FrancophonIA/ELRC3.0 huggingface dataset:
English: No animal fertility studies have been conducted with Iblias and its effect on human fertility has not been established in controlled clinical trials.
Maltese: Ma twettqux studji dwar il-fertilità fl-annimali b'Iblias, u l-effett tiegħu fuq il-fertilità umana ma ġiex stabbilit fi provi kliniċi kkontrollati.
English: • Finally, the PRAC noted that to date most studies evaluating a differential risk of inhibitor development between classes of FVIII products suffer from a variety of potential methodological limitations and based on the available data considered there is no clear and consistent evidence to suggest differences in relative risk between classes of FVIII products.
Maltese: • Finalment, il-PRAC innota li s'issa ħafna mill-istudji li jevalwaw riskju differenzjali tal-iżvilupp tal-inibituri bejn il-klassijiet ta' prodotti FVIII huma affettwati minn varjetà ta' limitazzjonijiet metodoloġiċi potenzjali u abbażi tad-dejta disponibbli kkunsidra li m'hemm l-ebda evidenza ċara u konsistenti biex tissuġġerixxi differenzi fir-riskju relattiv bejn ilklassijiet ta' prodotti FVIII.
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre inhibitors which are transiently present or remain consistently low titre posing less risk of insufficient clinical response than high titre inhibitors.
Maltese: Ir-rilevanza klinika tal-iżvilupp tal-inibituri se tiddependi fuq it-titru tal-inibitur, b'inibituri ta' titru baxx li jkunu preżenti temporanjament jew jibqgħu b'titru baxx b'mod konsistenti jkollhom inqas riskju ta' rispons kliniku insuffiċjenti minn inibituri b'titru għoli.
English: • One mL Iblias 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Maltese: IU / 2.5 mL) ta' fattur VIII tal-koagulazzjoni umana rikombinanti (INN: octocog alfa) wara r-rikostituzzjoni b'ilma għall-injezzjonijiet.
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of long-term treatment with Iblias, the MAH will submit the results of the ongoing study “13400 - Leopold Kids extension”
Maltese: Sabiex jinvestiga s-sigurtà u l-effikaċja ta' trattament fit-tul b'Iblias, l-MAH se jissottometti r-riżultati tal-istudju li għaddej bħalissa “13400 - Leopold Kids extension”
English: Dysgeusia uncommon
Maltese: Ilma għall-injezzjonijiet
English: After reconstitution this medicinal product contains 0.081 mmol sodium per vial of reconstituted solution (corresponding to 1.86 mg per vial).
Maltese: Wara r-rikostituzzjoni, dan il-prodott mediċinali ikun fih 0.081 mmol ta' sodium f'kull kunjett ta' soluzzjoni rikostitwita (li jikkorrispondi għal 1.86 mg f'kull kunjett).
English: Inject the solution into a vein over 2 to 5 minutes, keeping an eye on the position of the needle.
Maltese: Injetta s-soluzzjoni ġo vina fuq perjodu ta' 2 sa 5 minuti, waqt li żżomm għajnejk fuq ilpożizzjoni tal-labra.
English: • rapid heartbeat
Maltese: • diffikultà biex torqod
English: Haemophilia.
Maltese: dan il-fuljett.
English: 500 IU (octocog alfa) (200 IU/mL after reconstitution).
Maltese: IU octocog alfa (200 IU/mL wara r-rikostituzzjoni).
English: Allergic type hypersensitivity reactions are possible with Iblias.
Maltese: Reazzjonijiet ta' sensittività eċċessiva tat-tip li jikkaġunaw allerġiji huma possibbli b'Iblias.
English: Iblias 250 IU powder and solvent for solution for injection Iblias 500 IU powder and solvent for solution for injection Iblias 1000 IU powder and solvent for solution for injection Iblias 2000 IU powder and solvent for solution for injection Iblias 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni Iblias 3000 IU trab u solvent għal soluzzjoni għall-injezzjoni fattur VIII rikombinanti uman tal-koagulazzjoni (octocog alfa)
English: Common (may affect up to 1 in 10 users):
Maltese: Komuni (jistgħu jaffettwaw minn persuna waħda sa 10 persuni):
English: These may be signs of a rare severe sudden allergic reaction (an anaphylactic reaction) to Iblias.
Maltese: Dawn jistgħu jkunu sinjali ta' reazzjoni allerġika rari u severa li sseħħ għal għarrieda (reazzjoni anafilattika) għal Iblias.
English: 32 IU/kg 50 IU/kg)
Maltese: 32 IU/kg 50
English: The Pharmacokinetic (PK) profile of Iblias was evaluated in PTPs with severe haemophilia A following 50 IU/kg in 21 subjects ≥ 18 years, 5 subjects ≥ 12 years and < 18 years and 19 subjects < 12 years of age.
Maltese: IU/kg f'21 individwu li kellhom ≥ 18-il sena, 5 individwi li kellhom ≥ 12-il sena u < 18-il sena u 19-il individwi li kellhom < 12-il sena.
English: Uncommon (may affect up to 1 in 100 users):
Maltese: Mhux komuni (jistgħu jaffettwawsa persuna waħda li qed tużah minn kull 100):
English: Table 3: Consumption and overall success rates (patients treated with prophylaxis only) Younger children years)
Maltese: Tabella 3: Konsum u rati globali ta' suċċess (pazjenti kkurati bi profilassi biss) Tfal iżgħar (0 < 6 sni n)
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Maltese: Jekk tagħmir ta' aċċess venuż ċentrali (CVADs) ikun meħtieġ, ir-riskju ta' kumplikazzjonijiet relatati ma' CVAD inkluż infezzjonijiet lokali, batterimja u trombożi fis-sit tal-kateter, għandu jiġi kkunsidrat.
English: The table 4 below provides PK parameters based on the population PK model.
Maltese: It-tabella 4 hawn taħt tipprovdi parametri PK ibbażati fuq il-mudell PK tal-popolazzjoni.
English: In particular, only 13 patients (10% of the FVIII arm) received a third generation rFVIII product.
Maltese: B'mod partikolari, 13-il pazjent biss (10% tal-fergħa FVIII) irċivew prodott rFVIII tat-tielet ġenerazzjoni.
English: It is uncertain whether the findings of SIPPET can be extrapolated to the risk of inhibitors in PUPs in current clinical practice in the EU as treatment modality and intensity have been suggested as risk factors for inhibitor development in previous studies.
Maltese: Hemm inċertezza dwar jekk is-sejbiet ta' SIPPET jistgħux jiġu estrapolati għar-riskju tal-inibituri f'PUPs fil-prattika klinika attwali fl-UE peress li, fi studji preċedenti, il-modalità u l-intensità tal-kura ġew issuġġeriti bħala fatturi ta' riskju għall-iżvilupp talinibituri.
English: Powder: solid, white to slightly yellow.
Maltese: Trab: solidu, talewn abjad sa kemmxejn fl-isfar.
English: Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Maltese: Irrepeti l-infużjoni kull 12 - 24 siegħa għal 3 - 4 ijiem jew aktar, sakemm jitfejjaq l-uġigħ u ddiżabilità akuta.
English: Specifically, the findings from the SIPPET study, as well as those from the individual clinical trials and observational studies included in the MAH responses, are not sufficient to confirm any consistent statistically and clinically meaningful differences in inhibitor risk between the rFVIII and pdFVIII product classes.
Maltese: Speċifikament, is-sejbiet mill-istudju SIPPET, kif ukoll dawk mill-provi kliniċi individwali u mill-istudji ta' osservazzjoni inklużi fit-tweġibiet tal-MAH, mhumiex biżżejjed biex jikkonfermaw xi differenza statistikament konsistenti u klinikament sinifikanti fir-riskju ta' inibituri bejn klassijiet tal-prodotti rFVIII u pdFVIII.
English: The study was not designed and powered to generate sufficient product-specific data and, therefore, to draw any conclusions on the risk of inhibitor development for individual products.
Maltese: riżultati tal-istudju li ma jippermettux konklużjoni definita dwar ir-riskju ta' inibituri għal prodotti individwali.
English: However, the study found evidence of an increased risk of inhibitors (all and high titre) for 2nd generation rFVIII octocog alfa (Kogenate FS/Helixate NexGen) compared with 3rd generation rFVIII octocog alfa (which was driven solely by data for Advate).
Maltese: et ġenerazzjoni rFVIII octocog alfa (li kien xprunat biss minn dejta għal Advate).
English: CSL Behring AB Simi: +46-(0)8-54496670
Maltese: Simi: +46-(0)8-54496670
English: Repeat-dose toxicity studies longer than 5 days, reproductive toxicity studies, and carcinogenicity studies, have not been performed.
Maltese: Ma sarux studji dwar tossiċità minn dożi ripetuti itwal minn 5 ijiem, studji dwar tossiċità riproduttiva u studji dwar il-karċinoġeniċità.
English: Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.
Maltese: PedNet and RODIN Study Group. Factor VIII products and inhibitor development in severe hemophilia A.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Maltese: L-emofilja A hija marda ereditarja li taffettwa l-koagulazzjoni tad-demm, li tgħaddi mill-kromosoma tas-sess u hija kkawżata minn livelli mnaqqsa ta' fattur VIII:C u twassal għall- kwantità kbira ta' fsada fil-ġogi, muskoli, u organi interni, kemm b'mod spontanju kif ukoll wara xi aċċident jew trawma kirurġika.
English: CSL Behring AB Tlf: +46-(0)8-54496670
Maltese: Tlf: +46-(0)8-54496670
English: A total of 204 subjects have been included in the clinical trial program, 153 subjects ≥ 12 years and 51 subjects < 12 years.
Maltese: Total ta' 204 individwu kienu ġew inklużi fil-programm ta' prova klinika, 153 individwu li kellhom ≥ 12-il sena u 51 individwu li kellhom < 12-il sena. 140 individwu ġew ikkurati għal mill-inqas 12-il xahar, u 55 minn dawn l-individwi għal medjan ta' 24 xahar.
English: It is produced by recombinant DNA technology in baby hamster kidney cells (BHK) into which the human factor VIII gene has been introduced.
Maltese: Hu magħmul minn teknoloġija ta' DNA rikombinanti f'ċelluli tal-kliewi ta' frieħ tal-ħamsters (baby hamster kidney, BHK) li fihom ikun ġie introdott ilġene ta' fattur VIII uman.
English: This included published literature (SIPPET study6), data generated in individual clinical trials and a range of observational studies submitted by the marketing authorisation holders, including the data generated in large multicentre cohort studies, data submitted by the national competent authorities of the EU Member States as well as responses provided by the Authors of the SIPPET study.
Maltese: 6), dejta ġġenerata fi provi kliniċi individwali u medda ta' studji ta' osservazzjoni ppreżentati mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq, inkluż id-dejta ġġenerata fi studji ta' koorti multiċentriċi kbar, dejta ppreżentata mill-awtoritajiet nazzjonali kompetenti tal-Istati Membri tal-UE kif ukoll it-tweġibiet ipprovduti mill-Awturi tal-istudju SIPPET.
English: CSL Behring, S. A. Tel: +34 93 367 1870
Maltese: Tel: +34 93 367 1870
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/08/499/002 Valdoxan
Maltese: Numru tal-MA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Daxas is contraindicated in patients with moderate or severe liver impairment (Child Pugh B or C).
Maltese: Daxas hu kontraindikat f'pazjenti b'indeboliment moderat jew sever tal-fwied (Child Pugh B jew Ċ).
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g. multiple sclerosis, lupus erythematous, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daxas should not be initiated or should be stopped in these patients.
Maltese: In-nuqqas ta' esperjenza f'pazjenti b'infezzjoni bl-HIV jew epatite attiva, b'mard immunoloġiku sever (eż. sklerosi multipla, lupus eritematuż, lewkoenċefalopatija multifokali) jew li jkunu kkurati b'terapija immunosoppressiva (minbarra kortikosterojdi sistemiċi għal żmien qasir) u li Daxas m'għandux jinbeda jew għandu jitwaqqaf f'dawn il-pazjenti.
English: • Educational material for the physician.
Maltese: Materjal edukattiv għat-tabib.
English: • Prior to launch of the product in the Member State, the national competent authority shall agree the content and format of the educational material with the Marketing Authorisation Holder
Maltese: • Qabel it-tnedija tal-prodott fl-Istat Membru, l-awtorità kompetenti nazzjonali għandha taqbel dwar il-kontenut u l-format tal-materjal edukattiv mad-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq
English: That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females o Patients concomitantly treated with CYP1A2 inhibitors (such as fluvoxamine) or dual CYP3A4/1A2 inhibitors (such as enoxacin and cimetidine)
Maltese: ○ Popolazzjonijiet speċjali li għandhom żieda fl-inibizzjoni għal PDE4 bħal nisa suwed li ma jpejpux ○ Azjenti kkurati fl-istess ħin b'inibituri ta' CYP1A2 (bħal fluvoxamine) jew b'inibituri doppji ta' CYP3A4/1A2 (bħal enoxacin u cimetidine)
English: Clinical data are considered insufficient to recommend dose adjustment and caution should be observed in patients with mild liver impairment (child Pugh A).
Maltese: Dejta klinika hi kkunsidrata li hi insuffiċjenti biex wieħed jirrakkomanda aġġustament fid-doża, u għandu jkun hemm kawtela f'pazjenti b'indeboliment ħafif tal-fwied (Child Pugh A).
English: The limited or missing information in patients with liver impairment.
Maltese: L-informazzjoni limitata jew nieqsa f'pazjenti b'indeboliment tal-fwied.
English: The limited experience in patients with latent infections such as tuberculosis, viral hepatitis or herpes infections.
Maltese: L-esperjenza limitata f'pazjenti b'infezzjonijiet moħbija bħal tuberkulosi, epatite virali jew b'infezzjonijiet bil-herpes.
English: The lack of clinical data to support the combination with theophylline and that such combination is not recommended.
Maltese: In-nuqqas ta' dejta klinika li tissapportja l-kumbinazzjoni ma' theophylline u li kumbinazzjoni bħal din mhijiex rakkomandata.
English: The potential cardiac risk: Daxas has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
Maltese: Daxas ma ġiex studjat f'pazjenti b'insuffiċjenza konġestiva talqalb (NYHA grad 3 u 4); għaldaqstant, mhuwiex rakkomandat f'din il-popolazzjoni.
English: The fact that Daxas is not indicated for the treatment of COPD patients other than those covered by the approved indication, nor for use in patients with asthma or alpha 1 anti trypsine deficiency.
Maltese: Il-fatt li Daxas mhuwiex indikat għall-kura ta' pazjenti b'COPD, ħlief dawk koperti mill-indikazzjoni approvata, u lanqas għall-użu f'pazjenti b'ażżma jew defiċjenza ta' alpha 1 anti trypsine.
English: The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daxas and the potential risk of suicide.
Maltese: Ir-riskju ta' mard psikjatriku bħal nuqqas ta' rqad, ansjetà, u dipressjoni f'pazjenti li jkunu qed jirċievu Daxas u r-riskju potenzjali ta' suwiċidju.
English: • Summary of Product Characteristics and Patient Information Leaflet for Daxas
Maltese: Il-pakkett edukattiv għandu jinkludi dawn li ġejjin:
English: • The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Daxas are provided with an Educational pack.
Maltese: • Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jiżgura li, fit-tnedija talprodott, il-Professjonisti fil-Qasam tal-Kura tas-Saħħa li huma mistennija li jagħtu riċetta għal Daxas, jingħataw il-Pakkett edukattiv.
English: A typical dose will range from 7.5 mg (3.75 ml) to 25 mg (12.5 ml) once a week.
Maltese: Doża tipika tvarja bejn 7.5 mg (3.75 ml) sa 25 mg (12.5 ml) darba f'ġimgħa.
English: • Jylamvo (methotrexate 2mg/ml)
Maltese: • Jylamvo (metotressat 2mg/ml)
English: Dose in mg 5 mg
Maltese: Doża f'mg 5 mg
English: More information about Jylamvo can be found on the Agency's website: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003756/human_ med_002083.jsp
Maltese: Aktar informazzjoni dwar Jylamvo tista' tinsab fuq is-sit elettroniku talAġenzija: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003756 /human_med_002083.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29 March 2017 EMA/81869/2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: • active rheumatoid arthritis, an inflammatory joint disease;
Maltese: • artrite rewmatika attiva, marda infjammatorja tal-ġogi;
English: • severe juvenile idiopathic arthritis (JIA), a joint disease in children;
Maltese: • artrite idjopatika ġovanili severa (juvenile idiopathic arthritis - JIA), marda tal-ġogi fit-tfal;
English: Jylamvo, an oral solution containing methotrexate, is used to treat arthritis and the skin disease psoriasis, as well as a type of blood cancer called acute lymphoblastic leukaemia (ALL).
Maltese: Jylamvo, soluzzjoni orali li fiha l-metotressat, jintuża fil-kura tal-artrite u tal-marda tal-ġilda, il-psorjasi, kif ukoll fil-kura ta' tip ta' kanċer tad-demm magħruf bħala lewkimja limfoblastika akuta (acute lymphoblastic leukaemiaALL).
English: • severe psoriatic arthritis, an inflammatory joint disease that occurs in patients with psoriasis.
Maltese: • artrite psorjatika severa, infjammazzjoni tal-ġogi li sseħħ fil-pazjenti bi psorjasi.
English: • Patients should be monitored for signs and symptoms of overdose, such as bleeding, unusual feeling of weakness, ulcers in the mouth, feeling sick, vomiting, black or bloody stools, coughing up blood or vomiting blood and reduced urine output.
Maltese: • Il-pazjenti għandhom ikunu ssorveljati għal sinjali u s-sintomi ta' doża żejda, bħal fsada, sensazzjoni mhux tas-soltu ta' debbulizza, ulċeri fil-ħalq, tħossok ma tiflaħx, rimettar, ippurgar iswed jew bid-demm, tisgħol id-demm jew tirremetti d-demm u awrina mnaqqsa.
English: • For acute lymphoblastic leukaemia (ALL), the dose is usually higher and you may need to take Jylamvo more frequently.
Maltese: • Fil-każ tal-lewkimja limfoblastika akuta (ALL), id-doża normalment tkun ogħla u jista' jkollok bżonn tieħu Jylamvo aktar spiss.
English: These include: bleeding, unusual feeling of weakness, ulcers in the mouth, feeling sick, vomiting, black or bloody stools, coughing up blood or vomiting blood and a reduced urine production.
Maltese: Dawn jinkludu: fsada, sensazzjoni mhux tas-soltu ta' debbulizza, ulċeri fil-ħalq, tħossok ma tiflaħx, rimettar, ippurgar iswed jew bid-demm, tisgħol id-demm jew tirremetti d-demm u awrina mnaqqsa.
English: Information for healthcare professionals
Maltese: Aktar informazzjoni dwar il-mediċina
English: For acute lymphoblastic leukaemia (ALL), the dose is usually higher and given more frequently.
Maltese: Fil-każ tal-lewkimja limfoblastika akuta (ALL), id-doża normalment tkun ogħla u tista' tingħata aktar spiss.
English: You should follow your healthcare professional's instructions.
Maltese: Segwi l-istruzzjonijiet tal-professjonista tal-kura tas-saħħa.
English: The educational guide will advise healthcare professionals that for arthritis and psoriasis Jylamvo must be taken once a week.
Maltese: Il-gwida edukattiva ser tinforma lill-professjonisti tal-kura tas-saħħa li fil-każ tal-artrite u tal-psorjasi Jylamvo jrid jittieħed darba fil-ġimgħa.
English: Jylamvo is a medicine that is used for the treatment of the following inflammatory conditions:
Maltese: Jylamvo huwa mediċina li tintuża għall-kura tal-infjammazzjonijiet li ġejjin:
English: Healthcare professionals expected to prescribe and dispense Jylamvo will be given an educational guide to ensure that the medicine is used correctly.
Maltese: Il-professjonisti tal-kura tas-saħħa li huma mistennija li jagħtu b'riċetta u jqassmu Jylamvo għandhom jingħataw fuljett edukattiv sabiex jiżguraw li l-mediċina tintuża b'mod tajjeb.
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Maltese: +44 (0)20 7418 8427 Posta elettronika: press@ema.europa.eu
English: 29 May 2013 EMA/402567/2013 - Rev 1
Maltese: 29 ta' Mejju 2013 EMA/402567/2013 - Rev 1
English: Contact our press officers Monika Benstetter or Martin Harvey Allchurch
Maltese: Ikkuntattja lill-uffiċjali tagħna għall-istampa Monika Benstetter jew Martin Harvey Allchurch
English: • In the pharmacovigilance database of the originator product, Myolastan, a total of 513 cutaneous (or allergic) reactions were identified.
Maltese: • Fid-database ta' farmakoviġilanza tal-prodott oriġinatur, Myolastan, kien identifikat total ta' 513-il reazzjoni kutanja (jew allerġika).
English: Serious skin reactions include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome.
Maltese: Ir-reazzjonijiet serji tal-ġilda jinkludu ssindromu ta' Stevens-Johnson (SJS), nekroliżi epidermika tossika (TEN), eritema multiforme u ssindromu tar-raxx ikkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS).
English: Tetrazepam-containing medicines have been approved since the 1960s via national procedures in several EU Member States (Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Latvia, Lithuania, Luxembourg, Poland, Romania, Slovakia and Spain), and are available on prescription under various trade names, including Epsipam, Miozepam, Musapam, Musaril, Myolastan, Myopam, Panos,
Maltese: il-Latvja, il-Litwanja, il-Lussemburgu, il-Polonja, ir-Rumanija, is-Slovakkja u Spanja), u huma disponibbli b'riċetta ta' tabib taħt diversi ismijiet kummerċjali, fosthom Epsipam, Miozepam, Musapam, Musaril, Myolastan, Myopam, Panos, Relaxam, Spasmorelax, Tetra-saar, Tetramdura u Tetraratio.
English: Having assessed all available data on the risk of skin reactions, including post-marketing data in the EU and the published literature, the PRAC concluded that tetrazepam is associated with a low but increased risk of serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome) compared with other benzodiazepines.
Maltese: Wara li evalwa d-dejta kollha disponibbli dwar ir-riskju ta' reazzjonijiet tal-ġilda, inkluża d-dejta ta' wara ttqegħid fis-suq fl-UE u l-letteratura ppubblikata, il-PRAC ikkonkluda li tetrazepam huwa assoċjat ma' riskju baxx iżda akbar ta' reazzjonijiet serji tal-ġilda (li jinkludu s-sindrome ta' Stevens-Johnson, nekroliżi epidermika tossika u s-sindrome DRESS) meta mqabbel ma' benzodiazepines oħra.
English: 65 cases of SJS and TEN were reported.
Maltese: Kienu rrappurtati 65 każ ta' SJS u TEN.
English: The review of tetrazepam was triggered by the French National Agency for the Safety of Medicine and Health Products (ANSM), following reports of serious skin reactions with this medicine in France.
Maltese: Ir-reviżjoni ta' tetrazepam inbdiet mill-Aġenzija Nazzjonali Franċiża għas-Sigurtà tal-Prodotti Mediċinali u tas-Saħħa (ANSM), wara rapporti ta' reazzjonijiet serji tal-ġilda b'din il-mediċina fi Franza.
English: Tetrazepam belongs to a group of medicines called benzodiazepines.
Maltese: Tetrazepam jappartjeni għal grupp ta' mediċini msejħa benzodiazepines.
English: This is possibly explained by a structural difference between tetrazepam and other benzodiazepines (i.e. the substituted cyclohexenyl ring of tetrazepam).
Maltese: Dan jista' jkun spjegat minn differenza strutturali bejn tetrazepam u benzodiazepines oħra (jiġifieri ċ-ċirku ċikloesenili ta' tetrazepam).
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: Is-CMDh, korp li jirrappreżenta lill-Istati Membri tal-UE, huwa responsabbli biex jassigura standards armonizzati tas-sigurtà għall-mediċini awtorizzati permezz ta' proċeduri nazzjonali fl-UE kollha.