FrancophonIA/ELRC3.0 huggingface dataset:
English: • Sweet's syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred but other factors may play a role.
Croatian: • Sweetov sindrom (ljubičaste, izdignute, bolne promjene na udovima, a ponekad i na licu i vratu,
English: These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see section
Croatian: Obično su se javili u bolesnika s uznapredovalom malignom bolesti, sepsom, bolesnika koji su uzimali kemoterapiju s više lijekova ili bolesnika na aferezi (vidjeti dio 4.4).
English: Splenic rupture
Croatian: ruptura slezene
English: In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the filgrastim group (difference 0.23 days, 95 % CI -0.15, 0.63).
Croatian: U jednom ispitivanju (n = 157), u kojemu je primjenjivana fiksna doza pegfilgrastima od 6 mg, srednje vrijeme trajanja neutropenije 4. stupnja u skupini koja je primala pegfilgrastim iznosilo je 1,8 dana, a 1,6 dana u skupini koja je primala filgrastim (razlika od 0,23 dana, 95% CI -0,15, 0,63).
English: In all cases, call your doctor or healthcare provider.
Croatian: U bilo kojem od navedenih slučajeva, obratite se svom liječniku ili zdravstvenom radniku.
English: A higher frequency of serious adverse reactions in younger children aged 0-5 years (92 %) has been observed compared to older children aged 6-11 and 12-21 years respectively (80 % and 67 %) and adults.
Croatian: Primijećena je veća učestalost ozbiljnih nuspojava u mlađe djece, u dobi 0-5 godina (92%) u odnosu na stariju djecu, u dobi 6-11 godina (80%) i 12-21 godina (67%), odnosno odrasle.
English: How to store Grasustek
Croatian: Kako čuvati Grasustek
English: 13 24941 Flensburg Germany
Croatian: 24941 Flensburg
English: Step 1: Prepare
Croatian: 1. korak: Pripremite sve potrebno
English: various stages of renal impairment, including end-stage renal disease, had no impact on the pharmacokinetics of pegfilgrastim.
Croatian: U otvorenom ispitivanju pojedinačne doze (n = 31), različiti stadiji oštećenja funkcije bubrega, uključujući terminalni stadij bolesti bubrega, nisu utjecali na farmakokinetiku pegfilgrastima.
English: 4.4 Special warnings and precautions for use Traceability In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.
English: • coughing up blood (haemoptysis)
Croatian: • iskašljavanje krvi (hemoptiza).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 6 mg, tj. zanemarive količine natrija.
English: • Upper part of your thigh
Croatian: • gornji dio bedra
English: You can use:
Croatian: Injekciju možete primijeniti u:
English: Keep pre-filled syringes out of the sight and reach of children.
Croatian: Napunjene štrcaljke čuvajte izvan pogleda i dohvata djece.
English: Do not attempt to remove the peelable label on the pre-filled syringe barrel before administering your injection.
Croatian: Nemojte pokušavati ukloniti odljepljivu naljepnicu s napunjene štrcaljke prije primjene injekcije.
English: Pharmacokinetic properties
Croatian: Farmakokinetička svojstva
English: Do not rub the injection site.
Croatian: Nemojte trljati mjesto primjene injekcije.
English: Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon in patients receiving pegfilgrastim following cytotoxic chemotherapy.
Croatian: Reverzibilna, blaga do umjerena povišenja razina laktat dehidrogenaze bez povezanih kliničkih učinaka bila su manje česta u bolesnika koji su dobivali pegfilgrastim nakon citotoksične kemoterapije.
English: Nervous system Disorders
Croatian: Poremećaji živčanog sustava glavobolja
English: NAME OF THE MARKETING AUTHORISATION HOLDER Juta Pharma GmbH
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Juta Pharma GmbH
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER WITH SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP
English: Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously.
Croatian: Ispitivanja provedena u štakora ukazala su i na to da supkutana primjena pegfilgrastima nema utjecaja na reproduktivne sposobnosti, plodnost, ciklus estrusa, dane između parenja i koitusa i intrauterino preživljavanje.
English: − The active substance is pegfilgrastim.
Croatian: Što Grasustek sadrži - Djelatna tvar je pegfilgrastim.
English: Injecting Grasustek yourself
Croatian: Samostalno davanje Grasusteka
English: Important: Read the package leaflet before handling the pre-filled syringe.
Croatian: Važno: Prije rukovanja napunjenom štrcaljkom pročitajte uputu o lijeku.
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see section 4.8).
Croatian: Nakon primjene pegfilgrastima prijavljeni su uglavnom asimptomatski slučajevi splenomegalije te slučajevi rupture slezene, uključujući slučajeve sa smrtnim ishodom (vidjeti dio 4.8).
English: Hypersensitivity reactions;
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti; anafilaksija
English: Allow the pre-filled syringe to reach room temperature before injecting.
Croatian: Prije injiciranja pričekajte da napunjena štrcaljka dosegne sobnu temperaturu.
English: Only a solution that is clear and colourless should be injected.
Croatian: Injicirati se smije samo bistra i bezbojna otopina.
English: If you use more Grasustek than you should If you use more Grasustek than you should contact your doctor, pharmacist or nurse.
Croatian: Ako primijenite više lijeka Grasustek nego što ste trebali, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BLISTERED SYRINGE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received
Croatian: Farmakokinetika pegfilgrastima ispitivana je u 37 pedijatrijskih bolesnika sa sarkomom koji su primali 100 μg/kg pegfilgrastima nakon završetka kemoterapije po protokolu VAdriaC/IE.
English: • are pregnant or breast-feeding
Croatian: • ste trudni ili dojite
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. c-reactive protein and white blood cell count).
Croatian: U zdravih ispitanika i bolesnika oboljelih od raka nakon primjene G-CSF-a zabilježen je aortitis, čiji su simptomi uključivali vrućicu, bol u abdomenu, malaksalost, bolove u leđima te povišene upalne markere (npr. C-reaktivni protein i broj leukocita).
English: Do not shake the pre-filled syringe.
Croatian: Nemojte tresti napunjenu štrcaljku.
English: Grasustek is a clear, colourless solution for injection in pre-filled syringe (6 mg/0.6 ml).
Croatian: Kako Grasustek izgleda i sadržaj pakiranja Grasustek je bistra, bezbojna otopina za injekciju u napunjenoj štrcaljki (6 mg/0,6 ml).
English: Rare side effects (may affect up to 1 in 1,000)
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba)
English: The injections should be given into the thigh, abdomen or upper arm. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Haemoptysis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja akutni respiratorni distres sindrom plućne nuspojave (intersticijska upala pluća, plućni edem, plućni infiltrati i plućna fibroza) hemoptiza plućna hemoragija
English: Warning/Precaution: DO NOT lift the product by the plunger or needle cover.
Croatian: Upozorenje/mjera opreza: NEMOJTE vaditi štrcaljku hvatanjem za klip ili poklopac igle.
English: Unless your doctor directs you otherwise, you must stop breast-feeding if you use Grasustek.
Croatian: Ako primjenjujete Grasustek morate prekinuti s dojenjem, osim ako Vaš liječnik ne savjetuje drugačije.
English: Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use.
Croatian: Slučajevi sindroma povećane propusnosti kapilara uz primjenu faktora stimulacije rasta granulocita prijavljeni su nakon stavljanja lijeka na tržište.
English: In a second study (n = 310), which used a weight-adjusted dose (100 μg /kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95 % CI--0.36, 0.30).
Croatian: U drugom ispitivanju (n = 310), u kojemu je primjenjivana doza prilagođena tjelesnoj težini (100 μg/kg), srednje trajanje neutropenije 4. stupnja u skupini liječenoj pegfilgrastimom iznosilo je 1,7 dana, u usporedbi s 1,8 dana u skupini liječenoj filgrastimom (razlika 0,03 dana, 95% CI-0,36, 0,30).Ukupna stopa febrilne neutropenije u bolesnika liječenih pegfilgrastimom iznosila je 9 %, a u bolesnika liječenih filgrastimom 18% (razlika 9%, 95% CI - 16,8%; -1,1%).
English: Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim.
Croatian: U bolesnika koji su primali filgrastim i pegfilgrastim prijavljen je glomerulonefritis.
English: Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with pegfilgrastim.
Croatian: U bolesnika liječenih pegfilgrastimom prijavljena je preosjetljivost, uključujući anafilaktičke reakcije, koja se može javiti kod prvog ili sljedećeg liječenja.
English: Preclinical safety data
Croatian: Neklinički podaci o sigurnosti primjene
English: see section 2.
Croatian: PRILOG II.
English: Grasustek 6 mg solution for injection in a pre-filled syringe pegfilgrastim
Croatian: Grasustek 6 mg otopina za injekciju u napunjenoj štrcaljki pegfilgrastim
English: • Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Croatian: • u bolesnika oboljelih od raka i zdravih darivatelja rijetko je zabilježena upala aorte (velike krvne žile koja prenosi krv iz srca u tijelo), čiji simptomi mogu uključivati vrućicu, bol u trbuhu, malaksalost, bol u leđima i povišene upalne markere.
English: Investigations
Croatian: Dan ispitivanja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTERED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: Blood and lymphatic system disorders
Croatian: Poremećaji bubrega i mokraćnog sustava glomerulonefritis
English: Very common side effects (may affect more than 1 in 10 people) • bone pain.
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba)
English: Grasustek 6 mg pegfilgrastim SC
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Grasustek 6 mg pegfilgrastim s.c.
English: Uncommon elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy.
Croatian: Manje često su u bolesnika koji su nakon citotoksične kemoterapije primili pegfilgrastim, zabilježeni slučajevi povišenja vrijednosti testova jetrene funkcije za ALT (alanin aminotransferaze) ili AST (aspartat aminotransferaze).
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u kostima
English: Nausea and headaches were very commonly observed in patients receiving chemotherapy.
Croatian: U bolesnika koji su primali kemoterapiju vrlo su često uočene mučnina i glavobolja.
English: Elevations in uric acid
Croatian: Poremećaji metabolizma i prehrane povišena razina mokraćne kiseline
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml (10 mg/ml) solution for injection.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 6 mg pegfilgrastima u 0,6 ml (10 mg/ml) otopine za injekciju.
English: Do not touch the injection site before injecting.
Croatian: Nemojte dirati mjesto na koje ćete primijeniti injekciju.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.
Croatian: Jedna napunjena štrcaljka sadrži 6 mg pegfilgrastima u 0,6 ml otopine.
English: Injection site pain Non-cardiac chest pain
Croatian: Opći poremećaji i reakcije na mjestu primjene bol na mjestu injiciranja ne-kardijalna bol u prsištu reakcije na mjestu injiciranja2
English: *Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
Croatian: Popis pomoćnih tvari natrijev acetat * sorbitol (E420) polisorbat 20 voda za injekcije *Natrijev acetat nastaje titracijom ledene acetatne kiseline s natrijevim hidroksidom.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution for injection.
Croatian: Jedna napunjena štrcaljka sadrži 6 mg pegfilgrastima u 0,6 ml otopine za injekciju.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 ml solution for injection.
Croatian: Jedna napunjena štrcaljka sadrži 6 mg pegfilgrastima* u 0,6 ml otopine za injekciju.
English: Grasustek 6 mg solution for injection in pre-filled syringe
Croatian: NAZIV LIJEKA Grasustek 6 mg otopina za injekciju u napunjenoj štrcaljki
English: Warnings and precautions
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi
English: OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: Najčešće prijavljene nuspojave bile su bol u kostima (vrlo često) i mišićno-koštana bol (često).
English: Marketing Authorisation Holder Juta Pharma GmbH, Gutenbergstr.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Juta Pharma GmbH,
English: Immune system Disorders
Croatian: Poremećaji probavnog sustava mučnina
English: Uncommon events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim.
Croatian: U bolesnika liječenih pegfilgrastimom manje često su zabilježeni događaji kožnog vaskulitisa.
English: NAME OF THE MEDICINAL PRODUCT Grasustek 6 mg solution for injection in pre-filled syringe pegfilgrastim
Croatian: Uputa o lijeku: Informacije za korisnika Grasustek 6 mg otopina za injekciju u napunjenoj štrcaljki pegfilgrastim
English: PC:
Croatian: PC: SN: NN:
English: See the end of section 4 for how to report side effects
Croatian: Za postupak prijavljivanja nuspojava, pogledajte dio 4.
English: Sickle cell crisis Splenomegaly2;
Croatian: Poremećaji krvi i limfnog sustava trombocitopenija1 leukocitoza kriza srpastih stanica2 splenomegalija2
English: (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) was observed in younger children aged 0-5 years (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults.
Croatian: U multicentričnom (n = 37), randomiziranom, otvorenom ispitivanju faze II u pedijatrijskih bolesnika sa sarkomom koji su primali 100 μg/kg pegfilgrastima nakon 1. ciklusa kemoterapije vinkristinom, doksorubicinom i ciklofosfamidom (VAdriaC/IE) uočeno je dulje trajanje teške neutropenije (neutrofili < 0,5 x 109) u mlađe djece u dobi od 0 - 5 godina (8,9 dana) u odnosu na stariju djecu u dobi od 6-11 i 12-21 godine (6 odnosno 3,7 dana) te odrasle.
English: This medicine contains 30 mg sorbitol in each 6 mg dose, which is equivalent to 50 mg/ml This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 6 mg, tj. zanemarive količine natrija.
English: • spleen rupture.
Croatian: • prsnuće slezene.
English: 13, 24941 Flensburg, Germany
Croatian: Juta Pharma GmbH Gutenbergstr. 13 24941 Flensburg, Njemačka
English: If you have a cough, fever and difficulty breathing please tell your doctor.
Croatian: Obavijestite svog liječnika ako kašljete, imate vrućicu ili otežano dišete.
English: General disorders and administration
Croatian: Upravljanje vozilima i strojevima
English: INSERT the needle into skin.
Croatian: Injicirajte iglu na sljedeći način:
English: Manufacturer Juta Pharma GmbH, Gutenbergstr.
Croatian: Proizvođač Juta Pharma GmbH, Gutenbergstr. 13, 24941 Flensburg, Njemačka
English: Excipients
Croatian: Sljedivost
English: Juta Pharma GmbH, Gutenbergstr.
Croatian: Juta Pharma GmbH, Gutenbergstr. 13, 24941 Flensburg, Njemačka
English: Bottle (HDPE) 90 (3 x 30) tablets
Croatian: 90 (3 x 30) tableta
English: Bottle (HDPE) 30 tablets
Croatian: 30 tableta
English: The stopper should not be punctured more than 20 times.
Croatian: Čep se ne smije bušiti više od 20 puta.
English: 5 days
Croatian: 5 dana
English: The metabolism in horses has not been investigated.
Croatian: Metabolizam u konja nije istraživan.
English: Date of first authorisation: 22/04/2013 Date of last renewal: 20/04/2018
Croatian: Datum prvog odobrenja: 22/04/2013 Datum posljednjeg produljenja odobrenja: 20/04/2018
English: See also Section 12.
Croatian: Vidjeti također dio 12.
English: See also section 4.7.
Croatian: Vidi također odjeljak 4.7.
English: Accidental self-injection may give rise to pain.
Croatian: Nehotično samoinjiciranje može prouzročiti bol.
English: One ml contains:
Croatian: Jedan ml sadržava:
English: The active substance in Meloxidolor is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar u Meloxidoloru je dozvoljena tvar kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010:
English: ATCvet code: QM01AC06
Croatian: ATCvet kod: QM01AC06
English: The excipients 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 are 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, Dodatka 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 tim veterinarsko-medicinskim proizvodima.
English: In very rare cases elevated liver enzymes have been reported.
Croatian: U vrlo rijetkim slučajevima zabilježeni su povišeni jetreni enzimi.
English: It reduces leukocyte infiltration into the inflamed tissue.
Croatian: Smanjuje infiltraciju leukocita u upaljeno tkivo.
English: 21 % of the recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in the faeces (49 % as unchanged meloxicam, 30 % as metabolites).
Croatian: Od izlučene doze 21% eliminira se u mokraću (2% kao nepromijenjen meloksikam, 19% kao metaboliti) a 79% izmetom (49% kao nepromijenjen meloksikam, 30% kao metaboliti).
English: Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device and careful estimation of body weight.
Croatian: Posebnu pozornost treba posvetiti točnosti doziranja uz upotrebu odgovarajućeg pribora za doziranje i pažljivoj procjeni tjelesne težine.
English: These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Croatian: Te se nuspojave obično javljaju tijekom prvog tjedna liječenja i u većini su slučajeva prolazne te nestaju nakon prestanka liječenja, ali u vrlo rijetkim slučajevima mogu biti ozbiljne ili smrtonosne.
English: In cats, the detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion.
Croatian: U mačaka, detekcija metabolita iz ishodišnog spoja u mokraći i izmetu, ali ne u plazmi, ukazuje na njihovo brzo izlučivanje.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP-u, ili posumnjate u učinkovitost VMP-a, obavijestite svog veterinara.
English: Do not use in dogs and cats less than 6 weeks of age nor in cats of less than 2 kg.
Croatian: Ne primjenjivati u pasa i mačaka mlađih od 6 tjedana ili u mačaka lakših od 2 kg.
English: Pregnancy and lactation:
Croatian: Graviditet i laktacija
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi poslije EXP.
English: Dechra Veterinary Products Sp. z o.o.
Croatian: Dechra Veterinary Products Sp. z o.o. ul.
English: The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Croatian: Međutim, u razdoblju bez liječenja treba uzeti u obzir farmakološka svojstva prethodno primijenjenih veterinarsko-medicinskih proizvoda.
English: Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment.
Croatian: Prethodna primjena protuupalnih lijekova može rezultirati dodatnim ili pojačanim nuspojavama, tako da treba paziti da se najmanje 24 sata prije početka liječenja takvi veterinarsko-medicinski proizvodi ne primjenjuju.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojave) - česte (više od 1, ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1, ali manje od 10 životinja na 1000 tretiranih životinja) - rijetke (više od 1, ali manje od 10 životinja na 10 000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10 000 tretiranih životinja, uključujući izolirane slučajeve).
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s propisima o zbrinjavanju otpada.
English: Cattle: Can be used during pregnancy.
Croatian: Goveda: Može se primijeniti tijekom graviditeta.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, AKO JE PRIMJENJIVO
English: Excipient: Ethanol
Croatian: Pomoćna tvar: Etanol