natgillin/translations-raw huggingface dataset:
• tell your doctor of any other medical problems you may be experiencing (especially related to your kidneys or liver).
• obavijestite svog liječnika o drugim zdravstvenim problemima koje možda osjećate
Almirall SpA Tel.: +39 02 346181
Tel.: +39 02 346181
How to store Vaniqa
Kako čuvati kremu Vaniqa
Eflornithine slows down the growth of hair through its effect on a specific enzyme (a protein in the body involved in the production of hair).
Eflornitin usporava rast dlaka djelovanjem na specifičan enzim
Vaniqa contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Vaniqa sadrži cetostearilni alkohol i stearilni alkohol koji mogu uzrokovati lokalnu iritaciju kože
/ Ελλάδα / España / Κύπρος / Latvija / Lietuva / Magyarország / Malta / România / Slovenija / Slovenská republika
Magyarország / Malta / România / Slovenija / Slovenská republika
Vaniqa 11.5% cream
Vaniqa 11,5% krema
Improvement in the condition may be noticed within eight weeks of starting treatment.
Poboljšanje stanja može se uočiti unutar osam tjedana od početka liječenja.
Rosacea, seborrheic dermatitis, skin neoplasm, maculopapular rash, skin cysts, vesiculobullous rash, skin disorder, hirsutism, skin tightness
Rozacea, seboroični dermatitis, neoplazme na koži, makulopapularni osip, ciste na koži, vezikobulozni osip, poremećaji kože, hirzutizam, zategnutost kože
These patientobservable differences were seen 8 weeks after initiating treatment.
Takve razlike koje su primjećivale same bolesnice zapažene su osam tjedana nakon početka liječenja.
Ingrown hair, oedema face, dermatitis, oedema mouth, papular rash, bleeding skin, herpes simplex, eczema, cheilitis, furunculosis, contact dermatitis, abnormal hair texture and abnormal hair growth, hypopigmentation, flushing skin, lip numbness, skin soreness
Urastanje dlaka, edem lica, dermatitis, edem usta, papularni osip, krvarenje iz kože, herpes simplex, ekcem, heilitis, furunkuloza, kontaktni dermatitis, poremećena tekstura kose i poremećen rast kose, hipopigmentacija, crvenilo kože uz osjećaj vrućine, utrnulost usana, bolna koža
The condition returned to pre-treatment levels within eight weeks after discontinuation of treatment.
Stanje se vratilo na razine prije liječenja unutar 8 tjedana nakon prekida liječenja.
Very common (affects more than 1 user in 10)
Vrlo često (pogađa više od 1 na 10 korisnika)
very rare
rijetko
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
Almirall Hermal GmbH Tel./ Tél: +49 (0)40 72704-0
Tél: +49 (0)40 72704-0
Rare (≥1/10,000 to
Rijetko (≥1/10 000 i <1/1000)
Hands should be washed after applying this medicinal product.
Nakon nanošenja ove kreme nužno je oprati ruke.
Common (affects 1 to 10 users in 100)
Često (pogađa 1 do 10 korisnika na 100)
Almirall, S.A. Ronda General Mitre, 151,
Almirall, S.A Ronda General Mitre, 151 08022 Barcelona Španjolska
България / Česká republika / Hrvatska / Eesti
България / Česká republika / Hrvatska /Eesti / Ελλάδα / España / Κύπρος / Latvija / Lietuva /
How to use Vaniqa
Kako primjenjivati kremu Vaniqa
Almirall Sp. z o.o.
Almirall SpA
Steady state was reached within four days.
Stanje dinamičke ravnoteže koncentracije lijeka u plazmi postiže se unutar četiri dana.
o dry skin o hair loss o inflammation around the hair shaft o itching o rash o redness o skin irritation and bumps caused by shaving o skin irritation o stinging, tingling or burning feeling on the skin
○ suha koža ○ gubitak kose ○ upala uz dlaku ○ svrbež ○ osip ○ crvenilo ○ iritacija kože i čvorići uzrokovani brijanjem ○ iritacija kože ○ osjećaj peckanja, trnaca ili žarenja na koži
The other ingredients are: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water and stearyl alcohol.
6.1 Popis pomoćnih tvari cetilni i stearilni alkohol; makrogolcetilstearileter; dimetikon; glicerolstearat; makrogolstearat; metilparahidroksibenzoat (E218); parafin, tekući; fenoksietanol; propilparahidroksibenzoat (E216);
Propyl parahydroxybenzoate (E216); Purified water;
metilparahidroksibenzoat (E218); tekući parafin; fenoksietanol; propilparahidroksibenzoat (E216); pročišćena voda i stearilni alkohol.
Rare (affects 1 to 10 users in 10,000)
Manje često (pogađa 1 do 10 korisnika na 1000)
Pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin, pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis
Pseudofolikulitis brade, alopecija, pečenje kože*, peckanje kože*, suha koža,
The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment.
Stanje se može pogoršati na razine prije liječenja unutar 8 tjedana nakon prekida liječenja.
Phenoxyethanol;
trombocitopenija i leukopenija.
The skin effects of burning, stinging, tingling, rash and erythema were reported at higher levels in Vaniqa treated patients compared to vehicle, as indicated by the asterisk (*).
Učinci na kožu poput žarenja, peckanja, osipa i eritema prijavljeni su u većim razinama u bolesnica liječenih kremom
very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare
(pogađa 1 do 10 korisnika na 100) manje često (pogađa 1 do 10 korisnika na 1000)
It may sting or burn if you put this cream on cut or irritated skin.
Ako stavite kremu na posjekotinu ili nadraženu kožu možete osjetiti peckanje ili žarenje.
Excessive hair growth can result from serious underlying disorders (e.g. polycystic ovary syndrome, androgen secreting neoplasm) or certain active substances (e.g. cyclosporin, glucocorticoids, minoxidil, phenobarbitone, phenytoin, combined oestrogen-androgen hormone replacement therapy).
Prekomjerni rast dlaka može biti rezultat ozbiljnih osnovnih bolesti (primjerice, sindroma policističnih jajnika, tumora koji luče androgene) ili određenih djelatnih tvari (primjerice,
Almirall ApS Tel.: +45 70 25 75 75
Almirall Sp. z o.o. Tel.: +48 22 330 02 57
The frequency of possible side effects listed below is defined using the following convention:
Učestalost mogućih nuspojava navedenih u nastavku definirana je uporabom sljedećih kategorija: vrlo često (pogađa više od 1 na 10 korisnika) često
o abnormal skin growth (skin neoplasm) o excessive hair growth o flushing, facial redness and pimples possibly with pus o other skin disorders o red, scaly and itchy skin inflammation (seborrhoeic dermatitis) o red, bumpy or blistering rash o skin cysts o skin tightness
○ abnormalni rast kože (neoplazme kože) ○ prekomjerni rast dlaka ○ crvenilo lica uz osjećaj vrućine i prištići s mogućim gnojem
o bumpy rash (papular rash) o cold sores o redness and irritation at the site where the cream is applied o eczema o inflammed, dry, cracked or numb lips o ingrowing hairs o pale areas on the skin o skin bleeding o skin boils o skin flushing o skin inflammation o sore skin o swelling of the mouth or face o unusual hair texture or hair growth
○ osip sa sitnim kvržicama (papularni osip) ○ herpes simplex (groznica) ○ crvenilo i iritacija na mjestu primjene kreme ○ ekcem ○ upaljene, suhe, ispucale ili utrnule usne ○ urasle dlake
Eflornithine
FARMACEUTSKI
This is called ‘myeloablation'.
To se naziva „mijeloablacija”.
There were two main studies involving 103 adults and one involving 55 children.
Provedena su dva glavna ispitivanja koja su obuhvatila 103 odrasle osobe kao i jedno ispitivanje koje je obuhvatilo 55 djece.
The full EPAR for Busilvex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Busilvex nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Busilvex can affect fertility in both sexes.
Busilvex može utjecati na plodnost oba spola.
The European Commission granted a marketing authorisation valid throughout the EU for Busilvex on 9 July 2003.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Busilvex na snazi u Europskoj uniji od 9. srpnja 2003.
This type of transplant is used in patients who need to replace their blood-making cells, because they have a blood disorder (such as a rare type of anaemia) or a cancer of the blood.
Ovaj tip presađivanja primjenjuje se u bolesnika u kojih je potrebna zamjena krvotvornih stanica, jer imaju bolest krvi (poput rijetkog tipa anemije) ili rak krvi.
Because of this, female patients should not become pregnant during treatment and for up to six months afterwards, and male patients are advised not to father a child during and for up to six months after treatment with Busilvex.
S obzirom na prethodno navedeno, ženski bolesnici ne smiju zatrudnjeti tijekom liječenja i do šest mjeseci nakon liječenja, a muškim bolesnicima se preporuča da ne začinju dijete tijekom i do šest mjeseci nakon liječenja lijekom Busilvex.
These substances are ‘cytotoxic'.
Ove su tvari „citotoksične”.
Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant.
Svaka infuzija traje dva sata i daje se bolesniku svakih šest sati tijekom četiri uzastopna dana prije liječenja ciklofosfamidom ili melfalanom i presađivanja.
This is a summary of the European public assessment report (EPAR) for Busilvex.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Busilvex.
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 Busilvex.
Objašnjava kako je Odbor za lijekove za primjenu kod ljudi (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Busilvex.
This means that they kill cells, especially cells that develop rapidly, such as cancer or progenitor (or ‘stem') cells (cells that make other types of cell).
To znači da ubijaju stanice, posebice stanice koje se brzo razvijaju, poput tumorskih ili progenitorskih (ili „matičnih”) stanica (stanica koje tvore druge tipove stanica).
It contains the active substance busulfan.
Sadrži djelatnu tvar busulfan.
This helps the transplanted cells to ‘engraft' (when they start to grow and produce normal blood cells).
To pomaže da se presađene stanice „prime” (kada počnu rasti i proizvoditi normalne stanice krvi).
For more information about treatment with Busilvex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Busilvex pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
Before receiving Busilvex, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Prije primanja lijeka Busilvex, bolesnici moraju primiti premedikaciju antikonvulzivnim lijekovima (da bi se spriječili napadaji) i antiemeticima (da bi se spriječilo povraćanje).
Cyclophosphamide, melphalan or fludarabine are used to suppress the immune system, so that the body's natural defences are decreased.
Ciklofosfamid, melfalan ili fludarabin se zatim koriste za potiskivanje imunološkog sustava, tako da se oslabi prirodna obrana tijela.
Since Busilvex in combination with fludarabine has been used in clinical practice for many years, data from 7 studies (involving 731 patients) which looked at the effectiveness of Busilvex and fludarabine as ‘reduced-intensity' conditioning treatment were presented.
Budući da se Busilvex u kombinaciji s fludarabinom koristio u kliničkoj praksi tijekom dugog niza godina, dostavljeni su podaci iz 7 ispitivanja (sa 731 bolesnika) u kojima se istražila učinkovitost lijeka Busilvex i fludarabina pri kondicioniranju smanjenog intenziteta.
The main measures of effectiveness were the number of patients with myeloablation and ‘engraftment' (the time for the transplanted stem cells to begin growing and for white blood cells to return to higher levels).
Glavna mjera djelotvornosti bio je broj bolesnika s mijeloablacijom i „primanje presatka” (vrijeme potrebno da transplantirane matične stranice počnu rasti, a bijele krvne stanice vrate u više razine).
The data from the published studies showed that Busilvex in combination with fludarabine was effective as a ‘reduced-intensity' conditioning treatment, with complete engraftment achieved in 80 to 100% of patients.
Podaci iz objavljenih ispitivanja pokazali su da je lijek Busilvex u kombinaciji s fludarabinom učinkovit kao terapija kondicioniranja smanjenog intenziteta, s potpunim primanjem presatka postignutim u 80 do 100 % bolesnika.
Busilvex must not be used in women who are pregnant.
Lijek Busilvex ne smije se koristiti u trudnica.
Engraftment was obtained in 13 days in adults and 21 days in children with ‘allotransplantation' (when the patient receives cells from a donor).
Primanje presatka postignuto je 13 dana u odraslih osoba i 21 dan u djece nakon „alogenog presađivanja” (kada bolesnik zaprimi stanice od donatora).
When used in combination with fludarabine, the recommended dose of Busilvex is 3.2 mg per kilogram given once a day as a three-hour infusion immediately after fludarabine, for 2 or 3 consecutive days.
Kad se uzima u kombinaciji s fludarabinom, preporučena doza lijeka Busilvex iznosi 3,2 mg po kilogramu tjelesne težine, jedanput dnevno trosatnom infuzijom odmah nakon uzimanja fludarabina, 2 ili 3 uzastopna dana.
Busulfan is used before transplantation to destroy abnormal cells and the patient's existing haematopoietic progenitor cells.
Busulfan se koristi prije presađivanja za uništavanje abnormalnih stanica i postojećih hematopoetskih progenitorskih stanica bolesnika.
Apart from the decrease in blood cell counts, which is the intended effect of the medicine, the most serious side effects of Busilvex are infection, liver disorders including blocking of a liver vein, graft versus host disease (when the transplanted cells attack the body) and respiratory (lung) disorders.
Izuzev smanjivanja broja krvnih stanica, što je i predviđeno djelovanje lijeka, najozbiljnije nuspojave lijeka Busilvex su upale, poremećaji funkcije jetre, uključujući i blokiranje jetrene vene, reakcija presatka na domaćina (kada presađene stanice napadaju tijelo), te respiratorni poremećaji (poremećaji funkcije pluća).
The active substance in Busilvex, busulfan, belongs to a group of medicines called ‘alkylating agents'.
Djelatna tvar u lijeku Busilvex, busulfan, ubraja se u grupu lijekova poznatih pod nazivom „alkilirajuće tvari”.
Busilvex should be used by a doctor who has experience in treatments given before transplantation.
Primjenu lijeka Busilvex mora nadzirati liječnik iskusan u terapijama koje prethode presađivanju.
On average, engraftment was reached in 10 days in adults and 11 days in children with ‘autotransplantation' (when the patient receives their own cells, harvested and stored before the transplant).
Primanje presatka postignuto je u prosjeku 10 dana u odraslih osoba i 11 dana u djece nakon „autolognog presađivanja” (nakon što su bolesnici zaprimili svoje vlastite stanice, uzete i pohranjene prije presađivanja).
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom of Busilvex varies between 0.8 and 1.2 mg per kilogram depending on the weight of the child. Busilvex is given as a central intravenous infusion (drip into a central vein in the chest).
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom primjenjuje kao središnja intravenozna infuzija (drip u središnju venu u prsima).
The Committee decided that Busilvex's benefits are greater than its risks in these settings and recommended that Busilvex be given marketing authorisation.
Odbor je odlučio da koristi od lijeka Busilvex u ovim postavkama nadmašuju s njim povezane rizike, te je preporučio izdavanje odobrenja za stavljanje lijeka Busilvex u promet.
Other information about Busilvex
Ostale informacije o lijeku Busilvex
When used in combination with cyclophosphamide or melphalan the recommended dose of Busilvex in adults is 0.8 mg per kilogram body weight.
Ako se uzima u kombinaciji s kiklofosfamidom ili melpfalanom, preporučena doza lijeka Busilvex u odraslih osoba iznosi 0,8 mg po kilogramu tjelesne težine.
Busilvex is a concentrate to be made up into a solution for infusion (drip into a vein).
Busilvex je koncentrat za otopinu za infuziju (drip u venu).
The CHMP concluded that the effectiveness of Busilvex in combination with cyclophosphamide and melphalan for conventional conditioning, and with fludarabine for reduced-intensity conditioning had been shown; Busilvex also provides an alternative to busulfan tablets, which have disadvantages such as the large number of tablets that need to be taken.
CHMP je zaključio da je djelotvornost lijeka Busilvex u kombinaciji s kiklofosfamidom ili melpfalanom za konvencionalno kondicioniranje dokazano, tj. u kombinaciji s fludarabinom za kondicioniranje smanjenog intenziteta; Busilvex pruža alternativu liječenju tabletama busulfana, čiji je nedostatak velika količina tableta koja se mora popiti.
Breast-feeding should be stopped when treatment with Busilvex is started.
Dojenje se mora prekinuti prilikom počinjanja liječenja lijekom Busilvex.
Busilvex is used in adults and children as part of a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Busilvex je indiciran u odraslih i djece kao dio terapije kondicioniranja (pripreme) prije presađivanja hematopoetskih progenitorskih stanica (krvotvornih stanica).
Why has Busilvex been approved?
Zašto je Busilvex odobren?
Busilvex in combination with cyclophosphamide or melphalan has been studied in patients, mainly with blood cancer, who needed transplantation of haematopoietic progenitor cells.
Busilvex u kombinaciji s kiklofosfamidom ili melpfalanom ispitan je u bolesnika, uglavnom s rakom krvi, kojima je bilo potrebno presađivanje hematopoetskih progenitorskih stanica.
What is the risk associated with Busilvex?
Koji su rizici povezani s lijekom Busilvex?
In adult patients who are eligible for a ‘reduced-intensity' conditioning regimen, Busilvex is given right after treatment with another medicine, fludarabine.
U odraslih bolesnika podobnih za režim kondicioniranja smanjenog intenziteta, Busilvex se daje odmah nakon liječenja fludarabinom.
When Busilvex was given in combination with cyclophosphamide or melphalan, all adults and children achieved myeloablation.
Kod uzimanja lijeka Busilvex u kombinaciji s kiklofosfamidom ili melpfalanom, sve odrasle osobe i djeca postigla su mijeloablaciju.
What is Busilvex?
Što je Busilvex?
For a conventional conditioning treatment, Busilvex is given before treatment with a second medicine, cyclophosphamide, in adults, and either cyclophosphamide or an alternative medicine, melphalan, in children.
Kod konvencionalne terapije kondicioniranja, Busilvex se u odraslih daje prije liječenja drugim lijekom, kiklofosfamidom, tj. u slučaju djece prije liječenja kiklofosfamidom ili alternativnim lijekom, melpfalanom.
For the full list of all side effects and restrictions with Busilvex, see the package leaflet.
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Busilvex potražite u uputi o lijeku.
What benefit has Busilvex shown during the studies?
Koje su koristi lijeka Busilvex utvrđene u ispitivanjima?
What is Busilvex used for?
Za što se Busilvex koristi?
How is Busilvex used?
Kako se Busilvex koristi?
How has Busilvex been studied?
Kako je Busilvex ispitan?
How does Busilvex work?
Kako djeluje Busilvex?
Pifeltro (doravirine)
Pifeltro (doravirin)
Further information on Pifeltro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pifeltro.
Više informacija o lijeku Pifeltro nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/pifeltro.
What measures are being taken to ensure the safe and effective use of Pifeltro?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pifeltro?
Pifeltro (doravirine) EMA/821744/2018
Pifeltro (doravirin) EMA/661893/2018
Other information about Pifeltro
Ostale informacije o lijeku Pifeltro
Pifeltro must not be used with certain medicines that may reduce its effectiveness.
Lijek Pifeltro ne smije se primjenjivati u kombinaciji s određenim lijekovima koji mogu smanjiti njegovu učinkovitost.
Pifeltro is available as tablets (100 mg) and can only be obtained with a prescription.
Lijek Pifeltro dostupan je u obliku tableta (100 mg) i izdaje se samo na liječnički recept.
Side effects reported with Pifeltro are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Pifeltro pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Pifeltro helps keep the amount of HIV in the blood at a low level.
Lijek Pifeltro održava količinu HIV-a u krvi na niskoj razini.
Pifeltro is an antiviral medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Pifeltro je protuvirusni lijek koji se primjenjuje za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
What is Pifeltro and what is it used for?
Što je Pifeltro i za što se primjenjuje?
It does not cure HIV infection or AIDS but, when used in combination with other antivirals, it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
Ne liječi infekciju HIV-om ni AIDS, ali kada se primjenjuje u kombinaciji s drugim protuvirusnim lijekovima, može odgoditi oštećenje imunosnog sustava te razvoj infekcija i bolesti povezanih s AIDS-om.
Doravirine blocks the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Doravirin blokira djelovanje reverzne transkriptaze, enzima koji HIV-u omogućuje reprodukciju u zaraženim stanicama.
What are the risks associated with Pifeltro?
Koji su rizici povezani lijekom Pifeltro?
The most common side effects with Pifeltro (which may affect up to 1 in 10 people) are nausea (feeling sick) and headache.
Najčešće nuspojave lijeka Pifeltro (koje se mogu javiti u do 1 na 10 osoba) jesu mučnina (slabost) i glavobolja.
In addition, Pifeltro's side effects are mostly mild.
Osim toga, nuspojave lijeka Pifeltro uglavnom su blage.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pifeltro have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Pifeltro nalaze se u sažetku opisa svojstava i u uputi o lijeku.
As for all medicines, data on the use of Pifeltro are continuously monitored.
Kao i za sve lijekove, podatci o primjeni lijeka Pifeltro kontinuirano se prate.
An overview of Pifeltro and why it is authorised in the EU
Pregled informacija o lijeku Pifeltro i zašto je odobren u EU-u
The European Medicines Agency therefore decided that Pifeltro's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od lijeka Pifeltro nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
For more information about using Pifeltro, see the package leaflet or contact your doctor or pharmacist.
Više informacija o primjeni lijeka Pifeltro pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
Why is Pifeltro authorised in the EU?
Zašto je lijek Pifeltro odobren u EU-u?