FrancophonIA/ELRC3.0 huggingface dataset:
English: If serum magnesium levels are elevated (above reference range normal values) the infusion of <Invented Name> should be stopped or infusion rate reduced as deemed clinically appropriate and safe.
Maltese: Jekk il-livelli tal-manjeżju fis-serum ikunu għoljin (ogħla mill-valuri normali tal-medda), l-infużjoni ta' Numeta G16%E għandha titwaqqaf jew ir-rata ta' infużjoni għandha titnaqqas skont kif ikun meqjus klinikament xieraq u bla periklu.
English: There is a possibility that this may lead to hypermagnesaemia.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Annex IV Amendments to relevant sections of the summary of product characteristics and package leaflet
Maltese: Dan jinkludi xi effett sekondarju li mhuwiex elenkat f'dan il-fuljett.
English: EMA/831772/2015 EMEA/H/C/002669
Maltese: EMA/831772/2015 EMA/H/C/002669
English: The full EPAR for Voriconazole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Voriconazole Accord is available as tablets (50 mg or 200 mg).
Maltese: Voriconazole Accord jiġi f'pilloli (50 mg jew 200 mg).
English: Voriconazole Accord is a ‘generic medicine'.
Maltese: Voriconazole Accord huwa ‘mediċina ġenerika'.
English: Voriconazole Accord voriconazole
Maltese: Voriconazole Accord vorikonażol
English: • candidaemia (another type of fungal infection due to Candida) in non-neutropenic patients
Maltese: • kandidaemija (tip ieħor ta' infezzjoni fungali kkaġunata mill-Kandida) fuq pazjenti non-netropeniċi
English: (patients with a normal white blood cell count);
Maltese: (pazjenti b'għadd normali ta' ċelluli bojod fid-demm);
English: Voriconazole Accord is an antifungal medicine that contains the active substance voriconazole.
Maltese: Voriconazole Accord huwa mediċina antifungali li fiha s-sustanza attiva vorikonażol.
English: • serious invasive Candida infections when the fungus is resistant to fluconazole (another antifungal medicine);
Maltese: • infezzjonijiet invażivi serji tal-Candida meta l-fungu jkun reżistenti għall-flukonażolu (mediċina antifungali oħra);
English: This is a summary of the European public assessment report (EPAR) for Voriconazole Accord.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Voriconazole Accord.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Voriconazole Accord on 16 May 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Voriconazole Accord fis-16 ta' Mejju 2013.
English: The active substance in Voriconazole Accord, voriconazole, is an antifungal medicine that belongs to the ‘triazole' group.
Maltese: Is-sustanza attiva f'Voriconazole Accord, il-vorikonażolu, hija mediċina antifungali li tappartjeni lillgrupp tat-‘trijażoli'.
English: Because Voriconazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Voriconazole Accord huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, tqies li l-benefiċċji u r-riskji huma l-istess bħal dawk tal-mediċina ta' referenza.
English: • serious fungal infections caused by Scedosporium or Fusarium (two different types of fungus).
Maltese: • infezzjonijiet invażivi serji kkawżati mill-Scedosporium jew mill-Fusarium (żewġ tipi differenti ta'
English: The list of fungi against which Voriconazole Accord is active can be found in the summary of product characteristics (also part of the EPAR).
Maltese: Il-lista ta' fungi li Voriconazole Accord huwa attiv kontrihom tinsab fis-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell membranes.
Maltese: Din taħdem billi tipprevjeni l-formazzjoni tal-ergosterolu, li huwa parti importanti mill-ħitan taċ-ċelloli fungali.
English: Voriconazole Accord is also used to prevent fungal infections in patients who have had haematopoietic (blood) stem-cell transplantation (a transplant of a type of stem cells that can develop into blood cells) and are at high risk of infection.
Maltese: Voriconazole Accord jintuża wkoll biex jipprevjeni infezzjonijiet fungali invażivi f'pazjenti li jkun sarilhom trapjant ta' ċelloli staminali (tad-demm) ematopojetiċi (trapjant ta' tip ta' ċelloli staminali li jistgħu jiżviluppaw f'ċelloli tad-demm) u li jkunu f'riskju għoli ta' infezzjoni.
English: This means that Voriconazole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Vfend.
Maltese: Dan ifisser li Voriconazole Accord huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem kummerċjali Vfend.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Voriconazole Accord has been shown to have comparable quality and to be bioequivalent to Vfend.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) ikkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Voriconazole Accord għandu kwalità komparabbli u huwa bijoekwivalenti għal Vfend.
English: Because Voriconazole Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Vfend.
Maltese: Peress li Voriconazole Accord huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza Vfend.
English: Why is Voriconazole Accord approved?
Maltese: Għaliex ġie approvat Voriconazole Accord?
English: Therefore, the CHMP's view was that, as for Vfend, the benefit outweighs the identified risks.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Vfend, il-benefiċċji huma akbar mir-riskji identifikati.
English: How has Voriconazole Accord been studied?
Maltese: Kif ġie studjat Voriconazole Accord?
English: How is Voriconazole Accord used?
Maltese: Kif jaħdem Voriconazole Accord?
English: EU/2/09/104/001 EU/2/09/104/002
Maltese: EU/2/09/104/001
English: Date of last renewal: 07/11/2014
Maltese: Data tal-aħħar tiġdid: 07/11/2014
English: Portugal Zoetis Portugal, Lda.
Maltese: Zoetis Portugal, Lda.
English: Italia Zoetis Italia S.r.l.
Maltese: Zoetis Italia S.r.l.
English: ATC vet code: QI04AA02
Maltese: QI04AA02
English: Nederland Zoetis B.V.
Maltese: Zoetis B.V.
English: Zoetis Česká republika, s.r.o.
Maltese: Česká republika Zoetis Česká republika, s.r.o.
English: Zoetis Deutschland GmbH Tel: +49 30 330063 0
Maltese: Deutschland Zoetis Deutschland GmbH Tel: +49 30 330063 0
English: United Kingdom Zoetis UK Limited
Maltese: United Kingdom Zoetis UK Limited Tel: +44
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15/01/2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 15/01/2010
English: Lietuva Oriola Vilnius UAB
Maltese: Oriola Vilnius UAB
English: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, 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: Rue Laid Burniat 1 1348 Louvain-la-Neuve
Maltese: 1348 Louvain-la-Neuve
English: ADVICE ON CORRECT ADMINISTRATION
Maltese: U METODU TA‘ AMMINISTRAZZJONI
English: Active substance(s):
Maltese: Sustanza(i) Attiva(i):
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC 8 Ovis suspension for injection for sheep
Maltese: VETERINARJU ZULVAC 8 Ovis suspensjoni għall-injezzjoni għan-nagħaġ
English: Tél: +33 (0)810 734 937
Maltese: Zoetis France Tél: +33 (0)810 734 937
English: Name and address of the manufacturer(s) of the biological active substance(s) Zoetis Manufacturing & Research Spain, S.L.
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza(i) bioloġika(ċi) attiva(i) Zoetis Manufacturing & Research Spain, S.L.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box 1 x 100ml / Carton box 1 x 240 ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun 1 x 100 ml / Kaxxa tal-kartun 1 x 240 ml
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Maltese: BTV-8/BEL2006/02
English: Onset of immunity: 25 days after administration of the second dose.
Maltese: Bidu tal-immunità: 25 ġurnata wara l-għoti tat-tieni doża.
English: Tel: +353 (0) 1 256 9800
Maltese: Zoetis Belgium SA Tel: +353 (0) 1 256 9800
English: ADVERSE REACTIONS In one laboratory safety study, transient increase in rectal temperature during the 24 hours following vaccination not exceeding 1.2°C and local reaction at the injection site, in most cases in the form of a general swelling (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 48 days) were observed very commonly.
Maltese: Fi studju wieħed tas-sigurtà fil-laboratorju, waqt l-ewwel 24 siegħa wara t-tilqima żjieda temporanja fit-temperatura tar-rektum ta' mhux aktar minn 1.2°C u reazzjoni lokali fis-sit tal-injezzjoni filmaġġoranza tal-każijiet f'forma ta' nefħa ġenerali tas-sit tal-injezzjoni (li ddum mhux aktar minn 7 ijiem) jew bħala għoqiedi li jinħassu (granuloma taħt il-ġilda, li tista' tippersisti għal aktar minn 48 ġurnata) kienu komuni ħafna.
English: Tel: +356 21 465 797
Maltese: Agrimed Limited Tel: +356 21 465 797
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: To stimulate active immunity against bluetongue virus, serotype 8 in sheep.
Maltese: Biex jistimula immunità attiva kontra l-virus bluetongue, serotip 8, fin-nagħaġ.
English: 1st injection: from 1.5 months of age.
Maltese: L-ewwel injezzjoni: minn 1.5 xhur ‘il fuq.
English: Suomi/Finland Zoetis Finland Oy
Maltese: Suomi/Finland Zoetis Finland Oy Puh/Tel:
English: Tel : +40 21 202 3083
Maltese: Zoetis România S.R.L Tel : +40 21 202 3083
English: Pharmacotherapeutic group: Inactivated viral vaccines - bluetongue virus vaccine.
Maltese: Vaċċini b'virus inattivat - vaċċin kontra l-virus bluetongue Kodici ATC veterinarja:
English: Adjuvant(s):
Maltese: Sustanza(i) awziljari :
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIOLOĠIKA(ĊI) ATTIVA(I)
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 fittabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma ikunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju
English: 4.11 Withdrawal period(s)
Maltese: 4.11 Perijodu ta‘ tiżmim
English: Deutschland
Maltese: Norge
English: Tel: +361 224 5222
Maltese: Zoetis Hungary Kft. Tel: +361 224 5222
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara sezzjoni 6.1.
English: These clinical signs have been reported very rarely from the field.
Maltese: Dawn is-sinjali kliniċi rari ħafna ġew irrappurtati
English: PHARMACEUTICAL FORM Off-white or pink suspension for injection
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni.
English: Tlf: +358 (0)9 4300 40
Maltese: Zoetis Finland Oy Tlf: +358 (0)9 4300 40
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1 *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Maltese: Tilqim attiv ta' nagħaġ minn 1.5 xhur ‘il fuq għall-prevenzjoni* ta' viremija kkawżata mill-virus bluetongue, serotip 8. *(Valur cycling (Ct) ≥ 36 minn metodu RT_PCR validat, jindika li m'hemmx preżenza tal-ġenom virali)
English: MARKETING AUTHORISATION HOLDER Zoetis Belgium SA
Maltese: Република България Zoetis Belgium SA Teл:
English: Sími: +358 (0)9 4300 40
Maltese: Zoetis Finland Oy Sími: +358 (0)9 4300 40
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu għal taħt il-ġilda.
English: OTHER INFORMATION Pack sizes
Maltese: Daqsijiet tal-pakkett
English: The frequency of adverse reactions is defined using the following convention:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 9 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 63 days).
Maltese: Fil-maġġoranza tal-każijiet dawn ir-reazzjonijiet iseħħu bħala nefħa ġenerali tas-sit tal-injezzjoni (li ddum għal mhux aktar minn 9 ijiem) jew bħala għoqiedi li jinħassu (granuloma taħt il-ġilda, li tista' tippersisti għal aktar minn 63 ġurnata).
English: The duration of immunity is at least 1 year after the primary vaccination course.
Maltese: It-tul tal-immunità huwa ta' l-anqas ta' sena wara l-kors primarju ta' tilqim.
English: The manufacture, import, possession, sale, supply and/or use of ZULVAC 8 Ovis may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: L-importazzjoni, il-pussess, il-bejgħ, il-provvista u/jew l-użu tal-prodott mediċinali veterinarju jista' jiġi pprojibit f'ċerti Stati Membri fit-territorju Kollu tagħhom jew f'parti minnu.
English: BELGIUM
Maltese: España
English: Puh/Tel: +358 (0)9 4300 40
Maltese: Zoetis Finland Oy Tel: +358 (0)9 4300 40
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml / Vial label 240 ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ L-IPPAKKJAR LI JMISS MAL-PRODOTT Tikketta tal-kunjett 100 ml/Tikketta tal-kunjett 240 ml
English: PACKAGE LEAFLET FOR: ZULVAC 8 Ovis suspension for injection for sheep
Maltese: ZULVAC 8 Ovi suspensjoni għall-injezzjoni għan-nagħaġ
English: Any person intending to manufacture, import, possess, sell, supply and use ZULVAC 8 Ovis must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Maltese: Kull persuna li għandha l-ħsieb li timmanifattura, timporta, tieħu pussess, tbiegħ, tipprovdi u/jew tuża ZULVAC 8 Ovis għandha tikkonsulta mal-Awtorità Kompetenti tal-Istat Membru dwar il-programmi ta' tilqim fis-seħħ qabel ma timmanifattura, timporta, tieħu pussess, tbiegħ, tipprovdi u/jew tuża.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose of 2 ml of vaccine contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Doża waħda ta' 2 ml fiha:
English: A transient increase in rectal temperature, not exceeding 0.6°C, may occur during the 24 hours following administration of a two-fold overdose.
Maltese: Wara l-għoti ta' doża eċċessiva id-doppju ta' dik irrakkomandata, waqt l-ewwel 24 siegħa tista' sseħħ żjieda temporanja fit-temperatura tar-rektum ta' mhux aktar minn 0.6°C.
English: As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Maltese: Peress li t-tul tal-immunità għadu mhux stabbilit għal kollox, kull skeda ta' tilqim mill-ġdid għandha tiġi approvata mill-Awtorità Kompetenti jew mill-veterinarju responsabbli, li għandhom jikkunsidraw is-sitwazzjoni epidemjoloġika lokali.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against BTV.
Maltese: F'din il-kategorija ta' annimali il-vaċċin għandu jintuża biss skont stima tal-benefiċċju/riskju mill-veterinarju responsabbli u/jew mill-Awtoritajiet Kompetenti skont il-politika kurrenti dwar tilqim kontra
English: a) the administration of the product to animals will interfere with the implementation of national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: a) l-għotja tal-prodott lill-annimali tinterferixxi ma' l-implimentazzjoni ta' programm nazzjonali għad-djanjosi, il-kontroll jew l-eradikazzjoni tal-mard tal-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni tal-assenza tal-kontaminazzjoni f'annimali ħajjin jew fl-ikel jew prodotti oħrajn li jiġu minn annimali kkurati;
English: Median PFS: 28.8 Not
Maltese: PFS medjan: 28.8
English: Log-rank p value
Maltese: Log-rank valur p
English: Truxima contains the active substance “rituximab”.
Maltese: Truxima fih is-sustanza attiva “rituximab”.
English: p-value (Wald test, not adjusted)
Maltese: valur p (test ta'Wald,
English: +myocardial infarction4 and 6, arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Maltese: +infart mijokardijaku4 u 6, arritmija, +fibrillazjoni atrijali, takikardja, +disturb fil-qalb
English: Truxima is a biosimilar medicinal product.
Maltese: Truxima huwa prodott mediċinali bijoloġiku simili.
English: % SF‐36 PHS MCID
Maltese: MHS SF-36 MHS MCID%
English: • The active ingredient in Truxima is called rituximab.
Maltese: • Is-sustanza attiva fi Truxima hija msejħa rituximab.
English: Truxima is indicated in adults for the following indications:
Maltese: Truxima huwa indikat f'adulti għall-indikazzjonijiet li ġejjin:
English: Granulomatosis with polyangiitis and microscopic polyangiitis Truxima, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Maltese: Granulomatosi b'polianġite u polianġite mikroskopika Truxima, flimkien ma' glukokortikojdi, huwa indikat għat-trattament ta' pazjenti adulti bi granulomatosi b'polianġite (ta' Wegener) (GPA - granulomatosis with polyangiitis) attiva u severa u polianġite mikroskopika (MPA - microscopic polyangiitis).
English: INFORMATION IN BRAILLE truxima 500 mg
Maltese: truxima 500 mg
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Truxima.
Maltese: Huma se josservawk mill-viċin waqt li tkun qed tingħata din il-mediċina.
English: INFORMATION IN BRAILLE truxima 100 mg
Maltese: truxima 100 mg
English: • recurrence of a previous Hepatitis B infection d)
Maltese: • infezzjoni tal-Epatite B terġa' titfaċċa d)
English: In patients with rheumatoid arthritis, granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis in disease remission or pemphigus vulgaris, premedication with 100 mg intravenous methylprednisolone should be completed 30 minutes prior to Truxima infusions to decrease the incidence and severity of infusion related reactions (IRRs).
Maltese: F'pazjenti b'artrite rewmatika, granulomatosi b'polianġite (ta' Wegener) jew polianġite mikroskopika f'remissjoni tal-marda jew pemphigus vulgaris, medikazzjoni minn qabel b'100 mg methylprednisolone fil-vini għandha tiġi kompluta 30 minuta qabel infużjonijiet ta' Truxima biex titnaqqas l-inċidenza u s-severità ta' reazzjonijiet relatati mal-infuzjoni (IRRs - infusion related reactions).
English: Subsequent doses of Truxima can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Maltese: Dożi sussegwenti ta' Truxima jistgħu jiġu infużi b'rata inizjali ta' 100 mg/siegħa, u miżjuda b'żidiet ta' 100 mg/siegħa f'intervalli ta' 30 minuta, sa massimu ta' 400 mg/siegħa.
English: Truxima is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Maltese: Truxima huwa indikat għall-kura ta' pazjenti b'limfoma mhux ta' Hodgkin ta ċ-ċellula B kbira mifruxa pożittiva għal CD20 flimkien ma' kimoterapija CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone).
English: Truxima 500 mg concentrate for solution for infusion Rituximab
Maltese: Truxima 500 mg konċentrat għal soluzzjoni għal infużjoni rituximab
English: Truxima 100 mg concentrate for solution for infusion Rituximab
Maltese: Truxima 100 mg konċentrat għal soluzzjoni għal infużjoni rituximab
English: sciatica, migraine, dizziness
Maltese: emigranja, sturdament, xjatika
English: Infections and infestations bacterial infection, viral infections, +bronchitis sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, +sinusitis, hepatitis B1
Maltese: Infezzjonijiet u infestazzjonijiet infezzjonijiet mill-batterja, infezzjonijiet mill-virus, +bronkite sepsi, +pnewmonja, +infezzjoni bid-deni, +herpes zoster, +infezzjoni fl-apparat respiratorju, infezzjoni millmoffa, infezzjonijiet b'etjoloġija mhux magħrufa,
English: Aseptically withdraw the necessary amount of Truxima, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/mL (0.9%) solution for injection or 5% D-Glucose in water.
Maltese: minn 1 sa 4 mg/mL ta' rituximab f'borża tal-infużjoni li jkun fiha, soluzzjoni għall-injezzjoni sterili u mingħajr piroġeni ta' klorur tas-sodju 9 mg/mL (0.9%) jew 5% D-Glucose fl-ilma.
English: How to store Truxima
Maltese: X'inhu Truxima
English: Truxima may be used for the treatment of several different conditions in adults.
Maltese: Truxima jista' jintuża għall-kura ta' diversi kundizzjonijiet differenti fl-adulti.
English: In the PV population, 5 (13%) patients in the rituximab group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the rituximab group and 33 (92%) of patients in the standard-dose prednisone group had severe disease according to disease severity defined by Harman's criteria.
Maltese: pazjenti fil-grupp ta' rituximab u 3 (8%) pazjenti fil-grupp ta' prednisone standard kellhom marda moderata u 33 (87%) pazjent fil-grupp ta' rituximab u 33 (92%) pazjent fil-grupp b'doża standard ta' prednisone kellhom marda severa skont is-severità tal-marda ddefinita mill-kriterji ta' Harman.
English: This medicinal product contains 52.6 mg sodium per 10 mL vial, equivalent to 2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 52,6 mg sodium f'kull kunjett ta '10 mL, ekwivalenti għal 2,6% talammont massimu rakkomandat mill-WHO ta 2 g sodium li għandu jittieħed kuljum minn adult.
English: Truxima should be used in combination with CHOP chemotherapy.
Maltese: ċitokini u/jew medjaturi kimiċi oħra.
English: EFS - Event Free Survival
Maltese: EFS - Sopravivenza Mingħajr Avveniment