FrancophonIA/ELRC3.0 huggingface dataset:
English: (2) For subjects with a baseline hSBA titre ≥ 1:4, a 4-fold response was defined as an hSBA titre ≥ 4 times the lower limit of quantitation or ≥ 4 times the baseline titre, whichever was higher.
Maltese: (2) Għal individwi b'titru ta' hSBA tal-linja bażi ≥ 1:4, rispons ta' 4 darbiet ġie definit bħala titru ta' hSBA ≥ 4 darbiet tal-limitu aktar baxx ta' kwantitazzjoni jew ≥ 4 darbiet tat-titru fillinja bażi, skont liema minnhom kien ogħla.
English: Experience of overdose is limited.
Maltese: L-esperjenza ta' doża eċċessiva hija limitata.
English: 48 Months after last primary Dose
Maltese: 48 Xahar wara l-aħħar Doża primarja
English: The safety profile presented is based on analysis of over 15,000 subjects (aged 10 years and older) who have been vaccinated with at least 1 dose of Trumenba in 11 completed clinical studies.
Maltese: Il-profil tas-sigurtà ppreżentat huwa bbażat fuq analiżi ta' aktar minn 15,000 individwu (ta' età ta' 10 snin jew aktar) mlaqqma b'mill-inqas doża 1ta' Trumenba fi 11-il studju kliniku mitmum.
English: Composite response (A response for all 4 hSBA strains combined) Before
Maltese: Rispons kompost (Rispons għall-4 razez kollha ta' hSBA kkombinati)
English: The immunogenicity of Trumenba following 2 or 3 vaccinations was evaluated in individuals 11 to 18 years of age in Europe (Study B1971012) and following 3 vaccinations in individuals 10 to 25 years of age globally (Studies B1971009 and B1971016).
Maltese: 2 jew 3 tilqimiet ġiet evalwata f'individwi ta' 11 sa 18-il sena fl-Ewropa (Studju B1971012) u wara 3 tilqimiet f'individwi ta' 10 sa 25 sena b'mod globali (Studji B1971009 u B1971016).
English: In Studies B1971009 and B1971016, the proportion of subjects achieving a defined hSBA titre after 3 doses of Trumenba, administered on a 0-, 2-, and 6-month schedule, was evaluated against a panel of 10 additional strains, each expressing a different fHbp variant (Table 5).
Maltese: Fl-istudji B1971009 u B1971016, il-proporzjon tal-individwi li kisbu titru ta' hSBA definit wara 3 dożi ta' Trumenba, mogħtija fuq skeda ta' 0, 2 u 6 xhur, ġie evalwat kontra sensiela ta' 10 razez addizzjonali, li kull waħda tesprimi varjant ta' fHbp differenti (Tabella 5).
English: Table 6: Persistence of Immune and Booster Responses Among Individuals 11 to 18 Years of Age Administered a Primary Series of Trumenba on a 0-, 1-, 6-Month-; 0-, 2-, 6-Month- and 0-, 6-Month Schedule and a Booster 4 Years After Primary Series (Study B1971033) Primary Study B1971012 Vaccine Group (as Randomised) Group 1
Maltese: Tabella 6: Persistenza ta' Risponsi Immuni u Booster Fost Individwi ta' 11 sa 18-il Sena Mogħtija Serje Primarja ta' Trumenba fuq Kors ta' 0, 1, 6 Xhur; ta' 0, 2, 6 Xhur u ta' 0, 6 Xhur u Booster 4 Snin Wara Serje Primarja (Studju B1971033)
English: Dose 1
Maltese: Doża 3
English: Trumenba has not been evaluated for impairment of fertility in males.
Maltese: Trumenba ma ġiex evalwat għall-indeboliment tal-fertilità fl-irġiel.
English: During storage, a white deposit and clear supernatant may be observed.
Maltese: Waqt il-ħażna jista' jiġi osservat depożitu abjad u supernatant ċar.
English: For intramuscular injection only.
Maltese: Għal injezzjoni intramuskolari biss.
English: ≥ 4-Fold rise in hSBA titre (%)
Maltese: Żieda ta' ≥ 4 darbiet f'titri ta' hSBA (%)
English: One dose (0.5 ml) contains:
Maltese: doża waħda (0.5 ml) fiha:
English: Trumenba suspension for injection Meningococcal B vaccine IM
Maltese: Trumenba suspensjoni għall-injezzjoni Vaċċin meningokokkali ta' grupp B. IM
English: Table 2: Immune Responses Among Individuals 11 to 18 Years of Age Administered Trumenba After Various 2- and 3-Dose Schedules (Study B1971012) Group 1
Maltese: Tabella 2: Riponsi Immuni Fost Individwi ta' 11 sa 18-il Sena Mogħtija Trumenba Wara Diversi Korsijiet ta' 2 u 3 Dożi (Studju B1971012)
English: The hSBA responses observed after the third dose in Groups 1 and 2 are presented in Tables 3 and 4.
Maltese: Irrisponsi ta' hSBA osservati wara t-tielet doża fi Gruppi 1 u 2 huma ppreżentati fit-Tabelli 3 u 4.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility in females (see section 5.3).
Maltese: Studji f'annimali ma jindikawx effetti ħżiena diretti jew indiretti fir-rigward tal-fertilità f'dawk femminili (ara s-sezzjoni 5.3).
English: Nervous system disorders Very Common: Headache
Maltese: Disturbi fis-sistema nervuża Komuni Ħafna:
English: Table 1: Immune Responses Among Individuals 11 to 18 Years of Age Administered Trumenba After Various 2- and 3-Dose Schedules (Study B1971012) Group 1
Maltese: Tabella 1: Riponsi Immuni Fost Individwi ta' 11 sa 18-il Sena Mogħtija Trumenba Wara Diversi Korsijiet ta' 2 u 3 Dożi (Studju B1971012)
English: Protection against invasive meningococcal disease is mediated by serum bactericidal antibodies to bacterial surface antigens.
Maltese: Il-protezzjoni kontra marda meningokokkali invażiva hija medjata minn antikorpi batteriċidali tasserum għal antiġeni tas-superfiċje batterjali.
English: Vaccine efficacy has been inferred by demonstrating the induction of serum bactericidal antibody responses to 4 meningococcal serogroup B test strains (see the Immunogenicity section).
Maltese: L-effikaċja tal-vaċċin ġiet inferita bit-turija tal-induzzjoni tar-risponsi tal-antikorpi batteriċidali tas-serum għal 4 razez tat-test ta' serogrupp B meningokokkali (ara s-sezzjoni tal-Immunoġeniċità).
English: Immune Responses Among Individuals 10 to 25 Years of Age Against 10 Additional Strains 1 Month Following the Third Dose of Trumenba Given on a 0-, 2-, 6-Month Schedule (Study B1971009 and Study B1971016) Study B1971009
Maltese: Sena Kontra 10 Razez Addizzjonali Xahar Wara t-Tielet Doża ta' Trumenba Mogħtija fuq Kors ta' 0, 2, 6 Xhur (Studju B1971009 u Studju B1971016)
English: Study B1971009 was a Phase 3, randomised, active-controlled, observer-blinded, multicentre trial in which subjects aged 10 to 18 years received 1 of 3 lots (Groups 1, 2, and 3) of Trumenba or the active control hepatitis A virus (HAV) vaccine/saline.
Maltese: L-istudju B1971009 kien prova li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollata b'mod attiv, multiċentrika, moħbi mill-osservatur ta' Fażi 3 li fiha l-individwi li kellhom 10 sa 18-il sena rċevew lott 1 mit-3 lottijiet (Gruppi 1, 2, u 3) ta' Trumenba jew il-vaċċin/salina tal-virus tal-epatite A (HAV) ta' kontroll attiv.
English: Table 7: Persistence of Immune and Booster Responses Among Individuals 11 to 18 Years of Age Administered a Primary Series of Trumenba on a 0-, 1-, 6-Month-; 0-, 2-, 6-Month- and 0-, 6-Month Schedule and a Booster 4 Years After Primary Series (Study B1971033) Primary Study B1971012 Vaccine Group (as Randomised) Group 1
Maltese: Persistenza ta' Risponsi Immuni u Booster Fost Individwi ta' 11 sa 18-il Sena Mogħtija Serje Primarja ta' Trumenba fuq Kors ta' 0, 1, 6 Xhur-; ta' 0, 2, 6 Xhur u ta' 0, 6 Xhur u Booster 4 Snin Wara Serje Primarja (Studju B1971033)
English: Trumenba contains sodium This medicinal product contains less than 23 mg sodium per dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 23 mg ta' sodium f'kull doża, jiġifieri essenzjalment ħieles mis-sodium'.
English: The requirements for submission of periodic safety update repots for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Trumenba suspension for injection in pre-filled syringe Meningococcal group B vaccine (recombinant, adsorbed)
Maltese: Trumenba suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Vaċċin meningokokkali ta' grupp B (rikombinanti, adsorbit)
English: Individuals 10 years and older
Maltese: Individwi ta' 10 snin jew aktar
English: Neisseria meningitidis serogroup B fHbp subfamily A and B
Maltese: Neisseria meningitidis serogrupp B fHbp sottofamilja A u B 60 mikrogramma kull waħda
English: Shake well prior to use to obtain a homogeneous white suspension.
Maltese: Ħawwad sew qabel l-użu biex tikseb suspensjoni bajda omoġenja.
English: % hSBA ≥ 1:16 Dose 2 351
Maltese: % hSBA ≥ 1:16 Doża 2
English: The Meningococcal Antigen Surface Expression (MEASURE) assay was developed to relate the level of fHbp surface expression to killing of meningococcal serogroup B strains in serum bactericidal assays with human complement (hSBAs).
Maltese: L-assaġġ tal-Espressjoni tas-Superfiċje tal-Antiġen Meningokokkali (MEASURE) ġie żviluppat biex jirrelata l-livell ta' espressjoni tas-superfiċje ta' fHbp mal-qtil tar-razez ta' serogrupp B meningokokkali f'assaġġi batteriċidali tas-serum b'komplement tal-bniedem (hSBAs).
English: Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.
Maltese: Madankollu, it-tilqim m'għandux jitwaqqaf meta jkun hemm riskju ċar ta' esponiment għal infezzjoni meningokokkali.
English: The hSBA responses observed after the second or third dose for Groups 1, 2, and 3 are presented in Tables 1 and 2.
Maltese: Ir-risponsi ta' hSBA osservati wara ttieni u t-tielet doża għal Gruppi 1, 2 u 3 huma ppreżentati fit-Tabelli 1 u 2.
English: hSBA GMT Dose 2 344
Maltese: GMT Doża 2
English: Not known (cannot be estimated from available data) - Allergic reactions
Maltese: Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli) - Reazzjonijiet allerġiċi
English: Composite response (A response for all 4 hSBA strains combined) 1 Month after last primary Dose
Maltese: Rispons kompost (Rispons għall-4 razez kollha ta' hSBA kkombinati) Qabel 1 doża
English: Vivian Corporation Ltd. Tel: + 35621 344610
Maltese: Tel: + 35621 344610
English: Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B, even if they develop antibodies following vaccination with Trumenba.
Maltese: Persuni bi storja fil-familja ta' defiċjenzi tal-komplement (pereżempju, defiċjenzi ta' C5 jew ta' C3) u persuni li jkunu qed jirċievu kura li timpedixxi l-attivazzjoni tal-komplement terminali (pereżempju, eculizumab) huma f'riskju ogħla ta' mard invażiv ikkawżat mis-serogrupp B ta' Neisseria meningitidis, anki jekk jiżviluppaw antikorpi wara t-tilqim bi Trumenba.
English: % hSBA ≥ 1:8 Dose 2 344
Maltese: % hSBA ≥ 1:8 Doża 2
English: For instructions on the handling of the vaccine before administration, see section 6.6.
Maltese: Għal istruzzjonijiet dwar l-immaniġġjar tal-vaċċin qabel jingħata, ara sezzjoni 6.6.
English: Immunisation with Trumenba, which contains one fHbp variant each from subfamily A and B, is intended to stimulate the production of bactericidal antibodies that recognize fHbP expressed by meningococci.
Maltese: L-immunizzazzjoni bi Trumenba, li fiha varjant wieħed tal-fHbp minn sottofamilja A u ieħor minn dik B, hija maħsuba biex tistimula l-produzzjoni tal-antikorpi batteriċidali li jagħrfu l-fHbp espressa millmeningokokki.
English: 3 doses: 2 doses (0.5 ml each) administered at least 1 month apart, followed by a third dose at least 4 months after the second dose (see section 5.1).
Maltese: 3 dożi: 2 dożi (0.5 ml kull waħda) mogħtija mill-inqas xahar 'il bogħod minn xulxin, segwiti mit-tielet doża mogħtija mill-inqas 4 xhur wara t-tieni doża (ara sezzjoni 5.1).
English: A booster response in hSBA responses at 1 month following a dose of Trumenba approximately 4 years after a primary series of 2 doses (Group 3) or 3 doses (Groups 1 and 2) was observed.
Maltese: Ġie osservat rispons booster f'risponsi tal-hSBA f'xahar wara doża ta' Trumenba madwar 4 snin wara serje primarja ta' 2 dożi (Grupp 3) jew 3 dożi (Grupp 1 u 2).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Trumenba in one or more subsets of the paediatric population for prevention of invasive meningococcal disease caused by N. meningitidis serogroup B (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji bi Trumenba f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika għall-prevenzjoni tal-marda meningokokkali invażiva kkawżata minn N. meningitidis serogrupp B (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: The hSBA responses observed after the third dose in Group 1 are presented in Tables 3 and 4.
Maltese: Ir-risponsi ta' hSBA osservati wara t-tielet doża fi Grupp 1 huma ppreżentati fitTabelli 3 u 4.
English: How to store Trumenba
Maltese: X'fih Trumenba
English: * The following is considered an adverse reaction for Trumenba and was reported in the postmarketing experience.
Maltese: * Dan li ġej huwa meqjus bħala reazzjoni avversa għal Trumenba u ġie rrappurtat fl-esperjenza ta' wara t-tqegħid fis-suq.
English: Results from Groups 2 and 3 are not presented, as only 2 representative strains were evaluated.
Maltese: Ir-riżultati minn Gruppi 2 u 3 mhumiex ippreżentati peress li ġew evalwati biss 2 razez rappreżentattivi.
English: Trumenba suspension for injection in pre-filled syringe
Maltese: Trumenba hija għall-użu intramuskolari biss.
English: There are no data on the use of Trumenba in subjects above 65 years of age.
Maltese: M'hemm l-ebda dejta dwar l-użu ta' Trumenba f'invidiwi ta' aktar minn 65 sena.
English: The most common adverse reactions observed were injection site pain, redness and swelling at the vaccination site, headache, fatigue, chills, diarrhoea, muscle pain, joint pain, and nausea.
Maltese: L-aktar reazzjonijiet avversi komuni osservati kienu wġigħ fis-sit tal-injezzjoni, ħmura u nefħa fis-sit tattilqim, uġigħ ta' ras, għeja, tkexkix ta' bard, dijarea, uġigħ fil-muskoli, uġigħ fil-ġogi u dardir.
English: The 4 test strains express fHbP variants representing the 2 subfamilies (A and B) and, when taken together, are representative of meningococcal serogroup B strains causing invasive disease.
Maltese: L-4 razez tat-test jesprimu l-varjanti tal-fHbp li jirrappreżentaw iż-2 sottofamilji (A u B) u, meta jittieħdu flimkien, huma rappreżentattivi tar-razez ta' serogrupp B meningokokkali li jikkawżaw mard invażiv.
English: The following information is intended for healthcare professionals only:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq:
English: Vomiting
Maltese: FARMAĊEWTIKU
English: • have a weakened immune system which may prevent you or your child from getting the full benefit from Trumenba.
Maltese: • għandkom sistema immunitarja batuta li tista' tipprevjeni lilek jew lit-tifel/tifla tiegħek milli tieħdu l-benefiċċju sħiħ minn Trumenba.
English: ≥ 4-Fold rise in hSBA titre (%) Dose 2 343
Maltese: Żieda ta' ≥ 4 darbiet f'titri ta' hSBA (%) Doża 2
English: Abbreviations: GMT=geometric mean titre; hSBA=serum bactericidal assay using human complement; fHBP=factor H binding protein.
Maltese: GMT=titru medju ġeometriku; hSBA=assaġġ batteriċidali tas-serum bl-użu ta' komplement tal-bniedem; fHBP=proteina tat-twaħħil tal-fattur H.
English: There are no data on the use of Trumenba in immunocompromised individuals.
Maltese: M'hemm l-ebda dejta dwar l-użu ta' Trumenba f'individwi immunokompromessi.
English: Immune system disorder Not known:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni Ħafna:
English: Trumenba is a vaccine to prevent invasive meningococcal disease, caused by Neisseria meningitidis serogroup B, for use in people 10 years and older.
Maltese: Trumenba huwa vaċċin għall-prevenzjoni tal-marda meningokokkali invażiva, kkawżata minn Neisseria meningitidis serogrupp B, għall-użu f'persuni li għandhom 10 snin jew aktar.
English: These additional hSBAs support and extend the breadth of vaccine coverage demonstrated by the 4 representative primary strains (Tables 3 and 4).
Maltese: Dawn l-hSBAs addizzjonali jappoġġjaw u jestendu l-firxa tal-kisja tal-vaċċin murija mill-4 razez primarji rappreżentattivi (Tabelli 3 u 4).
English: Pre-filled syringe label
Maltese: TAL-PRODOTT MEDIĊINALI
English: Pack sizes of 1, 5, and 10 pre-filled syringes, with or without needle.
Maltese: Pakketti tad-daqsijiet ta' 1, 5 u 10 siringi mimlija għal-lest, bil-labar jew mingħajrhom.
English: Abbreviations: hSBA=serum bactericidal assay using human complement; fHbp=factor H binding protein.
Maltese: Abbrevjazzjonijiet: hSBA=assaġġ batteriċidali tas-serum bl-użu ta' komplement tal-bniedem; fHbp=proteina tat-twaħħil tal-fattur H.
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KOWD TAL-PRODOTT
English: Study B1971009 (10-18 years of age)
Maltese: Studju B1971009
English: All subjects received 4 study injections, either 2 or 3 doses of Trumenba and 1 or 2 doses of saline.
Maltese: L-individwi kollha rċevew 4 injezzjonijiet talistudju, jew 2 jew 3 dożi ta' Trumenba u 1 jew 2 dożi ta' salina.
English: Other paediatric population
Maltese: Popolazzjoni pedjatrika oħra
English: • Depression.
Maltese: • Depressjoni.
English: Teva Operations Poland Sp. z o.o.
Maltese: Teva Operations Poland Sp. z o.o. ul.
English: Adrenal function
Maltese: Funzjoni adrenali
English: Systemic effects
Maltese: Effetti sistemiċi
English: ATC code: R03AK07
Maltese: R03AK07
English: Paradoxical bronchospasm
Maltese: Bronkospażmu paradossikali
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Lactose monohydrate.
Maltese: 6.1 Lista ta' eċċipjenti Lactose monohydrate.
English: Elderly patients (≥65 years old)
Maltese: Pazjenti anzjani (≥65 sena)
English: If you are to take a second inhalation, repeat steps 1 to 7.
Maltese: Jekk se tieħu t-tieni inalazzjoni, irrepeti l-passi minn 1 sa 7.
English: Transfer from oral therapy
Maltese: Trasferiment minn terapija orali
English: β2 adrenoreceptor agonists
Maltese: Agonisti tal-adrenoriċetturi β2
English: NL-2031 GA Haarlem The Netherlands
Maltese: NL-2031 GA Haarlem Il-Pajjiżi l-Baxxi
English: Each pack contains 1 inhaler.
Maltese: Kull pakkett fih 1 inalatur.
English: clarithromycin and telithromycin).
Maltese: posaconazole, clarithromycin u telithromycin).
English: The inhaler is made of acrylonitrile butadiene styrene (ABS), polyethylene terephthalate (PT) , and polypropylene (PP).
Maltese: L-inalatur huwa magħmul minn acrylonitrile butadiene styrene (ABS), polyethylene terephthalate (PT), u polypropylene (PP).
English: Budesonide is eliminated via metabolism mainly catalysed by the enzyme CYP3A4.
Maltese: Budesonide jiġi eliminat permezz ta' metaboliżmu katalizzat prinċipalment mill-enzima CYP3A4.
English: • Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole,
Maltese: (eż. ketoconazole, itraconazole, voriconazole, posaconazole,
English: • Tricyclic antidepressants (such as amitriptyline) and the antidepressant nefazodone.
Maltese: • Antidepressanti triċikliċi (bħal amitriptyline) u l-antidepressant nefazodone.
English: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Maltese: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Il-Pajjiżi l-Baxxi
English: • Disturbance of the heart's electrical system (prolongation of the QTc-interval).
Maltese: • Disturb fis-sistema elettrika tal-qalb (titwil tal-intervall QTc)
English: The glucocorticosteroid activity of the major metabolites, 6-beta-hydroxy-budesonide and 16-alfa-hydroxyprednisolone, is less than 1% of that of budesonide.
Maltese: L-attività glukokortikosterojdi tal-metaboliti prinċipali, 6-β-hydroxybudesonide u 16-alfa-hydroxy-prednisolone, hija anqas minn 1% ta' dik ta' budesonide.
English: • Xanthine medicines (such as theophylline or aminophylline).
Maltese: • Mediċini xanthine (bħal theophylline jew aminophylline).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/950/002
Maltese: EU/1/14/950/002
English: Teva Operations Sp. Z o.o ul, Mogilska 80; 31-546 Krakow, Poland.
Maltese: Operations Poland Sp. z o.o., Mogilska 80 Str., 31-546
English: • Medicines called monoamine oxidase inhibitors (such as phenelzine, furazolidone and procardazine).
Maltese: • Mediċini msejħa inibituri tal-monoamine oxidase (bħal phenelzine, furazolidone u procardazine).
English: See leaflet for further information
Maltese: Sorsi oħra ta' informazzjoni
English: Oral infections
Maltese: Infezzjonijiet orali
English: Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase inhibitors and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.
Maltese: Il-kura konkomitanti ma' quinidine, disopyramide, procainamide, phenothiazines, antistamini (terfenadine),inibituri tal-monoamine oxidase u antidepressanti triċikliċi, tista' ttawwal l-intervall QTc u żżid ir-riskju ta' arritmiji ventrikolari.
English: Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland
Maltese: L-Irlanda Unit 27/35, IDA Industrial Park, Cork Road, Waterford, L-Irlanda
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/950/001
Maltese: EU/1/14/950/001
English: Immediate and delayed hypersensitivity reactions, e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction
Maltese: Reazzjonijiet immedjati u ttardjati ta' sensittività eċċessiva, eż. exanthema, urtikarja, ħakk, dermatite, anġjoedima u reazzjoni anafilattika
English: Asthma symptoms
Maltese: Sintomi tal-ażma
English: Τel: +353 51 321 740
Maltese: Tel: +353 51 321 740
English: Pharmacokinetic interactions
Maltese: Interazzjonijiet farmakodinamiċi
English: • Medicines for thyroid problems (such as levothyroxine).
Maltese: • Mediċini għal problemi tat-tirojde (bħal levothyroxine).
English: • Phenothiazine medicines (such as chlorpromazine and prochlorperazine).
Maltese: • Mediċini tal-phenothiazine (bħal chlorpromazine u prochlorperazine).
English: Recommended doses:
Maltese: Dożi rakkomandati:
English: Possible side effects (page 18)
Maltese: Effetti sekondarji possibbli (paġna 18)
English: Prolongation of QTc-interval
Maltese: Titwil tal-intervall QTc
English: In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards β2 sympathomimetics.
Maltese: Barra minn hekk L-Dopa, L-thyroxine, oxytocin u l-alkoħol jistgħu jdgħajfu t-tolleranza tal-qalb lejn il-β2-simpatomimetiċi.
English: • Other bronchodilators (such as salbutamol).
Maltese: • Bronkodilaturi oħra (bħal salbutamol).
English: Pharmacokinetic/pharmacodynamic relationship(s)
Maltese: Relazzjoni(ijiet) farmakokinetika(ċi)/farmakodinamika(ċi)
English: INFORMATION IN BRAILLE Budesonide/Formoterol Teva Pharma B.V. 160 mcg/4.5 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE Budesonide/Formoterol Teva Pharma B.V. 160 μg/4.5 μg
English: Possible side effects (page 16)
Maltese: Effetti sekondarji possibbli (paġna 16)
English: Concomitant use of other β adrenergic medicinal products and anticholinergic medicinal products can have a potentially additive bronchodilating effect.
Maltese: L-użu konkomitanti ta' prodotti mediċinali β-adrenerġiċi oħra u prodotti mediċinali antikolinerġiċi jista' jkollu effett bronkodilatorju potenzjalment addittiv.