mg tablet 
NAVODILO ZA UPORABO INCURIN 1 mg, tableta
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
PHARMACEUTICAL FORM Round single-scored tablets 
FARMACEVTSKA OBLIKA Okrogle tablete z zarezo na eni strani.
STATEMENT OF THE MRLs Not applicable. 
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Ni smiselno.
ANNEX II A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
6.1 Seznam pomožnih snovi
If treatment is successful, lower the dose to half a tablet a day. 
Če je učinkovito, odmerek zmanjšamo na polovico tablete na dan.
MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE BLISTER 
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI PRETISNI OMOT
If treatment is successful lower the dose to half a tablet a day. 
Če je zdravljenje s tem odmerkom učinkovito, ga zmanjšamo na polovico tablete na dan.
1 mg/tablet 
INCURIN 1 mg, tableta
Because of its short acting action, oestriol does not induce bone marrow suppression in the dog. 
Zaradi kratkotrajnega delovanja estriol pri psicah ne povzroča supresije kostnega mozga.
In case of oestrogenic effects, the dose should be lowered. 
Posebni previdnostni ukrepi za uporabo pri živalih Če se pojavijo estrogeni učinki, moramo zmanjšati odmerek.
BATCH NUMBER Batch number. 
ŠTEVILKA SERIJE Številka serije
OTHER INFORMATION Each push-through strip contains 30 tablets. 
Pretisni trak vsebuje 30 tablet.
To be supplied only on veterinary prescription 
Na veterinarski recept.
Treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs. 
Zdravljenje hormonsko odvisne urinske inkontinence, ki je posledica nepravilnega delovanja sfinkterskega mehanizma pri psicah
Mild, oestrogenic effects such as swollen vulva, swollen teats and/or attractiveness for males have been observed at the high dose of 2 mg. 
Po dajanju velikega odmerka, po 2 mg, so zasledili blage, estrogene učinke, kot so nabrekanje zunanjih spolovil, nabrekanje mlečnih žlez ali privlačnost za samca.
Pack size: carton box with 1 blister 
Velikost pakiranja: škatla z enim pretisnim omotom.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children. 
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM'' Zdravilo shranjujte nedosegljivo otrokom.
Because of its short-acting oestrogenic properties, Incurin does not induce bone marrow suppression in the dog. 
Incurin zaradi kratkotrajnega estrogenega učinka pri psicah ne povzroča supresije kostnega mozga.
Oestrogenic effects such as swollen vulva, swollen mammary glands and/or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog. 
Po dajanju največjega priporočenega odmerka, ki je 2 mg na psico, so zasledili estrogene učinke, kot so nabrekla zunanja spolovila, nabrekle mlečne žleze ali privlačnost za samca, in bljuvanje.
Upon oral administration a steady state is reached after the second treatment day and no accumulation occurs after multiple dosing. 
Pri peroralnem dajanju se ravnovesno stanje vzpostavi po dveh dneh zdravljenja.
D. STATEMENT OF THE MRLs 
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL)
The dose you will receive is decided by your doctor. 
Odmerek, ki ga boste prejeli, bo določil vaš zdravnik.
Haematological monitoring is thus necessary. 
Zato je potrebno hematološko spremljanje.
This substance belongs to a group of medicines which protect the heart (cardioprotective medicines). 
Ta snov sodi v skupino zdravil, ki ščitijo srce (kardioprotektivna zdravila).
If any of the above apply, you must not be given this medicine. 
Če karkoli od navedenega velja za vas, ne smete prejeti tega zdravila.
There is no specific antidote and symptomatic treatment should be provided. 
Specifičnega antidota ni in treba je poskrbeti za simptomatsko zdravljenje.
The plasma concentrations declined thereafter with an average half-life value of 2.2 ± 1.2 hours. 
Koncentracija v plazmi se je nato zniževala s povprečnim razpolovnim časom 2,2 ± 1,2 ure.
The difference was not statistically significant and no consistent cause was apparent, however a contribution of dexrazoxane to the difference cannot be ruled out. 
Razlika ni bila statistično pomembna in zanjo ni bilo mogoče odkriti enotnega vzroka, vendar vpletenosti deksrazoksana v nastanek te razlike ni mogoče izključiti.
If you get any of the above, tell your doctor straight away or go to the nearest emergency unit. 
Če opazite karkoli od navedenega, takoj obvestite zdravnika ali pa pojdite na najbližji urgentni oddelek.
Method of administration Intravenous use. 
Način uporabe Intravenska uporaba.
• Of these 76% were treated for breast cancer and 24% for a variety of advanced cancers. 
• med njimi se jih je 76 % zdravilo zaradi raka dojke, 24 % pa zaradi napredovale oblike različnih drugih vrst raka,
The majority of controlled clinical studies were performed in patients with advanced breast cancer. 
Večino kontroliranih kliničnih študij so izvajali pri bolnikih z napredovalim rakom dojke.
You may experience some of the side effects listed in section 4, “Possible side effects”. 
Lahko pride do nekaterih neželenih učinkov, ki so našteti v poglavju 4 “Možni neželeni učinki”.
Patients receiving chemotherapy alone (n=157) 
Bolniki, ki so prejemali samo kemoterapijo (n=157)
There are no adequate data from the use of dexrazoxane in pregnant women. 
Ustreznih podatkov o uporabi deksrazoksana pri nosečnicah ni.
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: very common ( 1/10); common ( 1/100 to  1/10); uncommon ( 1/1,000 to  1/100); not known (cannot be estimated from the available data). 
Neželeni učinki so razvrščeni po skupinah glede na pogostost, in sicer od najbolj do najmanj pogostih, pri čemer je uporabljen tale dogovor: zelo pogosti ( 1/10); pogosti ( 1/100 do  1/10); občasni ( 1/1.000 do  1/100); pogostnost neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6. 
Za navodila glede rekonstitucije in raztapljanja pred apliciranjem zdravila glejte poglavje 6.6.
Animal studies showed embryotoxic and teratogenic effects (see section 5.3). 
Študije na živalih so pokazale embriotoksično in teratogeno delovanje (glejte poglavje 5.3).
An increased risk of the development of second primary malignancies, particularly AML, has been reported. 
Poročali so o povečanem tveganju za razvoj drugih primarnih rakov, zlasti AML.
How {(Invented) Name} is given to you This medicine is prepared and given to you by your doctor or other medical staff. 
Kako boste prejemali zdravilo {(Lastniško) ime} Zdravilo bo pripravil in vam ga dal vaš zdravnik ali kdo drug izmed zdravstvenega osebja.
• If you are pregnant or plan to become pregnant (see also “Pregnancy and breast-feeding”). 
• če ste noseči ali nameravate zanositi (glejte tudi “Nosečnost in dojenje”),
{(Invented) Name} and its metabolites were detected in the plasma and urine of animals and man. 
Zdravilo {(Lastniško) ime} in njegove presnovke so zaznali v plazmi in urinu pri živalih in pri ljudeh.
A single high dose is better tolerated than the same dose administered several times a day. 
Bolniki bolje prenašajo en sam visok odmerek kot pa isti odmerek, razdeljen na več odmerkov preko dneva.
The total urinary excretion of unchanged dexrazoxane is in the order of 40%. 
Celotno izločanje nespremenjenega deksrazoksana z urinom je reda velikosti 40 %.
Therefore if you feel sleepy, do not drive or use machines. 
Iz tega razloga ne vozite in ne uporabljajte strojev, če ste zaspani.
{(Invented) Name} should not be used during pregnancy unless clearly necessary. 
Zdravila{(Lastniško) ime} ne smete uporabljati pri nosečnicah, razen če je to nedvomno potrebno.
The apparent volume of distribution is 44.0 ± 3.9 l, suggesting that dexrazoxane distributes mainly in the total body water. 
Navidezni volumen porazdelitve je 44,0 ± 3,9 l, kar nakazuje, da se deksrazoksan porazdeli večinoma v celotni telesni vodi.
Like all medicines, {(Invented) Name} can have side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo {(Lastniško) ime} neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
• All were treated for breast cancer 
• Vsi bolniki so se zdravili zaradi raka dojke.
QUALITATIVE AND QUANTITATIVE COMPOSITION [To be completed nationally] 
KAKOVOSTNA IN KOLIČINSKA SESTAVA [izpolni država članica]
Due to the spontaneous nature of post-marketing reporting, such events are listed with frequency “not known” if they were not already identified as reactions from clinical trials. 
Ker gre v obdobju trženja zdravila za spontano poročanje, so tovrstni dogodki v preglednici navedeni pod oznako “pogostnost neznana”, če jih niso kot neželene učinke ugotovili že prej v kliničnih preskušanjih.
This will start approximately 30 minutes before your cancer treatment (doxorubicin and/or epirubicin). 
Zdravilo boste začeli prejemati približno 30 minut pred prejemom zdravil proti raku (doksorubicina in/ali epirubicina).
WHAT {(Invented) Name} IS AND WHAT IT IS USED FOR 
KAJ JE ZDRAVILO {LASTNIŠKO IME} IN ZA KAJ GA UPORABLJAMO
Data from adults treated in 8 controlled randomised clinical studies have been reviewed, 780 patients received dexrazoxane plus chemotherapy and 789 received chemotherapy alone. 
Pregledali so podatke odraslih bolnikov, ki so jih zdravili v 8 kontroliranih randomiziranih kliničnih študijah, 780 bolnikov je prejemalo deksrazoksan in kemoterapijo, 789 pa jih je prejemalo le kemoterapijo.
Both dexrazoxane (ICRF-187) and ICRF-198 are capable of chelating metal ions. 
Tako deksrazoksan (ICRF-187) kot tudi ICRF-198 lahko kelirata kovinske ione.
• If you have or have had liver or kidney problems. 
• če imate ali ste imeli kdaj prej težave z jetri ali ledvicami,
Effects on CYP450 enzymes or drug transporters have not been studied. 
Vpliva na encime CYP450 in transportne proteine niso proučevali.