FrancophonIA/ELRC3.0 huggingface dataset:
English: This information should also be reflected in the package leaflet.
Croatian: Ova informacija treba biti navedena i u uputi lijeka.
English: Eight relevant studies with LNG-containing emergency contraceptives are available in public literature.
Croatian: U javno objavljenoj literaturi dostupno je osam relevantnih ispitivanja provedenih s kontraceptivima koji sadrže LNG.
English: Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010) BMI (kg/m2)
Croatian: Tabela 1.: Meta-analiza tri WHO ispitivanja (Von Hertzen et al., 1998. i 2002.; Dada et al., 2010.)
English: 95% Confidence Interval
Croatian: Pouzdanost Interval
English: The CHMP concluded that a warning in section 4.4 of the SmPC is appropriate to indicate that limited and inconclusive data are present regarding a possible reduced efficacy in women with a high body weight/BMI and that in all women emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI.
Croatian: CHMP je zaključio da je upozorenje u odjeljku 4.4 sažetka opisa svojstva lijeka (SPC-a) odgovarajuće jer navodi indikaciju za skromne i neuvjerljive podatke dostavljene u vezi s mogućim smanjenim djelovanjem u žena s povišenom tjelesnom težinom/BMI-om te da se u svih žena hitna kontracepcija mora uzeti što je prije moguće nakon nezaštićenog odnosa, bez obzira na tjelesnu težinu ili BMI žene.
English: The CHMP reviewed all data from clinical studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs), on the efficacy of emergency contraceptive medicinal products containing LNG or UPA, in particular with regards to the relation of high weight/BMI of women.
Croatian: CHMP je pregledao sve podatke dostupne iz kliničkih ispitivanja, objavljene literature, postmarketinškog iskustva, uključujući i odgovore dostavljene od strane nositelja odobrenja za stavljanje lijeka u promet (nositelja odobrenja), o djelotvornosti hitnih kontracepcijskih proizvoda koji sadrže LNG ili UPA, posebice u odnosu na tjelesnu težinu/BMI u žena.
English: The CHMP proposed that a warning in section 4.4 of the summary of product characteristics (SmPC) is an appropriate routine risk minimisation measure to reflect that limited and inconclusive data are present regarding a possible reduced efficacy in women with a high body weight/BMI.
Croatian: CHMP je predložio da je upozorenje u odjeljku 4.4 sažetka opisa svojstva lijeka (SPC-a) odgovarajuća rutinska mjera za smanjivanje rizika kako bi se prikazalo da su dostupni samo skromni i neuvjerljivi podaci o mogućem smanjenom djelovanju u žena s povišenom tjelesnom težinom/BMI-om.
English: The data are currently too limited and therefore insufficiently precise to draw definite conclusions whether efficacy is negatively influenced by increased body weight and BMI.
Croatian: Podaci su trenutno preskromni te stoga nisu dovoljno precizni kako bi se definirali zaključci je li povišenje tjelesne težine i BMI-a negativno utjecalo na djelotvornost.
English: • The Committee reviewed all data from clinical studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs), on the efficacy of emergency contraceptive medicinal products containing LNG or UPA, in particular with regards to a possible effect of high weight/BMI of women.
Croatian: • je Povjerenstvo pregledalo sve podatke dostupne iz kliničkih ispitivanja, objavljene literature, postmarketinškog iskustva, uključujući i odgovore dostavljene od strane nositelja odobrenja za stavljanje lijeka u promet (nositelja odobrenja), o djelotvornosti hitnih kontracepcijskih proizvoda koji sadrže LNG ili UPA, posebice u odnosu na tjelesnu težinu/BMI u žena.
English: For UPA-containing emergency contraceptive products (ellaOne) it is concluded that limited and inconclusive data suggest that there may be reduced efficacy of UPA with increased body weight in women.
Croatian: U slučaju hitnih kontraceptiva koji sadrže UPA (ellaOne) zaključeno je da skromni i neuvjerljivi podaci ukazuju da postoji smanjena djelotvornost UPA u slučaju povišene tjelesne težine u žena.
English: The information in the SmPC should also be reflected in the package leaflet.
Croatian: Ova informacija iz SPC-a treba biti navedena i u uputi lijeka.
English: There are limited and inconclusive data from clinical trials that evaluated the effect of high body weight/high BMI on the contraceptive efficacy.
Croatian: Postoje skromni i neuvjerljivi podaci iz kliničkih ispitivanja koji ocjenjuju djelovanje povišene tjelesne težine/visokog BMI-a na djelotvornost kontraceptiva.
English: The Committee concluded that the benefit-risk balance of emergency contraceptive medicinal products containing LNG or UPA remains positive for all women regardless of body weight/BMI, subject to the warnings and changes to the product information agreed.
Croatian: Povjerenstvo je zaključilo da omjer koristi i rizika hitnih kontraceptiva koji sadrže LNG ili UPA ostaje pozitivan u svih žena bez obzira na tjelesnu težinu/BMI, što je predmetom usuglašenih upozorenja i izmjena u informacijama o proizvodu.
English: The CHMP was requested to assess whether the efficacy of emergency contraceptives is affected in relation to body weight and/or body mass index (BMI) of the women.
Croatian: Od CHMP-a je zatraženo da ocjeni utječe li tjelesna težina i/ili indeks tjelesne mase (BMI) u žena na djelotvornost hitnih kontraceptiva.
English: • The Committee considered that in view of the currently available data, the benefit-risk balance of emergency contraceptive medicinal products containing LNG or UPA is favourable, subject to warnings and other changes to the product information.
Croatian: • je Povjerenstvo zaključilo da je u svjetlu trenutno dostupnih podataka omjer koristi i rizika hitnih kontraceptiva koji sadrže LNG ili UPA povoljan, što je predmetom usuglašenih upozorenja i izmjena u informacijama o proizvodu.
English: excluded intake later than 72 hours after unprotected intercourse (i.e. off-label use of LNG) and women who had further acts of unprotected intercourse.
Croatian: Obje meta-analize isključuju unos lijeka nakon 72 sata nakon nezaštićenog odnosa (odnosno uporaba LNG-a mimo indikacija) i u žena koje i dalje prakticiraju nezaštićene seksualne odnose.
English: The Committee, as a consequence, concluded that the benefit-risk balance of emergency contraceptive medicinal products containing LNG or UPA remains positive, subject to the warnings and changes to the product information agreed.
Croatian: Povjerenstvo zaključilo da omjer koristi i rizika hitnih kontraceptiva koji sadrže LNG ili UPA ostaje pozitivan, što je predmetom usuglašenih upozorenja i izmjena u informacijama o proizvodu.
English: Overall for of LNG-containing emergency contraceptives it is concluded that there is limited data on the effect of high body weight/high BMI on the contraceptive efficacy.
Croatian: U slučaju svih hitnih kontraceptiva koji sadrže LNG može se zaključiti da postoje skromni podaci o djelovanju povišene tjelesne težine/povišenog BMI-a na djelotvornost kontraceptiva.
English: During the data submission an analysis was provided on three WHO studies (Von Hertzen et al., 1998 1 and 2002 2; Dada et al., 2010 3) as well as an analysis on two other studies (Creinin et al., 2006 4; Glasier et al., 2010 5).
Croatian: 2; Dada et al., 2010. 3) kao i analiza dva druga ispitivanja (Creinin et al., 2006. 4; Glasier et al., 2010. 5).
English: For LNG-containing emergency contraceptives overall it is concluded that there is limited and inconsistent data on the effect of high body weight/high BMI on the contraceptive efficacy.
Croatian: Općenit zaključak za hitne kontraceptive koji sadrže LNG glasi da postoje skromni i neuvjerljivi podaci o djelovanju velike tjelesne težine/BMI-a na djelotvornost kontraceptiva.
English: N total
Croatian: Dodatak II
English: The third study involved 59 children aged two to 12 years.
Croatian: Treće ispitivanje obuhvatilo je 59 djece u dobi između 2 i 12 godina.
English: The full EPAR for Nuwiq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Nuwiq nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was based on patients' assessment of how well treatment worked.
Croatian: Glavno mjerilo djelotvornosti temeljilo se na procjeni bolesnika o uspješnosti liječenja.
English: Nuwiq simoctocog alfa
Croatian: Nuwiq simoktokog alfa
English: Nuwiq is intended for either short-term or long-term use.
Croatian: Nuwiq je predviđen za kratkotrajnu ili dugotrajnu primjenu.
English: Simoctocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Croatian: Simoktokog alfa proizvodi se metodom poznatom pod nazivom „tehnologija rekombinantne DNK”: tvori se od stanica u koje je uveden gen (DNK) kako bi mogle proizvoditi tu tvar.
English: In such cases, a specialised haemophilia centre should be contacted.
Croatian: U tim slučajevima trebalo bi se obratiti specijaliziranom centru za liječenje hemofilije.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nuwiq on 24 July 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Nuwiq u promet koje je na snazi u Europskoj uniji od 24. srpnja 2014.
English: This is a summary of the European public assessment report (EPAR) for Nuwiq.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Nuwiq.
English: What measures are being taken to ensure the safe and effective use of Nuwiq?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nuwiq?
English: It contains the active substance simoctocog alfa (human coagulation factor VIII).
Croatian: Sadrži djelatnu tvar simoktokog alfa (ljudski koagulacijski faktor VIII).
English: Other information about Nuwiq
Croatian: Ostale informacije o lijeku Nuwiq
English: What is Nuwiq and what is it used for?
Croatian: Što je Nuwiq i za što se koristi?
English: Treatment with Nuwiq was rated as ‘excellent' or ‘good' for 94% of bleeding episodes.
Croatian: Terapija lijekom Nuwiq ocijenjena je kao „izvrsna” ili „dobra” za 94 % epizoda krvarenja.
English: It is not intended to provide practical advice on how to use Nuwiq.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Nuwiq.
English: A total of 986 bleeding episodes were recorded, the majority of which resolved with one injection of Nuwiq.
Croatian: Zabilježeno je ukupno 986 epizoda krvarenja, a većina njih zaustavljena je jednom injekcijom lijeka Nuwiq.
English: The Agency decided that Nuwiq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Agencija je zaključila da koristi lijeka Nuwiq nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nuwiq 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 Nuwiq nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: When used for treatment, bleeding episodes resolved in 81% of cases following one or two injections with Nuwiq.
Croatian: Kada se lijek primjenjivao za liječenje, epizode krvarenja zaustavljene su u 81 % slučajeva nakon jedne ili dvije injekcije lijeka Nuwiq.
English: The dose and duration of treatment depend on whether Nuwiq is used to treat or prevent bleeding, or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Croatian: Doza i trajanje liječenja ovise o tome primjenjuje li se lijek Nuwiq za liječenje ili sprječavanje krvarenja ili tijekom kirurškog zahvata, kao i o razinama faktora VIII u bolesnika, o stupnju hemofilije, jačini i mjestu krvarenja te stanju i tjelesnoj težini bolesnika.
English: When used to prevent bleeding, an average of 0.19 bleeds per month was recorded for each patient.
Croatian: Kada se lijek primjenjivao za sprječavanje krvarenja, za svakog bolesnika zabilježeno je prosječno 0,19 krvarenja mjesečno.
English: When Nuwiq was used to prevent bleeding, an average of 0.34 bleeds per month was recorded for each child.
Croatian: Kada se lijek Nuwiq primjenjivao za sprječavanje krvarenja, za svako dijete zabilježeno je prosječno 0,34 krvarenja mjesečno.
English: What are the risks associated with Nuwiq?
Croatian: Koji su rizici povezani s lijekom Nuwiq?
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Croatian: Bolesnici s hemofilijom A nemaju dostatne razine faktora VIII, što uzrokuje probleme sa zgrušavanjem krvi, kao što su krvarenja u zglobovima, mišićima ili unutarnjim organima.
English: Nuwiq is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Croatian: Lijek Nuwiq koristi se za nadomješćivanje nedostatka faktora VIII tako što se njime zamjenjuje faktor VIII koji nedostaje, omogućujući privremenu kontrolu poremećaja krvarenja.
English: Nuwiq has been shown to be effective at preventing and treating bleeding episodes in three main studies involving 113 patients with haemophilia A.
Croatian: Lijek Nuwiq pokazao se djelotvornim u sprječavanju i liječenju epizoda krvarenja u trima glavnim ispitivanjima koja su uključivala 113 bolesnika s hemofilijom A.
English: The Agency concluded that Nuwiq has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Croatian: Agencija je zaključila da se lijek Nuwiq pokazao djelotvornim u liječenju i sprječavanju krvarenja u bolesnika s hemofilijom A i da ima prihvatljiv sigurnosni profil.
English: For more information about treatment with Nuwiq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Nuwiq pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Nuwiq is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Croatian: Nuwiq je lijek koji se koristi za liječenje i sprječavanje krvarenja u bolesnika svih dobi s hemofilijom A (nasljednim poremećajem krvarenja prouzročenim nedostatkom faktora VIII).
English: Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and may in some cases become severe.
Croatian: Prilikom primjene lijekova koji sadržavaju faktor VIII zabilježene su reakcije preosjetljivosti (alergijske reakcije) koje u nekim slučajevima mogu postati ozbiljne.
English: There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Croatian: Prilikom primjene lijekova koji sadržavaju faktor VIII postoji rizik da se u nekih bolesnika mogu razviti inhibitori (protutijela) faktora VIII koji onemogućuju djelovanje lijeka i dovode do gubitka kontrole nad krvarenjem.
English: Nuwiq can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in the treatment of haemophilia.
Croatian: Lijek Nuwiq izdaje se samo na liječnički recept, a liječenje mora započeti pod nadzorom liječnika s iskustvom u liječenju hemofilije.
English: Nuwiq is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Croatian: Lijek Nuwiq dostupan je u obliku praška i otapala koji se miješaju kako bi se pripremila otopina za intravensku injekciju.
English: Why is Nuwiq approved?
Croatian: Zašto je lijek Nuwiq odobren?
English: For full details, see the package leaflet.
Croatian: Za potpune informacije vidjeti uputu o lijeku.
English: Patients or their carers may be able to administer Nuwiq themselves at home once they have been trained appropriately.
Croatian: Nakon odgovarajuće obuke, bolesnici ili njihovi njegovatelji mogu samostalno primjenjivati lijek Nuwiq kod kuće.
English: The active substance in Nuwiq, simoctocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Croatian: Djelatna tvar u lijeku Nuwiq, simoktokog alfa (ljudski koagulacijski faktor VIII), pomaže u zgrušavanju krvi.
English: When used for the treatment of bleeding episodes, Nuwiq was mainly rated as ‘excellent' or ‘good' at treating major bleeding episodes and most bleeding episodes resolved following one or more injections of Nuwiq.
Croatian: U primjeni za liječenje epizoda krvarenja lijek Nuwiq uglavnom je ocijenjen kao „izvrstan” ili „dobar” u liječenju velikih epizoda krvarenja i većina epizoda krvarenja zaustavljena je nakon jedne injekcije lijeka Nuwiq ili više njih.
English: This summary was last updated in 10-2017.
Croatian: Sažetak je posljednji put ažuriran: 10.
English: For practical information about using Nuwiq, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Nuwiq bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: In the five surgeries that occurred during the study, Nuwiq was rated as excellent in preventing bleeding episodes for four surgeries and as moderate to prevent bleeding during one surgical intervention.
Croatian: U pet kirurških zahvata obavljenih tijekom ispitivanja lijek Nuwiq ocijenjen je kao izvrstan u sprječavanju epizoda krvarenja za četiri kirurška zahvata i kao umjeren za sprječavanje krvarenja tijekom jedne kirurške intervencije.
English: For the full list of all side effects and restrictions with Nuwiq, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Nuwiq potražite u uputi o lijeku.
English: The first study involved 22 patients aged 12 years and above, who were given Nuwiq for the treatment of bleeding episodes or to prevent bleeding during surgery.
Croatian: Prvo ispitivanje uključivalo je 22 bolesnika u dobi od 12 i više godina, koji su primali lijek Nuwiq za liječenje epizoda krvarenja ili za sprječavanje krvarenja tijekom kirurškog zahvata.
English: How does Nuwiq work?
Croatian: Kako djeluje Nuwiq?
English: How is Nuwiq used?
Croatian: Kako se Nuwiq koristi?
English: In the two surgeries that occurred during the study, Nuwiq was rated as excellent in preventing bleeding episodes.
Croatian: U dva kirurška zahvata obavljena tijekom ispitivanja lijek Nuwiq ocijenjen je kao izvrstan u sprječavanju epizoda krvarenja.
English: What benefits of Nuwiq have been shown in studies?
Croatian: Koje su koristi lijeka Nuwiq utvrđene u ispitivanjima?
English: The second study involved 32 patients aged 12 years and above who were given Nuwiq to prevent and treat bleeding events as well as to prevent bleeding during surgery.
Croatian: Drugo ispitivanje uključivalo je 32 bolesnika u dobi od 12 i više godina koji su primali lijek Nuwiq za sprječavanje i liječenje krvarenja kao i za sprječavanje krvarenja tijekom kirurškog zahvata.
English: Your doctor will determine what dose is appropriate for you.
Croatian: Vaš će liječnik odrediti koja doza je prikladna za Vas.
English: In that case, just carry on with the next dose as normal.
Croatian: U tom slučaju samo nastavite sa sljedećom dozom kao i obično.
English: Nine weeks after exposure, this effect was no longer observable.
Croatian: Devet tjedana nakon izloženosti taj se učinak više nije mogao opaziti.
English: This is different to the stresses and strains of everyday life.
Croatian: To se razlikuje od stresa i napetosti u svakodnevnom životu.
English: However, juvenile rats are more sensitive.
Croatian: Ipak, mladi su štakori osjetljiviji.
English: Do not take more medicine than prescribed.
Croatian: Ne uzimajte više lijeka nego što Vam je propisano.
English: The need for treatment should be reassessed regularly.
Croatian: Treba redovito procjenjivati potrebu za liječenjem.
English: If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.
Croatian: Ako ste zaboravili uzeti dozu, uzmite je čim se sjetite, osim ako nije vrijeme za sljedeću dozu.
English: Suicidal ideation and behaviour
Croatian: Suicidalne ideje i ponašanje
English: • Difficulty with writing properly
Croatian: • poteškoće pri pravilnom pisanju
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for pregabalin.
Croatian: Mehanizam ovog rizika nije poznat, a dostupni podaci ne isključuju mogućnost povećanog rizika i za pregabalin.
English: If your treatment is stopped it should be done gradually over a minimum of 1 week.
Croatian: Ako se liječenje prekida, to treba učiniti postupno tijekom najmanje tjedan dana.
English: Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
English: Swallow the capsule whole with water.
Croatian: Kapsule progutajte cijele s vodom.
English: • Slow or reduced movement of the body
Croatian: • usporeni ili umanjeni pokreti tijela
English: The patient should be informed about this at the start of the treatment.
Croatian: Bolesnika o tome treba obavijestiti na početku liječenja.
English: TID = Three divided doses
Croatian: TID = podijeljeno u 3 doze
English: • Take the number of capsules as instructed by your doctor.
Croatian: • Uzmite onoliko kapsula koliko Vam je odredio liječnik.
English: Dieselweg 25, 3752 LB Bunschoten The Netherlands
Croatian: Dieselweg 25, 3752 LB Bunschoten Nizozemska
English: The symptoms of GAD are prolonged excessive anxiety and worry that are difficult to control.
Croatian: Simptomi GAP-a su dugotrajna prekomjerna tjeskoba i zabrinutost koje je teško kontrolirati.
English: • Lorazepam - (used for treating anxiety)
Croatian: Lorazepam - (koristi se za liječenje tjeskobe)
English: In rare occasions, cases of coma have been reported.
Croatian: U rijetkim prilikama prijavljeni su slučajevi kome.
English: After 3 months of treatment, there were no effects on sperm motility.
Croatian: Nakon 3 mjeseca liječenja nije bilo utjecaja na pokretljivost spermija.
English: Mylan S.A.S 117 Allée des Parcs 69800 Saint-Priest France
Croatian: Mylan S.A.S 117 Allée des Parcs 69800 Saint-Priest Francuska
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Croatian: 17. JEDINSTVENA IDENTIFIKACIJSKA OZNAKA - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: In juvenile rats the types of toxicity do not differ qualitatively from those observed in adult rats.
Croatian: U mladih se štakora vrste toksičnosti kvalitativno ne razlikuju od onih opaženih u odraslih jedinki.
English: You should immediately tell your doctor if you experience any changes in your vision.
Croatian: Morate odmah obavijestiti svog liječnika ako primijetite bilo kakve promjene vida.
English: Seizures were also reported.
Croatian: Prijavljeni su također i napadaji.
English: Following repeated administration, steady state is achieved within 24 to 48 hours.
Croatian: Nakon ponovljene se primjene stanje dinamičke ravnoteže postiže za 24 do 48 sati.
English: Total pregabalin daily dose *
Croatian: Ukupna dnevna doza pregabalina*