FrancophonIA/ELRC3.0 huggingface dataset:
English: Each pre-filled syringe contains 30 MU (equivalent to 300 micrograms of filgrastim in 0.5 ml solution for injection or infusion.
Croatian: Jedna napunjena štrcaljka sadrži 30 MU (što odgovara 300 mikrograma) filgrastima u 0,5 ml otopine za injekciju ili infuziju.
English: Congenital neutropenia The recommended starting dose is 1.2 MU (12 µg)/kg/day as a single dose or in divided doses.
Croatian: Kongenitalna neutropenija Preporučena početna doza je 1,2 MU (12 µg))/kg/dan primijenjena u jednoj ili više doza.
English: • Get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder( these may be symptoms of enlarge spleen (splenomegaly) or possibly rupture of spleen).
Croatian: • osjetite bol u gornjem dijelu trbuha (abdomena), bol ispod lijeve strane prsnog koša ili na vrhu lijevog ramena (to mogu biti simptomi povećane slezene (splenomegalija) ili rupture slezene).
English: Each pre-filled syringe contains 48 MU (equivalent to 480 micrograms of filgrastim in 0.5 ml solution for injection or infusion.
Croatian: Jedna napunjena štrcaljka sadrži 48 MU (što odgovara 480 mikrograma) filgrastima u 0,5 ml otopine za injekciju ili infuziju.
English: MedDRA system organ class
Croatian: MedDRA klasifikacij a organskih sustava
English: Myelodysplastic syndrome or Chronic myeloid leukemia The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome or chronic myelogenous leukaemia have not been established.
Croatian: Sigurnost i djelotvornost primjene filgrastima u bolesnika s mijelodisplastičnim sindromom ili kroničnom mijeloičnom leukemijom nisu ustanovljene.
English: See leaflet for further information.
Croatian: Dodatne informacije potražite u Uputi o lijeku.
English: For mobilisation of peripheral blood progenitor cells (PBPC) in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MU (10 µg)/kg/day for 5-7 consecutive days.
Croatian: ABN = apsolutni broj neutrofila Mobilizacija stanica preteča periferne krvi u bolesnika u tijeku mijelosupresivnog i mijeloablativnog liječenja nakon kojeg slijedi transplantacija autolognih stanica preteča periferne krvi Preporučena doza filgrastima za mobilizaciju stanica preteča periferne krvi kad se primjenjuje sam iznosi 1,0 MU(10 µg)/kg/dan tijekom 5 do 7 uzastopnih dana.
English: Each pre-filled syringe contains 30 MU (300 micrograms) filgrastim in 0.5 ml, corresponding to 0.6 mg/ml.
Croatian: Svaka napunjena šrcaljka sadrži 30 MU (300 mikrograma) filgrastima u 0,5 ml, što odgovara koncentraciji od 0,6 mg/ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton - Pre-filled syringe with a needle safety guard in blister pack
Croatian: - Napunjena štrcaljka sa sigurnosnim štitnikom za iglu u blister pakiranju
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration.
Croatian: Nakon primjene G-CSF-a zabilježene su plućne nuspojave, osobito intersticijska pneumonija.
English: Cases of Sweets syndrome (acute febrile dermatosis) have been reported in the post-marketing setting.
Croatian: Nakon stavljanja lijeka u promet zabilježeni su slučajevi Sweetsovog sindroma (akutne febrilne dermatoze).
English: Each pre-filled syringe contains 48 MU (480 micrograms) filgrastim in 0.5 ml, corresponding to 0.96 mg/ml.
Croatian: Svaka napunjena šrcaljka sadrži 48 MU (480 mikrograma) filgrastima u 0,5 ml, što odgovara koncentraciji od 0,96 mg/ml.
English: Respiratory failurea
Croatian: Plućne nuspojave
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) of filgrastim.
Croatian: Jedan ml otopine sadrži 60 milijuna jedinica (MU) (što odgovara 600 mikrograma [µg]) filgrastima.
English: Pre-filled syringe with needle safety guard h.
Croatian: Napunjena štrcaljka sa sigurnosnim štitnikom za iglu h.
English: Gammaglutamyl transferase increased Aspartate aminotransfera se increased
Croatian: Poremećaji jetre i žuči povišena alkalna fosfataza u krvi hepatomegali ja povišena gamaglutamil transferaza povišena aspartat aminotransfera za
English: Metabolism and nutrition disorders
Croatian: Nuspojave klasifikacij a organskih sustava
English: For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MU (10 µg)/kg/day for 4 - 5 consecutive days.
Croatian: Za mobilizaciju stanica preteča periferne krvi u zdravih darivatelja, filgrastim je potrebno primijeniti u dozi od 1,0 MU (10 µg)/kg/dan tijekom 4-5 uzastopnih dana.
English: Do not use Accofil if you notice it is cloudy, or there is discoloration or there are particles in it. Do not put the cover back on used needles, as you may accidentally prick yourself.
Croatian: Nemojte stavljati poklopac natrag na korištene igle, jer se možete slučajno ubosti.
English: • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Croatian: • upala krvnih žila kože (kožni vaskulitis)
English: Accofil and bone marrow transplantation
Croatian: Accofil i presađivanje koštane srži
English: • if you get left upper belly (abdonimal) pain, pain below the left rib cage or pain at the tip of your shoulder since this may relate to a problem with your spleen (enlargement of the spleen (splenomegaly) or rupture of the spleen)..
Croatian: • ako osjetite bol u gornjem lijevom dijelu trbuha, bol ispod lijevog rebrenog luka ili bol u vrhu ramena, budući da to može biti povezano s tegobama sa slezenom (povećanje slezene (splenomegalija) ili ruptura slezene).
English: The safety and efficacy of Accofil are similar in adults and children receiving cytotoxic chemotherapy.
Croatian: Sigurnost i djelotvornost Accofila u djece koja primaju citotoksičnu kemoterapiju slične su onima u odraslih.
English: Dizziness, Hypoaesthesia, Paraesthesia
Croatian: Poremećaji živčanog sustava glavoboljaa omaglica, hipoestezija, parestezija
English: How Accofil is given
Croatian: Kako se Accofil primjenjuje
English: Always keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further.
Croatian: Uvijek držite nabor kože između prstiju te polako i jednoliko potiskujte klip dok ne primijenite cijelu dozu i dok se klip ne bude mogao dalje potisnuti.
English: Cases of splenomegaly and splenic rupture have been reported uncommonly following administration of filgrastim.
Croatian: Slučajevi splenomegalije i rupture slezene zabilježeni su manje često nakon primjene filgrastima.
English: Pyrophosphate) Fluid volume
Croatian: (poremećaj volumena tekućine)
English: Name and address of the manufacturer(s) of the biological active substance(s) Intas Pharmaceuticals Ltd.
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
English: Name and address of the manufacturer(s) responsible for batch release Accord Healthcare Ltd.
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: Malaise e
Croatian: I DOHVATA
English: Cutaneous vasculitis
Croatian: kožni vaskulitisa
English: Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Croatian: Posebna upozorenja i mjere opreza za sve indikacije Filgrastim se ne smije primjenjivati za povećanje doze citotoksične kemoterapije iznad doza propisanih u standardnim kemoterapijskim protokolima.
English: The mechanism of vasculitis in patients receiving Filgrastim is unknown.
Croatian: Nije poznat mehanizam vaskulitisa kod bolesnika koji primaju filgrastim.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti svog liječnika, ljekarnika ili medicinsku sestru.
English: Very common side effects (seen in more than 1 in 10 people who take Accofil):
Croatian: Vrlo česte nuspojave (javljaju se u više od 1 na 10 osoba koje primaju Accofil):
English: Cutaneous vasculitis has been reported in patients treated with Filgrastim.
Croatian: Kožni vaskulitis zabilježen je kod bolesnika liječenih filgrastimom.
English: Cases of splenomegaly and splenic rupture have been reported following administration of filgrastim.
Croatian: Manje česti slučajevi splenomegalije i rupture slezene zabilježeni su nakon primjene filgrastima.
English: Transfusion reactione a See section 4.8, Description of selected adverse reactions b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section 4.8, Description of selected adverse reactions) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain,
Croatian: Ozljede, trovanja i procedural ne komplikaci je tranfuzijska reakcijae aVidjeti odjeljak 4.8, Opis odabranih nuspojava bZabilježeni su slučajevi GvHD-a i smrtni ishodi u bolesnika nakon transplantacije alogene koštane srži (vidjeti odjeljak 4.8, Opis odabranih nuspojava) Uključuje koštanu bol, bol u leđima, artralgiju, mialgiju, bol u udovima, mišićno-koštanu bol prsišta, bol u vratu dSlučajevi opaženi nakon stavljanja filgrastima u promet u bolesnika kojima je transplantirana koštana srž ili je rađena mobilizacija stanica preteča koštane srži eNuspojave s povećanom učestalošću kod bolesnika koji su primali filgrastim u usporedbi s placebom te koje su povezane s posljedicama osnovne maligne bolesti ili citotoksične kemoterapije
English: Cases of splenomegaly have been reported very commonly and cases of splenic rupture have been reported commonly following administration of filgrastim.
Croatian: Nakon primjene filgrastima vrlo često su prijavljeni slučajevi splenomegalije a slučajevi rupture slezene često.
English: Special precautions in recipients of allogeneic PBPC mobilised with filgrastim
Croatian: Posebne mjere opreza u primatelja alogenih stanica preteča periferne krvi mobiliziranih filgrastimom
English: Thrombocytopenia has been reported commonly in patients receiving filgrastim.
Croatian: Trombocitopenija je često zabilježena u bolesnika koji primaju filgrastim.
English: Rare side effects (seen in more than 1 in 10,000 people taking Accofil):
Croatian: Rijetke nuspojave (javljaju se u više od 1 na 10.000 osoba koje primaju Accofil):
English: EU/1/14/946/003 - 1 prefilled syringe EU/1/14/946/004 - 5 prefilled syringes EU/1/14/946/012 - 3 prefilled syringe EU/1/14/946/015 - 10 prefilled syringe
Croatian: EU/1/14/946/003 - 1 napunjena štrcaljka EU/1/14/946/004 - 5 napunjenih štrcaljki EU/1/14/946/012 - 3 napunjene štrcaljke EU/1/14/946/015 - 10 napunjenih štrcaljki
English: Sarkhej Bavla Highway
Croatian: Procjena prinosa stanica preteča
English: Oropharyngeal paina,e
Croatian: Proljeva,e
English: EU/1/14/946/011 - 1 prefilled syringe with a needle safety guard EU/1/14/946/014 - 5 prefilled syringes with a needle safety guard EU/1/14/946/013 - 3 prefilled syringe with a needle safety guard EU/1/14/946/016 - 10 prefilled syringe with a needle safety guard EU/1/14/946/018 - 7 prefilled syringe with a needle safety guard
Croatian: EU/1/14/946/011 - 1 napunjena štrcaljka sa sigurnosnin štitnikom za iglu EU/1/14/946/014 - 5 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/013 - 3 napunjene štrcaljke sa sigurnosnim štitnikom za iglu EU/1/14/946/016 - 10 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/018 - 7 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu
English: The use of filgrastim-mobilised PBPCs has been shown to reduce the depth and duration of thrombocytopenia following myelosuppressive or myeloablative chemotherapy.
Croatian: Pokazalo se da primjena filgrastimom mobiliziranih stanica preteča periferne krvi smanjuje jačinu i trajanje trombocitopenije nakon mijelosupresivne ili mijeloablativne kemoterapije.
English: TRM
Croatian: Nuspojave
English: EU/1/14/946/001 - 1 prefilled syringe EU/1/14/946/002 - 5 prefilled syringes EU/1/14/946/006 - 3 prefilled syringe EU/1/14/946/009 - 10 prefilled syringe
Croatian: EU/1/14/946/001 - 1 napunjena štrcaljka EU/1/14/946/002 - 5 napunjenih štrcaljki EU/1/14/946/006 - 3 napunjene štrcaljke EU/1/14/946/009 - 10 napunjenih štrcaljki
English: • pain when passing urine (dysuria)
Croatian: • bol prilikom mokrenja (dizurija)
English: Acute respiratory distress syndromea
Croatian: hemoptiza dispneja kašalja akutni respiratorni distres
English: Subcutaneous or intravenous use.
Croatian: Za potkožnu primjenu ili primjenu u venu.
English: µg/kg/day).
Croatian: (300 mikrograma).
English: EU/1/14/946/005 - 1 prefilled syringe with a needle safety guard EU/1/14/946/008 - 5 prefilled syringes with a needle safety guard EU/1/14/946/007 - 3 prefilled syringe with a needle safety guard EU/1/14/946/010 - 10 prefilled syringe with a needle safety guard EU/1/14/946/017 - 7 prefilled syringe with a needle safety guard
Croatian: EU/1/14/946/005 - 1 napunjena štrcaljka sa sigurnosnim štitnikom za iglu EU/1/14/946/008 - 5 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/007 - 3 napunjene štrcaljke sa sigurnosnim štitnikom za iglu EU/1/14/946/010 - 10 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu EU/1/14/946/017 - 7 napunjenih štrcaljki sa sigurnosnim štitnikom za iglu
English: Patients with renal impairment
Croatian: Bolesnici s teškom kroničnom neutropenijom
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe in 0.5 ml contains 30 MU of filgrastim (0.6 mg/ml).
Croatian: Jedna štrcaljka sadrži 30 MU filgrastima u 0,5 ml (0,6 mg/ml).
English: Special precautions in sickle cell trait and sickle cell disease
Croatian: Posebne mjere opreza kod nasljednog obilježja srpastih stanica i anemije srpastih stanica
English: Special population
Croatian: Posebna populacija Starije osobe
English: Muscle spasms Osteoporosis
Croatian: Druge posebne mjere opreza Osteoporoza
English: Capillary leak syndrome has been reported after granulocyte colony-stimulating factor administration, and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration.
Croatian: Nakon primjene čimbenika poticanja granulocitnih kolonija (G-CSF) zabilježena je pojava stanja povećane kapilarne propusnosti („sindrom kapilarnog curenja“), koje karakteriziraju hipotenzija,
English: In patients with severe chronic neutropenia (SCN) Congenital neutropenia
Croatian: Pedijatrijski bolesnici s teškom kroničnom neutropenijom
English: How do I inject Accofil myself?
Croatian: Kako samostalno primijeniti injekciju lijekaAccofil?
English: Common side effects (seen in more than 1 in 100 people taking Accofil):
Croatian: Česte nuspojave (javljaju se u više od 1 na 100 osoba koje primaju Accofil)
English: Acetic acid glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80
Croatian: 6. FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari acetatna kiselina, ledena natrijev hidroksid sorbitol (E420) polisorbat 80 voda za injekcije
English: Prior exposure to cytotoxic agents
Croatian: Prethodno izlaganje citotoksičnim lijekovima
English: Accofil 48 MU/0.5 ml (0.96 mg/ml) solution for injection or infusion in pre-filled syringe filgrastim
Croatian: Uputa o lijeku: Informacije za korisnika Accofil 48 MU/0,5 ml (0,96 mg/ml) otopina za injekciju ili infuziju u napunjenoj štrcaljki filgrastim
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Accofil 30 MU/0.5 ml solution for injection/infusion filgrastim
Croatian: Uputa o lijeku: Informacije za korisnika Accofil 30 MU/0,5 ml (0,6 mg/ml) otopina za injekciju ili infuziju u napunjenoj štrcaljki filgrastim
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe in 0.5 ml contains 48 MU of filgrastim (0.96 mg/ml).
Croatian: Jedna štrcaljka sadrži 48 MU filgrastima u 0,5 ml (0,96 mg/ml).
English: In patients treated with myeloablative therapy followed by bone marrow transplantation The recommended starting dose of filgrastim is 1.0 MU/kg/day (10 micrograms/kg/day).
Croatian: Preporučena početna doza filgrastima je 1,0 MU/kg/dan (10 mikrograma/kg/dan).
English: NAME OF THE MEDICINAL PRODUCT Accofil 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Croatian: Accofil 30 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki
English: Aortitis
Croatian: Imunogenost
English: NAME OF THE MEDICINAL PRODUCT Accofil 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Croatian: Accofil 48 MU/0,5 ml otopina za injekciju ili infuziju u napunjenoj štrcaljki
English: Chest paina Astheniaa Paina
Croatian: • bol u prsnom košu
English: Leukocytosisa Splenic rupturea Sickle cell anaemia with crisis
Croatian: Poremećaji krvi i limfnog sustava trombocitopen ija anemijae splenomegali jaa smanjena razina hemoglobinae leukocitoza ruptura slezenea anemija srpastih stanica s krizom
English: Filgrastim for PBPC mobilisation after myelosuppressive chemotherapy Filgrastim should be given by subcutaneous injection.
Croatian: Filgrastim je potrebno primijeniti supkutanom injekcijom.
English: Filgrastim for PBPCs for mobilisation in normal donors prior to allogeneic PBPC transplantation Filgrastim should be given by subcutaneous injection.
Croatian: Filgrastim za mobilizaciju stanica preteča periferne krvi u zdravih darivatelja prije transplantacije alogenih stanica preteča periferne krvi
English: Uncommon side effects (seen in more than 1 in 1000 people taking Accofil):
Croatian: Manje česte nuspojave (javljaju se u više od 1 na 1000 osoba koje primaju Accofil)
English: • changes in blood chemistry
Croatian: • promjene rezultata krvnih pretraga • transfuzijska reakcija
English: The frequency is estimated as uncommon from clinical trial data.
Croatian: Na temelju podataka iz kliničkih ispitivanja, učestalost se procjenjuje kao manje česta.
English: Diarrhoeaa,e Vomitinga,e Nauseaa
Croatian: Učinak kemoterapije na eritrocite i trombocite
English: Decreased Appetitee Blood lactate dehydrogenase increased
Croatian: Poremećaji metabolizm a i prehrane smanjen apetita povišena laktat dehidrogenaz a u krvi hiperuricemija povišena mokraćna kiselina u krvi smanjena glukoza u krvi pseudogihta
English: Not know n itis
Croatian: Nepozna to periferni edem e
English: Fluid volume disturbance s
Croatian: poremećaji volumena tekućine
English: Cases of splenomegaly have been reported commonly following administration of filgrastim.
Croatian: Nakon primjene filgrastima često su prijavljeni slučajevi splenomegalije.
English: OTHER
Croatian: FR
English: • bone density decreased
Croatian: • smanjenje gustoće kostiju
English: Filgrastim for PBPC mobilisation when used alone:
Croatian: Filgrastim za mobilizaciju stanica preteča periferne krvi, kada se primjenjuje sam
English: Oedema peripherale
Croatian: Prijavljivanje nuspojava
English: (Chondrocalcino sis
Croatian: (hondrokalcino za pirofosfat)
English: Musculoskeletal painc
Croatian: • glavobolja • proljev
English: NAME OF THE MEDICINAL PRODUCT Accofil 30 MU/0.5 ml solution for injection/infusion filgrastim
Croatian: Accofil 30 MU/0,5 ml otopina za injekciju ili infuziju filgrastim s.c./i.v.
English: For the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Croatian: Za mobilizaciju stanica preteča periferne krvi u zdravih darivatelja prije transplantacije alogenih stanica preteča periferne krvi
English: Paraesthesia
Croatian: Sljedivost
English: Thrombocytopenia has been reported very commonly in patients receiving filgrastim .Platelet counts should therefore be monitored closely.
Croatian: Trombocitopenija je vrlo često zabilježena u bolesnika koji primaju filgrastim.
English: The recommended starting dose is 1.2 MU (12 µg)/kg/day as a single dose or in divided doses.
Croatian: Preporučena početna doza je 0,5 MU (5 µg)/kg/dan primijenjena u jednoj ili više doza.
English: Injection site reaction
Croatian: Opći bol u prsištua reakcija na
English: ATCvet code: QI06AH10.
Croatian: ATCvet kod: QI06AH10.
English: Do not use in pregnant animals.
Croatian: Ne koristiti na gravidnim životinjama.
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda zapakiranog za prodaju: 18 mjeseci.
English: Detailed information on this veterinary medicinal 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 (http://www.ema.europa.eu/).
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Croatian: Ukoliko zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da se javite veterinaru.
English: EU/2/04/048/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/048/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Croatian: EU/2/04/048/001 Liofilizat (10 bočica s po 1 dozom) + otapalo (10 bočica od 1 ml) EU/2/04/048/002 Liofilizat (50 bočica s po 1 dozom) + otapalo (50 bočica od 1 ml)
English: EXP (mm/yyyy) Once reconstituted use immediately.
Croatian: EXP (mm/gggg) Nakon rekonstitucije odmah primijeniti.
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs, - against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Croatian: Aktivna imunizacija mačaka starijih od 8 tjedana: - protiv virusnog rinotraheitisa mačaka za smanjenje kliničkih znakova, - protiv infekcije kalicivirusom za smanjenje kliničkih znakova, - protiv panleukopenije mačaka za sprječavanje smrtnosti i kliničkih znakova, - protiv leukemije mačaka za sprječavanje viremije i kliničkih znakova bolesti.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti primijenjeno istog dana, ali ne pomiješano s Merialovim cjepivom protiv bjesnoće.
English: Shelf life after reconstitution according to directions: use immediately.
Croatian: Rok valjanosti nakon rekonstitucije prema uputi: primijeniti odmah.
English: No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Croatian: Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku 4.6 “Nuspojave”, osim hipertermije koja iznimno može trajati 5 dana.
English: Primary vaccination course: - first injection: from 8 weeks of age; - second injection: 3 to 4 weeks later.
Croatian: Prvo cijepljenje: - prva injekcija: od 8. tjedna starosti; - druga injekcija: 3 do 4 tjedna kasnije.
English: Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the feline leukaemia component and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Croatian: Revakcinacija: - prva revakcinacija mora se provesti za sve komponente jednu godinu nakon prvog cijepljenja, - naknadne revakcinacije moraju biti provedene: svake godine za komponentu leukemije mačaka i u intervalima od najviše tri godine za komponente rinotraheitisa, kaliciviroze i panleukopenije.
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the product.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim otapalom priloženim za primjenu s proizvodom.
English: Per dose of 1 ml: Lyophilisate:
Croatian: Svaka doza od 1 ml sadrži: Liofilizat:
English: A local reaction may occur (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most.
Croatian: Može se javiti i lokalna reakcija (lagana bol pri palpaciji , svrbež ili ograničen otok) koja nestaje za najviše 1 ili 2 tjedna.