FrancophonIA/ELRC3.0 huggingface dataset:
English: Tulathromycin also possesses in vitro activity against Moraxella bovis, the bacterial pathogen most commonly associated with infectious bovine keratoconjunctivitis (IBK).
Croatian: Tulatromicin također ima in vitro djelovanje protiv Moraxella bovis, bakterijskog patogena koji je najčešće povezan sa zaraznim keratokonjunktivitisom goveda (IBK).
English: Ovine, caprine
Croatian: Ovce, koze
English: Porcine 800 µg/kg 300 µg/kg
Croatian: Svinje 800 µg/kg 300 µg/kg
English: 4.8 Interaction with other medicinal products and other forms of interaction
Croatian: 4.8 Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija Javlja se križna rezistencija s drugim makrolidima.
English: Read the package leaflet before use.
Croatian: Prije upotrebe pročitajte uputu.
English: For subcutaneous use.
Croatian: Za subkutanu primjenu.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU OPSKRBE ILI PRIMJENE
English: Vial sizes: 20 ml, 50 ml, 100 ml, 250 ml and 500 ml.
Croatian: Veličine bočica: 20 ml, 50 ml, 100 ml, 250 ml i 500 ml.
English: Manufacturers responsible for batch release: FAREVA AMBOISE
Croatian: FAREVA AMBOISE Zone Industrielle,
English: The safety of tulathromycin during pregnancy and lactation has not been established in cattle and pigs.
Croatian: Neškodljivost tulatromicina tijekom graviditeta i laktacije nije utvrđena.
English: In vitro activity against Dichelobacter nodosus (vir), the bacterial pathogen most commonly associated with infectious pododermatitis (foot rot) in sheep has been demonstrated.
Croatian: Dichelobacter nodosus (vir), dokazano je, da je bakterijski patogen najčešće povezan sa zaraznim pododermatitisom (zarazna šepavost) u ovaca.
English: Monothioglycerol Propylene glycol Citric acid Hydrochloric acid Sodium hydroxide Water for injections
Croatian: Klorovodična kiselina Natrijev hidroksid Voda za injekcije
English: In cattle at dosages of three, five or ten times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake.
Croatian: Kod goveda predoziranih trostrukom, peterostrukom ili deseterostrukom preporučenom dozom uočeni su prolazni znakovi koji se pripisuju nelagodi na mjestu injiciranja i uključuju nemir, tresenje glavom, kopanje zemlje papkom i kratkotrajni gubitak apetita.
English: Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Croatian: Ne primjenjivati na gravidnim kravama ili junicama koje su namijenjene za proizvodnju mlijeka za ljudsku upotrebu,u roku od 2 mjeseca od očekivanog poroda.
English: Clear colourless to slightly yellow solution.
Croatian: Bistra bezbojna do žućkasta otopina.
English: Cattle (meat and offal): 22 days.
Croatian: Goveda (meso i jestive iznutrice): 22 dana.
English: In lambs (approx. 6 weeks old), at dosages of three or five times the recommended dose, transient signs attributed to injection site discomfort were observed, and included walking backwards, head shaking, rubbing the injection site, lying down and getting up, bleating.
Croatian: U janjadi (starih približno 6 tjedana), prilikom doziranja od tri ili pet puta veće doze od preporučene, zabilježeni su prolazni znakovi pripisani nelagodi na mjestu injiciranja, što uključuje hodanje unatrag, tresenje glavom, trljanje mjesta ubrizgavanja, ležanje i ustajanje, blejanje.
English: Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site, generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLSB resistance); by enzymatic inactivation; or by macrolide efflux.
Croatian: ili neke ribosomske proteine; enzimskom modifikacijom (metilacijom) ciljnog mjesta 23S rRNK, što općenito pobuđuje križnu otpornost s linkozamidima i streptograminima skupine B (MLSB rezistencija); enzimskom inaktivacijom; ili makrolidnim efluksom.
English: Pigs (meat and offal): 13 days.
Croatian: Svinje (meso i jestive iznutrice): 13 dana.
English: Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are present for approximately 30 days after injection.
Croatian: Patomorfološke reakcije na mjestu injiciranja (uključujući reverzibilne promjene kongestije, edeme, fibroze i krvarenja) prisutne su približno do 30 dana nakon injiciranja.
English: Sheep (meat and offal): 16 days.
Croatian: Ovce (meso i jestive iznutrice): 16 dana.
English: EXP Once broached use by
Croatian: Jednom otvoren, upotrijebiti do
English: For treatment of cattle over 300 kg bodyweight, divide the dose so that no more than 7.5 ml are injected at one site.
Croatian: Prilikom liječenja goveda težih od 300 kg, dozu treba podijeliti tako da se na jedno mjesto aplicira najviše 7,5 ml.
English: In both bovine and porcine polymorphonuclear cells (PMNs; neutrophils), tulathromycin promotes apoptosis (programmed cell death) and the clearance of apoptotic cells by macrophages.
Croatian: U polimorfonuklearnim stanicama (PMN, neutrofili)goveda i svinja, tulatromicin potiče apoptozu (programirana smrt stanice) i klirens apoptoze stanica pomoću makrofaga.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (20 ml / 50 ml / 100 ml / 250 ml)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija (20 ml / 50 ml / 100 ml / 250 ml)
English: Following intravenous dosing the volume of distribution at steady-state (Vss) was 31.7 l/kg.
Croatian: Nakon intravenoznog doziranja volumen raspodjele u stanju ravnoteže (Vss) bio je 31,7 l/kg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (500 ml)
Croatian: PODACI NA VANJSKOM PAKOVANJU Kartonska kutija (500 ml)
English: Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Croatian: Ne primjenjivati na gravidnim životinjama koje su namijenjene za proizvodnju mlijeka za ljudsku upotrebu, u roku od 2 mjeseca od očekivanog poroda.
English: 5 mg/ml For the full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Primary packaging: Type I glass vial with a fluoropolymer coated chlorobutyl stopper and an aluminium overseal.
Croatian: I s klorobutilnim čepom, obloženim fluoropolimerom i aluminijskom kapicom.
English: Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.
Croatian: IBK) uzrokovanog bakterijom Moraxella bovis koja je osjetljiva na tulatromicin.
English: Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are very common for approximately 30 days after injection in cattle and pigs.
Croatian: Patomorfološke reakcije na mjestu injiciranja (uključujući reverzibilne promjene kongestije, edeme, fibroze i krvarenja) vrlo su česte približno 30 dana nakon injiciranja u goveda i svinja.
English: It differs from many other macrolides in that it has a long duration of action that is, in part, due to its three amine groups; therefore it has been given the chemical subclass designation of triamilide.
Croatian: Razlikuje se od mnogih drugih makrolida po tome što ima dugotrajno djelovanje koje je, djelomično, rezultat njegovih triju amino skupina; stoga je razvrstan u podskupinu triamilida.
English: In young pigs weighing approximately 10 kg given three or five times the therapeutic dose transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness.
Croatian: Kod odojaka od približno 10 kg koji su dobili trostruku ili peterostruku terapijsku dozu uočeni su prolazni znakovi koji se pripisuju boli na mjestu injiciranja i uključuju pretjerano glasanje i nemir.
English: In sheep, the pharmacokinetic profile of tulathromycin, when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, achieved a maximum plasma concentration (Cmax) of 1.19 µg/ml in approximately 15 minutes (Tmax) post-dosing and had an elimination half-life (t1/2) of 69.7 hours.
Croatian: U ovaca, farmakokinetički profil tulatromicina primijenjenog u 1 dozi od 2,5 mg/kg tjelesne težine intramuskularnim putem, maksimalnu koncentraciju u plazmi (Cmax) od 1,19 µg/ml postiže unutar 15
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial (50 ml)
Croatian: OSNOVNI DIJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Bočica (50 ml)
English: Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site,
Croatian: (rRNK) ili neke ribosomske proteine; enzimskom modifikacijom (metilacijom) ciljnog mjesta 23S
English: For treatment of pigs over 80 kg bodyweight, divide the dose so that no more than 2 ml are injected at one site.
Croatian: Pri liječenju svinja težih od 80 kg tjelesne težine, dozu treba podijeliti tako da se na jedno mjesto aplicira najviše 2 ml.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE U PROMET
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (50 ml / 100 ml / 250 ml)
Croatian: PODACI NA VANJSKOM PAKOVANJU Kartonska kutija (50 ml / 100 ml / 250 ml)
English: Lameness was also observed when the hind leg was used as the injection site.
Croatian: Uočena je i šepavost ako je injekcija ubrizgana u stražnji ekstremitet.
English: In cattle, the pharmacokinetic profile of tulathromycin when administered as a single subcutaneous dose of 2.5 mg/kg bodyweight, was characterised by rapid and extensive absorption followed by high distribution and slow elimination.
Croatian: Kada je tulatromicin primijenjen govedima kao pojedinačna subkutana doza od 2,5 mg/kg tjelesne težine, njegov je farmakokinetički profil bio karakteriziran vrlo brzom i ekstenzivnom apsorpcijom nakon koje je uslijedila opsežna distribucija i spora eliminacija.
English: Not for use in animals from which milk is produced for human consumption.
Croatian: Nije za primjenu na životinjama čije mlijeko se koristi za ljudsku uporabu.
English: In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, was also characterised by rapid and extensive absorption followed by high distribution and slow elimination.
Croatian: Kada je tulatromicin bio primijenjen na svinjama kao pojedinačna intramuskularna doza od 2,5 mg/kg tjelesne težine, njegov je farmakokinetički profil također bio karakteriziran vrlo brzom i ekstenzivnom apsorpcijom nakon koje je uslijedila opsežna distribucija i spora eliminacija.
English: For treatment of pigs over 40 kg bodyweight, divide the dose so that no more than 4 ml are injected at one site.
Croatian: Pri liječenju svinja težih od 40 kg, dozu treba podijeliti tako da se na jedno mjesto aplicira najviše 4
English: Name and address of the manufacturers responsible for batch release
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača odgovornih za puštanje serije u promet
English: The volume of distribution at steady-state (VSS) determined after intravenous administration was 11 l/kg.
Croatian: Volumen raspodjele u stanju ravnoteže (Vss) utvrđen nakon intravenske primjene bio je 11 l/kg.
English: The volume of distribution at steady-state (Vss) determined after intravenous administration was 11 l/kg.
Croatian: Volumen raspodjele u stanju ravnoteže (Vss) utvrđen nakon intravenske primjene bio je 11 L/kg.
English: Draxxin 100 mg/ml solution for injection for cattle tulathromycin
Croatian: Draxxin 100 mg/ml otopina za injekciju za goveda tulatromicin
English: PACKAGE LEAFLET: Draxxin 25 mg/ml solution for injection for pigs
Croatian: UPUTA O VMP: Draxxin 25 mg/ml otopina za injekciju za svinje
English: Vial sizes: 50, 100 and 250 ml.
Croatian: Veličine bočica: 50 ml, 100 ml i 250 ml.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Croatian: KOLIČINA DJELATNIH TVARI
English: Draxxin 25 mg/ml solution for injection for pigs
Croatian: Draxxin 25 mg/ml otopina za injekciju za svinje
English: Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, and Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumonia, Haemophilus parasuis and Bordetella bronchiseptica the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively.
Croatian: Tulatromicin je in vitro učinkovit protiv bakterija i mikoplazme: Mannheimia haemolytica, Pasteurella multocida, Histophilus somni i Mycoplasma bovis, te Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis i Bordetella bronchiseptica, bakterijskih patogena koji su najčešće povezani s respiratornim bolestima goveda, odnosno svinja.
English: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep tulathromycin
Croatian: Draxxin 100 mg/ml otopina za injekciju za goveda, svinje i ovce tulatromicin
English: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep Tulathromycin
Croatian: Draxxin 100 mg/ml otopina za injekciju za goveda, svinje i ovce Tulatromicin
English: Withdrawal period: Meat and offal: 22 days.
Croatian: Karencija: Meso i jestive iznutrice: 22 dana.
English: MARKETING AUTHORISATION
Croatian: 16. BROJEVI ODOBRENJA ZA STAVLJANJE U PROMET
English: Draxxin 25 mg/ml solution for injection for pigs Tulathromycin
Croatian: Draxxin 25 mg/ml otopina za injekciju za svinje tulatromicin
English: Draxxin 25 mg/ml solution for injection for pigs tulathromycin
Croatian: Draxxin 25 mg/ml otopina za injekciju za svinje Tulatromicin
English: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep
Croatian: Draxxin 100 mg/ml otopina za injekciju za goveda, svinje i ovce
English: In sheep transient signs of discomfort (head shaking, rubbing injection site, backing away) are very common after intramuscular injection.
Croatian: Nakon intramuskularne primjene u ovaca vrlo su učestali sljedeći znakovi nelagode koji su prolazni (tresenje glavom, trljanje mjesta injiciranja, povlačenje / odmicanje unatrag).
English: De Camprodon, s/n Finca La Riba
Croatian: De Camprodon, s/n
English: 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
Croatian: 2,5 mg tulatromicina/kg tjelesne težine (ekvivalentno 1 ml/40 kg tjelesne težine).
English: Treatment and metaphylaxis of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin.
Croatian: BRD) uzrokovane bakterijama Mannheimia haemolytica, Pasteurella multocida, Histophilus somni i mikoplazmom Mycoplasma bovis koje su osjetljive na tulatromicin.
English: Treatment and metaphylaxis of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin.
Croatian: Liječenje i metafilaksa respiratorne bolesti svinja uzrokovane bakterijama i mikoplazmama: Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae,Haemophilus parasuis i Bordetella bronchiseptica osjetljivim na tulatromicin.
English: A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/10 kg bodyweight) in the neck.
Croatian: Pojedinačna intramuskularna injekcija od 2.5 mg tulatromicina/kg tjelesne težine (ekvivalentno 1 ml/10 kg tjelesne težine) u vrat.
English: A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
Croatian: Pojedinačna subkutana injekcija od 2,5 mg tulatromicina po kilogramu tjelesne težine (ekvivalentno 1 ml/40 kg tjelesne težine).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial (500 ml)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Bočica (500 ml)
English: A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight) in the neck.
Croatian: Pojedinačna intramuskularna injekcija od 2,5 mg tulatromicina po kilogramu tjelesne težine (ekvivalentno 1 ml/40 kg tjelesne težine) u vrat.
English: Withdrawal period: Meat and offal: 13 days.
Croatian: Karencija: Meso i jestive iznutrice: 13 dana.
English: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin.
Croatian: SRD) uzrokovane bakterijama i mikoplazmama: Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae,Haemophilus parasuis i Bordetella bronchiseptica osjetljivih na tulatromicin.
English: Not authorised for use in lactating animals producing milk for human consumption.
Croatian: Nije odobrena primjena na životinjama u laktaciji koja proizvode mlijeko za ljudsku uporabu.
English: PACKAGE LEAFLET: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep
Croatian: UPUTA O VMP Draxxin 100 mg/ml otopina za injekciju za goveda, svinje i ovce
English: Do not use in lactating animals producing milk for human consumption.
Croatian: Ne primjenjivati kod životinja u laktaciji koja proizvode mlijeko za ljudsku uporabu.
English: Not authorised for use in lactating cattle producing milk for human consumption.
Croatian: Nije odobrena primjena na govedima u laktaciji koja proizvode mlijeko za ljudsku uporabu.
English: 5 mg/ml Clear colourless to slightly yellow solution for injection.
Croatian: Bistra bezbojna do žućkasta otopina za injekciju.
English: Muscle Fat
Croatian: Masno tkivo Jetra
English: Cattle (treatment and metaphylaxis) 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
Croatian: Svinje 2,5 mg tulatromicina/kg tjelesne težine (ekvivalentno 1 ml/40 kg tjelesne težine).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial (100 ml / 250 ml)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Bočica (100 ml / 250 ml)
English: EU/2/03/041/007 (100 ml) EU/2/03/041/008 (250 ml)
Croatian: EU/2/03/041/008 (250 ml)
English: Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis and Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively.
Croatian: Tulatromicin je in vitro učinkovit protiv bakterija i mikoplazmi: Mannheimia haemolytica, Pasteurella multocida, Histophilus somni i Mycoplasma bovis, te Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis i Bordetella bronchiseptica,
English: 4.7 Use during pregnancy, lactation or lay
Croatian: 4.7 Primjena tijekom graviditeta, laktacije ili nesenja Laboratorijska ispitivanja na štakorima i kunićima nisu dala nikakve dokaze teratogenog,
English: Target tissues
Croatian: tetrahidroksiheksametil-11
English: Pack size
Croatian: Veličina pakiraja
English: Pharmaceutical Form
Croatian: Farmaceutski oblik Put primjene Unutarnje pakiranje
English: EU Number
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza
English: EU Number
Croatian: Broj (EU) odobrenja Zaštićeno ime
English: (Invented) name Strength Pharmaceutical Form
Croatian: Doza Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja EU/1/15/1041/001 Ivabradine Anpharm 5 mg filmom obložene tablete kroz usta
English: Talk to your doctor or pharmacist before taking this medicine if you have any of the following conditions.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primite ovaj lijek ako imate bilo koje od sljedećih stanja.
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Croatian: Postojeće informacije o lijeku bit će izmijenjene (tekst umetnut, zamijenjen ili izbrisan prema potrebi) kako bi odgovarale dogovorenom tekstu kao što je navedeno u nastavku.
English: Administration of <invented name and strength(s)> should be stopped, and the patient's condition should be treated accordingly.
Croatian: Potrebno je prekinuti primjenu <novoizumljeno ime i jačina(e)>, a stanje bolesnika liječiti na odgovarajući način.
English: If you are allergic or suspected to be allergic to cow's milk.
Croatian: Ako ste alergični ili se sumnja da ste alergični na kravlje mlijeko.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu, prema potrebi, naknadno ažurirati informacije o lijeku u dogovoru s referentnom državom članicom, u skladu s postupcima utvrđenima u poglavlju 4. glave III.
English: In case of combined package leaflet with strength(s) not included in Annex I, the strength(s) of products in Annex I should be specified in the subheading above]
Croatian: U slučaju kombinirane upute o lijeku s jačinom (jačinama) koja(e) nije(nisu) uključena(e) u Prilog I., jačina(e) lijeka(ova) u Prilogu I. treba(ju) biti navedena(e) u podnaslovu iznad]
English: Allergic reactions to cow's milk proteins should be considered in patients receiving <invented name and strength(s)> for the treatment of acute allergic conditions in whom symptoms worsen or who are presenting new allergic symptoms (see section 4.3).
Croatian: Alergijske reakcije na proteine kravljeg mlijeka je potrebno uzeti u obzir u bolesnika koji primaju <novoizumljeno ime i jačina(e)> za liječenje akutnih alergijskih stanja u kojih se simptomi pogoršavaju ili u kojih se javljaju novi alergijski simptomi (vidjeti dio 4.3).
English: Serious allergic reactions, including bronchospasm and anaphylaxis, were reported in patients allergic to cow's milk proteins who were treated for acute allergic conditions.
Croatian: Ozbiljne alergijske reakcije, uključujući bronhospazam i anafilaksiju, prijavljene su u bolesnika koji su alergični na proteine kravljeg mlijeka, a koji su primali terapiju za akutna alergijska stanja.
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Croatian: Ove izmjene i dopune odgovarajućih dijelova Sažetka opisa svojstava lijeka i Upute o lijeku rezultat su arbitražnog postupka.
English: [A warning should be included as follows.
Croatian: [Potrebno je uključiti upozorenje kako slijedi.
English: <Invented name and strength(s)> contains lactose <monohydrate> produced from bovine origin as an excipient and may therefore contain trace amounts of cow's milk proteins (the allergens of cow's milk).
Croatian: <Novoizumljeno ime i jačina(e)> sadrži laktozu <hidrat> goveđeg porijekla kao pomoćnu tvar te stoga može sadržavati proteine kravljeg mlijeka u tragovima (alergeni kravljeg mlijeka).
English: Annex III Amendments to relevant sections of the Product Information
Croatian: Izmjene i dopune odgovarajućih dijelova informacija o lijeku
English: [A warning should be included as follows]
Croatian: [Potrebno je uključiti upozorenje kako slijedi]
English: What you need to know before you are given <invented name> Do not use <invented name and strength(s)>:
Croatian: Što morate znati prije nego primite <novoizumljeno ime>
English: 4.3 Contraindications [The following contraindication should be included]
Croatian: [Potrebno je uključiti sljedeću kontraindikaciju]