FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common adverse reactions: - Mild to moderate inflammation at the injection site that typically resolves within four days but in some cases may persist for up to 12 days post-vaccination was observed in safety studies.
Maltese: Reazzjonijiet avversi komuni ħafna: - Fi studji ta' sigurtà ġiet osservata infjammazzjoni ħafifa għal moderata fis-sit tal-injezzjoni li normalment tgħaddi fi żmien 4 t' ijiem iżda f'xi każijiet tista' tippersisti sa 12-il ġurnata wara t tilqima.
English: Type I colourless glass vials of 20, 50 and 100 ml.
Maltese: Kunjetti tal-ħġieġ bla kulur tat-Tip I ta' 20, 50 u 100 ml.
English: Adjuvants:
Maltese: Majjali.
English: However, the duration of immunity of the Erysipelas component following mixed use has not been investigated.
Maltese: Madankollu, it-tul tal-immunità tal-komponent tal-Erysipelas wara l-użu mħallat għadu ma ġiex investigat.
English: Ginseng.
Maltese: Ġinseng
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottles, (20 ml, 50 ml) and vials (20 ml, 50 ml)
Maltese: JMISS MAL-PRODOTT TAL-FLIXKUN (20 ml, 50 ml), TAL-KUNJETT (20 ml, 50 ml)
English: The vials are closed with a rubber stopper and aluminium cap.
Maltese: Vaċċini virali inattivati u vaċċini batterjali għall.
English: Cardboard box with 1 PET bottle of 10 doses (20 ml).
Maltese: Kaxxa tal-kartun b'kunjett tal-PET 1 ta' 10 dożi (20 ml).
English: Cardboard box with 1 PET bottle of 25 doses (50 ml).
Maltese: Kaxxa tal-kartun b'kunjett tal-PET 1 ta' 25 doża (50 ml).
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with UNISTRAIN PRRS (where this vaccine is authorised) and administered at one injection site.
Maltese: Huwa disponibbli dejta tas-sigurtà u l-effikaċja li turi li din it-tilqima tista' titħallat ma' UNISTRAIN PRRS (fejn dan il-vaċċin huwa awtorizzat) u tiġi amministrata f'post wieħed ta' titqib.
English: Cardboard box with 1 PET bottle of 50 doses (100 ml).
Maltese: Kaxxa tal-kartun b'kunjett tal-PET 1 ta' 50 doża (100 ml).
English: E. rhusiopathiae: vaccination protects against swine erysipelas until the time of the recommended revaccination (approximately six months after the basic vaccination scheme), see section 4.9.
Maltese: E. rhusiopathiae: tilqima li tipproteġi kontra l-erisipelas tal-majjali saż-żmien tat-tilqima mill-ġdid rakkomandata (bejn wieħed u ieħor sitt xhur wara l-iskema tat-tilqima bażika), irreferi għas-sezzjoni
English: Pharmacotherapeutic group: Immunologicals for suidae, Inactivated viral and bacterial vaccines.
Maltese: Kodici ATC veterinarja QI09AL01 Biex jistimula l-immunizzazzjoni attiva kontra l-parvovirus tal-majjali u l-erisipelas tal-majjali.
English: Do not mix with any other veterinary medicinal product, except with UNISTRAIN PRRS.
Maltese: Tħallatx ma' ebda prodott mediċinali veterinarju ieħor, minbarra ma' UNISTRAIN PRRS.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: Revaccination:
Maltese: Inkompatibilitajiet maġġuri:
English: Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule:
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni:
English: ATCvet code: QI09AL01.
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott.
English: Basic vaccination:
Maltese: GĦAMLA FARMAĊEWTIKA
English: PACKAGE LEAFLET: ERYSENG PARVO suspension for injection for pigs
Maltese: Suspensjoni għal injezzjoni bajdanija
English: Cardboard box with 1 glass vial of 10 doses (20 ml).
Maltese: Kaxxa tal-kartun b'kunjett tal-ħġieġ 1 ta' 10 dożi (20 ml).
English: MA (EU) number
Maltese: EU/1/17/1256/001 EU/1/17/1256/002
English: Strength Pharmaceutical Form
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: HPS2-THRIVE study.
Maltese: 1 HPS2-THRIVE:
English: Conditions for lifting the suspension
Maltese: Kundizzjonijiet għat-tneħħija tas-sospensjoni
English: The PRAC issued a recommendation to the CHMP on 10 January 2013.
Maltese: Il-PRAC ħareġ rakkomandazzjoni lis-CHMP fl-10 ta' Jannar 2013.
English: Previously available data on laropiprant/nicotinic acid included nine studies where a total of 5,782 patients were exposed to the medicine.
Maltese: Dejta disponibbli preċedentament dwar laropiprant/nicotinic acid inkludiet disa' studji fejn total ta' 5,782 pazjenti ġew esposti għall-mediċina.
English: Grounds for CHMP opinion Whereas,
Maltese: Raġunijiet għall-opinjoni tas-CHMP Billi,
English: The HPS2-THRIVE study was conducted by the Clinical Trial Service Unit at the University of Oxford and funded by the MAH.
Maltese: L-istudju HPS2-THRIVE twettaq mill-Clinical Trial Service Unit fl-Università ta' Oxford u ġie ffinanzjat mill-MAH.
English: Nicotinic acid/laropiprant (authorised in the EU as Tredaptive, Trevaclyn and Pelzont) is indicated for the treatment of dyslipidaemia, particularly in adult patients with combined mixed dyslipidaemia and in adult patients with primary hypercholesterolaemia in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.
Maltese: Nicotinic acid/laropiprant (awtorizzat fl-UE bħala Tredaptive, Trevaclyn u Pelzont) huwa indikat għallkura ta' dislipidemija, b'mod partikolari f'pazjenti adulti b'dislipidemija mħallta kkombinata u f'pazjenti adulti b'iperkolesterolemija primarja f'kombinazzjoni ma' inibituri HMG-CoA reductase (statins), meta leffett tat-tbaxxija tal-livelli ta' kolesterol ta' monoterapija ta' inibitur HMG-CoA reductase ma tkunx adegwata.
English: This increase was driven by differences observed in the system organ class blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin, which all favoured placebo.
Maltese: Din iż-żieda ġiet xprunata mid-differenzi osservati mis-sistema ta' klassifika tal-organi, demm u sistema limfatika, gastro-intestinali, infezzjonijiet, metaboliżmu, muskuloskeletali, respiratorji u ġilda, li lkoll iffavorixxew il-plaċebo.
English: The product is authorised as modified release tablets containing 1000mg of nicotinic acid and 20mg of laropiprant.
Maltese: Il-prodott huwa awtorizzat bħala pilloli b'rilaxx modifikat li fihom 1000mg ta' nicotinic acid u 20mg ta' laropiprant.
English: Preliminary results of this study became available and were submitted by the MAH for review end of December 2012.
Maltese: Riżultati preliminari ta' dan l-istudju saru disponibbli u ġew sottomessi mill-MAH għal reviżjoni fit-tmiem ta' Diċembru 2012.
English: The HSP2-THRIVE study was a very large randomised trial, enrolling 25,673 patients considered to be at high risk of cardiovascular events.
Maltese: L-istudju HSP2-THRIVE kien prova b'mod każwali kbira ħafna, li fiha kien hemm reġistrati 25,673 pazjent li tqiesu li huma f'riskju għoli ta' avvenimenti kardjovaskulari.
English: 1 HPS2-THRIVE: Hearth Protection Study 2 - Treatment of HDL (high density lipoprotein) to Reduce the Incidence of Vascular Events.
Maltese: Il-Protezzjoni tal-Qalb Studju 2 - Il-Kura ta' HDL (lipoprotein b'densità għolja) għat-Tnaqqis tal-Inċidenza ta' Avvenimenti
English: • The CHMP considered the notification under Article 20 of Regulation (EC) No 726/2004 for nicotinic acid/laropiprant (approved in the EU as Tredaptive, Trevaclyn and Pelzont) initiated by the European Commission,
Maltese: • Is-CHMP ikkunsidra n-notifikazzjoni skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għal nicotinic acid/laropiprant (approvati fl-UE bħala Tredaptive, Trevaclyn u Pelzont) mibdija millKummissjoni Ewropea,
English: • The CHMP considered the totality of the data available for laropiprant/nicotinic acid, including the emerging preliminary data from the HPS2-THRIVE study, which was not available at the time of the original marketing authorisation, the MAH responses, the PRAC assessment and the discussions within the CHMP,
Maltese: • Is-CHMP qies it-totalità tad-dejta disponibbli għal laropiprant/nicotinic acid, inkluż id-dejta preliminari emerġenti mill-istudju ta' HPS2-THRIVE, li ma kienx disponibbli fil-ħin talawtorizzazzjoni għat-tqegħid fis-suq oriġinali, ir-risposti tal-MAH, il-valutazzjoni tal-PRAC u ddiskussjonijiet fi ħdan is-CHMP,
English: The available evidence provided by the MAH in writing and at an oral explanation was reviewed by the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: L-evidenza disponibbli pprovduta mill-MAH bil-miktub u spjegazzjoni orali ġiet riveduta mill-Kumitat ta' Valutazzjoni tar-Riskji ta' Farmakoviġilanza (PRAC).
English: Identified risks were reflected in the product information and the risk management plan and included myopathy, glucose intolerance and abnormal liver function.
Maltese: Riskji identifikati ġew riflessi fl-informazzjoni tal-prodott u l-pjan ta' ġestjoni tar-riskji u inkludew mijopatija, intolleranza għall-glukożju u funzjoni tal-fwied mhux normali.
English: • The CHMP concluded that the statistically significant increase in the incidence of serious adverse events observed in the nicotinic acid/laropiprant group compared to the placebo group of the HPS2-THRIVE study raises serious concerns,
Maltese: • Is-CHMP ikkonkluda li żieda statistikament sinifikanti fl-inċidenza ta' avvenimenti avversi serji li ġiet osservata fil-grupp ta' nicotinic acid/laropiprant meta mqabbel mal-grupp tal-plaċebo talistudju HPS2-THRIVE tqajjem tħassib serju,
English: There was a statistically significant increase in the incidence of non-fatal serious adverse events in the nicotinic acid/laropiprant (study drug) group compared to the placebo group.
Maltese: Kien hemm żieda statistikament sinifikanti fl-inċidenza ta' avvenimenti avversi serji mhux fatali fil-grupp ta' nicotinic acid/laropiprant (mediċina tal-istudju) meta mqabbel mal-grupp tal-plaċebo.
English: As part of the pharmacovigilance activities included in the adopted risk management plan, the marketing authorization holder (MAH) agreed to report on a randomised clinical study (HPS2-THRIVE1) designed to assess the incremental benefit of nicotinic acid/laropiprant versus placebo as add-on to simvastatin 40mg, with or without ezetimibe.
Maltese: Bħala parti mill-attivitajiet ta' farmakoviġilanza inklużi fil-pjan ta' ġestjoni tar-riskji adottat, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) qabel li jirrapporta dwar studju kliniku b'mod każwali (HPS2-THRIVE1imfassal sabiex jivvaluta l-benefiċċju inkrimentali ta' nicotinic acid/laropiprant meta mqabbel ma' plaċebo bħala żieda (add-on) ma' simvastatin 40mg, bi jew mingħajr ezetimibe.
English: Overall summary of the scientific evaluation of nicotinic acid/laropiprant
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' nicotinic acid/laropiprant
English: Based on the known safety profile of the product, some adverse events were expected, such as elevations in transaminases, myopathy, some skin and gastrointestinal events and impaired glucose tolerance.
Maltese: Abbażi tal-profil tas-sigurtà magħruf tal-prodott, xi avvenimenti avversi kienu mistennija, bħal żidiet fit-transaminażi, mijopatija, xi avvenimenti tal-ġilda u gastrointestinali u tolleranza indebolita għall-glukożju.
English: Important missing information, such as the effects of long-term exposure, bleeding and thrombotic cardiovascular events was expected to be clarified through routine pharmacovigilance and through monitoring of patients in clinical trials, in particular the HPS2-THRIVE study.
Maltese: Informazzjoni importanti nieqsa, bħall-effetti ta' espożizzjoni fit-tul, fsada u avvenimenti kardjovaskulari trombotiċi kienet mistennija li tiġi ċċarata permezz ta' farmakoviġilanza ta' rutina u permezz ta' monitoraġġ ta' pazjenti fi provi kliniċi, b'mod partikolari l-istudju HPS2-THRIVE.
English: • The CHMP noted that no additional risk minimisation measures could be recommended at this point in time,
Maltese: • Is-CHMP innota li ebda miżura ta' minimizzazzjoni tar-riskji addizzjonali ma tista' tiġi rrakkomandata f'dan il-punt ta' żmien,
English: Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP recommends the suspension of the marketing authorisations for nicotinic acid/laropiprant (see Annex A).
Maltese: B'segwitu tad-dispożizzjonijiet skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004, is-CHMP jirrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal nicotinic acid/laropiprant (ara Anness A).
English: Although the population studied in HPS2-THRIVE was not selected based on high LDL cholesterol levels, the safety results observed in the 25,673 patients were considered to be of relevance to the current approved indication as there is no evidence to suggest that patients currently indicated for treatment with nicotinic acid/laropiprant would be protected from the adverse events observed in
Maltese: Għalkemm il-popolazzjoni studjata f'HPS2-THRIVE ma ntgħażlitx abbażi ta' livelli għoljin ta' kolesterol LDL, ir-riżultati tas-sigurtà osservati fil-25,673 pazjent ġew ikkunsidrati bħala ta' rilevanza għallindikazzjoni approvata attwalment minħabba li ma hemm ebda evidenza li tissuġġerixxi li pazjenti li fil
English: Considering the lack of clinically relevant efficacy and the negative safety profile (including the newly identified serious safety concerns) associated with the use of nicotinic acid/laropiprant, the PRAC considered that the benefit-risk balance has shifted towards a negative balance.
Maltese: Meta wieħed iqis in-nuqqas ta' effikaċja klinikament rilevanti u l-profil tas-sigurtà negattiv (inkluż ittħassib għas-sigurtà serju li għadu kif ġie identifikat) assoċjat mal-użu ta' nicotinic acid/laropiprant, ilPRAC qies li l-bilanċ tal-benefiċċju-riskju qaleb lejn bilanċ negattiv.
English: With regards to the risks observed, there were also strong new unfavourable safety signals.
Maltese: Fir-rigward tar-riskji osservati, kien hemm ukoll sinjali tas-sigurtà mhux favorevoli ġodda b'saħħithom.
English: • The CHMP therefore considered that a patient population in which nicotinic acid/laropiprant has a clear favourable benefit-risk cannot be identified based on the current data.
Maltese: • Għaldaqstant, is-CHMP qies li popolazzjoni ta' pazjenti li fiha nicotinic acid/laropiprant kellu benefiċċju-riskju favorevoli ċar ma tistax tiġi identifikata abbażi tad-dejta attwali.
English: Over the 3.9 years median follow-up, treatment with nicotinic acid/laropiprant compared to placebo did not achieve its primary endpoint.
Maltese: Tul is-segwitu medjan ta' 3.9 snin, il-kura b'nicotinic acid/laropiprant meta mqabbla ma' plaċebo ma laħqitx il-punt ta' tmiem primarju tagħha.
English: The CHMP therefore concluded that the benefit-risk balance of nicotinic acid/laropiprant is affected adversely by the results from the HPS2-THRIVE study and is considered no longer favourable.
Maltese: preżent huma indikati għall-kura b'nicotinic acid/laropiprant ikunu protetti kontra avvenimenti avversi osservati fl-istudju HPS2-THRIVE.
English: For the suspension to be lifted, the MAH would need to provide convincing data to identify a patient population in which the efficacy of nicotinic acid/laropiprant can be demonstrated, and in which the benefit clearly outweighs the risks, taking into account the new risks identified by the HPS2-THRIVE study.
Maltese: Dejta konvinċenti sabiex tiġi identifikata popolazzjoni ta' pazjenti li fiha tista' tintwera l-effikaċja ta' nicotinic acid/laropiprant, u li fiha, il-benefiċċju jkun b'mod ċar akbar mir-riskji, filwaqt li jitqiesu rriskji ġodda identifikati mill-istudju HPS2-THRIVE.
English: The full EPAR for Inflectra 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: Other information about Inflectra
Maltese: Informazzjoni oħra dwar Inflectra
English: Inflectra was compared with Remicade in one main study involving 606 adult patients with rheumatoid arthritis.
Maltese: Inflectra tqabbel ma' Remicade fi studju prinċipali li involva 606 pazjenti adulti b'artrite rewmatodje.
English: Why is Inflectra approved?
Maltese: Għal xiex ġiet approvat Inflectra?
English: Inflectra is produced by a method known as ‘recombinant DNA technology'.
Maltese: Inflectra jiġi prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA'.
English: The active substance in Inflectra, infliximab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Inflectra, l-infliximab, hija antikorp monoklonali.
English: An additional study was also carried involving 250 patients with ankylosing spondylitis out to show that Inflectra produces levels of the active substance in the body that are comparable to the reference medicine, Remicade.
Maltese: Sar ukoll studju addizzjonali li involva 250 pazjent li kienu jbatur minn spondilite ankilotika biex juri li Inflectra jipproduċi livelli tas-sustanza attiva fil-ġisem li huma komparabbli mal-mediċina ta' referenza, Remicade.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Inflectra on 10 September 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Inflectra fl-10 ta' Settembru 2013.
English: Inflectra is an anti-inflammatory medicine that contains the active substance infliximab.
Maltese: Inflectra huwa mediċina antiinfjammatorja li fiha s-sustanza attiva infliximab.
English: The dose is 5 mg per kilogram for the other diseases.
Maltese: Għall-mard l-ieħor id-doża hija 5 mg għal kull kilogramm.
English: This is a summary of the European public assessment report (EPAR) for Inflectra.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Inflectra.
English: Inflectra is used with methotrexate (a medicine that acts on the immune system);
Maltese: Inflectra jintuża ma' methotrexate (mediċina li taħdem fuq is-sistema immunitarja);
English: The reference medicine for Inflectra is Remicade.
Maltese: Il-mediċina ta' referenza għal Inflectra hija Remicade.
English: ‘Inflectra is a ‘biosimilar' medicine.
Maltese: ‘Inflectra huwa mediċina ‘bijosimili'.
English: A risk management plan has been developed to ensure that Inflectra is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Inflectra jintuża bl-aktar mod sigur possibbli.
English: What are the risks associated with Inflectra?
Maltese: X'inhuma r-riskji assoċjati ma' Inflectra?
English: • rheumatoid arthritis (an immune-system disease causing inflammation of the joints).
Maltese: • artrite rewmatojde (marda tas-sistema immunitarja li tikkawża infjammazzjoni tal-ġogi).
English: The most common side effects with Inflectra (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Maltese: apparat respiratorju (irjiħat), sinusite (infjammazzjoni tas-sinus), nawżja (tħossok imdardar), uġigħ addominali (uġigħ fl-istonku), reazzjonijiet relatati mal-infużjoni u wġigħ.
English: This means that Inflectra is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Inflectra and the reference medicine contain the same active substance.
Maltese: Dan ifisser li Inflectra huwa simili għal mediċina bijoloġika (il‘mediċina ta' referenza') li hija diġà awtorizzata fl-Unjoni Ewropea (UE) u li Inflectra u l-mediċina ta' referenza fihom l-istess sustanza attiva.
English: Inflectra was studied to show that it is comparable to the reference medicine, Remicade.
Maltese: Inflectra ġie studjat sabiex jintwera li huwa komparabbli mal-mediċina ta' referenza, Remicade.
English: • Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulae, abnormal passageways between the gut and other organs);
Maltese: • il-marda ta' Crohn (marda li tikkawża infjammazzjoni tal-musrana diġestiva), meta l-marda tkun moderata sa severa jew fistulanti (bil-formazzjoni ta' fistuli, passaġġi anormali bejn l-imsaren u organi oħra);
English: Inflectra infliximab
Maltese: Kif jintuża Inflectra?
English: Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Maltese: L-infliximab tfassal biex jeħel ma' messaġġier kimiku fil-ġisem imsejjaħ fattur alfa tan-nekrożi minn tumur (TNF-alpha).
English: Inflectra is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Maltese: Inflectra ġeneralment jingħata bħala 3 mg għal kull kilogramm tal-piż tal-ġisem fl-artrite rewmatodje, għalkemm id-doża tista' tiżdied jekk ikun meħtieġ.
English: Inflectra is also used in patients aged between six and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Maltese: Inflectra jintuża wkoll f'pazjenti ta' bejn sitta u 17-il sena bil-marda attiva ta' Crohn severa jew kolite ulċerattiva attiva gravi, meta ma jkunux irrispondew għal, jew ma jkunux jistgħu jieħdu mediċini jew kuri oħra.
English: How is Inflectra used?
Maltese: Kif jaħdem Inflectra?
English: By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.
Maltese: Billi jimblokka t-TNF-alpha, l-infliximab itejjeb l-infjammazzjoni u sintomi oħra tal-mard.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara d-dokument ‘mistoqsijiet u tweġibiet' hawnhekk.
English: In addition, the company that markets Inflectra will provide educational material to doctors who are expected to prescribe the medicine in adults and children including information on the safety of the medicine and an alert card to be given to patients.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Inflectra fis-suq se tipprovdi materjal edukattiv lit-tobba li huma mistennija jippreskrivu l-mediċina fl-adulti u t-tfal, fosthom informazzjoni dwar is-sigurtà talmediċina u skeda ta' twissija li għandha tingħata lill-pazjenti.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Maltese: • artrite psorjatika (marda li tikkawża rqajja' ħomor bil-qxur fuq il-ġilda u infjammazzjoni tal-ġogi);
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Inflectra has been shown to have a comparable quality, safety and efficacy profile to Remicade.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li, skont irrekwiżiti tal-UE, Inflectra ntwera li għandu profil ta' kwalità, sigurtà u effikaċja komparabbli għal Remicade.
English: Inflectra is available as a powder to be made up into a solution for infusion (drip) into a vein.
Maltese: Inflectra jiġi bħala trab biex isir soluzzjoni għall-infużjoni (dripp) ġo vina.
English: Some side effects, including infections, may be more common in children than in adults.
Maltese: Xi effetti sekondarji, inklużi linfezzjonijiet, jistgħu jkunu aktar komuni fit-tfal milli fl-adulti.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' struttura speċifika (imsejħa antiġen) filġisem.
English: After 30 weeks of treatment Inflectra was as effective as Remicade with around 60 % of patients responding to treatment with either medicine.
Maltese: Il-frekwenza li tiġi ripetuta l-kura tiddependi mill-marda li tkun qiegħda tiġi kkurata, u fuq ir-rispons tal-pazjent għall-mediċina.
English: The Committee recommended that Inflectra be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Inflectra jkun approvat għall-użu fl-UE.