FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, the CHMP looked at data on suppositories containing camphor, cineole (eucalyptol) and menthol, niaouli, thymus vulgaris and cineole, citral, cineole (eucapyptol), pine essential oil and guaiacol, turpentine and pine essence.
Maltese: B'mod partikolari, is-CHMP ħares lejn data dwar suppożitorji li fihom gamfra, cineole (ewkaliptol) u mentol, niaouli, thymus vulgaris u cineole, citral, cineole (ewkaliptol), żjut essenzjali tal-pina u guaiacol, terpentina u essenza tal-pina.
English: Benefits
Maltese: IPPREŻENTATI
English: The products are typically indicated for supportive treatment for benign (mild) acute bronchial disorders, particularly productive and non productive cough.
Maltese: Il-prodotti huma normalment indikati bħala terapija ta' appoġġ għal disturbi beninni (ħfief) akuti tal-bronki, b'mod partikolari għal sogħla produttiva u mhux produttiva.
English: The CHMP assessed the revised PI proposals submitted by the MAHs.
Maltese: Is-CHMP evalwa l-proposti riveduti dwar il-PI sottomessi mill-MAHs.
English: The main data was obtained from spontaneous reports, the literature and pre-clinical data.
Maltese: Id-dejta ewlenija kienet miksuba minn rapporti spontanji, mil-letteratura u minn dejta pre-klinika.
English: Six cases of local irritation and one case of rectorrhagia with favourable outcome were notified, together with 12 cases of cutaneous ADRs and 2 cases of respiratory ADRs.
Maltese: Kienu nnotifikati sitt każijiet ta' irritazzjoni lokali u każ wieħed ta' rectorrhagia b'riżultat favorevoli, flimkien ma' 12-il każ ta' ADRs tal-ġilda u 2 każijiet ta' ADRs respiratorji.
English: The CHMP also took into account the 2010 safety review conducted by the French National Agency.
Maltese: Is-CHMP qies ukoll ir-reviżjoni dwar is-sigurtà 2010 li saret mill-Aġenzija Nazzjonali Franċiża.
English: A number of adverse drug reactions, including serious nervous system disorders were reported in paediatric patients, including convulsions, agitation, somnolence, hypersomnia, hypotonia, disorientation, and hallucination.
Maltese: Kienu rrappurati għadd ta' reazzjonijiet avversi għall-mediċina, inkluż disturbi serji tas-sistema nervuża f'pazjenti pedjatriċi, inkluż konvulżjonijiet, aġitazzjoni, ngħas, ipersomnja, ipotonja, diżorjentament, u alluċinazzjonijiet.
English: Following a safety review completed in May 2010 by the French National Agency to investigate potential neurological risks, mainly represented by convulsions, suppositories containing terpenic derivatives (including camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needle, eucalyptus and turpentine) were contraindicated in France in children less than 30 months and in children with history of febrile convulsion or epilepsy.
Maltese: Wara reviżjoni dwar issigurtà mill-Aġenzija Nazzjonali Franċiża li tlestiet f'Mejju 2010 biex tinvestiga r-riskji newroloġiċi potenzjali, prinċipalment irrappreżentati minn konvulżjonijiet, is-suppożitorji li fihom derivati terpeniċi (inkluż gamfra, cineole, niaouli, sagħtar selvaġġ, terpineol, terpine, citral, mentol u żjut essenzjali tal-labar tal-pina, tal-ewkaliptu u tat-terpentina) kienu kontraindikati fi Franza fuq tfal ta' taħt it-30 xahar u fi tfal bi storja ta' konvulżjonijiet bid-deni jew ta' epilessija.
English: France subsequently submitted a notification on 27th October 2010, initiating a referral procedure under Article 31(2) of Directive 2001/83/EC, to assess the potential neurological risk and its impact on the benefit-risk of suppositories containing terpenic derivatives in children less than 30 months.
Maltese: Sussegwentement fis27ta' Ottubru 2010, Franza issottomettiet notifika li tat bidu għal proċedura ta' riferiment skont lArtikolu 31(2) tad-Direttiva 2001/83/KE, sabiex jiġi vvalutat ir-riskju newroloġiku potenzjali u limpatt tiegħu fuq il-benefiċċju-riskju ta' suppożitorji li fihom derivati terpeniċi fi tfal iżgħar minn 30 xahar.
English: In its assessment, the CHMP requested the MAHs to propose risk minimisation measures to address the identified risks.
Maltese: Fl-evalwazzjoni tiegħu, is-CHMP talab lill-MAHs sabiex jipproponu miżuri għall-minimizzazzjoni tar-riskju biex jindirizzaw ir-riskji identifikati.
English: From a mechanistic point of view, based on the pharmacological properties of terpenic derivatives, these substances are non-polar (or lipophilic) compounds which show an affinity for non-polar human body structures.
Maltese: Minn perspettiva mekkanistika, abbażi tal-karatteristiċi farmakoloġiċi ta' derivati terpeniċi, dawn issustanzi huma komposti mhux polari (jew lipofiliċi) li juru affinità għal strutturi umani mhux polari.
English: Camphor, menthol and eucalyptol are the most studied substances from a preclinical and clinical point of view.
Maltese: Il-gamfra, il-mentol u l-ewkaliptol huma l-aktar sustanzi studjati minn aspett prekliniku u dak kliniku.
English: Medication errors included 5 neurological ADRs.
Maltese: Żbalji fil-medikazzjoni kienu jinkludu 5
English: Having assessed the proposals submitted by the MAHs (including the introduction of special warnings, a lower weight limit, limiting treatment duration, a contra-indication in case of history of convulsions or epilepsy and highlighting the risk of interaction with other products containing terpenic which could result in an increased risk of neurological side effects), the CHMP considered that in addition to the measures proposed, a contraindication in children less than 30 months was necessary to adequately manage the risk profile of suppositories containing terpenic derivatives.
Maltese: Wara li evalwa l-proposti sottomessi mill-MAHs (inkluż l-introduzzjoni ta' twissijiet speċjali, limitu aktar baxx ta' piż, il-limitazzjoni tad-dewmien talkura, kontraindikazzjoni f'każ ta' storja ta' konvulżjonijiet jew ta' epilessija u l-enfasizzar tar-riskju ta' interazzjoni ma' prodotti oħra li fihom it-terpeniċi li jista' jirriżulta f'żieda fir-riskju ta' effetti newroloġiċi sekondarji), is-CHMP ikkunsidra li minbarra l-miżuri proposti, kien hemm il-ħtieġa ta' kontraindikazzjoni fi tfal ta' inqas minn 30 xahar sabiex il-profil tar-riskju ta' suppożitorji li fihom derivati terpeniċi jiġi ġestit b'mod adegwat.
English: Overall summary of the scientific evaluation of suppositories containing terpenic derivatives (see Annex I).
Maltese: Sommarju tal-evalwazzjoni xjentifika ta' suppożitorji li fihom derivati terpeniċi (ara Anness I).
English: Suppositories containing terpenic derivatives have been authorised through national procedures in Europe since the 1950s and are currently authorised and marketed in seven EU member states.
Maltese: Suppożitorji li fihom derivati terpeniċi ilhom awtorizzati permezz ta' proċeduri nazzjonali fl-Ewropa sa mis-snin ħamsin (1950s) u attwalment huma awtorizzati u mqiegħda fis-suq f'seba' stati membri tal-UE.
English: In reaching its opinion, the CHMP took into account the totality of the available data on the safety of suppositories containing terpenic derivatives in paediatric populations, noting the limited efficacy data in the paediatric population, the absence of data on efficacy in children less than 30 months, the known neurological toxicity of terpenic derivatives, the risk of potentially severe neurological and local lesions and the risk of medication errors arising from the mistaken use of children formulations in infants.
Maltese: Biex jilħaq l-opinjoni tiegħu, is-CHMP ħa f'kunsiderazzjoni t-totalità tad-dejta disponibbli dwar issigurtà ta' suppożitorji li fihom derivati terpeniċi f'popolazzjonijiet pedjatriċi, innota d-dejta limitata dwar l-effikaċja fil-popolazzjoni pedjatrika, in-nuqqas ta' dejta dwar l-effikaċja fi tfal iżgħar minn 30 xahar, it-tossiċità newroloġika magħrufa ta' derivati terpeniċi, ir-riskju ta' leżjonijiet newroloġiċi u lokali potenzjalment severi u r-riskju ta' żbalji fil-medikazzjoni li jirriżultaw mill-użu żbaljat ta' formulazzjonijiet għat-tfal fit-trabi.
English: Most clinical data are derived from open studies as well as data from clinical practice or expert opinions.
Maltese: Ħafna mid-dejta klinika ġejja minn studji miftuħa kif ukoll minn data minn prattika klinika jew minn opinjonijiet tal-esperti.
English: Having considered the totality of the data submitted by the MAHs related to the use of suppositories containing terpenic derivatives in children less than 30 months and taking into account the data identified during the 2010 French safety review, the CHMP was of the opinion that suppositories containing terpenic derivatives can induce neurological disorders, especially convulsions, in children less than 30 months, due to the immaturity of the central nervous system which results in a higher susceptibility to neurological toxicity.
Maltese: Wara li kkunsidra t-totalità tad-dejta sottomessa mill-MAHs relatata mal-użu ta' suppożitorji li fihom derivati terpeniċi fi tfal ta' anqas minn 30 xahar u ħa in kunsiderazzjoni d-dejta identifikata matul irreviżjoni Franċiża dwar is-sigurtà tal-2010, is-CHMP kien tal-fehma li s-suppożitorji li fihom derivati terpeniċi jistgħu jinduċu disturbi newroloġiċi, speċjalment konvulżjonijiet, fi tfal ta' taħt it-30 xahar, minħabba l-immaturità tas-sistema nervuża ċentrali li tirriżulta f'suxxettibilità aktar għolja għal tossiċità newroloġika.
English: • The biological plausibility of increased neurological toxicity in children less than 30 months was considered to be established due to the to immaturity of the central nervous system which results in a higher susceptibility;
Maltese: • Il-plawżibilità bijoloġika ta' żieda fit-tossiċità newroloġika fi tfal iżgħar minn 30 xahar kienet ikkunsidrata li kienet stabbilita minħabba l-immaturità tas-sistema nervuża ċentrali li tirriżulta f'suxxettibilità ogħla;
English: Risk minimisation measures
Maltese: Miżuri għall-minimizzazzjoni tar-riskju
English: • Serious adverse drug reactions including neurological events, mainly convulsions, have been associated with the use of suppositories containing terpenic derivatives in children less than 30 months;
Maltese: • Reazzjonijiet avversi serji għall-mediċina inkluż avvenimenti newroloġiċi, prinċipalment konvulżjonijiet, ġew assoċjati mal-użu ta' suppożitorji li fihom derivati terpeniċi fi tfal taħt it30 xahar;
English: The MAHs and the CHMP also agreed on the wording of a ‘Direct healthcare professional' communication, to inform prescribers on the above agreed contraindications to be sent to relevant health care professionals, including pharmacists.
Maltese: Il-MAHs u s-CHMP qablu wkoll dwar it-test ta' komunikazzjoni ‘Diretta minn professjonist tal-kura tas-saħħa', sabiex tinforma lil dawk li jippreskrivu dwar il-kontraindikazzjonijiet miftiehma hawn fuq li għandha tintbagħat lill-professjonisti rilevanti tal-kura tas-saħħa, inkluż lill-ispiżjara.
English: The main changes, agreed by the CHMP and to be included as relevant in the PI of all suppositories containing terpenic derivatives, according to the intended age range of the product, were the introduction in Section 4.3 of contraindications in children less than 30 months due to the risk of neurological disorders, especially convulsions, as well as in children with a history of febrile convulsion or epilepsy and in children with a recent history of anorectal lesion.
Maltese: It-tibdil ewlieni, miftiehem mis-CHMP u li għandu jiġi inkluż bħala rilevanti fil-PI tas-suppożitorji kollha li fihom derivati terpeniċi, skont il-firxa ta' età intenzjonata talprodott, kienu l-introduzzjoni tas-Sezzjoni 4.3 tal-kontraindikazzjonijiet fi tfal ta' taħt it-30 xahar minħabba r-riskju ta' disturbi newroloġiċi, speċjalment konvulżjonijiet, kif ukoll fi tfal bi storja ta' konvulżjonijiet bid-deni jew ta' epilessija u fi tfal bi storja reċenti ta' leżjonijiet anorettali.
English: A total of 92 cases of ADRs were identified in the national pharmacovigilance database and the periodic safety update reports, with about 82% (76/92) of these cases occurring in children less than 30 months.
Maltese: Kienu identifikati total ta' 92 każ ta' ADRs fiddatabase nazzjonali tal-farmakoviġilanza u mir-rapporti perjodiċi ta' aġġornament dwar is-sigurtà,
English: The CHMP also noted that terpenic derivatives administered by other route of administration (cutaneous and inhaled) are associated with risks of neurological, skin, and local toxicity.
Maltese: Is-CHMP innota wkoll li d-derivati terpeniċi mgħotija permezz ta' rotta oħra (fil-ġilda u man-nifs) huma assoċjati ma' riskji ta' tossiċità lokali, newroloġika, u tal-ġilda.
English: The CHMP also reviewed the French safety assessment of the use of suppositories containing terpenic derivatives in children, completed in May 2010.
Maltese: Is-CHMP irreveda wkoll il-valutazzjoni Franċiża dwar is-sigurtà dwar l-użu ta' suppożitorji li fihom derivati terpeniċi fit-tfal, li tlestiet f'Mejju 2010.
English: The CHMP was of the opinion that marketing authorisations with a wide approved age range should be varied to contraindicate use in children less than 30 months while marketing authorisations where the only approved age range is children less than 30 months should be revoked.
Maltese: Barra minn hekk, intweriet effikaċja klinikament rilevanti limitata fil-popolazzjoni pedjatrika u ebda dejta dwar l-effikaċja ma hija disponibbli fi tfal iżgħar minn 30 xahar.
English: The CHMP also considered it necessary to restrict the duration of treatment in the remaining approved paediatric population to 3 days, due to risk of rectal burning and to the risks related to storage of terpenic derivatives in tissues and brain (the rate of metabolism and elimination is unknown, as a consequence of their lipophilic properties) which can lead to neuropsychological disorders.
Maltese: Is-CHMP qies ukoll li kien meħtieġ li t-tul tal-kura jiġi ristrett fil-popolazzjoni pedjatrika approvata li kien baqa' għal 3 ijiem, minħabba r-riskju ta' ħruq rettali u għal riskji relatati mal-ħżin ta' derivattivi terpeniċi fit-tessut u fil-moħħ (ir-rata talmetaboliżmu u l-eliminazzjoni mhijiex magħrufa, bħala konsegwenza tal-karatteristiċi lipofiliċi tagħhom) li jistgħu jwasslu għal disturbi newropsikoloġiċi.
English: In member states where they are authorised, suppositories containing terpenic derivatives have been used for decades as treatment for benign acute bronchial disorders or oropharynx congestive states, particularly for non productive cough.
Maltese: Fl-Istati Membri fejn huma awtorizzati, is-suppożitorji li fihom derivati terpeniċi ilhom jintużaw għal għexieren ta' snin bħala kura għal disturbi akuti tal-bronki jew għal stati orofarinġi konġestivi, b'mod partikolari għal sogħla mhux produttiva.
English: Efficacy is based mainly on traditional use of these products and supported by data regarding pharmacodynamic properties and by their effects as cough suppressants and anti-inflammatory drug in pre-clinical models.
Maltese: L-effikaċja hija primarjament ibbażata fuq l-użu tradizzjonali ta' dawn il-prodotti u hija appoġġata minn dejta dwar il-karatteristiċi farmakodinamiċi u mill-effetti tagħhom bħala sustanzi li jrażżnu s-sogħla u bħala mediċina anti-infjammatorja f'mudelli pre-kliniċi.
English: The clinical evidence shows that children less than 30 months are more prone to neurological disorders due to immaturity of the central nervous system, which results in a higher susceptibility to neurological toxicity.
Maltese: L-evidenza klinika turi li t-tfal iżgħar minn 30 xahar huma aktar suxxettibbli għal disturbi newroloġiċi minħabba limmaturità tas-sistema nervuża ċentrali, li tirriżulta f'suxxettibilità ogħla għal tossiċità newroloġika.
English: • The CHMP concluded that the benefit-risk balance of suppositories containing terpenic derivatives in children less than 30 months is not positive under normal conditions of use and that their use should therefore be contraindicated in this age population as well as in children with a history of epilepsy or febrile convulsion and in children with a recent history of anorectal lesion;
Maltese: • Ma setgħat tiġi stabbilita l-ebda relazzjoni bejn l-ADR u d-doża u r-riskju ta' avvenimenti avversi newroloġiċi osservat ma setgħax jiġi indirizzat sew b'miżuri minbarra kontraindikazzjonijiet f'din il-popolazzjoni;
English: While acknowledging that direct comparisons of suppositories containing terpenic derivatives regarding these aspects are lacking and that suppositories could be a therapeutic alternative in children who do not tolerate treatment with ointments, the CHMP was of the opinion that the available data confirms that the safety profile of terpenic derivatives used by rectal route in infants and children is of concern.
Maltese: Filwaqt li jirrikonoxxi li ttqabbil dirett ta' suppożitorji li fihom derivati terpeniċi fir-rigward ta' dawn l-aspetti huwa nieqes u li s-suppożitorji jistgħu jkunu alternattiva terapewtika fi tfal li ma jittollerawx kura permezz ta' ingwenti, is-CHMP kien tal-fehma li d-dejta disponibbli tikkonferma li l-profil ta' sigurtà ta' derivati terpeniċi użati permezz tar-rotta rettali fit-trabi u fit-tfal hija ta' tħassib.
English: 120 doses
Maltese: 120 doża
English: Date of first authorisation: 19th November 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 19th novembru 2014
English: COPD Recommended doses:
Maltese: COPD Dożi rakkomandati:
English: • Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole,
Maltese: • Mediċini għall-kura ta' infezzjonijiet (bħal ketoconazole, itraconazole, voriconazole,
English: 3 years.
Maltese: tiegħek.
English: Budesonide/Formoterol Teva 160 mcg/4.5 mcg
Maltese: Budesonide/Formoterol Teva 160 μg/4.5 μg
English: The glucocorticosteroid activity of the major metabolites, 6-beta-hydroxy-budesonide and 16-alfa-hydroxyprednisolone, is less than 1% of that of budesonide.
Maltese: L-attività glukokortikosterojdi tal-metaboliti prinċipali, 6-β-hydroxy-budesonide u 16-alfa-hydroxy-prednisolone, hija anqas minn 1% ta' dik ta' budesonide.
English: Chronic Obstructive Pulmonary Disease (COPD) Recommended dose:
Maltese: Mard Kroniku Ostruttiv tal-Pulmuni (COPD) Doża rakkomandata:
English: Budesonide/Formoterol Teva 320 mcg/9 mcg
Maltese: Budesonide/Formoterol Teva 320 μg/9 μg
English: Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Maltese: Trattament sintomatiku ta' pazjenti b'COPD sever (FEV1 < 50% tan-normal imbassar) u storja ta' taħrix ripetut, li jkollhom sintomi sinifikanti minkejja terapija regolari bi bronkodilaturi li jaħdmu fittul.
English: Chronic obstructive pulmonary disease (COPD)
Maltese: Mard kroniku ostruttiv tal-pulmuni (COPD)
English: Budesonide/Formoterol Teva contains two different active substances: budesonide and formoterol fumarate dihydrate.
Maltese: Budesonide/Formoterol Teva fih żewġ sustanzi attivi differenti: budesonide u formoterol fumarate dihydrate.
English: Special populations: Elderly patients (≥65 years old)
Maltese: Pazjenti anzjani (≥65 sena)
English: Adults (18 years and older)
Maltese: Adulti (18-il sena u aktar)
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 huma magħmul minn acrylonitrile butadiene styrene (ABS), polyethylene (PE), u polypropylene (PP).
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 updatespublished 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: 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: Median FEV1 at inclusion in the trials was 36% of predicted normal.
Maltese: Il-FEV1 medjan fil-ħin tal-inklużjoni fil-provi kien ta' 36% tan-normal imbassar.
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: (eż. ketoconazole, itraconazole, voriconazole, posaconazole, 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: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Maltese: Fatturi ta' riskju għal pulmonite f'pazjenti b'COPD jinkludu tipjip attwali, età ikbar, kurrenti, indiċi tal-massa tal-ġisem baxx (BMI, body mass index) u COPD severa.
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 filġilda u pulmonite seħħew bi frekwenza ta' 10% u 6%, rispettivament, meta mqabbel ma' 4% u 3% filgrupp li ħa plaċebo (p<0.
English: Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles Angina pectoris.
Maltese: Arritmija tal-qalb, eż. fibrillazzjoni atrijali, takikardija sopraventrikolari, takikardija, extrasistoli
English: • Muscle cramps.
Maltese: Angina pectoris.
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: Budesonide/Formoterol Teva 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 għandu jitwaqqaf immedjatament, il-pazjent għandu jiġi valutat u jekk ikun meħtieġ, tinbeda terapija alternattiva (ara sezzjoni 4.4).
English: Budesonide/Formoterol Teva contains lactose
Maltese: Budesonide/Formoterol Teva fih il-lactose
English: Budesonide/Formoterol Teva is not indicated in children and adolescents under the age of 18 years (see section 4.2).
Maltese: Budesonide/Formoterol Teva mhuwiex indikat għall-użu fi tfal u adolexxenti li għandhom inqas minn 18-il sena (ara sezzjoni 4.2).
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Maltese: Teva Pharma B.V. Swensweg 5, 2031GA Haarlem,Il-Pajjiżi l-Baxxi