FrancophonIA/ELRC3.0 huggingface dataset:
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 75 mg/m² in combination with capecitabine
Croatian: Tablični popis nuspojava kod karcinoma dojke za TAXOTERE 75 mg/m² u kombinaciji s kapecitabinom
English: Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Croatian: osip praćen svrbežom (G3/4: promjene noktiju (G3/4: 0,7%); eksfolijacija kože (G3/4: 0%)
English: 0.5 ml (Fill 0.61 ml)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,5 ml (Punjenje 0,61 ml)
English: If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: TAXOTERE 80 mg/4 ml concentrate for solution for infusion
Croatian: NAZIV LIJEKA TAXOTERE 80 mg/4 ml koncentrat za otopinu za infuziju
English: Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija (G3/4: 3%); pireksija (G3/4: 1%); umor/slabost (G3/4: 5%); periferni edem (G3/4: 1%)
English: Post-marketing experience
Croatian: Razdoblje nakon stavljanja lijeka u promet
English: Each ml of concentrate contains 20 mg docetaxel as trihydrate.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan ml koncentrata sadržava 20 mg docetaksela u obliku docetaksel trihidrata.
English: Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G3/4: 63%); anemija (G3/4: 10%)
English: TAXOTERE 20 mg/1 ml concentrate for solution for infusion
Croatian: NAZIV LIJEKA TAXOTERE 20 mg/1 ml koncentrat za otopinu za infuziju
English: • 1312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Croatian: Nuspojave koje su moguće ili vjerojatno povezane s primjenom docetaksela zabilježene su u: • 1312 bolesnika koji su primali 100 mg/m i 121 bolesnika koji su primali 75 mg/m docetaksela kao monoterapiju,
English: TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion vial
Croatian: TAXOTERE 20 mg/0,5 ml koncentrat za otopinu za infuziju (bočica)
English: If TAXOTERE concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Croatian: Ako TAXOTERE koncentrat, pripremljena otopina koncentrata ili otopina za infuziju dođu u dodir s kožom, to mjesto odmah dobro i temeljito isperite sapunom i vodom.
English: TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion
Croatian: TAXOTERE 20 mg/0,5 ml koncentrat i otapalo za otopinu za infuziju docetaksel
English: Anaemia (G3/4: 8.9%); Febrile neutropenia
Croatian: trombocitopenija (G3/4: 0,6%); febrilna neutropenija
English: Esophagitis/dysphagia/ odynophagia (G3/4:
Croatian: Poremećaji kože i potkožnog tkiva alopecija (G3/4:
English: Vomiting (G3/4: 1.2%)
Croatian: bol izazvana karcinomom (G3/4: 1,2%)
English: VIAL LABEL / TAXOTERE 160 mg/8 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA / TAXOTERE 160 mg/8 ml
English: Dysgeusia/Parosmia (G3/4: 0.4%);
Croatian: abdominalna bol (G3/4: 0,4%)
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Croatian: Manje česte nuspojave sustava neuropatija (G 3: periferna motorna neuropatija (G 3/4: disgeuzija (teška:
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 0.2%)
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva mialgija (G3/4: 0,7%) artralgija (G3/4: 0,2%)
English: 4.1.1 If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature (below 25°C) for 5 minutes.
Croatian: PRIPREMA ZA INTRAVENSKU PRIMJENU 4.1 Priprema TAXOTERE otopine koncentrata (10 mg docetaksela/ml) 4.1.1 Ako su bočice pohranjene u hladnjaku, izvadite potreban broj kutija lijeka TAXOTERE iz hladnjaka i ostavite ih na sobnoj temperaturi (ispod 25°C) 5 minuta.
English: Metastatic castration-resistant prostate cancer The recommended dose of docetaxel is 75 mg/m2.
Croatian: Preporučena doza docetaksela iznosi 75 mg/m2.
English: Cautions for use in hormone-sensitive prostate cancer
Croatian: Upozorenja za primjenu kod karcinoma prostate rezistentnog na kastraciju
English: Patients on the comparator arm received cisplatin (P) 100 mg/m followed by 5-fluorouracil (F)
Croatian: Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m nakon čega je slijedio 5-fluorouracil (F) 1000 mg/m dnevno tijekom 5 dana.
English: 2.2 Solvent for TAXOTERE 20 mg/0.5 ml vial
Croatian: 2.2 Bočica s otapalom za TAXOTERE 20 mg/0,5 ml
English: Neutropenia (G3-4: 12 %) Anaemia
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G3-4: 12 %) anemija febrilna neutropenija (G3-4:
English: Tabulated list of adverse reactions in non-small cell lung cancer for TAXOTERE 75 mg/m² single agent
Croatian: Tablični popis nuspojava kod karcinoma nemalih stanica pluća za TAXOTERE 75 mg/m² u monoterapiji
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 100 mg/m² single agent
Croatian: Tablični popis nuspojava kod karcinoma dojke za TAXOTERE 100 mg/m² u monoterapiji
English: Alopecia (G3/4: 10.9%) Rash pruritic; Dry skin;
Croatian: Poremećaji kože i potkožnog tkiva alopecija (G3/4: 4,0%); osip praćen svrbežom suhoća kože; deskvamacija
English: Preparation of the intravenous administration
Croatian: Za intravensku primjenu
English: Anaemia (G3/4: 9.2%); Thrombocytopenia (G3/4: 5.2%)
Croatian: anemija (G3/4: 9,4%); febrilna neutropenija; trombocitopenija (G4: 0,8%)
English: 2.2 Solvent for TAXOTERE 80 mg/2 ml vial
Croatian: 2.2 Bočica s otapalom za TAXOTERE 80 mg/2 ml
English: Infection (G3/4: 3.6%) Neutropenic infection
Croatian: Infekcije i infestacije infekcija (G3/4: neutropenijska infekcija
English: If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Croatian: Ako TAXOTERE dođe u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
English: Median survival (months) 95% CI
Croatian: Medijan preživljenja (mjeseci) 95% CI
English: Common (may affect up to 1 in 10 people):
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba):
English: Weight increased (G3/4:
Croatian: pojačano suzenje (G3/4:
English: Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%)
Croatian: Poremećaji kože i potkožnog tkiva alopecija (G3/4: 4,0%)
English: Hypertension; Haemorrhage
Croatian: Krvožilni poremećaji hipotenzija; hipertenzija; krvarenje
English: Description of selected adverse reactions in breast cancer for TAXOTERE 100 mg/m² single agent
Croatian: Opis odabranih nuspojava kod karcinoma dojke za TAXOTERE 100 mg/m u monoterapiji
English: If TAXOTERE concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Croatian: Ako TAXOTERE koncentrat, otopina koncentrata ili otopina za infuziju dođe u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m as a 1 hour intravenous infusion every 3 weeks).
Croatian: Za liječenje docetakselom u monoterapiji (100 mg/m u obliku jednosatne intravenske infuzije svaka 3 tjedna) bilo je randomizirano 256 bolesnika.
English: Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%)
Croatian: Poremećaji probavnog sustava proljev (G 3/4: 19,7%); mučnina (G 3/4: 16%); stomatitis (G3/4: 23,7%); povraćanje (G3/4: 14,3%)
English: Tabulated list of adverse reactions in head and neck cancer for TAXOTERE 75 mg/m² in combination with cisplatin and 5-fluorouracil
Croatian: Tablični popis nuspojava za TAXOTERE 75 mg/m u kombinaciji s cisplatinom i 5-fluorouracilom za terapiju karcinoma glave i vrata
English: TAXOTERE 80 mg/2 ml concentrate for solution for infusion vial
Croatian: TAXOTERE 80 mg/2 ml koncentrat za otopinu za infuziju (bočica)
English: Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4:
Croatian: Poremećaji probavnog sustava mučnina (G3/4: 5%); stomatitis (G3/4: proljev (G3/4: 6,2%); povraćanje (G3/4: konstipacija
English: Hypocalcaemia (G3: 0%) Hypophosphataemia (G3-4: 1%) Hypokalaemia (G3: 0%)
Croatian: Opći poremećaji i reakcije na mjestu primjene letargija (G3-4: 2%) simptomi nalik na gripu (G3: astenija (G3: 0%) retencija tekućine vrućica (G3: 1%) oralna kandidijaza hipokalcijemija (G3: 0%) hipofosfatemija (G3-4: 1%) hipokalijemija (G3: 0%)
English: Thrombocytopenia (G4: 1.7%)
Croatian: Endokrini poremećaji dijabetes (G3-4: 1%)
English: If TAXOTERE concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Croatian: Ako TAXOTERE koncentrat, ili otopina za infuziju dođu u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Croatian: hipotenzija (G3/4: 0%); flebitis (G3/4: 0%)
English: Peripheral sensory neuropathy (G3/4: 1.2%);
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4: 1,2%); disgeuzija (G3/4: 0%)
English: More than one premix vial may be necessary to obtain the required dose for the patient.
Croatian: Ponekad je potrebno upotrijebiti više od jedne bočice TAXOTERE koncentrata kako bi se dobila potrebna doza za bolesnika.
English: TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion
Croatian: NAZIV LIJEKA TAXOTERE 80 mg/2 ml koncentrat i otapalo za otopinu za infuziju
English: 6.1 cy
Croatian: 6.3 Rok valjanosti
English: Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mialgija (G3/4: 2%) artralgija (G3/4: 1%)
English: Common adverse reactions disorders Nervous system disorders
Croatian: Poremećaji živčanog periferna senzorna
English: In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm. Lymphoedema that started during the treatment period persisted into the follow-up period in 5 patients (0.9%) in TAC arm and 2 patients (0.4 %) in FAC arm. At the end of the follow-up period, lymphoedema was observed to be ongoing in 4 patients (0.8%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Croatian: U bolesnika liječenih u TAC skupini, rizik povrata bolesti smanjio se za 32% u odnosu na bolesnike u FAC skupini (omjer hazarda = 0,68, 95% CI (0,49-0,93), p = 0,01).Pri medijanu vremena praćenja od 10 godina i 5 mjeseci u bolesnika liječenih u TAC skupini rizik povrata bolesti smanjio se za 16,5 % u odnosu na bolesnike liječene u FAC skupini (omjer hazarda =0 ,84, 95% CI (0,65-1,08), p=0,1646).
English: PARTICULARS TO APPEAR ON OUTER PACKAGING
Croatian: OTPADNIH MATERIJALA KOJI POTJEČU
English: Discard unused contents appropriately in accordance with local requirements.
Croatian: OD LIJEKA, KADA JE POTREBNO Neiskorišteni lijek treba odgovarajuće zbrinuti u skladu s lokalnim propisima.
English: Psychiatric disorders
Croatian: Psihijatrijski poremećaji nesanica
English: Nausea (G3/4: 0.6%); Stomatitis (G3/4:
Croatian: kožna toksičnost (G3/4: 0,6%) poremećaji noktiju (G3/4: 0,4%)
English: VIAL LABEL / TAXOTERE 20 mg/1 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA / TAXOTERE 20 mg/1 ml
English: Diarrhoea (G3/4: 4%); Nausea (G3/4: 4%);
Croatian: proljev (G3/4: 3,4%); konstipacija (G3/4:
English: PRESENTATION
Croatian: Ishod
English: VIAL/SOLVENT FOR TAXOTERE 20 mg/0.5 ml
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA OTAPALO za TAXOTERE 20 mg/0,5 ml
English: Diarrhoea (G3/4: 6.2%); Vomiting (G3/4: 5%); Constipation
Croatian: proljev (G3/4: 6,2%); povraćanje (G3/4:
English: Pyrexia (G3/4: NA); Oedema peripheral (G3/4: 0.2%)
Croatian: omaglica (G3/4:2,0%) periferna motorna neuropatija (G3/4:0,4%)
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m as a 1 hour infusion followed by cisplatin 75 mg/m over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m per day for five days.
Croatian: Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m nakon čega je slijedio cisplatin (P) 75 mg/m te 5-fluorouracil (F) 750 mg/m dnevno u obliku kontinuirane infuzije tijekom 5 dana.
English: ATCvet code: QM01AC06.
Croatian: ATCvet kod: QM01AC06.
English: EXP {month/year} Once broached use within 28 days.
Croatian: Jednom odčepljen upotrijebiti u roku od 28 dana.
English: Can Parellada Industrial 08228 Terrassa
Croatian: Can Parellada Industrial 08228 Terrassa ŠPANJOLSKA
English: Cattle and pigs
Croatian: Goveda i svinje
English: This veterinary medicinal product does not require any special storage conditions.
Croatian: Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne uvjeti čuvanja.
English: Cattle (calves and young cattle) and pigs
Croatian: CILJNE VRSTE ŽIVOTINJA Goveda (telad i mlada goveda) i svinje
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06
Croatian: Farmakoterapijska grupa: protuupalni i protureumatski proizvodi, nesteroidi (oksikami) ATCvet kod: QM01AC06
English: For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Croatian: Za pomoćnu terapiju u liječenju puerperalne septikemije i toksemije (sindrom mastitis-metritis-agalakcija) uz odgovarajuću antibiotsku terapiju.
English: Subcutaneous and intramuscular injection is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Croatian: Supkutana i intramuskularna primjena dobro se podnosi; samo lagano prolazno oticanje na mjestu uboda nakon supkutane primjene opaženo je u manje od 10% goveda tretiranih u sklopu kliničkih ispitivanja.
English: Single IM injection before surgery.
Croatian: Jedna i.m. injekcija prije kirurškog zahvata.
English: In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product should not be administered by pregnant women or women attempting to conceive.
Croatian: Uzimajući u obzir rizik od nehotičnog samoinjiciranja i poznate nuspojave ove skupine nesteroidnih protuupalnih lijekova (NSAID) te drugih inhibitora prostaglandina na trudnoću i/ili embriofetalni razvoj, trudnice ili žene koje pokušavaju zatrudnjeti ne bi smjele davati ovaj veterinarsko-medicinski proizvod.
English: This local reaction resolved within 8 hours following subcutaneous administration.
Croatian: Ova lokalna reakcija nestaje u roku od osam sati nakon potkožne primjene.
English: Novem alone will not provide adequate pain relief during the dehorning procedure.
Croatian: Ako se primjenjuje sam, Novem neće dovoljno smanjiti bolove za vrijeme postupka odrožnjavanja.
English: People with known hypersensitivity to non-steroidal antiinflammatory drugs (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: Shelf-life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml, 100 ml or 250 ml vials): 3 years
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju (20 ml, 50 ml, 100 ml ili 250 ml): 3 godine.
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: 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
English: For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
Croatian: Svinje: Za primjenu u neinfekcijskim poremećajima lokomotornog sustava u svrhu smanjenja simptoma hromosti i upale.
English: Treatment of piglets with Novem before castration reduces post-operative pain.
Croatian: Primjena Novema u prasadi prije kastracije smanjuje bol poslije zahvata.
English: The active substance in Novem is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar u Novemu je dozvoljena tvar kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010:
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, uključujući primjenu odgovarajućeg pribora za doziranje, i pažljivoj procjeni tjelesne mase.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
Croatian: Farmakoterapijska grupa: protuupalni i protureumatski proizvodi, nesteroidi (oksikami).
English: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Croatian: Meloksikam Meloksikam goveda, koze, svinje,
English: Cattle: Single SC injection.
Croatian: Goveda: Jedna s.c. injekcija.
English: Treatment of calves with Novem 20 minutes before dehorning reduces post-operative pain.
Croatian: Primjena Novema u teladi 20 minuta prije odrožnjavanja smanjuje bol poslije kirurškog zahvata.
English: Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Croatian: Svaka bočica je zatvorena gumenim čepom i osigurana aluminijskom kapicom.
English: Meloxicam in Novem 20 mg/ml solution for injection for cattle and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Novem 20 mg/ml otopini za injekcije za goveda i svinje, meloksikam je dozvoljena tvar kako je navedeno u tablici 1 Dodatka Uredbe Komisije (EU) br. 37/2010:
English: Take care of accurate dosing, use of appropriate dosing device and estimation of body weight.
Croatian: Pazite na precizno doziranje, primjenu odgovarajućeg pribora za doziranje i procjenu tjelesne mase.
English: Meloxicam in Novem 5 mg/ml solution for injection for cattle and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: U Novem 5 mg/ml otopini za injekcije za goveda i svinje, meloksikam je dozvoljena tvar kako je navedeno u tablici 1 Dodatka Uredbe Komisije (EU) br. 37/2010:
English: Date of first authorisation: Date of last renewal:
Croatian: Datum posljednjeg produljenja odobrenja:
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the relase of the concerned batch.
Croatian: Tiskana uputa o VMP mora sadržavati naziv i adresu proizvođača odgovornog za puštanje odnosne serije u promet.
English: Do not use after the expiry date stated on the carton and bottle after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici iza EXP.
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: Name and address of the manufacturers responsible for batch release Labiana Life Sciences S.A.
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije u promet Labiana Life Sciences S.A.
English: Manufacturer responsible for batch release: Labiana Life Sciences S.A.
Croatian: Proizvođači odgovorni za puštanje serije u promet: Labiana Life Sciences S.A.
English: To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed.
Croatian: Da bi se postiglo ublažavanje bola tijekom kirurškog zahvata, potrebna je istodobna primjena odgovarajućeg anestetika/sedativa.
English: EXP {month/year} Shelf-life of broached vial: 28 days.
Croatian: ROK VALJANOSTI EXP {mjesec/godina} Rok valjanosti otvorene bočice: 28 dana.
English: Do not administer concurrently with glucocorticosteroids, other NSAIDs or with anticoagulant agents.
Croatian: Ne primjenjivati istodobno s glukokortikosteroidima, drugim NSAID ili s antikoagulacijskim tvarima.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE SERIJE
English: THE WORDS "FOR ANIMAL TREATMENT ONLY"
Croatian: RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” Samo za primjenu na životinjama.
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, anti-exudative, analgesic and antipyretic effects.
Croatian: Meloksikam je nesteroidni protuupalni lijek (NSAID) iz skupine oksikama koji djeluje kočenjem sinteze prostaglandina, čime se postižu protuupalni, antieksudativni, analgetički i antipiretički učinci.
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight).
Croatian: Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne mase (tj. 2,0 ml/25 kg tjelesne mase).
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, anti-exudative, analgesic and antipyretic properties.
Croatian: Meloksikam je nesteroidni protuupalni lijek (NSAID) iz skupine oksikama koji djeluje kočenjem sinteze prostaglandina, čime se postižu protuupalna, antieksudativna, analgetička i antipiretička svojstva.
English: To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.
Croatian: Da bi se postiglo odgovarajuće ublažavanje bola tijekom kirurškog zahvata, potrebna je istodobna primjena prikladnog analgetika.
English: Solution for injection
Croatian: OBLIK Otopina za injekciju
English: In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.
Croatian: U svinja, nakon intramuskularne primjene, prosječni poluživot uklanjanja iz plazme iznosi približno
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.
Croatian: Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne mase (tj. 0,4 ml/5 kg tjelesne mase) prije kirurškog zahvata.
English: Shelf-life after first opening the container: 28 days.
Croatian: Rok valjanosti poslije prvog otvaranja spremnika: 28 dana.
English: IM
Croatian: U