FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Xromi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xromi?
English: As for every medicine, this included studies showing that the medicine was of acceptable quality.
Croatian: Kao i za svaki lijek, te su informacije sadržavale ispitivanja kojima se pokazuje da je lijek prihvatljive kakvoće.
English: Patients should drink water after a dose of Xromi to ensure the full dose reaches the stomach.
Croatian: Bolesnici trebaju popiti vode nakon uzimanja doze lijeka Xromi kako bi bili sigurni da će cijela doza lijeka dospjeti do želudca.
English: The company provided updated information showing the benefits of hydroxcarbamide in preventing complications of sickle cell disease in patients over 2 years of age.
Croatian: Tvrtka je dostavila ažurirane informacije koje pokazuju prednosti hidroksikarbamida u sprečavanju komplikacija bolesti srpastih stanica u bolesnika starijih od dvije godine.
English: Xromi must also not be used in patients taking medicines to treat HIV infection.
Croatian: Xromi se također ne smije primjenjivati u bolesnika koji uzimaju lijekove za liječenje infekcije HIV-om.
English: This reduces the risk of blood vessels becoming blocked.
Croatian: Time se smanjuje rizik od začepljenja krvnih žila.
English: Xromi must not be used in people who have severe problems with their kidneys or liver, or who have dangerously low blood cell counts.
Croatian: Xromi se ne smije primjenjivati u osoba koje imaju teške probleme s bubrezima ili jetrom ili koje imaju opasno nisku razinu krvnih stanica.
English: This included information from 4 main studies in sickle cell disease, including 3 studies involving 384 adults and children in whom hydroxycarbamide was shown to substantially reduce the risk of severe, painful blockages of blood supply (called vaso-occlusive crises) compared with a dummy treatment, and a fourth study involving 121 children that showed hydroxycarbamide to be at least as effective as standard treatment using blood transfusions in reducing blood vessel damage in the brain and the risk of stroke.
Croatian: One su obuhvaćale informacije iz četiriju glavnih ispitivanja bolesti srpastih stanica, uključujući tri studije kojima je bilo obuhvaćeno 384 djece i odraslih osoba kod kojih je utvrđeno da je hidroksikarbamid značajno smanjio rizik od teških i bolnih začepljenja krvnih žila (takozvanih vazookluzivnih kriza) u usporedbi s prividnim liječenjem, a četvrto je ispitivanje (kojim je bilo obuhvaćeno 121 dijete) pokazalo da je hidroksikarbamid barem jednako učinkovit kao standardno liječenje u kojem se primjenjuju transfuzije krvi za smanjenje oštećenja krvnih žila u mozgu i smanjenje rizika od moždanog udara.
English: Therefore the European Medicines Agency decided that Xromi'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 Xromi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The most common side effects with Xromi (which may affect more than 1 in 10 people) are bone marrow suppression (reduced ability to produce blood cells) and reduced fertility in men due to oligospermia (low sperm counts) or azoospermia (absence of sperm).
Croatian: Najčešće nuspojave lijeka Xromi (koje se mogu javiti u više od 1 na 10 osoba) jesu supresija koštane srži (smanjena sposobnost proizvodnje krvnih stanica) i smanjena plodnost u muškaraca zbog oligospermije (niskog broja spermija) ili azoospermije (odsutnosti spermija).
English: Because hydroxycarbamide is a well-established substance that has been used for many years in the EU the company provided information from the published literature on the benefits and risks of hydroxycarbamide in its approved uses.
Croatian: Zbog toga što je hidroksikarbamid provjerena djelatna tvar koja se dugi niz godina primjenjuje u EU-u, tvrtka je dostavila informacije iz objavljene literature o prednostima i rizicima hidroksikarbamida u njegovoj odobrenoj primjeni.
English: Although the way that it works in this disease is not fully understood, hydroxycarbamide can reduce the numbers of cells that are circulating in the blood, as well as prevent red blood cells changing shape in patients with sickle cell disease.
Croatian: Premda njezin način djelovanja u ovoj bolesti nije potpuno jasan, hidroksikarbamid može smanjiti broj stanica koje su u cirkulaciji u krvi i spriječiti promjenu oblika crvenih krvnih stanica u bolesnika oboljelih od bolesti srpastih stanica.
English: Xromi is available as a liquid to be swallowed containing hydroxycarbamide 100 mg/mL, and doses are based on the patient's body weight.
Croatian: Xromi je dostupan u obliku tekućine za piće koja sadrži hidroksikarbamid od 100 mg/ml, a doze se temelje na tjelesnoj težini bolesnika.
English: The company that markets Xromi will put in place an educational programme for doctors and patients about the correct use of the medicine and preventing harm, including guidance on use of the appropriate syringe for dosing and the need for regular blood testing.
Croatian: Tvrtka koja stavlja lijek Xromi u promet organizirat će program obuke za liječnike i bolesnike o pravilnoj primjeni lijeka i sprečavanju štetnih učinaka, uključujući upute o primjeni odgovarajuće štrcaljke za doziranje i potrebnim redovitim krvnim pretragama.
English: Side effects reported with Xromi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Xromi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Why is Xromi authorised in the EU?
Croatian: Zašto je lijek Xromi odobren u EU-u?
English: Other information about Xromi
Croatian: Ostale informacije o lijeku Xromi
English: Hydroxycarbamide, which used to be known as hydroxyurea, has been used for many years to treat sickle cell disease, and has been authorised in EU countries for several decades as Hydrea for use in some types of cancer.
Croatian: Hidroksikarbamid, ranije poznat pod nazivom hidroksiureja, primjenjuje se već dugi niz godina za liječenje bolesti srpastih stanica, a već je nekoliko desetljeća odobren u zemljama EU-a pod nazivom Hydrea za liječenje određenih vrsta raka.
English: An overview of Xromi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Xromi i zašto je odobren u EU-u
English: The medicine is supplied with two oral syringes for measuring the dose, a smaller red one for measuring doses up to a total of 300 mg (3 mL of liquid), and a larger white one for use if doses are bigger than this.
Croatian: Lijek dolazi s dvije štrcaljke za usta za mjerenje doze, od kojih se manja crvena štrcaljka koristi za mjerenje doza do ukupno 300 mg (3 ml tekućine), a veća bijela štrcaljka koristi se ako su doze veće od navedene.
English: What are the risks associated with Xromi?
Croatian: Koji su rizici povezani s lijekom Xromi?
English: Xromi is used to prevent so-called vaso-occlusive complications - problems that happen when blood vessels become blocked by the abnormal red blood cells, restricting the flow of blood to parts of the body.
Croatian: Xromi se koristi za prevenciju takozvanih vazookluzivnih komplikacija, poteškoća koje nastupaju kada dođe do začepljenja krvnih žila zbog abnormalnih crvenih krvnih stanica, čime se ograničava krvotok do drugih dijelova tijela.
English: For more information about using Xromi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Xromi pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Xromi is a ‘hybrid medicine'.
Croatian: Xromi je „hibridni lijek”.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xromi 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 Xromi nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: Xromi is a medicine used in adults, adolescents and children over two years of age who have sickle cell disease, a genetic disease where the red blood cells become rigid and sticky, and change from being disc-shaped to being crescent-shaped (like a sickle).
Croatian: Lijek Xromi koristi se u odraslih osoba, adolescenata i djece starije od dvije godine oboljelih od bolesti srpastih stanica, genetske bolesti u kojoj crvene krvne stanice postaju krute i ljepljive te se njihov oblik diska mijenja u oblik polumjeseca (nalik srpu).
English: As for all medicines, data on the use of Xromi are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Xromi kontinuirano se prate.
English: The safety issues with hydroxycarbamide are well understood, and Xromi has been shown to be bioequivalent to an authorised hydroxycarbamide medicine.
Croatian: Sigurnosna pitanja u vezi s hidroksikarbamidom točno su shvaćena, a Xromi se pokazao bioekvivalentnim odobrenom lijeku koji sadrži hidroksikarbamid.
English: Xromi can only be obtained with a prescription and treatment must be supervised by a healthcare professional experienced in the management of sickle cell disease.
Croatian: Xromi se izdaje samo na recept, a liječenje mora nadzirati zdravstveni radnik s iskustvom u liječenju bolesti srpastih stanica.
English: The active substance in Xromi, hydroxycarbamide, blocks the growth and reproduction of some cells, such as blood cells.
Croatian: Djelatna tvar lijeka Xromi, hidroksikarbamid, blokira rast i razmnožavanje određenih stanica kao što su krvne stanice.
English: It also carried out a study that showed Xromi is bioequivalent to the reference medicine, Hydrea.
Croatian: Tvrtka je također provela ispitivanje koje je pokazalo da je lijek Xromi „bioekvivalentan” referentnom lijeku Hydrea.
English: What benefits of Xromi have been shown in studies?
Croatian: Koje su koristi od lijeka Xromi utvrđene u ispitivanjima?
English: Xromi (hydroxycarbamide)
Croatian: Xromi (hidroksikarbamid)
English: How does Xromi work?
Croatian: Kako djeluje Xromi?
English: The reference medicine for Xromi is Hydrea.
Croatian: Referentni lijek za lijek Xromi je lijek Hydrea.
English: The active substance in Xromi is hydroxycarbamide.
Croatian: Djelatna tvar lijeka Xromi je hidroksikarbamid.
English: For the full list of side effects of Xromi, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Xromi potražite u uputi o lijeku.
English: How is Xromi used?
Croatian: Kako se Xromi primjenjuje?
English: Not to be sold separately.
Croatian: Ne prodaje se odvojeno.
English: telephone number: XXXXXXXXXXX e-mail: XXXXXXXXXXX
Croatian: Broj telefona: XXXXXXXXXXX e-mail: XXXXXXXXXXX
English: The warranty does not cover damages caused by:
Croatian: Jamstvo ne pokriva oštećenja uzrokovana:
English: Protect it from water, dust and moisture.
Croatian: Zaštitite je od vode, prašine i vlage.
English: In this case continue with step “2.
Croatian: U tom slučaju prijeđite na korak '2.
English: These reactions usually occur soon after injection.
Croatian: Te su se reakcije obično dešavale ubrzo nakon injekcije.
English: Wash your hands carefully with soap to minimise the risk of infection.
Croatian: Temeljito operite ruke sapunom da biste minimizirali rizik od infekcije.
English: Do not repeat this before each daily injection, otherwise you will not have enough Terrosa for 28 days.
Croatian: Nemojte ponavljati ovaj postupak prije svake dnevne injekcije jer inače nećete imati dovoljno lijeka Terrosa za 28 dana.
English: Teriparatide (N = 541) (%)
Croatian: Teriparatid (N = 541) (%)
English: Risk factors
Croatian: Faktori rizika
English: Never share your pen with others.
Croatian: Nikada ne dijelite svoju brizgalicu s drugim osobama.
English: Each cartridge should be properly disposed of after 28 days of first use, even if it is not completely empty.
Croatian: Svaki uložak morate na odgovarajući način zbrinuti nakon 28 dana od prve uporabe, čak i ako nije potpuno prazan.
English: 3401 Burgdorf, Switzerland
Croatian: 3401 Burgdorf, Švicarska
English: If no drops emerge, repeat step G until you see some drops.
Croatian: Ako ne iscuri nijedna kapljica lijeka, ponavljajte korak G sve dok ne vidite nekoliko kapljica.
English: Follow the instructions presented in this instructions for use.
Croatian: Slijedite upute navedene u ovim uputama za uporabu.
English: Do not press the push button.
Croatian: Nemojte pritiskati potisni gumb.
English: The primary objective of the study was to collect safety data of teriparatide.
Croatian: Primarni cilj tog ispitivanja bio je prikupiti podatke o sigurnosti primjene teriparatida.
English: Do not repeat the injection on the same day.
Croatian: Nemojte ponoviti injekciju istoga dana.
English: Your doctor will advise you and decide how long you should be treated with Terrosa.
Croatian: Liječnik će Vas savjetovati i odlučiti koliko dugo se trebate liječiti lijekom Terrosa.
English: What Terrosa is and what it is used for
Croatian: Što je Terrosa i za što se koristi
English: Legal manufacturer:
Croatian: Ovlašteni proizvođač:
English: Colourless, clear solution for injection with a pH of 3.8 - 4.5.
Croatian: Bezbojna, bistra otopina za injekciju s pH od 3,8 - 4,5.
English: Do not repeat step G more than four times, but follow the instructions given under Troubleshooting section on the back page.
Croatian: Nemojte ponoviti korak G više od četiri puta, već slijedite upute u dijelu 'Rješavanje problema' na poleđini ove upute.
English: Women of childbearing potential / Contraception in females
Croatian: Žene reproduktivne dobi / kontracepcija u žena
English: - Pregnancy and breast-feeding (see sections 4.4 and 4.6).
Croatian: - Trudnoća i dojenje (vidjeti dijelove 4.4 i 4.6).
English: No differences in teriparatide pharmacokinetics were detected with regard to age (range 31 to 85 years).
Croatian: Nisu otkrivene razlike u farmakokinetici teriparatida s obzirom na dob (u rasponu od 31 do 85 godina).
English: Other medicines and Terrosa
Croatian: Drugi lijekovi i Terrosa
English: If you forget an injection or cannot use your medicine at your usual time, inject it as soon as possible on that day.
Croatian: Ako ste zaboravili injekciju ili ne možete primijeniti svoj lijek u uobičajeno vrijeme, injektirajte ga što prije istoga dana.
English: Keep the needle in the skin fold for a further 6 seconds.
Croatian: Zadržite iglu u kožnom naboru još 6 sekundi.
English: There is no specific antidote for teriparatide.
Croatian: Ne postoji poseban antidot za teriparatid.
English: A small air bubble will not affect the dose, or harm.
Croatian: Mjehurić zraka neće utjecati na dozu niti Vam naškoditi.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 January 2017
Croatian: Datum prvog odobrenja: 04. siječnja 2017.
English: Do not use alcohol, other solvents or cleaning agents.
Croatian: Nemojte koristiti alkohol ni druga otapala ili sredstva za čišćenje.
English: If you use more Terrosa than you should
Croatian: Ako primijenite više lijeka Terrosa nego što ste trebali
English: - After your injection, leave the needle in the skin for six seconds to make sure that you receive the whole dose.
Croatian: Nakon injektiranja ostavite iglu u koži šest sekundi kako biste bili sigurni da ste primili cjelokupnu dozu.
English: Therefore, teriparatide should be used with caution.
Croatian: Stoga teriparatid treba primjenjivati uz oprez.
English: Tilting the pen may result in bending or breaking of the needle.
Croatian: Naginjanje brizgalice može dovesti do savijanja ili lomljenja igle.
English: Teriparatide is eliminated through hepatic and extra-hepatic clearance (approximately 62 L/hr in women and 94 L/hr in men).
Croatian: Teriparatid se eliminira hepatičkim i ekstrahepatičkim klirensom (približno 62 l/h u žena i 94 l/h u muškaraca).
English: If the instructions are not followed, there are risks of incorrect medication, inaccurate dosage, disease transmission or infection.
Croatian: Ako ne budete slijedili upute, postoji rizik od primjene pogrešnog lijeka ili pogrešne doze te prijenosa bolesti ili infekcije.
English: Check if the display is at the start position to make sure that the full dose has been injected.
Croatian: Provjerite je li prozorčić u početnom položaju kako biste bili sigurni da ste injicirali cijelu dozu.
English: The half-life of teriparatide is approximately 1 hour when administered subcutaneously, which reflects the time required for absorption from the injection site.
Croatian: Poluvijek teriparatida je približno 1 sat kad se primjenjuje supkutano, što odražava vrijeme potrebno za apsorpciju s mjesta injiciranja.
English: QR code to be included www.terrosapatient.com
Croatian: Uključiti QR kod www.terrosapatient.com
English: • Do not use your Terrosa Pen if it is damaged or if you have any doubts about its correct functioning.
Croatian: • Nemojte upotrijebiti brizgalicu Terrosa Pen ako je oštećena ili ako imate bilo kakve sumnje u njezin ispravan rad.
English: E: Attach the cartridge holder to the housing by turning it 90 degrees, until it stops.
Croatian: E: Pričvrstite držač uloška na kućište tako da ga zakrenete za 90 stupnjeva, dok se ne zaustavi.
English: If you have any questions concerning the use of the Terrosa Pen, contact our customer service at any time.
Croatian: Ako imate pitanja o uporabi brizgalice Terrosa Pen, možete se u bilo kojem trenutku obratiti našoj službi za korisnike.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Croatian: 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC:
English: Set the dose and complete the injection as described in section “2.
Croatian: Namjestite dozu i injicirajte lijek kako je opisano u dijelu '2.
English: If you have discomfort around the area of the injection such as redness of the skin, pain, swelling, itching, bruising or minor bleeding (which can occur in up to 1 in 10 people), this should clear up in a few days or weeks.
Croatian: Ako imate neugodu oko mjesta injiciranja, poput crvenila kože, boli, oticanja, svrbeža, nastanka modrica ili blagog krvarenja (može se javiti u do 1 na 10 osoba), te bi se nuspojave trebale povući za nekoliko dana ili tjedana.
English: • Select an appropriate injection site and prepare your skin as recommended by your doctor.
Croatian: • Odaberite odgovarajuće mjesto za injiciranje i pripremite kožu prema uputama liječnika.
English: Some patients have had severe back cramps or pain which led to admission into hospital.
Croatian: Neki su bolesnici imali jake grčeve ili bolove u leđima, što je dovelo do prijema u bolnicu.
English: Needle is broken/curved/kinked.
Croatian: Igla je slomljena/savijena/zakrivljena.
English: - Wash your hands before handling the cartridge or pen.
Croatian: - Operite ruke prije rukovanja uloškom ili brizgalicom.
English: Note: There is no need to change the needle when using directly after the pen preparation.
Croatian: Napomena: Iglu ne morate mijenjati ako brizgalicu koristite odmah nakon pripreme.
English: The pivotal study included 1,637 postmenopausal women (mean age 69.5 years).
Croatian: U pivotalno je ispitivanje uključeno 1637 žena u postmenopauzi (prosječna dob 69,5 godina).
English: This is not necessary when the rod is already in the starting position, such as at the very first use.
Croatian: Ovaj korak nije potreban ako je potisnik već u početnom položaju, kao što je to slučaj kod prve primjene.
English: Fracture incidence in postmenopausal women Placebo (N = 544) (%)
Croatian: ncidencija prijeloma u žena u postmenopauzi Placebo (N = 544) (%)
English: These may be signs there is too much calcium in your blood.
Croatian: To mogu biti znakovi prekomjerne količine kalcija u krvi.
English: What you need to know before you use Terrosa
Croatian: Što morate znati prije nego počnete primjenjivati lijek Terrosa
English: This is important, because some medicines (e.g. digoxin/digitalis, a medicine used to treat heart disease) may interact with teriparatide.
Croatian: To je važno jer neki lijekovi mogu imati međudjelovanje s teriparatidom (npr. digoksin/digitalis, lijek za liječenje srčanih bolesti).
English: Do not use the pen needle if the packaging is damaged or not opened by yourself.
Croatian: Nemojte upotrijebiti iglu ako je pakiranje oštećeno ili ako ga niste Vi otvorili.
English: Display does not return to start position after injection.
Croatian: Prozorčić se nije vratio u početni položaj nakon injekcije.
English: In a study of 15 healthy subjects administered digoxin daily to steady state, a single teriparatide dose did not alter the cardiac effect of digoxin.
Croatian: U ispitivanju provedenom s 15 zdravih ispitanika koji su svakodnevno primali digoksin do postizanja stanja dinamičke ravnoteže, jednokratna doza teriparatida nije promijenila učinke digoksina na srce.
English: Teriparatide (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone.
Croatian: Teriparatid (rhPTH(1-34)) je aktivni fragment (1-34) endogenog humanog paratiroidnog hormona.
English: Terrosa is a biosimilar medicinal product.
Croatian: Terrosa je biosličan lijek.
English: Immediately consult the doctor if a broken needle gets stuck in the skin.
Croatian: Odmah se obratite liječniku ako Vam se slomljena igla zaglavi u koži.
English: Brunnmattstrasse 6
Croatian: Ypsomed AG Brunnmattstrasse 6
English: • nerve pain in the leg
Croatian: • bol živaca u nozi
English: Chemical in-use stability has been demonstrated for 28 days at 2 - 8 °C.
Croatian: Dokazana je kemijska stabilnost lijeka u primjeni tijekom 28 dana na temperaturi od 2°C - 8°C.
English: Needles and used cartridges must be disposed of separately and safely.
Croatian: Igle i iskorišteni ulošci moraju se zbrinuti zasebno i na siguran način.
English: However, the hyperuricaemia did not result in an increase in gout, arthralgia, or urolithiasis.
Croatian: Ipak, hiperuricemija nije rezultirala povećanom pojavom gihta, artralgije ili urolitijaze.
English: Make sure that there are at least 28 days remaining before its expiry date.
Croatian: Pazite da je ostalo najmanje 28 dana prije isteka roka valjanosti.
English: Teriparatide should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
Croatian: Teriparatid treba primjenjivati uz oprez u bolesnika s aktivnom ili nedavnom urolitijazom jer može dovesti do pogoršanja tog stanja.
English: • if you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget's disease of bone (disease with abnormal bone changes).
Croatian: ako imate nerazjašnjena povišenja vrijednosti alkalne fosfataze u krvi, što znači da možda bolujete od Pagetove bolesti kostiju (bolest kod koje dolazi do abnormalnih promjena na kostima).
English: - Unexplained elevations of alkaline phosphatase.
Croatian: - Nerazjašnjena povišenja vrijednosti alkalne fosfataze.
English: Broken needles can get stuck in the skin.
Croatian: Slomljena igla može se zaglaviti u koži.
English: Paediatric population and young adults with open epiphyses The safety and efficacy of teriparatide in children and adolescents less than 18 years have not been established.
Croatian: Pedijatrijska populacija i mlađi odrasli s otvorenim epifizama Sigurnost i djelotvornost teriparatida u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: What Terrosa contains - The active substance is teriparatide.
Croatian: Što Terrosa sadrži - Djelatna tvar je teriparatid.
English: The embryotoxicity observed in rabbits may be related to their much greater sensitivity to the effects of PTH on blood ionised calcium compared with rodents.
Croatian: Zabilježena embriotoksičnost u kunića možda je povezana s njihovom značajno većom osjetljivošću na djelovanje PTH-a na ionizirani kalcij u krvi u usporedbi s glodavcima.
English: Change the needle and repeat the priming as described in pen preparation sections “F” and “G”.
Croatian: Zamijenite iglu i ponovite postupak provjere protoka kako je opisano u dijelovima o pripremi brizgalice 'F' i 'G'.