FrancophonIA/ELRC3.0 huggingface dataset:
English: How has Chanhold been studied?
Croatian: Kako se Chanhold primjenjuje?
English: Date of first authorisation: 23/02/2005 Date of last renewal: 15/01/2010
Croatian: Datum prvog odobrenja: 23/02/2005 Datum posljednje obnove: 15/01/2010
English: ATCvet code: QI06AH08.
Croatian: ATCvet kod: QI06AH08
English: Do not use in pregnant animals.
Croatian: Ne primjenjivati na gravidnim životinjama.
English: In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Croatian: U izuzetnim okolnostima može se javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajuće simptomatsko liječenje.
English: EXP (mm/yyyy)
Croatian: EXP (mm/gggg)
English: Store and transport refrigerated (2 °C - 8 °C).
Croatian: Čuvati i prevoziti rashlađeno (2°C - 8°C).
English: Use immediately after reconstitution.
Croatian: Primijeniti odmah nakon rekonstitucije.
English: 69800 SAINT-PRIEST FRANCE
Croatian: 69800 SAINT-PRIEST FRANCUSKA
English: Primary vaccination course: - first injection: from 8 weeks of age, - second injection: 3 to 4 weeks later.
Croatian: Prvo cijepljenje: - prva injekcija: od 8. tjedna starosti, - druga injekcija: 3 do 4 tjedna kasnije.
English: Use in healthy animals only.
Croatian: Primijeniti samo na zdravim životinjama.
English: EU/2/04/051/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/051/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Croatian: EU/2/04/051/001 Liofilizat (10 bočica s po 1 dozom) + otapalo (10 bočica od 1 ml) EU/2/04/051/002 Liofilizat (50 bočica s po 1 dozom) + otapalo (50 bočica od 1 ml)
English: In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Croatian: U normalnim uvjetima upotrebe, povremeno se mogu javiti apatija i anoreksija, kao i hipertermija (u trajanju obično 1 ili 2 dana).
English: Per dose of 1 ml:
Croatian: Svaka doza od 1 ml sadrži:
English: A local reaction may occur (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most.
Croatian: Može se javiti i lokalna reakcija (lagana bol pri palpaciji, svrbež ili ograničen otok) koja nestaje za najviše 1 ili 2 tjedna.
English: The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
Croatian: Proizvod smanjuje ekskreciju mačjeg kalicivirusa na početku imunosti i tijekom 1 godine nakon vakcinacije.
English: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50 FCV (431 and G1 strains) ............................................................................................... ≥ 2.0 ELISA U.
Croatian: FHV (soj F2) ..................................................................................................................... ≥ 104,.9 CCID50 FCV (soj 431 i G1) .......................................................................................................... ≥ 2,0 ELISA U.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samoinjiciranja, odmah potražiti pomoć liječnika i pokazati mu uputu o VMP ili etiketu.
English: Casein hydrolysate Collagen hydrolysate Dipotassium phosphate Potassium dihydrogen phosphate Potassium hydroxide Sodium chloride
Croatian: Kazein hidrolizat Kolagen hidrolizat Dikalijev fosfat Kalijev dihidrogenfosfat Kalijev hidroksid Natrijev klorid
English: The use is not recommended during lactation
Croatian: Ne preporučuje se primjena tijekom laktacije
English: No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Croatian: Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku 4.6 “Nuspojave”, osim hipertermije koja može izuzetno trajati 5 dana.
English: Shelf life after reconstitution according to directions: use immediately.
Croatian: Rok valjanosti nakon rekonstitucije prema uputama: primijeniti odmah .
English: EXP (mm/yyyy) Once reconstituted use immediately.
Croatian: EXP (mm/gggg) Nakon restitucije odmah primijeniti.
English: No effect other than those already mentioned in section “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
Croatian: Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku “Nuspojave” nakon primjene nekoliko doza, osim hipertermije koja iznimno može trajati 5 dana.
English: 1 cell culture infective dose 50%
Croatian: 1 količina virusa koja zarazi 50 % stanica kulture u koju je dodan virus
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs.
Croatian: Aktivna imunizacija mačaka starijih od 8 tjedana: - protiv virusnog rinotraheitisa mačaka za smanjenje kliničkih znakova,
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Croatian: Dostupni su podaci o sigurnosti i učinkovitosti koji pokazuju da se ova vakcina može miješati i primijeniti s Merialovomvakcinom protiv mačje leukemije i/ili primijeniti isti dan, ali se ne smije miješati s Merialovom vakcinom protiv bjesnoće.
English: Where high levels of maternal antibodies against rhinotracheitis or calicivirosis components are expected to be present (e.g. in kittens of 9-12 weeks of age borne from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Croatian: Kada se očekuje prisutnost visoke razine majčinih protutijela protiv komponenti rinotraheitisa ili kalicivirusa (npr. kod mačića u dobi od 9-12 tjedana od mačaka koje su bile cijepljene prije trudnoće i/ili s poznatim ili suspektnim prethodnim izlaganjem patogenima), prvo cijepljenje treba odgoditi do dobi od 12 tjedana.
English: Lyophilisate (10x1 dose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Croatian: Liofilizat (10 x 1 doza) + otapalo (10 x 1 ml) Liofilizat (50 x 1 doza) + otapalo (50 x 1 ml)
English: Store and transport refrigerated.
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati i prevoziti rashlađeno.
English: Water for injections ..................................................................................................................... q.s.
Croatian: Voda za injekcije .......................................................................................................................... q.s. 1 ml
English: Do not mix with Merial adjuvanted vaccine against rabies.
Croatian: Ne miješati s Merialovom vakcinom protiv bjesnoće.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti pomiješano s cjepivom protiv mačje leukemije tvrtke Merial i/ili primijenjeno istog dana, ali ne pomiješano s cjepivom protiv bjesnoće tvrtke Merial.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent bottle
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
English: Revaccination: - the first revaccination must be carried out one year after the primary vaccination course, - subsequent revaccinations must be carried out at intervals of up to three years for the rhinotracheitis and calicivirosis components.
Croatian: Revakcinacija: - prva revakcinacija mora biti provedena jednu godinu nakon prvog cijepljanja, - naknadne revakcinacije moraju biti provedene u intervalima od najviše tri godine za komponente rinotraheitisa i kalicivirusa.
English: The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis and calicivirosis components.
Croatian: Trajnost imuniteta nakon zadnje re-vakcinacije je 3 godine za komponente rinotraheitisa i kalicivirusa.
English: Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium or plastic cap.
Croatian: I staklena bočica s 1 ml otapala, obje zatvorene gumenim čepom i zapečaćene aluminijskom ili plastičnom kapicom.
English: Lyophilisate and solvent for suspension for injection.
Croatian: Liofilizat i otapalo za suspenziju za injekcije.
English: Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Croatian: Nakon rekonstitucije liofilizata otapalom injicirajte subkutano jednu dozu (1 ml) cjepiva, prema sljedećem rasporedu cijepljenja:
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous
Croatian: Dinatrijev hidrogenortofosfat Monokalijev fosfatanhidrid
English: Stimulates active immunity against feline rhinotracheitis herpesvirus and feline calicivirus.
Croatian: Potiče aktivni imunitet protiv herpesvirusa, rinotraheitisa i kaliciviroze mačaka.
English: Gentamicin, at most ....................................................................................................................... 16.5 µg Solvent:
Croatian: Gentamicin, najviše ....................................................................................................................... 16,5 µg Otapalo:
English: Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
Croatian: Pakovanje sadrži 50 bočica s 1 dozom liofilizata i 50 bočica sa po 1 ml otapala.
English: Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.
Croatian: Pakovanje sadrži 10 bočica s 1 dozom liofilizata i 10 bočica sa po 1 ml otapala.
English: Purevax RC lyophilisate and solvent for suspension for injection
Croatian: Purevax RC liofilizat i otapalo za suspenziju za injekcije
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pack containing 10 bottles of lyophilisate and 10 bottles of solvent Pack containing 50 bottles of lyophilisate and 50 bottles of solvent
Croatian: Pakovanje sadrži 10 bočica liofilizata i 10 bočica otapala Pakovanje sadrži 50 bočica liofilizata i 50 bočica otapala
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U.
Croatian: ≥ 104,9 CCID501 Inaktivirani antigen kalicivirusa mačaka (soj FCV 431 i FCV G1) ................................
English: Vaccine against feline viral rhinotracheitis and feline calicivirosis.
Croatian: Cjepivo protiv virusnog rinotraheitisa i kaliciviroze mačaka.
English: Manufacturing authorisation holder responsible for batch release: MERIAL
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet: MERIAL
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens .................................. ≥ 2.0 ELISA U.
Croatian: ≥ 104,9 CCID501 Inaktivirani antigen kalicivirusa mačaka (soj FCV 431 i G1) ........................................
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis and calicivirus components.
Croatian: Pokazalo se da imunitet nastupa 1 tjedan nakon prvog cijepljenja protiv komponenti rinotraheitisa i kalicivirusa.
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
English: Purevax RC lyophilisate and solvent for suspension for injection.
Croatian: Purevax RC liofilizat i otapalo za suspenziju za injekciju.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNIH TVARI I NOSITELJ
English: Special precautions for use in animals: Use in healthy animals only.
Croatian: Posebne mjere opreza prilikom primjene na životinjama:
English: Excipient:
Croatian: : Liofilizat:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: UPUTA O VMP: Purevax RC liofilizat i otapalo za suspenziju za injekcije NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE
English: Less than 10% Less than 10% Less than 10%
Croatian: Manje od 10% Manje od 10% Manje od 10%
English: Date of first authorisation: 14 May 2014
Croatian: Datum prvog odobrenja: 14. svibnja 2014.
English: The type of food is not important.
Croatian: Vrsta hrane nije važna.
English: Ribavirin can affect your unborn baby.
Croatian: Ribavirin može utjecati na Vaše nerođeno dijete.
English: Other double or triple mutations were observed with lower frequencies.
Croatian: Druge dvostruke ili trostruke mutacije bile su uočene s nižim frekvencijama.
English: The final study report shall be submitted by:
Croatian: Završno izvješće studija podnosi se do:
English: * see section below for further details.
Croatian: * pogledati odjeljak niže za daljnje informacije.
English: - Try to take OLYSIO at the same time each day.
Croatian: - Pokušajte uzeti OLYSIO svaki dan u isto vrijeme.
English: Use only if no other alternative is available.
Croatian: Primijeniti samo ako nije dostupna niti jedna, druga, alternativa.
English: A risk to the newborn/infant cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče.
English: Comparison based on historic controls.
Croatian: Usporedba temeljena na povijesnim kontrolama.
English: Alone or in combination with other substitutions (includes mixtures).
Croatian: Sam ili u kombinaciji s drugim supstitucijama (uključuje miješane).
English: Very common: may affect more than 1 in 10 people:
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 osoba:
English: Patients with these combinations are also included in other rows describing the individual substitutions.
Croatian: Bolesnici s tim kombinacijama su također uključeni u druge redove u kojima su opisane individualne supstitucije.
English: What OLYSIO is and what it is used for
Croatian: Što je OLYSIO i za što se koristi
English: There were no grade 3 events reported.
Croatian: Nije bilo prijavljenih događaja 3. stupnja.
English: rash*, pruritus*
Croatian: osip*, pruritus*
English: Do not drive or use machines if you feel faint or have problems with your vision.
Croatian: Nemojte upravljati vozilima ili strojevima ako osjećate nesvjesticu ili imate probleme s vidom.
English: - Always take OLYSIO with food.
Croatian: - Uvijek uzimajte OLYSIO s hranom.
English: The capsule should be
Croatian: Kapsula se mora
English: Rash may become severe.
Croatian: Osip može postati težak.
English: * Ketoconazole: pending further ATC classification.
Croatian: * Ketokonazol: očekuje se daljnja ATK klasifikacija.
English: X represents multiple amino acids.
Croatian: X predstavlja višestruke aminokiseline.
English: Elderly (above 65 years of age)
Croatian: Starije osobe (u dobi iznad 65 godina)
English: Your doctor will test your blood before you start your treatment and regularly during your treatment.
Croatian: Liječnik će Vam napraviti krvne pretrage prije nego što započnete s liječenjem i redovito tijekom liječenja.
English: pruritus*, photosensitivity photosensitivity reaction*
Croatian: pruritus*, reakcije reakcije fotoosjetljivosti*
English: Other medicines and OLYSIO
Croatian: Drugi lijekovi i OLYSIO
English: - OLYSIO must not be used by itself.
Croatian: - OLYSIO se ne smije uzimati samostalno.
English: Especially avoid intense or prolonged exposure to sunlight (including tanning devices).
Croatian: Naročito izbjegavajte intenzivno ili dugotrajno izlaganje sunčevoj svjetlosti (uključujući solarije).
English: OLYSIO contains lactose (a type of sugar).
Croatian: OLYSIO sadrži laktozu (vrstu šećera).
English: OLYSIO must not be used in children and adolescents (under 18 years of age) because it has not been studied in this age group.
Croatian: OLYSIO ne smiju uzimati djeca i adolescenti (u dobi manjoj od 18 godina) jer nije ispitan u ovoj dobnoj skupini.
English: This is because OLYSIO and other medicines may interact with each other.
Croatian: Zbog toga što OLYSIO i drugi lijekovi mogu imati interakciju jedni s drugima.
English: There are no adequate and well-controlled studies with simeprevir in pregnant women.
Croatian: Nema prikladnih i dobro kontroliranih ispitivanja sa simeprevirom u trudnica.
English: - This medicine may pose a risk to the environment.
Croatian: - Ovaj lijek može predstavljati rizik za okoliš.
English: You and your partner must use an effective method of contraception during treatment and for several months afterwards.
Croatian: Vi i Vaš partner morate koristiti učinkovitu metodu kontracepcije tijekom liječenja i nekoliko mjeseci nakon toga.
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.
Croatian: Značajni teratogeni i/ili embriocidni učinci dokazani su kod svih životinjskih vrsta koje su izložene ribavirinu.
English: Persistence of resistance-associated substitutions
Croatian: Ustrajnost supstitucija povezanih s rezistencijom
English: - The days of the week are printed on the blister strip - this will help you remember to take your
Croatian: - Dani u tjednu otisnuti su na traci blistera - što će Vam pomoći da se podsjetite uzeti kapsulu.
English: If the capsule shell has been broken or opened, some medicine may be lost and you should take a new capsule.
Croatian: Ako je ovojnica kapsule bila razlomljena ili otvorena, može se izgubiti nešto lijeka i trebate uzeti novu kapsulu.
English: Read all of this leaflet carefully before you start taking this medicine because it contains
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: Do not stop taking OLYSIO
Croatian: Nemojte prestati uzimati OLYSIO
English: If you do, your medicine may not work properly.
Croatian: Ukoliko ga prestanete uzimati, lijek Vam možda neće djelovati kako bi trebao.
English: Do not take OLYSIO if you are allergic to simeprevir or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati OLYSIO ako ste alergični na simeprevir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Do not stop taking OLYSIO unless your doctor tells you to.
Croatian: Nemojte prestati uzimati OLYSIO osim ako Vam to ne kaže liječnik.
English: Two patients had emerging single substitution I170T.
Croatian: Dva bolesnika imala su nastalu pojedinačnu supstituciju I170T.
English: Number of patients enrolled
Croatian: Broj uključenih bolesnika
English: HCV RNA
Croatian: HCV RNK
English: If you are pregnant, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate zatrudnjeti, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Pregnant women should not take OLYSIO unless specifically directed by the doctor.
Croatian: Trudnice ne smiju uzimati OLYSIO osim ako im to nije izričito odredio liječnik.
English: During your treatment with OLYSIO, use appropriate sun protection (such as a sun hat, sunglasses and sunscreen).
Croatian: Tijekom liječenja lijekom OLYSIO, koristite prikladnu zaštitu od sunca (poput šešira za zaštitu od sunca, sunčanih naočala i zaštitne kreme za sunčanje).
English: EU/1/14/924/002 (28 capsules)
Croatian: EU/1/14/924/002 (28 kapsula)
English: Like all medicines, OLYSIO can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, OLYSIO može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Ribavirin may cause birth defects and/or death of the exposed foetus.
Croatian: Ribavirin može uzrokovati prirođene defekte i/ili smrt fetusa koji mu je bio izložen.
English: C-simeprevir to healthy subjects, the majority of the radioactivity in plasma (up to 98%) was accounted for by unchanged drug and a small part of the radioactivity in plasma was related to metabolites (none being major metabolites).
Croatian: C-simeprevira zdravim ispitanicima, većina radioaktivnosti u plazmi (do 98%) brojala se kao nepromijenjen lijek, a mali dio radioaktivnosti u plazmi bio je povezan s metabolitima (nijedan nije bio metabolit u većini).
English: What OLYSIO is and what it is used for What you need to know before you take OLYSIO
Croatian: Što je OLYSIO i za što se koristi Što morate znati prije nego počnete uzimati OLYSIO
English: 24 weeks N = 31
Croatian: 24 tjedna N = 31
English: EU/1/14/924/001 (7 capsules)
Croatian: EU/1/14/924/001 (7 kapsula)
English: Less than 1% of the administered dose was recovered in urine.
Croatian: Manje od 1% primijenjene doze bilo je otkriveno u mokraći.
English: Severe bradycardia and heart block
Croatian: Teška bradikardija i srčani zastoj
English: Then continue taking OLYSIO at the usual scheduled time.
Croatian: Nakon toga nastavite uzimati OLYSIO u uobičajeno predviđeno vrijeme.
English: Cross-resistance is not expected between direct-acting antiviral agents with different mechanisms of action.
Croatian: Ukrižena rezistencija se ne očekuje između antivirusnih lijekova direktnog djelovanja s drugačijim mehanizmom djelovanja.
English: Patient individualised dose at the discretion of the physician, according to local clinical practice.
Croatian: Doza određena individualno za bolesnika kako je odredio liječnik, prema lokalnoj kliničkoj praksi.
English: Tell your doctor if any of the following applies: - you currently take, or have taken in the last few months, the medicine amiodarone (your doctor may consider alternative treatments if you have taken this medicine) - you take other medicines to treat irregular heart beat or high blood pressure.
Croatian: - Recite svom liječniku ukoliko je primjenjivo nešto od sljedećeg: trenutno uzimate, ili ste u zadnjih nekoliko mjeseci uzimali, lijek amiodaron (Vaš liječnik može razmotriti alternativno liječenje ukoliko ste uzimali ovaj lijek) uzimate druge lijekove za liječenje nepravilnih otkucaja srca ili visokog krvnog tlaka.
English: OLYSIO is available in packs containing 7 capsules (1 blister) or 28 capsules (4 blisters).
Croatian: OLYSIO je dostupan u pakiranjima koja sadrže 7 kapsula (1 blister) ili 28 kapsula (4 blistera).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in
Croatian: Bolesnici u kojih je prepoznat visok rizik za bradiaritmije trebaju biti kontinuirano praćeni tijekom 48 sati u prikladnom