FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Croatian: Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih u skupinu koja je primala pemetreksed, ubrajaju se: infekcija bez neutropenije, neutropenijska vrućica, alergijska reakcija/preosjetljivost, povišene vrijednosti kreatinina, motorička neuropatija, senzorna neuropatija, multiformni eritem i bol u abdomenu.
English: A multi-centre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (N = 359) with that of placebo plus BSC (N = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first-line doublet therapy of pemetrexed in combination with cisplatin.
Croatian: U multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III (PARAMOUNT) uspoređivala se djelotvornost i sigurnost liječenja lijekom pemetrekseda kao terapije održavanja uz BSC (N = 359) s djelotvornošću i sigurnošću primjene placeba uz BSC (N = 180) u bolesnika s lokalno uznapredovalim (stadij IIIB) ili metastatskim (stadij IV) NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice u kojih nije došlo do progresije nakon 4 ciklusa prve linije dvojne terapije pemetrekseda u kombinaciji s cisplatinom.Od 939 bolesnika liječenih uvodnom terapijom pemetreksedom i cisplatinom, 539 bolesnika randomizirano je u skupinu koja je primala terapiju održavanja pemetreksedom ili placebo.
English: Pemetrexed Sandoz in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Croatian: Pemetrexed Sandoz je u kombinaciji s cisplatinom indiciran u prvoj liniji liječenja bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice (vidjeti dio 5.1).
English: How to use Pemetrexed Sandoz
Croatian: Kako uzimati Pemetrexed Sandoz
English: Breast-feeding must be discontinued during Pemetrexed Sandoz treatment.
Croatian: Tijekom liječenja lijekom Pemetrexed Sandoz dojenje se mora prekinuti.
English: Therefore, patients should be cautioned against driving or operating machines if this event occurs.
Croatian: Ipak, prijavljeno je da pemetreksed može izazvati umor pa se bolesnike mora upozoriti da u tom slučaju ne upravljaju vozilima niti rukuju strojevima.
English: For patients with NSCLC other than predominantly squamous cell histology (N = 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio = 0.47 (95% CI = 0.37-0.60, p =
Croatian: U bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice (N=430, neovisno procijenjena populacija), medijan PFS-a bio je 4,4 mjeseci u skupini koja je primala pemetreksed te 1,8 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,47 (95% CI = 0,37-0,60, p = 0,00001).
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first-line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59, 95% CI = 0.47-0.74).
Croatian: Prema procjeni ispitivača medijan PFS-a randomiziranih bolesnika, mjeren od početka prve linije uvodnog liječenja pemetreksedom i cisplatinom, iznosio je 6,9 mjeseci za skupinu koja je primala pemetreksed i 5,6 mjeseci za skupinu s placebom (omjer hazarda = 0,59 95% CI = 0,47-0,74).
English: Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
Croatian: Pemetrexed Sandoz je u kombinaciji s cisplatinom indiciran za liječenje bolesnika s neoperabilnim malignim pleuralnim mezoteliomom koji prethodno nisu primali kemoterapiju.
English: 100% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
Croatian: 100% prethodne doze a Zajednički kriteriji toksičnosti Nacionalnog instituta za rak (CTC v2.0; NCI 1998) b Osim neurotoksičnosti Preporučena prilagodba doze lijeka Pemetrexed Sandoz i cisplatina u slučaju neurotoksičnosti navedena je u Tablici
English: For the purpose of this table a cut off of 5 % was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed.
Croatian: U ovu su tablicu uključene sve nuspojave čija je učestalost bila najmanje 5% i za koje je prijavitelj procijenio da bi mogle biti povezane s primjenom pemetrekseda.
English: Haemoglobin decreased Leucocytes decreased
Croatian: Toksičnost stupnja vrlo često snižene vrijednosti hemoglobina snižen broj leukocita
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Croatian: Manitol (E421) kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH)
English: Squamous cell (N = 473)
Croatian: Karcinom skvamoznih stanica (N=473)
English: Side effects with Pemetrexed Sandoz may include:
Croatian: Moguće nuspojave lijeka Pemetrexed Sandoz su:
English: Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Clear, colorless 50 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 500 mg of pemetrexed.
Croatian: Pemetrexed Sandoz 500 mg prašak za koncentrat za otopinu za infuziju Prozirna, bezbojna bočica (staklo tipa I) od 50 ml s klorbutilnim gumenim čepom i aluminijskim zatvaračem i flip-off kapicom, koja sadrži 500 mg pemetrekseda.
English: Including the induction phase, the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Croatian: Uključujući fazu uvodnog liječenja, medijan ukupnog preživljenja u bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice bio je 18,6 mjeseci u skupini koja je primala pemetreksed te 13,6 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,71 (95% CI = 0,56-0,88, p = 0,002).
English: Pemetrexed Sandoz 500 mg contains 54 mg sodium per vial.
Croatian: Pemetrexed Sandoz 500 mg: sadrži 54 mg natrija po bočici.
English: Pemetrexed Sandoz is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Croatian: Pemetrexed Sandoz je indiciran kao monoterapija u drugoj liniji liječenja bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice (vidjeti dio 5.1).
English: • Increased urine output
Croatian: • Povećano mokrenje
English: Oedema
Croatian: Mezoteliom
English: How to store Pemetrexed Sandoz
Croatian: Kako čuvati Pemetrexed Sandoz
English: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Clear, colorless 10 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 100 mg of pemetrexed.
Croatian: Pemetrexed Sandoz 100 mg prašak za koncentrat za otopinu za infuziju Prozirna, bezbojna bočica (staklo tipa I) od 10 ml s klorbutilnim gumenim čepom i aluminijskim zatvaračem i flip-off kapicom, koja sadrži 100 mg pemetrekseda.
English: From the start of pemetrexed plus cisplatin first-line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95% CI= 0.64-0.96).
Croatian: Medijan OS od početka prve linije uvodnog liječenja pemetreksedom i cisplatinom iznosio je 16,9 mjeseci u skupini koja je primala pemetreksed te 14,0 mjeseci u skupini koja je primala placebo (omjer hazarda = 0,78, 95% CI = 0,64-0,96).
English: Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion Clear, colorless 100 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 1000 mg of pemetrexed.
Croatian: Pemetrexed Sandoz 1000 mg prašak za koncentrat za otopinu za infuziju Prozirna, bezbojna bočica (staklo tipa I) od 100 ml s klorbutilnim gumenim čepom i aluminijskim zatvaračem i flip-off kapicom, koja sadrži 1000 mg pemetrekseda.
English: Time to treatment failure (months)
Croatian: Vrijeme do prestanka odgovora na liječenje (mjeseci) (95% CI)
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje česte(mogu se javiti u 1 na 100 osoba)
English: : +32 2 722 97 97 regaff.belgium@sandoz.com
Croatian: B-1800 Vilvoorde Tél/Tel.: +32 2 722 97 97 regaff.belgium@sandoz.com
English: Nephrogenic diabetes insipidus and renal tubular necrosis have been reported in post marketing setting with an unknown frequency.
Croatian: Nakon stavljanja na tržište, slučajevi nefrogenog dijabetes insipidusa i bubrežne tubularne nekroze su prijavljeni s nepoznatom učestalošću.
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma
Croatian: Djelotvornost pemetrekseda + cisplatina u odnosu na monoterapiju cisplatinom u bolesnika s malignim pleuralnim mezoteliomom Randomizirani i liječeni
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (N = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Croatian: Medijan ukupnog preživljenja u bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice (N = 481) bio je 15,5 mjeseci u skupini koja je primala pemetreksed i 10,3 mjeseca u skupini koja je primala placebo, omjer hazarda = 0,70 (95% CI = 0,56-0,88, p = 0,002).
English: Mucositis/
Croatian: • Mučnina
English: **In the pemetrexed/cisplatin arm, randomised and treated (N=225) and fully supplemented (N=167).
Croatian: Kratice: CI = interval pouzdanosti * p-vrijednost se odnosi na usporedbu između dviju skupina bolesnika ** Skupina liječena kombinacijom pemetreksed/cisplatin, randomizirani i liječeni bolesnici (N = 225) i bolesnici s potpunim nadomjeskom (N = 167)
English: Edvard Thomsens Vej 14 DK-2300 København S Danmark
Croatian: Edvard Thomsens Vej 14 DK-2300 København
English: In both treatment arms, these chemonaive patients were fully supplemented with folic acid and vitamin B12.
Croatian: U obje skupine ti su bolesnici, koji prethodno nisu primali kemoterapiju, dobivali potpun nadomjestak folatne kiseline i vitamina B12.
English: Pemetrexed Sandoz therapy.
Croatian: Pemetrexed Sandoz u monoterapiji
English: Edvard Thomsens Vej 14 DK-2300 Kööpenhamina S Tanska
Croatian: Edvard Thomsens Vej 14 DK-2300 Kööpenhamina
English: Neutrophils/Granulocyte s decreased
Croatian: Toksičnos t stupnja snižen hemoglobin snižen broj neutrofila/ granulocita snižen broj leukocita
English: Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Croatian: Pemetrexed Sandoz 500 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 500 mg pemetrekseda (u obliku pemetrekseddinatrija).
English: Common Constipation Common SGPT (ALT) elevation 7.9
Croatian: Poremećaji probavnog sustava često mukozitis/ stomatitis povišene vrijednosti ALT-a (SGPT-a)
English: Pemetrexed Sandoz 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
Croatian: Pemetrexed Sandoz 100 mg: Jedna bočica sadrži 100 mg pemetrekseda (u obliku pemetrekseddinatrija).
English: Pemetrexed Sandoz 1000 mg: Each vial contains 1000 milligrams of pemetrexed (as pemetrexed disodium).
Croatian: Pemetrexed Sandoz 1000 mg: Jedna bočica sadrži 1000 mg pemetrekseda (u obliku pemetrekseddinatrija).
English: Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium).
Croatian: Pemetrexed Sandoz 1000 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 1000 mg pemetrekseda (u obliku pemetrekseddinatrija).
English: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Croatian: Pemetrexed Sandoz 100 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 100 mg pemetrekseda (u obliku pemetrekseddinatrija).
English: Pemetrexed Sandoz 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
Croatian: Pemetrexed Sandoz 500 mg: Jedna bočica sadrži 500 mg pemetrekseda (u obliku pemetrekseddinatrija).
English: • Nausea
Croatian: • Umor
English: Stomatitis ALT (SGPT) elevation
Croatian: Često konstipacija povišene vrijednosti ALT-a (SGPT-a)
English: A multi-centre, randomised, open-label Phase 3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent-To-Treat [ITT] population N = 283) and 7.9 months for patients treated with docetaxel (ITT N = 288).
Croatian: U multicentričnom, randomiziranom, otvorenom ispitivanju faze III lijeka pemetreksed u odnosu na docetaksel u bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om nakon prethodne kemoterapije medijan preživljenja bolesnika liječenih pemetreksedom iznosio je 8,3 mjeseca (populacija svih uključenih bolesnika, engl.
English: Median overall survival (months)
Croatian: Medijan ukupnog preživljenja (mjeseci) (95% CI)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Pemetrexed Sandoz 1000 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: 4 C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA
English: Österreich Sandoz GmbH Biochemiestr.
Croatian: Magyarország Sandoz Hungária Kft.
English: Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Croatian: Bočice od 500 mg rekonstituirajte s 20 ml otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%), (bez konzervansa), čime se dobiva otopina koja sadrži 25 mg/ml pemetrekseda.
English: Nephrogenic diabetes insipidus and renal tubular necrosis were also reported in post marketing setting with pemetrexed alone or with other chemotherapeutic agents.
Croatian: Također, nakon stavljanja na tržište, tijekom primjene pemetrekseda samog ili u kombinaciji s drugim kemoterapeuticima, prijavljeni su slučajevi nefrogenog dijabetes insipidusa i bubrežne tubularne nekroze.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion pemetrexed
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Pemetrexed Sandoz 100 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion pemetrexed
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Pemetrexed Sandoz 500 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: Very common Creatinine clearance decreased**
Croatian: Poremećaji bubrega i mokraćnog sustava vrlo često smanjen klirens kreatinina**
English: Reconstitute 1000-mg vials with 40 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Croatian: Bočice od 1000 mg rekonstituirajte s 40 ml otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%), (bez konzervansa), čime se dobiva otopina koja sadrži 25 mg/ml pemetrekseda.
English: Leucocytes decreased Haemoglobin decreased 26.2
Croatian: Toksičnost stupnja snižen broj neutrofila/granulocita snižen broj leukocita 53,0 snižene vrijednosti hemoglobina
English: Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Croatian: Bočice od 100 mg rekonstituirajte s 4,2 ml otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%), (bez konzervansa), čime se dobiva otopina koja sadrži 25 mg/ml pemetrekseda.
English: Blood and lymphatic system disorders Common
Croatian: Poremećaji krvi i limfnog sustava često snižen broj neutrofila
English: Neuropathy-sensory
Croatian: pemetreksed/cisplatin cisplatin
English: Common Taste disturbance Eye disorders Common Conjunctivitis Diarrhoea
Croatian: Poremećaji probavnog sustava često dispepsija osip
English: Docetaxel
Croatian: • Proljev
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetrexed Sandoz 1000 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: • Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy)
Croatian: • Radijacijski pneumonitis (stvaranje ožiljaka na mjehurićima u plućima (alveolama) povezano s terapijom zračenjem) može se pojaviti u bolesnika koji su zračeni prije, tijekom ili nakon liječenja lijekom Pemetrexed Sandoz.
English: ul.
Croatian: Avda.
English: See package leaflet for further information.
Croatian: Za dodatne informacije pogledajte uputu o lijeku.
English: Pemetrexed at a dose of 500 mg/m2 was studied as a single agent in 64 chemonaive patients with malignant pleural mesothelioma.
Croatian: U 64 bolesnika s malignim pleuralnim mezoteliomom koji prethodno nisu primali kemoterapiju lijek pemetreksed ispitan je u dozi od 500 mg/m2 u monoterapiji.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium).
Croatian: TVARI Jedna bočica sadrži 1000 mg pemetrekseda (u obliku pemetrekseddinatrija).
English: • Loss of appetite
Croatian: • Gubitak osjeta
English: General disorders and administration site conditions Common Fever
Croatian: Opći poremećaji i reakcije na mjestu primjene često vrućica
English: 2 A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetrexed Sandoz 500 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Croatian: TVARI Jedna bočica sadrži 500 mg pemetrekseda (u obliku pemetrekseddinatrija).
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetrexed Sandoz 100 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Croatian: TVARI Jedna bočica sadrži 100 mg pemetrekseda (u obliku pemetrekseddinatrija).
English: Cisplatin (N = 222)
Croatian: (N = 222)
English: Fatigue Pain
Croatian: Učestal ost
English: MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: Taste disturbance Nausea
Croatian: Poremećaji živčanog sustava često poremećaj okusa
English: The pH of the reconstituted solution is between 6.6 and 7.8.
Croatian: Dobivena otopina je bistra i u rasponu boja od blijedožute, što ne utječe nepovoljno na kvalitetu lijeka. pH rekonstituirane otopine je između 6,6 i 7,8.
English: Cisplatin (N = 163)
Croatian: (N = 163)
English: The resulting solution is clear and ranges in colour from colourless to pale yellow without adversely affecting product quality.
Croatian: Dobivena otopina je bistra i u rasponu boja od bezbojne do blijedožute što ne utječe nepovoljno na kvalitetu lijeka. pH pripremljene otopine je između 6,6 i 7,8.
English: Leucocytes decreased 12.1 4.2 34.1 27.2
Croatian: Tel.: +36 1 430 2890
English: Skin and subcutaneous tissue disorders Common Rash/ desquamation 6.6
Croatian: Poremećaji kože i potkožnog tkiva često osip/ deskvamacija vrlo često umor bol
English: This summary was last updated in March 2017.
Croatian: Ovaj sažetak je posljednji put ažuriran u ožujku 2017.
English: Novem meloxicam
Croatian: Novem meloksikam
English: What is Novem and what is it used for?
Croatian: Što je Novem i za što se koristi?
English: The full EPAR for Novem can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Novem nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Why is Novem approved?
Croatian: Zašto je Novem odobren?
English: Appropriate studies have been carried out in various target animals to show that Novem is effective and safe in its approved uses.
Croatian: Na različitim ciljanim životinjama provedena su odgovarajuća ispitivanja kako bi se pokazalo da je Novem učinkovit i siguran za odobrene primjene.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Novem on 2 March 2004.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Novem na snazi u Europskoj uniji od 2. ožujka 2004.
English: The dose to use depends on the animal and its bodyweight.
Croatian: Doza koju treba upotrijebiti ovisi o životinji i njezinoj tjelesnoj težini.
English: In very rare cases anaphylactoid (allergic) reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Croatian: U vrlo rijetkim slučajevima mogu nastupiti anafilaktičke (alergijske) reakcije koje mogu biti ozbiljne (uključujući i smrtonosne) te ih treba liječiti simptomatski.
English: If the product is accidentally self-injected, the advice of a doctor should be sought immediately.
Croatian: U slučaju nehotičnog samoinjektiranja treba odmah potražiti liječnički savjet.
English: Injections are given under the skin for cattle and into the muscles for pigs.
Croatian: Injekcije se u goveda daju pod kožu, a u svinja u mišić.
English: The studies showed that the addition of Novem to antibiotic therapy significantly improved clinical parameters and reduced fever compared to antibiotics alone.
Croatian: Ispitivanja su pokazala da je dodavanje Novema antibiotskoj terapiji znatno poboljšalo kliničke parametre i smanjilo vrućicu u usporedbi s primjenom samo antibiotika.
English: • lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move)
Croatian: • hromosti i upala u neinfekcijskim poremećajima lokomotornog sustava (bolesti koje utječu na mogućnost kretanja)
English: The withdrawal period for meat is five days.
Croatian: Razdoblje karencije za meso iznosi pet dana.
English: Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Croatian: Meloksikam djeluje blokadom enzima nazvanog ciklooksigenaza koja je uključena u proizvodnju prostaglandina.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Croatian: S obzirom na to da su prostaglandini tvari koje potiču upalu, bol, eksudaciju (tekućina koja curi iz krvnih žila tijekom upale) i vrućicu, meloksikam smanjuje te znakove bolesti.