natgillin/translations-raw huggingface dataset:
Axura was compared with placebo (a dummy treatment) over 24 to 28 weeks.
Zdravilo Axura so primerjali s placebom (zdravilom brez zdravilne učinkovine) v obdobju 24 do 28 tednov.
Axura is used to treat patients with moderate to severe Alzheimer's disease.
Zdravilo Axura se uporablja za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
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 Axura.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Axura, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease.
Spremembe načina, kako glutamat prenaša signale v možganih, se povezujejo z izgubo spomina, kakršno opažamo pri Alzheimerjevi bolezni.
EPAR summary for the public memantine hydrochloride
Povzetek EPAR za javnost memantinijev klorid
Treatment should only be started if a caregiver is available who will regularly monitor the use of Axura by the patient.
Zdravljenje se sme uvesti samo, če je na voljo negovalec, ki bo redno spremljal bolnikovo jemanje zdravila Axura.
Axura must not be used in people who are hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients.
Zdravila Axura ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) memantinijev klorid ali katero koli drugo sestavino zdravila.
Axura was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Zdravilo Axura so proučevali še v treh dodatnih študijah, ki so vključevale skupno 1 186 bolnikov z blago do hudo boleznijo.
Axura is also available as an oral solution, which is supplied with a pump that delivers 5 mg memantine hydrochloride with each activation.
Zdravilo Axura je na voljo tudi kot peroralna raztopina z dodano črpalko, ki dovaja 5 mg memantinijevega klorida ob vsakem črpanju.
In the two studies of mild to moderate disease, patients on Axura had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
V dveh študijah blage do zmerne bolezni so imeli bolniki, ki so prejemali zdravilo Axura, po 24 tednih manj hudih simptomov, merjeno z globalnimi in kognitivnimi merili.
What is the risk associated with Axura?
Kakšna tveganja so povezana z zdravilom Axura?
The CHMP decided that Axura's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Axura večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
In the study of moderately severe to severe disease, patients taking Axura had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
V študiji z bolniki z zmerno hudo do hudo boleznijo je bilo po 28 tednih pri bolnikih, ki so jemali zdravilo Axura, ugotovljenih manj simptomov kot pri bolnikih, ki so jemali placebo, merjeno z globalnimi in funkcionalnimi merili.
Axura is a medicine that contains the active substance memantine hydrochloride.
Axura je zdravilo, ki vsebuje zdravilno učinkovino memantinijev klorid.
For the full list of all side effects reported with Axura, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Axura, glejte navodilo za uporabo.
The active substance in Axura, memantine hydrochloride, is an antidementia medicine.
Zdravilna učinkovina zdravila Axura, memantinijev klorid, je zdravilo za zdravljenje demence.
Why has Axura been approved?
Zakaj je bilo zdravilo Axura odobreno?
What is Axura used for?
Za kaj se zdravilo Axura uporablja?
How has Axura been studied?
Kako je bilo zdravilo Axura raziskano?
What is Axura?
Kaj je zdravilo Axura?
How is Axura used?
Kako se zdravilo Axura uporablja?
How does Axura work?
Kako zdravilo Axura deluje?
The full EPAR for Imatinib medac 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 Imatinib medac je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is also used in children in the ‘chronic phase' of the disease if it is not responding to interferon alpha (another anticancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis').
Uporablja se tudi pri otrocih v „kronični fazi“ bolezni, če se ta ne odziva na zdravljenje z interferonom alfa (drugim zdravilom proti raku), in v bolj napredovalih fazah bolezni („pospešeni fazi“ ter „blastni krizi“);
Imatinib medac is available as capsules (100 and 400 mg).
Zdravilo Imatinib medac je na voljo v obliki kapsul (100 in 400 mg).
The dose depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Odmerjanje je odvisno od zdravljene bolezni, starosti in stanja bolnika ter odziva na zdravljenje, vendar ne sme preseči 800 mg na dan. Za več informacij glejte navodilo za uporabo.
The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib medac on 25 September 2013.
Evropska komisija je dovoljenje za promet z zdravilom Imatinib medac, veljavno po vsej Evropski uniji, izdala 25. septembra 2013.
This means that it blocks some specific enzymes known as tyrosine kinases.
To pomeni, da zavira določene encime, imenovane tirozin kinaze.
This is a summary of the European public assessment report (EPAR) for Imatinib medac.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Imatinib medac.
What measures are being taken to ensure the safe and effective use of Imatinib medac?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imatinib medac?
It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
Prav tako se pri odraslih uporablja tudi samostojno za zdravljenje ALL Ph+, ki se je po predhodnem zdravljenju ponovno pojavila ali se ne odziva na druga zdravila;
The Committee recommended that Imatinib medac be approved for use in the EU.
Priporočil je, da se zdravilo Imatinib medac odobri za uporabo v EU.
This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
To pomeni, da je prišlo do prerazporeditve nekaterih genov, s čimer je nastal poseben kromosom, imenovan kromosom Philadelphia.
This means that Imatinib medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Glivec.
It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours.
Zdravljenje mora uvesti zdravnik z izkušnjami z zdravljenjem bolnikov s krvnim rakom ali trdnimi tumorji.
These enzymes can be found in certain receptors in cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Ti encimi se nahajajo v določenih receptorjih v rakavih celicah, med drugim tudi v receptorjih, ki pospešujejo nenadzorovano deljenje celic.
What are the benefits and risks of Imatinib medac?
Kakšne so koristi in tveganja, povezani z zdravilom Imatinib medac?
By blocking these receptors, Imatinib medac helps to control cell division.
Z zaviranjem teh receptorjev zdravilo Imatinib medac pomaga nadzorovati delitev celic.
Because Imatinib medac is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Imatinib medac generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
A risk management plan has been developed to ensure that Imatinib medac is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Imatinib medac je bil pripravljen načrt obvladovanja tveganj.
Imatinib medac is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Zdravilo Imatinib medac se uporablja za zdravljenje odraslih z DFSP, ki ga ni mogoče kirurško odstraniti, in odraslih, ki niso primerni za kirurški poseg, če se je rak po zdravljenju ponovil ali razširil v druge dele telesa.
Imatinib medac is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Zdravilo Imatinib medac se uporablja za zdravljenje odraslih s HES ali KEL, ki imajo specifično prerazporeditev dveh genov, imenovanih FIP1L1 in PDGFRα;
Therefore, the CHMP's view was that, as for Glivec, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi, tako kot pri zdravilu Glivec, odtehtajo znana tveganja.
For more information about treatment with Imatinib medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Imatinib medac preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Imatinib medac is a ‘generic medicine'.
Imatinib medac je „generično zdravilo“.
What is Imatinib medac and what is it used for?
Kaj je zdravilo Imatinib medac in za kaj se uporablja?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib medac has been shown to have comparable quality and to be bioequivalent to Glivec.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Imatinib medac primerljivo raven kakovosti kot referenčno zdravilo ter da mu je biološko enakovredno.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imatinib medac, including the appropriate precautions to be followed by healthcare professionals and patients.
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.
Imatinib medac is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Zdravilo Imatinib medac se zaužije peroralno z obrokom hrane in velikim kozarcem vode, da se zmanjša tveganje za draženje želodca in črevesja.
For practical information about using Imatinib medac, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Imatinib medac naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
• Adults with dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
• odraslih s protuberantnim dermatofibrosarkomom (DFSP), tj. vrsto raka (sarkoma), pri katerem se celice v tkivu pod kožo nenadzorovano delijo.
Because Imatinib medac is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Glivec.
Ker je zdravilo Imatinib medac generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Glivec.
The active substance in Imatinib medac, imatinib, is a protein-tyrosine kinase inhibitor.
Zdravilna učinkovina zdravila Imatinib medac, imatinib, je zaviralec protein-tirozin-kinaze.
• Adults with myelodysplastic or myeloproliferative diseases (MDS/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
• odraslih z mielodisplastičnimi ali mieloproliferativnimi boleznimi (MD/MPB), tj. skupino bolezni, pri katerih telo proizvaja veliko število nenormalnih krvnih celic.
Imatinib medac is used to treat adults with MDS/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Zdravilo Imatinib medac se uporablja za zdravljenje odraslih z MD/MPB, pri katerih pride do prerazporeditve gena za receptor za rastni faktor iz trombocitov (PDGFR);
Imatinib medac is used in combination with other anticancer medicines in patients who have been newly diagnosed with Ph+ ALL.
Zdravilo Imatinib medac se uporablja v kombinaciji z drugimi zdravili proti raku pri bolnikih z na novo postavljeno diagnozo ALL Ph+.
• Adults with Ph+ CML in blast crisis;
• odraslih s s kronično mieloično levkemijo s kromosomom Philadelphia (KML Ph+) v blastni krizi;
Other information about Imatinib medac
Druge informacije o zdravilu Imatinib medac
Imatinib medac is an anticancer medicine that contains the active substance imatinib.
Imatinib medac je zdravilo proti raku, ki vsebuje zdravilno učinkovino imatinib.
Imatinib medac is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Zdravilo Imatinib medac se uporablja pri bolnikih s kromosomom Philadelphia (Ph+).
• Adults and children with Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
• odraslih in otrok z akutno limfoblastno levkemijo (ALL) s kromosomom Philadelphia, tj. vrsto raka, pri katerem se limfociti (druga vrsta belih krvničk) razmnožujejo prehitro.
Imatinib medac is used in children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant.
Zdravilo Imatinib medac se uporablja pri otrocih z na novo postavljeno diagnozo KML Ph+, pri katerih presaditve kostnega mozga ni možno izvesti.
• Adults with advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
• odraslih z napredovalim hipereozinofilnim sindromom (HES) ali kronično eozinofilno levkemijo (KEL), tj. boleznima, pri kateri se eozinofilci (vrsta belih krvničk) začnejo nenadzorovano razraščati.
• Children with chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control.
• otrok s kronično mieloično levkemijo (KML), tj. rakom belih krvničk, pri katerem se granulociti (vrsta belih krvničk) začnejo nenadzorovano razraščati.
Why is Imatinib medac approved?
Zakaj je bilo zdravilo Imatinib medac odobreno?
It is not intended to provide practical advice on how to use Imatinib medac.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How has Imatinib medac been studied?
Kako je bilo zdravilo Imatinib medac raziskano?
How does Imatinib medac work?
Kako zdravilo Imatinib medac deluje?
How is Imatinib medac used?
Kako se zdravilo Imatinib medac uporablja?
Allergic-type reactions are rare.
Alergične reakcije so redke.
EXP: {month/year}
Exp : {mesec/leto}
ATC vet code : QI07AO01.
Oznaka ATC vet koda : QI07AO01.
For the full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glej poglavje 6.1.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti v živih živalih ali v živilih ali v drugih proizvodih, pridobljenih iz zdravljenih živali.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
Vaccination should not prevent other measures taken to reduce exposure to sandflies.
Cepljenje ne sme ovirati ukrepov za zmanjšanje izpostavljenosti peščeni mušici.
Pharmacotherapeutic group: Immunologicals for canidae - dog - inactivated parasitic vaccine.
Farmakoterapevtska skupina: Imunološka zdravila za Canidae - pse - inaktivirano parazitno cepivo.
In very rare cases, serious hypersensitivity reactions have been observed which could be fatal.
V zelo redkih primerih so opazili hude hipersenzitivne reakcije, ki so lahko usodne.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 2 leti.
After injection, moderate and transient local reactions such as swelling, nodule, pain on palpation or erythema are common, but these reactions resolve spontaneously within 2 to 15 days.
Po dajanju so običajne zmerne in prehodne lokalne reakcije, kot so oteklina, vozlički, bolečina na otipavanje ali eritem, toda te reakcije spontano minejo v 2 do 15 dneh.
In very rare cases a more severe reaction at the injection site (injection site necrosis, vasculitis) has been reported.
V izjemno redkih primerih so poročali, da je na mestu injiciranja prišlo do močnejše reakcije (nekroza injiciranega mesta, vaskulitis).
Antibodies due to vaccination can be differentiated from antibodies due to natural infection by using a rapid diagnostic serological test as a first step to a differential diagnosis.
Protitelesa, ki se pojavijo zaradi cepljenja, je mogoče razlikovati od protiteles, ki se pojavijo zaradi naravne okuženosti, z uporabo hitrih diagnostičnih seroloških testov, kot prvi korak za diferencialno diagnozo.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Za vse informacije o tem zdravilu za uporabo v veterinarski medicini se obrnite na lokalnega predstavnika imetnika dovoljenja za promet.
Vaccinate only healthy animals.
Cepite le zdrave živali.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO »SAMO ZA ŽIVALI« IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
Onset of immunity: 4 weeks after the primary vaccination course.
Nastop imunosti: 4 tedne po primarnem cepljenju.
Any person intending to import, sell, supply and/or use CaniLeish must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati CaniLeish, se mora posvetovati s pristojnimi organi države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ali uporabo.
In order to facilitate the quick implementation of such treatment, should an anaphylactic reaction occur, an observation of the dog by the owner during the hours following vaccination is recommended.
Da bi olajšali hitro izvedbo takega zdravljenja, če bi se morda pojavila anafilaktična reakcija, priporočamo, da lastnik opazuje psa nekaj ur po cepljenju .
In dogs developing a leishmaniosis (active infection and/or disease) despite vaccination, proceeding with vaccine injections showed no benefit.
Za pse, ki so kljub cepljenju razvili leishmaniozo (aktivno okuženost in/ali bolezen), nadaljevanje dajanja cepiva ni pokazalo nobene koristi.
The impact of the vaccine in terms of public health and control of the human infection cannot be estimated from available data.
Vpliva cepiva na zdravje ljudi in obvladovanje okuženosti ljudi ni mogoče oceniti iz razpoložljivih podatkov.
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Ne uporabljajte v primeru preobčutljivosti na zdravilno učinkovino, dodatek ali katere koli pomožne snovi.
• an enhancement of the leishmanicidal activity of the macrophages,
• povečanje dejavnosti leismanocidnih makrofagov,
Other transient signs seen following vaccination such as hyperthermia, apathy and digestive disorders lasting 1 to 6 days are common.
Po cepljenju so običajni tudi drugi prehodni znaki, kot so hipertermija, apatija, prebavne motnje, ki trajajo od 1 do 6 dni.
The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure in zones with high infection pressure.
Učinkovitost cepiva je bila dokazana pri psih, ki so bili izpostavljeni številnim naravnim parazitom na območjih, kjer je okuženost zelo razširjena.
Read the package leaflet before use.
Pred uporabo preberite navodila.
• a positive T-cell-mediated immune response, directed against the Leishmanian antigen (skin test).
• pozitiven T-limfocitni imunski odziv, neposredno proti Leishmania antigenu(kožni test).
In areas of low or no infection pressure a benefit/risk assessment must be undertaken by the veterinarian before deciding to use the vaccine in dogs.
Na območjih, kjer je okuženost nizka ali je sploh ni, mora veterinar oceniti razmerje korist/tveganje, preden se odloči za uporabo cepiva pri psih.
The import, sale, supply and/or use of CaniLeish is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Uvoz, prodaja, oskrba in/ali uporaba CaniLeish je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Vaccination induces a cell-mediated immunity evidenced by:
Dejstvo, da cepljenje inducira celično posredovano imunost dokazuje sledeče:
THE WORDS “FOR ANIMAL TREATMENT ONLY”
BESEDILO »SAMO ZA ŽIVALI«
• the appearance of specific IgG2 antibodies to Leishmania infantum excreted secreted proteins,
• pojavljanje specifičnih IgG2 protiteles proti Leishmania infantumekskrecijsko-sekrecijskim proteinom,
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini..
The efficacy of vaccination in dogs already infected has not been investigated and therefore cannot be recommended.
Učinkovitost cepiva pri že okuženih psih ni bila proučena, zato cepljenje ni priporočljivo.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
POGOJI IN OMEJITVE GLEDE OSKRBE IN UPORABE
The appearance of the reconstituted product is reddish-brown.
Izgled rekonstituiranega zdravila je rdeče-rjave barve.
Store and transport refrigerated (2 C - 8 C).
Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Varnost zdravila za uporabo v veterinarski medicini med brejostjo in laktacijo ni bila ugotovljena.