FrancophonIA/ELRC3.0 huggingface dataset:
English: Plegridy has been shown to reduce the rate of relapses in patients with relapsing-remitting MS in a main study which lasted two years and involved 1,516 patients.
Maltese: Plegridy wera li jnaqqas ir-rati ta' rikaduti f'pazjenti b'MS reċidiva-remittenti fi studju ewlieni li dam sentejn u li involva 1,516-il pazjent.
English: The Agency considered that Plegridy given every two weeks has been shown to produce about a 30% reduction in the number of relapses in patients with relapsing-remitting MS compared with placebo, which is comparable to the effect of other MS medicines containing nonpegylated interferon beta, and is considered clinically relevant.
Maltese: L-Aġenzija kkunsidrat li Plegridy mogħti kull ġimagħtejn wera li jipproduċi madwar 30 % tnaqqis fl-għadd ta' rikaduti f'pazjenti b'MS reċidiva-remittenti meta mqabbel mal-plaċebo, li huwa komparabbli mal-effett ta' mediċini oħra kontra l-MS li fihom interferon beta mhux pegilat, u huwa kkunsidrat klinikament rilevanti.
English: During the first year, patients treated with Plegridy every two or four weeks experienced fewer relapses on average than patients on placebo: 0.26 and 0.29 relapses versus 0.40, respectively.
Maltese: Matul l-ewwel sena, il-pazjenti kkurati bi Plegridy kull ġimagħtejn jew erba' ġimgħat esperjenzaw bħala medja inqas rikaduti mill-pazjenti fuq il-plaċebo: 0.26 u 0.29 rikaduti meta mqabbla ma' 0.40, rispettivament.
English: Treatment should start with a dose of 63 micrograms, followed by a dose of 94 micrograms after two weeks, and then 125 micrograms every two weeks thereafter.
Maltese: Il-kura għandha tinbeda b'doża ta' 63 mikrogramma, segwita minn doża ta' 94 mikrogramma wara ġimagħtejn, imbagħad 125 mikrogramma kull ġimagħtejn wara.
English: What are the risks associated with Plegridy?
Maltese: X'inhuma r-riskji assoċjati ma' Plegridy?
English: As for all medicines, data on the use of Plegridy are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Plegridy hija ssorveljata kontinwament.
English: this interferon has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: dan l-interferon ġie “pegilat” (twaħħal ma' kimika msejħa polietilenglikol).
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Maltese: F'MS, is-sistema immunitarja (id-difiżi naturali tal-ġisem) ma taħdimx tajjeb u tattakka partijiet missistema nervuża ċentrali (il-moħħ, l-ispina dorsali u n-nerv ottiku [nerv li jibgħat sinjali mill-għajn għall-moħħ]), u dan jikkawża infjammazzjoni li tagħmel ħsara lin-nervituri u lill-insulazzjoni ta' madwarhom.
English: Plegridy is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Maltese: Plegridy huwa mediċina li tintuża għall-kura ta' sklerożi multipla (MS), marda li fiha l-infjammazzjoni tagħmel ħsara lill-insulazzjoni protettiva madwar in-nervituri (demijelinazzjoni - demyelination) kif ukoll lin-nervituri innifishom.
English: With regards to the safety profile, the most common side effects observed during treatment with Plegridy are considered to be manageable and generally consistent with those seen with non-pegylated interferon products.
Maltese: Fir-rigward tal-profil tas-sigurtà, l-effetti sekondarji l-aktar komuni osservati matul il-kura bi Plegridy huma kkunsidrati maniġġabbli u huma ġeneralment konsistenti ma' dawk li jidhru ma' prodotti interferoni mhux pegilati.
English: For the full list of side effects and restrictions with Plegridy, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet bi Plegridy, ara l-fuljett ta' tagħrif.
English: Side effects reported with Plegridy are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Plegridy huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: How does Plegridy work?
Maltese: Kif jintuża Plegridy?
English: What measures are being taken to ensure the safe and effective use of Plegridy?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Plegridy?
English: When Plegridy was given every four weeks its beneficial effect was smaller, and it was not possible to identify a group of patients in whom this less frequent dosing was considered appropriate.
Maltese: Meta Plegridy ingħata kull erba' ġimgħat l-effett benefiċċjali tiegħu kien iżgħar, u ma kienx possibbli jiġi identifikat grupp ta' pazjenti li fihom dan id-dożaġġ inqas frekwenti kien meqjus adegwat.
English: The exact way that Plegridy works in MS is not yet known but it seems to calm down the immune system, and prevents relapses of MS.
Maltese: Il-mod eżatt li bih Plegridy jaħdem f'MS għadu mhux magħruf iżda jidher li jikkalma lissistema immunitarja, u jipprevjeni r-rikaduti tal-MS.
English: ATCvet code: QI01AD07.
Maltese: QI01AD07
English: Merck Sharp & Dohme Animal Health, S.L.
Maltese: Merck Sharp & Dohme Animal Health,S.
English: Live IBV, D388
Maltese: Ħaj IBV, D388
English: EID50/dose
Maltese: EID50/doża
English: Apply coarse spray ≥250 microns.
Maltese: Applika sprej oħxon ≥250 mikrons.
English: Store below 25 °C.
Maltese: Aħżen taħt 25 °C.
English: 10 x 1,000 doses 10 x 2,500 doses 10 x 5,000 doses 10 x 10,000 doses
Maltese: 10 x 1,000 doża 10 x 2,500 doża 10 x 5,000 doża 10 x 10,000 dożi
English: 50% egg infective dose.
Maltese: 50% doża infettiva fil-bajd.
English: Overdose (symptoms, emergency procedures, antidotes):
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti).
English: Date of first authorisation: 04/09/2014.
Maltese: Data tal-ewwel awtorizazzjoni: 04/09/2014.
English: 1,000 doses (3-100 spheres) 2,500 doses (3-100 spheres) 5,000 doses (3-100 spheres) 10,000 doses (3-400 spheres)
Maltese: 1,000 doża (3-100 sfera) 2,500 doża (3-100 sfera) 5,000 doża (3-100 sfera) 10,000 doża (3-400 sfera)
English: Date of last renewal: 13/06/2019.
Maltese: Data ta`l-ahhar tigdid: 13/06/2019.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer Olanda
English: Sodium chloride
Maltese: Klorajd tas-sodium
English: Solvent (Solvent Oculo/Nasal): blue-coloured solution.
Maltese: Solvent (Solvent għajnejn/nażali): soluzzjoni kulur blu.
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 trattati li juru effett(i) mhux mixtieqa - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal trattati) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal trattati) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal trattati) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal trattati, inklużi rapporti iżolati).
English: Zero days.
Maltese: 2 sigħat.
English: Sealed aluminium laminate cup with a polypropylene (cup) and polypropylene/polyethylene (lid) contact layer containing 1,000; 2,500; 5,000 or 10,000 doses.
Maltese: Tazza ssiġilata laminata bl-aluminju (tazza) ta' polypropylene u (għatu) wiċċ ta' kuntatt polypropylene/polyethylene li fiha 1,000, 2,500, 5,000 jew 10,000 dożi.
English: Solvent (Solvent Oculo/Nasal):
Maltese: Solvent (Solvent għall-għajnejn/mnifsejn) :
English: Onset of immunity: 3 weeks.
Maltese: Bidu tal-immunità: 3 ġimgħat.
English: To stimulate active immunity against the D388/QX type of avian infectious bronchitis virus.
Maltese: Sabiex jistimula immunità attiva kontra t-tip D388/QX tal-virus tat-tjur tal-Bronkite Infettiva .
English: Hydrolysed gelatine Pancreatic digest of casein Disodium phosphate dihydrate
Maltese: Ġelatina ħidroliżata Diġest tal-kasejn pankrijatiku Disodium phosphate dihydrate
English: Low density polyethylene (LDPE) vial of 35 ml with a halogenobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-polyethlyene (LDPE) ta' densita baxxa ta'35ml b'tapp tal gomma halodenobutyl u kappa tal-aliminju.
English: Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccine.
Maltese: Immunoloġiku għat-tjur, tjur domestiku , vaċċin virali ħaj.
English: Chickens
Maltese: Tiġieġ
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Packaging:
Maltese: Ipakkjar:
English: Sodium hydroxide or hydrochloric acid (for pH adjustment) Water for injections
Maltese: Sodium hydroxide jew hydrochloric acid (għall-aġustament tal-pH) Ilma għall-injezzjonijiet
English: LABEL - Solvent VIALS
Maltese: TIKETTA solvent KUNJETTI
English: Interaction with other medicinal products and other forms of interaction:
Maltese: Interazzjoni ma' prodotti mediċinali oħra jew forom oħra ta' interazzjoni:
English: Vaccinate healthy animals only.
Maltese: Laqqam animali f`saħħithom biss.
English: Cardboard box with 10 cups of lyophilisate (1,000 doses per 42 mm diameter cup (3-100 spheres)) + cardboard box with 10 x 35 ml vial of solvent supplemented with dropper and adapter.
Maltese: Kaxxa tal-kartun b'10 tazzi tal-lijofiliżat (1,000 doża f'tazza b'dijametru ta' 42 mm (3-100 sferi)). + kaxxa tal-kartun b`10 x 35ml kunjetti tas-solvent supplimentati bi dropper u adapter.
English: Potassium dihydrogen phosphate Disodium phosphate dihydrate Disodium edetate dihydrate
Maltese: Disodium phosphate dihydrate
English: 2) Shake the vaccine suspension.
Maltese: 2) Ħawwad is-suspensjoni tal-vaċċin.
English: Duration of immunity: 8 weeks.
Maltese: Kemm iddum l-immunità: 8 ġimgħat.
English: For active immunisation of chickens in order to reduce respiratory signs of avian infectious bronchitis caused by QX-like variants of infectious bronchitis virus (IBV).
Maltese: Immunità attiva fit-tiġieġ sabiex jitnaqqsu sinjali respiratorji tal-Bronkite Infettiva tat-tjur ikkawżata mill-varjant li jixbaħ il-virus QX tal-bronkite infettiva (IBV).
English: Active substance: Live attenuated avian infectious bronchitis virus, strain D388: 10
Maltese: Sustanza Attiva : Strejn tal-virus ħaj attenwat tal-Bronkite Infettiva tat-tjur D388: 10
English: Store in a refrigerator (2 C - 8 C).
Maltese: Aħżen fil-friġġ (2Ċ- 8Ċ).
English: CARDBOARD BOX with 10 vials of solvent
Maltese: KAXXA TAL_KARTUN b`10 kunjetti tas-solvent
English: EU/2/14/174/001 (10 x 1,000 doses)
Maltese: EU/2/14/174/001 (10 x 1,000 doża)
English: Nobilis IB Primo QX is intended to protect chickens against clinical signs of disease caused by IBV variant strain D388 only and should not be used as a replacement for other IBV vaccines.
Maltese: Nobilis IB Primo huwa maħsub sabiex jipproteġi lit-tiġieġ kontra sintomi kliniċi tal-marda kkawżata minn IBV strejn varjant D388 u m'għandux jintuża bħala sostitut għal vaċċini IBV oħra.
English: EU/2/14/174/002 (10 x 1,000 doses + 10 x 35 ml solvent) EU/2/14/174/003 (10 x 5,000 doses)
Maltese: EU/2/14/174/002 (10 x 1,000 doża + 10 x 35ml solvent)
English: 1) The contents of a cup (1,000 doses only) can be added to Solvent Oculo/Nasal using the included adapter and administered after connecting the included dropper.
Maltese: 1) Il-kontenut ta' tazza (1000 doża biss) jista' jiġi miżjud mas-Solvent Okkulu/Nażali billi tuża l adapter inkluż u amministra wara li jitwaħħal mad-dropper inkluż.
English: Read the product information of Nobilis IB Ma5 before use.
Maltese: Aqra l-fuljett tal-informazzjoni ta' Nobilis IB Ma5 qabel l-użu.
English: Chickens.
Maltese: Tiġieġ.
English: Live attenuated avian infectious bronchitis virus, strain D388: 10
Maltese: Strejn tal-virus ħaj attenwat tal-Bronkite Infettiva tal-għasafar D388: : 10
English: EU/2/14/174/005 (10 x 2,500 doses)
Maltese: EU/2/14/174/005 (10 x 2,500 doża)
English: Cups may contain 3 spheres to up to 400 spheres depending on the required dosages and production yields.
Maltese: It-tazzi jistgħu jkollhom minn 3 sferi sa 400 sferi skont id-doża meħtieġa u rendiment tal-produzzjoni.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan ilprodott mediċinali veterinarju.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonal tiegħu, jipprojbixxi il-manifattura, l-importazzjoni, ilpussess, il-bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fitterritorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Coarse spray:
Maltese: Sprej oħxon :
English: ROUTE OF ADMINISTRATION
Maltese: U METODU TA' AMMINISTRAZZJONI
English: Oculonasal use.
Maltese: U/JEW UŻU Mhux applikabbli.
English: LABEL - Lyophilisate CUPS
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR
English: Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension for chickens Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens
Maltese: Nobilis IB Primo QX lijofiliżat u solvent għall-suspensjoni għall-għajnejn/imnifsejn għat-tiġieġ Nobilis IB Primo QX lijofiliżat għall-suspensjoni għall-għajnejn/imnifsejn għat-tiġieġ
English: Solvent Oculo/Nasal for chickens
Maltese: Solvent għall-għajnejn/imnifsejn
English: Chickens should be vaccinated against other prevalent IBV serotypes (e.g. Massachusetts) according to the local IB vaccination programme.
Maltese: It-tiġieġ għandhom jiġu vaċċinati kontra strejns oħra prevalenti tas-serotipi IBV (e.ż. Massachusetts) skont ilprogramm lokali tal-vaċċinazzjoni tal-IB.
English: PACKAGE LEAFLET: Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension for chickens Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens
Maltese: VETERINARJU Nobilis IB Primo QX, lijofiliżat u solvent għall-suspensjoni għall-għajnejn/mnifsejn, għat-tiġieġ.
English: The IB D388 vaccine should only be applied in hatcheries to chickens from 1 day of age or older if adequate controls are in place to avoid the spread of the vaccine virus to birds that will be transported to non-IB QX exposed flocks.
Maltese: Il-vaċċin IB D388 għandu jingħata biss f'postijiet tat-tifqis jekk jeżiżtu kontrolli adekwati sabiex jiġi evitat it-tixrid tal-virus tal-vaċċin f'għasafar li jiġu trasportati għal qatgħat mhux esposti għall-IB QX.
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 li hija prinċipju ta' oriġini bijoloġiku maħsuba sabiex tipproduċi immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: 50% egg infective dose For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: CARDBOARD BOX with 10 cups of lyophilisate
Maltese: KAXXA TAL-KARTUN b`10 tazzi tal-lijofilizat
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Maltese: Intervet International B.V.
English: EU/2/14/174/004 (10 x 10,000 doses)
Maltese: EU/2/14/174/003 (10 x 5,000 doża)
English: 1) Reconstitute the lyophilisate using water of good quality (e.g. free from chlorine and/or disinfectants).
Maltese: 1) Ir-rikonstitwixxi il-ljofiliżat billi tuża ilma ta' kwalità tajba (e.ż. ma fihx klorin u /jew diżinfettant).
English: It is important to avoid introduction of the IB D388 vaccine virus into premises in which the wild type strain is not present.
Maltese: Huwa importanti li tevita l-introduzzjoni tal-IB D388 virus tal-vaċċin f'postijiet fejn t-tip ta' strejn selvaġġ mhux preżenti.
English: Lyophilisate and solvent for oculonasal suspension Lyophilisate for oculonasal suspension.
Maltese: Matul dan iżżmien, kuntatt bejn tiġieġ immunosoppressi u tiġieġ mhux vaċċinati għandu jiġi evitat.
English: Cardboard box with 10 cups of lyophilisate (10,000 doses per 61 mm diameter cup (3-400 spheres)).
Maltese: Kaxxa tal-kartun b'10 tazzi tal-lijofiliżat (10,000 doża f'tazza b'dijametru ta' 61 mm (3-400 sferi)).)
English: Cardboard box with 10 cups of lyophilisate (5,000 doses per 42 mm diameter cup (3-100 spheres)).
Maltese: Kaxxa tal-kartun b'10 tazzi tal-lijofiliżat (5,000 doża f'tazza b'dijametru ta' 42 mm (3-100 sferi)).
English: Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens
Maltese: Nobilis IB Primo QX lijofiliżat għall-suspensjoni għall-għajnejn/mnifsejn , għat-tiġieġ
English: Cardboard box with 10 cups of lyophilisate (1,000 doses per 42 mm diameter cup (3-100 spheres)).
Maltese: Kaxxa tal-kartun b'10 tazzi tal-lijofiliżat (1,000 doża f'tazza b'dijametru ta' 42 mm (3-100 sferi)).
English: Solvent: Store below 25 C.
Maltese: Aħżen taħt 25Ċ.
English: Cardboard box with 10 cups of lyophilisate (2,500 doses per 42 mm diameter cup (3-100 spheres)).
Maltese: Kaxxa tal-kartun b'10 tazzi tal-lijofiliżat (2,500 doża f'tazza b'dijametru ta' 42 mm (3-100 sferi)).
English: NAME OF THE VETERINARY PRODUCT
Maltese: Kodici ATC veterinarja:
English: For the mixed products the onset of immunity is 3 weeks and the duration of immunity is 8 weeks for the claimed protection against Massachusetts and QX-like strains of IBV.
Maltese: Għall-prodotti mħallta, l-bidu tal-immunità huwa 3 ġimgħat u l-immunità ddum 8 ġimgħat għall-protezzjoni msemijja kontra Massachussets u strejns tal-IBV li jixbħu QX.
English: The protection against other circulating IB strains has not been investigated.
Maltese: Protezzjoni kontra strejns oħra ċirkolanti ta' IB ma kienx investigat.
English: Solvent for oculonasal suspension.
Maltese: Wara li titħallat is-suspensjoni tidher ċara.
English: Very mild inflammatory changes have occasionally been found in the kidneys of specific pathogen free (SPF) chickens after administration of a 10-fold overdose.
Maltese: Wara l-vaċċinazzjoni, rarament ħafna, jista' jkun hemm reazzjoni respiratorja tranżitorja mhux qawwija (tinkludi efużjonijiet nażali) minn tal-anqas għal 10 ijiem.
English: Lyophilisate:
Maltese: Lijofiliżat:
English: PHARMACEUTICAL FORM
Maltese: FARMAĊEWTIKU
English: 6.3 Shelf life
Maltese: 4.4 Twissijiet speċjali
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis IB Ma5 for spray or oculonasal application.
Maltese: Is-sigurtà tal-prodott mediċinali veterinarju ma ġietx stabbilita fi żmien il-bidien.
English: --1 ≥ 3.2 x 10
Maltese: --1 ≥ 3.2 x 106 Unitajiet ELISA
English: Strength Pharmaceutical form
Maltese: Għamla Farmaċewtika
English: ELISA Units
Maltese: Qawwa
English: EU number
Maltese: Mod ta'
English: Propofol; valproate - Pharmacokinetic drug interaction leading to an increased propofol exposure (EPITT no 18696)
Maltese: Propofol; valproate - Interazzjoni farmakokinetika talmediċina li twassal għal esponiment miżjud ta' propofol (EPITT no 18696)
English: Summary of product characteristics (propofol) 4.5.
Maltese: Sommarju tal-karatteristiċi tal-prodott (propofol) 4.5.
English: Adopted at the 9-12 January 2017 PRAC
Maltese: Adottati fil-PRAC ta' bejn il-9-12 ta' Jannar 2017
English: Pericardial effusion
Maltese: Effużjoni perikardjali
English: Common side effects (may affect up to 1 in 10 people) - Collection of fluid around the heart (pericardial effusion)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10) - Ġbir ta' fluwidu madwar il-qalb (effużjoni perikardjali)
English: Interaction with other medicinal products and other forms of interaction A need for lower propofol doses has been observed in patients taking valproate.
Maltese: Interazzjoni ma' prodotti mediċinali oħrajn u forom oħra ta' interazzjoni Ġiet osservata ħtieġa ta' dożi aktar baxxi ta' propofol f'pazjenti li jieħdu valproate.
English: Azacitidine - Pericarditis and pericardial effusion (EPITT no 18733)
Maltese: Azacitidine - Effużjoni pericarditis u perikardjali (EPITT no
English: Undesirable effects Tabulated list of adverse reactions System Organ
Maltese: Lista f'tabella tar-reazzjonijiet avversi
English: Class
Maltese: Rari
English: The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals' which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
Maltese: Il-kliem tal-informazzjoni dwar il-prodott f'dan id-dokument huwa estratt mid-dokument bit-titlu ‘Rakkomandazzjonijiet tal-PRAC dwar is-sinjali' li fih it-test sħiħ tar-rakkomandazzjonijiet tal-PRAC għall-aġġornament tal-informazzjoni dwar il-prodott, kif ukoll xi gwida ġenerali dwar il-ġestjoni tassinjali.
English: Uncommon Rare Not known
Maltese: Komuni ħafna
English: Cardiac disorders
Maltese: Sistema talKlassifika talOrgani
English: Package leaflet
Maltese: Mhux magħruf
English: Very common
Maltese: Mhux komuni
English: New product information wording - Extracts from PRAC recommendations on signals
Maltese: Formulazzjoni ġdida tal-kliem tal-informazzjoni dwar prodott - Siltiet mir-rakkomandazzjonijiet tal-PRAC dwar is-sinjali
English: When used concomitantly, a dose reduction of propofol may be considered.
Maltese: It-test attwali li għandu jitħassar huwa maqtugħ.
English: Quinta da Fonte - Edifício D. José - Piso 1, 2780-730 Paço d' Arcos
Maltese: Quinta da Fonte - Edifício D. José - Piso 1, 2780730
English: Novo Nordisk, Coeur Défense - 100, avenue du Général de Gaulle - 92400 Courbevoie
Maltese: Novo Nordisk, Coeur Défense - 100, avenue du Général de Gaulle92400 Courbevoie Franza
English: Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, West Sussex RH11 9RT United Kingdom
Maltese: Ir-Renju Unit Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, West Sussex RH11 9RT
English: Luxembourg Novo Nordisk Pharma Riverside Business Park B-1070 Bruxelles
Maltese: Novo Nordisk Pharma Riverside Business Park B-1070 Bruxelles Il-Belġju
English: Novo Nordisk Hellas Ltd. A. Panagouli 80 & Aghias Triados 65.
Maltese: Panagouli 80 & Aghias Triados 65.
English: Flemingweg 18, 2408 AV ALPHEN A/D RIJN The Netherlands
Maltese: Flemingweg 18, 2408 AV ALPHEN A/D RIJN L-Olanda soluzzjoni għallinjezzjoni (oplossing voor injectie )
English: Belgium NOVO NORDISK PHARMA SA
Maltese: Il-Belġju NOVO NORDISK PHARMA SA
English: Novo Nordisk Pharma GmbH
Maltese: Il-Ġermanja Novo Nordisk Pharma GmbH
English: Boulevard international 55 1070 Brussels
Maltese: 1070 Brussels Il-Belġju
English: Slovenia Novo Nordisk A/S Novo Allé
Maltese: Is-Slovenja Novo Nordisk A/S Novo Allé
English: Finland Novo Nordisk A/S Novo Allé
Maltese: Il-Finlandja Novo Nordisk A/S Novo Allé