FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy, suggesting no age-related differences in the pharmacokinetics of filgrastim.
Croatian: Pedijatrijska populacija Podaci iz kliničkih ispitivanja pedijatrijskih bolesnika ukazuju da su sigurnost i djelotvornost filgrastima slične u odraslih i djece koji primaju citotoksičnu kemoterapiju, što upućuje na to da razlike u farmakokinetici filgrastima nisu povezane sa starošću.
English: - Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Croatian: 4.1 Terapijske indikacije - Skraćenje trajanja neutropenije i smanjenje incidencije febrilne neutropenije u bolesnika koji se liječe utvrđenom citotoksičnom kemoterapijom zbog zloćudne bolesti (uz iznimku kronične mijeloične leukemije i mijelodisplastičnih sindroma) i skraćenje trajanja neutropenije u bolesnika koji primaju mijeloablativnu terapiju prije presađivanja koštane srži u kojih se smatra da postoji povećani rizik od produljenog trajanja teške neutropenije.
English: If you use more Zarzio than you should
Croatian: Ako primijenite više lijeka Zarzio nego što ste trebali
English: Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 - 2 days, and to normal levels within 1 - 7 days.
Croatian: broj cirkulirajućih neutrofila smanjuje se za 50 % u roku od 1 - 2 dana, a na normalne vrijednosti u roku od 1 - 7 dana.
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Zarzio.
Croatian: Slučajno izlaganje niskim temperaturama neće štetno utjecati na stabilnost lijeka Zarzio.
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe EU/1/08/495/005
Croatian: Zarzio 48 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki EU/1/08/495/005
English: Initial dose adjustment to alternate day dosing with 30 MU/day (300 μg/day) is recommended.
Croatian: Preporučuje se prilagoditi početnu dozu na 30 MU/dan (300 μg/dan) za primjenu svaki drugi dan.
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe EU/1/08/495/001
Croatian: Zarzio 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki EU/1/08/495/001
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 96 million units (MU) (equivalent to 960 micrograms [μg]) filgrastim*.
Croatian: Zarzio 48 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki Jedan ml otopine sadrži 96 milijuna jedinica (MU) (što odgovara 960 mikrograma [μg]) filgrastima*.
English: Using the pre-filled syringe with a needle safety guard The needle safety guard covers the needle after injection to prevent needle stick injury.
Croatian: Sigurnosna zaštita za iglu pokriva iglu nakon davanja injekcije kako bi se spriječila ozljeda ubodom igle.
English: Filgrastim may have a minor influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Filgrastim može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Zarzio 30 MU/0.5 ml
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Zarzio 30 MU/0,5 ml
English: • if you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Croatian: • ako imate neku od navedenih ili kombinaciju navedenih nuspojava: - oticanje ili podbuhlost koji mogu biti povezani s rjeđim mokrenjem, otežano disanje,
English: Zarzio 48 MU/0.5 ml
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Zarzio 48 MU/0,5 ml
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 30 MU filgrastim in 0.5 ml, corresponding to 60 MU/ml.
Croatian: Zarzio 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki: Jedna napunjena štrcaljka sadrži 30 MU filgrastima u 0,5 ml, što odgovara 60 MU/ml.
English: Special warnings and precautions across indications
Croatian: Posebna upozorenja i mjere opreza povezani s komorbiditetima
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) filgrastim*.
Croatian: Zarzio 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki Jedan ml otopine sadrži 60 milijuna jedinica (MU) (što odgovara 600 mikrograma [μg]) filgrastima*.
English: Contents of the pack and other information What Zarzio contains
Croatian: Sadržaj pakiranja i druge informacije Što je Zarzio i za što se koristi
English: You will normally receive your first dose of Zarzio at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.
Croatian: Bolesnici koji su bili podvrgnuti transplantaciji koštane srži nakon kemoterapije: Uobičajeno je prvu dozu Zarzia primiti najmanje 24 sata nakon kemoterapije i najmanje 24 sata nakon transplantacije koštane srži.
English: Cutaneous vasculitis
Croatian: Kožni vaskulitisa
English: Single use only.
Croatian: Zarzio namijenjene su samo za jednokratnu uporabu.
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Croatian: Zarzio 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki Zarzio 48 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki
English: Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Croatian: Zarzio 48 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki filgrastim
English: Please tell your doctor before starting treatment if you have: - osteoporosis (bone disease); - sickle cell anaemia, as Zarzio may cause sickle cell crisis.
Croatian: - osteoporozu (bolest kostiju); - anemiju srpastih stanica jer Zarzio može uzrokovati krizu srpastih stanica.
English: Splenic rupturea Sickle cell anaemia with crisis
Croatian: Anemija srpastih stanica s krizom
English: Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Croatian: Zarzio 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki filgrastim
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Posebna upozorenja i mjere opreza za sve indikacije
English: Sandoz GmbH Biochemiestr.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sandoz GmbH
English: Special warning and precautions associated with co-morbidities Special precautions in sickle cell trait and sickle cell disease Sickle cell crises, in some cases fatal, have been reported with the use of filgrastim in patients with sickle cell trait or sickle cell disease.
Croatian: Kriza srpastih stanica, u nekim slučajevima sa smrtnim ishodom, zabilježena je uz primjenu filgrastima u bolesnika koji imaju nasljedno obilježje srpastih stanica ili bolest srpastih stanica.
English: Special precautions in SCN patients
Croatian: Posebne mjere opreza kod nasljednog obilježja srpastih stanica i bolesti srpastih stanica
English: Fatiguea Mucosal inflammationa Pyrexia
Croatian: Upala sluznicea Pireksija
English: Vascular Disorders
Croatian: Ruptura slezenea
English: Thrombocytopenia
Croatian: Pseudogihta
English: Paediatric SCN patients
Croatian: Primjena u starijih bolesnika
English: Zarzio 30 MU/0.5 ml injection or infusion Filgrastim
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Zarzio 30 MU/0,5 ml injekcija ili infuzija filgrastim s.c./i.v.
English: What is in this leaflet
Croatian: Što Zarzio sadrži
English: Zarzio 48 MU/0.5 ml injection or infusion Filgrastim
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Zarzio 48 MU/0,5 ml injekcija ili infuzija filgrastim s.c./i.v.
English: SC/IV
Croatian: GM-CSF
English: 84 x 1 capsules (unit dose)
Croatian: 84x1 Kapsula (jedinična doza)
English: 84 capsules
Croatian: 84 Kapsula
English: EMA procedure number
Croatian: EMA broj postupka
English: 21 September 2018 EMA/621972/2018 EMEA/H/C/004355
Croatian: EMA/621972/2018 EMEA/H/C/004355
English: The main measure of effectiveness was the change in the distance walked during a 6-minute walking test after 24 weeks.
Croatian: Glavna je mjera učinkovitosti bila promjena u prehodanoj udaljenosti tijekom šestominutnog testa hodanja nakon 24 tjedna.
English: What is Exondys?
Croatian: Što je Exondys?
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you in the trial.
Croatian: Ako sudjelujete u kliničkom ispitivanju te vam je potrebno više informacija o liječenju, obratite se liječniku koji vas liječi.
English: The methods for comparing results of the main studies with historical data were not satisfactory for showing that the medicine was effective.
Croatian: Metode usporedbe rezultata glavnih ispitivanja s podatcima iz povijesnih izvora nisu bile zadovoljavajuće kako bi se pokazalo da je lijek učinkovit.
English: The company also compared the results of these studies with those from a variety of historical data.
Croatian: Tvrtka je također usporedila rezultate tih ispitivanja s rezultatima iz nekoliko povijesnih izvora.
English: It was to be available as a concentrate for solution for infusion (drip) into a vein.
Croatian: Trebao je biti dostupan kao koncentrat za otopinu za infuziju (drip) u venu.
English: Refusal of the marketing authorisation for Exondys (eteplirsen) EMA/621972/2018
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Exondys (eteplirsen) EMA/621972/2018
English: The Committee considered further data were needed to show that the very low amounts of shortened dystrophin produced as a result of Exondys treatment bring lasting benefits relevant to the patient.
Croatian: Odbor smatra da su potrebni dodatni podatci kako bi se pokazalo da vrlo male količine skraćenog distrofina proizvedenog kao rezultat liječenja lijekom Exondys donose dugotrajne koristi važne za bolesnika.
English: The company that applied for authorisation, AVI Biopharma International Ltd, requested a re-examination of the CHMP's opinion on 1 June 2018.
Croatian: Tvrtka koja je podnijela zahtjev za odobrenje, AVI Biopharma International Ltd, zatražila je 1. lipnja 2018. preispitivanje mišljenja CHMP-a.
English: Refusal of the marketing authorisation for Exondys (eteplirsen)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Exondys (eteplirsen)
English: This shortened protein is expected to act in a similar way to normal dystrophin, helping the body to make up for the lack of dystrophin, and so relieve the symptoms of DMD.
Croatian: Očekuje se da će taj skraćeni protein djelovati na sličan način kao i normalni distrofin te da će pomoći organizmu da nadoknadi nedostatak distrofina te olakšati simptome DMD-a.
English: Patients with DMD do not produce a protein called dystrophin.
Croatian: Bolesnici s DMD-om ne proizvode protein koji se naziva distrofin.
English: What was Exondys expected to be used for?
Croatian: Za što se Exondys trebao koristiti?
English: The company presented the results of two main studies involving 12 boys aged 7 to 13 years with DMD who had a genetic mutation amenable to exon 51 skipping.
Croatian: Tvrtka je dostavila rezultate dvaju glavnih ispitivanja u kojima je sudjelovalo 12 dječaka u dobi od 7 do 13 godina s DMD-om koji su imali genetsku mutaciju pogodnu za preskakanje eksona 51.
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 20 September 2018.
Croatian: Nakon razmatranja razloga za ovaj zahtjev CHMP je preispitao prvotno mišljenje i potvrdio odbijanje izdavanja odobrenja za stavljanje lijeka u promet 20. rujna 2018.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Exondys.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se primjenjuje lijek Exondys.
English: The CHMP was concerned that the main study, which involved just 12 patients, did not compare Exondys with placebo beyond 24 weeks, during which there was no meaningful difference between Exondys and placebo in the 6-minute walking distance.
Croatian: CHMP je izrazio zabrinutost jer se u glavnom ispitivanju, u koje je bilo uključeno samo 12 bolesnika, lijek Exondys nije uspoređivao s placebom i nakon 24 tjedna, tijekom kojih nije bilo znatne razlike između lijeka Exondys i placeba s obzirom na šestominutnu prehodanu udaljenost.
English: Therefore, the CHMP was of the opinion that the balance of benefits and risks of Exondys in the treatment of DMD could not be established and recommended that the marketing authorisation be refused.
Croatian: Stoga CHMP smatra da nije moguće utvrditi povoljan omjer koristi i rizika lijeka Exondys u liječenju DMD-a i predložio je odbijanje davanja odobrenja za stavljanje u promet.
English: This means that the patients' DMD gene can make a working form of the dystrophin protein when a part of the gene called exon 51 is not used.
Croatian: To znači da DMD gen u bolesnika može stvoriti radni oblik proteina distrofina ako se dio gena koji se naziva ekson 51 ne upotrebljava.
English: Exondys was expected to be used for treating Duchenne muscular dystrophy (DMD) in patients aged from 4 years with mutation (change) in the DMD gene that allows treatment involving ‘exon 51 skipping'.
Croatian: Exondys se trebao primjenjivati za liječenje Duchenneove mišićne distrofije (DMD) u bolesnika starijih od četiri godine s mutacijom (promjenom) DMD gena koja omogućuje liječenje koje uključuje „preskakanje eksona 51”.
English: The second study, an extension of the first one, involved the same patients who were all treated with Exondys for another 4 years.
Croatian: U drugo ispitivanje, koje je bilo nastavak prvog ispitivanja, bili su uključeni isti bolesnici koji su svi bili liječeni lijekom Exondys tijekom dodatne četiri godine.
English: Exondys is a medicine that contains the active substance eteplirsen.
Croatian: Exondys je lijek koji sadržava djelatnu tvar eteplirsen.
English: The medicine allows exon 51 to be skipped over and so promote the production of a shortened form of dystrophin.
Croatian: Ovaj lijek omogućuje preskakanje eksona 51 te potiče proizvodnju skraćenog oblika distrofina.
English: In the first study, Exondys was compared with placebo (a dummy treatment) for the first 24 weeks, after which all patients were treated with Exondys.
Croatian: U prvom je ispitivanju lijek Exondys uspoređen s placebom (prividnim liječenjem) tijekom prva 24 tjedna, a nakon toga su svi bolesnici liječeni lijekom Exondys.
English: On 31 May 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Exondys, intended for the treatment of Duchenne muscular dystrophy.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) donio je negativno mišljenje i preporučio odbijanje zahtjeva za odobrenje za stavljanje u promet lijeka Exondys, koji je namijenjen liječenju Duchenneove mišićne distrofije.
English: Exondys was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 3 December 2008 for the treatment of DMD.
Croatian: Dana 3. prosinca 2008. lijek Exondys uvršten je na popis lijekova za rijetke bolesti za liječenje DMDa.
English: How does Exondys work?
Croatian: Kako djeluje Exondys?
English: What is Seresto?
Croatian: Što je Seresto?
English: The company applied for a change (variation) to the marketing authorisation to add a new indication to be recognised by Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Croatian: Društvo je podnijelo zahtjev za promjenu (izmjenu) odobrenja za stavljanje u promet radi dodavanja nove indikacije koju su trebali priznati Austrija, Belgija, Bugarska, Cipar, Češka, Danska, Estonija, Finska, Francuska, Grčka, Mađarska, Island, Irska, Italija, Latvija, Litva, Luksemburg, Nizozemska, Norveška, Poljska, Portugal, Rumunjska, Slovačka, Slovenija, Španjolska, Švedska i Ujedinjena Kraljevina („dotične države članice”).
English: Why was Seresto reviewed?
Croatian: Zašto je Seresto ponovno ocjenjivan?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25 May 2018
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25. svibnja 2018.
English: Seresto is authorised in the European Union (EU) under the decentralised procedure with Germany as the reference Member State.
Croatian: Seresto je odobren u Europskoj uniji (EU) u okviru decentraliziranog postupka s Njemačkom kao referentnom državom članicom.
English: Seresto is an antiparasitic collar containing 10% imidacloprid and 4.5% flumethrin.
Croatian: Seresto je ogrlica protiv nametnika koja sadrži 10 % imidakloprida i 4,5 % flumetrina.
English: The company that markets the product is Bayer Vital GmbH.
Croatian: Proizvod stavlja na tržište Bayer Vital GmbH.
English: Seresto, sometimes under its associated name Foresto, is authorised in nearly all EU/EEA Member States.
Croatian: Seresto, ponekad pod svojim pridruženim imenom Foresto, odobren je u gotovo svim državama članicama EU-a/EGP-a.
English: Because these Member States were not able to reach an agreement, the German Federal Office of Consumer Protection and Food Safety (BVL) referred the matter to the CVMP for arbitration on 18 August 2017.
Croatian: Budući da te države članice nisu uspjele postići dogovor, njemački savezni ured za sigurnost potrošača i sigurnost hrane (BVL) uputio je predmet Odboru na arbitražu 18. kolovoza 2017.
English: Questions and answers on Seresto and its associated name Foresto
Croatian: Pitanja i odgovori o VMP-u Seresto i njegovu pridruženom imenu Foresto
English: It is indicated for the treatment and prevention of infestations with fleas, ticks and lice in dogs and cats, and provides indirect protection against the diseases babesiosis and ehrlichiosis, which can be transmitted to dogs by ticks.
Croatian: Indiciran je za liječenje i sprječavanje zaraza buhama, krpeljima i ušima u pasa i mačaka i pruža neizravnu zaštitu od bolesti babesioza i erlihioza, koju psima mogu prenijeti krpelji.
English: Questions and answers on Seresto and its associated name Foresto EMA/392857/2018
Croatian: Pitanja i odgovori o VMP-u Seresto i njegovu pridruženom imenu Foresto EMA/468939/2018
English: The proposed new indication was against the disease leishmaniosis, which is caused by the parasite Leishmania infantum and transmitted to dogs by sand flies.
Croatian: Predložena nova indikacija bila je protiv bolesti lišmanioze, koje je uzrokovana parazitom Leishmania infantum i koju psima prenose papatači.
English: The grounds for the referral were the concerns of the UK that the efficacy of the product in repelling sand flies had not been sufficiently demonstrated.
Croatian: Razlog za upućivanje bila je zabrinutost Ujedinjene Kraljevine da djelotvornost proizvoda u pogledu odbijanja papatača nije dostatno dokazana.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the efficacy of Seresto in the reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months had been sufficiently demonstrated and therefore the variation to the marketing authorisation can be approved in all concerned Member States.
Croatian: Na temelju ocjene trenutačno dostupnih podataka i znanstvene rasprave u okviru Odbora, Odbor je zaključio da je djelotvornost VMP-a Seresto u smanjenju rizika od zaraze parazitom Leishmania infantum putem papatača u razdoblju do 8 mjeseci dostatno dokazana te da se stoga izmjene odobrenja za stavljanje u promet mogu odobriti u svim dotičnim državama članicama.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the change to the marketing authorisation for Seresto to add a new indication can be granted.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da se izmjena odobrenja za stavljanje u promet VMP-a Seresto radi dodavanja nove indikacije može odobriti.
English: On 15 February 2018, the European Medicines Agency (the Agency) completed an arbitration procedure for Seresto and its associated name Foresto.
Croatian: Europska agencija za lijekove (Agencija) dovršila je 15. veljače 2018. arbitražni postupak za VMP Seresto i njegovo pridruženo ime Foresto.
English: However, the CVMP recommended inclusion of the statement, in the product information of Seresto, that the demonstrated repellent efficacy against sand flies was variable.
Croatian: Međutim, Odbor je preporučio uključivanje izjave u informacije o VMP-u Seresto da je dokazana djelotvornost odbijanja papatača promjenjiva.
English: The European Commission issued an EU-wide legally binding decision to implement the CVMP recommendations on Seresto on 25 May 2018.
Croatian: Europska komisija objavila je 25. svibnja 2018. odluku o promjeni preporuka CVMP-a o VMP-u Seresto koja je zakonski obvezujuća na području cijelog EU-a.
English: 10 ml (3.5 mg/ml) 5 (5 x 1) vial (multipack)
Croatian: 5 (5 x 1) bočica (višestruko pakiranje)
English: 10 ml (3.5 mg/ml) 2 vials
Croatian: Veličina pakovanja za supkutanu primjenu bočica (staklo) 10 ml (3,5 mg/ml)
English: blister (aclar/alu) 56 tablets blister (aclar/alu);card
Croatian: Blister (aclar/Al) 56 tableta
English: Pack size bottle (HDPE)
Croatian: Bočica (HDPE) 56 tableta
English: Strength Pharmaceutical Form
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakiranje
English: 150 mg/ml Solution for injection
Croatian: 150 mg/ml Otopina za injekciju
English: 4 (1x4) vials
Croatian: 4 (1x4) bočice
English: Not relevant.
Croatian: Nije relevantan.
English: Between group difference ( 95% CI)
Croatian: Razlika između skupina (95% CI)
English: This medicine contains fructose (a type of sugar).
Croatian: Ovaj lijek sadrži fruktozu (vrstu šećera).
English: Duration of treatment should be based on the patient's clinical response.
Croatian: Trajanje liječenja treba se temeljiti na kliničkom odgovoru bolesnika.
English: The reconstituted solution has a pH of 3.5 to 5.5.
Croatian: Rekonstituirana otopina ima pH od 3,5 do 5,5.
English: [Justification for not including Braille accepted.]
Croatian: [Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.]
English: An updated RMP should be submitted:
Croatian: Ažuriani RMP treba dostaviti:
English: You should not be given a double dose by doctor.
Croatian: Liječnik Vam ne smije dati dvostruku dozu.
English: The expiry data refers to the last day of that month.
Croatian: Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: This medicinal product must not be mixed with other medicinal products or electrolytes except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati s drugim lijekovima i elektrolitima osim onih navedenih u dijelu 6.6.
English: * See section 4.4.
Croatian: * vidjeti dio 4.4.
English: For the clinical relevance of these findings see “Clinical efficacy and safety.”
Croatian: Za klinički značaj ovih nalaza pogledajte “Klinička djelotvornost i sigurnost.”