FrancophonIA/ELRC3.0 huggingface dataset:
English: The sofosbuvir resistance-associated substitution S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies by population or deep sequencing.
Maltese: Is-sostituzzjoni S282T assoċjata mar-reżistenza ta' sofosbuvir f'NS5B ma ġietx osservata fis sekwenza tal-linja bażi NS5B ta' ebda pazjent fl-istudji ta' Fażi 3 skont is-sekwenzjar tal-popolazzjoni jew sekwenzjar profond.
English: SOLAR-1 is an open-label, multicentre study evaluating 12 and 24 weeks of treatment with ledipasvir/sofosbuvir + ribavirin in patients with genotype 1 or 4 CHC who have advanced liver disease and/or who have undergone liver transplantation.
Maltese: SOLAR-1 huwa studju open-label, b'aktar minn ċentru wieħed li evalwa 12 u 24 ġimgħa ta' kura b'ledipasvir/sofosbuvir + ribavirin f'pazjenti b'CHC ta' ġenotip 1 jew 4 li għandhom marda tal-fwied avvanzata u/jew li għadhom kif kellhom trapjant tal-fwied.
English: Table 10: Response rates in study ION-1 LDV/SOF
Maltese: Rati ta' rispons fl-istudju ION-1 LDV/SOF
English: Otherb
Maltese: Tqala
English: Effects on medicinal product levels.
Maltese: Effetti fuq il-livelli tal prodott mediċinali.
English: Presence of baseline NS5A resistance-associated substitutionsc No
Maltese: Dejta ta' sekwenzjar profond NS5A u NS5B ta' wara l-linja bażi (cut off tal-assaġġ ta'
English: CPT B
Maltese: Oħrajn b
English: Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine) may decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of Harvoni.
Maltese: L-użu ma' indutturi moderati ta' P-gp Prodotti mediċinali li huma indutturi moderati ta' P-gp fl-imsaren (eż. oxcarbazepine) jistgħu jnaqqsu l-konċentrazzjonijiet ta' ledipasvir u sofosbuvir fil-plażma u jwasslu għal effett terapewtiku mnaqqas ta' Harvoni.
English: Ledipasvir ↔ Cmax 0.92 (0.85, 1.00) ↔ AUC 0.91 (0.84, 1.00) ↔ Cmin 0.89 (0.81, 0.98)
Maltese: Lamivudine ↔ Cmax 0.93 (0.87, 1.00) ↔ AUC 0.94 (0.90, 0.98) ↔ Cmin 1.12 (1.05, 1.20)
English: Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200 mg/ 25 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Maltese: Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200 mg/ 25 mg/ 300 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)
English: In vitro data indicate that ledipasvir may be a weak inducer of metabolising enzymes such as CYP3A4, CYP2C and UGT1A1.
Maltese: Dejta in vitro tindika li ledipasvir jista' jkun induttur dgħajjef ta' enzimi li jimmetabolizzaw bħal CYP3A4, CYP2C u UGT1A1.
English: In female rats, the mean number of corpora lutea and implantation sites were slightly reduced at maternal exposures 6-fold the exposure in humans at the recommended clinical dose.
Maltese: F'firien nisa, l-għadd medju ta' corpora lutea u siti ta' implimentazjzoni tnaqqas xi ftit f'esponimenti materni li huma 6 darbiet aktar mill-esponiment fil-bnedmin fid-doża klinika rakkomandata.
English: Change in MELD score: 53% (72/135) and 21% (28/135) had an improvement or no change of MELD score from baseline to post-treatment week 4, respectively; of the 35 patients whose MELD score was ≥ 15 at baseline, 63% (22/35) had a MELD score < 15 at post-treatment week 12.
Maltese: Bidla fil-punteġġ MELD: 53% (72/135) u 21% (28/135) kellhom titjib jew l-ebda bidla fil-punteġġ MELD mil-linja bażi sa ġimgħa 4 wara l-kura, rispettivament; mill-35 pazjent li l-punteġġ MELD
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of ledipasvir, sofosbuvir or Harvoni in pregnant women.
Maltese: M'hemmx dejta jew hemm dejta limitata (inqas min 300 riżultat ta' tqala) dwar l-użu ta' ledipasvir, sofosbuvir jew Harvoni fin-nisa tqal.
English: Gender Male Female IL28 genotype CC Non-CC Baseline HCV RNAa
Maltese: qabel (jekk inkisibx HCV RNA <LLOQ).
English: Following oral administration of ledipasvir/sofosbuvir to HCV-infected patients, ledipasvir median peak plasma concentration was observed at 4.0 hours post-dose.
Maltese: Assorbiment Wara l-għoti orali ta' ledipasvir/sofosbuvir lil pazjenti infettati bl-HCV, l-ogħla konċentrazzjoni medjana fil-plażma ta' ledipasvir ġiet osservata 4.0 sigħat wara d-doża.
English: Yes d
Maltese: Iva d
English: The three Phase 3 studies included one study conducted in non-cirrhotic treatment-naïve patients (ION-3); one study in cirrhotic and non-cirrhotic treatment-naïve patients (ION-1); and one study in cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2).
Maltese: It-tliet studji ta' Fażi 3 inkludew studju wieħed imwettaq f'pazjenti mhux ċirrotiċi li qatt ma rċivew kura fil-passat (ION-3); studju wieħed f'pazjenti li qatt ma rċivew kura fil-passat ċirrotiċi u mhux ċirrotiċi (ION-1); u studju wieħed f'pazjenti ċirrotiċi u mhux ċirrotiċi li ma rnexxewx f'kura preċedenti b'kors ibbażat fuq interferon, inkluż korsijiet li fihom inibitur tal-protease tal-HCV (ION-2).
English: Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)
Maltese: Atazanavir imsaħħaħ b'ritonavir (300 mg/ 100 mg darba kuljum)/ ledipasvir (90 mg darba kuljum)ċ/ sofosbuvir (400 mg darba kuljum)
English: Potential for Harvoni to affect other medicinal products Ledipasvir is an in vitro inhibitor of drug transporter P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of co-administered substrates for these transporters.
Maltese: Ledipasvir huwa inibitur in vitro tat-trasportatur tal-mediċina P-gp u tal-proteina tar-reżistenza talkanċer tas-sider (BCRP - breast cancer resistance protein) u jista' jżid l-assorbiment mill-imsaren ta' sottotrati mogħtija fl-istess ħin għal dawn it-trasportaturi.
English: Ledipasvir ↑ Cmax 1.98 (1.78, 2.20)
Maltese: ↑ Cmin 1.75 (1.58, 1.93) Ledipasvir ↑ Cmax 1.98 (1.78, 2.20)
English: c. Administered as Harvoni.
Maltese: Treddax matul il-kura b'Harvoni.
English: LDV/SOF+RBV 12 weeks
Maltese: LDV/SOF+ RBV 12-il ġimgħa
English: • light-headedness
Maltese: • sturdament • palpitazzjonijiet
English: The clinical studies enrolled patients with or without cirrhosis, who were treatment-naïve or with prior treatment failure after therapy with PEG-IFN + ribavirin +/- an HCV protease inhibitor.
Maltese: L-istudji kliniċi rreġistraw pazjenti bi jew mingħajr ċirrożi, li qatt ma rċivew kura fil-passat jew li kellhom falliment tal-kura wara t-terapija b'PEG-IFN + ribavirin +/-inibitur tal-protease tal-HCV.
English: Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Maltese: Rifampicin (600 mg darba kuljum)/ sofosbuvir
English: Table 13: Relapse rates for selected subgroups in study ION-2 LDV/SOF
Maltese: Tabella 13: Rati ta' rikaduta għal subgruppi magħżula fl-istudju ION-2 LDV/SOF
English: Not interpretable a. One patient in the LDV/SOF 8-week treatment arm did not have a confirmed genotype 1 subtype.
Maltese: Pazjent fil-fergħa ta' kura ta' 8 ġimgħat ta' LDV/SOF ma kellhomx subtip tal-ġenotip 1 konfermat.
English: Age (years): median (range)
Maltese: Età (snin): medjan (medda) Sess maskili
English: c. Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
Maltese: Oħrajn jinkludu pazjenti li ma kisbux SVR u ma ssodisfawx il-kriterji ta' falliment viroloġiku (eż., ma ġewx segwiti (lost to follow up)).
English: ION-4 was an open-label clinical study that evaluated the safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir without ribavirin in HCV treatment-naïve and treatment-experienced patients with genotype 1 or 4 CHC who were co-infected with HIV-1.
Maltese: ION-4 kien studju kliniku open-label li evalwa s-sigurtà u l-effikaċja ta' 12-il ġimgħa ta' kura b'ledipasvir/sofosbuvir mingħajr ribavirin f'pazjenti li qatt ma rċivew kura fil-passat u pazjenti li ħadu l-kura qabel b'ġenotip 1 jew 4 CHC li kienu koinfettati bl-HIV-1.
English: 8 weeks (n = 215)
Maltese: (n = 215)
English: When given with tenofovir disoproxil fumarate used in conjunction with atazanavir/ritonavir, Harvoni increased the concentration of tenofovir.
Maltese: Meta mogħti ma' tenofovir disoproxil fumarate użat flimkien ma' atazanavir/ritonavir, Harvoni żied ilkonċentrazzjoni ta' tenofovir.
English: It is given to treat chronic (long-term) hepatitis C virus infection in adults of 18 years and older.
Maltese: Jingħata biex jikkura infezzjoni kronika (għal żmien twil) bil-virus tal-epatite Ċ f'adulti li jkollhom 18-il sena u aktar.
English: Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Maltese: Gilead Sciences, S.L. Tel: + 34 91 378 98 30
English: 12 weeks (n = 214)
Maltese: (n = 214)
English: Metavir score F0-F3 96% (53/55) CPT A
Maltese: 12-il ġimgħa; l-SVR kienet 100% (44/44).
English: ↑ Digoxin ↔ Ledipasvir
Maltese: ↑ Digoxin ↔ Ledipasvir ↔ Sofosbuvir
English: Following treatment with ledipasvir/sofosbuvir with ribavirin for 12 weeks in patients with decompensated disease (irrespective of liver transplantation status), 3/7 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir relapsed, as compared to 4/68 in those without any baseline RAVs or RAVs conferring ≤ 100-fold reduced susceptibility to ledipasvir.
Maltese: ribavirin għal 12 ġimgħa f'pazjenti b'mard dikumpensat (irrispettivament mill-istat ta' trapjant talfwied), 3/7 pazjenti b'NS5A RAVs fil-linja bażi li rriżultaw f'suxxettibilità mnaqqsa ta' > 100 darba għal ledipasvir kellhom rikaduta, meta mqabbla ma' 4/68 f'dawk mingħajr l-ebda NS5A RAVs fil-linja bażi jew RAVs li rriżultaw f'suxxettibilità mnaqqsa ta' ≤ 100 darba għal ledipasvir.
English: Seven patient populations are being evaluated (patients with decompensated cirrhosis [CPT B and C] pre-transplant; post-transplant, no cirrhosis; post-transplant CPT A; post-transplant CPT B; post-transplant CPT C; post-transplant fibrosing cholestatic hepatitis [FCH]).
Maltese: Seba' popolazzjonijiet ta' pazjenti qegħdin jiġu evalwati (pazjenti b'ċirrożi dikumpensata [CPT B u C] qabel it-trapjant; wara t-trapjant, ebda ċirrożi; wara t-trapjant CPT A; wara t-trapjant CPT B; wara t-trapjant CPT C; epatite kolestatika tal fibrożi wara t-trapjant [FCH]).
English: ↑ Cmin 2.63 (2.32, 2.97) Ledipasvir ↓ Cmax 0.66 (0.59, 0.75)
Maltese: ↑ Cmin 2.36 (2.08, 2.67)
English: Although adverse events, including serious adverse events, occurred more frequently in this study compared to studies that excluded decompensated patients and/or patients who were post-liver transplantation, the adverse events observed were those expected as clinical sequelae of advanced liver disease and/or transplantation or were consistent with the known safety profile of ribavirin (see section 5.1 for details of this study).
Maltese: Għalkemm avvenimenti avversi, li jinkludu avvenimenti avversi serji, seħħew aktar ta' spiss f'dan l-istudju meta mqabbla ma' studji li eskludew pazjenti dikumpensati u/jew pazjenti wara trapjant tal-fwied, l-avvenimenti avversi osservati kienu dawk mistennija bħala konsegwenzi kliniċi ta' mard avvanzat tal-fwied u/jew trapjant, jew kienu konsistenti mal-profil tas-sigurtà magħruf ta' ribavirin (ara sezzjoni 5.1 għad-dettalji ta' dan l-istudju).
English: These studies did not include any control group not receiving ledipasvir/sofosbuvir.
Maltese: Dawn listudji ma inkludew ebda grupp ta' kontroll li ma rċeviex ledipasvir/sofosbuvir.
English: In the rat studies, exposure to sofosbuvir could not be determined but exposure margins based on the major human metabolite was approximately 5 times higher than the clinical exposure at 400 mg sofosbuvir.
Maltese: Fi studji fil-firien, l-esponiment għal sofosbuvir ma setax jiġi determinat iżda l-marġni tal-esponiment ibbażati fuq il-metabolit maġġuri uman kienu bejn wieħed u ieħor 5 darbiet ogħla mill-esponiment kliniku b'doża ta' 400 mg ta' sofosbuvir.
English: • St. John's wort (Hypericum perforatum - herbal medicine used to treat depression);
Maltese: John's wort [Hypericum perforatum], carbamazepine, phenobarbital u phenytoin).
English: GS-331007 ↔ Cmax 0.97 (0.83, 1.14) ↔ AUC 1.00 (0.87, 1.13)
Maltese: GS-331007 ↔ Cmax 0.97 (0.83, 1.14)
English: 47% (207)a
Maltese: 24% (4/17)e a.
English: When given with lopinavir/ritonavir used in conjunction with tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Maltese: Meta mogħti ma' lopinavir/ritonavir użat flimkien ma' tenofovir disoproxil fumarate, Harvoni huwa mistenni li jżid il-konċentrazzjoni ta' tenofovir.
English: Medicinal products that are potent P-gp inducers (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin) may significantly decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of ledipasvir/sofosbuvir and thus are contraindicated with Harvoni (see section 4.3).
Maltese: għoti flimkien se jnaqqas b'mod sinifikanti l-konċentrazzjonijiet ta' ledipasvir u sofosbuvir u jista' jirriżulta f'telf fl-effikaċja ta' Harvoni (ara sezzjoni 4.5).
English: ↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19)
Maltese: ↔ Cmin 1.08 (0.98, 1.20) Ritonavir ↔ Cmax 1.17 (1.01, 1.35)
English: Harvoni is contraindicated with St. John's wort, a potent intestinal P-gp inducer (see section 4.3).
Maltese: John's wort, induttur potenti ta' P-gp fl-imsaren (ara sezzjoni 4.3).
English: Table 14: Response rates in study ION-4
Maltese: Rati ta' rispons fi studju ION-4.
English: No Yes a. One patient was excluded from the LDV/SOF 12-week treatment arm and one patient was excluded from the LDV/SOF+RBV 24-week treatment arm as both patients were infected with genotype 4 CHC.
Maltese: Pazjent wieħed ġie eskluż mill-fergħa ta' kura ta' 12-il ġimgħa ta' LDV/SOF u pazjent wieħed ġie eskluż mill-fergħa ta' kura ta' 24 ġimgħa ta' LDV/SOF+RBV minħabba li ż-żewġ pazjenti kienu infettati b'ġenotip 4 CHC.
English: Genotype Genotype 1a Genotype 1b a. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Maltese: Id-denominatur għal rikaduta hu n-numru ta' pazjenti b'HCV RNA < LLOQ fl-aħħar evalwazzjoni matul il-kura. b.
English: Previously treated adults who have failed on sofosbuvir + ribavirin ± PEG-IFN The efficacy of ledipasvir/sofosbuvir in patients who had previously failed treatment with sofosbuvir + ribavirin ± PEG-IFN is supported by two clinical studies.
Maltese: Ma ġewx osservati reazzjonijiet avversi ġodda tal-mediċina fost pazjenti b'ċirrożi dikumpensata u/jew dawk wara trapjant tal-fwied u li kienu rċivew ledipasvir/sofosbuvir ma' ribavirin.
English: a. HCV RNA values were determined using the Roche TaqMan Assay; a patient's HCV RNA may vary from visit to visit.
Maltese: Id-denominatur għal rikaduta hu n-numru ta' pazjenti b'HCV RNA < LLOQ fl-aħħar evalwazzjoni tagħhom matul il-kura.
English: The vast majority of POTS reports came from a centre in Denmark (Brinth et al, 2015)1.
Maltese: Il-maġġoranza assoluta tar-rapporti tal-POTS ġew minn ċentru fid-Danimarka (Brinth et al, 2015)1.
English: 2 Donegan K, Beau-Lejdstrom R, King B, Seabroke S, Thomson A, Bryan P. Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK.
Maltese: Donegan K, Beau-Lejdstrom R, King B, Seabroke S, Thomson A, Bryan P.
English: In the review of clinical trial data a total of 60,594 subjects were included for Gardasil/Silgard and Gardasil 9 and 42,047 subjects for Cervarix.
Maltese: Fir-rieżami tad-data tal-provi kliniċi, total ta' 60,594 individwu kienu inklużi għal Gardasil/Silgard u Gardasil 9 u 42,047 individwu għal Cervarix.
English: Brinth LS, Pors K, Theibel AC, Mehlsen J. Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papillomavirus; Vaccine, 2015; 33(22):2602-5.
Maltese: Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papillomavirus; Vaccine, 2015;
English: POTS patients typically show persistent tachycardia for more than 10 minutes upon standing, as well as an increase in heart rate to above 120 bpm or by ≥ 30bpm, and in children and juveniles below 19 years of age by ≥ 40bpm, without arterial hypotension.
Maltese: Il-pazjenti tal-POTS normalment juru takikardja persistenti għal aktar minn 10 minuti meta jqumu bil-wieqfa, kif ukoll żieda fir-rata tat-taħbit tal-qalb għal aktar minn 120 bpm jew bi ≥ 30bpm, u fi tfal u ġuvenili taħt l-età ta' 19-il sena bi ≥ 40bpm, mingħajr ipotensjoni arterjali.
English: CRPS typically follows an episode of trauma including fracture of the wrist or carpal tunnel syndrome surgery, or immobilisation of the limb.
Maltese: Is-CRPS jiġi tipikament wara episodju ta' trawma inkluż ksur tal-polz jew kirurġija tassindromu tal-carpal tunnel, jew immobilizzazzjoni ta' parti tal-ġisem.
English: Taking into account the totality of the available information the PRAC concluded that the evidence does not support that HPV vaccines (Cervarix, Gardasil, Gardasil 9, Silgard) cause CRPS or POTS.
Maltese: Meta qies it-totalità tal-informazzjoni disponibbli, il-PRAC ikkonkluda li l-evidenza ma tappoġġjax li lvaċċini HPV (Cervarix, Gardasil, Gardasil 9, Silgard) jikkawżaw CRPS jew POTS.
English: • The PRAC considered the totality of the data submitted with regard to a potential association between HPV vaccination and the occurrence of Complex regional pain syndrome (CRPS) and Postural orthostatic tachycardia syndrome (POTS).
Maltese: • Il-PRAC qies it-totalità tad-data sottomessa rigward l-assoċjazzjoni potenzjali bejn it-tilqim HPV u l-okkorrenza tas-Sindromu tal-uġigħ reġjonali kumpless (CRPS) u s-Sindromu ta' takikardja ortostatika posturali (POTS).
English: Human papillomavirus (HPV) vaccines have been authorised in the European Union since 2006 for the prevention of cervical and various other cancers caused by HPV infection.
Maltese: Il-vaċċini tal-virus tal-papilloma uman (HPV) ilhom awtorizzati fl-Unjoni Ewropea mill-2006 għallprevenzjoni tal-kanċer ċervikali u għal tipi oħrajn ta' kanċer ikkawżati mill-infezzjoni HPV.
English: A study by Donegan and colleagues (2013)2, using self-controlled case series design (and therefore avoiding the issue of differential diagnostic practice in vaccinated and unvaccinated), evaluated diagnoses of CFS, as well as referrals from general practice for as yet undiagnosed symptoms of chronic fatigue and exhaustion, as well as diagnoses for fibromyalgia, post viral syndrome and neurasthenia.
Maltese: Studju minn Donegan u l-kollegi (2013)2, bl-użu ta' disinn awtokontrollat ta' serje ta' każijiet (u għaldaqstant tiġi evitata l-kwistjoni tal-prattika djanjostika differenzjali f'dawk li huma mlaqqma u dawk li mhumiex imlaqqma), evalwa dijanjożi tas-CFS, kif ukoll riferimenti mill-prattika ġenerali għal sintomi li għadhom mhux dijanjostikati ta' għeja kronika u eżawriment, kif ukoll dijanjożi għal fibromijalġija, sindromu ta' wara l-virus u newrastenja.
English: The PRAC requested data and analyses from the MAHs regarding CRPS and POTS from clinical trials and post-marketing safety data, and took into account literature review, data from Eudravigilance, reports submitted by member states, including Denmark, as well as information from Japan and information submitted voluntarily by the public.
Maltese: Il-PRAC talab għad-data u l-analiżi mill-MAHs rigward is-CRPS u l-POTS minn provi kliniċi u minn data tas-sigurtà wara t-tqegħid fis-suq, and qies ir-rieżami tal-letteratura, data mill-Eudravigilance, rapporti mressqa minn Stati Membri, inkluż id-Danimarka, kif ukoll informazzjoni mill-Ġappun u informazzjoni mressqa b'mod volontarju mill-pubbliku.
English: The incidence of POTS in the Gardasil/Silgard and Gardasil 9 clinical trials was less than 1 case per 10,000 person-years and comparable in the Gardasil/Silgard/Gardasil 9 and corresponding placebo cohorts.
Maltese: L-inċidenza tal-POTS fil-provi kliniċi Gardasil/Silgard u Gardasil 9 kienet inqas minn każ wieħed għal kull 10,000 sena-persuna u komparabbli fil-Gardasil/Silgard u Gardasil 9 u l-koorti talplaċebo korrispondenti.
English: The incidence of CRPS in the Gardasil/Silgard and Gardasil 9 clinical trials was less than 1 case per 10,000 person-years and comparable in the Gardasil/Silgard and Gardasil 9 and corresponding placebo cohorts.
Maltese: L-inċidenza tas-CRPS fil-provi kliniċi Gardasil/Silgard u Gardasil 9 kienet inqas minn każ wieħed għal kull 10,000 sena-persuna u komparabbli fil-Gardasil/Silgard u Gardasil 9 u l-koorti talplaċebo korrispondenti.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 20 of Regulation (EC) No 726/2004 for HPV vaccines.
Maltese: • Il-Kumitat tal-Evalwazzjoni tar-Riskju fil-qasam tal-Farmakoviġilanza (PRAC) qies il-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għall-vaċċini HPV.
English: Routine surveillance of suspected adverse reaction reports has raised questions on the potential association between the use of the vaccines and two syndromes in particular, which are known as Complex regional pain syndrome (CRPS) and Postural orthostatic tachycardia syndrome (POTS).
Maltese: Sorveljanza ta' rutina ta' rapporti ta' reazzjonijiet avversi suspettati qajmet mistoqsijiet dwar l-assoċjazzjoni potenzjali bejn l-użu tal-vaċċini u żewġ sindromi b'mod partikolari, li huma magħrufin bħala Sindromu tal-uġigħ reġjonali kumpless (Complex regional pain syndrome, CRPS) u Sindromu ta' takikardja ortostatika posturali (Postural orthostatic tachycardia syndrome, POTS).
English: The PRAC noted that some symptoms of these syndromes may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME).
Maltese: Il-PRAC innota li xi sintomi ta' dawn is-sindromi jistgħu jikkoinċidu mas-sindromu ta' għejja kronika (CFS, magħruf ukoll bħala myalgic encephalomyelitis jew ME).
English: Analyses of observed versus expected number of spontaneous reports were undertaken, covering a wide range of scenarios regarding underreporting (from 1 - 100 % reporting) and including reports that did not fully meet the diagnostic criteria for the syndrome.
Maltese: Twettqu għadd ta' analiżijiet tan-numru ta' rapporti spontanji osservati kontra dawk mistennija, li jkopru firxa wiesgħa ta' xenarji rigward in-nuqqas ta' rapportar (minn 1 - 100 % ta' rapportar) u inkluż rapporti li ma ssodisfawx il-kriterja tad-dijanjożi tas-sindromu b'mod sħiħ.
English: CRPS is defined as continuing pain that is disproportionate to the inciting event and may be associated with dysautonomic signs and symptoms and is usually confined to a single limb.
Maltese: Is-CRPS huwa definit bħala uġigħ kontinwu li huwa sproporzjonat għall-episodju ta' inċitament u jista' jkun assoċjat ma' sinjali u sintomi diżawtonomiċi u normalment huwa limitat għal parti tal-ġisem waħda.
English: • The PRAC took note of the fact that CRPS and POTS occur in the general unvaccinated population and have been described in the medical literature before HPV vaccines were introduced.
Maltese: • Il-PRAC ħa nota tal-fatt li s-CRPS u l-POTS iseħħu fil-popolazzjoni ġenerali mhux imlaqqma u kienu deskritti fil-letteratura medika qabel ma ġew introdotti l-vaċċini HPV.
English: On 09 July 2015 the European Commission therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the EMA to assess these concerns.
Maltese: Għaldaqstant, fid-9 ta' Lulju 2015, il-Kummissjoni Ewropea tat bidu għal proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 li tirriżulta minn data farmakoviġilanti, u talbet lill-EMA biex tivvaluta dan it-tħassib.
English: This should include follow-up of CRPS or POTS reports to determine relevant clinical characteristics, to identify possible cases of POTS and CRPS based on broad search strategies including outcome details and to compare reporting rates against available information on the known epidemiology of POTS and CRPS.
Maltese: Sar qbil li l-użu ta' strateġiji wiesgħin tat-tfittxija biex jiġu identifikati każijiet possibbli ta' CRPS u ta' POTS u paragun kontinwu ta' rati ta' rappurtar meta mqabbla ma' informazzjoni disponibbli dwar l-epidemjoloġija tas-CRPS u l-POTS huwa importanti.