FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vylaer Spiromax, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Vylaer Spiromax nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The reference medicine for Vylaer Spiromax is Symbicort Turbohaler.
Croatian: Referentni lijek za Vylaer Spiromax je Symbicort Turbohaler.
English: What is Vylaer Spiromax and what is it used for?
Croatian: Što je Vylaer Spiromax i za što se koristi?
English: Vylaer Spiromax is a ‘hybrid medicine'.
Croatian: Vylaer Spiromax je „hibridni lijek”.
English: For asthma reliever therapy, patients should take a separate ‘reliever inhaler' to relieve their symptoms.
Croatian: U slučaju primjene kao terapije za ublažavanje astme, bolesnici trebaju uzeti dodatne „inhalacijske lijekove” za ublažavanje simptoma.
English: It is not intended to provide practical advice on how to use Vylaer Spiromax.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Vylaer Spiromax.
English: Vylaer Spiromax is a medicine that contains the active substances budesonide and formoterol.
Croatian: Vylaer Spiromax je lijek koji sadrži djelatne tvari budezonid i formoterol.
English: Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi od lijeka Symbicort Turbohaler nadmašuju utvrđene rizike.
English: Why is Vylaer Spiromax approved?
Croatian: Zašto je Vylaer Spiromax odobren?
English: For more information about treatment with Vylaer Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Vylaer Spiromax pročitajte u uputi lijeka (također dio EPARa), odnosno obratite se svom liječniku ili ljekarniku.
English: Other information about Vylaer Spiromax
Croatian: Ostale informacije o lijeku Vylaer Spiromax
English: The Committee recommended that Vylaer Spiromax be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Vylaer Spiromax.
English: The benefits and risks of Vylaer Spiromax are therefore taken to be the same as those of the reference medicine.
Croatian: Pretpostavlja se stoga da su koristi i rizici lijeka Vylaer Spiromax isti kao i rizici i koristi referentnog lijeka.
English: A risk management plan has been developed to ensure that Vylaer Spiromax is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Vylaer Spiromax.
English: For practical information about using Vylaer Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Vylaer Spiromax pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How does Vylaer Spiromax work?
Croatian: Kako djeluje Vylaer Spiromax?
English: How is Vylaer Spiromax used?
Croatian: Kako se Vylaer Spiromax koristi?
English: What are the benefits and risks of Vylaer Spiromax?
Croatian: Koje su koristi i rizici lijeka Vylaer Spiroma?
English: 2132NP Hoofddorp The Netherlands
Croatian: 2132NP Hoofddorp Nizozemska
English: What Moventig is and what it is used for
Croatian: Što je Moventig i za što se koristi
English: Not known (frequency cannot be estimated from the available data):
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka):
English: Northumberland, NE61 3YA United Kingdom
Croatian: Northumberland, NE61 3YA Ujedinjeno Kraljevstvo
English: Moventig with drink
Croatian: Moventig s pićem
English: • Stir and drink immediately
Croatian: • promiješajte i odmah popijte
English: Alu/alu blister.
Croatian: Al/al blister.
English: You should not drink large amounts of grapefruit juice whilst taking Moventig.
Croatian: Ne smijete piti velike količine soka od grejpa dok uzimate Moventig.
English: The safety and efficacy of naloxegol in children <18 years of age has not yet been established.
Croatian: Sigurnost i djelotvornost naloksegola u djece <18 godina nisu još ustanovljene.
English: Patients over 65 years of age have been represented in the phase III studies.
Croatian: Bolesnici stariji od 65 godina sudjelovali su u ispitivanjima faze III.
English: Date of first authorisation: 8 December 2014 Date of latest renewal: 23 September 2019
Croatian: Datum posljednje obnove odobrenja: 23. rujna 2019.
English: Opioid withdrawal symptoms may affect up to 1 in 100 people.
Croatian: Simptomi ustezanja od opioida mogu se pojaviti u najviše 1 na 100 osoba.
English: • hard stools (stools which are hard “like a rock”)
Croatian: • tvrdih stolica (stolica koje su tvrde „poput kamena“)
English: • Do not take a double dose to make up for a missed dose.
Croatian: • Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu dozu.
English: Other medicines and Moventig
Croatian: Drugi lijekovi i Moventig
English: • If you miss a dose of Moventig, take it as soon as you remember.
Croatian: • Ako propustite uzeti dozu lijeka Moventig, uzmite je čim se sjetite.
English: Do not take Moventig if you are taking any of the following medicines (see section “Do not take Moventig”):
Croatian: Nemojte uzimati Moventig ako uzimate bilo koji od sljedećih lijekova (pogledajte dio „Nemojte uzimati Moventig“):
English: Constipation related to opioids can result in symptoms such as:
Croatian: Zatvor povezan s primjenom opioida može izazvati simptome poput:
English: Your doctor may tell you to take a lower dose of 12.5 mg
Croatian: Liječnik će Vam možda reći da uzimate nižu dozu od 12,5 mg
English: If you have trouble swallowing the tablet you can crush it and mix with water as follows:
Croatian: Ako imate problema s gutanjem tablete, možete je zdrobiti i pomiješati s vodom na sljedeći način:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and fertility.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i plodnosti.
English: What Moventig looks like and contents of the pack
Croatian: Kako Moventig izgleda i sadržaj pakiranja
English: Contents of the pack and other information What Moventig contains
Croatian: Sadržaj pakiranja i druge informacije Što Moventig sadrži
English: Tell your doctor what opioid pain medicines you are taking and the dose of them.
Croatian: Recite liječniku koje opioidne lijekove protiv boli uzimate i u kojoj dozi.
English: • if you have severe liver illness
Croatian: • ako imate tešku jetrenu bolest
English: The observed neoplastic changes are well known hormonal and centrally mediated effects in the rat which are not relevant for humans.
Croatian: Primijećene neoplastične promjene dobro su poznati hormonski i centralni učinci u štakora, koji nisu relevantni za ljude.
English: Of the 844 patients who were randomized, 61.1% completed the study (defined as completing the 2-week follow-up visit after the 52-week treatment period).
Croatian: Od 844 randomizirana bolesnika, njih 61,1% dovršilo je ispitivanje (završetak je definiran dolaskom na kontrolni pregled 2 tjedna nakon 52-tjednog razdoblja liječenja).
English: • if you are allergic to naloxegol or similar medicines or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na naloksegol ili slične lijekove ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: • Crush the tablet to a powder
Croatian: • zdrobite tabletu u prah
English: Take Moventig in the morning, to avoid bowel movements in the middle of the night.
Croatian: Uzmite Moventig ujutro, kako biste izbjegli pražnjenje crijeva usred noći.
English: Very Common Common Uncommon Rare
Croatian: Manje često Rijetko Nepoznato
English: If you forget to take Moventig
Croatian: Ako ste zaboravili uzeti Moventig
English: Food effects: A high-fat meal increased the extent and rate of naloxegol absorption.
Croatian: Učinci hrane: Obrok s visokim udjelom masnoća povećao je opseg i brzinu apsorpcije naloksegola.
English: If you take more Moventig than you should, talk to a doctor or go to hospital.
Croatian: Ako uzmete više lijeka Moventig nego što ste trebali, razgovarajte s liječnikom ili otiđite u bolnicu.
English: The overall benefit-risk profile for each patient should be taken into account.
Croatian: U obzir se mora uzeti ukupan profil koristi i rizika za svakog pojedinog bolesnika.
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Other possible side effects: Very common (may affect more than 1 in 10 people):
Croatian: Druge moguće nuspojave: Vrlo često (mogu se javiti kod više od 1 na 10 osoba):
English: This was observed in a higher proportion of patients taking methadone than those not taking methadone.
Croatian: To je primijećeno u većeg udjela bolesnika koji su uzimali metadon nego onih koji nisu uzimali metadon.
English: Moventig is not recommended for use in children and adolescents below 18 years of age because it has not been studied in these age-groups.
Croatian: Primjena lijeka Moventig ne preporučuje se u djece i adolescenata mlađih od 18 godina jer lijek nije ispitivan u tim dobnim skupinama.
English: Tablets are engraved with “nGL” on one side and the strength of the tablet on the other.
Croatian: Tablete imaju utisnutu oznaku „nGL“ s jedne strane te jačinu tablete s druge strane.
English: Common (may affect up to 1 in 10 people):
Croatian: Često (mogu se javiti kod do 1 na 10 osoba):
English: Opioid withdrawal syndrome typically develops within minutes to several days following administration of an opioid antagonist.
Croatian: Sindrom ustezanja od opioida obično se razvija unutar nekoliko minuta do nekoliko dana nakon primjene opioidnog antagonista.
English: Pharmacotherapeutic group: Drugs for constipation, peripheral opioid receptor antagonists ATC code: A06AH03
Croatian: Farmakoterapijska skupina: laksativi, antagonisti perifernih opioidnih receptora ATK oznaka: A06AH03
English: If you take more Moventig than you should
Croatian: Ako uzmete više lijeka Moventig nego što ste trebali
English: The mean apparent volume of distribution during the terminal phase (Vz/F) in healthy volunteers ranged from 968 to 2,140 L across dosing groups and studies.
Croatian: Srednja vrijednost prividnog volumena tijekom terminalne faze (Vz/F) u zdravih dobrovoljaca kretala se u rasponu od 968 do 2140 l u svim liječenim skupinama i ispitivanjima.
English: None of the metabolites were present in > 10% of the plasma concentrations of parent or total parent and metabolite related material.
Croatian: Nijedan od metabolita nije bio prisutan u koncentraciji > 10% plazmatske koncentracije ishodišnog spoja ili ukupnog materijala povezanog s ishodišnim spojem i metabolitima.
English: • clarithromycin or telithromycin - antibiotics
Croatian: • klaritromicin ili telitromicin - antibiotici
English: For patients who are unable to swallow the tablet whole, the tablet can be crushed to a powder and mixed in half a glass of water (120 ml) and drunk immediately.
Croatian: Za bolesnike koji ne mogu progutati cijelu tabletu, tableta se može smrviti u prah i izmiješati u pola čaše vode (120 ml) te odmah popiti.
English: Do not use Moventig if any of the above applies to you.
Croatian: Nemojte uzimati Moventig ako se bilo što od navedenoga odnosi na Vas.
English: Embryo-foetal development studies were conducted in rats and rabbits.
Croatian: Ispitivanja embriofetalnog razvoja provedena su na štakorima i kunićima.
English: • Pour the powder into half a glass of water (120 ml)
Croatian: • uspite prah u pola čaše vode (120 ml)
English: • if you have had a heart attack within the last 6 months, have heart failure with daily shortness of breath or other severe problems with your heart which cause daily symptoms
Croatian: • ako ste imali srčani udar unutar posljednjih 6 mjeseci, ako imate zatajenje srca praćeno svakodnevnim nedostatkom zraka ili druge teške srčane tegobe koje uzrokuju svakodnevne simptome
English: • recurrent or advanced ovarian cancer
Croatian: • s rekurentnim ili uznapredovalim rakom jajnika
English: No data are available on the concomitant use of naloxegol with grapefruit juice.
Croatian: Nema dostupnih podataka o istodobnom uzimanju naloksegola sa sokom od grejpa.
English: The recommended dose is 1 tablet of 25 mg each day.
Croatian: Preporučena doza je 1 tableta od 25 mg svakoga dana.
English: The mixture can also be administered via a nasogastric tube (CH8 or greater), in this case the tablet can be crushed to a powder and mixed with water (120 ml).
Croatian: Mješavina lijeka može se primijeniti i putem nazogastrične sonde (CH8 ili veća), a u tom se slučaju tabletu može smrviti u prah i pomiješati s vodom (120 ml).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Moventig in one or more subsets of the paediatric population in opioid induced constipation (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Moventig u jednoj ili više podskupina pedijatrijske populacije u liječenju konstipacije uzrokovane primjenom opioida (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or any other opioid antagonist.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na neki drugi opioidni antagonist.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: How to take Moventig
Croatian: Kako uzimati Moventig
English: • if the natural protective barrier between the blood vessels in the head and in the brain is damaged, for example if you have cancer in the brain or the central nervous system, or if you have a disease of the central nervous system like multiple sclerosis or Alzheimer's diseasecontact your doctor immediately if you experience lack of pain relief from your opioid medicine or symptoms of opioid withdrawal syndrome (see section 4).
Croatian: • ako je oštećena prirodna zaštitna barijera između krvnih žila u glavi i mozga, primjerice ako imate rak u mozgu ili središnjem živčanom sustavu, ako imate bolest središnjeg živčanog sustava poput multiple skleroze ili Alzheimerove bolesti - odmah se obratite svom liječniku ako opioidni lijekovi ne ublažavaju bol ili ako primijetite simptome sindroma ustezanja od opioida (pogledajte dio 4.)
English: According to the ICH E14 Guideline, this is considered a definitively negative thorough QT/QTc study.
Croatian: Smjernici ICH E14, to se smatra potpuno negativnim nalazom detaljnog ispitivanja QT/QTc intervala.
English: Kyowa Kirin Holdings B.V. Bloemlaan 2
Croatian: Kyowa Kirin Holdings B.V.
English: Safety and efficacy have not been established in patients with severe hepatic impairment (see section 5.2).
Croatian: Sigurnost i djelotvornost nisu ustanovljene u bolesnika s teškim oštećenjem jetrene funkcije (vidjeti dio 5.2).
English: Studies in animals have shown reproductive toxicity where systemic exposures were several times above the therapeutic exposure level (see section 5.3).
Croatian: Ispitivanja na životinjama ukazala su na reproduktivnu toksičnost pri sistemskim izloženostima nekoliko puta većima od terapijske razine izloženosti (vidjeti dio 5.3).
English: In clinical pharmacology studies, the half-life of naloxegol at therapeutic dose ranged from 6-11 hours.
Croatian: U kliničkim farmakološkim ispitivanjima poluvijek naloksegola u terapijskim dozama kretao se u rasponu od 6-11 sati.
English: Time to first spontaneous bowel movement
Croatian: Vrijeme do prvog spontanog pražnjenja crijeva
English: Moventig has no or negligible influence on the ability to drive and use machines.
Croatian: Moventig ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In a mass balance study in humans, a total of 6 metabolites were identified in plasma, urine and faeces.
Croatian: U ispitivanju masene bilance u ljudi pronađeno je ukupno 6 metabolita u plazmi, mokraći i stolici.
English: Patients with cancer-related pain No dose adjustment is required for patients with cancer-related pain (see sections 4.3 and 4.4).
Croatian: Bolesnici s boli uzrokovanom rakom Nije potrebna prilagodba doze u bolesnika s boli uzrokovanom rakom (vidjeti dijelove 4.3 i 4.4).
English: In a thorough QT/QTc study, as defined by the ICH E14 Guideline, there were no clinically important changes in HR, RR, QT, PR or QRS intervals or T wave morphology observed.
Croatian: U detaljnom ispitivanju QT/QTc intervala, definiranom prema Smjernici ICH E14, nisu primijećene klinički važne promjene HR, RR, QT, PR ni QRS intervala niti promjene u morfologiji T-vala.
English: These metabolites represented more than 32% of the administered dose and were formed via N-dealkylation, O-demethylation, oxidation and partial loss of the PEG chain.
Croatian: Ti su metaboliti činili više od 32% primijenjene doze, a nastali su N-dealkilacijom, O-demetilacijom, oksidacijom i djelomičnim gubitkom polietilenglikolskog lanca.
English: • if you have kidney problems - your doctor may tell you to take a different dose (see section below “How to take Moventig”)
Croatian: • ako imate bubrežnih tegoba - liječnik će Vam možda reći da uzmete drukčiju dozu (pogledajte dio „Kako uzimati Moventig“ u nastavku)
English: This could be a symptom of damage to the wall of the gut and can be life-threatening.
Croatian: To bi mogao biti simptom oštećenja crijevne stijenke, koje može biti opasno po život.
English: If you have trouble swallowing the tablet
Croatian: Ako imate problema s gutanjem tablete
English: No dose adjustment is recommended for elderly patients.
Croatian: Ne preporučuje se prilagodba doze u starijih bolesnika.
English: The primary objective was to compare safety and tolerability among the three treatment groups for an additional 12 weeks (beyond that observed in Kodiac 4) using descriptive statistics.
Croatian: Primarni cilj bio je usporediti sigurnost i podnošljivost između tih triju skupina liječenja tijekom dodatnih 12 tjedana (više od onog što je opaženo u ispitivanju Kodiac 4) primjenom deskriptivne statistike.
English: Patients should be advised to discontinue therapy with naloxegol and promptly notify their physician if they develop unusually severe or persistent abdominal pain.
Croatian: Bolesnicima treba savjetovati da prekinu terapiju naloksegolom i da se odmah obrate svom liječniku ako se razvije neuobičajeno jaka ili trajna bol u abdomenu.
English: Tell your doctor immediately, you may need a lower dose or to stop taking Moventig.
Croatian: Odmah o tome obavijestite liječnika jer ćete možda morati uzimati manju dozu ili prestati uzimati Moventig.
English: • if you are taking methadone (see section below “Other medicines and Moventig”)
Croatian: • ako uzimate metadon (pogledajte odlomak „Drugi lijekovi i Moventig“ u nastavku)
English: Moventig should be taken on an empty stomach at least 30 minutes before the first meal of the day or 2 hours after the first meal.
Croatian: Moventig treba uzeti na prazan želudac najmanje 30 minuta prije prvog dnevnog obroka ili 2 sata nakon prvog obroka.
English: The glass should be rinsed with a further half glass of water (120 ml) and the contents drunk.
Croatian: Čašu je potrebno isprati s dodatnih pola čaše vode (120 ml) te popiti sadržaj.
English: Patients with moderate or severe hepatic insufficiency (Child's-Pugh Class B or C) were excluded from the Phase III studies (Kodiac 4 and 5).
Croatian: Bolesnici s umjerenom ili teškom insuficijencijom jetre (Child-Pugh stadij B ili C) nisu bili uključeni u ispitivanja faze III (Kodiac 4 i 5).
English: • if you have cancer-related pain
Croatian: • ako imate bol koja je posljedica raka
English: As there are additional data from the use of this medicine in pregnant women, the use of Moventig during pregnancy is not recommended.
Croatian: Na temelju dodatnih podataka o primjeni ovoga lijeka u trudnica, ne preporučuje se primjena lijeka Moventig u trudnoći.
English: Concomitant consumption of grapefruit juice while taking naloxegol should generally be avoided and considered only in consultation with a healthcare provider (see section 4.3).
Croatian: Istodobnu konzumaciju soka od grejpa tijekom liječenja naloksegolom u načelu se mora izbjegavati te razmotriti samo u dogovoru sa zdravstvenim radnikom (vidjeti dio 4.3).
English: A QTc study performed with naloxegol in healthy volunteers did not indicate any prolongation of the QT interval.
Croatian: Ispitivanje QTc intervala provedeno uz primjenu naloksegola u zdravih dobrovoljaca nije ukazalo ni na kakvo produljenje QT intervala.
English: Patients should be advised to promptly report severe, persistent or worsening symptoms to their physician.
Croatian: Bolesnicima se mora savjetovati da teške i trajne simptome ili simptome koji se pogoršavaju odmah prijave svome liječniku.
English: No dose adjustment is recommended based on age (see section 5.2).
Croatian: Ne preporučuje se prilagođavati dozu s obzirom na dob (vidjeti dio 5.2).
English: Tell your doctor, you may need to stop taking Moventig.
Croatian: Obavijestite svog liječnika jer ćete možda morati prestati uzimati Moventig.
English: All these effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: Svi su ti učinci opaženi samo pri razinama izloženosti koje su se smatrale dovoljno većima od maksimalne izloženosti u ljudi, što ukazuje na to da je njihov značaj za kliničku primjenu malen.
English: As the effects of P-gp inhibitors on the PK of naloxegol were small relative to the effects CYP3A4 inhibitors, the dosing recommendations for Moventig when co-administered with medicinal products causing both P-gp and CYP3A4 inhibition should be based on CYP3A4 inhibitor status - strong, moderate or weak (see sections 4.2, 4.3 and 4.5).
Croatian: Budući da su učinci inhibitora P-gp-a na farmakokinetiku naloksegola bili maleni u odnosu na učinke inhibitora CYP3A4, preporuke za doziranje lijeka Moventig pri istodobnoj primjeni s lijekovima koji inhibiraju P-gp i CYP3A4 moraju se temeljiti na statusu inhibitora CYP3A4 - snažan, umjeren ili slab (vidjeti dijelove 4.2, 4.3 i 4.5).
English: Piramal Pharma Solutions (Dutch) B.V. Bargelaan 200 u 715
Croatian: Piramal Pharma Solutions (Dutch) B.V.
English: In a majority of subjects, a secondary plasma concentration peak of naloxegol was observed approximately 0.4 to 3 hours after the first peak.
Croatian: U većine je ispitanika primijećena sekundarna vršna koncentracija naloksegola u plazmi približno 0,4 do 3 sata nakon postizanja prve vršne koncentracije.
English: Naloxegol exposure was found to increase with increased weight, however, the differences in exposure were not considered clinically relevant.
Croatian: Utvrđeno je da se izloženost naloksegolu povećava s povećanjem tjelesne težine, ali se razlike u izloženosti ne smatraju klinički značajnima.