FrancophonIA/ELRC3.0 huggingface dataset:
English: • Insulin Human Long Marvel: isophane insulin,
Maltese: • Insulin Human Long Marvel: insulina isophane,
English: The reference medicines for these insulins were to be Humulin S, Humulin I and Humulin M3.
Maltese: Il-mediċini ta' referenza għal dawn l-insulini kellhom ikunu Humulin S, Humulin I u Humulin M3.
English: International non-proprietary name (INN): human insulin
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): insulina umana
English: The active substance, insulin human, is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin.
Maltese: Is-sustanza attiva, l-insulina umana, hija magħmula permezz ta' metodu magħruf bħala ‘teknoloġija rekombinanti tad-DNA': hija magħmula minn batterju li jkun irċieva ġene (DNA), li jagħmlu kapaċi jipproduċi l-insulina.
English: • Insulin Human Rapid Marvel: soluble insulin,
Maltese: • Insulin Human Rapid Marvel: insulina li tinħall,
English: Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel are replacement insulins, which contain an active substance that is identical to the insulin made by the pancreas.
Maltese: Insulin Human Rapid Marvel, Insulin Human Long Marvel u Insulin Human 30/70 Mix Marvel huma insulini ta' sostituzzjoni, li fihom sustanza attiva li hija identika għall-insulina magħmula mill-frixa (pankreas).
English: Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel were to be ‘biosimilar' medicines.
Maltese: Insulin Human Rapid Marvel, Insulin Human Long Marvel u Insulin Human 30/70 Mix Marvel kellhom ikunu mediċini ‘bijosimili'.
English: • Insulin Human 30/70 Mix Marvel: 30% soluble insulin and 70% isophane insulin.
Maltese: 30% insulina li tinħall u 70% insulina isophane.
English: Therefore, at the time of the withdrawal, the CHMP's view was that Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel could not be considered as biosimilar to the reference medicinal products Humulin S, Humulin I and Humulin M3.
Maltese: Għaldaqstant, fiż-żmien ta' l-irtirar, l-opinjoni tas-CHMP kienet li Insulin Human Rapid Marvel, Insulin Human Long Marvel u Insulin Human 30/70 Mix Marvel ma setgħux jiġu kkunsidrati bħala bijosimili għall-prodotti mediċinali ta' referenza Humulin S, Humulin I u Humulin M3.
English: What are Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel?
Maltese: X'inhuma Insulin Human Rapid Marvel, Insulin Human Long Marvel u Insulin Human 30/70 Mix Marvel?
English: On 20 December 2007, Marvel LifeSciences Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its applications for marketing authorisations for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel, for the treatment of diabetes mellitus.
Maltese: Fl-20 ta' Diċembru 2007, Marvel LifeSciences Ltd. għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għal Użu tal-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjonijiet għallawtorizzazzjonijiet għat-tqegħid fis-suq għal Insulin Human Rapid Marvel, Insulin Human Long Marvel u Insulin Human 30/70 Mix Marvel, għat-trattament ta' dijabete mellitu (diabetes mellitus).
English: The studies in healthy volunteers did not show that the Marvel insulins had the same effect in lowering blood sugar levels as the Humulin insulins, and the main study showed a trend in favour of Humulin.
Maltese: Marvel kellhom l-istess effett fittnaqqis tal-livelli taz-zokkor fid-demm bħall-insulini Humulin, u l-istudju ewlieni wera tendenza favur Humulin.
English: The main measure of effectiveness was the effect of the medicines on the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: Il-kejl ewlieni ta' l-effikaċja kien l-effett tal-mediċini fuq il-livelli ta' sustanza fid-demm imsejħa emoglobina glikosilata (glycosylated haemoglobin) (HbA1c), li tagħti indikazzjoni ta' kemm huwa kkontrollat sewwa il-glukożju fid-demm.
English: These three medicines are all solutions for injection that contain 100 International Units of insulin per millilitre.
Maltese: Unità Internazzjonali ta' insulina kull millilitru.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING AUTHORISATION APPLICATION for INSULIN HUMAN RAPID MARVEL INSULIN HUMAN LONG MARVEL INSULIN HUMAN 30/70 MIX MARVEL
Maltese: RAPID MARVEL INSULIN HUMAN LONG MARVEL INSULIN HUMAN 30/70 MIX MARVEL
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Insulin Human Rapid Marvel, Insulin Human Long Marvel or Insulin Human 30/70 Mix Marvel?
Maltese: X'inhuma l-konsegwenzi ta' l-irtirar għal dawk il-pazjenti li jkunu involuti fi provi kliniċi/programmi ta' użu b'kumpassjoni b'Insulin Human Rapid Marvel, Insulin Human Long Marvel jew Insulin Human 30/70 Mix Marvel?
English: The company presented data from studies designed to show that the Marvel insulins were comparable with the reference medicines in experimental models and in humans.
Maltese: Il-kumpanija ppreżentat dejta minn studji mfasslin biex juru li l-insulini kienu komparabbli malmediċini ta' referenza f'mudelli sperimentali u fil-bnedmin.
English: Based on the review of the data, the CHMP had some concerns and was of the provisional opinion that Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel could not have been approved for the treatment of diabetes mellitus.
Maltese: Skond l-analiżi tad-dejta, is-CHMP wera xi tħassib u kien ta' l-opinjoni provviżorja li Insulin Human Rapid Marvel, Insulin Human Long Marvel u Insulin Human 30/70 Mix Marvel ma setgħux ikunu approvati għat-trattament ta' dijabete mellitu.
English: These medicines would have contained insulin in two different forms: a soluble form, which acts quickly (within 30 minutes of injection), and an ‘isophane' form, which is absorbed more slowly and gives a longer duration of action.
Maltese: Dawn il-mediċini kienu sejrin ikun fihom insulina f'żewġ forom differenti: forma li tinħall, li taħdem malajr (fi żmien 30 minuta mill-injezzjoni), u forma ‘isophane', li hija assorbita aktar bil-mod u tagħti tul ta' żmien ta' azzjoni itwal.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar tagħrif dwar mediċini bijosimili, ara d-dokument ta' 'mistoqsija u tweġiba' hawn.
English: Whereas
Maltese: Is
English: Glimepiride has been authorised in the EU since 1996.
Maltese: Glimepiride ilu awtorizzat fl-UE sa mill-1996.
English: A procedure under Article 29(4) was therefore triggered in June 2012.
Maltese: Għalhekk f'Ġunju 2012 inbdiet proċedura skont l-Artikolu 29(4).
English: Regarding the risk for incomplete dissolution, the CHMP considered that the test and reference formulations exhibited a similar performance, indicating a similar risk for all formulations.
Maltese: Rigward ir-riskju ta' dissoluzzjoni mhux kompluta, il-CHMP ikkunsidra li formulazzjonijiet tat-test u ta' referenza urew prestazzjoni simili, u dan jindika riskju simili għall-formulazzjonijiet kollha.
English: • the CHMP considered the requested biowaiver for the 2, 3 and 4 mg strengths to be acceptable,
Maltese: • is-CHMP ikkunsidra li bijorinunzja mitluba għall-qawwiet ta' 2, 3 u 4 mg kienet aċċettabbli,
English: Overall summary of the scientific evaluation of Glimepirida Parke-Davis and associated names (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Glimepirida Parke-Davis u ismijiet assoċjati (ara Anness I)
English: However, concerns were raised regarding the evidence of bioequivalence, considering the study conducted with the 1 mg tablet to be insufficient to provide evidence of bioequivalence for the higher strengths, as bioequivalence studies for substances with low solubility should be conducted at the highest strength according to the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), unless the active substance is highly soluble or if there are safety/tolerability reasons.
Maltese: Madankollu, kien hemm tħassib dwar l-evidenza ta' bijoekwivalenza, u l-istudju li sar bil-pillola ta' 1 mg kien ikkunsidrat li ma kienx biżżejjed biex jipprovdi evidenza ta' bijoekwivalenza għall-qawwiet aktar b'saħħithom, peress li skont il-Linja Gwida dwar l-Investigazzjoni ta' Bijoekwivalenza tas-CHMP (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), studji ta' bijoekwivalenza għal sustanzi b'solubbilità baxxa għandhom isiru fl-aktar qawwa b'saħħitha, sakemm is-sustanza attiva ma tkunx solubbli ħafna jew jekk ikun hemm raġunijiet ta' sigurtà/ tollerabbilità.
English: • the CHMP reviewed the available data and the justifications submitted by the Applicant,
Maltese: • is-CHMP irreveda d-dejta disponibbli u l-ġustifikazzjonijiet sottomessi mill-Applikant,
English: Finally, the Applicant stated that glimepiride exhibits linear pharmacokinetic properties.
Maltese: Fl-aħħar nett, l-Applikant iddikjara li glimepiride juri karatteristiċi farmakokinetiċi lineari.
English: The CHMP also reviewed the biopharmaceutical data and agreed that the proposed and the reference products have similar dissolution profiles, when comparing the 1 mg and the 4 mg strengths separately.
Maltese: Is-CHMP irreveda wkoll id-dejta bijofarmaċewtika u qabel li l-prodotti proposti u ta' referenza għandhom profili ta' dissoluzzjoni simili, meta tqabbel id-dożaġġi ta' 1mg u 4mg separatament.
English: As a result, all tablet strengths have the same average weight (170 mg) and identical qualitative and quantitative composition in terms of functional excipients, with the exception of small differences in the quantity of the filler lactose monohydrate, which is used proportionally to compensate for the differences in the active substance content (less than 5 % of the total tablet weight) resulting from the range of tablet strengths.
Maltese: B'riżultat ta' dan, id-dożaġġi kollha tal-pilloli għandhom l-istess piż medju (170 mg) u huma b'kompożizzjoni kwalitattiva u kwantitattiva identika fir-rigward ta' eċċipjenti funzjonali, bl-eċċezzjoni ta' diferenzi żgħar fil-kwantità tal-lattożju monoidrat, li jintuża proporzjonalment biex jikkumpensa għad-differenzi fil-kontenut tas-sustanza attiva (inqas minn 5 % tal-piż totali tal-pillola) li jirriżulta mill-firxa ta' dożaġġi tal-pillola.
English: Regarding the drug substance particle size, the Applicant stated that a micronized grade of glimepiride is used, ensuring that 95% of the particles are below 10μm and 50% of the particles are below 4μm.
Maltese: Firrigward tad-daqs tal-partikola tas-sustanza mediċinali, l-Applikant iddikjara li jintuża grad mikronizzat ta' glimepiride, u dan jiżgura li 95% tal-partikoli jkunu taħt l-10μm u li 50% tal-partikoli jkunu taħt l4μm.
English: In addition, the fraction of absorbed glimepiride is consistently described as being non dose-dependent and close to 100%, as evidenced from the rapid and complete absorption from the gastro-intestinal tract with linear increase in Cmax and AUC.
Maltese: Barra minn hekk, ilfrazzjoni ta' glimepiride li jiġi assorbit hija deskritta b'mod konsistenti bħala mhux dipendenti mid-doża u qrib il-100%, kif jidher mill-assorbiment rapidu u komplet mill-apparat gastro-intestinali b'żieda lineari fis-Cmax u fl-AUC.
English: Glimepiride is a second generation sulphonylurea anti-hyperglycaemic agent used in patients with type 2 diabetes mellitus insufficiently controlled by diet and exercise alone or in combination with insulin in patients in whom diet and exercise plus oral anti-hyperglycaemic therapy have failed to control blood glucose.
Maltese: Glimepiride huwa aġent tat-tieni ġenerazzjoni tat-tip sulfonilurea kontra l-ipergliċemija użat fuq pazjenti bid-dijabete mellitus tat-tip 2 li mhijiex ikkontrollata biżżejjed bid-dieta u bl-eżerċizzju weħidhom jew f'kombinazzjoni mal-insulina f'pazjenti li fuqhom, id-dieta u l-eżerċizzju flimkien ma' terapija orali kontra l-ipergliċemija jkunu naqsu milli jikkontrollaw il-glukożju fid-demm.
English: The Applicant investigated the solubility of drug substance across the physiological pH range and confirmed the very low solubility of glimepiride.
Maltese: L-Applikant investiga s-solubbilità tas-sustanza mediċinali madwar il-medda fiżjoloġika tal-pH u kkonferma s-solubbilità baxxa ħafna ta' glimepiride.
English: The CHMP was therefore of the opinion that the benefit-risk ratio of Glimepirida Parke-Davis and associated names is favourable.
Maltese: Is-CHMP kien għalhekk tal-fehma li l-proporzjon tal-benefiċċju-riskju ta' Glimepirida Parke-Davis u ismijiet assoċjati huwa favorevoli.
English: The CHMP assessed the Applicant justifications and agreed that glimepiride is associated with a risk of hypoglycaemic reactions, in particular in healthy subjects, including at the lowest 1 mg dose.
Maltese: Is-CHMP evalwa l-ġustifikazzjonijiet tal-Applikant u qabel li glimepiride huwa assoċjat ma' riskju ta' reazzjonijiet ipogliċemiċi, b'mod partikolari f'suġġetti b'saħħithom, inkluż fl-aktar doża baxxa ta' 1 mg.
English: The CHMP was therefore of the view that absorption is not dependent or limited by in vivo drug dissolution and that the low solubility of glimepiride does not prevent granting a biowaiver for the 2, 3 and 4 mg strengths.
Maltese: Is-CHMP kien għalhekk tal-fehma li l-assorbiment mhuwiex dipendenti jew limitat mid-dissoluzzjoni tal-mediċina in vivo u li s-solubbilità baxxa ta' glimepiride ma twaqqafx l-għoti ta' biowaiver għall-qawwiet ta' 2, 3 u 4 mg.
English: With such a low rate of dissolution, the Applicant considered that even the 1 mg strength possesses enough sensitivity to detect formulation differences.
Maltese: B'rata daqshekk baxxa ta' dissoluzzjoni, lApplikant ikkunsidra li anki l-qawwa ta' 1 mg fiha biżżejjed sensittività biex tikxef differenzi filformulazzjoni.
English: The CHMP also considered that the presented biopharmaceutical and pharmacokinetic data confirmed the adequate sensitivity of the bio-analytical method and further supported the acceptability of the requested biowaiver for the 2, 3 and 4 mg strengths.
Maltese: Is-CHMP ikkunsidra wkoll li d-dejta bijofarmaċewtika u farmakokinetika ppreżentata kkonfermat is-sensittività adegwata tal-metodu bijoanalitiku u appoġġat ulterjorment laċċettabilità tal-biorinunzja mitlub għall-qawwiet ta' 2, 3 u 4 mg.
English: The Applicant submitted a marketing authorisation application for Glimepirida Parke-Davis, based on claims of essential similarity to the marketed reference product.
Maltese: L-Applikant issottometta applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq għal Glimepirida Parke-Davis, abbażi ta' dikjarazzjonijiet ta' similarità essenzjali mal-prodott ta' referenza mqiegħed fis-suq.
English: The CHMP considered that the dissolution studies confirmed that the low dissolution of glimepiride is related to the drug substance rather than to the formulation and that all strengths of the proposed product have similar qualitative and quantitative compositions, leading to similar in vivo absorption.
Maltese: CHMP ikkunsidra li l-istudji ta' dissoluzzjoni kkonfermaw li d-dissoluzzjoni baxxa ta' glimepiride hijarelatata mas-sustanza mediċinali aktar milli mal-formulazzjoni u li d-dożaġġi kollha tal-prodott propost għandhom l-istess kompożizzjonijiet kwalitattivi u kwantitattivi li jwasslu għal assorbiment simili in vivo.
English: The CHMP assessed the open label, randomized, comparative bioavailability study of glimepiride 1 mg tablets under fasting conditions and the Applicant justifications for the design of the study.
Maltese: Is-CHMP evalwa l-istudju b'tikketta miftuħa, randomizzat, komparattiv ta' bijodisponibilità tal-pilloli ta' 1 mg ta' glimepiride taħt kundizzjonijiet ta' sawm u l-ġustifikazzjonijiet tal-Applikant għad-disinn tal-istudju.
English: the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Glimepirida Parke-Davis and associated names (see Annex I).
Maltese: is-CHMP irrakkomanda l-għoti tal-awtorizzazzjonijiet għat-tqegħid fis-suq li għalihom, is-sommarju talkaratteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif jibqgħu skont il-verżjonijiet finali miksuba waqt il-proċedura tal-grupp ta' Koordinazzjoni kif imsemmi fl-Anness III għal Glimepirida Parke-Davis u ismijiet assoċjati (ara Anness I).
English: The CHMP considered that a further bioequivalence study using the 4 mg dose is not anticipated to provide significantly better discriminatory power between the different formulations, given the biopharmaceutical features of this glimepiride formulation and that such a study would therefore be unnecessary and ethically unacceptable, given the risk of hypoglycaemia.
Maltese: Is-CHMP ikkunsidra li studju ieħor ta' bijoekwivalenza bl-użu tad-doża ta' 4 mg mhux mistenni li jipprovdi qawwa diskriminatorja ferm aħjar bejn il-formulazzjonijiet differenti, minħabba l-karatteristiċi bijofarmaċewtiċi ta' din il-formulazzjoni ta' glimepiride u li għalhekk studju bħal dan ikun bla bżonn u etikament inaċċettabbli, minħabba r-riskju ta' ipogliċemija.
English: Having reviewed the available literature, the Applicant concluded that fasting studies involving glimepiride appeared to be associated with a considerable risk of hypoglycaemia, even with the 1 mg dose.
Maltese: Wara li rreveda r-riċensjoni disponibbli, lApplikant ikkonkluda li l-kundizzjonijiet ta' sawm li kienu jinvolvu lil glimepiride dehru li kienu assoċjati ma' riskju konsiderevoli ta' ipogliċemija, anki bid-doża ta' 1 mg.
English: Packaging Content (concentration)
Maltese: Mnejn jingħata Il-pakkett Kontenut (konċentrazzjoni)
English: Strength Pharmaceutical Form
Maltese: Isem Qawwa Għamla Farmaċewtika
English: Invented name Strength Pharmaceutical Form
Maltese: Isem inventat Qawwa Għamla farmaċewtika
English: EU number
Maltese: Tekturna
English: ATCvet code: QI09AB03.
Maltese: Kodici ATC veterinarja QI09AB03
English: EU/2/14/166/001 EU/2/14/166/002 EU/2/14/166/003 EU/2/14/166/004 EU/2/14/166/005 EU/2/14/166/006 EU/2/14/166/007
Maltese: EU/2/14/166/001 EU/2/14/166/002 EU/2/14/166/003 EU/2/14/166/004
English: LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Gerona) SPAIN
Maltese: LABORATORIOS HIPRA, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral
English: Date of first authorisation: 4/07/2014 Date of latest renewal:
Maltese: Data tal-ewwel awtorizazzjoni: 4/07/2014
English: LABORATORIOS HIPRA, S.A. Avda.
Maltese: LABORATORIOS HIPRA, S.A. Avda. la Selva, 135
English: Cardboard box, (20 ml, 50 ml, 100ml, and 250ml) bottles (100 ml and 250 ml) and vials (100 ml)
Maltese: Kaxxa tal-kartun, (20 ml, 50 ml, 100ml u 250ml) 'kunjett tal-ħġieġ (100ml, 250ml) u 'kunjett tal-PET (100 ml)
English: 10 doses (20 ml) 25 doses (50 ml)
Maltese: 25 doża (50 ml)
English: For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Maltese: Għat-tilqim attiv tal-majjali rġiel u nisa sabiex jitnaqqsu s-sinjali kliniċi (leżjonijiet tal-ġilda u deni) ta' erisipelas tal-majjali kkawżata minn Erysipelothrix rhusiopathiae, serotip 1 and serotip 2.
English: Duration of immunity: six months.
Maltese: Tul tal-immunità:
English: <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Maltese: Jiskadi {xahar/sena}
English: Whitish suspension.
Maltese: Suspensjoni bajdanija
English: Very rare adverse reactions: - Anaphylactic-type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended.
Maltese: Reazzjonijiet avversi rari ħafna: - Reazzjonijiet tat-tip anafilattiku ġew rappurtati f'rapporti spontanji u kura sintomatika xierqa hija rakkomandata.
English: Inactivated Erysipelothrix rhusiopathiae, strain R32E11, .................... ELISA > 3.34 log2 IE50% * * IE50% - Inhibition ELISA 50%.
Maltese: Erysipelothrix rhusiopathiae Inattivat, razza R32E11 ................... ELISA > 3.34 log2 IE50 % * * IE50 % inibizzjoni ELISA - 50%
English: Cardboard box with 1 PET bottle of 125 doses (250 ml).
Maltese: Kaxxa tal-kartun b'kunjett tal-PET 1 ta' 125 dożi (250 ml).
English: Pharmacotherapeutic group: Immunologicals for suidae, Inactivated bacterial vaccines, erysipelothrix.
Maltese: Biex jistimulaw l-immunizzazzjoni attiva kontra l-erisipelas.
English: ERYSENG suspension for injection for pigs
Maltese: VETERINARJU ERYSENG suspensjoni għal injezzjoni għall-majjali
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottles (20 ml, 50 ml) and vials (20 ml, 50 ml)
Maltese: JMISS MAL-PRODOTT TAL-FLIXKUN (20 ml, 50 ml), TAL-KUNJETT (20 ml, 50 ml)
English: Very common adverse reactions: - Mild to moderate inflammation at the injection site that typically resolves within four days but in some cases may persist for up to 12 days post-vaccination was observed in safety studies.
Maltese: Reazzjonijiet avversi komuni ħafna: - Fi studji ta' sigurtà ġiet osservata infjammazzjoni ħafifa għal moderata fis-sit tal-injezzjoni li normalment tgħaddi fi żmien 4 ijiem iżda f'xi każijiet tista' tippersisti sa 12-il ġurnata wara t-tilqima.
English: Cardboard box with 1 PET bottle of 25 doses (50 ml).
Maltese: Kaxxa tal-kartun b'kunjett tal-PET 1 ta' 25 dożi (50 ml).
English: Cardboard box with 1 PET bottle of 50 doses (100 ml).
Maltese: Kaxxa tal-kartun b'kunjett tal-PET 1 ta' 50 dożi (100 ml).
English: Whitish suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għal injezzjoni
English: Pigs from 6 months of age which have not been previously vaccinated with the product should be given two injections with an interval of 3-4 weeks.
Maltese: Majjali li għandhom 6 xhur u iktar li ma ġewx imlaqqmin qabel bil-prodott għandhom jingħataw żewġ injezzjonijiet b'intervall ta' 3-4 ġimgħat.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Maltese: MANIFATTUR(I) TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I) U> MANIFATTUR(I) RESPONSABBLI GĦALL
English: NL-1316 BN Almere The Netherlands
Maltese: NL-1316 BN Almere L-Olanda
English: EU/1/15/1017/001 EU/1/15/1017/002 EU/1/15/1017/003 EU/1/15/1017/004 EU/1/15/1017/005
Maltese: EU/1/15/1017/001 EU/1/15/1017/002 EU/1/15/1017/003 EU/1/15/1017/004
English: • insomnia
Maltese: • insomnja
English: Hazard Ratio: 1.032 [95% CI: 0.876; 1.216]
Maltese: Riskju proporzjonali: 1.032 [95% CI: 0.876; 1.216]
English: Taxespira contains alcohol.
Maltese: Taxespira fih l-alkoħol.
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor
Maltese: TAC = docetaxel, doxorubicin u cyclophosphamide FAC = 5-fluorouracil, doxorubicin u cyclophospamide CI = confidence interval - intervall ta' kunfidenza; ER = estrogen receptor - riċettatur tal-estroġen PR = progesterone receptor - riċettatur tal-progesterone a
English: Hazard ratio (TAC/FAC)
Maltese: Proporzjon ta' periklu (TAC/FAC)
English: 3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Maltese: 3) kien ta' 7 ijiem), anemija, alopeċja, tqalligħ, rimettar, stomatite, dijarea u astenja.
English: Toxicity Diarrhoea grade 3
Maltese: Tossiċità Dijarrea ta' grad 3
English: ER/PR-negative or Grade 3 or tumour size >5 cm
Maltese: ER/PR-negattiv jew Grade 3 jew daqs tat-tumur >5 cm
English: Dehydration and pulmonary oedema have rarely been reported.
Maltese: Id-deidrazzjoni u l-edima pulmonari rarament kienu irrapportati.
English: Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Maltese: Riskju proporzjonali: 1.122 [97.2% CI: 0.937; 1.342]* Differenza fit-Trattament: 5.4% [95% CI: -1.1; 12.0] Differenza fit-Trattament: 6.2% [95% CI: 0.2; 12.3]
English: Immune system disorders
Maltese: Disturbi tas-sistema immuni