FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of Cymbalta 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17 score for duloxetine-treated patients compared to placebo.
Maltese: L-effett ta' Cymbalta 60 mg darba kuljum, f'pazjenti anzjani b'depressjoni (> 65 sena) ġie speċifikament eżaminat f'studju li wera differenza statistikament sinifikanti fit-tnaqqis tal-punteġġ ta' l-HAMD 17 għal pazjenti kkurati b'duloxetine meta mqabbel ma' plaċebo.
English: Caution is advised if Cymbalta is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Maltese: prodotti mediċinali li huma fil-biċċa l-kbira metabolizzati min CYP2D6 (risperidone, anti-depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
English: Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Maltese: Imġiba assoċjata massuwiċidju (attentati ta' suwiċidju u ħsibijiet suwiċidali), u ostilità (l-aktar aggressjoni, imġiba konfrontali, u rabja), kienu osservati aktar spiss f'provi kliniċi fuq tfal u adolexxenti kkurati b'anti depressivi meta mqabbla ma' dawk ikkurati bil-plaċebo.
English: The 60 mg capsules are blue and green and are printed with ‘60 mg' and the code ‘9542'.
Maltese: Il-kapsuli ta' 60 mg huma blu u ħodor u huma stampati b''60 mg' u l-kodiċi ‘9542'
English: Data on the use of Cymbalta 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
Maltese: L-informazzjoni dwar l-użu ta' Cymbalta 120 mg f'pazjenti anzjani b'disturb depressiv maġġuri u b'disturb ta' ansjetà ġeneralizzata hija limitata.
English: The initiation of treatment with Cymbalta is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
Maltese: Huwa kontra-indikat li tinbeda l-kura b'Cymbalta f'pazjenti b'pressjoni għolja mhux ikkontrollata li tista' tesponi l-pazjenti għal riskju potenzjali ta' kriżi ipertensiva (ara sezzjonijiet 4.4 u 4.8).
English: • muscle pain, muscle spasm
Maltese: Uġigħ muskoluskeletali
English: Cymbalta 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p<0.001) on the prevention of relapse, as measured by time to relapse.
Maltese: Cymbalta 60 mg sa 120 mg kuljum wera superjorità statistikament sinifikanti meta mqabbel ma'
English: However, as with any medicine, caution should be exercised when treating the elderly, especially with Cymbalta 120 mg per day for major depressive disorder or generalised anxiety disorder, for which data are limited (see sections 4.4 and 5.2).
Maltese: Madankollu, bħal b'mediċina oħra, il-kura ta' l-anzjani għandha tiġi segwita b'attenzjoni, speċjalment b'Cymbalta 120 mg kuljum għal disturb depressiv maġġuri jew disturb ta' ansjetà ġeneralizzata, fejn l informazzjoni hija limitata (ara sezzjonijiet 4.4 u 5.2).
English: Monoamine oxidase inhibitors (MAOIs): You should not take Cymbalta if you are taking, or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
Maltese: Inibituri ta' monoamine oxidase (MAOI): M'għandekx tieħu Cymbalta jekk qiegħed/qiegħda tieħu jew ħadt recentament (f'dawn l-aħħar 14-il ġurnata) xi mediċina oħra kontra d-depressjoni msejħa inibitur ta' monamino oxidase.
English: Cymbalta with food, drink and alcohol
Maltese: Cymbalta mal-ikel, max-xorb u mal-alkoħol
English: Cymbalta 60 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.004) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Maltese: Cymbalta 60 mg darba kuljum wera superjorità statistikament sinifikanti meta mqabbel ma' plaċebo (p=0.004) f'daq li għandu x'jaqsam ir-riżultat primarju, ilprevenzjoni ta' rikaduta depressiva, ikkalkulata permezz taż-żmien li għadda sar-rikaduta.
English: Cymbalta contains the active substance duloxetine.
Maltese: X'inhu Cymbalta u gћalxiex jintuża Cymbalta fih is-sustanza attiva duloxetine.
English: Talk to your doctor before you take Cymbalta if you: - are taking other medicines to treat depression (see ‘Other medicines and Cymbalta') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and Cymbalta')
Maltese: - għandek problemi f'għajnejk bħal xi tip ta' glawkoma (pressjoni għolja fl-għajn). - għandek passat ta' emorraġija (tendenza li tiżviluppa tbenġil), speċjalment jekk inti tqila (ara ‘Tqala u treddigħ') qiegħed/qiegħda f'riskju li jitbaxxielek il-livell ta' sodium (per eżempju jekk qiegħed/qiegħda tieħu d-dijuretiċi, speċjalment jekk inti anzjan/anzjana) qiegħed/qiegħda tirċievi fl-istess waqt kura b'mediċina oħra li tista' tikkawżalek ħsara fil fwied.
English: Capsule content Hypromellose
Maltese: Kontenut tal-kapsula
English: − are taking other medicines containing duloxetine (see ‘Other medicines and Cymbalta')
Maltese: - qiegħed/qiegħda tieħu mediċini oħra li fihom duloxetine (ara ‘Medicini oħra u Cymbalta')
English: Female rats receiving duloxetine (45 mg/kg/day) before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
Maltese: (45 mg/kg/ġurnata), qabel u waqt li kienu qed jgħamlu s-sess u fil-bidu tat-tqala, kellhom tnaqqis filkonsum ta' l-ikel matern u fil-piż, diżordni fiċ-ċiklu oestrous, nuqqas fl-indiċi ta' twelid ta' frieħ hajjin u fis-sopravivenza tal-ferħ ta' l-annimal, u dewmien biex jikbru l-frieħ f'livelli ta' espożizzjoni sistemika, stmata li hija mhux anqas mill-esponiment massimu kliniku (AUC).
English: Cymbalta 30 mg Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Maltese: Il-parti prinċipali abjad opak, stampat b' ‘30 mg' u għatu blu opak, stampat b' ‘9543'.
English: Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Maltese: Sturdament, disturbi tas-sensi (fosthom parastizja jew sensazzjonijiet li jixbħu dak ta' xokk elettriku, speċjalment fir-ras), disturbi fl-irqad, (fosthom insomnja u ħolm intens), għeja, ħedla ta' rqad, aġitazzjoni jew ansjetà, dardir u/jew rimettar, rogħda, wġigħ ta' ras, uġigħ fil-muskoli, irritabilità, dijarea, iperidrożi u vertigo huma l-aktar reazzjonijiet komunement irrappurtati.
English: Muscle tightness Muscle twitching
Maltese: Disturbi muskolu-skeletriki u tat-tessuti konnetivi
English: Urinary retention Urinary hesitation Nocturia
Maltese: Tegħreq matul il-lejl Urtikarja Dermatite minħabba kuntatt
English: Photo-sensitivity reactions Increased tendency to bruise Musculoskeletal and connective tissue disorders Musculo-skeletal pain Muscle spasm
Maltese: Riġidità tal muskoli Kontrazzjoni involontarja tal-muskolu
English: Cymbalta 30 mg Each capsule contains 30 mg of duloxetine (as hydrochloride).
Maltese: Kull kapsula fiha 30 mg jew 60 mg ta' duloxetine (bħala hydrochloride).
English: Overall, Cymbalta's efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Maltese: B'mod ġenerali , leffikaċja ta' Cymbalta ġiet ipprovata f'dożaġġi ta' kuljum ta' bejn 60 u 120 mg f'total ta' ħamsa minn seba' studji li saru f'sitwazzjonijiet akuti, b'doża fissa, randomised, double-blind u kkontrollati bilplaċebo f'pazjenti li mhumiex residenti ġo sptar u li għandhom mard depressiv maġġuri.
English: The 30 mg capsules are blue and white and are printed with ‘30 mg' and the code ‘9543'.
Maltese: Il-kapsuli ta' 30 mg huma blu u abjad u huma stampati b''30 mg' u l-kodiċi ‘9543'
English: Hyponatraemia has been reported when administering Cymbalta, including cases with serum sodium lower than 110 mmol/l.
Maltese: Meta ġie mogħti Cymbalta, ġiet irrapportata l-iponatrimja, li inkludew każijiet ta' livell ta' sodium fi serum ta' inqas minn 110 mmol/l.
English: In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label Cymbalta 60 mg once daily were randomised to either Cymbalta 60 mg once daily or placebo for a further 6-months.
Maltese: Fiż-żewġ studji, Cymbalta 60 mg darba kuljum u 60 mg darbtejn kuljum naqqsu b'mod sinifikanti l uġigħ meta mqabbla ma' plaċebo.
English: Myoclonus Akathisia7
Maltese: Kodiċi ATC:
English: Excipient(s) with known effect Each capsule may contain up to 56 mg sucrose.
Maltese: Kull kapsula jista' jkollha sa 56 mg sucrose. Cymbalta 60 mg
English: Cymbalta is a hard gastro-resistant capsule.
Maltese: Cymbalta issibu bħala kapsula gastro-reżistenti, iebsa.
English: • sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles,
Maltese: motivazzjoni kontrazzjoni jew ġbid f'daqqa involontarju tal-muskoli, sensazzjoni ta' rrekwitezza jew linkapaċità li wieħed joqgħod mingħajr ma jiċċaqlaq, tħossok nervuż, diffikultà biex tikkonċentra, ttiegħem l-affarijiet differenti mis-soltu, diffikultà biex tikkontrolla l-movimenti eż. nuqqas ta' koordinazzjoni jew movimenti involontarji tal-muskoli, is-sindromu ta'
English: When stopping treatment with Cymbalta the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Maltese: Meta l-kura b'Cymbalta tkun ser titwaqqaf id-doża għandha tiġi mnaqqsa gradwalment fuq perijodu ta' mill-anqas ġimgħa sa ġimagħtejn sabiex jitnaqqas ir-riskju ta' reazzjonijiet ta' rtirar (ara sezzjonijiet 4.4 u 4.8).
English: Cymbalta showed comparable efficacy results to venlafaxine in terms of improvements on the HAM-A total score.
Maltese: Cymbalta wera riżultati ta' effikaċja simili għal venlafaxine f'dak li għandu x'jaqsam titjib fil-punteġġ totali tal-HAM-A.
English: Cymbalta demonstrated statistical superiority over placebo as measured by improvement in the 17item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
Maltese: mg) ma sseparaw b'mod statistiku mill-plaċebo fil-valur totali taċ-Children´s Depression Rating Scale-Revised (CDRS-R).
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials.
Maltese: Dożi ta' aktar minn 60 mg darba kuljum, sa doża massima ta' 120 mg kuljum mogħtija f'dożi mqassma ndaqs, ġew valutati mill-aspett tas-sigurtà f'provi kliniċi.
English: Other psychiatric conditions for which Cymbalta is prescribed can also be associated with an increased risk of suicide-related events.
Maltese: Kundizzjonijiet psikjatriċi oħra li għalihom jista' jiġi mogħti Cymbalta huma wkoll assoċjati ma' riskju akbar ta' avvenimenti marbuta ma' suwiċidju.
English: The efficacy of Cymbalta at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Maltese: L-effikaċja ta' Cymbalta fid-doża rakkomandata ta' 60 mg darba kuljum ġiet ppruvata fit-tlieta minn tliet studji li saru f'sitwazzjonijiet akuti, b'doża fissa, randomised, double-blind u kkontrollati bil-plaċebo f'pazjenti li mhumiex residenti ġo sptar u li għandhom mard depressiv maġġuri.
English: Cymbalta 60 mg Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Maltese: Il-parti prinċipali aħdar opak, stampat b' ‘60 mg' u għatu blu opak, stampat b' ‘9542'.
English: As with other serotonergic agents, serotonin syndrome, a potentially life-threatening condition, may occur with duloxetine treatment, particularly with concomitant use of other serotonergic agents (including SSRIs, SNRIs tricyclic antidepressants or triptans), with agents that impair metabolism of serotonin such as MAOIs, or with antipsychotics or other dopamine antagonists that may affect the serotonergic neurotransmitter systems (see sections 4.3 and 4.5).
Maltese: Bħal kull sustanza serotonerġika oħra, il-kura b'duloxetine tista' tikkawża s-sindromu ta' serotonin, kundizzjoni li tista' tkun ta' periklu għall-ħajja, speċjalment jekk fl-istess ħin ikun qed jintużaw sustanzi serotonerġiċi oħra (li jinkludu SSRIs, antidipressivi triċikliċi SNRIsm jew triptans), sustanzi li jnaqqsu l-metaboliżmu ta' serotonin bħal MAOIs jew antipsikotiċi jew antagonisti oħra ta' dopamine li jistgħu jaffettwaw is-sistemi ta' newrotrasmissjoni seotonerġiċi (ara sezzjonijiet 4.3 u 4.5).
English: Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section 4.8).
Maltese: Inibituri selettivi tal-assorbiment mill-ġdid ta' serotonina (SSRIs)/inibituri tal-assorbiment mill-ġdid ta' serotonina norepinefrina (SNRIs) jistgħu jikkawżaw sintomi ta' disfunzjoni sesswali (ara sezzjoni
English: Effect of duloxetine on other medicinal products
Maltese: Effett ta' duloxetine fuq prodotti mediċinali oħra
English: Your doctor will tell you if you should be taking Cymbalta.
Maltese: It-tabib se jgħidlek jekk għandekx tieħu Cymbalta.
English: How to store Cymbalta
Maltese: Kif gћandek tieћu Cymbalta
English: How to take Cymbalta
Maltese: X'fih Cymbalta
English: Fertility
Maltese: Apatija
English: Cymbalta demonstrated statistically significant superiority over placebo as measured by improvement in the Hamilton Anxiety Scale (HAM-A) total score and by the Sheehan Disability Scale (SDS) global functional impairment score.
Maltese: Cymbalta wera superjorità statistikament sinifikanti fuq plaċebo f'kull wieħed minn ħames studji li jinkludu erba' studji magħmula f'sitwazzjonijiet akuti, ikontrollati bi plaċebo, double-blind u randomised u studju ta' prevenzjoni ta' rikaduta f'pazjenti adulti b'disturb ta' ansjetà ġeneralizzata. Cymbalta wera superjorità statistikament sinifikanti fuq plaċebo kemm meta kkalkulat skond it-titjib fil-punteġġ totali tal-Hamilton Anxiety Scale (HAM-A) u kemm skond il-punteġġ ta' indeboliment funzjonali globali tas-Sheehan Disability Scale (SDS).
English: The concomitant use of Cymbalta with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Maltese: Mhux irrakkomandat l-użu fl-istess ħin ta' Cymbalta ma' MAOIs riversibbli u selettivi bħal moclobemide (ara sezzjoni 4.4).
English: MARKETING AUTHORISATION HOLDER
Maltese: It-tollerabilità ta'
English: The efficacy and safety of Cymbalta 30-120 mg once daily in elderly patients with generalised anxiety disorder was similar to that seen in studies of younger adult patients.
Maltese: L-effikaċja u s-sigurtà ta' Cymbalta 30-120 mg mogħti darba kuljum f'pazjenti anzjani b'disturb ta' ansjetà ġeneralizzata kienu simili għal dak li ħareġ mill-istudji fuq pazjenti adulti iżgħar.
English: Throat tightness Epistaxis
Maltese: Għaraq kiesaħ
English: Palpitations
Maltese: Epistassi
English: Postpartum haemorrhage6
Maltese: Insuffiċjenza epatika6 Suffejra6
English: In a relapse prevention study, patients responding to 6 months of acute treatment with open-label Cymbalta were randomised to either Cymbalta or placebo for a further 6-months.
Maltese: L-aktar reazzjonijiet avversi komunement irrappurtati f'pazjenti fuq kura ta' Cymbalta kienu dardir,
English: The antibiotic linezolid is a reversible non-selective MAOI and should not be given to patients treated with Cymbalta (see section 4.4).
Maltese: L-antibijotiku linezolid huwa MAOI riversibbli u mhux selettiv u m'għandux jingħata lill-pazjenti kkurati b'Cymbalta (ara sezzjoni 4.4).
English: Caution is advisable if Cymbalta is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Maltese: Cymbalta jintuża fl-istess ħin ma' sustanzi serotoninerġiċi bħal SSRIs, SNRIs, antidipressivi triċikliċi bħal clomipramine jew amitriptyline, MAOIs bħal moclebemide jew linezolid, St.
English: No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.
Maltese: Ma ġiet osservata l-ebda differenza klinikament sinifikanti meta ġie kkalkulat il-QT, il-PR,
English: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Cymbalta to patients with increased intraocular pressure, or those at risk of acute narrowangle glaucoma.
Maltese: Fertilità Fi studji fuq l-annimali, duloxetine ma kellu ebda effett fuq il-fertilità tar-raġel u effetti fin-nisa kienu evidenti biss b'dożi li kkawżaw tossiċità materna.
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of Cymbalta 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Maltese: F'pazjenti fejn ir-rispons ma jkunx suffiċjenti d doża għandha tiżdied għal 60 mg li hija d-doża ta' manteniment li s-soltu tintuża fil-parti l-kbira tal pazjenti.
English: Vertigo Ear pain
Maltese: Dewmien fl eġakulazzjoni
English: Each capsule of Cymbalta contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Maltese: Kull kapsula ta' Cymbalta fiha pritkuni ta' duloxetine hydrochloride b'kisja sabiex tipproteġihom mill-aċtu ta' l-istonku.
English: ATC vet code: QI09AB02.
Maltese: QI09AB02.
English: ≥ 3.2 x 106 ELISA units
Maltese: ≥ 3.2 x 106 Unitajiet ELISA
English: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Germany
Maltese: Pharmapark 06861 Dessau-Rosslau
English: Water for injections Glutaraldehyde
Maltese: Ilma għall-injezzjonijiet Glutaraldehyde
English: INDICATION(S)
Maltese: INDIKAZZJONI(IET)
English: PACKAGE SIZE 50 ml (50 doses) 100 ml (100 doses)
Maltese: 50 ml (50 doża) 100 ml (100 doża)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/001 PET bottle of 50 ml EU/2/13/149/002 PET bottle of 100 ml
Maltese: EU/2/13/149/001 flixkun PET li jkun fih 50 ml EU/2/13/149/002 flixkun PET li jkun fih 100 ml
English: EXPIRY DATE EXP {month/year}
Maltese: DATA TA' SKADENZA EXP: {xahar/sena}
English: Overdose (symptoms, emergency procedures, antidotes):
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn):
English: PACKAGE SIZE 100 doses
Maltese: 100 doża
English: Genetically modified recombinant Stx2e antigen:
Maltese: Antiġen Stx2e rikombinanti modifikat ġenetikament:
English: The vaccine consisting of genetically modified recombinant Stx2e stimulates an active immunity against Shiga toxin 2e produced by the causative agent of oedema disease in pigs.
Maltese: Il-vaċċin li jikkonsisti f'Stx2e rikombinanti modifikat ġenetikament tistimula immunità attiva kontra tossina 2e Shiga prodotta mill-aġent kawżattiv tal-marda tal-edema fil-qżieqeż.
English: Excipient: Thiomersal max. 0.115 mg For the full list of excipients, see section 6.1.
Maltese: Thiomersal massimu 0.115 mg Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva tkun prinċipju ta' oriġini bijoloġika intiża li tipproduċi immunità attiva ma jkunx fl ambitu tar-Regolament (KE) Nru 470/2009.
English: 4.1 Target species
Maltese: 4.3 Kontraindikazzjonijiet
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Maltese: Sustanzi mhux attivi (inklużi awżiljari) elenkati fit-taqsima 6.1 tal-SPC huma permessi sustanzi li għalihom tabella 1 tal-Anness għar-Regolament (UE) Nru 37/2010 tindika li għalihom mhumiex meħtieġa MRLs.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ecoporc SHIGA suspension for injection for pigs
Maltese: VETERINARJU Ecoporc SHIGA Suspensjoni għall-injezzjoni għal qżieqeż
English: Pharmacotherapeutic group: Immunologicals for suidae, inactivated bacterial vaccines.
Maltese: Mediċini immunoloġiċi għal suidae, il-vaċċin batterjali inattivat.
English: Active immunisation of piglets from the age of 4 days, to reduce the mortality and clinical signs of oedema disease caused by Stx2e toxin produced by E. coli (STEC).
Maltese: Tilqima attiva ta' qżieqeż mill-età ta' 4 ijiem, biex titnaqqas il-mortalità u sinjali kliniċi ta' mard taledema kkawżat minn tossina Stx2e prodotta minn E. coli (STEC).
English: Excipient: Thiomersal max. 0.115 mg Appearance after shaking: yellowish to brownish, homogenous suspension.
Maltese: Thiomersal massimu 0.115 mg Dehra wara li tħawdu: suspensjoni omoġena minn safranija sa kannella
English: A single intramuscular injection (1 ml) to pigs from the age of 4 days.
Maltese: Injezzjoni waħda ġol-muskoli (1 ml) lil qżieqeż mill-età ta' 4 ijiem.
English: IM.
Maltese: Qżieqeż.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/2/13/149/001
English: Clinical signs such as temporary mild behavioural disturbances can uncommonly be observed after application of Ecoporc SHIGA.
Maltese: Jistgħu jiġu osservati wkoll sinjali kliniċi oħra bħal disturbi temporanji ħfief flimġieba, imma dawn jiġu osservati b'mod inqas komuni wara l-applikazzjoni ta' Ecoporc SHIGA.