FrancophonIA/ELRC3.0 huggingface dataset:
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni kienet atipika b'żieda moderata biss fil-valuri tal-glucose fid-demm, inqas minn 14 mmol/l (250 mg/dL).
English: If Fournier's gangrene is suspected, Forxiga should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk tiġi suspettata kankrena ta' Fournier, Edistride għandu jitwaqqaf u għandha tinbeda kura minnufih (li tinkludi antibijotiċi u tneħħija kirurġika).
English: Results of 24-week (LOCF a) placebo-controlled studies of dapagliflozin in add-on combination with metformin or sitagliptin (with or without metformin) Add-on combination
Maltese: Riżultati ta' studji kontrollati bil-plaċebo fuq 24-ġimgħa (LOCF a) b'dapagliflozin f'taħlita miżjud ma' metformin jew sitagliptin (bi jew mingħajr metformin) Taħlita miżjuda
English: Prior to launch of the new adult indication for dapagliflozin, for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Miżuri addizzjonali għall-minimizzazzjoni tar-riskji Qabel it-tnedija tal-indikazzjoni ġdida fl-adulti għal dapagliflozin, għall-kura ta' dijabete mellitus tattip 1 mhux ikkontrollata biżżejjed bħala żieda mal-insulina f'pazjenti b'BMI ≥ 27 kg/m2, meta linsulina waħidha ma tipprovdix kontroll gliċemiku adegwat minkejja l-aħjar terapija bl-insulina, f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel dwar ilkontenut u l-format tal-materjal edukattiv, inkluż fuq il-mezz tal-komunikazzjoni, fuq il-modalitajiet ta' distribuzzjoni, u fuq kwalunkwe aspett ieħor tal-programm, mal-Awtorità Nazzjonali Kompetenti.
English: What Edistride looks like and contents of the pack Edistride 10 mg film-coated tablets are yellow and diamond-shaped approximately 1.1 x 0.8 cm diagonally.
Maltese: Edistride 10 mg pilloli miksijin b'rita huma sofor u b'forma ta' djamant madwar 1.1 x 0.8 cm middijagonali.
English: If ketones are elevated (blood betahydroxybutyrate reading greater than 0.6 mmol/L or urine ketones one plus (+)), treatment with dapagliflozin should not be started until the ketone levels are normal (see section 4.4).
Maltese: Jekk il-“ketones” ikunu għoljin (qari ta' beta-hydroxybutyrate fid demm ta' 0.6 mmol/L jew akbar), il-kura b'dapagliflozin m'għandhiex tinbeda sakemm il-livelli tal-”ketone” jkunu normali (ara sezzjoni 4.2).
English: The combination treatment with dapagliflozin 10 mg and prolonged-release exenatide group showed superior reductions in HbA1c from baseline compared to dapagliflozin alone and prolonged-release exenatide alone (Table 9).
Maltese: Il-kura kkombinata mal-grupp ta' dapagliflozin 10 mg u exenatide li jerħi lmediċina bil-mod wera tnaqqis superjuri fl-HbA1c mil-linja bażi meta mqabbel ma' dapagliflozin waħdu u exenatide li jerħi l-mediċina bil-mod waħdu (Tabella 9).
English: The safety profile of dapagliflozin in subjects with type 1 diabetes mellitus was similar to the known safety profile of dapagliflozin in subjects with type 2 diabetes mellitus, with the exception of a higher number of DKA events in dapagliflozin-treated subjects in the type 1 diabetes mellitus studies.
Maltese: Il-profil tas-sigurtà ta' dapagliflozin f'individwi b'dijabete mellitus tat-tip 1 kien simili għall-profil tas-sigurtà magħruf ta' dapagliflozin f'individwi b'dijabete mellitus tat-tip 2, bl-eċċezzjoni ta' għadd ogħla ta' avvenimenti ta' DKA f'individwi kkurati b'dapagliflozin fl-istudji tad-dijabete mellitus tattip 1.
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 1 diabetes patients, type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Maltese: Pazjenti li jistgħu jkunu f'riskju ogħla ta' DKA jinkludu pazjenti b'riżerva baxxa tal-funzjoni taċ-ċellula beta (eż. pazjenti b'dijabete tat-tip 1, pazjenti b'dijabete tat-tip 2 b'C-peptide baxx jew dijabete awtoimmuni moħbija fl-adulti (LADA) jew pazjenti bi storja ta' pankreatite), pazjenti b'kundizzjonijiet li jwasslu għal teħid ristrett tal-ikel jew b'deidrazzjoni severa, pazjenti li għalihom id-dożi tal-insulina huma mnaqqsa u pazjenti b'żieda firrekwiżiti tal-insulina minħabba mard mediku akut, kirurġija jew abbuż mill-alkoħol.
English: Dapagliflozin as an add-on with either metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant reductions in HbA1c at 24 weeks compared with subjects receiving placebo (p < 0.0001; Tables 5, 6 and 7).
Maltese: Dapagliflozin miżjud ma' metformin, glimepiride, metformin u sulphonylurea, sitagliptin (bi jew mingħajr metformin) jew insulina wassal għal tnaqqis statistikament sinifikanti fl-Hb1Ac f'ġimgħa 24 meta mqabbel ma' individwi li kienu fuq plaċebo (p < 0.0001; Tabelli 5, 6 u 7).
English: These subjects had detectable glucose in the urine for a dose-related period of time (at least 5 days for the 500 mg dose), with no reports of dehydration, hypotension or electrolyte imbalance, and with no clinically meaningful effect on QTc interval.
Maltese: Dawn l-individwi kellhom glukows li seta' jitkejjel fl-awrina għal perijodu ta' ħin relatat mad-doża (mill-anqas 5 ijiem għal doża ta' 500 mg), bl-ebda rapport ta' deidratazzjoni, pressjoni baxxa jew żbilanċ fl-elettroliti, u bl-ebda effett ta' sinifikat kliniku fuq l-intervall QTc.
English: Vulvovaginitis , balanitis and related genital infections
Maltese: Jonqos il ketoaċidożi metaboliżmu u nnutrizzjoni
English: • It should be ensured that the patient demonstrates the ability to monitor ketone levels.
Maltese: • Pazjenti li ma jistgħux jew li ma jridux jimmonitorjaw il-“ketones”.
English: Before initiating dapagliflozin
Maltese: Dapagliflozin
English: • The risk of DKA is increased with dapagliflozin treatment.
Maltese: Ir-riskju ta' DKA jiżdied bil-kura b'dapagliflozin.
English: LOCF: Last observation (prior to rescue for rescued subjects) carried forward All randomised subjects who took at least one dose of double-blind study medication during the short-term double-blind period
Maltese: L-aħħar osservazzjoni (qabel is-salvataġġ għal individwi salvati) miġjuba minn qabel L-individwi kollha randomised li ħadu mill-anqas doża waħda tal-medikament studjat double-blind waqt il-perijodu qasir double-blind.
English: These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): - increased levels of “ketone bodies” in your urine or blood - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat - rapid weight loss.
Maltese: Dawn huma s-sinjali ta' ketoaċidożi dijabetika (ara wkoll sezzjoni 2 Twissijiet u prekawzjonijiet): - żieda fil-livelli ta' “korpi ketone” fl-awrina jew fid-demm tiegħek - tħossok ma tiflaħx jew tkun ma tiflaħx - uġigħ fl-istonku - għatx eċċessiv - nifs mgħaġġel u fil-fond - konfużjoni - ngħas jew għejja mhux tas-soltu - riħa ħelwa fin-nifs tiegħek, togħma ħelwa jew metallika f'ħalqek jew riħa tal-awrina jew talgħaraq tiegħek differenti minn tas-soltu. - telf fil-piż f'qasir żmien.
English: Be aware that either uro-genital infection or perineal abscess may precede necrotising fasciitis.
Maltese: Kun af li tista' tidher infezzjoni uroġenitali jew jista' jidher axxess perineali qabel faxxite nekrotizzanti.
English: • When needed to prevent hypoglycaemia, insulin dose reduction should be done cautiously to avoid ketosis and DKA (see section 4.2).
Maltese: • Meta jkun meħtieġ li tiġi evitata l-ipogliċemija, it-tnaqqis fid-doża tal-insulina għandu jsir b'kawtela biex tiġi evitata ketożi u DKA (ara sezzjoni 4.2).
English: How to store Edistride
Maltese: X'inhu Edistride
English: Results at Week 24 of two placebo-controlled clinical studies of dapagliflozin as an adjunct to insulin in adults with type 1 diabetes mellitus
Maltese: Riżultati f'Ġimgħa 24 ta' żewġ studji kliniċi kkontrollati bi plaċebo ta' dapagliflozin bħala żieda mal-insulina f'adulti b'dijabete mellitus tat-tip 1
English: The combination treatment with dapagliflozin 10 mg and prolonged-release exenatide group showed superior reductions in HbA1c from baseline compared to dapagliflozin alone and prolonged-release exenatide alone (Table 8).
Maltese: Il-kura kkombinata mal-grupp ta' dapagliflozin 10 mg u exenatide li jerħi lmediċina bil-mod wera tnaqqis superjuri fl-HbA1c mil-linja bażi meta mqabbel ma' dapagliflozin waħdu u exenatide li jerħi l-mediċina bil-mod waħdu (Tabella 8).
English: What Edistride looks like and contents of the pack Edistride 5 mg film-coated tablets are yellow and round with diameter of 0.7 cm.
Maltese: • Edistride 5 mg pilloli miksijin b'rita huma sofor u tondi b'dijametru ta' 0.7 cm.
English: The efficacy of dapagliflozin was assessed in a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2 who had inadequate glycaemic control on usual care.
Maltese: L-effikaċja ta' dapagliflozin ġiet evalwata fi studju dedikat f'pazjenti dijabetiċi b'eGFR ≥ 45 sa < 60 mL/min/1.73 m2 li kellhom kontroll gliċemiku inadegwat bil-kura tas-soltu.
English: • Patients should be informed, in a dedicated education session, on the risk of DKA, how to recognize DKA risk factors, signs or symptoms, how and when to monitor ketone levels and what actions to take at elevated ketone readings (see section 4.4).
Maltese: • Il-pazjenti għandhom jiġu infurmati, f'sessjoni ta' edukazzjoni ddedikata, dwar ir-riskju ta' DKA, kif jirrikonoxxu fatturi ta' riskju ta' DKA, sinjali jew sintomi, kif u meta għandhom jimmonitorjaw il-livelli tal-“ketone” u x'azzjonijiet għandhom jieħdu meta l-qari tal-”ketone” jkun għoli (ara sezzjoni 4.4).
English: Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo
Maltese: Medja tal-inqas kwadri aġġustata għall-valur tal-linja bażi Valur-p < 0.0001 kontra l-plaċebo
English: In a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2, treatment with dapagliflozin demonstrated reductions in seated systolic blood pressure at Week 24: -4.8 mmHg compared to -1.7 mmHg for placebo (p < 0.05).
Maltese: Fi studju dedikat f'pazjenti dijabetiċi b'eGFR ≥ 45 sa < 60 mL/min/1.73 m2, il-kura b'dapagliflozin uriet tnaqqis fil-pressjoni sistolika tad-demm meta l-pazjent ikun bilqiegħda f'Ġimgħa 24: -4.8 mmHg meta mqabbel ma' -1.7 mmHg għal plaċebo (p < 0.05).
English: The results showed a similar mean reduction in HbA1c from baseline to Week 52, compared to glipizide, thus demonstrating non-inferiority (Table 4).
Maltese: Ir-riżultati wrew medja ta' tnaqqis fl-Hb1Ac simili mil-linja bażi sa' Ġimgħa 52, imqabbel ma' glipizide, b'hekk juri li mhux inferjuri (Tabella 4).
English: Use in patients at risk for volume depletion and/or hypotension Due to its mechanism of action, dapagliflozin increases diuresis which may lead to the modest decrease in blood pressure observed in clinical studies (see section 5.1).
Maltese: Użu f'pazjenti li jkollhom riskju li l-volum jonqos u/jew pressjoni baxxa Minħabba l-mod ta' kif jaħdem, dapagliflozin iżid id-dijuresi li tista' twassal għat-tnaqqis modest filpressjoni tad-demm li ġie osservat fl-istudji kliniċi (ara sezzjoni 5.1).
English: • DKA may occur in patients treated with dapagliflozin even if blood glucose levels are below 14 mmol/l (250 mg/dl), i.e. an explanation of the concept of euglycaemic DKA
Maltese: • DKA tista' sseħħ f'pazjenti kkurati b'dapagliflozin anki jekk il-livelli tal-glucose fid-demm ikunu inqas minn 14 mmol/l (250 mg/dl).
English: Of the 27 patients with DKA events in the dapagliflozin group, 22 had concomitant insulin treatment at the time of the event.
Maltese: Mis27 pazjent b'avvenimenti ta' DKA fil-grupp ta' dapagliflozin, 22 kellhom kura bl-insulina konkomitanti meta seħħ l-avveniment.
English: These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier's gangrene which destroys the tissue under the skin.
Maltese: Dawn is-sintomi jistgħu jkunu sinjal ta' infezzjoni rari iżda serja jew saħansitra ta' periklu għallħajja, li tissejjaħ faxxite nekrotizzanti tal-perinew jew kankrena ta' Fournier li teqred it-tessut taħt ilġilda.
English: • The patients should be educated on what actions to take when ketosis/DKA is suspected and when to discontinue dapagliflozin therapy (see section 4.2).
Maltese: • Il-pazjenti għandhom jiġu edukati dwar x'azzjonijiet għandhom jieħdu meta l-ketożi/DKA tiġi suspettata u meta għandhom iwaqqfu t-terapija b'dapagliflozin (ara sezzjoni 4.2).
English: In case of intercurrent conditions that may lead to volume depletion (e.g. gastrointestinal illness), careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit and electrolytes) is recommended.
Maltese: F'każ ta' kondizzjonijiet interkurrenti li jistgħu jwasslu għal tnaqqis tal-volum (eż. mard gastrointestinali), monitoraġġ bir-reqqa tal-istat tal-volum (eż eżami fiżiku, kejl tal-pressjoni taddemm, testijiet tal-laboratorju inkluż l-ematokrit u tal-elettroliti) huwa rakkomandat.
English: • Contact details of the dapagliflozin prescriber' and ‘Name of patient'.
Maltese: Dettalji ta' kuntatt tal-preskrivent ta' dapagliflozin u “Isem il-pazjent”.
English: Your doctor may ask you to stop taking Edistride.
Maltese: Mediċini oħra u Edistride
English: Packs of 1 and 3 inhalers.
Maltese: Pakketti ta' 1 u 3 inalaturi.
English: Vylaer Spiromax 160 mcg/4.5 mcg
Maltese: Vylaer Spiromax 160 μg/4.5 μg
English: Vylaer Spiromax 320 mcg/9 mcg
Maltese: Vylaer Spiromax 320 μg/9 μg
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 < 1/1,000), rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Vylaer Spiromax contains lactose')
Maltese: - Is-sustanza l-oħra hi lactose monohydrate (ara sezzjoni 2 taħt ‘ Vylaer Spiromax fih il-lactose' )
English: Vylaer Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.
Maltese: Vylaer Spiromax fih żewġ sustanzi attivi differenti: budesonide u formoterol fumarate dihydrate.
English: The requirements for submission of periodic safety update reports 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 għall-preżentazzjoni tar-rapporti perjodiċi ta 'aġġornament dwar is- sikurezza għal dan il-prodott mediċinali huma stabbiliti fil-lista ta' dati ta 'referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c (7) tad-Direttiva 2001/83 / KE u kwalunkwe aġġornamenti sussegwenti ppubblikati fuq il-Ewropea mediċini web-portal.
English: In a 3-year clinical trial with budesonide in COPD, skin bruises and pneumonia occurred at a frequency of 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p<0.001 and p<0.01, respectively).
Maltese: Fi studju kliniku ta' 3 snin b'budesonide fil-COPD, it-tbenġil fil-ġilda u pulmonite seħħew bi frekwenza ta' 10% u 6%, rispettivament, meta mqabbel ma' 4% u 3% fil-grupp li ħa plaċebo (p<0.
English: The inhaler is made of acrylonitrile butadiene styrene (ABS), polyethylene terephthalate (PT) , and polypropylene (PP).
Maltese: Il-partijiet ta 'kuntatt tad-droga / mukosali tal-inalatur humamagħmul minn acrylonitrile butadiene styrene (ABS), polyethylene (PE), u polypropylene (PP).
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), adults with chronic obstructive pulmonary disease (COPDaged >50 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 Spiromax (li fih plaċebo) meta mqabbel ma' inalazzjoni minn apparat ta' teħid man-nifs bi trab xott b'doża multipla diġa kkummerċjalizzat (li fih plaċebo).
English: Teva Pharma B.V. Swensweg 5, 2031GA HaarlemThe Netherlands
Maltese: Teva Pharma B.V. Swensweg 5, 2031GA Haarlem
English: Date of first authorisation: 19th November 2014 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 19 novembru 2014
English: Paediatric population Interaction studies have only been performed in adults.
Maltese: Studji ta' interazzjoni twettqu biss f'adulti.
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: Vylaer Spiromax is not indicated in children and adolescents under the age of 18 years (see section 4.2).
Maltese: Vylaer Spiromax mhuwiex indikat għall-użu fi tfal u adolexxenti li għandhom inqas minn 18-il sena (ara sezzjoni 4.2).
English: Vylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
Maltese: Vylaer Spiromax hu ndikat għat-trattament regolari tal-ażma, fejn l-użu ta' kombinazzjoni (kortikosterojd li jittieħed man-nifs u agonist tal-adrenoriċetturi β2 li jaħdem fit-tul) ikun adattat:
English: Vylaer Spiromax contains lactose
Maltese: Vylaer Spiromax fih il-lactose
English: • Use Vylaer Spiromax every day.
Maltese: • Uża Vylaer Spiromax kuljum.
English: The safety and efficacy of Vylaer Spiromax 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' Vylaer Spiromax fit-tfal, sa 12-il sena u l-adolexxenti, minn 13 sa 17-il sena ma ġewx determinati s'issa.
English: Asthma Budesonide/formoterol maintenance therapy
Maltese: Terapija ta' manteniment għall-ażma b'budesonide/formoterol
English: Vylaer Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section
Maltese: Vylaer Spiromax għandu jitwaqqaf immedjatament, il-pazjent għandu jiġi valutat u jekk ikun meħtieġ, tinbeda terapija alternattiva (ara sezzjoni 4.4).
English: 3 inhalers each containing 60 doses.
Maltese: 3 inalaturi b'kull wieħed fih 60 doża.
English: Vylaer Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate
Maltese: Vylaer Spiromax 160 mikrogramma/4.5 mikrogrammi trab li jittieħed man-nifs budesonide/ formoterol fumarate dihydrate
English: Vylaer Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Maltese: Vylaer Spiromax 320 mikrogramma/9 mikrogrammi trab li jittieħed man-nifs budesonide/ formoterol fumarate dihydrate
English: Other medicines and Vylaer Spiromax
Maltese: Mediċini oħra u Vylaer Spiromax
English: Vylaer Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: Vylaer Spiromax 160 mikrogramma /4.5 mikrogrammi trab li jittieħed man-nifs budesonide/ formoterol fumarate dihydrate DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: 3 inhalers each containing 120 doses.
Maltese: 3 inalaturi b'kull wieħed fih 120 doża.
English: Vylaer Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: Vylaer Spiromax 320 mikrogramma /9 mikrogrammi trab li jittieħed man-nifs budesonide/ formoterol fumarate dihydrate DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Vylaer Spiromax contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Maltese: Vylaer Spiromax fih formoterol u budesonide, li għandhom modi ta' azzjoni differenti u juru effetti addittivi f'termini tat-tnaqqis fit-taħrix tal-ażma.
English: Budesonide and formoterol have not been observed to interact with any other medicinal products used in the treatment of asthma.
Maltese: Budesonide u formoterol ma kienu osservati li jinteraġixxu mal-ebda prodott mediċinali ieħor użat filkura tal-ażma.
English: Vylaer Spiromax 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate
Maltese: Vylaer Spiromax 160 μg/4.5 μg trab li jittieħed man-nifs budesonide/formoterol fumarate dihydrate
English: Vylaer Spiromax 320 mcg/9 mcg inhalation powder budesonide/formoterol fumarate dihydrate
Maltese: Vylaer Spiromax 320 μg/9 μg trab li jittieħed man-nifs budesonide/formoterol fumarate dihydrate
English: Contents of the pack and other information What Vylaer Spiromax contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X' fih Vylaer Spiromax
English: Vylaer Spiromax is indicated for use in adults 18 years of age and older only.
Maltese: Vylaer Spiromax huwa indikat għall-użu f'persuni adulti minn 18-il sena 'l fuq biss.
English: Vylaer Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Maltese: Terapija ta' manteniment b'Vylaer Spiromax: Vylaer Spiromax jittieħed bħala kura regolari ta' manteniment ma' bronkodilatur separat li jaħdem malajr bħala inalatur ta' solliev.
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Vylaer Spiromax .
Maltese: Ladarba s-sintomi tal-ażma jiġu kkontrollati, għandu jiġi kkunsidrat it-tnaqqis gradwali tad-doża ta' Vylaer Spiromax.
English: If the patient experiences paradoxical bronchopasm Vylaer Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Maltese: Jekk il-pazjent jesperjenza bronkospażmu paradossali, Vylaer Spiromax għandu jiġi mwaqqaf immedjatament, il-pazjent għandu jiġi valutat u jekk ikun meħtieġ, tinbeda terapija alternattiva.