FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the Committee was still concerned by the modest effectiveness of Fanaptum and its delayed onset of action.
Croatian: Nadalje, Odbor je i dalje bio zabrinut zbog skromnog učinka lijeka Fanaptum i njegova odgođenog početka djelovanja.
English: Finally, the CHMP was concerned that Fanaptum is broken down in the body by liver enzymes whose activity is reduced in certain patients and by certain other medicines.
Croatian: Konačno, CHMP je izrazio zabrinutost da lijek Fanaptum u tijelu razlažu enzimi jetre čija je aktivnost smanjena u određenih bolesnika i pri upotrebi drugih lijekova.
English: During the re-examination the CHMP looked again at the data submitted by the company and the company's proposal to introduce several new measures to manage the risk of QT prolongation.
Croatian: Tijekom preispitivanja, CHMP je ponovo pregledao podatke koje je podnijela tvrtka kao i prijedlog tvrtke za uvođenje nekoliko novih mjera za upravljanje rizikom od produljenja QT intervala.
English: Refusal of the marketing authorisation for Fanaptum (iloperidone)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Fanaptum (iloperidon)
English: The longterm study, involving 193 patients, compared Fanaptum with placebo.
Croatian: U dugoročnom ispitivanju, u kojem su sudjelovala 193 bolesnika, lijek Fanaptum uspoređen je s placebom.
English: Therefore, the CHMP concluded that the benefits of Fanaptum did not outweigh its risks and maintained its previous recommendation that the medicine be refused marketing authorisation.
Croatian: Stoga je CHMP zaključio da koristi od lijeka Fanaptum ne nadmašuju s njim povezane rizike te je potvrdio svoju prethodnu preporuku za odbijanje odobrenja za stavljanje lijeka u promet.
English: As a result, some patients may have increased blood concentrations of Fanaptum, which would increase their risk of QT prolongation.
Croatian: Kao posljedica toga, u nekih bi se bolesnika mogle povećati koncentracije lijeka Fanaptum u krvi što bi dovelo do većeg rizika od produljenja QT intervala.
English: However, the CHMP was still concerned about the risk of QT prolongation and considered that the measures proposed would not appropriately address this risk in clinical practice.
Croatian: Međutim, CHMP je i dalje smatrao da postoje razlozi za zabrinutost zbog rizika od produljenja QT intervala te je smatrao da predložene mjere ne bi na odgovarajući način odgovorile na rizik u kliničkoj praksi.
English: Fanaptum is a medicine that contains the active substance iloperidone.
Croatian: Fanaptum je lijek koji sadrži djelatnu tvar iloperidon.
English: The short-term study, involving 567 patients, compared Fanaptum with the schizophrenia medicine ziprasidone and with placebo (a dummy treatment).
Croatian: U kratkoročnom ispitivanju u kojem je sudjelovalo 567 bolesnika uspoređivan je lijek Fanaptum s lijekom za shizofreniju naziva ziprasidon i s placebom (prividnim liječenjem).
English: The active substance in Fanaptum, iloperidone, is an antipsychotic medicine.
Croatian: Djelatna tvar lijeka Fanaptum, iloperidon, jest antipsihotik.
English: On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Fanaptum, intended for the treatment of schizophrenia.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) donio je negativno mišljenje i preporučio odbijanje odobrenja za stavljanje u promet lijeka Fanaptum, koji je namijenjen liječenju shizofrenije.
English: Date of first authorisation: 23/02/2012
Croatian: Datum prvog odobrenja: 23/02/2012
English: RevitaCAM is presented in:
Croatian: RevitaCAM se nalazi:
English: Do not use in dogs less than 6 weeks of age.
Croatian: Ne primjenjivati na psima u dobi manjoj od 6 tjedana.
English: Please carefully follow the instructions of the veterinarian.
Croatian: Molimo da pažljivo slijedite upute veterinara.
English: A clinical response is normally seen within 3-4 days.
Croatian: Klinički odgovor obično se vidi u roku od 3-4 dana.
English: This product is for dogs and should not be used in cats as it is not suitable for use in this species.
Croatian: Ovo je proizvod za pse i ne smije se primjenjivati na mačkama, jer nije pogodan za primjenu u te životinjske vrste.
English: Approximately 97 % of meloxicam is bound to plasma proteins.
Croatian: Približno 97% meloksikama vezano je za proteine plazme.
English: The mouth should not be opened any wider than necessary to facilitate application.
Croatian: Usta ne trebaju biti otvorena više nego što je potrebno da bi se olakšala primjena.
English: Use during pregnancy and lactation: See section "Contraindications".
Croatian: Primjena tijekom graviditeta i laktacije: Vidi dio "Kontraindikacije".
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: SADRŽAJ: TEŽINA, VOLUMEN I BROJ DOZA
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).
Croatian: Sigurnost primjene ovog veterinarsko-medicinskog proizvoda tijekom graviditeta i laktacije nije utvrđena (vidi dio 4.3).
English: If adverse reactions occur, treatment should be discontinued and the advice of the veterinarian should be sought.
Croatian: Ukoliko nastupe nuspojave, liječenje treba prekinuti i potražiti savjet veterinara.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “SAMO ZA LIJEČENJE ŽIVOTINJA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, AKO JE PRIMJENJIVO
English: Ethyl alcohol Polycarbophil Boric acid Potassium chloride Hydrochloric acid Sodium hydroxide Water, purified
Croatian: Etilni alkohol Polikarbofil Borna kiselina Kalijev klorid Klorna kiselina Natrijev hidroksid Voda, pročišćena
English: Avoid direct contact between the product and skin, if accidental exposure occurs wash hands immediately with soap and water.
Croatian: Izbjegavajte izravni dodir proizvoda s kožom; ako se slučajno dogodi izlaganje kože proizvodu, odmah operite ruke sapunom i vodom.
English: Remove Cap
Croatian: Uklonite zatvarač
English: Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Croatian: Meloksikam se razgrađuje do alkohola, kiselog derivata i do nekoliko polarnih metabolita.
English: The MAH must ensure that the system of pharmacovigilance as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the product is on the market.
Croatian: Nositelj odobrenja 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: Spray RevitaCAM into dog's mouth
Croatian: Raspršite RevitaCAM u usta psa
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Croatian: RIJEČI “SAMO ZA LIJEČENJE ŽIVOTINJA”
English: Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.
Croatian: Oko 75% primijenjene doze eliminira se stolicom, a preostali dio mokraćom.
English: It reduces leukocyte infiltration into the inflamed tissue.
Croatian: Smanjuje infiltraciju upaljenog tkiva leukocitima.
English: For longer term treatment, once a clinical response has been observed (after ≥ 4 days), the dose of the product can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
Croatian: Kod dugotrajnijeg liječenja, kad nastupi vidljiv klinički odgovor (nakon ≥ 4 dana), doza proizvoda može se smanjiti na najnižu djelotvornu pojedinačnu dozu, koja pokazuje da stupanj boli i upale povezane s kroničnim mišićno-koštanim poremećajima može varirati tijekom vremena.
English: Pharmacovigilance system
Croatian: Sustav farmakovigilancije
English: These side effects 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: Ove nuspojave općenito nastaju tijekom prvog tjedna liječenja i u većini su slučajeva prolazne i nestaju nakon prekida liječenja, ali u vrlo rijetkim slučajevima mogu biti ozbiljne ili imati smrtni ishod.
English: Maintenance dosage range meloxicam delivered (mg/kg)*
Croatian: Raspon doze održavanja dostavljenog meloksikama (mg/kg)*
English: Overdose (symptoms, emergency procedures, antidotes): In case of overdose symptomatic treatment should be initiated.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti) : U slučaju predoziranja potrebno je započeti simptomatsko liječenje.
English: The pump should be depressed fully, ensuring no mist escapes from the mouth.
Croatian: Pumpicu trebate pritisnuti do kraja, pazeći da nimalo spreja ne pobjegne iz usta.
English: In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Croatian: Ispitivanja in vitro i in vivo pokazala su da meloksikam u većoj mjeri inhibira ciklooksigenazu-2 (COX-2) nego ciklooksigenazu-1 (COX-1).
English: There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range.
Croatian: Postoji linearni odnos između primijenjene doze i koncentracije u plazmi, koji se vidi u terapijskom rasponu doza.
English: Meloxicam is eliminated with a half-life of 24 hours.
Croatian: Poluvrijeme eliminacije meloksikama je 24 sata.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Croatian: Izbjegavati primjenu kod dehidriranih, hipovolemičnih ili hipotenzivnih životinja, zbog mogućeg rizika od povećane bubrežne toksičnosti.
English: In case of pump failure, wipe nozzle and then re-prime the pump as described above.
Croatian: U slučaju da pumpica zakaže, obrišite mlaznicu i onda ponovno pripremite pumpicu kako je gore opisano.
English: To prime the pump depress at least 10 times prior to first use or until a fine spray appears.
Croatian: Da biste pripremili pumpicu, pritisnite je najmanje 10 puta prije prve primjene ili dok se ne pojavi fino raspršeni sprej.
English: Particular care should be taken with regard to the accuracy of dosing.
Croatian: Potreban je poseban oprez kako bi se primijenila točna doza.
English: Meloxicam is completely absorbed following oromucosal administration and maximal plasma concentrations are obtained after approximately 4.5 hours.
Croatian: Meloksikam se potpuno apsorbira nakon primjene na usnu sluznicu i postiže najvišu koncentraciju u plazmi nakon približno 4,5 sati.
English: When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.
Croatian: Kad se proizvod koristi prema preporučenom režimu doziranja, dinamička ravnoteža koncentracije meloksikama u plazmi postiže se drugog dana liječenja.
English: Oromucosal spray Yellow colloidal dispersion
Croatian: Sprej za usnu sluznicu Žuta koloidna disperzija
English: Wash hands after administration of the product.
Croatian: Nakon primjene proizvoda operite ruke.
English: In the case of overdose symptomatic treatment should be initiated.
Croatian: U slučaju predoziranja potrebno je započeti sa simptomatskim liječenjem.
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Croatian: Meloksikam je nesteroidni protuupalni lijek (NSAID) iz klase oksikama, koji djeluje putem inhibicije sinteze prostaglandina i na taj način izaziva protuupalne, analgetske, antieksudativne i antipiretičke učinke.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 30 months Shelf-life after first opening the immediate packaging: 6 months
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 2 godine Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 6 mjeseci
English: RevitaCAM must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Croatian: RevitaCAM se ne smije primjenjivati zajedno s drugim nesteroidnim protuupalnim lijekovima ili glukokortikosteroidima.
English: To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
Croatian: U manjoj mjeri također inhibira agregaciju trombocita koju izaziva kolagen.
English: EU/2/12/138/001 6 ml/10ml vial EU/2/12/138/002 11 ml/20 ml vial EU/2/12/138/003 33 ml/50 ml vial EU/2/12/138/004 3 ml/10 ml vial EU/2/12/138/005 3 ml/20 ml vial EU/2/12/138/006 8 ml/50 ml vial
Croatian: EU/2/12/138/001 6 ml/10 ml staklena bočica EU/2/12/138/002 11 ml/20 ml staklena bočica EU/2/12/138/003 33 ml/50 ml staklena bočica EU/2/12/138/004 3 ml/10 ml staklena bočica EU/2/12/138/005 3 ml/20 ml staklena bočica EU/2/12/138/006 8 ml/50 ml staklena bočica
English: If RevitaCAM is not used for two days or more, re-prime with one or more sprays or until a fine spray appears.
Croatian: Ako RevitaCAM nije upotrebljavan dva ili više dana, ponovo pripremite pumpicu tako da je nekoliko puta pritisnete da se napuni proizvodom ili dok se ne pojavi fino raspršeni sprej.
English: All major metabolites have been shown to be pharmacologically inactive.
Croatian: Pokazalo se da su svi glavni metaboliti farmakološki nedjelatni.
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: Prethodno liječenje protuupalnim lijekovima može rezultirati dodatnim ili pojačanim nuspojavama, pa se sukladno tome prije početka liječenja mora poštivati razdoblje od 24 sata u kojem se takvi veterinarsko-medicinski proizvodi ne primjenjuju.
English: The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Croatian: Međutim, kod razdoblja u kojem se ti proizvodi ne primjenjuju treba uzeti u obzir farmakološka svojstva prethodno korištenih proizvoda.
English: Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects.
Croatian: Drugi nesteroidni protuupalni lijekovi, diuretici, antikoagulansi, aminoglikozidni antibiotici i tvari koje jako vežu proteine, mogu se natjecati za mjesto vezanja i tako dovesti do toksičnih učinaka.
English: Body weight range (kg)
Croatian: Raspon tjelesne mase (kg)
English: Excipients: Ethyl alcohol 150 mg
Croatian: Pomoćne tvari: Etilni alkohol 150 mg
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial.
Croatian: Ne koristiti ovaj veterinarsko - medicinski proizvod poslije isteka roka valjanosti koji je naznačen na kutiji i bočici.
English: Shelf-life after first opening the container: 6 months.
Croatian: Rok valjanosti poslije prvog otvaranja spremnika: 6 mjeseci.
English: The mist should be directed to the back and towards the gums and/or inner cheek, mucosal surfaces.
Croatian: Raspršeni proizvod treba usmjeriti straga i prema desnima i/ili površini sluznice obraza.
English: Manufacturer for the batch release: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, THE NETHERLANDS
Croatian: Nositelj odobrenja za proizvodnju za puštanje proizvodne serije: Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, NIZOZEMSKA
English: EXP {month/year} Shelf-life of opened vial: 6 months
Croatian: EXP {mjesec/godina} Rok valjanosti otvorene bočice: 6 mjeseci
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - 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: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - 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: Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Croatian: Meloksikam se pretežno nalazi u plazmi i uglavnom se izlučuje putem žuči, dok mokraća sadrži samo tragove ishodnog spoja.
English: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Croatian: Ublažavanje upale i boli kod akutnih i kroničnih mišićno-koštanih poremećaja u pasa.
English: Shake gently before use.
Croatian: Lagano protresti prije primjene.
English: To administer RevitaCAM, the dog's top lip should be grasped and gently pulled away exposing the gums.
Croatian: Da biste primijenili RevitaCAM, uhvatite psa za gornju usnicu i nježno je povucite tako da mu otkrijete desni.
English: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Croatian: Ublažavanje upale i boli kod akutnih i kroničnih mišićno-koštanih poremećaja.
English: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Croatian: Osobe preosjetljive na nesteroidne protuupalne lijekove (NSAID) trebaju izbjegavati kontakt s veterinarsko-medicinskim proizvodom.
English: Immediately after administration of the spray use a moist paper towel or tissue to clean the tip of the pump.
Croatian: Odmah nakon primjene spreja obrišite vrh pumpice vlažnom maramicom ili papirnatim ubrusom.
English: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM
Croatian: Zoetis Belgium SA, Rue Laid Burniat, 1 1348 Louvain-la-Neuve BELGIJA
English: EXP {month/year}> Shelf-life of opened vial: 6 months Once broached, use by …
Croatian: Rok valjanosti otvorene bočice: 6 mjeseci Jednom otvoren, primijeniti do …
English: Wipe pump with tissue to prevent clogging
Croatian: Obrišite pumpicu maramicom da se ne začepi
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Croatian: Posebne mjere predostrožnosti koje mora poduzeti osoba koja primjenjuje veterinarskomedicinski proizvod na životinjama:
English: In some dogs sneezing, coughing/gagging or drooling may be observed immediately after treatment administration.
Croatian: U nekih se pasa neposredno nakon primjene liječenja može primijetiti kihanje, kašljanje/pokušaji povraćanja ili slinjenje.
English: * For the initial treatment of a single dose of 0.2 mg meloxicam/kg body weight, the above maintenance doses should be doubled.
Croatian: * Kad liječenje započinje jednokratnom dozom od 0,2 mg meloksikama/kg tjelesne mase, gore navedene doze održavanja potrebno je udvostručiti.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Croatian: UVJETI ILI OGRANIČENJA U PROMET U POGLEDU OPSKRBE I PRIMJENE
English: Medicines should not be disposed of via wastewater or household waste but in accordance with local requirements.
Croatian: Lijekovi se ne smiju odlagati u otvorene vode ili kućni otpad.
English: Marketing authorisation holder: Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM
Croatian: Nositelj odobrenja za stavljanje u promet: Zoetis Belgium SA, Rue Laid Burniat, 1, 1348 Louvain-la-Neuve, BELGIJA
English: Allow the pump to fully reflate before administering consecutive sprays.
Croatian: Pričekajte da se pumpica ponovno napuni prije sljedećeg nanošenja spreja.
English: Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Croatian: Ukoliko nema vidljivog kliničkog poboljšanja, liječenje treba prekinuti najkasnije nakon 10 dana.
English: Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Croatian: Ne primjenjivati na životinjama koje boluju od gastrointestinalnih poremećaja, kao što su nadraženost i krvarenje, oštećena funkcija jetre, srca ili bubrega i poremećaji krvarenja.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet Code:
Croatian: Farmakoterapijska skupina: nesteroidni protuupalni i antireumatski lijekovi (oksikami) ATKvet oznaka: QM01AC06
English: Treatment should be continued once daily by application of the spray to the oral mucosa (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight (see dosing table).
Croatian: Liječenje treba nastaviti jedanput dnevno primjenom spreja na usnu sluznicu (u razmacima od 24 sata) dozom održavanja od 0,1 mg meloksikama/kg tjelesne mase (vidi tablicu s dozama).
English: - 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: Prime pump by spraying into tissue
Croatian: Pripremite pumpicu raspršivanjem u maramicu
English: Store the vial in an upright position.
Croatian: Bočicu čuvajte u uspravnom položaju.
English: Insert pump into vial
Croatian: Uvedite pumpicu u bočicu
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - 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)
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja)
English: PACKAGE LEAFLET FOR: RevitaCAM 5mg/ml oromucosal spray for Dogs
Croatian: UPUTA O VMP ZA: RevitaCAM 5 mg/ml sprej za usnu sluznicu za pse
English: Typical adverse drug reactions of Non Sterioidal Anit-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Croatian: Povremeno su zabilježene tipične nuspojave nesteroidnih protuupalnih lijekova (NSPUL), kao što su gubitak apetita, povraćanje, proljev, okultno krvarenje u stolicu, apatija i zatajenje bubrega.
English: 100µl pump
Croatian: 33 ml
English: Active substance: Meloxicam 5 mg
Croatian: Jedan ml sadrži: Djelatna tvar: Meloksikam 5 mg
English: 10 ml glass vial containing either 3ml or 6 ml 20 ml glass vial containing either 3ml or 11ml 50 ml glass vial containing either 8 ml or 33 ml Not all pack sizes may be marketed.
Croatian: Staklena bočica od 10 mlsadrži 3 ml ili 6 mlpumpica od 50 µl Staklena bočica od 20 mlsadrži 3 ml ili 11 mlpumpica od 100 µl Staklena bočica od 50 mlsadrži 8 ml ili 33 mlpumpica od 215 µl Ne moraju sve veličine pakovanja biti u prometu.
English: RevitaCAM 5 mg/ml oromucosal spray for Dogs Meloxicam
Croatian: RevitaCAM 5 mg/ml sprej za usnu sluznicu za pse Meloksikam
English: RevitaCAM 5 mg/ml oromucosal spray for Dogs
Croatian: RevitaCAM 5 mg/ml sprej za usnu sluznicu za pse
English: 50 ml glass vial containing either 8 ml or 33 ml
Croatian: Staklena bočica od 50 ml sadrži 8 ml ili 33 ml pumpica od 215 µl
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET