FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ tal-benefiċċju-riskju jista' jinstab fil-modulu tad-diskussjoni xjentifika ta' dan l-EPAR.
English: How has Equisolon been studied?
Maltese: Kif ġie studjat Equisolon?
English: Equisolon must not be used in horses with viral or fungal infections, gastrointestinal or corneal ulcers or in pregnant mares.
Maltese: Equisolon m'għandux jintuża fiż-żwiemel b'infezzjonijiet virali jew fungali, b'ulċeri gastrointestinali jew tal-kornea jew fi dwieb tqal.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equisolon exceed the risks for the approved indication and recommended that Equisolon be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Equisolon jisbqu r-riskji għall-indikazzjoni approvata u rrakkomanda li Equisolon jingħata awtorizzazzjoni għattqegħid fis-suq.
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni.
English: The use of prednisolone in horses with RAO has been well described in the scientific literature.
Maltese: L-użu ta' prednisolone fiż-żwiemel b'RAO ġie ukoll deskritt sew fil-letteratura xjentifika.
English: Other information about Equisolon:
Maltese: Tagħrif ieħor dwar Equisolon:
English: What is the risk associated with Equisolon?
Maltese: X'riskji huma assoċjati ma' Equisolon?
English: Equisolon is used to treat recurrent airway obstruction (RAO or heaves) in horses in combination with environmental measures.
Maltese: Equisolon jintuża għall-kura ta' imblukkar rikorrenti tal-passaġġi tal-arja (RAO jew heaves) fiż-żwiemel flimkien ma' miżuri ambjentali.
English: How does Equisolon work?
Maltese: Għaliex ġie appruvat Equisolon?
English: In addition to treatment with prednisolone, the exposure to organic dust was reduced by substituting hay with silage and by improving the ventilation in the stable.
Maltese: Minbarra l-kura bi prednisolone, l-espożizzjoni għat-trab organiku tnaqqset billi l-ħuxlief ġie sostitwit b'għalf iffermentat u permezz ta' titjib fil-ventilazzjoni fl-istalel.
English: For a full list of all side effects reported with Equisolon, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportata b'Equisolon, ara l-fuljett ta' tagħrif.
English: What benefit has Equisolon shown during the studies?
Maltese: Liema benefiċċju wera Equisolon waqt l-istudji li twettqu?
English: RAO is a chronic (long-term) allergic condition in which horses wheeze, cough and have difficulty in breathing.
Maltese: RAO hija kundizzjoni allerġika kronika (fit-tul) li fiha, iż-żwiemel iħarħru, jisogħlu u jkollhom diffikultà fit-teħid tan-nifs.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: L-informazzjoni dwar l-istat tal-preskrizzjoni ta' dan il-prodott jista' jiġi kkonsultat fuq it-tikketta jew fuq il-qoxra tal-pakkett.
English: EU/2/12/143/001 EU/2/12/143/002 EU/2/12/143/003 EU/2/12/143/004 EU/2/12/143/005
Maltese: EU/2/12/143/001 EU/2/12/143/002 EU/2/12/143/003 EU/2/12/143/004
English: Date of last renewal: 13/03/2017.
Maltese: Data tal-aħħar tiġdid: 13/03/2017
English: Overdose (symptoms, emergency procedures, antidotes):
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti):
English: 5 x 1 ml (1 dose) 10 x 1 ml (1 dose) 25 x 1 ml (1 dose) 50 x 1 ml (1 dose) 10 ml (10 doses)
Maltese: 5 x 1 ml ( 1 doża) 10 x 1ml (1 doża) 25 x 1ml (1 doża) 50 x 1ml ( 1 doża) 1 x 10ml (10 dożi)
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' ingredjenti
English: CONTRAINDICATIONS
Maltese: KONTRAINDIKAZZJONIJIET
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16/07/2012.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16/07/2012
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer In-Netherlands
English: 1 Antigenic mass ELISA units.
Maltese: 1 Unitajiet ELISA tal-massa antiġenika .
English: - L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
Maltese: - L. interrogans serogroup Australis serovar Bratislava (strejn As-05-073)
English: Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate
Maltese: Sodjum klorajd Potassjum klorajd Disodjum fosfejt diħajdrejt
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Maltese: - L. kirschneri serogrupp Grippotyphosa serovar Dadas (strejn Gr-01-005)
English: ATCvet code: QI07AB01.
Maltese: Kodici veterinarja ATC QI07B01
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: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali ttrattati juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat, inklużi rapporti iżolati).
English: Excipient:
Maltese: Tqala:
English: BATCH NUMBER Lot {number}
Maltese: NUMRU TAL-LOTT Lott {numru}
English: Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Maltese: Strejns ta' Leptospira inattivati: - L. interrogans serogrupp Canicola serovar Portland-vere (strejn Ca-12-000)
English: Thiomersal
Maltese: Tajomersal
English: Colourless suspension.
Maltese: Suspensjoni bla kulur.
English: To stimulate active immunity in dogs against L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang.
Maltese: Sabiex jistimula l-immunità attiva fil-klieb kontra L. interrogans serogrupp Canicola serovar Canicola, L. interrogans serogrupp Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogrupp Australis serovar Bratislava, and L. kirschneri serogrupp Grippotyphosa serovar Bananal/Lianguang.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/143/001-005
Maltese: EU/2/12/143/001-005
English: Subcutaneous use.
Maltese: Mhux applikabbli.
English: (just for 10 ml vials)
Maltese: (għal kunjetti ta' 10 ml biss)
English: 6.2 Major incompatibilities
Maltese: .2 Inkompatibilitajiet maġġuri
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fil-friġġ (2°C - 8°C ) Tiffriżax.
English: Vial of 1 ml or 10 ml
Maltese: Kunjetti 1ml u 10ml
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Maltese: - L. interrogans serogrupp Icterohaemorrhagiae serovar Copenhageni (strejn Ic
English: Pack sizes:
Maltese: Vaċċinazzjoni bażika:
English: In very rare cases, clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia, or immune-mediated polyarthritis have been reported.
Maltese: F'każijiet rari ħafna ġew rappurtati sinjali kliniċi ta' anemija emolitika, trombosajtopinja u poli-artrite permezz ta' effetti immunitarji.
English: Do not mix with any other veterinary medicinal product except those mentioned in section 4.8.
Maltese: Tħallatx ma' tilqim jew prodotti veterinarji mediċinali oħra għajr dawk imsemmija f'sezzjoni 4.8.
English: Plastic box with 5, 10, 25 or 50 vials of 1 ml Cardboard box with 1 vial of 10 ml
Maltese: Kaxxa tal-plastik b'5, 10, 25 jew 50 kunjett ta' 1ml Kaxxa tal-kartun b'kunjett 1 ta' 10 ml
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac L4 suspension for injection for dogs
Maltese: VETERINARJU Nobivac L4, suspensjoni għal injezzjoni għall-klieb
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott {numru}
English: Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccines.
Maltese: Immunoloġiċi għall-Canidae, vaċċin batteriku inattivat.
English: PHARMACEUTICAL PARTICULARS
Maltese: GĦAMLA FARMAĊEWTIKA
English: Type I glass vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Maltese: Kunjett tal-ħġieġ tip I ta' 1ml (doża1) jew 10ml (10 dożi) magħluq b'tapp tal-gomma halogenbutyl u ssiġillat b'kappa tal-aluminjum kodifikat.
English: The mixed vaccines should be at room temperature (15°C - 25°C) before they are administered by subcutaneous injection.
Maltese: Il-vaċċini mħaltin għandhom ikunu f'temperatura tal-kamra (15°C - 25°C) qabel ma jiġu amministrati b'injezzjoni taħt il-ġilda.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarju tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: B. PACKAGE LEAFLET
Maltese: FIL-PAKKETT
English: PHARMACEUTICAL FORM Suspension for injection.
Maltese: Suspensjoni għal injezzjoni.
English: Active substances:
Maltese: Sustanzi Attivi:
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: 4.4 Special warnings for each target species
Maltese: 4.5 Prekawzjonijiet Speċjali għall-Użu
English: Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: PHARMACEUTICAL FORM Suspension for injection
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għal injezzjoni
English: For simultaneous use, 1 dose of a Nobivac vaccine containing canine distemper virus, canine adenovirus type 2, canine parvovirus, and/or canine parainfluenza virus components should be reconstituted with 1 dose (1 ml) of Nobivac L4.
Maltese: Għall-użu flimkien, doża 1 ta' vaċċin Nobivac li fih il-canine distemper virus, canine adenovirus tip 2, canine parvovirus, u/jew komponenti tal-canine parainfluenza virus għandha tiġi rikostitwita ma' doża (1ml) ta' Nobivac L4.
English: For example, local swelling, which can be up to 5 cm in diameter and which may take over 5 weeks to completely disappear, may be observed at the site of injection.
Maltese: Pereżempju, nefħiet lokali, li jistgħu jkunu sa 5cm fid-dijametru u li jistgħu jdumu aktar minn 5 ġimgħat biex jinżlu kompletament, jistgħu jiġu osservati fil-post tal-injezzjoni.
English: 4.11 Withdrawal period
Maltese: 4.11 Perjodu ta' Tiżmim
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: 0.1 mg. For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Dogs
Maltese: IEĦOR
English: Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination.
Maltese: Kull nefħa simili tisparixxi jew tonqos sew wara 14-il ġurnata wara l-vaċċinazzjoni.
English: The CVMP at their meeting on 17-19 January 2017 decided that one further five-year renewal was required in view of the outstanding pharmacovigilance concerns regarding serious adverse events that were undergoing evaluation at the time of the renewal procedure.
Maltese: Is-CVMP fil-laqgħa tagħhom tas-17-19 ta' Jannar 2017 iddeċidew li hemm bżonn ta' tiġdid ieħor ta' 5 snin fid-dawl ta' tħassib ta' farmakoviġilanza dwar effetti serji mhux mixtieqa li kienu qed jiġu evalwati fl-istess żmien tal-proċess ta' tiġdid.
English: Name and address of the manufacturer of the biological active substances
Maltese: Isem u indirizz tal-manufattur tas-sustanzi bijoloġiċi attivi
English: Not applicable.
Maltese: Inkompatibilitajiet:
English: When mixed with Nobivac vaccines containing canine parainfluenza virus at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
Maltese: Ġie stabbilit li meta mħallat ma' vaċċini Nobivac li fihom il-canine parainfluenza virus waqt ir-rivaċċinazzjoni, ma hemm l-ebda interferenza mar-rispons anamnestiku indott mill-komponent tal-canine parainfluenza virus injettat.
English: Interaction with other medicinal products and other forms of interaction:
Maltese: Interazzjoni ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni:
English: SPECIAL STORAGE PRECAUTIONS
Maltese: KOMPOŻIZZJONI KWALITATTIVA
English: In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of crossprotection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Maltese: Data in vitro u in vivo fi speċje mhux fil-mira jissuġġerixxu li l-vaċċin jista' jipprovdi grad ta' transprotezzjoni kontra L. interrogans serogrupp Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogrupp Grippotyphosa serovar Grippotyphosa.
English: PACKAGE LEAFLET: Nobivac L4 suspension for injection for dogs
Maltese: Nobivac L4, suspensjoni għal injezzjoni għall-klieb
English: Administer two vaccinations of 1 dose (1 ml) of vaccine with an interval of 4 weeks to dogs from 6 weeks of age onwards.
Maltese: Amministra żewġ tilqimiet ta' doża 1 (1ml) tal-vaċċin b'intervall ta' 4 ġimgħat lill-klieb mill-età ta' 6 ġimgħat 'il quddiem.
English: ROUTE(S) OF ADMINISTRATION
Maltese: MOD TA' AMMINISTRAZZJONI
English: ADVERSE REACTIONS
Maltese: MANIFATTUR RESPONSABBLI
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac L4
Maltese: Prodott mediċinali veterinarju li jingħata bir-riċetta.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Nobivac series containing canine distemper virus, canine adenovirus type 2, canine parvovirus, and/or canine parainfluenza virus components for subcutaneous administration.
Maltese: Data fuq is-sigurtà u l-effikaċja huma disponibbli li juru li dan il-vaċċin jista' jitħallat u jingħata ma' vaċċini tas-serje Nobivac li fihom canine distemper virus, canine adenovirus tip 2, canine parvovirus u/jew komponenti tal-parvovirus għal amministrazzjoni taħt il-ġilda.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Maltese: .8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
English: Ref. EMEA/309003/2008
Maltese: EMEA/378425/2008
English: London, 26 June 2008 Doc.
Maltese: Londra, 26 ta' Ġunju 2008 Dok. Ref.
English: What is Spanidin?
Maltese: X'inhu Spanidin?
English: International non-proprietary name (INN): gusperimus
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): gusperimus
English: It contains the active substance gusperimus.
Maltese: Fih is-sustanza attiva gusperimus.
English: The active substance in Spanidin, gusperimus, is an immunosuppressive medicine, which means that it reduces the activity of the immune system (the body's natural defences).
Maltese: Is-sustanza attiva fi Spanidin, gusperimus, hija mediċina immunosuppressiva, li jfisser li tnaqqas l-attività tas-sistema immunitarja (id-difiżi naturali tal-ġisem).
English: The CHMP normally takes up to 210 days to evaluate a new application.
Maltese: Is-CHMP normalment jieħu sa 210 ġranet sabiex jevalwa applikazzjoni ġdida.
English: How far into the evaluation was the application when it was withdrawn?
Maltese: Sa fejn kienet waslet l-evalwazzjoni ta' l-applikazzjoni qabel ma din ġiet irtirata?
English: On 17 June 2008, Euro Nippon Kayaku GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Spanidin, for the induction of remission in adult patients suffering from clinically refractory Wegener's granulomatosis.
Maltese: Fis-17 ta' Ġunju, Euro Nippon Kayaku GmbH innotifikaw uffiċjalment lill-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li xtaqu jirtiraw l-applikazzjoni tagħhom għallawtorizzazzjoni għat-tqegħid fis-suq ta' Spanidin, għall-induzzjoni tar-remissjoni f'pazjenti adulti li jbatu minn granulomatożi ta' Wegener refrattarja klinikament Spanidin kien indikat bħala mediċina orfni fid-29 ta' Marzu 2001.
English: How is Spanidin expected to work?
Maltese: Għal xiex huwa mistenni li jintuża Spanidin?
English: Spanidin has been studied in one main study involving 45 patients with Wegener's granulomatosis who were ‘refractory' (not responding) to standard treatment.
Maltese: Spanidin ġie studjat fi studju ewlieni li kein jinvolvi 45 pazjent bil-granulomatożi ta' Wegener li kienu ‘refrattarji' (li ma jirrispondux) għat-trattament standard.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Spanidin could not have been approved for the induction of remission in adult patients suffering from clinically refractory Wegener's granulomatosis.
Maltese: Skond l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien l-irtirar, is-CHMP kellu xi tħassib u kellu opinjoni proviżorja li Spanidin ma setax jiġi approvat għall-induzzjoni ta' remissjoni f'pazjenti adulti li jbatu minn granulomatożi ta' Wegener refrattarja klinikament.
English: Wegener's granulomatosis is a rare, auto-immune disease (a disease which is caused by the body's own defence system attacking normal tissue).
Maltese: Granulomatożi ta' Wegener hija marda rari u awtoimmuni (marda li hija kkawżata meta s-sistema ta' difiża tal-ġisem stess tattakka tessut normali).
English: Spanidin was not compared with any other treatment in this study, but the patients could take corticosteroids (a group of immunosuppressive medicines) in addition to Spanidin.
Maltese: Spanidin ma tqabbilx ma trattament ieħor f'dan l-istudju, iżda lpazjenti setgħu jieħdu kortikosterjodi (grupp ta' mediċini immunosuppressivi) minbarra is-Spanidin.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Fuq il-bażi tar-reviżjoni tad-dokumentazzjoni inizjali, is-CHMP iħejji lista ta' mistoqsijiet fil-120 jum, li mbagħad tintbagħat lillkumpanija.
English: The CHMP was also concerned that the study included some patients for whom induction treatment was not necessary, and others who did not have the symptoms of ‘classic' Wegener's granulomatosis affecting the airways, lungs or kidneys.
Maltese: Is-CHMP kien imħasseb ukoll dwar il-fatt li listudju kien jinkludi xi pazjenti li ma kenux jeħtieġu trattament ta' induzzjoni, u oħrajn li ma kellhomx sintomi tal-granulomatożi ta' Wegener ‘klassika' li taffettwa l-passaġġi ta' l-arja, il-pulmun u l-kliewi.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Maltese: Wara li s-CHMP kien evalwa ttweġibiet mill-kumpanija għal lista ta' mistoqsijiet, kien għad fadal xi kwistjonijiet pendenti li baqgħu ma ġewx solvuti.
English: In addition, Spanidin was not compared with any other treatment, so it was not possible to distinguish the effects of Spanidin and of steroids.
Maltese: Barra minn hekk, Spanidin ma tqabbilx ma trattament ieħor, u għalhekk ma kienx possibbli li wieħed jiddistingwi l-effetti ta' Spanidin u dawk ta' sterojdi.
English: In this disease, the immune system attacks neutrophils (a type of white blood cell), causing inflammation of small and medium-sized blood vessels and the formation of granulomas (clumps of white blood cells).
Maltese: F'din il-marda, is-sistema immunitarja tattakka n-newtrofili (tip ta' ċellula bajda tad-demm), li jirriżulta fl-infjammazzjoni tal-vini u l-arterji tad-demm ta' daqs żgħir u medju u l-formazzjoni ta' granulomi (mases ta' ċelluli bojod tad-demm).
English: What documentation did the company present to support its application to the CHMP?
Maltese: X'dokumentazzjoni ippreżentat il-kumpanija għas-sostenn ta' l-applikazzjoni tagħha lis-CHMP?
English: The effects of Spanidin were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Spanidin għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fil-bniedem.
English: Spanidin was expected to be used to control the symptoms of Wegener's granulomatosis in patients who were not responding to other treatments.
Maltese: Spanidin kien mistenni li jintuża biex jikkontrolla s-sintomi tal-granulomatożi ta' Wegener f'pazjenti li ma kenux qegħdin jirrispondu għal trattamenti oħra.
English: They received Spanidin for six ‘cycles', with each cycle consisting of three weeks ‘on' treatment followed by one week ‘off'.
Maltese: Ingħataw Spanidin għal sitt ‘ċikli', fejn kull ċiklu kien jikkonsisti fi tliet ġimgħat ‘taħt' trattament segwiti b'ġimgħa ‘mingħajr' trattament.
English: By reducing the number of lymphocytes and interfering with the way they work, Spanidin is expected to reduce the inflammation in the blood vessels that causes the symptoms of the disease.
Maltese: Billi jnaqqas l-għadd ta' linfoċiti u jfixkel il-mod kif jaħdmu, Spanidin huwa mistenni jnaqqas l-infjammazzjoni fil-vini u l-arterji tad-demm li jikkawżaw is-sintomi tal-marda.
English: System Organ Class
Maltese: Sistema talKlassifika talOrgani
English: 24 June 2016
Maltese: 24 ta' Ġunju 2016
English: Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Ireland
Maltese: Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork L-Irlanda
English: Stevens-Johnson syndrome
Maltese: Sindrome ta' Stevens-Johnson
English: 5-10 days
Maltese: 5-10 ijiem
English: C]-avibactam.
Maltese: avibactam.
English: CrCL estimated using the Cockcroft-Gault formula
Maltese: CrCL stmata bl-użu tal-formula Cockcroft-Gault
English: Limitations of the clinical data
Maltese: Limitazzjonijiet tad-data klinika
English: Gram-negative micro-organisms
Maltese: Mikro-organiżmi Gram-negattivi
English: Danmark Pfizer ApS Tlf: +45 44 20 11 00
Maltese: Pfizer ApS Tlf: +45 44 20 11 00
English: Lab tests
Maltese: Testijiet tal-laboratorju
English: Erythema multiforme
Maltese: Eritema multiformi
English: • an antibiotic called chloramphenicol
Maltese: • antibijotiku msejjaħ chloramphenicol
English: Aspartate aminotransferase increased
Maltese: Żieda fl-aspartate aminotransferase
English: Common (≥1/100 and <1/10) Uncommon (≥1/1,000 and <1/100) Rare (≥1/10,000 and <1/1000) Very rare (<1/10,000)
Maltese: Mhux komuni (≤1/1,000 u <1/100) Rari (≤1/10,000 u <1/1000)
English: Alanine aminotransferase increased
Maltese: Żieda fl-alanine aminotransferase
English: Direct antiglobulin test (DAGT or Coombs test) seroconversion and potential risk of haemolytic anaemia
Maltese: Test dirett tal-antiglobulina (DAGT jew it-test ta' Coombs) serokonverżjoni u r-riskju potenzjali ta' anemija emolitika
English: Plasma exposure levels at maternal and foetal NOAEL (100 mg/kg/day) indicate moderate to low margins of safety.
Maltese: Il-livelli talesponiment tal-plażma f'NOAEL matern u fetali (100 mg/kg/jum) jindikaw marġini ta' sigurtà moderat sa baxxi.
English: Table 3 Frequency of adverse reactions by system organ class
Maltese: Tabella 3 Frekwenza ta' reazzjonijiet avversi skont is-sistema tal-klassifika tal-organi
English: • Staphylococcus aureus (methicillin-susceptible and methicillin-reistant)
Maltese: • Staphylococcus aureus (suxxettibbli għal methicillin u reżistenti għal methicillin)