FrancophonIA/ELRC3.0 huggingface dataset:
English: Nyxoid is not a substitute for emergency medical care and may be used instead of intravenous (IV) injection, when IV access is not immediately available.
Maltese: Nyxoid mhuwiex sostitut għall-kura medika ta' emerġenza u jista' jintuża minflok injezzjoni ġol-vini (IV), meta aċċess IV ma jkunx disponibbli immedjatament.
English: • Increased skin sensitivity
Maltese: • Żieda fis-sensittività tal-ġilda
English: Tel: +44(0) 1223 424444
Maltese: Napp Pharmaceuticals Limited Tel: +44(0) 1223 424444
English: The immediate container consists of a type I glass vial with siliconised chlorobutyl stopper containing 0.1 ml solution.
Maltese: Il-kontenitur immedjat jikkonsisti minn kunjett tal-ħġieġ ta' tip I b'tapp silikonizzat tal-chlorobutyl li fih 0.1 ml ta' soluzzjoni.
English: Naloxone has not been shown to produce tolerance or cause physical or mental dependence.
Maltese: Ma ntweriex li naloxone jipproduċi tolleranza jew jikkawża dipendenza fiżika jew mentali.
English: • Build-up of fluid in the lungs
Maltese: • Akkumulazzjoni ta' fluwidu fil-pulmun
English: Ιρλανδία Tel +353 1 206 3800
Maltese: Mundipharma Pharmaceuticals Limited Tel +353 1 206 3800
English: • A list of the educational material included in the training program
Maltese: • Lista tal-materjal edukattiv inkluż fil-programm ta' taħriġ
English: Prior to launch of Nyxoid in each Member State the Marketing Authorisation Holder must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Nyxoid f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) irid jaqbel dwar il-kontenut u l-format tal-materjali edukattivi, li jinkludu media talkomunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: restlessness or irritability
Maltese: Ġenotossiċità u karċinoġeneċità
English: • Awareness of possible important risks such as opioid withdrawal symptoms and recurrence of respiratory depression
Maltese: • Għarfien ta' riskji possibbli importanti bħal sintomi ta' meta wieħed jieħu l-opjojdi u lokkorrenza mll-ġdid ta' tnaqqis respiratorju
English: Pharmacotherapeutic group: Antidotes, ATC code: V03AB15
Maltese: Antidoti, Kodiċi ATC:
English: In reports on intravenous/intramuscular naloxone: hypotension, hypertension, cardiac arrhythmia (including ventricular tachycardia and fibrillation) and pulmonary oedema have occurred with the postoperative use of naloxone.
Maltese: Disturbi vaskulari Fir-rapporti dwar IV/IM naloxone: pressjoni baxxa, pressjoni għolja, arritmija kardijaka (li tinkludi takikardija ventrikulari u fibrillazzjoni) u edema pulmonari, seħħew bl-użu wara l-operazzjoni ta' naloxone.
English: It is not a substitute for emergency medical care.
Maltese: Mhuwiex sostitut għal kura medika ta' emerġenza.
English: MUNDIPHARMA SAS infomed@mundipharma.fr
Maltese: SAS infomed@mundipharma.fr
English: Studies in animals have shown reproductive toxicity only at maternally toxic doses (see section 5.3).
Maltese: Studji f'annimali urew tossiċità fissistema riproduttiva biss f'dożi tossiċi għall-omm (ara sezzjoni 5.3).
English: Frequency, type and severity of adverse reactions in adolescents are expected to be the same as in adults.
Maltese: Il-frekwenza, it-tip u s-severità ta' reazzjonijiet avversi fl-adolexxenti huma mistennija li jkunu simili għal dawk fl-adulti.
English: ADRs are listed below by system organ class and frequency.
Maltese: L-ADRs huma elenkati hawn taħt, skont il-klassi tal-organi tas-sistema u l-frekwenza.
English: • Changes in behaviour including violent behaviour, nervousness, anxiety, excitement,
Maltese: • Tibdiliet fl-imġiba li jinkludu mġiba vjolenta, nervożiżmu, ansjetà, eċċitament, irrekwitezza jew irritabbiltà
English: Dizziness, Headache Uncommon Tremor Cardiac disorders Common
Maltese: Sensittività eċċessiva, Xokk anafilattiku Disturbi fis-sistema nervuża Komuni
English: Mundipharma Oy
Maltese: MUNDIPHARMA
English: • Information about Nyxoid and the fact that it cannot replace provision of basic life support
Maltese: • Informazzjoni dwar Nyxoid u l-fatt li ma jistax jieħu post il-provvediment ta' sapport bażiku tal-ħajja (basic life support)
English: • Details of what information needs to be shared when training the patient/carer o how to manage a known or suspected opioid overdosed and how to properly administer Nyxoid o how to minimise the occurrence and severity of the following risks associated with Nyxoid: reappearance of respiratory depression, precipitation of acute opioid withdrawal effect and lack of efficacy due to medication error
Maltese: • Dettalji dwar liema informazzjoni jeħtieġ li jiġu maqsuma ma' persuni oħrajn meta lpazjent/il-persuna li tieħu ħsiebu jingħataw it-taħriġ o kif timmaniġġja doża eċċessiva magħrufa jew issuspettata tal-opjojdi, u kif tagħti Nyxoid kif suppost o kif timminimizza l-okkorrenza u s-severità tar-riskji li ġejjin assoċjati ma' Nyxoid: id-dehra mill-ġdid ta' tnaqqis respiratorju, l-iżvilupp ta' effett akut ta' meta wieħed jieħu l-opjojdi, u n-nuqqas ta' effikaċja minħabba żball fl-għoti tal-mediċina
English: Other medicines and Nyxoid
Maltese: Mediċini oħra u Nyxoid
English: No clinical data on effects of naloxone on fertility are available, however data from rat studies (see section 5.3) indicate no effects.
Maltese: M'hemmx dejta klinika disponibbli dwar l-effetti ta' naloxone fuq il-fertilità, madankollu, dejta minn studji fuq il-firien (ara sezzjoni 5.3) ma tindika l-ebda effetti.
English: The most common adverse drug reaction (ADR) seen with naloxone administration is nausea (frequency very common).
Maltese: L-aktar reazzjoni avversa komuni tal-mediċina (ADR, adverse drug reaction) li ġiet osservata bl-għoti ta' naloxone hu d-dardir (frekwenza komuni ħafna).
English: Bard Pharmaceuticals Limited Cambridge Science Park Milton Road
Maltese: Cambridge Science Park
English: • Instructions that the HCP has to provide the patient/carer with the PIC and to make sure that the patients/carers will have access to the video (either through the PIC or memory stick) and are encouraged to read the quick starting guide (QSG) and package leaflet included in the medicinal product outer carton.
Maltese: • Istruzzjonijiet li l-HCP irid jipprovdi lill-pazjent/il-persuna li tieħu ħsiebu b'PIC (Patient Information Card, Kard ta' Informazzjoni lill-Pazjent), u biex jiżgura li l-pazjenti/ilpersuni li jieħdu ħsiebhom se jkollhom aċċess għall-vidjo (jew permezz tal-PIC jew memory stick), u li jridu jiġu mħeġġa biex jaqraw il-gwida kif tibda fil-pront (QSG, quick starting guide) u l-fuljett ta' tagħrif inkluż fil-kartuna ta' barra tal-prodott mediċinali.
English: However, reversal of respiratory depression caused by buprenorphine is limited.
Maltese: Madankollu, it-treġġigħ lura ta' tnaqqis respiratorju kkawżata minn buprenorphine hu limitat.
English: Trisodium citrate dihydrate Sodium chloride Hydrochloric acid Sodium hydroxide Purified water
Maltese: Sodium chloride Hydrochloric acid
English: • Feeling sick, vomiting, diarrhoea
Maltese: • Tħossok imdardar, rimettar, dijarea
English: Each nasal spray contains 1.8 mg of naloxone (as hydrochloride dihydrate).
Maltese: Kull sprej nażali jforni 1.8 mg ta' naloxone (bħala hydrochloride dihydrate).
English: • It should be available as o A link for online access in the HPD and PIC o Memory stick for HCP use to train, if WiFi not accessible
Maltese: • Għandu jkun disponibbli bħala o Link għal aċċess online fl-HPD u l-PIC o Memory stick għall-użu tal-HCP fit-taħriġ, jekk il-WiFi ma jkunx aċċessibbli
English: Signs of overdose include:
Maltese: Sinjali ta' doża eċċessiva jinkludu:
English: Following an IV dose of 125 µg, 38% of the dose was recovered in the urine within 6 hours in healthy volunteers compared with 25% of the dose being recovered in opioid-dependent patients in the same time period.
Maltese: Wara doża IV ta' 125 µg, 38% tad-doża ġiet irkuprata fl-awrina fi żmien 6 sigħat f'voluntiera b'saħħithom, meta mqabbla ma' 25% tad-doża li ġiet irkuprata f'pazjenti dipendenti fuq l-opjojdi fl-istess perjodu ta' żmien.
English: Naloxone was not mutagenic in the bacterial reverse mutation assay, but was positive in mouse lymphoma assay and was clastogenic in vitro, however, naloxone was not clastogenic in vivo.
Maltese: Naloxone ma kienx mutaġeniku fl-analiżi tal-mutazzjoni reverse batterika, iżda kien pożittiv fl-assaġġ tal-limfoma fil-ġrieden, u kien klastoġeniku in vitro, madankollu, naloxone ma kienx klastoġeniku in vivo.
English: How to store Nyxoid
Maltese: Tużax Nyxoid
English: • If you are physically dependent on opioids or if you have received high doses of opioids (for example heroin, methadone, fentanyl, oxycodone, buprenorphine or morphine).
Maltese: (pereżempju eroina, methadone, fentanyl, oxycodone, buprenorphine jew morfina).
English: Acute withdrawal symptoms occur uncommonly (may affect up to 1 in 100 people).
Maltese: Sintomi akuti ta' meta wieħed jieqaf jieħu l-mediċina jseħħu b'mod mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna).
English: Nyxoid works for a short time only to reverse the effects of opioids while you wait for emergency medical attention.
Maltese: Nyxoid jaħdem għal żmien qasir biss biex ireġġa' lura l-effetti tal-opjojdi waqt li int tkun qed tistenna attenzjoni medika ta' emerġenza.
English: Naloxone was not carcinogenic following oral administration in a rat 2-year study or in a 26-week study in Tg-rasH2 mice.
Maltese: Naloxone ma kienx karċinoġeniku wara l-għoti orali fi studju ta' sentejn li sar fuq il-firien, jew fi studju ta' 26 ġimgħa fi ġrieden Tg-rasH2.
English: • A brief introduction on Nyxoid
Maltese: • Introduzzjoni qasira dwar Nyxoid
English: Mundipharma Comm. VA info@mundipharma.be
Maltese: VA info@mundipharma.be
English: Nyxoid 1.8 mg nasal spray, solution in a single-dose container naloxone
Maltese: Nyxoid 1.8 mg sprej nażali, soluzzjoni f'kontenitur b'doża waħda naloxone
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Mundipharma Comm. VA
English: Intranasal absorption and efficacy of naloxone can be altered in patients with damaged nasal mucosa and septal defects.
Maltese: L-assorbiment intranażali u l-effikaċja ta' naloxone jistgħu jinbidlu f'pazjenti li jkollhom ħsara filmukuża nażali u difetti septali.
English: • Being sick (vomiting)
Maltese: • attakki ta' puplesija (aċċessjonijiet)
English: It undergoes extensive hepatic metabolism mainly by glucuronide conjugation.
Maltese: Jgħaddi minn metaboliżmu epatiku estensiv, l-aktar permezz ta' konjugazzjoni ta' glucuronide.
English: Nasal spray, solution in a single-dose container 2 single-dose containers
Maltese: U KONTENUT Sprej nażali, soluzzjoni f'kontenitur b'doża waħda 2 kontenituri b'doża waħda.
English: • severe sleepiness
Maltese: • Tħossok imdardar
English: info@mundipharma.at
Maltese: info@mundipharma.be
English: Nyxoid may not fully reverse breathing problems.
Maltese: Nyxoid jista' ma jreġġax lura għal kollox problemi tan-nifs.
English: Contents of the pack and other information What Nyxoid contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Nyxoid
English: Nasal use.
Maltese: Mejjel rasu lura.
English: Nyxoid 1.8 mg nasal spray, solution in a single-dose container
Maltese: Nyxoid 1.8 mg sprej nażali, soluzzjoni f'kontenitur b'doża waħda
English: Naloxone
Maltese: TIKKETTAR
English: OTHER
Maltese: PROVVISTA
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP) L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Naloxone elicits a pharmacological response due to the interaction with opioids and opioid agonists.
Maltese: Naloxone jikkawża rispons farmakoloġiku minħabba l-interazzjoni mal-opjojdi u agonisti tal-opjojdi.
English: Each nasal spray container delivers 1.8 mg of naloxone (as hydrochloride dihydrate)
Maltese: Kull kontenitur tal-isprej nażali iforni 1.8 mg ta' naloxone (bħala hydrochloride)
English: The following adverse reactions have been reported with Nyxoid and/or other naloxone-containing medicinal products during clinical studies and post marketing experience.
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati b'Nyxoid u bi prodotti mediċinali oħrajn li fihom naloxone, matul l-istudji kliniċi u fl-esperjenza ta' wara tqegħid fis-suq.
English: Tel: +43 (0)1 523 25 05-0
Maltese: Tel: +43 (0)1 523 25 05-0 info@mundipharma.at
English: Method of administration
Maltese: Austria - organizační složka
English: Nyxoid is a nasal spray used for the emergency treatment of opioid overdose or possible opioid overdose in adults and adolescents over 14 years.
Maltese: Nyxoid huwa sprej għall-imnieħer li jintuża għal trattament ta' emerġenza ta' doża eċċessiva a' opjojdi jew doża eċċessiva possibbli ta' opjojdi fl-adulti u adoloxxenti li jkollhom aktar minn 14-il sena.
English: You may get strong withdrawal symptoms with this medicine (see later in section 4 of this leaflet under ‘Conditions to look out for')
Maltese: Inti jista' jkollok sintomi qawwija b'din il-mediċina (ara aktar tard f'sezzjoni 4 ta' dan il-fuljett taħt ‘Kundizzjonijiet li għandek toqgħod attent għcalihom')
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s­sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r­riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Tlf.
Maltese: Rogħda
English: Tlf: + 47 67 51 89 00
Maltese: Mundipharma AS Tlf: + 47 67 51 89 00 post@mundipharma.no
English: There are no data available on the excretion of naloxone following intranasal administration, however, the disposition of labelled naloxone following IV administration was studied in healthy volunteers and opioid-dependent patients.
Maltese: M'hemmx dejta disponibbli dwar it-tneħħija ta' naloxone wara għoti intranażali, madankollu, iddispożizzjoni ta' naloxone ittikkettat wara għoti IV ġiet studjata f'voluntiera b'saħħithom u f'pazjenti dipendenti fuq l-opjojdi.
English: Immune system disorders Very rare:
Maltese: Rari ħafna:
English: If this happens, further doses may be given after 2 to 3 minutes using a new nasal spray.
Maltese: Jekk il-pazjent ma jmurx għall-aħjar fi żmien 2 - 3 minuti, tista' tingħata t-tieni doża.
English: If the patient does not respond, the second dose should be administered after 2-3 minutes.
Maltese: Jekk il-pazjent ma jirrispondix, it-tieni doża għandha tingħata wara 2-3 minuti.
English: anita@ibti.lv
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Hypotension, Hypertension Respiratory, thoracic and mediastinal disorders Uncommon Hyperventilation Very rare
Maltese: Pressjoni baxxa, Pressjoni għolja Disturbi respiratorji, toraċiċi u medjastinali
English: Mundipharma Farmacêutica Lda
Maltese: GĦAMLA FARMAĊEWTIKA
English: A study investigating intranasal naloxone at doses of 1, 2, 4 mg (MR903-1501) shows that the median (range) tmax associated with intranasal administration of naloxone was 15 (10, 60) minutes for
Maltese: Adulti u adolexxenti li għandhom 14-il sena u aktar Id-doża rakkomandata hi ta' 1.8 mg mogħtija ġo minfes wieħed (sprej nażali wieħed).
English: Adverse cardiovascular effects have occurred more frequently in postoperative patients with a pre-existing cardiovascular disease or in those receiving other medicines that produce similar adverse cardiovascular effects.
Maltese: Effetti avversi kardjovaskulari seħħew b'mod aktar frekwenti f'pazjenti wara operazzjoni ma' mard kardjovaskulari li kien jeżisti minn qabel, jew f'dawk li kienu qed jirċievu mediċini oħra li jipproduċu effetti avversi kardjovaskulari simili.
English: The MAH shall ensure that in each MS where Nyxoid is marketed, all relevant health care professionals (HCP) who are expected to prescribe and/or supply Nyxoid are provided with:
Maltese: L-MAH għandu jiżgura li f'kull MS fejn Nyxoid jitqiegħed fis-suq, il-professjonisti tal-kura tas-saħħa (HCP, health care professionals) rilevanti kollha li huma mistennija li jippreskrivu u/jew jipprovdu Nyxoid, jiġu pprovduti b':
English: Conditions to look out for
Maltese: Twissijiet u prekawzjonijiet
English: This should be performed in accordance with the educational guidance for Nyxoid.
Maltese: Jekk tkun issuspettata doża eċċessiva, Nyxoid għandu jingħata.
English: Ireland .
Maltese: Airija
English: Onset of action following intranasal administration can reasonably be expected to occur in each individual before the tmax is reached.
Maltese: Il-bidu tal-azzjoni wara lgħoti intranażali jista' raġonevolment ikun mistenni li jseħħ f'kull individwu qabel tintlaħaq it-tmax.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Medis Hungary Kft
Maltese: Użu għall-imnieħer
English: Drug withdrawal syndrome
Maltese: Sodium hydroxide
English: • Identification of signs of suspected opioid overdose, especially respiratory depression and information on how to check the airways and breathing
Maltese: • Identifikazzjoni ta' sinjali ta' doża eċċessiva ssuspettata tal-opjojdi, speċjalment tnaqqis respiratorju u informazzjoni dwar kif tiċċekkja l-passaġġi tal-arja u n-nifs
English: • Body aches and stomach cramps
Maltese: • Diffikultà biex torqod.
English: Nyxoid is intended to be administered as a part of a resuscitation intervention in suspected overdose casualties, where opioid drugs may be involved or suspected, likely in a non-medical setting.
Maltese: Nyxoid hu intenzjonat biex jingħata bħala parti minn intervent ta' risuxxitazzjoni f'persuni li jkunu ssuspettati li ħadu doża eċċessiva, fejn mediċini li jkunu fihom l-opjojdi jistgħu jkunu involuti jew issuspettati, li x'aktarx ikun f'ambitu mhux mediku.
English: Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings.
Maltese: opjojdi magħrufa jew issuspettata, kif manifestat minn tnaqqis fis-sistema respiratorja u/jew mis sistema ċentrali nervuża, f'ambiti kemm mhux mediċi kif ukoll tal-kura tas-saħħa.
English: The appropriate maximum dose of Nyxoid is situation specific.
Maltese: Id-doża massima adattata ta' Nyxoid hi speċifika skont is-sitwazzjoni.
English: It is thought that this effect is a result of the arch-shaped dose-response curve of buprenorphine with decreasing analgesia in the event of high doses.
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: 29 May 2019 EMA/285298/2019
Maltese: 29 ta' Mejju 2019 EMA/285298/2019
English: In the EU, fenspiride medicines have been authorised via national procedures in Bulgaria, France, Latvia, Lithuania, Poland, Portugal and Romania and are available under various brand names (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал and Сиресп).
Maltese: Fl-UE, il-mediċini ta' fenspiride ġew awtorizzati permezz ta' proċeduri nazzjonali fil-Bulgarija, Franza, il-Latvja, il-Litwanja, il-Polonja, il-Portugall u rRumanija u jiġu taħt ismijiet ta' ditti differenti (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал u Сиресп).
English: The review of fenspiride was initiated on 14 February 2019 at the request of France, under Article 107i of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' fenspiride nbdiet fl-14 ta' Frar 2019 fuq talba ta' Franza, skont l-Artikolu 107i tadDirettiva 2001/83/KE.
English: On 16 May 2019, EMA's safety committee (PRAC) recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU.
Maltese: Fit-16 ta' Mejju 2019, il-kumitat tas-sigurtà tal-EMA (PRAC) irrakkomanda li l-awtorizzazzjonijiet għattqegħid fis-suq għall-mediċini ta' fenspiride jiġu revokati, għalhekk il-mediċini ma jistgħux jibqgħu jitqiegħdu fis-suq fl-UE.
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures.
Maltese: Dan huwa responsabbli biex jiżgura standards tas-sigurtà armonizzati għall-mediċini awtorizzati permezz ta' proċeduri nazzjonali.
English: The PRAC recommendation was sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted it by consensus on 29 May 2019.
Maltese: Ir-rakkomandazzjoni tal-PRAC intbagħtet lill-Grupp ta' Koordinazzjoni għal Proċedura tarRikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh), li adottaha b'kunsens fid29 ta' Mejju 2019.
English: • The withdrawal of the marketing authorisations of fenspiride medicines is based on case reports and nonclinical studies (including hERG channel binding) that showed that fenspiride can cause QT prolongation and has proarrhythmia potential (could cause triggering or worsening of arrhythmia) with the associated risk of torsades de pointes.
Maltese: • L-irtirar tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' mediċini ta' fenspiride huwa bbażat fuq rapporti tal-każijiet u studji mhux kliniċi (inkluż it-twaħħil tal-kanal hERG) li wrew li fenspiride jista' jikkawża titwil tal-QT u għandu potenzjal għal proarritmija (jista' jikkawża bidu jew aggravar ta' arritmija) bir-riskju assoċjat ta' torsades de pointes.
English: This included cases of QT prolongation and torsades de pointes (abnormalities of the heart's electrical activity that may lead to heart rhythm disturbances) in patients using these medicines, results of laboratory studies, data from published literature and stakeholder input.
Maltese: Din kienet tinkludi każijiet ta' titwil tal-QT u torsades de pointes (anormalitajiet fl-attività elettrika tal-qalb li jistgħu jwasslu għal disturbi fir-ritmu tal-qalb) f'pazjenti li jużaw dawn il-mediċini, riżultati ta' studji fil-laboratorju, dejta minn letteratura ppubblikata u input minn partijiet ikkonċernati.
English: • Cough medicines containing fenspiride will no longer be marketed in the EU because of data showing a risk of sudden, serious heart rhythm problems.
Maltese: • Il-mediċini tas-sogħla li fihom fenspiride mhux ser jibqgħu jitqiegħdu fis-suq fl-UE minħabba dejta li turi riskju ta' problemi serji u f'daqqa fir-ritmu tal-qalb.
English: The PRAC considered all the available evidence in its review.
Maltese: Il-PRAC ikkunsidra l-evidenza kollha disponibbli fir-reviżjoni tiegħu.
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Maltese: Is-CMDh huwa korp li jirrappreżenta lill-Istati Membri tal-UE kif ukoll lill-Iżlanda, lilLiechtenstein u lin-Norveġja.
English: The PRAC recommendation was adopted by the CMDh1 by consensus and will be implemented directly at national level.
Maltese: Ir-rakkomandazzjoni tal-PRAC ġiet adottata mis-CMDh1 b'kunsens u ser tiġi implimentata direttament fil-livell nazzjonali.