FrancophonIA/ELRC3.0 huggingface dataset:
English: What Zykadia looks like and contents of the pack Zykadia hard capsules have a white opaque body and blue opaque cap, with “LDK 150MG” imprinted on the cap and “NVR” on the body.
Maltese: Il-kapsuli iebsa Zykadia għandhom qafas opak abjad u b'tapp opak blu, b'“LDK 150MG” stampata fuq it-tapp u b'“NVR” fuq il-qafas. Fihom trab abjad għal kważi abjad.
English: If you experience any of the following side effects, tell your doctor or pharmacist immediately: Chest pain or discomfort, changes in your heartbeat (fast or slow), light-headedness, fainting, dizziness, blue discoloration of your lips, shortness of breath, swelling of your lower limbs or skin (potential signs or symptoms of heart problems) New or worsening cough with or without mucus, fever, chest pain, trouble breathing or shortness of breath (potential signs of lung problems) Tiredness, itchy skin, yellowing of your skin or the whites of your eyes, nausea (feeling sick) or vomiting, decreased appetite, pain on the right side of your abdomen (belly), dark or brown urine, bleeding or bruising more easily than normal (potential signs or symptoms of liver problems)
Maltese: Zykadia jista' jżid l-effetti sekondarji assoċjati mal-mediċini li ġejjin: mediċini użati biex jittrattaw taħbit irregolari tal-qalb jew problemi tal-qalb oħrajn (eż. amiodarone, disopyramide, procainamide, quinidine, sotalol, dofetilide, ibutilide u digoxin). mediċini użati biex jittrattaw problemi fl-istonku (eż. cisapride). mediċini użati biex jittrattaw problemi ta' saħħa mentali (eż. haloperidol, droperidol, pimozide). mediċini użati biex jittrattaw id-dipressjoni (eż. nefazodone). midazolam, mediċina użata biex tittratta aċċessjonijiet gravi jew bħala sedattiv qabel jew waqt operazzjoni jew proċeduri mediċi. warfarina u dabigatran, mediċini użati biex jipprevjenu l-eboli. diclofenac, mediċina użata biex tittratta uġigħ jew infjammazzjoni fil-ġogi.
English: In vitro studies demonstrated that CYP3A was the major enzyme involved in the metabolic clearance of ceritinib.
Maltese: Studji in vitro wrew li CYP3A kien l-enzima ewlenija involuta fit-tneħħija metabolika ta' ceritinib.
English: Each tablet contains 150 mg ceritinib.
Maltese: Kull pillola fiha 150 mg ceritinib.
English: Hard capsule
Maltese: Qafas tal-kapsula
English: It is used to treat adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC).
Maltese: Din il-mediċina tintuża biex titratta adulti bi stadji avvanzati ta' forma ta' kanċer tal-pulmun imsejjaħ kanċer taċ-ċelloli mhux żgħar tal-pulmun (NSCLC).
English: Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis have been observed in patients treated with ceritinib.
Maltese: Kienu osservati mard tal-pulmun interstizzjali (ILD)/pulmonite gravi u ta' theddida għall-ħajja jew fatali f'pazjenti ttrattati b'ceritinib.
English: NE = not estimable
Maltese: NE = mhux stimabbli
English: Fatigue (fatigue, asthenia)
Maltese: Għeja (għeja, astenja)
English: Previously untreated ALK-positive advanced NSCLC - randomised phase 3 Study A2301 (ASCEND-4) The efficacy and safety of Zykadia for the treatment of advanced ALK-positive NSCLC patients who have not received previous systemic treatment anti-cancer therapy (including ALK inhibitor) with the exception of neo-adjuvant or adjuvant therapy, was demonstrated in a global multicentre, randomised, open-label phase 3 Study A2301.
Maltese: L-effikaċja u s-sigurtà ta' Zykadia għat-trattament ta' pazjenti b'NSCLC avvanzat b'ALK-pożittiv, li ma ngħatawx terapija kontra l-kanċer (li tinkludi inibitur ALK) bħala trattament sistemiku preċedenti bl-eċċezzjoni ta' terapija neo-adjuvanti jew adjuvanti, intwerew fl-Istudju A2301 li huwa studju globali, multiċentriku, randomizzat, b'tikketta mikxufa, ta' fażi 3.
English: Hyperglycaemia
Maltese: Kategorija talfrekwenza
English: Children and adolescents The use of Zykadia in children and adolescents up to 18 years of age is not recommended.
Maltese: Tfal u adolexxenti L-użu ta' Zykadia fi tfal u adoloxxenti sal-età ta' 18-il sena mhuwiex irrakkomandat.
English: Significant improvements were reported for the majority of lung cancer specific symptoms for Zykadia compared to chemotherapy (four out of six LCSS and 10 out of 12 QLQ-LC13 symptom scores).
Maltese: Kien irrapportat titjib sinifikanti għallmaġġoranza tas-sintomi speċifiċi għall-kanċer tal-pulmun għal Zykadia meta mqabbel malkimoterapija (erbgħa minn sitt punteġġi ta' sintomi LCSS u 10 minn 12-il QLQ-LC13).
English: Figure 2 ASCEND-4 (Study A2301)- Kaplan-Meier plot of overall survival by treatment arm
Maltese: (Studju A2301)- Plott Kaplan-Meier ta' sopravivenza globali skont ilgrupp ta' trattament
English: 93.3% had adenocarcinoma and 96.9% had either never been or were former smokers.
Maltese: 93.3% kellhom adenokarċinoma u 96.9% qatt ma pejpu jew kienu jpejpu qabel.
English: A dedicated pharmacokinetic study in patients with renal impairment has not been conducted.
Maltese: Ma twettaq ebda studju farmakokinetiku ddedikat fuq pazjenti b'indeboliment renali.
English: The median PFS in patients without brain metastases was 8.3 months (95% CI: 4.1, 14.0) versus 2.8 months (95% CI: 1.4, 4.1) in the ceritinib and chemotherapy arms, respectively with HR=0.41 (95% CI: 0.24, 0.69).
Maltese: Il-PFS medjana f'pazjenti mingħajr metastażijiet fil-moħħ kienet ta' 8.3 xhur (95% CI: 4.1, 14.0) meta mqabbla ma' 2.8 xhur (95% CI:
English: The maximum recommended dose of Zykadia is 450 mg taken orally once daily with food (see section 4.2).
Maltese: Id-doża massima rrakkomandata ta' Zykadia hija ta' 450 mg meħuda mill-ħalq darba kuljum mal-ikel (ara sezzjoni 4.2).
English: Patients should be monitored for liver laboratory test abnormalities and managed as recommended in sections 4.2 and 4.4.
Maltese: Il-pazjenti għandhom jiġu mmonitorati għal anormalitajiet tat-testijiet tal-fwied fil-laboratorju u għandhom jiġu mmaniġġjati kif irrakkomandat fis-sezzjonijiet 4.2 u 4.4.
English: How to take Zykadia
Maltese: X'fih Zykadia
English: Agents that affect gastric pH
Maltese: Aġenti li jaffettwaw il-pH gastriku
English: Caution should be exercised with concomitant use of P-gp inhibitors and ADRs carefully monitored.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: The drug-drug interaction study was designed to observe the impact of proton pump inhibitor in the worst scenario, but in clinical use the impact of proton pump inhibitor on ceritinib exposure appears to be less pronounced.
Maltese: Studji formali u mhux kliniċi dwar l-effetti potenzjali ta' ceritinib fuq ilfertilità ma sarux.
English: 6.5 Nature and contents of container
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Kontenut tal-kapsula
English: Blood tests during treatment with Zykadia
Maltese: Testijiet tad-demm matul it-trattament b'Zykadia
English: Hyperglycaemia (all grades) was reported in 9.4% of patients treated with ceritinib across the seven clinical studies; grade 3 or 4 events were reported in 5.4% of patients.
Maltese: Kienu rrapportati każijiet ta' ipergliċemija (gradi kollha) f'9.4% tal-pazjenti ttrattati b'ceritinib matul is-seba' studji kliniċi; kienu rrapportati avvenimenti tal-grad 3 jew 4 f'5.0% tal-pazjenti.
English: Then take the next tablets at the usual time.
Maltese: Waqqaf it-teħid ta' Zykadia b'mod permanenti.
English: ECG studies in monkeys after 4- or 13-weeks of dosing with ceritinib have not shown QT prolongation or abnormal ECGs.
Maltese: Studji tal-ECG fix-xadini wara 4 ġimgħat jew 13-il ġimgħa ta' dożi b'ceritinib ma wrewx titwil tal-QT jew ECGs anormali.
English: If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose modified, reinitiate Zykadia with dose reduced by 150 mg upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
Maltese: Jekk ma ġie identifikat l-ebda prodott mediċinali konkomitanti, jew jekk il-prodotti mediċinali konkomitanti kontributorji ma twaqqfux jew ma sarilhomx tibdil tad-doża, erġa' ibda Zykadia bid-doża mnaqqsa b'150 mg malli kien hemm fejqan millbradikardija asintomatika jew ir-rata tal-qalb kienet ta' 60 bpm jew aktar.
English: Patients should be monitored and managed using standards of care, including anti-diarrhoeals, anti-emetics or fluid replacement, as clinically indicated.
Maltese: Il-pazjenti għandhom ikunu mmonitorati u mmaniġġjati billi jintużaw standards ta' kura, inkluż antidijarreali, antiemitiċi jew sostituzzjoni tal-fluwidi, kif indikat klinikament.
English: London, June 2008 EMEA/532206/2007- Rev.1
Maltese: Londra, Ġunju 2008 EMEA/532206/2007- Rev.1
English: EMEA/532206/2007- Rev.1
Maltese: EMEA/532206/2007- Rev.1-MT
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR DOXYPREX 100mg PREMIX
Maltese: OPINJONI WARA REFERENZA SKOND L-ARTIKOLU 33 (4) GĦAL DOXYPREX 100mg PREMIX
English: Doxyprex 100 mg premix presented in 5 kg, 20 kg and 25 kg bags containing 100 mg/g doxycycline base as hyclate.
Maltese: Doxyprex 100 mg premix ippreżentat f'boroż ta' 5 kg, 20 kg u 25 kg li fihom 100 mg/g ta' bażi ta' doxycycline bħala hyclate.
English: In December 2005, a Mutual Recognition Procedure (MRP) started with Spain acting as Reference Member State and ten Concerned Member States.
Maltese: F'Diċembru 2005, inbdiet Proċedura ta' Rikonoxximent Reċiproku (MRP) ma' Spanja bħala Stat Membru ta' Referenza u għaxar Stati Membri Konċernati.
English: The applicant provided evidence of efficacy of the active substance, doxycycline, against M. hyopneumoniae in pigs from published literature and from MIC studies.
Maltese: Lapplikant ipprovda evidenza ta' l-effikaċja tas-sustanza attiva, doxycycline, kontra M. hyopneumoniae fil-majjali minn letteratura ppubblikata u minn studji tal-MIC.
English: The CVMP Opinion was adopted on 14 February 2007 and the subsequent Commission Decision on 22 May 2007.
Maltese: L-Opinjoni tas-CVMP ġiet adottata fl-14 ta' Frar 2007 u d-Deċiżjoni suċċessiva tal-Kummissjoni ġiet adottata fit-22 ta' Mejju 2007.
English: The product is authorised with the indication the treatment of swine respiratory disease caused by Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.
Maltese: Il-prodott huwa awtorizzat bl-indikazzjoni tat-trattament tal-marda respiratorja fil-majjali kkawżata minn Pasteurella multocida, Bordetella bronchiseptica u Mycoplasma hyopneumoniae.
English: The CVMP during its meeting of 21-22 June 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Doxyprex 100 mg premix.
Maltese: Waqt il-laqgħa tiegħu tal-21-22 ta' Ġunju 2006, is-CVMP beda proċedura ta' referenza taħt l-Artikolu 33(4) tad-Direttiva 2001/82/KE, kif emendata, għal Doxyprex 100 mg premix.
English: A benefit-risk analysis could not be conducted due to the lack of pivotal evidence on clinical efficacy for the indication M. hyopneumoniae.
Maltese: Ma setgħetx titwettaq analiżi tal-benefiċċju-riskju minħabba n-nuqqas ta' evidenza pivitali dwar leffikaċja klinika għall-indikazzjoni M. hyopneumoniae.
English: “For the treatment and prevention of porcine respiratory disease, caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.”
Maltese: “Għat-trattament u l-prevenzjoni tal-marda respiratorja fil-majjali, ikkawżata minn Pasteurella multocida u Bordetella bronchiseptica, suxxettibbli għal doxycycline, meta l-marda tkun ġiet dijanjostika fil-merħla.
English: Germany could not agree to the granting a marketing authorisation and the matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), and subsequently to the Committee for Medicinal Products for Veterinary Use (CVMP).
Maltese: Il-Ġermanja ma setgħetx taqbel ma' l-għoti ta' l-awtorizzazzjoni għat-tqegħid fis-suq u l-kwistjoni ġiet riferuta lill-Grupp ta' Koordinament għal Proċeduri ta' Rikonoxximent Reċiproku u Deċentralizzati, CMD(v), u suċċessivament lill-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju (CVMP).
English: The CVMP recommended the granting of the marketing authorisation to Doxyprex 100 mg/g Premix for medicated feeding stuff for pigs for the following indication because a positive benefit/risk analysis has been demonstrated and no potential serious risk has been identified.
Maltese: Il-CVMP irrakkomanda l-għoti ta' l-awtorizzazzjoni għat-tqegħid fis-suq għal Doxyprex 100 mg/g Premix għal għalf immedikat għall-majjali għall-indikazzjoni segwenti minħabba li ntweriet analiżi pożittiva tal-benefiċċju/riskju u ma ġie identifikat l-ebda riskju potenzjali serju.
English: Annex I of Directive 2001/82/EC as amended by directive 2004/28/EC notes that post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.
Maltese: LAnness I tad-Direttiva 2001/82/KE kif emendat bid-Direttiva 2004/28/KE jinnota li l-esperjenza ta' wara t-tqegħid fis-suq ta' prodotti oħra li fihom l-istess kostitwenti hija ta' importanza partikolari u lapplikanti għandhom jagħmlu enfasi speċjali fuq din il-kwistjoni.
English: Within the EU doxycycline-based premix products for pigs at recommended dose rates of 10mg/kg once daily for 5 days are stated as having been authorised since 1985.
Maltese: Fi ħdan l-UE, il-prodotti premix ibbażati fuq doxycycline għall-majjali b'rati rakkomandati ta' doża ta' 10mg/kg darba kuljum għal 5 ijiem huma ddikjarati li ilhom awtorizzati sa mill-1985.
English: In the pivotal clinical trial, the presence of P. multocida and B. bronchiseptica was clearly demonstrated in sick pigs, however, no post treatment sampling was done to show bacteriological cure.
Maltese: Fil-prova klinika pivitali, il-preżenza ta' P. multocida u B. bronchiseptica ġiet murija b'mod ċar f'majjali morda, madankollu, ma ttieħed ebda kampjun wara t-trattament biex juri kura batterjoloġika.
English: Therefore, the CVMP considered that the reports mentioned above give favourable evidence for the safety and efficacy of doxycycline in general, but also for the specific final formulation as marketed in Spain.
Maltese: Għalhekk, is-CVMP ħass li rrapporti msemmija hawn fuq jagħtu evidenza favorevoli għas-sigurtà u l-effikaċja ta' doxycycline b'mod ġenerali, iżda wkoll għall-formulazzjoni finali speċifika kif imqiegħda fis-suq fi Spanja.
English: The applicant justifies that the presence of M. hyopneumoniae was not determined by bacteriological methods because it was difficult to isolate at that time.
Maltese: L-applikant jiġġustifika li l-preżenza ta' M. hyopneumoniae ma kinitx stabbilita b'metodi batterjoloġiċi minħabba li kien diffiċli li din tiġi iżolata f'dak il-ħin.
English: The applicant submitted a scientific report on Porcine Respiratory Disease Complex (PRDC).
Maltese: L-applikant ippreżenta rapport xjentifiku dwar il-Kumpless tal-Marda Respiratorja tal-Majjali (PRDC).
English: 1 pre-filled syringe pre-filled syringe (glass) with needle guard
Maltese: 1 siringa mimlija għal-lest siringa mimlija għal-lest (ħġieġ) bi protezzjoni tallabra
English: 1 pre-filled syringe with needle guard
Maltese: 1 siringa mimlija għal-lest bi protezzjoni tallabra
English: Pack size pre-filled syringe (glass)
Maltese: Daqs talpakkett siringa mimlija għal-lest (ħġieġ)
English: EU/1/14/920/004 EU/1/14/920/005 EU/1/14/920/006
Maltese: EU/1/14/920/005 EU/1/14/920/006
English: DuoResp Spiromax 160 mcg/4.5 mcg
Maltese: DuoResp Spiromax 160 μg/4.5 μg
English: • you regularly drink alcohol.
Maltese: • tixrob l-alkoħol b'mod regolari.
English: The drug/mucosal contact parts of the inhaler are made of acrylonitrile butadiene styrene (ABS), polyethylene (PE), and polypropylene (PP).
Maltese: Il-partijiet talkuntatt tal-mediċina mal-mukuża tal-inhalatur huma magħmulin minn acrylonitrile butadiene styrene (ABS), polyethylene (PE), u polypropylene (PP).
English: Date of first authorisation: 28th April 2014 Date of latest renewal:
Maltese: Apr 28, 2014
English: DuoResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.
Maltese: DuoResp Spiromax fih żewġ sustanzi attivi differenti: budesonide u formoterol fumarate dihydrate.
English: Mogilska 80 Str. 31-546 Kraków Poland
Maltese: Teva Operations Poland Sp. z o.o., Mogilska 80 Str., 31-546
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 12
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 ttabella hawn isfel).
English: • Antidepressant medicines such as monoamine oxidase inhibitors and those with similar properties (such as the antibiotic furazolidone 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: 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: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà s 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: - The other ingredient is lactose monohydrate (see section 2 under ‘DuoResp Spiromax contains lactose')
Maltese: - Is-sustanza l-oħra hi lactose monohydrate (ara sezzjoni 2 taħt ‘ DuoResp Spiromax fih il lactose' )
English: There are no clinical study data on DuoResp 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 DuoResp 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: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands Teva Operations Poland Sp. z o.o.
Maltese: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Il-Pajjiżi l-Baxxi Teva Operations Poland Sp. z o.o., Mogilska 80
English: DuoResp Spiromax contains lactose
Maltese: DuoResp Spiromax fih il-lactose
English: Budesonide/Formoterol Furmarate Dihydrate 160/4.5 µg bd + as needed
Maltese: Budesonide/Formoterol Furmarate Dihydrate 160/4.5 µg bd + formoterol 4.5 µg kif meħtieġ
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal products.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: DuoResp 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: DuoResp 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: DuoResp Spiromax is NOT indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Maltese: DuoResp Spiromax MHUWIEX indikat għall-użu fi tfal, ta' 12-il sena jew iżgħar jew f'adolexxenti, ta' 13 sa 17-il sena.
English: In Study 735, lung function, symptom control, and reliever use were similar in all treatment groups.
Maltese: Fl-Istudju 735, il-funzjoni tal-pulmun, il-kontroll tas-sintomi, u l-użu tas-sustanza ta' solljiev kienu simili fil-gruppi kollha ta' kura.
English: In patients using potent CYP3A4 inhibitors, a budesonide/formoterol fumarate fixed-dose combination is not recommended.
Maltese: F'pazjenti li jkunu qegħdin jużaw inibituri qawwija ta' CYP3A4, mhijiex rakkomandata terapija b'kombinazzjoni ta' doża fissa ta' budesonide/formoterol fumarate.
English: Teva Pharma B.V. Swensweg 5, 2031GA HaarlemThe Netherlands
Maltese: Teva Pharma B.V. Swensweg 5, 2031GA HaarlemIl-Pajjiżi l-Baxxi
English: If the patient experiences paradoxical bronchopasm DuoResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Maltese: Jekk il-pazjent jesperjenza bronkospażmu paradossali, DuoResp Spiromax għandu jiġi mwaqqaf immedjatament, il-pazjent għandu jiġi valutat u jekk ikun meħtieġ, tinbeda terapija alternattiva.
English: DuoResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section
Maltese: DuoResp Spiromax għandu jitwaqqaf immedjatament, il-pazjent għandu jiġi valutat u jekk ikun meħtieġ, tinbeda terapija alternattiva (ara sezzjoni 4.4).
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: (terfenadine), u antidepressanti triċikliċi, tista' ttawwal l-intervall QTc u żżid ir-riskju ta' arritmiji ventrikolari.
English: Other medicines and DuoResp Spiromax
Maltese: Mediċini oħra u DuoResp Spiromax
English: Adults (18 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening.
Maltese: Adulti (18-il sena u iktar): Id-doża ta' manteniment rakkomandata hija 2 inalazzjonijiet kuljum,
English: In the 5 studies combined, patients receiving budesonide/formoterol maintenance and reliever therapy used, on average, no reliever inhalations on 57% of treatment days.
Maltese: Fil-5 studji kombinati, il-pazjenti li kienu qegħdin jirċievu terapija ta' manteniment b'budesonide/formoterol u sustanza ta' solljiev ma użaw, bħala medja, l-ebda inalazzjoni tas-sustanza ta' solljiev f'57% tal-jiem ta' kura.
English: Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure (see section 5.3).
Maltese: Studji dwar irriproduzzjoni fl-annimali b'formoterol urew fertilità xi ftit imnaqqsa f'firien irġiel b'esponiment sistemiku għoli (ara sezzjoni 5.3).
English: DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder
Maltese: DuoResp Spiromax 320 mikrogramma/9 mikrogrammi trab li jittieħed man-nifs
English: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Maltese: Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Il-Pajjiżi l-Baxxi
English: DuoResp Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
Maltese: DuoResp Spiromax 160 mikrogramma/4.5 mikrogrammi, trab li jittieħed man-nifs budesonide/formoterol fumarate dihydrate
English: DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Maltese: DuoResp Spiromax 320 mikrogramma /9 mikrogrammi trab li jittieħed man-nifs budesonide/ formoterol fumarate dihydrate