FrancophonIA/ELRC3.0 huggingface dataset:
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 24 hours refrigerated (2 °C − 8 °C), unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Razrijeđeni lijek ne bi se smio čuvati dulje od 24 sata u hladnjaku (2°C - 8°C), osim u slučajevima kada je razrjeđivanje provedeno u kontroliranim i validiranim aseptičnim uvjetima.
English: In most cases you will not have any symptoms but tell your doctor or nurse straight away if you get: • yellowing of your skin and of the whites of your eyes (jaundice).
Croatian: U većini slučajeva nema nikakvih simptoma, ali odmah se obratite svom liječniku ili medicinskoj sestri ako se pojavi:
English: IRRs, PN, fatigue, and dizziness may occur during treatment with Polivy (see sections 4.4 and 4.8).
Croatian: Tijekom liječenja lijekom Polivy mogu se javiti reakcije povezane s infuzijom, periferna neuropatija, umor i omaglica (vidjeti dijelove 4.4 i 4.8).
English: After reconstitution each millilitre (mL) contains 20 mg polatuzumab vedotin.
Croatian: Nakon pripreme za primjenu jedan mililitar (ml) sadrži 20 mg polatuzumab vedotina.
English: Polivy and any concomitant chemotherapy should be discontinued in patients who develop serious infections.
Croatian: U bolesnika kod kojih se razviju ozbiljne infekcije potrebno je prekinuti liječenje lijekom Polivy i bilo kojom istodobnom kemoterapijom.
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 24 hours refrigerated (2 °C − 8 °C), unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Rekonstituirani lijek ne bi se smio čuvati dulje od 24 sata u hladnjaku (2°C - 8°C), osim u slučajevima kada je rekonstitucija provedena u kontroliranim i validiranim aseptičnim uvjetima.
English: Defined as all adverse reactions reported as related to study treatment within 24 hours after treatment infusion Uncommon, rare and very rare ADRs: none
Croatian: Nuspojave povezane sa smrtnim ishodom b Definiraju se kao sve nuspojave prijavljene kao povezane s ispitivanim liječenjem unutar 24 sata nakon infuzije terapije
English: All except one patient in the pola+BR arm of the randomized Phase II were naïve to bendamustine treatment.
Croatian: Od svih bolesnika u randomiziranom ispitivanju faze II bendamustinom je prethodno bio liječen samo jedan ispitanik u skupini koja je primala polatuzumab plus BR.
English: Very common neuropathy peripheral, peripheral sensory neuropathy, dizziness Common gait disturbance, paraesthesia, hypoaesthesia
Croatian: Poremećaji metabolizma i prehrane vrlo često hipokalijemija, hipokalcijemija, hipoalbuminemija, smanjen tek Poremećaji živčanog sustava vrlo često periferna neuropatija, periferna senzorna neuropatija, omaglica često poremećaj hoda, parestezija, hipoestezija
English: The pharmacokinetics (PK) of rituximab and bendamustine are not affected by co-administration with polatuzumab vedotin.
Croatian: Istodobna primjena polatuzumab vedotina ne utječe na farmakokinetiku rituksimaba i bendamustina.
English: Discontinue Polivy.
Croatian: Obustaviti liječenje lijekom Polivy.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Polivy 140 mg powder for concentrate polatuzumab vedotin
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Polivy 140 mg prašak za koncentrat polatuzumab vedotin
English: Polysorbate 20 (E 432)
Croatian: 6.1 Popis pomoćnih tvari sukcinatna kiselina natrijev hidroksid (za podešavanje pH) saharoza polisorbat 20 (E 432)
English: Women of childbearing potential should be advised to use effective contraception during treatment with polatuzumab vedotin and for at least 9 months after the last dose.
Croatian: Ženama reproduktivne dobi treba savjetovati da koriste učinkovitu kontracepciju tijekom liječenja polatuzumab vedotinom i još najmanje 9 mjeseci nakon posljednje doze.
English: Inspect the reconstituted solution for discoloration and particulate matter.
Croatian: Pregledajte rekonstituiranu otopinu kako biste utvrdili je li promijenila boju i sadrži li čestice.
English: Rituximab was administered at 375 mg/m2 on Day 1 of Cycles 1-6.
Croatian: Rituksimab se primjenjivao u dozi od 375 mg/m
English: Male patients with female partners of childbearing potential should be advised to use effective contraception during treatment with polatuzumab vedotin and for at least 6 months after the last dose.
Croatian: Bolesnicima čije su partnerice reproduktivne dobi treba savjetovati da koriste učinkovitu kontracepciju tijekom liječenja polatuzumab vedotinom i još najmanje 6 mjeseci nakon posljednje doze.
English: Grade 3-4 Neutropenia
Croatian: Reakcija povezana s infuzijom 4. stupnja
English: PN reported with treatment with Polivy is predominantly sensory PN.
Croatian: Kod liječenja lijekom Polivy prvenstveno se prijavljuje senzorna periferna neuropatija.
English: Grade 4 IRR
Croatian: 4.8 Nuspojave
English: • look pale
Croatian: • ako izgledate blijedo
English: OTHER Do not shake Cytotoxic
Croatian: Ne tresti Citotoksično
English: This includes any possible side effects not listed in this leaflet you can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: Polatuzumab vedotin did not prolong the mean QTc interval to any clinically relevant extent based on ECG data from two open-label studies in patients with previously treated B-cell malignancies at the recommended dosage.
Croatian: Prema podacima prikupljenima EKG-om u dvama otvorenim ispitivanjima provedenima u bolesnika s prethodno liječenim zloćudnim B-staničnim bolestima, polatuzumab vedotin primijenjen u preporučenoj dozi nije produljio srednju vrijednost QTc intervala u klinički značajnoj mjeri.
English: Up to 24 hours refrigerated (2 °C − 8 °C) or up to 4 hours at room temperature (9 °C − 25 °C) Sodium chloride 4.5 mg/mL (0.45%) Up to 72 hours refrigerated (2 °C − 8 °C) or up to 8 hours at room temperature (9 °C − 25 °C)
Croatian: Do 24 sata u hladnjaku (2°C - 8°C) ili do 4 sata na sobnoj temperaturi (9°C - 25°C)
English: Polivy is a cancer medicine that contains the active substance polatuzumab vedotin.
Croatian: Polivy je lijek za liječenje raka koji sadrži djelatnu tvar polatuzumab vedotin.
English: The infusion rate of Polivy should be slowed or interrupted if the patient develops an infusion-related reaction.
Croatian: Ako se u bolesnika javi reakcija povezana s infuzijom, treba smanjiti brzinu infuzije lijeka Polivy ili privremeno prekinuti njezinu primjenu.
English: No Grade 3-5 PN events were reported in either the Polivy plus BR arm or BR arm. 2.2% of patients discontinued Polivy treatment due to PN and 4.4% of patients had Polivy dose reduction due to PN. No patients in the BR arm discontinued treatment or had dose reductions due to PN.
Croatian: Zbog periferne je neuropatije 2,2% bolesnika prekinulo liječenje lijekom Polivy, dok je u njih 4,4% smanjena doza lijeka Polivy.
English: Roche farmacevtska družba d.o.o.
Croatian: Proizvođač Roche Pharma AG
English: • fever or chills
Croatian: • proljev ili zatvor
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 140 mg of polatuzumab vedotin.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 140 mg polatuzumab vedotina.
English: Immunogenicity
Croatian: Hepatotoksičnost
English: No dedicated mutagenicity studies have been performed with polatuzumab vedotin.
Croatian: Nisu provedena posebna ispitivanja mutagenosti polatuzumab vedotina.
English: Polivy contains a cytotoxic component which is covalently attached to the monoclonal antibody.
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Polivy sadrži citotoksičnu sastavnicu koja je kovalentno vezana za monoklonsko protutijelo.
English: Q3 2020
Croatian: 3. tromjesečje
English: MARKETING AUTHORISATION HOLDER
Croatian: • Uvjetno odobrenje za stavljanje lijeka u promet
English: • fevers and chills
Croatian: • osip/koprivnjača
English: In the Polivy plus BR arm, Grade 1 PN and Grade 2 PN were reported in 26.7% and 13.3% of patients, respectively.
Croatian: Periferna neuropatija 1. stupnja prijavljena je u 26,7%, a periferna neuropatija 2. stupnja u 13,3% bolesnika koji su primali Polivy plus BR.
English: • dizziness
Croatian: • utrnulost
English: Polivy must not be administered as intravenous push or bolus.
Croatian: Polivy se ne smije primijeniti brzom ni bolusnom intravenskom injekcijom.
English: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Croatian: Emil-Barell-Strasse 1
English: • vomitting
Croatian: • mučnina
English: If possible, the first dose should be given before this season starts.
Croatian: Ako je moguće, prva se doza mora primijeniti prije početka sezone.
English: This helps to prevent RSV infection.
Croatian: Ovo pomaže pri sprječavanju infekcije RSV-om.
English: In children born with heart disease, there was a reduction of 45%.
Croatian: U djece rođene s bolešću srca, ostvareno je smanjenje od 45%.
English: • children who are less than two years of age and were born with a serious heart disease.
Croatian: • djece mlađe od dvije godine i rođene s ozbiljnom bolesti srca.
English: The full EPAR for Synagis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Synagis nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Patients generally receive a total of five monthly injections into the thigh muscle.
Croatian: Bolesnici načelno prime ukupno pet mjesečnih injekcija u bedreni mišić.
English: Synagis is given once a month when there is a risk of RSV infection in the community: in the northern hemisphere, this is from November to April.
Croatian: Synagis se primjenjuje jednom mjesečno kada postoji rizik od infekcije RSV-om u zajednici: na sjevernoj hemisferi od studenog do travnja.
English: When palivizumab is attached to this protein, the virus becomes unable to enter the body's cells, especially those in the lungs.
Croatian: Nakon što se palivizumab veže na ovaj protein, virus ne može ući u stanice tijela, pogotovo one u plućima.
English: • children who are less than six months old and were born five or more weeks prematurely (at 35
Croatian: • djece mlađe od šest mjeseci i rođene pet ili više tjedana prije termina (u 35. tjednu trudnoće ili ranije);
English: Another study was also carried out comparing Synagis with placebo in 1,287 children who were born with heart disease.
Croatian: Provedeno je još jedno ispitivanje koje je usporedilo Synagis s placebom u 1.287 djece rođene s bolesti srca.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Synagis on 13 August 1999.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Synagis vrijedi na prostoru Europske unije od 13. kolovoza 1999.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen).
Croatian: Monoklonalno protutijelo je tip protutijela (tip protein) koji je dizajniran za prepoznavanje i vezanje na specifičnu strukturu (naziva antigen).
English: The most common side effects with Synagis (seen in between 1 and 10 patients in 100) are fever and rash.
Croatian: Najčešće nuspojave od lijeka Synagis (kod oko 1 i 10 na 100 osoba) su groznica i osip.
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 Synagis.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Synagis.
English: Palivizumab has been designed to attach to a protein called ‘fusion protein A' on the surface of RSV.
Croatian: Palivizumab je dizajniran za vezanje na protein naziva „fuzijski protein A” na površini RSV-a.
English: For more information about treatment with Synagis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Synagis pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: This is a summary of the European public assessment report (EPAR) for Synagis.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Synagis.
English: Other information about Synagis
Croatian: Ostale informacije o lijeku Synagis
English: Synagis must not be used in people who are hypersensitive (allergic) to palivizumab, any of the other ingredients or other ‘humanised' monoclonal antibodies.
Croatian: Synagis se ne smije koristiti u ljudi koji su preosjetljivi (alergični) na palivizumab, bilo koju od pomoćnih tvari i druga „humanizirana” monoklonalna protutijela.
English: Synagis was more effective than placebo in reducing RSV-related hospitalisations: 5% of the children who received Synagis were admitted to hospital for RSV infection during the study, compared with 11% of those who received placebo.
Croatian: Synagis bio je djelotvorniji od placeba u smanjivanju broja hospitalizacija povezanih s RSV-om: 5% djece koja su primila lijek Synagis bilo je hospitalizirano zbog infekcije RSV-om tijekom ispitivanja, u usporedbi s 11% onih koji su zaprimili placebo, što predstavlja smanjenje od 55%.
English: • children who are less than two years of age and have had treatment for bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely) within the last six months;
Croatian: • djece mlađe od dvije godine te koja su u proteklih 6 mjeseci liječena zbog bronhopulmonalne displazije (abnormalna bolest pluća koja je česta u prijevremeno rođene djece);
English: It contains the active substance palivizumab.
Croatian: Sadrži djelatnu tvar palivizumab.
English: Synagis is a powder and solvent that are made up into a solution for injection.
Croatian: Synagis je prašak i otapalo koji se miješaju i tvore otopinu za injekciju.
English: The CHMP decided that Synagis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Synagis nadmašuju s njim povezane rizike te je preporučio davanje odobrenja za stavljanje lijeka u promet.
English: The active substance in Synagis, palivizumab, is a monoclonal antibody.
Croatian: Djelatna tvar u lijeku Synagis, palivizumab, je monoklonalno protutijelo.
English: The main study of Synagis was carried out in 1,502 high-risk children and compared Synagis with placebo (a dummy treatment) during one RSV season.
Croatian: Glavno ispitivanje lijeka Synagis provedeno je u 1.502 visokorizične djece te je lijek Synagis uspoređen s placebom (prividnim liječenjem) tijekom sezone RSV-a.
English: It is used in the following groups of children, who are at high risk for this disease:
Croatian: Primjenjuje se u djece s visokim rizikom pojave RSV bolesti:
English: What is Synagis?
Croatian: Što je Synagis?
English: Synagis is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) that would require hospitalisation.
Croatian: Synagis koristi se za suzbijanje teške bolesti donjeg dišnog sustava koja zahtijeva hospitalizaciju, a prouzrokovana je respiratornim sincicijskim virusom (RSV).
English: What is the risk associated with Synagis?
Croatian: Koji su rizici povezani s lijekom Synagis?
English: Why has Synagis been approved?
Croatian: Zašto je lijek Synagis odobren?
English: For the full list of all side effects reported with Synagis, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Synagis potražite u uputi o lijeku.
English: What benefit has Synagis shown during the studies?
Croatian: Koje su koristi lijeka Synagis dokazane u ispitivanjima?
English: What is Synagis used for?
Croatian: Za što se Synagis koristi?
English: In both studies, the main measure of effectiveness was the number of children who had to be admitted to hospital because of RSV infection.The effects of Synagis were first tested in experimental models before being studied in humans.
Croatian: U oba ispitivanja, glavna mjera djelotvornosti bio je broj djece koja su morala biti hospitalizirana zbog infekcije RSV-om.
English: How does Synagis work?
Croatian: Kako djeluje Synagis?
English: How has Synagis been studied?
Croatian: Kako je Synagis ispitivan?
English: How is Synagis used?
Croatian: Kako se Synagis koristi?
English: N=30, 6 and 34 for the 3 above groups.
Croatian: N=30, 6 i 34 za gornje 3 skupine.
English: The results are presented in Table 2.
Croatian: Rezultati su predstavljeni u Tablici 2.
English: • Safety information;
Croatian: • sigurnosne informacije;
English: However, no data are available for children under the age of 4 years.
Croatian: Međutim ne postoje dostupni podaci za djecu mlađu od 4 godine.
English: Extension Study 044
Croatian: Produžetak ispitivanja 044
English: There are 5 potential N-linked glycosylation sites, four of which are occupied.
Croatian: Postoji 5 potencijalno N-veznih mjesta glikozilacije, od kojih su 4 zauzeta.
English: Ask your pharmacist how to throwaway medicines you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: - You may be given additional medicines to treat or help prevent future reactions.
Croatian: - Možda ćete dobiti dodatne lijekove za liječenje ili sprečavanje budućih reakcija.
English: Elderly population (≥65 years)
Croatian: Starija populacija (≥65 godina)
English: Read all of this leaflet carefully before this medicine is used because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije primjene ovog lijeka jer sadrži Vama važne podatke.
English: Water for Injections
Croatian: Voda za injekcije
English: 400 Units
Croatian: 400 jedinica
English: Ask your doctor or pharmacist for advice before this medicine is used.
Croatian: Upitajte svog liječnika ili ljekarnika za savjet prije primjene ovog lijeka.
English: • Description on how to prepare and administer the infusion including safety information;
Croatian: • opis kako pripremiti i primijeniti infuziju uključujući sigurnosne informacije;
English: These medicines may include antihistamines, antipyretics, and corticosteroids.
Croatian: Ti lijekovi mogu uključivati antihistaminike, antipiretike i kortikosteroide.
English: Overall velaglucerase alfa group (N=39)
Croatian: Ukupna skupina velagluceraze alfa (N=39)
English: • Infusion diary;
Croatian: • dnevnik infuzija;
English: In some cases vomiting can be serious (reported from post-marketing experience).
Croatian: U nekim slučajevima povraćanje može biti ozbiljno (prijavljeno na temelju iskustva nakon stavljanja lijeka na tržište).
English: The effect on height was assessed in the study 044 (see section 5.1, Extension Study 044).
Croatian: Učinak na visinu procijenjen je u ispitivanju 044 (vidjeti dio 5.1, Produžetak ispitivanja 044).
English: Dose adjustments can be made on an individual basis based on achievement and maintenance of therapeutic goals.
Croatian: Doza se može individualno prilagoditi na temelju uspjeha i održavanja terapijskih ciljeva.
English: These are called infusion-related reactions and may affect more than 1 in 10 people (very common).
Croatian: To su takozvane reakcije povezane s infuzijom i mogu se javiti u više od 1 na 10 osoba (vrlo često).
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2C to 8C under protection from light.
Croatian: Dokazana kemijska i fizikalna stabilnost u primjeni iznosi 24 sata pri 2°C do 8°C, zaštićeno od svjetlosti.
English: What VPRIV is and what it is used for
Croatian: Što je VPRIV i za što se koristi
English: VPRIV should not be used in children under the age of 2 years.
Croatian: VPRIV se ne smije koristiti kod djece mlađe od 2 godine.
English: Gaucher disease may become more active in a woman during pregnancy and for a few weeks after birth.
Croatian: Gaucherova bolest može postati aktivnija kod žena tijekom trudnoće i nekoliko tjedana nakon poroda.
English: Doses higher than 60 Units/kg have not been studied.
Croatian: Doze više od 60 jedinica/kg nisu proučavane.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza i reproduktivne i razvojne toksičnosti.
English: The total volume of infusion should be delivered over a period of 60 minutes.
Croatian: Ukupni volumen infuzije treba primijeniti kroz razdoblje od 60 minuta.
English: Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required.
Croatian: Premedikacija antihistaminicima i/ili kortikosteroidima može spriječiti daljnje reakcije u slučajevima u kojima je bilo potrebno simptomatsko liječenje.
English: Home administration under the supervision of a healthcare professional may be considered only for those patients who have received at least three infusions and were tolerating their infusions well.
Croatian: Primjena kod kuće pod nadzorom zdravstvenog radnika može se razmotriti samo u onih bolesnika koji su primili najmanje tri infuzije i dobro su ih podnosili.
English: Date of first authorisation: 26 August 2010 Date of latest renewal: 19 June 2015
Croatian: Datum posljednje obnove odobrenja: 19. lipnja 2015.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Croatian: Ispitivanja na životinjama nisu uputila na direktne ili indirektne štetne učinke na trudnoću, embrionalni/fetalni razvoj, porod ili postnatalni razvoj.
English: The safety and efficacy profiles were similar between paediatric and adult patients.
Croatian: Profili sigurnosti i djelotvornosti bili su slični kod pedijatrijskih i odraslih bolesnika.
English: - if you are severely allergic to velaglucerase alfa or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste jako alergični na velaglucerazu alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: *Liver and spleen volume is normalized as a percentage of body weight.
Croatian: *Volumen jetre i slezene normalizira se kao postotak tjelesne težine.
English: The studies allowed the inclusion of patients 2 years and older and the safety and efficacy profiles are expected to be similar down to the age of 2 years.
Croatian: Ispitivanja su dopuštala uključivanje bolesnika u dobi od 2 ili više godina te se očekivalo da će profili sigurnosti i djelotvornosti biti slični sve do dobi od 2 godine.
English: In studies with VPRIV additional side effects have also been reported:
Croatian: U ispitivanjima sa VPRIV-om također su prijavljene dodatne nuspojave:
English: Response to treatment
Croatian: Odgovor na liječenje
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not exceed 24 hours at 2C to 8C.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika te ne smiju prijeći 24 sata pri 2C do 8C.
English: It is given by a doctor or nurse by intravenous infusion.
Croatian: Daje ga liječnik ili medicinska sestra putem intravenske infuzije.