FrancophonIA/ELRC3.0 huggingface dataset:
English: Rasilamlo 150 mg/10 mg film-coated tablets are yellow, convex, oval film-coated tablets, with “T7” debossed on one side and “NVR” on the other.
Maltese: Il-pilloli miksijin b'rita Rasilamlo 150 mg/10 mg huma pilloli sofor, konvessi, ovali, miksijin b'rita, b'“T7” imnaqqxa fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: Rasilamlo was studied in a number of active and placebo-controlled trials and long-term trials which included a total of 5,570 hypertensive patients with mild to moderate hypertension (diastolic blood pressure between 90 mmHg and 109 mmHg).
Maltese: Rasilamlo ġie studjat f'għadd ta' provi kkontrollati b'mod attiv u bi plaċebo u provi fuq perijodu twil ta' żmien li kienu jinkludu 5,570 pazjent bi pressjoni għolja minn ħafifa sa moderata (pressjoni dijastolika bejn 90 mmHg u 109 mmHg).
English: A number of these patients had a history of angioedema or symptoms suggestive of angioedema, which in some cases followed use of other medicinal products that can cause angioedema, including RAAS blockers (angiotensin converting enzyme inhibitors or angiotensin receptor blockers) (see
Maltese: Numru minn dawn il-pazjenti kellhom storja ta' anġjoedima jew sintomi li jissuġġerixxu anġjoedima, li f'xi każijiet seħħet wara użu ta' mediċini oħra li jistgħu jikkawżaw anġjoedima, inkluż imblokkaturi tal-RAAS (impedituri tal-enzima li tikkonverti angiotensin jew imblokkaturi tarriċettur ta' angiotensin) (ara sezzjoni 4.8).
English: The plasma exposure was approximately 100-fold higher in rats aged 14 days and 3-fold higher in rats aged 21 days compared to adult rats.
Maltese: L-esponiment fil-plażma kien madwar 100 ogħla f'firien fl-età ta' 14-il jum u 3 darbiet ogħla f'firien fl-età ta' 21 jum meta mqabbel ma' firien adulti.
English: Acute renal failure a, renal impairment a,
Maltese: Reazzjonijiet anafilattiċi a, reazzjonijiet ta'
English: Amlodipine has demonstrated beneficial clinical effects in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Maltese: Amlodipine wera effetti kliniċi ta' ġid f'pazjenti b'anġina kronika stabbli, b'anġina vasospastika u b'mard tal-arterji koronarji ddokumentat b'mod anġjografiku.
English: Rasilamlo has been administered to more than 2,800 patients in completed clinical trials, including 372 patients for one year or more.
Maltese: Rasilamlo ngħata lil aktar minn 2,800 pazjent fi provi kliniċi li tlestew, li jinkludu 372 pazjent li ħaduh għal sena jew aktar.
English: Preclinical studies indicate that aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion.
Maltese: Kienet osservata varjabbiltà kbira fl-esponiment bejn lindividwi.
English: The MAH submitted an analysis with 1407 cases of “dyspnoea”, in 13 of them there was positive dechallenge and three cases with positive rechallenge.
Maltese: L-MAH issottometta analiżi b'1407 każijiet ta' “qtugħ ta' nifs”, li fi 13 minnhom kien hemm irtirar pożittiv u fi tliet każijiet kien hemm riesponiment pożittiv.
English: No interaction studies with other medicinal products were performed with Rasilamlo.
Maltese: Ma saru l-ebda studji ta' interazzjoni ma' prodotti mediċinali oħra b'Rasilamlo.
English: • severe upper stomach pain
Maltese: • taħbit irregolari tal-qalb
English: Dizziness a,am
Maltese: , suffejra a,am
English: As for any medicine that acts directly on the RAAS, aliskiren should not be used during the first trimester of pregnancy and is contraindicated during the second and third trimesters (see section 4.3).
Maltese: Bħal kull mediċina oħra li taħdem direttament fuq ir-RAAS, aliskiren m'għandux jintuża waqt l-ewwel trimestru tat-tqala u huwa kontraindikat waqt ittieni u t-tielet trimestri (ara sezzjoni 4.3).
English: Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 300 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or amlodipine 10 mg alone or Rasilamlo 150 mg/10 mg or
Maltese: Rasilamlo 300 mg/10 mg jista' jingħata lil pazjenti li l-pressjoni tagħhom mhijiex ikkontrollata b'mod xieraq b'aliskiren 300 mg jew amlodipine 10 mg waħdu jew Rasilamlo 150 mg/10 mg jew Rasilamlo 300 mg/5 mg.
English: micturition disorder
Maltese: .2 Inkompatibbiltajiet
English: , hypoesthesia paraesthesia
Maltese: , ipoestesija parestesija
English: Rasilamlo 300 mg/10 mg film-coated tablets are brown-yellow, convex, oval film-coated tablets, with “T12” debossed on one side and “NVR” on the other.
Maltese: Il-pilloli miksijin b'rita Rasilamlo 300 mg/10 mg huma pilloli miksijin b'rita sofor fil-kannella, konvessi, ovali, miksijin b'rita, b'“T12” imnaqqxa fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: Aliskiren induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide.
Maltese: Aliskiren ikkawża tnaqqis fil-pressjoni tad-demm akbar meta żdied ma' hydrochlorthiazide.
English: Patients with hepatic insufficiency have decreased clearance of amlodipine with resulting increase in AUC of approximately 40-60%.
Maltese: Pazjenti b'insuffiċjenza tal-fwied għandhom tneħħija ta' amlodipine mnaqqsa li tirriżulta f'żieda fl-AUC ta' madwar 40-60%.
English: Coadministration of orange or apple juice with aliskiren 150 mg resulted in a 62% decrease in aliskiren AUC or in a 63% decrease in aliskiren AUC, respectively.
Maltese: L-għoti flimkien tal-meraq tal-larinġ jew tat-tuffieħ ma' aliskiren 150 mg wassal għal tnaqqis ta' 62% flAUC ta' aliskiren jew għal tnaqqis ta' 63% fl-AUC ta' aliskiren, rispettivament.
English: High acute mortality (within hours) and severe morbidity were observed at 100 and 300 mg/kg/day (2.3- and 6.8-fold the maximum recommended basis assuming a 60 kg adult patient) with no cause of death established and occurring without signs or prodromal symptoms.
Maltese: Ġew osservati mortalità akuta għolja (fi ftit sigħat) u morbidità severa b'doża ta' 100 u 300 mg/kg/jum (għal 2.3 u 6.8 darbiet aktar mid-doża umana massima rrakkomandata (MRHD) fuq bażi ta' mg/m li tassumi pazjent adult b'piż ta' 60 kg) mingħajr ma ġiet stabbilita l-kawża tal-mewt u mingħajr ma tfaċċaw sinjali jew sintomi prodromali.
English: Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 300 mg/5 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg alone or with Rasilamlo 150 mg/5 mg.
Maltese: Rasilamlo 300 mg/5 mg jista' jingħata lil pazjenti li l-pressjoni tagħhom mhijiex ikkontrollata b'mod xieraq b'aliskiren 300 mg waħdu jew b'Rasilamlo 150 mg/5 mg.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Maltese: Kull pillola fiha 300 mg aliskiren (bħala aliskiren hemifumarate) u 10 mg amlodipine (bħala amlodipine besylate).
English: There is a potential for aliskiren overexposure in children with an immature MDR1 (P-gp) system (see “Transporters” above
Maltese: Hemm potenzjal ta' esponiment eċċessiv għal aliskiren fi tfal b'sistema immatura ta' MDR1 (P-gp) (ara “Trasportaturi” aktar 'il fuq u sezzjonijiet 4.2, 4.4 u 5.3).
English: Vomiting a,am
Maltese: Sturdament a,am
English: Calcium channel blockers act to prevent the influx of calcium into the vascular smooth muscle cells in the vessel wall, thereby preventing smooth muscle cell contraction and vasoconstriction.
Maltese: L-imblokkaturi tal-kanali tal-calcium jaħdmu biex iwaqqfu l-influss tal-calcium għal ġoċċelluli tal-muskolu vaskulari lixx fis-superfiċje ta' barra tal-arterja u tal-vina, b'hekk iwaqqfu ilkontrazzjoni tal-muskolu lixx u t-tgħafis tal-arterji u tal-vini.
English: Each film-coated tablet contains 300 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Maltese: Kull pillola miksija b'rita fiha 300 mg aliskiren (bħala hemifumarate) u 5 mg amlodipine (bħala besylate).
English: Rasilamlo 300 mg/5 mg film-coated tablets are dark yellow, convex, oval film-coated tablets, with “T11” debossed on one side and “NVR” on the other.
Maltese: Il-pilloli miksijin b'rita Rasilamlo 300 mg/5 mg huma pilloli sofor skuri, konvessi, ovali, miksijin b'rita, b'“T11” imnaqqxa fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: - Each Rasilamlo 150 mg/5 mg film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Maltese: X'fih Rasilamlo - Kull pillola miksija b'rita ta' Rasilamlo 150 mg/5 mg fiha 150 mg aliskiren (bħala hemifumarate) u 5 mg amlodipine (bħala besylate).
English: Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome, have been reported with amlodipine.
Maltese: Pressjoni għolja sistemika evidenti u probabbilment fit-tul sa u nkluż xokk li jista' jwassal għall-mewt kienet irrapportata b'amlodipine.
English: Fertility, pre-natal development and post-natal development were unaffected in rats at doses up to 250 mg/kg/day.
Maltese: Il-fertilità, l-iżvilupp ta' qabel u wara t-twelid ma kinux effettwati fil-firien b'dożi sa 250 mg/kg/jum.
English: Amlodipine should be used with caution together with CYP3A4
Maltese: L-użu flistess ħin ta' indutturi ta' CYP3A4
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 5 mg amlodipine (as besylate).
Maltese: Kull pillola fiha 150 mg aliskiren (bħala aliskiren hemifumarate) u 5 mg amlodipine (bħala amlodipine besylate).
English: Tablet core
Maltese: KALENDARJU BISS
English: Each film-coated tablet contains 150 mg aliskiren (as hemifumarate) and 10 mg amlodipine (as besylate).
Maltese: Kull pillola fiha 150 mg aliskiren (bħala aliskiren hemifumarate) u 10 mg amlodipine (bħala amlodipine besylate).
English: In a 36-week study involving 820 patients with ischaemic left ventricular dysfunction, no changes in ventricular remodelling as assessed by left ventricular end systolic volume were detected with aliskiren compared to placebo on top of background therapy.
Maltese: Waqt studju li dam għaddej 36 ġimgħa fost 820 pazjent b'disfunzjoni iskemika tal-ventrikolu xellugi, ma deher l-ebda tibdil fl-immudellar mill-ġdid tal-ventrikolu li kien evalwat permezz talvolum sistoliku aħħari tal-ventrikolu xellugi b'aliskiren meta mqabbel mal-plaċebo fil-quċċata tatterapija ta' sfond.
English: Somnolence
Maltese: Assorbiment
English: , exanthema
Maltese: , edima
English: Rasilamlo 300 mg/10 mg film-coated tablets
Maltese: Rasilamlo 300 mg/10 mg pilloli Aliskiren/amlodipine
English: Therefore, in view of available data regarding aliskiren/ aliskiren,amlodipine / aliskiren, hydrochlorothiazide, the PRAC considered that changes to the product information were warranted.
Maltese: Għalhekk, fid-dawl tad-dejta disponibbli rigward aliskiren / aliskiren,amlodipine / aliskiren, hydrochlorothiazide, il-PRAC kien tal-fehma li l-bidliet fl-informazzjoni tal-prodott kienu ġustifikati.
English: The blood-pressure-lowering effect was sustained during long-term treatment, and was independent of age, gender, body mass index and ethnicity.
Maltese: L-effett li jbaxxi l-pressjoni nżamm waqt kura li ngħatat fit-tul, u ma kienx jiddependi mill-età, sess, indiċi talmassa tal-ġisem u etniċità.
English: Anaphylactic reactions a, hypersensitivity reactions a
Maltese: sensittività eċċessiva a
English: Rasilamlo 150 mg/5 mg film-coated tablets
Maltese: Rasilamlo 150 mg/5 mg pilloli Aliskiren/amlodipine
English: The study showed no benefit of aliskiren when administered on top of standard therapy for acute heart failure and an increased risk of cardiovascular events in patients with diabetes mellitus.
Maltese: L-istudju ma wera l-ebda benefiċċju meta mogħti mat-terapija standard għal insuffiċjenza akuta talqalb u wera żieda fir-riskju ta' episodji kardjovaskulari f'pazjenti bid-dijabete mellitus.
English: Posology in patients not adequately controlled with aliskiren or amlodipine monotherapy Rasilamlo 150 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg alone or with Rasilamlo 150 mg/5 mg.
Maltese: Rasilamlo 150 mg/10 mg jista' jingħata lil pazjenti li l-pressjoni tagħhom mhijiex ikkontrollata b'mod xieraq b'amlodipine 10 mg waħdu jew b'Rasilamlo 150 mg/5 mg.
English: If blood pressure remains uncontrolled after 4 to 6 weeks of therapy, the dose may be titrated up to a maximum of 300 mg aliskiren/10 mg amlodipine.
Maltese: Jekk il-pressjoni tibqa' mhix ikkontrollata wara bejn 4 u 6 ġimgħat ta' terapija, id-doża tista' tiżdied sa massimu ta' 300 mg aliskiren/10 mg amlodipine biex jinkiseb l-aħjar rispons.
English: Rasilamlo 300 mg/5 mg film-coated tablets
Maltese: Rasilamlo 300 mg/5 mg pilloli Aliskiren/amlodipine
English: Aliskiren has been studied in 1,864 patients aged 65 years or older, and in
Maltese: Aliskiren kien studjat f'1,864 pazjent ta' etajiet minn 65 sena 'l fuq, u f'426 pazjent ta' etajiet minn 75 sena 'l fuq.
English: Rasilamlo 150 mg/10 mg film-coated tablets
Maltese: Rasilamlo 150 mg/10 mg pilloli Aliskiren/amlodipine
English: Rasilamlo combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: aliskiren belongs to the class of direct renin inhibitors and amlodipine belongs to the calcium antagonist class.
Maltese: Rasilamlo huwa taħlita ta' żewġ komposti kontra l-pressjoni għolja b'mekkaniżmi li jikkumplimentaw lil xulxin biex jikkontrollaw il-pressjoni f'pazjenti bi pressjoni għolja naturali: aliskiren jagħmel parti minn klassi ta' inibituri indiretti ta' renin u amlodipine jagħmel parti millklassi ta' antagonisti tal-calcium.
English: Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25 and 2.5 mg/kg/day showed no evidence of carcinogenicity.
Maltese: Il-firien u l-ġrieden ikkurati b'amlodipine fid-dieta għal sentejn, f'konċentrazzjonijiet ikkalkulati biex jagħtu livelli ta' dożaġġ kuljum ta' 0.5, 1.25, u 2.5 mg/kg/ġurnata ma wrew l-ebda evidenza ta' karċinoġeniċità.
English: Clearance in rats aged 8 or 14 days was similar, but at these ages the clearance was only about 23% of clearance in rats aged 21 days and 16% of clearance in rats aged 28 days.
Maltese: It-tneħħija f'firien fl-età ta' 8 ijiem jew 14-il jum kienet simili, iżda f'dawn l-etajiet, it-tneħħija kienet biss madwar 23% tat-tneħħija f'firien fl-età ta' 21 jum u 16% tat-tneħħija f'firien fl-età ta' 28 jum.
English: Aliskiren monotherapy studies have shown blood-pressure-lowering effects comparable to other classes of antihypertensive medicinal products including selected ACEI and ARB.
Maltese: Tnaqqis simili deher meta aliskiren ingħata ma' prodotti mediċinali kontra l-pressjoni għolja oħrajn.
English: As with other medicinal products acting on the renin-angiotensinaldosterone system, angioedema or symptoms suggestive of angioedema (swelling of the face, lips, throat and/or tongue) have been reported in patients treated with aliskiren.
Maltese: Bħal bi prodotti mediċinali oħra li jaħdmu fuq is-sistema tar-renin -angiotensin-aldosterone, anġjoedima jew sintomi li jissuġġerixxu anġjoedima (nefħa fil-wiċċ, fixxofftejn, fil-gerżuma u/jew fl-ilsien) kienu rrappurtati f'pazjenti kkurati b'aliskiren.
English: Brown-yellow, convex, ovaloid tablet with a bevelled edge, with “T12” debossed on one side and
Maltese: Pillola safra fil-kannella, konvessa, forma ta' bajda b'ġenb tasturat, b'“T12” imnaqqxa fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: , altered bowel habits (including diarrhoea and constipation)
Maltese: , tibdil fid-drawwiet talippurgar (inkluż dijarea u stitikezza)
English: • inflammation of the gastric lining
Maltese: Disturbi gastro-intestinali Komuni
English: The incidence of adverse events did not show any association with gender, age, body mass index, race or ethnicity.
Maltese: Aliskiren huwa kura effettiva kontra l-pressjoni għolja li tingħata darba kuljum f'pazjenti adulti, ikun x'ikun is-sess, l-età, l-indiċi tal-massa tal-ġisem u l-etniċità.
English: Dark yellow, convex, ovaloid tablet with a bevelled edge, with “T11” debossed on one side and
Maltese: Pillola safra skura, konvessa, forma ta' bajda b'ġenb tasturat, b'“T11” imnaqqxa fuq naħa waħda u “NVR” fuq in-naħa l-oħra.
English: Exceptional cases of extrapyramidal syndrome have been reported.
Maltese: Amlodipine Każijiet eċċezzjonali tas-sindromu ekstrapiramidali kienu rrapurtati.
English: Vial (glass)
Maltese: Isem (ivvintat)
English: (Invented) name
Maltese: (konċentrazzjo ni)
English: 40 mg Powder for solution for injection
Maltese: EU/1/02/209/005 Dynastat 40 mg Trab għal soluzzjoni għall-injezzjoni
English: Ref.: EMEA/758620/2009 EMEA/H/C/557
Maltese: EMEA/758620/2009 EMEA/H/C/557
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@ema.europa.eu http://www.ema.europa.eu
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
English: Apidra insulin glulisine EPAR summary for the public
Maltese: Apidra insulina glulisina Sommarju tal-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the European Union for Apidra to Sanofi-Aventis Deutschland GmbH on 27 September 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Apidra lil Sanofi-Aventis Deutschland GmbH fis-27 ta' Settembru 2004.
English: In the first study of adults with type 1 diabetes, there was a decrease of 0.14% (from 7.60% to 7.46%) after six months, and a decrease of 0.14% for insulin lispro.
Maltese: Fl-ewwel studju ta' adulti bid-dijabete tat-tip 1, kien hemm tnaqqis b'0.14% (minn 7.60% għal 7.46%) wara sitt xhur, u tnaqqis ta' 0.14% għall-insulina lispro.
English: The active substance in Apidra, insulin glulisine, is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin glulisine.
Maltese: Is-sustanza attiva f'Apidra, insulina glulisina tiġi prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': din hija magħmula minn batterju li jkun irċieva ġene (DNA), li jwassal sabiex ikun kapaċi li jipproduċi l-insulina glulisina.
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni relatata mar-rakkomandazzjonijiet għas-CHMP, aqra dDiskussjoni Xjentifika (parti wkoll mill-EPAR).
English: In adults with type 2 diabetes, there was a decrease in HbA1c of 0.46% after six months of Apidra, compared with 0.30% for regular human insulin.
Maltese: F'adulti bid-dijabete tat-tip 2, kien hemm tnaqqis f'HbA1c ta' 0.46% wara sitt xhur ta' Apidra, meta mqabbel ma' 0.30% għall-insulina normali tal-bniedem.
English: Apidra is a solution for injection that contains the active substance insulin glulisine.
Maltese: Apidra huwa soluzzjoni għall-injezzjoni li fiha s-sustanza attiva insulina glulisina.
English: Similar reductions were seen in the second study in adults, which compared Apidra with regular human insulin.
Maltese: Tnaqqis simili deher fit-tieni studju ta' adulti, li qabbel Apidra ma' insulina normali tal-bniedem.
English: Apidra, used in combination with a long-acting insulin, has been studied in type 1 diabetes (when the body cannot produce insulin) in two studies involving a total of 1,549 adults and in one study involving 572 children and adolescents aged between four and 17 years.
Maltese: Apidra użat mal-insulina li taġixxi għal żmien twil, ġie studjat f'dawk tad-dijabete tat-tip 1 (meta lġisem ma jkunx jista' jipproduċi l-insulina) f'żewġ studji li kienu jinvolvi 1, 549 adult u fi studju ieħor li kien jinvolvi 572 tifel u tifla u adolexxent bejn erba' snin u 17-il sena.
English: What is the risk associated with Apidra?
Maltese: X'inhu r-riskju assoċjat ma' Apidra?
English: Apidra can also be injected into a vein, but this can only be done by a doctor or nurse.
Maltese: Apidra jista' jiġi injettat ġo vina wkoll, iżda dan jista' jsir biss minn tabib jew infirmiera.
English: Why has Apidra been approved?
Maltese: Għaliex ġie approvat Apidra?
English: It is supplied in vials, cartridges and prefilled disposable pens (OptiSet and SoloStar).
Maltese: Huwa pprovdut bħala kunjetti, skrataċ u pinen mimlija minn qabel (OptiSet u SoloStar).
English: What is Apidra?
Maltese: X'inhu Apidra?
English: In all four studies, Apidra was compared with other insulins or insulin analogues (regular human insulin or insulin lispro).
Maltese: Fl-erba' studji, Apidra tqabbel ma' insulini oħra jew analoġiji tal-insulina (insulina regolari talbniedem jew insulina lispro).
English: Apidra is given by injection under the skin in the abdominal wall (tummy), the thigh or the shoulder, or by continuous infusion using an insulin pump.
Maltese: Apidra jingħata minn taħt il-ġilda permezz ta' injezzjoni fil-parti addominali (iż-żaqq), fil-koxxa jew fl-ispalla, jew inkella permezz ta' infużjoni kontinwa bl-użu ta' pompa tal-insulina.
English: It may also be used in combination with antidiabetes medicines taken by mouth.
Maltese: Tista' tintuża wkoll ma' mediċini orali għal kontra d-dijabete.
English: How has Apidra been studied?
Maltese: Kif ġie studjat Apidra?
English: Insulin glulisine is very slightly different from human insulin.
Maltese: L-insulina glulisina hija ftit biss differenti mill-insulina tal-bniedem.
English: In type 2 diabetes (when the body is unable to use insulin effectively), Apidra has been studied in one study involving 878 adults.
Maltese: Fid-dijabete tat-tip 2 (meta l-ġisem ma jkunx jista' juża l-insulina b'mod effikaċi), Apidra ġie studjat fi studju wieħed li kien jinvolvi 878 adult.
English: The most common side effect with Apidra (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Maltese: L-iktar effett sekondarju komuni b'Apidra (li deher f'iktar minn pazjent 1 minn kull 10) hija lipogliċemija (livelli baxxi ta' glukożju fid-demm).
English: In the study in children and adolescents, Apidra and insulin lispro produced similar changes in HbA1c after six months.
Maltese: Fl-istudji fit-tfal u l-adolexxenti, Apidra u insulina lispro kellhom l-istess bidliet f'HbA1c wara sitt xhur.
English: The marketing authorisation is valid for an unlimited period.
Maltese: L-awtorizzazzjoni għattqegħid fis-suq hija valida għal perjodu mhux limitat.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Maltese: L-insulina ta' sostituzzjoni taġixxi bl-istess mod bħall-insulina prodotta naturalment u tgħin lill-glukożju jidħol fiċ-ċelloli mid-demm.
English: Apidra is a short-acting insulin that is used in combination with intermediate- or long-acting insulins or insulin analogues (modified forms of insulin).
Maltese: Apidra huwa insulina li taħdem għal żmien qasir li tintuża flimkien ma' insulina intermedja jew li tkun taġixxi fuq żmien twil jew tip ta' insulina analoga (forom modifikati ta' insulina).
English: Control(2)
Maltese: Kontroll(2)
English: Clinical AOM
Maltese: AOM klinika
English: Control vaccine N=10,201
Maltese: Vaċċin ta' kontroll N=10,201
English: (4) Not statistically significant.
Maltese: Mhux statistikament sinifikanti.
English: Bacteria can be responsible for 60-70% of clinical episodes of AOM.
Maltese: Batterja għandu mnejn tkun responsabbli għal 60-70% ta' l-episodji kliniċi ta' AOM.
English: Immunosuppressive therapy and immunodeficiency
Maltese: Terapija immunosoppressiva u immunodefiċjenza
English: For adsorbent, see section 2.
Maltese: Għall-adsorbent, ara sezzjoni 2.
English: Acute Otitis Media (AOM)
Maltese: Otite Medja Akuta (AOM)
English: IPD due to individual serotypes(4) - 6B
Maltese: IPD minħabba serotipi individwali(4) - 6B
English: Type of IPD
Maltese: Tip ta' IPD
English: N=10,295
Maltese: Synflorix N=10,295
English: Synflorix does not provide protection against other microorganisms.
Maltese: Synflorix ma jipprovdix protezzjoni kontra mikro-organiżmi oħra.
English: Table 3: Vaccine efficacy against AOM(1) in COMPAS
Maltese: Tabella 3: Effikaċja tal-vaċċin kontra AOM(1) f'COMPAS