natgillin/translations-raw huggingface dataset:
It works by increasing the elimination of salt and water in the urine. 
Deluje tako, da poveča izločanje soli in vode z urinom.
UpCard is given once daily, with or without food, with the dose adjusted to produce the required effect. 
Zdravilo UpCard se daje enkrat na dan s hrano ali brez nje, odmerek pa je prilagojen tako, da omogoča želeni učinek.
This is a summary of the European public assessment report (EPAR) for UpCard. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo UpCard.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that UpCard's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila UpCard večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
People with known hypersensitivity (allergy) to torasemide or other sulphonamides should give the medicine with caution. 
Osebe z znano preobčutljivostjo (alergijo) na torasemid ali druge sulfonamide morajo to zdravilo dajati previdno.
Tablets should be kept in the blister packs until required, and the blisters should be kept in the outer carton. 
Tablete je treba shranjevati v pretisnih omotih, dokler jih ne potrebujete, pretisne omote pa je treba shranjevati v zunanji škatli.
Congestive heart failure is a condition, usually of older dogs, where the heart fails to pump blood efficiently around the body leading to clinical signs such as exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention. 
Kongestivno srčno popuščanje je stanje, navadno pri starejših psih, ko srce ne zmore učinkovito črpati krvi po telesu, kar povzroča klinične znake, kot so intoleranca za telesno vadbo (nesposobnost izvajanja vadbe), težave z dihanjem in zastajanje (retencija) urina.
The most common side effects with UpCard are kidney problems and increased thirst, water consumption and urine output, which may affect more than 1 in 10 dogs. 
Najpogostejši neželeni učinki zdravila UpCard so težave z ledvicami in povečanje žeje, uživanja vode ter izločanja urina, ki se lahko pojavijo pri več kot 1 psu od 10.
Once signs of congestive heart failure have been controlled, if long-term treatment is required the lowest effective dose should be given. 
Ko so znaki kongestivnega srčnega popuščanja pod nadzorom, je treba v primeru dolgotrajnega zdravljenja uporabiti najmanjši učinkoviti odmerek.
Other information about UpCard 
Druge informacije o zdravilu UpCard
It is not intended to provide practical advice on how to use UpCard. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
In a field study involving 251 dogs with congestive heart failure, treatment with UpCard was compared to a standard treatment with the diuretic furosemide. 
V terenski študiji, ki je zajela 251 psov s kongestivnim srčnim popuščanjem, so zdravljenje z zdravilom UpCard primerjali s standardnim zdravljenjem z diuretikom, furosemidom.
The main measure of effectiveness was response to treatment after about 3 months of treatment, scoring the difficulty breathing, cough frequency, exercise intolerance and fluid retention in the abdomen. 
Glavno merilo učinkovitosti je bil odziv na zdravljenje po približno treh mesecih zdravljenja, kar je vključevalo oceno težav z dihanjem, pogostnosti kašlja, intolerance za telesno vadbo in zastajanja tekočine v trebuhu.
What benefits of UpCard have been shown in studies? 
Kakšne koristi je zdravilo UpCard izkazalo v študijah?
UpCard is a veterinary medicine used to treat signs of congestive heart failure in dogs. 
UpCard je veterinarsko zdravilo, ki se uporablja za zdravljenje znakov kongestivnega srčnega popuščanja pri psih.
What are the risks associated with UpCard? 
Kakšna tveganja so povezana z zdravilom UpCard?
The European Commission granted a marketing authorisation valid throughout the EU for UpCard on 
Evropska komisija je dovoljenje za promet z zdravilom UpCard, veljavno po vsej EU, odobrila dne
For the full list of restrictions and side effects reported with UpCard, see the package leaflet. 
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila UpCard, glejte navodilo za uporabo.
What is UpCard and what is it used for? 
Kaj je zdravilo UpCard in za kaj se uporablja?
In case of accidental ingestion, particularly by children, medical advice should be sought immediately and the package leaflet or label shown to the doctor. 
V primeru nenamernega zaužitja, predvsem pri otrocih, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
Why is UpCard approved? 
Zakaj je bilo zdravilo UpCard odobreno?
This product may increase urination and gastrointestinal disturbances if ingested. 
Če zdravilo zaužijete, lahko poveča uriniranje in prebavne motnje.
Safety information has been included in the summary of product characteristics and the package leaflet for UpCard, including the precautions to be followed by healthcare professionals and animal owners or keepers. 
V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo UpCard so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
The study showed UpCard to be at least as effective as furosemide for treatment of signs related to congestive heart failure. 
V študiji se je izkazalo, da je zdravilo UpCard pri zdravljenju znakov, povezanih s kongestivnim srčnim popuščanjem, vsaj tako učinkovito kot furosemid.
For more information about treatment with UpCard, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za več informacij o zdravljenju z zdravilom UpCard naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For practical information about using UpCard, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za praktične informacije o uporabi zdravila UpCard naj lastniki in imetniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
UpCard contains the active substance torasemide. 
Zdravilo UpCard vsebuje zdravilno učinkovino torasemid.
How does UpCard work? 
Kako zdravilo UpCard deluje?
How is UpCard used? 
Kako se zdravilo UpCard uporablja?
It is available as capsules (5, 20, 100, 140, 180 and 250 mg). 
Na voljo je v obliki kapsul (5-, 20-, 100-, 140-, 180- in 250-miligramskih).
The full EPAR for Temozolomide Sun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Temozolomide Sun je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This means that Temozolomide Sun is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal. 
To pomeni, da je zdravilo Temozolomide Sun podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Temodal.
The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Sun on 13 July 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Temozolomide Sun, veljavno po vsej Evropski uniji, odobrila dne 13. julija 2011.
For more information about treatment with Temozolomide Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Temozolomide Sun preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Temozolomide Sun. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Temozolomide Sun.
Temozolomide Sun is used first with radiotherapy and then on its own; 
Zdravilo Temozolomide Sun se najprej uporabi skupaj z radioterapijo, nato pa samostojno;
Temozolomide Sun should be taken without food. 
Zdravilo Temozolomide Sun je treba jemati brez hrane.
Because Temozolomide Sun is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Temozolomide Sun generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
What are the benefits and risks of Temozolomide Sun? 
Kakšne so koristi in tveganja, povezana z zdravilom Temozolomide Sun?
Treatment with Temozolomide Sun should be prescribed by a doctor with experience in the treatment of brain tumours. 
Zdravljenje z zdravilom Temozolomide Sun mora predpisati zdravnik, ki ima izkušnje z zdravljenjem možganskih tumorjev.
Other information about Temozolomide Sun 
Druge informacije o zdravilu Temozolomide Sun
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 Temozolomide Sun. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Temozolomide Sun, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe
The Committee recommended that Temozolomide Sun be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Temozolomide Sun odobri dovoljenje za promet.
The CHMP concluded that, in accordance with EU requirements, Temozolomide Sun has been shown to have comparable quality and to be bioequivalent to Temodal. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Temozolomide Sun primerljivo raven kakovosti kot zdravilo Temodal ter da mu je biološko enakovredno.
Therefore, the CHMP's view was that, as for Temodal, the benefit outweighs the identified risk. 
Zato je CHMP menil, da tako kot pri zdravilu Temodal koristi odtehtajo znana tveganja.
Because Temozolomide Sun is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal. 
Ker je zdravilo Temozolomide Sun generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Temodal.
Temozolomide Sun is a ‘generic medicine'. 
Temozolomide Sun je „generično zdravilo“.
The active substance in Temozolomide Sun, temozolomide, belongs to a group of anticancer medicines called alkylating agents. 
Zdravilna učinkovina zdravila Temozolomide Sun, temozolomid, spada v skupino zdravil proti raku, ki se imenuje alkilirajoči citostatiki.
Temozolomide Sun is an anticancer medicine. 
Temozolomide Sun je zdravilo proti raku.
The dose of Temozolomide Sun depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day. 
Odmerek zdravila Temozolomide Sun je odvisen od telesne površine (izračunane glede na telesno višino in maso bolnika) in znaša od 75 do 200 mg na kvadratni meter, enkrat na dan. Odmerek in število odmerkov sta odvisna od vrste zdravljenega tumorja ter od tega, ali je bil bolnik že zdravljen, ali se zdravilo Temozolomide Sun uporablja samostojno ali skupaj z drugimi zdravljenji in kako se bolnik odziva na zdravljenje.
Temozolomide Sun is a medicine that contains the active substance temozolomide. 
Temozolomide Sun je zdravilo, ki vsebuje zdravilno učinkovino temozolomid.
Why has Temozolomide Sun been approved? 
Zakaj je bilo zdravilo Temozolomide Sun odobreno?
Temozolomide Sun is used on its own in these patients. 
Pri teh bolnikih se zdravilo Temozolomide Sun uporablja samostojno.
What is Temozolomide Sun? 
Kaj je zdravilo Temozolomide Sun?
How has Temozolomide Sun been studied? 
Kako je bilo zdravilo Temozolomide Sun raziskano?
What is Temozolomide Sun used for? 
Za kaj se zdravilo Temozolomide Sun uporablja?
Patients may also need to take medicines to prevent vomiting before taking Temozolomide Sun. Temozolomide Sun should be used with caution in patients with severe liver problems or with kidney problems. 
Pri bolnikih, ki imajo hude težave z jetri ali ledvicami, je treba zdravilo Temozolomide Sun uporabljati previdno.
How is Temozolomide Sun used? 
Kako se zdravilo Temozolomide Sun uporablja?
How does Temozolomide Sun work? 
Kako zdravilo Temozolomide Sun deluje?
*Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep. 
*Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri ovcah.
The Member States shall ensure that the following key elements are included in the appropriate material: 
Države članice bodo zagotovile, da zajema ustrezno gradivo naslednje ključne elemente:
• Post-marketing and compliance assessment (as applicable to a Member State) 
• ocenitev pomarketinških izkušenj in skladnosti (kot velja v državi članici)
The Dear Healthcare Professional letter will consist of two parts: 
Pismo za zdravstvene delavce bo sestavljeno iz dveh delov:
It is not a contract and does not absolve anybody from his/her responsibilities with regard to the safe use of the product and prevention of foetal exposure.” 
To ni pogodba in nikogar ne odvezuje njegovih odgovornosti v zvezi z varno uporabo zdravila in preprečevanjem izpostavljenosti ploda temu zdravilu.”
The Member States should agree the local implementation of the patient card system 
Države članice bodo dorekle lokalni način izvajanja sistema kartice za bolnika.
CONDITIONS OR RESTRICTION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES 
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJAJO DRŽAVE ČLANICE
• The need for effective contraception 
• opozorilo, da je potrebna učinkovita kontracepcija
The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: 
Države članice morajo zagotoviti, da so izpolnjeni vsi pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, opisani v nadaljevanju:
Dear Healthcare Professional letter 
Pismo za zdravstvene delavce
The Member States shall ensure that the MAH implements a pregnancy prevention programme (PPP) within their territory. 
Države članice bodo zagotovile, da imetnik dovoljenja za promet z zdravilom na svojih ozemljih izvaja program za preprečevanje nosečnosti (PPN).
Details of how the PPP will be implemented should be agreed with the Marketing Authorisation Holder and put in place prior to the marketing of the product. 
Podrobnosti o izvajanju PPN bodo dogovorjene z imetnikom dovoljenja za promet z zdravilom in uveljavljene pred začetkom trženja zdravila.
• Need to avoid foetal exposure 
• treba je preprečiti izpostavljenost ploda
• National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o procedures to ensure that all appropriate measures have been performed prior to thalidomide being dispensed 
• posebnih zahtev posameznih držav po dogovoru s pristojnim nacionalnim organom glede: o distribucije zdravila o postopkov za zagotovitev izvedbe vseh ustreznih ukrepov pred začetkom izdajanja talidomida.
The Member States shall put into place measures to ensure that: o The maximum treatment duration for one prescription shall be 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Prescriptions can only be dispensed within 7 days of the date of the prescription 
Države članice bodo uvedle ukrepe, s katerimi bodo zagotovile: o Najdaljši čas zdravljenja za eno predpisano obdobje bo 4 tedne za ženske v rodni dobi 12 tednov za moške in ženske, ki ne morejo zanositi o Zdravilo na recept je možno izdati le v roku 7 dni od datuma na receptu
• The need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment 
• potrebna je učinkovita kontracepcija brez prekinitev, 4 tedne pred pričetkom zdravljenja, med celotnim trajanjem zdravljenja ter 4 tedne po koncu zdravljenja
• That if she is pregnant or plans to be, she must not take Thalidomide Celgene 
• če je ženska noseča ali načrtuje nosečnost, ne sme jemati zdravila Thalidomide Celgene
The Member States shall report to the EMEA the following information at 6 monthly intervals following the Commission Decision: o The status of implementation of the PPP within their MS o Estimates of usage in their MS 
Država članica bo Evropsko agencijo za zdravila (EMEA) v 6-mesečnih časovnih presledkih po sklepu Komisije obveščala o naslednjem: o statusu izvajanja PPN v državi članici o ocenjeni rabi v državi članici
• Pregnancy testing requirements o Advice on suitable tests o Frequency (before commencing, monthly during treatment and after finishing treatment) 
• zahteve testa nosečnosti o nasvete o ustreznih testih o pogostnost (pred pričetkom, mesečno med zdravljenjem in po končanem zdravljenju)
Educational healthcare professional's kit The Educational healthcare professional's kit shall contain the following elements: 
Izobraževalni paket za zdravstvene delavce Izobraževalni paket za zdravstvene delavce naj vsebuje naslednje elemente:
The Member State should agree with the Marketing Authorisation Holder prior to the launch of the product: o The most appropriate strategies to monitor the off label use within national territory o The collection of detailed data with at least patient demographics and indication in order to monitor closely the off-label use within national territory o The set-up of national measures to assess the effectiveness of and compliance with the PPP. 
Države članice se bodo z imetnikom dovoljenja za promet z zdravilom pred uvedbo zdravila na trg dogovorile o: o najustreznejših strategijah za nadzor nenamenske uporabe zdravila znotraj nacionalnega območja, o zbiranju podrobnih podatkov z vsaj demografijo in indikacijo bolnika, da bi skrbno nadzorovali nenamensko uporabo znotraj nacionalnega območja, o vzpostavitvi nacionalnih ukrepov za določanje učinkovitosti in skladnosti s PPN.
The Member States should ensure that the MAH provides the educational materials to the national patients' organisations for review or if such an organisation does not exist or can not be involved, to a relevant patients group. 
Države članice bodo zagotovile, da bo imetnik dovoljenja za promet z zdravilom zagotovil izobraževalno gradivo za nacionalne organizacije za bolnike, ki jih pregledajo, oziroma če te ne obstajajo ali če ne morejo sodelovati, zadevnim skupinam bolnikov, ki še niso bili zdravljeni s talidomidom.
• Pregnancy initial and outcome reporting forms 
• obrazce za poročanje o začetku in izidu nosečnosti
• That she should not share the treatment with any other person 
• svojega zdravila ne sme dajati nikomur drugemu
• Patient cards and/or equivalent tools: o verification that appropriate counselling has taken place o documentation of childbearing status potential o check box (or similar) which physician ticks to confirm that patient is using effective contraception (if female with childbearing potential) o verification of initial negative pregnancy test prior to start of treatment (if female with childbearing potential) o pregnancy test dates and results 
• Kartice za bolnike in/ali ustrezno orodje o potrdilo o ustreznem svetovanju o dokumentacijo o statusu plodnosti o kontrolno okence (ali podobno) kjer zdravnik potrdi, da bolnik uporablja učinkovito kontracepcijo (za ženske v rodni dobi) o potrdilo o začetnem negativnem testu nosečnosti pred začetkom zdravljenja (za ženske v rodni dobi) o datume testov nosečnosti in izide
• Neuropathy and adverse reaction reporting forms 
• nevropatija in obrazci za poročanje neželenih učinkov
• That if she needs to change or stop using her method of contraception she should inform: - the physician prescribing her contraception that she is on thalidomide - the physician prescribing thalidomide that she has stopped or changed her method of contraception 
• če želi ženska spremeniti ali zamenjati svojo kontracepcijsko metodo, mora obvestiti - zdravnika, ki je kontracepcijo predpisal, da jemlje talidomid - zdravnika, ki je talidomid predpisal, da je prenehala uporabljati ali spremenila svojo kontracepcijsko metodo
• The need for pregnancy tests i.e. before treatment, every 4 weeks during treatment and after treatment 
• potrebno je izvesti teste nosečnosti pred zdravljenjem, vsake 4 tedne med zdravljenjem in po zdravljenju
• Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority using the forms provided in the “Educational Healthcare Professional's Kit” (if applicable to a Member State) 
• Brošuro za zdravstvene delavce o zgodovino talidomida, povzetek podatkov o zdravilu Thalidomide Celgene in indikacijah, za katere je odobreno, o odmerjanje, o najdaljše obdobje predpisovanja 4 tedne za ženske v rodni dobi 12 tednov za moške in ženske, ki ne morejo zanositi o opozorilo o teratogenosti in da je treba preprečiti izpostavljenost ploda o obveznosti za zdravstvene delavce, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, kar vključuje: obveznost izčrpnega svetovanja in vodenja bolnika bolniki morajo biti sposobni izpolnjevati zahteve za varno rabo talidomida obveznost oskrbeti bolnike z zadevnim izobraževalnim gradivom poročanje o vsaki nosečnosti, nevropatiji ali drugih neželenih učinkih podjetju Celgene in lokalnim zdravstvenim organom na obrazcu v „Izobraževalnem paketu za zdravstvene delavce“ (če je primerno za državo članico)
• That she should return the capsules to the pharmacist at the end of treatment o Treatment initiation forms for male patients should also include: Confirmation that the physician has discussed the following: 
• ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu o Obrazci za začetek zdravljenja za moške bolnike morajo vsebovati tudi naslednje elemente: potrdilo, da se je zdravnik pogovoril o naslednjem:
• Need to tell treating doctor immediately upon suspicion of pregnancy Safety advice for men 
• opozorilo, da je v primeru suma na nosečnost, o tem treba nemudoma obvestiti zdravnika, ki vodi zdravljenje varnostne nasvete za moške
• That he should not donate semen during therapy and for one week following discontinuation of thalidomide o Pregnancy reporting requirements Stop Thalidomide Celgene immediately upon suspicion of pregnancy Refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation Complete pregnancy reporting form as provided in the “Educational Healthcare Professional's Kit” 
• Opozorilo, da ne sme darovati sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida o Zahteve poročanja nosečnosti opozorilo, da je v primeru suma na nosečnost treba takoj prekiniti zdravljenje z zdravilom Thalidomide Celgene napotitev k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji na svetovanje in oceno izpolnitev obrazca o poročanju nosečnosti, ki se nahaja v „Izobraževalnem paketu za zdravstvene delavce“ lokalne kontaktne podrobnosti za poročanje kakršnegakoli suma na nosečnost