FrancophonIA/ELRC3.0 huggingface dataset:
English: Laboratory studies in rats have not produced any evidence of teratogenic effects, although foetotoxicity has been reported.
Maltese: Studji fil-laboratorju fil-ġrieden ma pproduċew l-ebda evidenza ta' effetti teratoġeniċi, għalkemm tossiċità tal-fetu ġiet irrappurtata.
English: On 5 July 2016 the European Commission sent a referral notification under Article 34 of Directive 2001/82/EC to the European Medicines Agency for Lincocin and its associated names.
Maltese: Fil-5 ta' Lulju 2016, il-Kummissjoni Ewropea bagħtet notifika ta' riferiment skont l-Artikolu 34 tadDirettiva 2001/82/KE lill-Aġenzija Ewropea għall-Mediċini għal Lincocin u ismijiet assoċjati tiegħu.
English: “The susceptibility of Mycoplasma hyopneumoniae to antimicrobial agents is difficult to test in vitro owing to technical constraints.
Maltese: “Is-suxxettibbiltà ta' Mycoplasma hyopneumoniae għal aġenti antimikrobiċi hija diffiċli tiġi ttestjata in vitro minħabba limitazzjonijiet tekniċi.
English: Concerning the indication for treatment and metaphylaxis of swine dysentery caused by Brachyspira hyodysenteriae and/or other bacteria susceptible to lincomycin, the marketing authorisation holder presented Minimum Inhibitory Concentration (MIC) data from several studies (including recent proprietary studies performed in 2016), clinical trials and studies from the scientific literature.
Maltese: Dwar l-indikazzjoni għall-kura u l-metafilassi ta' disinterija tal-ħnieżer ikkawżata minn Brachyspira hyodysenteriae u/jew batterji oħra suxxettibbli għal-linkomiċina, iddetentur tal-awtorizzazzjoni għat-tqegħid fuq is-suq ippreżenta data dwar il-Konċentrazzjoni Minima Inibitorja (MIC) minn diversi studji (fosthom studji proprjetarji reċenti li saru fl-2016), minn provi kliniċi u studji mil-letteratura xjentifika.
English: The number of animals (18 castrated males and 18 females) included in the study and their weights (36.5 to 71 kg) were adequate.
Maltese: L-għadd ta' annimali (18-il ħanżir ikkastrat u 18-il ħanżira) inklużi fl-istudju u l-piżijiet tagħhom (36.5 sa 71 kg) kienu adegwati.
English: The marketing authorisation holder also provided additional data from one study which investigated the efficacy of lincomycin as the soluble powder, administered in drinking water to pigs on a farm with known problems with enzootic pneumonia.
Maltese: Id-detentur talawtorizzazzjoni għat-tqegħid fis-suq ipprovda wkoll data addizzjonali minn studju wieħed li investiga l-effikaċja ta' linkomiċina bħala t-trab solubbli, li ngħatat fl-ilma tax-xorb lil ħnieżer f'razzett bi problemi magħrufa ta' pulmonite enzootika.
English: Use only according to the benefitrisk assessment by the responsible veterinarian.
Maltese: Uża biss skont il-valutazzjoni tal benefiċċju u r-riskju mill-veterinarju responsabbli.
English: Chickens were administered lincomycin hydrochloride in the drinking water at a level of approximately 34 mg/litre (5.1-6.6 mg/kg body weight) for seven days.
Maltese: 34 mg/litru (5.1-6.6 mg/kg piż tal ġisem) għal sebgħat-ijiem.
English: For chickens, the currently authorised dose and the harmonised proposal was to administer 3-6 mg lincomycin per kg of body weight daily for 7 consecutive days.
Maltese: Għat-tiġieġ, id-doża attwalment awtorizzata u l-proposta armonizzata kienet li l-linkomiċina tingħata f'doża ta' 3-6 mg għal kull kg tal-piż tal-ġisem kuljum għal 7 ijiem konsekuttivi.
English: Metabolites comprised more than 75% of total residues in the liver.
Maltese: Metaboliti ffurmaw aktar minn 75% tar residwi totali fil-fwied. Lincomycin mhux immetaboliżat naqas b'half-life naqra aktar mgħaġġla (t½ =
English: In support of the indication for treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae the marketing authorisation holder provided in vitro susceptibility data including a recent proprietary study and clinical data including field studies.
Maltese: F'appoġġ għall-indikazzjoni għall-kura u l-metafilassi ta' pulmonite enzootika kkawżata minn Mycoplasma hyopneumoniae d-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq pprovda data dwar is-suxxettibbiltà in vitro, inkluż studju proprjetarju reċenti, u data klinika, fosthom studji fuq ilpost.
English: In addition, there is a the lack of clinical breakpoints for both M. hyopneumoniae and C. perfringens.
Maltese: Barra minn hekk, hemm nuqqas ta' breakpoints kliniċi kemm għal M. hyopneumoniae kif ukoll għal C. perfringens.
English: However, in light of the fact that the lincomycin dose given in the study provided was several times higher than the recommended dose for Lincocin, and the duration of treatment was similar, it was considered that the available study provides a rather conservative result, even though the possibility of pharmacokinetic interactions between lincomycin and spectinomycin were not addressed.
Maltese: Madankollu, fid-dawl tal-fatt li d-doża ta' linkomiċina li ngħatat fl-istudju pprovdut kienet diversi drabi ogħla mid-doża rakkomandata għal Lincocin, u t-tul tal-kura kien simili, tqies li l-istudju disponibbli jipprovdi riżultat pjuttost konservattiv, minkejja l-fatt li ma ġietx indirizzata l-possibbiltà ta' interazzjonijiet farmakokinetiċi bejn linkomiċina u spektinomiċina.
English: Chickens:
Maltese: Tiġieġ:
English: The harmonised warnings and precautions proposed in the product information were considered adequate to ensure safety to users of the product.
Maltese: It-twissijiet u l-prekawzjonijiet armonizzati proposti fl-informazzjoni dwar il-prodott tqiesu adegwati biex tiġi żgurata s-sigurtà għall-utenti tal-prodott.
English: Resistance to lincomycin is frequently conferred by plasmid-borne factors (erm genes) coding for methylases modifying the ribosomal binding site and frequently leading to cross-resistance to other antimicrobials of the macrolides, lincosamides and streptogramins group.
Maltese: Ir-reżistenza għall-lincomycin tas-spiss isseħħ permezz ta' fatturi fil-plasmids (il-ġene erm ) li jikkodifikaw għall-methylases li jimmodifikaw is-sit tal-abbinar tar-ribosome u dan spiss iwassal għal reżistenza inkroċjata għal-antimikrobiċi tal-gruppi tal-macrolides, lincosamides u streptogramins.
English: However, also see text under section 4.4.
Maltese: Mandankollu, ara wkoll il kitba f'sezzjoni 4.4.
English: It was calculated that a concentration of 16.9 mg/l was the minimal dose that would give the maximum effect; this corresponds with a calculated dose of 3.9 mg/kg body weight.
Maltese: Ġie kkalkulat li konċentrazzjoni ta' 16.9 mg/l kienet id-doża l-aktar baxxa li tipproduċi l-akbar effett; dan jikkorrispondi ma' doża kkalkulata ta' 3.9 mg/kg tal-piż tal-ġisem.
English: Tissue residues levels were measured in composite samples from 4 birds at 0, 2 and 7 days after the end of treatment.
Maltese: Il-livelli tar-residwi fit-tessut tkejlu f'kampjuni aggregati minn 4 għasafar fil-jiem 0, 2 u 7 wara t-tmiem tal-kura.
English: Although these risks have not been unequivocally assessed, the possibility of impact on human health through cross-resistance to clindamycin and other substances of the macrolides, lincosamides and streptogramins group is a reality.
Maltese: Għalkemm dawn ir-riskji ma ġewx ivvalutati b'mod assolut, il-possibbiltà ta' impatt fuq is-saħħa tal-bniedem permezz ta' reżistenza inkroċjata għal klindamiċina u għal sustanzi oħrajn tal-grupp ta' makrolidi, ta' linkosamidi u ta' streptogramini hija realtà.
English: The CVMP acknowledged the difficulties in determining a single dose and agreed that although somewhat arbitrarily selected, the proposal for a dose rate of 5 mg lincomycin per kg of body weight for 7 days is acceptable.
Maltese: Is-CVMP irrikonoxxa d-diffikultajiet fid-determinazzjoni ta' doża unika u qabel li għalkemm kienet intgħażlet kemmxejn b'mod arbitrarju, il-proposta għal rata ta' doża ta' 5 mg ta' linkomiċina għal kull kg talpiż tal-ġisem għal 7 ijiem hija aċċettabbli.
English: Therefore, it was considered that the proposed withdrawal period of 5 days can be regarded as safe for the recommended dosing regimen of 5 mg of lincomycin per kg of body weight per day for 7 days.
Maltese: Għalhekk, tqies li l-perjodu ta' tiżmim propost ta' 5 ijiem jista' jitqies bħala sigur għall-iskeda taddożaġġ rakkomandata ta' 5 mg ta' linkomiċina għal kull kg tal-piż tal-ġisem kuljum għal 7 ijiem.
English: = ___ mg product per litre drinking water
Maltese: = ___ mg prodott ma' kull litru ilma tax-xorb
English: With regard to the in vitro susceptibility data, although there is no standardised methodology for determination of the MIC for antibiotics against B. hyodysenteriae, it was evident that the majority of isolates fall outside the apparent wild-type population.
Maltese: Fir-rigward tad-data dwar is-suxxettibbiltà in vitro, għalkemm ma hemm l-ebda metodoloġija standardizzata għad-determinazzjoni tal-MIC għallantibijotiċi kontra B. hyodysenteriae, kien evidenti li l-maġġoranza tal-iżolati jaqgħu barra millpopolazzjoni tat-tip selvaġġ apparenti.
English: The provided clinical data demonstrated that Lincocin was effective in the treatment and metaphylaxis of necrotic enteritis caused by C. perfringens at a dose rate of 5 mg lincomycin per kg of body weight for 7 consecutive days.
Maltese: Id-data klinika pprovduta wriet li Lincocin kien effettiv għall-kura u l-metafilassi ta' enterite nekrotika kkawżata minn C.
English: Additionally, the CVMP considered that the following warning needed to be added to section 4.4 ‘Special warnings for each target species' of the summary of product characteristics (SPC):
Maltese: Barra minn hekk, is-CVMP qies li għandha tiżdied it-twissija li ġejja fis-sezzjoni 4.4 ‘Twissijiet speċjali għal kull speċi li għaliha hu indikat il-prodott' tas-sommarju tal-karatteristiċi tal-prodott (SPC):
English: The in vitro data from published literature and from the marketing authorisation holder's own study indicated that the MICs for lincomycin had wide ranges and were not unimodal.
Maltese: Id-data in vitro mil-letteratura ppubblikata u mill-istudju stess tad-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq indikat li l-MICs għal-linkomiċina kellhom firxiet wiesgħa u ma kinux unimodali.
English: Regarding the determination of the withdrawal period, no residue depletion studies have been conducted with Lincocin in chickens using a modern (HPLC) assay method.
Maltese: Fir-rigward tad-determinazzjoni tal-perjodu ta' tiżmim, ma sar ebda studju dwar it-tnaqqis tarresidwi b'Lincocin fit-tiġieġ bl-użu ta' metodu ta' assaġġ modern (HPLC).
English: It seemed to be in line with the posology assessed in the studies provided; however, the two-fold dose range with no clear guidance for the end-user as to when to administer the product at either the higher or lower limit of the range was considered to be ambiguous.
Maltese: mingħajr ebda gwida ċara għall-utent aħħari dwar meta l-prodott għandu jingħata fl-ogħla jew flaktar limitu baxx tal-medda kienu meqjusa bħala ambigwi.
English: Use of the veterinary medicinal product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria resistant to the lincomycin and may decrease the effectiveness of treatment with other lincosamides, macrolides and streptogramin B due to the potential for cross-resistance.
Maltese: L-użu tal-prodott mediċinali veterinarju mhux skont l-istruzzjonijiet mniżżla fil-karatteristiċi tal-prodott fil-qosor jista' jżid il-prevalenza ta' reżistenza tal-mikrobi għall-lincomycin u jista' jnaqqas l-effikaċja tattrattament b'lincosamides oħra, macrolides u streptogramin B minħabba il-potenzjal għal reżistenza nkroċjata.
English: Therefore, the high in vitro resistance level in B. hyodysenteriae constitutes a major uncertainty as to the clinical effectiveness of Lincocin.
Maltese: Għalhekk, il-livell għoli ta' reżistenza in vitro f'B. hyodysenteriae jikkostitwixxi inċertezza kbira dwar l-effikaċja klinika ta' Lincocin.
English: The intake of medicated water depends on the physiological and clinical condition of the animals.
Maltese: Prodott medicinal veterinarju suġġett għal riċetta veterinarja.
English: A dose titration study investigated the therapeutic effect of various levels of lincomycin administered via drinking water on necrotic enteritis in broilers under simulated natural conditions.
Maltese: Studju dwar it-titrazzjoni tad-doża investiga l-effett terapewtiku ta' diversi livelli ta' linkomiċina li ngħatat permezz tal-ilma tax-xorb fuq enterite nekrotika f'tiġieġ tas-simna taħt kundizzjonijiet naturali simulati.
English: Crossing the intestinal barrier, lincomycin is widely distributed to all tissues, especially the lungs and joint cavities; the volume of distribution is about 1 litre.
Maltese: Malli jaqsam il-konfini tal-imsaren, lincomycin jitqassam b'firxa wiesgħa mat-tessuti kollha, b'mod speċjali fil-pulmun u fl-ispazji tal-ġogi; il-volum ta' distribuzzjoni huwa ta' 1 litru bejn wieħed u ieħor.
English: This is similar to that seen in most of the earlier studies.
Maltese: Dan huwa simili għal dak li deher f'ħafna mill-istudji preċedenti.
English: White to off-white powder.
Maltese: Trab abjad għal offwajt.
English: In conclusion, considering that the susceptibility pattern of C. perfringens to lincomycin has not changed significantly over the last 25 years and the lack of a definite correlation between MICs and clinical efficacy and in the context of the procedure, the CVMP considered that the indication is adequately justified and hence chickens can be retained as a target species.
Maltese: Bħala konklużjoni, meta jitqies li l-mudell ta' suxxettibilità ta' C. perfringens għal-linkomiċina ma nbidilx b'mod sinifikanti matul l-aħħar 25 sena u n-nuqqas ta' korrelazzjoni definita bejn il-MICs u leffikaċja klinika u fil-kuntest tal-proċedura, is-CVMP qies li l-indikazzjoni hija adegwatament iġġustifikata u għalhekk it-tiġieġ jistgħu jinżammu bħala speċi fil-mira.
English: Lincocin is a powder for oral solution containing 400 mg lincomycin per gram product.
Maltese: Lincocin huwa trab għal soluzzjoni orali li fih 400 mg ta' linkomiċina f'kull gramma tal-prodott.
English: People with known hypersensitivity to lincomycin or any other lincosamide, or to lactose monohydrate, should avoid contact with the veterinary medicinal product.
Maltese: Persuni li jafu li huma ppersensittivi għall-lincomycin jew lincosamides oħra, jew għall-monoidrat tal-lattożju, għandhom jevitaw il-kuntatt mal-prodott mediċinali veterinarju.
English: The dosage used (approximately 10 mg lincomycin/kg body weight/day administered in drinking water) was considered to be representative of the maximum amount of lincomycin recommended for the product.
Maltese: Id-doża li ntużat (bejn wieħed u ieħor 10 mg ta' linkomiċina/kg tal-piż tal-ġisem/kuljum mogħtija fl-ilma taxxorb) tqieset bħala rappreżentattiva tal-ammont massimu ta' linkomiċina rakkomandat għallprodott.
English: Unmetabolised lincomycin declined at a slightly faster half-life (t½ = 5.8 hours) than total residue.
Maltese: Metaboliti ffurmaw aktar minn 75% tar residwi totali fil-fwied. Lincomycin mhux immetaboliżat naqas b'half-life naqra aktar mgħaġġla (t½ = 5.8 sigħat) mir-residwu totali.
English: 26 June 2019
Maltese: 26 ta' Ġunju 2019
English: Adoption of CMDh position by consensus:
Maltese: Adozzjoni tal-pożizzjoni tas-CMDh b'kunsens:
English: May 2019 CMDh meeting
Maltese: Laqgħa tas-CMDh Mejju 2019
English: 26 July 2019
Maltese: Implimentazzjoni tal-pożizzjoni mill-Istati Membri: 26 ta' Lulju 2019
English: Proteinuria
Maltese: Proteinurija
English: Section 4.4
Maltese: Sezzjoni 4.4
English: Adopted at the 14-17 March 2016 PRAC
Maltese: Adottati fil-PRAC ta' bejn l-14-17 ta' Marzu 2016
English: Mutagenicity and carcinogenicity/Carcinogenicity
Maltese: Mutaġeniċità u karċinoġeniċità/karċinoġeniċità
English: Mercaptopurine (XALUPRINE); azathioprineLymphoproliferative disorders (EPITT no 18503)
Maltese: Mercaptopurine (XALUPRINE); azathioprine - Disturbi limfoproliferattivi (EPITT nru 18503)
English: • tumours, including skin cancer.
Maltese: • tumuri, inkluż kanċer tal-ġilda.
English: In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported (see section 4.8).
Maltese: Fi studji kliniċi b'axitinib, ġiet irrapportata l-proteinurja, inkluż dik b'severità tal-Grad 3 u 4 (ara sezzjoni 4.8).
English: Rare: neoplasms including lymphoproliferative disorders, skin cancers (melanomas and nonmelanomas), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ…(see section
Maltese: Rari: neoplażmi inkluż id-disturbi limfoproliferattivi, kankrijiet tal-ġilda (melanoma u mhux melanoma), sarkomi (ta' Kaposi u mhux ta' Kaposi) u kanċer ċervikali fl-utru in situ...(ara sezzjoni 4.4).
English: Summary of Product Characteristics (mercaptopurine and azathioprine):
Maltese: Sommarju tal-Karatteristiċi tal-Prodott (mercaptopurine u azathioprine):
English: A combination of multiple immunosuppressants, given concomitantly increases the risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders.
Maltese: Kombinament ta' diversi immunosuppressanti, mogħtija b'mod konkomitanti jżid ir-riskju ta' disturbi limfoproliferattivi assoċjati mal-virus ta' Epstein-Barr (EBV).
English: Summary of Product Characteristics (mercaptopurine)
Maltese: Sommarju tal-Karatteristiċi tal-Prodott (mercaptopurine)
English: o A combination of multiple immunosuppressants, given concomitantly increases the risk of disorders of the lymph system due to a viral infection (Epstein-Barr virus (EBV)-associated lymphoproliferative disorders).
Maltese: o Kombinament ta' diversi immunosuppressanti, mogħtija b'mod konkomitanti jżid ir-riskju ta' disturbi tas-sistema limfatika minħabba infezzjoni virali (disturbi limfoproliferattivi assoċjati mal-virus ta' Epstein-Barr (EBV)).
English: Rare (affects less than 1 in 1,000 people)
Maltese: Rari (jaffetwaw inqas minn persuna 1 minn kull 1,000)
English: Patients receiving immunosuppressive therapy, including <azathioprine> <mercaptopurine> are at an increased risk of developing lymphoproliferative disorders and other malignancies, notably skin cancers (melanoma and non-melanoma), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ.
Maltese: Il-pazjenti li jkunu qegħdin jirċievu terapija immunosuppressiva, inkluż <azathioprine> <mercaptopurine> huma f'żieda fir-riskju li jiżviluppaw disturbi limfoproliferattivi u tumuri oħrajn, b'mod partikolari kankrijiet tal-ġilda (melanoma u mhux melanoma), sarkomi (ta' Kaposi u mhux ta' Kaposi) u kanċer ċervikali fl-utru in situ.
English: Tigecycline (TYGACIL) - Hypofibrinogenaemia (EPITT no
Maltese: 3. Tigecycline (TYGACIL)
English: Axitinib (INLYTA) - Nephrotic syndrome (EPITT no
Maltese: Axitinib (INLYTA)
English: Taking <X> could put you at greater risk of:
Maltese: Jekk tieħu <X> jista' jpoġġik f'riskju akbar ta':
English: Summary of Product Characteristics (azathioprine)
Maltese: Sommarju tal-Karatteristiċi tal-Prodott (azathioprine)
English: • lymphoproliferative disorders o treatment with <X> increases your risk of getting a type of cancer called lymphoproliferative disorder.
Maltese: • disturbi limfoproliferattivi o il-kura b'<X> iżżidlek ir-riskju li jkollok tip ta' kanċer li jissejjaħ disturb limfoproliferattiv.
English: • Low fibrinogen levels in the blood (a protein involved in blood clotting)
Maltese: • Livelli baxxi ta' fibrinogen fid-demm (proteina li hija involuta fl-għaqid tad-demm)
English: Neoplasms benign and malignant (including cysts and polyps)
Maltese: Neoplażmi beninni u malinni (inklużi ċesti u polipi)
English: For patients who develop moderate to severe proteinuria, reduce the dose or temporarily interrupt axitinib treatment (see section 4.2).
Maltese: Għal pazjenti li jiżviluppaw proteinurja moderata sa severa, naqqas id-doża jew waqqaf il-kura b'axitinib b'mod temporanju (ara sezzjoni 4.2).
English: It has been reported that discontinuation of immunosuppression may provide partial regression of the lymphoproliferative disorder.
Maltese: Ġie rrapportat li t-twaqqif tal-immunosuppressjoni jista' jipprovdi rigressjoni parzjali tad-disturb limfoproliferattiv.
English: Package leaflet (mercaptopurine and azathioprine) 2.
Maltese: Fuljett ta' tagħrif (mercaptopurine u azathioprine) 2.
English: Therefore, when taking <X>, avoid excessive exposure to sunlight, wear protective clothing and use protective sunscreen with a high protection factor.
Maltese: Għaldaqstant, meta tieħu <X>, evita esponiment eċċessiv għaddawl tax-xemx, ilbes ilbies protettiv u uża prodotti ta' protezzjoni kontra x-xemx b'fattur ta' protezzjoni għoli.
English: With treatment regimen containing multiple immunosuppressants (including thiopurines), this may lead to death.
Maltese: Bliskema tal-kura li fiha diversi immunosuppressanti (inkluż thiopurines), dan jista' jwassal għal mewt.
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD) (unlicensed indication), and there could potentially be an increased susceptibility for developing the condition with the use of mercaptopurine.
Maltese: Is-sindrome tal-attivazzjoni tal-makrofagu (MAS) huwa disturb magħruf, ta' theddida għall-ħajja li jista' jiżviluppa f'pazjenti b'kundizzjonijiet awtoimmuni, b'mod partikolari l-marda ta' infjammazzjoni tal-imsaren (IBD) (indikazzjoni mhux liċenzjata), u jista' jkun hemm b'mod potenzjali żieda fissuxxetibbiltà ta' żvilupp tal-kundizzjoni bl-użu ta' mercaptopurine.
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD), and there could potentially be an increased susceptibility for developing the condition with the use of azathioprine.
Maltese: Is-sindrome tal-attivazzjoni tal-makrofagu (MAS) huwa disturb magħruf, ta' theddida għall-ħajja li jista' jiżviluppa f'pazjenti b'kundizzjonijiet awtoimmuni, b'mod partikolari l-marda ta' infjammazzjoni tal-imsaren (IBD), u jista' jkun hemm b'mod potenzjali żieda fis-suxxetibbiltà ta' żvilupp talkundizzjoni bl-użu ta' azathioprine.
English: 4.8 Undesirable effects
Maltese: .8 Effetti mhux mixtieqa
English: Not known side effects are (frequency cannot be estimated from the available data):
Maltese: Effetti sekondarji mhux magħrufa huma (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli):
English: • developing a serious condition called Macrophage Activation Syndrome (excessive activation of white blood cells associated with inflammation), which usually occurs in people who have certain types of arthritis
Maltese: • żvilupp ta' kundizzjoni serja li tissejjaħ Sindrome tal-Attivazzjoni tal-Makrofagu (attivazzjoni eċċessiva taċ-ċelloli bojod tad-demm assoċjata mal-infjammazzjoni), li ġeneralment isseħħ f'nies li għandhom ċerti tipi ta' artrite.
English: What you need to know before you <take> <use> X Warnings and precautions Talk to your doctor <or> <pharmacist> <or nurse> before <taking> <using> X If you are receiving immunosuppressive therapy, taking <X> could put you at greater risk of:
Maltese: X'għandek tkun taf qabel ma <tieħu> <tuża> X Twissijiet u prekawzjonijiet Kellem lit-tabib <jew> <lill-ispiżjar> <jew lill-infermier> tiegħek qabel <tieħu> <tuża> X Jekk qed tirċievi terapija immunosuppressiva, li tieħu <X> jista' jpoġġik f'riskju akbar ta':
English: New product information wording - Extracts from PRAC recommendations on signals
Maltese: Formolazzjoni tal-kliem ġdida tal-informazzjoni dwar ilprodott - Siltiet mir-rakkomandazzjonijiet tal-PRAC dwar is-sinjali
English: Physicians should be attentive to symptoms of infection such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS.
Maltese: It-tobba għandhom joqogħdu attenti għal sintomi ta' infezzjoni bħall-EBV u ċ-ċitomegalovirus (CMV), minħabba li dawn huma fatturi ta' attivazzjoni magħrufa talMAS.
English: 4 x 10 mg + 4 x 20 mg + 19 x 30 mg tablets
Maltese: 10 mg + 20 mg + 30 mg folja (PVC/alu) f'kard 4 x 10 mg + 4 x 20 mg + 19 x 30 mg pilloli
English: 10 mg + 20 mg + 30 mg blister (PVC/alu) in a card
Maltese: Il-pakkett li jmiss malprodott
English: * Fatal events were reported.
Maltese: * Avvenimenti fatali rrappurtati.