FrancophonIA/ELRC3.0 huggingface dataset:
English: As a general rule in EU, if such a study would have to be conducted, the 50 µg/h strength would be recommended.
Maltese: Bħala regola ġenerali, fl-UE, jekk ikun irid isir studju bħal dan, il-qawwa ta' 50 µg/siegħa għandha tkun irrakkomandata.
English: This applies, for example, to: - medicines used for treating anxiety (tranquillisers) - medicines used for treating depression (antidepressants) - medicines used for treating psychological disorders (neuroleptics) - anaesthetics, if you think you are going to have an anaesthetic, tell the doctor or dentist that you are using Fentanyl-ratiopharm - medicines used for treating sleep disorders (hypnotics, sedatives) - medicines used for treating allergies or travel sickness (antihistamines/antiemetics) - other strong-acting painkillers (opioids) - alcohol
Maltese: Fentanyl-ratiopharm - mediċini għal kura ta' disturbi tal-irqad (ipnotiċi, aġenti sedattivi, barbiturates) - mediċini kontra l-allerġiji jew id-dardir tas-safar (Antiħistaminiċi/anti-emetiċi) - analġesiċi qawwijin oħrajn (opjojdi) - l-alkoħol
English: Because of the importance of an adequate pain management for the mother, the CHMP agrees, in accordance with the “guideline on summary of product characteristics”, that the proposed text stays in section 4.6 and should not be included as a contra-indication.
Maltese: Minħabba l-importanza ta' ġestjoni adegwata ta' l-uġigħ għall-omm, il-CHMP jaqbel, b'mod konformi mal-“linja gwida tas-sommarju tal-karatteristiċi tal-prodott”, li t-test ipproponut jibqa' f'sezzjoni 4.6 u m'għandux ikun inkluż bħala kontra-indikazzjoni.
English: Fenturogenox 100 µg/h - transdermales Matrixpflaster
Maltese: L-Awstrija Fenturogenox 100 µg/h - transdermales Matrixpflaster
English: Uncommon: Unnatural feeling of happiness, memory loss, difficulties in sleeping, hallucinations, agitation, tremor, sensitivity disturbances, speech disorders, fall or rise in the blood pressure and heart rate, difficulties in breathing, diarrhoea, difficulty in passing urine, skin rash, skin reddening (erythema).
Maltese: Mhux komuni: Ferħ bla ebda raġuni , telf tal- memorja, problemi ta' rqad, alluċinazzjonijiet, aġitazzjoni, tregħid, disturbi tas-sensi, disturbi fil-kliem u fil-lingwa, inżul jew żieda fil-pressjoni u t-tħabbit tal-qalb, problemi fin-nifs, dijarea, problemi biex tgħaddi l-awrina, raxx, ħmura (eritema).
English: Chronic pulmonary disease
Maltese: Meta tuża mediċini oħra
English: Additional or alternative methods of analgesia or alternative administration of opioids should be considered when the Fentanyl-ratiopharm dose exceeds 300 micrograms/hour.
Maltese: Metodi addizzjonali jew alternattivi ta' kura kontra l-uġigħ jew anke amministrazzjoni ta' opjojdi oħrajn għandhom jiġu kkunsidrati meta d-doża ta' Fentanyl ratiopharm taqbeż 300 mikrogramma/siegħa.
English: headache, visual disturbances), changes in your state of consciousness or loss of consciousness or coma - slow irregular heartbeat (bradyarrhythmias) - myasthenia gravis (a disease causing tiredness and weakness of the muscles)
Maltese: (eż. uġigħ ta' ras, tibdil fil-vista), tibdil fl-isstat konxju jew tintilef minn sensik jew koma - rata baxxa u irregolari tat-taħbit tal-qalb (bradiarritmija) - Majastenja gravis (marda li tikkawza għejja u indeboliment fil-muskoli)
English: Fentanyl-ratiopharm 50 µg/h TTS and associated names (see Annex I)
Maltese: Fentanyl-ratiopharm 50 µg/h TTS u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Polypropylene foil
Maltese: TAL-PRODOTT MEDIĊINALI
English: Fentanyl-ratiopharm 75 µg/h TTS and associated names (see Annex I)
Maltese: Fentanyl-ratiopharm 75 µg/h TTS u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Fentanyl-ratiopharm 25 µg/h TTS and associated names (see Annex I)
Maltese: Fentanyl-ratiopharm 25 µg/h TTS u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: HOW TO USE Fentanyl-ratiopharm
Maltese: X'INHU FENTANYL-RATIOPHARM
English: HOW TO STORE Fentanyl-ratiopharm
Maltese: X'fih Fentanyl-ratiopharm
English: If higher dosages than 500 mg morphine-equivalent are needed, a reassessment of opioid-therapy is recommended.
Maltese: Jekk ikun hemm bżonn ta' dożi ‘l fuq mill-ekwivalenti ta' 500 mg morfina, huwa rrakkomandat illi t-terapija bl-opjojdi tiġi evalwata mill ġdid.
English: Fentanyl-ratiopharm 100 µg/h TTS and associated names (see Annex I)
Maltese: Fentanyl-ratiopharm 100 µg/h TTS u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Concomitant use of potent CYP3A4-inhibitors (e.g. ritonavir) with transdermally administered fentanyl may result in increased plasma concentrations of fentanyl.
Maltese: L-użu fl-istess ħin ta' inibituri qawwijin ta' CYP3A4 (ez.ritonavir) ma użu transdermali ta' fentanyl jista' jirriżulta f'żieda fil- konċentrazzjoni filplażma ta' fentanyl.
English: After switching from previously prescribed opioid analgesics to Fentanyl-ratiopharm or after abrupt discontinuation of therapy patients may show opioid withdrawal symptoms (for instance: nausea, vomiting, diarrhoea, anxiety and shivering).
Maltese: Wara bidla minn analġesiċi opjojdi għall-Fentanyl-ratiopharm jew wara tmiem ħesrem tat-terapija, il-pazjenti jistgħu jezibixxu sintomi assoċjati mal-waqfien tal-kura tal-opjojdi (per eżempju: tqalliegħ, rimettar, dijarea, anzjeta' u tregħid).
English: Furthermore, a study at the highest dose (100 µg/h) would be possible only in intensive care units and under concomitant treatment with opioid antagonists (naltrexone) in order to avoid life threatening side effects.
Maltese: Barra dan, studju fl-aktar doża għolja (100 µg/siegħa) jkun possibbli biss fis-swali tal-kura intensiva u taħt trattament konkomitanti b'antagonisti opijojdi (naltrexone) sabiex jiġu evitati effetti sekondarji li jipperikolaw il-ħajja.
English: Regarding the dose conversion schemes provided in the SPC from oral morphine to transdermal fentanyl, the CHMP, based on the available data, is of the opinion that both tables should be mentioned in the SPC (section 4.2).
Maltese: Rigward l-iskemi ta' konverżjoni tad-dożi ipprovduti fis-Sommarju tal-Karatteristiċi tal-Prodotti (SPC) minn morfina orali sa fentanyl transdermali, il-CHMP, abbażi tat-tagħrif disponibbli, huwa ta' lopinjoni li ż-żewġ tabelli għandhom jissemmew fis-Sommarju tal-Karatteristiċi tal-Prodotti (SPC) (sezzjoni 4.2).
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 100 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Maltese: Fentanyl-ratiopharm 100 µg/h TTS u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]> fentanyl
English: The corresponding fentanyl dosage should be determined as follows:
Maltese: Sustanzi mhux attivi:
English: Psychiatric disorders Very common: somnolence.
Maltese: Disturbi psikjatriċi Komuni ħafna: ngħas.
English: The small differences observed are not deemed to be of clinical importance and suggests that Fentanyl ratiopharm has a somewhat more pronounced prolonged release profile, which is as expected for a matrix patch in comparison with a reservoir patch.
Maltese: Id-differenzi żgħar osservati m'humiex meqjusin li huma ta' importanza klinika u jissuġġerixxu li Fentanyl ratiopharm x'aktarx għandu profil ta' rilaxx fit-tul aktar fid-deher, li huwa mistenni għal roqgħa matriċi meta mqabbla ma' roqgħa riserva
English: Take special care with Fentanyl-ratiopharm
Maltese: Kif tapplika l-Fentanyl-ratiopharm
English: Method of administration
Maltese: Metodu ta' l-mministrazzjoni
English: Drug dependence
Maltese: Dipendenza fuq id-droga
English: All dosages given in the table are equivalent in analgesic effect to 10 mg parenteral morphine.
Maltese: Id-dożi li jidhru f'din it-tabella għandhom l-effett analġesiku ekwivalenti ta'10mg morfina parenterali
English: Fenturogenox 75 µg/h - transdermales Matrixpflaster
Maltese: L-Awstrija Fenturogenox 75 µg/h - transdermales Matrixpflaster
English: Pay special attention to see that the patch sticks properly at the edges.
Maltese: f'xi individwi, ġew osservati żiediet tal-konċentrazzjoni fil-plażma.
English: Fentanyl-ratiopharm 25 µg/h TTS
Maltese: Il-Ġermanja Fentanyl-ratiopharm 25 µg/h TTS Spanja
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 75 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Maltese: Fentanyl-ratiopharm 75 µg/h TTS u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]> fentanyl
English: Fenturogenox 50 µg/h - transdermales Matrixpflaster
Maltese: L-Awstrija Fenturogenox 50 µg/h - transdermales Matrixpflaster
English: Treatment with Fentanyl-ratiopharm should only be initiated by an experienced physician familiar with the pharmacokinetics of fentanyl transdermal patches and the risk for severe hypoventilation.
Maltese: Fentanyl-ratiopharm huwa prodott mediċinali li jista' jkun ta' theddida għall-ħajja fit-tfal.
English: Fentanyl passes into the breast-milk and may cause side effects in the breast-fed infant as sedation and respiratory depression.
Maltese: Mandankollu, effetti teratoġeniċi ma ġewx stabbiliti.
English: Fentanyl-ratiopharm 75 µg/h TTS
Maltese: Il-Ġermanja Fentanyl-ratiopharm 75 µg/h TTS Spanja
English: Spain
Maltese: Billi
English: Fentanyl-ratiopharm 50 µg/h TTS
Maltese: Il-Ġermanja Fentanyl-ratiopharm 50 µg/h TTS Spanja
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 50 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Maltese: Fentanyl-ratiopharm 50 µg/h TTS u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]> fentanyl
English: After the first application of Fentanyl-ratiopharm, serum fentanyl concentrations increase gradually, generally levelling off between 12 and 24 hours, and remaining relatively constant for the remainder of the 72-hour application period.
Maltese: Wara l-ewwel applikazzjoni ta' Fentanyl-ratiopharm, il-konċentrazzjoni ta' fentanyl fis-serum tiżdied b'mod gradwali, issir livell bejn 12 u 24 siegħa wara, u tibqa' relattivament kostanti għall-bqija talperijodu ta' l-applikazzjoni ta' 72 siegħa.
English: Oral morphine dose (mg/24 h)
Maltese: (milligramma/24 siegħa)
English: Animal studies have shown reduced fertility and increased mortality in rat foetuses.
Maltese: Studji fuq annimali urew fertilita' mnaqqsa u żieda fil-mortalita' tal-fetu tal-ġrieden.
English: Other symptoms may be hypothermia, decreased muscle tonus, bradycardia, hypotension.
Maltese: Sintomi oħrajn jistgħu jkunu ipotermja, tnaqqis fit-ton tal-muskoli (ipotonija), bradikardija, pressjoni baxxa.
English: They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients (see also section 4.4).
Maltese: Għaldaqstant jopponu parzjalment l-effett analġesiku ta' fentanyl u jistgħu ikunu kawża ta' sintomi assoċjati mal-waqfien tal-kura f'pazjenti dipendenti fuq l-opjojdi (ara sezzjoni 4.4)
English: NAME OF THE MEDICINAL PRODUCT Fentanyl-ratiopharm 25 µg/h TTS and associated names (see Annex I) [See Annex I - To be completed nationally] fentanyl
Maltese: Fentanyl-ratiopharm 25 µg/h TTS u ismijiet assoċjati miegħu (Ara Anness I) [Ara Anness I - Biex timtela mill-pajjiż partikolari]> fentanyl
English: Skin and subcutaneous tissue disorders
Maltese: Żieda tal-pressjoni ġol-kranju
English: Bear in mind that the design of this medicinal product could be tempting to a child. Fentanyl-ratiopharm can have life-threatening side-effects in persons that are not using prescribed opioid medicines on a regular basis.
Maltese: Fentanyl-ratiopharm jista' jkollu effetti mhux mixtieqa ta' theddida għall-ħajja f'persuni li mhux qed jieħdu mediċini tat-tip opjojdi fuq bażi regolari.
English: Withdrawal symptoms may be nausea, vomiting, diarrhoea, anxiety and shivering.
Maltese: Dawn is-sintomi jinkludu tqalliegħ, rimettar, dijarea, ansjeta' u tregħid.
English: 3 transdermal patches 5 transdermal patches 10 transdermal patches 20 transdermal patches
Maltese: Tista' toqgħod barra fix-xemx, iżda trid tgħatti l-garża b'xi ħwejjeġ fil-ġranet sħan tas-sajf.
English: Registration of a manufacturing site for the active substance, finished product and batch release.
Maltese: Reġistrazzjoni ta' sit tal-manifattura għas-sustanza attiva, il-prodott lest u l-ħruġ tal-lott.
English: For the suspension to be lifted, the marketing authorisation holder for MACI shall provide the following:
Maltese: Biex titneħħa s-sospensjoni, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għal MACI jrid jipprovdi s-segwenti:
English: Conditions for lifting the suspension of the manufacturing authorisation
Maltese: Kundizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjoni għat
English: Conditions for lifting the suspension of the marketing authorisation
Maltese: Kundizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjoni għat-tqegħid fis-suq
English: International non-proprietary name (INN): enrofloxacin
Maltese: Denominazzjoni internazzjonali komuni (INN): enrofloxacin
English: The Committee appointed Mrs Ruth Kearsley, who was later replaced by Ms Helen Jukes, as rapporteur and Dr Lotte Winther, who was later replaced by Dr Ellen-Margrethe Vestergaard, as co-rapporteur.
Maltese: Il-Kumitat ħatar lis-Sinjura Ruth Kearsley, li aktar tard ġiet sostitwita mis-Sinjura Helen Jukes, bħala rapporteur u lil Dr Lotte Winther, li aktar tard ġiet sostitwita minn Dr Ellen-Margrethe Vestergaard, bħala ko-rapporteur.
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylic acid derivatives.
Maltese: Enrofloxacin huwa aġent sintetiku kemoterapewtiku mill-klassi tad-derivati ta' fluoroquinolone carboxylic acid.
English: Oral explanations were given on 14 May 2012.
Maltese: Spjegazzjonijiet orali ingħataw fl-14 ta' Mejju 2012.
English: It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Maltese: Għandu attività antibatterika kontra spettru wiesa' ta' batterji Gram-negattivi u Grampożittivi.
English: Baytril 10% oral solution and its associated names contain 100 mg enrofloxacin per ml oral solution for use in drinking water.
Maltese: Baytril 10% soluzzjoni orali u ismijiet assoċjati fihom 100 mg enrofloxacin kull ml ta' soluzzjoni orali għall-użu fl-ilma tax-xorb.
English: Opinion following an Article 340F referral for Baytril 10% oral solution and associated names
Maltese: Opinjoni wara riferiment skont l-Artikolu 340F għal Baytril 10% soluzzjoni orali u ismijiet assoċjati
English: Due to divergent national decisions taken by Member States with respect to e.g. target species, indications, amounts to be administered and withdrawal periods concerning the authorisations of Baytril 10% oral solution and its associated names, on 15 October 2010 the United Kingdom referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised product information across the European Union.
Maltese: Minħabba deċiżjonijiet nazzjonali diverġenti li ttieħdu mill-Istati Membri fir-rigward ta' pereżempju lispeċi fil-mira, l-indikazzjonijiet, l-ammonti li għandhom jingħataw u l-perjodi ta' tiżmim dwar lawtorizzazzjonijiet ta' Baytril 10% soluzzjoni orali u ismijiet assoċjati, fil-15 ta' Ottubru 2010, ir-Renju Unit irrefera l-kwistjoni lis-CVMP skont l-Artikolu 34(1) tad-Direttiva 2001/82/KE, sabiex jiġu riżolti ddiverġenzi fost l-informazzjoni nazzjonalment awtorizzata dwar il-prodott madwar l-Unjoni Ewropea.
English: The referral procedure started on 11 November 2010.
Maltese: Il-proċedura ta' riferiment bdiet fil-11 ta' Novembru 2010.
English: Written explanations were provided by the marketing authorisation holders on 12 August 2011 and 14 February 2012.
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fit12 ta' Awwissu 2011 u fl-14 ta' Frar 2012.
English: The final opinion was converted into a Decision by the European Commission on 8 October 2012.
Maltese: L-opinjoni finali ġiet konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fit-8 ta' Ottubru 2012.
English: Opinion following an Article 341 referral for Baytril 10% oral solution and associated names
Maltese: għal Baytril 10% soluzzjoni orali u ismijiet assoċjati
English: The products are authorised for use in the target species chickens, turkeys and rabbits for treatment of the respiratory tract and of the digestive tract infections caused by bacteria susceptible to enrofloxacin.
Maltese: Il-prodotti huma awtorizzati għall-użu fl-ispeċi fil-mira ta' tiġieġ, dundjani u fniek għall-kura ta' infezzjonijiet tal-apparat respiratorju u tal-apparat diġestiv ikkawżati minn batterji suxxettibbli għal enrofloxacin.
English: 8 October 2012
Maltese: III.
English: Overall summary of the scientific evaluation by the PRAC
Maltese: Sommarju globali tal-evalwazzjoni xjentifika mill-PRAC
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for fenspiridecontaining medicinal products (see Annex I).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 107i tad-Direttiva 2001/83/KE, għall-prodotti mediċinali li fihom fenspiride (ara l-Anness I).
English: Fenspiride has been shown in the Aptuit study to block hERG channels at supratherapeutic doses in vitro in a heterologous expression system, with an IC50 value of 15.14 µM.
Maltese: Fenspiride intwera fl-istudju Aptuit li jimblokka l-kanali hERG b'dożi supraterapewtiċi in vitro f'sistema ta' espressjoni eterologa, b'valur ta' IC50 ta' 15.
English: The PRAC adopted a recommendation on 16 May 2019 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Il-PRAC adotta rakkomandazzjoni, fis-16 ta' Mejju 2019 li dak iż-żmien kienet ikkunsidrata mis-CMDh, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
English: In addition, no protective effects regarding the triggering of TdP arrhythmias (blockade of Nav1.5 and cardiac L-type Ca2+ channels) was shown for fenspiride.
Maltese: Barra minn hekk, l-ebda effett protettiv rigward liskattar ta' arritmiji TdP (imblokk ta' Nav1.5 u kanali Ca2+ tat-tip L kardijaċi) ma ntwera għal fenspiride.
English: There is a possibility that the IC50 value is overestimated (i.e. experiments performed at room temperature, external K+ concentration in the milieu unknown, no DMSO cells perfusion before adding fenspiride in DMSO yet substracting DMSO effect) and fenspiride could be a more potent blocker of hERG channels than shown in vitro.
Maltese: Hemm possibbiltà li l-valur tal-IC50 ikun sopravvalutat (jiġifieri esperimenti mwettqa f'temperatura ambjentali, konċentrazzjoni esterna K + f'dak li ilu mhux magħruf, l-ebda perfużjoni ta' ċelloli DMSO qabel ma jiżdied fenspiride f'DMSO iżda jnaqqas l-effett ta' DMSO) u fenspiride jista' jkun imblokkatur aktar b'saħħtu tal-kanali hERG minn dawk murija in vitro.
English: • The PRAC reviewed the totality of the data available for fenspiride-containing medicinal products in relation to the risk of QT prolongation.
Maltese: • Il-PRAC irreveda t-totalità tad-dejta disponibbli għall-prodotti mediċinali li fihom fenspiride firrigward tar-riskju ta' titwil tal-QT.
English: In in silico models, fenspiride induced QT prolongation and “early afterdepolarizations” (EADs; arrhythmic makers) in specific cardiovascular disease state models.
Maltese: F'mudelli in silico, fenspiride indotta titwil tal-QT u “wara d-depolarizzazzjonijiet bikrin” (EADs; ġeneraturi arritmiċi) f'mudelli tal-istat tal-marda kardjovaskulari speċifiċi.
English: The CMDh considered the arguments presented in writing by one MAH (Aflofarm Farmacja Polska Sp. Z O.O.)
Maltese: Is-CMDh qies l-argumenti ppreżentati bil-miktub minn MAH wieħed (Aflofarm Farmacja Polska Sp. Z O.O.) u kkonkluda li l-elementi rilevanti kollha kienu diġà ġew ikkunsidrati mill-PRAC.
English: In summary based on non-clinical assays of the accepted surrogate markers of TdP, i.e. blockade of hERG tail current and prolongation of the QT/QTc interval, and on post-marketing spontaneous reports of confirmed cases of TdP, QT prolongation and ventricular fibrillation/arrhythmia, the risk of QT prolongation, a proarrhythmic potential and associated risk of TdP is considered confirmed with fenspiride use.
Maltese: Fil-qosor abbażi ta' assaġġi mhux kliniċi tal-markaturi surrogati aċċettati ta' TdP, jiġifieri imblokk talkurrenti fid-denb ta' hERG u titwil tal-intervall QT/QTc, u fuq rapporti spontanji ta' wara t-tqegħid fissuq ta' każijiet ikkonfermati ta' TdP, titwil tal-QT u fibrillazzjoni/arritmija ventrikulari, ir-riskju ta' titwil tal-QT, potenzjal proarritmiku u r-riskju assoċjat ta' TdP huwa kkunsidrat bħala kkonfermat bl-użu ta' fenspiride.
English: The calculated safety margins between the hERG IC50 obtained and the effective therapeutic plasma concentration for fenspiride, was below the lowest acceptable safety margin proposed in the literature (between 6 and 26, depending on the pharmaceutical form/dose administered and on the administration schedule).
Maltese: Il-marġini tas-sigurtà kkalkulati bejn l-IERG IC50 miksub u l-konċentrazzjoni filplażma terapewtika effettiva għal fenspiride, kienet taħt l-aktar marġni baxx tas-sigurtà aċċettabbli propost fil-letteratura (bejn 6 u 26, skont l-għamla farmaċewtika/doża mogħtija u l-iskeda tal-għoti).
English: Fenspiride-containing medicinal products are authorised nationally for the treatment of symptoms (e.g. cough and expectoration) related to bronchopulmonary diseases.
Maltese: Il-prodotti mediċinali li fihom fenspiride huma awtorizzati fuq livell nazzjonali għall-kura tas-sintomi (eż. sogħla u eskorazzjoni) relatati ma' mard bronkopulmonari.
English: However, some risk factors of TdP like congenital long QT syndrome are usually silent and unpredictable.
Maltese: Madankollu, xi fatturi ta' riskju ta' TdP bħas-sindrome ta' QT twil konġenitali huma normalment siekta u imprevedibbli.
English: • The PRAC considered that the use of fenspiride is associated with a risk of QT prolongation, and therefore it has proarrhythmic potential and present a risk of Torsade de Pointes (TdP).
Maltese: • Il-PRAC ikkunsidra li l-użu ta' fenspiride huwa assoċjat ma' riskju ta' titwil tal-QT, u għalhekk għandu potenzjal proarritmiku u jippreżenta riskju ta' Torsade de Pointes (TdP).
English: On 8 February 2019 the French Competent Authority (ANSM) therefore triggered an urgent Union procedure under Article 107i of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of fenspiride containing medicinal products and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Għalhekk, fit-8 ta' Frar 2019, l-Awtorità Kompetenti Franċiża (ANSM) tat bidu għal proċedura talUnjoni urġenti skont l-Artikolu 107i tad-Direttiva 2001/83/KE bħala riżultat ta' dejta talfarmakoviġilanza, u talbet lill-PRAC biex jivvaluta l-impatt tat-tħassib imsemmi hawn fuq, fuq il-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti mediċinali li fihom fenspiride u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq rilevanti għandhomx jinżammu, jiġu varjati, sospiżi jew revokati.
English: The PRAC considered that in view of the available data the generation of additional evidence via an ICH E14 thorough QT/QTc clinical study would not be justified and would not allow identifying defined patient population in whom the benefits could outweigh the risks.
Maltese: Il-PRAC ikkunsidra li fid-dawl tad-dejta disponibbli, il-ġenerazzjoni ta' evidenza addizzjonali permezz ta' studju kliniku fid-dettall tal-QT/QTc ICH E14 ma tkunx iġġustifikata u ma tippermettix lidentifikazzjoni ta' popolazzjoni tal-pazjenti definita li fiha l-benefiċċji jistgħu jkunu akbar mir-riskji.