FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies also showed that the active substances in Rasitrio are absorbed in the body in the same way as the active substances when given as separate tablets.
Slovenian: Študije so tudi pokazale, da se zdravilne učinkovine iz zdravila Rasitrio v telo absorbirajo enako kot zdravilne učinkovine, ki se jemljejo kot posamezne tablete.
English: By blocking the activity of renin, levels of both, angiotensin I and angiotensin II, fall.
Slovenian: Z zaviranjem delovanja renina se zniža raven angiotenzina I in angiotenzina II.
English: Rasitrio is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose.
Slovenian: Zdravilo Rasitrio se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih, pri katerih je krvni tlak že ustrezno uravnan z uporabo kombinacije aliskirena, amlodipina in hidroklorotiazida, ki se jemljejo sočasno v enakih odmerkih.
English: By reducing the flow of calcium into the cells, amlodipine prevents the blood vessel walls from contracting, thus lowering the blood pressure.
Slovenian: Amlodipin z zmanjševanjem pretoka kalcija v celice preprečuje krčenje žilnih sten in tako znižuje krvni tlak.
English: In a main study in 1,191 patients with moderate or severe hypertension, Rasitrio combinations containing the three active substances were compared with combinations containing only two active substances: aliskiren plus amlodipine, amlodipine plus hydrochlorothiazide, and aliskiren plus hydrochlorothiazide.
Slovenian: V glavni študiji, v kateri je bilo vključenih 1 191 bolnikov z zmerno ali hudo hipertenzijo, so primerjali zdravilo Rasitrio, ki je vsebovalo kombinacijo treh zdravilnih učinkovin, s kombinacijo, ki je vsebovala samo dve zdravilni učinkovini: aliskiren z amlodipinom, amlodipin s hidroklorotiazidom in aliskiren s hidroklorotiazidom.
English: Why has Rasitrio been approved?
Slovenian: Zakaj je bilo zdravilo Rasitrio odobreno?
English: The strength of the Rasitrio tablet that the patient takes depends on the doses of aliskiren, amlodipine and hydrochlorothiazide that they received previously.
Slovenian: Jakost tablet Rasitrio, ki jih bolnik jemlje, je odvisna od odmerka aliskirena, amlodipina in hidroklorotiazida, ki ga je bolnik predhodno jemal.
English: The Rasitrio combination was more effective than the double combinations at reducing systolic blood pressure.
Slovenian: Kombinacija zdravila Rasitrio je bila pri zniževanju sistoličnega krvnega tlaka učinkovitejša od kombinacije z dvema zdravilnima učinkovinama.
English: Rasitrio is a medicine that contains the active substances aliskiren, amlodipine and hydrochlorothiazide.
Slovenian: Rasitrio je zdravilo, ki vsebuje zdravilne učinkovine aliskiren, amlodipin in hidroklorotiazid.
English: Reductions of 28.2 mmHg, 30.6 mmHg and 30.8 mmHg were seen for aliskiren plus hydrochlorothiazide, aliskiren plus amlodipine and amlodipine plus hydrochlorothiazide respectively.
Slovenian: Pri jemanju aliskirena v kombinaciji s hidroklorotiazidom se je znižal za 28,2 mmHg, pri jemanju aliskirena v kombinaciji z amlodipinom za 30,6 mmHg, pri jemanju amlodipina v kombinaciji s hidroklorotiazidom pa za 30,8 mmHg.
English: What is Rasitrio used for?
Slovenian: Za kaj se zdravilo Rasitrio uporablja?
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Slovenian: Zavira dejavnost encima, imenovanega renin, ki v telesu sodeluje pri tvorjenju spojine, imenovane angiotenzin I. Angiotenzin I se pretvori v hormon angiotenzin II, ki deluje kot močan vazokonstriktor (učinkovina, ki oži žile).
English: How has Rasitrio been studied?
Slovenian: Kako je bilo zdravilo Rasitrio raziskano?
English: How does Rasitrio work?
Slovenian: Kako zdravilo Rasitrio deluje?
English: How is Rasitrio used?
Slovenian: Kako se zdravilo Rasitrio uporablja?
English: Rasitrio contains three active substances, aliskiren, amlodipine, and hydrochlorothiazide.
Slovenian: Zdravilo Rasitrio vsebuje tri zdravilne učinkovine: aliskiren, amlodipin in hidroklorotiazid.
English: What is Rasitrio?
Slovenian: Kaj je zdravilo Rasitrio?
English: London, 26 June 2008 Doc.
Slovenian: London, 26. junij 2008 Dok.
English: The virus used in the vaccine was first inactivated (killed) so that it does not cause any disease.
Slovenian: Virus, ki se uporablja pri tem cepivu, je najprej inaktiviran (ubit), tako da ne more povzročati nobenih obolenj.
English: Aflunov also contains an ‘adjuvant' (a compound containing oil), which is expected to stimulate a better response.
Slovenian: Aflunov vsebuje tudi adjuvant (sestavino, ki vsebuje olje), ki naj bi spodbujalo boljšo odzivnost.
English: On 13 June 2008, Novartis Vaccines and Diagnostics S.r.l.
Slovenian: Družba Novartis Vaccines and Diagnostics S.r.l.
English: This helps to protect against the disease.
Slovenian: To pomaga zaščititi telo pred boleznijo.
English: Consequently, the study results could not be considered reliable and could not be used for the evaluation of the vaccine.
Slovenian: Posledično rezultati študije niso bili ocenjeni kot zanesljivi in jih ni bilo mogoče uporabiti pri ocenjevanju cepiva.
English: The main clinical study of Aflunov involved over 4,000 adults.
Slovenian: Glavna klinična študija zdravila Aflunov je vključevala več kot 4000 odraslih.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Slovenian: Potem ko CHMP izda svoje mnenje, navadno traja približno dva meseca, preden Evropska komisija dovoljenje odobri.
English: This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic.
Slovenian: To je posebna vrsta cepiva, namenjenega zaščiti pred sevom gripe, ki lahko povzroča pandemijo v prihodnosti.
English: As a result, the size of the clinical database for the assessment of the vaccine's safety was not sufficient to fulfil the requirements of the EMEA's guidelines on prepandemic vaccines.
Slovenian: Tako velikost klinične podatkovne baze za ocenjevanje varnosti cepiva ni bila zadostna za izpolnitev določil smernic agencije EMEA o predpandemičnih cepivih.
English: The effects of Aflunov were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Aflunov so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Then, the outer membranes that contain the ‘surface antigens' (proteins on the outer membrane of the virus that the body recognises as foreign) were extracted and purified before being included in the vaccine.
Slovenian: Nato so bile zunanje membrane, ki vsebujejo površinske antigene (beljakovine na zunanji membrani virusa, ki ga telo prepoznava kot tujek), izločene in prečiščene, preden so bile ponovno dodane v cepivo.
English: It consists of a suspension for injection that contains some parts (outer membranes) of the influenza (flu) virus strain called A/VietNam/1194/2004.
Slovenian: Sestavljeno je iz suspenzije za injiciranje, ki vsebuje nekatere dele (zunanje membrane) seva virusa influence (gripa), imenovanega A/VietNam/1194/2004.
English: An inspection of some of the study sites showed that the study had not been conducted in compliance with ‘good clinical practice' (GCP).
Slovenian: Pregled nekaterih točk študije je namreč razkril, da študija ni bila izvedena v skladu z dobro klinično prakso.
English: The immune system will be able to produce antibodies more quickly when it is exposed to flu virus of the same strain.
Slovenian: Imunski sistem bo tako lahko proizvedel protitelesa hitreje, kadar bo dejansko izpostavljen virusu gripe istega seva.
English: Health experts are concerned that the next flu pandemic could be caused by the H5N1 strain of the virus.
Slovenian: Zdravstveni strokovnjaki so zaskrbljeni, da bi naslednjo pandemijo gripe lahko povzročil sev virusa H5N1.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Slovenian: Ko družba predloži odgovore na vprašanja, jih CHMP in lahko pred izdajo svojega mnenja na 180. dan postopka zastavi morebitna druga vprašanja.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni sistem telesa) „naučijo“, kako se zaščiti pred boleznijo.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Slovenian: Potem ko je odbor za zdravila za uporabo v humani medicini ocenil odgovore družbe na seznam vprašanj, so nekatera tehtna vprašanja še vedno ostala nerešena.
English: The comparator vaccine contained different strains of seasonal flu virus, but the rest of the components were the same as in Aflunov.
Slovenian: Primerjalno cepivo je vsebovalo različne seve virusa sezonske gripe, ostale komponente cepiva pa so bile enake kot pri cepivu Aflunov.
English: Aflunov is a ‘prepandemic' vaccine.
Slovenian: Zdravilo Aflunov je „predpandemično“ cepivo.
English: The CHMP was concerned over the way the main clinical study was carried out.
Slovenian: Odbor za zdravila za uporabo v humani medicini je izrazil zadržke zaradi načina izvedbe glavne klinične študije.
English: Aflunov is a vaccine.
Slovenian: Zdravilo Aflunov je cepivo.
English: Aflunov was expected to provide protection against this strain, so that it could be used before or during a flu pandemic.
Slovenian: Zdravilo Aflunov naj bi zagotovilo zaščito pred tem sevom in bi se lahko uporabljalo pred ali med pandemijo gripe.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Aflunov could not have been approved for the prophylaxis of H5N1 avian influenza.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Aflunov ni mogoče odobriti za zaščito pred virusom H5N1 aviarne influence.
English: It compared Aflunov's safety and its ability to stimulate the production of antibodies (‘immunogenicity') with those of a similar vaccine against seasonal flu.
Slovenian: Študija je primerjala varnost zdravila Aflunov in njegovo zmožnost za spodbujanje proizvodnje protiteles (imunogenost), v primerjavi s podobnimi cepivi proti sezonskim virusom gripe.
English: Aflunov contains small parts of the H5N1 strain of the flu virus.
Slovenian: Zdravilo Aflunov vsebuje majhne delce H5N1 seva virusa gripe.
English: The company informed the CHMP that there are no consequences for individuals currently included in clinical trials with Aflunov.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih cepiva Aflunov.
English: When a person is given the vaccine, the immune system recognises the parts of the flu virus it contains as ‘foreign' and makes antibodies against them.
Slovenian: Kadar posameznik prejme cepivo, imunski sistem prepozna dele virusa, ki ga le-to vsebuje, kot tuje in proti njim pripravi protitelesa.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Slovenian: Pandemija gripe nastopi, kadar se pojavi nov sev virusa gripe, ki se zlahka širi med ljudmi, saj posamezniki pred njim niso imuni (nimajo zaščite).
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for AFLUNOV Common name: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (A/VietNam/1194/2004)
Slovenian: Splošno ime: Cepivo za predpandemično influenco (H5N1) (površinski antigen, inaktiviran, adjuvant) (A/VietNam/1194/2004)
English: The application was at day 190 when the company withdrew.
Slovenian: Družba je vlogo umaknila na 190. dan postopka.
English: What is Aflunov?
Slovenian: Kaj je zdravilo Aflunov?
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Aflunov?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe cepiva Aflunov?
English: Aflunov was expected to be used in adults and the elderly to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Slovenian: Zdravilo Aflunov naj bi se uporabljalo pri odraslih in starejših za zaščito pred gripo, ki jo povzroča H5N1, sev (vrsta) virusa influence A.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aflunov, for the prophylaxis of H5N1 avian influenza in adults and the elderly.
Slovenian: je dne 13. junija 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Aflunov, namenjenemu zaščiti pred virusom aviarne influence H5N1, pri odraslih in starejših.
English: What was Aflunov expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Aflunov uporabljalo?
English: How is Aflunov expected to work?
Slovenian: Kako naj bi zdravilo Aflunov delovalo?
English: Therefore, at the time of the withdrawal, the CHMP could not conclude on the benefit-risk balance of Aflunov.
Slovenian: Odbor za zdravila za uporabo v humani medicini je v času umika menil, da ne more sklepati o razmerju med koristmi in tveganji za cepivo Aflunov.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bondronat on 25 June 1996.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Bondronat, veljavno po vsej Evropski uniji, izdala 25. junija 1996.
English: Bondronat is used in adults in the following ways:
Slovenian: Zdravilo Bondronat se uporablja pri odraslih na naslednje načine:
English: The full EPAR for Bondronat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Bondronat je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Bondronat?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bondronat?
English: The main measure of effectiveness was based on the number of new bone complications.
Slovenian: Glavno merilo učinkovitosti je temeljilo na številu novih z okostjem povezanih zapletov.
English: Other information about Bondronat
Slovenian: Druge informacije o zdravilu Bondronat
English: The main measure of effectiveness was the change in blood calcium levels.
Slovenian: Glavno merilo učinkovitosti je bila sprememba ravni kalcija v krvi.
English: This is a summary of the European public assessment report (EPAR) for Bondronat.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bondronat.
English: Bondronat treatment should only be started by a doctor who has experience in the treatment of cancer.
Slovenian: Zdravljenje z zdravilom Bondronat lahko začne le zdravnik z izkušnjami pri zdravljenju raka.
English: This leads to less bone loss.
Slovenian: S tem se zmanjša izguba kostnine.
English: What benefit has Bondronat shown during the studies?
Slovenian: Kakšne koristi je zdravilo Bondronat izkazalo med študijami?
English: For more information about treatment with Bondronat, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Bondronat preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: About three-quarters responded to a 4-mg dose.
Slovenian: Približno tri četrtine bolnikov se je odzvalo na 4-miligramski odmerek.
English: A risk management plan has been developed to ensure that Bondronat is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Bondronat je bil pripravljen načrt obvladovanja tveganj.
English: Bondronat must not be used in people with hypocalcaemia.
Slovenian: Zdravila Bondronat ne smejo uporabljati osebe s hipokalciemijo.
English: The infusion will normally bring the blood calcium level down to normal levels within a week.
Slovenian: Običajno se bo z infundiranjem raven kalcija v krvi v tednu dni znižala na normalno raven.
English: Bondronat reduced the risk of having a skeletal event by about 40% compared with placebo.
Slovenian: Zdravilo Bondronat je v primerjavi s placebom zmanjšalo tveganje z okostjem povezanih dogodkov za približno 40 %.
English: Bondronat was more effective than placebo in preventing bone complications.
Slovenian: Zdravilo Bondronat je bilo učinkovitejše od placeba pri preprečevanju z okostjem povezanih zapletov.
English: Bondronat was not compared with any other treatments in these studies.
Slovenian: V teh študijah zdravila Bondronat niso primerjali z nobeno drugo vrsto zdravljenja.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Slovenian: Zavira delovanje osteoklastov, tj. celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
English: Bondronat ibandronic acid
Slovenian: Bondronat ibandronska kislina
English: The CHMP decided that Bondronat's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Bondronat večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein, and as tablets (50 mg).
Slovenian: Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno in tablet (50 mg).
English: The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit up for at least an hour.
Slovenian: Tablet ne smejo jemati bolniki z nepravilnostmi v požiralniku ali tisti, ki ne morejo stati ali sedeti vzravnano vsaj eno uro.
English: • as an infusion to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Slovenian: • kot infuzija za zdravljenje hiperkalciemije (visokih ravni kalcija v krvi), ki jo povzročajo tumorji.
English: In addition, the company that markets Bondronat will provide a card to inform patients receiving Bondronat infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Slovenian: Poleg tega bo družba, ki trži zdravilo Bondronat, pripravila kartico, s katero bo bolnike, ki prejemajo infuzije tega zdravila, seznanila s tveganjem pojava osteonekroze čeljustne kosti in jih pozvala, naj v primeru pojava simptomov poiščejo zdravniško pomoč.
English: Bondronat has also been studied in the treatment of hypercalcaemia caused by tumours in three fourweek studies involving a total of 343 patients.
Slovenian: Zdravilo Bondronat je bilo raziskano tudi z vidika zdravljenja tumorsko povzročene hiperkalciemije v treh štiritedenskih študijah, v katere je bilo vključenih skupaj 343 bolnikov.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bondronat, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: What is the risk associated with Bondronat?
Slovenian: Kakšna tveganja so povezana z zdravilom Bondronat?
English: 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 Bondronat.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Bondronat, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: About a half to two-thirds of the patients responded to a 2-mg dose of Bondronat, with blood calcium levels returning to within the normal range.
Slovenian: Približno polovica do dve tretjini bolnikov se je odzvalo na 2-miligramski odmerek zdravila Bondronat tako, da so se ravni kalcija v krvi znižale na normalno vrednost.
English: In the treatment of hypercalcaemia caused by tumours, Bondronat is given over 2 hours as an infusion of either 2 or 4 mg, depending on how severe the hypercalcaemia is.
Slovenian: Pri zdravljenju tumorsko povzročene hiperkalciemije se zdravilo Bondronat daje v obliki dvourne infuzije v odmerku 2 ali 4 mg, odvisno od resnosti hiperkalciemije.
English: Patients with moderate or severe kidney problems should receive Bondronat infusions at a lower dose over an hour, or the tablet every two days or every week.
Slovenian: Bolniki z zmernimi ali hudimi ledvičnimi težavami morajo infuzije zdravila Bondronat prejemati v nižjem odmerku z infundiranjem, ki traja eno uro, ali vzeti tablete vsaka dva dni ali vsak teden.
English: Patients with tumours can have high levels of calcium in their blood, released from the bones.
Slovenian: Bolniki s tumorji lahko imajo v krvi visoke ravni kalcija, ki se sprošča iz kosti.
English: The most serious side effects with Bondronat are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), and eye inflammation.
Slovenian: Najresnejši neželeni učinki zdravila Bondronat so anafilaktične reakcije (hude alergijske reakcije), neznačilni zlomi stegnenice (neobičajne vrste zloma kosti v stegnu), osteonekroza čeljusti (poškodbe čeljustne kosti, ki lahko povzroči bolečine, oteklost v ustih ali majanje zob) ter vnetje oči.
English: It took longer for patients on Bondronat infusions or tablets to develop a new bone complication (50 to 76 weeks) than for patients on placebo (33 to 48 weeks).
Slovenian: Pri bolnikih, ki so prejemali injekcije ali tablete zdravila Bondronat, so se novi z okostjem povezani zapleti pojavili kasneje (po 50 do 76 tednih) kot pri bolnikih, ki so prejemali placebo (po 33 do 48 tednih).
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Slovenian: Zmanjševanje izgubljanja kostnine vpliva na manjšo lomljivost kosti, kar je koristno pri preprečevanju zlomov pri bolnikih z rakom, ki imajo metastaze v kosteh.
English: In the prevention of skeletal events in patients with breast cancer and bone metastases, Bondronat has been compared with placebo (a dummy treatment) in three main studies lasting two years: one with the infusions in 466 patients and two with the tablets in a total of 846 patients.
Slovenian: Zdravilo Bondronat so pri preprečevanju z okostjem povezanih dogodkov pri bolnikih z rakom dojke in metastazami v kosteh primerjali s placebom (zdravilom brez zdravilne učinkovine) v treh glavnih študijah, ki so trajale dve leti: v eni z infuzijami pri 466 bolnikih in v dveh s tabletami pri skupaj 846 bolnikih.