FrancophonIA/ELRC3.0 huggingface dataset:
English: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): increased levels of “ketone bodies” in your urine or blood rapid weight loss feeling sick or being sick stomach pain excessive thirst fast and deep breathing confusion unusual sleepiness or tiredness a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Croatian: povišene razine “ketonskih tijela” u mokraći ili krvi nagli gubitak tjelesne težine mučnina ili povraćanje bol u trbuhu prekomjerna žeđ ubrzano i duboko disanje smetenost neuobičajena pospanost ili umor zadah slatkog mirisa, slatki ili metalni okus u ustima ili drugačiji miris mokraće ili znoja.
English: NAME OF THE MEDICINAL PRODUCT Invokana 100 mg film-coated tablets
Croatian: NAZIV LIJEKA Invokana 100 mg filmom obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Invokana 100 mg tablets Invokana 300 mg tablets canagliflozin
Croatian: NAZIV LIJEKA Invokana 100 mg tablete Invokana 300 mg tablete kanagliflozin
English: Latvija Janssen-Cilag Polska Sp. z o.o.
Croatian: Latvija Janssen-Cilag Polska Sp. z o.o. filiāle Latvijā
English: • Invokana 100 mg film-coated tablets (tablets) are yellow, capsule-shaped, 11 mm long, with
Croatian: Kako Invokana izgleda i sadržaj pakiranja - Invokana 100 mg filmom obložene tablete (tablete) su žute, oblikovane poput kapsule, dužine
English: Table 2: Efficacy results from placebo-controlled clinical studiesa
Croatian: Tablica 2: Rezultati djelotvornosti iz placebo-kontroliranih kliničkih ispitivanjaa Monoterapija (26 tjedana) Kanagliflozin
English: Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea
Croatian: Trojna terapija s metforminom i sulfonilurejom (26 tjedana) Kanagliflozin + metformin i sulfonilureja
English: • bone fracture
Croatian: Fraktura kostijue
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Croatian: U slučaju pojave nespecifičnih simptoma poput mučnine, povraćanja, anoreksije, boli u abdomenu,
English: Steady-state was reached after 4 days to 5 days of once-daily dosing with canagliflozin 100 mg to 300 mg. Canagliflozin does not exhibit time-dependent pharmacokinetics, and accumulated in plasma up to 36% following multiple doses of 100 mg and 300 mg.
Croatian: Kanagliflozin ne pokazuje farmakokinetiku ovisnu o vremenu, te se akumulirao u plazmi do 36% nakon višekratnih doza od 100 mg i 300 mg.
English: Invokana 100 mg film-coated tablets Invokana 300 mg film-coated tablets canagliflozin
Croatian: Invokana 100 mg filmom obložene tablete Invokana 300 mg filmom obložene tablete kanagliflozin
English: NAME OF THE MEDICINAL PRODUCT Invokana 300 mg film-coated tablets
Croatian: NAZIV LIJEKA Invokana 300 mg filmom obložene tablete
English: In patients tolerating canagliflozin whose eGFR falls persistently below 60 mL/min/1.73 m2 or CrCl 60 mL/min, the dose of canagliflozin should be adjusted to or maintained at 100 mg once daily.
Croatian: 60 mL/min/1,73 m2 ili CrCl 60 mL/min, doza kanagliflozina mora se prilagoditi ili održavati na 100 mg jedanput dnevno.
English: NO-1325-Lysaker Tlf: +47 24 12 65 00
Croatian: Janssen-Cilag AS Drammensveien 288 Postboks 144 NO-1325-Lysaker Tlf: +47 24 12 65 00
English: In other type 2 diabetes studies with canagliflozin, which enrolled a general diabetes population of approximately 5,800 patients, no difference in fracture risk was observed relative to control.
Croatian: U drugim ispitivanjima dijabetesa tipa 2 s kanagliflozinom, koja su uključila opću populaciju s dijabetesom od oko
English: SK-821 08 Bratislava Tel: +421 232 408 400
Croatian: SK-821 08 Bratislava
English: Reporting of side effects
Croatian: Prijavljivanje nuspojave
English: Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 1.5% for placebo.
Croatian: k Srednje vrijednosti postotka promjene kreatinina u odnosu na početnu bila je 2,8% i 4,0% za kanagliflozin od 100 mg odnosno 300 mg naspram 1,5% za placebo.
English: Patients with renal impairment For patients with an eGFR 60 mL/min/1.73 m2 to < 90 mL/min/1.73 m2 or CrCl 60 mL/min to
Croatian: U bolesnika s eGFR 60 mL/min/1,73 m2 do < 90 mL/min/1,73 m2 ili s CrCl 60 mL/min do
English: In the clinical development programme, 1,085 patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 were evaluated.
Croatian: 1085 bolesnika s početnom vrijednosti eGFR 30 mL/min/1,73 m2 do < 60 mL/min/1,73 m2.
English: respectively, compared to 0.6% for placebo.
Croatian: odnosno 4,3%) u usporedbi s 4,0% s placebom.
English: NAME OF THE MEDICINAL PRODUCT Invokana 100 mg film-coated tablets Invokana 300 mg film-coated tablets canagliflozin
Croatian: Uputa o lijeku: Informacija za bolesnika Invokana 100 mg filmom obložene tablete Invokana 300 mg filmom obložene tablete kanagliflozin
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Croatian: Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 100 mg kanagliflozina.
English: Baseline (mean) in kg % change from baseline (adjusted mean) Difference from glimepiride (adjusted mean) (95% CI)
Croatian: Početna vrijednost (srednja vrijednost) u kg % promjene u odnosu na početnu vrijednost (prilagođena srednja vrijednost) Razlika u odnosu na glimepirid
English: Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.0% for placebo.
Croatian: Srednje vrijednosti promjene hematokrita u odnosu na početnu bila je 2.4% i 2,5% za kanagliflozin od 100 mg odnosno 300 mg naspram 0,0% za placebo.
English: In patients with an eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 or CrCl 45 mL/min to
Croatian: Bolesnici s eGFR 45 mL/min/1,73 m2 do < 60 mL/min/1,73 m2
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin.
Croatian: Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 300 mg kanagliflozina.
English: When pregnancy is detected, treatment with canagliflozin should be discontinued.
Croatian: Liječenje kanagliflozinom mora se prekinuti ako se ustanovi trudnoća.
English: • nausea
Croatian: • koprivnjača
English: Iron oxide yellow (E172)
Croatian: Filmska ovojnica polivinilni alkohol titanijev dioksid (E171)
English: CrCl < 60 mL/min.
Croatian: 476 kcal/dan.
English: Urinary tract infections
Croatian: Infekcije mokraćnog sustava
English: Patients (%) achieving HbA1c < 7% 19.8b
Croatian: Bolesnici (%) koji su postigli HbA1c
English: Difference from placebo (adjusted mean) (95% CI)
Croatian: (prilagođena srednja vrijednost) (95% CI)
English: EU/1/13/884/001 (10 tablets) EU/1/13/884/002 (30 tablets) EU/1/13/884/003 (90 tablets) EU/1/13/884/004 (100 tablets)
Croatian: EU/1/13/884/003 (90 tableta)
English: Tell your doctor as soon as possible if you get any of the signs of low blood sugar.
Croatian: Što je prije moguće recite svom liječniku ako imate bilo koju od slijedećih nuspojava:
English: Urinary tract infections were more frequently reported for canagliflozin 100 mg and 300 mg (5.9% versus 4.3%, respectively) compared to 4.0% with placebo.
Croatian: Infekcije mokraćnog sustava bile su češće prijavljene za kanagliflozin od 100 mg i 300 mg (5,9%
English: Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular.
Croatian: Osip uključuje pojmove eritemni osip, generalizirani osip, makularni osip, makulopapularni osip, papularni osip,
English: Urine glucose
Croatian: Glukoza u mokraći
English: Change from baseline (adjusted mean) Difference from glimepiride (adjusted mean) (95% CI)
Croatian: % promjene u odnosu na početnu vrijednost (prilagođena srednja vrijednost) Razlika u odnosu na glimepirid
English: < 60 mL/min taking canagliflozin 100 mg who are receiving concurrent therapy with a UGT enzyme inducer and who require additional glycaemic control, other glucose-lowering therapies should be considered (see sections 4.2 and 4.4).
Croatian: U bolesnika s eGFR 45 mL/min/1,73 m2 do < 60 mL/min/1,73 m2 ili CrCl 45 mL/min do < 60 mL/min koji uzimaju kanagliflozin od 100 mg, koji istovremeno primaju terapiju induktorima UGT enzima i koji zahtjevaju dodatnu regulaciju glikemije, u obzir treba uzeti druge lijekove za snižavanje glukoze (vidjeti dijelove 4.2 i 4.4).
English: Patients (%) achieving HbA1c < 7% 53.6 Body weight
Croatian: Bolesnici (%) koji su postigli HbA1c Tjelesna težina
English: Janssen-Cilag Polska Sp. z o.o.
Croatian: Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Lõõtsa 2
English: For patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2, the incidences were 4.8% on canagliflozin 100 mg and 8.1% on canagliflozin 300 mg compared to 2.6% in the control group.
Croatian: Bolesnici s početnom vrijednosti eGFR 45 mL/min/1,73 m2 do < 60 mL/min/1,73 m2 koji su liječeni kanagliflozinom od 100 mg i 300 mg pokazali su poboljšanja srednje vrijednosti postotka promjene tjelesne težine u odnosu na placebo od -1,8% odnosno -2,0%.
English: respectively, compared to 1.5% for placebo.
Croatian: 100 mg odnosno 300 mg naspram 1,5% za placebo.
English: The overall incidence of elevated serum potassium was higher in patients with moderate renal impairment with incidences of 7.5%, 12.3%, and 8.1% on canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Croatian: Ukupna incidencija povišenog kalija u serumu bila je viša u bolesnika s umjerenim oštećenjem bubrega uz kanagliflozin od 100 mg, kanagliflozin od 300 mg, odnosno placebo s incidencijama od
English: Canagliflozin + insulin
Croatian: Primijećeno je da kanagliflozin inhibira
English: • other antidiabetics - either insulin or a sulphonylurea (such as glimepiride or glipizide) - your doctor may want to reduce your dose in order to avoid your blood sugar level from getting too low (hypoglycaemia)
Croatian: • druge antidijabetike - ili inzulin ili sulfonilureju (poput glimepirida ili glipizida) - liječenik će
English: canagliflozin treatment should be discontinued.
Croatian: Liječenje kanagliflozinom mora se prekinuti u slučaju da je eGFR
English: Johnson & Johnson România SRL Str. Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5 013714 Bucureşti, ROMÂNIA Tel: +40 21 207 1800
Croatian: Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5
English: Change from baseline (adjusted mean) Difference from sitagliptin (adjusted mean) (95% CI)
Croatian: % promjene u odnosu na početnu vrijednost (prilagođena srednja vrijednost) Razlika u odnosu na sitagliptin
English: Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg, compared to 1.5% for placebo.
Croatian: Srednje vrijednosti postotka promjene kalija u krvi u odnosu na početnu bila je 0,5% i 1,0% za kanagliflozin od 100 mg odnosno 300 mg naspram 0,6% za placebo.
English: h
Croatian: m
English: j Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively,
Croatian: j Srednje vrijednosti promjene hematokrita u odnosu na početnu bila je 2.4% i 2,5% za kanagliflozin od 100 mg odnosno 300 mg naspram 0,0% za placebo.
English: Adverse reaction
Croatian: Peroralna primjena
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Početna vrijednost (srednja vrijednost)
English: d Based on postmarketing experience with canagliflozin.
Croatian: pruritički osip, pustularni osip i vezikularni osip. d Temeljeno na iskustvu nakon stavljanja kanagliflozina u promet.
English: Tell your doctor as soon as possible if you have any of the following side effects: Hypoglycaemia (very common, may affect more than 1 in 10 people)
Croatian: Dijabetička ketoacidoza (rijetko, može se javiti u do 1 na 1000 osoba)
English: Pregnancy
Croatian: Proizvođač
English: Based on postmarketing experience with canagliflozin.
Croatian: Djelovanje drugih lijekova na kanagliflozin
English: Patients (%) achieving HbA1c < 7% Body weight Baseline (mean) in kg % change from baseline (adjusted mean)
Croatian: HbA1c, postotak bolesnika koji su postigli HbA1c < 7%, promjenu u odnosu na početnu vrijednost glukoze u plazmi natašte (FPG) i 2-satne postprandijalne glukoze (PPG).
English: n Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg,
Croatian: n Srednje vrijednosti postotka promjene fosfata u krvi u odnosu na početnu bila je 3,6% i 5,1% za kanagliflozin od
English: Angioedemad
Croatian: Nuspojava
English: An additional statement may be necessary to take account of this possibility.
Croatian: Tada može zatrebati dodatni navod o toj mogućnosti.
English: *** The actual name of the container should be used (e.g. bottle, blister, etc.)
Croatian: *** Treba koristiti odgovarajući naziv spremnika (npr. bočica, blister, itd.).
English: Low temperatures may also have an effect on the packaging in certain cases.
Croatian: U određenim slučajevima niske temperature mogu utjecati i na pakovanje.
English: The statement should only be used in exceptional cases.
Croatian: Navod treba koristiti samo u iznimnim slučajevima.
English: ***** Depending on the pharmaceutical form and the properties of the product, there may be a risk of deterioration due to physical changes if subjected to low temperatures.
Croatian: ***** Ovisno o farmaceutskom obliku i svojstvima lijeka, postoji opasnost od nepoželjnih promjena uzrokovanih fizičkim promjena nastalim uslijed izlaganja lijeka niskim temperaturama.
English: ** The statement should be used only when critical.
Croatian: ** Navod treba koristiti samo u kritičnim slučajevima.
English: **** It should be specified if the product is sensitive to light and/or moisture.
Croatian: **** Potrebno je posebno naznačiti ukoliko je lijek osjetljiv na svjetlost i/ili vlagu.
English: * The stability data generated at 25(C/60%RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary.
Croatian: * Prilikom odlučivanja da li je neophodan prijevoz na hladnom uzeti u obzir prikupljene podatke o stabilnosti na 25(C/60%RV (acc).
English: <This medicine does not require any special storage conditions>
Croatian: <Lijek ne zahtijeva posebne uvjete čuvanja>
English: STORING X
Croatian: 5. KAKO ČUVATI X
English: <Store in a refrigerator (2(C - 8(C)>
Croatian: <Čuvati u hladnjaku (2(C - 8(C)>
English: ENGLISH
Croatian: HRVATSKI
English: <Store and transport refrigerated (2(C - 8(C)>*
Croatian: <Čuvati i prevoziti na hladnom (2(C - 8(C)>*
English: <Store and transport frozen {temperature range}>**
Croatian: <Čuvati i prevoziti zamrznuto {temperaturni raspon}>**
English: <This medicine does not require any special temperature storage conditions>*****
Croatian: <Lijek ne zahtijeva čuvanje na određenoj temperaturi>*****
English: <Store in a refrigerator>
Croatian: <Čuvati u hladnjaku>
English: <Store and transport frozen>**
Croatian: <Čuvati i prevoziti zamrznuto>**
English: SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: <Store in a freezer {temperature range}>
Croatian: <Čuvati u zamrzivaču {temperaturni raspon}>
English: <Store in a freezer>
Croatian: <Čuvati u zamrzivaču>
English: <Store and transport refrigerated>*
Croatian: <Čuvati i prevoziti na hladnom>*
English: This product contains mineral oil.
Croatian: Proizvod sadrži mineralno ulje.
English: Shake well before use.
Croatian: Dobro protresti prije upotrebe.
English: ATC-vet code: QI01AA23.
Croatian: ATCvet kod: QI01AA23
English: White homogeneous emulsion.
Croatian: Homogena bijela emulzija.
English: Glass vials: 1 year.
Croatian: Staklene bočice: 1 godinu.
English: 4.8 Interactions with other medicinal products and other forms of interaction
Croatian: 4.8 Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija
English: Sorbitane mono-oleate Glycine
Croatian: Sorbitan mono-oleat Glicin
English: 37008 Carbajosa de la Sagrada Salamanca
Croatian: 37008 Carbajosa de la Sagrada
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Croatian: Ako bol potraje više od 12 sati nakon liječničkog pregleda, ponovo potražite pomoć liječnika.
English: Active substance:
Croatian: Aktivna tvar:
English: Allow the vaccine to reach a temperature of 15 °C - 25 °C.
Croatian: Pričekati da cjepivo dostigne temperaturu od 15°C - 25
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Croatian: Nemojte koristiti ovaj veterinarsko medicinski proizvod nakon isteka roka valjanosti navedenog na naljepnici.
English: Efficacy has been evaluated on the basis of preliminary results in chickens.
Croatian: Učinkovitost je procijenjena na temelju preliminarnih rezultata kod pilića.
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 navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodataka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u ovom veterinarsko medicinskom proizvodu.
English: Shelf-life of the veterinary medicinal product as packaged for sale: PET vials: 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: PET bočice: 2 godine.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated.
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati i prevoziti rashlađeno.
English: Use sterile syringes and needles.
Croatian: Koristiti sterilne šprice i igle.
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: Zbog toga odluku o upotrebi ovog cjepiva prije ili poslije drugog veterinarsko-medicinskog proizvoda treba donijeti ovisno od slučaja do slučaja.
English: The level of efficacy for other species may differ from that observed in chickens.
Croatian: Razina učinkovitosti za druge vrste mogu se razlikovati od onoga u pilića.
English: Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination.
Croatian: Smanjenje kliničkih znakova, smrtnosti i izlučivanje virusa nakon izlaganja dokazani su tri tjedna nakon cijepljenja.
English: Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine.
Croatian: Prisustvo serumskih antitijela može se očekivati 12 mjeseci nakon primjene dvije doze cjepiva.
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Croatian: b) je bolest za koju je odnosni proizvod namijenjen da pruži imunost, odsutna s tog područja.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: SADRŽAJ: TEŽINA, VOLUMEN IL BROJ DOZA
English: Adjuvant:
Croatian: Adjuvans:
English: Pharmacotherapeutic group: Immunologicals for Aves; Inactivated viral vaccines, avian influenza virus.
Croatian: Farmakoterapijska grupa:Imunologija za perad, inaktivirana virusna cjepiva, virus ptičje influence.
English: Name and address of the manufacturers of the biological active substance
Croatian: Naziv i adresa proizvođača biološki djelatne tvari
English: For subcutaneous or intramuscular use.
Croatian: Za potkožnu ili intramuskularnu upotrebu.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da se javite veterinaru.
English: 3732 CN De Bilt
Croatian: Ambachtstraat 4 3732 CN De Bilt
English: It is recommended to use a closed multiject vaccination system.
Croatian: Preporuča se upotreba zatvorenog uređaja za višestruko injiciranje.
English: Do not mix with any other veterinary medicinal product.
Croatian: Ne miješati sa bilo kojim drugim veterinarsko medicinskim proizvodom.
English: Store and transport refrigerated (2 °C - 8 °C).
Croatian: Čuvati i transportirati ohlađeno ( 2°C - 8°C).
English: Any person intending to manufacture, import, possess, sell, supply and/or use Nobilis Influenza H5N2 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 uvesti, prodavati, opskrbljivati i/ili primjenjivati Nobilis Influenza H5N2 mora konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju prije uvoza, prodaje, opskrbe i/ili primjene.
English: MARKETING AUTHORISATION NUMBER EU/2/06/061/001-004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/061/001-004
English: The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Croatian: Boce se zatvaraju s gumenim čepom i aluminijskom kapicom.
English: DATE OF REVISION OF THE TEXT Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove (EMA) http://www.ema.europa.eu/.>
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION Date of first authorisation: 01/09/2006
Croatian: Datum prvog odobrenja: 01/09/2006
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: - 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: This vaccine has been tested for safety in chickens.
Croatian: Ovo cjepivo je testirano na neškodljivost u pilića.
English: No information is available on vaccination in the presence of maternally derived antibodies.
Croatian: Nema dostupnih informacija o cijepljenju u prisustvu materalnih antitijela.
English: One dose of 0.5 ml contains:
Croatian: Jedna doza od 0,5 ml sadrži:
English: Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.
Croatian: Inaktivirani antigen podtip H5N2 virusa ptičje influence (soj A/pačji/Potsdam/1402/86) koji inducira HI titar najmanje 6,0 Log2, testirano prema potencijskom testu.
English: The manufacture, import, possession, sale, supply and/or use of Nobilis Influenza H5N2 may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Proizvodnja, uvoz, prodaja, opskrba i/ili primjena Nobilis Influenza H5N2 je ili može biti zabranjena u određenim državama članicama na cijelom teritoriju ili na jednom njegovom dijelu sukladno nacionalnim odredbama zaštite zdravlja životinja.
English: If used in other avian species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of birds prior to mass vaccination.
Croatian: Ako se koristiti kod drugih ptičjih vrsta kod kojih postoji rizik od infekcije, njegovu primjenu u tih vrsta treba provoditi pažljivo te je poželjno testirati cjepivo na malom broj ptica prije masovnog cijepljenja.
English: Do not administer intramuscularly in chickens less than 2 weeks old.
Croatian: Ne smije se primjenjivati intramuskularno kod pilića mlađih od 2 tjedana starosti.