FrancophonIA/ELRC3.0 huggingface dataset:
English: Conversely, if a patient who is concomitantly treated with Buvidal and a CYP3A4 inducer stops treatment with the CYP3A4 inducer, the patient should be monitored for symptoms of overtreatment.
Croatian: Za razliku od toga, ako bolesnik koji istodobno prima terapiju Buvidalom i induktorom CYP3A4 prekine liječenje induktorom CYP3A4, treba ga nadzirati za simptome predoziranja.
English: Treatment
Croatian: Terapija
English: Buprenorphine should be used with caution in patients with moderate hepatic impairment (see sections 4.2 and 5.2).
Croatian: Buprenorfin treba oprezno primjenjivati u bolesnika s umjerenim oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 5.2).
English: The needle shield of the safety syringe may contain rubber latex that may cause allergic reactions in latexsensitive individuals.
Croatian: Zaštitni poklopac igle sigurnosne štrcaljke može sadržavati lateks gumu koja može uzrokovati alergijske reakcije kod osoba osjetljivih na lateks.
English: diarrhoea - Rash, itching, hives - Joint pain, back pain, muscle pain, muscle spasms, neck pain, bone pain - Painful period - Injection site reactions e.g. pain, itching, red skin, swelling and hardening of skin, swelling of the ankles, feet or fingers, weakness, feeling unwell, fever, chills, drug withdrawal syndrome in the new-born, chest pain - Abnormal liver test results
Croatian: - reakcije na mjestu ubrizgavanja, npr. bol, svrbež, crvena koža, oticanje i otvrdnjavanje kože, oticanje gležanja, stopala ili prstiju, slabost, loše osjećanje, vrućica, zimica, sindrom ustezanja lijeka kod novorođenčeta, bolovi u prsištu - odstupanja u rezultatima pretraga funkcije jetre
English: Instructions for Use for Healthcare Professionals
Croatian: 15. UPUTE ZA UPORABU
English: Patients already on Buvidal who start treatment with CYP3A4 inhibitors should be treated with weekly Buvidal and be monitored for signs and symptoms of overtreatment.
Croatian: Bolesnici koji već primaju Buvidal i počinju liječenje inhibitorima CYP3A4 trebaju se liječiti tjednim dozama Buvidala i nadzirati zbog znakova i simptoma prekomjernih doza.
English: (With needle protection mechanism activated)
Croatian: Sigurnosna štrcaljka: Nakon primjene (S aktiviranim mehanizmom zaštite igle)
English: The use of buprenorphine is contraindicated in patients with severe hepatic impairment (see section 4.3).
Croatian: Primjena buprenorfina kontraindicirana je u bolesnika s teškim oštećenjem jetre (vidjeti dijelove 4.3).
English: Excipients: Soybean phosphatidylcholine, glycerol dioleate, N-methylpyrrolidone
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: sojin fosfatidilkolin, gliceroldioleat, N-metilpirolidon
English: - The needle shields of the safety syringe may contain rubber latex that may cause allergic reactions in latex-sensitive individuals.
Croatian: - Zaštitni poklopac sigurnosne štrcaljke može sadržavati lateks gumu koja može uzrokovati alergijske reakcije kod osoba osjetljivih na lateks.
English: 64 mg prolonged-release solution for injection Each pre-filled syringe contains 64 mg buprenorphine 96 mg prolonged-release solution for injection Each pre-filled syringe contains 96 mg buprenorphine 128 mg prolonged-release solution for injection Each pre-filled syringe contains 128 mg buprenorphine For the full list of excipients, see section 6.1.
Croatian: Jedna napunjena štrcaljka sadrži 64 mg buprenorfina 96 mg otopina za injekciju s produljenim oslobađanjem Jedna napunjena štrcaljka sadrži 96 mg buprenorfina 128 mg otopina za injekciju s produljenim oslobađanjem Jedna napunjena štrcaljka sadrži 128 mg buprenorfina Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: Excipients: Soybean phosphatidylcholine, glycerol dioleate, ethanol anhydrous
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: sojin fosfatidilkolin, gliceroldioleat, bezvodni etanol
English: Buvidal 8 mg prolonged-release solution for injection Buvidal 16 mg prolonged-release solution for injection Buvidal 24 mg prolonged-release solution for injection Buvidal 32 mg prolonged-release solution for injection Buvidal 64 mg prolonged-release solution for injection Buvidal 96 mg prolonged-release solution for injection Buvidal 128 mg prolonged-release solution for injection buprenorphine
Croatian: Buvidal 8 mg otopina za injekciju s produljenim oslobađanjem Buvidal 16 mg otopina za injekciju s produljenim oslobađanjem Buvidal 24 mg otopina za injekciju s produljenim oslobađanjem Buvidal 32 mg otopina za injekciju s produljenim oslobađanjem Buvidal 64 mg otopina za injekciju s produljenim oslobađanjem Buvidal 96 mg otopina za injekciju s produljenim oslobađanjem Buvidal 128 mg otopina za injekciju s produljenim oslobađanjem buprenorfin
English: To avoid precipitated withdrawal, induction must be undertaken when objective signs and symptoms of mild to moderate withdrawal are evident (see section 4.2).
Croatian: Kako bi se izbjeglo izazivanje sindroma ustezanja, uvođenje buprenorfina treba poduzeti nakon očitih, objektivnih, blagih do umjerenih znakova i simptoma ustezanja lijeka (vidjeti dio 4.2).
English: One pre-filled syringe contains 96 mg buprenorphine
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 96 mg buprenorfina
English: The maximum dose per month for patients who are on monthly Buvidal treatment is 128 mg with an additional 8 mg dose.
Croatian: Najviša mjesečna doza za bolesnike koji su na mjesečnom liječenju Buvidalom je 128 mg s dodatnom dozom od 8 mg.
English: The maximum dose per week if you are on weekly Buvidal treatment is 32 mg with an additional 8 mg dose.
Croatian: Najviša tjedna doza ako ste na tjednom liječenju Buvidalom je 32 mg s dodatnom dozom od 8 mg.
English: Injection site inflammation Injection site bruising Injection site urticaria
Croatian: Upala na mjestu primjene injekcije Oticanje mjesta primjene injekcije Urtikarija na mjestu primjene injekcije
English: Buvidal avoids first-pass effects and CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or azole antifungals such as ketoconazole or itraconazole, or macrolide antibiotics) are expected to have less effects on buprenorphine metabolism when co-administered with Buvidal as compared to when co-administered with sublingual buprenorphine.
Croatian: • Inhibitori CYP3A4 mogu inhibirati metabolizam buprenorfina što rezultira povećanim vrijednostima za Cmax i AUC buprenorfina i norbuprenorfina: Buvidal zaobilazi metabolizam prvog prolaska kroz jetru i očekuje se slabiji učinak inhibitora CYP3A4 (npr. inhibitora proteaze poput ritonavira, nelfinavira ili indinavira ili azolnih antimikotika poput ketokonazola ili itrakonazola, ili makrolidnih antibiotika) na metabolizam buprenorfina kod istodobne primjene s Buvidalom u usporedbi s istodobnom primjenom sa sublingvalnim buprenorfinom.
English: Following switching, patients may need closer monitoring.
Croatian: Možda će biti potrebno pomnije praćenje bolesnika nakon prelaska.
English: N 213 Median 26.7
Croatian: N 213 Srednja vrijednost
English: Pyrexia
Croatian: Malaksalost Pireksija
English: Dysmenorrhoea
Croatian: Dismenoreja
English: Buvidal 8 mg, 16 mg, 24 mg, 32 mg Soybean phosphatidylcholine Glycerol dioleate
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Buvidal 8 mg, 16 mg, 24 mg, 32 mg: Sojin fosfatidilkolin Gliceroldioleat
English: One pre-filled syringe contains 128 mg buprenorphine
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 128 mg buprenorfina
English: Buvidal is a prolonged-release solution for injection.
Croatian: Buvidal je otopina za injekciju s produljenim oslobađanjem.
English: Buvidal for monthly treatment can be used, if appropriate for you, once stabilisation has been achieved with Buvidal for weekly treatment (four weeks treatment or more, where practical).
Croatian: Nakon što je postignuta stabilizacija Buvidalom za tjedno liječenje (četiri tjedna liječenja ili više tamo gdje je to praktično) može se koristiti Buvidal za mjesečnu terapiju, ako Vama to odgovara,
English: Buprenorphine may cause severe, possibly fatal, respiratory depression in children and non-opioid dependent persons who accidentally or deliberately use it.
Croatian: Buprenorfin u djece i osoba koje nisu ovisne o opioidima može, u slučaju nehotične ili hotimične primjene, uzrokovati tešku, potencijalno smrtonosnu depresiju disanja.
English: The maximum dose per week for patients who are on weekly Buvidal treatment is 32 mg with an additional 8 mg dose.
Croatian: Najviša tjedna doza u bolesnika koji su na tjednom liječenju Buvidalom je 32 mg s dodatnom dozom od 8 mg.
English: Patients already on Buvidal who start treatment with CYP3A4 inducers should be treated with weekly Buvidal and be monitored for signs and symptoms of withdrawal.
Croatian: Bolesnici koji već primaju Buvidal i počinju liječenje inhibitorima CYP3A4 trebaju se liječiti tjednim dozama Buvidala i nadzirati zbog znakova i simptoma ustezanja.
English: Opioid agonist ceiling effects were observed during clinical pharmacology studies in opioid-dependent persons.
Croatian: U kliničkim farmakološkim ispitivanjima u bolesnika ovisnih o opioidima primijećeni su „učinci plafona“ za opioidne agoniste.
English: The dose must not be administered intravascularly (intravenously), intramuscularly or intradermally.
Croatian: Doza se ne smije davati u krvne žile (intravenski),
English: Urinary retention
Croatian: Retencija mokraće
English: One pre-filled syringe contains 24 mg buprenorphine
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 24 mg buprenorfina
English: (only in weekly formulation) and N-methylpyrrolidone (only in monthly formulation).
Croatian: Što Buvidal sadrži - Djelatna tvar je buprenorfin - Drugi sastojci su sojin fosfatidilkolin, gliceroldioleat, bezvodni etanol (samo u formulaciji za tjednu primjenu) i N-metilpirolidon (samo u formulaciji za mjesečnu primjenu).
English: The maximum dose per month if you are on monthly Buvidal treatment is 128 mg with an additional 8 mg dose.
Croatian: Najviša mjesečna doza ako ste na mjesečnom liječenju Buvidalom je 128 mg s dodatnom dozom od 8
English: One pre-filled syringe contains 64 mg buprenorphine
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 64 mg buprenorfina
English: Buvidal is given as a single injection under the skin (subcutaneously) in any of the allowed injection areas buttock, thigh, abdomen or upper arm. You can receive several injections in the same injection area, but the exact injection sites will be different for each weekly and monthly injection for a minimum period of 8 weeks.
Croatian: Isto područje ubrizgavanja može se koristiti nekoliko puta, ali točna mjesta ubrizgavanja će biti različita za svaku tjednu ili mjesečnu injekciju primjenjenu tijekom sljedećih minimalno 8 tjedana.
English: Buvidal 64 mg prolonged-release solution for injection Buvidal 96 mg prolonged-release solution for injection Buvidal 128 mg prolonged-release solution for injection
Croatian: Buvidal 64 mg otopina za injekciju s produljenim oslobađanjem Buvidal 96 mg otopina za injekciju s produljenim oslobađanjem Buvidal 128 mg otopina za injekciju s produljenim oslobađanjem
English: If you start to feel faint as this may be a sign of low blood pressure, feeling sick, vomit and/or slurred speech.
Croatian: Ako počinjete gubiti svijest, jer to može biti znak sniženog krvnog tlaka, imate mučninu,
English: Supplemental dosing
Croatian: Dodatne doze
English: Buvidal 96 mg prolonged-release solution for injection buprenorphine
Croatian: Buvidal 96 mg otopina za injekciju s produljenim oslobađanjem buprenorfin
English: One pre-filled syringe contains 32 mg buprenorphine
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 32 mg buprenorfina
English: Severe hepatic impairment
Croatian: - bolno ili teško mokrenje
English: Nausea
Croatian: Zimica
English: - macrolide antibiotics (used to treat bacterial infections) such as clarithromycin and erythromycin as they may increase the effects of this medicine.
Croatian: - makrolidne antibiotike (koriste se za liječenje bakterijskih infekcija) poput klaritromicina i eritromicina jer mogu povećati učinke ovog lijeka. - neke antiepileptičke lijekove (koriste se za liječenje epilepsije), poput fenobarbitala, karbamazepina i fenitoina, jer mogu smanjiti učinak Buvidala.
English: Very common side effects (may affect more than 1 in 10 people): - Insomnia (inability to sleep) - Headache - Nausea (feeling sick) - Sweating, drug withdrawal syndrome, pain
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba): - nesanica (ne možete spavati)
English: 1.6-fold increase
Croatian: 6.3 Rok valjanosti
English: Injection site swelling Injection site reaction Injection site induration
Croatian: Svrbež na mjestu primjene injekcije Eritem na mjestu primjene injekcije Oticanje na mjestu primjene injekcije Reakcija na mjestu primjene injekcije
English: One pre-filled syringe contains 8 mg buprenorphine
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 8 mg buprenorfina
English: Buvidal 128 mg prolonged-release solution for injection buprenorphine
Croatian: Buvidal 128 mg otopina za injekciju s produljenim oslobađanjem buprenorfin
English: One pre-filled syringe contains 16 mg buprenorphine
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 16 mg buprenorfina
English: Prolonged-release solution for injection.
Croatian: OBLIK Otopina za injekciju s produljenim oslobađanjem.
English: The apparent volume of distribution for buprenorphine is approximately 1900 L. Buprenorphine is approximately 96% protein-bound, primarily to alpha and beta globulin.
Croatian: Postotak vezanja buprenorfina za proteine iznosi 96%,.
English: 1.7-fold increase
Croatian: Cmax povećanje od 1,2 puta povećanje od 1,1 puta povećanje od 1,7 puta
English: Agitation
Croatian: Nervoza
English: Renal impairment
Croatian: Faringitis Rinitis
English: Pack contains 1 pre-filled syringe with stopper, needle, needle shield, safety device and 1 plunger rod.
Croatian: Pakiranje sadrži 1napunjenu štrcaljku s čepom klipa, iglu, zaštitni poklopac za iglu, sigurnosni uređaj i
English: - certain antiretrovirals (used to treat HIV infection) such as ritonavir, nelfinavir or indinavir as they may increase the effects of this medicine.
Croatian: Ne smijete ih uzimati istodobno s ovim lijekom. - određene antiretrovirotike (koriste se za liječenje HIV-a) poput ritonavira, nelfinavira ili indinavira jer mogu povećati učinke ovog lijeka. - neke antimikotike (koriste se za liječenje gljivičnih infekcija) poput ketokonazola ili itrakonazola jer mogu povećati učinke ovog lijeka.
English: Buvidal 32 mg prolonged-release solution for injection buprenorphine
Croatian: Buvidal 32 mg otopina za injekciju s produljenim oslobađanjem buprenorfin
English: Buvidal 24 mg prolonged-release solution for injection buprenorphine
Croatian: Buvidal 24 mg otopina za injekciju s produljenim oslobađanjem buprenorfin
English: Administration (see also section 4.2) - Take the syringe out of the cardboard box: pick up the syringe by the syringe guard body.
Croatian: Primjena - Izvadite štrcaljku iz kartonske kutije: uhvatite štrcaljku za štitnik.
English: Pack sizes
Croatian: N-metilpirolidon
English: Buvidal 64 mg prolonged-release solution for injection buprenorphine
Croatian: Buvidal 64 mg otopina za injekciju s produljenim oslobađanjem buprenorfin
English: Each pre-filled syringe contains 8 mg buprenorphine 16 mg prolonged-release solution for injection
Croatian: Buvidal 8 mg otopina za injekciju s produljenim oslobađanjem Buvidal 16 mg otopina za injekciju s produljenim oslobađanjem
English: increase in muscle tension, speech disorders - Watery eyes, abnormal widening or narrowing of the pupil (the dark part of the eye) - Palpitations - Low blood pressure - Cough, shortness of breath, yawning, asthma, bronchitis - Constipation, vomiting (being sick), belly pain, flatulence (wind), indigestion, dry mouth,
Croatian: - kašalj, nedostatak zraka, zijevanje, astma, bronhitis - zatvor, povraćanje, bolovi u trbuhu, flatulencija (vjetrovi), probavne smetnje, suha usta, proljev - osip, svrbež, koprivnjača - bolovi u zglobovima, bolovi u leđima, bolovi u mišićima, grčevi u mišićima, bolovi u vratu,
English: An individual recommendation should be given by the treating healthcare professional.
Croatian: Injekcije treba davati zdravstveni radnik.
English: Buvidal 8 mg prolonged-release solution for injection buprenorphine
Croatian: Buvidal 8 mg otopina za injekciju s produljenim oslobađanjem buprenorfin
English: Buvidal 16 mg prolonged-release solution for injection buprenorphine
Croatian: Buvidal 16 mg otopina za injekciju s produljenim oslobađanjem buprenorfin
English: Neonatal withdrawal syndrome
Croatian: Neonatalni sindrom ustezanja
English: Injection site pain Injection site pruritus Injection site erythema
Croatian: Svrbež na mjestu primjene injekcije Eritem na mjestu primjene injekcije Oticanje na mjestu primjene injekcije
English: P-value
Croatian: Srednja vrijednost LS
English: Elderly
Croatian: Astenija
English: Read the package leaflet before use Subcutaneous use Once weekly
Croatian: Supkutana primjena Jednom tjedno
English: Contents of the pack and other information What Buvidal contains
Croatian: Moguće nuspojave Kako čuvati Buvidal Sadržaj pakiranja i druge informacije
English: EXPIRY DATE
Croatian: Camurus AB
English: Common side effects (may affect up to 1 in 10 people): - Infection, influenza, sore throat and painful swallowing, runny nose - Swollen glands (lymph nodes) - Hypersensitivity - Decreased appetite - Anxiety, agitation, depression, hostility, nervousness, abnormal thinking, paranoia - Sleepiness, feeling dizzy, migraine, burning or tingling in hands and feet, fainting, tremor,
Croatian: - tjeskoba, uznemirenost, depresija, netrpeljivost, nervoza, nenormalno razmišljanje, paranoja - pospanost, omaglica, migrena, žarenje ili trnci u šakama i stopalima, nesvjestica, nevoljno drhtanje, povećanje napetosti mišića, poremećaji govora - suzenje očiju, nenormalno širenje ili sužavanje zjenice (tamnog dijela oka) - palpitacije (osjećaj lupanja srca)
English: There may be a small amount of blood at the injection site, if required wipe with a cotton ball or gauze.
Croatian: Ako je potrebno obrišite je pamučnim jastučićem ili gazom.
English: 8 mg prolonged-release solution for injection
Croatian: 16 mg otopina za injekciju s produljenim oslobađanjem
English: Acute pain management
Croatian: Liječenje akutne boli
English: Lymphadenopathy
Croatian: Bronhitis
English: Lacrimal disorder Mydriasis Miosis
Croatian: Midrijaza Mioza
English: Disposing of the syringe
Croatian: Odlaganje štrcaljke
English: Vertigo
Croatian: Proljev
English: - Abnormal redness of the skin - Painful or difficult urination
Croatian: bolovi u kostima - bolna menstruacija
English: Hyperhidrosis Drug withdrawal syndrome Pain
Croatian: Sindrom ustezanja lijeka Bol
English: Figure 6:
Croatian: Slika 2:
English: Chest pain
Croatian: Suha usta
English: • monoamine oxidase inhibitors (MAOI): Possible exacerbation of the opioids effects, based on experience with morphine.
Croatian: Na osnovi iskustva s morfinom, moguće je pojačanje učinaka opioida.
English: System Organ Class Very common Common
Croatian: Klasifikacija organskih sustava
English: Depression Hostility
Croatian: Anksioznost Agitacija
English: Each pre-filled syringe contains 24 mg buprenorphine 32 mg prolonged-release solution for injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Buvidal 32 mg otopina za injekciju s produljenim oslobađanjem buprenorfin s.c.
English: EU/1/18/1336/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1336/005
English: The recommended dose should not be exceeded.
Croatian: Preporučena doze se ne smije prekoračiti.
English: Macrogol 300
Croatian: Makrogol 300
English: The metabolism in horses has not been investigated.
Croatian: Metabolizam u konja nije istražen.
English: Please carefully follow the instructions of the veterinarian.
Croatian: Pažljivo slijedite upute veterinara.
English: ATC-vet: QM01AC06.
Croatian: ATCvet kod: QM01AC06.
English: Five major metabolites have been identified.
Croatian: Identificirano je pet glavnih metabolita.
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 (EMA) http://www.ema.europa.eu/.
English: Cattle and pigs: Can be used during pregnancy and lactation.
Croatian: Goveda i svinje: Može se koristiti tijekom graviditeta i laktacije.
English: Accidental self-injection may give rise to pain.
Croatian: Slučajno samoinjiciranje može izazvati bol.
English: If the animal is fed at the time of dosing, the absorption may be slightly delayed.
Croatian: Ukoliko se životinje hrane pri davanju absorpcija može malo kasniti.
English: Ceva Santé Animale ensures that the system of pharmacovigilance, as described in Part I of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
Croatian: Ceva Santé Animale treba osigurati da je sustav farmakovigilancije, kako je opisano u Dijelu I zahtjeva za izdavanje odobrenja, uspostavljen i funkcionalan prije i za vrijeme stavljanja veterinarsko medicinskog proizvoda u promet.
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 naznačeno 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: 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: 21 % unesene doze izlučuje se mokraćom (2 % kao nepromijenjeni meloksikam, 19 % kao metaboliti), a 79 % izmetom (49 % kao nepromijenjeni meloksikam, 30 % kao metaboliti).
English: Reduction of post-operative pain (over a period of 24 hours):
Croatian: Umanjenje post operativnih bolova (tijekom razdoblja od 24 sata):
English: See also section 4.3.
Croatian: Vidi odjeljak 4.3
English: See also section 4.7.
Croatian: Vidi i dio 4.7.
English: Do not store above 25°C.
Croatian: Ne čuvati iznad 25 °C.
English: To be administered orally either mixed with food or directly into the mouth.
Croatian: Veterinarsko-medicinski proizvod se daje peroralno, umješan u hrani ili izravno u usta.
English: The active substance in Meloxidyl is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar u Meloxidyl 20 mg/ml je dozvoljena tvar kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010:
English: The volume of distribution is 0.3 l/kg.
Croatian: Volumen distribucije iznosi 0,3 L/kg.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
Croatian: SADRŽAJ PO TEŽINI, VOLUMENI ILI BROJU DOZA
English: If required, a second administration of meloxicam can be given after 24 hours.
Croatian: Po potrebi, drugo davanje meloksikama se može ponoviti nakon 24 sata.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Croatian: NAZIV VETERINARSKO - MEDICINSKOG PROIZVODA
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 ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.