FrancophonIA/ELRC3.0 huggingface dataset:
English: • in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own;
Maltese: • f'pazjenti li mhumiex ikkontrollati b'mod sodisfaċenti bil-metformina (mediċina kontra d-dijabete)
English: When linagliptin and metformin were given with a sulphonylurea or insulin, hypoglycaemia was the most frequent side effect (seen in more than 1 patient in 10).
Maltese: Meta l-linagliptina u l-metformina ngħataw mas-sulfonilurea jew linsulina, l-effett sekondarju l-aktar frekwenti kien ipogliċemija (li deher f'aktar minn pazjent 1 minn 10).
English: Another study was carried out involving 791 patients with type 2 diabetes, where the combination of linagliptin plus metformin given twice per day was compared with giving metformin alone, linagliptin alone or placebo.
Maltese: Sar studju ieħor li kien jinvolvi 791 pazjent bid-dijabete tat-tip 2, fejn il-kombinazzjoni tal-linagliptina flimkien mal-metformina mogħtija darbtejn kuljum tqabblet mal-għoti tal-metformina waħidha, illinagliptina waħidha jew ma' plaċebo.
English: Linagliptin was given at 2.5 mg twice per day in the combination treatment and at 5 mg once per day in the single treatment.
Maltese: Il-linagliptina ngħatat f'doża ta' 2.5 mg darbtejn kuljum fil-kura ta' kombinazzjoni u f'doża ta' 5 mg darba kuljum fil-kura waħidha.
English: By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Billi ttawwal l-azzjoni tal-ormoni inkretini fid-demm, il-linagliptina tistimula l-frixa biex tipproduċi aktar insulina meta l-livelli ta' glukożju fid-demm jkunu għoljin.
English: The study looking at linagliptin in combination with metformin and insulin showed that this combination was more effective than the combination of insulin and metformin at reducing HbA1c levels (reduction of 0.77 percentage points was seen with linagliptin compared with a reduction of 0.10 percentage points with placebo).
Maltese: HbA1c (deher tnaqqis ta' 0.77 punt perċentwali bil-linagliptina meta mqabbel ma' tnaqqis ta' 0.10 punti perċentwali bi plaċebo).
English: Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Maltese: Il-linagliptina tnaqqas ukoll l-ammont ta' glukożju magħmul millfwied, billi żżid il-livelli ta' insulina u tnaqqas il-livelli tal-ormon glukagon.
English: In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment.
Maltese: Fl-istudji kollha, il-kejl ewlieni tal-effikaċja kien il-bidla fil-livelli ta' sustanza msejħa emoglobina glikosilata (HbA1c) fid-demm wara 24 ġimgħa ta' kura.
English: Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mid =WC0b01ac058004d5c1
Maltese: Disponibbli fuq: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_0014 46.jsp&mid=WC0b01ac058004d5c1
English: 9 September 2014 EMA/554928/2014
Maltese: EMA/554928/2014
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Maltese: 3660 8427 Indirizz elettroniku: press@ema.europa.eu
English: Parving HH, Brenner BM, McMurray JJ, et al. (ALTITUDE Investigators).
Maltese: Parving HH, Brenner BM, McMurray JJ, et al.
English: Yusuf S, Teo KK, Pogue J, et al. (ONTARGET Investigators).
Maltese: Yusuf S, Teo KK, Pogue J, et al.
English: Fried LF, Emanuele N, Zhang JH, et al. (VA NEPHRON-D Investigators).
Maltese: 3. Fried LF, Emanuele N, Zhang JH, et al.
English: ACE-inhibitors (benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril or zofenopril) and the direct renin inhibitor aliskiren block the actions of specific enzymes involved in the production of angiotensin II in the body (ACE-inhibitors block angiotensin-converting enzyme, while renin inhibitors block an enzyme called renin).
Maltese: L-inibituri ACE (benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril jew zofenopril) u l-inibitur dirett ta' renin aliskiren jimblokkaw l-azzjonijiet ta' enzimi speċifiċi involuti fil-produzzjoni ta' angiotensin II filġisem (l-inibituri ACE jimblokkaw l-enzima li tikkonverti l-angiotensin, waqt li l-inibituri ta' renin jimblokkaw enzima msejħa renin).
English: ARBs (containing the active substances azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan or valsartan) block receptors for a hormone called angiotensin II.
Maltese: L-ARBs (li fihom is-sustanzi attivi azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan jew valsartan) jimblokkaw ir-riċetturi ta' ormon imsejjaħ anġjotensin II.
English: 2013; 346: f360.
Maltese: BMJ. 2013; 346: f360. doi: 10.
English: Makani H, Bangalore S, Desouza KA, et al. Efficacy and safety of dual blockade of the reninangiotensin system: meta-analysis of randomised trials.
Maltese: Efficacy and safety of dual blockade of the reninangiotensin system: meta-analysis of randomised trials.
English: The review of RAS-acting agents was initiated at the request of the Italian Medicines Agency (AIFA), under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni dwar l-aġenti b'azzjoni RAS inbdiet fuq talba tal-Aġenzija Taljana tal-Mediċini (AIFA), skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: BMJ.
Maltese: Tel.
English: • The existing contraindication on the concomitant use of ACE-inhibitors or ARBs with aliskirencontaining products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2), which is based on the ALTITUDE study data, was confirmed in the light of the additional data reviewed.
Maltese: • Il-kontraindikazzjoni eżistenti dwar l-użu konkomitanti ta' inibituri ACE jew ARBs ma' prodotti li fihom aliskiren f'pazjenti bid-dijabete mellitus jew b'indeboliment renali (GFR < 60 ml/min/1.73 m2), li hija bbażata fuq id-dejta tal-istudju ALTITUDE, ġiet ikkonfermata fid-dawl tad-dejta addizzjonali riveduta.
English: These medicines can be of three different classes known as ARBs, ACE inhibitors and direct renin inhibitors (the last represented by the medicine aliskiren).
Maltese: Dawn il-mediċini jistgħu jkunu ta' tliet klassijiet differenti magħrufin bħala ARBs, inibituri ACE u inibituri diretti ta' renin (talaħħar irrappreżentat mill-mediċina aliskiren).
English: • There is considerable evidence from large clinical trials such as ONTARGET1, ALTITUDE2 and VA NEPHRON-D3 and from meta-analyses such as that of Makani4 (involving over 68,000 patients) demonstrating that dual RAS blockade through the combined use of ACE-inhibitors, ARBs or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and renal failure compared with monotherapy, in particular in patients with diabetic nephropathy.
Maltese: D3 u minn metaanaliżijiet bħal dik ta' Makani4 (li tinvolvi iktar minn 68,000 pazjent) li turi li l imblokk doppju tar-RAS permezz tal-użu kkombinat ta' inibituri ACE, ARBs jew aliskiren huwa assoċjat ma' riskju ikbar ta' avvenimenti avversi, inklużi ipotensjoni, iperkalemija u indeboliment renali meta mqabbel mal-monoterapija, b'mod partikolari f'pazjenti b'nefropatija dijabetika.
English: This broad review of evidence relating to all RAS-acting agents supported the conclusions of a previous EMA review relating specifically to medicines containing aliskiren.1
Maltese: Din ir-reviżjoni wiesgħa tal-evidenza relatata mal-aġenti kollha b'azzjoni RAS sostniet ilkonklużjonijiet ta' reviżjoni preċedenti tal-EMA relatata speċifikament ma' mediċini li fihom aliskiren.
English: On 23 May 2014 the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) endorsed restrictions on combining different classes of medicines that act on the reninangiotensin system (RAS), a hormone system that controls blood pressure and the volume of fluids in the body.
Maltese: Fit-23 ta' Mejju 2014, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija Ewropea għall-Mediċini approva restrizzjonijiet dwar il-kombinazzjoni ta' klassijiet differenti ta' mediċini li jaġixxu fuq is-sistema renin-anġjotensini (RAS), sistema ta' ormoni li tikkontrolla l-pressjoni taddemm u l-volum ta' fluwidi fil-ġisem.
English: RAS-acting agents work by blocking different stages of the renin-angiotensin system (RAS).
Maltese: L-aġenti b'azzjoni RAS jaħdmu billi jimblokkaw stadji differenti tas-sistema renin-angiotensin (RAS).
English: However, in patients with chronic heart failure, dual blockade should be limited to those intolerant to mineralocorticoid antagonists and with persistent symptoms despite other optimal therapy.
Maltese: Madankollu, f'pazjenti b'insuffiċjenza kronika tal-qalb, l-imblokk doppju għandu jkun limitat għal dawk li huma intolleranti għal antagonisti mineralokortikojdi u li għandhom sintomi persistenti minkejja terapija ottimali oħra.
English: In particular, ACE-inhibitors and ARBs should not be used concomitantly in patients with diabetic nephropathy, and existing contraindications on the use of aliskiren with either an ARB or an ACE inhibitor in patients with diabetes mellitus or moderate to severe renal impairment (GFR < 60 ml/min/1.73 m2) are confirmed.
Maltese: B'mod partikolari, l-inibituri ACE u l-ARBs ma għandhomx jintużaw b'mod konkomittanti f'pazjenti b'nefropatija dijabetika, u lkontraindikazzjonijiet eżistenti dwar l-użu ta' aliskiren jew ma' ARB jew ma' inibitur ACE f'pazjenti bid-dijabete mellitus jew b'indeboliment renali moderat sa sever (GFR < 60 ml/min/1.73 m2) huma kkonfermati.
English: The CHMP opinion was forwarded to the European Commission, which issued final decisions valid throughout the EU in September 2014.
Maltese: L-opinjoni tas-CHMP ġiet mgħoddija lill-Kummissjoni Ewropea, li ħarġet deċiżjonijiet finali validi fl-UE kollha f'Settembru 2014.
English: These recommendations are based on a detailed review of the available data, including clinical trials, meta-analyses and publications, as well as advice from a group of experts on cardiovascular medicine.
Maltese: Dawn ir-rakkomandazzjonijiet huma bbażati fuq reviżjoni dettaljata tad-dejta disponibbli, inklużi provi kliniċi, metaanaliżijiet u pubblikazzjonijiet, kif ukoll fuq pariri minn grupp ta' esperti tal-mediċina kardjovaskulari.
English: These medicines (called RAS-acting agents) belong to three main classes: angiotensin-receptor blockers (ARBs, sometimes known as sartans), angiotensin-converting enzyme inhibitors (ACEinhibitors) and direct renin inhibitors such as aliskiren.
Maltese: Dawn il-mediċini (imsejħin aġenti b'azzjoni RAS) jappartjenu għal tliet klassijiet ewlenin: imblokkaturi tar-riċettur ta' anġjotensini (ARBs, kultant magħrufin bħala sartans), inibituri tal-enzimi li jikkonvertu anġjotensini (inibituri ACE) u inibituri diretti ta' renin bħal aliskiren.
English: The CHMP opinion confirmed recommendations made by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC) in April 2014, following assessment of evidence from several large studies in patients with various pre-existing heart and circulatory disorders, or with type 2 diabetes.
Maltese: L-opinjoni tas-CHMP ikkonfermat ir-rakkomandazzjonijiet magħmula mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) tal-Aġenzija f'April 2014, wara valutazzjoni tal-evidenza minn diversi studji kbar f'pazjenti b'disturbi varji tal-qalb jew taċ-ċirkolazzjoni li kienu jeżistu minn qabel, jew bid-dijabete tat-tip 2.
English: Slovenská republika Sevaron ltd
Maltese: Česká republika Sevaron ltd
English: ATCvet code: QM01AC06.
Maltese: Kodici ATC veterinarja: QM01AC06.
English: Elimination Meloxicam is eliminated with a terminal half-life of 7.7 hours.
Maltese: Eliminazzjoni Melossikam jiġi eliminat b'half-life terminali ta' 7.7 sigħat.
English: 7171 Uldum
Maltese: 7171 Uldum Tel.
English: Active substance Meloxicam 15 mg.
Maltese: Sustanza attiva Meloxicam 15 mg.
English: Genera Sl, Podjetje za zastopanje in trgovino d.o.o.
Maltese: Genera Sl, Podjetje za zastopanje in trgovino d.o.o. Parmova Ulica 53
English: Date of first authorisation: 08/09/2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 08/09/2015
English: Polysorbate 80
Maltese: Polisorbat 80
English: EU/2/15/186/001-002
Maltese: FIS-SUQ EU/2/15/186/001-002
English: Meloxicam 15 mg/ml
Maltese: Melossikam 15 mg/ml
English: The major metabolites found in all species were the 5-hydroxyand 5-carboxy-metabolites and the oxalyl-metabolite.
Maltese: Il-metaboliti maġġuri li jinsabu f'kull speċi kienu lmetaboliti 5-hydroxy- u 5-carboxy u l-metabolit oxalyl.
English: Pregnancy and lactation: See section “Contraindications”.
Maltese: Tqala u treddigħ Ara s-sezzjoni “Kontraindikazzjonijiet”.
English: All major metabolites have been shown to be pharmacologically inactive.
Maltese: Intwera li l-metaboliti maġġuri kollha huma farmakoloġikament inattivi.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams).
Maltese: Prodotti antiinfjammatorji u antirewmatiċi, mhux sterojdi (oxicams)
English: No entry Anti-inflammatory agents/Nonsteroidal antiinflammatory agents
Maltese: Mediċini antiinfjammatorji/ Mediċini mhux sterojdi antiinfjammatorji
English: The active substance in Novaquin is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Novaquin hi sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness għarRegolament tal-Kummissjoni (UE) Nru 37/2010:
English: Approximately 98 % of meloxicam is bound to plasma proteins.
Maltese: Madwar 98 % ta' melossikam jeħel mal-proteini tal-plażma.
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.
Maltese: Melossikam hu Mediċina Mhux Sterojdi Kontra l-Infjammazzjoni (NSAID) tal-klassi oxicam li taġixxi bl-inibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti anti-infjammatorji, analġesiċi, kontra t-tnixxija u antipiretiċi.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Česká republika Sevaron ltd Palackeho trida 163 a 61200 Brno Tel. +420 541 426 370
Maltese: Slovenská republika Sevaron ltd Palackeho trida 163 a 61200 Brno Tel.
English: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Maltese: Melossikam Melossikam Gniedes, mogħoż, qżieżeż, fniek,
English: Meat and offal: 3 days.
Maltese: Laħam u ġewwieni tal-annimal: 3 ijiem.
English: Manufacturer responsible for batch release: Produlab Pharma B.V.
Maltese: Manifattur responsabbli mill-ħrug tal-lott Produlab Pharma B.V.
English: Hydroxyethylcellulose Silica, colloidal anhydrous Disodium phosphate dodecahydrate Citric acid monohydrate Sodium cyclamate Sorbitol, liquid
Maltese: Idrossietilċellulożi Silika, anhydrous kollojdali Fosfat tad-disodju dodekaidrat Aċidu ċitriku monoidrat Sodju ċiklamat
English: Cardboard box containing one high density polyethylene (HDPE) bottle of 125 ml or 336 ml with a HDPE screw cap and a polypropylene measuring syringe.
Maltese: Kaxxa tal-kartun li fiha flixkun tal-polietilin (HDPE) b'densità għolja ta' 125 ml jew 336 ml b'tapp (HDPE) magħmul apposta biex ma jinfetaħx u siringa tal-kejl tal-polietilin.
English: Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects.
Maltese: Studji fil-laboratorju fil-frat ma pprovdew l-ebda evidenza ta' effetti teratoġeniċi, fetotossiċi jew maternotossiċi.
English: 15 mg
Maltese: Melossikam 15mg
English: HDPE-bottle
Maltese: JEKK MEĦTIEĠ
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.
Maltese: Melossikam għandu wkoll kwalitajiet antiendotossiċi għax intwera li jinibixxi l-produzzjoni ta' trombossan B2 ikkaġunata mill-għoti ġol-vina ta' E. coli endotossin fl-għoġġiela u fil-majjali.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of 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 product.
Maltese: L-eċċipjenti elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor (SPC) huma jew sustanzi ammissibbli li għalihom it-tabella numru 1 tal-anness għar-Regolament tal-Kummissjoni (UE) Nru 37/2010 tindika li mhumiex meħtieġa MRLs jew huma kkunsidrati li ma jaqgħux fl-ambitu tarRegolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott.
English: In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.
Maltese: F'każijiet rari ħafna, nuqqas ta' aptit, letarġija, uġigħ addominali u kolite ġew irrappurtati.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
Maltese: Evita l-użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, peress li hemm riskju potenzjali ta' tossiċità renali.
English: Yellowish-green viscous oral suspension.
Maltese: Sospensjoni orali viskuża, safra fl-aħdar.
English: PACKAGE LEAFLET:
Maltese: Eċċipjent:
English: Novaquin 15 mg/ml oral suspension for horses meloxicam
Maltese: Novaquin 15 mg/ml sospensjoni orali għaż-żwiemel melossikam
English: Dosage Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.
Maltese: Dożaġġ Sospensjoni orali biex tingħata f'dożaġġ ta' 0.6 mg / kg ta' piż tal-ġisem, darba kuljum, sa 14-il jum.
English: Excipient: Sodium benzoate
Maltese: Benżoat tas-sodju Gliċerol
English: ul.
Maltese: Tel.
English: Avoid introduction of contamination during use.
Maltese: Evita li tintroduċi xi kontaminazzjoni matul l-użu.
English: Novaquin 15 mg/ml oral suspension for horses
Maltese: VETERINARJU Novaquin 15 mg/ml sospensjoni orali għaż-żwiemel
English: People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma ipersensittivi għal Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) għandhom jevitaw kuntatt mal-prodott mediċinali veterinarju.
English: Anise aroma
Maltese: Aroma tal-aniżetta Ilma purifikat
English: Outer carton
Maltese: KARATTERISTIĊI
English: 15 μg/kg Milk
Maltese: 12 l/kg.
English: Interaction with other medicinal products and other forms of interaction: Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Maltese: Interazzjonijiet ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni M'għandux jingħata flimkien ma' glukokortikosterojdi, mediċini antiinfjammatorji mhux sterojdi oħra jew ma' antikoagulanti.
English: Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Maltese: Tużax fuq żwiemel li jsofru minn mard gastrointestinali, bħal irritazzjoni jew emorraġija, jew annimali li għandhom indeboliment fil-funzjoni epatika, kardijaka jew renali, u mard emorraġiku.
English: Active substance: Meloxicam
Maltese: EFFETTI MHUX MIXTIEQA
English: Isolated cases of adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea).
Maltese: Każijiet iżolati ta' reazzjonijiet avversi li ġeneralment huma assoċjati ma' Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) kienu osservati fi provi kliniċi (urtikarja ħafifa, dijarea).
English: Pharmacologically active substance
Maltese: Sustanza attiva b'mod farmakoloġiku
English: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Maltese: Nies li hu magħruf li huma ipersensittivi għal NSAIDs għandhom jevitaw kuntatt mal-prodott mediċinali veterinarju.
English: The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.
Maltese: Il-fattur talakkumulazzjoni ta' 1.08 jindika li melossikam ma jakkumulax meta jingħata kuljum.
English: Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea).
Maltese: Każijiet iżolati ta' reazzjonijiet avversi li ġeneralment huma assoċjati mal-NSAIDs kienu osservati fi provi kliniċi (urtikarja ħafifa, dijarea).
English: It reduces leukocyte infiltration into the inflamed tissue.
Maltese: Tnaqqas l-infiltrazzjoni tal-lewkoċiti fit-tessut infjammat.
English: To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
Maltese: Sa ċertu punt tinibixxi wkoll l-aggregazzjoni tat-tromboċiti kkaġunata mill-kollaġen.
English: The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively there are differences.
Maltese: Il-metaboliżmu huwa simili b'mod kwalitattiv fil-firien, majjali żgħar, fil-bniedem, frat u majjali, għalkemm jeżistu xi differenzi kwantitattivi.
English: Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Maltese: M'għandux jingħata flimkien ma' glukokortikosterojdi, mediċini anti-infjammatorji mhux sterojdi oħrajn jew ma' antikoagulanti.
English: If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Maltese: Jekk ikun hemm reazzjonijiet avversi, il-kura għandha titwaqqaf u għandu jittieħed il-parir ta' veterinarju.
English: 2 July 2012
Maltese: 2 ta' Lulju 2012
English: 1 Revlimid is marketed in Austria, Belgium, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Greece Ireland, Italy, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
Maltese: 1 Revlimid huwa mqiegħed fis-suq fl-Awstrija, il-Belġju, Ċipru, ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, Franza, ilĠermanja, il-Greċja, l-Irlanda, l-Italja, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, is-Slovakkja, isSlovenja, Spanja, l-Isvezja u r-Renju Unit.
English: The active substance in Revlimid, lenalidomide, is an immunomodulating agent.
Maltese: Is-sustanza attiva f'Revlimid, lenalidomide, hija aġent immunomodulanti.
English: The full European Public Assessment Report for Revlimid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Revlimid?
Maltese: X'inhu Revlimid?
English: Revlimid was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 12 December 2003 for multiple myeloma.
Maltese: Revlimid ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-12 ta' Diċembru 2003 għal majeloma multipla.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Revlimid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The applicant presented data from two main studies involving 1073 patients with newly diagnosed multiple myeloma.
Maltese: L-applikant ippreżenta dejta minn żewġ studji ewlenin li involvew 1073 pazjent b'majeloma multipla li tkun għadha kif ġiet djanjostikata.