FrancophonIA/ELRC3.0 huggingface dataset:
English: On the basis of evidence of harm from reports of fatal overdose, of divergent safety reviews and previous regulatory action taken in several Member States, the European Commission initiated a referral under Article 31(2) of Directive 2001/83/EC, as amended, to address this public health issue for medicinal products containing dextropropoxyphene and paracetamol, and therefore referred the matter to the CHMP on 30 November 2007.
Maltese: Fuq il-bażi ta' evidenza ta' danni minn rapporti ta' doża eċċessiva fatali, ta' reviżjonijiet diverġenti dwar is-sigurtà u ta' azzjoni regolatorja preċedenti meħuda f'bosta Stati Membri, il-Kummissjoni Ewropea bdiet riferiment skont l-Artikolu 31(2) tad-Direttiva 2001/83/KE, kif emendata, biex tindirizza din il-kwistjoni ta' saħħa pubblika għall-prodotti mediċinali li fihom dextropropoxyphene u paracetamol, u għalhekk irreferiet il-kwistjoni lis-CHMP fit-30 ta' Novembru 2007.
English: - The Committee considered the risk of fatal overdose with dextropropoxyphene.
Maltese: - Il-Kumitat ikkunsidra r-riskju ta' doża eċċessiva fatali b'dextropropoxyphene.
English: The most frequently reported adverse reactions with fatal outcome involved hepatobiliary disorders, skin disorders, general disorders, blood and lymphatic disorders, nervous system disorders, gastrointestinal disorders and cardiac disorders.
Maltese: Ir-reazzjonijiet avversi li l-aktar li ġew irrapportati b'eżitu fatali involvew disturbi fil-kliewi u fis-sistema urinarja, disturbi tal-ġilda, disturbi ġenerali, disturbi tad-demm u tas-sistema limfatika, disturbi fis-sistema nervuża, disturbi gastro-intestinali u disturbi fil-qalb.
English: The different figures provided by the available data sources (spontaneous reports, forensic and poison centres, national mortality statistics) showed overall a significant number of deaths in which dextropropoxyphene is present at toxic levels.
Maltese: Iċ-ċifri differenti pprovduti missorsi ta' dejta disponibbli (rapporti spontanji, ċentri forensiċi u tal-avvelenament, statistiċi nazzjonali talmortalità) urew, b'mod ġenerali, numru sinifikanti ta' każijiet ta' mewt li fihom dextropropoxyphene kien preżenti f'livelli tossiċi.
English: Since the benefit/risk reviews of dextropropoxyphene containing products were carried out in the UK, Sweden, France, and Ireland in 2005 - following which the fixed dose combination product (paracetamol + dextropropoxyphene) was withdrawn from the market in the UK, Sweden, and Ireland - a substantial body of important new safety information has become available.
Maltese: Billi l-valutazzjonijiet tal-benefiċċju/riskju tal-prodotti li fihom dextropropoxyphene saru fir-Renju Unit, l-Iżvezja, Franza u l-Irlanda fl-2005 - wara liema valutazzjonijiet, il-prodott ta' kombinazzjoni b'doża fissa (paracetamol + dextropropoxyphene) ġie rtirat mis-suq fir-Renju Unit, l-Iżvezja u l-Irlanda - sar disponibbli korp sostanzjali ta' informazzjoni importanti ġdida dwar is-sigurtà.
English: Risk Minimisation measures proposed by the MAHs included restriction of the use of the product (i.e. changes in SPC to restrict the population; pack size reduction), modification of the posology (e.g. reduction of posology in elderly population) and addition of further safety warnings (e.g. on concomitant use with alcohol, dependence and tolerance, combination with other central acting analgesics and overdose in children).
Maltese: Il-miżuri ta' Minimizzazzjoni tar-Riskju li pproponew id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fisSuq kienu jinkludu r-restrizzjoni tal-użu tal-prodott (jiġifieri bidliet fis-SPC sabiex jillimitaw ilpopolazzjoni, tnaqqis fid-daqs tal-pakkett), modifika tal-pożoloġija (eż. tnaqqis tal-pożoloġija filpopolazzjoni anzjana) u ż-żieda ta' aktar twissijiet dwar is-sigurtà (eż. dwar l-użu simultanju mal-alkoħol, id-dipendenza u t-tolleranza, il-kombinazzjoni ma' analġeżiċi oħra li jaħdmu b'mod ċentrali u d-doża eċċessiva fit-tfal).
English: Whilst there is a risk of fatal overdose, the CHMP considered that it is limited for the parenteral dextropropoxyphene medicinal products, given the administration under hospital setting (given by healthcare professionals) and the classification of these medicinal products as narcotic prescription (in the Member State where the product is authorised) and the lack of evidence of fatal overdose particularly of accidental overdose.
Maltese: Filwaqt li hemm riskju ta' dożaġġ eċċessiv fatali, is-CHMP ikkunsidrat li dan huwa limitat għal prodotti mediċinali li fihom id-dextropropoxyphene parenterali, magħrufa l-amministrazzjoni f'post ta' sptar (mogħti minn professjonisti fil-kura tas-saħħa) u l-klassifikazzjoni ta' dawn il-prodotti mediċinali bħal preskrizzjoni narkotika (fl-Istat Membru fejn il-prodott huwa awtorizzat) u n-nuqqas ta' evidenza ta' dożaġġ eċċessiv fatali b'mod partikolari ta' dożaġġ eċċessiv aċċidentali.
English: Whereas
Maltese: Stat Membru
English: - The Committee assessed the grounds for re-examination submitted by a group of MAHs on 15 July 2009, the information provided by the MAHs at an oral explanation on 20 October 2009 and the scientific discussion within the Committee;
Maltese: - Il-Kumitat evalwa r-raġunijiet għal eżami mill-ġdid sottomess mill-grupp tal-MAHs fil-15 ta' Lulju 2009, l-informazzjoni pprovduta mill-MAHs fi spjegazzjoni orali fl-20 ta' Ottubru 2009 u d-diskussjoni xjentifika fi ħdan il-Kumitat;
English: Therefore, the CHMP concluded by majority that the benefit-risk balance of dextropropoxyphene containing medicinal products is negative and that its Opinion of 25 June 2009 should not be revised for oral/rectal dextropropoxyphene containing medicinal products and recommended the withdrawal of the Marketing Authorisations to be effective within the next 15 months of the Commission Decision in order to allow switching patients to safer alternatives, considering the extensive clinical use of dextropropoxyphene containing medicinal products and the wide patient exposure in some Member States.
Maltese: Għalhekk, is-CHMP ikkonkludiet b'maġġoranza li l-bilanċ bejn benefiċċju u riskju ta' prodotti mediċinali li fihom id-dextropropoxyphene huwa negattiv u li l-Opinjoni tiegħu tal-25 ta' Ġunju 2009 ma għandhiex tiġi riveduta għal prodotti mediċinali li fihom id-dextropropoxyphene u rrakkomandat l-irtirar talAwtorizzazzjonijiet għat-Tqegħid fuq is-Suq ikun effettiv fi żmien 15 -il xahar mid-Deċiżjoni talKummissjoni sabiex tippermetti li pazjenti li jaqilbu għal alternattivi aktar siguri meta jiġi kkunsidrat lużu kliniku estensiv ta' prodotti mediċinali li fihom id-dextropropoxyphene u l-espożizzjoni wiesa talpazjent f'xi Stati Membri.
English: However, the key safety concern with dextropropoxyphene is that it has a very narrow therapeutic index under normal conditions of use: following overdose, cardiac arrhythmias (which cannot be reversed using naloxone) and opioid side effects (such as respiratory depression) are rapid in onset and often fatal - there is evidence that the case fatality rate is higher than, for example, for tricyclic antidepressants.
Maltese: Madankollu, it-tħassib ewlieni dwar is-sigurtà b'dextropropoxyphene huwa li dan għandu indiċi terapewtiku dejjaq ħafna f'kundizzjonijiet ta' użu normali: wara doża eċċessiva, arritmiji tal-qalb (li ma jistgħux jinqalbu bl-użu ta' naloxone) u effetti sekondarji opojdi (bħal dipressjoni respiratorja) ma jdumux ma jibdew u ħafna drabi huma fatali - hemm evidenza li r-rata ta' fatalità ta' dan il-każ hija ogħla milli, pereżempju, għall-antidipressanti triċikliċi.
English: Based on the limited efficacy and the significant risk of fatal overdose (in particular accidental overdose), the CHMP was of the opinion that the benefit/risk balance of dextropropoxyphene containing medicinal products was negative.
Maltese: Fuq il-bażi tal-effikaċja limitata u r-riskju sinifikanti ta' doża eċċessiva fatali (b'mod partikolari doża eċċessiva aċċidentali), il-CHMP kien tal-opinjoni li l-bilanċ bejn il-benefiċċji u riskji tal-prodotti mediċinali li fihom dextropropoxyphene kien wieħed negattiv.
English: Nevertheless, the CHMP also took the well-established narrow therapeutic index into account, as well as other known risks associated with the use of parenteral opioids and potentially associated with the use of parenteral dextropropoxyphene such as abuse and dependence and given that the efficacy of parenteral dextropropoxyphene containing medicinal products has not been established, the CHMP concluded that the benefit-risk balance for the parenteral dextropropoxyphene containing medicinal products was negative and recommended the suspension of the Marketing Authorisations to be effected within 15 months of the Commission Decision to allow healthcare professionals to prepare for a potential switch to using alternatives.
Maltese: ikkunsidra wkoll l-indiċi terapewtiku dejjaq stabbilit sewwa, kif ukoll riskji magħrufa oħra assoċjati malużu ta' opojdi parenterali u li jistgħu jkunu assoċjati mal-użu ta' dextropropoxyphene parenterali bħallabbuż u d-dipendenza and minħabba li l-effikaċja tal-prodotti mediċinali li fihom id-dextropropoxyphene parenterali ma ġietx stabbilita, is-CHMP ikkonkludiet li l-bilanċ bejn il-benefiċċju u r-riskju għal prodotti mediċinali li fihom id-dextropropoxyphene kien negattiv u rrakkomandat is-sospensjoni talAwtorizzazzjonijiet għat-Tqegħid fuq is-Suq li jsir fi żmien 15 -il xahar mid-Deċiżjoni tal-Kummissjoni sabiex professjonisti fil-kura tas-saħħa jippreparaw qalba potenzjali għall-użu ta' alternattivi.
English: Similarly in Ireland, analysis in 2009 of further data from the Alcohol and Drug Research Unit of the Health Research Board revealed significant under-reporting of deaths associated with dextropropoxyphene-containing products - indicating fatality rates fifteen-fold higher than previously reported.
Maltese: L-istess fl-Irlanda, analiżi fl-2009 ta' aktar dejta mit-Taqsima tar-Riċerka dwar l-Alkoħol u d-Droga talBord ta' Riċerka dwar is-Saħħa, żvelat rappurtaġġ nieqes sinifikanti ta' mwiet assoċjati ma' prodotti li fihom dextropropoxyphene - li indikat rati ta' mwiet ħmistax-il darba ogħla milli kien irrappurtat qabel.
English: However no consideration was given to the need for national mortality data, and in particular forensic pathology data, to ensure that any risk minimisation measures are working: it is not possible to use routinely-collected (spontaneous) data to assess the effectiveness of the risk minimisation measures, because of the significant under-reporting of even serious adverse events, including death.
Maltese: Madankollu, ma ngħatat l-ebda konsiderazzjoni għall-ħtieġa ta' dejta nazzjonali dwar il-mortalità, u b'mod partikolari dejta dwar il-patoloġija forensika, sabiex jiġi żgurat li kwalunkwe miżura ta' minimizzazzjoni tar-riskju tkun qiegħda taħdem: mhuwiex possibbli li tuża dejta miġbura b'rutina (spontanja) sabiex tivvaluta l-effikaċja tal-miżuri ta' minimizzazzjoni tar-riskju, minħabba r-rappurtaġġ nieqes sinifikanti anki ta' episodji avversi serji, inkluża l-mewt.
English: Though a parenteral formulation of dextropropoxyphene might be viewed as providing a further therapeutic option, parenteral opioids carry further significant risks in themselves, such as abuse/dependence and diversion, which would appear difficult to justify in this instance given the lack of evidence of efficacy.
Maltese: Għalkemm formulazzjoni parenterali ta' dextropropoxyphene tista' titqies li tipprovdi għażla terapewtika oħra, opjojdi parenterali għandhom aktar riskji sinifikanti fihom infushom, bħal pereżempju abbuż/dipendenza u diverżjoni, li jista' jkun diffiċli biex jiġu ġġustifikati f'dan il-każ minħabba n-nuqqas ta' evidenza ta' effikaċja.
English: Intramuscular, intravenous use
Maltese: TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA`
English: Although spontaneous reporting suggested that the safety signal concerning the overdose was not significant, other more complete data, particularly from forensic centres and national mortality statistics confirmed that the risk of accidental fatal overdose under normal conditions of use associated with dextropropoxyphene containing products is of major concern, mainly due to their narrow therapeutic index and high case fatality.
Maltese: Għalkemm ir-rappurtar spontanju ssuġġerixxa li s-sinjal ta' sigurtà dwar id-doża eċċessiva ma kienx sinifikanti, dejta oħra aktar kompluta, b'mod partikolari minn ċentri forensiċi u minn statistiċi nazzjonali tal-mortalità kkonfermat li r-riskju ta' doża eċċessiva fatali aċċidentali f'kundizzjonijiet ta' użu normali assoċjati ma' prodotti mediċinali li fihom dextropropoxyphene huwa ta' tħassib ewlieni, l-aktar minħabba l-indiċi terapewtiku żgħir tagħhom u l-għadd kbir ta' każijiet ta' fatalità.
English: - The Committee considered that the efficacy of parenteral dextropropoxyphene containing medicinal products has not been established;
Maltese: - Il-Kumitat ikkunsidra li l-effikaċja ta' prodotti mediċinali li fihom dextropropoxyphene parenterali ma ġietx stabbilita;
English: Having considered the detailed grounds for re-examination provided by the group of MAHs in writing and in an oral explanation, the CHMP considered that the design of the proposed clinical study to demonstrate the superior efficacy for combination of dextropropoxyphene and paracetamol versus paracetamol alone was flawed, and even a well-designed study would not change the benefit-risk balance of the dextropropoxyphene medicinal products in view of the narrow therapeutic index.
Maltese: Wara li kkunsidra r-raġunijiet dettaljati għal eżami mill-ġdid ipprovduti mill-grupp tal-MAHs bil-miktub u bi spjegazzjoni orali, is-CHMP ikkunsidra li l-għamla tal-istudju kliniku propost biex juri effikaċja superjuri għat-taħlita ta' dextropropoxyphene u paracetamol vs. paracetamol waħdu kienet difettuża, u għalhekk anki prova klinika ddisinjata tajjeb tista' ma tbiddilx il-bilanċ bejn benefiċċju u riskju talprodotti mediċinali dextropropoxyphene minħabba l-indiċi terapewtiku dejjaq..
English: In view of the complex context in which cases of fatal overdose occurred under normal conditions of use and in view of the narrow therapeutic index and the potential for rapid death, the CHMP was of the opinion that the above proposed risk minimisation activities of narrowing the indication, reducing the pack sizes and/or introducing further safety warnings and contraindications (including those beyond the Product Information) would not be able to reduce the risks to an acceptable level.
Maltese: Minħabba l-kuntest kumpless li fih seħħew każijiet ta' doża eċċessiva fatali f'kundizzjonijiet ta' użu normali u minħabba l-indiċi terapewtiku dejjaq u l-potenzjal ta' mewt malajr, il-CHMP kien tal-opinjoni li l-attivitajiet ta' minimizzazzjoni tar-riskju hawn fuq proposti ta' limitazzjoni tal-indikazzjoni, it-tnaqqis ddaqsijiet tal-pakketti u/jew l-introduzzjoni ta' aktar avviżi ta' sigurtà u kontra-indikazzjonijiet (inklużi dawk minbarra t-Tagħrif dwar il-Prodott) mhumiex sejrin ikunu jistgħu jnaqqsu r-riskji għal livell aċċettabbli.
English: Immediate Packaging Pack size bottle (HDPE)
Maltese: Daqs tal-pakkett flixkun (HDPE)
English: 100 tablets
Maltese: 8 x 1 pillola (doża talunità)
English: Date of last renewal: 11/04/2019.
Maltese: Data tal-aħħar tiġdid: 11/04/2019.
English: Komenského 212, 683 23 Ivanovice na Hané, CZECH REPUBLIC
Maltese: Komenského 212, 683 23 Ivanovice na Hané,
English: ATC vet code: QI07AI08.
Maltese: QI07AI08.
English: Lyophilisate: Trometamol Edetic acid Sucrose Dextran 70
Maltese: Trometamol Edetic acid Sucrose Dextran 70
English: Adjuvant: Aluminium hydroxide
Maltese: Aluminium hydroxide
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Water for injections
Maltese: Klorur tal-potassju Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Ilma għall-injezzjonijiet
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/172/001
Maltese: FIS-SUQ EU/2/14/172/001
English: Minimum Maximum Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10
Maltese: Canine parainfluenza virus Tip 2, strejn CPiV-2 -Bio 15 10
English: L. interrogans serovar Icterohaemorrhagiae
Maltese: Sospensjoni (inattivat): L. interrogans serovar Icterohaemorrhagiae
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral and inactivated bacterial vaccines.
Maltese: Immunoloġiċi għal canidae, vaċċini virali ħajjin u batterji inattivati.
English: Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus Pi/L4.
Maltese: Tal-anqas sena wara l-kors primarju għall-komponenti kollha ta' Versican Plus Pi/L4.
English: − to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava,
Maltese: - biex tilqa' għas-sinjali kliniċi, infezzjoni u tixrid mal-urina kkawżati minn L. interrogens serogrupp Australis serovar Bratislava,
English: − to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,
Maltese: - biex tilqa' għas-sinjali kliniċi (tnixxija mill-imnieħer u l-għajnejn) u tnaqqas it-tixrid virali kkważati mill-canine parainfluenza virus,
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Maltese: Bratislava, Leptospira interrogens serogrupp Canicola servar Canicola, Leptospira kirschneri serogrupp Grippotyphosa serovar Grippotyphosa u Leptospira interrogens serogrupp
English: Type I glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-ħġieġ Tip I li fih 1 ml sospensjoni magħluq b'tapp tal-chlorobutyl rubber u kappa talaluminju.
English: Primary vaccination scheme: Two doses of Versican Plus Pi/L4 3-4 weeks apart from 6 weeks of age.
Maltese: Żewġ dożi ta' Versican Plus Pi/L4 3 - 4 ġimgħat minn xulxin minn età ta' 6 ġimgħat.
English: PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection
Maltese: GĦAMLA FARMAĊEWTIKA Lijofiliżat u sospensjoni għal sospensjoni għall-injezzjoni.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs
Maltese: VETERINARJU Versican Plus Pi/L4 lijofiliżat u sospensjoni għal sospensjoni għall-injezzjoni għall-klieb
English: PACKAGE LEAFLET: Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs
Maltese: Versican Plus Pi/L4 lijofiliżat u sospensjoni għal sospensjoni għall-injezzjoni għall-klieb
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 lyophilisate for dogs
Maltese: Doża waħda ta' Versican Plus Pi/L4 għandha tingħata kull sena.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 suspension for dogs
Maltese: Versican Plus Pi/L4 sospensjoni għall-klieb
English: International non-proprietary name (INN): tilmicosin
Maltese: Denominazzjoni internazzjonali komuni (INN): tilmicosin
English: The Committee appointed Mr G. Johan Schefferlie as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.
Maltese: Johan Schefferlie bħala relatur u lit-tabib Michael Holzhauser-Alberti bħala korelatur.
English: Written explanations were provided by the marketing authorisation holders on 18 September 2012, 11 February 2013 and 26 May 2013.
Maltese: Ingħataw spjegazzjonijiet bil-miktub mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fit-18 ta' Settembru 2012, fil-11 ta' Frar 2013 u fis-26 ta' Mejju 2013.
English: The referral procedure started on 15 May 2012.
Maltese: Il-proċedura ta' referenza nbdiet fil-15 ta' Mejju 2012.
English: Opinion following an Article 341 referral for Micotil 300 Injectie and its associated names
Maltese: Opinjoni skont referenza tal-Artikolu 341 għal Micotil 300
English: Oral explanations were given on 11 June 2013.
Maltese: L-ispjegazzjonijiet orali ngħataw fil-11 ta' Ġunju 2013.
English: Due to divergent national decisions taken by Member States concerning the authorisations of Micotil 300 Injectie and its associated names, on 24 April 2012 the Netherlands referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve discrepancies in the product information across the European Union.
Maltese: Injectie u l-ismijiet assoċjati, fl-24 ta' April 2012 il-Pajjiżi l-Baxxi rreferew il-kwistjoni lisCVMP skont l-Artikolu 34(1) tad-Direttiva 2001/82/EC, sabiex jissolvew id-diskrepanzi fl-informazzjoni tal-prodott madwar l-Unjoni Ewropea.
English: Micotil 300 Injectie and its associated names are veterinary medicinal products authorised for use in the target species cattle, sheep and rabbits for treatment of various infections caused by microorganisms susceptible to tilmicosin.
Maltese: Micotil 300 Injectie u l-ismijiet assoċjati huma prodotti mediċinali veterinarji awtorizzati għall-użu fl-ispeċijiet fil-mira bħall-ifrat, in-nagħaġ u l-fniek għall-kura ta' diversi infezzjonijiet ikkawżati minn mikroorganiżmi suxxettibbli għal tilmicosin.
English: Based on the currently available data, the CVMP considered that the benefit-risk profile of Micotil 300 Injectie and its associated names remains positive, subject to variation of the marketing authorisations in accordance with the recommended product information.
Maltese: Skont id-dejta disponibbli bħalissa, is-CVMP kkunsidra li l-profil bejn il-benefiċċju u r-riskju ta' Micotil 300 Injectie u l-ismijiet assoċjati jibqa' pożittiv soġġett għal varjazzjoni tal-awtorizzazzjonijiet għattqegħid fis-suq skont l-informazzjoni tal-prodott rakkomandat.
English: 18 October 2013
Maltese: 18 ta' Ottubru 2013 EMA/539469/2013
English: 270 capsules blister (PVC/Aclar (PCTFE)) Initiation pack: 63 (1 x 21 and 2 x 21) tablets
Maltese: Pakkett biex tibda: 63 (1 x 21 u 2 x 21) pillola
English: Immediate Packaging Pack size blister (PVC/PE/PCTFE/alu) Initiation pack: 63 (7 x 3 and 7 x 6) capsules blister (PVC/PE/PCTFE/alu) 252 x 1 capsules (unit dose)
Maltese: Pakkett biex tibda: 63 (7 x 3 u 7 x 6) kapsula
English: Strength Pharmaceutical Form
Maltese: Daqs tal-pakkett
English: Further information on Instanyl can be found on the Agency's website: ema.europa.eu/medicines/Human/EPAR/Instanyl.
Maltese: Aktar informazzjoni dwar Instanyl tinstab fis-sit elettroniku talAġenzija: ema.europa.eu/medicines/Human/EPAR/Instanyl.
English: Other information about Instanyl
Maltese: Informazzjoni oħra dwar Instanyl
English: Instanyl contains the active substance fentanyl.
Maltese: Instanyl fih is-sustanza attiva fentanil.
English: Instanyl is available as a nasal spray (50, 100 and 200 micrograms per dose).
Maltese: Instanyl jiġi bħala sprej nażali (50, 100 u 200 mikrogramma kull doża).
English: This overview was last updated in 03-2019
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'03-2019.
English: The most common side effects with Instanyl (which may affect up to 1 in 10 people) are somnolence (sleepiness), dizziness, headache, vertigo (a spinning sensation), flushing (reddening of the skin), hot flushes, throat irritation, nausea (feeling sick), vomiting and hyperhidrosis (excessive sweating).
Maltese: L-effetti sekondarji l-aktar komuni b'Instanyl (li jistgħu jaffettwaw sa persuna 1 minn 10) huma somnolenza (ngħas), sturdament, uġigħ ta' ras, vertiġini (sensazzjoni ta' tidwir), ħmura (ħmura talġilda), fwawar ta' sħana, irritazzjoni tal-griżmejn, nawżja (tħossok ma tiflaħx), remettar u iperidrożi (għaraq eċċessev).
English: Instanyl received a marketing authorisation valid throughout the EU on 20 July 2009.
Maltese: Instanyl ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-20 ta' Lulju 2009.