natgillin/translations-raw huggingface dataset:
Recordati Rare Diseases Immeuble "Le Wilson" 70, avenue du Général de Gaulle F-92800 Puteaux France
Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F - 92800 Puteaux Francija
Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du General de Gaulle F-92 800 Puteaux France
Imetnik dovoljenja za promet z zdravilom Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F - 92800 Puteaux
This overview was last updated in October 2019.
Povzetek zdravila je bil nazadnje posodobljen oktobra 2019.
A single treatment is required however the full effect may only be seen 28 days later.
Potrebno je eno samo zdravljenje, vendar pa se lahko učinek v celoti pokaže šele 28 dni pozneje.
Other information about Neptra
Druge informacije o zdravilu Neptra
The European Medicines Agency decided that Neptra's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila Neptra večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The inside of the ear should be cleaned and dry before treatment.
Notranjost ušesa je treba pred zdravljenjem očistiti in posušiti.
Further information on Neptra can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/neptra.
Nadaljnje informacije o zdravilu Neptra so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/neptra.
The contents of one tube are given into each infected ear.
V vsako okuženo uho se nanese vsebina ene tube.
In case of accidental eye exposure, the eyes should be flushed thoroughly with water for 10 to 15 minutes.
V primeru nenamernega stika z očmi je treba temeljito izpirati oči z vodo od 10 do 15 minut.
What benefits of Neptra have been shown in studies?
Kakšne koristi zdravila Neptra so se pokazale v študijah?
Although no potential for skin irritation was indicated by studies, skin contact should be avoided.
Čeprav študije niso pokazale možnosti draženja kože, se je treba izogibati stiku s kožo.
Neptra received a marketing authorisation valid throughout the EU on 10 December 2019.
Zdravilo Neptra je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 10/12/2019.
Why is Neptra authorised in the EU?
Zakaj je zdravilo Neptra odobreno v EU?
This was more effective than the control group of 27 dogs, which received a placebo (dummy treatment) and for which the reduction was 49%.
To je bilo učinkovitejše kot pri kontrolni skupini 27 psov, ki so prejeli placebo (zdravilo brez učinkovine) in pri katerih se je klinična ocena zmanjšala za 49 %.
Two of the active substances in Neptra, florfenicol and terbinafine, act against possible causes of infection.
Dve od učinkovin v zdravilu Neptra, florfenikol in terbinafin, učinkujeta proti mogočim vzrokom okužbe.
What are the risks associated with Neptra?
Kakšna tveganja so povezana z zdravilom Neptra?
The third active substance, mometasone, is a corticosteroid, a medicine that reduces inflammation and pain associated with the infection.
Tretja učinkovina, mometazon, je kortikosteroid, zdravilo, ki zmanjšuje vnetje in bolečino, ki sta povezana z okužbo.
It is therefore recommended that this medicine is applied only by veterinarians or under their close supervision and that measures are taken to reduce the risk (e.g. wearing safety glasses during treatment, massaging the ear canal well after application to ensure even distribution of product, restraining the dog after application).
Zato se priporoča, da to zdravilo dajejo samo veterinarji ali da se uporablja pod njihovim neposrednim nadzorom in da se sprejmejo ukrepi za zmanjšanje tveganja (npr. uporaba zaščitnih očal pri dajanju zdravila, dobro masiranje ušesnega kanala po dajanju, da se zagotovi enakomerna porazdelitev zdravila, z omejevanjem gibanja psa po dajanju zdravila).
Florfenicol is an antibiotic which works by blocking the production of proteins, which are essential components of bacterial cell walls.
Florfenikol je antibiotik, ki učinkuje tako, da zavira tvorbo beljakovin, ki so osnovni gradniki bakterijskih celičnih sten.
An overview of Neptra and why it is authorised in the EU
Pregled zdravila Neptra in zakaj je odobreno v EU
What is Neptra and what is it used for?
Kaj je zdravilo Neptra in za kaj se uporablja?
In case of accidental skin contact, exposed skin should be thoroughly washed with water.
V primeru nenamernega stika s kožo je treba izpostavljeno kožo temeljito sprati z vodo.
In a field study in Europe involving dogs with ear infections with both Staphylococcus pseudintermedius and Malassezia pachydermatitis 43 Neptra treated dogs had their signs of infection reduced by 71% after 28 days which was as effective as the comparator group of 45 dogs, treated with another veterinary medicine authorised for ear infections, for which the reduction was 74%.
V terenski študiji v Evropi, v katero so bili vključeni psi z okužbami ušes z bakterijo Staphylococcus pseudintermedius in z glivico Malassezia pachydermatitis, so se znaki okužbe pri 43 psih, zdravljenih z zdravilom Neptra, po 28 dneveh zmanjšali za 71 %, kar je bilo enako učinkovito kot pri primerjalni skupini 45 psov, zdravljenih z drugim zdravilom za uporabo v veterinarski medicini, ki je odobreno za zdravljenje okužb ušes, pri katerem je bilo zmanjšanje 74-odstotno.
Neptra (florfenicol / terbinafine / mometasone) EMA/560411/2019
Neptra (florfenikol/terbinafin/mometazon) EMA/687952/2019
For more information about using Neptra, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Neptra glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
Side effects with Neptra occur very rarely, with the most often reported (which may affect up to 1 in 10,000 dogs) being whining, head shaking, nystagmus (uncontrolled eye movements), vomiting, inner ear disorders causing imbalance, loss of appetite, hyperactivity and application site pain and inflammation shortly after applying the medicine.
Neželeni učinki zdravila Neptra se pojavijo zelo redko; najpogosteje (ki se lahko pojavijo pri največ 1 psu od 10 000) so poročali o cviljenju, stresanju z glavo, nistagmusu (nenadzorovanih premikih oči), bruhanju, motnjah notranjega ušesa, ki povzročajo neravnotežje, izgubi teka, hiperaktivnosti ter bolečini in vnetju na mestu nanosa kmalu po uporabi zdravila.
Terbinafine kills fungi by blocking the formation of ergosterol, an important part of fungal cell walls.
Terbinafin ubija glive z zaviranjem tvorbe ergosterola, pomembnega dela glivičnih celičnih sten.
Neptra must not be used in dogs who are allergic to the active substances, to other corticosteroids or to any of the other ingredients.
Zdravilo Neptra se ne sme uporabljati pri psih, ki so alergični na učinkovine, druge kortikosteroide ali katero koli drugo sestavino zdravila.
In a field study in the US involving dogs again with ear infections due to both organisms, 67 dogs treated with Neptra had a reduction in clinical score of 77% over 30 days.
V terenski študiji v ZDA, v katero so bili prav tako vključeni psi z okužbami ušes zaradi obeh organizmov, se je klinična ocena pri 67 psih, zdravljenih z zdravilom Neptra, v 30 dneh zmanjšala za 77 %.
Neptra is a veterinary medicine used to treat dogs with short lived or recurrent ear infections (otitis externa) caused by two organisms: Staphylococcus pseudintermedius (a bacterium) and Malassezia pachydermatitis (a yeast).
Neptra je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zdravljenje psov s kratkotrajnimi ali ponavljajočimi se okužbami ušes (otitis externa), ki jih povzročata dva organizma: Staphylococcus pseudintermedius (bakterija) in Malassezia pachydermatitis (glivica).
Neptra may be harmful after swallowing.
Zdravilo Neptra je lahko škodljivo po zaužitju.
It must also not be used if the ear drum is perforated, in dogs with generalised demodectic mange (skin infestation caused by a specific type of mite) or in pregnant or breeding animals.
Prav tako se ne sme uporabljati v primeru predrtega bobniča, pri psih z generalizirano demodikozo (infestacijo kože s posebno vrsto pršice) ter pri brejih ali vzrejnih živalih.
The medicine is available as ear drops and can only be obtained with a prescription.
Zdravilo je na voljo v obliki ušesnih kapljic, njegovo predpisovanje in izdaja pa je le na recept.
If symptoms develop, medical advice should be sought and the package leaflet or the label shown to the doctor.
Če se pojavijo simptomi, je treba poiskati zdravniško pomoč in zdravniku pokazati navodilo za uporabo ali nalepko.
Neptra contains three active substances: florfenicol, terbinafine and mometasone.
Zdravilo Neptra vsebuje tri učinkovine: florfenikol, terbinafin in mometazon.
How does Neptra work?
Kako zdravilo Neptra deluje?
Avoid swallowing the product or accidentally transferring it from hand to mouth.
Izogibajte se zaužitju zdravila in nenamernemu vnosu preko rok v usta.
How is Neptra used?
Kako se zdravilo Neptra uporablja?
In case of accidental swallowing medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
V primeru nenamernega zaužitja nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
Neptra can cause serious eye irritation if it accidentally gets into the eyes when the dog shakes its head during or just after application.
Če zdravilo Neptra nenamerno pride v oči, ko pes med dajanjem zdravila ali tik po njem stresa z glavo, lahko povzroči resno draženje oči.
The medicine must not be given to patients who have a severe infection.
Zdravilo se ne sme dajati bolnikom z resno okužbo.
Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Agencija bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in po potrebi posodobila ta pregled.
Serious side effects can occur; however, these are manageable if appropriate measures are in place.
Lahko se pojavijo resni neželeni učinki, vendar so ob ustreznih ukrepih obvladljivi.
What measures are being taken to ensure the safe and effective use of Polivy?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Polivy?
The Agency therefore decided that Polivy's benefits are greater than its risks and it can be authorised for use in the EU.
Agencija je zato zaključila, da so koristi zdravila Polivy večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
Other information about Polivy
Druge informacije o zdravilu Polivy
Although the study included a limited number of patients and more data are needed to confirm the results, the European Medicines Agency considered that Polivy meets an unmet medical need.
Čeprav je študija vključevala omejeno število bolnikov in je za potrditev rezultatov potrebnih več podatkov, je Evropska agencija za zdravila ocenila, da zdravilo Polivy izpolnjuje neizpolnjeno medicinsko potrebo.
As for all medicines, data on the use of Polivy are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Polivy stalno spremljajo.
If the patient develops an infusion-related reaction, the infusion should be slowed down or interrupted.
Če se pri bolniku pojavi z infuzijo povezana reakcija, je treba infundiranje upočasniti ali prekiniti.
Why is Polivy authorised in the EU?
Zakaj je bilo zdravilo Polivy odobreno v EU?
Polivy has been given a ‘conditional authorisation'.
Zdravilo Polivy je pridobilo „pogojno dovoljenje za promet“.
Polivy can affect the production of blood cells.
Zdravilo Polivy lahko vpliva na nastajanje krvnih celic.
MMAE then stops the B cells from dividing and causes them to die.
MMAE nato prepreči delitev celic B in povzroči njihovo odmrtje.
An overview of Polivy and why it is authorised in the EU
Pregled zdravila Polivy in zakaj je odobreno v EU
The dose of Polivy depends on the patient's bodyweight and is given for 6 cycles.
Odmerek zdravila Polivy je odvisen od bolnikove telesne mase in se daje šest ciklov.
What is Polivy and what is it used for?
Kaj je zdravilo Polivy in za kaj se uporablja?
Polivy is for infusion (drip) into a vein over 90 minutes.
Zdravilo Polivy je namenjeno infundiranju (kapalni infuziji) v veno v trajanju 90 minut.
What are the risks associated with Polivy?
Kakšna tveganja so povezana z zdravilom Polivy?
What benefits of Polivy have been shown in studies?
Kakšne koristi zdravila Polivy so se pokazale v študijah?
The main study showed that Polivy is effective at treating patients whose disease was not responding to previous treatment or had returned and who could not have a transplant.
Glavna študija je pokazala, da je zdravilo Polivy učinkovito pri zdravljenju bolnikov, pri katerih se bolezen ni odzvala na predhodno zdravljenje ali se je ponovila in pri katerih presaditev ni mogoča.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Polivy have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Polivy upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Polivy are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Polivy, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
It is used in combination with two other medicines, bendamustine and rituximab.
Uporablja se v kombinaciji z dvema drugima zdraviloma, bendamustinom in rituksimabom.
It is given in 21-day cycles with rituximab and bendamustine.
Daje se v 21dnevnih ciklih skupaj z rituksimabom in bendamustinom.
For more information about using Polivy, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Polivy glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What information is still awaited for Polivy?
Katere informacije o zdravilu Polivy še pričakujemo?
Since Polivy has been given conditional authorisation, the company that markets Polivy will provide further data on its effects to confirm Polivy's safety and effectiveness when used in combination with other cancer medicines in patients with DLBCL.
Ker je zdravilo Polivy prejelo pogojno dovoljenje za promet, bo podjetje, ki ga trži, zagotovilo dodatne podatke o njegovih učinkih, da bi potrdili učinkovitost in varnost zdravila Polivy, kadar se pri bolnikih z difuznim velikoceličnim limfomom B uporablja v kombinaciji z drugimi zdravili proti raku.
Polivy can only be obtained with a prescription, and treatment must be given under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer.
Predpisovanje in izdaja zdravila Polivy je le na recept, zdravljenje z njim pa se mora izvajati pod nadzorom zdravnika, ki ima izkušnje z diagnostiko in zdravljenjem raka.
After 6 to 8 weeks of treatment, there were no signs of the cancer (complete response) in 40% of patients receiving Polivy plus rituximab and bendamustine compared with 18% of patients receiving rituximab and bendamustine alone.
Po šestih do osmih tednih zdravljenja znakov raka ni bilo več (popolni odziv) pri 40 % bolnikov, ki so prejemali zdravilo Polivy v kombinaciji z rituksimabom in bendamustinom, in pri 18 % bolnikov, ki so prejemali samo rituksimab in bendamustin.
The monoclonal antibody attaches to a protein called CD79b on B cells, including cancerous B cells, and in doing so causes MMAE to be released inside them.
Monoklonsko protitelo se veže na beljakovino CD79b, prisotno na celicah B, vključno z rakavimi celicami B, pri tem pa vanje sprosti MMAE.
Serious side effects (which may affect up to 1 in 10 people) include febrile neutropenia (low white blood cell count with fever), fever, and pneumonia (infection of the lungs).
Resni neželeni učinki (ki se lahko pojavijo pri največ 1 od 10 bolnikov) vključujejo febrilno nevtropenijo (nizko raven belih krvnih celic s povišano telesno temperaturo), povišano telesno temperaturo in pljučnico (okužbo pljuč).
The active substance in Polivy, polatuzumab vedotin, is made up of a monoclonal antibody (a type of protein) combined with a substance called monomethyl auristatin E (MMAE).
Učinkovina v zdravilu Polivy, polatuzumab vedotin, je sestavljena iz monoklonskega protitelesa (vrste beljakovine) v kombinaciji s snovjo, imenovano monometil avristatin E (MMAE).
DLBCL is rare, and Polivy was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 April 2018.
Difuzni velikocelični limfom B je redka bolezen, zato je bilo zdravilo Polivy 16. aprila 2018 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Polivy is a cancer medicine used to treat adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has stopped responding to other treatments and who cannot have a bonemarrow transplantation.
Polivy je zdravilo proti raku, ki se uporablja za zdravljenje odraslih z difuznim velikoceličnim limfomom B, pri katerih se je rak ponovil ali se je prenehal odzivati na druga zdravljenja in pri katerih ni mogoče opraviti presaditve kostnega mozga.
Polivy received a conditional marketing authorisation valid throughout the EU on 16 January 2020 Further information on Polivy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/polivy.
Nadaljnje informacije za zdravilo Polivy so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/polivy.
For the full list of side effects and restrictions of Polivy, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Polivy glejte navodilo za uporabo.
The most common side effects with Polivy in combination with bendamustin and rituximab (which may affect more than 3 in 10 people) were anaemia (low red blood cell count), thrombocytopenia (low blood platelet count), neutropenia (low white blood cell count), tiredness, diarrhoea, nausea (feeling sick) and fever.
Najpogostejši neželeni učinki zdravila Polivy v kombinaciji z bendamustinom in rituksimabom (ki se lahko pojavijo pri več kot 3 od 10 bolnikov) so bili anemija (nizka raven rdečih krvnih celic), trombocitopenija (nizka raven trombocitov), nevtropenija (nizka raven belih krvnih celic), utrujenost, driska, navzeja (siljenje na bruhanje) in povišana telesna temperatura.
How does Polivy work?
Kako zdravilo Polivy deluje?
Patients with DLBCL have cancerous B cells, which are a type of white blood cell.
Pri bolnikih z difuznim velikoceličnim limfomom B so celice B, tj. vrsta belih krvnih celic, rakave.
How is Polivy used?
Kako se zdravilo Polivy uporablja?
Patients are given paracetamol and an antihistamine medicine before receiving Polivy to reduce the risk of reactions to the infusion.
Za zmanjšanje tveganja za pojav reakcij, povezanih z infuzijo, bolniki pred zdravljenjem z zdravilom Polivy prejmejo paracetamol in antihistaminik.
Half of the patients received Polivy added to the standard regimen of bendamustine plus rituximab whereas the other half received bendamustine plus rituximab alone.
Zdravilo Polivy so preučevali v študiji, ki je vključevala 80 bolnikov z difuznim velikoceličnim limfomom B. Polovica bolnikov je prejemala zdravilo Polivy, dodano standardnemu režimu z bendamustinom in rituksimabom, druga polovica pa je prejemala samo bendamustin in rituksimab.
The doctor may reduce or stop the dose of Polivy if the patient develops side effects affecting blood cells.
Če se pri bolniku pojavijo neželeni učinki, ki vplivajo na krvne celice, lahko zdravnik zmanjša odmerek zdravila Polivy ali prekine zdravljenje.
Polivy contains the active substance polatuzumab vedotin.
Zdravilo Polivy vsebuje učinkovino polatuzumab vedotin.
This was confirmed in the fourth study.
To je potrdila tudi četrta študija.
This summary was last updated in 03-2009.
Povzetek je bil nazadnje posodobljen 03-2009.
The marketing authorisation was renewed on 14 February 2001 and on 14 February 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano 14. februarja 2001 in 14. februarja 2006.
It is available as white, round tablets (60 mg).
Na voljo je v obliki belih okroglih tablet (60 mg).
The marketing authorisation holder is Orion Corporation.
Imetnik dovoljenja za promet z zdravilom je družba Orion Corporation.
‘Metastatic' means that the cancer has spread to other parts of the body.
Beseda „metastatski“ pomeni, da se je rak že razširil na druge dele telesa.
The recommended dose of Fareston is one tablet once a day.
Priporočeni odmerek zdravila Fareston je ena tableta enkrat dnevno.
Other information about Fareston:
Druge informacije o zdravilu Fareston:
The main measures of effectiveness were response rate (the number of patients whose tumours responded to treatment), time to progression (the length of time until the disease got worse) and survival.
Glavna merila učinkovitosti so bila stopnja odziva (število bolnic, pri katerih so se tumorji odzvali na zdravljenje), čas do napredovanja bolezni (čas do poslabšanja bolezni) in preživetje.
The European Commission granted a marketing authorisation valid throughout the European Union for Fareston on 14 February 1996.
Evropska komisija je dovoljenje za promet z zdravilom Fareston, veljavno po vsej Evropski uniji, odobrila dne 14. februarja 1996.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FARESTON EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) FARESTON Povzetek EPAR za javnost
The effects of Fareston were first tested in experimental models before being studied in humans.
Učinki zdravila Fareston so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Fareston must not be used in patients with ‘QT prolongation' (a disruption of the electrical activity of the heart), electrolyte disturbances (altered levels of salts in the blood) especially hypokalaemia (low potassium levels), bradycardia (a very slow heart rate), heart failure (an inability of the heart to pump enough blood to the rest of the body) or a history of symptomatic arrhythmias (abnormal heart rhythms), or in patients also taking other medicines that can cause QT prolongation.
Zdravilo Fareston se ne sme uporabljati pri bolnicah, s podaljšanim intervalom QT (motnja električne aktivnosti srca), motnjami elektrolitov (spremenjenimi ravnmi soli v krvi), zlasti hipokaliemijo (nizkimi ravnimi kalija), bradikardijo (zelo počasnim bitjem srca), srčnim popuščanjem (nezmožnostjo srca črpati dovolj krvi po telesu) ali anamnezo simptomatske aritmije (nepravilnimi srčnimi ritmi) ali pri bolnicah, ki jemljejo tudi druga zdravila, ki povzročajo podaljšanje intervala QT. Za celoten seznam teh zdravil glejte navodilo za uporabo.
It attaches to the receptors for oestrogen on the surface of cells, where its main effect is to block the effects of the hormone.
Veže se na estrogenske receptorje na površini celic, kjer je njegova glavna naloga zaviranje učinkov hormona.
As a result, the tumour cells are not stimulated to grow by oestrogen and the growth of the tumour is reduced.
Posledica tega je, da estrogen ne spodbuja rasti tumorskih celic, rast tumorja pa se upočasni.
What benefit has Fareston shown during the studies?
Kakšne koristi je zdravilo Fareston izkazalo med študijami?
What is the risk associated with Fareston?
Kakšna tveganja so povezana z zdravilom Fareston?
The most common side effects with Fareston (seen in more than 1 patient in 10) are hot flushes and sweating.
Najpogostejši neželeni učinki zdravila Fareston (opaženi pri več kot 1 bolnici od 10) so navali vročine in potenje.
Fareston should not be used in people who may be hypersensitive (allergic) to toremifene or any of the other ingredients.
Zdravila Fareston ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) toremifen ali katero koli drugo sestavino zdravila.