FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Effentora (that may affect more than 1 patient in 10) are dizziness, headache, nausea (feeling sick), vomiting, and reactions at the site of application including bleeding, pain, ulcers, irritation, unusual sensations, numbness, redness, swelling and spots.
Maltese: L-effetti sekondarji l-aktar komuni b'Effentora (li dehru f'iktar minn pazjent wieħed minn kull għaxra) kienu sturdament, uġigħ ta' ras, nawżja (tħossok ma tiflaħx), remettar, u reazzjonijiet fil-post talapplikazzjoni inkluż dmija, uġigħ, ulċeri, irritazzjoni, sensazzjonijiet mhux tas-soltu, titrix, ħmura, nefħa u ponot.
English: Effentora is a medicine that contains the active substance fentanyl.
Maltese: Effentora huwa mediċina li fiha s-sustanza attiva fentanil.
English: The active substance in Effentora, fentanyl, is an opioid.
Maltese: Is-sustanza attiva f'Effentora, il-fentanil, hija oppjojde.
English: This is a summary of the European public assessment report (EPAR) for Effentora.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Effentora.
English: It is available as ‘buccal tablets' (tablets that dissolve in the mouth).
Maltese: Jiġi bħala ‘pilloli bukali' (pilloli li jinħallu filħalq).
English: Doses of Effentora above 800 micrograms have not been tested.
Maltese: Id-dożaġġi ta' Effentora 'l fuq minn 800 mikrogramma ma ġewx eżaminati.
English: In the first study, pain intensity had fallen by an average of 3.2 points at 30 minutes after the patients took Effentora and by 2.0 points after they took placebo.
Maltese: Fl-ewwel studju, lintensità tal-uġigħ naqset b'medja ta' 3.2 punti wara 30 minuta li l-pazjenti kienu ħadu Effentora u b'2.0 punti wara li ħadu l-plaċebo.
English: The ability of Effentora to treat breakthrough pain was tested in two main studies involving a total of 150 adults with cancer who were being treated with opioids.
Maltese: L-abbiltà ta' Effentora sabiex tikkura wġigħ qawwi li jiġi f'daqqa ġiet ittestjata f'żewġ studji prinċipali li involvew total ta' 150 adult li jbatu bil-kanċer li kienu taħt il-kura b'oppjojdi.
English: Effentora is used to treat ‘breakthrough' pain in adults with cancer who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Maltese: Effentora jintuża għat-trattament ta' wġigħ ‘qawwi li jiġi f'daqqa' f'adulti li jkollhom kanċer u li jkunu diġà qegħdin jużaw oppjojdi (grupp ta' mediċini li jtaffu l-uġigħ li jinkludi l-morfina u l-fentanil) sabiex jikkontrollaw l-uġigħ kroniku kkawżat mill-kanċer.
English: The tablets usually dissolve in 14 to 25 minutes, releasing the active substance, which is absorbed directly into the bloodstream.
Maltese: Il-pilloli, li normalment jinħallu f'temp ta' bejn 14 u 25 minuta, jirrilaxxaw is-sustanza attiva, li mbagħad tiġi assorbita direttament fid-demm.
English: After 30 minutes, any pieces of tablet remaining can be swallowed with a glass of water.
Maltese: Wara 30 minuta, kwalunkwe fdal li jkun fadal mill-pillola jista' jinbela' ma' tazza ilma.
English: A risk management plan has been developed to ensure that Effentora is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Effentora jintuża bl-aktar mod sigur possibbli.
English: See the package leaflet for further information.
Maltese: Ara l-fuljett ta' tagħrif għal aktar informazzjoni.
English: Why has Effentora been approved?
Maltese: Għaliex ġie approvat Effentora?
English: The most serious of these are respiratory depression (inhibition of breathing), circulatory depression (slow heartbeat), hypotension (low blood pressure) and shock (a steep fall in blood pressure).
Maltese: L-iktar gravi minn dawn huma d-dipressjoni respiratorja (ma tkunx tista' tieħu n-nifs sew), id-dipressjoni ċirkolatorja (taħbit ilqalb bil-mod), ipotensjoni (pressjoni baxxa tad-demm) u xokk (inżul f'daqqa fil-pressjoni tad-demm).
English: What is Effentora?
Maltese: Għal xiex jintuża Effentora?
English: The company that makes Effentora will also provide educational materials in each European Union (EU) Member State to make sure that patients and doctors are aware of how the medicine should be used safely, the risks of accidental exposure to fentanyl and how to dispose of Effentora.
Maltese: Il-kumpanija li tipproduċi Effentora ser tipprovdi materjali edukattivi f'kull Stat Membru tal-Unjoni Ewropea (UE) sabiex tiżgura li l-pazjenti u t-tobba jkunu konxji dwar kif il-mediċina għandha tintuża b'mod sigur, ir-riskji għal esponiment aċċidentali għal fentanil u kif għandu jintrema Effentora.
English: What is the risk associated with Effentora?
Maltese: X'inhu r-riskju assoċjat ma' Effentora?
English: In both studies, each patient was treated during 10 separate episodes of breakthrough pain: in seven of these episodes, each patient received Effentora, and in the other three episodes, each patient received placebo (a dummy tablet).
Maltese: Fiż-żewġ studji, kull pazjent kien ikkurat matul 10 episodji separati ta' wġigħ qawwi li jiġi f'daqqa: f'seba' minn dawn lepisodji, kull pazjent irċieva Effentora, u fit-tliet episodji l-oħra, kull pazjent irċieva plaċebo (trattament finta).
English: For the full list of all side effects reported with Effentora, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Effentora, ara l-fuljett ta' tagħrif.
English: The main measure of effectiveness was the change in pain intensity over the first 30 or 60 minutes after taking the tablet.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fl-intensità tal-uġigħ fl-ewwel 30 jew 60 minuta wara tteħid tal-pillola.
English: How has Effentora been studied?
Maltese: Kif ġie studjat Effentora?
English: The CHMP decided that Effentora's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Effentora huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Treatment with Effentora should be started by and remain under the guidance of a doctor who has experience in the management of opioid treatment in cancer patients.
Maltese: It-trattament b'Effentora għandu jinbeda minn u jibqa' taħt il-gwida ta' tabib b'esperjenza fil-ġestjoni ta' terapija b'oppjojdi f'pazjenti bil-kanċer.
English: In Effentora, it is given as a buccal tablet, so that the fentanyl is absorbed through the lining of the mouth.
Maltese: F'Effentora, din is-sustanza tingħata bħala pillola bukali, sabiex il-fentanil jiġi assorbit mir-rita tal-ħalq.
English: EU/1/15/995/001 DUTREBIS 150 mg / 300 mg Film-coated tablet
Maltese: EU/1/15/995/001 DUTREBIS 150 mg / 300 mg Pillola miksija b'rita
English: MA (EU) Number (Invented) name
Maltese: Numru tal-MA (UE)
English: Pack size
Maltese: Daqs tal-pakkett
English: Medicinal product no longer authorised
Maltese: Għamla farmaċewtika
English: Veluwezoom 22 1327 AH Almere Netherlands
Maltese: Veluwezoom 22 1327 AH Almere L-Olanda
English: ATC Code: R01AD05
Maltese: R01AD05
English: Dispersible cellulose (Microcrystalline cellulose and carboxymethylcellulose sodium, (89:11, w/w)) Polysorbate 80
Maltese: Cellulose li tinħall (Microcrystalline cellulose u carboxymethylcellulose sodium, (89:11, w/w)) Polysorbate 80
English: Nasalspray, suspension
Maltese: Nasenspray, Suspension
English: C.F. Tietgens Boulevard 40 DK-5220 Odense SØ Danmark
Maltese: Tietgens Boulevard 40 DK-5220
English: Raiffeisenstraße 11 83607 Holzkirchen Germany
Maltese: Raiffeisenstraße 11 83607 Holzkirchen Il-Ġermanja
English: • adrenal supression.
Maltese: • trażżin adrenali.
English: 0.06 mg of potassium sorbate / 0.05 ml nasal spray, suspension
Maltese: 0.06 mg ta' potassium sorbate / 0.05 ml sprej għall-imnieħer, suspensjoni
English: Question 1b
Maltese: Mistoqsija 1b
English: Question 1a
Maltese: Mistoqsija 1a
English: The main metabolites 6-beta-hydroxybudesonide and 16-alpha-hydroxyprednisolon are almost ineffective.
Maltese: Il-metaboliti ewlenin 6-beta-hydroxybudesonide u 16-alpha-hydroxyprednisolon huma kważi ineffettivi.
English: • itraconasole, a medicine to treat fungal infections
Maltese: • itraconasole, mediċina għall-kura ta' infezzjoni fungali
English: Budesonide is eliminated through metabolism, mainly by the enzyme CYP3A4.
Maltese: Budesonide jiġi eliminat permezz tal-metaboliżmu, primarjament mill-enzima CYP3A4.
English: • ethinylestradiol, used for contraception.
Maltese: • ethinylestradiol, li jintuża għal kontraċezzjoni.
English: Norway
Maltese: In-Norvegja
English: Budesonide Nasal Spray contains budesonide, a synthetic corticosteroid.
Maltese: Budesonide Sprej għall-Imnieħer fih budesonide, kortikosterojde sintetiku.
English: Hydrochloric acid, concentrated
Maltese: Hydrochloric acid, ikkonċentrat
English: Figure 3.
Maltese: Figura 3:
English: - very common (≥1/10) - common (≥1/100 to <1/10) - uncommon (≥1/1,000 to <1/100) - rare (≥1/10,000 to <1/1,000) - very rare (<1/10,000), not known (cannot be estimated from the available data)
Maltese: - 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)
English: Remove the protective cap.
Maltese: Neħħi l-għatu protettiv.
English: Mikrogramm/Sprühstoß Nasenspray, Suspension
Maltese: Mikrogramm/Sprühstoß
English: Budesonid Sandoz 32 mcg/dose 64 mcg/dose
Maltese: Budesonid Sandoz 32 mcg/doża 64 mcg/doża
English: 32 mcg/dose 64 mcg/dose
Maltese: 32 mcg/doża 64 mcg/doża
English: • troleandomycin, a medicine to treat bacterial infections
Maltese: • troleandomycin, mediċina għall-kura ta' infezzjonijiet batterjali
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletrali u talconnective tissue
English: • The active substance(s) is (are)…
Maltese: • Is-sustanza(i) attiva(i) hi (huma)...
English: Maintenance dose
Maltese: Doża tal-manteniment
English: • irritation of the skin
Maltese: • irritazzjoni tal-ġilda
English: Figure 2.
Maltese: Figura 2. 4.
English: You are unlikely to experience any medical problems.
Maltese: X'aktarx li mhux ser ikollok kwalunkwe problemi mediċi.
English: White homogeneous suspension
Maltese: Suspensjoni omoġenja bajda
English: Impaired liver function influences the pharmacokinetics of corticosteroids.
Maltese: L-indeboliment fil-funzjoni tal-fwied tinfluwenza l-farmakokinetika tal-kortikosterojdi.
English: Uncommon: immediate or delayed hypersensitivity reaction (urticaria, rash, itching, dermatitis, angioedema)
Maltese: Mhux komuni: reazzjoni ta' sensittività eċċessiva immedjat jew li ddum biex isseħħ (urtikarja, raxx, ħakk, dermatite, anġjoedema)
English: Budesonide nasal powder (200 and 400 µg once daily) was shown not to affect the HPA axis in 83 children and adolescents with SAR in a 4-week study.
Maltese: It-trab tal-imnieħer Budesonide (200 u 400 µg darba kuljum) intwera li ma jaffettwax l-assi IPA fi 83 tifel u tifla u adolexxenti bis-SAR fi studju ta' 4 ġimgħat.
English: The systemic availability of budesonide is 33% of the delivered intranasal amount of budesonide.
Maltese: Id-disponibilità sistemika ta' budesonide hi ta' 33% tal-ammont ta' budesonide fornut minn ġol-imnieħer.
English: The area under the curve (AUC) after administration of 256 micrograms of Budesonide nasal spray suspension is 2.7 nmol*h/L in adults and 5.5 nmol*h/L in children, indicating a higher systemic exposure in children.
Maltese: Iż-żona taħt il-kurva (AUC) wara l-għoti ta' 256 mikrogramma ta' Budesonide suspensjoni ta' sprej għall-imnieħer hi ta' 2.7 nmol*siegħa/L fl-adulti u 5.5 nmol*siegħa/L fit-tfal, li tindika espożizzjoni sistemika ogħla fit-tfal.
English: The maximal daily dose of Budesonide Sandoz was determined as being 256 µg/d.
Maltese: Id-doża massima ta' kuljum ta' Budesonide Sandoz ġiet deċiża li hija 256 µg/kuljum.
English: The CHMP adopted the following List of Questions focusing on the paediatric and adolescent indication:
Maltese: Il-CHMP adotta l-Lista ta' Mistoqsijiet li ġejja li tiffoka fuq l-indikazzjoni pedjatrika u adolexxenti:
English: 64 mcg/dose Nasalspray, suspension
Maltese: 64 mcg/doża Sprej għallimnieħer, suspensjoni
English: Allergic rhinitis
Maltese: Rinite allerġika
English: The Applicant stated that the only difference with the originator product is an additional 0.01% of ascorbic acid, a well-characterised chemical substance and a well-established excipient in locally applied products, with no reported adverse effects.
Maltese: LApplikant iddikjara li l-unika differenza mill-prodott oriġinatur hija żieda addizzjonali ta' 0.01% ta' aċidu asorbiku, sustanza kimika kkaratterizzata sew u sustanza mhux attiva stabbilita sew fi prodotti applikati lokalment, bl-ebda effett sekondarju ma jiġi rrappurtat.
English: Respiratroy, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: The volume of distribution of budesonide is approximately 3 L/kg.
Maltese: Il-volum tad-distribuzzjoni ta' budesonide hu ta' madwar 3 L/kg.
English: Severe impairment of hepatic function influences the pharmacokinetics of orally administered budesonide resulting in increased systemic availability and reduced elimination capacity.
Maltese: Indeboliment sever tal-funzjoni epatika tinfluwenza l-farmakokinetika ta' budesonide li jingħata mill-ħalq, li jirriżulta f'żieda fid-disponibilità sistemika u tnaqqis fil-kapaċità tal-eliminazzjoni.
English: • itching
Maltese: • tinfaraġ
English: Shake the bottle (figure 1).
Maltese: Ċaqlaq il-flixkun (Figura 1).
English: Rare: osteoporosis (with longterm treatment)
Maltese: Rari: osteoporożi (b'kura fit-tul)
English: PHARMACEUTICAL FORM Nasal spray, suspension.
Maltese: GĦAMLA FARMAĊEWTIKA Sprej għall-imnieħer, suspensjoni.
English: Budesonide Sandoz is an aqueous nasal spray containing budesonide, a glucocorticosteroid with a high local anti-inflammatory effect, indicated for the treatment and prevention of signs and symptoms of seasonal and perennial allergic rhino-conjunctivitis (SAR, PAR) as well as of nasal polyps.
Maltese: Budesonide Sandoz huwa sprej milwiem għall-imnieħer li fih budesonide, glukokortikosterojd b'effett anti-infjammatorju lokali għoli, indikat għall-kura u l-prevenzjoni tas-sinjali u s-sintomi ta' rinokonġuntivite allerġika perenni u staġjonali (SAR, PAR) kif ukoll tal-qarnit fl-imnieħer.
English: Orally ingested budesonide is in the first passage rapidly and extensively biotransformed by the liver (90%) to metabolites with lower glucocorticosteroid activity.
Maltese: Budesonide li jinbela' mill-ħalq jiġi bijotrasformat b'mod mgħaġġel u estensiv fl-ewwel passaġġ millfwied (90%) għal metaboliti b'attività glukokortikosterojdi iktar baxxa.
English: The Applicant therefore concludes that there is no justification for additional clinical data in the paediatric population.
Maltese: L-Applikant għalhekk jikkonkludi li mhemmx ġustifikazzjoni għal dejta klinika addizzjonali fil-popolazzjoni pedjatrika.
English: An excessive level of systemic glucocorticoids would reduce the endogenous production of cortisol, which can be detected by evaluating basal HPA activity, therefore measurements of HPA function, such as area-under-the curve cortisol concentrations and urinary free cortisol excretion, are considered the most sensitive indicators of INC systemic bioavailability, while stimulation tests of HPA-axis function are not as sensitive in identifying the systemic bioavailability of the INCs, but predict the likelihood of adverse events more accurately.
Maltese: Livell eċċessiv ta' glukokortikojdi sistematiċi jnaqqsu l-produzzjoni endoġena ta' kortisol, li jista' jinkixef permezz tal-evalwazzjoni tal-attività IPA bażika, għalhekk kejl tal-funzjoni IPA, bħalma huma konċentrazzjonijiet ta' kortisol tal-erja taħt il-kurva u tneħħija millġisem ta' kortisol mingħajr awrina, huma meqjusa bħala l-indikaturi l-aktar sensittivi ta' bijodisponibbiltà sistematika ta' kortikosterojds minn ġol-imnieħer (INC), filwaqt li testijiet ta' stimolu tal-funzjoni tal-assi IPA mhumiex daqshekk sensittivi biex jidentifikaw il-bijodisponibbiltà sistematika ta' kortikosterojdi minn ġol-imnieħer, iżda jipprevedu l-possibbiltà ta' avvenimenti avversi b'aktar preċiżjoni.
English: Nasal polyps
Maltese: Polipi tal-imnieħer
English: Concomitant administration of oral ketoconazol 200 mg once daily and oral budesonide (3 mg single dose) increased the plasma concentrations of budesonide on average 6-fold.
Maltese: L-għoti fl-istess ħin ta' ketoconazol orali 200 mg darba kuljum u budesonide orali (doża waħda ta' 3 mg) żied il-konċentrazzjonijiet fil-plażma ta' budesonide b'medja ta' 6 darbiet iktar.
English: In adults the maximal plasma concentration after administration of 256 micrograms of budesonide is 0,64 nmol/L and is reached within 0,7 hours.
Maltese: Fl-adulti il-konċentrazzjoni massima fil-plażma wara l-għoti ta' 256 mikrogramma ta' budesonide hi ta' 0.64 nmol/L u tintlaħaq fi żmien 0.7 ta' siegħa.
English: • ciclosporin, immune suppression drug used e.g. in connection with transplants
Maltese: • ciclosporin, mediċina ta' trażżin immuni li tintuża, per eżempju, b'konnessjoni ma' trapjanti
English: Clinically, the most important outcome measure of human growth is the final height in relation to the expected final height.
Maltese: Klinikament, l-aktar kejl importanti ta' effett tal-iżvilupp tal-bniedem huwa t-tul finali mqabbel mat-tul finali mistenni.
English: The results of a study in children and adolescents with perennial rhinitis were in line with the observations for adults, and no consistent differences in 24-hour urinary cortisol measurements were observed, therefore no systemic effects are expected in the paediatric population, irrespective of plasma budesonide concentrations.
Maltese: Ir-riżultati ta' studju fi tfal u adolexxenti b'rinite perenni kienu konformi mal-osservazzjonijiet fl-adulti, u ma ġiet osservata l-ebda differenza konsistenti fil-kejl ta' 24 siegħa kortisol fl-urina, għaldaqstant mhumiex mistennija effetti sistematiċi fil-popolazzjoni pedjatrika, irrispettivament mill-konċentrazzjonijiet ta' budesonide tal-plażma.
English: The Applicant is of the opinion that Budesonide Sandoz and the originator show comparable local tolerability and systemic safety in children and are fully interchangeable.
Maltese: L-Applikant huwa tal-opinjoni li Budesonide Sandoz u loriġinatur juru tollerabbiltà lokali komparabbli u sigurtà sistematika fit-tfal u huma kompletament interkambjabbli.
English: Neither clinical data from the literature nor the clinical studies conducted by the originator indicate any adverse systemic effects for budesonide doses up to 400 µg daily and therefore, the Applicant considered that no “systemic adverse reactions” are expected and that no additional data are necessary.
Maltese: La dejta klinika mill-materjal għall-qari u lanqas l-istudji kliniċi mmexxija mill-oriġinatur ma jindikaw effetti avversi sistematiċi għal dożi ta' budesonide sa 400 µg kuljum u għaldaqstant, l-Applikant ikkunsidra li ma hija mistennija l-ebda “reazzjoni avversa sistematika” u li l-ebda dejta addizzjonali ma hija meħtieġa.
English: The product was submitted under the Decentralised Procedure with Germany as Reference Member State, as a hybrid application (Art.10 (3)) and is claimed to be almost identical to the reference product, Rhinocort, with the addition of ascorbic acid (as antioxidant) being the only difference.
Maltese: Il-prodott ġie ppreżentat skont il-Proċedura Deċentralizzata bil-Ġermanja tkun l-Istat Membru ta' Referenza, bħala applikazzjoni ibrida (Art.10 (3)) u huwa sostnut li huwa kważi identiku għall-prodott ta' referenza, Rhinocort, bl-unika differenza tkun iż-żieda tal-aċidu asorbiku (bħala antiossidant).
English: At clinically relevant doses the kinetics of budesonide are dose proportional.
Maltese: F'dożi klinikament rilevanti, il-kinetiċa ta' budesonide hi proporzjonali għad-doża.
English: The recommended dose for the treatment of nasal polyps is 256 micrograms.
Maltese: Id-doża rakkomandata għall-kura ta' polipi tal-imnieħer hi ta' 256 mikrogramma.
English: Concomitant administration of other potent inhibitors of CYP3A4 (e.g.: ketoconazol, ciclosporin, ethinylestradiol und troleandomycin) is likely to result in a marked increase of budesonide plasma concentrations.
Maltese: (eż.: ketoconazol, ciclosporin, ethinylestradiol u troleandomycin) x'aktarx li se jirriżulta f'żieda notevoli talkonċentrazzjonijiet ta' budesonide fil-plażma.
English: The delivered (metered) dose of 0.05 ml nasal spray, suspension contains 32 micrograms of budesonide.
Maltese: Id-doża fornuta (metered) ta' 0.05 ml sprej għall-imnieħer, suspensjoni fiha 32 mikrogramma ta' budesonide.
English: Dosage
Maltese: Qawwa
English: Adults, adolescents and children from 6 years of age:
Maltese: Adulti, adolexxenti u tfal minn 6 snin 'il fuq:
English: The CHMP agreed with the rationale for including ascorbic acid as an anti-oxidant and that the amount of ascorbic acid contained in Budesonide Sandoz will not affect the pharmacokinetics/pharmacodynamics of the product.
Maltese: Il-CHMP qabel mar-raġuni fundamentali għall-inklużjoni tal-aċidu asorbiku bħala antiossidant u li lammont ta' aċidu asorbiku li hemm f'Budesonide Sandoz mhux sejjer jaffettwa lfarmakokinetiċi/farmakodinamiċi tal-prodott.
English: This medicinal product contains potassium sorbate and may cause skin reactions (e.g. contact dermatitis).
Maltese: Dan il-prodott mediċinali fih potassium sorbate u jista' jikkawża reazzjonijiet tal-ġilda (eż. dermatite tal-kuntatt).
English: • if you were told by your doctor you have infection of airways or lung tuberculosis.
Maltese: • jekk it-tabib tiegħek ikun qallek li għandek infezzjoni fil-passaġġi tan-nifs jew tuberkulosi fil-pulmun.
English: In the therapeutic equivalence study, systemic exposure was determined indirectly by measurement of 12-h free cortisol in the urine, correcting for creatinine excretion.
Maltese: Fl-istudju ta' ekwivalenza terapewtika, l-espożizzjoni sistematika kienet iddeterminata b'mod indirett bil-kejl ta' 12-il siegħa kortisol liberu fl-urina, b'korrezzjoni għall-eliminazzjoni tal-kreatinina mill-ġisem.
English: The impact of the differences of the two preparations is unknown.
Maltese: Mhux magħruf l-impatt tad-differenzi taż-żewġ preparazzjonijiet.
English: • fragile bones
Maltese: • għadam fraġli
English: In conclusion, the Applicant considered that the pharmacology of budesonide in the paediatric population has been well investigated and characterised and that it is reasonable to assume that Budesonide Sandoz will be therapeutically equivalent to the originator in the paediatric population as equivalence has been convincingly demonstrated in the adult population.
Maltese: Fl-aħħar nett, l-Applikant ikkunsidra li l-farmakoloġija ta' budesonide filpopolazzjoni pedjatrika ġiet investigata u kkaratterizzata sew u li huwa raġonevoli li wieħed jassumi li Budesonide Sandoz sejjer ikun terapewtikament ekwivalenti għall-oriġinatur fil-popolazzjoni pedjatrika minħabba li l-ekwivalenza ntweriet b'mod konvinċenti fil-popolazzjoni adulta.
English: The most sensitive and accurate methods of detection of systemic corticosteroid bioactivity available (measurement of endogenous cortisol secretion from the adrenal cortex) found measurable effects but only at doses above 400 µg/d.
Maltese: L-aktar metodi sensittivi u preċiżi disponibbli ta' skoperta tal-bijoattività sistematika talkortikosterojde (kejl ta' sekrezzjoni ta' cortisol endoġena mill-kortiċi adrenali) sabu effetti li jistgħu jitkejlu iżda biss f'dożi ogħla minn 400 µg/kuljum.
English: Potassium sorbate, an ingredient of this medicine, might cause irritation of the skin or mucous membranes, such as the inside if your nose.
Maltese: Potassium sorbate, sustanza ta' din il-mediċina, tista' tikkawża irritazzjoni tal-ġilda jew tal-membrani mukużi, bħan-naħa ta' ġewwa ta' mnieħrek.
English: The delivered (metered) dose of 0.05 ml nasal spray, suspension contains 64 micrograms of budesonide.
Maltese: Id-doża fornuta (metered) ta' 0.05 ml sprej għall-imnieħer, suspensjoni fiha 64 mikrogramma ta' budesonide.