FrancophonIA/ELRC3.0 huggingface dataset:
English: Colobreathe was compared with another medicine, tobramycin nebuliser solution, in 380 cystic fibrosis patients aged six years and above with P. aeruginosa lung infection.
Maltese: Colobreathe tqabbel ma' mediċina oħra, soluzzjoni nebulizzanti ta' tobramycin, fuq 380 pazjent bilfibrożi ċistika'l fuq minn sitt snin li kellhom infezzjoni tal-pulmun bi P. aeruginosa.
English: What is Colobreathe?
Maltese: X'inhu Colobreathe?
English: Colistimethate sodium is a well-known antibiotic that has been used for several years to treat lung infection in cystic fibrosis patients and is available in the form of a solution used with a nebuliser (a machine that changes a solution into an aerosol that the patient can breathe in).
Maltese: Colistimethate sodium huwa antibijotiku magħruf sew li ilu jintuża għal bosta snin fil-kura ta' infezzjonijiet tal-pulmun f'pazjenti bil-fibrożi ċistika u huwa disponibbli fil-forma ta' soluzzjoni użata permezz ta' nebulizzatur (magna li tbiddel soluzzjoni f'aerosol li l-pazjent jista' jieħu man-nifs).
English: Why has Colobreathe been approved?
Maltese: Għaliex ġie approvat Colobreathe?
English: The CHMP concluded that the modest improvement in FEV1 seen with Colobreathe was sufficient evidence of the medicine's effectiveness, given that larger improvements would not be expected in patients whose condition was already stabilised on tobramycin nebuliser.
Maltese: Is-CHMP ikkonkluda li t-titjib modest fl-FEV1 li deher bi Colobreathe kien evidenza suffiċjenti taleffikaċja tal-mediċina, minħabba li ma setax ikun mistenni titjib akbar f'pazjenti li l-kundizzjoni tagħhom kienet diġà stabbilita permezz ta' nebulizzatur bi tobramycin.
English: The effects of Colobreathe were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Colobreathe ġew l-ewwel analizzati fuq mudelli sperimentali qabel ma ġew studjati filbniedem.
English: What measures are being taken to ensure the safe use of Colobreathe?
Maltese: Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Colobreathe?
English: The most common side effects seen with Colobreathe in studies were: unpleasant taste, cough, throat irritation, difficulty breathing and dysphonia (difficulty speaking).
Maltese: L-effetti sekondarji l-aktar komuni bi Colobreathe fl-istudji kienu: togħma ħażina, sogħla, irritazzjoni fil-griżmejn, diffikultà fit-teħid tan-nifs u disfonijia (diffikultà biex titkellem).
English: The contents of Colobreathe capsules are inhaled using a powder inhaler called Turbospin.
Maltese: Il-kontenut tal-kapsuli ta' Colobreathe jittieħed man-nifs permezz ta' inalatur tat-trab imsejjaħ Turbospin.
English: Colobreathe compared well with the tobramycin treatment, considering the fact that the patients were already stabilised on tobramycin nebuliser.
Maltese: Colobreathe tqabbel sew mal-kura bi tobramycin, meta wieħed jikkunsidra l-fatt li l-pazjenti kienu diġà stabbilizzati fuq in-nebulizzatur bi tobramycin.
English: Cystic fibrosis is an inherited disease that affects the cells in the lungs and the glands in the gut and pancreas which secrete fluids such as mucus and digestive juices.
Maltese: Fil-fibrożi ċistika dawn il-fluwidi jsiru aktar magħqudin u viskużi, u jimblokkaw il-passaġġi tal-arja u l-fluss tal-likwidi diġestivi.
English: Polymyxins work by disrupting the cell membrane of bacteria by interacting with certain components of the membrane called phospholipids.
Maltese: Polymyxins jaħdmu billi jfixklu lill-membrana taċ-ċellola tal-batterji billi jinteraġixxu ma' ċerti komponenti tal-membrana msejħa fosfolipidi.
English: The company that makes Colobreathe will supply education packs to patients and healthcare professionals.
Maltese: Il-kumpanija li tipproduċi Colobreathe sejra tqassam pakketti edukattivi lill-pazjenti u lill-professjonisti tal-kura tas-saħħa.
English: The patients' condition had been stabilised by treatment with tobramycin before the study.
Maltese: Il-kundizzjoni talpazjenti kienet ġiet stabilizzata permezz ta' kura bi tobramycin qabel l-istudju.
English: What is the risk associated with Colobreathe?
Maltese: X'inhu r-riskju assoċjat ma' Colobreathe?
English: How has Colobreathe been studied?
Maltese: Kif ġie studjat Colobreathe?
English: Inhalation may also lead to coughing or bronchospasm (tightening of the muscles in the airway), which may be controlled by first treating the patients with inhaled beta-2 agonist medicines.
Maltese: It-teħid man-nifs jista' jwassal ukoll għal sogħla jew bronkospażmu (ebusija tal-muskoli fil-passaġġi tal-arja), li jistgħu jiġu kkontrollati billi l-pazjenti l-ewwel jiġu kkurati permezz ta' mediċini beta-2 agonisti li jittieħdu mannifs.
English: How does Colobreathe work?
Maltese: Għal xiex jintuża Colobreathe?
English: Colobreathe must not be used in people who are hypersensitive (allergic) to colistimethate sodium or to colistin sulphate or polymyxin B.
Maltese: Colobreathe ma għandux jintuża f'persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal colistimethate sodium jew għal colistin sulphate jew għal polymyxin B.
English: No more serious side effects were seen with Colobreathe than with tobramycin.
Maltese: Ma deher l-ebda effett sekondarju serju ieħor b'Colobreathe milli bi tobramycin.
English: Dermatol Venereol 2008;22(7):887-8 Cabreizo Ballesteros et al. Erythema multiforme to tetrazepam.
Maltese: Dermatol Venereol 2008;22(7):887-8 5 Cabreizo Ballesteros et al.
English: 4 Bachmeyter C. Probable drug rash with eosinophilia and systemic symptoms syndrome related to tetrazepam.
Maltese: Probable drug rash with eosinophilia and systemic symptoms syndrome related to tetrazepam.
English: Severe cutaneous adverse reactions with tetrazepam are also described in published literature1,2,3,4,5,6,7,8,9,10,11.
Maltese: Reazzjonijiet avversi severi tal-ġilda bl-użu tat-tetrażepam ġew deskritti wkoll f'dokumentazzjoni ppubblikata1,2,3,4,5,6,7,8,9,10,11.
English: Benzodiazepines (BZP) facilitate the inhibitory activity of gamma-aminobutyric acid (GABA) leading to sedative, hypnotic, anticonvulsant and muscle relaxant properties.
Maltese: Il-benżodijażepini (BZP) jiffaċilitaw l-attività inibitorja tal-aċidu gamma-aminobutirriku (GABA) li jwassal għal karatteristiċi sedattivi, ipnotiċi, anti-konvulżivi u rilassanti tal-muskoli.
English: Tetrazepam containing medicinal products are authorised in Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Latvia, Lithuania, Luxembourg, Poland, Romania, Slovakia and Spain (see Annex I for the list of tetrazepam containing medicinal products authorised in the EU).
Maltese: Prodotti mediċinali li fihom it-tetrażepam huma awtorizzati fl-Awstrija, il-Belġju, il-Bulgarija, ir-Repubblika Ċeka, Franza, il-Ġermanja, il-Latvja, il-Litwanja, il-Lussemburgu, il-Polonja, ir-Rumanija, is-Slovakkja u Spanja (ara Anness I għal-lista ta' prodotti mediċinali li fihom it-tetrażepam awtorizzati fl-UE).
English: After excluding one double entry, 1616 cases were considered for the analysis.
Maltese: Wara li ġiet eskluża entrata doppja, 1616-il każ kienu kkunsidrati għall-analiżi.
English: 2 Camarasa JG et al. Tetrazepam allergy detected by patch test.
Maltese: Tetrazepam allergy detected by patch test.
English: Of these, 1617 had a "suspected” or “interaction” WHO code.
Maltese: Minn dawn, 1617 kellhom kodiċi WHO “suspettat” jew “interazzjoni”.
English: These included 33 cases of SJS (including 1 fatal case), 33 cases of Lyell's Syndrome (TEN) (including 9 fatal cases), 59 cases of EM (including 1 fatal case), 15 cases of DRESS Syndrome, 3 possible cases of DRESS Syndrome and 5 cases of acute generalised exanthematous pustulosis.
Maltese: Dawn kienu jinkludu 33 każ ta' SJS (inkluż każ fatali 1), 33 każ tas-sindromu ta' Lyell (TEN) (inkluż 9 każijiet fatali), 59 każ ta' EM (inkluż każ fatali 1), 15-il każ tas-sindromu DRESS, 3 każi possibbli tas-Sindromu DRESS u 5 każi ta' pustulożi esantematika ġeneralizzata akuta.
English: Overall, the most frequently reported skin reactions are by decreasing order various types of rashes without any specificity (162 cases), pruritus (94 cases), Erythema Multiforme (48 cases), urticaria (47 cases), Toxic Epidermal Necrolysis (35 cases), angioedema (34 cases), Stevens-Johnson Syndrome (31 cases), erythema (28 cases), toxic skin eruption (19 cases), skin exfoliation (16 cases), dermatitis bullous, Not Otherwise Specified (NOS) (16 cases) and DRESS Syndrome (7 cases).
Maltese: B'mod ġenerali, l-aktar reazzjonijiet tal-ġilda rrapportati b'mod frekwenti huma ppreżentati skont is-serjetà tagħhom, b'dawk l-aktar serji jitniżżlu l-ewwel: tipi varji ta' raxx mingħajr xi speċifiċità (162 każ), ħakk (94 każ), Eritema Multiforme (48 każ), urtikarja (47 każ), Nekroliżi Epidermali Tossika (35 każ), angjoedema (34 każ), is-Sindromu ta' Stevens-Johnson (31 każ), eritema (28 każ), eruzzjoni tossika tal-ġilda (19-il każ), tqaxxir tal-ġilda (16-il każ), dermatite bulluża, Mhux speċifikat b'Mod Ieħor (NOS) (16-il każ) u s-Sindromu DRESS (7 każi).
English: 1 Sanchez I et al. Stevens-Johnson syndrome from tetrazepam.
Maltese: Stevens-Johnson syndrome from tetrazepam.
English: J Investig Allergol Clin Immunol 2007;17(3):205-6 Delesalle F et la.
Maltese: J Investig Allergol Clin Immunol 2007;17(3):205-6
English: Allergy 1997;52(11):1145-6 10 LagnouiR et al.
Maltese: Allergy 1997;52(11):1145-6
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for tetrazepam containing products.
Maltese: • Il-PRAC qies il-proċedura skont l-Artikolu 107i tad-Direttiva 2001/83/KE, għal prodotti li fihom ittetrażepam.
English: The potential for nucleophilic attack proposed in the literature (by Barbaud et al, 2009) is consistent with the mechanism proposed by in silico analysis, and may explain the reported lack of cross-reactivity between tetrazepam and other benzodiazepines in patients with cutaneous hypersensitivity reactions.
Maltese: Ilpotenzjal għal attakk nukleofilu propost fid-dokumentazzjoni (minn Barbaud et al, 2009) huwa konsistenti mal-mekkaniżmu propost f'analiżi in silico, u jista' jispjega n-nuqqas ta' krossreattività rrapportat bejnittetrażepam u l-benżodijażepini oħra f'pazjenti b'reazzjonijiet ta' sensittività eċċessiva tal-ġilda.
English: International Journal of Dermatology 2006;45(4):480 Del Pozo MD et al. Tetrazepam Allergy.
Maltese: International Journal of Dermatology 2006;45(4):480
English: This evaluation highlighted an increased cutaneous risk of tetrazepam in addition to the pharmacological expected ADRs of benzodiazepines: half of the ADRs reported with tetrazepam were cutaneous and amongst the 648 serious cases reported, 305 cases were reported under the System Organ Class (SOC) “Skin and subcutaneous disorders”: 33 cases of Stevens - Johnson syndrome (SJS), 33 of Toxic Epidermal Necrolysis (TEN), 59 Erythema Multiforme (EM) and 15 cases of Drug Reaction (or Rash) with Eosinophilia and Systemic Symptoms (DRESS Syndrome) were detected with fatal outcome in 11 cases.
Maltese: Din il-valutazzjoni enfasizzat żieda fir-riskju tat-tetrażepam għall-ġilda minbarra lADRs farmakoloġiċi mistennija tal-benżodijażepini: nofs l-ADRs irrapportati bl-użu tat-tetrażepam kienu kutanji, u fost is-648 każ serju rrapportat ġew irrapportati 305 każi taħt is-Sistema tal-Klassifika Organi (SOC) “Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda”: instabu 33 każ tas-sindromu ta' Stevens - Johnson (SJS), 33 ta' Nekroliżi Epidermali Tossika (TEN), 59 ta' Eritema Multiforme (EM) u 15-il każ ta' Reazzjoni għall-Mediċina (jew Raxx) b'Eosinofilja u Sintomi Sistemiċi (Sindromu DRESS) b'riżultat fatali fi 11-il każ.
English: Overall, an estimated 70%-80% of the allergy tests performed were positive.
Maltese: B'mod ġenerali, madwar 70%-80% tat-testijiet għal allerġiji li saru kienu pożittivi.
English: At the date of 30 June 2012, 2382 cases with tetrazepam were registered in the French national database.
Maltese: Fid-data tat-30 ta' Ġunju 2012, fil-bażi tad-dejta nazzjonali Franċiża ġew irreġistrati 2382 każ bl-użu tattetrażepam.
English: Thirty-eight (38) cases were non medically-confirmed cases and 475 cases were medically-confirmed; among them, 180 cases were directly reported to the Company, 245 cases were reported by Health Authorities, and 50 cases were identified in the scientific worldwide literature.
Maltese: Tmienja u tletin (38) każ kienu każi li ma kinux medikament ikkonfermati u 475 każ kienu medikament ikkonfermati; fosthom 180 każ ġew irrapportati direttament lill-Kumpanija, 245 każ ġew irrapportati mill-Awtoritajiet tas-Saħħa, u 50 każ ġew identifikati fid-dokumentazzjoni xjentifika mid-dinja kollha.
English: • The PRAC noted that serious adverse cutaneous reactions have been reported with tetrazepam, including fatal cases.
Maltese: • Il-PRAC innota li ġew irrrapporti reazzjonijiet avversi serji tal-ġilda bl-użu tat-tetrażepam, inkluż każi fatali.
English: • The PRAC considered, after having reviewed the available data that tetrazepam, compared to the medicines of the same pharmacological class, is associated with an increased risk of serious cutaneous adverse reactions including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis , Erythema Multiform and Drug Reaction of Eosinophilia Systemic Symptoms (DRESS) which can be life threatening and fatal.
Maltese: • Il-PRAC qies, wara li rreveda d-dejta disponibbli, li apparagun mal-mediċini tal-istess klassi farmakoloġika, it-tetrażepam hija assoċjata ma' riskju akbar ta' reazzjonijiet avversi serji tal-ġilda inklużi s-sindromu ta' Stevens-Johnson, Nekroliżi Epidermali Tossika, Eritema Multiforme u Reazzjoni tal-Mediċina ta' Eosinofilja u Sintomi Sistemiċi (DRESS) li jistgħu jkunu ta' periklu għallħajja u fatali.
English: 3 Quinones D et al. Photodermatitis from tetrazepam.
Maltese: Photodermatitis from tetrazepam.
English: The CMDh, having considered the PRAC recommendation dated 11 April 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC and the oral explanation attended by a Marketing Authorisation Holder on 22 April 2013, reached a position on the suspension of the marketing authorisations of tetrazepam containing medicinal products.
Maltese: Is-CMDh, wara li qies ir-rakkomandazzjoni tal-PRAC tal-11 ta' April 2013 skont l-Artikolu 107k(1) u (2) tadDirettiva 2001/83/KE u l-ispjegazzjoni oral li attenda għaliha Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq fit-22 ta' April 2013, laħaq pożizzjoni dwar is-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali li fihom it-tetrażepam.
English: In most of the cases, the causal relationship of tetrazepam was reported as possible (86% of the cases) and in some cases as probable (11% of the cases).
Maltese: F'ħafna mill-każi rrelazzjoni kawżali tat-tetrażepam kienet irrapportata bħala possibbli (86% tal-każi) u f'xi każi bħala probabbli (11% tal-każi).
English: The CMDh, having considered the PRAC recommendation dated 11 April 2013 with regards to the tetrazepam containing medicinal products, agrees with the recommendation therein as stated below:
Maltese: Is-CMDh, wara li qies bis-sħiħ ir-rakkomandazzjoni tal-PRAC tal-11 ta' April 2013 rigward il-prodotti mediċinali li fihom it-tetrażepam, jaqbel mar-rakkomandazzjoni tagħha kif iddikjarat hawn taħt:
English: As provided by the Marketing Authorisation Holder of the originator medicinal product in their written response to the PRAC list of questions, according to the MAH's pharmacovigilance database since the product launch in 1969 up to the 31 of May 2012 (Data Lock Point), 513 cutaneous or allergic distinct cases referring to 748 reactions were reported with tetrazepam.
Maltese: Kif indikat mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq tal-prodott mediċinali oriġinarju fittweġiba bil-miktub tiegħu għal-lista ta' mistoqsijiet tal-PRAC, skont il-bażi tad-dejta tal-farmakoviġilanza tad-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) mit-tnedija tal-prodott fl-1969 sal-31 ta' Mejju 2012 (Data Lock Point), ġew irrapportati 513-il każ tal-ġilda jew każi allerġiċi distinti li jirreferu għal 748 reazzjoni bit-tetrażepam.
English: Following reporting of new serious cutaneous reactions with the use of tetrazepam, the French National Competent Authority reviewed in November 2012 the cutaneous risk associated with tetrazepam based on results of a national pharmacovigilance survey.
Maltese: Wara r-rappurtar ta' reazzjonijiet serji ġodda tal-ġilda bl-użu tat-tetrażepam, f'Novembru 2012 l-Awtorità Nazzjonali Kompetenti Franċiża rrivediet ir-riskju għall-ġilda assoċjat mat-tetrażepam abbażi ta' riżultati ta' stħarriġ nazzjonali tal-farmakoviġilanza.
English: Many of the skin adverse events were maculopapular, but they were also vesicular, pustular, purpuric or bullous at times.
Maltese: Ħafna episodji avversi tal-ġilda kienu makulopapulari, iżda kienu wkoll vesikulari, pustulari, purpuriċi jew xi drabi bullużi.
English: Allergy 1999;54(11):1226-27 Sanchez-Morillas L et al.
Maltese: Allergy 1999;54(11):1226-27
English: In view of the unpredictability of this type of adverse reactions, a restricted indication would not be an effective risk minimisation measure.
Maltese: Minħabba l-imprevedibbiltà ta' dawn it-tipi ta' reazzjonijiet avversi, indikazzjoni ristretta mhijiex se tkun miżura effettiva għall-minimizzazzjoni tar-riskji.
English: Overall, more than 40% of the reported cases are related to the skin disorder SOC; severe Cutaneous Adverse Reactions to Drugs (SCARs), such as SJS, TEN, DRESS Syndrome and EM were diagnosed upon tetrazepam treatment and 11 fatal cases were reported; in 8 cases, it was reported as the result of the skin reaction and in 3 cases, it was related to an associated reaction.
Maltese: B'mod ġenerali, aktar minn 40% tal-każi rrapportati huma relatati mas-SOC disturbi fil-ġilda; Reazzjonijiet Avversi severi tal-Ġilda għall-Mediċini (SCARs), bħal SJS, TEN, is-sindromu DRESS u EM ġew dijanjostikati waqt kura bit-tetrażepam u ġew irrapportati 11-il każ fatali; fi 8 każi l-episodju ġie rrapportat bħala r-riżultat tarreazzjoni tal-ġilda u fi 3 każi kien relatat ma' reazzjoni assoċjata.
English: • The PRAC considered the totality of the data available for tetrazepam containing products in relation to the risk of cutaneous adverse reactions.
Maltese: • Il-PRAC qies it-totalità tad-dejta disponibbli għal prodotti li fihom it-tetrażepam fir-rigward tarriskju ta' reazzjonijiet avversi tal-ġilda.
English: In view of the safety concerns in relation to serious, potentially fatal, skin reactions and the limited efficacy of tetrazepam, the PRAC concluded that pursuant to Article 116 of Directive 2001/83/EC the benefit-risk balance of tetrazepam containing medicines is considered no longer favourable.
Maltese: Fid-dawl tat-tħassib dwar is-sigurtà fir-rigward ta' reazzjonijiet serji u potenzjalment fatali tal-ġilda u leffikaċja limitata tat-tetrażepam, il-PRAC ikkonkluda li skont l-Artikolu 116 tad-Direttiva 2001/83/KE ilbilanċ tal-benefiċċju-riskju ta' mediċini li fihom it-tetrażepam ma għadux meqjus favorevoli.
English: The PRAC considered available data including data from the French pharmacovigilance survey, data provided by other Member States, stakeholder's submissions and data submitted by MAHs, as well as published data.
Maltese: Il-PRAC qies id-dejta disponibbli inkluża dejta mill-istħarriġ Franċiż tal-farmakoviġilanza, dejta mogħtija minn Stati Membri oħra, sottomissjonijiet tal-partijiet interessati u dejta mressqa mid-detenturi talawtorizzazzjoni għat-tqegħid fis-suq (MAHs), kif ukoll dejta ppubblikata.
English: The MAH presented its views on the possible mechanism of cutaneous reactions induced by tetrazepam: a structural difference between tetrazepam and other benzodiazepines (i.e. the substituted cyclohexenyl ring of tetrazepam) may be linked to the various cutaneous hypersensitivity reactions observed for tetrazepam.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) ippreżenta l-opinjonijiet tiegħu dwar ilmekkaniżmu possibbli ta' reazzjonijiet tal-ġilda kkawżati mit-tetrażepam: differenza strutturali bejn ittetrażepam u l-benżodijażepini oħra (jiġifieri ċ-ċirku ċikloesenili sostitwit tat-tetrażepam) tista' tkun marbuta mad-diversi reazzjonijiet ta' sensittività eċċessiva tal-ġilda osservati bl-użu tat-tetrażepam.
English: In view of the above, the PRAC considered that tetrazepam, compared to the medicines of the same pharmacological class, is associated with an increased risk of serious cutaneous adverse reactions including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis , Erythema Multiform and DRESS syndrome which can be life threatening and fatal.
Maltese: Fid-dawl ta' dan kollu msemmi hawn fuq il-PRAC qies li t-tetrażepam - apparagun mal-mediċini tal-istess klassi farmakoloġika - huwa assoċjat ma' riskju akbar ta' reazzjonijiet avversi serji tal-ġilda, inklużi ssindromu ta' Stevens-Johnson, Nekroliżi Epidermali Tossika, Eritema Multiforme u s-sindromu DRESS li jistgħu jkunu ta' periklu għall-ħajja u anke fatali.
English: This is indicative that serious cutaneous reactions with tetrazepam are probably linked to a type IV delayed hypersensitivity mechanism, as supported by positive patch tests in 79 out of 115 cases having had an allergy test.
Maltese: Dan huwa indikattiv għall-fatt li reazzjonijiet serji tal-ġilda bl-użu tat-tetrażepam huma probabbilment marbuta ma' mekkaniżmu ttardjat ta' sensittività eċċessiva tat-tip IV, kif intwera b'testijiet pożittivi fuq roqgħa tal-ġilda f'79 minn 115-il każ li kien sarilhom test għal allerġija.
English: Time to onset ranged from 1 to 3 weeks in 14 patients, while 9 cases were reported with a shorter time to onset (< 7 days) including 6 cases with a very short time to onset between 1- 3 days.
Maltese: Iż-żmien tal-eżordju kien ivarja minn ġimgħa sa 3 ġimgħat f'14-il pazjent, filwaqt li 9 każi ġew irrapportati bi żmien tal-eżordju iqsar (< 7 ijiem) inkluż 6 każi bi żmien ta' eżordju qasir ħafna bejn 1 u 3 ijiem.
English: These cases concerned 31 cases of SJS and 35 cases of TEN, including one case with both reactions.
Maltese: Dawn il-każi kienu jirrigwardaw 31 każ ta' SJS u 35 każ ta' TEN, inkluż wieħed biż-żewġ reazzjonijiet.
English: The efficacy of tetrazepam was also compared to other active drugs in controlled double blind studies: these studies did not show statistically significant difference between the groups in both indications.
Maltese: L-effikaċja tat-tetrażepam tqabblet ukoll ma' mediċini attivi oħra fi studji kkontrollati bi blindaġġ doppju: dawn l-istudji ma wrew l-ebda differenza statistikament sinifikanti bejn il-gruppi fiż-żewġ indikazzjonijiet.
English: The PRAC considered risk minimisations measures, including reduction of duration of treatment to 6 days and a restricted indication, to mitigate the risk of serious cutaneous adverse reactions.
Maltese: Il-PRAC qies miżuri għall-minimizzazzjoni tar-riskji, inkluż it-tnaqqis tat-tul ta' kura għal 6 ijiem u indikazzjoni ristretta, biex jittaffa r-riskju ta' reazzjonijiet avversi serji tal-ġilda.
English: Tetrazepam was the only suspected drug or had a causality score higher than the concomitant treatments in 18 out 81 cases of SJS, TEN or DRESS.
Maltese: It-tetrażepam kienet l-unika mediċina suspettata jew li kellha punteġġ ta' kawżalità ogħla mill-kura konkomitanti fi 18 mill-81 każ ta' SJS, TEN jew DRESS.
English: In addition, 10 cases of angioedema evoking an immediate hypersensitivity mechanism and 67 cases of drug eruption, in addition to the previous cases, with or without the involvement of at least one organ were described.
Maltese: Barra dan, ġew deskritti 10 każi ta' anġjoedema li evokaw mekkaniżmu immedjat ta' sensittività eċċessiva u 67 każ ta' eruzzjoni minħabba l-mediċina, minbarra l-każi preċedenti, bi jew mingħajr l-involviment ta' mill-inqas organu wieħed.
English: The option of a patient alert card was also discussed but this was not considered effective in preventing these types of SCARs.
Maltese: Ġiet diskussa wkoll il-possibbiltà ta' skeda ta' twissija għall-pazjent, iżda din ma tqisitx effettiva filprevenzjoni ta' dawn it-tipi ta' SCARs.