FrancophonIA/ELRC3.0 huggingface dataset:
English: It works by attaching to A2A adenosine receptors in the walls of the blood vessels in the heart, causing the blood vessels to widen and increasing blood flow into the heart muscle.
Croatian: Djeluje vezivanjem na adezonske receptore A2A u stjenci krvne žile u srcu, uzrokujući širenje krvnih žila i povećavajući protok krvi u srčani mišić.
English: What is the risk associated with Rapiscan?
Croatian: Koji su rizici povezani s lijekom Rapiscan?
English: Rapiscan is a solution for injection that contains the active substance regadenoson.
Croatian: Rapiscan je otopina za injekciju koja sadrži djelatnu tvar regadenoson.
English: The most common side effects with Rapiscan (seen in more than 1 patient in 10) are headache, dizziness, ST segment changes (an abnormal reading on the electrocardiogram or ECG), flushing (reddening of the skin), dyspnoea (difficulty breathing), gastrointestinal (stomach and gut) discomfort and chest pain.
Croatian: Najčešće nuspojave lijeka Rapiscan (mogu se javiti u više od 1 na 10 osoba) su glavobolja, omaglica, promjene u ST segmentu (abnormalno očitavanje elektrokardiograma ili EKG-a), crvenilo (crvenilo kože), dispneja (otežano disanje), gastrointestinalna (trbuh i crijeva) nelagoda i bol u prsima.
English: It is used in a type of heart scan called ‘radionuclide myocardial perfusion imaging' to see the blood flow in the heart muscle.
Croatian: Koristi se kod vrste snimanja srca pod nazivom "slikovna dijagnostika perfuzije miokarda pomoću radionuklida" kako bi se vidio protok krvi u srčanom mišiću
English: What is Rapiscan?
Croatian: Što je Rapiscan?
English: Before this type of scan, the patient's heart is usually put under stress by exercise such as walking or running on a treadmill to help dilate (widen) the blood vessels in the heart and increase the blood flow to the heart muscle.
Croatian: Prije ove vrste snimanja, srce bolesnika se najčešće se izlaže stresu tjelovježbom, poput hodanja ili trčanja na traci kako bi se pomogla dilatacija (širenje) krvnih žila u srcu i povećao protok krvi u srčanom mišiću.
English: For further information on the use of Rapiscan, see the summary of product characteristics (also part of the EPAR).
Croatian: Za dodatne informacije o korištenju lijeka Rapiscan pogledajte sažetak opisa svojstava lijeka (također dio EPAR-a).
English: What benefit has Rapiscan shown during the studies?
Croatian: Koje su koristi lijeka Rapiscan dokazane u ispitivanjima?
English: How is Rapiscan used?
Croatian: Kako se Rapiscan koristi?
English: What is Rapiscan used for?
Croatian: Za što se Rapiscan koristi?
English: For the full list of restrictions, see the package leaflet.
Croatian: Potpuni popis ograničenja potražite u uputi o lijeku
English: For the full list of all side effects reported with Rapiscan, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Rapiscan potražite u uputi o lijeku.
English: How has Rapiscan been studied?
Croatian: Kako je Rapiscan ispitivan?
English: The results of scans using Rapiscan and adenosine were comparable.
Croatian: Dobiveni su slični rezultati oslikavanja primjenom lijeka Rapiscan i adenozina.
English: How does Rapiscan work?
Croatian: Kako djeluje Rapiscan?
English: § Not statistically significant
Croatian: § Nije statistički značajno
English: The duration of protection beyond 4 years is currently under investigation.
Croatian: Trajanje zaštite nakon 4 godine trenutno se ispituje.
English: This protein is not infectious.
Croatian: Taj protein nije zarazan.
English: It usually occurs in one part of the body and can last for several weeks.
Croatian: Obično se javlja na jednom dijelu tijela, a može potrajati nekoliko tjedana.
English: Speak to your doctor for more information.
Croatian: Razgovarajte sa svojim liječnikom za dodatne informacije.
English: The clinical relevance of this data is not known.
Croatian: Klinički značaj ovih podataka nije poznat.
English: Most of these reactions were not long-lasting (median duration of 2 to 3 days).
Croatian: Većina tih reakcija nije bila dugotrajna (medijan trajanja: 2 - 3 dana).
English: A minor infection such as a cold should not be a problem, but talk to your doctor first;
Croatian: Manja infekcija poput prehlade ne bi smjela biti problem, ali najprije razgovarajte sa svojim liječnikom.
English: Therefore tell the doctor or nurse if you fainted with a previous injection.
Croatian: Stoga recite liječniku ili medicinskoj sestri ako ste onesvijestili kod prethodne primjene injekcije.
English: From a microbiological point of view, the vaccine should be used immediately.
Croatian: S mikrobiološkog stanovišta, cjepivo se mora odmah primijeniti.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Croatian: Dokazana je kemijska i fizikalna stabilnost rekonstituiranog cjepiva tijekom 24 sata na temperaturi od 30°C.
English: Shake gently until the powder is completely dissolved.
Croatian: Nježno tresite dok se prašak potpuno ne otopi.
English: In these cases, the vaccination may have to be postponed until you have recovered.
Croatian: U tom će se slučaju cijepljenje možda morati odgoditi dok se ne oporavite.
English: If not used within 6 hours it should be discarded.
Croatian: Ako se cjepivo ne upotrijebi unutar 6 sati, treba ga baciti.
English: • You will receive 2 injections with an interval of 2 months.
Croatian: • Primit ćete 2 injekcije u razmaku od 2 mjeseca.
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription, or have recently received any other vaccine.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući one koje ste nabavili bez recepta, ili ako ste nedavno primili neko drugo cjepivo.
English: Reactions reported as severe lasted 1 to 2 days.
Croatian: Reakcije koje su prijavljene kao teške trajale su 1 - 2 dana.
English: Maladministration via the subcutaneous route may lead to an increase in transient local reactions.
Croatian: Pogrešna primjena supkutanim putem može dovesti do povećanja prolaznih lokalnih reakcija.
English: Make sure you finish the complete vaccination course.
Croatian: Pobrinite se da dovršite cijeli ciklus cijepljenja.
English: The first injection can be given from the age of 50 years onwards.
Croatian: Prvu injekciju možete primiti od navršenih 50 godina nadalje.
English: CI Confidence interval
Croatian: CI interval pouzdanosti
English: Immunocompromised subjects
Croatian: Imunokompromitirani ispitanici
English: Month 3*
Croatian: 3. mjesec*
English: Efficacy has not been assessed for the 0, 6-month schedule.
Croatian: Nije se ocjenjivala djelotvornost cijepljenja prema rasporedu primjene u 0. i 6. mjesecu.
English: However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Croatian: Međutim, prisutnost manje infekcije, kao što je prehlada, ne bi trebala biti razlog za odgodu cijepljenja.
English: • Sometimes, after many years, if your immune system (the body's natural defences) becomes weaker (due to age, an illness or a medicine you are taking), the virus can cause shingles.
Croatian: • Ponekad, nakon mnogo godina, ako Vam imunosni sustav (prirodni obrambeni sustav tijela) oslabi (zbog dobi, bolesti ili lijeka koji uzimate), taj virus može izazvati herpes zoster.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primite ovo cjepivo.
English: Month 38**
Croatian: 38. mjesec**
English: Systemic immunosuppressive medications and immunodeficiency
Croatian: Sistemski imunosupresivni lijekovi i imunodeficijencija
English: Suspension
Croatian: Suspenzija
English: For adjuvant see also section 2.
Croatian: Za adjuvans vidjeti i dio 2.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.5 ml) contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Nakon rekonstitucije jedna doza (0,5 ml) sadrži:
English: • you are allergic (hypersensitive) to the active substances or any of the other ingredients of this vaccine (listed in section 6).
Croatian: • ste alergični (preosjetljivi) na djelatne tvari ili neki drugi sastojak ovog cjepiva (naveden u dijelu 6.).
English: As a consequence of the high vaccine efficacy against HZ, a low number of breakthrough cases were accrued, and it was therefore not possible to draw firm conclusions on these study objectives.
Croatian: Zahvaljujući visokoj djelotvornosti cjepiva protiv HZ-a, zabilježen je malen broj probojnih slučajeva pa nije bilo moguće donijeti čvrste zaključke o tim ciljevima ispitivanja.
English: This helps your immune system (the body's natural defences) stay prepared to fight the virus and protect you against shingles and its complications.
Croatian: Na taj način pomaže Vašem imunosnom sustavu (prirodnom obrambenom sustavu tijela) da bude spreman za borbu protiv tog virusa i da Vas zaštiti od herpes zostera i njegovih komplikacija.
English: The vaccines should be administered at different injection sites.
Croatian: Cjepiva treba injicirati na različitim mjestima.
English: The vaccine is for prophylactic use only and is not intended for treatment of established clinical disease.
Croatian: Ovo je cjepivo isključivo za profilaktičku primjenu i nije namijenjeno za liječenje potvrđene kliničke bolesti.
English: Vaccine efficacy [95% CI]
Croatian: Djelotvornost cjepiva (%) [95% CI]
English: The adjuvant (AS01B) is used to improve the body's response to the vaccine.
Croatian: Adjuvans (AS01B) se koristi da bi se poboljšao odgovor tijela na cjepivo.
English: Most of these side effects are mild to moderate in intensity and are not long-lasting.
Croatian: Većina tih nuspojava je blage do umjerene težine i ne traju dugo.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you receive Shingrix.
Croatian: Ako se bilo što od navedenoga odnosi na Vas (ili niste sigurni), razgovarajte sa svojim liječnikom ili ljekarnikom prije nego primite Shingrix.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at 2°C to 8°C.
Croatian: Ako se ne primijeni odmah, trajanje i uvjeti čuvanja rekonstituiranog cjepiva prije uporabe odgovornost su korisnika i čuvanje ne bi smjelo biti dulje od 6 sati na temperaturi od 2°C do 8°C.
English: Non-clinical data show that AS01B induces a local and transient activation of the innate immune system through specific molecular pathways.
Croatian: Neklinički podaci pokazuju da AS01B potiče lokalnu i prolaznu aktivaciju prirođenog imunosnog sustava specifičnim molekularnim putovima.
English: • skin infections, weakness, muscle paralysis and loss of hearing or vision - these are less common.
Croatian: • kožne infekcije, slabost, paraliza mišića i gubitak sluha ili vida - ove su nuspojave manje česte
English: Adverse reactions reported during post-marketing surveillance are also tabulated below.
Croatian: Nuspojave prijavljene tijekom postmarketinškog praćenja nalaze se u tablici ispod.
English: Age group (years)
Croatian: Dobna skupina (godine)
English: Healthcare professionals therefore need to weigh the benefits and risks of HZ vaccination on an individual basis.
Croatian: Stoga zdravstveni radnici trebaju odvagnuti koristi i rizike cijepljenja protiv HZ-a kod svake osobe pojedinačno.
English: The safety and efficacy of Shingrix in children and adolescents have not been established.
Croatian: Sigurnost i djelotvornost cjepiva Shingrix u djece i adolescenata nisu ustanovljene.
English: Contents of the pack and other information What Shingrix contains
Croatian: Sadržaj pakiranja i druge informacije Što Shingrix sadrži
English: The administration of Shingrix to immunocompromised subjects should be based on careful consideration of potential benefits and risks.
Croatian: Primjena cjepiva Shingrix imunokompromitiranim osobama treba se temeljiti na pažljivoj ocjeni mogućih koristi i rizika.
English: However, do not drive or use machines if you are feeling unwell.
Croatian: Međutim, ako se ne osjećate dobro, nemojte upravljati vozilima ni raditi sa strojevima.
English: • Risk management plan (RMP)
Croatian: PRIMJENU LIJEKA • Plan upravljanja rizikom (RMP)
English: For intramuscular injection only, preferably in the deltoid muscle.
Croatian: Način primjene Samo za intramuskularnu injekciju, po mogućnosti u deltoidni mišić.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2018
Croatian: Datum prvog odobrenja: 21. ožujka 2018.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of acute and repeated dose toxicity, local tolerance, cardiovascular/respiratory safety pharmacology and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja akutne toksičnosti i toksičnosti ponovljenih doza, lokalne podnošljivosti, sigurnosti za kardiovaskularni/dišni sustav te reproduktivne i razvojne toksičnosti.
English: As with all vaccines, Shingrix may not fully protect all people who are vaccinated.
Croatian: Kao i sva druga cjepiva, Shingrix možda neće potpuno zaštititi sve osobe koje se cijepe.
English: Change the needle so that you are using a new needle to administer the vaccine.
Croatian: Promijenite iglu tako da za primjenu cjepiva upotrijebite novu iglu.
English: Efficacy against HZ-related complications other than PHN
Croatian: Djelotvornost protiv komplikacija povezanih s HZ-om osim PHN-a
English: • Shingrix is given as an injection into a muscle (usually in the upper arm).
Croatian: • Shingrix se daje kao injekcija u mišić (obično nadlakticu).
English: • You will be informed when you should come back for the second dose of Shingrix.
Croatian: • Liječnik će Vam reći kada trebate doći da biste primili drugu dozu cjepiva Shingrix.
English: As a precautionary measure, it is preferable to avoid the use of Shingrix during pregnancy.
Croatian: Kao mjera opreza, poželjno je izbjegavati primjenu cjepiva Shingrix tijekom trudnoće.
English: Laboratory confirmation of HZ cases was not part of the study procedures.
Croatian: Laboratorijska potvrda slučajeva HZ-a nije se provodila u sklopu ispitivanja.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Powder and suspension to be reconstituted before administration
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Prašak i suspenziju potrebno je rekonstituirati prije primjene
English: One pack of Shingrix consists of:
Croatian: Jedno pakiranje cjepiva Shingrix sastoji se od:
English: No cases of visceral disease or stroke were reported during these studies.
Croatian: Tijekom tih ispitivanja nije prijavljen nijedan slučaj visceralne bolesti ni moždanog udara.
English: • After you have had chickenpox, the virus that caused it stays in your body in nerve cells.
Croatian: • Nakon što prebolite vodene kozice, virus koji ih je uzrokovao ostaje u živčanim stanicama u Vašem tijelu.
English: plant extract Quillaja saponaria Molina, fraction 21 (QS-21)
Croatian: ekstrakt biljke Quillaja saponaria Molina, frakcija 21 (QS-21)
English: Shingrix may have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination.
Croatian: Shingrix može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima tijekom 2 - 3 dana nakon cijepljenja.
English: The adjuvant effect of AS01B is the result of interactions between MPL and QS-21 formulated in liposomes.
Croatian: Adjuvantni učinak AS01B rezultat je interakcija između MPL-a i QS-21 u liposomskoj formulaciji.
English: • The powder is white.
Croatian: • Prašak je bijele boje.
English: Shingrix is given to adults 50 years and above.
Croatian: Shingrix se daje odraslim osobama u dobi od 50 i više godina.
English: You should not receive Shingrix if any of the above apply to you.
Croatian: Ne smijete primiti Shingrix ako se nešto od navedenog odnosi na Vas.
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website
Croatian: Ova uputa o lijeku dostupna je na svim jezicima EU-a/EGP-a na internetskim stranicama Europske agencije za lijekove
English: The powder and the suspension must be reconstituted prior to administration.
Croatian: Prašak i suspenzija moraju se rekonstituirati prije primjene.
English: If you are not sure, talk to your doctor or pharmacist.
Croatian: Ako niste sigurni, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: The powder and suspension should be inspected visually for any foreign particulate matter and/or variation of appearance.
Croatian: Prašak i suspenziju treba vizualno pregledati kako bi se isključila prisutnost stranih čestica i/ili promjena izgleda.
English: The primary vaccination schedule consists of two doses of 0.5 ml each: an initial dose followed by a second dose 2 months later.
Croatian: Raspored primarnog cijepljenja sastoji se od dvije doze od po 0,5 ml: druga doza primjenjuje se 2 mjeseca nakon prve.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Croatian: Znakovi alergijske reakcije mogu uključivati kožni osip koji svrbi, nedostatak zraka te oticanje lica ili jezika.
English: The benefit of Shingrix in the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.
Croatian: Korist cjepiva Shingrix u prevenciji PHN-a može se pripisati učinku cjepiva na prevenciju HZ-a.
English: The use of Shingrix should be in accordance with official recommendations.
Croatian: Shingrix treba primijeniti u skladu sa službenim preporukama.
English: Post-hoc analysis of efficacy against confirmed HZ undertaken in patients with common conditions (chronic kidney disease, chronic obstructive pulmonary disease, coronary artery disease, depression or diabetes mellitus), indicates that the vaccine efficacy is aligned with the overall HZ efficacy.
Croatian: Post-hoc analiza podataka o djelotvornosti protiv potvrđenog HZ-a provedena u bolesnika s čestim stanjima (kronična bolest bubrega, kronična opstruktivna plućna bolest, bolest koronarnih arterija, depresija ili šećerna bolest) ukazuje na to da je djelotvornost cjepiva u skladu sa sveukupnom djelotvornošću protiv HZ-a.
English: Immunogenicity in subjects receiving 2 doses of Shingrix 6 months apart
Croatian: Imunogenost u ispitanika koji su primili 2 doze cjepiva Shingrix u razmaku od 6 mjeseci
English: • Do not use this medicine after the expiry date which is stated on the label and carton.
Croatian: • Ovo se cjepivo ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake 'EXP'.
English: Safety and immunogenicity data on a limited number of immunocompromised subjects with human immunodeficiency virus (HIV) or haematopoietic stem cell transplant (HCT) are available (see section 5.1).
Croatian: Dostupni su podaci o sigurnosti i imunogenosti u ograničenog broja imunokompromitiranih osoba zaraženih virusom humane imunodeficijencije (engl. human immunodeficiency virus, HIV) ili podvrgnutih presađivanju hematopoetskih matičnih stanica (engl. haematopoietic stem cell transplant, HSCT) (vidjeti dio 5.1).
English: There are no safety, immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another HZ vaccine.
Croatian: Nema podataka o sigurnosti, imunogenosti ni djelotvornosti koji bi poduprli zamjenu doze cjepiva Shingrix dozom nekog drugog cjepiva protiv HZ-a.
English: Pharmacotherapeutic group: Varicella zoster vaccines, ATC code: J07BK03.
Croatian: Farmakoterapijska skupina: Cjepiva protiv varičela i herpes zostera, ATK oznaka: J07BK03.
English: • long-lasting nerve pain - called post-herpetic neuralgia or PHN.
Croatian: • dugotrajna živčana bol uzrokovana oštećenjem živaca, koja se naziva postherpetička neuralgija ili PHN.
English: The glycoprotein E is a protein present in the Varicella Zoster Virus.
Croatian: Glikoprotein E je protein prisutan u virusu varicella zoster.
English: Subcutaneous administration is not recommended.
Croatian: Ne preporučuje se supkutana primjena.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ni neizravne štetne učinke na graviditet, embrionalni/fetalni razvoj, okot ni postnatalni razvoj (vidjeti dio 5.3).
English: Shingrix can be given at the same time as other vaccines.
Croatian: Shingrix se može primijeniti istodobno s drugim cjepivima.
English: Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 50 years of age or older (see section 5.1).
Croatian: Shingrix je indiciran za prevenciju herpes zostera (HZ) i postherpetičke neuralgije (PHN) u odraslih osoba u dobi od 50 ili više godina (vidjeti dio 5.1).
English: * Over a median follow-up period of 3.1 years ** Over a median follow-up period of 4.0 years
Croatian: * Tijekom razdoblja praćenja čiji je medijan iznosio 3,1 godinu ** Tijekom razdoblja praćenja čiji je medijan iznosio 4,0 godina
English: Shingrix reminds your body about the virus that causes shingles.
Croatian: Shingrix podsjeća Vaše tijelo na virus koji uzrokuje herpes zoster.
English: The burden-of-illness (BOI) score incorporates the incidence of HZ with the severity and duration of acute and chronic HZ-related pain over a 6 month period following rash onset.
Croatian: Burden of Illness, BOI) objedinjuje incidenciju HZ-a te težinu i trajanje akutne i kronične boli povezane s HZ-om tijekom razdoblja od 6 mjeseci nakon nastupa osipa.
English: Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these subjects.
Croatian: Shingrix treba primijeniti uz oprez osobama s trombocitopenijom ili bilo kojim poremećajem koagulacije jer nakon intramuskularne primjene u tih osoba može doći do krvarenja.
English: Two phase I/II clinical studies, Zoster-001 and Zoster-015, were conducted in subjects with autologous hematopoietic stem cell transplant or HIV infection.
Croatian: Provedena su dva klinička ispitivanja faze I/II (Zoster-001 i Zoster-015) u ispitanika podvrgnutih presađivanju autolognih hematopoetskih matičnih stanica ili ispitanika s HIV infekcijom.
English: If flexibility in the vaccination schedule is necessary, the second dose can be administered between 2 and 6 months after the first dose (see section 5.1).
Croatian: Ako je potrebna fleksibilnost u rasporedu primjene, druga se doza može primijeniti između 2 mjeseca i 6 mjeseci nakon prve doze (vidjeti dio 5.1).
English: Fatigue and malaise may occur following administration (see section 4.8).
Croatian: Nakon primjene mogu se javiti umor i malaksalost (vidjeti dio 4.8).
English: Before administration:
Croatian: Prije primjene:
English: What Shingrix looks like and contents of the pack
Croatian: Kako Shingrix izgleda i sadržaj pakiranja
English: The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance.
Croatian: Rekonstituirano cjepivo treba vizualno pregledati kako bi se isključila prisutnost stranih čestica i/ili promjena izgleda.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Croatian: Nakon ili čak prije bilo kojeg cijepljenja može doći do sinkope (nesvjestice) kao psihogenog odgovora na injekciju iglom.
English: 10 vials: powder (antigen) 10 vials: suspension (adjuvant)
Croatian: 10 bočica: prašak (antigen) 10 bočica: suspenzija (adjuvans)