FrancophonIA/ELRC3.0 huggingface dataset:
English: 180 g of oral powder and three measuring spoons.
Slovenian: 180 g peroralnega praška in tri merilne žličke.
English: BOTTLE LABEL
Slovenian: NALEPKA NA STEKLENICI
English: A. MANUFACTURERs RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: Each carton contains one bottle and three measuring spoons.
Slovenian: Škatla vsebuje eno plastenko in tri merilne žličke.
English: If you notice side effects like headaches, vomiting or a change in your vision and you are of the homocystinuria subtype called CBS (cystathionine beta-synthase deficiency), please contact your doctor immediately, they could be signs of a swelling in the brain (cerebral oedema).
Slovenian: Če opazite neželene učinke, kot so glavoboli, bruhanje ali spremembe vida, in imate podtip homocistinurije, ki je posledica pomanjkanja encima CBS (cistationin beta-sintaze), se nemudoma obrnite na svojega zdravnika, ker bi to lahko bili znaki možganske otekline (cerebralnega edema).
English: Lightly shake the bottle before opening.
Slovenian: • Rahlo pretresite steklenico, preden jo odprete.
English: This will give the following doses: small measure 100 mg, middle size measure 150 mg and large measure 1 g of betaine anhydrous.
Slovenian: Tako boste dobili naslednje odmerke: mala merilna žlička 100 mg, srednja merilna žlička 150 mg in velika merilna žlička 1 g brezvodnega betaina.
English: How to take Cystadane
Slovenian: Kako jemati zdravilo Cystadane
English: It is recommended that a heaped measuring spoon is removed from the bottle and a flat surface e.g. base of a knife is drawn across the top of the measure.
Slovenian: Priporočamo, da iz plastenke vzamete zvrhano merilno žličko praška, nato pa čeznjo potegnite z ravno površino, na primer z noževim rezilom.
English: Long-term carcinogenicity and reproductive toxicity studies have not been conducted on betaine anhydrous.
Slovenian: Dolgoročnih študij kancerogenosti in vpliva na sposobnost razmnoževanja z brezvodnim betainom niso opravili.
English: Medicinal product subject to restricted medical prescription (see annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Gastrointestinal disorders like diarrhoea, nausea, vomiting, stomach discomfort and inflammation of the tongue may occur uncommonly (may affect up to 1 in 100 people).
Slovenian: Prebavne motnje kot so driska, navzea, bruhanje, nelagodje v trebuhu in vnetje jezika se lahko pojavijo občasno (pri 1 od 100 bolnikov).
English: In CBS-deficient patients without dietary restriction of methionine, excessive accumulation of methionine has been observed.
Slovenian: Pri bolnikih s pomanjkanjem CBS brez omejitve vnosa metionina s hrano so opazili čezmerno kopičenje metionina.
English: Betaine anhydrous has also been shown to increase plasma methionine and S-adenosyl methionine (SAM) levels in patients with MTHFR deficiency and cbl defects.
Slovenian: Pokazali so tudi, da brezvodni betain zvišuje koncentracijo metionina in S-adenozilmetionina (SAM) v plazmi pri bolnikih s pomanjkanjem MTHFR in napakami cbl.
English: What Cystadane contains - The active substance is betaine anhydrous.
Slovenian: Kaj vsebuje zdravilo Cystadane - Zdravilna učinkovina je brezvodni betain.
English: Biotransformation Betaine anhydrous is a methyl group donor
Slovenian: Brezvodni betain je donor metilne skupine.
English: Betaine anhydrous was shown to lower plasma homocysteine levels in the three types of homocystinuria, i.e. CBS deficiency; MTHFR deficiency and cbl defect.
Slovenian: Pokazali so, da brezvodni betain znižuje koncentracijo homocisteina v plazmi pri treh vrstah homocistinurije, in sicer pri pomanjkanju CBS, pomanjkanju MTHFR in napaki cbl.
English: Elevated homocysteine plasma levels are associated with cardiovascular events (such as thrombosis), osteoporosis, skeletal abnormalities, and optic lens dislocation.
Slovenian: Zvišana koncentracija homocisteina v plazmi je povezana s kardiovaskularnimi dogodki, na primer trombozo, z osteoporozo, nenormalnostmi okostja in izpahom očesne leče.
English: Betaine anhydrous supplementation was shown to improve the metabolic abnormalities in the cerebrospinal fluid of patients with homocystinuria.
Slovenian: Izkazalo se je, da dodajanje brezvodnega betaina izboljša presnovne nenormalnosti v cerebrospinalni tekočini bolnikov s homocistinurijo.
English: As cerebral oedema has also been reported in patients with hypermethioninemia, secondary hypermethioninemia due to betaine anhydrous therapy has been postulated as a possible mechanism of action.
Slovenian: Ker so pri bolnikih s hipermetioninemijo poročali tudi o možganskem edemu, so domnevali, da je možni mehanizem delovanja sekundarna hipermetioninemija zaradi zdravljenja z brezvodnim betainom.
English: - If you have any further questions, ask your doctor or your pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali farmacevtom.
English: Three measuring spoons (green, blue, pink) dispense 100mg, 150mg or 1g of betaine anhydrous.
Slovenian: Priložene so tri merilne žličke (zelena, modra, rožnata), s katerimi odmerimo 100 mg, 150 mg ali 1 g brezvodnega betaina.
English: - If any symptoms of cerebral oedema like morning headaches with vomiting and/or visual changes appear, plasma methionine level and compliance to the diet should be checked and treatment with Cystadane interrupted.
Slovenian: - Če se pojavijo simptomi možganskega edema, na primer jutranji glavoboli z bruhanjem ali spremembami vida ali oboje, je treba preveriti koncentracijo metionina v plazmi, ugotoviti, ali se bolnik drži diete, in prekiniti zdravljenje z zdravilom Cystadane.
English: Unopened bottle: 3 years After the first opening: 3 months.
Slovenian: Neodprta steklenica: 3 leta.
English: However, the dose should be individually titrated according to plasma levels of homocysteine and methionine.
Slovenian: Vendar je treba odmerek titrirati glede na ravni homocisteina in metionina za vsakega bolnika posebej.
English: With a slow elimination rate (mean half life = 14 h, mean total body clearance, CL/F, = 84 ml/h/kg),
Slovenian: Z majhno hitrostjo izločanja (povprečni razpolovni čas = 14 ur), povprečni celotni telesni očistek, CL/F = 84 ml/h/kg) je ledvični očistek zanemarljiv (5 % celotnega telesnega očistka), če predpostavimo 100-odstotno biološko uporabnost.
English: It is presented in bottles with child resistant closures.
Slovenian: Na voljo je v plastenkah s pokrovčkom z za otroke varno zaporko.
English: Do not take a double dose to make up for forgotten doses.
Slovenian: Če ste pozabili vzeti zdravilo zdravilo Cystadane Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Each bottle contains 180 g of powder.
Slovenian: Ena plastenka vsebuje 180 g praška.
English: Cystadane 1 g oral powder
Slovenian: Cystadane 1 g peroralni prašek
English: Data on a limited number of exposed pregnancies indicate no adverse event of betaine anhydrous on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiologic data are available.
Slovenian: Podatki, zbrani pri omejenem številu nosečnic, ki so bile izpostavljene zdravilu, ne kažejo na možnost škodljivih vplivov brezvodnega betaina na nosečnost ali zdravje zarodka/novorojenca.
English: After the first opening of the bottle, the medicine should be used within 3 months.
Slovenian: Zdravilo morate porabiti v 3 mesecih od takrat, ko plastenko prvič odprete.
English: White crystalline free flowing powder.
Slovenian: peroralni prašek Bel kristalen sipek peroralni prašek.
English: Uncommon cases of severe cerebral oedema associated with hypermethioninemia were reported with betaine anhydrous therapy in patients with CBS deficiency (see section 4.8).
Slovenian: Pri bolnikih s pomanjkanjem CBS so poročali o občasnih primerih težkega možganskega edema, povezanega s hipermetioninemijo, po začetku zdravljenja z brezvodnim betainom (glejte poglavje 4.8).
English: Three measuring spoons are provided which dispense either 100 mg, 150 mg or 1 g of betaine anhydrous.
Slovenian: Priložene so tri merilne žličke, s katerimi odmerimo 100 mg, 150 mg in 1 g brezvodnega betaina.
English: • pass the flat back of a knife over the top of the spoon
Slovenian: • Potegnite čez merilno žličko z noževim rezilom.
English: • the middle size blue spoon measures 150 mg of betaine anhydrous powder ;
Slovenian: • s srednjo žličko odmerite 150 mg betaina v obliki brezvodnega praška;
English: At high doses, a CNS depressant effect and irritation of the gastrointestinal tract was seen in rats.
Slovenian: Pri podganah so pri velikih odmerkih ugotovili depresiven učinek na centralno živčevje in draženje prebavil.
English: In general, adverse reactions seen with betaine anhydrous therapy appeared to be not serious and are mainly related to the gastrointestinal system.
Slovenian: Na splošno kaže, da neželeni učinki pri zdravljenju z brezvodnim betainom niso resni, in da se povečini našanajo na prebavila.
English: Gastrointestinal disorders like diarrhoea, glossitis, nausea, stomach discomfort, vomiting and dental disorders may occur uncommonly.
Slovenian: Občasno se lahko pojavijo prebavne motnje kot so driska, glositis, navzea, nelagodje v trebuhu, bruhanje in bolezni zob.
English: How to store Cystadane
Slovenian: Shranjevanje zdravila Cystadane
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 15 februar 2007
English: Shelf life after the first opening: 3 months.
Slovenian: Rok uporabnosti po prvem odpiranju: 3 mesecev.
English: Tél/Tel: +32 2 46101 36 Belgique
Slovenian: Tél/Tel: +32 2 46101 36
English: Tabulated list of adverse reactions
Slovenian: Seznam neželenih učinkov v obliki tabele
English: Talk to your doctor or pharmacist before taking Cystadane.
Slovenian: Pred začetkom jemanja zdravila Cystadane se posvetujte z zdravnikom ali farmacevtom.
English: Symptoms of cerebral oedema include morning headaches with vomiting and/or visual changes High increases in plasma methionine levels in a range from 1,000 to 3,000 µM were noted in these patients.
Slovenian: Pri teh bolnikih so opazili močno zvišanje koncentracije metionina v plazmi, ki je bila med 1.000 in 3.000 µM.
English: 1 g of powder contains 1 g of betaine anhydrous.
Slovenian: 1 g praška vsebuje 1 g brezvodnega betaina.
English: 1 g of oral powder contains 1 g of betaine anhydrous.
Slovenian: 1 g peroralnega praška vsebuje 1 g brezvodnega betaina.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: • the powder left in the spoon is one spoonful
Slovenian: • V merilni žlički ostane za eno žličko praška.
English: What Cystadane looks like and contents of the pack Cystadane is a white crystalline free flowing powder.
Slovenian: Zdravilo Cystadane je bel kristalen sipki prašek.
English: Cystadane 1 g oral powder Betaine anhydrous
Slovenian: Cystadane 1 g peroralni prašek brezvodni betain
English: • the small green spoon measures 100 mg of betaine anhydrous powder;
Slovenian: • z malo žličko odmerite 100 mg betaina v obliki brezvodnega praška;
English: Uncommon: diarrhoea, glossitis, nausea, stomach discomfort, vomiting Skin and subcutaneous tissue disorders Uncommon: hair loss, hives, skin odour abnormal Renal and urinary disorders
Slovenian: Občasne: izpadanje las, koprivnica, nenormalen vonj kože
English: Contact your doctor or pharmacist before stopping.
Slovenian: Preden prenehate, se obrnite na zdravnika ali farmacevta.
English: Homocystinuria is a disease caused by the accumulation of homocysteine which is not converted to cysteine and is characterised by formation of clots in the veins, bone weakness, and skeletal and crystalline lens abnormalities.
Slovenian: Zanjo je značilno nastajanje strdkov v venah, šibkost kosti in nenormalnosti okostja in očesne leče.
English: Recordati Rare Diseases Immeuble "Le Wilson" 70, avenue du Général de Gaulle F-92800 Puteaux France
Slovenian: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F - 92800 Puteaux Francija
English: Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du General de Gaulle F-92 800 Puteaux France
Slovenian: Imetnik dovoljenja za promet z zdravilom Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F - 92800 Puteaux
English: This overview was last updated in October 2019.
Slovenian: Povzetek zdravila je bil nazadnje posodobljen oktobra 2019.
English: A single treatment is required however the full effect may only be seen 28 days later.
Slovenian: Potrebno je eno samo zdravljenje, vendar pa se lahko učinek v celoti pokaže šele 28 dni pozneje.
English: Other information about Neptra
Slovenian: Druge informacije o zdravilu Neptra
English: The European Medicines Agency decided that Neptra's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: 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.
English: The inside of the ear should be cleaned and dry before treatment.
Slovenian: Notranjost ušesa je treba pred zdravljenjem očistiti in posušiti.
English: Further information on Neptra can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/neptra.
Slovenian: Nadaljnje informacije o zdravilu Neptra so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/neptra.
English: The contents of one tube are given into each infected ear.
Slovenian: V vsako okuženo uho se nanese vsebina ene tube.
English: In case of accidental eye exposure, the eyes should be flushed thoroughly with water for 10 to 15 minutes.
Slovenian: V primeru nenamernega stika z očmi je treba temeljito izpirati oči z vodo od 10 do 15 minut.
English: What benefits of Neptra have been shown in studies?
Slovenian: Kakšne koristi zdravila Neptra so se pokazale v študijah?
English: Although no potential for skin irritation was indicated by studies, skin contact should be avoided.
Slovenian: Čeprav študije niso pokazale možnosti draženja kože, se je treba izogibati stiku s kožo.
English: Neptra received a marketing authorisation valid throughout the EU on 10 December 2019.
Slovenian: Zdravilo Neptra je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 10/12/2019.
English: Why is Neptra authorised in the EU?
Slovenian: Zakaj je zdravilo Neptra odobreno v EU?
English: This was more effective than the control group of 27 dogs, which received a placebo (dummy treatment) and for which the reduction was 49%.
Slovenian: 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 %.
English: Two of the active substances in Neptra, florfenicol and terbinafine, act against possible causes of infection.
Slovenian: Dve od učinkovin v zdravilu Neptra, florfenikol in terbinafin, učinkujeta proti mogočim vzrokom okužbe.
English: What are the risks associated with Neptra?
Slovenian: Kakšna tveganja so povezana z zdravilom Neptra?
English: The third active substance, mometasone, is a corticosteroid, a medicine that reduces inflammation and pain associated with the infection.
Slovenian: Tretja učinkovina, mometazon, je kortikosteroid, zdravilo, ki zmanjšuje vnetje in bolečino, ki sta povezana z okužbo.
English: 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).
Slovenian: 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).
English: Neptra (florfenicol / terbinafine / mometasone)
Slovenian: Neptra (florfenikol/terbinafin/mometazon)
English: Florfenicol is an antibiotic which works by blocking the production of proteins, which are essential components of bacterial cell walls.
Slovenian: Florfenikol je antibiotik, ki učinkuje tako, da zavira tvorbo beljakovin, ki so osnovni gradniki bakterijskih celičnih sten.
English: An overview of Neptra and why it is authorised in the EU
Slovenian: Pregled zdravila Neptra in zakaj je odobreno v EU
English: What is Neptra and what is it used for?
Slovenian: Kaj je zdravilo Neptra in za kaj se uporablja?
English: In case of accidental skin contact, exposed skin should be thoroughly washed with water.
Slovenian: V primeru nenamernega stika s kožo je treba izpostavljeno kožo temeljito sprati z vodo.
English: 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%.
Slovenian: 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.
English: Neptra (florfenicol / terbinafine / mometasone) EMA/560411/2019
Slovenian: Neptra (florfenikol/terbinafin/mometazon) EMA/687952/2019
English: For more information about using Neptra, see the package leaflet or contact your veterinarian or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Neptra glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
English: 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.
Slovenian: 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.
English: Terbinafine kills fungi by blocking the formation of ergosterol, an important part of fungal cell walls.
Slovenian: Terbinafin ubija glive z zaviranjem tvorbe ergosterola, pomembnega dela glivičnih celičnih sten.
English: Neptra must not be used in dogs who are allergic to the active substances, to other corticosteroids or to any of the other ingredients.
Slovenian: Zdravilo Neptra se ne sme uporabljati pri psih, ki so alergični na učinkovine, druge kortikosteroide ali katero koli drugo sestavino zdravila.
English: 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.
Slovenian: 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 %.
English: 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).
Slovenian: 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).
English: Neptra may be harmful after swallowing.
Slovenian: Zdravilo Neptra je lahko škodljivo po zaužitju.
English: 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.
Slovenian: 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.
English: The medicine is available as ear drops and can only be obtained with a prescription.
Slovenian: Zdravilo je na voljo v obliki ušesnih kapljic, njegovo predpisovanje in izdaja pa je le na recept.
English: If symptoms develop, medical advice should be sought and the package leaflet or the label shown to the doctor.
Slovenian: Če se pojavijo simptomi, je treba poiskati zdravniško pomoč in zdravniku pokazati navodilo za uporabo ali nalepko.
English: Neptra contains three active substances: florfenicol, terbinafine and mometasone.
Slovenian: Zdravilo Neptra vsebuje tri učinkovine: florfenikol, terbinafin in mometazon.
English: How does Neptra work?
Slovenian: Kako zdravilo Neptra deluje?
English: Avoid swallowing the product or accidentally transferring it from hand to mouth.
Slovenian: Izogibajte se zaužitju zdravila in nenamernemu vnosu preko rok v usta.
English: How is Neptra used?
Slovenian: Kako se zdravilo Neptra uporablja?
English: In case of accidental swallowing medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Slovenian: V primeru nenamernega zaužitja nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
English: Neptra can cause serious eye irritation if it accidentally gets into the eyes when the dog shakes its head during or just after application.
Slovenian: Če zdravilo Neptra nenamerno pride v oči, ko pes med dajanjem zdravila ali tik po njem stresa z glavo, lahko povzroči resno draženje oči.
English: The medicine must not be given to patients who have a severe infection.
Slovenian: Zdravilo se ne sme dajati bolnikom z resno okužbo.
English: Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Slovenian: Agencija bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in po potrebi posodobila ta pregled.
English: Serious side effects can occur; however, these are manageable if appropriate measures are in place.
Slovenian: Lahko se pojavijo resni neželeni učinki, vendar so ob ustreznih ukrepih obvladljivi.
English: What measures are being taken to ensure the safe and effective use of Polivy?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Polivy?
English: The Agency therefore decided that Polivy's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Agencija je zato zaključila, da so koristi zdravila Polivy večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
English: Other information about Polivy
Slovenian: Druge informacije o zdravilu Polivy