FrancophonIA/ELRC3.0 huggingface dataset:
English: The most serious risk associated with CellCept is the possible development of cancer, particularly lymphoma and skin cancer.
Slovenian: Najbolj resno tveganje, povezano z zdravilom CellCept, je možnost pojava raka, še zlasti limfoma in kožnega raka.
English: There will also be very close monitoring of the outcomes of any accidentally exposed pregnancies.
Slovenian: Poleg tega bo podrobno spremljala izide morebitnih nenamernih nosečnosti.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom between two and 18 years, the dose of CellCept is calculated depending on height and weight and should be given by mouth.
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom starih od dveh do 18 let, se odmerek zdravila CellCept izračuna glede na višino in maso bolnika, zdravilo pa se jemlje peroralno.
English: CellCept capsules and tablets have been studied in three studies involving a total of 1,493 adults following kidney transplant, in one study involving 650 adults following heart transplant and in one study involving 565 adults following liver transplant.
Slovenian: Kapsule in tablete zdravila CellCept so raziskali v treh študijah, ki so vključevale skupno 1 493 odraslih po presaditvi ledvic, v eni študiji, ki je vključevala 650 odraslih po presaditvi srca, in eni študiji, ki je vključevala 565 odraslih po presaditvi jeter.
English: This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Slovenian: Ta encim je pomemben za tvorjenje DNK v celicah, še zlasti v limfocitih (vrsti belih krvničk, ki sodelujejo pri zavračanju presajenih organov).
English: In all of the studies, all of the patients also received ciclosporin and corticosteroids, and the main measure of effectiveness was the proportion of patients whose new organ had been rejected after six months.
Slovenian: V vseh študijah so vsi bolniki prejemali tudi ciklosporin in kortikosteroide, glavno merilo učinkovitosti pa je bil delež bolnikov, pri katerih je po šestih mesecih telo zavrnilo novi organ.
English: The most common side effects with CellCept used in combination with ciclosporin and corticosteroids (seen in more than 1 patient in 10) are sepsis (blood infection), gastrointestinal candidiasis (a fungal infection of the stomach or gut), urinary tract infection (infection of the structures that carry urine), herpes simplex (a viral infection that causes cold sores), herpes zoster (a viral infection that causes chickenpox and shingles), leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), vomiting, abdominal (tummy) pain, diarrhoea and nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinki, ki so bili opaženi pri uporabi zdravila CellCept v kombinaciji s ciklosporinom in kortikosteroidi (opaženi pri več kot 1 bolniku od 10), so sepsa (okužba krvi), gastrointestinalna kandidoza (glivična okužba želodca ali črevesja), okužba urinarnega trakta (okužba struktur za odvajanje urina), herpes simpleks (virusna okužba, ki povzroča značilne kožne mehurčke), herpes zoster (virusna okužba, ki povzroča norice in pasasti izpuščaj), levkopenija (nizko število belih krvničk), trombocitopenija (nizko število trombocitov), anemija (nizko število rdečih krvničk), bruhanje, trebušne bolečine, driska in navzeja (slabost).
English: CellCept treatment should be initiated and maintained by a qualified transplant specialist.
Slovenian: Zdravljenje z zdravilom CellCept mora začeti in voditi specialist za presaditve.
English: The CHMP decided that CellCept's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila CellCept večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: The dose may need to be adjusted in patients with liver or kidney disease.
Slovenian: Odmerek bo morda treba prilagoditi pri bolnikih z okvarami ledvic ali jeter.
English: Other information about CellCept
Slovenian: Druge informacije o zdravilu CellCept
English: Therefore, CellCept must not be used during pregnancy unless there is no suitable alternative to prevent rejection of the transplant.
Slovenian: Zato se zdravilo ne sme jemati med nosečnostjo, razen če ni na voljo nobenega drugega nadomestnega zdravljenja za preprečevanje zavrnitve presadka.
English: The way that CellCept should be given and the dose depend on the type of organ transplant and the patient's age and size.
Slovenian: Način jemanja zdravila CellCept in odmerek sta odvisna od vrste presajenega organa ter starosti in velikosti bolnika.
English: It can also be given as an infusion lasting two hours starting within 24 hours after the transplant, for up to 14 days.
Slovenian: Zdravilo se lahko daje tudi kot infuzija, ki traja dve uri in se začne dajati v 24 urah po presaditvi ter se daje največ 14 dni.
English: It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Slovenian: Uporablja se skupaj s ciklosporinom in kortikosteroidi (drugimi zdravili za preprečevanje zavrnitve presajenih organov).
English: Women must not breastfeed while using CellCept and patients should not donate blood or sperm during treatment or for a period afterwards.
Slovenian: Med jemanjem zdravila CellCept ženske ne smejo dojiti, bolniki pa med zdravljenjem in še nekaj časa po njegovem zaključku ne smejo darovati krvi ali sperme.
English: The company that markets CellCept will provide educational materials for patients and healthcare professionals explaining the risk of harm to a developing baby and the precautions and measures to be taken to avoid pregnancy during treatment.
Slovenian: Družba, ki trži zdravilo CellCept, bo pripravila izobraževalno gradivo za bolnike in zdravstvene delavce, v katerem bodo pojasnjeni tveganja za poškodbe še nerojenega otroka in preventivni ukrepi za preprečitev nosečnosti med zdravljenjem.
English: It is available as capsules (250 mg), tablets (500 mg), a powder to be made up into an oral suspension (1 g/5 ml) and a powder to be made up into a solution for infusion (drip) into a vein (500 mg).
Slovenian: Zdravilo je na voljo v obliki kapsul (250 mg), tablet (500 mg), praška za pripravo peroralne suspenzije (1 g/5 ml) in praška za pripravo raztopine za infundiranje (kapalne infuzije v veno; 500 mg).
English: What benefit has CellCept shown during the studies?
Slovenian: Kakšne koristi je zdravilo CellCept izkazalo med študijami?
English: For more information about treatment with CellCept, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom CellCept preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: CellCept is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Slovenian: Zdravilo CellCept se uporablja, da bi telesu preprečili zavrnitev presajenih organov, in sicer ledvic, srca ali jeter.
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 CellCept.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Safety information has also been included in the summary of product characteristics and the package leaflet for CellCept, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo CellCept so bile vključene tudi informacije o varnosti, vključno z ustreznimi previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Both men and women must use highly effective contraception before, during and for a suitable period after CellCept treatment.
Slovenian: Moški in ženske morajo pred začetkom zdravljenja z zdravilom CellCept, ves čas med njim in dovolj časa po koncu prejemanja zdravila uporabljati učinkovito kontracepcijsko zaščito.
English: CellCept was compared with azathioprine (another anti-rejection medicine) in all studies except for one of the kidney transplant studies, in which it was compared with placebo (a dummy treatment).
Slovenian: Zdravilo CellCept so v vseh študijah primerjali z azatioprinom (drugo vrsto zdravil proti zavračanju presadkov), razen v eni študiji pri presaditvah ledvic, v kateri so ga primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: A further study looked at the effect of CellCept oral suspension in 100 children following a kidney transplant.
Slovenian: V drugi študiji so opazovali učinke peroralne suspenzije zdravila CellCept pri 100 otrocih po presaditvi ledvic.
English: Women able to have children should be tested before starting treatment to ensure that they are not pregnant.
Slovenian: Ženske, ki lahko zanosijo, morajo pred začetkom zdravljenja opraviti test nosečnosti in se prepričati, da je negativen.
English: Following liver transplant, 38% of the adult patients taking CellCept had rejected their new liver after six months, compared with 48% of those taking azathioprine, but the proportion of patients who had lost their new liver after a year was similar in the two groups, at around 4%.
Slovenian: Po presaditvi jeter je po šestih mesecih pri 38 % odraslih bolnikov, ki so jemali zdravilo CellCept, prišlo do zavrnitve novih jeter, v primerjavi z 48 % tistih, ki so jemali azatioprin, vendar je bil delež bolnikov, pri katerih je prišlo do zavrnitve novih jeter po enem letu, podoben v obeh skupinah, kar je bilo približno 4 %.
English: In children undergoing kidney transplants, the rejection rates were similar to those seen in adults taking CellCept and lower than those seen in other studies of children who did not receive CellCept.
Slovenian: Pri otrocih, ki so prestali presaditev ledvic, je bil delež zavrnitev podoben deležu pri odraslih, ki so jemali zdravilo CellCept, in nižji od deleža v drugih študijah pri otrocih, ki zdravila niso prejemali.
English: It has been shown that there is a significant risk of harm to a developing baby and of miscarriage if CellCept is used in pregnancy.
Slovenian: Dokazano je bilo, da obstaja veliko tveganje za poškodbe še nerojenega otroka ali spontani splav, če se zdravilo jemlje med nosečnostjo.
English: In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase'.
Slovenian: Zdravilo se v telesu pretvori v mikofenolno kislino, ki zavira encim inozin-monofosfat-dehidrogenaza.
English: What is the risk associated with CellCept?
Slovenian: Kakšna tveganja so povezana z zdravilom CellCept?
English: CellCept was as effective as azathioprine and more effective than placebo in preventing the rejection of transplanted kidneys after six months.
Slovenian: Zdravilo CellCept je bilo pri preprečevanju zavrnitve presajenih ledvic po šestih mesecih enako učinkovito kot azatioprin.
English: For kidney transplants, the recommended dose in adults is 1 g twice a day by mouth (capsules, tablets or oral suspension) starting within 72 hours after the transplant.
Slovenian: Pri presaditvi ledvic je priporočeni odmerek za odrasle 1 g dvakrat na dan peroralno (kapsule, tablete ali peroralna suspenzija), jemanje pa se uvede v 72 urah po presaditvi.
English: By preventing the production of new DNA, CellCept reduces the rate at which the lymphocytes multiply.
Slovenian: Zdravilo CellCept s preprečevanjem tvorjenja nove DNK zmanjša hitrost razmnoževanja limfocitov.
English: For heart transplants, the recommended adult dose is 1.5 g twice a day by mouth, starting within five days following the transplant.
Slovenian: Pri presaditvi srca je priporočeni odmerek za odrasle 1,5 g dvakrat na dan peroralno, zdravilo pa se začne jemati v petih dneh po presaditvi.
English: CellCept mycophenolate mofetil
Slovenian: CellCept mofetilmikofenolat
English: CellCept is a medicine containing the active substance mycophenolate mofetil.
Slovenian: CellCept je zdravilo, ki vsebuje zdravilno učinkovino mofetilmikofenolat.
English: Further studies showed that the solution for infusion and the oral suspension produced similar levels of the active substance in the blood as the capsules.
Slovenian: Nadaljnje študije so pokazale, da so bile ravni zdravilne učinkovine v krvi po uporabi raztopine za infundiranje ali peroralne suspenzije približno enake kot pri uporabi kapsul.
English: For liver transplants in adults, CellCept should be given as a 1-g infusion twice a day for the first four days after the transplant, before the patient is switched to 1.5 g twice a day by mouth as soon as it can be tolerated.
Slovenian: Pri presaditvi jeter pri odraslih je treba zdravilo CellCept prve štiri dni po presaditvi dajati kot 1-gramsko infuzijo dvakrat na dan, takoj ko je bolnik sposoben požirati, pa se preide na peroralno jemanje 1,5 g zdravila dvakrat na dan.
English: Why has CellCept been approved?
Slovenian: Zakaj je bilo zdravilo CellCept odobreno?
English: In the heart transplant study, around 38% of adult patients taking CellCept and those taking azathioprine experienced rejection after six months.
Slovenian: V študiji pri presaditvah srca je do zavrnitve organa po šestih mesecih prišlo pri približno 38 % odraslih bolnikov, ki so jemali zdravilo CellCept, in tistih, ki so jemali azatioprin.
English: For the full list of side effects reported with CellCept, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila CellCept, glejte navodilo za uporabo.
English: The active substance in CellCept, mycophenolate mofetil, is an immunosuppressive medicine.
Slovenian: Zdravilna učinkovina zdravila CellCept, mofetilmikofenolat, je zdravilo za zmanjšanje imunskega odziva.
English: For full details of the restrictions with CellCept, see the package leaflet.
Slovenian: Za celoten seznam omejitev pri uporabi zdravila CellCept glejte navodilo za uporabo.
English: What is CellCept used for?
Slovenian: Za kaj se zdravilo CellCept uporablja?
English: How has CellCept been studied?
Slovenian: Kako je bilo zdravilo CellCept raziskano?
English: What is CellCept?
Slovenian: Kaj je zdravilo CellCept?
English: How does CellCept work?
Slovenian: Kako zdravilo CellCept deluje?
English: How is CellCept used?
Slovenian: Kako se zdravilo CellCept uporablja?
English: Pack size
Slovenian: pprašek:
English: Invented name
Slovenian: Izmišljeno ime Jakost
English: Strength Pharmaceutical form
Slovenian: Farmacevtska oblika Pot uporabe Stična ovojnina
English: EU/1/10/629/001
Slovenian: EU/1/10/629/001 HUMENZA
English: 3.8 micrograms HA**
Slovenian: 3,8 mikrogramov**
English: Suspension and emulsion for emulsion for injection
Slovenian: Suspenzija in emulzija za emulzijo za injiciranje
English: Split Influenza virus, inactivated, containing antigen* equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A)
Slovenian: Razgrajen virus gripe*, inaktiviran, vsebuje antigene, ki ustrezajo naslednjim sevom: A/California/7/2009 (H1N1) podoben sevu (NYMC X-179A)
English: AF03 adjuvant composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams)
Slovenian: Adjuvans AF03, ki ga sestavljajo skvalen (12,4 miligramov), sorbitan oleat (1,9 miligramov), polioksietilen cetostearil eter (2,4 miligramov) in manitol (2,3 miligramov).
English: 10 vials (suspension)
Slovenian: 10 vial (suspenzije)
English: After mixing, 1 dose (0.5 ml) contains:
Slovenian: Po premešanju 1 odmerek (0,5 ml) vsebuje:
English: Intramuscular use
Slovenian: Intramuskular na uporaba
English: Suspension (H1N1): vial (glass);
Slovenian: Suspenzija (H1N1): viala (steklo);
English: 10 vials (emulsion)
Slovenian: 10 vial (emulzije)
English: Emulsion (adjuvant): vial (glass)
Slovenian: Emulzija (adjuvant): viala (steklo)
English: * propagated in eggs ** haemagglutinin
Slovenian: razmnožen v jajcih ** izražen v mikrogramih hemaglutinina
English: Suspension: 1.5 ml Emulsion: 4.5 ml
Slovenian: Suspenzija: 1.5 ml
English: Content
Slovenian: o ā
English: Route of Administration
Slovenian: Način uporabe
English: This summary was last updated in 04-2014.
Slovenian: Povzetek je bil nazadnje posodobljen 04-2014.
English: It can also be used for the treatment of COPD.
Slovenian: Uporablja se lahko tudi za zdravljenje KOPB.
English: If patients need to take more than 8 inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
Slovenian: Če bolniki potrebujejo več kot 8 vpihov na dan, je priporočljivo, da se posvetujejo s svojim zdravnikom, ki bo ponovno ocenil njihovo zdravljenje astme.
English: The full EPAR and risk management plan summary for BiResp Spiromax 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) in povzetek načrta obvladovanja tveganj za zdravilo BiResp Spiromax sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used for the treatment of asthma in adults for whom a combination product is considered appropriate.
Slovenian: Uporablja se za zdravljenje astme pri odraslih, za katere je primerna kombinacija zdravil.
English: Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids.
Slovenian: Budezonid spada v skupino protivnetnih zdravil, ki jih imenujemo kortikosteroidi.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.
Slovenian: KOPB je dolgotrajna bolezen, pri kateri so dihalne poti in zračni mešički v pljučih poškodovani ali blokirani, zaradi česar je dihanje oteženo.
English: Formoterol is a long-acting beta-2 agonist.
Slovenian: Formoterol je dolgodelujoči agonist adrenergičnih receptorjev beta-2.
English: This is a summary of the European public assessment report (EPAR) for BiResp Spiromax.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo BiResp Spiromax.
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Slovenian: Uporablja se lahko pri bolnikih, pri katerih bolezni ne moremo ustrezno nadzorovati z drugimi zdravili za astmo, imenovanimi inhalacijski kortikosteroidi in kratkodelujoči agonisti adrenergičnih receptorjev beta-2, ali pri katerih je bolezen že ustrezno nadzorovana z inhalacijskimi kortikosteroidi in dolgodelujočimi agonisti adrenergičnih receptorjev beta-2.
English: The European Commission granted a marketing authorisation valid throughout the European Union for BiResp Spiromax on 28 April 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom BiResp Spiromax, veljavno po vsej Evropski uniji, odobrila 28. aprila 2014.
English: BiResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Slovenian: Zdravilo BiResp Spiromax se uporablja tudi za zdravljenje simptomov hude kronične obstruktivne pljučne bolezni (KOPB) pri odraslih s ponavljajočimi se poslabšanji simptomov bolezni v preteklosti kljub rednemu zdravljenju.
English: BiResp Spiromax budesonide / formoterol
Slovenian: BiResp Spiromax budezonid/formoterol
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but BiResp Spiromax is given using a different inhaler.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isti zdravilni učinkovini, vendar se zdravilo BiResp Spiromax uporablja z drugačnim inhalatorjem.
English: What measures are being taken to ensure the safe and effective use of BiResp Spiromax?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila BiResp Spiromax?
English: This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Slovenian: To povzroči zmanjšano sproščanje snovi, ki sodelujejo v vnetnih procesih, na primer histamina, kar pripomore k ohranjanju prehodnosti dihalnih poti in bolniku olajša dihanje.
English: Because BiResp Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo BiResp Spiromax generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The company initially also applied for a lower strength of BiResp Spiromax, however bioequivalence to the reference product was not demonstrated and the application for this strength was withdrawn.
Slovenian: Prvotno je družba predložila tudi vlogo za manjšo jakost zdravila BiResp Spiromax, vendar biološka enakovrednost z referenčnim zdravilom ni bila dokazana, zato je bila vloga za to jakost umaknjena.
English: A risk management plan has been developed to ensure that BiResp Spiromax is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila BiResp Spiromax je bil pripravljen načrt obvladovanja tveganj.
English: It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine.
Slovenian: Zdravilo je na voljo v obliki praška za inhaliranje v prenosnem pripomočku za inhaliranje, pri čemer se z vsako inhalacijo bolniku dovaja fiksni odmerek zdravila.
English: It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Slovenian: Deluje tako, da se veže na receptorje, imenovane adrenergični receptorji beta-2, ki jih najdemo v dihalnih mišicah.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BiResp Spiromax, 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 BiResp Spiromax in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Slovenian: Deluje podobno kot kortikosteroidni hormoni, ki naravno nastajajo v telesu, pri čemer se veže na receptorje v različnih vrstah imunskih celic ter tako zmanjša dejavnost imunskega sistema.
English: The two active substances in BiResp Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Slovenian: Zdravilni učinkovini v zdravilu BiResp Spiromax sta dobro znani in sta prisotni v več zdravilih, ki se samostojno ali v kombinaciji z drugimi zdravili uporabljajo za zdravljenje astme in KOPB.
English: For more information about treatment with BiResp Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom BiResp Spiromax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.