FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP was requested to review the marketing authorisations and the available data in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Croatian: U tom je postupku od CVMP-a zatraženo ocjenjivanje odobrenja za stavljanje proizvoda u promet i dostupnih podataka kako bi se osigurala odgovorna uporaba tvari u zaštiti zdravlja životinja i ograničenju mogućnosti budućeg rizika za javno zdravlje.
English: In addition, the marketing authorisation holders were asked to justify the benefits of using a colistin combination product over the use of monotherapy for the treatment of the respective conditions, particularly taking into account the CVMP guideline on pharmaceutical fixed combination products
Croatian: Osim toga, od nositelja odobrenja za stavljanje proizvoda u promet zatraženo je da opravdaju prednosti primjene kombiniranog proizvoda koji sadrži kolistin u odnosu na primjenu monoterapije u liječenju predmetnih stanja, osobito uzimajući u obzir smjernice CVMP-a o farmaceutskim fiksnim kombinacijama proizvoda
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the aforementioned products is negative, due to a lack of clinical relevance and in view of over-exposure of colistin that could pose a potential risk to animal and human health from an acceleration of the occurrence of colistin resistance.
Croatian: Odbor za medicinsko-veterinarske proizvode (CVMP) pri Agenciji zaključio je da je ukupan omjer koristi i rizika za navedene proizvode negativan zbog nedostatka kliničke važnosti i pretjeranog izlaganja kolistinu, što bi moglo predstavljati mogući rizik za zdravlje životinja i ljudi zbog ubrzavanja rezistencije na kolistin.
English: Colistin belongs to the polymyxin group of antibiotics.
Croatian: Kolistin se ubraja u skupinu antibiotika koji se nazivaju polimiksini.
English: On 21 April 2016, the European Medicines Agency (the Agency) completed a review of the effectiveness of and antimicrobial resistance to all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Croatian: Europska agencija za lijekove (Agencija) dovršila je 21. travnja 2016. ocjenjivanje djelotvornosti i antimikrobne otpornosti svih veterinarsko-medicinskih proizvoda koji sadrže kolistin u kombinaciji s drugim antimikrobnim tvarima za oralnu primjenu.
English: CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf
Croatian: Smjernice CVMP-a o farmaceutskim fiksnim kombinacijama proizvoda (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf
English: Why were veterinary medicinal products containing colistin in combination with other antimicrobial substances reviewed?
Croatian: Zašto su ocjenjivani veterinarsko-medicinski proizvodi koji sadrže kolistin u kombinaciji s drugim antimikrobnim tvarima?
English: Based on the evaluation of the currently available data, the CVMP concluded that no benefit could be demonstrated when using colistin combination products instead of monotherapy and no feasible risk mitigation measures could be identified to address the identified potential risk for human health, as even limited use of colistin combination products was considered unnecessary.
Croatian: CVMP je na temelju procjene trenutačno dostupnih podataka zaključio da nije moguće potvrditi prednosti primjene kombiniranih proizvoda koji sadrže kolistin u odnosu na monoterapiju te utvrditi izvedive mjere za smanjenje rizika kako bi se riješio problem utvrđenog mogućeg rizika za zdravlje ljudi jer se čak i ograničena primjena kombiniranih proizvoda koji sadrže kolistin smatrala nepotrebnom primjenom kolistina.
English: Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally
Croatian: Pitanja i odgovori o veterinarsko-medicinskim proizvodima koji sadrže kolistin u kombinaciji s drugim antimikrobnim tvarima za oralnu primjenu
English: Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf
Croatian: Uporaba proizvoda koji sadrže kolistin u životinja u Europskoj uniji: razvoj rezistencije i mogući učinak na zdravlje ljudi i životinja (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf
English: Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm
Croatian: Direktive 2001/82/EZ Europskog parlamenta i Vijeća za sve veterinarsko-medicinske proizvode koji sadrže kolistin za oralnu uporabu ((2015)1916 od 16.3.2015.) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm
English: Request for scientific advice on the impact on public health and animal health of the use of antibiotics in animals, answer to the first request from the European Commission (EMA/363834/2013) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/07/WC500146812.pdf
Croatian: Traženje znanstvenih savjeta o učinku uporabe antibiotika u životinja na javno zdravlje i zdravlje životinja, odgovor Europske komisije na prvi zahtjev (EMA/363834/2013) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/07/WC500146812.pdf
English: In May 2014 the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin as sole active substance for oral administration to food-producing species (EMEA/V/A/106).
Croatian: Direktive 2001/82/EZ za sve veterinarsko-medicinske proizvode koji sadrže kolistin kao jedinu djelatnu tvar za oralnu primjenu u životinjskih vrste koje se upotrebljavaju za proizvodnju hrane (EMEA/V/A/106).
English: The CVMP recommended that all marketing authorisations for veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn throughout the European Union (EU).
Croatian: CVMP je preporučio povlačenje svih odobrenja za stavljanje proizvoda u promet za veterinarsko-medicinske proizvode koji sadrže kolistin u kombinaciji s drugim antimikrobnim tvarima za oralnu primjenu na prostoru Europske unije (EU-a).
English: Therefore the CVMP recommended that all marketing authorisations for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn.
Croatian: Stoga je CVMP preporučio povlačenje odobrenja za stavljanje proizvoda u promet za sve veterinarsko-medicinske proizvode koji sadrže kolistin u kombinaciji s drugim antimikrobnim tvarima za oralnu primjenu.
English: On 4 May 2015, the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Croatian: Direktive 2001/82/EZ za sve veterinarsko-medicinske proizvode koji sadrže kolistin u kombinaciji s drugim antimikrobnim tvarima za oralnu primjenu.
English: This clinical sign has been reported very rarely from the field.
Croatian: Ovaj klinički znak rijetko je prijavljen s terena.
English: Pregnancy: Can be used during pregnancy.
Croatian: Graviditet: Može se upotrebljavati tijekom graviditeta.
English: The level of efficacy for other species may differ from that observed in cattle.
Croatian: Djelotvornost u drugih vrsta može se razlikovati od one uočene u goveda.
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: a) će primjena proizvoda na životinjama interferirati s provedbom nacionalnih programa za otkrivanje, kontrolu ili iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: EU/2/09/105/001 EU/2/09/105/002
Croatian: EU/2/09/105/002
English: ATC vet code: QI02AA08
Croatian: ATCvet kôd: QI02AA08
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals, unless otherwise required.
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET Periodička izvješća o neškodljivosti (PSUR) treba ponovo podnositi putem 6 mjesečnih izvješća (pokrivajući sva odobrena pakovanja proizvoda) za naredne dvije godine, nakon kojih slijede godišnja izvješća za sljedeće dvije godine, a nakon toga u trogodišnjim intervalima, ako nije drukčije propisano.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EZ) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
English: - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
English: The vaccine can be used during pregnancy.
Croatian: Cjepivo se može primjenjivati tijekom graviditeta.
English: Magyarország Zoetis Hungary Kft.
Croatian: Zoetis Hungary Kft.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and on the label after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije roka valjanosti naznačenog na kartonskoj kutiji i etiketi poslije EXP.
English: *(Cycling value (Ct) ≥ 36 by a validated RT- PCR method, indicating no presence of viral genome).
Croatian: *(Vrijednost cikliranja (Ct) ≥ 36 potvrđenom metodom RT-PCR, koja ukazuje da nema viralnog genoma).
English: 1st injection: from 3 months of age.
Croatian: Prva injekcija: od 3 mjeseca starosti.
English: Adjuvants: Aluminium hydroxide (Al3+)
Croatian: Adjuvansi: Aluminij-hidroksid (Al3+)
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
Croatian: *Relativna potentnost dobivena testiranjem na miševima u usporedbi s referentnim cjepivom koje se pokazalo učinkovitim kod goveda.
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 3 months of age.
Croatian: Primijenite jednu dozu od 2 ml prema sljedećoj shemi cijepljenja: Prva injekcija: od 3. mjeseca starosti.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar koja se sastoje od tvari biološkog podrijetla, je namijenjena za stvaranje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EZ) br. 470/2009.
English: On day 2 after vaccination, rectal temperatures had returned to normal values.
Croatian: Drugog dana nakon cijepljenja rektalne su se temperature vratile na normalne vrijednosti.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended,
Croatian: Sukladno članku 71. Direktive 2001/82/EZ i Europskog Parlamenta i Vijeća s izmjenama i dopunama, države članice, u skladu s nacionalnim zakonodavstvom mogu zabraniti proizvodnju,
English: Type I glass bottle (10 doses) or type II glass bottle (50 doses) with butyl elastomer closure
Croatian: I (10 doza) ili staklena bočica tipa II (50 doza) sa zatvaračem od butil elastomera.
English: Aluminium hydroxide
Croatian: Aluminij-hidroksid
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15/01/2010
Croatian: Datum prvog odobrenja: 15/01/2010 Datum zadnjeg produljenja odobrenja: 07/11/2014
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box 1 x 20ml / Carton box 1 x 100 ml
Croatian: Kartonska kutija 1 x 20 ml / Kartonska kutija 1 x 100 ml
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable
Croatian: Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
English: Each dose of 2 ml of the vaccine contains:
Croatian: Jedna doza od 2 ml cjepiva sadrži:
English: 4.4 Special warnings for each target species
Croatian: 4.4 Posebna upozorenja, za svaku od ciljnih vrsta životinja.
English: No information is available on the use of the vaccine in animals with maternally derived antibodies however the vaccine has been shown safe and efficacious in seropositive cattle.
Croatian: Nema dostupnih podataka o primjeni cjepiva u životinja s majčinski dobivenim antitijelima, međutim cjepivo se pokazalo neškodljivo i djelotvorno kod seropozitivnih goveda.
English: Local reactions of more than 2 cm are common after 2 fold overdose while reactions of up to 5 cm may occasionally occur after overdose administration, these resolve within a maximum of 57 days.
Croatian: Nakon predoziranja dvostrukom dozom česta je lokalna reakcija veća od 2 cm; dok lokalne reakcije do 5 cm ponekad se mogu javiti nakon predoziranja i mogu potrajati do najviše 57 dana.
English: In one laboratory safety study, no adverse reactions were observed after the first injection of a single dose of vaccine to calves.
Croatian: U jednom laboratorijskom istraživanju neškodljivosti, nakon prve injekcije pojedinačne doze, nisu uočene nikakve nuspojave u teladi.
English: Pack of 1 bottle of 10 doses (20 ml).
Croatian: Pakovanje od 1 bočice s 10 doza (20 ml).
English: To stimulate active immunity against bluetongue virus, serotype 8 in cattle.
Croatian: Za stimulaciju aktivnog imuniteta na virus bolesti plavog jezika serotipa 8 u goveda.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: 3. SADRŽAJ: PO TEŽINI, VOLUMENU ILI BROJU DOZA 20 ml (10 doza)
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated.
Croatian: 11. POSEBNI UVIJETI ČUVANJA Čuvati i prevoziti rashlađeno.
English: PHARMACEUTICAL FORM Off-white or pink suspension for injection
Croatian: Bjelkasta do ružičasta suspenzija za injekciju.
English: Intramuscular use:
Croatian: Intramuskularna primjena:
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
Croatian: Radi izbjegavanja slučajne kontaminacije cjepiva tijekom primjene većih pakovanja, preporučuje se upotreba sustava cijepljenja s višestrukim ubrizgavanjem.
English: Marketing authorisation holder: Zoetis Belgium SA
Croatian: Nositelj odobrenja za stavljanje u promet: Zoetis Belgium SA
English: PACKAGE LEAFLET FOR: ZULVAC 8 Bovis suspension for injection for cattle
Croatian: ZULVAC 8 Bovis suspenzija za injekcije za goveda
English: 20 ml (10 doses) 100 ml (50 doses)
Croatian: VELIČINA PAKOVANJA 20 ml (10 doza) 100 ml (50 doza)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC 8 Bovis suspension for injection for cattle
Croatian: ZULVAC 8 Bovis suspenzija za injekciju za goveda
English: Active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus, serotype 8.
Croatian: Aktivna imunizacija goveda od 3 mjeseca starosti na dalje, radi prevencije* viremije uzrokovane virusom bolesti plavog jezika serotipa 8.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKI DJELATNIH TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: TARGET SPECIES Cattle
Croatian: CILJNE VRSTE ŽIVOTINJA
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES One dose of 2 ml contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza od 2 ml cjepiva sadrži:
English: 100 ml (50 doses)
Croatian: VELIČINA PAKOVANJA 100 ml (50 doza)
English: Any person intending to manufacture, import, possess, sell, supply and use ZULVAC 8 BOVIS must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Croatian: Tko namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i/ili primjenjivati ZULVAC 8 Bovis mora se savjetovati s nadležnim tijelom odnosne države članice u pogledu važećih odredbi o cijepljenju prije proizvodnje, uvoza, posjedovanja, prodaje, opskrbe i/ili primjene.
English: Any person intending to manufacture, import, possess, sell, supply and use ZULVAC 8 Bovis must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Croatian: Tko namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i/ili primjenjivati ZULVAC 8 BOVIS mora se savjetovati s nadležnim tijelom odnosne države članice u pogledu važećih odredbi o cijepljenju prije proizvodnje, uvoza, posjedovanja, prodaje, opskrbe i/ili primjene.
English: The manufacture, import, possession, sale, supply and/or use of ZULVAC 8 BOVIS may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Proizvodnja, uvoz, posjedovanje, prodaja, opskrba i/ili primjena ZULVAC 8 BOVIS može biti zabranjena u određenim državama članicama na cijelom ili na dijelu njihovog teritorija sukladno nacionalnim propisima.
English: 6.5 Nature and composition of immediate packaging
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja Staklena bočica tipa
English: After the second injection of a single dose, a slight and transient but significant increase in the mean rectal temperature of 0.4ºC was very commonly recorded in the vaccinated calves during the first 24 hours.
Croatian: Tijekom prva 24 sata nakon druge injekcije pojedinačne doze u cijepljene teladi, vrlo često zabilježen je lagan i prolazan ali značajan porast srednje rektalne temperature od 0,4 ºC.
English: After administration of a double dose, a slight and transient but significant increase in the mean rectal temperature of 0.7 ºC was recorded in the vaccinated calves during the first 24 hours.
Croatian: Tijekom prva 24 sata nakon primjene dvostruke doze, u cijepljene teladi zabilježen je lagan i prolazan, ali značajan porast srednje rektalne temperature od 0,7 ºC.
English: a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunoloških veterinarsko-medicinskih proizvoda na cijelom ili na dijelu svog teritorija ako je utvrđeno da:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) One dose of 2 ml: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Croatian: Jedna doza od 2 ml: inaktivirani virus plavog jezika, serotip 8, soj BTV-8/BEL2006/02
English: 4.2 Indications for use, specifying the target species Active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus, serotype 8.
Croatian: Aktivna imunizacija goveda od 3. mjeseca starosti nadalje radi prevencije* viremije uzrokovane virusom bolesti plavog jezika serotipa 8.
English: ROUTE(S) OF ADMINISTRATION IM
Croatian: 4. PUT(EVI) PRIMJENE
English: WITHDRAWAL PERIOD Withdrawal period: zero days
Croatian: KARENCIJA Karencija: 0 dana
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNIH TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use.
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: Active substance: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1
Croatian: Djelatna tvar: Inaktivirani virus bolesti plavog jezika, serotip 8, soj BTV-8/BEL2006/02
English: After administration of a double dose, a slight and transient but significant increase in the mean rectal temperature of 0.7ºC was recorded in the vaccinated calves during the first 24 hours.
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Tijekom prva 24 sata nakon primjene dvostruke doze, u cijepljene teladi zabilježen je lagan i prolazan, ali značajan porast srednje rektalne temperature od 0,7 ºC.
English: Special precautions for use in animals: Only use in healthy animals
Croatian: Posebne mjere opreza prilikom primjene na životinjama:
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Croatian: • simptomatsko liječenje kroničnog patološkog oštećenja kognitivne i neurosenzoričke funkcije u starijih osoba (isključujući Alzheimerovu bolest i druge demencije)
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Croatian: [trenutno odobrene indikacije navedene u nastavku moraju se izbrisati (specifičan način opisa indikacije može se razlikovati od lijeka do lijeka)]
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Croatian: Sve reference na gore navedene indikacije moraju se izbrisati iz odgovarajućih dijelova uputa o lijeku.
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Croatian: Prilog III Izmjene odgovarajućih dijelova sažetaka opisa svojstava lijeka i uputa o lijeku
English: All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Croatian: Sve reference na gore navedene indikacije moraju se izbrisati iz ostalih odgovarajućih dijelova sažetaka opisa svojstava lijeka.
English: The dose to be given depends on the patient's bodyweight and the infusion is repeated every 3 weeks.
Croatian: Doza koju treba primijeniti ovisi o tjelesnoj težini bolesnika, a infuzija se ponavlja svaka tri tjedna.