FrancophonIA/ELRC3.0 huggingface dataset:
English: Ch ange Fro m Bas eline Ser um Fre e In sulin C oncen tra tion ( uU/ml)
Maltese: Bidla minn Linja Bażi ta' Insulina Mingħajr Serum Konċentrazzjoni (uU/ml)
English: The table below contains adverse reactions seen in controlled clinical studies including more than 1970 patients exposed to EXUBERA.
Maltese: It-tabella hawn taħt fiha r-reazzjonijiet avversi li dehru fi provi kliniċi b'kontrolli li jinkludu aktar minn 1970 pazjent esposti għal EXUBERA.
English: The following symptoms indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Maltese: Is-sintomi li ġejjin jindikaw livell baxx taz-zokkor fid-demm fil-moħħ: uġigħ ta' ras, ġuħ qawwi, dardir, rimettar, għeja, ngħas, disturbi fl-irqad, irrekwitezza, imġiba aġġressiva, nuqqas ta' konċentrazzjoni, reazzjonijiet imxekkla, depressjoni, konfużjoni, disturbi fil-kliem (xi kultant telf għal kollox tal-kliem), disturbi fil-vista, tregħid, paraliżi, sensazzjonijiet ta' tnemnim (parastiżja), tirżiħ u sensazzjonijiet ta' tnemnim fil-parti tal-ħalq, sturdament, telf ta' kontroll tiegħek innifsek, inabilità li tieħu ħsieb tiegħek innifsek, aċċessjonijiet, telf mis-sensi.
English: A decline from baseline in FEV1 of > 15% occurred in 1.3% of EXUBERA-treated and 1.0% of comparator-treated type 1 subjects and in 5.0% of EXUBERA-treated and 3.4% of comparator-treated
Maltese: Seħħ tnaqqis fil-FEV1 mil-linja bażi ta' > 15% f'1.3% ta' suġġetti ta' tip 1 ittrattati b'EXUBERA u f'1.0% ta' dawk ittrattati b'mediċina ta' tqabbil u f'5.0% ta' suġġetti ta' tip 2 ittrattati b'EXUBERA u fi 3.4% ta' dawk ittrattati b'mediċina ta' tqabbil.
English: Grey Button
Maltese: Pum Blu
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton/Unit dose blisters (30, 60, 90, 180 and 270)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Pakkett ta' barra/Bżieżaq ta' doża waħda (30, 60, 90, 180 u 270)
English: NAME OF THE MEDICINAL PRODUCT EXUBERA 3 mg inhalation powder pre-dispensed Insulin human
Maltese: TAL-PRODOTT MEDIĊINALI EXUBERA 3 mg trab għall-inalazzjoni magħmul għal-lest Insulina umana
English: Figure 4: Mean changes in serum free insulin concentrations (µU/mL) after inhalation of 4mg of human insulin or subcutaneous injection of 12 IU fast-acting human insulin in obese subjects with
Maltese: Figura 4: Tibdil medju fil-konċentrazzjonijiet ħielsa ta' insulina fis-serum (µU/mL) wara inalazzjoni ta' 4 mg ta' insulina umana jew injezzjoni taħt il-ġilda ta' 12 IU insulina umana li taħdem malajr f'suġġetti ħoxnin ħafna b'dijabete tip 2.
English: NAME OF THE MEDICINAL PRODUCT EXUBERA 1 mg inhalation powder pre-dispensed Insulin human
Maltese: TAL-PRODOTT MEDIĊINALI EXUBERA 1 mg trab għall-inalazzjoni magħmul għal-lest Insulina umana
English: This may include a mix of 1 mg (green coloured) and 3 mg (blue coloured) blisters.
Maltese: Din tista' tinkludi taħlita ta' bżieżaq ta' 1 mg (kulur aħdar) u ta' 3 mg (kulur blu).
English: Chest Pain
Maltese: FEJN MA
English: Inhaled human insulin, like fast-acting insulin analogues, has a more rapid onset of glucose lowering activity compared to subcutaneously administered soluble human insulin.
Maltese: L-insulina umana inalata, bħal analogi ta' insulina li jaħdmu malajr, għandha bidu aktar rapidu ta' lattività li tnaqqas il-glukosju meta mqabbla ma' l-insulina umana li ddub mogħtija taħt il-ġilda.
English: EXUBERA is available in the following pack sizes:
Maltese: EXUBERA tiġi f'pakketti tad-daqsijiet li ġejjin:
English: If at 6 months a decline of 15-20% or > 500ml from baseline lung function is observed, spirometry should be repeated after 3 months.
Maltese: Jekk fis-6 xahar, jiġi osservat tnaqqis ta' 15-20% jew > 500ml mill-funzjoni tal-pulmun fil-linja bażi, l-ispirometrija
English: Administration of fluticasone 30 minutes prior to EXUBERA did not affect the pharmacokinetics of EXUBERA in non-diabetic subjects with mild-moderate asthma (see section 4.5).
Maltese: Għoti ta' fluticasone 30 minuta qabel EXUBERA ma effettwax il-farmakokinetiċi ta' EXUBERA f'suġġetti mhux dijabetiċi b'ażżma ħafifa-moderata (ara sezzjoni 4.5).
English: a) The need for consistent and standard inhalation technique to ensure both optimal and consistent b) Special precaution with the insulin inhaler d) 1 mg and 3 mg dose inequivalence e) Magnitude of titration steps and resulting precautions f) The change in pulmonary function and the need for pulmonary function monitoring g) Smoking in relation to induced alteration in pharmacokinetics i) Increased insulin antibody levels j) Recommendation for special populations; underlying lung diseases such as asthma and COPD,
Maltese: a) Il-ħtieġa ta' teknika ta' inalazzjoni konsistenti u standard li tassigura għotja kemm ottima kif b) Prekawzjoni speċjali bl-inalatur ta' l-insulina d) In-nuqqas ta' ekwivalenza bejn doża ta' 1 mg u doża ta' 3 mg e) Id-daqs tal-passi tat-titrazzjoni u l-prekawzjonijiet li jridu jittieħdu f) Il-bidla fil-funzjoni pulmonari u l-ħtieġa għal sorveljanza tal-funzjoni pulmonari g) It-tipjip fir-rigward tal- kambjament indott fil-farmakokinetiċi i) Żjieda fil-livelli ta' antikorpi ta' l-insulina j) Rakkomandazzjoijiet għall-popolazzjonijiet speċjali; mard diġà eżistenti bħal ażżma jew COPD,
English: In a prospective exploratory 6 month study in subjects with type 1 diabetes, alterations in the glucose pharmacodynamics with inhaled human insulin were not observed.
Maltese: Fi studju esploratorju prospettiv ta' 6 xhur f'suġġetti b'dijabete tip 1, ma ġewx osservati alterazzjonijiet fil-farmakodinamiċi b'insulina inalata.
English: Small treatment group differences in decline of FEV1 were observed in the EXUBERA group relative to comparator therapy.
Maltese: Ġew osservati differenzi żgħar fit-tnaqqis ta' FEV1 fil-grupp ta' trattament, jiġifieri fil-grupp ta' EXUBERA meta mqabbel ma' terapija ta' tqabbil.
English: After opening the foil overwrap: Store below 25˚C.
Maltese: Aħżen f'temperatura taħt 25˚C.
English: If at 6 months a decline of < 15% FEV1 is observed, spirometry should be repeated at one year and then annually.
Maltese: Jekk fis-6 xahar jiġi osservat tnaqqis ta' < 15% FEV1, l-ispirometrija għandha tiġi rrepetuta wara sena u mbagħad ta' kull sena.
English: Medicines that may cause your blood sugar to rise include corticosteroids (used to treat inflammatory conditions, except topical administration), danazol (used for the treatment of some female hormonal disorders), oral contraceptives (used for birth control), thyroid hormones (used for the treatment of malfunction of the thyroid gland), growth hormones (used in endocrine conditions), sympathomimetic agents (used for the treatment of asthma) and thiazides (used in special endocrine conditions).
Maltese: Mediċini li jistgħu jgħollu z-zokkor f'demmek jinkludu kortikosterojdi (użati fit-trattament ta' kondizzjonijiet infjammatorji, ħlief għal amministrazzjoni topika), danazol (użat għat-trattament ta' xi disturbi ormonali tan-nisa), kontraċettivi orali (użati għall-kontroll tat-twelid), ormoni tat-tirojde (użati għat-trattament ta' funzjoni ħażina tat-tirojde), ormoni ta' l-iżvilupp (użati f'kondizzjonijiet endokrinoloġiċi), mediċini simpatomimetiċi (użati fit-trattament ta' l-ażżma) u thiazides (użati f'kondizzjonijiet endokrinoloġiċi speċjali).
English: Medicines that may cause your blood sugar to fall include diabetes tablets, angiotensin converting enzyme (ACE) inhibitors (used for the treatment of certain heart conditions, high blood pressure or elevated protein/albumin in the urine), monoamine oxidase (MAO) inhibitors (used for the treatment of depression), certain beta-blockers (used for the treatment of certain heart conditions and high blood pressure), salicylates (e.g. aspirin, used to relieve pain and lower fever) and
Maltese: Mediċini li jistgħu jikkaġunaw waqa' fil-livell taz-zokkor f'demmek jinkludu pilloli tad-dijabete, impedituri ta' angiotensin converting enzyme (ACE) (użati għat-trattament ta' ċerti kondizzjonijiet talqalb, pressjoni għolja jew proteina/albumina għolja fl-awrina), impedituri monoamine oxidase (MAO) (użati fit-trattament ta' depressjoni), ċertu beta-blockers (użati għat-trattament ta' ċerti kondizzjonijiet tal-qalb u pressjoni għolja), salicylates (eż. aspirina, użata biex ittaffi l-uġigħ u tniżżel id-deni) u
English: Insulin treatment can cause the body to produce antibodies to insulin (substances that bind to insulin).
Maltese: L-insulina inalata ta' spiss tinduċi antikorpi kontra l-insulina.
English: Store the insulin inhaler in a dry place at room temperature.
Maltese: Aħżen l-inalatur ta' l-insulina f'post xott f'temperatura tal-kamra.
English: Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi (ara sezzjoni 6.1).
English: Pfizer Manufacturing Frankfurt GmbH & Co. KG Industry Park Hoechst
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Pfizer Manufacturing Frankfurt GmbH & Co.
English: EXP: {MM/YYYY}
Maltese: {XX/SSSS}
English: Insulin therapy may cause sodium retention and oedema.
Maltese: Terapija bl-insulina tista' tikkaġuna ritenzjoni ta' sodju u edema.
English: See
Maltese: ISEM
English: In non-diabetic subjects with COPD, the absorption of inhaled human insulin appeared greater compared with that in subjects without COPD (see section 4.4).
Maltese: F'suġġetti mhux dijabetiċi b'COPD, l-assorbiment ta' insulina inalata deher ogħla meta mqabbel ma' dak f'suġġetti mingħajr COPD (ara sezzjoni 4.4).
English: You will see a blue line on it.
Maltese: Fuqha għandek tara linja blu.
English: It inhibits glycogenolysis and gluconeogenesis, increases lipogenesis in the liver and adipose tissue and inhibits lipolysis.
Maltese: Hija timpedixxi glycogenolysis u gluconeogenesis, iżżid il-lipoġenesi fil-fwied u tessut adipożju u timpedixxi l-lipoliżi.
English: Substances that may reduce the blood-glucose lowering effect include corticosteroids, danazol, oral contraceptives, thyroid hormones, growth hormone, sympathomimetic agents and thiazides.
Maltese: Sustanzi li jistgħu jnaqqsu l-effett ta' tnaqqis ta' l-ammont ta' glukosju fid-demm jinkludu kortikosterojdi, danazol, kontraċettivi orali, ormoni tat-tirojde, l-ormon ta' l-iżvilupp, mediċini simpatomimetiċi u thiazides.
English: The effect of hepatic impairment on the absorption of inhaled human insulin has not been studied (see section 4.2).
Maltese: L-effett ta' indeboliment tal-kliewi fuq l-assorbiment ta' insulina umana inalata ma ġiex studjat (ara sezzjoni 4.2).
English: Therefore, the 3 mg blister is not interchangeable with three 1 mg blisters (see sections 4.2, 4.4 and 5.2).
Maltese: Għaldaqstant, il-bużżieqa ta' 3 mg ma tistax tinbidel ma' tliet bżieżaq ta' 1 mg (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: Epistaxis Bronchospasm Wheezing Dysphonia Pharyngolaryngeal Pain Tonsillar Disorder Dry Mouth
Maltese: Agħfas iż-żewġ buttuni ta' rilaxx taċ-ċejmber f'daqqa fuq il-ġenb tal-bażi.
English: and 2 spare Insulin Release Units (IRU)
Maltese: 2 Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ
English: Pharyngitis
Maltese: Anzjani
English: More severe episodes, with coma, seizure, or neurological impairment may be treated with intramuscular/subcutaneous glucagon (0.5 to 1 mg) or concentrated intravenous glucose.
Maltese: Episodji aktar serji, b'koma, aċċessjoni, jew indeboliment newroloġiku jistgħu jiġu ttrattati bi glukagon intramuskolari/taħt il-ġilda (0.5 sa 1 mg) jew glukosju ikkonċentrat mogħti ġol-vini.
English: Cough
Maltese: KG
English: Dyspnoea Productive Cough Throat Irritation Dry Throat
Maltese: Qtugħ ta' Nifs Sogħla Produttiva Irritazzjoni tal-Gerżuma Gerżuma Xotta
English: Substances that may enhance the blood-glucose lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, monoamino oxidase (MAO) inhibitors, non-selective beta-blocking agents, salicylates and sulphonamide antibiotics.
Maltese: Sustanzi li jistgħu jżidu l-effett tat-tnaqqis tal-glukosju fid-demm u jżidu s-suxxettibilità għal ipogliċemija jinkludu mediċini orali ta' kontra d-dijabete, impedituri ta' l-enzima li tibdel lanġjotensin (ACE), impedituri ta' monoamino oxidase (MAO), mediċini magħrufin bħala betablockers mhux selettivi, salicylates u antibijotiċi ta' sulphonamide.
English: Each unit dose blister contains 3 mg insulin human.
Maltese: Kull bużżieqa ta' doża waħda fiha 3 mg ta' insulina umana.
English: EXUBERA is a fast-acting insulin.
Maltese: X'fiha EXUBERA - Is-sustanza attiva hija insulina umana.
English: Following oral inhalation of a single dose of human insulin approximately 30% of the total blister content remains in the blister or device, 20% is deposited in the oropharynx, 10% in the conducting airways and 40% reaches the deep lung.
Maltese: Wara inalazzjoni orali ta' doża waħda ta' insulina umana madwar 30% tal-kontenut totali tal-bużżieqa jibqa' fil-bużżieqa jew fl-inalatur, 20% huwa depożitat fl-orofarinġi, 10% fil-passaġġi li jwasslu l-arja
English: Mild episodes of hypoglycaemia usually can be treated with oral carbohydrates.
Maltese: Episodji ħfif ta' ipogliċemija jistgħu ġeneralment jiġu ttrattati b'karboidrati orali.
English: In type 2 subjects, resolution of small treatment group differences (0.039L favouring comparator) occurred within 6 weeks of EXUBERA cessation following 2 years of therapy (Figure 3).
Maltese: 039L jiffavorixxi l-mediċina ta' tqabbil) fi żmien 6 ġimgħat mit- twaqqif ta' EXUBERA wara sentejn ta' terapija (Figura 3).
English: and 6 spare Insulin Release Units (IRU)
Maltese: u 6 Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ
English: Use of inhaled human insulin is associated with an increase in frequency, and levels of insulin antibodies.
Maltese: L-użu ta' insulina inalata huwa assoċjat ma' żieda fil-frekwenza, u livelli ta' antikorpi ta' l-insulina.
English: EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic agents and requiring insulin therapy.
Maltese: EXUBERA hija indikata għat-trattament ta' pazjenti adulti bid-dijabete mellitus tip 2 li mhijiex ikkontrollata b'mod adegwat b'mediċini orali kontra d-dijabete u li jeħtieġu terapija bl-insulina.
English: MINIMUM PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING FOIL OVERWRAP
Maltese: Id-Dehra ta' EXUBERA u d-daqs tal-pakkett
English: The relative bioavailability of EXUBERA compared to subcutaneous fast-acting human insulin is approximately 10%.
Maltese: Il-bijodisponibilità relattiva ta' EXUBERA meta mqabbla ma' insulina umana li taħdem malajr mogħtija taħt il-ġilda hija madwar 10%.
English: Exubera (6mg)
Maltese: Żjara (gimghat)
English: The concomitant use of bronchodilators such as salbutamol may increase the absorption of EXUBERA and may therefore increase the risk of hypoglycaemia when used to relieve acute respiratory symptoms (see section 4.5).
Maltese: L-użu fl-istess ħin ta' dilaturi tal-bronki bħalma huwa salbutamol jistgħu jżidu l-assorbiment ta' EXUBERA u jistgħu jżidu r-riskju ta' ipogliċemija meta wżati biex itaffu sintomi respiratorji akuti (ara sezzjoni 4.5).
English: Mistakes in dosage
Maltese: Sistema talĠisem
English: • Cardboard box containing 180 x 1 PVC/Aluminium perforated unit dose blisters (6 pouches)
Maltese: • Kaxxa tal-kartun fiha 180 x 1 bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (6 pawċijiet)
English: In type 1 subjects, resolution of small treatment group differences (0.010L favouring comparator) occurred within 2 weeks of EXUBERA cessation following 12 weeks of therapy.
Maltese: F'suġġetti ta' tip 1, kien hemm riżoluzzjoni ta' differenzi żgħar fil-grupp ta' trattament (0.010L jiffavorixxi l-mediċina ta' tqabbil) fi żmien ġimagħtejn mit- twaqqif ta' EXUBERA wara 12-il ġimgħa ta' terapija.
English: • Cardboard box containing 270 x 1 PVC/Aluminium perforated unit dose blisters (9 pouches)
Maltese: • Kaxxa tal-kartun fiha 270 x 1 bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (9 pawċijiet)
English: Re-administration of EXUBERA requires a careful risk evaluation, and may only be done under close medical monitoring with appropriate clinical facilities.
Maltese: L-għoti mill-ġdid ta' EXUBERA jeħtieg evalwazzjoni tar-riskju bir-reqqa, u jista' jsir biss taħt sorveljanza medika mill-qrib b'faċilitajiet kliniċi adattati.
English: Octreotide/lanreotide (used in special endocrine conditions) may change the need for insulin.
Maltese: Octreotide/lanreotide (użat f'kondizzjonijiet endokrinoloġiċi speċjali) jistgħu jnaqqsu l-ħtieġa għall
English: Each unit dose blister contains 1 mg insulin human.
Maltese: Kull bużżieqa ta' doża waħda fiha 1 mg ta' insulina umana.
English: EXUBERA has been administered to patients with intercurrent respiratory illness (e.g. bronchitis, upper respiratory tract infections) during clinical trials.
Maltese: Waqt provi kliniċi, EXUBERA ngħatat lil pazjenti b'mard respiratorju interkurrenti (eż. bronkite, infezzjonijiet fil-passaġġi tal-parti ta' fuq tas-sistema respiratorja).
English: Where pulmonary oedema is present, or there is a clinically relevant reduction in pulmonary function, EXUBERA should be discontinued and the patient switched to injectable insulin.
Maltese: Meta jkun hemm edema pulmonari, jew ikun hemm tnaqqis filfunzjoni pulmonari klinikament relevanti, EXUBERA għandha titwaqqaf u l-pazjent għandu jinqeleb
English: Type 1 Diabetes
Maltese: Dijabete ta' Tip 1
English: These subjects experienced an average decrease in FEV1 of 21% (range 16%-33%) from baseline and were treated with EXUBERA for an average of 23 months.
Maltese: Dawn is-suġġetti esperjenzaw tnaqqis medju fl-FEV1 ta' 21% (fuq medda ta' 16%-33%) mil-linja ta' referenza bażi u kienu ttrattati b'EXUBERA għal medja ta' 23 xahar.
English: Number of 1 mg Blisters per Dose
Maltese: Numru ta' Bżieżaq ta' 1 mg kull doża
English: In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.130 (5 cases over 3800 patient-years) for Exubera-treated patients and 0.03 (1 case over 3900 patient-years) for comparator-treated patients.
Maltese: Fi studji kliniċi kontrollati ta' Exubera, l-inċidenza ta' tumuri primarji tal-pulmun fi studju ta' 100-sena ta' pazjenti b'esposizzjoni għall-mediċina ta' 0.130 (5 każijiet fuq medda ta' 3800 - snin ta' pazjenti) għal pazjenti trattati b'Exubera, u 0.03 (1 każ fuq medda ta' 3900 snin ta' pazjenti) għal pazjenti trattati komparattivament.
English: For information on the treatment of hypoglycaemia, see the end of section 4 “Possible side effects”.
Maltese: Għal tagħrif dwar it-trattament ta' l-ipergliċemija, ara t-tmiem ta' sezzjoni 4 “Effetti sekondarji li jista' jkollu”.
English: The safety of EXUBERA alone, or in combination with subcutaneous insulin or oral agents has been evaluated in clinical studies of more than 2700 patients with type 1 or type 2 diabetes, including more than 1975 adults exposed for greater than 6 months and more than 745 adults for greater than 2 years.
Maltese: Fost dawn, aktar minn 1975 adult ġew esposti għal aktar minn 6 xhur u aktar minn 745 adult ġew esposti għal aktar minn sentejn.
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: MANIFATTUR(I)
English: Oedema and refraction abnormalities of the eye
Maltese: Edema u anormalitajiet fir-refrazzjoni ta' l-għajn
English: • A pack containing 180 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (6 pouches) and 2 spare Insulin Release Units (IRU)
Maltese: • Pakkett fih 180 x 1 ta' 3 mg bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (6 pawċijiet) u 6 Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton/Unit dose blisters (60, 90, 180, 270)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kartuna/Bżieżaq ta' doża waħda (60, 90, 180, 270)
English: 6 of these discontinued subjects underwent follow-up pulmonary function testing.
Maltese: Sitta minn dawn issuġġetti li twaqqfu sarulhom testijiet ta' follow-up tal-funzjoni pulmonari.
English: EXUBERA is an inhalation powder, pre-dispensed, and is supplied as tear-off unit dose blisters marked with either ‘1 mg EXUBERA' with green ink or ‘3 mg EXUBERA' with blue ink.
Maltese: EXUBERA hija trab għall-inalazzjoni, diġà lest, u tiġi f'bżieżaq ta' doża waħda li jiċċartu immarkati jew b'‘1 mg EXUBERA' b'linka ħadra jew ‘3 mg EXUBERA' b'linka blu.
English: The tray is sealed in a foil laminate pouch with a desiccant.
Maltese: Uża ċarruta ratba u nadifa niedja bl-ilma.
English: In a study in healthy subjects, systemic exposure (AUC and Cmax) of inhaled human insulin increased in an approximately dose proportional fashion from 1 mg to 6 mg when a maximum of two blisters from either strength or their combination was administered.
Maltese: Fi studju f'pazjenti b'saħħithom, l-espożizzjoni sistemika (AUC u Cmax) ta' insulina umana inalata żdiedet b'mod bejn wieħed u ieħor proporzjonali għad-doża minn 1 mg għal 6 mg meta ngħataw massimu ta' żewġ bżieżaq ta' qawwa waħda jew l-oħra jew il-kombinazzjoni tagħhom.
English: Your blood sugar levels may fall too much, if for example: - you take too much insulin, - you miss meals or delay them, - you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates), - you lose or are unable to consume carbohydrates due to vomiting or diarrhoea, - you drink alcohol, particularly if you are not eating much, - you take more physical exercise than usual or a different type of physical activity, - you are recovering from an injury or operation or other stress, - you are recovering from a feverish illness or from another illness, - you are taking or have stopped taking certain other medicines (see section 2, “Taking other
Maltese: - ma tikolx biżżejjed, jew tiekol ikel li fih inqas karboidrati mis-soltu (zokkor u sustanzi simili għazzokkor huma msejjħin karboidrati: madankollu, sweeteners artifiċjali MHUMIEX karboidrati), - titlef jew ma tkunx tista' tikkonsma karboidrati minħabba rimettar jew dijarea, - tixrob l-alkoħol, partikolarment jekk ma tkunx qed tiekol ħafna, - tagħmel aktar eżerċizzju fiżiku mis-soltu jew tagħmel tip differenti ta' attività fiżika, - tkun qed tirkupra minn korriment jew operazzjoni jew stress ieħor, - tkun qed tirkupra minn mard bid-deni jew xi mard ieħor, - qed tieħu jew waqaft tieħu ċerti mediċini oħra (ara sezzjoni 2 “Meta tieħu mediċini oħra”).
English: INH and INH washout N=158, 155, 143, 139, 123.
Maltese: N=Numru ta' Suġġetti f'Linja Bażi, ġimgħa 52, ġimgħa 104, ġimgħa +6, ġimgħa +12. INH u INH washout N=158, 155, 143, 139, 123.
English: BATCH NUMBER BN: {number}
Maltese: NUMRU TAL-LOTT BN:
English: Three 1 mg unit dose blisters should not be substituted for one 3mg blister (see section 2, “Take special care with EXUBERA”, section 3, “How to take EXUBERA” and section 6
Maltese: Tliet bżieżaq ta' doża waħda ta' 1 mg m'għandhomx jiġu ssostitwiti b'bużżieqa waħda ta' 3 mg (ara sezzjoni 2, “Oqgħod attent ħafna b'EXUBERA”, sezzjoni 3, “Kif tieħu EXUBERA” u sezzjoni 6 “Aktar tagħrif”).
English: In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients.
Maltese: Fi studji kliniċi ta' Exubera, kien hemm 6 każijiet ġodda ta' tumuri primarji tal-pulmun f'pazjenti trattati b'Exubera, u każ wieħed ġdid qalb il-pazjenti trattati komparattivament.
English: Discontinuation of EXUBERA therapy after 2 years resulted in resolution of treatment group differences within 6 weeks (see sections 4.4 and 5.1).
Maltese: Twaqqif ta' terapija b'EXUBERA wara sentejn irriżulta f'riżoluzzjoni tad-differenzi fil-gruppi tat-trattament fi żmien 6 ġimgħat (ara sezzjonijiet 4.4 u