FrancophonIA/ELRC3.0 huggingface dataset:
English: Light yellow, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 1 on one side.
Croatian: Svjetložuta, okrugla, promjera 6 mm, blago konveksna, s kosim rubovima i utisnutim BRX i 1 na jednoj strani.
English: Co-administration of a 2 mg single oral dose of brexpiprazole with quinidine (324 mg/day for 7 days), a potent inhibitor of CYP2D6, increased the AUC of brexpiprazole by 94 % and no change in Cmax.
Croatian: 7 dana), jakim inhibitorom CYP2D6, povećala je AUC brekspiprazola za 94 %, bez promjene u Cmax.
English: RXULTI 1 mg film-coated tablets Iron oxide E 172 (yellow)
Croatian: Željezov oksid E 172 (žuti)
English: Apparent oral clearance of brexpiprazole tablet after once daily administration is 19.8 (± 11.4) mL/h/kg.
Croatian: 19,8 (± 11,4) ml/h/kg.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
English: Tel: +421 2 5341 42 18
Croatian: Lundbeck Slovensko s.r.o. Tel: +421 2 5341 42 18
English: Dental caries Flatulence
Croatian: Ispitiv anje
English: How to store RXULTI
Croatian: Moguće nuspojave Kako čuvati RXULTI
English: • shaking,
Croatian: (engl.
English: Weight gain
Croatian: ROK VALJANOSTI
English: Daily dose must not exceed 12 mg when brexpiprazole is used concomitantly with strong CYP3A4 inducers.
Croatian: Kad se brekspiprazol primjenjuje istodobno s jakim induktorima CYP3A4, dnevna doza ne smije biti viša od 12 mg.
English: Pregnancy, puerperium and perinatal conditions
Croatian: Stanja vezana uz trudnoću, babinje i perinatalno razdoblje sindrom ustezanja od lijeka u novorođenčeta
English: (Invented) name
Croatian: (Novoizumljen o) ime
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Croatian: Popis naziva, farmaceutskog oblika, jačina lijekova, puta primjene, nositelja odobrenja u državama članicama
English: Netherlands Sanofi-Aventis Netherlands B.V.
Croatian: Nizozemska Sanofi-Aventis Netherlands B.V.
English: Five main studies were carried out.
Croatian: Provedeno je pet glavnih ispitivanja.
English: However, the duration of protection is not known.
Croatian: Međutim, trajanje zaštite nije poznato.
English: It is not yet known how long the protection will last.
Croatian: Još uvijek se ne zna koliko će dugo trajati zaštita.
English: Imvanex has been authorised under ‘exceptional circumstances'.
Croatian: Imvanex je odobren pod „iznimnim okolnostima”.
English: Further information on Imvanex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imvanex.
Croatian: Više informacija o cjepivu Imvanex dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/imvanex.
English: Smallpox was officially declared eradicated in 1980 with the last known case of the disease occurring in 1977.
Croatian: Velike boginje službeno su proglašene iskorijenjenima 1980. s posljednjim poznatim slučajem bolesti 1977.
English: The vaccine can only be obtained with a prescription.
Croatian: Cjepivo se izdaje samo na recept.
English: Imvanex (live modified vaccinia ankara virus)
Croatian: Imvanex (živi modificirani virus vakcinije Ankara)
English: Vaccines work by ‘teaching' the immune system how to defend itself against a disease.
Croatian: Cjepiva djeluju „učeći” imunosni sustav kako se obraniti od bolesti.
English: When the person comes into contact again with this or a similar virus, these antibodies together with other components of the immune system will be able to kill the viruses and help protect against the disease.
Croatian: Kada je osoba ponovno izložena ovom ili sličnom virusu, ta će protutijela zajedno s drugim dijelovima imunosnog sustava moći uništiti virus i pomoći pri zaštiti od bolesti.
English: This vaccine will be used when it is considered necessary to protect against smallpox in accordance with official recommendations.
Croatian: Ovo cjepivo koristit će se u situacijama kad se smatra potrebnim zaštititi stanovništvo od velikih boginja u skladu sa službenim preporukama.
English: The most common side effects with Imvanex (which may affect more than 1 in 10 people) are headache, nausea, myalgia (muscle pain), tiredness and injection site reactions (pain, redness, swelling, hardening and itching).
Croatian: Najčešće nuspojave cjepiva Imvanex (koje se mogu javiti u više od 1 na 10 osoba) jesu glavobolja, mučnina, mijalgija (bol u mišićima), umor i reakcije na mjestu primjene (bol, crvenilo, oticanje, otvrdnuće i svrbež).
English: Vaccines containing vaccinia viruses were effective in the campaign to eradicate smallpox.
Croatian: Cjepiva koja sadrže viruse vakcinije bila su učinkovita u kampanji iskorjenjivanja velikih boginja.
English: Imvanex would therefore be beneficial for people who cannot be given vaccines containing replicating viruses, such as patients with a weakened immune system.
Croatian: Imvanex bi stoga bio koristan za osobe koje ne mogu primiti cjepiva koja sadrže replicirajuće viruse, kao što su bolesnici s oslabljenim imunosnim sustavom.
English: What is Imvanex and what is it used for?
Croatian: Što je Imvanex i za što se koristi?
English: This is because it has not been possible to obtain complete information about Imvanex due to the rarity of the disease.
Croatian: Razlog tome je nemogućnost dobivanja potpunih informacija o cjepivu Imvanex zbog male učestalosti bolesti.
English: Since Imvanex has been authorised under exceptional circumstances, the company that markets Imvanex will provide data on the vaccine's benefits and risks from observational studies in patients who are given the vaccine, and if ever there is an outbreak of the disease in the future.
Croatian: Budući da je cjepivo Imvanex odobreno u iznimnim okolnostima, tvrtka koja stavlja cjepivo Imvanex u promet dostavit će podatke o koristima i rizicima cjepiva iz opservacijskih ispitivanja na bolesnicima koji primaju to cjepivo te u slučaju izbijanja bolesti u budućnosti.
English: Imvanex must not be used in patients who are hypersensitive (allergic) to the active substance or any of the substances found at trace levels, such as chicken protein, benzonase and gentamicin.
Croatian: Imvanex se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na djelatnu tvar ili bilo koju tvar prisutnu u tragovima poput pilećih proteina, benzonaza i gentamicina.
English: When a person is given the vaccine, the immune system recognises the virus in the vaccine as ‘foreign' and makes antibodies against it.
Croatian: Kada osoba primi cjepivo, imunosni sustav prepoznaje virus u cjepivu kao „strano tijelo” i proizvodi protutijela na virus.
English: Side effects reported with Imvanex are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za cjepivo Imvanex pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What measures are being taken to ensure the safe and effective use of Imvanex?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena cjepiva Imvanex?
English: It contains a live modified form of the vaccinia virus called ‘vaccinia Ankara', which is related to the smallpox virus.
Croatian: Sadrži živi modificirani oblik virusa vakcinije zvan „vakcinija Ankara”, koji je povezan s virusom velikih boginja.
English: The studies involved over 2,000 adults, including patients with HIV and atopic dermatitis (an itchy skin condition caused by an overactive immune system) and people who had been vaccinated against smallpox in the past.
Croatian: Ispitivanja su obuhvatila više od 2 000 odraslih osoba, uključujući bolesnike s HIV-om i atopijskim dermatitisom (kožna bolest praćena svrbežom uzrokovana prekomjerno aktivnim imunosnim sustavom) i osobe koje su prethodno primile cjepivo protiv velikih boginja.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imvanex 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 cjepiva Imvanex nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: If a booster dose is necessary for those who have been vaccinated against smallpox in the past, a single 0.5 ml dose should be given except for patients with a weakened immune system (the body's natural defences) who should receive two booster doses, with the second dose given at least 28 days after the first.
Croatian: Ako je potrebno provesti docjepljivanje osoba koje su u prošlosti cijepljene protiv velikih boginja, potrebno je dati pojedinačnu dozu od 0,5 ml s izuzetkom bolesnika s oslabljenim imunosnim sustavom (prirodna obrana tijela) koji trebaju primiti dvije doze docjepljivanja, pri čemu drugu dozu treba dati najranije 28 dana nakon prve doze.
English: As for all medicines, data on the use of Imvanex are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni cjepiva Imvanex kontinuirano se prate.
English: Other information about Imvanex
Croatian: Ostale informacije o cjepivu Imvanex
English: For more information about using Imvanex, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni cjepiva Imvanex pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Imvanex received a marketing authorisation valid throughout the EU on 31 July 2013.
Croatian: Cjepivo Imvanex dobilo je odobrenje za stavljanje u promet koje je na snazi u EU-u od 31. srpnja
English: An overview of Imvanex and why it is authorised in the EU
Croatian: Pregled informacija o cjepivu Imvanex i zašto je odobreno u EU-u
English: Imvanex contains a modified form of the vaccinia virus called vaccinia Ankara, which does not cause disease in humans and cannot replicate (reproduce) in human cells.
Croatian: Imvanex sadrži modificirani oblik virusa vakcinije zvan „vakcinija Ankara” koji ne uzrokuje bolest u ljudi i ne može se umnažati u ljudskim stanicama.
English: What are the risks associated with Imvanex?
Croatian: Koji su rizici povezani s cjepivom Imvanex?
English: A subsequent study in 433 people who had not been vaccinated before found that the level of protective antibodies after vaccination with Imvanex was at least as high as with a conventional smallpox vaccine.
Croatian: U sljedećem ispitivanju na 433 osobe koje prethodno nisu bile cijepljene utvrđeno je da je razina zaštitnih protutijela nakon cijepljenja cjepivom Imvanex bila najmanje jednaka kao kod konvencionalnog cjepiva protiv velikih boginja.
English: Two of the studies specifically looked at the effectiveness of Imvanex as a booster.
Croatian: U dvama ispitivanjima posebno se ispitala djelotvornost cjepiva Imvanex u docjepljivanju.
English: Because of its similarity to the smallpox virus, antibodies produced against this virus are also expected to protect against smallpox.
Croatian: S obzirom na sličnost s virusom velikih boginja, očekuje se da će protutijela koja se proizvode na ovaj virus također štititi od velikih boginja.
English: Why is Imvanex authorised in the EU?
Croatian: Zašto je cjepivo Imvanex odobreno u EU-u?
English: Imvanex is a vaccine used to protect against smallpox in adults.
Croatian: Imvanex je cjepivo za zaštitu od velikih boginja u odraslih osoba.
English: The vaccinia virus in Imvanex cannot replicate in human cells and hence is less likely to cause side effects than conventional smallpox vaccines.
Croatian: Virus vakcinije u cjepivu Imvanex ne može se umnažati u ljudskim stanicama i stoga je, u usporedbi s konvencionalnim cjepivima protiv velikih boginja, manje vjerojatno da će izazvati nuspojave.
English: The European Medicines Agency considered that Imvanex is effective at triggering the production of antibodies against smallpox to a level that provides protection at least as high as that from conventional smallpox vaccines.
Croatian: Europska agencija za lijekove zaključila je da je cjepivo Imvanex djelotvorno u poticanju proizvodnje protutijela za velike boginje do razine kojom se osigurava najmanje jednaka zaštita kao kod konvencionalnog cjepiva protiv velikih boginja.
English: How does Imvanex work?
Croatian: Kako djeluje Imvanex?
English: What information is still awaited for Imvanex?
Croatian: Koje se još informacije očekuju o cjepivu Imvanex?
English: Imvanex was shown in studies to be effective at triggering the production of antibodies to a level expected to provide protection against smallpox.
Croatian: U ispitivanjima je dokazano da je Imvanex djelotvoran u poticanju proizvodnje protutijela do razine pri kojoj se očekuje pružanje zaštite od velikih boginja.
English: What benefits of Imvanex have been shown in studies?
Croatian: Koje su koristi od cjepiva Imvanex utvrđene u ispitivanjima?
English: Imvanex is given by injection under the skin, preferably in the upper arm. People who have not been previously vaccinated against smallpox should receive two 0.5 ml doses, with the second dose given at least 28 days after the first.
Croatian: Osobe koje nisu prethodno cijepljene protiv velikih boginja trebaju primiti dvije doze od 0,5 ml, a drugu dozu treba dati najranije 28 dana nakon prve.
English: Condition for lifting the suspension of the marketing authorisations
Croatian: Uvjet za ukidanje suspenzije odobrenja za stavljanje lijeka u promet
English: • Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Croatian: • Bioekvivalencija u odnosu na referentni lijek odobren u EU-u dokazana je na temelju relevantnih podataka, sukladno sa zahtjevima iz članka 10.
English: For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities of the EU Member States shall ensure that the below condition has been completed by the marketing authorisation holder(s)
Croatian: Kako bi se ukinula suspenzija odobrenja za stavljanje lijeka u promet iz Priloga I.B, nadležna tijela država članica osiguravaju da nositelj/nositelji odobrenja za stavljanje lijeka u promet ispune sljedeće uvjete:
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene
English: 1 pre-filled pen + 1 pre-filled pen
Croatian: 1 napunjena brizgalica+ 1 napunjena brizgalica
English: Solution for injection
Croatian: Otopina za injekciju Za potkožnu primjenu
English: nonacog alfa
Croatian: nonakog alfa
English: This summary was last updated in 09-2015.
Croatian: Ovaj sažetak je posljednji put ažuriran u 09.2015.
English: Out of 972 infusions, 84% were rated as bringing about ‘good' or ‘excellent' responses.
Croatian: Od 972 infuzije, 84 % je ocijenjeno „dobrim” ili „odličnim” odgovorima.
English: The full EPAR for BeneFIX can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek BeneFIX nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for BeneFIX on 27 August 1997.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek BeneFIX na snazi u Europskoj uniji od 27. kolovoza 1997.
English: In previously treated patients, 82% of the 693 bleeding episodes treated resolved after a single infusion of BeneFIX.
Croatian: U prethodno liječenih bolesnika, 82 % od 693 liječenih epizoda krvarenja uklonjeno je nakon jedne infuzije lijeka BeneFIX.
English: They include angioedema (swelling of the face and limbs), burning and stinging at the injection site, chills, flushing, urticaria (itchy rash), headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (fast heartbeat), tightness of the chest, tingling, vomiting and wheezing.
Croatian: Također obuhvaćaju angioedem (oticanje lica i udova), žarenje i peckanje na mjestu davanja injekcije, zimicu, crvenilo uz osjećaj vrućine, urtikariju (svrbljivi osip), glavobolju, koprivnjaču, hipotenziju (niski krvni tlak), letargiju, mučninu (osjećaj slabosti), nemir, tahikardiju (ubrzane otkucaje srca), stezanje u prsima, trnce, povraćanje i piskanje.
English: It has also been studied in patients who have not received any treatment for their haemophilia.
Croatian: Također je ispitivan u bolesnika koji nisu primili nikakvo prethodno liječenje za svoju hemofiliju.
English: The lack of factor IX causes blood-clotting problems, such as bleeding in the joints, muscles and internal organs.
Croatian: Manjak faktora IX uzrokuje probleme s grušanjem krvi, kao što je krvarenje u zglobovima, mišićima i unutarnjim organima.
English: During treatment, the doctor should regularly carry out blood tests to adjust the dose to be given.
Croatian: Tijekom terapije liječnik treba redovito provoditi analize krvi kako bi prilagodio dozu koja se daje bolesniku.
English: Hypersensitivity (allergic) reactions have been seen in patients treated with products containing factor IX and may sometimes be severe.
Croatian: Reakcije preosjetljivosti (alergijske reakcije) uočene su u bolesnika koji su liječeni lijekovima koji sadrže faktor IX i one ponekad mogu biti ozbiljne.
English: It corrects the factor IX deficiency and gives temporary control of the bleeding disorder.
Croatian: Ispravlja manjak faktora IX i omogućuje privremenu kontrolu nad poremećajem krvarenja.
English: BeneFIX is used to replace the missing factor IX.
Croatian: BeneFIX se koristi kao zamjena za faktor IX koji nedostaje.
English: The studies assessed the number of bleeding episodes that occurred and rated BeneFIX's effectiveness using a scale from ‘no response' to ‘excellent'.
Croatian: U ispitivanjima su ocijenjeni broj epizoda krvarenja koje su nastupile i djelotvornost lijeka BeneFIX primjenom ljestvice od „bez odgovora” do „odlično”.
English: Nonacog alfa is not extracted from human blood but produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce human coagulation factor IX.
Croatian: Nonakog alfa se ne ekstrahira iz ljudske krvi, nego se proizvodi metodom poznatom kao „tehnologija rekombinantne DNK”: ovu tvar proizvode stanice koje su primile gen (DNK) koji im omogućuje stvaranje ljudskog koagulacijskog faktora IX.
English: BeneFIX is intended for either short-term or long-term use.
Croatian: BeneFIX je predviđen za kratkotrajnu ili dugotrajnu primjenu.
English: If antibodies develop, BeneFIX will not work effectively, which may result in a loss of bleeding control.
Croatian: Ako se protutijela razviju, BeneFIX neće djelovati djelotvorno, što može rezultirati gubitkom kontrole nad krvarenjem.
English: What measures are being taken to ensure the safe and effective use of BeneFIX?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka BeneFIX?
English: For more information about treatment with BeneFIX, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom BeneFIX pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: This document is a summary of the European Public Assessment Report (EPAR) for BeneFIX.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku BeneFIX.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for BeneFIX.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka BeneFIX.
English: BeneFIX is given by a slow injection into a vein, usually at up to 4 ml per minute and should not be mixed with other infusion solutions or given using a kit other than the one supplied with the medicine.
Croatian: BeneFIX se primjenjuje polaganom injekcijom u venu, najčešće do 4 ml po minuti te se ne smije miješati s drugim otopinama za infuziju niti se primjenjivati pomoću kompleta koji se ne isporučuje s lijekom.
English: Other information about BeneFIX
Croatian: Ostale informacije o lijeku BeneFIX
English: A risk management plan has been developed to ensure that BeneFIX is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka BeneFIX.
English: Full details on how to calculate the dose are included in the summary of product characteristics.
Croatian: Potpune informacije o načinu izračunavanja doze dostupne su u sažetku opisa svojstava lijeka.
English: BeneFIX should be started by a doctor who has experience in the treatment of haemophilia.
Croatian: Terapiju lijekom BeneFIX treba započeti liječnik koji ima iskustva u liječenju hemofilije.
English: Patients or their carers can give injections of BeneFIX, provided that they have been trained appropriately.
Croatian: Bolesnici ili njihovi pružatelji skrbi mogu primjenjivati injekcije lijeka BeneFIX ukoliko su prošli primjerenu obuku.
English: BeneFIX is used for the treatment and prevention of bleeding in adults and children with haemophilia B (an inherited bleeding disorder).
Croatian: BeneFIX se koristi za liječenje i prevenciju krvarenja u odraslih osoba i djece sa hemofilijom B (nasljednim poremećajem krvarenja).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BeneFIX, 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 BeneFIX nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The dose is adjusted depending on the severity and location of the bleeding, or the type of surgery.
Croatian: Dozu treba prilagoditi ozbiljnosti i mjestu krvarenja ili vrsti kirurškog zahvata.
English: BeneFIX is a medicine that contains the active substance nonacog alfa.
Croatian: BeneFIX je lijek koji sadrži djelatnu tvar nonakog alfa.
English: Patients with haemophilia B may also develop neutralising antibodies (inhibitors) to factor IX.
Croatian: Bolesnici s hemofilijom B mogu također razviti neutralizirajuća protutijela (inhibitore) faktora IX.
English: The CHMP decided that BeneFIX's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka BeneFIX nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: BeneFIX must not be used in people who are hypersensitive (allergic) to recombinant coagulation factor IX, to any of the other ingredients, or to hamster proteins.
Croatian: BeneFIX se ne smije koristiti u osoba koje su preosjetljive (alergične) na rekombinantni koagulacijski faktor IX, na bilo koji drugi sastojak ovog lijeka ili na proteine hrčka.
English: Patients with haemophilia B lack a protein called factor IX, which is involved in blood clotting.
Croatian: Bolesnicima s hemofilijom B manjka protein naziva faktor IX, koji je uključen u koagulaciju krvi.
English: The dose and the frequency of injection depend on whether BeneFIX is used to treat or prevent bleeding, or to reduce bleeding during surgery, and on the patient's condition.
Croatian: Doza i učestalost injekcije ovise o tome primjenjuje li se BeneFIX za liječenje ili sprječavanje krvarenja ili za smanjenje krvarenja tijekom kirurškog zahvata, te o stanju bolesnika.