FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Zycortal.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zycortal.
English: Zycortal was given by injection under the skin to 113 dogs and 39 dogs were given a similar medicine, which also contains desoxycortone pivalate, for injection into the muscle.
Maltese: Zycortal ingħata b'injezzjoni taħt il-ġilda lil 113-il kelb u 39 kelb ingħataw mediċina simili, li kien fiha wkoll id-desoksikorton pivalat, għal injezzjoni ġol-muskolu.
English: Zycortal is given as an injection under the skin at an initial dose of 2.2 mg/kg.
Maltese: Zycortal jingħata bħala injezzjoni taħt il-ġilda f'doża inizjali ta' 2.2 mg/kg.
English: The effectiveness of Zycortal was investigated in a field study involving 152 dogs with Addison's disease.
Maltese: L-effikaċja ta' Zycortal kienet investigata fi studju fuq il-post li involva 152 kelb bil-marda ta' Addison.
English: Other information about Zycortal
Maltese: Informazzjoni oħra dwar Zycortal
English: Desoxycortone pivalate is a synthetically produced steroid hormone very similar to the natural hormone aldosterone.
Maltese: Id-desoksikorton pivalat huwa ormon sterojdi prodott sintetikament simili ħafna għall-ormon naturali aldosteron.
English: Why is Zycortal approved?
Maltese: Għaliex ġie approvat Zycortal?
English: Addison's disease is a condition, known as hypoadrenocorticism, where the adrenal glands (located above the kidneys) do not produce enough of two steroid hormones, called cortisol and aldosterone.
Maltese: Il-marda ta' Addison hija kundizzjoni, magħrufa bħala ipoadrenokortiċiżmu, fejn il-glandoli adrenali (li jinsabu 'l fuq millkliewi) ma jipproduċux biżżejjed minn żewġ ormoni sterojdi, imsejħin kortisol u aldosteron.
English: 90 days after start of treatment, 84% (92 out of 109) of Zycortal-treated dogs had improved clinical signs and normal sodium and potassium blood levels.
Maltese: F'dan l-istudju, Zycortal intwera li huwa tal-inqas effikaċi daqs il-mediċina simili l-oħra. 90 jum wara l-bidu tal-kura, 84% (92 minn 109) tal-klieb ikkurati b'Zycortal kellhom titjib fis-sinjali kliniċi u livelli normli ta' sodju u potassju fid-demm.
English: Zycortal is a veterinary medicine used to treat dogs with Addison's disease.
Maltese: Zycortal huwa mediċina veterinarja użata biex tikkura klieb bil-marda ta' Addison.
English: A corticosteroid medicine is likely to be needed, in addition, to replace the cortisol.
Maltese: Barra minn hekk, huwa probabbli li tkun meħtieġa mediċina kortikosterojde, biex jiġi ssostitwit il-kortisol.
English: Zycortal may cause adverse effects on male reproductive organs and as a result can affect fertility.
Maltese: Zycortal jista' jikkawża effetti avversi fuq l-organi riproduttivi tar-raġel u b'riżultat ta' dan jista' jaffettwa l-fertilità.
English: What are the risks associated with Zycortal?
Maltese: X'inhuma r-riskji assoċjati ma' Zycortal?
English: The most common side effects with Zycortal (which may affect more than 1 in 10 dogs) are polydipsia (increase in water intake) and polyuria (increase in urine production).
Maltese: L-effetti sekondarji l-aktar komuni b'Zycortal (li jistgħu jaffettwaw aktar minn kelb 1 minn kull 10) huma polidipsja (żieda fil-konsum tal-ilma) u poljurija (żieda fil-produzzjoni tal-awrina).
English: The European Commission granted a marketing authorisation valid throughout the EU for Zycortal on
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Zycortal fil
English: The lack of aldosterone can cause fluid loss, dehydration and weight loss.
Maltese: In-nuqqas ta' aldosteron jista' jikkawża telf ta' fluwidu, deidrazzjoni u telf ta' piż.
English: Dogs with Addison's disease have insufficient levels of aldosterone in their blood and Zycortal is used to replace the missing hormone.
Maltese: Il-klieb bil-marda ta' Addison għandhom livelli insuffiċjenti ta' aldosteron f'demmhom u Zycortal jintuża biex jissostitwixxi l-ormon nieqes.
English: If irritation occurs, seek medical advice immediately and show the package leaflet or the label to the doctor.
Maltese: Jekk ikun hemm irritazzjoni, itlob parir mediku minnufih u uri l-fuljett ta' tagħrif jew it-tikketta lit-tabib.
English: For the full list of all side effects reported with Zycortal, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zycortal, ara l-fuljett ta' tagħrif.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zycortal'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 Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Zycortal huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Zycortal, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward issigurtà ta' Zycortal, inkluż il-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti talkura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom.
English: EMA/295851/2014 EMEA/V/C/003681
Maltese: EMEA/V/C/003681
English: This will help protect them against kennel cough.
Maltese: Dan se jgħin jipproteġihom kontra l-kennel cough.
English: The effectiveness of Versican Plus Pi was investigated in a field study involving 129 dogs.
Maltese: L-effikaċja ta' Versican Plus Pi ġiet investigata fi studju prattiku li involva 129 kelb.
English: The field study showed that vaccination with Versican Plus Pi resulted in protective levels of antibodies for parainfluenza virus ranging from 73 to 97%.
Maltese: Studju prattiku wera li tilqima b'Versican Plus Pi rriżultat f'livelli protettivi ta' antikorpi għall-virus talparainfluwenza f'firxa minn 73 sa 97%.
English: Canine parainfluenza virus vaccine (live attenuated)
Maltese: Vaċċin tal-virus tal-parainfluwenza tal-klieb (ħaj attenwat)
English: The field study involved the larger vaccine combinations Versican Plus DHPPi/L4 and Versican Plus DHPPi/L4R, which are also intended to protect against kennel cough in addition to other diseases, to demonstrate effectiveness of Versican Plus Pi.
Maltese: L-istudju prattiku involva l-kombinazzjonijiet ta' vaċċini akbar Versican Plus DHPPi/L4 u Versican Plus DHPPi/L4R, li huma wkoll maħsubin biex jipproteġu kontra l-kennel cough apparti mard ieħor, biex juru l-effikaċja ta' Versican Plus Pi. Il-klieb kienu jew imlaqqma darbtejn b'intervall ta' tlieta sa erba' ġimgħat jew irċevew tilqima booster waħda fis-sena.
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus Pi is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Maltese: L-effett sekondarju l-aktar komuni (li deher f'iktar minn 1 minn kull 100 kelb) b'Versican Plus Pi huwa nefħa għal żmien qasir sa 5 cm li tista' sseħħ fil-post tal-injezzjoni wara t-tilqima.
English: Versican Plus Pi is a veterinary vaccine that contains live attenuated (weakened) canine parainfluenza virus type 2.
Maltese: Versican Plus Pi huwa vaċċin veterinarju li fih il-virus tal-parainfluenza tip 2 tal-klieb ħaj attenwat (imdgħajjef).
English: What is the risk associated with Versican Plus Pi?
Maltese: X'riskji huma assoċjati ma' Versican Plus Pi?
English: Versican Plus Pi is used to protect dogs against canine parainfluenza virus, which causes kennel cough.
Maltese: Versican Plus Pi jintuża biex jipproteġi lill-klieb kontra l-virus tal-parainfluwenza tal-klieb, li jikkawża lkennel cough.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus Pi exceed the risks for the approved indications and recommended that Versican Plus Pi be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Versican Plus Pi jisbqu r-riskji għall-indikazzjoni approvata u rrakkomanda li Versican Plus Pi jingħata lawtorizzazzjoni għat-tqegħid fis-suq.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ tal-benefiċċju-riskju jista' jinsab fil-modulu ta' diskussjoni xjentifika ta' dan l-EPAR.
English: Versican Plus Pi is available as a lyophilisate (freeze-dried pellet) with a solvent that are made up into a suspension for injection.
Maltese: Versican Plus Pi huwa disponibbli bħala lijofilizzat (pellit imnixxfa bl-iffriżar) b'solvent li jitħalltu flimkien f'sospensjoni għal injezzjoni.
English: Versican Plus Pi is a vaccine.
Maltese: Versican Plus Pi huwa vaċċin.
English: Other information about Versican Plus Pi:
Maltese: Tagħrif ieħor dwar Versican Plus Pi:
English: Why has Versican Plus Pi been approved?
Maltese: Għaliex ġie approvat Versican Plus Pi?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus Pi on 4 July 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Versican Plus Pi fl-4 ta' Lulju 2014.
English: What is Versican Plus Pi?
Maltese: X'inhu Versican Plus Pi?
English: 180 tablets l t o r
Maltese: 180 pillola t x
English: 800 mg Film-coated tablet Oral use bottle (HDPE)
Maltese: 800 mg Pillola miksija b'rita
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Numru ta' l-EU Numru tal-MA
English: --1 Virus titer no less than of 5 x 107 Inf.U
Maltese: --1 titre ta' mhux inqas minn 5 x 107 Inf.U
English: On 11 November 2
Maltese: 17 ta' Novembru 2011
English: 17 November 2011 EMA/888548/2011 EMEA/H/C/002200
Maltese: EMA/888548/2011
English: Withdrawal of the marketing authorisation application for Kalbitor (ecallantide) EMA/888548/2011
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Kalbitor (ecallaEMA/888548/2011
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Kalbitor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation causes the swelling attacks seen in angioedema.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Kalbitor jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The application was withdrawn after ‘day 181'.
Maltese: L-applikazzjoni ġiet irtirata wara ‘jum 120'.
English: Kalbitor was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 18 December 2002 for the treatment of angioedema.
Maltese: Kalbitor kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-18 ta' Diċembru 2002 għall-kura tal-anġjoedema.
English: The CH
Maltese: madwar.
English: Kalbitor is a medicine that contains the active substance ecallantide.
Maltese: Kalbitor huwa mediċina li fiha s-sustanza attiva ecallantide.
English: The active substance in Kalbitor, ecallantide, blocks an enzyme in the blood called ‘kallikrein'.
Maltese: Is-sustanza attiva f'Kalbitor, l-ecallantide, timblokka enzima fid-demm imsejħa 'kalliċreina'.
English: What is Kalbitor?
Maltese: X'inhu Kalbitor?
English: Kalbitor was expected to be used to treat symptoms of attacks of hereditary angioedema.
Maltese: Kalbitor kien mistenni jintuża għall-kura ta' sintomi ta' attakki tal-anġjoedema ereditarja.
English: Kalbitor (ecallantide)
Maltese: Mistoqsijiet u tweġibiet
English: Kallikrein is part of a complex network of proteins (known as the kallikrein-kinin system) that has several effects in the body, one of which results in increased levels of a protein called bradykinin that causes the blood vessels to widen and leak fluid into the surrounding tissue.
Maltese: Il-kalliċreina hija parti minn netwerk kumpless ta' proteini (magħruf bħala s-sistema ta' kininakalliċreina) li għandha bosta effetti fil-ġisem, li wieħed minnhom irriżulta f'żieda fil-livelli miżjudin ta' proteina msejħa bradikinina li tikkawża twessiegħ fil-vini tad-demm u tnixxija ta' fluwidu fit-tessut tal
English: he actions of kallikrein, Kalbitor is lantide in Kalbitor is produced by a method known as ‘recombinant DNA technology'.
Maltese: L-ecallantide f'Kalbitor tingħamel b'metodu magħruf bħala 'teknoloġija rikombinanti tad-DNA'.
English: the CHMP had evaluated the r the CHMP had ation, there were still onse to the CHMP lists of questions, at the pinion that Kalbitor en approved.
Maltese: Dan ifisser li s-CHMP kien evalwa d-dokumentazzjoni inizjali pprovduta mill-kumpanija u fformula lista ta' mistoqsijiet.
English: How is Kalbitor expected to work?
Maltese: Għal xiex kien mistenni jintuża Kalbitor?
English: 011, Dyax s.a. officially notified the Committee for Medicinal Products for Human ation for Kalbitor, treatment of symptoms of acute attacks of hereditary angioedema.
Maltese: Fil-11 ta' Novembru 2011, Dyax s.a. għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għall-awtorizzazzjoni għat-tqegħid fissuq għal Kalbitor, maħsub għall-kura tas-sintomi ta' attakki akuti tal-anġjoedema ereditarja.
English: Hypersensitivity reactions occur when the body's immune system reacts against MP also had concerns related to the effectiveness of the proposed doses in heavier patients.
Maltese: Ir-reazzjonijiet ta' sensittività eċċessiva jseħħu meta s-sistema immunitarja talġisem tirreaġġixxi kontra mediċina, u tinkludi reazzjonijet magħrufin b'mod komuni bħala reazzjonijiet allerġiċi.
English: available as a solution for injection.
Maltese: Kellu jkun disponibbli f'soluzzjoni għal injezzjoni.
English: There were 72 patients in one study and 96 in the other treated with either Kalbitor or placebo (a dummy treatment) w judged to be at risk of blockage of the airway were given additional treatments i The main measure of effectiveness was based on the improvement in pati hours.
Maltese: Kien hemm 72 pazjent fi studju wieħed u 96 fl-ieħor.
English: The effects of Kalbitor were first tested in experimental models before being studie The company presented the results of two main studies in patients aged 1 hereditary angioedema.
Maltese: L-effetti ta' Kalbitor ġew l-ewwel ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq il-bnedmin.
English: Pack size
Maltese: Pożoloġija
English: MA (EU) number (Invented) name
Maltese: NUMRU(I)
English: 28 vials + 28 prefilled syringes; 6 plungers
Maltese: - 28 siringa mimlija għal-lest b'solvent
English: Strength Pharmaceutical Form Route of Administration
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Content (concentration)
Maltese: Revestive”).
English: 28 vials + 28 prefilled syringes
Maltese: Daqs tal-pakkett ta' 28 kunjett bit-trab bi 28 siringa mimlija lesta.
English: Immediate Packaging
Maltese: Sensittività eċċessiva
English: 1 vial + 1 prefilled syringe
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti
English: • Circulation, within 25 days of the Commission Decision, of the adopted Dear Healthcare Professional Communication as specified in the communication plan
Maltese: • Fi żmien 25 jum mid-Deċiżjoni tal-Kummissjoni, iċ-ċirkulazzjoni tal-Komunikazzjoni adottata mill-Professjonisti tal-Kura tas-Saħħa kif speċifikat fil-pjan ta' komunikazzjoni
English: Annex IV Conditions of the Marketing Authorisation
Maltese: Anness IV Kundizzjonijiet tal-Awtorizzazzjoni għat-Tqegħid fis-Suq
English: National Competent Authorities shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: L-Awtoritajiet Kompetenti Nazzjonali għandhom jiżguraw li d-Detenturi tal-Awtorizzazzjoni għatTqegħid fis-Suq jissodisfaw il-kundizzjonijiet li ġejjin:
English: one type I glass bottle of lyophilisate and one type I glass bottle of solvent, 1 syringe and 1 needle
Maltese: flixkun tal-ħġieġ wieħed ta' tip I ta' lyophilisate u flixkun tal-ħġieġ wieħed ta' tip I ta' solvent, 1 siringa u 1 labra.
English: Humenza contains a flu strain called A/California/7/2009 (H1N1)-like strain (NYMC X-179A).
Maltese: Humenza fih razza ta' influwenza msejħa A/California/7/2009 (H1N1) tip li tixbah lil (NYMC X-179A).
English: Humenza is a vaccine to protect against ‘pandemic' flu.
Maltese: Humenza huwa vaċċin li jipproteġi kontra l-influwenza ‘pandemika'.
English: Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Maltese: Vaċċin għall-influwenza pandemika (H1N1) (virjon maqsum, diżattivat, adjuvant)
English: This summary was last updated in 06-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'06-2010.
English: Humenza has been given ‘Conditional Approval'.
Maltese: Humenza ingħata ‘Approvazzjoni Kundizzjonali'.
English: This document is a summary of the European Public Assessment Report (EPAR) for Humenza.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Humenza.
English: Three studies are being carried out with Humenza containing the H1N1 strain, one in 300 adults and 150 elderly patients (over 60 years of age), and two in a total of 700 children aged between six months and 17 years of age.
Maltese: Qed isiru tliet studji b'Humenza li fih ir-razza H1N1, wieħed fi 300 adult u 150 pazjent anzjan ('il fuq minn 60 sena), u tnejn f'total ta' 700 tifel u tifla ta' bejn sitt xhur u 17-il sena.
English: Humenza should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace levels in the vaccine, such as ovalbumin (a protein in egg white), egg or chicken proteins, neomycin, octoxinol-9 and formaldehyde.
Maltese: Humenza m'għandux jingħata lil nies li kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill-komponenti tal-vaċċin, jew għal kwalunkwe sustanza li tinsab f'livelli ta' traċċi fil-vaċċin, bħal ovalbumin (proteina fl-abjad tal-bajd), proteini tal-bajd jew tat-tiġieġ, neomiċina, octoxinol-9 u formaldehyde.
English: Humenza is a vaccine.
Maltese: Humenza huwa vaċċin.
English: What is the risk associated with Humenza?
Maltese: X'inhu r-riskju assoċjat ma' Humenza?
English: What is Humenza?
Maltese: X'inhu Humenza?
English: Why has Humenza been approved?
Maltese: Għaliex ġie approvat Humenza?
English: The company also presented information from studies in 641 adults carried out using an earlier version of Humenza, containing a ‘bird flu' strain H5N1.
Maltese: Il-kumpanija ppreżentat ukoll tagħrif minn studji f'641 adult li saru bl-użu ta' verżjoni aktar bikrija ta' Humenza, li fih razza ta' ‘influwenza tat-tjur' H5N1.
English: Humenza contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v that is causing the current pandemic.
Maltese: Humenza fih ammonti żgħar ta' haemagglutinins (proteini mill-wiċċ) ta' virus imsejjaħ A(H1N1)v li qed jikkawża l-pandemija attwali.
English: The company that makes Humenza will supply further data on the medicine, in particular on its safety from a study in 3,000 subjects.
Maltese: Il-kumpanija li tagħmel Humenza ser tforni aktar dejta dwar il-mediċina, b'mod partikolari dwar issigurtà tagħha minn studju fi 3,000 suġġett.
English: How has Humenza been studied?
Maltese: Kif ġie studjat Humenza?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Humenza to Sanofi Pasteur SA on 08 June 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unojoni Ewropea kollha għal Humenza lil Sanofi Pasteur SA fit-8 ta' Ġunju 2010.
English: The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Maltese: Is-solvent fih ‘adjuvant' (taħlita li fiha ż-żejt) biex itejjeb ir-rispons immunitarju.
English: The Committee decided that Humenza's benefits are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation and recommended that it be given marketing authorisation.
Maltese: Il-Kumitat iddeċieda li l-benefiċċji ta' Humenza huma akbar mir-riskji tiegħu għall-profilassi talinfluwenza fis-sitwazzjoni pandemika H1N1 iddikjarata uffiċjalment u rrakkomanda jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: These studies are looking at the ability of Humenza to trigger the production of antibodies (‘immunogenicity') against the H1N1 flu strain.
Maltese: Dawn l-istudji qed iħarsu lejn l-abbiltà ta' Humenza sabiex jagħti bidu għall-produzzjoni ta' antikorpi (‘immunoġeniċità') kontra r-razza tal-influwenza H1N1.
English: It should only be used for the influenza A (H1N1) flu pandemic that was officially declared by the World Health Organization on 11 June 2009.
Maltese: Dan għandu jintuża biss għallinfluwenza tat-tip A (H1N1) pandemika li ġiet iddikjarata uffiċjalment mill-Organizzazzjoni Dinjija tasSaħħa fil-11 ta' Ġunju 2009.
English: The percentage of subjects who had a level of antibodies in their blood that was high enough to neutralise the H1N1 virus (seroprotection rate) was 100% in children and close to 100% in adults.
Maltese: Il-perċentwal ta' suġġetti li kellhom livell ta' antikorpi fid-demm tagħhom li kien għoli biżżejjed sabiex jinnewtralizza l-virus talH1N1 (rata ta' seroprotezzjoni) kien ta' 100% fit-tfal u qrib il-100% fl-adulti.
English: This second dose must be given to patients over 60 years of age.
Maltese: Din it-tieni doża għandha tingħata lill-pazjenti ta' 'l fuq minn 60 sena.
English: Other information about Humenza:
Maltese: Tagħrif ieħor dwar Humenza:
English: The most common side effects with Humenza (seen with more than 1 in 10 doses of the vaccine) are headache, myalgia (muscle pain) and pain at the site of injection.
Maltese: L-effetti sekondarji l-aktar komuni b'Humenza (dehru f'aktar minn doża 1 minn kull 10 tal-vaċċin) huma wġigħ ta' ras, mijalġija (uġigħ fil-muskoli) u wġigħ fis-sit tal-injezzjoni.
English: What benefit has Humenza shown during the studies?
Maltese: Liema benefiċċju wera Humenza matul l-istudji?
English: Humenza is given according to official recommendations.
Maltese: L-EPAR sħiħ għal Humenza jista' jiġi kkonsultat hawn.
English: This means that there is more evidence to come about the medicine, in particular the results of further clinical studies in children, adolescents and adults.
Maltese: Dan ifisser li għad baqa' aktar evidenza li trid tinġabar dwar il-mediċina, b'mod partikolari r-riżultati ta' studji kliniċi ulterjuri fit-tfal, l-adoloxxenti u l-adulti.
English: Fipronil: Absolute bioavailability: 9.5 %.
Maltese: Fipronil: Bijodisponibiltà assoluta: 9.5 %.
English: EU/2/11/125/005 EU/2/11/125/006 EU/2/11/125/007 EU/2/11/125/008
Maltese: EU/2/11/125/006 EU/2/11/125/007 EU/2/11/125/008
English: Amitraz degrades on the haircoat of the dog into N-methyl-N'-(2,4-xylyl) formamidine (< 5 % of amitraz concentrations).
Maltese: Amitraz jiddegrada fuq il-pil tal-kelb f'N-methyl-N'-(2,4-xylyl) formamidine (< 5% talkonċentrazzjonijiet ta' amitraz).
English: Known side-effects of amitraz and its metabolites are due to alpha-2-adreno-receptor agonist effects.
Maltese: Effetti sekondarji magħrufin ta' amitraz u l-metaboliti tiegħu huma dovuti għal effetti ta' alpha-2-adreno-receptor agonist.
English: Treatment and prevention of infestations in dogs by ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, Haemaphysalis longicornis, Amblyomma americanum and Amblyomma maculatum) and fleas (Ctenocephalides felis and Ctenocephalides canis).
Maltese: Kura u prevenzjoni ta' infestazzjonijiet fil-klieb b'qurdien (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, Haemaphysalis longicornis, Amblyomma americanum u Amblyomma maculatum) u briegħed (Ctenocephalides felis u Ctenocephalides canis).