FrancophonIA/ELRC3.0 huggingface dataset:
English: 8) Ensure that the pipette plunger is pushed all the way down.
Croatian: 8) Provjerite da je klip kapaljke potisnut prema dolje do kraja.
English: The recommended dose is one drop of OXERVATE in the conjunctival sac of the affected eye(s), 6 times a day at 2 hourly intervals, starting from the morning and within 12 hours.
Croatian: Preporučena doza je jedna kap lijeka OXERVATE primijenjena u konjunktivalnu vreću zahvaćenog oka (očiju), 6 puta na dan s razmacima od 2 sata, počevši ujutro te tijekom sljedećih 12 sati.
English: • Turn the vial upside-down (with the pipette still connected) and gently pull the plunger until it stops, to draw the solution into the pipette.
Croatian: • Okrenite bočicu naopako (s još uvijek pričvršćenom kapaljkom) i navucite otopinu u kapaljku tako da nježno povlačite klip dok se ne zaustavi.
English: The vials are contained in a weekly cardboard carton containing 7 vials.
Croatian: Bočice se nalaze u kartonskoj kutiji za tjednu terapiju koja sadrži 7 bočica.
English: Use only with the vial adapters, pipettes and disinfectant wipes provided separately.
Croatian: Primjenjivati samo s nastavcima za bočicu, kapaljkama i tupferima s dezinficijensom koji su dostupni zasebno.
English: The recommended dose is 1 drop in the affected eye 6 times a day at 2-hourly intervals, starting in the morning (i.e. 6 drops per day within 12 hours).
Croatian: Preporučena doza je 1 kap u bolesno oko 6 puta na dan s razmacima od 2 sata, počevši ujutro (tj. 6 kapi na dan tijekom 12 sati).
English: How to store OXERVATE Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije
English: Pack size: 7 multi-dose vials per carton
Croatian: Veličina pakiranja: 7 višedoznih bočica po kutiji
English: After this period of time the vial contents should be discarded irrespective of whether some residual product remains in the vial.
Croatian: Nakon tog vremena sadržaj bočice mora se baciti bez obzira na to koliko ga je ostalo u bočici.
English: Extra adapter (1), pipettes (3) and wipes (3) are included as spares.
Croatian: Kao rezerva u kutiju su priloženi dodatni nastavak (1), dodatne kapaljke (3) i dodatni tupferi (3)
English: If eye ointment, gel or other viscous eye drops are used, OXERVATE should be administered first.
Croatian: Ako se primjenjuje mast za oči, gel za oči ili druge viskozne kapi za oko, najprije se mora primijeniti OXERVATE.
English: Pack size: 7 multi-dose vials.
Croatian: Veličina pakiranja: 7 višedoznih bočica.
English: • Take a single disinfectant wipe and gently clean the surface of the valve on the connector part of the vial adapter (picture 4).
Croatian: • Uzmite jedan tupfer s dezinficijensom i nježno očistite površinu ventila na spojnom (luer-lock) dijelu nastavka za bočicu (slika 4).
English: OXERVATE is intended to allow the healing of the cornea.
Croatian: OXERVATE je namijenjen za omogućavanje zarastanja rožnice
English: - The other ingredients are trehalose dihydrate, mannitol, disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate dihydrate, hydroxypropylmethyl cellulose, polyethylene glycol 6000, L-methionine and water for injections, hydrochloric acid and sodium hydroxide and nitrogen.
Croatian: - Drugi sastojci su trehaloza dihidrat, manitol, bezvodni natrijev hidrogenfosfat, natrijev dihidrogenfosfat dihidrat, hidroksipropilmetilceluloza, polietilenglikol 6000, L-metionin i voda za injekcije, kloridna kiselina, natrijev hidroksid i dušik.
English: Disodium hydrogen phosphate, anhydrous Sodium dihydrogen phosphate, dihydrate Hydroxypropylmethylcellulose Polyethylene glycol 6000
Croatian: Natrijev hidrogenfosfat, bezvodni Natrijev dihidrogenfosfat dihidrat Hidroksipropilmetilceluloza Polietilenglikol 6000
English: It is important that the risk of corneal melting or impending perforation, and the need to undergo emergency surgery or another procedure is assessed before starting therapy with OXERVATE as cenegermin should not be used in patients requiring immediate surgery.
Croatian: Prije započinjanja liječenja lijekom OXERVATE važno je utvrditi postoji li kod bolesnika rizik od “topljenja“ rožnice (engl. corneal melting) ili prijeteće perforacije rožnice, odnosno treba li se bolesnik podvrći hitnom kirurškom zahvatu ili nekom drugom postupku, jer se cenegermin ne bi trebao primjenjivati u bolesnika kojima neposredno predstoji kirurški zahvat.
English: OXERVATE 72.2 % Vehicle (p value)
Croatian: Vehikulum 4,2 % (p vrijednost)
English: - if you have an eye cancer, because this medicine might worsen your cancer.
Croatian: - ako imate rak oka, jer ovaj lijek može pogoršati rak. - ako primjenjujete bilo koje kapi za oko koje sadrže kortikosteroide (npr. za liječenje upale oka)
English: Treatment with OXERVATE may cause you mild to moderate eye discomfort such as eye pain.
Croatian: Liječenje lijekom OXERVATE može izazvati blag do umjeren osjećaj neugode u oku poput boli u oku.
English: The missed dose can be administered later, within the 12 hours shelf-life of the daily vial.
Croatian: Preskočena doza može se primijeniti kasnije, unutar 12 sati roka valjanosti bočice za jednodnevnu primjenu.
English: The multi-dose vial of OXERVATE is now ready for use (1 drop in the affected eye every 2 hours six times a day).
Croatian: Višedozna bočica lijeka OXERVATE sad je spremna za primjenu (1 kap u bolesno oko svaka 2 sata šest puta na dan).
English: 9) Turn the vial upside-down with the pipette connected and gently pull the pipette plunger outwards until it stops, to draw the solution into the pipette (ensure that the plunger has reached the stop point).
Croatian: 9) Bočicu s pričvršćenom kapaljkom okrenite naopako i nježno povucite klip kapaljke prema van dok se ne zaustavi, kako biste na taj način navukli otopinu u kapaljku (provjerite da je klip dosegao točku zaustavljanja). 10) Provjerite kapaljku i uvjerite se da sadrži nešto otopine.
English: Special populations Elderly:
Croatian: Starije osobe:
English: Once a vial is opened store below 25 °C or store in a refrigerator.
Croatian: Nakon otvaranja bočicu čuvati na temperaturi do 25 °C ili u hladnjaku.
English: This medicinal product should only be used with specific vial adapters and disposable devices (pipettes) that will be provided separately from the weekly OXERVATE carton.
Croatian: Ovaj lijek se smije primjenjivati samo s posebnim nastavcima za bočicu i kapaljkama za jednokratnu primjenu, koji su dostupni odvojeno od kutije lijeka OXERVATE za tjednu terapiju.
English: Cenegermin administered by eye drops is mostly eliminated with the tear secretion.
Croatian: Cenegermin primijenjen u obliku kapi za oko većinom se eliminira sekrecijom suza.
English: Extra adapter (1), pipettes (3) and wipes (3) will also be provided as spares.
Croatian: Kao rezerva u kutiji također dolaze priloženi dodatni nastavak (1), dodatne kapaljke (3) i dodatni tupferi (3).
English: Excipients: trehalose dihydrate, mannitol, disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate dihydrate, hydroxypropylmethyl cellulose, polyethylene glycol 6000, L-methionine, water for injections, hydrochloric acid, sodium hydroxide, nitrogen.
Croatian: Pomoćne tvari: trehaloza dihidrat, manitol, bezvodni natrijev hidrogenfosfat, natrijev dihidrogenfosfat dihidrat, hidroksipropilmetilceluloza, polietilenglikol 6000, L-metionin, voda za injekcije, kloridna kiselina, natrijev hidroksid, dušik.
English: OXERVATE 20 µg/ml eye drops cenegermin
Croatian: OXERVATE 20 mikrograma/ml kapi za oko, otopina cenegermin
English: 1 ml of OXERVATE contains 20 micrograms of cenegermin.
Croatian: Jedan ml lijeka OXERVATE sadrži 20 mikrograma cenegermina.
English: Pharmacy:
Croatian: Ljekarna:
English: 1) With clean freshly-washed hands, place the vial on a steady flat surface and remove the plastic flip-off cap. 2) Peel-off the back of the vial adapter blister pack.
Croatian: 1) Čistim, tek opranim rukama postavite bočicu na čvrstu ravnu površinu i skinite plastični flip-off poklopac.
English: On that card the patient should track the date of the first use of the weekly supply, the time of the vial opening (i.e. when the vial adapter is connected to the vial), and the time of daily ocular instillations occurring over the week.
Croatian: Na tu karticu bolesnik treba zabilježiti datum prve primjene izdane količine za tjednu terapiju, vrijeme otvaranja bočice (tj. kada je na bočicu pričvršćen nastavak za bočicu) i vremena ukapavanja u oko za svaki dan u tjednu.
English: Each vial contains 1 ml eye drops, solution.
Croatian: Jedna bočica sadrži 1 ml otopine kapi za oko.
English: 11) Once it has been correctly filled, unscrew the pipette from the luer lock connector of the vial adapter.
Croatian: 11) Kada je kapaljka ispravno napunjena, odvrnite je s luer-lock spoja nastavka za bočicu.
English: Very common (may affect more than 1 in 10 people)
Croatian: Vrlo često (može se javiti u više od 1 na 10 ljudi) • bol u oku.
English: OXERVATE contains the active ingredient cenegermin.
Croatian: OXERVATE sadrži djelatnu tvar cenegermin.
English: • Without removing the vial adapter from its blister pack, connect it to the vial by firmly pushing it down until it snaps into place over the neck of the vial.
Croatian: • Bez da izvadite nastavak iz blistera, spojite ga na bočicu čvrsto potiskujući prema dolje dok ne sjedne na mjesto preko vrata bočice.
English: Once the vial adapter has been connected correctly, it should not be removed from the vial.
Croatian: Nakon što se nastavak pravilno spoji na bočicu više ga se ne smije skidati.
English: Nerve growth factor receptors are expressed in the anterior segment of the eye (cornea, conjunctiva, iris, ciliary body, and lens), by the lacrimal gland, and by posterior segment intraocular tissues.
Croatian: Receptori za faktor rasta živaca eksprimiraju se u prednjem očnom segment (rožnica, konjunktiva, šarenica, cilijarno tijelo i leća), suznoj žlijezdi i tkivima stražnjeg očnog segmenta.
English: Complete corneal healing rate
Croatian: Postotak potpunog cijeljenja rožnice
English: How to use OXERVATE
Croatian: Kako čuvati OXERVATE
English: • Ensure that the pipette plunger is pushed all the way down.
Croatian: • Provjerite da je klip kapaljke potisnut prema dolje do kraja.
English: 5) Take an individual disinfectant wipe and gently clean the surface of the valve on the luer lock connector of the vial adapter.
Croatian: 5) Uzmite tupfer s dezinficijensom i nježno očistite površinu ventila na luer-lock spoju nastavka za bočicu.
English: After the vial adapter is connected to the vial, it can be stored in the fridge or below 25 °C.
Croatian: Nakon što se na bočicu pričvrsti nastavak, bočica se može čuvati u hladnjaku ili na temperaturi do 25 °C.
English: An individual pipette should be used per application.
Croatian: Za svaku primjenu potrebno je koristiti novu kapaljku.
English: The patient will receive a weekly carton including 7 vials of OXERVATE in an insulated pack.
Croatian: Bolesnik će dobiti kutiju za tjednu terapiju koja sadrži 7 bočica lijeka OXERVATE u izoliranom pakiranju.
English: • Once it has been correctly filled, unscrew the pipette from the connector part of the vial adapter.
Croatian: • Kada je kapaljka ispravno napunjena, odvrnite je sa spojnog dijela nastavka bočice.
English: Ensure the plunger has reached the stop point
Croatian: Provjerite da je klip dosegao krajnju točku zaustavljanja (slika 6).
English: The percentage of patients experiencing complete corneal clearing (grade 0 on the modified Oxford scale), the least squares mean change in best corrected distance visual acuity score (Early Treatment Diabetic Retinopathy Study letters) from baseline and any improvement in corneal sensitivity as measured in millimetres by Cochet-Bonnet aesthesiometry (difference compared to baseline >0) was also measured after 8 weeks of treatment in both studies, and summarized in the table below.
Croatian: Early Treatment Diabetic Retinopathy Study, ETDRS) u odnosu na početne vrijednosti i bilo kakvo poboljšanje senzibiliteta rožnice, mjereno u milimetrima pomoću Cochet-Bonnetovog esteziometra (razlika od početne vrijednosti >0), također mjereno nakon 8 tjedana za oba ispitivanja, sažeto su prikazani u tablici u nastavku.
English: • Take a pipette (dropper) and remove it from its protective packaging.
Croatian: • Uzmite kapaljku i izvadite je iz zaštitne ambalaže.
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU oxervate
English: • eye pain.
Croatian: • upala oka;
English: 14) If a mistake is made and a drop is not instilled into the eye, repeat the steps described above using a new pipette and wipe.
Croatian: 14) Ako je došlo do greške i kap nije ukapana u oko, ponovite gore opisane korake koristeći se novom kapaljkom i novim tupferom. 15) Tijekom dana bočicu se može vratiti u hladnjak ili čuvati na temperaturi do 25 °C (zajedno sa spojenim nastavkom za bočicu).
English: Hepatic and renal impairment:
Croatian: Oštećena funkcija jetre i bubrega:
English: The spike of the vial adapter should pierce through the vial's rubber stopper.
Croatian: Šiljak nastavka za bočicu mora probiti gumeni čep bočice.
English: - if you are taking any eye drops containing corticosteroids (e.g. to treat an ocular inflammation) or preservatives (e.g. benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide).
Croatian: ili konzervanse (npr. benzalkonijev klorid, polikvaternij-1, benzododecinijev bromid, cetrimid).
English: • excessive ingrowth of blood vessels into the cornea; • infection of the cornea with pus and swelling.
Croatian: • pretjerano urastanje krvnih žila u rožnicu;
English: OXERVATE 20 micrograms/ml eye drops, solution
Croatian: NAZIV LIJEKA OXERVATE 20 mikrograma/ml kapi za oko, otopina
English: OXERVATE may cause mild to moderate eye discomfort, such as eye pain, to the patient.
Croatian: OXERVATE u bolesnika može izazvati blag do umjeren osjećaj neugode u oku, poput boli u oku.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet DOMPE' farmaceutici S.p.A.
English: The patient will receive a weekly carton containing 7 vials of OXERVATE.
Croatian: Bolesnik će dobiti kutiju za tjednu terapiju koja sadrži 7 bočica lijeka OXERVATE.
English: You will receive a new supply of OXERVATE each week, for the duration of the treatment period.
Croatian: Tijekom trajanja terapije, svakog tjedna dobit ćete novu količinu lijeka OXERVATE.
English: - The active substance is cenegermin.
Croatian: Što OXERVATE sadrži - Djelatna tvar je cenegermin.
English: 3) Without removing the vial adapter from its blister pack, connect the vial adapter to the vial by firmly pushing the vial adapter down vertically until it snaps into place over the neck of the vial and the spike of the vial adapter pierces through the vial's rubber stopper.
Croatian: Bez da ga izvadite iz blistera, spojite nastavak na bočicu čvrsto potiskujući nastavak na bočicu okomito prema dolje, sve dok ne sjedne na mjesto preko vrata bočice, a šiljak u nastavku probije gumeni čep bočice.
English: OXERVATE Vehicle (p value)
Croatian: Vehikulum 3,53 (p vrijednost)
English: A new OXERVATE supply will be issued each week for the duration of the treatment period.
Croatian: Tijekom trajanja terapije, nove količine lijeka OXERVATE izdavat će se svakog tjedna.
English: PHARMACEUTICAL PARTICULARS 6.1 List of Excipients
Croatian: 6.1 Popis pomoćnih tvari
English: • Peel-off the back of the vial adapter blister pack (picture 2).
Croatian: • Otvorite blister s nastavkom za bočicu povlačenjem pokrova sa stražnje strane (slika 2).
English: 4) Remove and discard the vial adapter blister pack.
Croatian: 4) Uklonite i bacite blister u kojem je bio nastavak za bočicu.
English: Eye pain was the most frequently reported adverse reaction, followed by eye irritation and abnormal sensation in the eye, when considering the whole population treated with the medicinal product (i.e. population included in clinical trials also on indications other than neurotrophic keratitis).
Croatian: Kada je uzeta u obzir cijela populacija liječena lijekom (tj. cijela populacija uključena u klinička ispitivanja, uključujući i ispitanike s drugim indikacijama osim neurotrofnog keratitsa) najčešće prijavljena nuspojava bila je bol u oku, a zatim iritacija oka i abnormalan osjećaj u oku.
English: OXERVATE is a clear, colourless eye drops, solution.
Croatian: Kako OXERVATE izgleda i sadržaj pakiranja OXERVATE je bistra, bezbojna otopina, kapi za oko.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I)
English: • Screw the pipette (clockwise) into the connector part of the vial adapter (picture 5).
Croatian: • Kapaljku pričvrstite na spojni dio na nastavku bočice, zakrećući je u smjeru kazaljke na satu (slika 5).
English: • Remove and discard the packaging of the vial adapter.
Croatian: • Uklonite i bacite pakiranje u kojem je bio nastavak za bočicu.
English: Uncommon Corneal abscess Nervous system disorders Common
Croatian: Poremećaji živčanog sustava
English: You should wait at least 15 minutes before or after using OXERVATE if you use any other eye drops.
Croatian: Ako primjenjujete bilo koje druge kapi za oko, morate pričekati najmanje 15 minuta prije ili poslije primjene lijeka OXERVATE.
English: Method of administration For ocular use only.
Croatian: Samo za okularnu primjenu.
English: METHOD OF ADMINISTRATION
Croatian: NAČIN PRIMJENE
English: 7) Screw the pipette clockwise into the luer lock connector of the vial adapter.
Croatian: 7) Na luer-lock spoj na nastavku za bočicu pričvrstite kapaljku zakrećući je u smjeru kazaljke na satu.
English: * Recombinant form of human nerve growth factor produced in Escherichia Coli.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine sadrži 20 mikrograma cenegermina* * Rekombinantni oblik ljudskog faktora rasta živaca dobiven iz bakterije Escherichia Coli.
English: • inflammation of the eye;
Croatian: • bol u očnom kapku;
English: This helps to bring relief from pain.
Croatian: Ovo pomaže pri ublažavanju boli.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 17 January 2014.
Croatian: Budući da je tvrtka dostavila dodatne zatražene informacije, „iznimne okolnosti” su završene 17. siječnja 2014.
English: The dose must not be increased more than once in any 24 hour period.
Croatian: Doza se ne smije povećati više od jednom tijekom razdoblja od 24 sata.
English: The third study looked at the use of the medicine over three weeks.
Croatian: Treće je ispitivanje istražilo primjenu lijeka tijekom tri tjedna.
English: EPAR summary for the public ziconotide
Croatian: EPAR, sažetak za javnost ziconotid
English: Other information about Prialt
Croatian: Ostale informacije o lijeku Prialt
English: The dose should be gradually increased, preferably every two days or more, to obtain the best balance between pain relief and possible side effects.
Croatian: Dozu treba postupno povećavati, po mogućnosti svaka dva dana ili više, kako bi se dobila najbolja ravnoteža između ublažavanja boli i mogućih nuspojava.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prialt on 21 February 2005..
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Prialt vrijedi na prostoru Europske unije od 21. veljače 2005.
English: In all of the studies, the main measure of effectiveness was the change in the Visual Analog Scale of Pain Intensity (VASPI).
Croatian: U svim je ispitivanjima glavna mjera djelotvornosti bila promjena u vizualnoj analognoj skali intenziteta boli (Visual Analog Scale of Pain Intensity - VASPI).
English: What measures are being taken to ensure the safe and effective use of Prialt?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Prialt?
English: Prialt was more effective than placebo in the first two studies.
Croatian: Prialt je bio djelotvorniji od placeba.
English: What is Prialt?
Croatian: Što je Prialt?
English: This is a score given by the patients of their pain on a scale from 0 mm (no pain) to 100 mm (maximum pain).
Croatian: Bolesnici su ocjenjivali svoju bol na skali od 0 mm (nema boli) do 100 mm (maksimalna bol).
English: The maximum dose is 21.6 micrograms per day.
Croatian: Maksimalna doza iznosi 21,6 mikrograma na dan.
English: The most common side effects with Prialt (seen in more than 1 patient in 10) are confusion, dizziness, nystagmus (uncontrolled eye movement), impaired memory (forgetfulness), headache, somnolence (sleepiness), blurred vision, nausea (feeling sick), vomiting, abnormal gait (difficulty walking) and asthenia (weakness).
Croatian: Najčešće nuspojave s lijekom Prialt (kod više od 1 na 10 osoba) su konfuzija, vrtoglavica, nistagmus (nekontrolirani pokreti očiju), oštećeno pamćenje (zaboravljivost), glavobolja, somnolencija (pospanost), zamućeni vid, mučnina (osjećaj slabosti), povraćanje, abnormalni hod (poteškoće pri hodanju) i astenija (slabost).
English: What is the risk associated with Prialt?
Croatian: Koji su rizici povezani s lijekom Prialt?
English: Most patients need doses lower than 9.6 micrograms per day.
Croatian: Većini bolesnika potrebne su doze manje od 9,6 mikrograma na dan.
English: Two of the studies were short-term, lasting five or six days: one in pain due to cancer or AIDS, and one in pain due to other causes such as nerve damage.
Croatian: Dva su ispitivanja bila kratkoročna i trajala su pet ili šest dana: jedno je ispitivanje bilo ispitivanje boli zbog raka ili SIDA-e, a drugo je bilo ispitivanje boli uzrokovane drugim uzrocima poput oštećenja živca.
English: A risk management plan has been developed to ensure that Prialt is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Prialt.
English: The company that makes Prialt is carrying out a study looking at the long-term use of the medicine, looking in particular at the possibility of development of tolerance to treatment (when doses of a medicine that used to be effective become less effective over time).
Croatian: Proizvođač lijeka Prialt provodi ispitivanje kojim istražuje dugoročnu primjenu lijeka, posebice istražujući mogućnost razvoja tolerancije na liječenje (u slučajevima kada doze lijeka koje su prethodno bile djelotvorne postanu manje djelotvorne tijekom određenog razdoblja).
English: Why has Prialt been approved?
Croatian: Zašto je lijek Prialt odobren?
English: 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 Prialt.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Prialt.
English: Prialt may need to be diluted before use, especially with the lower doses needed at the start of treatment.
Croatian: Prialt će se možda morati razrijediti prije primjene, posebice u slučaju manjih doza na početku liječenja.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Prialt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Prialt možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Prialt provides an alternative to other intrathecal painkillers, such as opioids.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da lijek Prialt predstavlja alternativu za druge intratekalne analgetike, poput opioida.
English: What information is still awaited for Prialt?
Croatian: Koje se još informacije očekuju o lijeku Prialt?