natgillin/translations-raw huggingface dataset:
Exforge HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment. 
Prav tako se ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), pri bolnikih s sladkorno boleznijo tipa 2 ali zmerno do hudo ledvično okvaro.
Finally, Exforge HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms. 
Zdravila Exforge HCT poleg tega ne smejo uporabljati bolniki s hipokaliemijo (nizko ravnjo kalija v krvi), hiponatriemijo (nizko ravnjo natrija v krvi) in hiperkalciemijo (visoko ravnjo kalcija v krvi), ki se ne odzivajo na zdravljenje, ter bolniki s simptomatsko hiperurikemijo (visoko koncentracijo sečne kisline v krvi).
What is the risk associated with Exforge HCT? 
Kakšna tveganja so povezana z zdravilom Exforge HCT?
It must also not be used in patients who have liver or bile problems (such as jaundice), severe kidney problems, anuria (a condition in which a patient cannot make or pass urine) or in patients undergoing dialysis (a blood clearance technique). 
Zdravila prav tako ne smejo uporabljati osebe, ki imajo obolenja jeter ali žolčnika (kot je npr. zlatenica), hude ledvične okvare, anurijo (nezmožnost izločanja urina) ali bolniki na dializi (tehniki čiščenja krvi).
In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Exforge HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide). 
Poleg tega je bila izvedena glavna študija, v kateri so proučevali 2 271 bolnikov z zmerno do hudo hipertenzijo, ki so prejemali največji odmerek zdravila Exforge HCT (320 mg valsartana, 10 mg amlodipina in 25 mg hidroklorotiazida) Bolniki so osem tednov prejemali bodisi zdravilo Exforge HCT bodisi eno od treh kombinacij, ki so vsebovale le dve zdravilni učinkovini.
Why has Exforge HCT been approved? 
Zakaj je bilo zdravilo Exforge HCT odobreno?
The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Exforge HCT which combines the three substances in a single tablet. 
CHMP je menil, da bi uporaba zdravila Exforge HCT, pri katerem so tri zdravilne učinkovine prisotne v eni tableti, bolnikom, ki tri zdravilne učinkovine že prejemajo ločeno, omogočila doslednejše jemanje zdravila.
How has Exforge HCT been studied? 
Kako je bilo zdravilo Exforge HCT raziskano?
How is Exforge HCT used? 
Kako se zdravilo Exforge HCT uporablja?
What is Exforge HCT? 
Kaj je zdravilo Exforge HCT?
What is Exforge HCT used for? 
Za kaj se zdravilo Exforge HCT uporablja?
It is a hybrid medicine. 
Je „hibridno zdravilo“.
The tablets are taken in 2 to 4 divided doses. 
Tablete se jemljejo razdeljene v od 2 do 4 odmerke.
In adults, the total recommended daily dose is from 3 to 6.5 tablets, and in children from 1.5 to 4 tablets. 
Pri odraslih je skupni priporočeni dnevni odmerek od 3 do 6,5 tablet, pri otrocih pa od 1,5 do 4 tablete.
What measures are being taken to ensure the safe and effective use of Cuprior? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cuprior?
Cuprior is available as 150 mg tablets. 
Zdravilo Cuprior je na voljo v obliki tablet po 150 mg.
This means that it is similar to a ‘reference medicine' (in this case Trientine Dihydrochloride 300 mg capsules) also containing trientine. 
To pomeni, da je podobno „referenčnemu zdravilu“ (v tem primeru zdravilu trientinijev dihidroklorid v obliki 300-miligramskih kapsul), ki tudi vsebuje trientin.
The company provided data from the published literature, which show that trientine significantly increases copper elimination in the urine. 
Družba je predložila podatke iz objavljene literature, ki kažejo, da trientin bistveno poveča izločanje bakra v urinu.
Other information about Cuprior 
Druge informacije o zdravilu Cuprior
The CHMP noted that trientine has been used for over 30 years to treat patients with Wilson's disease. 
Odbor CHMP je upošteval, da se trientin pri zdravljenju bolnikov z Wilsonovo boleznijo uporablja več kot 30 let.
What are the benefits and risks of Cuprior? 
Kakšne so koristi in tveganja, povezani z zdravilom Cuprior?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cuprior's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Cuprior večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Cuprior. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cuprior.
The difference between Cuprior and the reference medicine is that Cuprior contains another form of trientine (trientine tetrahydrochloride) and does not need to be stored in a refrigerator. 
Razlika med zdravilom Cuprior in referenčnim zdravilom je, da Cuprior vsebuje drugo vrsto trientina (trientinijev tetrahidroklorid) in ga ni treba shranjevati v hladilniku.
Cuprior should be taken on an empty stomach, at least one hour before or two hours after meals. 
Zdravilo Cuprior je treba vzeti na tešče vsaj eno uro pred obrokom ali dve uri po njem.
The full EPAR for Cuprior 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 Cuprior je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Since Cuprior is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Cuprior hibridno zdravilo, se njegove koristi in tveganja štejejo za enake kot pri referenčnem zdravilu.
It is not intended to provide practical advice on how to use Cuprior. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Doses are adjusted according to patient response and levels of copper in the body. 
Odmerki se prilagajajo glede na bolnikov odziv in ravni bakra v telesu.
It works by attaching to copper in the body and forming a complex that is then eliminated in the urine. 
Deluje tako, da se veže na baker v telesu in tvori kompleks, ki se nato izloči z urinom.
Cuprior is used in patients who cannot take D-penicillamine, another medicine for this condition. 
Zdravilo Cuprior se uporablja pri bolnikih, ki ne smejo jemati D-penicilamina, drugega zdravila za to bolezen.
Cuprior is a medicine used to treat patients aged 5 years and older with Wilson's disease, a genetic condition in which copper absorbed from food builds up in the body, particularly in the liver and the brain, causing damage. 
Zdravilo Cuprior se uporablja za zdravljenje bolnikov, starih 5 let in več, ki imajo Wilsonovo bolezen, genetsko motnjo, pri kateri se baker iz hrane nalaga v telesu, še posebej v jetrih in možganih, kjer povzroča okvare.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cuprior have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cuprior upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Although Cuprior releases more trientine in the body than the reference medicine, this difference can be addressed by lowering the dose, which is in any case adjusted according to patient response and levels of copper in the body. 
Čeprav zdravilo Cuprior sprosti v telo več trientina kot referenčno zdravilo, je mogoče to razliko upoštevati z zmanjšanjem odmerka, ki je v vsakem primeru prilagojen odzivu bolnika in ravnem bakra v telesu.
The company also carried out a study to compare the levels of trientine in the blood after having taken Cuprior with those for the reference medicine. 
Družba je izvedla tudi študijo za primerjavo ravni trientina v krvi po jemanju zdravila Cuprior s tistimi pri referenčnem zdravilu.
For more information about treatment with Cuprior, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Cuprior preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Results showed that Cuprior produces higher levels of the active substance in the blood than the reference medicine. 
Rezultati so pokazali, da zdravilo Cuprior proizvede višje ravni zdravilne učinkovine v krvi kot referenčno zdravilo.
Why is Cuprior approved? 
Zakaj je bilo zdravilo Cuprior odobreno?
For practical information about using Cuprior, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Cuprior naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Cuprior can only be obtained with a prescription and treatment should be started by a specialist with experience in the management of Wilson's disease. 
Predpisovanje in izdaja zdravila Cuprior je le na recept, zdravljenje pa mora uvesti zdravnik specialist, ki ima izkušnje z zdravljenjem Wilsonove bolezni.
What is Cuprior and what is it used for? 
Kaj je zdravilo Cuprior in za kaj se uporablja?
To take account of this difference, Cuprior is used at lower doses. 
Ta razlika je upoštevana tako, da so odmerki zdravila Cuprior manjši.
Cuprior contains the active substance trientine. 
Zdravilo Cuprior vsebuje zdravilno učinkovino trientin.
The active substance in Cuprior, trientine, is a chelating agent. 
Zdravilna učinkovina zdravila Cuprior, trientin, je kelator.
How has Cuprior been studied? 
Kako je bilo zdravilo Cuprior raziskano?
How is Cuprior used? 
Kako se zdravilo Cuprior uporablja?
How does Cuprior work? 
Kako zdravilo Cuprior deluje?
The Member States should 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 vsi spodaj opisanih pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila izpolnjeni:
CONDITIONS OR RESTRICTIONS 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 IZPOLNIJO DRŽAVE ČLANICE
The Marketing Authorisation Holder (MAH) shall agree the details of a controlled distribution system for the 20 ml vial of Revatio 0.8 mg/ml solution for injection with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all health care professionals who intend to prescribe and/or dispense Revatio 0.8 mg/ml solution for injection are provided the following: - Information for Healthcare professionals - Copy of the Summary of Product Characteristics (SPC) - Data Capture Form (DCF) designed to facilitate reporting of events of hypotension and associated problems 
Takšen program mora izvesti nacionalno, da bodo pred predpisovanjem zdravila vsi zdravstveni delavci, ki nameravajo predpisovati in/ali izdajati Revatio 0,8 mg/ml raztopina za injiciranje dobili: - Informacije za zdravstveno osebje - Izvod povzetka glavnih značilnosti zdravila (SmPC) - Obrazec za zajem podatkov (angl. Data Capture Form - DCF) za lažje poročanja o hipotenziji in povezanih težavah
The Information for Healthcare professionals should contain the following key elements: - Information about the Pharmacovigilance Monitoring Programme regarding the potential risk of clinically relevant hypotension and related problems to be put into place with the use of the DCF. 
Informacije za zdravstveno osebje morajo vključevati naslednje ključne elemente: - informacije o programu farmakovigilančnega nadzora v zvezi možnimi tveganji klinično pomembne hipotenzije in povezanih težav, ki jih je treba evidentirati z obrazcem za zajem podatkov (DCF) - informacije o prehodu s 50-ml viale na 20-ml vialo Revatio 0,8 mg/ml raztopina za injiciranje.
The Marketing Authorisation Holder shall agree the information for healthcare professionals, and the healthcare professionals to be targeted, with the national competent authority of each Member State prior to the launch of the 20 ml vial of Revatio 0.8 mg/ml solution for injection in that country. 
Imetnik dovoljenja za promet (MAH) bo podrobnosti sistema nadzorovane distribucije za 20-ml viale zdravila Revatio 0,8 mg/ml raztopina za injiciranje uskladil s pristojnimi nacionalnimi organi.
Undesirable effects 
Neželeni učinki
If necessary, <Product name> can be used during pregnancy. 
Zdravilo <ime zdravila> se po potrebi lahko uporablja med nosečnostjo.
Adopted at the 12-15 March 2019 PRAC 
Sprejeto na seji odbora PRAC med 12. in 15. marcem 2019
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available. 
Običajne študije z uporabo trenutno sprejetih standardov vrednotenja toksičnosti za razmnoževanje in razvoj niso na voljo.
What you need to know before you use [product name] 
Kaj morate vedeti, preden boste uporabili zdravilo [ime zdravila]
If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency. 
Če je klinično potrebno, se paracetamol lahko uporablja med nosečnostjo, vendar v čim manjšem še učinkovitem odmerku, čim krajši čas in z najmanjšo možno pogostnostjo.
Hypoparathyroidismh 
Hipoparatiroidizemh
Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. 
Epidemiološke študije o razvoju živčevja pri otrocih, izpostavljenih paracetamolu in utero, kažejo nejasne rezultate.
• Decreased function of the parathyroid gland 
• Zmanjšano delovanje obščitnične žleze
Paracetamol - Paracetamol use in pregnancy and child neurodevelopment and effects on the urogenital apparatus (EPITT no 17796) 
Paracetamol - uporaba paracetamola med nosečnostjo in razvoj živčevja pri otroku ter učinki na urogenitalni aparat (št. EPITT 17796)
Contact your <doctor><midwife> if the pain and/or fever are not reduced or if you need to take the medicine more often. 
Posvetujte se z <zdravnikom> <babico>, če bolečina ne mine in/ali se telesna temperatura ne zniža ali če morate zdravilo vzeti pogosteje.
Signs and symptoms that these glands are not working properly may include fatigue (extreme tiredness), weight change or headache, decreased blood levels of calcium and visual disturbances. 
Znaki in simptomi okvare delovanja teh žlez lahko vključujejo izčrpanost (ekstremno utrujenost), spremembe telesne mase ali glavobol, znižane ravni kalcija v krvi in motnje vida.
Nivolumab - Hypoparathyroidism (EPITT no 19310) 
Nivolumab - hipoparatiroidizem (št. EPITT 19310)
You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. 
Uporabljati morate najmanjši možni odmerek, ki še lajša bolečino in/ali zniža povišano telesno temperaturo, ter ga uporabljati čim krajši čas.
What you need to know before you use OPDIVO Warnings and precautions 
Kaj morate vedeti, preden boste uporabili zdravilo OPDIVO
Other immune-related adverse reactions: […] Cases of Vogt-Koyanagi-Harada syndrome and hypoparathyroidism have been reported post-marketing (see section 4.8). 
Drugi imunsko pogojeni neželeni učinki […] V obdobju trženja zdravila so poročali o primerih sindroma Vogt-Koyanagi-Harada in hipoparatiroidizma (glejte poglavje 4.8).
New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/157160/2019 
Novo besedilo informacij o zdravilu - izvlečki iz priporočil odbora PRAC o signalih EMA/PRAC/189303/2019
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. 
Veliko število podatkov pri nosečnicah ne kaže na pojav prirojenih napak niti na toksičnost za plod oziroma novorojenčka.
Frequency: Not known for nivolumab monotherapy / nivolumab in combination with ipilimumab [Table key: h Post-marketing event (also see section 4.4)] 
Pogostnost: Neznana pogostnost pri nivolumabu v monoterapiji/nivolumabu v kombinaciji z ipilimumabom [Legenda preglednice: h Neželeni učinek v obdobju trženja zdravila (glejte tudi poglavje 4.4)] Navodilo za uporabo
Problems with your hormone producing glands (including the pituitary, the thyroid, the parathyroid and adrenal glands) that may affect how these glands work. 
Opozorila in previdnostni ukrepi težave z žlezami, ki izločajo hormone (vključno s hipofizo, ščitnico, obščitnično žlezo in nadledvičnimi žlezami).
The marketing authorisation was renewed on 13 April 2004 and on 13 April 2009. 
Dovoljenje za promet z zdravilom je bilo podaljšano dne 13. aprila 2004 in 13. aprila 2009.
The European Commission granted a marketing authorisation valid throughout the European Union for Beromun to Boehringer Ingelheim International GmbH on 13 April 1999. 
Evropska komisija je dovoljenje za promet z zdravilom Beromun, veljavno po vsej Evropski uniji, odobrila družbi Boehringer Ingelheim International GmbH dne 13. aprila 1999.
The replacement TNFα acts in same way as the naturally produced protein. 
Nadomestni TNFα deluje enako kot naravno proizvedena beljakovina..
Other information about Beromun: 
Druge informacije o zdravilu Beromun:
Beromun is not recommended for patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group. 
Uporaba zdravila Beromun pri bolnikih, mlajših od 18 let, zaradi pomanjkanja informacij o varnosti in učinkovitosti v tej starostni skupini ni priporočljiva.
Beromun is usually only used once, but a second perfusion can be considered six to eight weeks after the first. 
Zdravilo Beromun se običajno uporabi samo enkrat, vendar pa se ponovna perfuzija lahko izvede najmanj šest do osem tednov po prvi.
What benefit has Beromun shown during the studies? 
Kakšne koristi je zdravilo Beromun izkazalo med študijami?
Therefore, the main measure of effectiveness was based on the experts' assessment of the outcome of these 145 patients, in comparison with the outcome that would be expected without using Beromun. 
Glavno merilo učinkovitosti je zato temeljilo na ocenah, ki so jih podali strokovnjaki o rezultatih pri teh 145 bolnikih, v primerjavi s pričakovanim rezultatom brez uporabe zdravila Beromun.
It contains the active substance tasonermin. 
Vsebuje zdravilno učinkovino tasonermin.
There were too few patients also receiving interferon-gamma to determine whether this improved the patients' outcome further. 
Bolnikov, ki so prejemali tudi interferon gama, je bilo premalo, da bi lahko potrdili, ali je to pri bolnikih dodatno izboljšalo izid.
It can be used before surgery to reduce the size of a tumour, or instead of surgery when the tumour cannot be removed by surgery alone. 
Lahko se uporablja pred operacijo za zmanjšanje velikosti tumorja ali namesto operacije, kadar tumorja ni mogoče odstraniti samo z operacijo.
The Committee recommended that Beromun be given marketing authorisation. 
Odbor je zato priporočil, da se za zdravilo Beromun odobri dovoljenje za promet.
The remains of the tumour should be removed whenever this is possible, usually after several weeks. 
Če je le mogoče, je treba preostanke tumorja kirurško odstraniti, navadno po nekaj tednih.
Beromun has been studied in four main studies involving a total of 188 patients, in which it was given in combination with melphalan. 
Zdravilo Beromun so proučevali v štirih glavnih študijah s skupno 188 bolniki, v katerih je bilo to zdravilo uporabljeno v kombinaciji z melfalanom.
The exact way that TNFα works against certain types of cancer is not fully understood, but it is thought that it can kill tumour cells directly, as well as destroy the blood vessels supplying tumours and stimulate the immune system to attack them. 
Natančen način delovanja TNFα proti določenim vrstam raka ni v celoti znan, vendar se domneva, da lahko neposredno ubija tumorske celice, uničuje krvne žile, ki dovajajo snovi v tumorje, ter spodbudi imunski sistem, da jih napade.
A review of the studies by three independent experts found that only 145 of these patients were candidates for amputation or surgical removal of the tumour that would have resulted in significant loss of function (disability). 
Ob pregledu študij so trije neodvisni strokovnjaki ugotovili, da je bilo izmed teh bolnikov samo 145 takšnih, ki bi bili primerni za amputacijo ali kirurško odstranitev tumorja, ki bi povzročila bistveno zmanjšano funkcionalnost (invalidnost).
The centres must also have intensive care units readily available and facilities to continuously look out for leakage of the medicine into the rest of the body using radioactive tracers. 
Centri morajo imeti tudi oddelek za intenzivno nego in opremo za neprekinjeno spremljanje uhajanja zdravila v preostalo telo z radioaktivnimi sledilci.
Sixty-two of the patients also received interferon-gamma (another anticancer medicine). 
Dvainšestdeset bolnikov je prejemalo tudi interferon gama (drugo zdravilo proti raku).
This leads to the tumour dying back and getting smaller, particularly when the medicine is combined with other cytotoxic (cellkilling) medicines and raised temperature. 
To povzroči, da tumor odmira in se manjša, še zlasti takrat, kadar se zdravilo daje v kombinaciji z drugimi citotoksičnimi zdravili (zdravili za uničenje celic) in ob povišani temperaturi.
What is the risk associated with Beromun? 
Kakšna tveganja so povezana z zdravilom Beromun?
It must also not be used in patients who cannot receive vasopressors (medicines to increase the blood pressure), anticoagulants (medicines to prevent blood clotting) or medicines that can harm the heart. 
Prav tako ga ne smejo uporabljati bolniki, ki ne smejo prejemati vazopresornih sredstev (zdravil za povečanje krvnega tlaka), antikoagulantov (zdravil za preprečevanje krvnih strdkov) ali zdravil, ki lahko škodijo srcu.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) BEROMUN EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) BEROMUN Povzetek EPAR za javnost
The independent reviewers agreed that 62% of the patients receiving Beromun and melphalan (90 out of 145) had a better outcome than predicted, since their limb was saved without surgery to remove the tumour or their tumour was removed without causing significant loss of function. 
Neodvisni pregledovalci so se strinjali, da je imelo 62 % bolnikov, ki so prejeli zdravilo Beromun in melfalan (90 bolnikov od 145), boljši izid od pričakovanega, saj je bila njihova okončina ohranjena, ne da bi bila izvedena operativna odstranitev tumorja, oziroma je bil tumor odstranjen, ne da bi to povzročilo bistveno zmanjšanje funkcionalnosti.
The active substance in Beromun, tasonermin, is a copy of the human protein tumour necrosis factor alfa-1a (TNFα). 
Zdravilna učinkovina zdravila Beromun, tasonermin, je kopija človeške beljakovine tumorjenekrotizirajočega faktorja alfa-1a (TNFα).
Beromun is then injected into the perfusion solution at a dose of 3 mg for an arm and 4 mg for a leg, given over 90 minutes. 
Zdravilo Beromun se nato injicira v perfuzijsko raztopino v odmerku 3 mg za roko in 4 mg za nogo, ki se daje 90 minut.
Some side effects of Beromun are serious and could require a patient to spend time in an intensive care unit after treatment. 
Nekateri neželeni učinki zdravila Beromun so resni in lahko povzročijo, da mora bolnik nekaj časa po zdravljenju ostati na oddelku za intenzivno nego.