FrancophonIA/ELRC3.0 huggingface dataset:
English: Eculizumab contains only naturally occurring amino acids and has no known active metabolites.
Maltese: Eculizumab fih biss aċidi amminiċi li jseħħu b'mod naturali u ma fih ebda metaboliti attivi magħrufa.
English: The haemoglobin set-point was less than or equal to 9 g/dL in patients with symptoms and was less than or equal to 7 g/dL in patients without symptoms.
Maltese: Il-punt stabbilit ta' l-emoglobina kien inqas minn jew ugwali għal 9 g/dL f'pazjenti bis-sintomi u anqas minn jew ugwali għal 7 g/dL f'pazjenti mingħajr sintomi.
English: In TRIUMPH, study patients treated with Soliris had significantly reduced (p< 0.001) haemolysis resulting in improvements in anaemia as indicated by increased haemoglobin stabilization and reduced need for RBC transfusions compared to placebo treated patients (see Table 3).
Maltese: Fi TRIUMPH, il-pazjenti fl-istudju kkurati b'Soliris kellhom emolisi mnaqqsa b'mod sinifikanti (p< 0.001) li rriżultat f'titjib fl-anemija kif indikat minn żieda fl-istabbilizzazzjoni ta' l-emoglobina u ħtieġa anqas għal trasfużjonijiet ta' ċelluli ħomor tad-demm meta mqabbel malpazjenti ttrattati bil-plaċebo (ara Tabella 3).
English: Hepatobiliary disorders
Maltese: Depigmentazzjoni talġilda,
English: In all clinical studies, the most serious adverse reaction was meningococcal sepsis which is a common presentation of meningococcal infections in patients treated with Soliris (see section 4.4).
Maltese: Fl-istudji kliniċi kollha, l-aktar reazzjoni avversa serja kienet sepsis meningokokkali li hija preżentazzjoni komuni ta' infezzjonijiet meningokokkali f'pazjenti kkurati b'Soliris (ara sezzjoni 4.4).
English: The Soliris antibody contains human constant regions and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions.
Maltese: L-antikorp ta' Soliris fih reġjuni kostanti umani u reġjuni ta' stabbiliment tal-komplimentarità mill-ġrieden imlaqqma fuq ir-reġjuni varjabbli ta' katini ħfief u tqal tal-qafas uman.
English: • swelling (edema), chest discomfort, feeling of weakness (asthenia), chest pain, infusion site pain, chills
Maltese: • nefħa (edema), skumdità tas-sider, tħossok dgħajjef (astenja), uġigħ fis-sider, uġigħ fis-sit talinfużjoni, tertir ta' bard
English: shortness of breath (dyspnoea), anaemia (haemoglobin <100 g/L), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction.
Maltese: • infjammazzjoni tal-peritonew (it-tessut li jiksi l-biċċa l-kbira tal-organi taż-żaqq), stitikezza, skumdità fl-istonku wara ikla (dispepsja), distensjoni addominali
English: Change from baseline at 12 weeks in Plasma Free Haemoglobin (mg/dL) Change from baseline Type III RBC clone size (Percent of aberrant cells) Change from baseline at 12 weeks of PedsQLTM4.0 Generic Core scale (patients) 10.5 (6.66)
Maltese: L-analiżi primarja tal-MG-ADL kienet Worst-Rank ANCOVA bi klassifikazzjoni (rank) medja ta' 56.6 għal Soliris u 68.3 tal-plaċebo, ibbażat fuq 125 pazjenti fl-istudju (p=0.0698).
English: Platelet count normalization TMA event-free status Complete TMA response eGFR improvement ≥ 15 mL/min/1.73m2
Maltese: Fl-aħħar evalwazzjoni, 19 minn 22 pazjent (86%) kisbu titjib f'eGFR ta' ≥15 mL/min/1.73 m2 mil-linja bażi.
English: Serious haemolysis was not observed.
Maltese: Ma kinetx osservata emolisi serja.
English: Your doctor will administer a vaccine to your child aged less than 18 years against Haemophilus influenzae and pneumococcal infections according to the national vaccination recommendations for each age group.
Maltese: It-tabib tiegħek se jagħti tilqima lit-it-tifel/tifla tiegħek li jkollhom inqas minn 18-il sena kontra Haemophilus influenzae u infezzjonijiet pnewmokokkali skont ir-rakkomandazzjonijiet nazzjonali dwar it-tilqim għal kull grupp ta' età.
English: These include: o steroids (e.g. prednisolone), o diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide, o medicines for breathing problems such as theophylline.
Maltese: Dawn jinkludu: o sterojdi (eż. prednisolone), o dijuretiċi (pilloli tal-pipì) użati għall-pressjoni għolja tad-demm bħall hydrochlorothiazide, o mediċini minħabba problemi tan-nifs bħat-theophylline.
English: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Onbrez 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 Onbrez 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 Onbrez Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate.
Maltese: - Kull kapsula Onbrez Breezhaler ta' 300 mikrogramma fiha 300 mikrogramma indacaterol bħala indacaterol maleate.
English: Onbrez 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: Onbrez 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 Onbrez 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'Onbrez Breezhaler b'doża ta' 300 mikrogramma darba kuljum.
English: Onbrez Breezhaler contains lactose
Maltese: Onbrez Breezhaler fih il-lactose
English: What Onbrez Breezhaler contains - Each Onbrez Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate.
Maltese: X'fih Onbrez Breezhaler - Kull kapsula Onbrez Breezhaler ta' 150 mikrogramma fiha 150 mikrogramma indacaterol bħala indacaterol maleate.
English: At the recommended doses, the adverse reaction profile of Onbrez 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' Onbrez Breezhaler f'pazjenti b'COPD juri effetti sistemiċi mhux sinifikanti klinikament tal-istimulazzjoni bil-beta2adrenerġiċi.
English: Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Onbrez Breezhaler at recommended therapeutic doses (see section 5.1).
Maltese: Studji kliniċi dwar Onbrez Breezhaler ma wrewx effetti relevanti klinikament fuq it-titwil tal-intervall QTc meta mogħti skont id-dożi terapewtiċi rrakkomandati (ara sezzjoni 5.1).
English: Carton containing 30 capsules and one Onbrez Breezhaler inhaler.
Maltese: Kartuna li fiha 30 kapsula u inhaler wieħed Onbrez Breezhaler.
English: Onbrez Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed clinically meaningful improvements in lung function.
Maltese: Onbrez Breezhaler, mogħti darba kuljum f'dożi ta' 150 mikrogramma u 300 mikrogramma, wera titjib sinifikanti klinikament fil-funzjoni tal-pulmun.
English: Do not swallow Onbrez Breezhaler capsules.
Maltese: Tiblax il-kapsuli Onbrez Breezhaler.
English: During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Onbrez 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 Onbrez Breezhaler skont id-dożi rrakkomandati milli meta ngħata l-plaċebo.
English: Show the pack of Onbrez Breezhaler.
Maltese: Uri l-pakkett ta' Onbrez Breezhaler.
English: Carton containing 10 capsules and one Onbrez Breezhaler inhaler.
Maltese: Kartuna li fiha 10 kapsuli u inhaler wieħed Onbrez Breezhaler.
English: Onbrez Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators.
Maltese: Onbrez Breezhaler fih is-sustanza attiva indacaterol li tagħmel parti minn grupp ta' mediċini msejħa bronkodilataturi.
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules Onbrez Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Maltese: Onbrez Breezhaler 150 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa Onbrez Breezhaler 300 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa indacaterol
English: Onbrez Breezhaler inhaler
Maltese: Inhaler Onbrez Breezhaler
English: Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Onbrez 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: If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, Onbrez 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), Onbrez Breezhaler għandu jitwaqqaf minnufih u għandha tinbeda terapija alternattiva.
English: Onbrez Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Maltese: Onbrez Breezhaler mhuwiex indikat sabiex jikkura episodji gravi ta' spażmi fil-bronki, jiġifieri bħala terapija ta' salvataġġ.
English: Other medicines and Onbrez Breezhaler
Maltese: Mediċini oħra u Onbrez Breezhaler
English: The capsules must be administered only using the Onbrez Breezhaler inhaler (see section 6.6).
Maltese: Il-kapsuli għandhom jittieħdu biss billi jintuża l-inhaler Onbrez Breezhaler (ara sezzjoni 6.6).
English: In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Onbrez 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 Onbrez Breezhaler (jiġifieri mediċini bħalma huma salmeterol u formoterol).
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules indacaterol
Maltese: Onbrez Breezhaler 150 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa indacaterol
English: Common 1 Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Onbrez Breezhaler.
Maltese: Waslu rapporti ta' sensittività eċċessiva mill-esperjenza ta' wara l-approvazzjoni tas-suq rigward lużu ta' Onbrez Breezhaler.
English: Onbrez Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists.
Maltese: Onbrez 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: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Onbrez 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' Onbrez Breezhaler.
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 Onbrez 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'Onbrez Breezhaler u dawk mogħtija l-plaċebo jew il-kura bit-tiotropium.
English: Onbrez Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Maltese: Onbrez Breezhaler 300 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa indacaterol
English: Your Onbrez Breezhaler pack: Each Onbrez Breezhaler pack contains: one Onbrez Breezhaler inhaler one or more blisters containing Onbrez Breezhaler capsules to be used in the inhaler.
Maltese: Kull pakkett Onbrez Breezhaler fih: inhaler wieħed Onbrez Breezhaler folja waħda jew aktar b'kapsuli Onbrez Breezhaler biex jintużaw mal-inhaler.
English: There are no data available for use of Onbrez Breezhaler in patients with severe hepatic impairment.
Maltese: Ma teżisti l-ebda informazzjoni dwar l-użu ta' Onbrez Breezhaler f'pazjenti b'indeboliment epatiku gravi.
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules
Maltese: Onbrez Breezhaler 150 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa
English: Onbrez Breezhaler 300 microgram inhalation powder, hard capsules
Maltese: Onbrez Breezhaler 300 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa
English: Please read the following instructions carefully to learn how to use and care for your Onbrez Breezhaler inhaler.
Maltese: Reazzjonijiet immedjati ta' sensittività eċċessiva ġew irrappurtati wara l-għoti ta'Onbrez Breezhaler.
English: Never blow into the mouthpiece of the Onbrez Breezhaler inhaler.
Maltese: Qatt m'għandek iżżarma l-inhaler Onbrez 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 Onbrez 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'Onbrez Breezhaler.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Onbrez Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (COPD) (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jigu ppreżentati r-riżultati tal-istudji b'Onbrez Breezhaler f'kull sett tal-popolazzjoni pedjatrika bil-marda pulmonari ostruttiva kronika (COPD) (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: This medicine contains lactose (milk sugar).
Maltese: Din il-mediċina fiha l-lactose (zokkor tal-ħalilb).
English: How to store Onbrez Breezhaler
Maltese: X'inhu Onbrez Breezhaler
English: The full EPAR for Ontruzant 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: Ontruzant contains the active substance trastuzumab.
Maltese: Ontruzant fih is-sustanza attiva trastuzumab.
English: Absence of invasive cancer cells was noted in the tissue removed at surgery in 52% of women given Ontruzant and 42% of those given Herceptin, but in the light of all the available information from the study this difference was not assessed to be relevant.
Maltese: Ġie nnotat nuqqas ta' ċelloli tal-kanċer invażivi fit-tessut imneħħi fil-kirurġija fi 52 % tan-nisa li ngħataw Ontruzant u fi 42 % ta' dawk li ngħataw Herceptin, iżda fid-dawl tal-informazzjoni kollha disponibbli mill-istudju din id-differenza ma ġietx ivvalutata bħala rilevanti.
English: Ontruzant trastuzumab
Maltese: Informazzjoni oħra dwar Ontruzant
English: • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or 5‑fluorouracil (other cancer medicines).
Maltese: • kanċer gastriku (fl-istonku) metastatiku, flimkien ma' cisplatin u jew ma' capecitabine jew 5-fluorouracil (mediċini oħra kontra l-kanċer).
English: Laboratory studies comparing Ontruzant with Herceptin have shown that the active substance in Ontruzant is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Ontruzant ma' Herceptin urew li s-sustanza attiva f'Ontruzant hija simili ħafna għal dik f'Herceptin f'termini ta' struttura, purità u attività bijoloġika.
English: Why is Ontruzant approved?
Maltese: Għaliex ġie approvat Ontruzant?
English: This is a summary of the European public assessment report (EPAR) for Ontruzant.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ontruzant.
English: The reference medicine for Ontruzant is Herceptin.
Maltese: Il-mediċina ta' referenza għal Ontruzant hija Herceptin.
English: Ontruzant is a ‘biosimilar medicine'.
Maltese: Ontruzant huwa 'mediċina bijosimili'.
English: The study showed that 94% of women given Ontruzant and 93% of those given Herceptin survived without return or worsening of their disease when followed up for around 14 months.
Maltese: L-istudju wera li 94 % tan-nisa li ngħataw Ontruzant u 93 % ta' dawk li ngħataw Herceptin għexu mingħajr ma l-marda tagħhom reġgħet feġġet meta ġew segwiti għal madwar 14il xahar.
English: In addition, a study involving 875 patients with early or locally advanced breast cancer looked at the effectiveness of Ontruzant and Herceptin.
Maltese: Barra minn hekk, studju li involva 875 pazjent b'kanċer tas-sider li jkun għadu fil-bidu jew lokalment avvanzat eżamina l-effikaċja ta' Ontruzant u Herceptin.
English: Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Maltese: Il-pazjenti li jittolleraw l-ewwel infużjoni ta' 90 minuta jistgħu jirċievu linfużjonijiet sussegwenti fuq perjodu ta' 30 minuta.
English: What are the risks associated with Ontruzant?
Maltese: X'inhuma r-riskji assoċjati ma' Ontruzant?
English: The active substance in Ontruzant, trastuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the HER2 protein, which is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Maltese: Is-sustanza attiva f'Ontruzant, it-trastuzumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet biex tirrikonoxxi u teħel mal-proteina HER2, li tiġi espressa żżejjed f'madwar kwart tal-kanċers tassider u wieħed minn kull ħames kanċers gastriċi.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ontruzant has been shown to have a comparable quality, safety and effectiveness to Herceptin.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Ontruzant wera li għandu kwalità, sigurtà u effikaċja komparabbli għal Herceptin.
English: For tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Ontruzant is used before surgery in combination with chemotherapy and then again after surgery on its own;
Maltese: Għal tumuri li huma lokalment avvanzati (inkluż dawk li huma infjammatorji) jew usa' aktar minn 2 cm, Ontruzant jintuża qabel l-kirurġija flimkien malkimoterapija mbagħad għal darb'oħra wara l-kirurġija waħdu;
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku trastuzumab
English: The most common or serious side effects with Ontruzant are heart problems, reactions related to the Ontruzant infusion, reduced levels of blood cells, especially white blood cells, infections and lung problems.
Maltese: L-effetti sekondarji l-aktar komuni jew serji b'Ontruzant huma problemi fil-qalb, reazzjonijiet relatati mal-infużjoni ta' Ontruzant, livelli mnaqqsa ta' ċelloli tad-demm, speċjalment taċ-ċelloli bojod taddemm, infezzjonijiet u problemi fil-pulmun.
English: This means that Ontruzant is similar to another biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Ontruzant huwa simili għal mediċina bijoloġika (‘ilmediċina ta' referenza') diġà awtorizzata fl-Unjoni Ewropea (UE).
English: The women received one or the other trastuzumab medicine before and after surgery, with other cancer medicines and radiotherapy according to standard practice.
Maltese: In-nisa rċevew mediċina jew waħda jew l-oħra ta' trastuzumab qabel u wara l-kirurġija, ma' mediċini oħra kontra l-kanċer u radjoterapija skont ilprattika standard.
English: For the full list of all side effects and restrictions with trastuzumab, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati bi trastuzumab, ara l-fuljett ta
English: How does Ontruzant work?
Maltese: Kif jintuża Ontruzant?
English: Studies have also shown that giving Ontruzant produces similar levels of the active substance in the body to giving Herceptin.
Maltese: L-istudji wrew ukoll li lgħoti ta' Ontruzant jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Herceptin.
English: • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Maltese: • kanċer tas-sider li jkun għadu fil-bidu (meta l-kanċer ikun infirex fis-sider jew fil-glandoli taħt iddriegħ iżda mhux f'partijiet oħra tal-ġisem) wara kirurġija, kimoterapija (mediċini li jikkuraw ilkanċer) u radjoterapija (kura bir-radjazzjoni) jekk applikabbli.
English: It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;
Maltese: Ontruzant huwa mediċina kontra l-kanċer li tintuża biex tikkura l-kondizzjonijiet li ġejjin:
English: On the basis of all the data provided it was concluded that Ontruzant would behave in the same way as Herceptin in its approved indications.
Maltese: Abbażi tad-data kollha pprovduta ġie konkluż li Ontruzant iġib ruħu bl-istess mod bħal Herceptin fl-indikazzjonijiet approvati tiegħu.
English: What benefits of Ontruzant have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Ontruzant li ħarġu mill-istudji?
English: There are no apparent age-related effects on the pharmacokinetics of PegIntron.
Maltese: M'hemm l-ebda effetti evidenti relatati mal-età fuq il-farmakokinetika ta' PegIntron.
English: Dextromethorphan hydrobromide (CYP2D6 and CYP3A substrate)
Maltese: Dextromethorphan hydrobromide (substrat ta' CYP2D6 u ta' CYP3A)