FrancophonIA/ELRC3.0 huggingface dataset:
English: Palynziq must be used with stringent measures to manage any serious allergic reactions, especially in the first few months.
Croatian: Palynziq se mora primjenjivati uz stroge mjere upravljanja bilo kakvim ozbiljnim alergijskim reakcijama, pogotovo u prvim mjesecima terapije.
English: Palynziq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 January 2010.
Croatian: Palynziq je dobio status „lijeka za rijetku bolest” 28. siječnja 2010.
English: The safety of Palynziq is considered acceptable, and important side effects such as allergic reactions are considered manageable with additional stringent measures (see below).
Croatian: Sigurnost lijeka Palynziq smatra se prihvatljivom, a značajne nuspojave poput alergijskih reakcija može se kontrolirati uz pomoć dodatnih strogih mjera (vidjeti u nastavku).
English: In the extension phase of the study patients received an individual optimized dose of Palynziq.
Croatian: U fazi nastavka ispitivanja bolesnici su primili individualiziranu optimiziranu dozu lijeka Palynziq.
English: The enzyme in pegvaliase is ‘pegylated' (attached to a chemical called PEG), allowing it to remain in the body and to act for longer.
Croatian: Enzim u pegvaliazi je „pegiliran” (vezan na kemikaliju naziva PEG), što mu omogućava da duže ostane u organizmu i duže djeluje.
English: The European Medicines Agency therefore decided that Palynziq's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Palynziq nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Why is Palynziq authorised in the EU?
Croatian: Zašto je Palynziq odobren u EU-u?
English: What measures are being taken to ensure the safe and effective use of Palynziq?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Palynziq?
English: During treatment, monthly measurements are recommended.
Croatian: Tijekom terapije preporučuju se mjesečna mjerenja fenilanina.
English: The most common side effects with Palynziq (which may affect more than 7 in 10 people) are reactions at the injection site, pain in the joints and allergic reactions.
Croatian: Najčešće nuspojave lijeka Palynziq (koje se mogu javiti u više od 7 na 10 osoba) su reakcije na mjestu injiciranja, bol u zglobovima i alergijske reakcije.
English: Palynziq is a medicine that is used to treat phenylketonuria (PKU) in adults and adolescents from 16 years of age.
Croatian: Palynziq je lijek za liječenje fenilketonurije (PKU) u odraslih i adolescenata u dobi od 16 godina i starijih.
English: Side effects reported with Palynziq are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Palynziq pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Phenylalanine blood levels must be measured before starting treatment.
Croatian: Razine fenilalanina u krvi mora se izmjeriti prije početka terapije.
English: What is Palynziq and what is it used for?
Croatian: Što je Palynziq i za što se primjenjuje?
English: Palynziq must not be used in patients who have had an allergic reaction to pegvaliase, to any of the other components of Palynziq or to any other pegylated medicine.
Croatian: Palynziq se ne smije primjenjivati u bolesnika koji su imali alergijsku reakciju na pegvaliazu, na bilo koji drugi sastojak lijeka Palynziq ili na bilo koji drugi pegilirani lijek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Palynziq have also 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 Palynziq također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: The company that markets Palynziq will provide information material for doctors and for patients and carers about the risk of allergic reactions with Palynziq, including how to identify them promptly and what to do in case such a reaction occurs.
Croatian: Tvrtka koja lijek Palynziq stavlja u promet osigurat će informativne materijale za liječnike i bolesnike te njihove njegovatelje o rizicima od alergijskih reakcija pri primjeni lijeka Palynziq, uključujući informacije o tome kako ih odmah prepoznati te kako postupiti u slučaju pojave tih reakcija.
English: It was shown that for the majority of patients continued treatment with Palynziq for 18 months was effective at keeping blood phenylalanine levels under control (below 600 micromoles per litre).
Croatian: Utvrđeno je da je kod većine bolesnika nastavak terapije lijekom Palynziq tijekom 18 mjeseci bio učinkovit u održavanju razina fenilalanina u krvi pod kontrolom (manje od 600 mikromola na litru).
English: After 8 weeks of treatment, blood phenylalanine levels remained under control in patients taking Palynziq but they returned to pre-treatment levels in patients on placebo, showing that Palynziq was more effective than placebo in reducing blood phenylalanine levels and keeping them within an acceptable range.
Croatian: Nakon osam tjedana terapije razine fenilalanina u krvi moglo se kontrolirati u bolesnika koji su primali Palynziq, no vratile su se na razine prije početka terapije u bolesnika koji su primali placebo, što pokazuje da je Palynziq bio učinkovitiji od placeba u smanjivanju razina fenilalanina u krvi i održavanju njegove razine u prihvatljivom rasponu.
English: As for all medicines, data on the use of Palynziq are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Palynziq kontinuirano se prate.
English: The main study investigating Palynziq in patients with PKU consisted of different parts.
Croatian: Glavno ispitivanje lijeka Palynziq u bolesnika s PKU-om sastojalo se od različitih faza.
English: Eighty-six patients who responded to treatment (i.e. whose blood phenylalanine levels were reduced by at least 20%) where then either kept on the same dose of Palynziq or were given placebo (a dummy treatment).
Croatian: Među njima, 86 bolesnika koji su reagirali na terapiju (tj. čije su razine fenilalanina u krvi smanjene za barem 20 %) zadržano je na istoj dozi lijeka Palynziq ili su primili placebo (prividno liječenje).
English: Other information about Palynziq
Croatian: Ostale informacije o lijeku Palynziq
English: What are the risks associated with Palynziq?
Croatian: Koji su rizici povezani s lijekom Palynziq?
English: For more information about using Palynziq, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Palynziq pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: An overview of Palynziq and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Palynziq i zašto je odobren u EU-u
English: Throughout the study, patients were required to maintain a constant level of dietary protein intake, to ensure that changes in blood phenylalanine levels could be attributed to treatment rather than to changes in protein intake.
Croatian: Tijekom ispitivanja bolesnici su morali održavati jednaku razinu unosa proteina hranom kako bi se osiguralo da se promjene razina fenilalanina u krvi može pripisati terapiji, a ne promjenama uzrokovanim unosom proteina hranom.
English: Palynziq contains the active substance pegvaliase.
Croatian: Palynziq sadrži djelatnu tvar pegvaliazu.
English: The active substance in Palynziq, pegvaliase, is a bacterial enzyme that can break down phenylalanine, thereby stopping phenylalanine from building up in the body and helping to relieve the symptoms of phenylketonuria.
Croatian: Djelatna tvar lijeka Palynziq, pegvaliaza, bakterijski je enzim koji razgrađuje fenilalanin, čime onemogućava njegovo nakupljanje u organizmu i pomaže pri ublažavanju simptoma fenilketonurije.
English: Palynziq was shown to be effective at reducing levels of blood phenylalanine and keeping them under control.
Croatian: Lijek Palynziq pokazao se učinkovitim u smanjivanju razina fenilalanina u krvi te u njihovu održavanju pod kontrolom.
English: Palynziq is used in patients whose blood levels of phenylalanine have not been adequately controlled with other treatments.
Croatian: Palynziq se primjenjuje u bolesnika čije se razine fenilalanina na odgovarajući način nisu mogle kontrolirati drugim terapijama.
English: What benefits of Palynziq have been shown in studies?
Croatian: Koje su koristi od lijeka Palynziq utvrđene u ispitivanjima?
English: How does Palynziq work?
Croatian: Kako djeluje Palynziq?
English: How is Palynziq used?
Croatian: Kako se Palynziq primjenjuje?
English: Patients with this genetic disease cannot process the amino acid phenylalanine from dietary protein, and as a result the amino acid builds up in the blood to abnormally high levels, causing problems in the nervous system.
Croatian: Iz tog se razloga aminokiselina nakuplja u krvi do abnormalno visokih razina, uzrokujući probleme u živčanom sustavu.
English: For the full list of side effects of Palynziq, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Palynziq potražite u uputi o lijeku.
English: Anise oil EMA/412178/2016
Croatian: EMA/412178/2016
English: They must also not be used in patients who are allergic to aniseed or to plants of the Apiaceae family (Umbelliferae) (caraway, celery, coriander, dill, fennel) or anethole.
Croatian: Također se ne smiju primjenjivati u bolesnika koji su alergični na anišev plod ili biljke iz porodice Apiaceae (Umbelliferae) (kim, celer, korijander, kopar, komorač) ili anetol.
English: If symptoms last or get worse during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Croatian: Ako se simptomi nastave ili pogoršaju tijekom primjene lijeka, potrebno je obratiti se liječniku ili kvalificiranom zdravstvenom radniku.
English: Aniseed oil medicines must not be used in children and adolescents under 18 years.
Croatian: Lijekovi koji sadrže ulje od aniševa ploda ne smiju se primjenjivati u djece i adolescenata mlađih od 18 godina.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/412178/2016
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● Ujedinjena Kraljevina
English: In addition they can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Croatian: Osim toga, mogu se koristiti kao ekspektorans (lijek za olakšavanje iskašljavanja sluzi) za kašalj uslijed prehlade.
English: Anise oil medicines should only be used in adults and should not be taken for longer than two weeks.
Croatian: Lijekovi koji sadrže aniševo eterično ulje smiju se koristiti samo u odraslih osoba osobe i ne smiju se koristiti dulje od dva tjedna.
English: Anise oil is the common name for the essential oil obtained from the dry ripe fruits of the plant Pimpinella anisum L.
Croatian: Aniševo eterično ulje je uobičajeni naziv za eterično ulje koje je dobiveno od suhih zrelih plodova biljke Pimpinella anisum L.
English: What is anise oil?
Croatian: Što je aniševo eterično ulje?
English: Further information on the HMPC assessment of anise oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Daljnje informacije o HMPC-ovoj ocjeni lijekova koji sadrže aniševo eterično ulje, uključujući pojedinosti zaključaka Povjerenstva, mogu se pronaći pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with these anise oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više o rizicima povezanim s ovim lijekovima koji sadrže aniševo eterično ulje, uključujući odgovarajuće mjere opreza za njihovu sigurnu primjenu, možete pronaći u monografiji pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing anise oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže aniševo eterično ulje moraju se podnijeti nacionalnim tijelima nadležnima za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Herbal medicines containing these anise oil preparations are usually available in solid or liquid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže te pripravke aniševog eteričnog ulja najčešće su dostupni u krutom ili tekućem obliku i uzimaju se kroz usta.
English: This summary is not intended to provide practical advice on how to use medicines containing anise oil.
Croatian: Svrha ovog sažetka nije davati praktične savjete o načinu primjene lijekova koji sadrže aniševo eterično ulje.
English: Anise oil preparations may also be found in combination with other herbal substances in some herbal medicines.
Croatian: Pripravci aniševog eteričnog ulja mogu postojati također i u kombinaciji s drugim biljnim tvarima u nekim biljnim lijekovima.
English: The HMPC conclusions on the use of these anise oil medicines for indigestion complaints and coughs are based on their ‘traditional use' .
Croatian: Zaključci HMPC-a o primjeni ovih lijekova koji sadrže aniševo eterično ulje za probavne tegobe i kašalj temelje se na njihovoj „tradicionalnoj primjeni”.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of anise oil.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske primjene aniševog eteričnog ulja.
English: In its assessment, the HMPC considered studies in laboratory tests which showed anise oil to have a relaxing effect on the muscle of the gut and airways.
Croatian: Prilikom svoje ocjene HMPC je razmotrio ispitivanja provedena u laboratoriju koja su pokazala da aniševo eterično ulje ima učinak opuštanja mišića crijeva i dišnih putova.
English: Information on the use and licensing of anise oil medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o primjeni i davanju odobrenja za lijekove koji sadrže aniševo eterično ulje u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: Allergic reactions to aniseed oil that affect the skin or airways may occur.
Croatian: Moguće su alergijske reakcije na ulje aniševog ploda koje zahvaćaju kožu ili dišne putove.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing anise oil.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjene zahtjeva za davanje odobrenja za biljne lijekove koji sadrže aniševo eterično ulje.
English: The HMPC concluded that, on the basis of its long-standing use, these anise oil preparations can be used for treating symptoms of mild indigestion complaints including bloating and flatulence.
Croatian: Na temelju dugotrajne primjene, HMPC je zaključio da se ovi pripravci aniševog eteričnog ulja mogu koristiti za liječenje simptoma blagih probavnih tegoba, uključujući nadutost i flatulenciju.
English: The HMPC conclusions only cover anise oil preparations which are obtained by steam distillation of the dry ripe fruits.
Croatian: Zaključcima HMPC-a obuhvaćeni su samo pripravci aniševog eteričnog ulja koji su dobiveni parnom destilacijom suhih zrelih plodova.
English: Other information about anise oil medicines
Croatian: Ostale informacije o lijekovima koji sadrže aniševo eterično ulje
English: For more information about treatment with anise oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Za više informacija o liječenju lijekovima koji sadrže aniševo eterično ulje pročitajte uputu o lijeku priloženu uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: What are the risks associated with anise oil medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže aniševo eterično ulje?
English: For practical information about using anise oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o primjeni lijekova koji sadrže aniševo eterično ulje bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: Detailed instructions on how to take anise oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: koji sadrže aniševo eterično ulje i o tome tko ih smije uzimati navedene su u uputi o lijeku koja je priložena uz lijek.
English: How are anise oil medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže aniševo eterično ulje?
English: What evidence supports the use of anise oil medicines?
Croatian: Kojim se dokazima potkrjepljuje primjena lijekova koji sadrže aniševo eterično ulje?
English: What Eporatio is and what it is used for What Eporatio is
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: Date of first authorisation: 29 October 2009.
Croatian: Datum prvog odobrenja: 29. listopada 2009.
English: Date of latest renewal: 11 September 2014.
Croatian: Datum posljednje obnove odobrenja: 11. rujna 2014.
English: - Allergic reactions:
Croatian: - Alergijske reakcije:
English: The safety and efficacy of Eporatio in children and adolescents aged up to 17 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Eporatio u djece i adolescenata u dobi do 17 godina nisu još ustanovljene.
English: Healthy people should not use Eporatio.
Croatian: Zdrave osobe ne smiju uzimati Eporatio.
English: Do not warm Eporatio in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Eporatio ni na koji drugi način (npr. ne zagrijavajte ga u mikrovalnoj pećnici ili u vrućoj vodi).
English: Other medicines and Eporatio
Croatian: Drugi lijekovi i Eporatio
English: What Eporatio looks like and contents of the pack
Croatian: Kako Eporatio izgleda i sadržaj pakiranja
English: Contents of the pack and other information What Eporatio contains
Croatian: Sadržaj pakiranja i druge informacije Što Eporatio sadrži
English: You may experience the following additional side effects:
Croatian: Moguće su i sljedeće dodatne nuspojave:
English: As a precautionary measure, it is preferable to avoid the use of Eporatio during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Eporatio tijekom trudnoće.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Eporatio therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Nužno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Eporatio uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: If your doctor suspects or confirms that you have this condition, you must not be treated with Eporatio or another epoetin.
Croatian: Ako Vaš liječnik sumnja na tu bolest ili je potvrdi, ne smijete uzimati Eporatio ili neki drugi epoetin.
English: The safety of epoetin theta has been evaluated based on results from clinical studies including 972 patients.
Croatian: Tablični popis nuspojava Sigurnost epoetina theta procijenjena je na temelju rezultata kliničkih ispitivanja u kojima su sudjelovala 972 bolesnika.
English: Push the plunger up to the number (IU) on the syringe that matches the dose of Eporatio that your doctor prescribed.
Croatian: Polagano pritisnite klip štrcaljke do broja (IU) na štrcaljki koji odgovara dozi lijeka Eporatio koju Vam je propisao liječnik.
English: If you use more Eporatio than you should
Croatian: Ako primjenite više lijeka Eporatio nego što ste trebali
English: Check the appearance of Eporatio.
Croatian: Provjerite izgled lijeka Eporatio.
English: It may also be necessary to reduce your dose of Eporatio or to stop the treatment with Eporatio for a short period of time.
Croatian: Možda će biti potrebno i smanjiti Vašu dozu lijeka Eporatio ili prekinuti liječenje lijekom Eporatio na kraće vrijeme.
English: Treatment with Eporatio is normally a long-term therapy.
Croatian: Liječenje lijekom Eporatio je obično dugotrajno.
English: If you do not respond adequately to Eporatio, your doctor will check your dose and will inform you if you need to change doses of Eporatio.
Croatian: Ako ne odgovorite na Eporatio na odgovarajući način, Vaš liječnik će provjeriti dozu koju primate i obavijestiti Vas trebate li promijeniti doze Eporatia.
English: If a dose adjustment is required to maintain the desired haemoglobin level, it is recommended that the dose be adjusted by approximately 25%.
Croatian: Ako je dozu potrebno prilagoditi da se održi željena razina hemoglobina, preporučuje se prilagoditi dozu za oko 25%.
English: If you are receiving Eporatio as an injection under the skin, your doctor may suggest that you learn how to inject yourself this medicine.
Croatian: Ako primate Eporatio otopinu za injekciju potkožno, liječnik Vam može predložiti da naučite kako sami primjenjivati ovaj lijek.
English: Eporatio contains the active substance epoetin theta, which is almost identical to erythropoietin, a natural hormone produced by your body.
Croatian: Eporatio sadrži djelatnu tvar epoetin theta, koja je skoro identična eritropoetinu, prirodnom hormonu koji stvara Vaše tijelo.
English: Eporatio contains sodium
Croatian: Eporatio sadrži natrij
English: The dose of Eporatio (expressed in International Units or IU) depends on your disease condition, your body weight and the way the injection is given (under the skin [subcutaneous injection] or into a vein [intravenous injection]).
Croatian: Doza lijeka Eporatio (izražena u internacionalnim jedinicama ili IU) ovisi o stanju Vaše bolesti, Vašoj tjelesnoj težini i načinu primjene injekcije (potkožno [supkutana injekcija] ili u venu [intravenska injekcija]).
English: If you think you are having this type of reaction, you must stop your Eporatio injection and get medical help immediately.
Croatian: Ako mislite da imate takve reakcije, morate prekinuti primjenu Eporatio injekcije i odmah zatražiti liječničku pomoć.
English: Eporatio is a clear and colourless solution for injection in pre-filled syringe along with an injection needle.
Croatian: Eporatio je bistra i bezbojna otopina za injekciju u napunjenoj štrcaljki zajedno s injekcijskom iglom.
English: Eporatio has not been tested in pregnant women.
Croatian: Nije ispitivana primjena lijeka Eporatio u trudnica.
English: You will usually receive Eporatio until 1 month after the end of chemotherapy.
Croatian: Eporatio se obično primjenjuje do mjesec dana nakon završetka kemoterapije.