FrancophonIA/ELRC3.0 huggingface dataset:
English: The two related adverse events were reported in the same patient who received 30/60 U of Xeomin (one injection site pain and one dysphagia).
Maltese: Iż-żewġ episodji sekondarji relatati kienu rappurtati fl-istess pazjent li kien ingħata 30/60 U ta' Xeomin (uġigħ fis-sit ta' l-injezzjoni u tbatija biex jibla').
English: Spasmodic torticollis The following adverse reactions were reported with Xeomin:
Maltese: Spażmodika Dawn ir-reazzjonijiet avversi li ġejjin kienu rrappurtati b'Xeomin:
English: Dysphagia appears to be dose-dependent.
Maltese: Id-disfaġja tidher li tiddependi mid-doża.
English: Uncommon: breathing difficulties (dyspnoea), double vision (diplopia), drooping eyelid (ptosis), voice alteration, fever
Maltese: diffikultajiet biex tibla' (disfaġja), dgħjufija fil-muskoli, uġigħ fid-dahar
English: EXPIRY DATE EXP: MM/YYYY
Maltese: It-Trattament ta' l-Istudju Il-punt tal-kejl primarju
English: Native Botulinum toxin is a high molecular weight complex, which, in addition to the neurotoxin (150 kD) contains other non-toxic proteins, like haemagglutinins and nonhaemagglutinins.
Maltese: It-tossina tal-Botulinum nattiva hi kumpless b'piż molekulari għoli, li, flimkien mannewrotossina (150 kD) fiha proteini oħrajn mhux tossiċi, bħal emagglutinini u nonemagglutinini.
English: Xeomin has been developed with the aim of reducing the risk of formation of neutralising antibodies, which may lead to secondary therapy failure.
Maltese: Xeomin ġie żviluppat bil-għan li jnaqqas ir-riskju tal-formazzjoni ta' antikorpi newtralizzanti, li tista' twassal għal falliment sekondarju tat-terapija.
English: Uncommon: muscle weakness, pins and needles (paraesthesia), headache, inflammation of the conjunctiva (conjunctivitis), dry mouth, skin rash, inflicted injury
Maltese: Mhux komuni: diffikultajiet biex tieħu n-nifs (dispnea), tara doppju (diplopja), tebqet il-għajn imdendla (ptosi), bidla fil-vuċi, deni
English: Xeomin has a protein content of only 0,6 ng/100U as it only consists of the 150 kDa neurotoxin, free from complexing proteins.
Maltese: Xeomin għandu kontenut tal-proteini ta' 0,6 ng/100U biss għax jikkonsisti biss min-newrotossin tal150 kDa, mingħajr proteini komplessanti.
English: Theoretically, the effect of Xeomin may be increased by:
Maltese: Teoretikament, l-effett ta' Xeomin jista' jiżdied b':
English: There have been rare reports of undesirable effects related to cardiovascular system, such as arrhythmia and myocardial infarction, some with fatal outcomes.
Maltese: Kien hemm rapporti rari ta' effetti mhux mixtieqa relatati mas-sistema kardjovaskulari, bħal arritmija u infart mijokardijaku, x'uħud b'riżultati fatali.
English: Reproductive toxicity studies with Xeomin, performed in rabbits, did not show adverse effects on male or female fertility nor direct effects on embryo-foetal development.
Maltese: Studji dwar it-tossiċità riproduttiva b'Xeomin, li twettqu fil-fniek, ma wrew l-ebda effetti avversi fuq il-fertilità fl-irġiel jew fin-nisa, u lanqas effetti diretti fuq l-iżvilupp embrijo-fetali.
English: Hypersensitivity to the active substance Botulinum neurotoxin type A or to any of the excipients.
Maltese: Sensittività eċċessiva għas-sustanza attiva Botulinum newrotossina ta' tip A jew għal xi sustanzi mhux attivi.
English: Ecchymosis easily occurs in the soft tissues of the eyelid.
Maltese: Tikkettjar adegwat u fuljetti għall-pazjenti.
English: EXPIRY DATE EXP: MM/JJJJ
Maltese: tebqet il-għajn imdendla (ptosi), għajnejn xotti
English: swelling of eyelid
Maltese: TWISSIJA/IET SPEĊJALI
English: Retrograde transsynaptic passage of active Botulinum neurotoxin type A into the central nervous system however has not been found.
Maltese: Madankollu, ma ġiex identifikat il-passaġġ retrogradu transsinattiku ta' Botulinum newrotossina attiva ta' tip A ġossistema nervuża ċentrali.
English: HDA tests are performed at baseline and repeatedly during the course of the study and the results which are, amongst others, available for 107 patients after the 2nd injection cycle and for 73 patients four weeks after 3rd injection did not show any neutralising antibodies.
Maltese: Isiru testijiet ta' l-HDA fil-bidu u ripetutament matul l-istudju u r-riżultati li huma, fost l-oħrajn, disponibbli għal 107 pazjenti wara t-2 ċiklu ta' l-injezzjonijiet u għal 73 pazjent erba' ġimgħat wara t-3 ċiklu ta' injezzjonijiet ma wrew l-ebda antikorpi newtralizzanti.
English: As with any medicine, an allergic reaction may occur with Xeomin.
Maltese: Bħal ma jiġri bi kwalunkwe mediċina, tista' sseħħ reazzjoni allerġika b'Xeomin.
English: (peripheral neuromuscular dysfunction)
Maltese: Disturbi fis-sistema nervuża
English: The clinical effects of Botulinum neurotoxin type A can increase or decrease by repeated injections.
Maltese: L-effetti kliniċi ta' Botulinum newrotossina ta' tip A jistgħu jiżdiedu jew jitnaqqsu minn injezzjonijiet ripetuti.
English: Rare reports of severe allergic (anaphylactic) reactions after injection of a conventional preparation containing the Botulinum toxin type A complex have been received.
Maltese: Inkitbu rapporti rari ta' reazzjonijiet severi allerġiċi (anafilattiċi) wara injezzjoni ta' preparazzjoni konvenzjonali li fiha kumpless tat-tossina Botulinum ta' tip A.
English: Xeomin is injected into the medial and lateral orbicularis oculi of the upper lid and the lateral orbicularis oculi of the lower lid. Additional sites in the brow area, the lateral orbicularis and in the upper facial area may also be injected if spasms here interfere with vision.
Maltese: Xeomin ikun injettat ġol-orbicularis oculi medjali u laterali tal-kappell tal-għajn, in-naħa ta' fuq u t'isfel.
English: In clinical trials with Botulinum toxin type A complex it was reported that dysphagia occurs less frequently with total doses below 200 U per treatment session.
Maltese: Fi provi kliniċi bil-kumpless tattossina Botulinum ta' tip A, kien irrappurtat li d-disfaġja sseħħ inqas b'mod frekwenti b'dożi totali taħt 200 U f' kull sessjoni ta' kura.
English: VIAL LABEL
Maltese: L-indikazzjonijiet kollha
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fuq l-annimali wrew tossiċità riproduttiva (ara sezzjoni 5.3). Ir-riskju potenzjali għall-bnedmin mhuwiex magħruf.
English: An anaphylactic reaction may occur rarely after injection of Botulinum neurotoxin type A (see section 4.8).
Maltese: Reazzjoni anafilattika tista' sseħħ b'mod rari wara l-injezzjoni ta' Botulinum newrotossina ta' tip A (ara sezzjoni 4.8).
English: This disease leads to a wasting of muscle tissue.
Maltese: tessut tal-muskoli.
English: The treatment of twisted neck may cause swallowing difficulties with varying degrees of severity.
Maltese: Il-kura ta' għonq mgħawweġ tista' tikkawża diffikultajiet biex tibla' bi gradi diversi ta' severità.
English: Selamectin
Maltese: Selamektin
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom to treat biting lice in cats and dogs,
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom biex jikkura l-qamel li jigdem fil-qtates u l-klieb,
English: It is available as a spot-on solution in 2 different concentrations (6% and 12%) and in tubes of various strengths (15, 30, 45, 60, 120, 240 and 360 mg).The concentration and the strength to use depends on the weight and species of the animal being treated.
Maltese: Jiġi bħala soluzzjoni spot-on f'2 konċentrazzjonijiet differenti (6% u 12%) u f'tubi f'diversi qawwiet (15, 30, 45, 60, 120, 240 u 360 mg).
English: Other information about Stronghold:
Maltese: Informazzjoni oħra dwar Stronghold:
English: Stronghold is an antiparasitic medicine that contains the active substance selamectin.
Maltese: Stronghold huwa mediċina antiparassitika li fiha s-sustanza attiva s-selamektin.
English: In field studies, it reduced the flea comb counts by up to 98% in cats and 99% in dogs 90 days after treatment, as well as preventing flea eggs from hatching, and killing and preventing the development of flea larvae.
Maltese: Fl-istudji fuq il-post, huwa naqqas l-għadd ta' briegħed b'sa 98% fil-qtates u 99% fil-klieb wara l-kura, kif ukoll fil-prevenzjoni tat-tfaqqis tal-bajd, u fil-qtil u l-prevenzjoni tal-iżvilupp tal-larva tal-briegħed.
English: to treat sarcoptic mange (scabies) in dogs.
Maltese: biex jikkura sarcoptic mange (skabbja) fil-klieb.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stronghold on 25 November 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Stronghold fil-25 ta' Novembru 1999.
English: Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity.
Maltese: Is-selamektin tattiva proteini speċjali magħrufa bħala ‘kanali tal-klorur' fuq is-superfiċje taċ-ċelloli tan-nervituri u tal-muskoli tal-parassita, u b'hekk tippermetti li partiċelli tal-klorur iċċarġjati jidħlu fiċ-ċelloli tan-nervituri u jħarbtu l-attività elettrika normali tagħhom.
English: Stronghold contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin' class.
Maltese: Stronghold fih is-selamektin, li hi mediċina antiparassitika li tagħmel parti mill-klassi magħrufa bħala ‘avermektin'.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni abbażi tar-rakkomandazzjonijiet tal-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: In the treatment of sarcoptic mange in dogs, two treatments given 30 days apart were required to completely eliminate the mites in dogs.
Maltese: Filkura tal-mard sarcoptic mange fil-klieb, kien hemm bżonn ta' żewġ kuri bi 30 jum differenza bejn kura u oħra biex jeliminaw kompletament id-dud iż-żgħir fil-klieb.
English: It can also be used as part of a treatment for flea allergy dermatitis (skin inflammation), to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and intestinal hookworms in cats, to treat adult intestinal roundworms in dogs,
Maltese: Jista' jintuża wkoll bħala parti mill-kura għal dermatite allerġika għall-briegħed (infjammazzjoni tal-ġilda), biex jipprevjeni l-marda heartworm fil-qtates u l-klieb, biex jikkura d-dud iż-żgħir fil-widnejn tal-klieb u l-qtates, biex jikkura r-roundworms intestinali adulti u l-hookworms intestinali fil-qtates, biex jittratta r-roundworms intestinali adulti fil-klieb,
English: Stronghold causes temporary alopecia (hair loss) at the application site in less than 1 in 1,000 cats.
Maltese: Stronghold jikkawża alopeċja temporarja (telf ta' xagħar) fuq is-sit tal-applikazzjoni f'inqas minn 1 minn kull 1,000 qattus.
English: How has Stronghold been studied?
Maltese: Kif ġie studjat Stronghold?
English: Stronghold was also effective in the treatment of adult intestinal hookworms in cats, adult intestinal roundworms in cats and dogs, and biting lice in dogs and cats.
Maltese: Stronghold kien effettiv ukoll fil-kura ta' hookworms intestinali adulti fil-qtates, roundworms intestinali adulti fil-qtates u l-klieb, u qamel li jigdem fil-klieb u l-qtates.
English: The effectiveness of Stronghold against the specified parasites was investigated in laboratory studies in cats and dogs.
Maltese: L-effikaċja ta' Stronghold kontra l-parassiti speċifikati ġiet investigata fi studji fil-laboratorju fuq ilqtates u l-klieb.
English: Field studies also showed that Stronghold was 100% effective in preventing heartworm disease in dogs and cats.
Maltese: Listudji fuq il-post urew ukoll li Stronghold kien 100% effettiv fil-prevenzjoni tal-marda heartworm disease fil-klieb u l-qtates.
English: Stronghold may produce clumping of the hair at the application site or the appearance of a small quantity of a white powder in less than 1 in 1,000 cats.
Maltese: Stronghold jista' jipproduċi tagħqid tax-xagħar fuq is-sit tal-applikazzjoni jew id-dehra ta' kwantità żgħira ta' trab abjad f'inqas minn 1 minn kull 1,000 qattus.
English: What is the risk associated with Stronghold?
Maltese: X'inhu r-riskju assoċjat ma' Stronghold?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Stronghold exceed the risks for the approved indications and recommended that Stronghold be given a marketing authorisation.
Maltese: ll-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Stronghold huma akbar mir-riskji tiegħu għall-indikazzjonijiet approvati, u għaldaqstant irrakkomanda li Stronghold jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċji u r-riskji jista' jinstab fil-modulu ta' diskussjoni xjentifika ta' dan l-EPAR.
English: Why has Stronghold been approved?
Maltese: Għaliex ġie approvat Stronghold?
English: This summary was last updated in January 2015.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'Jannar 2015.
English: Denmark Intervet Danmark A/S.
Maltese: Danimarka Intervet Danmark A/S.
English: Pol. Ind. El Montalvo I C/ Zeppelin, 6
Maltese: Ind. El Montalvo I C/ Zeppelin, 6
English: Slovakia Ceva AH Slovakia Račianska 77, 831 02
Maltese: Slovakkja Ceva AH Slovakia Račianska 77, 831 02
English: Denmark Ceva Animal Health A/S, Ladegårdsvej 2
Maltese: Danimarka Ceva Animal Health A/S, Ladegårdsvej 2
English: Slovenia Ceva Santé Animale 10 avenue de La
Maltese: Slovenja Ceva Santé Animale 10 avenue de La
English: Ireland Intervet Ireland Limited Magna Drive
Maltese: Irelanda Intervet Ireland Limited Magna Drive
English: Belgium Ceva Santé Animale N.V. Metrologielaan 6
Maltese: Belġjum Ceva Santé Animale N.V. Metrologielaan 6
English: Slovakia Intervet Ltd Cookstown
Maltese: Slovakkja Intervet Ltd Cookstown
English: Belgium MSD Animal Health BVBA Lynx Binnenhof 5
Maltese: Belġjum MSD Animal Health BVBA Lynx Binnenhof 5
English: Lithuania Ceva Sante Animale ZI La Ballastiere
Maltese: Litwanja Ceva Sante Animale ZI La Ballastiere
English: Poland Ceva Animal Health Polska Sp. z o.o.
Maltese: Polonja Ceva Animal Health Polska Sp. z o.o.
English: Altrenogest is a synthetic steroidal hormone, an orally active progestogen.
Maltese: Altrenogest huwa ormon sterojde sintetiku, proġestoġen oralment attiv.
English: Ceva Salute Animale Viale Colleoni, 15 20864 Agrate Brianza Italy
Maltese: Ceva Salute Animale Viale Colleoni, 15 20864
English: Ceva Animal Health Ltd Unit 3 Anglo Office Park White Lion Road Amersham
Maltese: Renju Unit Ceva Animal Health Ltd Unit 3 Anglo Office Park White Lion Road
English: The results from STEP 4 ranged from 16 pg/l (R1) to 219 pg/l (R3).
Maltese: Irriżultati minn PASS 4 varjaw minn 16 pg/l (R1) għal 219 pg/l (R3).
English: Germany CEVA Tiergesundheit GmbH
Maltese: Germanja CEVA Tiergesundheit GmbH
English: Germany Intervet Deutschland GmbH
Maltese: Germanja Intervet Deutschland GmbH
English: 1 CVMP guideline on environmental impact assessment for veterinary medicinal products in support of VICH GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf 2 VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004394.pdf
Maltese: 1 Linja Gwida tas-CVMP dwar il-valutazzjoni tal-impatt ambjentali għal prodotti mediċinali veterinarji f'appoġġ għal VICH GL6 u GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf 2 Linja gwida tal-VICH GL6: dwar il-valutazzjoni tal-impatt ambjentali (VIA) għall-prodotti mediċinali veterinarji - Fażi I http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004394.pdf
English: 3 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/03/WC500104495.pdf OECD guideline for the testing of chemicals 307
Maltese: 3 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/03/WC500104495.pdf Linja gwida 307 tal-OECD għall-ittestjar tal-kimiċi ta' dixxendenti).
English: Pigs
Maltese: FOR PIGS
English: Extrapolation of EC10 values was not possible, in line with the recommendations of the OECD 54 guideline on Current Approaches in the Statistical Analysis of Ecotoxicity Data: A Guidance to Application (2006)5.
Maltese: Linja gwida 54 tal-OECD dwar Current Approaches in the Statistical Analysis of Ecotoxicity Data: A Guidance to
English: The aerobic transformation of altrenogest was investigated in four different soils (OECD Test Guideline 3074 (21.1 ± 0.1 °C for 21 days)).
Maltese: It-trasformazzjoni aerobika ta' altrenogest kienet investigata f'erba' ħamriji differenti (Linja Gwida tat-Testijiet 307 tal-OECD4 (21.1 ± 0.1 °C għal 21 jum)).
English: Ireland Ceva Sante Animale 10, avenue de La
Maltese: Irelanda Ceva Sante Animale 10, avenue de La Ballastiere
English: Intervet UK Ltd Walton Manor Walton
Maltese: Renju Unit Intervet UK Ltd Walton Manor
English: Romania Intervet International B.V Wim de Korverstr.35
Maltese: Rumanija Intervet International B.V Wim de Korverstr.35
English: The anaerobic transformation of altrenogest was investigated in pig manure incubated anaerobically according to the CVMP guideline on determining the fate of veterinary medicinal products in manure (EMA/CVMP/ERA/430327/2009)3.
Maltese: It-trasformazzjoni anaerobika ta' altrenogest ġiet investigata fid-demel tal-ħnieżer inkubati b'mod anaerobiku skont il-linja gwida tas-CVMP dwar id-determinazzjoni tad-destin tal-prodotti mediċinali veterinarji fid-demel (EMA/CVMP/ERA/430327/2009)3.
English: The anaerobic and aerobic degradation of altrenogest were investigated for altrenogest in manure and soil, respectively.
Maltese: Id-degradazzjoni anaerobika u aerobika ta' altrenogest ġiet investigata għal altrenogest fid-demel u l-ħamrija, rispettivament.
English: Intervet GmbH Siemensstraße 107 1210 Wien Austria
Maltese: Awstrija Intervet GmbH Siemensstraße 107
English: Metabolism data
Maltese: Dejta dwar il-metaboliżmu
English: Intervet International Wim de Korverstraat 35 P.O.
Maltese: Intervet International Wim de Korverstraat 35 P.O. Box 31
English: Of the total radioactivity in urine, 2% was identified as altrenogest and 24% as altrenogest conjugates, corresponding to 0.5% to 6% of the total dose.
Maltese: Mir-radjuattività totali fl-awrina, 2% kienu identifikati bħala altrenogest u 24% bħala konjugati ta' altrenogest, li jikkorrespondu għal 0.5% sa 6% taddoża totali.
English: After 45 days, altrenogest and its transformation products (the latter at or above 10%) were not detected in the manure using high performance liquid chromatography- radiochromatography (HPLC-RAM) and liquid chromatography tandem mass spectrometry (LC/MS-MS) (mean of two replicates).
Maltese: Wara 45 jum, altrenogest u l-prodotti ta' trasformazzjoni tiegħu (tal-aħħar fi jew 'il fuq minn 10%) ma kinux osservati fid-demel bl-użu ta' kromatografija likwida ta' prestazzjoni għolja - radjukromatografija (HPLC-RAM) u kromatografija likwida - spettrometrija tal-massa (LC-MS/MS) (medja ta' żewġ repliki).
English: Based on a PNEC <40 pg/l as well as the PECsurfacewater values from the scenarios above (release factor: 0.31, application rate of 0.094 g/ha) a risk was identified in STEP 4 for the R3 scenario (buffer zone 1-10 m), with risk quotients (RQs) of 3.29 (1 m), 2.84 (3 m), 2.59 (5 m), and 2.18 (10 m).
Maltese: Abbażi ta' PNEC <40 pg/l kif ukoll ta' valuri tal-PECilma tal-wiċċ mix-xenarji ta' hawn fuq (fattur ta' rilaxx: 0.31, rata ta' applikazzjoni ta' 0.094 g/ha) ġie identifikat riskju f'PASS 4 għax-xenarju R 3 (żona ta' lqugħ 1-10m), bi kwozjenti ta' riskju (RQs) ta' 3.29 (1 m), 2.84 (3 m), 2.59 (5 m), u 2.18 (10 m).
English: Results show that the dissipation time (DT50) of altrenogest in manure was 6.0 days (20±2 °C).
Maltese: Ir-riżultati juru li l-ħin ta' dissipazzjoni (DT50) ta' altrenogest fid-demel kien ta' 6.0 ijiem (20±2 °C)
English: A PECsoil refined of 0.013 µg/kg was determined accordingly, resulting on an application rate of 0.000094 kg/ha.
Maltese: PECħamrija raffinata ta' 0.013 µg/kg ġiet iddeterminata kif xieraq, u dan irriżulta f'rata ta' applikazzjoni ta' 0.000094 kg/ha.
English: Of the total radioactivity in bile, 6% was altrenogest (after multiple dose) and 14% altrenogest conjugates, corresponding to 4.5% to 10.5% of the total dose.
Maltese: Mir-radjuattività totali fil-bila, 6% kienu altrenogest (wara doża multipla) u 14% kienu konjugati ta' altrenogest, li jikkorrespondu għal 4.5% sa 10.
English: Following normalisation from the 21.1 °C study temperature to standard 20°C laboratory conditions using the Arrhenius equation (equivalent to a correction factor of 1.11), the DT50 proposed for use in modelling is 6.5 days.
Maltese: Wara n-normalizzazzjoni mit-temperatura ta' studju ta' 21.1 °C għal kundizzjonijiet tallaboratorju ta' 20°C bl-użu tal-ekwazzjoni Arrhenius (ekwivalenti għal fattur ta' korrezzjoni ta' 1.11), id-DT50 propost għall-użu fl-immudellar huwa ta' 6.5 jiem.
English: The DT50 values for soils 1, 2, 3 and 4 are 23.7, 5.3, 2.0, and
Maltese: Il-valuri tad-DT50 għall-ħamriji 1, 2, 3 u 4 huma 23.7, 5.3, 2.0 u 4.6 jiem, rispettivament, li rriżultaw f'valur tad-DT50 ġeometriku medju ta' 5.8 jiem.
English: However, the RQs calculated for the R3 scenario were above the threshold, i.e. 1.67 (1 m), >1.36 (3 m), >1.24 (5 m), and >1.04 (10 m), thus, indicating a risk for the aquatic environment for this scenario.
Maltese: Madankollu, l-RQs ikkalkolati għax-xenarju R3 kienu ogħla mil-limitu, jiġifieri 1.67 (1 m), >1.36 (3 m), >1.24 (5 m), u >1.04 (10 m), għaldaqstant, dawn jindikaw riskju għall-ambjent akwatiku għal dan ix-xenarju.
English: Environmental risk assessment of altrenogest
Maltese: Valutazzjoni tar-riskju ambjentali ta' altrenogest
English: STEP 2 lead to a PECsurfacewater of 245 pg/l, and STEP 3 PECsurfacewater ranged between 16 to 219 pg/l depending on the scenarios considered, with scenario R3 having the highest PECsurfacewater value.
Maltese: PASS 2 wassal għal PECilma tal-wiċċ ta' 245 pg/l, u PECilma tal-wiċċ ta' PASS 3 varjat bejn 16 sa 219 pg/l skont ix-xenarji kkunsidrati, bix-xenarju R3 jkollu l-ogħla valur tal-PECilma tal-wiċċ.
English: Spain aniMedica GmbH Im Sudfeld
Maltese: Spanja aniMedica GmbH Im Sudfeld
English: SPC section 4.5 Special precautions for use.
Maltese: Sezzjoni 4.5 tal-SPC Prekawzjonijiet speċjali għall-użu.
English: The MAHs used this latter value (69% metabolism) for the PECsoil refinement.
Maltese: Il-MAHs użaw dan il-valur tal-aħħar (69% ta' metaboliżmu) għar-raffinament ta' PECħamrija.
English: • the CVMP considered that at present in the EU there is no alternative available for oestrus synchronisation of gilts;
Maltese: • is-CVMP ikkunsidra li bħalissa fl-UE m'hemmx alternattiva disponibbli għas-sinkronizzazzjoni tal-estru tal-qżieqeż nisa żgħar;
English: 1a
Maltese: Feldstr. 1a
English: A PNEC (Predicted No Effect Concentration) of <0.4 ng altrenogest/l was used for the risk assessment.
Maltese: PNEC (Konċentrazzjoni ta' Bla Effett Previst) ta' <0.4 ng altrenogest/l intuża għal din il-valutazzjoni tar-riskju.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwa tal-prodott veterinarju mediċinali, speċi tal-annimal, mod ta'amministrazzjoni, applikant fl-Istati Membri.