FrancophonIA/ELRC3.0 huggingface dataset:
English: The iron complexes involved in this procedure are iron gluconate (sodium ferric gluconate), iron sucrose, iron dextran, iron carboxymaltose, and iron (III) isomaltoside 1000.
Maltese: Il-kumplessi tal-ħadid involuti f'din il-proċedura huma l-glukonat tal-ħadid (glukonat ferriku tas-sodju), iron sucrose, iron dextran, iron carboxymaltose, u iron (III) isomaltoside 1000.
English: A total of 168 cases were reported with a primary event within the System Organ Class (SOC) of immune system disorders (28.6%) including 147 serious.
Maltese: Total ta' 168 każ kienu rrappurtati b'avveniment primarju fis-Sistema tal-Klassifika tal-Organi (SOC) ta' disturbi fis-sistema immuni (28.6%) li kienu jinkludu 147 li kienu serji.
English: Anti-allergic treatment was reported for 94/168 cases.
Maltese: Kura kontra l-allerġija kienet irrapportata għal 94/168 każ.
English: Iron(III)-hydroxide dextran complex
Maltese: Il-kumpless iron(III)-hydroxide dextran
English: This corresponds to a hypersensitivity events frequency rate of 0.060%, which is lower than the frequency rate found in clinical trials.
Maltese: Dan jikkorrispondi għal rata ta' frekwenza ta' avvenimenti ta' sensittività eċċessiva ta' 0.060%, li hija aktar baxxa mir-rata ta' frekwenza fil-provi kliniċi.
English: According to the MAH, of 9 fatal cases of hypersensitivity reactions reported, six (1.9%, 6/317) were considered to be related.
Maltese: Skont il-MAH, mid-9 każijiet fatali ta' reazzjonijiet ta' sensittività eċċessiva rrapportata, sitta (1.9%, 6/317) tqiesu li kienu relatati.
English: In conclusion, a total of 26 spontaneous reports have been reported with iron(III) isomaltoside 1000.
Maltese: Bħala konklużjoni, total ta' 26 rapport spontanju kienu rrapportata b'iron(III) isomaltoside 1000.
English: Nevertheless, there was one grade IV (cardiac arrest) reported in Fishbane and colleagues (1996) publication and a total of fifteen hypersensitivity (7.3%) mainly grade II-III, reported in HD population (Haddad et al, 2009), all occurring during the test dose.
Maltese: Madankollu, kien hemm waħda tal-grad IV (arrest kardijaku) irrapportata fil-pubblikazzjoni ta' Fishbane u l-kollegi (1996) u total ta' ħmistax-il sensittività eċċessiva (7.3%) prinċipalment tal-grad II-III, irrapportati filpopolazzjoni ta' HD (Haddad et al, 2009), li kollha seħħew matul id-doża tat-test.
English: According to this definition Grade I show skin symptoms and or mild fever reaction; Grade II show measurable symptoms, but not life threatening, cardiovascular reaction (tachycardia, hypotension), gastrointestinal disturbance (nausea) and respiratory; Grade III symptoms show shock, life threatening spams of smooth muscles (bronchi, uterus); and Grade IV show cardiac and/or respiratory arrest.
Maltese: Skont din id-definizzjoni Grad I juri sintomi tal-ġilda u jew reazzjoni ta' deni ħafif; Grad II juri sintomi li jistgħu jitkejlu, iżda mhux ta' periklu għall-ħajja, reazzjoni kardjovaskulari (takikardja, pressjoni baxxa), disturbi gastrointestinali (dardir) u respiratorji; sintomi tal-Grad III juru xokk, spażmi tal-muskoli l-lixxi (il-bronki, l-utru) li huma ta' periklu għall-ħajja; u Grad IV juri arrest kardijaku u/jew respiratorju.
English: A total of 13,134 patients have been included in 29 MAH sponsored Phase 1 to 3 studies in different therapeutic areas (nephrology, gynaecology, gastroenterology, neurology, cardiology and iron deficiency anaemia), of which 6,608 have received ferric carboxymaltose and compared with those receiving other parenteral irons.
Maltese: Total ta' 13,134 pazjent ħadu sehem f'29 studju tal-Fażi 1 sa 3 sponsorjati mill-MAH f'oqsma terapewtiċi differenti (nefroloġija, ġinekoloġija, gastroenteroloġija, newroloġija, kardjoloġija u anemija minħabba defiċjenza tal-ħadid), li minnhom 6,608 irċevew ferric carboxymaltose u tqabblu ma' dawk li kienu qed jirċievu ħadid parenterali ieħor.
English: Different regimens were employed from 100 mg maintenance doses in HD to high accelerated total dose infusions (TDIs).
Maltese: Intużaw reġimi differenti minn dożi ta' manteniment ta' 100 mg f'HD għal infużjonijiet għoljin aċċellerati ta' dożi totali (TDIs).
English: Between the 20 patients who presented an anaphylactic reaction grade IV, 35% (7/20) patients had a medical history of hypersensitivity reactions.
Maltese: Bejn l-20 pazjent li ppreżentaw reazzjoni anafilattika tal-grad IV, 35% (7/20) tal-pazjenti kellhom storja medika ta' reazzjonijiet ta' sensittività eċċessiva.
English: A total of 317 cases of hypersensitivity were identified from the MAH database, which occurred in 13,824,369 patient years (cut-off date 31 December 2011).
Maltese: 317-il każ ta' sensittività eċċessiva ġie identifikat mid-dejtabejż tal-MAH, li seħħew fi 13,824,369 pazjent snin (data ta' skadenza 31 ta' Diċembru 2011).
English: Until 31 December 2011, a total of 236 hypersensitivity associated cases were identified, for a total exposure of 393,160 patient-years.
Maltese: Sal-31 ta' Diċembru 2011, kienu identifikati total ta' 236 każ assoċjati ma' sensittività eċċessiva, għal espożizzjoni totali ta' 393,160 pazjent-snin.
English: In conclusion, regarding post-marketing data, 317 cases of hypersensitivity were reported (frequency rate 0.0022%).
Maltese: Bħala konklużjoni, fir-rigward tad-dejta wara t-tqegħid fis-suq, ġew irrapportati 317-il każ ta' sensittività eċċessiva (rata ta' frekwenza ta' 0.0022%).
English: The majority of cases were reported as serious (366/587; 62%).
Maltese: Il-maġġoranza tal-każijiet kienu rrapportati bħala serji (366/587; 62%).
English: The majority of cases were classified as grade III (53%) followed by grade II (32%).
Maltese: Il-maġġoranza tal-każijiet kienu kklassifikati bħala tal-grad III (53%) segwiti minn grad II (32%).
English: A total of 236 cases of hypersensitivity reactions were reported (mainly grade I and II).
Maltese: Total ta' 236 każ ta' reazzjonijiet ta' sensittività eċċessiva ġew irrapportati (prinċipalment tal-grad I u II).
English: As of 29 February 2012 a total of 26 case reports regarding hypersensitivity have been received yielding an ADR reporting rate of 0.02 %.
Maltese: Mid-29 ta' Frar 2012 waslu b'kollox 26 rapport ta' każijiet dwar sensittività eċċessiva li taw rata ta' rapportar ta' ADRs ta' 0.02 %.
English: A higher incidence of total adverse events (AEs) per patient and exposure within LMWID compared to iron sucrose group was identified but no difference between iron sucrose and iron gluconate (Ganguli et al 2008) in CKD population was observed.
Maltese: Ġiet identifikata inċidenza ogħla ta' avvenimenti avversi totali (AEs) għal kull pazjent u espożizzjoni f'LMWID meta mqabbla mal-grupp ta' iron sucrose imma ma ġiet osservata l-ebda differenza bejn iron sucrose u l-glukonat tal-ħadid (Ganguli et al 2008) fil-popolazzjoni ta' CKD.
English: The most frequent AEs experienced by patients in all treatment groups were hypotension (48.7%), nausea (31.9%), vomiting (22.1%) and cramps.
Maltese: L-aktar AEs frekwenti esperjenzati mill-pazjenti kollha fil-gruppi kollha ta' kura kienu pressjoni baxxa (48.7%), dardir (31.9%), rimettar (22.1%) u bugħawwieġ.
English: Among the 846 cases with allergic reaction, 55 patients (6.5%) received a dose-test of sodium ferric gluconate prior to the first IV infusion.
Maltese: Fost it-846 każ b'reazzjoni allerġika, 55 pazjent (6.5%) irċevew doża tat-test ta' glukonat ferriku tassodju qabel l-ewwel infużjoni ġol-vini.
English: The frequency of hypersensitivity related events reported with iron sucrose in the analysed clinical trials (0.27%) was considerably less than the hypersensitivity event risk for the respective background populations (1.2
Maltese: Il-frekwenza ta' avvenimenti relatati ma' sensittività eċċessiva rrapportata b'iron sucrose filprovi kliniċi analizzati (0.27%) kienet ferm anqas mir-riskju ta' avveniment ta' sensittività eċċessiva għall-popolazzjonijiet rispettivi ta' sfond (1.2-16.8%).
English: The CHMP also agreed that the MAHs should submit annual cumulative reviews of hypersensitivity case reports, all fatal cases and all pregnancy cases, together with usage data, using same data lock point, same exposure definition, same event definition and the severity classification according to Ring and Messmer classification.
Maltese: Is-CHMP qabel ukoll li l-MAHs għandhom jissottomettu reviżjonijiet kumulattivi annwali ta' rapporti ta' każijiet ta' sensittività eċċessiva, tal-każijiet fatali kollha u l-każijiet kollha ta' tqala, flimkien ma' dejta dwar l-użu, bl-użu tal-istess data lock point, l-istess definizzjoni ta' espożizzjoni, l-istess definizzjoni ta' avveniment u l-klassifika tas-severità skond il-klassifika ta' Ring u Messmer.
English: A systematic review of the relevant published literature has been performed and randomised clinical study and other study designs including uncontrolled retrospective and prospective studies have been included if they reported on ADRs associated with the use of low molecular weight iron dextran (LMWID) complex.
Maltese: Saret reviżjoni sistematika tal-riċensjoni ppubblikata rilevanti u studju kliniku randomizzat u disinji oħra ta' studji li jinkludu studji retrospettivi u prospettivi mhux ikkontrollati ġew inklużi jekk irrapportaw dwar ADRs assoċjati mal-użu tal-kumpless ta' iron dextran b'piż molekulari baxx (LMWID).
English: Cytotoxicity is mediated throughout the formation of reactive oxygen species (ROS).
Maltese: Iċ-ċitossiċità hija medjata permezz tal-formazzjoni ta' speċi reattivi tal-ossiġenu (ROS).
English: Iron gluconate (sodium ferric gluconate)
Maltese: Glukonat tal-ħadid (glukonat ferriku tas-sodju)
English: In the pivotal controlled study a total of 88 patients received sodium ferric gluconate.
Maltese: Fl-istudju pivotali kkontrollat total ta' 88 pazjent irċevew glukonat ferriku tas-sodju.
English: In addition in vitro reactivity of various marketed intravenous iron preparations towards anti-dextran antibodies was tested in a reverse radial immunodiffusion assays.
Maltese: Barra minn hekk ir-reattività in vitro ta' bosta preparazzjonijiet tal-ħadid li jingħataw ġol-vini mqiegħda fis-suq lejn antikorpi kontra dextran kienet ittestjata f'analiżi reverse radial immunodiffusion.
English: A total of 1649 cases including 546 serious and 1103 non-serious cases corresponding to 6179 ADRs were recorded.
Maltese: Total ta' 1649 każ li jinkludu 546 każ serju u 1103 mhux serji li jikkorrispondu għal 6179 ADRs kienu rreġistrati.
English: Out of these 6 patients, 5 patients died from a non-allergic reaction a few days after the last injection (e.g. complications of amputation, septic shock, bronchopulmonary disease complication, rhabdomyolysis and pulmonary embolism).
Maltese: Minn dawn is-6 pazjenti, 5 pazjenti mietu minn reazzjoni mhux allerġika ftit jiem wara l-aħħar injezzjoni (eż. kumplikazzjonijiet ta' amputazzjoni, xokk settiku, kumplikazzjonijiet ta' mard bronkopulmonari, rabdomijolisi u emboliżmu pulmonari).
English: In inflammatory bowel disease population, according to Khalil et al (2011), 6% of IBD patients experienced anaphylactoid reactions (Ring and Messmer grade I-II).
Maltese: Fil-popolazzjoni b'mard infjammatorju tal-musrana, skont Khalil et al (2011), 6% tal-pazjenti b'IBD esperjenzaw reazzjonijiet anafilattojdi (tal-grad I-II ta' Ring u Messmer).
English: A fatal case also reported.
Maltese: Kien rapportat ukoll każ fatali.
English: Iron (III)-hydroxide dextran complex
Maltese: Kumpless ta' iron (III)-hydroxide dextran
English: This is out of around 260 patients being included in clinical studies regarding iron (III) isomaltoside 1000 (studies that also assessed safety parameters).
Maltese: Dan huwa minn madwar 260 pazjent li ħadu sehem fl-istudji kliniċi dwar iron (III) isomaltoside 1000 (studji li vvalutaw ukoll il-parametri tas-sigurtà).
English: Sodium ferric gluconate
Maltese: Glukonat ferriku tas-sodju
English: For some cases (108 out of 168) the time-to-onset of the reaction was reported.
Maltese: Għal xi każijiet (108 minn 168) iż-żmien għall-bidu tar-reazzjoni kien irrapportat.
English: The CHMP endorsed a Dear healthcare professional communication (DHPC), to communicate the outcome of the present review.
Maltese: Is-CHMP approva Komunikazzjoni għażiż professjonist tal-kura tas-saħħa (DHPC), biex jiġi kkomunikat ir-riżultat tar-reviżjoni preżenti.
English: It might be of interest to note, that these patients had penicillin allergy and latex allergy, respectively.
Maltese: Jista' jkun ta' interess li jiġi nnotat, li dawn il-pazjenti kellhom allerġija għall-peniċillina u allerġija għal-lattiċe, rispettivament.
English: When outcome is known, most patients recovered without sequelae (94.8%).
Maltese: Meta l-eżitu huwa magħruf, ħafna mill-pazjenti irkupraw mingħajr konsegwenzi (94.8%).
English: Three patients experienced ADRs of potential allergic nature in completed studies.
Maltese: Fl-istudji li tlestew tliet pazjenti esperjenzaw ADRs ta' natura potenzjalment allerġika.
English: One of the ways to classify the hypersensitivity reactions is according to Ring and Messmer1 definition.
Maltese: Wieħed mill-modi kif ir-reazzjonijiet ta' sensittività eċċessiva jiġu kklassifikati huwa skont id-definizzjoni ta' Ring u Messmer1.
English: The majority of hypersensitivity associated AEs (26.1%) occurred between 5 to 30 minutes after treatment with ferric carboxymaltose, closely followed by hypersensitivity associated AEs which occurred during the infusion/injection (15.9%).
Maltese: 1%) seħħew bejn 5 minuti sa nofs siegħa wara l-kura b'ferric carboxymaltose, segwiti mill-qrib minn AEs assoċjati ma' sensittività eċċessiva li seħħew matul l-infużjoni/injezzjoni (15.9%).
English: Over all studies, 36 hypersensitivity events occurring in 35 patients were reported.
Maltese: Fl-istudji kollha, ġew irrapportati 36 avveniment ta' sensittività eċċessiva li seħħew f'35 pazjent.
English: In most publications the majority of anaphylactoid reactions reported with LMWID were classified as grade I-II of severity according to Ring and Messmer classification.
Maltese: F'ħafna mill-pubblikazzjonijiet, il-maġġoranza tar-reazzjonijiet anafilattojdi rrapportati b'LMWID kienu kklassifikati bħala ta' severità tal-grad I-II skont il-klassifika ta' Ring u Messmer.
English: In 8 cases of the total 51 life-threatening cases (15.7%; 8/51 cases, one graded as Grade IV), the patient presented with a history of allergy.
Maltese: 7%; 8/51 każ, wieħed iggradad bħala talGrad IV), il-pazjent ippreżenta bi storja ta' allerġija.
English: One patient with previous allergies and severe complications NOS after administration of dextran, received an overdose of sodium ferric gluconate and died from an acute myocardial infarction the day of sodium ferric gluconate infusion.
Maltese: Pazjent wieħed b'allerġiji preċedenti u komplikazzjonijiet NOS severi wara lgħoti ta' dextran, irċieva doża eċċessiva tal-glukonat ferriku tas-sodju u miet minn infart mijokardijaku akut dakinhar tal-infużjoni tal-glukonat ferriku tas-sodju.
English: Only a few preclinical studies with low molecular weight iron dextrans (LMWID), iron(III) isomaltoside 1000 have been carried out and only studies with safety findings relevant to immunogenicity were referenced in the data submission by the MAHs.
Maltese: L-istudji prekliniċi li saru b'iron dextrans b'piż molekulari baxx (LMWID) u iron(III) isomaltoside 1000 huma ftit biss u fil-preżentazzjoni tad-dejta mill-MAHs kienu referenzjati biss l-istudji b'sejbiet dwar issigurtà rilevanti għall-immunoġeniċità.
English: In summary, there is only very limited data on safety from clinical studies.
Maltese: Fil-qosor, hemm biss dejta limitata dwar is-sigurtà minn studji kliniċi.
English: However the discussion of the existing preclinical data did not clear the immunogenic point, therefore the existing pre-clinical data do not allow for any firm conclusions; the CHMP conclusions were reached based on clinical and pharmacovigilance data.
Maltese: Madankollu d-diskussjoni tad-dejta preklinika eżistenti ma ċċaratx ilpunt immunoġeniku, għalhekk id-dejta pre-klinika eżistenti ma tippermettix li jsiru xi konklużjonijiet sodi; il-konklużjonijiet tas-CHMP intlaħqu abbażi ta' dejta klinika u ta' farmakoviġilanza.
English: Among 20 patients who presented a reaction of grade IV, six (6) patients died.
Maltese: Fost l-20 pazjent li ppreżentaw b'reazzjoni tal-grad IV, sitt (6) pazjenti mietu.
English: Sodium ferric gluconate was mainly prescribed for the treatment of iron deficiency anaemia and rarely for the treatment of anaemia in pregnancy.
Maltese: Il-glukonat ferriku tas-sodju kien prinċipalment preskritt għall-kura tal-anemija minħabba defiċjenza tal-ħadid u rarament għall-kura tal-anemija waqt it-tqala.
English: The majority of hypersensitivity associated events (15.1%) occurred between 1 hour and 24 hours after treatment with iron sucrose, closely followed by hypersensitivity associated events which occurred between 5 and 30 minutes (13.9%)
Maltese: 1%) seħħew bejn siegħa u 24 siegħa wara l-kura b'iron sucrose, segwiti mill-qrib minn avvenimenti assoċjati ma' sensittività eċċessiva li seħħew bejn 5 minuti u nofs siegħa (13.9%)
English: Thus, four cases of allergic reactions possibly related to iron (III) isomaltoside 1000 have been found in the trials.
Maltese: Għalhekk, erba' każijiet ta' reazzjonijiet allerġiċi possibbilment relatati ma' iron (III) isomaltoside 1000 instabu fil-provi.
English: The Committee concluded that the benefit-risk balance of intravenous iron containing medicinal products in the iron deficiency situations where the oral iron is not sufficient or tolerated remains positive under normal conditions of use, subject to the restrictions, warnings, changes to the product information, additional pharmacovigilance activities and risk minimisation measures agreed.
Maltese: Il-Kumitat ikkonkluda li l-bilanċ tal-benefiċċju-riskju ta' prodotti mediċinali li fihom il-ħadid li jingħataw ġol-vini fis-sitwazzjonijiet ta' defiċjenza tal-ħadid fejn il-ħadid orali mhuwiex biżżejjed jew ittollerat jibqa' pożittiv taħt kundizzjonijiet normali ta' użu, soġġett għar-restrizzjonijiet, twissijiet, tibdil lillinformazzjoni tal-prodott, attivitajiet addizzjonali ta' farmakoviġilanza u miżuri għall-minimizzazzjoni tar-riskji miftiehma.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for intravenous iron containing medicinal products.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal prodotti mediċinali li fihom il-ħadid li jingħataw ġol-vini.
English: For iron gluconate (sodium ferric gluconate) an overview of the toxicology program performed between 1970's and 1996 to support the registration of sodium ferric gluconate complex was submitted.
Maltese: Għall-glukonat tal-ħadid (glukonat ferriku tas-sodju) ġiet ippreżentata ħarsa ġenerali tal-programm tossikoloġiku li sar bejn is-snin sebgħin u l-1996 b'appoġġ għar-reġistrazzjoni tal-kumpless tal-glukonat ferriku tas-sodju.
English: Hypersensitivity (also called allergic reactions) refers to undesirable reactions produced by the normal immune system, including allergies and autoimmunity.
Maltese: Sensittività eċċessiva (magħrufa wkoll bħala reazzjonijiet allerġiċi) tirreferi għal reazzjonijiet mhux mixtieqa prodotti mis-sistema immuni normali, li jinkludu allerġiji u awtoimmunità.
English: The Committee reviewed all available data from pre-clinical, clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience on the safety of intravenous iron containing medicinal products with regards to hypersensitivity reactions.
Maltese: Il-Kumitat irreveda d-dejta kollha disponibbli minn studji pre-kliniċi, kliniċi, studji farmakoepidemjoloġiċi, riċensjoni ppubblikata, l-esperjenza wara t-tqegħid fis-suq dwar is-sigurtà ta' prodotti mediċinali li fihom il-ħadid li jingħataw ġol-vini fir-rigward ta' reazzjonijiet ta' sensittività eċċessiva.
English: In 2011 the French medicines agency (ANSM) had concerns with regards to the risk of hypersensitivity reactions of intravenous iron containing products indicated in iron deficiency situations when the oral route is insufficient or poorly tolerated especially in chronic kidney disease (CKD) patients (haemodialysis), but also in pre- or post-operative situations, or in case of intestinal absorption disorders.
Maltese: Fl-2011, l-aġenzija Franċiża tal-mediċini (ANSM) kellha tħassib fir-rigward tar-riskji ta' reazzjonijiet ta' sensittività eċċessiva ta' prodotti li fihom il-ħadid li jingħataw ġol-vini indikati f'sitwazzjonijiet ta' defiċjenza tal-ħadid fejn ir-rotta orali mhijiex biżżejjed jew mhux ittollerata tajjeb speċjalment f'pazjenti b'mard kroniku tal-kliewi (CKD) (emodijalisi), iżda wkoll f'sitwazzjonijiet qabel jew wara operazzjoni, jew fil-każ ta' disturbi ta' assorbiment intestinali.
English: All serious cases reported with a primary event other than within the immune system disorders has been reviewed according to the common terminology criteria for adverse events (CTCAE) grade III-V in order not to oversee any severe potential allergic reactions (n=219 additional cases).
Maltese: Il-każijiet kollha rrapportati b'avveniment primarju minbarra fid-disturbi fis-sistema immuni ġew riveduti skont il-kriterji ta' terminoloġija komuni għal avvenimenti avversi (CTCAE) tal-grad III-V sabiex ma jinqabżux xi reazzjonijiet allerġiċi severi potenzjali (n=219-il każ addizzjonali).
English: The CHMP reviewed all available data from pre-clinical and clinical studies, published literature and post-marketing experience on the hypersensitivity reactions of intravenous iron containing medicinal products.
Maltese: Is-CHMP irreveda d-dejta kollha disponibbli minn studji pre-kliniċi u kliniċi, riċensjoni ppubblikata u esperjenza wara t-tqegħid fis-suq dwar ir-reazzjonijiet ta' sensittività eċċessiva ta' prodotti mediċinali li fihom il-ħadid li jingħataw ġol-vini.
English: One pivotal and one supportive controlled studies were conducted in adults to assess the efficacy and safety of sodium ferric gluconate as first line treatment for iron deficiency anaemia in renal haemodialysis patients on supplemental recombinant human erythropoietin.
Maltese: Sar studju pivotali uniku u studju uniku kkontrollat ta' appoġġ fuq adulti biex jivvalutaw l-effikaċja u ssigurtà tal-glukonat ferriku tas-sodju bħala kura tal-ewwel linja għall-anemija minħabba defiċjenza talħadid f'pazjenti b'emodijalisi renali fuq eritropojetin uman rikombinanti supplimentari.
English: However, no skin reactions were seen when ferric carboxymaltose or iron sucrose was administered.
Maltese: Madankollu, ma dehret l-ebda reazzjoni tal-ġilda meta ngħata ferric carboxymaltose jew iron sucrose.
English: The Committee considered that the risk of hypersensitivity is increased in patients with known allergies (including drug allergies) and in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis) as well as in patients with a history of severe asthma, eczema or other atopic allergy.
Maltese: Il-Kumitat ikkunsidra li r-riskju ta' sensittività eċċessiva jiżdied f'pazjenti b'allerġiji magħrufa (inkluż allerġiji għall-mediċini) u f'pazjenti b'kundizzjonijiet immuni jew infjammatorji (eż. lupus erythematosus sistemika, artrite rewmatika) kif ukoll f'pazjenti bi storja ta' ażżma severa, ekżema jew allerġija atopika oħra.
English: Analysis on the severity of the hypersensitivity post marketing cases showed 33 cases of the 178 serious cases required hospitalization, 31 cases of the 178 serious cases were of a life-threatening nature, from which 6 patients presented with a history of allergy.
Maltese: Analiżi dwar is-severità tal-każijiet ta' sensittività eċċessiva wara t-tqegħid fis-suq wriet li 33 każ mill178 każ serju kienu jeħtieġu kura l-isptar, 31 każ mill-178 każ serju kienu ta' periklu għall-ħajja, li minnhom 6 pazjenti ppreżentaw bi storja ta' allerġija.