FrancophonIA/ELRC3.0 huggingface dataset:
English: On 30 November 2017 the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Esmya and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Fit-30 ta' Novembru 2017, il-Kummissjoni Ewropea tat bidu għal proċedura skont l-Artikolu 20 tarRegolament (KE) Nru 726/2004 bħala riżultat tad-data dwar il-farmakoviġilanza, u talbet lill-PRAC jivvaluta l-impatt tat-tħassib ta' hawn fuq dwar il-bilanċ bejn il-benefiċċju u r-riskju ta' Esmya u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjonijiet rilevanti għat-tqegħid fis-suq għandhomx jinżammu, jiġu varjati, sospiżi jew revokati.
English: The therapeutic indication for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on results from another study providing data for up to 4 intermittent treatment courses of 3 months each with ulipristal acetate along with data for repeated treatment courses from the previous studies.
Maltese: L-indikazzjoni terapewtika għall-kura intermittenti ta' sintomi moderati sa severi ta' fibrojdi fl-utru f'nisa adulti ta' età riproduttiva ġiet ibbażata fuq ir-riżultati minn studju ieħor li pprovda data għal sa 4 korsijiet ta' kura intermittenti ta' 3 xhur kull wieħed b'ulipristal acetate flimkien ma' data għal korsijiet ta' kura ripetuti mill-istudji preċedenti.
English: In patients suffering from heavy menstrual bleeding associated with uterine fibroids, repeated 3-month treatment courses with ulipristal acetate provide a medical alternative to surgery and have the potential to reduce the need for surgical intervention.
Maltese: F'pazjenti li jbatu minn ħafna fsada tal-menstruwazzjoni assoċjata ma' fibrojdi fl-utru, korsijiet ta' kura ta' 3 xhur ripetuti b'ulipristal acetate jipprovdu alternattiva medika għall-kirurġija u għandhom il-potenzjal li jnaqqsu lħtieġa għal intervent kirurġiku.
English: The PRAC considered the potential risk of hepatotoxicity of the product, together with the fact that Esmya is a symptomatic treatment and not curative, that has the potential to reduce the need for surgical intervention.
Maltese: Il-PRAC ikkunsidra r-riskju potenzjali tal-epatotossiċità tal-prodott, flimkien mal-fatt li Esmya huwa kura sintomatika u mhux kurattiva, li għandu l-potenzjal li jnaqqas il-ħtieġa għal intervent kirurġiku.
English: The absence of findings in clinical trials has to be interpreted with caution as abnormal values of ALT/AST was an exclusion criterion as per protocols
Maltese: In-nuqqas ta' sejbiet fil-provi kliniċi għandu jiġi interpretat b'kawtela peress li l-valuri anormali tal-ALT/AST kienu kriterju ta' esklużjoni skont il-protokolli.
English: The above provisional measures should be reflected in the terms of the marketing authorisation, including the product information of Esmya, and communicated to HCPs via a DHPC.
Maltese: Il-miżuri proviżorji ta' hawn fuq għandhom jiġu riflessi fit-termini tal-awtorizzazzjoni għat-tqegħid fissuq, inkluż l-informazzjoni dwar il-prodott ta' Esmya, u għandhom jiġu kkomunikati lill-HCPs permezz ta' DHPC.
English: No signal of hepatic toxicity was identified during the review of non-clinical or clinical trials of Esmya inducing hepatic toxicity.
Maltese: Ma ġie identifikat l-ebda sinjal ta' tossiċità epatika waqt ir-rieżami ta' provi mhux kliniċi u ta' provi kliniċi ta' Esmya inkluż tossiċità epatika.
English: • During the ongoing review of safety and efficacy data in relation to the overall risk of liver injury with Esmya, the PRAC reviewed all data currently available from post-marketing settings and from clinical trials as well as the responses provided by the marketing authorisation holder on cases of serious liver injury reported with Esmya.
Maltese: • Waqt ir-rieżami li għadu għaddej tad-data dwar is-sigurtà u l-effikaċja fir-rigward tar-riskju globali ta' ħsara fil-fwied b'Esmya, il-PRAC irrieżamina d-data kollha disponibbli attwalment minn ambjenti ta' wara t-tqegħid fis-suq u minn provi kliniċi kif ukoll it-tweġibiet ipprovduti mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq dwar każijiet ta' ħsara serja fil-fwied irrappurtati b'Esmya.
English: PRAC reviewed all data currently available from post-marketing settings and from clinical trials as well as the responses provided by the marketing authorisation holder on cases of serious liver injury reported with Esmya.
Maltese: Għalkemm ma jistgħux jinstiltu konklużjonijiet konkreti li dawn il-każijiet ġew ikkawżati minn Esmya, id-data disponibbli tqajjem tħassib serju.
English: While the magnitude and nature (e.g. pattern of hepatotoxicity and possible mechanism of action) of the risk are being reviewed in depth, having considered the seriousness of the risk, the PRAC considered that the above raised a reasonable doubt that justifies adopting provisional measures in the meantime.
Maltese: Filwaqt li d-daqs u n-natura (eż. it-tendenza talepatotossiċità u l-mekkaniżmu ta' azzjoni possibbli) tar-riskju qegħdin jiġu rieżaminati fil-fond, wara li kkunsidra s-serjetà tar-riskju, il-PRAC qies li dan ta' hawn fuq qajjem dubju raġonevoli li jiġġustifika lfatt li sadanittant jiġu adottati miżuri proviżorji.
English: • The PRAC noted that four cases of acute liver failure leading to liver transplantation including one with fatal outcome have been reported with Esmya.
Maltese: • Il-PRAC innota li ġew irrappurtati total ta' erba' każijiet ta' insuffiċjenza akuta tal-fwied li wasslet għal trapjant tal-fwied inkluż wieħed b'riżultat fatali.
English: A fourth case of hepatic liver failure leading to transplantation was reported on 30th of January 2018.
Maltese: Fit-30 ta' Jannar 2018, ġie rrappurtat ir-raba' każ ta' indeboliment tal-fwied epatiku li wassal għal trapjant.
English: It may harm them,
Maltese: Onduarp kmieni fit-tqala
English: See section 3.
Maltese: Ara sezzjoni 3.
English: • Erythromycin (antibiotic).
Maltese: • Erythromycin (antibijotiku).
English: • Diltiazem (cardiac medicine).
Maltese: • Diltiazem (mediċina kardijaka).
English: • Rifampicin, St. John's wort.
Maltese: • Rifampicin, St.
English: Absolute bioavailability has been estimated to be between 64 and 80%.
Maltese: Il-bijodisponibilità assoluta kienet stmata li hi bejn 64 u 80%.
English: −24.7/−20.2 mmHg (40 mg/10 mg) and −26.4/−20.1 mmHg (80 mg/10 mg).
Maltese: 7/20.2 mmHg (40 mg/10 mg) u -26.4/-20.1 mmHg (80 mg/10 mg).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 November 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24 ta' Novembru 2011
English: Grapefruit and grapefruit juice
Maltese: Grejpfrut u meraq tal-grejpfrut
English: PHARMACEUTICAL FORM AND CONTENTS 28 tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 28 pillola
English: Amlodipine exhibits linear pharmacokinetics.
Maltese: Amlodipine juri farmakokinetika lineari.
English: Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Maltese: Telmisartan fil-biċċa l-kbira tiegħu jeħel mal-proteini fil-plażma (>99.5%), primarjament malalbumina u alpha-1 acid glycoprotein.
English: Do not take Onduarp
Maltese: Tiħux Onduarp
English: Amlodipine is extensively (approximatively 90 %) metabolised by the liver to inactive metabolites.
Maltese: Amlodipine jiġi metabolizzat b'mod estensiv (madwar 90%) mill-fwied għal metaboliti inattivi.
English: (It is also better to avoid Onduarp in early pregnancysee Warnings and precautions and Pregnancy section.)
Maltese: (ara s-sezzjoni Twissijiet u prekawzjonijiet u s-sezzjoni dwar it-Tqala.)
English: Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist.
Maltese: Telmisartan hu attiv oralment u antagonist speċifiku ta' riċettur ta' angiotensin II (tip AT1).
English: • NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen),
Maltese: • NSAIDs (mediċini mhux sterojdi kontra l-infjammazzjoni, eż. aspirina jew ibuprofen), eparina,
English: Onduarp contains sorbitol.
Maltese: Onduarp fih sorbitol.
English: CYP3A4 inducers
Maltese: Inducers ta' CYP3A4
English: • Narrowing of the aorta (aortic stenosis).
Maltese: • Tidjiq tal-aorta (stenosi aortika).
English: Myocardial infarction, arrhythmia, ventricular tachycardia, atrial fibrillation
Maltese: Infart mijokardijaku, arritmija, takikardija ventrikulari, fibrillazzjoni atrijali
English: • Second and third trimesters of pregnancy (see sections 4.4 and 4.6)
Maltese: • It-tieni u t-tielet trimestri tat-tqala (ara sezzjonijiet 4.4 u 4.6)
English: heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Maltese: immunosoppressivi (eż. cyclosporin jew tacrolimus), u l-antibijotiku trimethoprim.
English: Paediatric population (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Maltese: Popolazzjoni pedjatrika (persuni li għandhom inqas minn 18-il sena) M'hemmx dejta farmakokinetika disponibbli fil-popolazzjoni pedjatrika.
English: Adverse reactions have been ranked under headings of frequency using the following convention: 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: Ir-reazzjonijiet avversi ġew ikklassifikati skont kategoriji ta' frekwenza bl-użu tal-konvenzjoni li ġejja: 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 magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Each tablet contains 168.64 mg sorbitol (E420).
Maltese: Kull pillola fiha 168.64 mg ta' sorbitol (E420).
English: Dyspnoea, rhinitis
Maltese: Jekk tieqaf tieħu Onduarp
English: Leukocytopenia, thrombocytopenia
Maltese: Lewkoċitopenija, tromboċitopenija
English: The most common adverse reactions were peripheral oedema and dizziness, see also section 4.8.
Maltese: L-iktar reazzjonijiet avversi komuni kienu edema periferali u sturdament, ara wkoll sezzjoni 4.8.
English: Anaemia Thrombocytopenia, eosinophilia
Maltese: Anemija Tromboċitopenija, eosinofilija
English: The mean absolute bioavailability for telmisartan is about 50 %.
Maltese: Il-medja talbijodisponibilità assoluta għal telmisartan hi ta' madwar 50%.
English: • ACE inhibitors, angiotensin II receptor antagonists, renin inhibitors.
Maltese: • Inibituri ta' ACE, antagonisti tar-riċettur ta' angiotensin II.
English: Amlodipine has been safely administered with digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicinal products (aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, ciclosporin, antibiotics and oral hypoglycaemic medicinal products.
Maltese: Amlodipine ingħata b'mod sigur flimkien ma' digoxin, warfarin, atorvastatin, sildenafil, prodotti mediċinali kontra l-aċidu (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine,
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanzi attivi, għal derivattivi ta' dihydropyridine, jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: Telmisartan is characterised by biexponential decay pharmacokinetics with a terminal elimination half-life of >20 hours.
Maltese: Telmisartan hu kkaratterizzat minn farmakokinetika b'decay bi-esponenzjali, b'half-life tat-tneħħija terminali ta' >20 siegħa.
English: The safety and tolerability of Onduarp has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine.
Maltese: Is-sigurtà u tollerabilità ta' Onduarp ġew evalwati f'ħames studji kliniċi kkontrollati fuq iktar minn 3500 pazjent, li iktar minn 2500 minnhom irċivew telmisartan flimkien ma' amlodipine.
English: Telmisartan has been studied in a large outcome study in 25,620 patients with high cardiovascular risk (ONTARGET).
Maltese: Telmisartan kien studjat fi studju kbir tat-tip outcome li sar fuq 25,620 pazjent b'riskju għoli kardjovaskulari (ONTARGET).
English: Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters and in a folding box containing 360 (4 x 90 x 1) tablets in aluminium/aluminium perforated unit dose blisters.
Maltese: Onduarp hu disponibbli f'kaxxa li tintewa li fiha 28 pillola f'folji tal-aluminju/aluminju u f'kaxxa li tintewa li fiha 360 (4 x 90 x 1) pillola f'folji perforati tal-aluminju/aluminju bl-unità tad-doża.
English: Each tablet contains 337.28 mg sorbitol (E420).
Maltese: Kull pillola fiha 337.28 mg ta' sorbitol (E420).
English: Onduarp is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Onduarp hu kontraindikat f'pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 4.3).
English: Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.
Maltese: Filwaqt li m'hemm l-ebda dejta epidemjoloġika kkontrollata dwar ir-riskju b'antagonisti tar-riċetturi ta' angiotensin II, riskji simili jistgħu jeżistu għal din il-klassi ta' prodotti mediċinali.
English: Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Maltese: Prodotti mediċinali jew klassijiet terapewtiċi ta' prodotti mediċinali li jistgħu jikkawżaw iperkalemija huma sostituti talmelħ li fihom potassium, dijuretiċi li jisperjaw potassium, inibituri ta' ACE, antagonisti tarriċetturi ta' angiotensin II, mediċini mhux sterojdi kontra l-infjammazzjoni (NSAIDs, li jinkludu inibituri COX-2 selettivi), eparina, immunosoppressivi (cyclosporin jew tacrolimus) u trimethoprim.
English: Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets or aluminium/aluminium perforated unit dose blisters (PA/Al/PVC/Al) in multipacks containing 360 (4 packs of 90 x 1) tablets.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folji tal-aluminju/aluminju (PA/Al/PVC/Al) f'kaxxa tal-kartun li jkun fiha 28 pillola jew folji perforati tal-aluminju/aluminju bl-unità tad-doża (PA/Al/PVC/Al) f'pakketti multipli li jkun fihom 360 (4 pakketti ta' 90 x 1) pillola.
English: Telmisartan is metabolised by conjugation to the glucuronide of the parent compound.
Maltese: Telmisartan hu metabolizzat permezz ta' konjugazzjoni għal glucuronide tal-kompost prinċipali.
English: Cardiac disorders bradycardia, palpitations
Maltese: Disturbi fil-qalb bradikardija, palpitazzjonijiet
English: • Simvastatin to treat elevated levels of cholesterol.
Maltese: • Simvastatin għall-kura ta' livelli għoljin ta' kolesterol.
English: Reproductive system, and breast disorders erectile dysfunction
Maltese: Disturbi fis-sistema riproduttiva u fis-sider anormalità erettili
English: Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 1,500 ml/min).
Maltese: Ittneħħija totali mill-plażma (Cltot) hi għolja (madwar 1,000 ml/min) meta mqabbla mal-fluss tad-demm tal-fwied (madwar 1,500 ml/min).
English: The antihypertensive efficacy of telmisartan is comparable to that of substances representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).
Maltese: telmisartan hi komparabbli ma' dik ta' mediċini li jirrappreżentaw kategoriji oħrajn ta' mediċini kontra l-pressjoni għolja (dan intwera fi provi kliniċi li qabblu telmisartan ma' amlodipine, atenolol, enalapril, hydrochlorothiazide, u lisinopril).
English: There is no data available regarding the effect of CYP3A4 inducers on amlodipine.
Maltese: M'hemm l-ebda dejta disponibbli dwar l-effett ta' inducers ta' CYP3A4 fuq amlodipine.
English: The overall incidence of adverse reactions with Onduarp in the clinical trial programme was low with only 12.7 % of patients on treatment experiencing adverse reactions.
Maltese: L-inċidenza totali ta' reazzjonijiet avversi b'Onduarp fil-programm ta' provi kliniċi kienet baxx bi 12.7% biss tal-pazjenti fuq il-kura li kellhom reazzjonijiet avversi.
English: −15.0/−10.6 mmHg with 40 mg/5 mg, 80 mg/5 mg versus −6.2/−5.7 mmHg, −11.1/−8.0 mmHg with amlodipine 5 mg and 10 mg and higher diastolic blood pressure control rates compared to the respective monotherapies were achieved (56.7 %, 63.8 % with 40 mg/5 mg and 80 mg/5 mg versus 42 %, 56.7 % with amlodipine 5 mg and 10 mg).
Maltese: 0/10.6 mmHg b'40 mg/5 mg, 80 mg/5 mg kontra -6.2/-5.7 mmHg, -11.1/-8.0 mmHg b'amlodipine 5 mg u 10 mg u nkisbu rati ogħla ta' kontroll ta' pressjoni tad-demm dijastolika meta mqabbla ma' mediċini rispettivi mogħtija waħidhom (56.7%, 63.8% b'40 mg/5 mg u 80 mg/5 mg kontra 42%, 56.7% b'amlodipine 5 mg u 10 mg).
English: Alopecia, purpura, skin discolouration, hyperhidrosis Angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity
Maltese: Anġjoedema, eritema multiforme, urtikarja, dermatite bil-qxur, sindrome ta' Stevens-Johnson, sensittività għad-dawl
English: Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.
Maltese: Amlodipine hu inibitur tal-influss tal-joni tal-calcium tal-grupp dihydropyridine (imblokkatur bil-mod tal-kanal jew antagonist tal-joni tal-calcium) u jinibixxi l-influss transmembrane tal-joni tal-calcium ġol-muskolu lixx kardijaku u vaskulari.
English: In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo (see section 5.1).
Maltese: Fi studju fit-tul, ikkontrollat bi plaċebo (PRAISE-2) dwar amlodipine f'pazjenti b'insuffiċjenza talqalb ta' etjoloġija mhux iskemika NYHA III u IV, amlodipine kien assoċjat ma' żieda fir-rapporti ta' edema pulmonari minkejja li ma kien hemm l-ebda differenza sinifikanti fl-inċidenza ta' aggravament ta' insuffiċjenza tal-qalb meta mqabbel ma' plaċebo (ara sezzjoni 5.1).
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability of telmisartan up to nearly 100 %.
Maltese: Studji dwar il-farmakokinetika f'pazjenti b'indeboliment tal-fwied urew żieda fil-bijodisponibilità assoluta ta' telmisartan bi kważi 100%.
English: In the factorial design trial the oedema rates were 1.3% with Onduarp 40 mg/5 mg and 80 mg/5 mg, 8.8 % with Onduarp 40 mg/10 mg and 80 mg/10 mg and 18.4 % with Amlodipine 10 mg.
Maltese: Fil-prova factorial design, irrati ta' edema kienu 1.3% b'Onduarp 40 mg/5 mg u 80 mg/5 mg, 8.8% b'Onduarp 40 mg/10 mg u 80 mg/10 mg u 18.4% b'Amlodipine 10 mg.
English: Hypersensitivity Metabolism and nutrition disorders Very rare:
Maltese: Sensittività eċċessiva Disturbi fil-metaboliżmu u n-nutrizzjoni Rari ħafna:
English: Studies with telmisartan in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji b'telmisartan fuq l-annimali wrew tossiċità riproduttiva (ara sezzjoni 5.3).
English: Pregelatinised starch
Maltese: • Pressjoni baxxa severa
English: In a subset of 1050 patients with moderate to severe hypertension (DBP ≥100 mmHg) 32.7 - 51.8 % responded sufficiently to monotherapy of either telmisartan or amlodipine.
Maltese: F'sottosett ta' 1050 pazjent bi pressjoni għolja minn moderata sa severa (DBP ≥100 mmHg) 32.7 - 51.8% irrispondew suffiċjentement għal telmisartan jew amlodipine mogħtija waħidhom.
English: Common side effects (may affect up to 1 in 10 people): Dizziness, ankle swelling (oedema).
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10 min-nies): Sturdament, nefħa fl-għekiesi (edema).
English: Automated ambulatory blood pressure monitoring (ABPM) performed in a subset of 562 patients confirmed the results seen with in-clinic systolic and diastolic blood pressure reductions consistently over the entire 24-hours dosing period.
Maltese: Monitoraġġ awtomatiku ambulatorju ta' pressjoni tad-demm (ABPM) li twettaq f'sottosett ta' 562 pazjent, ikkonferma r-riżultati li kienu osservati fil-klinika fi tnaqqis fil-pressjoni tad-demm sistolika u dijastolika b'mod konsistenti fuq perjodu kollu tad-dożaġġ ta' 24 siegħa.
English: • Lithium-containing medicines to treat some types of depression.
Maltese: • Mediċini li fihom il-lithium għall-kura ta' xi tipi ta' dipressjoni.
English: Experimental data indicate that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Maltese: Dejta sperimentali tindika li amlodipine jeħel kemm mas-siti ta' dihydropyridine kif ukoll ta' non-dihydropyridine.
English: Amlodipine has been studied in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Maltese: Amlodipine kien studjat f'pazjenti b'anġina kronika stabbli, anġina vażospastika u mard tal-arterja koronarja ddokumentat b'mod anġjografiku.
English: The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Maltese: Il-farmakokinetika ta' amlodipine mhijiex influwenzata b'mod sinifikanti minn indeboliment tal-kliewi.
English: Patients with rare hereditary problems of fructose intolerance should not take Onduarp.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallfructose, m'għandhomx jieħdu Onduarp.
English: In humans, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase.
Maltese: Fil- bnedmin, doża ta' 80 mg ta' telmisartan kważi tinibixxi kompletament iż-żieda fil-pressjoni taddemm ikkawżata minn angiotensin II.
English: In patients not controlled on amlodipine 5 mg the oedema rates were 4.4 % for 40 mg/5 mg and 80 mg/5 mg and 24.9 % for amlodipine 10 mg.
Maltese: F'pazjenti mhux ikkontrollati li kienu fuq amlodipine 5 mg, ir-rati ta' edema kienu ta' 4.4% għal 40 mg/5 mg u 80 mg/5 mg u 24.9% għal amlodipine 10 mg.
English: However, there may be a risk of prolonged delivery.
Maltese: Madankollu, jista' jkun hemm riskju ta' ħlas imtawwal.
English: When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6 % (40 mg dose) to approximately 19 % (160 mg dose).
Maltese: Meta telmisartan jittieħed mal-ikel, ittnaqqis taż-żona taħt il-kurva tal-konċentrazzjoni tal-plażma-żmien (AUC0-∞) ta' telmisartan ivarja minn madwar 6% (doża ta' 40 mg) sa madwar 19% (doża ta' 160 mg).
English: Immune system disorders Very rare:
Maltese: Disturbi fis-sistema immune Rari:
English: Co-administration of multiple doses of amlodipine with simvastatin 80 mg resulted in an increase in exposure to simvastatin up to 77 % compared to simvastatin alone.
Maltese: L-għoti flimkien ta' dożi multipli ta' amlodipine ma' simvastatin 80 mg irriżulta f'żieda fl-esponiment għal simvastatin ta' sa 77% meta mqabbel ma' simvastatin waħdu.
English: Hepato-biliary disorders Rare:
Maltese: Disturbi fil-qalb Rari:
English: Heart failure
Maltese: Indeboliment tal-vista
English: INFORMATION IN BRAILLE Onduarp 80 mg/5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Onduarp 80 mg/5 mg
English: INFORMATION IN BRAILLE Onduarp 80 mg/10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Onduarp 80 mg/10 mg