FrancophonIA/ELRC3.0 huggingface dataset:
English: The most commonly reported undesirable effects related to pemetrexed, whether used as monotherapy or in combination, are bone marrow suppression manifested as anaemia, neutropenia, leucopenia, thrombocytopenia; and gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, pharyngitis, mucositis, and stomatitis.
Maltese: L-aktar effetti mhux mixtieqa li ġew irrapportati b'mod komuni u li għandhom x'jaqsmu ma' pemetrexed kemm jekk jintuża bħala monoterapija u kemm jekk jintuża flimkien ma' prodotti mediċinali oħra huma t-tnaqqis fil-funzjoni tal-mudullun li jidher bħala anemija, newtropinja,lewkopinja, tromboċitopinja;u tossiċitajiet gastrointestinali li jidhru bħala anoressija, dardir, rimettar dijarrea, stitikezza, farinġite, mukosite u stomatite.
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.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f' > 1% u < 5% (komuni) tal-pazjenti li ntgħażlu b'mod arbitrarju biex jirċievu pemetrexed jinkludu: infezzjoni mingħajr newtropenja newtropenja bid-deni, reazzjoni allerġika/sensittivita aċċessiva, żieda fil-krejatinina, newropatija motorja, newropatija sensittiva, eritema multiforme u wġigħ addominali.
English: 100% of previous dose
Maltese: 100 % tad-doża ta' qabel
English: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion
Maltese: Pemetrexed Sandoz 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Pemetrexed Sandoz 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Pemetrexed Sandoz 1000 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Pemetrexed Sandoz is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Maltese: Pemetrexed Sandoz tingħata flimkien ma' cisplatin, mediċina oħra kontra l-kanċer, bħala kura għal mesoteljoma plewrali malinna, tip ta' kanċer li jaffettwa r-rita tal-pulmun, lil pazjenti li jkunu għadhom ma ngħatawx kimoterapija.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Sandoz and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Sandoz treatment).
Maltese: B12 (1000 microgramma) fil-ġimgħa ta' qabel li tingħata Pemetrexed Sandoz u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3
English: Slovenská republika Sandoz d.d.
Maltese: Slovenská republika Sandoz d.d. organizačná zložka Galvaniho 15/C
English: Pemetrexed Sandoz must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Maltese: Pemetrexed Sandoz għandu jingħata biss bis-superviżjoni ta' tabib ikkwalifikat fl-użu tal-kimoterapija kontra l-kanċer.
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Sandoz powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Maltese: Qabel ma' jingħatalek, it-trab ta' Pemetrexed Sandoz jiġi mħallat ma' soluzzjoni għall-injezzjoni ta' 9 mg/ml(0.9 %) sodium chloride, mill-ispiżjar tal-isptar, infermier jew tabib.
English: Side effects with Pemetrexed Sandoz may include:
Maltese: Effetti sekondarji ta' Pemetrexed Sandoz jistgħu jinkludu:
English: • Blood clots in the lung blood vessels (pulmonary embolism)
Maltese: • Ċapep tad-demm fis-sistema vaskulari tal-pulmun (emboliżmu pulmunarju)
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 265 patients randomly assigned to receive single-agent pemetrexed with folic acid and vitamin B12 supplementation, and 276 patients randomly assigned to receive single-agent docetaxel.
Maltese: It-tabella hawn taħt tati l-frekwenza u s-severità tal-effetti mhux mixtieqa li ġew irrapportati f'>5% tal-265 pazjent li ntgħażlu b'mod arbitrarju biex jirċievu pemetrexed waħdu b'supplimentazzjoni ta' folic acid u vitamina
English: Österreich Sandoz GmbH Biochemiestr.
Maltese: Österreich Sandoz GmbH Biochemiestr. 10 A-6250
English: Dose modification table for Pemetrexed Sandoz (as single agent or in combination) and cisplatin - Neurotoxicity
Maltese: TABELLA 3 - Tabella għall-modifikazzjoni fid-doża ta' Pemetrexed Sandoz (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Newrotossiċità Grad CTCa
English: • Median
Maltese: • Dijarrea
English: Clinically relevant toxicity that was reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Maltese: Tossiċitajiet klinikament rilevanti li ġew irrapportati f' ≥ 1% u ≤5% (komuni) tal-pazjenti li ntgħażlu b'mod arbitrarju biex jirċievu cisplatin u pemetrexed jinkludu: żieda fl-AST, żieda fl-ALT, infezzjoni, newtropenja bid-deni, insuffiċjenza renali, deni, diżidratazzjoni, konġuntivite u tnaqqis fit-tneħħija ta' krejatinina.
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.
Maltese: Pemetrexed Sandoz 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett tal-ħġieġ ta' Tip I tat-tip ċar, bla kulur ta' 50 ml, b'tapp tal-lasktu tal-chlorobutyl u b'kappa li titgħaffeġ tal-aluminju b'kappa li tfaqqa' meta tinfetaħ, li fih 500 mg ta' pemetrexed.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq rikostituzzjoni u dilwizzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: PARAMOUNT: Kaplan-Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Maltese: Dijagrammi Kaplan Meier ta' sopravivenza mingħajr progressjoni (PFS) u Sopravivenza Totali (OS) għat-tkomplija ta' manteniment b'pemetrexed kontra plaċebo f'pazjenti b'NSCLC minbarra dawk fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous ( kkwantifikat permezz ta' għażla b'mod arbitrarju)
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.
Maltese: Irrikostitwixxi kull kunjett ta' 500mg b'20 ml ta' soluzzjoni għall-injezzjoni ta' 9mg/ml (0.9%) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
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 =
Maltese: Għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċ-ċelluli huma liżjed tat-tip squamous (n= 430, popolazzjoni analizzata indipendentement), il-medjan tal-PFS kien ta' 4.4 xhur għall-fergħa ta'pemetrexed u ta' 1.8 xhur għall-fergħa tal-plaċebo, hazard ratio = 0.47, 95 % CI = 0.37-0.60,p= 00001.
English: Very common Creatinine clearance decreased**
Maltese: Tnaqqis fittneħħija talkrejatinina**
English: EXP
Maltese: Dispepsja
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.
Maltese: Pemetrexed Sandoz 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) kull kunjett, jiġifieri huwa essenzjalment ħieles mis-sodium.
English: Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia, and anaemia.
Maltese: Komplikazzjonijiet mistennija ta' doża eċċessiva jinkludu: soppressjoni tal-mudullun kif jixhdu n-newtropenja, t-tromboċitopenja u l-anemija.
English: Median overall survival in months (95% CI)
Maltese: Sopravivenza globali medjana (xhur) (95 % CI)
English: Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Maltese: Pemetrexed Sandoz 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 500 mg ta' pemetrexed (bħala pemexetred disodium).
English: 50% of previous dose (both pemetrexed and cisplatin)
Maltese: 50 % tad-doża ta' qabel (kemm pemetrexed kif ukoll cisplatin).
English: SGPT (ALT) elevation 7.9
Maltese: Сгр.7Б, ет.3
English: Dose modification table for Pemetrexed Sandoz (as single agent or in combination) and cisplatin - Haematologic toxicities
Maltese: TABELLA 1 - Tabella għall-modifikazzjoni fid-doża ta' Pemetrexed Sandoz ( bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Tossiċitajiet ematoloġiċi
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.
Maltese: Pemetrexed Sandoz 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett tal-ħġieġ ta' Tip I tat-tip ċar, bla kulur ta' 10 ml, b'tapp tal-lasktu tal-chlorobutyl u b'kappa li titgħaffeġ tal-aluminju b'kappa li tfaqqa' meta tinfetaħ, li fih 100 mg ta' pemetrexed Pakkett b'kunjett wieħed bi tgeżwira protettiva tal-plastik.
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.
Maltese: Irrikostitwixxi kull kunjett ta' 1,000mg b'40 ml ta' soluzzjoni għall-injezzjoni ta' 9mg/ml (0.9%) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1,500 cells/mm3 and platelets should be ≥ 100,000 cells/mm3.
Maltese: newtrofili (ANC) ma jerġa' jkun ≥ 1,500 ċellula/mm3 u l-għadd ta' plejtlits ma jerġa' jkun ≥ 100,000
English: Blood and lymphatic system disorders Common
Maltese: Disturbi fiddemm u fissistema limfatika Komuni
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1,000 micrograms) on a daily basis.
Maltese: Il-pazjenti għandhom jieħdu b'mod orali folic acid jew xi prodott multivitaminiku li jkun fih folic acid (minn 350 sa 1,000 mikrogramma) kuljum.
English: Vomiting
Maltese: Cisplatin
English: Contents of the pack and other information What Pemetrexed Sandoz contains The active substance is pemetrexed.
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Pemetrexed Sandoz Is-sustanza attiva hi pemetrexed.
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).
Maltese: Meta tinkludi lfażi tal-induzzjoni l-medjan tal-OS għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċċelluli huma l-iżjed tat-tip squamous kien ta' 18.6 xhur għall-fergħa ta' pemetrexed u ta' 13.6 xhur għall-fergħa tal-plaċebo (hazard ratio =0.71, 95% CI = 0.56-0.88, p = 0.002).
English: Cisplatin (N = 163)
Maltese: (N = 163)
English: Pemetrexed Sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1).
Maltese: Ħlief meta l-istoloġija turi li ċ-ċelluli jkunu l-iżjed tat-tip squamous, Pemetrexed Sandoz huwa indikat bħala monoterapija fil-kura ta' manteniment tal-kanċer fil-pulmun mhux b'ċelluli żgħar li jkun lokalment avanzat jew metastatiku f'pazjenti fejn ma kienx hemm progress fil-marda immedjatament wara l-kimoterapija bbażata fuq il-platinum (ara sezzjoni 5.1).
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.
Maltese: Irrikostitwixxi kunjetti ta' 100mg b'4.2 ml ta' soluzzjoni għall-injezzjoni ta' 9mg/ml (0.9%) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: • 95% CI for median
Maltese: 95% CI għalmedjan
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio = 0.78, 95%CI=0.64-0.96, p=0.0195).
Maltese: Wara li bdiet il-kura b'pemetrexed flimkien ma' cisplatin (4 ċikli), il-kura b'pemetrexed kienet statistikament superjuri għal placebo għall-OS (medjan 13.9 xhur kontra 11.0 xhur, hazard ratio = 0.78, 95%CI=0.
English: Cisplatin (N = 222)
Maltese: (N = 222)
English: Neuropathy-sensory
Maltese: Newropatija sensittiva
English: Grade 3-4 toxicity
Maltese: Kull tossiċità ta' Grad 3 jew 4 minbarra mukożite
English: After reconstitution and infusion:
Maltese: Stima tal-frekwenza:
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (N = 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio = 0.60,95% CI = 0.49-0.73, p < 0.00001).
Maltese: L-istudju laħaq ir-riżultat primarju tiegħu u wera titjib statistikament sinifikanti fil-PFS fil-fergħa ta' Pemetrexed Sandoz fuq dik il-fergħa ta' plaċebo (n = 581, popolazzjoni analizzata indipendentement; medjan ta' 4.0 xhur u 2.0 xhur, rispettivament) (hazard ratio = 0.60, 95%CI = 0.490.73,p < 0.00001).Analiżi indipendenti tar-radjografiji tal-pazjenti kkonfermat ir-riżultati talevalwazzjoni tal-investigatur dwar il-PFS.
English: Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
Maltese: Il-prodotti mediċinali parenterali għandhom jiġu spezzjonati viżwalment għal frak u telf fil-kulur qabel jingħataw.
English: Pemetrexed Sandoz as single agent In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of pemetrexed is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: F'pazjenti kkurati għall-kanċer tal-pulmun mhux b'ċelluli żgħar wara kimoterapija preċedenti, id-doża rakkomandata ta' pemetrexed hi ta' 500 mg/m2 BSA mogħtija b'infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Pemetrexed Sandoz in combination with cisplatin
Maltese: Pemetrexed Sandoz flimkien ma' cisplatin
English: Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent-to-treat; N = total population size.
Maltese: ITT = intenzjoni li tikkura; n = daqs tal-popolazzjoni kollha
English: • Skin rash
Maltese: •Raxx fil-ġilda
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis).
Maltese: Għamel kuntatt mat-tabib tiegħek jekk ikollok raxx sever jew ħakk jew jkollok ħafna nfafet (Is-sindromu ta' Stevens-Johnson jew Toxic epidermal necrolysis).
English: • Low platelet count
Maltese: • Insuffiċjenza tal-kliewi akuta
English: Pemetrexed Sandoz should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: Pemetrexed Sandoz għandha tingħata fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata bħala infużjoni minn ġol-vini li ddum 10 minuti.
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).
Maltese: Għal dawk il-pazjenti magħżula b'mod arbitrarju, kif mkejjel mill-bidu tal-kura primarja inizjali ta' pemetrexed flimkien ma' cisplatin, il-medjan talPFS evalwat mill-investigatur kien ta' 6.9 xhur għall-fergħa ta' pemetrexed u ta' 5.6 ta' xahar għallfergħa tal-plaċebo (hazard ratio = 0.59 95% CI = 0.
English: Skin and subcutaneous tissue disorders
Maltese: Johnson u Nekrożi epidermali tossika
English: Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Sandoz and should therefore use effective contraception during treatment with Pemetrexed Sandoz and for up to 6 months afterwards.
Maltese: Jekk għandek akkumulazzjoni ta' fluwidu madwar il-pulmun tiegħek, it-tabib tiegħek jista' jiddeċiedi li jneħħilek dak il-fluwidu qabel ma jagħtik Pemetrexed Sandoz.
English: Clinically relevant CTC toxicities that were reported in < 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f'< 1% (mhux komuni) tal-pazjenti li ntgħażlu b'mod arbitrarju biex jirċievu cisplatin u pemetrexed jinkludu arritmja u newropatija motorja.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion pemetrexed
Maltese: U KWANTITATTIVA Pemetrexed Sandoz 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Novem meloxicam
Maltese: Novem melossikam
English: Other information about Novem:
Maltese: Informazzjoni oħra dwar Novem:
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.
Maltese: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports.
English: This summary was last updated in March 2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Marzu 2017.
English: It contains the active substance meloxicam.
Maltese: Fih is-sustanza attiva melossikam.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Novem on 2 March 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Novem fit-2 ta' Marzu 2004.
English: Novem contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: Novem fih is-sustanza melossikam li tappartieni għall-klassi ta' mediċini msejħin mediċini antinfjammatorji nonsterojdali (non-steroidal anti-inflammatory drugs, NSAIDs).
English: What are the risks associated with Novem?
Maltese: X'inhuma r-riskji assoċjati ma' Novem?
English: Cattle
Maltese: Ħnieżer
English: Why is Novem approved?
Maltese: Għaliex Novem huwa approvat?
English: • acute respiratory infection (infection of the lungs and airways) together with antibiotics
Maltese: • infezzjoni respiratorja akuta (infezzjoni fil-pulmun u fil-passaġġi tal-arja) flimkien mal-antibijotiċi
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni dwar il-bażi tar-rakkomandazzjonijiet tas-CVMP, aqra d-diskussjoni xjentifika (parti mill-EPAR ukoll).
English: In cattle and pigs both subcutaneous and intramuscular administration are well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Maltese: L-għoti minn taħt il-ġilda u b'mod intramuskolari huwa ttollerat tajjeb mill-frat u l-ħnieżer; ġiet osservata biss nefħa temporanja fis-sit tat-titqiba wara l-għoti minn taħt il-ġilda f'inqas mill-10% talfrat li ġew ikkurati fi studji kliniċi.
English: Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Maltese: Il-melossikam taġixxi billi timblokka enzima msejħa ċiklossiġenażi li hija involuta fil-produzzjoni tal-prostaglandini.
English: • pain following minor soft tissue surgery such as castration
Maltese: • uġigħ wara interventi kirurġiċi fuq it-tessuti artab minuri bħall-kastrazzjoni
English: • acute mastitis (inflammation of the udder) together with the main treatment with antibiotics.
Maltese: • mastite akuta (infjamazzjoni tal-beżżula) flimkien mal-kura prinċipali bl-antibijotiċi.
English: The studies showed that the addition of Novem to antibiotic therapy significantly improved clinical parameters and reduced fever compared to antibiotics alone.
Maltese: L-istudji wrew li ż-żieda ta' Novem ma' terapija antibijotika tejbet b'mod sinifikanti l-parametri kliniċi u naqqset id-deni meta mqabbla mal-antibijotiċi waħedhom.
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.
Maltese: Peress li l-prostaglandini huma sustanzi li jiskattaw l-infjamazzjoni, l-uġigħ u t-tagħriq (fluwidu fl-għamla ta' għaraq li jillikja mill-vini matul l-infjamazzjoni) u d-deni, il-melossikam tnaqqas is-sinjali tal-mard.
English: • diarrhoea in calves of over one week of age and young, non-lactating cattle together with oral re hydration therapy (medicines given by mouth to restore water levels in the body)
Maltese: • dijarea f'għoġġiela ikbar minn ġimgħa u f'baqar ta' età żgħira li ma jkunux qed ireddgħu flimkien ma' terapija orali ta' reidratazzjoni (mediċini li jingħataw b'mod orali biex ireġġgħu lura l-livell tal ilma fil-ġisem)
English: • infections that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia
Maltese: • zappip u infjammazzjoni kontra disturbi lokomotorji mhux infettużi (mard li jaffettwa l-ħila taċ ċaqliq)
English: What benefits of Novem have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Novem li ħarġu mill-istudji?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Novem's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Novem huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Novem.
Maltese: Persuni li huma ipersensittivi (allerġiċi) għal NSAIDs għandhom jevitaw il-kuntatt ma' Novem.
English: How is Novem used?
Maltese: Kif jaħdem Novem?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: Dawn jistgħu jkunu serji (u anke fatali) u għandhom jiġu ttrattati b'mod sintomatiku.
English: Novem is an anti-inflammatory medicine used in cattle and pigs.
Maltese: Novem huwa mediċina antiinfjammatorja li tintuża fuq il-frat u l-ħnieżer.
English: Condition for lifting the suspension of the marketing authorisations for Numeta G13%E and associated names
Maltese: Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjonijiet għattqegħid fis-suq għal Numeta G13%E u ismijiet assoċjati