FrancophonIA/ELRC3.0 huggingface dataset:
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 s-sistema tal-ġestjoni tar-riskju tiġi modifikata, speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċjuu r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: If Yellox is accidentally swallowed, a glass of water or other fluid should be taken to water down the medicine.
Maltese: Jekk Yellox jinbela' aċċidentalment, għandha tittieħed tazza ilma jew fluwidu ieħor biex tlaħlaħ il-mediċina.
English: There is practically no risk of adverse effects due to accidental oral ingestion.
Maltese: Hemm prattikament l-ebda riskju ta' effetti avversi minħabba inġestjoni orali aċċidentali.
English: Bausch & Lomb-IOM S.p.A. Tel: + 39 (0)2 27407300
Maltese: Tel: + 39 (0)2 27407300
English: Studies in rabbits using radio-labelled bromfenac have demonstrated that highest concentrations after topical administration are observed in the cornea followed by the conjunctiva and the aqueous humour.
Maltese: Studji fil-fniek meta ntuża bromfenac radjutikkettat, urew li l-ogħla konċentrazzjonijiet wara lgħoti topiku kienu osservati fil-kornea, segwiti minn konġuntiva u l-aqueous humour.
English: Yellox is used to reduce eye inflammation following cataract surgery in adults.
Maltese: Yellox jintuża biex inaqqas l-infjamazzjoni fl-għajnejn wara operazzjoni tal-katarretti fl-adulti.
English: Eyelid bleeding
Maltese: TA' KIF JINGĦATA
English: It has been observed in rare cases that upon withdrawal of Yellox, a flare-up of the inflammatory response, e.g. in the form of macular oedema, due to the cataract operation may occur.
Maltese: F' każijiet rari ġie osservat li malli twaqqaf Yellox, kien hemm aggravament tar-rispons infjammatorju, eż. fil-forma ta' edema makulari, jista' jseħħ minħabba l-operazzjoni tal-katarretti.
English: After ocular administration the half-life of bromfenac in aqueous humour is 1.4 h indicating rapid elimination.
Maltese: Wara l-għoti okulari, il-half-life ta' bromfenac fl-aqueous humour hi ta' 1.4 sigħat, li tindika tneħħija mgħaġġla.
English: Pregnancy
Maltese: Infetaħ
English: Wearing contact lenses is not recommended after cataract surgery.
Maltese: Li tilbes il-contact lenses mhux rakkomandat wara operazzjoni tal-katarretti.
English: There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaema) in conjunction with ocular surgery.
Maltese: Kien hemm rapporti li NSAIDs oftalmiċi jistgħu jikkawżaw żieda fi ħruġ ta' demm minn tessuti tal-għajnejn (inkluż ifema) meta jkun hemm operazzjoni okulari.
English: Ocular infection An acute ocular infection may be masked by the topical use of anti-inflammatory medicinal products.
Maltese: Infezzjoni akuta tal-għajnejn tista' tinħeba mill-użu topiku ta' prodotti mediċinali antiinfjammatorji.
English: Conjunctival hyperaemia Abnormal sensation in eye Ocular discomfort
Maltese: Sensazzjoni anormali fl-għajnejn Skomfort fl-għajnejn
English: EU/2/09/101/002 EU/2/09/101/004 EU/2/09/101/006 EU/2/09/101/008 EU/2/09/101/010
Maltese: EU/2/09/101/006 EU/2/09/101/008 EU/2/09/101/010
English: ATCvet code: QP52AX09.
Maltese: QP52AX09.
English: Dose, ml
Maltese: Doża, ml
English: Incompatibilities:
Maltese: Inkompatibilitajiet:
English: 2.5 l 5 l
Maltese: 2.5 l
English: Cooperia curticei C. oncophora
Maltese: Cooperia curticei C. onchophora
English: Nematodirus battus N. filicollis
Maltese: Nematodirus battus N. fillicollis
English: 27472 Cuxhaven Germany
Maltese: 27472 Cuxhaven
English: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue France
Maltese: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue Franza
English: 700 µg/kg 7000 µg/kg 5000 µg/kg 2000 µg/kg
Maltese: 700 µg/kg 7000 µg/k g
English: Pack sizes of 250 ml, 500 ml, 1 l, 2.5 l, and 5 l.
Maltese: Pakketti ta' 250 ml, 500 ml, 1 l, 2. 5 l, u 5 l.
English: Dunsinane Industrial Estate Dundee, DD2 3XR
Maltese: Dunsinane Industrial EstateDundee DD2 3XR
English: After oral administration monepantel is readily absorbed and oxidised to a sulfone metabolite.
Maltese: Wara amministrazzjoni orali, monepantel jiġi assorbit minnufih u jiġi ossidat għal metabolit sulfone.
English: * including inhibited larvae
Maltese: * Inkluż larva inibita
English: Manufacturer responsible for batch release: Argenta Dundee Limited Kinnoull Road
Maltese: Argenta Dundee Limited Kinnoull Road
English: The active substance in ZOLVIX is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'ZOLVIX hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tarRegolament tal-Kummissjoni (UE) Nru 37/2010:
English: Pack sizes of 250 ml, 500 ml, 1 l, 2.5 l, and 5 l Not all pack sizes may be marketed.
Maltese: Pakketti ta' 250 ml, 500 ml, 1 l, 2.5 l, u 5 l Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee, DD2 3XR United Kingdom
Maltese: Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Maltese: Sustanza Attiva:
English: 1 ml for each additional 10 kg Administer orally with a suitable dose device.
Maltese: 1 ml għal kull 10 kg addizzjonali Amministra oralment b'apparat tad-doża xieraq.
English: Monepantelsulfone
Maltese: Monepantel -sulfone
English: Pharmacotherapeutic group: anthelmintics.
Maltese: Grupp farmako-terapewtiku: antelmintiċi, Kodiċi ATC veterinarja:
English: Marketing authorisation holder: Elanco GmbH
Maltese: Elanco GmbH
English: Pharmacologically active substance(s)
Maltese: farmakoloġikamen t attiva(i)
English: ADVICE ON CORRECT ADMINISTRATION
Maltese: U METODU TA' AMMINISTRAZZJONI
English: Orange clear solution.
Maltese: Soluzzjoni orali.
English: Fluorinated high density polyethylene (HDPE) bottles with a polypropylene cap.
Maltese: Fliexken ta' polyethylene ta' densità għolja fluworinati (HDPE) b'tapp tal-polypropylene.
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST {JJ/XX/SSSS}
English: Antiparasitic agents/ Agents acting against endoparasites
Maltese: Aġenti li jaġixxu kontra l-endoparassiti
English: ZOLVIX was shown to be effective against strains of gastro-intestinal parasites, listed in section 4, resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.
Maltese: Zolvix intwera li huwa effettiv kontra r-razez tal-parassiti elenkati fis-sezzjoni 4, reżistenti għal (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones u razez ta' H. contortus reżistenti għas-salicylanilides.
English: Spectrum of activity includes fourth larvae and adults of:
Maltese: Il-firxa ta' attività tinkludi r-raba' dudu (fourth larvae) u l-adult ta':
English: Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany
Maltese: 4 27472 Cuxhaven
English: 1 ml for each additional 10 kg
Maltese: 1 ml għal kull 10 kg addizzjonali
English: Body weight, kg
Maltese: Piż tal-ġisem, kg
English: The dose rate is 2.5 mg/kg bodyweight of monepantel.
Maltese: Id-doża hija 2.5 mg/kg piż tal-ġisem ta' monepantel.
English: Monepantel is an anthelmintic belonging to the amino-acetonitrile derivative (AAD) class of molecules.
Maltese: Monepantel huwa prodott kontra l-ħniex li jagħmel parti mill-kategorija ta' molekuli aminoacetonitrile derivative (AAD).
English: 4.8 Interaction with other medicinal products and other forms of interaction
Maltese: .8 Interazzjoni ma' prodotti mediċinali oħra jew forom oħra ta' interazzjoni
English: Dose table:
Maltese: Tabella tad-doża:
English: MANUFACTURER'S BATCH NUMBER Lot
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Withdrawal period(s): 7 days.
Maltese: Żmien ta' tiżmim: 7 ijiem
English: 4.9 Amounts to be administered and administration route
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep
Maltese: VETERINARJU ZOLVIX 25 mg/ml soluzzjoni orali għan-nagħaġ
English: Therapeutic classification
Maltese: Klassifikazzjon i terapewtika
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep Monepantel
Maltese: VETERINARJU ZOLVIX 25 mg/ml soluzzjoni oranġjo ċara orali għan-nagħaġ
English: Overdose (symptoms, emergency procedures, antidotes): No adverse effects were observed after a 10-fold overdose.
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti):
English: Monepantel acts on the nematode specific nicotinic acetylcholine receptor sub-unit HcoMPTL-1.
Maltese: Monepantel jaġixxi fuq is-sub-unità Hco-MPTL-1 tar-riċettur ta' nicotinic acetylcholine speċifiku tan-nematodi.
English: Target tissues
Maltese: Tabella tad-doża
English: Each ml contains 25 mg of monepantel Excipient:
Maltese: Kull ml fih 25 mg ta' monepantel Sustanza mhux attiva:
English: Sheep
Maltese: IEĦOR
English: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany
Maltese: Elanco GmbH Heinz-Lohmann-Str.
English: Disposal: read the package leaflet.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu jitpoġġew fis-suq.
English: 250 ml 500 ml 1 l
Maltese: 500 ml
English: MRLs
Maltese: L-ISEM
English: STATEMENT OF THE MRLs
Maltese: MRL Tessuti mmirati
English: Muscle Fat
Maltese: Muskol u
English: Each ml of ZOLVIX orange clear oral solution contains 25 mg of monepantel
Maltese: U INGREDJENT(I) OĦRA Kull ml ta' ZOLVIX soluzzjoni orali oranġjo ċara fiha 25 mg ta' monepantel
English: STATEMENT OF ACTIVE SUBSTANCES Each ml contains 25 mg of monepantel
Maltese: Kull ml fih 25 mg ta' monepantel
English: The efficacy has not been established in sheep weighing less than 10 kg.
Maltese: L-effikaċja ma ġietx stabbilita fi ħrief li jiżnu inqas minn 10kg.
English: 4.11 Withdrawal period(s)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: Increasing refugia (i.e. a source of parasites which have not been exposed to the anthelmintic) has been demonstrated to delay the development of resistance.
Maltese: Ġie demostrat li żjieda ta' refugia (i.e. sors ta' parassiti li ma ġewx esposti għall-mediċina antiparassitarja) iddewwem l-iżvilupp ta' reżistenza.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Maltese: L-addittivi elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: • Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
Maltese: • Użu frekwenti ħafna u ripetut ta' antelmintiċi mill-istess klassi, fuq perjodu ta' żmien estiż.
English: Not authorised for use in animals producing milk for human consumption.
Maltese: Mhux awtorizzat għall-użu f'annimali li qed jipproduċu ħalib għall-konsum uman.
English: PACKAGE LEAFLET: ZOLVIX 25 mg/ml oral solution for sheep
Maltese: ZOLVIX 25 mg/ml soluzzjoni orali għan-nagħaġ
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse effects were observed after a 10-fold overdose.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) jekk ikun hemm bżonn Ebda effett avvers ma ġie osservat wara doża eċċessiva għal għaxar darbiet.
English: This is the first biological function to be described for the Hco-MPTL-1 receptor and therefore monepantel is effective against nematodes resistant to other anthelmintic classes.
Maltese: Din hija l-ewwel funzjoni bijoloġika li qiegħda tiġi deskritta għar-riċettur Hco-MPTL-1 u għalhekk, monepantel huwa effettiv kontra nematodi reżistenti għal klassijiet antelmintiċi oħrajn.
English: Interaction with other medicinal products and other forms of interaction: No interaction with other medicinal products and other forms of interaction are known.
Maltese: Ma hija magħrufa l-ebda interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni.
English: Thus, the risk assessment is based on a potential worst case scenario, which would be a partially combined exposure to the highest levels of NDEA for 4 years (2011 - 2015) and to NDMA for 6 years (2012 - 2018) reported from a sartan, resulting in a cumulative theoretical excess cancer risk of 29.5:100,000 or 1:3390 (0.029%) when extrapolated from the available rat studies according to ICH M7(R1).
Maltese: Għalhekk, il-valutazzjoni tar-riskju hija bbażata fuq l-agħar xenarju possibbli, li jkun l-espożizzjoni parzjali magħquda mal-ogħla livelli ta' NDEA għal 4 snin (2011 - 2015) u mal-NDMA għal 6 snin (2012 - 2018) irrappurtati minn sartan, li tirriżulta f'riskju kumulattiv teoretiku eċċessiv ta' kanċer ta' 29.5:100,000 jew 1:3390 (0.029%) meta estrapolat mill-istudji talfirien disponibbli skont ICH M7(R1).
English: Assessment of the excess risk of cancer
Maltese: Valutazzjoni tar-riskju żejjed tal-kanċer
English: In addition to NDMA and NDEA, other N-nitrosamines have been detected in a few sartan-containing medicinal products.
Maltese: Minbarra l-NDMA u n-NDEA, N-nitrosamini oħra ġew skoperti fi ftit prodotti mediċinali li fihom is-sartan.
English: Appropriate regulatory actions (such as quarantine or batch recalls) have been taken where relevant.
Maltese: Azzjonijiet regolatorji xierqa (bħal kwarantina jew ġbir lura tal-lott) ittieħdu fejn relevanti.
English: Implement a control strategy to detect and control N-nitrosamine impurities in the API (or intermediate, if justified).
Maltese: L-implimentazzjoni ta' strateġija ta' kontroll biex jiġu skoperti u kkontrollati impuritajiet Nnitrosamina fl-API (jew intermedji, jekk iġġustifikati).
English: • During this period, NDMA and NDEA impurities in the API should be controlled for a transition period at limits calculated based on the principles of ICH M7(R1) using validated assays
Maltese: • Matul dan il-perjodu, l-impuritajiet NDMA u NDEA fl-API għandhom ikunu kkontrollati għal perjodu ta' transizzjoni fil-limiti kkalkulati bbażati fuq il-prinċipji ta' ICH M7(R1) bl-użu ta' analiżi vvalidati
English: Obligatory risk assessments to be performed for manufacturing processes of the drug substances in order to evaluate the theoretical risk of N-nitrosamine formation and contamination
Maltese: Valutazzjonijiet obbligatorji tar-riskju li għandhom jitwettqu għall-proċessi tal-manifattura tassustanzi tal-mediċina sabiex jiġi evalwat ir-riskju teoretiku tal-formazzjoni u l-kontaminazzjoni ta' Nnitrosamina
English: The CHMP also carried out a risk assessment for patients previously exposed to NDMA and NDEA in sartans and calculated daily intake levels based on the principles of ICH M7(R1) which are associated with an additional lifetime risk of 1 in 100,000 patients.
Maltese: Is-CHMP wettaq ukoll valutazzjoni tar-riskju għal pazjenti li qabel kienu esposti għal NDMA u NDEA f'sartani u kkalkula livelli ta' konsum ta' kuljum ibbażati fuq il-prinċipji ta' ICH M7(R1) li huma assoċjati ma' riskju addizzjonali matul il-ħajja ta' 1 minn kull 100,000 pazjent.
English: Nitrosamines are chemically simple molecules and can be formed in pharmaceutical manufacturing steps whenever there is a presence of a secondary (or tertiary) amines and nitrites, usually in acidic conditions.
Maltese: In-nitrosamini huma molekuli kimikament sempliċi u jistgħu jiġu ffurmati fi stadji tal-manifattura farmaċewtiċi kull meta jkun hemm preżenza ta' amini u nitriti sekondarji (jew terzjarji), ġeneralment f'kundizzjonijiet aċidużi.
English: • After the transition period, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented, which reflects the lowest quantifiable level based on capability of the available analytical methods.
Maltese: • Wara l-perjodu ta' transizzjoni, għandu jiġi implimentat limitu għall-NDMA u l-NDEA ta' massimu ta' 0.03 ppm, li jirrifletti l-inqas livell kwantifikabbli bbażat fuq il-kapaċità tal-metodi analitiċi disponibbli.
English: In addition, advancing age, comorbidity and use of anticoagulants were found to be strongly associated with both gastrointestinal and non-gastrointestinal complications.
Maltese: Barra minn hekk, l-età avvanzata, ilkomorbidità u l-użu ta' antikoagulanti nstabu li huma assoċjati sew kemm mal-kumplikazzjonijiet gastrointestinali kif ukoll dawk mhux gastrointestinali.
English: • CHMP could not identify cancer screening methods that patients would benefit from, considering the uncertainty of the target organ(s) of NDMA/NDEA toxicity in humans and the risks of measures to monitor patients such as colonoscopy or gastroscopy which may exceed the theoretical excess cancer risk.
Maltese: • Is-CHMP ma setax jidentifika metodi ta' skrinjar tal-kanċer li minnhom jibbenefikaw il-pazjenti, meta titqies l-inċertezza tal-organu/organi fil-mira tat-tossiċità NDMA/NDEA fil-bnedmin u rriskji ta' miżuri biex jissorveljaw pazjenti bħal kolonoskopija jew gastroskopija li jistgħu jaqbżu r-riskju teoretiku eċċessiv ta' kanċer.
English: Whilst the measures are focused on NDMA and NDEA, the principles used in this procedure in terms of toxicology assessment, control strategy and changes to the manufacturing processes for drug substances should be applied by analogy to other nitrosamines.
Maltese: Filwaqt li l-miżuri huma ffokati fuq NDMA u NDEA, il-prinċipji użati f'din il-proċedura f'termini ta' valutazzjoni tossikoloġika, strateġija ta' kontroll u bidliet fil-proċessi ta' manifattura għal sustanzi mediċinali għandhom jiġu applikati b'analoġija għal nitrosamini oħra.
English: In this regard, a limit of quantification of 0.03 ppm for NDMA and NDEA would be achievable according to the available data on analytical methods.
Maltese: F'dan ir-rigward, limitu ta' kwantifikazzjoni ta' 0.03 ppm għal NDMA u NDEA jista' jinkiseb skont id-data disponibbli dwar metodi analitiċi.
English: In case of identification of other nitrosamines, this should be forthwith reported to the competent authorities, together with a toxicology assessment of the impurity, a clinical assessment for the exposed patients, a root cause analysis and a corrective action plan (e.g. changes to the manufacturing process).
Maltese: Fil-każ ta' identifikazzjoni ta' nitrosamini oħra, dan għandu jiġi rrappurtat minnufih lill-awtoritajiet kompetenti, flimkien ma' valutazzjoni tossikoloġika tal-impurità, valutazzjoni klinika għall-pazjenti esposti, analiżi tal-għeruq tal-kawża u pjan ta' azzjoni korrettiva (eż. bidliet fil-proċess ta' manifattura).
English: The determination of an acceptable intake (AI) is based on extrapolation of carcinogenic risk from rodent carcinogenicity data, as the dose resulting in one cancer case among 100,000 individuals exposed for a life-time to the impurity.
Maltese: Id-determinazzjoni ta' konsum aċċettabbli (AI, acceptable intake) hija bbażata fuq estrapolazzjoni ta' riskju karċinoġeniku minn data ta' karċinoġeniċità ta' rodituri, bħala ddoża li tirriżulta f'każ ta' kanċer wieħed fost 100,000 individwu esposti tul il-ħajja kollha għall-impurità.
English: Additional measures are needed to minimise prospectively the reoccurrence of such contamination.
Maltese: Miżuri addizzjonali huma meħtieġa biex prospettivament jimminimizzaw ir-ripetizzjoni ta' tali kontaminazzjoni.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for products containing candesartan, irbesartan, losartan, olmesartan, valsartan.
Maltese: Għalhekk, is-CHMP jirrakkomanda l-varjazzjoni tat-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali li fihom candesartan, irbesartan, losartan, olmesartan, valsartan.
English: The limit of 0.03 ppm for NDMA and NDEA will be enforceable after a transitional period of 2 years from the notification of the Commission Decision.
Maltese: Il-limitu ta' 0.03 ppm għall-NDMA u l-NDEA għandu jkun infurzabbli wara perjodu tranżitorju ta' sentejn min-notifika tad-Deċiżjoni tal-Kummissjoni.
English: • In case of detection of other N-nitrosamines this should be forthwith reported to the competent authorities, together with a toxicology assessment of the impurity, a clinical assessment for the exposed patients, a root cause analysis and a corrective action plan.
Maltese: • Fil-każ ta' identifikazzjoni ta' N-nitrosamini oħra, dan għandu jiġi rrappurtat minnufih lillawtoritajiet kompetenti, flimkien ma' valutazzjoni tossikoloġika tal-impurità, valutazzjoni klinika għall-pazjenti esposti, analiżi tal-għeruq tal-kawża u pjan ta' azzjoni korrettiva.
English: • A two-year transition period) is considered acceptable to change production processes to achieve syntheses in which N-nitrosamines are not formed, to adopt analytical methods for the control strategy and in order to avoid product shortages.
Maltese: • Perjodu ta' transizzjoni ta' sentejn huwa kkunsidrat aċċettabbli biex jinbidlu l-proċessi talproduzzjoni biex jinkisbu sinteżi li fihom in-N-nitrosamini ma jiġux iffurmati, biex jiġu adottati metodi analitiċi għall-istrateġija ta' kontroll u biex jiġu evitati nuqqasijiet ta' prodotti.
English: The above stated very small theoretical risk has to be balanced against the risks of potential measures to monitor patients such as colonoscopy or gastroscopy which may exceed the theoretical excess cancer risk.
Maltese: Ir-riskju teoretiku żgħir ħafna ddikjarat hawn fuq għandu jiġi bbilanċjat mar-riskji ta' miżuri potenzjali għall-monitoraġġ ta' pazjenti bħal kolonoskopija jew gastroskopija li jistgħu jaqbżu r-riskju teoretiku eċċessiv tal-kanċer.
English: An interim limit based on daily intakes according to principles in ICH M7(R1) using toxicology data are set in order to control these impurities in the meantime at an acceptable level.
Maltese: Limitu interim ibbażat fuq konsum ta' kuljum skont ilprinċipji fl-ICH M7(R1) bl-użu ta' data tossikoloġika huwa stabbilit sabiex sadanittant dawn limpuritajiet jiġu kkontrollati f'livell aċċettabbli.
English: A full risk assessment for patients previously exposed to NDMA and/or NDEA impurities in sartans, especially valsartan which was found to contain the highest nitrosamine contamination, is not possible as the real extent of exposure of patients is unknown.
Maltese: Valutazzjoni sħiħa tar-riskju għal pazjenti li qabel kienu esposti għal impuritajiet ta' NDMA u/jew NDEA f'sartani, speċjalment valsartan li nstab li kien fiha l-ogħla kontaminazzjoni ta' nitrosamina, mhijiex possibbli minħabba li l-estent ta' espożizzjoni tal-pazjenti mhuwiex magħruf.
English: However, it should be noted that nitrosamines can also be formed in many other situations, including in biological processes.
Maltese: Madankollu, ta' min jinnota li n-nitrosamini jistgħu jiġu ffurmati wkoll f'ħafna sitwazzjonijiet oħra, inkluż fi proċessi bijoloġiċi.
English: Overall, taking into account the available data assessed in this procedure, the benefit risk balance of medicines containing a sartan with a tetrazole ring remains positive subject to the conditions imposed.
Maltese: B'mod ġenerali, meta titqies id-data disponibbli evalwata f'din il-proċedura, il-bilanċ bejn il-benefiċċju u r-riskju ta' mediċini li fihom sartan b'ċirku ta' tetrazole jibqa' pożittiv soġġett għall-kundizzjonijiet imposti.
English: 1 June 2018
Maltese: 1 ta' Ġunju 2018