FrancophonIA/ELRC3.0 huggingface dataset:
English: Driving and using machines Vantobra is not expected to affect your ability to drive or use machines.
Croatian: Ne očekuje se utjecaj lijeka Vantobra na sposobnost upravljanja vozilima ili rada sa strojevima.
English: To re-start the treatment, press and hold the On/Off button again for one full second to resume treatment.
Croatian: Za nastavak liječenja ponovno pritisnite i držite dugme
English: Vantobra is available together with a Tolero nebuliser handset.
Croatian: Lijek Vantobra dostupan je zajedno s ručnim nebulizatorom Tolero.
English: What Vantobra is
Croatian: Što je Vantobra
English: OFF Vantobra Use Vantobra twice a day for 28 days Do not use any Vantobra for the next 28 days
Croatian: Primjenjujte lijek Vantobra dva puta na dan tijekom 28 dana.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svakog organskog sustava nuspojave su poredane po učestalosti, počevši od najučestalijih.
English: • The nebuliser handset must be kept horizontally during operation.
Croatian: • Ručni nebulizator se mora držati u vodoravnom položaju prilikom korištenja.
English: In controlled clinical trials, 97% of patients receiving tobramycin nebuliser solution achieved sputum concentrations 10-fold of the highest P. aeruginosa MIC cultured from the patient and 95% of patients receiving tobramycin nebuliser solution achieved 25-fold of the highest MIC.
Croatian: U kontroliranim kliničkim ispitivanjima 97 % bolesnika koji su primali otopinu tobramicina za nebulizator postiglo je u sputumu 10 puta veće koncentracije od najviše MIK za P.
English: How Vantobra works
Croatian: Kako Vantobra djeluje
English: Rare (may affect up to 1 in 1,000 people)
Croatian: Rijetko (može se javiti u najviše 1 na 1000 osoba)
English: The elimination of tobramycin administered by the inhalation route has not been studied.
Croatian: Eliminacija Eliminacija tobramicina primjenjenog inhalacijom nije ispitivana.
English: 1 connected with an eBase controller or eFlow rapid controller 2 connected with a PARI Boy SX compressor
Croatian: 2 spojen s kompresorom PARI Boy SX
English: Development of resistance during inhaled tobramycin therapy could limit treatment options during acute exacerbations; this should be monitored.
Croatian: Potrebno je pratiti razvoj rezistencije tijekom inhalacijske terapije tobramicinom jer bi ona mogla ograničiti mogućnosti liječenja tijekom akutnih egzacerbacija.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava vrlo rijetko limfadenopatija
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read both the package leaflet of Vantobra and the Instructions for Use of the Tolero nebuliser handset before use.
Croatian: Prije uporabe pročitajte uputu o lijeku Vantobra i upute za korištenje ručnog nebulizatora Tolero.
English: In the event of accidental ingestion of Vantobra, toxicity is unlikely as tobramycin is poorly absorbed from an intact gastrointestinal tract.
Croatian: Kod nenamjernog gutanja lijeka Vantobra, toksičnost se vjerojatno neće razviti s obzirom da se tobramicin slabo apsorbira iz neoštećenog probavnog trakta.
English: • fungal infections of the mouth or throat, such as thrush
Croatian: • gljivične infekcije usta ili grla, poput kandidijaze • oticanje limfnih čvorova
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane rijetko anoreksija
English: Sodium chloride
Croatian: Sojevi bakterije
English: Back pain
Croatian: • bol u leđima
English: One ampoule contains 170 mg of tobramycin as a single dose.
Croatian: Jedna ampula sadrži 170 mg tobramicina, što čini pojedinačnu dozu.
English: • sleepiness
Croatian: • pospanost
English: Magnesium sulphate Sulphuric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev klorid kalcijev klorid magnezijev sulfat sulfatna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
English: 1, and TOBI/PARI LC PLUS Performance parameter/ Drug/Device combination*
Croatian: Parametar funkcionalnosti/ kombinacija lijek/uređaj*
English: What Vantobra is used for
Croatian: Za što se koristi Vantobra
English: Package leaflet: Information for the patient Vantobra 170 mg nebuliser solution tobramycin
Croatian: Uputa o lijeku: Informacije za bolesnika Vantobra 170 mg otopina za nebulizator tobramicin
English: • Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with the medicine.
Croatian: • Za svaki ciklus liječenja (28 dana liječenja) koristite novi ručni nebulizator Tolero isporučen uz lijek.
English: Total Drug Delivered [mg±SD] Fine Particle Mass < 5 µm [mg±SD] Drug Delivery Rate [mg/min] Mass Median Aerodynamic Diameter [µm ± SD]
Croatian: Masa sitnih čestica < 5 µm [mg±SD]
English: Vantobra is administered by inhalation using the Tolero nebuliser handset provided in the pack.
Croatian: Lijek Vantobra primjenjuje se inhalacijom uz pomoć ručnog nebulizatora Tolero isporučenog zajedno s lijekom u pakiranju.
English: UNIQUE IDENTIFIER - 2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: No studies have been performed on patients with hepatic impairment.
Croatian: Nisu provedena ispitivanja u bolesnika s oštećenjem funkcije jetre.
English: Nephrotoxicity has been associated with parenteral aminoglycoside therapy.
Croatian: Nefrotoksičnost Nefrotoksičnost je povezana s parenteralnom terapijom aminoglikozidima.
English: The use of an alternative untested nebuliser system may alter the pulmonary deposition of the active substance.
Croatian: Korištenje drugog neprovjerenog nebulizatorskog sustava može izmijeniti taloženje djelatne tvari u plućima, a to može utjecati na djelotvornost i sigurnost lijeka.
English: Occasionally, patients with a history of prolonged previous or concomitant use of intravenous aminoglycosides may experience hearing loss.
Croatian: U bolesnika koji su ranije dugotrajno ili istodobno primali aminoglikozide intravenski ponekad može doći do gubitka sluha.
English: Adverse drug reactions reported for tobramycin nebuliser solution are listed in Table 1.
Croatian: Nuspojave zabilježene pri primjeni otopine tobramicina za nebulizator navedene su u Tablici
English: Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).
Croatian: 4.1 Terapijske indikacije Vantobra je indiciran za liječenje kronične plućne infekcije uzrokovane bakterijom Pseudomonas aeruginosa u bolesnika s cističnom fibrozom (CF) u dobi od 6 i više godina.
English: Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with the medicine.
Croatian: Za svaki ciklus liječenja (28 dana liječenja) koristite novi ručni nebulizator Tolero koji je isporučen uz lijek.
English: • One box with 56 ampoules with nebuliser solution in 7 sachets.
Croatian: • Jedna kutija s 56 ampula s otopinom za nebulizator zapakiranih u 7 vrećica.
English: As tobramycin is not metabolised, an effect of hepatic impairment on the exposure to tobramycin is not expected.
Croatian: ne očekuje se učinak oštećenja funkcije jetre na izloženost tobramicinu.
English: • One box with the medicinal product: 56 ampoules with nebuliser solution in 7 sachets.
Croatian: • Jedna kutija s lijekom: 56 ampula s otopinom za nebulizator zapakiranih u 7 vrećica.
English: Talk to your doctor if you are concerned about this.
Croatian: Ako ste zabrinuti zbog toga, obratite se svom liječniku.
English: • kidney problems;
Croatian: • poteškoće s bubrezima;
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PRILOG II. A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: How to use Vantobra
Croatian: Kako primjenjivati Vantobra
English: PARI Pharma GmbH Lochhamer Schlag 21 82166 Graefelfing GERMANY
Croatian: 82166 Graefelfing
English: • nosebleed, runny nose
Croatian: • krvarenje iz nosa, curenje nosa
English: If any of these apply to you, tell your doctor before using Vantobra.
Croatian: Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika prije primjene lijeka Vantobra.
English: • other medicines which may harm your kidneys or hearing: o amphotericin B, cefalotin, polymyxins (used to treat microbial infections), ciclosporin, tacrolimus (used to reduce the activity of immune system).
Croatian: o amfotericin B, cefalotin, polimiksini (za liječenje mikrobnih infekcija), ciklosporin, takrolimus
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ampoule of 1.7 ml contains 170 mg tobramycin.
Croatian: Svaka ampula od 1,7 ml sadrži 170 mg tobramicina.
English: NAME OF THE MEDICINAL PRODUCT Vantobra 170 mg nebuliser solution
Croatian: NAZIV LIJEKA Vantobra 170 mg otopina za nebulizator
English: The contents of one ampoule should be emptied into the medication reservoir of the Tolero nebuliser handset and administered by inhalation until no medicine is left in the reservoir.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Sadržaj jedne ampule potrebno je uliti u spremnik za lijek koji se nalazi na ručnom nebulizatoru Tolero te primijeniti inhalacijom dok se lijek iz spremnika ne potroši.
English: Excipients: sodium chloride, calcium chloride, magnesium sulphate, water for injections, sulphuric acid and sodium hydroxide for pH adjustment.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev klorid, kalcijev klorid, magnezijev sulfat, voda za injekcije,
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet PARI Pharma GmbH
English: NAME OF THE MEDICINAL PRODUCT Vantobra 170 mg nebuliser solution tobramycin
Croatian: Vantobra 170 mg otopina za nebulizator tobramicin
English: Hypoxia
Croatian: Hemoptiza
English: Hypersensitivity
Croatian: Granične koncentracije osjetljivosti
English: • The active substance is tobramycin.
Croatian: Što Vantobra sadrži - Djelatna tvar je tobramicin.
English: Inhalation use
Croatian: Za inhaliranje
English: Ototoxicity, manifested as both auditory toxicity (hearing loss) and vestibular toxicity, has been reported with parenteral aminoglycosides.
Croatian: Uz primjenu parenteralnih aminoglikozida zabilježena je ototoksičnost, koja se manifestira kao auditivna toksičnost (gubitak sluha) i vestibularna toksičnost.
English: In patients with a predisposing risk due to previous prolonged systemic aminoglycoside therapy it may be necessary to consider audiological assessment before initiating Vantobra therapy.
Croatian: Možda će biti neophodno razmotriti provođenje audiološke obrade prije početka terapije lijekom Vantobra u bolesnika s predisponirajućim rizikom zbog prethodne dugotrajne sistemske terapije aminoglikozidima.
English: Pulmonary function test decreased
Croatian: Pretrage rijetko smanjene vrijednosti na testu funkcije pluća
English: PHARMACEUTICAL FORM AND CONTENTS Package contains 56 ampoules with nebuliser solution in 7 sachets.
Croatian: Pakiranje sadrži 56 ampula s otopinom za nebulizator zapakiranih u 7 vrećica.
English: Clinical experience with tobramycin nebuliser solutions reports dysphonia and tinnitus in patients treated with tobramycin.
Croatian: U bolesnika koji su liječeni tobramicinom zabilježena je pojava disfonije i tinitusa prilikom kliničke primjene otopina tobramicina za nebulizator.
English: Dysgeusia
Croatian: • grlobolja
English: Bronchodilator therapy, such as salbutamol 2.
Croatian: Terapija bronhodilatatorima, kao što je salbutamol Fizioterapija prsnog koša Ostali lijekovi za inhalaciju Vantobra
English: This does not change how Vantobra works provided that the storage instructions have been followed.
Croatian: To ne utječe na njegovo djelovanje ako se s lijekom postupa u skladu s uputama za čuvanje.
English: ON Vantobra
Croatian: UZ lijek Vantobra
English: Urticaria Pruritus
Croatian: Tablica 1 Nuspojave
English: Rare
Croatian: Osjetljivi
English: Malaise
Croatian: Doziranje
English: INNER BOX CONTAINING THE MEDICINE
Croatian: PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva rijetko osip vrlo rijetko urtikarija svrbež
English: Chest physiotherapy 3.
Croatian: Moosstrasse 3
English: Opened ampoule should never be stored for re-use.
Croatian: Nikada ne pohranjujte otvorenu ampulu za daljnju primjenu.
English: What Vantobra looks like and contents of the pack Vantobra nebuliser solution is provided in a ready-to-use ampoule.
Croatian: Otopina lijeka Vantobra za nebulizator isporučuje se u ampulama koje su spremne za primjenu.
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Ostale nuspojave mogu uključivati: Manje često (može se javiti u najviše 1 na 100 osoba)
English: Laryngitis
Croatian: Dojenje
English: Immune system disorders
Croatian: (za smanjenje aktivnosti imunološkog sustava).
English: Rash
Croatian: Njemačka
English: Epistaxis
Croatian: FARMACEUTSKI
English: Uncommon
Croatian: Neosjetljivi
English: Dyspnoea Dysphonia Pharyngitis Cough
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET PARI Pharma GmbH
English: 24 March 2017 EMA/192276/2017 EMEA/H/C/004193
Croatian: EMA/192276/2017 EMEA/H/C/004193
English: It was to be available as capsules to be taken by mouth.
Croatian: Dostupan je u obliku kapsula koje se uzimaju na usta.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom ispitivanju ili u programu milosrdnog davanja lijeka i trebate više informacija o liječenju, obratite se liječniku koji provodi liječenje.
English: The company presented data from a main study in 327 patients with myelofibrosis that looked at the number of patients whose spleen size reduced by at least 35% after 24 weeks of treatment.
Croatian: Tvrtka je predstavila podatke iz glavnog ispitivanja na 327 bolesnika s mijelofibrozom u kojem se istraživao broj bolesnika čija se veličina slezene smanjila za najmanje 35 % nakon 24 tjedna liječenja.
English: What is Enpaxiq?
Croatian: Što je Enpaxiq?
English: Furthermore, the CHMP noted that more information was needed about the starting materials used in the manufacture of Enpaxiq and how it acts on certain target proteins in the body.
Croatian: Štoviše, CHMP primijetio je da je potrebno više informacija o materijalima koji su korišteni u proizvodnji lijeka Enpaxiq i o tome kako djeluje na određene ciljane proteine u tijelu.
English: On 20 February 2017, CTI BioPharma officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Enpaxiq, for treating patients with an enlarged spleen or other symptoms of myelofibrosis.
Croatian: Tvrtka CTI BioPharma 20. veljače 2017. službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Enpaxiq za liječenje bolesnika s povećanom slezenom ili drugim simptomima mijelofibroze.
English: The Committee had a number of concerns: the reduction in spleen size, the main measure of effectiveness in the study, appeared to be lower with Enpaxiq than with another medicine of its class, with no improvement in symptom scores; the incidence of low blood platelet levels (which can cause bleeding) was higher in patients treated with Enpaxiq; and a higher number of deaths occurred in patients taking Enpaxiq than in those receiving best available therapy, including deaths due to bleeding and effects on the heart.
Croatian: Odbor je izrazio zabrinutost u pogledu mnogih stvari: pokazalo se da je smanjenje veličine slezene, glavna mjera djelotvornosti u ispitivanju, bilo manje tijekom liječenja lijekom Enpaxiq nego tijekom liječenja drugim lijekovima iz istog razreda te je ustanovljeno da nije bilo poboljšanja u ocjeni simptoma; učestalost niskih razina trombocita u krvi (koji mogu uzrokovati krvarenje) bila je veća kod bolesnika koji su primali Enpaxiq; prijavljen je veći broj smrtnih slučajeva kod bolesnika koji su primali Enpaxiq nego kod bolesnika koji su primali najbolje moguće liječenje, uključujući smrtne slučajeve uzrokovane krvarenjem i utjecajima na srce.
English: The company stated in its letter to the Agency that it was withdrawing the application because there was not enough time in the current application procedure to provide new data from a second main study with Enpaxiq.
Croatian: Tvrtka je u svojem pismu Agenciji izjavila da povlači zahtjev jer u trenutačnom postupku zahtjeva nema dovoljno vremena za podnošenje novih podataka iz drugog glavnog ispitivanja lijeka Enpaxiq.
English: The study compared Enpaxiq with ‘best available therapy', which included treatments that do not act on JAK proteins such as hydroxyurea or supportive care.
Croatian: U ispitivanju je Enpaxiq uspoređen s „najboljim mogućim liječenjem” koje je uključivalo liječenje koje ne utječu na JAK proteine, kao što su hidroksiurea ili suportivnu terapiju.
English: Enpaxiq is a medicine that contains the active substance pacritinib.
Croatian: Enpaxiq je lijek koji sadrži djelatnu tvar pakritinib.
English: The company said that it intends to integrate the new data from the study into its current dossier before approaching EMA to discuss a new application.
Croatian: Tvrtka je izjavila da nove podatke iz ispitivanja namjerava unijeti u trenutačni dosje prije nego što se obrati EMA-i u vezi s novim zahtjevom.
English: By blocking these proteins, Enpaxiq is expected to slow down the production of immature blood cells and thereby help reduce the symptoms of the disease.
Croatian: Očekuje se da će Enpaxiq blokiranjem tih proteina usporiti proizvodnju nezrelih krvnih stranica i na taj način pomoću u smanjivanju simptoma bolesti.
English: At the time of the withdrawal of application, the CHMP was of the provisional opinion that Enpaxiq could not have been approved for myelofibrosis.
Croatian: U vrijeme povlačenja zahtjeva, CHMP je donio privremeno mišljenje o tome da se Enpaxiq ne može odobriti za liječenje mijelofibroze.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Enpaxiq.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi lijek Enpaxiq ili u programe milosrdnog davanja lijeka Enpaxiq.
English: Further information on its orphan designations can be found here.
Croatian: Dodatne informacije o oznakama za lijekove za rijetke bolesti mogu se pronaći ovdje.
English: Enpaxiq was expected to be used to treat patients with an enlarged spleen or other symptoms of myelofibrosis - a disorder in which scar tissue builds up in the bone marrow where blood cells are produced.
Croatian: Enpaxiq se trebao koristiti za liječenje bolesnika s povećanom slezenom ili drugim simptomima mijelofibroze, poremećaja u kojem se fibrozno tkivo nakuplja u koštanoj srži gdje se proizvode krvne stanice.
English: Given these concerns, the Committee was of the opinion that the benefits of Enpaxiq had not been shown to outweigh its risks.
Croatian: Uzimajući u obzir te zabrinutosti, Odbor je smatrao da koristi lijeka Enpaxiq ne nadmašuju njegove rizike.
English: In myelofibrosis, patients have too much of these proteins, which cause the production of immature blood cells, some of which migrate to organs such as the spleen, causing them to become enlarged.
Croatian: Bolesnici koji boluju od mijelofibroze imaju previše tih proteina koji uzrokuju proizvodnju nezrelih krvnih stanica od kojih neke prelaze u organe kao što je slezena te uzrokuje povećanje tih organa.
English: Withdrawal of the marketing authorisation application for Enpaxiq (pacritinib)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Enpaxiq (pakritinib)
English: The active substance in Enpaxiq, pacritinib, blocks the action of JAK2 and FLT3, two proteins involved in the production and growth of blood cells.
Croatian: Pakritinib, djelatna tvar u lijeku Enpaxiq blokira djelovanje proteina JAK2 i FLT3 koji su uključeni u proizvodnju i rast krvnih stanica.
English: Enpaxiq was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 25 August 2010 for different types of myelofibrosis.
Croatian: Enpaxiq je 25. kolovoza 2010. označen kao lijek za rijetku bolest za liječenje različitih vrsta mijelofibroze.
English: What was Enpaxiq expected to be used for?
Croatian: Za što se lijek Enpaxiq trebao koristiti?
English: How does Enpaxiq work?
Croatian: Kako djeluje Enpaxiq?
English: Withdrawal of the marketing authorisation application for Enpaxiq (pacritinib) EMA/192276/2017
Croatian: (pakritinib) EMA/192276/2017
English: Further information on Mulpleo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/mulpleo.
Croatian: Više informacija o lijeku Mulpleo dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/mulpleo.
English: What is Mulpleo and what is it used for?
Croatian: Što je Mulpleo i za što se koristi?
English: Mulpleo is available as 3 mg tablets.
Croatian: Mulpleo je dostupan u obliku tableta od 3 mg.
English: Similar effects occurred in patients receiving placebo.
Croatian: Slične su nuspojave nastupile i kod bolesnika koji su primali placebo.
English: What measures are being taken to ensure the safe and effective use of Mulpleo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Mulpleo?
English: Treatment with Mulpleo should start at least 8 days before the procedure and the recommended dose is 1 tablet daily for 7 days.
Croatian: Terapiju lijekom Mulpleo treba započeti barem osam dana prije zahvata, a preporučena doza iznosi jednu tabletu dnevno tijekom sedam dana.
English: 1 Previously known as Lusutrombopag Shionogi.
Croatian: 1 Prethodno poznat kao Lusutrombopag Shionogi.
English: Other information about Mulpleo
Croatian: Ostale informacije o lijeku Mulpleo
English: Side effects reported with Mulpleo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Mulpleo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The European Medicines Agency decided that Mulpleo's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Mulpleo nadmašuju s njim povezane rizike te se može izdati odobrenje za njegovu primjenu u EU-u.
English: What are the risks associated with Mulpleo?
Croatian: Koji su rizici povezani s lijekom Mulpleo?
English: Why is Mulpleo authorised in the EU?
Croatian: Zašto je lijek Mulpleo odobren u EU-u?
English: The medicine is for use in patients having an invasive procedure (a medical procedure that involves cutting into or puncturing the skin or inserting instruments into the body).
Croatian: Lijek se primjenjuje u bolesnika koji će biti podvrgnuti invazivnom postupku (medicinskom postupku koji podrazumijeva rezanje ili punkciju kože, odnosno uvođenje instrumenata u tijelo).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mulpleo have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Mulpleo nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of Mulpleo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Mulpleo kontinuirano se prate.
English: Mulpleo received a marketing authorisation valid throughout the EU on 18 February 2019.
Croatian: Za lijek Mulpleo izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 18. veljače