FrancophonIA/ELRC3.0 huggingface dataset:
English: Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, dry mouth, pins and needles, dizziness, vertigo, difficulty in sleeping, inflammation of the liver (hepatitis), oral irritation (such as mouth ulcers and gum inflammation), bone, muscle and/or joint pain, muscle cramps, hair loss, reduction in production of blood cells in the bone marrow, itching, hives, blistering, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), swelling in limbs, feeling unwell, feeling confused, bronchial hyperreactivity (symptoms include wheezing, shortness of breath and cough).
Maltese: Remettar, uġigħ ta' żaqq, rifluss, indiġestjoni, stitikezza, gass, ħalq xott, partijiet tal-ġisem li jorqdulek, sturdament, vertigo, diffikultà biex torqod, infjammazzjoni tal-fwied (epatite), irritazzjoni fil-ħalq (bħal ulċeri fil-ħalq u infjammazjoni fil-ħanek), uġigħ fl-għadam, fil-muskoli u/jew fil-ġogi, bugħawwieġ, jaqa' x-xagħar, tnaqqis fil-produzzjoni ta' ċelloli tad-demm fil-mudullun, ħakk, urtikarja, infafet, anġjoedema (bħal nefħa fil-wiċċ, fl-ilsien jew fil-griżmejn, diffikultà biex tieħu nnifs jew biex tibla'), tħossok ma tiflaħx, nefħa fl-idejn u fis-saqajn, tħossok konfuż, reattività eċċessiva tal-bronki (sintomi jinkludu tħarħir, qtugħ ta' nifs u sogħla).
English: However, it is recommended to drink the suspension immediately after preparation (see section 4.2) 6.4 Special precautions for storage
Maltese: Madankollu huwa rrakkommandat li s-sospensjoni tinxtorob immedjatamet wara li titħejja (ara sezzjoni 4.2) 6.4
English: Together, SOTI and TROPOS enrolled 1,556 patients over 80 years at inclusion (23.1% of the study population).
Maltese: TROPOS ħadu sehem 1,556 pazjent ta' aktar minn 80 sena fil-bidu tal-istudju (23.1% tal-popolazzjoni fl-istudju).
English: Discontinuation of therapy was mainly due to nausea (1.3% and 2.2% in the placebo and strontium ranelate groups respectively).
Maltese: 2.2% fil-gruppi plaċebo u strontium ranelate rispettivament).
English: Aspartame (E951)
Maltese: Aspartame (E951) Maltodextrin
English: Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of PROTELOS.
Maltese: nekroliżi epidermali tossika (TEN) u raxx minħabba xi mediċina b'eosinofilja u sintomi sistemiċi (DRESS)) ġew irrapportati bl-użu ta' PROTELOS.
English: Tel: +46 (8) 52 25 08 00 United Kingdom Servier Laboratories Ltd Tel: +44 (0)1753 666409
Maltese: United Kingdom Servier Laboratories Ltd Tel: +44 (0)1753 666409
English: Strontium ranelate is made up of 2 atoms of stable strontium and 1 molecule of ranelic acid, the organic part permitting the best compromise in terms of molecular weight, pharmacokinetics and acceptability of the medicinal product.
Maltese: .2 Tagħrif farmakokinetiku Strontium ranelate huwa magħmul minn 2 atomi ta' strontium stabbli u molekula waħda ta' ranelic acid, il-parti organika tippermetti l-aħjar kompromess bejn il-piż molekulari, il-farmakokinetika u l aċċettabilità tal-prodott mediċinali.
English: Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2).No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see section 5.2).
Maltese: Pazjenti b'indeboliment tal-kliewi Strontium renalate mhuwiex irrakkomandat f'pazjenti b'indeboliment sever tal-kliewi (eliminazzjoni tal-kreatinina inqas minn 30 ml/min) (ara sezzjonijiet 4.4 u 5.2).
English: The efficacy of PROTELOS was demonstrated in men with osteoporosis in a 2-year, doubleblind,placebo-controlled study with a main analysis after one year in 243 patients (Intention to treatpopulation, 161 patients received strontium ranelate) at high risk of fracture (mean age 72,7 years; mean lumbar BMD T-score value of -2.6; 28% of prevalent vertebral fracture).
Maltese: L-effikaċja ta' PROTELOS intweriet fi rġiel b'osteoporożi fi studju kkontrollat bi plaċebo, doubleblind ta' sentejn b'analiżi ewlenija wara sena f'243 pazjent (popolazzjoni b'intenzjoni li tiġi kkurata, 161 pazjent ingħataw strontium ranelate) b'riskju għoli ta' ksur (età medja ta' 72.7 sena; valur tal punteġġ BMD T lumbari medju ta' -2.6; 28% tal-ksur vertebrali prevalenti).
English: What PROTELOS contains - The active substance is strontium ranelate.
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih PROTELOS - Is-sustanza attiva hi strontium ranelate.
English: Table 1: Incidence of patients with vertebral fracture and relative risk reduction Placebo
Maltese: Tabella 1: L-inċidenza ta' pazjenti bi ksur fis-sinsla u t-tnaqqis fir-riskju relattiv Plaċebo PROTELOS Tnaqqis fir-Riskju
English: o If symptoms or signs of Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) (e.g. rash, fever, eosinophilia and systemic involvement, e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, PROTELOS treatment should be discontinued immediately.
Maltese: o Jekk ikun hemm preżenti sinjali jew sintomi tas-Sindromu ta' Stevens-Johnson (SJS), Nekroliżi Epidermali Tossika (TEN) jew Raxx dovut għall-Mediċina b'Esinofilja jew Sintomi Sistemiċi (DRESS) (eż. raxx, deni, esinofilja u invovliment sistemiku, eż.
English: In phase III studies, which demonstrated the anti-fracture efficacy of PROTELOS treatment, measured mean BMD increased from baseline with PROTELOS by approximately 4% per year at the lumbar spine and 2% per year at the femoral neck, reaching 13% to 15% and 5% to 6% respectively after 3 years, depending on the study.
Maltese: III, li wrew l-effett kontra lksur bil-kura bi PROTELOS, il-medja mkejla ta' BMD mill-bażi żdiedet bejn wieħed u ieħor b'4% kull sena fil-lumbari tal-ispina tad-dahar bi PROTELOS u b'2% kull sena fl-għonq tal-femur, u tilħaq 13% sa 15% u 5% sa 6% rispettivament wara 3 snin skont l-istudju.
English: The binding of strontium to human plasma proteins is low (25%) and strontium has a high affinity for bone tissue.
Maltese: It-twaħħil ta' strontium mal proteini tal-plażma tad-demm uman huwa baxx (25%) u strontium għandu affinità kbira għat-tessuti tal-għadam.
English: Excipient
Maltese: Ekżema
English: Abdominal pain Oral mucosal irritation (stomatitis and/or mouth ulceration) Gastrooesophageal reflux Dyspepsia Constipation Flatulence Dry mouth Hepatobiliary disorders Frequency unknown:a Serum transaminase increased (in association with hypersensitivity skin reactions) Hepatitis Skin and subcutaneous tissue disorders Common: Dermatitis Eczema Rare: DRESS (see section 4.4) Very rare: Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome and toxic epidermal necrolysisc (see section 4.4) Frequency unknown:a Hypersensitivity skin reactions (rash, pruritus, urticaria, angioedema) Alopecia Musculoskeletal and connective tissue disorders Frequency unknown:a Musculoskeletal pain (muscle spasm, myalgia, bone pain, arthralgia and pain in extremity) General disorders and administration site conditions Frequency unknown:a Peripheral oedema Pyrexia (in association with hypersensitivity skin reactions) Malaise Blood and Lymphatic disorders Frequency unknown:a Bone marrow failure Eosinophilia (in association with hypersensitivity skin reactions) Lymphadenopathy (in association with hypersensitivity skin reactions) Investigations Common: Blood Creatine phosphokinase (CPK) increasedb a
Maltese: Ir-riskju ta' trombożi tal-vini (emboli tad-demm fis-saqajn jew fil-pulmuni) jista' jiżdied fil-każ ta' immobilizzazzjoni fit-tul. - jekk għandek mard iskemiku tal-qalb, jew mard ċerebrovaskulari, eż. ġejt iddijanjostikat/a b'attakk tal-qalb, puplesija, jew attakk iskemiku temporanju (tnaqqis temporanju tal-fluss tad demm għall-moħħ; magħruf ukoll bħala “riħ ta' puplesija”), anġina, jew imblokk tal-vini għallqalb jew għall-moħħ. - jekk għandek jew kellek problemi biċ-ċirkolazzjoni tad-demm tiegħek (mard arterjali periferali) jew jekk kellek kirurġija fuq l-arterji ta' riġlejk.
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of PROTELOS.
Maltese: nekroliżi epidermali tossika u reazzjonijiet severi dovuti ta' ipersensittività (DRESS)) ġew irrapportati bl-użu ta' PROTELOS.
English: Mannitol (E421)
Maltese: Prodott, sezzjoni 4.2)
English: PROTELOS 2 g granules for oral suspension
Maltese: TAL-PRODOTT MEDIĊINALI PROTELOS 2 g granijiet għal sospensjoni orali
English: In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), PROTELOS reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
Maltese: F'analiżi posterjuri ta' pazjenti mill-istudji SOTI u TROPOS miġbura flimkien b'bażi lumbari talispina u/jew tal-għonq tal-femur BMD fil-wisa' osteopenika u mingħajr ksur prevelanti iżda mill-inqas b'fattur ta' riskju addizjonali għall-ksur (N = 176), PROTELOS naqqas ir-riskju li jkun hemm l-ewwel ksur tas-sinsla b'72% tul 3 snin (inċidenza ta' ksur tas-sinsla 3.6% bi strontium ranelate vs.
English: The frequency of possible side effects listed below is defined using the following convention: very common: may affect more than 1 in 10 people common:may affect up to 1 in 10 people uncommon: mayaffect up to 1 in 100 people rare: mayaffect up to 1 in 1,000 people very rare: mayaffect up to 1 in 10,000 people not known: frequency cannot be estimated from the available data
Maltese: komuni: tista' taffettwa sa persuna 1 minn kull 10 mhux komuni: tista' taffettwa sa persuna 1 minn kull 100 rari: tista' taffettwa sa persuna 1 minn kull 1000
English: Measurement of strontium concentration in iliac crest bone biopsies from patients treated for up to 60 months with strontium ranelate 2 g/day indicate that bone strontium concentrations may reach a plateau after about 3 years of treatment.
Maltese: pazjenti trattati sa 60 xahar bi strontium ranelate 2 g/jum jindikaw li l-konċentrazzjoni ta' strontium fl għadam tista' tilħaq limitu wara bejn wieħed u ieħor 3 snin ta' kura.
English: In addition to their treatment (2 g/day strontium ranelate or placebo), the patients received adapted calcium and vitamin D supplements throughout both studies.
Maltese: Flimkien mat-terapija (2 g/jum ta' strontium ranelate jew plaċebo), il-pazjenti, matul iżżewġ studji, ingħataw supplimenti adattati ta' kalċju u vitamina D.
English: PROTELOS contains a source of phenylalanine, which may be harmful for people with phenylketonuria.
Maltese: Eċċipjenti PROTELOS għandu sors ta' phenylalanine, li jista' jkun ta' ħsara f'nies b'phenylketonuria.
English: In postmenopausal women, strontium ranelate reduces the risk of fracture at the spine and at the hip.
Maltese: F'nisa wara lmenopawża, strontium ranelate inaqqas ir-riskju ta' ksur tal-vertebri u tal-ġenbejn.
English: 6.3 Shelf life - 3 years.
Maltese: Kif taħżen PROTELOS 6.
English: Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration
Maltese: Jekk strontium ranelate jittieħed ma' kalċju jew mal-ikel, dan inaqqas il-bijodisponibiltà ta' strontium bejn wieħed u ieħor b'60%-70% meta mqabbel mal-għoti 3 sigħat wara l-ikel.
English: If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of PROTELOS, you must not be re-started on PROTELOS at any time If you develop a rash or these skin symptoms, stop taking PROTELOS, seek urgent advice from a doctor and tell him that you are taking this medicine.
Maltese: Jekk żviluppajt is-sindromu ta' Stevens-Johnson jew nekroliżi epidermali tossika jew DRESS bl-użu ta' PROTELOS, inti qatt ma għandek terġa' tieħu PROTELOS.
English: How to take protelos
Maltese: Twissijiet u prekawzjonijiet
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' eċċipjenti Kontenut tal-kapsula
English: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Hirobriz Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2adrenergic agonists.
Maltese: Minkejja li wara li jingħata Hirobriz Breezhaler skont id-dożi rrakkomandati normalment ma jidher lebda effett relevanti klinikament fuq is-sistema kardjovaskulari, l-istess kif jiġri fil-każ ta' agonisti beta2-adrenerġiċi oħrajn, l-indacaterol għandu jintuża b'kawtela f'pazjenti b'disturbi kardjovaskulari (mard tal-arterja koronarja, infart mijokardijaku akut, arritmija kardijaka, pressjoni għolja), f'pazjenti b'disturbi konvulżivi jew tirotossikożi, u f'pazjenti li jirrispondu b'mod mhux tas-soltu għall-agonisti beta2-adrenerġiċi.
English: - Each Hirobriz Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate.
Maltese: - Kull kapsula Hirobriz Breezhaler ta' 300 mikrogramma fiha 300 mikrogramma indacaterol bħala indacaterol maleate.
English: Hirobriz Breezhaler, administered once a day at doses of 150 and 300 microgram consistently provided clinically significant improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) over 24 hours across a number of clinical pharmacodynamic and efficacy studies.
Maltese: Hirobriz Breezhaler, mogħti darba kuljum f'dożi ta' 150 u 300 mikrogramma għen sabiex b'mod konsistenti jkun hemm titjib sinifikanti klinikament fil-funzjoni tal-pulmun (kif imkejjel skont ilvolum espiratorju furzat f'sekonda, l-FEV1) għal 24 siegħa fuq firxa ta' studji kliniċi dwar ilfarmakodinamiċità u l-effikaċja.
English: Systemic exposures (AUC) in rats and mice at the no-observed adverse effect levels in these studies were at least 7- and 49-fold higher, respectively, than in humans treated with Hirobriz Breezhaler once a day at a dose of 300 microgram.
Maltese: Lespożizzjonijiet sistemiċi (AUC) fil-firien u l-ġrieden fuq livelli ta' effett avvers mhux osservat f'dawn l-istudji kienu mill-inqas 7 u 49 darba aktar, rispettivament, milli fil-bnedmin ikkurati b'Hirobriz Breezhaler b'doża ta' 300 mikrogramma darba kuljum.
English: During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Hirobriz Breezhaler at the recommended doses than on placebo.
Maltese: Waqt studji kliniċi, it-tibdil notevoli klinikament fil-livell tal-glukosju fid-demm kien ġeneralment bejn 1% u 2% aktar frekwenti meta ngħata Hirobriz Breezhaler skont id-dożi rrakkomandati milli meta ngħata l-plaċebo.
English: What Hirobriz Breezhaler contains - Each Hirobriz Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate.
Maltese: X'fih Hirobriz Breezhaler - Kull kapsula Hirobriz Breezhaler ta' 150 mikrogramma fiha 150 mikrogramma indacaterol bħala indacaterol maleate.
English: Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Hirobriz Breezhaler at recommended therapeutic doses (see section 5.1).
Maltese: Studji kliniċi dwar Hirobriz Breezhaler ma wrewx effetti relevanti klinikament fuq it-titwil talintervall QTc meta mogħti skont id-dożi terapewtiċi rrakkomandati (ara sezzjoni 5.1).
English: Do not swallow Hirobriz Breezhaler capsules.
Maltese: Tiblax il-kapsuli Hirobriz Breezhaler.
English: Carton containing 30 capsules and one Hirobriz Breezhaler inhaler.
Maltese: Kartuna li fiha 30 kapsula u inhaler wieħed Hirobriz Breezhaler.
English: Show the pack of Hirobriz Breezhaler.
Maltese: Uri l-pakkett ta' Hirobriz Breezhaler.
English: Hirobriz Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed clinically meaningful improvements in lung function.
Maltese: Hirobriz Breezhaler, mogħti darba kuljum f'dożi ta' 150 mikrogramma u 300 mikrogramma, wera titjib sinifikanti klinikament fil-funzjoni tal-pulmun.
English: Hirobriz Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Maltese: Hirobriz Breezhaler mhuwiex indikat sabiex jikkura episodji gravi ta' spażmi fil-bronki, jiġifieri bħala terapija ta' salvataġġ.
English: Carton containing 10 capsules and one Hirobriz Breezhaler inhaler.
Maltese: Kartuna li fiha 10 kapsuli u inhaler wieħed Hirobriz Breezhaler.
English: Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Hirobriz Breezhaler huwa indikat biex jissokta bil-kura bronkodilatatorja f'każ li jinstaddu l-passaġġi tal-arja f'pazjenti adulti li jbatu mill-marda pulmonari ostruttiva kronika (COPD).
English: Hirobriz Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators.
Maltese: Hirobriz Breezhaler fih is-sustanza attiva indacaterol li tagħmel parti minn grupp ta' mediċini msejħa bronkodilataturi.
English: The 300 microgram dose resulted in a 170-180 ml increase compared to placebo (p<0.001) and a 100 ml increase compared to formoterol 12 microgram twice a day (p<0.001).
Maltese: 001) u għal żieda ta' 100 ml meta mqabbla ma' 12-il mikrogramma formoterol darbtejn kuljum (p<0.
English: Hirobriz Breezhaler inhaler
Maltese: Inhaler Hirobriz Breezhaler
English: In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Hirobriz Breezhaler (i.e. medicines such as salmeterol and formoterol).
Maltese: B'mod speċjali, jekk jogħġbok għid lit-tabib tiegħek jekk qed tuża: mediċini minħabba problemi tan-nifs li jixbhu lil Hirobriz Breezhaler (jiġifieri mediċini bħalma huma salmeterol u formoterol).
English: At the recommended doses, the adverse reaction profile of Hirobriz Breezhaler in patients with COPD shows clinically insignificant systemic effects of beta2-adrenergic stimulation.
Maltese: Meta mogħtija skont id-dożi rrakkomandati, il-profil tar-reazzjoni avversa ta' Hirobriz Breezhaler f'pazjenti b'COPD juri effetti sistemiċi mhux sinifikanti klinikament tal-istimulazzjoni bil-beta2adrenerġiċi.
English: Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Maltese: Id-doża rrakkomandata hija ta' kapsula waħda kuljum ta' 150 mikrogramma, fejn il-kontenut jittieħed man-nifs billi jintuża l-inhaler Hirobriz Breezhaler.
English: Hirobriz Breezhaler contains lactose
Maltese: Hirobriz Breezhaler fih il-lactose
English: The Hirobriz Breezhaler inhaler enables you to inhale the medicine contained in an Hirobriz Breezhaler capsule.
Maltese: Bl-inhaler Hirobriz Breezhaler tkun tista' tiġbed il-mediċina li hemm fil-kapsula Hirobriz Breezhaler man-nifs.
English: Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Hirobriz Breezhaler.
Maltese: Waslu rapporti ta' sensittività eċċessiva mill-esperjenza ta' wara l-approvazzjoni tas-suq rigward lużu ta' Hirobriz Breezhaler.
English: What Hirobriz Breezhaler is
Maltese: Hirobriz Breezhaler.
English: Therefore, long-acting beta2-adrenergic agonists such as Hirobriz Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or treated with medicinal products affecting the QT interval.
Maltese: Għaldaqstant, l-agonisti beta2-adrenerġiċi li jibqgħu attivi fit-tul bħalma hu Hirobriz Breezhaler għandu jintuża b'kawtela f'pazjenti b'titwil tal-intervall QT magħruf jew issuspettat jew ittrattati bi prodotti mediċinali li jaffettwaw l-intervall QT.
English: If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, Hirobriz Breezhaler should be discontinued immediately and alternative therapy instituted.
Maltese: Jekk iseħħu sinjali li jissuġġerixxu reazzjonijiet allerġiċi (b'mod partikolari, diffikultajiet biex tieħu nnifs jew biex tibla', nefħa tal-ilsien, tax-xufftejn u tal-wiċċ, urtikarja, raxx), Hirobriz Breezhaler għandu jitwaqqaf minnufih u għandha tinbeda terapija alternattiva.
English: The capsules must be administered only using the Hirobriz Breezhaler inhaler (see section 6.6).
Maltese: Il-kapsuli għandhom jittieħdu biss billi jintuża l-inhaler Hirobriz Breezhaler (ara sezzjoni 6.6).
English: As demonstrated in 605 patients with COPD in a 26-week, double-blind, placebo-controlled Phase III study, there was no clinically relevant difference in the development of arrhythmic events monitored over 24 hours, at baseline and up to 3 times during the 26-week treatment period, between patients receiving recommended doses of Hirobriz Breezhaler treatment and those patients who received placebo or treatment with tiotropium.
Maltese: III li dam 26 ġimgħa, ikkontrollat bi plaċebo, ma kienx hemm differenza relevanti klinikament fejn jidħol l-iżvilupp ta' episodji arritmiċi kif osservati tul 24 siegħa, la fil-linja bażi u lanqas sa tliet darbiet aktar waqt is26 ġimgħa li matulhom ingħatat il-kura, bejn il-pazjenti mogħtija l-kura skont id-dożi rrakkomandati b'Hirobriz Breezhaler u dawk mogħtija l-plaċebo jew il-kura bit-tiotropium.
English: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Hirobriz Breezhaler.
Maltese: L-għoti flimkien ma' prodotti mediċinali simpatomimetiċi oħrajn (waħedhom jew inkella bħala parti minn terapija kkombinata) jista' jżid fil-qawwa tar-reazzjonijiet avversi ta' Hirobriz Breezhaler.
English: At 600 microgram once-daily, the safety profile of Hirobriz Breezhaler was overall similar to that of recommended doses.
Maltese: Meta ngħataw 600 mikrogramma darbtejn kuljum, il-profil ta' sigurtà ta' Hirobriz Breezhaler kien kollox ma' kollox l-istess bħal dak ta' meta ngħataw id-dożi rrakkomandati.
English: Hirobriz Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists.
Maltese: Hirobriz Breezhaler m'għandux jintuża flimkien ma' agonisti beta2-adrenerġiċi oħrajn li jibqgħu attivi fit-tul jew ma' prodotti mediċinali li fihom agonisti beta2-adrenerġiċi li jibqgħu attivi fit-tul.
English: Immediate hypersensitivity reactions have been reported after administration of Hirobriz Breezhaler.
Maltese: Reazzjonijiet immedjati ta' sensittività eċċessiva ġew irrappurtati wara l-għoti ta'Hirobriz Breezhaler.
English: Although indacaterol did not affect general reproductive performance in a rat fertility study, a decrease in the number of pregnant F1 offspring was observed in the peri- and post-developmental rat study at an exposure 14-fold higher than in humans treated with Hirobriz Breezhaler.
Maltese: Minkejja li l-indacaterol ma affettwax il-ħila riproduttiva waqt studju dwar il-fertilità fost il-firien, kien osservat tnaqqis fl-għadd ta' frieħ F1 tqal waqt studju magħmul tul l-iżvilupp tal-firien u wara u li ngħataw doża 14-il darba aktar minn dik mogħtija lill-bnedmin ikkurati b'Hirobriz Breezhaler.
English: Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules
Maltese: Il-kapsuli Hirobriz Breezhaler ta' 150 mikrogramma għandhom il-kodiċi tal-prodott “IDL 150”
English: Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules indacaterol
Maltese: Hirobriz Breezhaler 150 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa indacaterol
English: Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules
Maltese: Hirobriz Breezhaler 300 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa