FrancophonIA/ELRC3.0 huggingface dataset:
English: • Itchy skin; rash; itching of the body; skin peeling; dry skin; hair loss; redness of the skin including the hands and body; acne.
Maltese: • Ġilda bil-ħakk; raxx; ; raxx; ħakk tal-ġisem; tqaxxir tal-ġilda; ġilda xotta; telf ta' xagħar; ħmura tal-ġilda inkluż fl-idejn u l-ġisem; akne.
English: Healthcare professions should be aware that elderly patients may be at increased risk of adverse reactions.
Maltese: Professjonijiet tas-saħħa għandhom ikunu konxji li l-pazjenti anzjani jistgħu jkunu f'riskju akbar ta' reazzjonijiet avversi.
English: Clinical studies with tivozanib were conducted in RCC patients with serum creatinine concentration ≤ 2 times the upper limit of normal, including those who may have had a prior nephrectomy.
Maltese: Studji kliniċi b'tivozanib saru f'pazjenti b'RCC b'konċentrazzjoni ta' kreatinina fis-serum ≤ darbtejn mill-limitu ogħla tan-normal, inklużi dawk li setgħu kellhom nefrektomija minn qabel.
English: anus, adrenal gland.
Maltese: Tfal u adolexxenti
English: • ketoconazole (an antifungal)
Maltese: • ketoconazole (antifungali)
English: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (mucormycosis)
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (mukormikożi)
English: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (invasive aspergillosis)
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (asperġillożi invażiva)
English: The active substance in Cresemba, isavuconazole, belongs to the ‘triazole' class of antifungal medicines.
Maltese: Is-sustanza attiva f'Cresemba, isavuconazole, tagħmel parti mill-klassi 'triazole' tal-mediċini antifungali.
English: Other information about Cresemba
Maltese: Informazzjoni oħra dwar Cresemba
English: • high-dose ritonavir (an HIV medicine)
Maltese: • ritonavir (mediċina kontra l-HIV) f'doża għolja
English: Regarding safety, Cresemba was relatively well tolerated.
Maltese: Fir-rigward tas-sigurtà, Cresemba ġeneralment ġie tollerat sew.
English: The most common side effects with Cresemba (seen in more than 10% of patient studied) were: abnormal liver tests, nausea, vomiting, difficulty breathing, abdominal pain, diarrhea, injection site reactions, headache, low blood potassium and skin rash.
Maltese: L-effetti sekondarji l-aktar komuni b'Cresemba (li dehru f'anqas minn 10% tal-pazjenti li ġew studjati) kienu: testijiet tal-fwied mhux normali, nawsja, rimettar, diffikultà fit-teħid tan-nifs, uġigħ addominali, dijarea, reazzjonijiet fis-sit tal-injezzjoni, uġigħ ta' ras, livell baxx ta' potassju fid-demm u raxx filġilda.
English: This is a summary of the European public assessment report (EPAR) for Cresemba.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cresemba.
English: Cresemba contains the active substance isavuconazole.
Maltese: Cresemba fih is-sustanza attiva isavuconazole.
English: In a main study of 516 patients with invasive aspergillosis, the mortality rate at 42 days was similar in patients treated with Cresemba (19%) and those treated with another antifungal medicine voriconazole (20%).
Maltese: Fi studju ewlieni f'516-il pazjent b'asperġillożi invażiva, ir-rata ta' mortalità wara 42 jum kienet simili f'pazjenti kkurati b'Cresemba (19%) u f'dawk ikkurati b'mediċina antifungali oħra voriconazole (20%).
English: The dosage for the infusions and capsules are the same: 200 mg every 8 hours for the first 48 hours, followed by a 200-mg maintenance dose once a day.
Maltese: Id-dożaġġ għall-infużjonijiet u l-kapsuli huwa l-istess: 6 dożi ta' 200 mg kull 8 sigħat għal 48 siegħa, segwiti minn doża ta' manteniment ta' 200 mg darba kuljum.
English: What are the risks associated with Cresemba?
Maltese: X'inhuma r-riskji assoċjati ma' Cresemba?
English: It works by disrupting the formation of ergosterol, an important component of fungal cell membranes.
Maltese: Din taħdem billi timpedixxi l-formazzjoni ta' ergosterol, li huwa komponent importanti talmembrani taċ-ċelloli fungali.
English: Why is Cresemba approved?
Maltese: Għaliex ġie approvat Cresemba?
English: It must also not be used in patients with familial short QT syndrome, a heart rhythm problem.
Maltese: Ma għandux jintuża wkoll f'pazjenti b'sindrome ta' QT qasir familjali, problema fir-ritmu tal-qalb.
English: Another study included 146 patients, among which 37 patients had mucormycosis and were treated with Cresemba; in patients with mucormycosis the mortality rate after 84 days was 43%, which is similar to rates seen in the published literature for standard treatments with amphotericin-B.
Maltese: Studju ieħor ewlieni inkluda 146 pazjent b'asperġillożi invażiva jew mukormikożi, li fostom 37 pazjent kellhom mukormikożi u ġew ikkurati b'Cresemba; f'pazjenti b'mukormikożi r-rata ta' mortalità wara 84 jum kienet 43%.
English: The full EPAR and risk management plan summary for Cresemba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For mucormycosis, Cresemba is used when amphotericin B is inappropriate.
Maltese: Għal mukormikożi, Cresemba jintuża meta amphotericin B mhuwiex adegwat.
English: Cresemba isavuconazole
Maltese: Sommarju tal-EPAR għall-pubbliku isavuconazole
English: It is possible to switch between the infusion and the oral capsule if needed.
Maltese: Huwa possibbli li teqleb bejn l-infużjoni u l-kapsula orali jekk ikun meħtieġ.
English: Because the number of patients with these diseases is low, they are considered ‘rare', and Cresemba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 June 2014 (for mucormycosis) and 4 July 2014 (for aspergillosis).
Maltese: Peress li n-numru ta' pazjenti li jbatu minn dan il-mard huwa baxx, huma ġew ikkunsidrati bħala ‘rari', u Cresemba ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl-4 ta' Ġunju 2014
English: Cresemba is an antifungal medicine used to treat adults with either of two life-threatening fungal infections: invasive aspergillosis and mucormycosis.
Maltese: Cresemba huwa mediċina antifungali li tintuża fil-kura ta' adulti b'waħda minn dawn l-infezzjonijiet fungali ta' periklu għall-ħajja: asperġillożi invażiva u mukormikożi.
English: A risk management plan has been developed to ensure that Cresemba is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Cresemba jintuża bl-aktar mod sigur possibbli.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Cresemba can be found on the Agency's website:
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Cresemba jinstab fis-sit elettroniku tal-Aġenzija:
English: Cresemba is available as a powder used to make a solution for infusion (drip) into a vein and as capsules to be taken by mouth.
Maltese: Cresemba huwa disponibbli bħala trab li jitħallat f'soluzzjoni għal infużjoni (dripp) ġol-vina u bħala kapsuli li jittieħdu mill-ħalq.
English: CYP3A4/5, see the package leaflet).
Maltese: • ċerti mediċini li jżidu t-tkissir ta' isavuconazole fil-ġisem (indutturi qawwija ta' CYP3A4/5, ara l fuljett ta' tagħrif).
English: Invasive aspergillosis and mucormycosis are life-threatening infections associated with high mortality.
Maltese: Asperġillożi invażiva u mukormikożi huma infezzjonijiet ta' periklu għall-ħajja assoċjati ma' mortalità għolja.
English: Although amphotericin B is the first line treatment for mucormycosis, there is a need for alternative treatments and Cresemba will benefit patients for whom amphotericin B is not appropriate.
Maltese: Għalkemm amphotericin B huwa l-kura ppreferuta għal mukormikożi, hemm bżonn ta' kuri alternattivi u Cresemba ser ikun ta' benefiċċju għal pazjenti li amphotericin B mhuwiex xieraq għalihom.
English: Studies show that survival following treatment with Cresemba is similar to that seen with other treatments.
Maltese: Studji wrew li s-sopravivenza wara kura b'Cresemba hija simili għal dik osservata b'kuri oħrajn.
English: What benefits of Cresemba have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Cresemba li ħarġu mill-istudji?
English: {Name and address} {tel} {fax} {e-mail}
Maltese: [Isem u indirizz] {telefon} {fax} {e-mail}
English: 1070 Bruxelles Belgium
Maltese: 1070 Bruxelles
English: - Martindale: The Complete Drug Reference 36.
Maltese: The Complete Drug Reference 36.
English: indometacin and ibuprofen.
Maltese: indometacin u ibuprofen.
English: - Aldosterone antagonists.
Maltese: - Antagonisti ta' aldosterone.
English: - Sympathomimetics.
Maltese: - Simpatomimetiċi.
English: Glossitis, pancreatitis
Maltese: Glossite, pankreatite
English: 2040 / Budaörs Hungary
Maltese: 2040 / Budaörs L-Ungerija
English: Roche Bulgaria EOOD 16, Bvalo pole Str. 1618 / Sofia Bulgaria
Maltese: Roche Bulgaria EOOD 16, Bvalo pole Str. 1618 / Sofia Il-Bulgarija
English: - Anaesthetics, narcotics.
Maltese: - Anestetiċi, narkotiċi.
English: Roche Nederland BV Beneluxlaan 2A 3446 GG Woerden Netherlands
Maltese: Roche Nederland BV Beneluxlaan 2A 3446 GG Woerden L-Olanda
English: Roche Farma S.A. Eucalipto n° 33 28016 / Madrid Spain
Maltese: Roche Farma S.A. Eucalipto n° 33 28016 / Madrid Spanja
English: (a) Summary of the safety profile
Maltese: (a) Sommarju tal-profil tas-sigurtà
English: Roche S.p.A Via G.B Stucchi 110 20052/Monza Italy
Maltese: Roche S.p.A Via G.B Stucchi 110 20052/Monza L-Italja
English: Domaniewska 39B 02-672 / Warsaw Poland
Maltese: Ul. Domaniewska 39B 02-672 / Warsaw Il-Polonja
English: - Tricyclic antidepressants, antipsychotics.
Maltese: - Antidepressanti triċikliċi, antipsikotiċi.
English: Uncommon ≥ 1/1,000 and < 1/100
Maltese: ≥ 1/1,000 u <1/100
English: Common ≥ 1/100 and < 1/10
Maltese: ≥ 1/100 u < 1/10
English: Roche Pharma AG Emil-Barell-Strasse 1 79639/Grenzach Germany
Maltese: Roche Pharma AG Emil-Barell-Strasse 1 79639/Grenzach Il-Ġermanja
English: - Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions 2006.
Maltese: - Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and
English: Roche Austria GmbH, Engelhorngasse 3, A - 1211 Vienna Austria
Maltese: Roche Austria GmbH, Engelhorngasse 3, A - 1211 Vienna L-Awstrija
English: - Medicines called ‘non-steroidal anti-inflammatory drugs' (NSAIDs).
Maltese: - Mediċini msejħa ‘mediċini anti-infjammatorji mhux sterojdi' (NSAIDs).
English: 11 avenue Dubonnet 92 400 Courbevoie France
Maltese: Immeuble le Doublon, bâtiment B 11 avenue Dubonnet 92 400 Courbevoie Franza
English: Czech Republic Roche s.r.o.
Maltese: Ir-Repubblika Ċeka Roche s.r.o.
English: Estrada Nacional 249-1 2720-413 / Amadora Portugal
Maltese: 2720-413 / Amadora
English: EXPIRY DATE [To be completed nationally] EXP {MM YYYY}
Maltese: DATA TA' META JISKADI [Biex timtela mill-pajjiż partikolari] EXP {MM YYYY}
English: Surgery/anaesthesia
Maltese: Kirurġija/anestesija
English: These include aspirin,
Maltese: Dawn jinkludu aspirin,
English: Diuretics (thiazide or loop diuretics)
Maltese: Dijuretiċi (thiazide jew loop)
English: Greece, Ireland, United Kingdom: Vascace Italy, Portugal: Inibace
Maltese: Il-Greċja, L-Irlanda, Vereinigtes Königreich: Vascace L-Italja, Il-Portugall:
English: Vascace was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Maltese: Vascace kien inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi talProdott (SPC), imfassla mis-CMD(h), f'konformità mal-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendat.
English: If possible, diuretic therapy should be discontinued temporarily.
Maltese: Jekk possibbli, terapija b'dijuretiċi għandha titwaqqaf temporanjament.
English: Anaphylaxis (see section 4.4)
Maltese: Anafilassi (ara sezzjoni 4.4)
English: Pharmacotherapeutic group: ACE inhibitor, ATC code: C09AA08
Maltese: Inibitur ta' ACE, Kodiċi ATC: C09AA08
English: Austria: Inhibace "Roche"
Maltese: Inhibace „Roche“
English: Myocardial ischaemia, angina pectoris, tachycardia, palpitations Rare
Maltese: Iskemija mijokardijaka, anġina pectoris, takikardija, palpitazzjonijiet Rari
English: Serum potassium
Maltese: Potassju fis-serum
English: Although the study by Carlsen et al (Carlsen JE, Buchmann M, Hoeglund C, Pellinen T, Honkanen T, Soerensen OH, et al. 24-hour antihypertensive effect of oral cilazapril?
Maltese: Għalkemm l-istudju ta' Carlsen et al (Carlsen JE, Buchmann M, Hoeglund C, Pellinen T, Honkanen T, Soerensen OH, et al. 24-hour antihypertensive effect of oral cilazapril? A placebo-controlled study evaluating 1, 2.5 and 5mg once daily.
English: The recommended treatment of overdosage is intravenous infusion of sodium chloride 9 mg/ml (0.9%) solution.
Maltese: Il-kura rrakkomandata ta' doża eċċessiva hija infużjoni fil-vini ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride.
English: Rash, maculopapular rash
Maltese: Raxx, raxx makulopapulari
English: (b) Tabulated list of adverse reactions
Maltese: (b) Lista f'tabella ta' reazzjonijiet avversi
English: The active substance of Vascace tablets is cilazapril.
Maltese: Is-sustanza attiva tal-pilloli Vascace hija cilazapril.
English: Severe reactions:
Maltese: Reazzjonijiet severi:
English: Myocardial infarction, arrhythmia
Maltese: Infart mijokardijaku, arritmija
English: Psoriaform dermatitis, psoriasis (exacerbation), lichen planus, exfoliative dermatitis, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous pemphigoid, pemphigus, Karposi's sarcoma, vasculitis/purpura, photosensitivity reactions, alopecia, onycholysis Musculoskeletal and connective tissue disorders Uncommon
Maltese: Dermatite psoriaformi, psorjasi (irkadar), lichen planus, dermatite esfoljattiva, urtikarja, eritema multiforme, sindrome ta' Stevens-Johnson, nekrolisi epidermali tossika, bullous pemphigoid, pemphigus, sarkoma ta' Karposi, vaskulite/purpura, reazzjonijiet ta' fotosensittività, alopeċja, onikolisi
English: Estimates of frequency are based on the proportion of patients reporting each adverse reaction during cilazapril clinical trials that included a total combined population of 7171 patients.
Maltese: Stimi ta' frekwenza huma bbażati fuq ilproporzjon ta' pazjenti li rappurtaw kull reazzjoni avversa waqt il-provi kliniċi b'cilazapril li inkludew popolazzjoni kombinata totali ta' 7171 pazjent.
English: Hypersensitivity/angioedema
Maltese: Sensittività eċċessiva/anġjoedima
English: Aortic stenosis/hypertrophic cardiomyopathy
Maltese: Stenożi aortika/kardjomijopatija ipertrofika
English: Roche Products Ltd 6 Falcon Way, Shire Park Welwyn Garden City / AL7 1TW
Maltese: Roche Products Ltd 6 Falcon Way, Shire Park Welwyn Garden City / AL7 1TW Ir-Renju Unit
English: Belgium, Bulgaria, Czech Republic, Hungary, Luxembourg, Poland, Spain: Inhibace France: Justor
Maltese: Il-Belġju, Il-Bulgarija, Ir-Repubblika Ċeka, L-Ungerija, Il-Lussemburgu, Il-Polonja, Spanja:
English: Other possible side effects:
Maltese: Effetti sekondarji oħra possibbli:
English: Dyspnoea, bronchospasm, rhinitis
Maltese: Qtugħ ta' nifs, bronkospażmu, rinite
English: Maximal dose of Vascace
Maltese: Doża massima ta' Vascace
English: Most ACE inhibitors (e.g. captopril, cilazapril, enalapril, ramipril, perindopril, trandolapril, benazepril) were shown to have beneficial action on hard and intermediete outcomes in patients with chronic heart failure.
Maltese: Il-parti l-kbira tal-inibituri ACE (eż. captopril, cilazapril, enalapril, ramipril, perindopril, trandolapril, benazepril) intwerew li għandhom azzjoni benefika fuq riżultati iebsin u intermedji f'pazjenti b'insuffiċjenza kronika tal-qalb.
English: In a careful literature search, covering the time period up to November 2009, only a single publication was identified, describing a case report of a patient with diabetic nephropathy and cirrhotic ascites.
Maltese: F'riċerka attenta tal-letteratura, li tkopri l-perijodu ta' żmien sa Novembru 2009, ġiet identifikata biss pubblikazzjoni waħda, li tiddeskrivi rapport ta' każ ta' pazjent b'nefropatija dijabetika u axxite ċirrotika.
English: All adverse drug reactions (ADRs) listed in the company reference safety information, the Core Data Sheet (CDS) have been included.
Maltese: Ir-reazzjonijiet avversi kollha tal-mediċina (ADRs) elenkati fl-informazzjoni tas-sigurtà ta' referenza tal-kumpanija, id-Dokument tad-Dejta Bażika (Core Data Sheet - CDS) ġew inklużi.
English: Tricyclic antidepressants/antipsychotics/anesthetics/narcotics Concomitant use of certain anesthetic medicinal products, tricyclic antidepressants and antipsychotics with ACE inhibitors may result in further reduction of blood pressure (see section 4.4).
Maltese: Antidepressanti triċikliċi/antipsikotiċi/anestetiċi/narkotiċi L-użu ta' ċerti prodotti mediċinali anestetiċi, antidepressanti triċikliċi u antipsikotiċi flimkien ma' inibituri ta' ACE jista' jwassal għal aktar tnaqqis fil-pressjoni tad-demm (ara sezzjoni 4.4).
English: Vascace contains a medicine called cilazapril.
Maltese: Vascace fih mediċina msejħa cilazapril.
English: A variant form is angioedema of the intestine, which tends to occur within the first 24-48 hours of treatment.
Maltese: Forma differenti hija anġjoedima talmusrana, li għandha tendenza li sseħħ fl-ewwel 24-48 siegħa ta' kura.
English: Non-steroidal anti-inflammatory medicinal products (NSAIDs) including aspirin  3 g/day When ACE inhibitors are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Maltese: Prodotti mediċinali anti-infjammatorji mhux sterojdi (NSAIDs) inkluż aspirin  3 g/kuljum Meta inibituri ta' ACE jingħataw flimkien ma' mediċini anti-infjammatorji mhux sterojdi (i.e. acetylsalicylic acid f'korsijiet ta' dożaġġ kontra l-infjammazzjoni, inibituri ta' COX-2 u NSAIDs mhux selettivi), jista' jkun hemm tnaqqis fl-effett ta' tnaqqis fil-pressjoni għolja.
English: “Vascace is indicated for the treatment of chronic heart failure.”
Maltese: “Vascace huwa indikat għat-trattament ta' insuffiċjenza kronika tal-qalb.”
English: - Steroide medicines (such as hydrocortisone, prednisolone and dexamethasone) or other medication which suppress the immune system.
Maltese: - Sterojdi (bħal hydrocortisone, prednisolone u dexamethasone) jew xi medikazzjoni oħra li tissopprimi s-sistema immuni.
English: MedDRA System Organ Class (SOC) and Preferred Terms (PTs) are used where appropriate.
Maltese: Is-Sistema tal-Klassi tal-Organi tal-MedDRA (SOC) u t-Termini Preferuti (PTs) jintużaw fejn hu xieraq.
English: 4.9 Overdose
Maltese: 4.9 Doża eċċessiva
English: Second and third trimesters of pregnancy (see section 4.4. and 4.6)”
Maltese: It-tieni u t-tielet trimestri tat-tqala (ara sezzjoni 4.4. u 4.6)”
English: Section 4.4 - Special warnings and precautions for use With a few exceptions, the scientific basis for the proposed text in Section 4.4 is provided by reviews of adverse effects of ACE inhibitors found in the following texts: Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions 2006 and the Martindale: The Complete Drug Reference 36.
Maltese: Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions 2006 ta' Meyler u: The Complete Drug Reference 36 ta' Martindale.
English: Abnormal liver function test (including transaminases, bilirubin, alkaline phosphatase, gamma GT) Cholestatic hepatitis with or without necrosis
Maltese: Test tal-funzjoni tal-fwied mhux normali (inkluż transaminases, bilirubin, alkaline phosphatase, gamma GT)
English: Pacemaker therapy is indicated for therapy-resistant bradycardia.
Maltese: Terapija b'pacemaker hija indikata għall-bradikardija reżistenti għat-terapija.
English: Gynaecomastia
Maltese: Ginekomastja
English: Neutropenia, agranulocytosis, thrombocytopenia, anaemia Immune system disorders
Maltese: Newtropenija, agranuloċitosi, tromboċitopenija, anemija Disturbi fis-sistema immuni
English: Rare (affects less than 1 in 1'000 people)
Maltese: Rari (jaffettwa inqas minn persuna waħda minn kull 1,000 persuna)
English: Hyperkalaemia, hyponatraemia, proteinuria, nephrotic syndrome, nephritis Reproductive and breast disorders
Maltese: Iperkalimja, iponatrimija, protenurja, sindrome nefrotiku, nefrite Disturbi fis-sistema riproduttiva u fis-sider
English: Cerebral ischaemia, transient ischaemic attack, ischaemic stroke Peripheral neuropathy
Maltese: Iskemija ċerebrali, attakk iskemiku temporanju, puplesija iskemika Newropatija periferali
English: Cilazapril belongs to the family of angiotensin converting enzyme (ACE) inhibitors.
Maltese: Cilazapril jagħmel parti mill-familja ta' inibituri tal-enżima li tikkonverti l-angiotensin (ACE).
English: Inhibace "Roche" 0,5 mg - Filmtabletten
Maltese: Inhibace "Roche" 0,5 mgFilmtabletten
English: Vascace and associated names (see Annex I) 0.5 mg film-coated tablets Vascace and associated names (see Annex I) 1 mg film-coated tablets Vascace and associated names (see Annex I) 2.5 mg film-coated tablets Vascace and associated names (see Annex I) 5 mg film-coated tablets [See Annex I - To be completed nationally]
Maltese: Vascace u ismijiet assoċjati (Ara Anness I) 0.5 mg pilloli miksija b'rita Vascace u ismijiet assoċjati (Ara Anness I) 1 mg pilloli miksija b'rita Vascace u ismijiet assoċjati (Ara Anness I) 2.5 mg pilloli miksija b'rita Vascace u ismijiet assoċjati (Ara Anness I) 5 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Netherlands: Vascase
Maltese: Vascase
English: However, racial differences in response are no longer evident when Vascace is administered in combination with hydrochlorothiazide.
Maltese: Madankollu, id-differenzi razzjali fir-rispons ma jibqgħux evidenti meta Vascace jingħata flimkien ma' hydrochlorothiazide.
English: Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.
Maltese: Is-sintomi assoċjati ma' doża eċċessiva ta' inibituri ACE jistgħu jinkludu pressjoni baxxa, xokk ċirkolatorju, disturbi tal-elettroliti, indeboliment renali, iperventilazzjoni, takikardija, palpitazzjonijiet, bradikardija, sturdament, ansjetà u sogħla.
English: Hypotension, postural hypotension (see section 4.4).
Maltese: Pressjoni baxxa, pressjoni baxxa mal-waqfien (ara sezzjoni 4.4).
English: Inhibace "Roche" 2,5 mg - Filmtabletten
Maltese: Inhibace "Roche" 2,5 mgFilmtabletten
English: Germany: Dynorm
Maltese: Isem (Ivvintat)
English: Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Maltese: L-espożizzjoni għat-terapija bl-inibituri ACE matul it-tieni u t-tielet trimestri hija magħrufa li tikkawża il-fetotossiċità umana (tnaqqis tal-funzjoni renali, oligohydramnios, dewmien flossifikazzjoni tal-kranju)u tossiċità fit-trabi tat-twelid (indeboliment renali, pressjoni baxxa, hyperkalaemia).
English: Section 5.3 - Preclinical safety data
Maltese: Sezzjoni 5.3 - Dejta dwar is-sigurtà preklinika
English: (It is also better to avoid Vascace in early pregnancysee the sections on ‘Pregnancy' and ‘Breast-feeding'.)
Maltese: (Ikun aħjar ukoll li tevita' Vascace fi tqala bikrija - ara s-sezzjonijiet dwar ‘Tqala' u ‘Treddigħ').
English: - Soreness of your tongue - Pancreatitis (inflammation of the pancreas).
Maltese: - Uġigħ fl-ilsien - Pankrejatite (infjammazzjoni tal-frixa).
English: Hereditary or idiopathic angioedema
Maltese: Anġjoedima ereditarja jew idjopatika