FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: Učestalost javljanja nuspojava izražava se kao: - vrlo česte (u više od 1 na 10 tretiranih životinja uočljive su nuspojave) - česte (u više od 1 ali manje od 10 na 100 tretiranih životinja) - manje česte (u više od 1 ali manje od 10 na 1.000 tretiranih životinja)
English: For the full list of excipients, see section 6.1.
Croatian: Popis pomoćnih tvari vidi u odjeljku 6.1
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Croatian: Odluku o korištenju ove vakcine prije ili nakon bilo kojeg drugog veterinarsko medicinskog proizvoda valja prosuditi od slučaja do slučaja.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Croatian: RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA ”
English: Overdose (symptoms, emergency procedures, antidotes):
Croatian: Predoziranje (simptomi, hitni postupci, antidoti): Goveda:
English: Every 9 months, as described for primary vaccination, based on a duration of immunity of 280 days.
Croatian: Svakih 9 mjeseci, na način kako je opisano za primarnu vakcinaciju, temeljem trajanja imunosti od 280 dana.
English: Marketing authorisation holder: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne FRANCE
Croatian: Nositelj odobrenja za stavljanje u promet: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne
English: Duration of immunity: 280 days after completion of the primary vaccination course.
Croatian: Trajanje imuniteta: 280 dana po završetku primarnog vakcinalnog ciklusa.
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološki djelatne(ih) tvari
English: Pharmacotherapeutic group: immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Croatian: IMUNOLOŠKA SVOJSTVA Farmakoterapijska grupa: imunobiološki pripravci za bovidae; inaktivirana bakterijska vakcina za goveda,
English: Each container is closed with a 20 mm bromobutyl rubber stopper and a central tear-off aluminiumplastic cap.
Croatian: Svaka bočica zatvorena je 20 mm bromobutilnim gumenim čepom i zaštićenim aluminijsko - plastičnim poklopcem.
English: Re-vaccination: One dose should be given yearly.
Croatian: Revakcinacija: Ponovljenim davanjem jedne doze svake godine.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ukoliko primijetite ikakve ozbiljne nuspojave ili nuspojave koje nisu spomenute u ovoj uputi molimo o tome obavijestiti vašeg veterinara.
English: Re-vaccination: Every 9 months, as described for primary vaccination, based on duration of immunity of 280 days.
Croatian: Revakcinacija: Svakih 9 mjeseci, na način kako je opisano za primarnu vakcinaciju, temeljem trajanja imunosti od 280 dana.
English: Meat, milk and offal: Zero days.
Croatian: KARENCIJA(E) Meso, mlijeko i iznutrice: 0 dana
English: Do not mix with any other veterinary medicinal product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko - medicinskim proizvodom.
English: Under field conditions, vaccination with COXEVAC has commonly been followed by a decrease in milk production in goats.
Croatian: U terenskim uvjetima, vakcinacija COXEVAC vakcinom u koza je obično popraćena smanjenjem proizvodnje mlijeka.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: će primjena veterinarsko-medicinskog proizvoda na životinjama interferirati s provedbom nacionalnih programa za otkrivanje, kontrolu i iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja. b) je bolest za koju je odnosni veterinarsko-medicinski proizvod namijenjen da pruži imunost, odsutna s tog područja.
English: For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when nonpregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of Coxiella burnetii in these animals via milk and vaginal mucus.
Croatian: Za aktivnu imunizaciju goveda kako bi se smanjio rizik da nezaražene životinje vakcinirane van razdoblja graviditeta postanu kliconoše (5 puta manja vjerojatnost u usporedbi sa životinjama koje su primale placebo) te kako bi se smanjilo širenje
English: The manufacture, import, possession, sale, supply and/or use of COXEVAC may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Proizvodnja, uvoz, posjedovanje prodaja, nabava i/ili korištenje vakcine COXEVAC mogu biti zabranjeni u zemlji članici EU, na cijelom teritoriju ili dijelu teritorija, u skladu s nacionalnim propisima.
English: > 72 QF Units/ml
Croatian: ≥72 QF jedinica / ml
English: For the active immunisation of goats to reduce abortion caused by Coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta.
Croatian: Za aktivna imunizacija koza kako bi se smanjio broj pobačaj uzrokovanih infekcijom s Coxiella burnetii te smanjilo širenje mikroorganizama mlijekom, vaginalnom sluzi, izmetom i putem posteljice.
English: Two doses should be given subcutaneously with an interval of 3 weeks.
Croatian: Subkutano se daju dvije doze vakcine, u razmaku od 3 tjedna.
English: It was very common to observe in laboratory trials a slight increase of rectal temperature for 4 days post-vaccination.
Croatian: Vrlo često se u laboratorijskim ispitivanjima javlja blagi porast rektalne temperature do 4 dana nakon vakcinacije.
English: CEVA-Phylaxia Veterinary Biologicals Co. Ltd. Szállás u. 5
Croatian: Ceva-Phylaxia Veterinarska biološkog Co Ltd.
English: Re-vaccination:
Croatian: Revakcinacija:
English: Subcutaneous use.
Croatian: Za subkutano davanje.
English: EXP {month/year} Once broached, use within 10 hours.
Croatian: ROK VALJANOSTI EXP: (mjesec/godina) Jednom otvoreno koristiti unutar 10 sati.
English: No efficacy data are available concerning the use of COXEVAC in male animals.
Croatian: Ne postoje podaci o učinkovitosti vakcine COXEVAC pri korištenju u muških životinja.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko - medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: Lactation: In cattle and goats the vaccine can be used during lactation.
Croatian: U goveda i koza vakcinu se može koristiti tijekom laktacije.
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: ZABRANA PRODAJE, OPSKRBE I/ILI PRIMJENE Svaka osoba koja namjerava proizvoditi, uvoziti, posjedovati, prodavati, opskrbljivati i koristiti ovaj veterinarsko-medicinski proizvod mora prethodno konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju, jer te aktivnosti mogu biti zabranjenje u državi članici, u cijelosti ili samo na djelu njezinog teritorija, u skladu s nacionalnim zakonodavstvom.
English: Shelf life after first opening the container: 10 hours.
Croatian: Rok valjanosti po prvom otvaraju: 10 sati.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUTEVI PRIMJENE
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA ” I UVJETI ILI OGRANIČENJA U
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: Pri slučajnom samoinjiciranju potrebno je odmah potražiti liječnički savjet uz predočenje upute.
English: EU/2/10/110/001 (40 ml) EU/2/10/110/002 (100 ml)
Croatian: EU/2/10/110/002 (100 ml)
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Croatian: Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko - medicinski proizvod na životinjama
English: The vaccine contains phase I Coxiella burnetii as active ingredient inducing active immunity against Q fever in cattle and goats.
Croatian: Vakcina sadržava fazu I Coxiella burnetii kao djelatnu tvar koja potiče razvoj aktivne imunosti protiv Q
English: Manufacturer responsible for batch release: CEVA-Phylaxia Veterinary Biologicals Co. Ltd. Szállás u. 5
Croatian: Proizvođač odgovoran za puštanje serije u promet: CEVA-Phylaxia Veterinary Biologicals Co.
English: Goats:
Croatian: Koze:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE PROIZVODNE SERIJE,
English: The reaction gradually reduced and disappeared without need for treatment.
Croatian: Reakcija se postupno smanjila te se spontano povukla bez potrebe za liječenjem.
English: The reaction gradually reduces and disappears without need for treatment.
Croatian: Reakcija se postupno smanjuje te se spontano povuče bez potrebe za liječenjem.
English: Diarrhoea has been observed rarely in post marketing safety experience.
Croatian: Pojava proljeva rijetko je uočena nakon stavljanja na tržište.
English: Carton box with 1 plastic (LDPE) bottle, containing 40 ml of suspension.
Croatian: Kartonska kutija s 1 plastičnom (LDPE) bočicom koja sadržava 40 ml suspenzije.
English: It was very common to see in laboratory trials a palpable reaction of maximum diameter of 9 to 10 cm at the injection site, which may last for 17 days.
Croatian: Vrlo često se u laboratorijskim ispitivanjima na mjestu uboda javlja opipljiva reakcija najvećeg promjera 9 do 10 cm, koja može trajati 17 dana.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after {EXP}.
Croatian: Ne koristiti nakon roka naznačenog na kutiji i bočici, poslije EXP.
English: Carton box with 1 plastic (LDPE) bottle, containing 100 ml of suspension.
Croatian: Kartonska kutija s 1 plastičnom (LDPE) bočicom koja sadržava 100 ml suspenzije.
English: With double dose, a palpable reaction of maximum diameter of 10 cm was observed at the injection site, lasting for 16 days.
Croatian: Uz dvostruku dozu, opipljiva reakcija najvećeg promjera 10 cm zabilježena je na mjestu uboda, u trajanju od 16 dana.
English: However, in safety laboratory trials, the use of COXEVAC in males proved to be safe.
Croatian: laboratorijska ispitivanja neškodljivosti korištenja vakcine COXEVAC u muških životinja potvrdila su njenu neškodljivost.
English: Systemic signs as lethargy, malaise and/or anorexia have been observed uncommonly in post marketing safety experience.
Croatian: Nakon stavljanja na tržište uočena je pojava manje čestih sustavnih znakova kao što su letargija, slabost i/ili anoreksija.
English: It was very common to see in laboratory trials a palpable reaction of 3 to 4 cm diameter at the injection site which may last for 6 days.
Croatian: Vrlo često se u laboratorijskim ispitivanjima na mjestu uboda javlja opipljiva reakcija najvećeg promjera 3 do 4 cm, koja može trajati 6 dana.
English: Pack sizes: 40 ml or 100 ml in a plastic LDPE bottle.
Croatian: Veličine pakovanja: plastične (LDPE) bočice od 40 ml ili 100 ml.
English: With double dose, a moderate palpable reaction of diameter of 4 to 5 cm was observed at the injection site, lasting for 4 days.
Croatian: Koze: Uz dvostruku dozu, umjerena opipljiva reakcija promjera 4 do 5 cm zabilježena je na mjestu uboda, koji traje četiri dana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX for 40 ml or 100 ml plastic bottle
Croatian: Kartonska kutija za plastičnu bočicu od 40 ml ili od 100 ml
English: EU/2/10/110/001-002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/10/110/001-002
English: Name and address of the manufacturer responsible for batch release
Croatian: MAĐARSKA Naziv i adresa proizvođača odgovornog(ih) za puštanje serije u promet
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Croatian: Rok trajanja u originalnom pakovanju: 2 godine.
English: COXEVAC suspension for injection for cattle and goats
Croatian: UPUTA O VMP COXEVAC, injekcijska suspenzija za goveda i koze
English: Any person intending to manufacture, import, possess, sell, supply and use COXEVAC must consult the relevant
Croatian: Svako tko namjerava proizvesti, uvesti, posjedovati, prodati, opskrbiti i/ili primijeniti COXEVAC treba se posavjetovati s nadležnim tijelom države članice o važećim propisima za vakcinaciju, prije proizvodnje, uvoza, prodaje, nabave i/ili primjene imunobiološkog VMP.
English: Read the package leaflet before use.
Croatian: Pročitati uputu o imunobiološkom VMP prije primjene.
English: PACKAGE LEAFLET: COXEVAC suspension for injection for cattle and goats
Croatian: NAZIV VETERINARSKO - MEDICINSKOG PROIZVODA COXEVAC, injekcijska suspenzija za goveda i koze
English: {MM/YYYY}
Croatian: A.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I PROIZVOĐAČ
English: Excipient:
Croatian: Lot:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 40 ml plastic bottle
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: EXPIRY DATE
Croatian: ROK VALJANOSTI EXP:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml plastic bottle
Croatian: Plastična bočica od 100 ml
English: Shake well before use.
Croatian: Prije korištenja potrebno je dobro protresti bočicu s vakcinom.
English: Withdrawal period(s): zero days.
Croatian: KARENCIJA(E) Karencija(e): 0 dana
English: SPECIAL WARNING(S)
Croatian: I ODGOVORAN(I)
English: MARKETING AUTHORISATION HOLDER
Croatian: ZA PUŠTANJE SERIJE U PROMET
English: Pack size
Croatian: Veličina pakovanja bottle (HDPE)
English: 4 mg Powder for concentrate for dispersion for infusion
Croatian: 4 mg Prašak za koncentrat za disperziju za infuziju
English: EMA Procedure Number
Croatian: EMA broj postupka
English: 1 vial + 1 filter
Croatian: 1 bočica + 1 filtar
English: MA (EU) Number (Invented) name
Croatian: Broj (EU) odobrenja Ime
English: Strength Pharmaceutical Form Route of administration
Croatian: Farmaceutski oblik Put primjene
English: Pharmaceutical Form
Croatian: Jačina Farmaceutski oblik
English: MA (EU) Numbers (Invented) name Strength
Croatian: Broj (EU) odobrenja
English: Powder for solution for injection
Croatian: 3,5 mg Prašak za otopinu za injekciju
English: Intravenous use, Subcutaneous use vial (glass)
Croatian: Intravenska primjena, Supkutana primjena
English: 10 (2 x 5) prefilled pens (multipack)
Croatian: 10 (2 x 5) napunjenih brizgalica (višestruko pakovanje)
English: 5 (5 x 1) vials (multipack)
Croatian: 5 (5 x 1) bočica (višestruko pakovanje)
English: 25 (5 x 5) cartridges (multipack)
Croatian: 25 (5 x 5) uložaka (višestruko pakiranje)
English: Section 4 [Existing text may vary between products]
Croatian: Dio 4 [Postojeći tekst može se razlikovati između proizvoda]
English: A frequency of ‘not known (cannot be estimated from available data)' is considered appropriate.
Croatian: Smatra se da je odgovarajuća učestalost „nepoznato (ne može se procijeniti iz dostupnih podataka)”.
English: The latter ones may be attributed to paclitaxel regardless of the treatment regimen.
Croatian: Potonje nuspojave mogu se pripisati paklitakselu bez obzira na režim liječenja.
English: The PL should be updated accordingly.
Croatian: Uputu o lijeku treba ažurirati u skladu s tim.
English: Very common (may effect more than 1 in 10 people) - Numbness, tingling or weakness in arms and legs (all symptoms of peripheral neuropathy)* *Can persist beyond 6 months of paclitaxel discontinuation Frequency not known (cannot be estimated from the available data): - redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel
Croatian: Vrlo često (pojavljuju se u više od 1 na 10 osoba) - Utrnulost, trnci ili slabost u rukama i nogama (svi simptomi periferne neuropatije)* *Može se nastaviti javljati nakon više od šest mjeseci od prekida primjene paklitaksela Učestalost nepoznata (ne može se procijeniti iz dostupnih podataka): - crvenilo i otekline na dlanovima ili tabanima što može uzrokovati ljuštenje kože.
English: Annex II Amendments to the product information of the nationally authorised medicinal product(s)
Croatian: Izmjene informacija o lijeku nacionalno odobrenog(ih) lijeka(ova)
English: Taking into account the PRAC Assessment Report on the PSUR(s) for paclitaxel, the scientific conclusions of the CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za paklitaksel, znanstveni zaključci CHMP-a su sljedeći:
English: In addition, palmar-plantar erythrodysesthesia syndrome associated with paclitaxel treatment has been reported in clinical trials and in the published literature.
Croatian: Pored toga, sindrom palmarno-plantarne eritrodisestezije povezan s liječenjem paklitakselom prijavljen je u kliničkim ispitivanjima i objavljenim radovima.
English: Therefore, the SmPC of paclitaxel should be updated with the inclusion of palmar-plantar erythrodysesthesia syndrome as an ADR in section 4.8 under SOC Skin and subcutaneous tissue disorders.
Croatian: Stoga SmPC za paklitaksel treba ažurirati uključivanjem sindroma palmarno-plantarne eritrodisestezije kao nuspojave u dijelu 4.8 pod klasifikaciju organskih sustava (SOC) Poremećaji kože i potkožnog tkiva.
English: Based on the data provided, it is recommended to update the current information on neuropathy in the SmPC, by adding information concerning persistent neuropathy after paclitaxel discontinuation.
Croatian: Na temelju dostavljenih podataka, preporučuje se ažuriranje trenutačnih informacija o neuropatiji u sažetku opisa svojstava lijeka (SmPC) dodavanjem informacija u vezi s perzistirajućom neuropatijom nakon prekida primjene paklitaksela.
English: The following adverse reaction should be added under the SOC Skin and subcutaneous tissue disorders with a frequency “not known” (cannot be estimated from available data): “Palmar-plantar erythrodysesthesia syndrome*” *As reported in the post marketing surveillance of paclitaxel.
Croatian: Pod klasifikaciju organskih sustava (SOC) Poremećaji kože i potkožnog tkiva treba dodati sljedeću nuspojavu s oznakom učestalosti „nepoznato“ (ne može se procijeniti iz dostupnih podataka): „Sindrom palmarno-plantarne eritrodisestezije*” *Kao što je prijavljeno u nadzoru nakon stavljanja paklitaksela u promet.
English: Amendments to be included in the relevant sections of the Package Leaflet (new text underlined and in bold, deleted text strike through)
Croatian: Izmjene koje treba unijeti u odgovarajuće dijelove upute o lijeku (novi tekst je podcrtan i podebljan, izbrisani tekst je precrtan)
English: Based on a cumulative review of data from all the MAHs, the causal role of paclitaxel for palmarplantar erythrodysesthesia syndrome is at least a reasonable possibility.
Croatian: Na temelju kumulativnog pregleda podataka od svih nositelja odobrenja za stavljanje lijeka u promet (MAH), uzročna uloga paklitaksela kod sindroma palmarno-plantarne eritrodisestezije realna je mogućnost.
English: Data from published literature and administrative claims databases confirmed the persistence of neuropathy with paclitaxel exposure beyond 12 months.
Croatian: Podaci iz objavljenih radova i baza podataka potvrđuju ustrajnost neuropatije kod izloženosti paklitakselu nakon 12 mjeseci.
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for paclitaxel the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing paclitaxel is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za paklitaksel, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) paklitaksel nepromijenjen, uz predložene izmjene informacija o lijeku.
English: The following phrase should be included as a footnote of the ADR ‘neuropathy' in the table listing adverse reactions: *Can persist beyond 6 months of paclitaxel discontinuation The following sentence should be included in the text describing nervous system disorders under the section 4.8:
Croatian: Sljedeću frazu potrebno je uključiti u fusnotu nuspojave „neuropatija” u tablici s popisom nuspojava: *Može se nastaviti javljati nakon više od šest mjeseci od prekida primjene paklitaksela Sljedeću rečenicu potrebno je uključiti u tekst koji opisuje poremećaje živčanog sustava u dijelu 4.8: Nadalje, pokazano je kako se periferne neuropatije mogu nastaviti javljati nakon više od šest mjeseci od prekida primjene paklitaksela.
English: Neuropathy is a known ADR with the use of paclitaxel.
Croatian: Neuropatija je poznata nuspojava na lijek do koje dolazi uz uporabu paklitaksela.
English: Review of the post-marketing data revealed that neuropathy can persist after discontinuation of paclitaxel treatment.
Croatian: Pregled podataka nakon stavljanja lijeka u promet otkrio je prisustvo neuropatije i nakon prekida liječenja paklitakselom.
English: From the cases of palmarplantar erythrodysesthesia syndrome and symptoms received by the MAHs, there were several cases with a positive dechallenge and with a positive rechallenge.
Croatian: U pogledu slučajeva sindroma palmarno-plantarne eritrodisestezije i simptoma koje su zabilježili nositelji odobrenja za stavljanje lijeka u promet, zabilježeno je nekoliko slučajeva potpunog povlačenja nuspojave nakon prekida primjene lijeka (pozitivan dechallenge) i slučajeva ponovnog javljanja nuspojave nakon ponovnog uvođenja lijeka (pozitivan rechallenge).
English: Annex I Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: In addition, the introductory sentence to the table listing adverse reactions is to be amended to reflect that it includes adverse reactions from post marketing experience, as appropriate: Table X lists adverse reactions (…) observed in (a) clinical study(ies) and adverse reactions from post-marketing experience.
Croatian: Pored toga, uvodnu rečenicu u tablici s popisom nuspojava treba izmijeniti tako da uključuje nuspojave zabilježene nakon stavljanja lijeka u promet, kako je prikladno:
English: MA (EU) Number
Croatian: Broj EU odobrenja (Zaštićeno) ime
English: It is best to take your tablet at the same time each day.
Croatian: Najbolje je popiti tabletu svaki dan u isto vrijeme.
English: No patients received placebo alone.
Croatian: Nijedan bolesnik nije primao samo placebo.