FrancophonIA/ELRC3.0 huggingface dataset:
English: Nausea
Maltese: Lattożju
English: SAPPHIRE-II was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 394 subjects with genotype 1 chronic hepatitis C virus infection without cirrhosis who did not achieve SVR with prior treatment with pegIFN/RBV.
Maltese: SAPPHIRE-II kien prova globali b'aktar minn ċentru wieħed, double-blind, ikkontrollata bi plaċebo u magħmula b'mod każwali mwettqa f'394 individwu b'infezzjoni kronika tal-virus tal-epatite Ċ
English: Smephenytoin
Maltese: DIJURETIĊI
English: The dasabuvir exposures obtained with the 400 mg formulation and the 250 mg tablet are similar.
Maltese: ritonavir 100 mg darba kuljum u dasabuvir 400 mg darbtejn kuljum jew 250 mg darbtejn kuljum.
English: Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin were administered for either 12 or 24 weeks of treatment.
Maltese: Exviera u ombitasvir/paritaprevir/ritonavir f'kombinazzjoni ma' ribavirin ġew amministrati għal 12 jew 24 ġimgħa ta' kura.
English: paritaprevir the same time as Exviera +ombitasvir/paritaprevi r/ritonavir.
Maltese: Exviera + ombitasvir/paritaprevi r/ritonavir.
English: EFFECT Cmax
Maltese: Effetti tal-ikel
English: Two patients discontinued Exviera and ombitasvir/paritaprevir/ritonavir due to elevated ALT, including one on ethinylestradiol.
Maltese: Żewġ pazjenti waqfu Exviera u ombitasvir/paritaprevir/ritonavir minħabba ALT elevat, inkluża waħda fuq ethinylestradiol.
English: Exviera and ombitasvir/paritaprevir/ritonavir
Maltese: Exviera u ombitasvir/paritaprevir/ritonavir
English: Exviera and ombitasvir/paritaprevir /ritonavir
Maltese: Exviera u ombitasvir/paritaprevir /ritonavir
English: Table 11 shows the SVR12 rates for genotype 1b-infected, treatment-experienced subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL II.
Maltese: Tabella 11 turi r-rati SVR12 għal pazjenti infettati b'ġenotip 1b lli ħadu l-kura qabel li rċevew Exviera u ombitasvir/paritaprevir/ritonavir bi jew mingħajr ribavirin għal 12-il ġimgħa f'PEARL II.
English: Exviera ombitas vir/parit aprevir/r itonavir dolutegravir
Maltese: Exviera + ombitasvir/ paritaprevi r/ritonavir dolutegravir
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir
Maltese: Possibilment minħabba inibizzjoni ta' UGT1A1 minn paritaprevir, dasabuvir u ombitasvir u inibizzjoni ta' CYP3A4 ta' ritonavir
English: Gastrointestinal disorders Very common
Maltese: Insomnja Disturbi gastrointestinali:
English: The safety summary is based on pooled data from phase 2 and 3 clinical trials in more than 2,600 subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin.
Maltese: Is-sommarju ta' sigurtà huwa bbażat fuq dejta miġbura minn provi kliniċi tat-tieni (2) u tielet (3) fażi f'iktar minn 2,600 individwu li rċieva Exviera u ombitasvir/paritaprevir/ritonavir bi jew mingħajr ribavirin.
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, Asian subjects had 29% to 39% higher dasabuvir exposures than non-Asian subjects.
Maltese: Ażjatiċi kellhom minn 29 % sa 39% espożizzjonijiet ogħla għal dasabuvir minn suġġetti mhux Asjatiċi.
English: MEDICINAL PRODUCTS USED IN MULTIPLE SCLEROSIS Teriflunomid e
Maltese: Teriflunomide għall-sklerożi multipla
English: It may not be excluded that the systemic exposure of dabigatran etexilate is increased by dasabuvir due to inhibition of P-gp in the intestine.
Maltese: Ma jistax jiġi eskluż li l-espożizzjoni sistemika ta' dabigatran etexilate tiġi miżjuda b'dasabuvir minħabba l-inibizzjoni ta' Pgp fil-musrana.
English: Table 9 shows the SVR12 rates for genotype 1a-infected, treatment-naïve subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL IV. Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin was not non-inferior to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin.
Maltese: Individwi magħżulin b'mod każwali għall-fergħa tal-plaċebo rċevew plaċebo għal 12-il ġimgħa, u wara dan il-perjodu rċevew Exviera u ombitasvir/paritaprevir/ritonavir open-label kkombinati ma' ribavirin għal 12-il ġimgħa.
English: Purpose of the medicine carbamazepine, phenytoin, phenobarbital for epilepsy efavirenz, etravirine, nevirapine for HIV infection enzalutamide for prostate cancer ethinylestradiol containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception gemfibrozil to lower cholesterol and other fats in the blood mitotane for some tumours of the adrenal glands rifampicin for bacterial infections
Maltese: Għan tal-mediċina carbamazepine, phenytoin, phenobarbital għal epilessija efavirenz, etravirine, nevirapine għal infezzjoni tal-HIV
English: Atazanavir
Maltese: Atazanavir/ ritonavir
English: Exviera ombitas vir/parit aprevir/ ritonavi r
Maltese: Exviera +ombitasvi r/paritapre vir/ritonavi r
English: Exviera ombitas vir/parit aprevir/ ritonavi r omeprazole
Maltese: Exviera + ombitasvir/ paritaprevi r/ritonavir omeprazole
English: Dasabuvir is a substrate of P-gp and BCRP and its major metabolite M1 is a substrate of OCT1 in vitro.
Maltese: Dasabuvir huwa substrat ta' P-gp u BCRP in vitro u l-metabolit ewlieni tiegħu M1 huwa substrat tal
English: Table 3 lists adverse reactions for which a causal relationship between dasabuvir, in combination with ombitasvir/paritaprevir/ritonavir, with or without ribavirin, and the adverse event is at least a reasonable possibility.
Maltese: Tabella 3 telenka reazzjonijiet avversi li għalihom, relazzjoni kawżali bejn dasabuvir, flimkien ma ombitasvir/paritaprevir/ritonavir, flimkien ma' jew mingħajr ribavirin, u l-avveniment avvers hija tal anqas possibbiltà raġonevoli.
English: Table 8 shows the SVR12 rates for genotype 1b-infected, treatment-naïve subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL III.
Maltese: Tabella 8 turi r-rati ta' SVR12 għal individwi li qatt ma ħadu l-kura qabel infettati b'ġenotip 1b li rċevew Exviera u ombitasvir/paritaprevir/ritonavirbi jew mingħajr ribavirin għal 12-il ġimgħa f'PEARL III.
English: Cyclobenzap rine 5 mg single dose
Maltese: Cyclobenzaprine 5
English: Exviera ombitas vir/parit aprevir/ ritonavi furosemide
Maltese: Exviera jingħata ma ombitasvir / paritaprevir /ritonavir.
English: The combination of atazanavir and ombitasvir/paritaprevir/ ritonavir + dasabuvir increase bilirubin levels, in particular when ribavirin is part of the hepatitis C regimen, see sections 4.4 and
Maltese: Il-kombinazzjoni ta' atazanavir u ombitasvir/ paritaprevir/ritonavir +dasabuvir iżżid llivelli ta' bilirubin, b'mod partikolari meta ribavirin huwa parti mill-kors ta'
English: Exviera paritapr evir/ ritonavi r
Maltese: Exviera + paritaprevi r/ritonavir
English: Dasabuvir administered with ombitasvir/paritaprevir/ritonavir did not affect the exposures of the CYP2C9 substrate warfarin.
Maltese: Dasabuvir amministrat ma' ombitasvir/paritaprevir/ritonavir ma affetwax l-espożizzjoni tas-substrat tal-CYP2C9, warfarin.
English: Exviera film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blister packs.
Maltese: In-natura tal-kontenitur u ta'dak li hemm ġo fih Pilloli miksija b'rita ta' Exviera jiġu f'pakketti ta' folji tal-aluminju PVC/PE/PCTFE. 56 pillola (pakkett multiplu li fih 4 kartun interni ta' 14-il pillola.)
English: Relapse rates in GT1a cirrhotic subjects by baseline laboratory values are presented in Table 13.
Maltese: Rati ta' rikaduta f'individwi ta' GT1 I u ċirrożi b'valuri tal-linja bażi tal-laboratorju huma ppreżentati f'Tabella 13.
English: In genotype 1b, substitutions C316N, C316Y, M414T, Y448H, and S556G in HCV NS5B reduced susceptibility to dasabuvir.
Maltese: Fil-ġenotip 1b, is-sostituzzjonijiet C316N, C316Y, M414T, Y448H,
English: No dose adjustment of Exviera is warranted in elderly patients (see section 5.2).
Maltese: Ma hemm bżonn ta' ebda aġġustament tad-doża ta' Exviera f'pazjenti anzjani (ara sezzjoni 5.2).
English: As the incidence of such elevations was 26% among women taking a concomitant ethinylestradiol-containing medicine, such medicinal products are contraindicated with Exviera and ombitasvir/paritaprevir/ritonavir.
Maltese: Peress li l-inċidenza ta' elevazzjonijiet bħal dawn kien ta' 26% fost in-nisa li jieħdu ukoll mediċina li fiha ethinylestradiol, dawn il-prodotti mediċinali huma kontraindikati ma' Exviera u ombitasvir/paritaprevir/ritonavir.
English: Concomitant use with efavirenz containing regimens is contraindicated (see section 4.3).
Maltese: Użu konkomittanti ma' korsijiet li fihom efavirenz huwa kontraindikat (ara sezzjoni 4.3).
English: The combination was not linked to any particular safety issues in a limited set of patients treated for 12-24 weeks.
Maltese: Il-kombinazzjoni ma kienitx marbuta ma' xi kwistjonijiet partikolari ta' sigurtà f'sett limitat ta' pazjenti kkurati għal 12-24 ġimgħa.
English: The replicon activity of dasabuvir was attenuated 12- to 13
Maltese: L-attività replikon ta' dasabuvir kienet mnaqqsa minn 12- sa 13-il darba fil-preżenza ta' 40% tal-plażma umana.
English: Ombita svir/par itaprevi r /ritonav ir
Maltese: UŻATI FL-ISKLEROŻI MULTIPLA
English: ANTICOAGULANTS Warfarin
Maltese: ANTIMIKOBATTERJALI Rifampicin
English: In all seven trials, the Exviera dose was 250 mg twice daily and the ombitasvir/paritaprevir/ritonavir dose was 25 mg/150 mg/100 mg once daily.
Maltese: Fis-seba' provi, id-doża ta' Exviera kienet 250 mg darbtejn kuljum u d-doża ta'ombitasvir/ paritaprevir/ ritonavir kienet 25/150/100 mg darba kuljum.
English: In the CORAL-1 study, the safety and efficacy of Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin for 24 weeks was studied in 34 HCV genotype 1-infected liver transplant recipients who were at least 12 months post-transplant at study enrolment.
Maltese: Fl-istudju CORAL-I, is-sigurtà u l-effikaċja ta' Exviera u ombitasvir/paritaprevir/ritonavir ma' ribavirin għal 24 ġimgħa ġiet studjata fi 34 reċipjenti ta' trapjant tal-fwied b' infezzjoni ta' HCV ġenotip 1 li mar-reġistrazzjoni għal istudju kienu għaddew mill-inqas 12-il xahar mit-trapjant.
English: Mechanism: possibly due to UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Maltese: possibbilment minħabba l inibizzjoni ta' UGT minn paritaprevir, ombitasvir u dasabuvir.
English: nordiazepam
Maltese: Alprazolam
English: Clinical Trial in patients receiving chronic opioid substitution therapy
Maltese: Provi kliniċi f'individwi li qegħdin jirċievu terapija ta' sostituzzjoni ta' opjojdi
English: Exviera and ombitasvir/paritaprevir/ritonavir with RBV 12-week arm
Maltese: Exviera u ombitasvir/paritaprevir/ritonavir għal 12-il ġimgħa B'RBV
English: The full EPAR for Qtern can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Qtern
Maltese: Informazzjoni oħra dwar Qtern
English: • saxagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Maltese: • saxagliptin, huwa inibitur ta' dipeptidyl-peptidase-4 (DPP-4).
English: Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;
Maltese: Dapagliflozin ilu awtorizzat fl-Unjoni Ewropea (UE) bħala Forxiga sa mill-2012;
English: Qtern contains two different active substances, which work in different ways:
Maltese: Qtern fih żewġ sustanzi attivi differenti, li jaħdmu b'modi differenti:
English: Why is Qtern approved?
Maltese: Għaliex ġie approvat Qtern?
English: This is a summary of the European public assessment report (EPAR) for Qtern.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Qtern.
English: Dapagliflozin in combination with saxagliptin (the same combination as in Qtern) was evaluated in 3 main studies involving 1,169 adults with type 2 diabetes.
Maltese: Dapagliflozin f'kombinazzjoni ma' saxagliptin (l-istess kombinazzjoni bħal fi Qtern) ġie evalwat fi 3 studji prinċipali li involvew 1,169 adult b'dijabete tat-tip 2.
English: • dapagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Maltese: • dapagliflozin jaħdem billi jimblokka proteina fil-kliewi msejħa kotrasportatur 2 ta' sodju-glukożju (SGLT2).
English: • metformin, a sulphonylurea and one of the components of Qtern.
Maltese: • metformina, sulfonilurea u wieħed mill-komponenti ta' Qtern.
English: It contains the active substances saxagliptin and dapagliflozin.
Maltese: Fih is-sustanzi attivi saxagliptin u dapagliflozin.
English: Qtern is available as tablets (5 mg saxagliptin and 10 mg dapagliflozin) and can only be obtained with a prescription.
Maltese: Qtern jiġi bħala pilloli (5 mg saxagliptin u 10 mg dapagliflozin) u jista' jinkiseb biss b'riċetta ta' tabib.
English: • metformin and one of the components of Qtern;
Maltese: • metformina u wieħed mill-komponenti ta' Qtern;
English: • a sulphonylurea and one of the components of Qtern;
Maltese: • sulfonilurea u wieħed mill-komponenti ta' Qtern;
English: Results showed that when saxagliptin and dapagliflozin were taken together with metformin, they decreased HbA1c levels by 1.5 percentage points after 24 weeks, compared with a reduction of 0.9 percentage points with saxagliptin and metformin and 1.2 percentage points with dapagliflozin and metformin.
Maltese: Ir-riżultati wrew li meta saxagliptin u dapagliflozin ittieħdu flimkien ma' metformina, huma naqqsu l-livelli ta' HbA1c b'1.5 punti perċentwali wara 24 ġimgħa, meta mqabbla ma' tnaqqis ta' 0.9 punti perċentwali b'saxagliptin u metformina u 1.2 punti perċentwali b'dapagliflozin u metformina.
English: How is Qtern used?
Maltese: Kif jaħdem Qtern?
English: A further study, which included patients not controlled with metformin and saxagliptin, showed that adding dapagliflozin to treatment with saxagliptin and metformin for 24 weeks reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin.
Maltese: Studju ulterjuri, li inkluda pazjenti mhux ikkontrollati b'metformina u saxagliptin, wera li ż-żieda ta' dapagliflozin mal-kura b'saxagliptin u metformina għal 24 ġimgħa naqqset il-livelli ta' HbA1c b'0.8 punti perċentwali meta mqabbla ma' tnaqqis ta' 0.1 punti perċentwali meta plaċebo żdied ma' saxagliptin u metformina.
English: On the basis of previous studies with the individual components of Qtern used together with a sulphonylurea, the CHMP also approved the combination of Qtern with a sulphonylurea.
Maltese: Fuq il-bażi ta' studji preċedenti bil-komponenti individwali ta' Qtern użati flimkien ma' sulfonilurea, isCHMP approva wkoll il-kombinazzjoni ta' Qtern ma' sulfonilurea.
English: Results showed that adding saxagliptin to treatment with dapagliflozin and metformin for 24 weeks reduced HbA1c levels by 0.5 percentage points, compared with a reduction of 0.2 percentage points when placebo (a dummy treatment) was added to treatment with dapagliflozin and metformin.
Maltese: Ir-riżultati wrew li ż-żieda ta' saxagliptin mal-kura b'dapagliflozin u metformina għal 24 ġimgħa, naqset il-livelli ta' HbA1c b'0.5 punti perċentwali meta mqabbla ma' tnaqqis ta' 0.2 punti perċentwali meta żdied plaċebo (kura finta) mal-kura b'dapagliflozin u metformina.
English: What are the risks associated with Qtern?
Maltese: X'inhuma r-riskji assoċjati ma' Qtern?
English: The most common side effects with Qtern (which may affect more than 1 in 10 people) are upper respiratory tract infection (such as nose and throat infections) and, when used with a sulphonylurea, hypoglycaemia (low blood glucose levels).
Maltese: L-effetti sekondarji l-aktar komuni bi Qtern (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjoni fil-parti ta' fuq tal-apparat respiratorju (bħal infezzjonijiet fl-imnieħer u fil-griżmejn) u, meta użat ma' sulfonilurea, ipogliċemija (livelli baxxi ta' glukożju fid-demm).
English: Regarding its safety profile, Qtern was well tolerated with side effects being characteristic of SGLT2 and DDP-4 inhibitors.
Maltese: Fir-rigward tal-profil tas-sigurtà, Qtern ġie ttollerat sew bl-effetti sekondarji jkunu karatteristiċi ta' inibituri ta' SGLT2 u DDP-4.
English: The CHMP concluded that Qtern is effective when using it to replace saxagliptin and dapagliflozin taken as separate tablets.
Maltese: Is-CHMP ikkonkluda li Qtern huwa effettv meta jintuża biex jissostitwixxi saxagliptin u dapagliflozin meħudin bħala pilloli separati.
English: By blocking the action of SGLT2, dapagliflozin causes more glucose to be removed via the kidney, through the urine, thereby reducing the levels of glucose in the blood.
Maltese: Billi jimblokka l-azzjoni ta' SGLT2, dapagliflozin iwassal biex aktar glukożju jitneħħa permezz tal-kliewi, mal-urina, u b'hekk inaqqas il-livelli ta' glukożju fiddemm.
English: By increasing levels of incretin hormones in the blood, saxagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Billi jżid il-livelli ta' ormoni ta' inkretin fid-demm, saxagliptin jistimula lill-frixa biex tipproduċi aktar insulina meta l-livelli ta' glukożju fid-demm ikunu għoljin.
English: The company also provided studies that were used in the authorisation of Forxiga and Onglyza where saxagliptin or dapagliflozin were used together with a sulphonylurea.
Maltese: Il-kumpanija pprovdiet ukoll studji li ntużaw fl-awtorizzazzjoni ta' Forxiga u Onglyza fejn saxagliptin jew dapagliflozin intużaw flimkien ma' sulfonilurea.
English: Qtern must not be used in people who are hypersensitive (allergic) to saxagliptin, dapagliflozin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor.
Maltese: Qtern ma għandux jintuża f'nies li huma ipersensittivi (allerġiċi) għal saxagliptin, dapagliflozin, kwalunkwe wieħed mill-ingredjenti l-oħra jew li xi darba kellhom reazzjoni allerġika serja għal kwalunkwe inibitur DPP-4 jew SGLT2.
English: Saxagliptin has been authorised in the EU as Onglyza since 2009.
Maltese: Saxagliptin ilu awtorizzat fl-UE bħala Onglyza sa mill-2009.
English: Saxagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Maltese: Saxagliptin inaqqas ukoll l-ammont ta' glukożju prodott mill-fwied, billi jżid il-livelli ta' insulina u jnaqqas il-livelli tal-ormon glukagon.
English: What is Qtern and what is it used for?
Maltese: X'inhuma l-benefiċċji ta' Qtern li ħarġu mill-istudji?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Qtern's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Qtern huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Invented name Strength Pharmaceutical Form Route of Administration
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: MA (EU) number (Invented) name
Maltese: Numru tal-EU Isem (ivvintat)
English: 4 (4 x 1) vials + 4 (4 x 1) ampoules (multipack) 10 (10 x 1) vials + 10 (10 x 1) ampoules (multipack) 1 pre-filled syringe
Maltese: Il-pakkett li jmiss mal-prodott
English: • Pharmacist checklist;
Maltese: • Lista ta' kontroll tal-ispiżjar;
English: The data support that for isotretinoin and alitretinoin the information in section 4.4 and 4.8, of the SmPC, should be in line with the agreed outcome of the 2003 Art 30 referral for isotretinoin.
Maltese: Id-dejta tappoġġja li għal isotretinoin u alitretinoin, l-informazzjoni f'sezzjoni 4.4 u 4.8, tal'SmPC, għandha tkun konformi mar-riżultat maqbul tar-referenza tal-2003 tal-Art 30 għal isotretinoin.
English: CHMP opinion
Maltese: Konklużjonijiet xjentifiċi
English: The human data on congenital malformations after oral retinoid exposure show a significant risk of retinoid embryopathy (of up to 30% of fetuses exposed); furthermore it is known that approximately one-third of pregnant patients exposed to oral retinoids during pregnancy will have spontaneous abortions.
Maltese: Id-dejta mill-bniedem dwar malformazzjonijiet konġenitali wara esponiment għal retinojd orali turi riskju konsiderevoli ta' embrijopatija mir-retinojdi (sa 30 % tal'feti esposti); barra minn hekk huwa magħruf li madwar terz tal-pazjenti tqal esposti għar retinojdi orali waqt it-tqala ser ikollhom abort spontanju.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for retinoid-containing medicinal products.
Maltese: • Il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali li fihom ir-retinojdi.
English: • The implementation of the 7-day prescription validity rule, in order not to impact on existing national legislation where 7 days validity exists;
Maltese: • L-implimentazzjoni ta' regola ta' validità tal-preskrizzjoni ta' 7 ijiem, sabiex ma jkunx hemm impatt fuq il-leġiżlazzjoni nazzjonali eżistenti fejn teżisti validità ta' 7 ijiem;
English: • With regards to the teratogenic risk of topical retinoids (adapalene, alitretinoin, isotretinoin, tretinoin and tazarotene), the PRAC concluded that the data available show that after topical application, systemic exposure is expected to be negligible and unlikely to result in adverse fetal outcomes.
Maltese: • Fir-rigward tar-riskju teratoġeniku tar-retinojdi topiċi (adapalene, alitretinoin, isotretinoin, tretinoin u tazarotene), il-PRAC ikkonkluda li d-dejta disponibbli turi li wara applikazzjoni topika, l-esponiment sistemiku mistenni li jkun negliġibbli u aktarx ma jirriżultax f'riżultati fetali avversi.
English: On 7 July 2016 the United Kingdom triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to review the routine risk minimisation measures in place for the oral and topical retinoids to ensure the available data and the risks associated with the adverse teratogenic effects and neuropsychiatric disorders are accurately and consistently addressed within the product information where appropriate and justified by data.
Maltese: Fis'7 ta' Lulju 2016, ir'Renju Unit ta bidu għal referenza skont l-Artikolu 31 tad'Direttiva 2001/83/KE li tirriżulta minn dejta tal-farmakoviġilanza, u talab lill-PRAC biex jirrevedi l-miżuri tal-imminimizzar tar riskju ta' rutina fis-seħħ għar-retinojdi orali u topiċi sabiex jiżgura li d-dejta disponibbli u r-riskji assoċjati mal-effetti teratoġeniċi avversi u d-disturbi newropsikjatriċi huma eżatti u huma ndirizzati b'mod konsistenti fl-informazzjoni dwar il-prodott fejn xieraq u ġġustifikati minn dejta.
English: Pregnancy is an absolute contraindication for all oral retinoids in the EU.
Maltese: It-tqala hija kontraindikazzjoni assoluta għarretinojdi orali kollha fl-UE.
English: • A direct healthcare professional communication (DHPC) was also considered appropriate for all oral and topical retinoids.
Maltese: • Komunikazzjoni diretta għall-professjonisti tal-kura tas-saħħa (DHPC) ukoll ġiet ikkunsidrata xierqa għar-retinojdi orali u topiċi kollha.
English: After reviewing all the available data to address the concerns discussed, the PRAC adopted a recommendation on 8 February 2018 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: adotta rakkomandazzjoni, li dak iż-żmien ġiet ikkunsidrata mis-CHMP, skont l-Artikolu 107k tad'Direttiva 2001/83/KE.
English: The animal reproductive toxicity data for the oral retinoids demonstrate a typical pattern of retinoid embryopathy.
Maltese: Id-dejta dwar it-tossiċità riproduttiva fl-annimali għar-retinojdi orali turi xejra tipika ta' embrijopatija bir-retinojdi.