FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Thalidomide Celgene used together with melphalan and prednisone (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), lymphopenia (low levels of lymphocytes, another type of white blood cell), thrombocytopenia (low levels of platelets in the blood), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet), tremor (shaking), dizziness, paraesthesia (unusual sensations like pins and needles), dysaesthesia (reduced sense of touch), sleepiness, constipation and peripheral oedema (swelling, usually in the legs).
Maltese: L-effetti sekondarji laktar komuni b'Thalidomide Celgene użat flimkien ma' melphalan u prednisone (li dehru f'iktar minn pazjent 1 minn kull 10) huma newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellula tad-demm bajda), lewkopenija (għadd baxx ta' ċelluli tad-demm bojod), anemija (għadd baxx ta' ċelloli tad-demm ħomor), linfopenija (livelli baxxi ta' linfoċiti, tip ieħor ta' ċellula bajda tad-demm), tromboċitopenija (livelli baxxi ta' pjastrini fid-demm), newropatija periferika (ħsara fin-nervituri, li tikkawża tnemnim, uġigħ fl-idejn u fis-saqajn li kif ukoll jinħassu mtarrxin), tregħid, sturdament, parestesija (sensazzjonijiet mhux tas-soltu bħal tniggiż), disestesija (tnaqqis fis-sens tal-mess), ħedla tan-ngħas, stitikezza u edema periferika (nefħa ġeneralment fir-riġlejn).
English: ema.europa.eu/en/medicines/human/EPAR/thalidomide-celgene-previously-thalidomide-pharmion.
Maltese: Aktar informazzjoni dwar Thalidomide Celgene tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/en/medicines/human/EPAR/thalidomide-celgene-previously-thalidomide-pharmion.
English: Previously known as Thalidomide Pharmion.
Maltese: Preċedentement magħruf bħala Thalidomide Pharmion.
English: Thalidomide Celgene thalidomide
Maltese: Informazzjoni oħra dwar Thalidomide Celgene
English: It contains the active substance thalidomide.
Maltese: Fih is-sustanza attiva talidomid.
English: Patients receiving melphalan and prednisone lived for an average of 33.2 months from the start of the study, compared with 51.6 months when the treatment also included Thalidomide Celgene.
Maltese: Il-pazjenti li ngħataw melphalan u prednisone għexu għal medja ta' 33.2 xhur mill-bidu tal-istudju, meta mqabbla ma' 51.6 xhur meta l-kura inkludiet ukoll Thalidomide Celgene.
English: In patients over 75 years of age a starting dose of 100 mg (2 capsules) a day is recommended.
Maltese: F'pazjenti li għandhom 'il fuq minn 75 sena, hija rakkomandata doża tal-bidu ta' 100 mg (2 kapsuli) kuljum.
English: Thalidomide Celgene, in combination with melphalan and prednisone, has been shown to prolong the life of patients with multiple myeloma.
Maltese: Thalidomide Celgene, f'kombinazzjoni ma' melphalan and prednisone, intwera li jtawwal il-ħajja talpazjenti b'mijeloma multipla.
English: Thalidomide Celgene is used to treat multiple myeloma (a cancer of the bone marrow) in combination with the cancer medicines melphalan and prednisone in patients who have not been treated for multiple myeloma before.
Maltese: Thalidomide Celgene jintuża għall-kura tal-mijeloma multipla (kanċer tal-mudullun) f'kombinazzjoni mal-mediċini kontra l-kanċer melphalan u prednisone f'pazjenti li ma jkunux ġew ikkurati għallmijeloma multipla qabel.
English: The recommended dose is 200 mg (4 capsules) a day, taken at the same time, preferably at bedtime.
Maltese: Id-doża rakkomandata hija ta' 200 mg (4 kapsuli) kuljum, meħudin fl-istess ħin tal-jum, preferibbilment f'ħin l-irqad.
English: As for all medicines, data on the use of Thalidomide Celgene are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Thalidomide Celgene hija ssorveljata kontinwament.
English: The company that markets Thalidomide Celgene will set up a pregnancy prevention programme in each Member State.
Maltese: Il-kumpanija li tqiegħed Thalidomide Celgene fis-suq se tistabbilixxi programm għall-prevenzjoni tattqala f'kull Stat Membru.
English: What are the risks associated with Thalidomide Celgene?
Maltese: X'inhuma r-riskji assoċjati ma' Thalidomide Celgene?
English: The doctor may delay, reduce or stop doses if the patient gets certain side effects, including blood clots, nerve damage, rash, low heart rate, fainting or sleepiness.
Maltese: It-tabib jista' jittardja, inaqqas jew iwaqqaf id-dożi jekk il-pazjent jesperjenza ċerti effetti sekondarji, inklużi emboli taddemm, ħsara fin-nervituri, raxx, tnaqqis fir-rata tat-taħbit tal-qalb, sturdament jew ngħas.
English: For the full list of side effects reported with Thalidomide Celgene, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Thalidomide Celgene, ara l-fuljett ta' tagħrif.
English: How is Thalidomide Celgene used?
Maltese: Kif jaħdem Thalidomide Celgene?
English: The active substance in Thalidomide Celgene, thalidomide, is thought to work by blocking the development of cancer cells, and by stimulating some of the specialised cells of the immune system
Maltese: Huwa maħsub li s-sustanza attiva f'Thalidomide Celgene, it-talidomid, taħdem billi timblokka l-iżvilupp ta' ċelluli tal-kanċer, u billi tistimula wħud miċ-ċelluli speċjalizzati tas-sistema immunitarja (id-difiżi
English: • women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment;
Maltese: • nisa li jistgħu joħorġu tqal jekk ma jiħdux il-passi kollha meħtieġa biex ikun żgurat li mhumiex tqal qabel il-kura u li ma joħorġux tqal waqt il-kura jew ftit wara l-kura;
English: It is used in patients aged 65 years or over, and in younger patients if they cannot be treated with high-dose chemotherapy.
Maltese: L-istudju kien jinkludi pazjenti li għandhom 'il fuq minn 65 sena, kif ukoll pazjenti iżgħar li ma setgħux jiġu kkurati b'kimoterapija b'doża għolja.
English: EMA/57956/2014 EMEA/H/C/002735
Maltese: EMEA/H/C/002735
English: Overall, the effect of Eperzan in reducing HbA1c varied between 0.6 and 0.9%.
Maltese: B'mod globali, l-effett ta' Eperzan fit-tnaqqis ta' HbA1c varja bejn 0.6 u 0.9 %.
English: The full EPAR and risk management plan summary for Eperzan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Eperzan, albiglutide, is a ‘GLP-1 receptor agonist'.
Maltese: Is-sustanza attiva f'Eperzan, albiglutide, hija ‘agonista ta-riċettur GLP-1'.
English: This summary was last updated in 02-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 02-2014.
English: This is a summary of the European public assessment report (EPAR) for Eperzan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Eperzan.
English: Eperzan is available as prefilled pens that contain a powder (30 and 50 mg) and solvent for making a solution to be injected under the skin.
Maltese: Eperzan huwa disponibbli bħala pinen mimlija għal-lest li fihom trab (30 u 50 mg) u solvent biex issir soluzzjoni li għandha tiġi injettata taħt il-ġilda.
English: Eperzan is a diabetes medicine that contains the active substance albiglutide.
Maltese: Eperzan huwa mediċina tad-dijabete li fiha s-sustanza attiva albiglutide.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eperzan on 28 March 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Eperzan fit-21 ta' Marzu 2014.
English: Eperzan was more effective than placebo at reducing HbA1c levels when used alone, and was more effective than the diabetes medicines sitagliptin and glimepiride and comparable to insulin glargine and insulin lispro when used as add-on to other treatments.
Maltese: Eperzan kien aktar effettiv minn plaċebo fit-tnaqqis tal-livelli ta' HbA1c meta ntuża waħdu, u aktar effettiv mill-mediċini kontra d-dijabete sitaglipitin u glimepiride u paragunabbli mal-insulina glargine u l-insulina lispro meta jintuża bħala żieda ma' kuri oħra.
English: The most common side effects with Eperzan, affecting more than 1 in 20 people, are diarrhoea, nausea (feeling sick) and reactions at the injection site including rash, redness, or itching.
Maltese: L-effetti sekondarji l-aktar komuni b'Eperzan (li jistgħu jolqtu lil aktar minn persuna 1 minn kull 20) huma dijarea, dardir (tħossok ma tiflaħx) u reazzjonijiet fis-sit tal-injezzjoni inkluż raxx, ħmura, jew ħakk.
English: Why is Eperzan approved?
Maltese: Għaliex ġie approvat Eperzan?
English: When used in combination with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Maltese: Meta jintuża flimkien ma' sulfonilurea jew insulina, id-doża ta' sulfonilurea jaf ikollha bżonn titbaxxa biex tiġi evitata ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: Eperzan can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of blood glucose.
Maltese: Eperzan jista' jintuża wkoll bħala "żieda" ma' mediċini oħrajn kontra d-dijabete, inkluż l-insulina, meta dawn il-mediċini flimkien mal-eżerċizzju u d-dieta ma jkunux qegħdin jipprovdu kontroll xieraq talglukożju fid-demm.
English: Other information about Eperzan
Maltese: Kif jintuża Eperzan?
English: What are the risks associated with Eperzan?
Maltese: X'inhuma r-riskji assoċjati ma' Eperzan?
English: The benefits of Eperzan were studied in over 5,000 patients with type 2 diabetes in which Eperzan was compared with placebo (a dummy treatment) or with other diabetes medicines when used as an addon to various combination treatments or when used alone.
Maltese: Il-benefiċċji ta' Eperzan ġew studjati f'aktar minn 5,000 pazjent b'dijabete tat-tip 2 fejn Eperzan tqabbel ma' plaċebo (kura finta) jew ma' mediċini oħra kontra d-dijabete meta użat bħala żieda għal diversi kuri kombinati jew meta jintuża waħdu.
English: The main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fil-livell ta' emoglobina glikosilata (HbA1c), li huwa l-perċentwal ta' emoglobina fid-demm li għandha l-glukożju marbut magħha.
English: How is Eperzan used?
Maltese: Kif jaħdem Eperzan?
English: The CHMP noted that the effects of Eperzan in controlling blood glucose were shown to be clinically meaningful when the medicine was used alone and when compared with other medicines in combination treatments.
Maltese: Dan ġie kkunsidrat bħala klinikament sinifikanti u kien hemm dejta ta' tliet snin li turi li dan l-effett inżamm matul kura fit-tul.
English: The recommended dose is 30 mg injected once a week, though this may be increased by their doctor to 50 mg depending on the effects on their blood sugar levels.
Maltese: Id-doża rakkomandata hija ta' 30 mg injettata darba f'ġimgħa, għalkemm din tista' tiżdied mit-tabib tagħhom għal 50 mg skont l-effetti fuq il-livelli ta' zokkor fid-demm tagħhom.
English: It works by attaching to receptors for a substance called glucagon-like peptide 1 (GLP-1), which are found on the surface of the cells in the pancreas and stimulate them to release insulin.
Maltese: Taħdem billi teħel mar-riċetturi għal sustanza msejħa peptidi li jixbhu lil glucagon 1 (GLP-1), li jinstabu fuq wiċċ iċ-ċelloli fil-frixa u tistimulahom biex jirrilaxxaw l-insulina.
English: Two other medicines, pioglitazone and liraglutide, were found to be more effective as an add-on than Eperzan.
Maltese: Żewġ mediċini oħra, pioglitazone u liraglutide, instabu li huma aktar effikaċi bħala żieda minn Eperzan.
English: This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.
Maltese: Dan jikkawża r-rilaxx ta' insulina u jgħin inaqqas il-livelli ta' glukożju fid-demm u jikkontrolla d-dijabete tattip 2.
English: A risk management plan has been developed to ensure that Eperzan is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Eperzan jintuża bl-aktar mod sigur possibbli.
English: 60 doses
Maltese: 60 doża
English: EU/1/14/921/004 EU/1/14/921/005 EU/1/14/921/006
Maltese: EU/1/14/921/005 EU/1/14/921/006
English: Packs of 1, 2, and 3 inhalers.
Maltese: Pakketti ta' 1, 2, u 3 inalaturi.
English: Budesonide/Formoterol Furmarate Dihydrate 320/9
Maltese: Budesonide/Formoterol Furmarate Dihydrate 320/9 µg bd
English: BiResp Spiromax 160 mcg/4.5 mcg
Maltese: BiResp Spiromax 160 μg/4.5 μg
English: Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine) 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), u antidepressanti triċikliċi, tista' ttawwal l-intervall QTc u żżid ir-riskju ta' arritmiji ventrikolari.
English: • Antipsychotic phenothiazine medicines (such as chlorpromazine and prochlorperazine).
Maltese: • Mediċini antipsikotiċi tal-phenothiazine (bħal chlorpromazine u prochlorperazine).
English: Pack sizes of 1, 2 or 3 inhalers.
Maltese: Pakketti multipli li fihom 1, 2 jew 3 inalaturi.
English: Budesonide/formoterol maintenance and reliever therapy provided statistically significant and clinically meaningful reductions in severe exacerbations for all comparisons in all 5 studies.
Maltese: It-terapija ta' manteniment u ta' solljiev b'budesonide/formoterol ipprovdiet tnaqqis statistikament sinifikanti u klinikament importanti fit-taħrix sever għall-paraguni kollha fil-5 studji kollha kemm huma.
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: prevista skont l-Artikolu 107c (7) tad-Direttiva 2001/83 / KE u kwalunkwe aġġornamenti sussegwenti ppubblikati fuq il-Ewropea mediċini web-portal.
English: A total of 12076 asthma patients were included in 5 double-blind clinical studies (4447 were randomised to budesonide/formoterol maintenance and reliever therapy) for 6 or 12 months.
Maltese: Total ta' 12076 pazjent bl-ażma kienu inklużi f'5 studji kliniċi double-blind (4447 ġew magħżula b'mod aleatorju għal terapija ta' manteniment jew ta' solljiev b'budesonide/formoterol) għal 6 jew 12il xahar.
English: • Antidepressant medicines such as monoamine oxidase inhibitors and those with similar properties (such as the antibiotic furazolidine and the chemotherapy medicine procarbazine).
Maltese: • Mediċini kontra d-depressjoni bħal inibituri ta' monoamine oxidase u dawk bi kwalitajiet simili (bħall-antibijotiku furazolidone u l-mediċina għall-kimoterapija procarbazine).
English: BiResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.
Maltese: BiResp Spiromax fih żewġ sustanzi attivi differenti: budesonide u formoterol fumarate dihydrate.
English: This included a comparison with budesonide/formoterol at a higher maintenance dose with terbutaline as reliever (study 735) and budesonide/formoterol at the same maintenance dose with either formoterol or terbutaline as reliever (study 734) (see table below).
Maltese: Dan kien jinkludi tqabbil ma' budesonide/formoterol f'doża ta' manteniment aktar għolja ma' terbutaline bħala sustanza ta' solljiev (studju 735) u budesonide/formoterol fl-istess doża ta' manteniment jew ma' formoterol jew ma' terbutaline bħala sustanza ta' solljiev (studju 734) (ara t tabella hawn isfel).
English: - The other ingredient is lactose monohydrate (see section 2 under ‘BiResp Spiromax contains lactose')
Maltese: - Is-sustanza l-oħra hi lactose monohydrate (ara sezzjoni 2 taħt ‘ BiResp Spiromax fih il-lactose' )
English: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects.
Maltese: Il-kura flimkien ma' inibituri ta' CYP3A inklużi prodotti li fihom cobicistat, hija mistennija li żżid irriskju ta' effetti sekondarji sistemiċi.
English: • you regularly drink alcohol
Maltese: • tixrob l-alkoħol b'mod regolari.
English: Adults (18 years and older): 2 inhalations twice daily
Maltese: Adulti (18-il sena u iktar): 2 inalazzjonijiet darbtejn kuljum
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: Attenzjoni b'mard speċjali 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: Chronic Obstructive Pulmonary Disease (COPD)
Maltese: Mard kroniku ostruttiv tal-pulmuni (COPD)
English: Chronic obstructive pulmonary disease (COPD)
Maltese: Mard Kroniku Ostruttiv tal-Pulmuni (COPD)
English: The mean number of exacerbations per year (as defined above) was significantly reduced with budesonide/formoterol as compared with treatment with formoterol alone or placebo (mean rate 1.4 compared with 1.8-1.9 in the placebo/formoterol group).
Maltese: In-numru medju ta' taħrixiet kull sena (kif definiti hawn fuq) tnaqqas b'mod sinifikanti b'budesonide/formoterol meta mqabbel mal-kura b'formoterol waħdu jew plaċebo (rata medja ta' 1.4 meta mqabbel ma' 1.8-1.9 fil-grupp li tal-plaċebo/formoterol).
English: Republic of Ireland
Maltese: Repubblika tal-Irlanda
English: • Disturbance of the heart's electrical system which does not cause symptoms (prolongation of the QTc interval).
Maltese: • Disturb fis-sistema elettrika tal-qalb li ma jikkawżax sintomi (titwil tal-intervall QTc)
English: µg bd + terbutaline 0.4 mg as needed Salmeterol/fluticasone 2 x 25/125 µg bd + terbutaline 0.4 mg as needed
Maltese: Salmeterol/fluticasone 2 x 25/125 µg bd + terbutaline 0.4 mg kif meħtieġ
English: Budesonide/Formoterol Furmarate Dihydrate
Maltese: budesonide/formoterol fumarate.
English: Mild irritation in the throat, coughing, hoarseness
Maltese: Irritazzjoni ħafifa fil-gerżuma, sogħla, ħanqa
English: The drug/mucosal contact parts of the inhaler are made of acrylonitrile butadiene styrene (ABS), polyethylene (PE), and polypropylene (PP).
Maltese: (ABS), polyethylene (PE), u polypropylene (PP).
English: White powder.
Maltese: Studju Nru.
English: There are no clinical study data on BiResp Spiromax available in COPD patients with a pre-bronchodilator FEV1 >50% predicted normal and with a post-bronchodilator FEV1 <70% predicted normal (see section 5.1)
Maltese: M'hemm l-ebda dejta disponibbli minn studji kliniċi dwar BiResp Spiromax f'pazjenti b'COPD b'normal imbassar ta' FEV1 >50% qabel il-bronkodilatur, u b'normal imbassar ta' FEV1 <70% wara lbronkodilatur (ara sezzjoni 5.1).
English: Adults (18 years and older):
Maltese: Adulti (18-il sena u iktar):
English: Budesonide/Formoterol Furmarate Dihydrate 160/4.5 µg bd + as needed
Maltese: Budesonide/Formoterol Furmarate Dihydrate 160/4.5 µg bd + kif meħtieġ
English: Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Maltese: - forced expiratory volume in 1 second) < 70% tan-normal imbassar (wara bronkodilatur) u storja ta'
English: Date of first authorisation: 28th April 2014 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 28th April 2014
English: 80 micrograms/4.5 micrograms/inhalation twice daily), and a short acting β2 adrenoceptor agonist as needed.
Maltese: 80 mikrogramma/4.5 mikrogramma/inalazzjoni darbtejn kuljum), u agonist tal-andrenoriċetturi β2 kif meħtieġ.
English: BiResp 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: BiResp 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: N Severe exacerbationsa Events Events/ patient-year
Maltese: Avvenimenti/ pazjent-sena
English: • Periodic safety update reports
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà s
English: BiResp Spiromax contains lactose
Maltese: BiResp Spiromax fih il-lactose
English: Frequencies are defined as: very common (≥1/10), common (≥1/100,
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: Other medicines and BiResp Spiromax
Maltese: Mediċini oħra u BiResp Spiromax
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Maltese: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem
English: Reduction in exacerbation rate is statistically significant (P value <0.01) for both comparisons
Maltese: 001 u p<0.01, rispettivament).
English: Swensweg 5, 2031GA Haarlem The Netherlands
Maltese: Swensweg 5, 2031GA Haarlem Il-Pajjiżi l-Baxxi
English: Budesonide/formoterol maintenance therapy
Maltese: Terapija ta' manteniment għall-ażma b'budesonide/formoterol
English: <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: <1/1,000), rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: • Sudden, unexpected and acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm').
Maltese: • Tħarħir akut f'daqqa u mħux mistenni u/jew qtugħ ta' nifs immedjatament wara li tuża l-inalatur tiegħek (issir referenza għalih ukoll bħala ‘bronkospażmu paradossikali'.
English: BiResp Spiromax can be prescribed for asthma in two different ways.
Maltese: BiResp Spiromax jista' jiġi ordnat għall-ażma b'żewġ modi differenti.
English: Supportive and symptomatic treatment may be indicated.
Maltese: tkun indikata kura sintomatika u ta' sostenn.
English: The prophylactic use of BiResp Spiromax, e.g. before exercise, has not been studied.
Maltese: L-użu profilattiku ta' BiResp Spiromax, eż. qabel l eżerċizzju, ma ġiex studjat.
English: BiResp Spiromax is NOT indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Maltese: BiResp Spiromax MHUWIEX indikat għall-użu fi tfal, ta' 12-il sena jew iżgħar jew f'adolexxenti, ta' 13 sa 17-il sena.
English: If the patient experiences paradoxical bronchopasm BiResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Maltese: Jekk il-pazjent jesperjenza bronkospażmu paradossali, BiResp Spiromax għandu jiġi mwaqqaf immedjatament, il-pazjent għandu jiġi valutat u jekk ikun meħtieġ, tinbeda terapija alternattiva.
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands.
Maltese: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Il-Pajjiżi l-Baxxi.