FrancophonIA/ELRC3.0 huggingface dataset:
English: To conclude, given the cases reported for a reaction difficult to diagnose early (delayed symptoms) and probably under reported, the use of the drug at an approved dosage, added to a plausible pharmacological profile, dihydroergotamine is considered to be strongly associated with a risk of fibrotic reactions.
Croatian: Zaključno, s obzirom na teško rano dijagnosticiranje (kasni simptomi) slučajeva prijavljenih za reakciju i vjerojatno su premalo prijava, te uporabu lijeka u odobrenoj dozi, uz plauzibilan farmakološki profil, dihidroergotamin se smatra usko povezanim s rizikom od fibrotičke reakcije.
English: − Is not favourable for prophylaxis of migraine headache.
Croatian: nije povoljan za profilaksu migrenske glavobolje.
English: Although significant reduction in venous capacity, capillary flow of erythrocytes and peak flow of reactive hyperemia were demonstrated, due to a very small study group, the uncontrolled design and other methodological limitations, the CHMP could not draw any conclusion on the efficacy of dihydroergotamine.
Croatian: Iako je demonstrirano značajno smanjenje u venskom kapacitetu, kapilarnom protoku eritrocita i vršnom protoku reaktivne hiperemije, CHMP nije mogao donijeti zaključak o djelotvornosti dihidroergotamina zbog vrlo male grupe na kojoj je provedeno ispitivanje, nekontroliranog dizajna i drugih metodoloških ograničenja.
English: The CHMP also noted the position of several MAHs that there is not enough evidence to support an indication of oral dihydroergotamine in orthostatic hypotension.
Croatian: CHMP je također napomenuo stajalište nekoliko nositelja odobrenja da ne postoji dovoljno dokaza koji podržavaju indikaciju oralnog dihidroegotamina za ortostatsku hipotenziju.
English: Grounds for the suspension/variation to the terms of the marketing authorisations
Croatian: Razlozi za suspenziju/varijaciju uvjeta odobrenja za stavljanje lijeka u promet Budući da
English: No significant improvement over placebo was observed in the subset of patients with unaffected QOL.
Croatian: U podgrupi bolesnika s nepromijenjenim QOL nije uočeno značajno poboljšanje u odnosu na placebo.
English: In the only recent, large study with appropriate design (PROMISE study) there was no statistically significant difference between dihydroergotamine and placebo with respect to the reduction of the frequency of migraine attacks (the primary efficacy criterion) in the overall population.
Croatian: U jedinom novijem, velikom ispitivanju odgovarajućeg dizajna (ispitivanje PROMISE) nema statistički značajne razlike između dihidroergotamina i placeba s obzirom na smanjenje učestalosti napadaja migrene (primarni kriterij djelotvornosti) u ukupnoj populaciji.
English: These included restricting the therapeutic indications, recommending close monitoring of patients and the issuing of a DHPC.
Croatian: CHMP je razmotrio prijedlog nositelja odobrenja za mjere za smanjivanje rizika, koje uključuju ograničavanje terapijskih indikacija, preporuku pažljivog praćenja bolesnika i izdavanje pisma upućenog zdravstvenim djelatnicima.
English: • The Committee considered that the benefit-risk balance of oral dihydroergotamine containing products:
Croatian: • Povjerenstvo smatra da omjer koristi i rizika lijekova koji sadrže oralni dihidroergotamin:
English: The number of patients included was small and the duration of treatment was too short and the clinical efficacy parameters used are not in line with the European Guidelines on clinical investigation of medicinal products for the treatment of migraine.
Croatian: Korišteni parametri kliničke djelotvornosti nisu u skladu s Europskim smjernicama za kliničko istraživanju lijekova koji se koriste za liječenje migrene.
English: • Symptomatic treatment of veno-lymphatic insufficiency
Croatian: • simptomatsko liječenje vensko limfne insuficijencije
English: For the percentage of responders (61.1% in the dihydroergotamine group vs. 55.9% in the placebo group) the difference was not statistically significant.
Croatian: Razlika nije bilo statistički značajna za određeni postotak odgovarača (61,1% u grupi koja je primala dihidroergotamin u odnosu na 55,9% u grupi koja je primala placebo).
English: • Prophylaxis of migraine headache
Croatian: • profilaksa migrenske glavobolje
English: In some published literature, they are considered as aetiology of retroperitoneal fibrosis (P. Meier et al, La fibrose rétropéritonéale, une maladie inflammatoire méconnue.
Croatian: Meier et al, La fibrose rétropéritonéale, une maladie inflammatoire méconnue.
English: − Is not favourable for symptomatic treatment of veno-lymphatic insufficiency.
Croatian: nije povoljan za simptomatsko liječenje vensko limfne insuficijencije.
English: The relationship between fibrosis and serotoninergic receptor activation, particularly 5-HT2B receptors by ergot derivatives is extensively described in the literature.
Croatian: U literaturi je dostupan opsežan opis odnosa između fibroze i aktivacije serotoninergijskog receptora, posebice 5-HT2B receptora, derivatima ergota.
English: These co-suspected drugs are known to induce fibrosis.
Croatian: Poznato je da ovi lijekovi, koji mogu izazvati iste nuspojave, mogu uzrokovati fibrozu.
English: • The variation to the terms of the marketing authorisation for dihydroergotamine containing medicinal products referred to in Annex I, to delete the below indications from the Product Information (specific wording of the indication may vary from product to product and from country to country) as well as any relevant reference to these indications in the Product Information, when there are other therapeutic indications approved as part of their marketing authorisation:
Croatian: I kako bi se obrisale niže navedene indikacije (specifična formulacija indikacija može varirati od proizvoda do proizvoda i od države do države) kao i bilo koja relevantna referenca na ove indikacije, kada postoje druge terapijske indikacije odobrene kao dio njihovog odobrenja za stavljanje lijeka u promet: profilaksa migrenske glavobolje. ortostatska hipertenzija. simptomatsko liječenje vensko limfne insuficijencije.
English: The Committee concluded that the benefit-risk balance of dihydroergotamine containing products for oral use is not favourable pursuant to Article 116 of Directive 2001/83/EC for prophylaxis of migraine, for orthostatic hypotension and for symptomatic treatment of veno-lymphatic insufficiency.
Croatian: Direktive 2001/83/EC za profilaksu migrenske glavobolje, ortostatsku hipotenziju i za simptomatski liječenje vensko limfne insuficijencije.
English: • The suspension of the marketing authorisation for dihydroergotamine containing medicinal products referred to in Annex I in the event that no other indications are approved as part of their marketing authorisation.
Croatian: • Suspenzija odobrenja za stavljanje lijeka u promet za lijekove koji sadrže dihidroergotamin, a koji su navedeni u Dodatku
English: What does the black triangle mean?
Croatian: Što znači crni trokut?
English: For more information, visit www.ema.europa.eu
Croatian: Za više informacija posjetite www.ema.europa.eu
English: How to report side effects
Croatian: Kako prijavljivati nuspojave
English: Why are medicines monitored after they are approved?
Croatian: Zašto se lijekove prati nakon što su odobreni?
English: The European Union (EU) has introduced a new way of identifying medicines that are being monitored particularly closely.
Croatian: Europska unija (EU) uvela je novi postupak označavanja lijekova koje se posebno prati.
English: They may have other diseases and they may be taking other medicines.
Croatian: Ti bolesnici mogu imati druge bolesti i mogu uzimati druge lijekove.
English: This is generally because there is less information available about them compared with other medicines, for example because they are new on the market.
Croatian: To je općenito iz razloga što je o tom lijeku dostupno manje informacija nego o drugim lijekovima, primjerice jer su novi na tržištu.
English: It does not mean that the medicine is unsafe.
Croatian: To ne znači da lijek nije siguran za primjenu.
English: In a real-life setting, a larger and more diverse group of patients will use the medicine.
Croatian: U stvarnom životu veća i raznolikija skupina bolesnika koristit će lijek.
English: "This medicinal product is subject to additional monitoring."
Croatian: „Ovaj se lijek pod dodatnim praćenjem.”
English: It is therefore vital that the safety of all medicines continues to be monitored while they are on the market.
Croatian: Stoga je ključno nastaviti nadzor sigurnost svih lijekova dok su na tržištu.
English: Clinical trials usually involve a limited number of patients for a defined time period in controlled conditions.
Croatian: Klinička ispitivanja obično uključuju ograničeni broj bolesnika tijekom definiranog vremenskog razdoblja u kontroliranim uvjetima.
English: Only medicines whose benefits have been shown to be greater than their risks can be marketed.
Croatian: Samo lijekove za koje je dokazano da im je korist veća od rizika mogu može se staviti u promet.
English: This ensures that patients can access the treatments they need without being exposed to unacceptable side effects.
Croatian: To bolesnicima osigurava pristup potrebnom liječenju bez izlaganja neprihvatljivim nuspojavama.
English: You can report side effects to your doctor, pharmacist or nurse.
Croatian: Nuspojave možete prijaviti svom liječniku, ljekarniku ili medicinskoj sestri.
English: Examples of medicines under additional monitoring include new medicines authorised since the start of 2011 and medicines for which regulators require more studies to be carried out, e.g. on long-term use or on rare side effects seen in clinical trials.
Croatian: Primjeri lijekova koje se dodatno prati uključuju nove lijekove odobrene nakon početka 2011. godine i lijekove za koje nadležna tijelai službenici zahtijevaju provođenje dodatnih ispitivanja, primjerice o dugoročnoj upotrebi ili o rijetkim nuspojavama primijećenim u kliničkim ispitivanjima.
English: You should report any suspected side effects with a medicine you are taking, particularly if it displays the black triangle.
Croatian: Trebate prijaviti bilo koju sumnju na nuspojave lijeka koji uzimate, posebice ako je na lijeku prikazan crni trokut.
English: However, medicines with the black triangle are being monitored even more closely than others.
Croatian: Međutim, lijekove označene crnim trokutom prati se još intenzivnije od ostalih lijekova.
English: All medicines are carefully monitored after they are placed on the EU market.
Croatian: Svi se lijekovi pomno prate nakon stavljanja u promet u EU-u.
English: European regulatory authorities decide to authorise medicines after assessing the results of laboratory tests and clinical trials.
Croatian: Europska regulatorna tijela odlučuju odobriti lijekove nakon ocjene njihove koristi i rizika na temelju rezultata kliničkih ispitivanja i laboratorijskih testiranja.
English: These medicines have a black inverted triangle displayed in their package leaflet, together with a short sentence that reads:
Croatian: Ovi lijekovi na uputi imaju obrnuti crni trokut zajedno s kratkom rečenicom koja glasi:
English: By reporting side effects, you can help medicines regulators assess whether the benefits of a medicine remain greater than its risks.
Croatian: Prijavljivanjem nuspojava možete pomoći regulatornim tijelima nadležnim za lijekove procijeniti jesu li koristi lijeka veće od njegovih rizika.
English: Some less common side effects may only be apparent when a medicine has been used for a long time by a large number of people.
Croatian: Neke manje česte nuspojave mogu se uočiti samo nakon što veći broj osoba duže vrijeme koristi lijek.
English: You can also report side effects directly to your national medicines regulator, using the reporting system in your country.
Croatian: Nuspojave također možete prijaviti izravno nacionalnom regulatornom tijelu nadležnom za lijekove upotrebom sustava za prijavljivanje u Vašoj državi.
English: Information on how to do this can be found in the package leaflet of your medicine or on your national medicines regulator's website.
Croatian: Informacije o tome možete naći u uputi o lijeku ili na internetskim stranicama nacionalnog regulatornog tijela nadležnog za lijekove.
English: Visit your national medicines regulator at: www.mhra.gov.uk (United Kingdom) www.imb.ie (Ireland) www.medicinesauthority.gov.mt (Malta)
Croatian: www.halmed.hr
English: Pharmaceutical Form Route of Administration Packaging
Croatian: Farmaceutski oblik
English: Use immediately.
Croatian: Koristite odmah.
English: Repeat every 24 hours.
Croatian: Ponoviti svaka 24 sata.
English: It is not known whether they respond differently from younger subjects.
Croatian: Nije poznato reagiraju li oni drugačije od mlađih ispitanika.
English: If not coinciding with week 26 visit.
Croatian: Ako se ne poklapa s posjetom u 26. tjednu.
English: The product dissolves rapidly (within 2 minutes).
Croatian: Lijek se brzo otapa (unutar 2 minute).
English: Your doctor may need to treat you promptly for these reactions.
Croatian: Vaš liječnik će Vas možda trebati odmah liječiti zbog ovih reakcija.
English: Required units
Croatian: Potrebne jedinice
English: A-2304 Orth an der Donau Austria
Croatian: A-2304 Orth an der Donau Austrija
English: Uferstraße 15
Croatian: Uferstrasse 15
English: Your doctor may need to treat you promptly for these reactions (see section 2 ‘Warnings and precautions').
Croatian: Vaš liječnik će Vas možda trebati odmah liječiti zbog ovih reakcija (vidjeti dio 2 "Upozorenja i mjere opreza").
English: You or somebody else might also administer RIXUBIS as an injection but only after receiving adequate training.
Croatian: Vi ili netko drugi također možete primijeniti RIXUBIS kao injekciju, ali tek nakon što ste prošli adekvatnu obuku.
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Croatian: To je naročito važno kada se mijenjaju laboratoriji i/ili reagensi upotrijebljeni u testu.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature not above 30°C.
Croatian: Kemijska i fizikalna stabilnost tijekom korištenja zabilježena je u trajanju od 3 sata pri temperaturi ne višoj od 30 °C.
English: Your doctor will decide the dose of RIXUBIS you will receive.
Croatian: Vaš liječnik će odlučiti koju dozu lijeka RIXUBIS ćete primiti.
English: Always use this medicine exactly as your doctor has told you.
Croatian: Uvijek primijenite ovaj lijek točno kako Vam je rekao Vaš liječnik.
English: Haemophilia B very rarely occurs in women.
Croatian: Hemofilija B se vrlo rijetko pojavljuje u žena.
English: What RIXUBIS is and what it is used for
Croatian: Što je RIXUBIS i za što se koristi
English: Other medicines and RIXUBIS
Croatian: Drugi lijekovi i RIXUBIS
English: As for all patients, dose selection for an elderly patient should be individualised.
Croatian: Kao i za sve bolesnike, odabir doze za starijeg bolesnika mora biti individualiziran.
English: The osmolality is greater than 240 m osmol/kg.
Croatian: Osmolalnost je veća od 240 m osmol/kg.
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Croatian: Trombin zatim pretvara fibrinogen u fibrin te se stvara ugrušak.
English: If you injected more RIXUBIS than recommended, tell your doctor as soon as possible.
Croatian: Ako ste injicirali više lijeka RIXUBIS nego što je preporučeno, obavijestite svog liječnika što je prije moguće.
English: If you suffer from liver or cardiac disease or if you have recently had major surgery, please inform your doctor, as there is an increased risk for blood clotting (coagulation) complications.
Croatian: Ako imate bolest jetre ili srčanu bolest ili ako ste nedavno imali veliki kirurški zahvat, molimo Vas da obavijestite svog liječnika, jer postoji povećani rizik od komplikacija zgrušavanja krvi (koagulacije).
English: Tell your doctor if you are using or have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ako primjenjujete ili ste nedavno primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: 6.5 Nature and contents of container and special equipment for use
Croatian: 6.5 Vrsta i sadržaj spremnika i posebna oprema za uporabu
English: In each of these situations, the benefit of treatment with RIXUBIS should be weighed against the risk of these complications.
Croatian: U svakoj od tih situacija potrebno je odvagnuti korist od liječenja lijekom RIXUBIS i rizik od tih komplikacija.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka odgovornost su korisnika.
English: After reconstitution, the solution is clear, colourless, free from foreign particles and has a pH of 6.8 to 7.2.
Croatian: Nakon rekonstitucije otopina je bistra, bezbojna, bez stranih čestica i ima pH od 6,8 do 7,2.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Croatian: Količina koja će se primjenjivati i učestalost primjene uvijek moraju biti usmjerene na kliničku učinkovitost u pojedinom slučaju.
English: One vial contains 19 mg sodium.
Croatian: Jedna bočica sadrži 19 mg natrija.
English: Talk to your doctor immediately if your bleeding does not stop as expected or if you experience a significant increase in your usage of RIXUBIS in order to control a bleed.
Croatian: Odmah se obratite svom liječnikom ako se Vaše krvarenje ne zaustavi kako je očekivano ili ako primijetite značajan porast Vašeg korištenja lijeka RIXUBIS kako biste kontrolirali krvarenje.
English: Treatment was individualised based on the severity, cause and site of bleed.
Croatian: Liječenje je bilo individualizirano na temelju težine, uzroka i mjesta krvarenja.
English: (pre- and postoperative)
Croatian: (prije i poslije operacije)
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, osim ako metoda rekonstitucije isključuje rizik kontaminacije mikroorganizmima, lijek se mora odmah upotrijebiti.
English: Frequencies have been evaluated according to the following convention: very common (1/10), common (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), not known (cannot be estimated from the available data).
Croatian: Učestalost je procijenjena prema sljedećoj konvenciji: vrlo često (1/10), često (1/100 i <1/10), manje često (1/1000 i <1/100), rijetko (1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: However, no data are available on previously untreated patients as only previously treated patients have been enrolled in the clinical studies; no immunogenicity investigation on inhibitor development was therefore made in this at risk population.
Croatian: Međutim, podaci o prethodno neliječenim bolesnicima nisu dostupni, jer su samo prethodno liječeni bolesnici bili uključeni u klinička ispitivanja; stoga istraživanje imunogenosti o razvoju inhibitora nije provedeno kod te rizične populacije.
English: The specific activity of RIXUBIS is approximately 200-390 IU/mg protein.
Croatian: Specifična aktivnost lijeka RIXUBIS je otprilike 200-390 IU/mg proteina.
English: Swirl gently until all material is dissolved.
Croatian: Nježno protresite bočicu dok se sav materijal ne otopi.
English: • one BAXJECT II (needle-less reconstitution device)
Croatian: • jedan BAXJECT II (uređaj za pripremu bez igle)
English: Repeat infusion every 8 to 24 hours until threat is resolved.
Croatian: Ponoviti infuziju svakih 8 do 24 sata dok se ne ukloni opasnost.
English: The effects of higher than recommended doses of RIXUBIS have not been characterised.
Croatian: Učinci doza većih od preporučenih doza lijeka RIXUBIS nisu opisani.
English: Twenty procedures were major including 13 orthopaedic and 3 dental surgeries.
Croatian: Dvadeset postupaka bilo je veliko, uključujući 13 ortopedskih i 3 dentalna zahvata.
English: At study completion/ termination b
Croatian: Pri završetku / prekidu ispitivanja b
English: 17 procedures, including 10 dental extractions, were considered minor.
Croatian: Sedamnaest postupaka, uključujući 10 vađenja zuba, smatrali su se manjima.
English: - Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Croatian: - Ne koristiti ako su uređaj BAXJECT II, njegov sterilni zaštitni sustav ili pakiranje oštećeni ili pokazuju znakove dotrajalosti.
English: Proceed with the next injection as scheduled and continue as advised by your doctor.
Croatian: Nastavite sa sljedećom injekcijom prema rasporedu i nastavite prema savjetu svog liječnika.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Croatian: Pedijatrijska populacija Navedena upozorenja i mjere opreza odnose se i na odrasle osobe i na djecu.
English: Careful monitoring of replacement therapy is especially important in cases of major surgery or life-threatening haemorrhages.
Croatian: Pažljivo praćenje nadomjesne terapije posebno je važno u slučajevima velikih kirurških zahvata ili krvarenja opasnog po život.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data) - allergic reactions (hypersensitivity).
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka) - alergijske reakcije (preosjetljivost).
English: Pack size of 1.
Croatian: Veličina pakiranja: 1.
English: Factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Croatian: Faktor IX se u trudnoći i tijekom dojenja smije primjenjivati samo ako za to postoji jasna indikacija.
English: No investigations on carcinogenicity, fertility impairment, and fetal development have been conducted.
Croatian: Nisu provedena nikakva istraživanja kancerogenosti, oštećenja plodnosti i fetalnog razvoja.
English: The contents of the pack are:
Croatian: Pakiranje sadrži:
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Croatian: Doza koja se bazira na tjelesnoj težini može zahtijevati prilagodbu u bolesnika s premalenom ili prekomjernom težinom.
English: Paediatric population (previously treated patients younger than 12 years)
Croatian: Pedijatrijska populacija (prethodno liječeni bolesnici mlađi od 12 godina)
English: The same table as for adults can be used to guide dosing in bleeding episodes and surgery (see above).
Croatian: Ista tablica kao za odrasle osobe može se koristiti za usmjeravanje doziranja pri epizodama krvarenja i operaciji (vidjeti gore).
English: Be sure that RIXUBIS is completely dissolved, otherwise not all reconstituted solution will pass through the device filter.
Croatian: Budite sigurni da je RIXUBIS u potpunosti otopljen, inače sva rekonstituirana otopina neće proći kroz filter uređaja.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Croatian: U takvim slučajevima, preporučuje se kontaktirati specijalizirani centar za liječenje hemofilije.
English: Invert the system (the vial with the reconstituted solution has to be on top).
Croatian: Preokrenite sustav (bočica s rekonstituiranom otopinom mora biti na vrhu).
English: The product contains traces of hamster proteins.
Croatian: Lijek sadrži tragove proteina hrčka.
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also 4.4).
Croatian: U nekim slučajevima te su reakcije napredovale do teške anafilaksije i dogodile se u bliskom vremenskom odnosu s razvojem inhibitora faktora IX (vidjeti također 4.4).
English: The use of high purity factor IX is rarely associated with such adverse reactions.
Croatian: Korištenje faktora IX visoke čistoće rijetko se povezuje s takvim nuspojavama.
English: Disconnect the syringe.
Croatian: Odspojite štrcaljku.