natgillin/translations-raw huggingface dataset:
• Oral almitrine-containing products should no longer be prescribed or dispensed to patients. 
• Peroralnih zdravil, ki vsebujejo almitrin, bolnikom ni več dovoljeno predpisovati ali dajati.
Furthermore, oral almitrine is no longer included as a recommended therapy in international treatment guidelines for the management of COPD. 
Poleg tega peroralni almitrin ni več vključen kot priporočeno zdravljenje v mednarodne smernice za obravnavo KOPB.
• The PRAC noted that cases of weight loss and peripheral neuropathy have continued to be reported, despite the introduction of a number of risk minimisation measures, including sequential administration (two months treatment followed by a one-month break), dose reduction and appropriate warnings in the product information. 
• Odbor PRAC je ugotovil, da še vedno poročajo o primerih izgube telesne mase in periferne nevropatije, čeprav so uvedli številne ukrepe za zmanjševanje tveganja, vključno s ciklično uporabo (dva meseca zdravljenja, ki mu sledi enomesečni presledek), zmanjšanjem odmerka in ustreznimi opozorili v informacijah o zdravilu.
Almitrine is a stimulant of the part of the brain responsible for the breathing reflex. 
Almitrin spodbuja del možganov, odgovoren za dihalni refleks.
In three of the latter cases, patients were rechallenged with almitrine and this led to a recurrence of neuropathic symptoms, including sequelae in two. 
Pri treh primerih so pri bolnikih ponovno uporabili almitrin, kar je povzročilo ponoven pojav nevropatskih simptomov, vključno s posledicami pri dveh primerih.
In 489 cases, neuropathy was indicated to have been irreversible, or to have led to sequelae. 
Pri 489 primerih je bila nevropatija označena kot ireverzibilna ali s posledicami.
• Prescribers and pharmacists will be sent a letter giving them further information on the withdrawal of oral almitrine. 
• Zdravniki, ki predpisujejo zdravilo, in farmacevti bodo prejeli pismo z dodatnimi informacijami o umiku peroralnega almitrina.
In view of the potentially serious adverse effects and the lack of an established role in the current management of hypoxaemic pulmonary disease, the benefit-risk of oral almitrine is no longer considered favourable. 
Zaradi morebitnih resnih neželenih učinkov in odsotnosti uveljavljene vloge pri trenutni obravnavi pljučne bolezni s hipoksemijo razmerje med tveganji in koristmi peroralnega almitrina ni več ugodno.
Almitrine is a respiratory stimulant, a medicine that stimulates the part of the brain responsible for the breathing reflex. 
Almitrin je respiratorni stimulans, ki spodbuja del možganov, odgovoren za dihalni refleks.
Almitrine is not one of the treatments currently recommended in international guidelines for COPD management (GOLD), and the available evidence does not support a clinical benefit for long-term oral treatment with the medicine. 
Almitrin ni ena od oblik zdravljenja, ki se trenutno priporočajo v mednarodnih smernicah za obravnavo KOPB (GOLD), razpoložljivi dokazi pa ne podpirajo klinične koristi dolgotrajnega peroralnega zdravljenja s tem zdravilom.
• If you are taking an almitrine-containing medicine, you should make a non-urgent appointment with your doctor to review your treatment. 
• Če jemljete zdravila, ki vsebujejo almitrin, se dogovorite za neurgenten obisk pri svojem zdravniku, ki bo pregledal vaše zdravljenje.
The PRAC concluded that there is a clear association between oral almitrine treatment and potentially serious and long-lasting peripheral neuropathy (damage to the nerves in the hands and feet) and significant weight loss that further weakens patients. 
Odbor PRAC je sklenil, da obstaja jasna povezava med zdravljenjem s peroralnim almitrinom in morebitno resno ter dolgotrajno periferno nevropatijo (poškodbo živcev v dlaneh in stopalih) in veliko izgubo telesne mase, ki dodatno ošibi bolnike.
As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented directly by the Member States where oral almitrine is authorised, according to an agreed timetable which should be completed by 25 July 2013. 
Ker je skupina CMDh soglasno podprla priporočilo odbora PRAC, ga bodo odslej neposredno izvajale vse države članice, v katerih je odobren peroralni almitrin, v skladu z dogovorjenim časovnim razporedom, ki bo pripravljen do 25. julija 2013.
The safety review of oral almitrine was requested by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), because of concerns about side effects and a view that the available evidence did not support the use of the medicine in the current management of COPD. 
Francoska agencija za zdravila, Nacionalna agencija za varnost zdravil in medicinskih pripomočkov (ANSM), je zaprosila za varnostni pregled peroralnega almitrina zaradi pomislekov glede neželenih učinkov in stališča, da razpoložljivi dokazi niso podprli uporabe tega zdravila za trenutno obravnavo KOPB.
In line with the PRAC recommendation, the marketing authorisations for oral almitrine-containing medicines will be revoked in the affected Member States, which means that permission for the medicines to be marketed has been withdrawn. 
Skladno s priporočilom odbora PRAC se bodo dovoljenja za promet s peroralnimi zdravili, ki vsebujejo almitrin, odvzela v zadevnih državah članicah, kar pomeni, da se je dovoljenje za promet s temi zdravili umaknilo.
Of the spontaneous reports, 7 cases of weight loss and 20 of peripheral neuropathy had been reported since September 2003 when all these measures were in operation. 
Od septembra 2003, ko so uvedli vse te ukrepe, so spontano poročali o 7 primerih izgube telesne mase in 20 primerih periferne nevropatije.
• The safety review confirmed a clear association of oral almitrine therapy with significant weight loss and peripheral neuropathy (which can be long-lasting and possibly irreversible). 
• Varnostni pregled je potrdil jasno povezavo med zdravljenjem s peroralnim almitrinom in veliko izgubo telesne mase ter periferno nevropatijo (ki je lahko dolgotrajna in morebitno ireverzibilna).
• Pharmacists should refer patients presenting a new or repeat prescription to their treating physician. 
• Farmacevti morajo bolnike, ki imajo nov ali obnovljiv recept, napotiti k njihovim lečečim zdravnikom.
• Patients being treated with oral almitrine should have their treatment reviewed at the next scheduled appointment, and appropriate alternative treatments should be considered. 
• Zdravljenje bolnikov, ki jemljejo peroralni almitrin, je treba pregledati ob naslednjem načrtovanem obisku in razmisliti o uporabi drugih ustreznih oblik zdravljenja.
In the EU, it is authorised in France, Poland and Portugal as 50-mg tablets (Vectarion, Armanor) for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood). 
V EU je v obliki 50-miligramskih tablet (Vectarion, Armanor) odobren v Franciji, na Poljskem in Portugalskem, kjer se uporablja za zdravljenje kronične dihalne odpovedi (nezmožnosti pljuč za pravilen vnos kisika in izdihovanje ogljikovega dioksida), povezane s hipoksemijo (nižje ravni kisika v krvi od normalnih).
In the EU, it is authorised in France, Poland and Portugal to be taken orally for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood). 
V EU je odobren v Franciji, na Poljskem in Portugalskem, kjer se uporablja peroralno za zdravljenje kronične dihalne odpovedi (nezmožnosti pljuč za pravilen vnos kisika in izdihovanje ogljikovega dioksida), povezane s hipoksemijo (nižje ravni kisika v krvi od normalnih).
As the CMDh position was adopted by consensus, it will be directly implemented by the Member States where oral almitrine-containing medicines are authorised. 
Ker je skupina CMDh soglasno sprejela sklep, ga bodo neposredno izvajale države članice, v katerih so peroralna zdravila, ki vsebujejo almitrin, odobrena.
The company marketing almitrine identified 795 spontaneously reported cases of weight loss and 2,304 cases of peripheral neuropathy over the 30-year period that the medicine has been marketed (representing several million patient months of treatment). 
Imetnik dovoljenja za promet z almitrinom je v 30-letnem obdobju trženja zdravila (kar predstavlja več milijonov bolnikovih mesecev zdravljenja) odkril 795 spontano poročanih primerov izgube telesne mase in 2304 primerov periferne nevropatije.
This will depend on your individual situation. 
Ta bo odvisna od vaše individualne situacije.
However, a risk cannot be completely excluded. 
Vendar tveganja ni mogoče popolnoma izključiti.
Read the information carefully and follow the instructions. 
Informacije si pozorno preberite in sledite navodilom.
The usual doses are shown below. 
Običajni odmerki so prikazani spodaj.
Children aged 2 to 18 years 
Otroci (stari od 2 do 18 let)
Your doctor will have to advise you on what vaccines you can have. 
Vaš zdravnik vam bo svetoval, katera cepiva lahko prejmete.
The effect of sunlight 
Učinek sončne svetlobe
Take the medicine pack with you. 
S seboj vzemite škatlo zdravila.
• wearing protective clothing which also covers your head, neck, arms and legs 
• uporabljate zaščitna oblačila, ki pokrijejo tudi vašo glavo, vrat, roke in noge,
Your doctor will do regular blood tests to check for any changes in 
Vaš zdravnik bo izvajal redne preiskave krvi, da bo preverjal spremembe v:
• You have sex without using an effective method of contraception. 
• imate spolne odnose brez uporabe učinkovite metode kontracepcije.
Influenza vaccination may be of value. 
Cepljenje proti gripi je lahko koristno.
This means you may catch more infections than usual. 
To pomeni, da se lahko okužite pogosteje kot ponavadi.
Do this by: 
To storite tako, da:
These patients should also be carefully observed. 
Te bolnike moramo še posebej skrbno nadzorovati.
Usual problems 
Običajne težave
Do not take this medicine if any of the above applies to you. 
Ne jemljite tega zdravila, če karkoli izmed naštetega velja za vas.
Other unwanted effects may include: 
Drugi neželeni učinki lahko vključujejo:
In many of these cases, no adverse events were reported. 
Pri veliko teh primerov o neželenih dogodkih niso poročali.
Prescribers should refer to national guidelines for influenza vaccination. 
Predpisovalci se morajo ravnati po nacionalnih navodilih za cepljenje proti gripi.
• using a sunscreen with a high protection factor. 
• uporabljate sončne kreme z visokim zaščitnim faktorjem.
The amount you take depends on the type of transplant you have had. 
Količina ki jo vzamete, je odvisna od tipa presadka, ki ga imate.
If you are planning to have a child, talk to your doctor about the potential risks. 
Če nameravate imeti otroka, se pogovorite z zdravnikom o možnih tveganjih.
Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill. 
Čim prej se posvetujte z zdravnikom, če menite, da vaša kontracepcija morda ni bila učinkovita oziroma če ste pozabili vzeti kontracepcijsko tableto.
• the number of your blood cells 
• številu krvnih celic,
Hepatic transplant patients were followed for at least 1 year, but less than 3 years. 
Bolnikom z jetrnim presadkom so sledili vsaj 1 leto, vendar pa manj kot 3 leta.
As a result, there is an increased risk of skin cancer. 
Posledično obstaja zvečana možnost nastanka kožnega raka.
Date of latest renewal: 27 May 2015 
Datum zadnje revizije besedila: 27. maj 2015
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2010 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 7. oktober 2010
Guides should also mention that patients should not to give this drug to any other person. 
V vodnikih mora biti prav tako omenjeno, da bolniki ne smejo dati tega zdravila drugim osebam.
Effects of hepatic disease on this process probably depend on the particular disease. 
Učinki jetrne bolezni na ta proces so verjetno odvisni od vrste bolezni.
This is because small amounts of the medicine can pass into the mother's milk. 
Manjše količine zdravila namreč lahko prehajajo v materino mleko.
The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. 
Zdi se, da je tveganje bolj odvisno od intenzivnosti in trajanja imunosupresije kot od uporabe določene učinkovine.
See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”. 
Glejte tudi dodatne informacije v tem poglavju pod "Opozorila in previdnostni ukrepi" in "Nosečnost in dojenje".
Your doctor may request more than one test to ensure you are not pregnant before starting treatment. 
Zdravnik lahko zahteva več kot en test, da se pred začetkom zdravljenja zagotovi, da niste noseči.
Results of all pregnancy tests should be discussed with the patient. 
O rezultatih vseh testov nosečnosti se je treba pogovoriti z bolnico.
Contraception (see section 4.6) 
Kontracepcija (glejte poglavje 4.6)
These changes are not associated with impaired neutrophil function. 
Te spremembe niso povezane s slabšo funkcijo nevtrofilcev.
Talk to your doctor about the most suitable contraception for you. 
S svojim zdravnikom se pogovorite o izbiri kontracepcije, ki je za vas najbolj primerna.
There are limited safety and efficacy data in children below the age of 2 years. 
O varnosti in učinkovitosti pri otrocih, mlajših od dveh let je na voljo premalo podatkov.
If you forget to take your medicine at any time, take it as soon as you remember. 
Če ste pozabili vzeti zdravilo, ga vzemite takoj, ko se spomnite.
The proportion of patients with CMV viraemia/syndrome was 13.5 %. 
Delež bolnikov s sindromom CMV/viremijo je znašal 13,5 %.
Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if: 
Zdravnik se bo z vami pogovoril o tveganjih v primeru nosečnosti in drugih zdravilih, ki jih lahko jemljete za preprečitev zavrnitve vašega presadka, če:
This medicine does not require any special storage conditions. 
Zdravilo ne zahteva posebnih pogojev shranjevanja.
• rifampicin (an antibiotic used to prevent and treat infections such as tuberculosis) 
• rifampicin (antibiotik, ki se uporablja za preprečevanje in zdravljenje okužb, kot je tuberkuloza),
300 hard capsules 
300 trdih kapsul
If neutropenia develops (absolute neutrophil count < 1.3 x 10 
Če se pojavi nevtropenija (absolutno število nevtrofilcev < 1,3 x 10
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
PRILOGA II A. IZDELOVALCI ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Two forms of contraception are preferable as this will reduce the risk of unintended pregnancy. 
Priporočljivi sta dve obliki kontracepcije, ker to zmanjša tveganje nenamerne nosečnosti.
Pregnancy tests should be repeated as clinically required (e.g. after any gap in contraception is reported). 
Teste nosečnosti je treba ponavljati, kot je klinično primerno (npr. po kakršni koli vrzeli v kontracepciji).
Paediatric population Interaction studies have only been performed in adults. 
Pediatrični bolniki Študije medsebojnega delovanja so izvedli le pri odraslih.
For contraception advice for men see section 4.6. 
Za nasvete o kontracepciji za moške glejte poglavje 4.6.
• The dose given will vary depending on the size of the child. 
• Dani odmerek bo odvisen od velikosti otroka.
Then continue to take it at the usual times. 
Nato nadaljujte z jemanjem kot običajno.
• If this happens, wash the area thoroughly with soap and water. 
• Če se to zgodi, površino temeljito sperite z milom in vodo.
Live vaccines should not be given to patients with an impaired immune response. 
Živih cepiv ne smemo dajati bolnikom z oslabelim imunskim odzivom.
This effect tended to diminish with continued antibiotic use and to cease within a few days of antibiotic discontinuation. 
Ta učinek je pojemal z nadaljnjo uporabo antibiotikov in prenehal v nekaj dneh po ukinitvi antibiotikov.
The following malformations were most frequently reported: 
O naslednjih so poročali najpogosteje:
SPECIAL STORAGE CONDITIONS Store below 30 °C. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C.
Myclausen should be used together with other medicines: 
Zdravilo Myclausen je treba uporabljati skupaj z drugimi zdravili, kot so:
Calculations based on animal data show that the maximum amount of MPA that could potentially be transferred to woman is so low that it would be unlikely to have an effect. 
Izračuni, ki temeljijo na podatkih na živalih, kažejo, da je največja količina mofetilmikofenolata, ki bi se lahko prenesla na žensko, tako nizka, da ni verjetno, da bi imela učinek.
Live vaccines 
Živa cepiva
Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies. 
Zdravnik se bo z vami pogovoril in vam dal pisna navodila, zlasti o učinkih mofetilmikofenolata na nerojene otroke.
Store below 30 °C. 
Shranjujte pri temperaturi do 30 °C.
• cholestyramine (used to treat high cholesterol) 
• holestiramin (uporablja se za zdravljenje visokega holesterola),
The risk of bronchiectasis may be linked to hypogammaglobulinaemia or to a direct effect on the lung. 
Tveganje za bronhiektazijo je lahko povezano s hipogamaglobulinemijo ali z neposrednim učinkom na pljuča.
Also other medicines can affect the way Myclausen works. 
Prav tako lahko druga zdravila vplivajo na delovanje zdravila Myclausen.
Talk to a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment: 
Takoj obvestite zdravnika, če opazite katerega koli od naslednjih resnih neželenih učinkovmorda boste potrebovali nujno medicinsko pomoč:
You may get general side effects affecting your body as a whole. 
Pojavijo se lahko splošni neželeni učinki, ki prizadenejo celo telo.
There have also been reports of bronchiectasis in children and adults (frequency not known). 
Poročali so o primerih bronhiektazije pri otrocih in odraslih (pogostnost ni poznana).
• You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant. 
• vam je ali menite, da bi vam lahko izostala menstruacija, imate neobičajno menstrualno krvavitev ali sumite, da ste noseči;
Two complementary forms of contraception simultaneously are preferred. 
Priporočljivo je hkrati uporabljati dve zanesljivi obliki kontracepcije.
• Do not take any capsules that have broken open or split. 
• Ne zaužijte kapsul, ki so odprte ali poškodovane.
In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the medicinal product. 
Pri tistih primerih prevelikega odmerjanja, kjer so poročali o neželenih dogodkih, pa so ti sovpadali z znanim varnostnim profilom zdravila.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila prek nacionalnega centra za poročanje, ki je naveden v Prilogi V.
These effects can be related to the pharmacodynamic mode of action, i.e. inhibition of nucleotide synthesis in sensitive cells. 
Te učinke lahko povežemo s farmakodinamičnim načinom delovanja, to je zaviranje sinteze nukleotidov v občutljivih celicah.
Three-year safety data in renal and cardiac transplant patients did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data. 
Triletni podatki o varnosti pri bolnikih z ledvičnim in srčnim presadkom ne kažejo nobenih nepričakovanih sprememb v incidenci malignosti v primerjavi z enoletnimi podatki.
• feeling anxious or depressed, changes in your mood or thoughts. 
• občutek strahu ali depresija, spremembe v razpoloženju ali načinu mišljenja.
If you stop your treatment you may increase the chance of rejection of your transplanted organ. 
Če prenehate z zdravljenjem, lahko povečate možnost zavrnitve vašega presadka.
What Myclausen is and what it is used for 
Kaj je zdravilo Myclausen in za kaj ga uporabljamo
The antibody response to other vaccines may be diminished (see also section 4.4). 
Tudi odziv protiteles na druga cepiva je lahko zmanjšan (glejte tudi poglavje 4.4).
Additional precautions 
Dodatni previdnostni ukrepi
Serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection. 
Resne življenjsko nevarne okužbe vključno z meningitisom, endokarditisom, tuberkulozo in atipičnimi mikobakterijskimi okužbami.
The need to plan a pregnancy will be highlighted. 
Poudarjeno bo, da je nosečnost nujno načrtovati.
Urinary problems such as: • kidney problems or the urgent need to pass water (urine). 
Težave s sečili, kot so: • težave z ledvicami, nujna potreba po odvajanju vode (urina).
• the amount in your blood of things like sugar, fat or cholesterol. 
• količinah drugih snovi v krvi, kot so krvni sladkor, maščobe ali holesterol.
Treatment with Myclausen should be initiated and maintained by appropriately qualified transplant specialists. 
Zdravljenje z zdravilom Myclausen mora vpeljati in voditi ustrezen specialist za presaditve.
• phosphate binders (used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood). 
• fosfatne vezalce (jemljejo jih ljudje s kronično ledvično odpovedjo, da zmanjšajo količino fosfatov, ki se absorbirajo v kri).
The pharmacodynamic profile and the reported adverse reactions indicate that an effect is unlikely. 
Farmakodinamični profil in neželeni učinki, o katerih so poročali, kažejo na to, da vpliv ni verjeten.
• Ciclosporin and corticosteroids. 
• ciklosporin in kortikosteroidi.
In this leaflet the shorter name Myclausen is used. 
V tem navodilu se uporablja skrajšano ime Myclausen.
The information provided in this section will facilitate a correct understanding of the risk and explain the rationale for the following pregnancy prevention measures. 
Informacije v tem poglavju bodo olajšale pravilno razumevanje tveganja in utemeljile vzroke za upoštevanje ukrepov za preprečitev zanositve.
The need for subsequent pregnancy tests during treatment will also be explained. 
Pojasnjena bo tudi potreba po nadaljnjih testiranjih nosečnosti med zdravljenjem.
However, at high MPAG plasma concentrations (> 100 µg/mL), small amounts of MPAG are removed. 
Pri visokih koncentracijah mikofenolglukuronida v plazmi (> 100 μg/ml) se majhne količine mikofenolglukuronida vendarle odstranijo.
As general advice to minimise the risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor. 
Splošen nasvet za zmanjšanje tveganja nastanka kožnega raka je, da se bolniki ne izpostavljajo soncu in UV-svetlobi brez uporabe zaščitne obleke in sončne kreme z visokim zaščitnim faktorjem.
As a result, your body will not be as good as normal at fighting infections. 
Posledično se vaš organizem ne bo sposoben ubraniti okužb, kot bi se sicer.
If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. 
Če teh navodil ne boste popolnoma razumeli, se posvetujte s svojim zdravnikom, da vam jih bo ponovno razložil, preden boste vzeli mofetilmikofenolat.
• pneumonia, bronchitis 
• pljučnica, bronhitis,