FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of Copalia HCT has been evaluated at its maximum dose of 10 mg/320 mg/25 mg in one controlled short-term (8 weeks) clinical study with 2,271 patients, 582 of whom received valsartan in combination with amlodipine and hydrochlorothiazide.
Maltese: Is-sigurtà ta' Copalia HCT ġiet evalwata bl-ogħla doża ta' 10 mg/320 mg/25 mg fi studju kliniku wieħed ikkontrollat li sar fuq perjodu qasir ta' żmien (8 ġimgħat) b'2,271 pazjent, li minnhom 582 irċevew valsartan flimkien ma' amlodipine u hydrochlorthiazide.
English: Other medicines and Copalia HCT
Maltese: Mediċini oħra u Copalia HCT
English: Copalia HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Copalia HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Copalia HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg.
Maltese: Hija rrakkomandata kawtela f'pazjenti b'insuffiċjenza tal-qalb u b'mard tal-arterji koronarji, b'mod partikulari meta tingħata logħla doża ta' Copalia HCT, 10 mg/320 mg/25 mg.
English: Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Maltese: Copalia HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita huma pilloli sofor ċari, ovali b'“NVR” fuq naħa waħda u b'“VDL” fuq in-naħa l-oħra.
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Copalia HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita Is-sustanzi attivi ta' Copalia HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: Copalia HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: Copalia HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),160 mg valsartan, and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 10 mg amlodipine (bħala amlodipine besylate), 160 mg valsartan u 12.5 mg hydrochlorthiazide.
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Copalia HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Copalia HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan, and 25 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 10 mg amlodipine (bħala amlodipine besylate), 160 mg valsartan u 25 mg hydrochlorthiazide.
English: Do not take Copalia HCT with grapefruit or grapefruit juice.
Maltese: Tiħux Copalia HCT ma' grejpfrut jew ma' meraq tal-grejpfrut.
English: EU/1/09/575/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/575/036 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/575/035 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża waħda)
English: EU/1/09/575/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/575/048 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/575/047 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża waħda)
English: Copalia HCT 5 mg/160 mg/25 mg film-coated tablets
Maltese: Copalia HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Copalia HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorothiaziade
English: 56 x 1 film-coated tablet (unit dose) 98 x 1 film-coated tablet (unit dose) 280 x 1 film-coated tablet (unit dose)
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 56 pillola miksija b'rita 90 pillola miksija b'rita 98 pillola miksija b'rita 280 pillola miksija b'rita 56 x pillola 1 miksija b'rita (doża waħda) 98 x pillola 1 miksija b'rita (doża waħda) 280 x pillola 1 miksija b'rita (doża waħda)
English: EU/1/09/575/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/575/060 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/575/059 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża waħda)
English: EU/1/09/575/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/575/012 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/575/011 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża waħda)
English: EU/1/09/575/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Maltese: EU/1/09/575/024 280 pillola miksija b'rita (pakkett multiplu, 20 kartuna b'14-il pillola) EU/1/09/575/023 280 pillola miksija b'rita (pakkett multiplu, 4 kartuniet b'70 pillola) (doża waħda)
English: Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Maltese: TAL-PRODOTT MEDIĊINALI Copalia HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets
Maltese: Copalia HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita
English: Copalia HCT tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide.
Maltese: Il-pilloli Copalia HCT fihom tliet sustanzi li jissejħu amlodipine, valsartan u hydrochlorthiazide.
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets
Maltese: Copalia HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita
English: There are no clinical studies on fertility with Copalia HCT.
Maltese: Ma saru l-ebda studji kliniċi fuq il-fertilità b'Copalia HCT.
English: EU/1/09/575/006 98 film-coated tablets
Maltese: EU/1/09/575/009 98 x pillola 1 miksija b'rita (doża waħda)
English: What Copalia HCT looks like and contents of the pack Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Maltese: Kif jidher Copalia HCT u l-kontenut tal-pakkett Copalia HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita huma pilloli bojod, ovali b'“NVR” fuq naħa waħda u b'“VCL” fuq in-naħa l-oħra.
English: Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets
Maltese: Copalia HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita
English: EU/1/09/575/056 56 x 1 film-coated tablet (unit dose) EU/1/09/575/057 98 x 1 film-coated tablet (unit dose) EU/1/09/575/058 280 x 1 film-coated tablet (unit dose)
Maltese: EU/1/09/575/049 14-il pillola miksija b'rita EU/1/09/575/050 28 pillola miksija b'rita EU/1/09/575/051 30 pillola miksija b'rita EU/1/09/575/052 56 pillola miksija b'rita EU/1/09/575/053 90 pillola miksija b'rita EU/1/09/575/054 98 pillola miksija b'rita EU/1/09/575/055 280 pillola miksija b'rita EU/1/09/575/056 56 x pillola 1 miksija b'rita (doża waħda)
English: Since renal clearance of lithium is reduced by thiazides, the risk of lithium toxicity may presumably be increased further with Copalia HCT.
Maltese: Minħabba li t-tneħħija ta' lithium millkliewi titnaqqas bit-thiazides, ir-riskju ta' tossiċità b'lithium jaf jiżdied aktar b'Copalia HCT.
English: EU/1/09/575/032 56 x 1 film-coated tablet (unit dose) EU/1/09/575/033 98 x 1 film-coated tablet (unit dose) EU/1/09/575/034 280 x 1 film-coated tablet (unit dose)
Maltese: EU/1/09/575/037 14-il pillola miksija b'rita EU/1/09/575/038 28 pillola miksija b'rita EU/1/09/575/039 30 pillola miksija b'rita EU/1/09/575/040 56 pillola miksija b'rita EU/1/09/575/041 90 pillola miksija b'rita EU/1/09/575/042 98 pillola miksija b'rita EU/1/09/575/043 280 pillola miksija b'rita EU/1/09/575/044 56 x pillola 1 miksija b'rita (doża waħda)
English: Therefore, Copalia HCT is not recommended in this population.
Maltese: Għaldaqstant, Copalia HCT mhuwiex irrakkomandat għal din il-popolazzjoni.
English: Medicinal products that could induce torsades de pointes
Maltese: Prodotti mediċinali li jistgħu jwasslu għal torsades de pointes
English: The increase in mean AUC is linear and dose proportional in the therapeutic range.
Maltese: Iżżieda fil-medja tal-AUC hija lineari u fi proporzjon mad-doża fil-medda terapewtika.
English: Grapefruit and grapefruit juice should not be consumed by people who are prescribed Copalia HCT.
Maltese: Grejpfrut u meraq tal-grejpfrut ma għandhomx jiġu kkunsmati minn nies li ngħataw Copalia HCT.
English: It is available as capsules (150 mg).
Maltese: Jiġi bħala kapsuli (150 mg).
English: The full EPAR for Erivedge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Around 33% (11 out of 33) of patients with metastatic disease and 48% (30 out of 63) of patients with locally advanced disease responded to treatment.
Maltese: Madwar 33 % (11 minn 33) tal-pazjenti bil-marda metastatika u 48 % (30 minn 63) tal-pazjenti bilmarda lokalment avvanzata rrispondew għall-kura.
English: This is a summary of the European public assessment report (EPAR) for Erivedge.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Erivedge.
English: Why is Erivedge approved?
Maltese: Għal xiex ġiet approvat Erivedge?
English: Vismodegib attaches to a protein called ‘SMO', which is involved in activating the Hedgehog signalling pathway.
Maltese: Il-vismodegib teħel ma' proteina magħrufa bħala ‘SMO', li hija involuta fl-attivazzjoni tal-Hedgehog signalling pathway.
English: Other information about Erivedge
Maltese: Informazzjoni oħra dwar Erivedge
English: Erivedge is a cancer medicine that contains the active substance vismodegib.
Maltese: Erivedge huwa mediċina tal-kanċer li fiha s-sustanza attiva vismodegib.
English: Erivedge was studied in one main study involving 104 patients with either metastatic or locally advanced basal cell carcinoma.
Maltese: Erivedge kien studjat fi studju ewlieni wieħed li fih ħadu sehem 104 pazjenti jew b'karċinoma taċċellola bażali metastatika jew lokalment avvanzata.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Erivedge on 12 July 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Erivedge fit-12 ta' Lulju 2013.
English: It is used to treat adults with basal cell carcinoma (a slow-growing form of skin cancer) in advanced stages: when the cancer is metastatic (has spread to other parts of the body) and is causing symptoms, or when it is locally advanced (has started to spread to nearby areas) and is not suitable for surgery or radiotherapy (treatment with radiation).
Maltese: Jintuża fil-kura ta' adulti b'karċinoma taċ-ċellola bażali (forma ta' kanċer tal-ġilda li tikber bil-mod) fi stadji avvanzati: meta lkanċer ikun metastatiku (ikun infirex lejn partijiet oħra tal-ġisem) u jkun qed jikkawża sintomi, jew meta jkun lokalment avvanzat (beda jinfirex lejn żoni fil-qrib) u ma jkunx adattat għal kirurġija jew radjuterapija (kura b'radjazzjoni).
English: Erivedge was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Maltese: Oriġinarjament, Erivedge ngħata ‘approvazzjoni b'kundizzjoni' peress li kien hemm iktar evidenza x'tingħata dwar il-mediċina.
English: The active substance in Erivedge, vismodegib, disrupts the so-called ‘Hedgehog signalling pathway', which is normally involved in regulating the early stages of cell development in unborn babies and certain cell processes in adults.
Maltese: Is-sustanza attiva f'Erivedge, il-vismodegib, tfixkel l-hekk imsejjaħ ‘Hedgehog signaling pathway', li normalment huwa involut fir-regolamentazzjoni tal-istadji bikrin tal-iżvilupp taċ-ċelloli fi trabi fil-ġuf u ċerti proċessi taċ-ċelloli fl-adulti.
English: The most common side effects with Erivedge (seen in more than 3 in 10 people) are muscle spasms, hair loss, taste disturbances, weight loss, tiredness, nausea (feeling sick) and diarrhoea.
Maltese: L-effetti sekondarji l-iktar komuni b'Erivedge (li dehru f'iktar minn 3 persuni minn kull 10) huma spażmi fil-muskoli, telf ta' xagħar, disturbi fit-togħma, telf fil-piż, għeja, nawżja (tħossok ma tiflaħx) u dijarrea.
English: It also considered that the side effects were manageable.
Maltese: Kien ukoll meqjus li l-effetti sekondarji kienu maniġġabbli.
English: What are the risks associated with Erivedge?
Maltese: X'inhuma r-riskji assoċjati ma' Erivedge?
English: The company will implement a pregnancy prevention programme, by providing educational materials on the risks to the unborn baby, including a reminder card, to patients and healthcare professionals who prescribe and dispense Erivedge.
Maltese: Il-kumpanija se timplimenta programm għall-prevenzjoni tat-tqala, billi tipprovdi materjal edukattiv dwar ir-riskji għat-tarbija li għadha ma twelditx, inkluż kard ta' tfakkir, għall-pazjenti u l-professjonisti tal-kura tas-saħħa li jippreskrivu u jagħtu Erivedge.
English: For the full list of all side effects reported with Erivedge, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Erivedge, ara l-fuljett ta' tagħrif.
English: Erivedge must not be used in women who are pregnant or breast-feeding, or who could potentially have children and do not comply with the special pregnancy prevention programme for Erivedge.
Maltese: Erivedge m'għandux jintuża f'nisa tqal jew li qed ireddgħu, jew li potenzjalment jistgħu joħorġu tqal u ma jikkonformawx mal-programm speċjali għall-prevenzjoni tat-tqala għal Erivedge.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Maltese: Peress li l-kumpanija forniet l-informazzjoni addizzjonali meħtieġa lawtorizzazzjoni nbidlet minn approvazzjoni b'kundizzjoni għal approvazzjoni sħiħa.
English: The recommended dose is one capsule once a day.
Maltese: Id-doża rakkomandata hija ta' kapsula waħda darba kuljum.
English: Since Erivedge disrupts the mechanism involved in the early development stages of unborn babies, the CHMP concluded that appropriate measures were needed for both men and women treated with Erivedge to prevent pregnancy during and after stopping treatment.
Maltese: Peress li Erivedge jfixkel ilmekkaniżmu involut fl-istadji bikrin ta' żvilupp ta' trabi fil-ġuf, is-CHMP ikkonkluda li kien hemm ilħtieġa ta' miżuri xierqa kemm għall-irġiel kif ukoll għan-nisa li ġew ikkurati b'Erivedge biex tiġi evitata t-tqala matul il-kura u wara li l-kura titwaqqaf.
English: How does Erivedge work?
Maltese: Kif jaħdem Erivedge?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Erivedge's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Erivedge huma ikbar mir-riskji tiegħu u rrakkomanda li jiġi approvat għall-użu fl-UE.
English: The benefits of continuing treatment should be regularly assessed and the best duration of treatment will vary based on the benefit and side effects experienced by each patient.
Maltese: Il-benefiċċji talkontinwazzjoni tal-kura għandhom jiġu vvalutati b'mod regolari u l-aqwa tul ta' kura ser invarja abbażi tal-benefiċċju u l-effetti sekondarji esperjenzati minn kull pazjent.
English: How is Erivedge used?
Maltese: Kif jintuża Erivedge?
English: In basal cell carcinoma, the Hedgehog signalling pathway becomes abnormally active and leads to the growth and spread of the cancerous cells.
Maltese: Fil-karċinoma taċ-ċellola bażali, il-Hedgehog signaling pathway isir attiv b'mod anormali u jwassal għat-tkabbir u l-firxa taċ-ċelloli kanċerużi.
English: It must not be used together with St John's wort (a herbal medicine used to treat depression).
Maltese: M'għandux jintuża flimkien ma' St John's wort (mediċina erbali li tintuża fil-kura tad-dipressjoni).
English: IM, IV, endo peritoneal
Maltese: IM, IV, endo peritoneali
English: Camí Pedra Estela s/n 43205 Reus (Tarragona) Spain
Maltese: Camí Pedra Estela s/n 43205 Reus (Tarragona)
English: Belgium VMD nv Hoge Mauw 900
Maltese: Il-Belġju VMD nv Hoge Mauw 900
English: 19 300 Aspropyrgos mailbox 26
Maltese: Ir-Rumanija Alapis SA 19 300 Aspropyrgos mailbox 26
English: Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria
Maltese: Il-Bulgarija Biovet JSC 39 Petar Rakov Str. 4550 Peshtera Bulgaria
English: Vetoquinol SA Magny-Vernois 70200 Lure France
Maltese: Vetoquinol SA Magny-Vernois 70200
English: 1ere Avenue 2065 MLID 06516 Carros Cedex France
Maltese: MLID 06516 Carros Cedex France
English: Belgium EMDOKA bvba John Lijsenstraat 16
Maltese: Il-Belġju EMDOKA bvba John Lijsenstraat 16
English: Novo mesto, Šmarješka cesta 6
Maltese: Is-Slovenja KRKA, d.d. Novo mesto, Šmarješka cesta 6
English: Lithuania Interchemie werken "de Adelaar" B.V.
Maltese: Il-Litwanja Interchemie werken "de Adelaar" B.V.
English: WPnew = WPold + {log2(Dnew/Dold) x T1/2(final phase)}
Maltese: WPġdid = WPqadim + {log2(Dġdid/Dqadim) x T1/2(fażi finali)}
English: LABIANA LIFE SCIENCES, S.A.
Maltese: LIFE SCIENCES, S.A.
English: A validated HPLC-MS/MS analytical method was used.
Maltese: Intuża metodu analitiku HPLC-MS/MS validat.
English: Gentaprim trimethoprim gentamicin sulphate sulfadimethoxinum
Maltese: Gentaprim trimethoprim sulfat gentamicin sulfadimethoxinum
English: Dopharma B.V.
Maltese: Dopharma Research B.V.)
English: Interchemie werken "de Adelaar" B.V.
Maltese: Il-Bulgarija Interchemie werken "de Adelaar" B.V.
English: GENTAMICIN KRKA 80 mg/ml raztopina za injiciranje za govedo, prašiče, pse in mačke
Maltese: KRKA 80 mg/ml raztopina za injiciranje za govedo, prašiče, pse in mačke
English: Lithuania Dopharma Research B.V. Zalmweg 24m
Maltese: Il-Litwanja Dopharma Research B.V. Zalmweg 24m
English: PASTEUR - Filiala Filipesti SRL
Maltese: Ir-Rumanija PASTEUR - Filiala Filipesti
English: Cattle (calves up to 250kg)
Maltese: Frat (għoġġiela sa 250 kg)
English: Krka - Farma d.o.o.
Maltese: Il-Kroazja Krka - Farma d.o.o. Radnička cesta 48
English: A GLP compliant study conducted with Gentamicina 4% solucion inyectabile (applicable for Gentacalier 40 mg/ml, Maycoli inyectable 40 mg/ml, Gentavall 40 mg/ml, Vetersan gentamicina 40 mg/ml, Gentamiciven 40 mg/ml and Purmicina 40 mg/ml (MAHs: Laboratorios Calier, Laboratorios Maymo, Super's Diana, Mevet, Laboratorios e Industrias Iven and Cenavisa)) was provided.
Maltese: Ġie pprovdut studju konformi mal-GLP li sar b'Gentamicina 4 % solucion inyectabile (applikabbli għal Gentacalier 40 mg/ml, Maycoli inyectable 40 mg/ml, Gentavall 40 mg/ml, Vetersan gentamicina 40 mg/ml, Gentamiciven 40 mg/ml u Purmicina 40 mg/ml (MAHs: Laboratorios Calier, Laboratorios Maymo, Super's Diana, Mevet, Laboratorios e Industrias Iven u Cenavisa)).
English: Huvepharma AD 33 James Boucher Blvd. Sofia 1407
Maltese: L-Estonja Huvepharma AD 33 James Boucher Blvd.
English: Milk: 7 days.
Maltese: Ħalib: 7 ijiem.
English: Wolfgang Schmälzl Gasse 6 1020 Wien
Maltese: L-Awstrija Vana GmbH Wolfgang Schmälzl Gasse 6 1020
English: Germany Eurovet Animal Health B.V. Handelsweg 25
Maltese: Il-Ġermanja Eurovet Animal Health B.V.
English: VetProm JSC 26, Otets Paisii Str 2400 Radomir Bulgaria
Maltese: Il-Bulgarija VetProm JSC 26, Otets Paisii Str 2400
English: n.v.)
Maltese: V.M.D. n.v.)
English: Residue concentrations in milk were determined 12, 24, 36, 48, 60, 72, 84 and 96 hours after the last administration.
Maltese: Il-konċentrazzjonijiet tar-residwu fil-ħalib ġew stabbiliti 12, 24, 36, 48, 60, 72, 84 u 96 siegħa wara l-aħħar għotja.
English: Overall for the species cattle, three studies allow derivation of withdrawal periods of 103 days for Aagent 50 mg/ml (MAH: Fatro), 192 days for Gentacalier 40 mg/ml, Maycoli inyectable 40 mg/ml, Gentavall 40 mg/ml, Vetersan gentamicina 40 mg/ml, Gentamiciven 40 mg/ml and Purmicina 40 mg/ml (MAHs: Laboratorios Calier, Laboratorios Maymo, Super's Diana, Mevet, Laboratorios e Industrias Iven and Cenavisa), and 139 days for Genta-ject 10% (MAH: Dopharma).
Maltese: B'mod ġenerali għall-ispeċijiet tal-frat, tliet studji jippermettu d-derivazzjoni tal-perjodi ta' tiżmim ta' 103 ijiem għal Aagent 50 mg/ml(MAH: Fatro), 192 jum għal Gentacalier 40 mg/ml, Maycoli inyectable 40 mg/ml, Gentavall 40 mg/ml, Vetersan gentamicina 40 mg/ml, Gentamiciven 40 mg/ml u Purmicina 40 mg/ml (MAHs: Laboratorios Calier, Laboratorios Maymo, Super's Diana, Mevet, Laboratorios e Industrias Iven and Cenavisa), u 139 jum għal Genta-ject 10 % (MAH: Dopharma).
English: Groups of 4 to 5 animals were slaughtered at days 3, 10, 17, 27, 67 and 89 after the last administration.
Maltese: Gruppi ta' 4 sa 5 annimali nqatlu f'jiem 3, 10, 17, 27, 67 u 89 wara l-aħħar għotja.
English: IM, SC (only dogs)
Maltese: IM, SC (klieb biss)
English: Using the data available in the CVMP EPMAR for gentamicin (EMEA/MRL/803/01)
Maltese: Waqt li ntużat id-data disponibbli fis-CVMP EPMAR għal gentamicin (EMEA/MRL/803/01)
English: CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf
Maltese: CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf kollha li jittieklu, kien hemm disponibbli numru insuffiċjenti ta' punti ta' data.
English: The withdrawal periods are, respectively, 44, 66 and 146 days.
Maltese: VMD). Ilperjodi ta' tiżmim huma 44, 66 u 146 jum rispettivament.
English: Repeated injections should be made at different injection sites.
Maltese: Injezzjonijiet ripetuti għandhom isiru f'siti ta' injezzjoni differenti.
English: Lithuania CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Maltese: Il-Litwanja CP-Pharma Handelsgesellschaft mbH Ostlandring 13
English: Gentamicin is an aminoglycoside antibiotic indicated for the treatment of a variety of bacterial infections.
Maltese: Gentamicin hu antibijotiku aminoglycoside indikat għall-kura ta' varjetà ta' infezzjonijiet batterjali.
English: Groups of 4 animals were slaughtered at days 40, 45 and 50 after the last administration.
Maltese: Gruppi ta' 4 annimali nqatlu f'jiem 40, 45 u 50 wara l-aħħar għotja.
English: A GLP compliant study conducted with Genta-ject 10% (MAH: Dopharma), was provided.
Maltese: Ġie pprovdut studju konformi mal-GLP li sar b'Genta-ject 10 % (MAH: Dopharma).
English: Groups of cattle were slaughtered 60, 70, 80 and 90 days after the last administration.
Maltese: Gruppi ta' frat inqatlu 60, 70, 80 u 90 jum wara l-aħħar għotja.
English: Groups of 5 animals each were slaughtered at 14, 42, 70 and 112 days after the last administration.
Maltese: Gruppi ta' 5 annimali kull wieħed inqatlu f'jiem 14, 42, 70 u 112 wara l-aħħar għotja.
English: LABORATORIOS HIPRA, S.A. Avda.
Maltese: LABORATORIOS HIPRA, S.A. Avda. la Selva 135
English: Animals were slaughtered at 4, 11, 20, and 89 days after the last administration, in groups of 4 to 5.
Maltese: L-annimali nqatlu f'jiem 4, 11, 20, u 89 wara l-aħħar għotja, fi gruppi ta' 4 sa 5.
English: IM (cattle, pigs), IV (horses), SC (dogs, cats)
Maltese: IM (frat, ħnieżer), IV (żwiemel), SC (klieb, qtates)