FrancophonIA/ELRC3.0 huggingface dataset:
English: - Uncommon side effects(may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test.
Maltese: - Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100): uġigħ ta' ras; sturdament; dijarea; dardir, rimettar; nefħa u gass fl-istonku; stitikezza; ħalq xott; uġigħ ta' żaqq u skonfort; raxx tal-ġilda jew urtikarja; ħakk; tħossok dgħajjef, għajjien jew ġeneralment ma tħossokx tajjeb; problemi biex torqod; żieda fl-enzimi tal-fwied f'test tad-demm.
English: Ireland
Maltese: Portugal
English: PANTECTA Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Maltese: PANTECTA Control fih is-sustanza attiva pantoprazole, li timblokka l-'pompa' li tipproduċi l-aċidu fl-istonku.
English: - Serious allergic reactions (rare: may affect up to 1 in 1,000 people): Hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema.
Maltese: - Reazzjonijiet allerġiċi serji (rari: (jistgħu jaffettwaw sa persuna 1 f'1,000)): Reazzjonijiet ta' sensittività eċċessiva, dawk hekk imsejħa reazzjonijiet anafilattiċi, xokk anafilattiku u anġjoedema.
English: However, an interaction of pantoprazole with other substances which are metabolised by the same enzyme system cannot be excluded.
Maltese: Madanakollu, interazzjoni ta' pantoprazole ma' sustanzi oħrajn li jkunu metabolizzati mill-istess sistema ta' enzimi
English: You may need further blood tests - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your PANTECTA Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Maltese: Jista' jkollok bżonn ta' testijiet tad-demm addizzjonali - methotrexate (użat għat-trattament ta' artrite rewmatojdi, psorjasi, u kanċer) - jekk qed tieħu methotrexate t-tabib tiegħek għandu mnejn iwaqqaf it-trattament tiegħek bi PANTECTA Control peress li pantoprazole jista' jgħolli l-livelli ta' methotrexate fid-demm.
English: - if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test.
Maltese: Kellem lit-tabib tiegħek qabel tieħu PANTECTA Control - jekk kont ikkurat/a għal qrusa fl-istonku jew indiġestjoni kontinwament għal 4 ġimgħat jew iktar - jekk għandek iktar minn 55 sena u qed tieħu kura ta' kuljum għall-indiġestjoni mingħajr riċetta tat-tabib - jekk għandek iktar minn 55 sena u għandek sintomi tar-rifluss ġodda jew sintomi li nbidlu dan l aħħar - jekk kellek operazzjoni minħabba ulċera gastrika jew tal-istonku - jekk għandek problemi tal-fwied jew suffejra (sfura tal-ġilda jew fl-għajnejn) - jekk regolarment tara lit-tabib tiegħek għal problemi jew kundizzjonijiet serji - jekk ser ikollok endoskopija jew test tan-nifs imsejjaħ C-urea test.
English: Luxembourg/Luxemburg Takeda Belgium
Maltese: Magyarország Takeda Pharma
English: България
Maltese: Polska
English: - Serious skin reactions (frequency not known: frequency cannot be estimated from the available data): rash with swelling, blistering or peeling of the skin, losing skin and bleeding around eyes, nose, mouth or genitals and rapid deterioration of your general health, or rash when exposed to the sun. - Other serious reactions (frequency not known): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as painful urination and lower back pain with fever.
Maltese: - Reazzjonijiet serji oħra (frekwenza mhux magħrufa: frekwenza ma tistax tiġi stmata mittagħrif disponibbli): sfurija tal-ġilda u l-għajnejn (minħabba ħsara severa fil-fwied), jew problemi fil-kliewi bħal uġigħ meta tagħmel l-awrina u uġigħ fin-naħa t'isfel tad-dahar bid-deni.
English: Такеда България Teл.
Maltese: PANTECTA - Żomm dan il-fuljett.
English: Especially medicines containing one of the following active substances: - atazanavir (used to treat HIV-infection).
Maltese: Partikolarment mediċini li fihom xi wieħed mis-sustanzi attivi li ġejjin: - atazanavir (jintuża għal kura ta' infezzjoni bl-HIV).
English: - Rare side effects: distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities; depression; increased bilirubin and fat levels in blood (seen in blood tests), breast enlargement in males; high fever and a sharp drop in circulating granular white blood cells (seen in blood tests).
Maltese: sens ta' togħma distort jew jitlaq għal kollox, disturbi fil-vista bħal vista mċajpra; uġigħ fil-ġogi; uġigħ fil-muskoli; tibdil fil-piż; temperatura għolja tal-ġisem; nefħa tal-estremitajiet; depressjoni; żieda fil-livelli tal-bilirubina u x-xaħam fid-demm (kienu osservati f'testijiet tad-demm), sider li jikber fl-irġiel, deni għoli u tnaqqis f'daqqa f'ċelluli granulari tad-demm bojod fiċ-ċirkolazzjoni
English: Do not take PANTECTA Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Maltese: Tiħux PANTECTA Control ma' mediċini oħrajn li jillimitaw l-ammont ta' aċidu li jiġi prodott flistonku tiegħek, bħal inibitur tal-pompa tal-proton ieħor (omeprazole, lansoprazole jew rabeprazole) jew antagonist ta' H2 (eż. ranitidine, famotidine).
English: Polysorbate 80
Maltese: Tomgħodx
English: España
Maltese: Sverige
English: Takeda Products Ireland Limited Tel: + 353 16 42 00 21
Maltese: United Kingdom Takeda UK Limited Tel: +44 (0)1628 537 900
English: Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Maltese: Għid lit-tabib tiegħek immedjatament, qabel jew wara li tieħu din il-mediċina, jekk tinnota kwalunkwe mis-sintomi li ġejjin, li jistgħu jkunu sinjal ta' marda oħra li tkun iktar serja: - telf ta' piż mhux intenzjonat (mhux marbut ma' dieta jew programm ta' eżerċizzju) - rimettar, partikularment jekk ikun ripetut - tirremetti d-demm; dan jista' jidher bħala frak tal-kafè skur fir-rimettar tiegħek - tinnota d-demm fl-ippurgar tiegħek; li jista' jidher iswed jew qisu qatran - diffikultà biex tibla' jew uġigħ meta tibla' - tidher musfar u tħossok dgħajjef (anemija)
English: Therefore, pantoprazole must not be co-administered with atazanavir (see section 4.3).
Maltese: Għalhekk, pantoprazole m'għandux jingħata flimkien ma' atazanavir (ara sezzjoni 4.3).
English: Interstitial nephritis
Maltese: TAGĦRIF
English: Adverse reactions with pantoprazole in clinical trials and post-marketing experience
Maltese: Reazzjonijiet avversi bi pantoprazole fi provi kliniċi u fl-esperjenza ta' wara l-bejgħ
English: Posology The recommended dose is 20 mg pantoprazole (one tablet) per day.
Maltese: Id-doża rakkomandata hi ta' 20 mg ta' pantoprazole (pillola waħda) kuljum.
English: A slight increase of neoplastic changes of the thyroid was observed in the group of rats receiving the highest dose (200 mg/kg) in one 2-year study.
Maltese: Żieda żgħira ta' tibdil neoplastiku tat-tirojde kien osservat fil-grupp ta' firien li kienu qed jirċievu logħla doża (200 mg/kg) fi studju wieħed li dam sentejn.
English: Since pantoprazole binds to the enzyme distal to the receptor level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin).
Maltese: Minħabba li pantoprazole jeħel mal-enzima distali fil-livell tar-riċettur, jista' jinibixxi t-tnixxija ta' hydrochloric acid indipendentement millistimulazzjoni minn sustanzi oħrajn (acetylcholine, istamina, gastrin).
English: • They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
Maltese: • Ikunu fuq kura sintomatika kontinwa għal indiġestjoni jew qrusa fl-istonku għal 4 ġimgħat jew
English: Triethyl citrate
Maltese: TWISSIJA(IET) SPEĊJALI
English: Although no interaction during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in International Normalised Ratio (INR) have been reported during concomitant treatment in the post-marketing period.
Maltese: Għalkemm ma kienet osservata l-ebda interazzjoni waqt l-għoti fl-istess ħin ta' phenprocoumon jew warfarin fi studji farmakokinetiċi kliniċi, ftit każijiet iżolati ta' tibdil fl-International Normalised Ratio
English: Penetration of the placenta was investigated in the rat and was found to increase with advanced gestation.
Maltese: Il-penetrazzjoni tal-plaċenta kienet investigata fil-firien u nstab li din tiżdied mal-avvanz tat-tqala.
English: Patients should not take another proton pump inhibitor or H2 antagonist concomitantly.
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati bi pantoprazole.
English: PANTECTA Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Maltese: Madanakollu, jistgħu jseħħu reazzjonijiet avversi tal-mediċina bħal sturdament u disturbi tal-vista (ara sezzjoni 4.8).
English: Ref. EMEA/372952/2009 EMEA/H/C/901
Maltese: EMEA/454535/2009 EMEA/H/C/901
English: London, 25 June 2009 Doc.
Maltese: Londra, 25 ta' Ġunju 2009 Dok. ta' Ref.
English: What is Biferonex?
Maltese: X'inhu Biferonex?
English: The active substance in Biferonex, interferon beta-1a, belongs to the group ‘interferons'.
Maltese: Is-sustanza attiva f'Biferonex, interferon beta-1a, hija parti mill-grupp ta' 'interferoni'.
English: The company also used information relating to Avonex, and information from the published literature on other medicines containing interferon beta.
Maltese: Il-kumpanija użat ukoll informazzjoni relatata ma' Avonex, u informazzjoni mid-dokumentazzjoni ppubblikata fuq mediċini oħra li fihom interferon beta.
English: Interferon beta-1a is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce interferon beta-1a.
Maltese: L-interferon beta-1a huwa prodott permezz ta' metodu magħruf bħala ‘teknoloġija rikombinanti tadDNA': huwa magħmul minn ċellula li tkun kisbet ġene (DNA), li jagħtiha l-abbiltà li tipproduċi interferon beta1a.
English: In contrast to these medicines, Biferonex is made in such a way that it does not contain the human blood protein, albumin.
Maltese: B'kuntrast ma' dawn il-mediċini, Biferonex huwa magħmul b'tali mod li ma fihx il-proteina umana tad-demm, l-albumina.
English: Biferonex contains the same active substance as other medicines called Avonex and Rebif, which have been authorised in the European Union since 1997 and 1998, respectively.
Maltese: Biferonex fih l-istess sustanza attiva bħal mediċini l-oħra msejħa Avonex u Rebif, li ilhom li ngħataw l-awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea sa mill-1997 u 1998, rispettivament.
English: On 28 May 2009, BioPartners GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Biferonex, for the treatment of relapsing-remitting multiple sclerosis.
Maltese: Fit-28 ta' Mejju 2009, BioPartners GmbH uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Biferonex, għat-trattament tal-isklerożi multipla reċidiva-remittenti.
English: Biferonex is a solution for injection that contains the active substance interferon beta-1a.
Maltese: Biferonex huwa soluzzjoni għall-injezzjoni li fiha s-sustanza attiva interferon beta-1a.
English: The interferon beta-1a in Biferonex acts in the same way as naturally produced interferon beta.
Maltese: L-interferon beta-1a f'Biferonex jaġixxi bl-istess mod bħal interferon beta li jiġi prodott b'mod naturali.
English: The company presented the results of one main study, in which Biferonex was compared with placebo (a dummy treatment) in 339 adults with relapsing-remitting multiple sclerosis.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju ewlieni, li fih Biferonex tqabbel ma' plaċebo (trattament finta) fi 339 adult bi sklerożi multipla reċidiva-remittenti.
English: Questions and answers on the withdrawal of the marketing authorisation application for Biferonex interferon beta-1a
Maltese: Mistoqsija u tweġiba dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Biferonex interferon beta-1a
English: Biferonex was expected to be used to treat adults with relapsing-remitting multiple sclerosis.
Maltese: Biferonex kien mistenni jintuża fil-kura tal-adulti bl-isklerożi multipla reċidiva-remittenti.
English: Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
Maltese: L-isklerożi multipla hija marda tas-sistema nervuża, fejn l-infjammazzjoni teqred il-kisja protettiva madwar innervituri.
English: Biferonex is expected to work by modulating the activity of the immune system (the body's natural defences) and preventing relapses of multiple sclerosis.
Maltese: Biferonex huwa mistenni jaħdem billi jimmodula l-attività tas-sistema immunitarja (id-difiża naturali tal-ġisem) u jipprevjeni r-reċidivi ta' sklerożi multipla.
English: How is Biferonex expected to work?
Maltese: Għal xiex kien mistenni li jintuża Biferonex?
English: The effects of Biferonex were first tested in experimental models before being studied in humans.
Maltese: Għall-ewwel, l-effetti ta' Biferonex ġew ittestjati f'mudelli sperimentali qabel ġew studjati fuq ilbniedem.
English: At the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Biferonex for the treatment of relapsing-remitting multiple sclerosis.
Maltese: Fi żmien l-irtirar, is-CHMP kien ta opinjoni negattiva, bir-rakkomandazzjoni li l-awtorizzazzjoni għattqegħid fis-suq tiġi rifjutata għal Biferonex għall-kura tal-isklerożi multipla reċidiva-remittenti.
English: The Committee noted that there were differences between the active substance in Biferonex and other interferon beta-containing medicines available on the market.
Maltese: Il-Kumitat innota li kien hemm differenzi bejn is-sustanza attiva f'Biferonex u mediċini oħra li fihom interferon beta li hemm fis-suq.
English: It therefore concluded that using the published studies on these interferon beta-containing medicines to support the use of Biferonex was not justified, and that studies on Biferonex itself were required.
Maltese: Huwa għaldaqstant ikkonkluda li l-użu tal-istudji ppubblikati fuq dawn il-mediċini li fihom interferon beta sabiex isostnu l-użu ta' Biferonex ma kienx ġustifikat, u li studji fuq Biferonex innifsu kienu meħtieġa.
English: Adolescents (13 to 17 years)
Maltese: Adoloxxenti (13 sa 17-il sena)
English: Aseptic meningitis syndrome (AMS)
Maltese: Sindrome ta' Meninġite Asettika (Aseptic meningitis syndrome - AMS)
English: Pulmonary embolism, pulmonary edema
Maltese: Emboliżmu pulmonari, edema pulmonari
English: Date of first authorization: 19 January 2006 Date of latest renewal: 06 December 2010
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Jannar, 2006 Data tal-aħħar tiġdid: 06 ta' Diċembru, 2010
English: In-vivo recovery (%)
Maltese: Irkupru in-vivo (%)
English: Immunomodulation:
Maltese: Immunomodulazzjoni:
English: IgG1 ≥56.9% IgG2 ≥26.6% IgG3 ≥3.4% IgG4 ≥1.7%
Maltese: IgG1 ≥ 56.9% IgG2 ≥ 26.
English: *CI - Confidence Interval
Maltese: *CI - Intervall ta' Kunfidenza
English: Congenital AIDS
Maltese: AIDS konġenitali
English: Distribution of IgG subclasses (approx. values):
Maltese: Distribuzzjoni tas-sottoklassijiet ta' IgG (valuri approssimattivi):
English: Human normal immunoglobulin ……………100 mg (purity of at least 98% IgG)
Maltese: Immunoglobulina normali umana ……………100 mg (purità ta' mill-inqas 98% ta' IgG)
English: KIOVIG is a solution for infusion in vials of 10, 25, 50, 100, 200 or 300 ml.
Maltese: KIOVIG huwa soluzzjoni għall- infużjoni f'kunjetti ta' 10, 25, 50, 100, 200 jew 300 ml.
English: 10, 25, 50, 100, 200 or 300 ml of solution in a vial (Type I glass) with a stopper (bromobutyl).
Maltese: 10, 25, 50, 100, 200 jew 300 ml ta' soluzzjoni f'kunjett (ħġieġ ta' Tip I) b'tapp (bromobutyl).
English: Human protein, 100 mg/ml, at least 98% is IgG.
Maltese: Proteina umana, 100 mg/ml, għallinqas 98 % huwa IgG.
English: Maximum immunoglobulin A (IgA) content: 140 micrograms/ml.
Maltese: Kontenut massimu ta' immunoglobulina A (IgA): 140 mikrogramma/ml.
English: IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Maltese: IgG u IgG-complexes jitkissru f'ċelloli tas-sistema retikuloendoteljali.
English: It is usually prepared from pooled plasma from not fewer than 1000 donations.
Maltese: Normalment jitħejja minn plażma miġbura minn mhux inqas minn 1,000 donazzjoni.
English: 121 87 to 137 99 75 to 121 104 96 to 114
Maltese: 121 87 sa 137 99 75 sa 121 104 96 sa 114
English: 0.8-1 g/kg or
Maltese: 0.8-1 g/kg jew
English: KIOVIG does not contain sucrose, maltose or glucose.
Maltese: KIOVIG ma fihx sucrose, maltose jew glucose.
English: 4.44 3.30 to 4.90 4.43 3.78 to 5.16 4.50 3.99 to 4.78
Maltese: 4.44 3.30 sa 4.90 4.43 3.78 sa 5.16 4.50 3.99 sa 4.78
English: AUC0-21d (g·h/dl) (area under the curve)
Maltese: AUC0-21d (g·h/dl) (erja taħt il-kurva)
English: • Guillain Barré syndrome.
Maltese: • Sindrome ta' Guillain Barré.
English: • Multifocal Motor Neuropathy (MMN).
Maltese: • Newropatija Multifokali tal-Moviment (Multifocal Motor Neuropathy -MMN).
English: Secondary immunodeficiencies (as defined in 4.1.)
Maltese: Immunodefiċjenzi sekondarji (kif iddefiniti f'4.1.)
English: There are two groups:
Maltese: Jeżistu ħames gruppi:
English: Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02
Maltese: Kategorija farmakoterapewtika: sera immuni u immunoglobulini: immunoglobulini, umani normali, għal teħid intravaskulari, Kodiċi ATC:
English: VIAL LABEL (1G)
Maltese: TIKKETTA TAL-KUNJETT (1G)
English: Cmax (mg/dl)/(mg/kg) (peak level)
Maltese: Cmax (mg/dl)/(mg/kg) (l-ogħla livell)
English: • Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2).
Maltese: • Il-marda ta' Kawasaki (flimkien ma' acetylsalicylic acid; ara 4.2).
English: Incremental recovery (mg/dl)/(mg/kg)
Maltese: Irkupru inkrimentali (mg/dl)/(mg/kg)
English: VIAL LABEL (5G, 10G, 20G AND 30G)
Maltese: TIKKETTA TAL-KUNJETT (5G, 10G 20G U 30G)
English: VIAL LABEL (2.5G)
Maltese: TIKKETTA TAL-KUNJETT (2.5G)
English: Maintenance doses:
Maltese: Dożi ta' manteniment:
English: Table 1 Frequency of Adverse Reactions (ADRs) in clinical studies with KIOVIG MedDRA System Organ Class (SOC)
Maltese: Tabella 1 Frekwenza ta' Reazzjonijiet Avversi (ADRs) fl-istudji kliniċi b'KIOVIG Sistema tal-Klassifika tal-Organi (SOC) fid-database MedDRA
English: OUTER CARTON (1G, 2.5G, 5G, 10G, 20G AND 30G)
Maltese: KARTUNA TA' BARRA (IG, 2.5G, 5G, 10G, 20G U 30G)
English: • Primary immunodeficiency syndromes (PID) with impaired antibody production (see section 4.4).
Maltese: • Sindromi ta' immunodefiċjenza primarja (PID - primary immunodeficiency syndromes) b'indeboliment tal-produzzjoni ta' antikorpi (ara sezzjoni 4.4).
English: • The active substance of KIOVIG is human normal immunoglobulin.
Maltese: • Is-sustanza attiva ta' KIOVIG hija immunoglobulina normali umana.
English: All parameters were analysed separately for three age groups, children (below 12 years, n=5), adolescents (13 to 17 years, n=10), and adults (above 18 years of age, n=64).
Maltese: Il-paramteri kollha ġew analizzati separatament għal tliet gruppi t'età, tfal (taħt it-12-il sena, n=5), adoloxxenti (13 sa 17-il sena, n=10), u adulti (akbar minn 18-il sena, n=64).
English: Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Maltese: Il-frekwenzi ġew evalwati skont il-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100, sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: EU/1/05/329/001 EU/1/05/329/002 EU/1/05/329/003 EU/1/05/329/004 EU/1/05/329/005 EU/1/05/329/006
Maltese: EU/1/05/329/001 EU/1/05/329/002 EU/1/05/329/003 EU/1/05/329/004
English: • 1 ml of KIOVIG contains 100 mg of human protein of which at least 98% is immunoglobulin G (IgG).
Maltese: • 1 ml ta' KIOVIG fih 100 mg ta' proteina umana li mill-inqas 98% tagħha huwa immunoglobulina G (IgG).
English: Solution for infusion (10%) 1 vial
Maltese: Soluzzjoni għall-infużjoni (10%) 1 kunjett
English: 1.49 1.34 to 1.81 1.67 1.45 to 2.19 1.62 1.50 to 1.78
Maltese: 1.49 1.34 sa 1.81 1.67 1.45 sa 2.19 1.62 1.50 sa 1.78
English: 2.28 1.72 to 2.74 2.25 1.98 to 2.64 2.24 1.92 to 2.43
Maltese: 2.28 1.72 sa 2.74 2.25 1.98 sa 2.64 2.24 1.92 sa 2.43
English: It is distributed relatively rapidly between plasma and extravascular fluid; after approximately 3 to 5 days equilibrium is reached between the intra- and extravascular compartments.
Maltese: Tinfirex relattivament malajr bejn il-plażma u l-fluwidu ekstravaskulari; wara bejn wieħed u ieħor 3 sa 5 ijiem, jintlaħaq ekwilibriju bejn kompartimenti intrau ekstravaskulari.
English: Insomnia, anxiety
Maltese: Insomnija, ansjetà
English: The maximum IgA content is 140 micrograms/ml.
Maltese: Il-kontenut massimu ta' IgA hu ta' 140 mikrogramma/ml.
English: Table 1 shows the adverse reactions from clinical trials and Table 2 shows the post-marketing ARs.
Maltese: It-Tabella 1 turi r-reazzjonijiet avversi minn provi kliniċi u t-Tabella 2 turi r-reazzjonijiet avversi wara t-tqegħid fis-suq.
English: Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thromboses.
Maltese: Rari ħafna: Reazzjonijiet tromboemboliċi bħal infart mijokardjali, puplesija, emboliżmu pulmonari u trombożi venuża profonda.
English: Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D, may interfere with some serological tests for red cell antibodies, for example the direct antiglobulin test (DAT, direct Coombs' test).
Maltese: It-trasmissjoni passiva ta' antikorpi lil antiġeni eritroċiti, eż. A, B, D, tista' tinterferixxi ma' xi testijiet seroloġiċi għal antikorpi taċ-ċelluli ħomor, pereżempju t-test dirett ta' antiglobulin (DAT, test dirett ta' Coombs).
English: 0.8-1 g/kg or 0.4 g/kg/d on day 1, possibly repeated once within 3 days for 2-5 days
Maltese: 0.8-1 g/kg jew 0.4 g/kg/jum f'jum 1 possibilment ripetuta darba fi 3 ijiem għal 2-5 ijiem