FrancophonIA/ELRC3.0 huggingface dataset:
English: Possible systemic effects include Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see section 4.8).
Maltese: L-effetti sistemiċi possibbli jinkludu s-sindrome ta' Cushing, karatteristiċi Cushingoid, sopressjoni adrenali, dewmien fit-tkabbir fi tfal u adolexxenti, tnaqqis fid-densità minerali tal-għadam, katarretti u glawkoma u b'mod aktar rari, firxa ta' effetti psikoloġiċi jew komportamentali fosthom attività psikomotorja eċċessiva, disturbi fl-irqad, ansjetà, depressjoni jew aggressjoni (partikolarment fi tfal) (ara sezzjoni 4.8).
English: Volume of distribution is about 4 L/kg for formoterol and 3 L/kg for budesonide.
Maltese: Ilvolum ta' distribuzzjoni huwa ta' madwar 4 L/kg għal formoterol u 3 L/kg għal budesonide.
English: Adults (18 years and older): 1-2 inhalations twice daily.
Maltese: Adulti (18-il sena u iktar): 1-2 inalazzjonijiet darbtejn kuljum.
English: Budesonide/Formoterol Teva Pharma B.V. should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section 4.4).
Maltese: Budesonide/Formoterol Teva Pharma B.V. għandu jitwaqqaf immedjatament, il pazjent għandu jiġi valutat u jekk ikun meħtieġ, tinbeda terapija alternattiva (ara sezzjoni 4.4).
English: • Feeling restless, nervous, agitated, anxious or angry.
Maltese: • Tħossok bla kwiet, nervuż, aġitat, ansjuż jew irrabjat.
English: Aggression, psychomotor hyperactivity, anxiety, sleep disorders
Maltese: Aggressjoni, attività psikomotorja eċċessiva,
English: The marketing authorisation holder shall submit PSURs for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Budesonide/Formoterol Teva Pharma B.V. contains two different active substances: budesonide and formoterol fumarate dihydrate.
Maltese: Budesonide/Formoterol Teva Pharma B.V. fih żewġ sustanzi attivi differenti: budesonide u formoterol fumarate dihydrate.
English: Nervous system disorders Common
Maltese: Disturbi fis-sistema nervuża
English: A fixed-dose combination of budesonide and formoterol fumarate dihydrate should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
Maltese: Kombinazzjoni ta' doża fissa ta' budesonide u formoterol fumarate dihydrate għandha tingħata b'kawtela f'pazjenti li jkollhom thyrotoxicosis, phaeochromocytoma, dijabete mellitus, ipokalimja mhux ikkurata, kardjomijopatija ostruttiva ipertrofika, stenożi idjopatika tal-aorta subvalvulari, pressjoni għolja severa, anewriżma jew disturb kardjovaskulari sever ieħor, bħal mard tal-qalb iskemiku, takiarritmiji jew insuffiċjenza severa tal-qalb.
English: B.V. contains lactose')
Maltese: Pharma B.V. fih il-lactose')
English: INFORMATION IN BRAILLE Budesonide/Formoterol Teva Pharma B.V.320 mcg/9 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE Budesonide/Formoterol Teva Pharma B.V. 320 μg/9 μg
English: Cushing´s syndrome, adrenal suppression, growth retardation, decrease in bone mineral density
Maltese: Sindrome ta' Cushing, soppressjoni adrenali, dewmien fit-tkabbir, tnaqqis fid-densità minerali tal-għadam
English: • Chest pain or tightness in the chest (angina pectoris).
Maltese: • Uġigħ fis-sider jew issikkar fis-sider (angina pectoris).
English: Concomitant treatment with itraconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided (see section 4.5).
Maltese: Il-kura konkomitanti b'itraconazole, ritonavir jew inibituri qawwija oħra ta' CYP3A4 għandha tiġi evitata (ara sezzjoni 4.5).
English: • Uneven heartbeat.
Maltese: • Tħossok stordut.
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Budesonide/Formoterol Teva Pharma
Maltese: - Is-sustanza l-oħra hi lactose monohydrate (ara sezzjoni 2 taħt ‘ Budesonide/Formoterol Teva
English: • Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β2 adrenoceptor agonists' or ‘bronchodilators'.
Maltese: • Formoterol fumarate dihydrate jappartjeni għal grupp ta' mediċini msejħa'agonisti taladrenoriċetturi β2 li jaħdmu fit-tul' jew ‘bronkodilaturi' .
English: Two 12-week paediatric studies have been performed in which 265 children aged 6-11 years were treated with a maintenance dose of budesonide/formoterol (2 inhalations of 80 micrograms/4.5 micrograms /inhalation twice daily), and a short acting β2 adrenoceptor agonist as needed.
Maltese: Saru żewġ studji pedjatriċi ta' 12-il ġimgħa li fihom, 265 tifel u tifla ta' bejn 6 u 11-il sena ġew ikkurati b'doża ta' manteniment ta' budesonide/formoterol (2 inalazzjonijiet ta' 80 mikrogramma/4.5 mikrogramma/inalazzjoni darbtejn kuljum), u agonist tal-andrenoriċetturi β2 kif meħtieġ.
English: Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles
Maltese: takikardija sopraventrikolari, takikardija, extrasistoli
English: Headache, tremor
Maltese: Uġigħ ta' ras, tregħid
English: Rare side effects: may affect up to 1 in 1,000 people
Maltese: Effetti sekondarji rari: jistgħu jaffettwaw sa 1 minn kull 1,000 persuna
English: • For inhalations remaining from 20 downwards to ‘8', 6','4','2' the numbers are displayed in red on a white background.
Maltese: • Għal inalazzjonijiet li jifdal minn 20 'l isfel sa ‘8' ,' 6' ,' 4' ,' 2' ‘in-numri jintwerew bl-aħmar fuq sfond abjad.
English: Very rare side effects: may affect up to 1 in 10,000 people
Maltese: Effetti sekondarji rari ħafna: jistgħu jaffettwaw sa 1 minn kull 10,000 persuna
English: Excipient(s) with known effect:
Maltese: Effetti sekondarji oħra possibbli:
English: Contents of the pack and other information (page 22)
Maltese: Kontenut tal-pakkett u informazzjoni oħra (paġna 22)
English: Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa < 1/100), rari (≥1/10,000 sa <
English: A randomised, open-label placebo study was performed in children and adolescents with asthma (aged 6-17 years), adults with asthma (aged 18-45 years), and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device (containing placebo).
Maltese: Sar studju wieħed aleatorju u open-label bi plaċebo fi tfal u adolexxenti bl-ażma (età minn 6-17-il sena), adulti bl-ażma (età minn 18-45 sena), adulti b'mard kroniku ostruttiv tal-pulmuni (COPD - età ta' > 50 sena u voluntiera b'saħħithom (età minn 18-45 sena) sabiex tiġi evalwata r-rata massima talfluss ta' nifs 'il ġewwa (PIFR) u parametri ta' inalazzjoni relatati oħrajn wara inalazzjoni minn apparat
English: After inhalation, 8% to 13% of the delivered dose of formoterol is excreted unmetabolised in the urine.
Maltese: Wara t-teħid man-nifs, 8% sa 13% tad-doża mogħtija ta' formoterol titneħħa mhux metabolizzata fl-awrina.
English: The systemic bioavailability is approximately 49% of the delivered dose.
Maltese: Il-bijodisponibilità sistemika hija madwar 49% tad-doża mogħtija.
English: Concomitant treatment with monoamine oxidase inhibitors including medicinal products with similar properties such as furazolidone and procarbazine may precipitate hypertensive reactions.
Maltese: Il-kura konkomitanti ma' inibituri tal-monoamine oxidase, li jinkludu prodotti mediċinali bi proprjetajiet simili bħal furazolidone u procarbazine, tista' tippreċipa r-reazzjonijiet ta' pressjoni għolja.
English: Peak Inspiratory Flow Rate through the Spiromax Device
Maltese: Rata Massima tal-Fluss ta' Nifs 'il Ġewwa mill-Apparat Spiromax
English: The potent CYP3A4 inhibitor ketoconazole, 200 mg once daily, increased plasma levels of concomitantly orally administered budesonide (single dose 3 mg) on average six-fold.
Maltese: L-inibitur qawwi ta' CYP3A4, ketoconazole, 200 mg darba kuljum, żied il-livelli ta' budesonide mogħti b'mod orali fl-istess ħin (doża waħda ta' 3 mg) b'medja ta' sitt darbiet aktar.
English: Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands.
Maltese: Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Il-Pajjiżi l-Baxxi
English: 5.2 Pharmacokinetic properties
Maltese: .2 Tagħrif farmakokinetiku Assorbiment
English: Recommended dose:
Maltese: Doża rakkomandata:
English: Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting.
Maltese: Is-sintomi rrappurtati minn każijiet iżolati huma takikardija, ipergliċemija, ipokalimja, titwil fl-intervall QTc, arritmija, dardir u rimettar.
English: Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht The Netherlands
Maltese: Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht Il-Pajjiżi l-Baxxi
English: There are no indications of any metabolic interactions or any displacement reactions between formoterol and budesonide.
Maltese: Ma hemm lebda indikazzjoni ta' interazzjonijiet metaboliċi jew reazzjonijiet ta' spostament bejn formoterol u budesonide.
English: Treatment with β2 adrenoceptor agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
Maltese: Kura b'agonisti ta' adrenoriċettur β2 tista' tirriżulta f'żieda fil-livelli tad-demm tal-insulina, aċidi grassi liberi, gliċerol u korpi ta' ketone.
English: 1 inhaler containing 120 doses.
Maltese: Inalatur wieħed li fih 120 doża.
English: Budesonide/Formoterol Teva Pharma B.V. is not indicated in children and adolescents under the age of 18 years (see section 4.2).
Maltese: Budesonide/Formoterol Teva Pharma B.V. mhuwiex indikat għall-użu fi tfal u adolexxenti li għandhom inqas minn 18-il sena (ara sezzjoni 4.2).
English: Each dose contains approximately 5 milligrams of lactose (as monohydrate).
Maltese: Kull doża fiha madwar 5 milligrammi ta' lactose (bħala monohydrate).
English: Budesonide undergoes an extensive degree (approximately 90%) of biotransformation on first passage through the liver to metabolites of low glucocorticosteroid activity.
Maltese: (madwar 90%) ta' bijotrasformazzjoni mal-ewwel passaġġ mill-fwied għal metaboliti ta' attività glukokortikosterojdi baxxa.
English: • Medicines called ‘HIV protease inhibitors' (such as ritonavir) to treat HIV infection.
Maltese: • Mediċini msejħa ‘inibituri tal-protease tal-HIV' (bħal ritonavir) għall-kura ta' infezzjoni tal
English: Excipient(s) with known effect: Each dose contains approximately 10 milligrams of lactose (as monohydrate) .
Maltese: Kull doża fiha bejn wieħed u ieħor 10 milligrammi ta' lactose (bħala monohydrate).
English: Very few patients had PIFRs below 40L/min; when PIFRs were less than 40L/min there appeared to be no clustering by age or disease severity.
Maltese: Ftit li xejn pazjenti kellhom PIFRs inqas minn 40L/min; meta PIFRs kienu inqas minn 40L/min deher li ma kien hemm ebda għaqid skont l-età jew severità tal-marda.
English: Supportive and symptomatic treatment may be indicated.
Maltese: Tista' tkun indikata kura sintomatika u ta' sostenn.
English: ul.
Maltese: C.
English: If the patient experiences paradoxical bronchopasm Budesonide/Formoterol Teva Pharma B.V. should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Maltese: Jekk il-pazjent jesperjenza bronkospażmu paradossali, Budesonide/Formoterol Teva Pharma B.V. għandu jiġi mwaqqaf immedjatament, il-pazjent għandu jiġi valutat u jekk ikun meħtieġ, tinbeda terapija alternattiva.
English: • Medicines for Parkinson's disease (such as levodopa).
Maltese: • Mediċini għall-marda ta' Parkinson (bħal levodopa).
English: • Medicines for allergies or antihistamines (such as terfenadine).
Maltese: • Mediċini għall-allerġiji jew antistamini (bħal terfenadine).
English: Candida infections in the oropharynx
Maltese: toraċiċi u medjastinali
English: Plasma protein binding is approximately 50% for formoterol and 90% for budesonide.
Maltese: It-twaħħil mal-proteini tal-plażma huwa ta' madwar 50% għal formoterol u 90% għal budesonide.
English: • Budesonide belongs to a group of medicines called ‘corticosteroids' also known as ‘steroids'.
Maltese: • Budesonide jappartjeni għal grupp ta' mediċini msejħa kortikosterojdi' magħrufin ukoll bħala ‘sterojdi'.
English: Formoterol is inactivated via conjugation reactions (active O-demethylated and deformylated metabolites are formed, but they are seen mainly as inactivated conjugates).
Maltese: Formoterol jiġi inattivat permezz ta' reazzjonijiet ta' konjugazzjoni (jiġu ffurmati metaboliti Odemetilati u deformilati attivi, iżda dawn jidhru prinċipalment bħala konjugati inattivati).
English: Immune system disorders Rare
Maltese: Disturbi fis-sistema immuni
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: There was no evidence of pharmacokinetic interactions between budesonide and formoterol.
Maltese: Ma kien hemm ebda evidenza ta' interazzjonijiet farmakokinetiċi bejn budesonide u formoterol.
English: The bronchodilating effect is dose-dependant, with an onset of effect within 1-3 minutes.
Maltese: L-effett bronkodilatorju huwa dipendenti fuq id-doża, bl-effett jibda fi żmien 1-3 minuti.
English: • Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm').
Maltese: • Tħarħir akut f'daqqa u/jew qtugħ ta' nifs immedjatament wara li tuża l-inalatur tiegħek (issir referenza għalih ukoll bħala ‘bronkospażmu paradossikali'.
English: No data on fertility are available.
Maltese: Fertilità Mhix disponibbli dejta dwar il-fertilità.
English: Infections and infestations Common
Maltese: Infezzjonijiet u infestazzjonijiet
English: Contents of the pack and other information (page 19)
Maltese: Kontenut tal-pakkett u informazzjoni oħra (paġna 19)
English: Hyperglycaemia
Maltese: Ipergliċemija
English: • Diuretics, also known as ‘water tablets' (such as furosemide).
Maltese: • Dijuretiċi, magħrufin ukoll bħala ‘pilloli tal-ilma' (bħal furosemide).
English: The safety and efficacy of Budesonide/Formoterol Teva Pharma B.V. in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Budesonide/Formoterol Teva Pharma B.V. fit-tfal, sa 12-il sena u l adolexxenti, minn 13 sa 17-il sena ma ġewx determinati s'issa.
English: In patients using potent CYP3A4 inhibitors, a budesonide/formoterol fumarate fixed-dose combination is not recommended.
Maltese: F' pazjenti li jkunu qegħdin jużaw inibituri qawwija ta' CYP3A4, mhijiex rakkomandata terapija b'kombinazzjoni ta' doża fissa ta' budesonide/formoterol fumarate.
English: Adults (18 years and older )
Maltese: Adulti (18-il sena u iktar):
English: Start Teva Pharma B.V.
Maltese: Ibda Teva Pharma B.V.
English: Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Maltese: (miġbuda man-nifs) fiha 320 mikrogramma ta' budesonide u 9 mikrogrammi ta' formoterol fumarate dihydrate.
English: How to store Budesonide/Formoterol Teva Pharma B.V. (page 21) 6.
Maltese: Kif taħżen Budesonide/Formoterol Teva Pharma B.V. (paġna 21)
English: The toxicity observed in animal studies with budesonide and formoterol, given in combination or separately, were effects associated with exaggerated pharmacological activity.
Maltese: L-effett tossiku osservat fi studji fuq l-annimali b'budesonide u formoterol, mogħtija flimkien jew separatament, kienu effetti assoċjati ma' attività farmakoloġika esaġerata.
English: Budesonide/formoterol maintenance therapy
Maltese: budesonide/formoterol fumarate.
English: Budesonide/Formoterol Teva Pharma B.V. 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
Maltese: Budesonide/Formoterol Teva Pharma B.V. 160 mikrogramma /4.5 mikrogrammi trab li jittieħed mannifs budesonide/ formoterol fumarate dihydrate
English: For a fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate or the concomitant treatment with formoterol and budesonide, no clinical data on exposed pregnancies are available.
Maltese: Għal kura ta' kombinazzjoni ta' doża fissa ta' budesonide u formoterol fumarate dihydrate jew il-kura konkomitanti b'formoterol u budesonide, ma hija disponibbli l-ebda dejta klinika dwar it-tqaliet esposti.
English: Vascular disorders
Maltese: Disturbi gastro-intestinali
English: Budesonide/Formoterol Teva Pharma B.V. 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Maltese: Budesonide/Formoterol Teva Pharma B.V. 320 mikrogramma /9 mikrogrammi trab li jittieħed mannifs budesonide/ formoterol fumarate dihydrate
English: Effects on bone density
Maltese: GĦAMLA KWALITATTIVA
English: Each delivered (inhaled) dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Maltese: (miġbuda man-nifs) fiha 160 mikrogramma ta' budesonide u 4.5 mikrogrammi ta' formoterol fumarate dihydrate.
English: Cataract and glaucoma
Maltese: F'dan il-fuljett
English: How to store Budesonide/Formoterol Teva Pharma B.V. (page 19) 6.
Maltese: Kif taħżen Budesonide/Formoterol Teva Pharma B.V. (paġna 19)
English: The systemic bioavailability is about 61% of the delivered dose.
Maltese: Ilbijodisponibilità sistemika hija madwar 61% tad-doża mogħtija.
English: In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva Pharma B.V. was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
Maltese: Fi studji farmakokinetiċi bi u mingħajr imblokk bil-faħam, Budesonide/Formoterol Teva Pharma B.V. ġie evalwat billi tqabbel ma' prodott li jittieħed man-nifs ta' kombinazzjoni b'doża fissa awtorizzat alternattiv li fih l-istess sustanzi attivi, budesonide u formoterol u ntwera li huwa ekwivalenti kemm flesponiment sistemiku (sigurtà) kif ukoll fid-depożitu fil-pulmuni (effikaċja).
English: Contains lactose.
Maltese: Katarretti u glawkoma
English: How to use Budesonide/Formoterol Teva Pharma B.V. (page 8) 4.
Maltese: Kif għandek tuża Budesonide/Formoterol Teva Pharma B.V. (paġna 8)
English: Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased risks for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.
Maltese: Studji fl-annimali identifikaw l-involviment ta' glukokortikosterojdi eċċessivi qabel it-twelid fiż-żieda fir-riskji għal dewmien fit-tkabbir ġewwa l-utru, mard kardjovaskulari fl-adulti u bidliet permanenti fid-densità tar-riċetturi tal-glukokortikojdi, it-telf u s-sostituzzjoni tan-newrotrasmettituri u l-imġiba f'esponiment aktar baxxi mill-medda tad-dożi teratoġeniċi.
English: Effects are probably dependent on dose, exposure time, concomitant and previous steroid exposure and individual sensitivity.
Maltese: L-effetti probabbilment huma dipendenti fuq id doża, il-ħin tal-esponiment, l-esponiment konkomitanti u preċedenti għall-isterojdi u s-sensittività individwali.
English: This is equivalent to a metered dose of 200 micrograms budesonide and 6 micrograms of formoterol fumarate dihydrate.
Maltese: Dan huwa ekwivalenti għal doża mkejla ta' 200 mikrogramma budesonide u 6 mikrogrammi ta' formoterol fumarate dihydrate.
English: Budesonide/Formoterol Teva Pharma B.V.320 micrograms/9 micrograms, inhalation powder (budesonide/formoterol fumarate dihydrate)
Maltese: Budesonide/Formoterol Teva Pharma B.V. 320 mikrogramma/9 mikrogrammi, trab li jittieħed man-nifs (budesonide/formoterol fumarate dihydrate)
English: If your doctor feels that you need a lower dose than is available from your Budesonide/Formoterol Teva Pharma B.V., your doctor may prescribe an alternative inhaler containing the same active substances as your Budesonide/Formoterol Teva Pharma B.V. but with a lower dose of the corticosteroid.
Maltese: it-tabib tiegħek jista' jagħtik inalatur alternattiv li jkun fih l-istess sustanzi attivi bħal Budesonide/Formoterol Teva Pharma B.V. tiegħek, iżda b'doża iktar baxxa ta' kortikosterojde.
English: Potent inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors) are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.
Maltese: clarithromycin, telithromycin, nefazodone u inbituri tal-protease tal-HIV protease) huma probabbli li jżidu b'mod qawwi l-livelli ta' budesonide fil-plażma u għalhekk l-użu konkomitanti għandu jiġi evitat.
English: Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C .
English: Budesonide/Formoterol Teva Pharma B.V. pharmacokinetic profile
Maltese: Jekk tuża Budesonide/Formoterol Teva Pharma B.V. aktar milli suppost
English: This is equivalent to a metered dose of 400 micrograms budesonide and 12 micrograms of formoterol fumarate dihydrate.
Maltese: Dan huwa ekwivalenti għal doża mkejla ta' 400 mikrogramma budesonide u 12-il mikrogramma ta' formoterol fumarate dihydrate.
English: • Do not use this medicine after the expiry date which is stated on the carton or on the label of your inhaler after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna jew fuq it-tikketta tal inalatur tiegħek wara JIS/EXP.
English: Formoterol has a high systemic clearance (approximately 1.4 L/min) and the terminal elimination half-life averages 17 hours.
Maltese: L/min) u l-half-life tal-eliminazzjoni terminali medja hija ta' 17-il siegħa.
English: How to store Budesonide/Formoterol Teva Pharma B.V.
Maltese: Tużax Budesonide/Formoterol Teva Pharma B.V.
English: This is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
Maltese: Dan huwa ekwivalenti għal doża mkejla ta' 200 mikrogramma ta' budesonide u 6 mikrogrammi ta' formoterol fumarate dihydrate.
English: Do not use Budesonide/Formoterol Teva Pharma B.V. if:
Maltese: Tużax Budesonide/Formoterol Teva Pharma B.V. jekk:
English: Serious asthma-related adverse reactions and exacerbations may occur during treatment with Budesonide/Formoterol Teva Pharma B.V..
Maltese: Jistgħu jseħħu reazzjonijiet avversi u taħrixiet serji relatati mal-ażma waqt il-kura b'Budesonide/Formoterol Teva Pharma B.V..