FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Vepured (which may affect more than 1 in 10 animals) are mild inflammation at the injection site that resolves within 3 days of vaccination without treatment, mild depression on the day of vaccination and an increase in body temperature of maximum 1.1 °C which returns to normal within 1 day.
Maltese: L-aktar effetti sekondarji komuni b'Vepured (li jistgħu jaffettwaw aktar minn annimal wieħed f'għaxra) huma infjammazzjoni mhux qawwija fis-sit tal-injezzjoni li tgħaddi fi żmien 3 ijiem mit-tilqim mingħajr trattament, dipressjoni ħafifa fil-jum tat-tilqim u żieda fit-temperatura tal-ġisem ta' massimu ta' 1.1 C li terġa' lura għan-normal fi żmien jum.
English: What are the risks associated with Vepured?
Maltese: X'inhuma r-riskji assoċjati ma' Vepured?
English: Vepured is a veterinary vaccine used to protect piglets against oedema disease (caused by verotoxin 2e produced by E. coli) and to reduce the loss of daily weight gain until slaughter.
Maltese: Vepured huwa vaċċin veterinarju użat sabiex jipproteġi l-qżieqeż kontra l-marda oedema (ikkawżata minn tossina Shiga 2e prodotta minn E.coli) u biex inaqqas it-telf ta' piż żejjed kuljum sat-tbiċċir.
English: Vepured is a vaccine containing modified, inactivated verotoxin 2e.
Maltese: Vepured huwa vaċċin li fih verotossina 2e mmodifikata u inattivata.
English: How is Vepured used?
Maltese: Kif jintuża Vepured?
English: In the future, if the animals are exposed to the bacteria producing the unmodified toxin, their immune system will be able to make antibodies against the toxin more quickly.
Maltese: Fil-futur, jekk l-annimali jiġu esposti għall-batterji li jipproduċu t-tossina mhux modifikata, is-sistema immunitarja tagħhom tkun tista' tagħmel antikorpi kontra t-tossina b'mod aktar mgħaġġel.
English: Vepured contains verotoxin 2e that has been modified and inactivated so it can no longer cause disease.
Maltese: Vepured fih tossina Shiga 2e li ġiet immodifikata u inattivata sabiex ma tikkawżax aktar mard.
English: Oedema disease is found worldwide and usually occurs in the first few weeks of life of the piglets.
Maltese: Il-marda Oedema tinsab madwar id-dinja u normalment isseħħ fl-ewwel ftit ġimgħat ta' ħajja tal-qżieqeż.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Vepured's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Vepured huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Oedema disease is caused by a bacterial toxin (poison) known as verotoxin 2e that is produced by certain strains of Escherichia coli.
Maltese: Il-marda Oedema hija kkawżata minn tossina batterjali (velenu) magħrufa bħala t-tossina Shiga 2e li tiġi prodotta minn ċerti razez ta' Escherichia coli.
English: How does Vepured work?
Maltese: Kif jaħdem Vepured?
English: It results in damage to blood vessels, causing fluid build up in the tissues of the stomach and bowel and affecting the blood supply of the brain, and can lead to death within 24 to 48 hours.
Maltese: Din tirriżulta fi ħsara għall-vażi, ħaġa li twassal għal akkumulazzjoni tal-fluwidi fit-tessuti tal-istonku u l-musrana u dan jaffettwa l-provvista tad-demm tal-moħħ, u jista' jwassal għal mewt fi żmien 24 sa 48 siegħa.
English: • Aronson JK (editor).
Maltese: • Aronson JK (editur).
English: Drug Reactions and Interactions 2006.
Maltese: Drug Reactions and Interactions 2006 ta' Meyler.
English: Section 4.3 Contraindications
Maltese: Taqsima 4.3 Kontra-indikazzjonijiet
English: • Sweetman SC (editor), Martindale: The Complete Drug Reference 36.
Maltese: • Sweetman SC (editor), Martindale:
English: Serum electrolytes
Maltese: Elettroliti tas-serum
English: Also the MAH presented the studies published which evaluated the combination of cilazapril and hydrochlorothiazide: Pordy et al (1995; 1994), Martina et al (1994), Yodfat et al. (1994), and Sanchez
Maltese: Pordy et al (1995; 1994), Martina et al (1994), Yodfat et al. 1994), u Sanchez
English: However, hydrochlorothiazide is currently listed as `safe' or `probably safe' by several authorities (e.g. European Porphyria Initiative http://www.porphyria-europe.com/03-drugs/drugs-and-porphyrias.asp; The Drug Data-base for Acute Porphyria http://www.drugs-porphyria.com.
Maltese: Madankollu, filpreżent, hydrochlorothiazide huwa elenkat bħala `sigur' jew `probabbilment sigur' minn bosta awtoritajiet (eż. European Porphyria Initiative http://www.porphyria-europe.com/03-drugs/drugs-andporphyrias.asp; The Drug Data-base for Acute Porphyria http://www.drugs-porphyria.com.
English: Porphyria
Maltese: Porfirja
English: Of these patients with mild to moderate hypertension (sitting diastolic blood pressure 95 - 115 mm hg), 1.027 patients were treated with the cilazapril/hydrochlorothiazide combination, 453 patients with cilazapril and 366 with hydrochlorothiazide alone and 238 patients received placebo.
Maltese: Minn dawn il-pazjenti bi pressjoni għolja minn ħafifa sa moderata (pressjoni tad-demm dijastolika ta' bilqiegħda ta' 95 - 115 mm hg), 1.027 pazjent ġew ikkurati bil-kombinazzjoni ta' cilazapril/hydrochlorothiazide, 453 pazjent b'cilazapril u 366 b'hydrochlorothiazide waħdu u 238 pazjent irċevew plaċebo.
English: Section 5.2 Pharmacokinetic properties
Maltese: Taqsima 5.2 - Tagħrif farmakokinetiku
English: Additional information was included in some Member States in warnings in respect of risk of hypotension, renovascular hypertension/renal artery stenosis, kidney transplantation, use in concomitant heart failure, anaemia, cough, ethnic groups, primary aldosteronism, and doping.
Maltese: Ġiet inkluża Informazzjoni addizzjonali f'xi Stati Membri fi twissijiet fir-rigward tar-riskju ta' pressjoni baxxa, pressjoni renovaskulari għolja/stenożi renali arterjali, trapjant tal-kliewi, użu f'kollass konkomittanti tal-qalb, anemija, sogħla, gruppi etniċi, aldosteronismu primarju, u doping.
English: Vascace Plus is a combination of cilazapril (an angiotensin-converting enzyme inhibitor) and hydrochlorothiazide (a thiazide-diuretic agent).
Maltese: Vascace Plus huwa kombinazzjoni ta' cilazapril (inibitur tal-enżimi li jikkonvertu l-anġjotensina) u hydrochlorothiazide (aġent dijuretiku-thiazide).
English: The MAH acknowledged the number of contraindications in the SPCs of Members States and explained that:
Maltese: Il-MAH għaraf in-numru ta' kontra-indikazzjonijiet fl-SPCs ta' Stati Membri u spjega li:
English: Therefore, Vascace Plus is not recommended for patients with severe renal impairment (see section 4.3)”.
Maltese: Għaldaqstant, Vascace Plus mhuwiex irrakkomandat għal pazjenti b'indeboliment renali sever (ara taqsima 4.3)”.
English: Some SPCs included a detailed description of the symptoms of anaphylaxis.
Maltese: Xi SPCs inkludew deskrizzjoni dettaljata tas-sintomi ta' anafilassi.
English: A total of 214 patients (age range 64 - 81 years) were included in this trial.
Maltese: Total ta' 214-il pazjent (ta' bejn l-64 u l-81 sena) kienu inklużi f'din il-prova.
English: The MAH, to support the proposed section 4.4, presented reviews of adverse effects of ACE inhibitors and thiazide diuretics from the scientific literature avaible:
Maltese: Il-MAH, biex jappoġġja t-taqsima 4.4 proposta, ippreżenta r-reviżjonijiet ta' effetti avversi ta' inibituri ACE u ta' dijuretiċi ta' thiazide mil-litteratura xjentifika disponibbli:
English: The CHMP endorsed the following harmonised wording for the posology: “The dosage of Vascace Plus is one tablet (5.0 mg cilazapril and 12.5 mg hydrochlorothiazide) administered once daily”.
Maltese: Is-CHMP awtorizza l-kliem armonizzat li ġej għall-pożoloġija: “Id-dożaġġ ta' Vascace Plus huwa ta' pillola waħda (5.0 mg cilazapril u 12.5 mg hydrochlorothiazide) li tingħata darba kuljum”.
English: For hydrochlorothiazide, the MAH was requested to include the possible interactions with digoxin and complete the list with the agents as such non-depolarizing muscle relaxants, calcium slats and vitamin D, anticholinergics, amantidine, cytotoxic drugs, cyclosporine.
Maltese: Għal hydrochlorothiazide, il-MAH intalab jinkludi linterazzjonijiet possibbli ma' digoxin u li jimla l-lista bl-aġenti bħalma huma rilassanti tal-muskoli mhux depolarizzanti, imluħa tal-kalċju u vitamina D, antikolinerġiċi, amantidine, mediċini ċitotossiċi, cyclosporine.
English: The information on HCTZ overdose is consistent with other approved ACEI and hydrochlorothiazide combinations (ramipril/HCTZ) SPC.
Maltese: L-informazzjoni dwar doża eċċessiva ta' HCTZ hija konsistenti ma' SPC ta' kombinazzjonijiet approvati ta' ACEI u hydrochlorothiazide oħrajn (ramipril/HCTZ).
English: To support the proposed indication the MAH presented 4 placebo controlled clinical trials sponsored by Roche and run in 2.084 hypertensive patients.
Maltese: Sabiex jappoġġja l-indikazzjoni proposta, il-MAH ippreżenta 4 provi kliniċi kkontrollati bi plaċebo li kienu sponsorjati minn Roche u li saru fuq 2,084 pazjent bi pressjoni għolja.
English: These were conducted with patients randomized to one of several possible treatment groups with cilazapril doses of 0.5 mg, 1.0 mg or 2.5 mg and hydrochlorothiazide doses of 6.25 mg, 12.5 mg or 25 mg alone or in combination.
Maltese: Dawn saru fuq pazjenti randomizzati għal wieħed mill-gruppi ta' kura possibbli b'dożi ta' cilazapril ta' 0.5 mg, 1.0 mg jew 2.5 mg u dożi ta' hydrochlorothiazide ta' 6.25 mg, 12.5 mg jew 25 mg biss jew f'kombinazzjoni.
English: Section 4.9 Overdose
Maltese: Taqsima 4.9 - Doża eċċessiva
English: Section 5.1 Pharmacodynamic properties
Maltese: Taqsima 5.1 - Tagħrif farmakodinamiċi
English: The MAH proposed to include a separate warning concerning this issue in section 4.4.
Maltese: Il-MAH ippropona li jinkludi twissijiet separata dwar din il-kwistjoni f'taqsima 4.4.
English: It reflected the relevant information on nonclinical safety data with cilazapril and hydrochlorothiazide.
Maltese: Irriflettiet l-informazzjoni relevanti dwar id-dejta tas-sigurtà mhux klinika b'cilazapril u hydrochlorothiazide.
English: The wording proposed by the MAH integrated all information provided in individual SPCs in different countries.
Maltese: Il-formolazzjoni proposta mill-MAH integrat l-informazzjoni kollha pprovduta fl-SPCs individwali f'pajjiżi differenti.
English: Of these, 68 patients responded to monotherapy with cilazapril and 70 patients to hydrochlorothiazide.
Maltese: Minn dawn, 68 pazjent irrispondew għal monoterapija b'cilazapril u 70 pazjent b'hydrochlorothiazide.
English: The CHMP agreed to change the text “Pregnancy and lactation (see section 4.6)” under this section to “Second and third trimesters of pregnancy (see sections 4.4 and 4.6)”.
Maltese: 6)” taħt din is-sezzjoni għat-“Tieni u t-tielet trimestri tat-tqala (ara t-taqsimiet 4.4 u 4.6)”.
English: Section 5.3 Preclinical safety data
Maltese: Taqsima 5.3 - Dejta dwar is-sigurtà preklinika
English: Following review and discussion regarding the teratogenic potential of ACE inhibitors, the Pharmacovigilance Working Party (PhVWP) concluded that the contraindication of ACE inhibitors during the first trimester of pregnancy is not justified given the limited evidence related to a teratogenic risk.
Maltese: Wara reviżjoni u diskussjoni dwar il-potenzjal tetratoġeniku tal-inibituri ACE, il-Grupp ta' Ħidma tal-Farmakoviġilanza (PhVWP) ikkonkluda li lkontra-indikazzjoni tal-inibituri ACE waqt l-ewwel trimestru tat-tqala mhijiex iġġustifikata minħabba l-evidenza limitata relatata ma' riskju tetratoġeniku.
English: To justify the proposed dosage (5 mg cilazapril and 12.5 mg hydrochlorothiazide) the MAH presented data from several placebo controlled randomized trials.
Maltese: Bħala ġustifikazzjoni tad-dożaġġ propost (5 mg cilazapril u 12.5 mg hydrochlorothiazide), il-MAH ippreżenta dejta minn diversi provi randomizzati kkontrollati bi plaċebo.
English: In one trial (protocol no. N2960C) it was shown that patients had an overall decrease in SDBP of 4.3 mm Hg before the addition of hydrochlorothiazide and 11.1 mm Hg after the addition of hydrochlorothiazide.
Maltese: F'waħda mill-provi (protokoll nru N2960C) intwera li l-pazjenti kellhom tnaqqis ġenerali fl-SDBP ta' 4.3 mm Hg qabel iż-żieda ta' hydrochlorothiazide u ta' 11.1 mm
English: Section 4.8 Undesirable Effects
Maltese: Taqsima 4.8 - Effetti mhux mixtieqa
English: In some SPCs, relative contraindications were discussed in section 4.4 (Special Warnings and Precautions), rather than in section 4.3;
Maltese: F'xi SPCs, kontraindikazzjonijiet relattivi ġew diskussi fit-taqsima 4.4 (Twissijiet speċjali u prekawzjonijiet għallużu), milli fit-taqsima 4.3;
English: Doubling the initial dose (5.0 mg cilazapril 12.5 mg hydroclorthiazide) resulted in a further increase in efficacy.
Maltese: L-irdupjar tad-doża inizjali (5.0 mg cilazapril 12.5 mg hydroclorthiazide) irriżulta f'aktar żieda fleffikaċja.
English: The MAH proposed to describe the symptoms/signs of angioedema more succinctly than in some current SPCs, and to use the term “acute oropharyngeal edema and airways obstruction” (as in Meyler's review).
Maltese: Il-MAH ippropona li jiddeskrivi s-sintomi/sinjali ta' anġjoedema b'mod aktar fil-qosor u preċiż milli f'xi SPCs attwali u sabiex jintuża t-terminu “edema orofarinġeali akuta u ostruzzjoni tal-passaġġi talarja” (bħal fir-reviżjoni ta' Meyler).
English: The ADR ‘lupus like syndrome' is now listed under the SOC Immune System Disorders in both subsections of the table of ADRs (i.e., ADRs attributable to cilazapril and ADRs attributable to HCTZ).
Maltese: L-ADR ‘sindromu simili għal-lupus' hija issa elenkata taħt id-Disturbi tas-Sistema Immuni tas-SOC fiż-żewġ subsezzjonijiet tat-tabella tal-ADRs (jiġifieri ADRs li jistgħu ikunu attribwiti għal cilazapril u ADRs li jistgħu ikunu attribwiti għal HCTZ).
English: The text proposed by the MAH and endorsed by CHMP for anaphylaxis was consistent with the current Vascace Plus CDS and reviews of ACE inhibitors in Meyler and Martindale.
Maltese: It-test propost mill-MAH u approvat mis-CHMP għal anafilassi kien konsistenti mas-CDS attwali ta' Vascace Plus u marreviżjonijiet ta' inibituri ta' ACE f'Meyler u Martindale.
English: It is widely known that thiazides as a class can increase uric acid levels (Meyler; Martindale).
Maltese: Huwa magħruf tajjeb li thiazides bħala klassi jistgħu jżidu l-livelli tal-aċidu uriku (Meyler; Martindale).
English: Section 4.1 Therapeutic indications
Maltese: Taqsima 4.1 Indikazzjonijiet terapewtiċi
English: Many medicinal products were listed for Vascace Plus in one or several local SPCs.
Maltese: Ħafna prodotti mediċinali ġew elenkati għal Vascace Plus f'wieħed jew f'ħafna mill-SPCs lokali.
English: The lowest dose which generated a significant effect was a dose of 2.5/6.25 mg.
Maltese: Id-doża l-aktar baxxa li ġġenerat effett sinifikanti kienet doża ta' 2.5/6.25 mg.
English: Estimates of frequency were based on the proportion of patients reporting each adverse reaction during Vascace Plus clinical trials.
Maltese: L-estimi tal-frekwenza kienu bbażati fuq il-proporzjoni ta' pazjenti li rrapportaw kull waħda mirreazzjonijiet avversi waqt il-provi kliniċi ta' Vascace Plus.
English: The CHMP endorsed the harmonised text.
Maltese: Is-CHMP awtorizza t-test armonizzat.
English: As it is not foreseen to start treatment with the fixed combination, the CHMP endorsed the following: “In clinical studies, the efficacy and tolerability of cilazapril and hydrochlorothiazide administered concomitantly was similar in both elderly and younger hypertensive patients, although pharmacokinetic data show that clearance of both components in elderly patients was reduced (see section 5.2)”.
Maltese: Minħabba li mhuwiex imbassar li tinbeda kura bil-kombinazzjoni fissa, is-CHMP awtorizza dan li ġej: “Fi studji kliniċi, l-effikaċja u t-tollerabbiltà ta' cilazapril u hydrochlorothiazide mogħtijin fl-istess ħin kienu simili kemm f'pazjenti anzjani kif ukoll f'pazjenti iżgħar fl-età bi pressjoni għolja, għalkemm dejta farmakokinetika turi li t-tneħħija mill-ġisem taż-żewġ komponenti f'pazjenti anzjani tnaqqset (ara taqsima 5.2)”.
English: • lack of data concerning safety in specific patients groups was the only justification for listing certain contraindications;
Maltese: • nuqqas ta' dejta dwar is-sigurtà fi gruppi ta' pazjenti speċifiċi kien l-unika ġustifikazzjoni għallelenkar ta' ċerti kontra-indikazzjonijiet;
English: Elderly
Maltese: Billi
English: The original proposed text concerning the hydrochlorothiazide component of Vascace Plus was already in agreement with the PhVWP wording.
Maltese: It-test oriġinali propost li jikkonċerna l-komponent ta' hydrochlorothiazide ta' Vascace Plus kien diġà konformi mal-kliem tal-PhVWP.
English: The 76 non-responders were treated with combination therapy.
Maltese: Is-76 li ma rrispondewx kienu kkurati b'terapija ta' kombinazzjoni.
English: Electrolyte disturbances including hypokalaemia, hyponatraemia and dehydration are mainly associated with thiazides, whilst ACE inhibitors can cause hyperkalaemia.
Maltese: Disturbi ta' elettroliti li jinkludu hypokalaemia, hyponatraemia u deitrazzjoni huma prinċipalment assoċjati ma' thiazides, filwaqt li inibituri ta' ACE jistgħu jikkawżaw hyperkalaemia.
English: Patients with renal impairment
Maltese: Pazjenti b'indeboliment renali:
English: The proposed text for hepatic disorders incorporated all the information which was provided in the CDS and in local SPCs for Vascace Plus, and was consistent with wording used in the reviews in Meyler and Martindale.
Maltese: It-test propost għal disturbi tal-fwied inkorpora l-informazzjoni kollha li ġiet ipprovduta fis-CDS u flSPCs lokali għal Vascace Plus, u kien konsistenti mal-formolazzjoni tal-kliem użata fir-reviżjonijiet f'Meyler and Martindale.
English: The paragraph ‘Clinical/Efficacy Studies' has been slightly rewording for more clarity.
Maltese: Il-paragrafu ‘Studji Kliniċi/Effikaċja' ġie riformulat kemmxejn għal aktar ċarezza.
English: The CHMP endorsed the MAH proposal after the frequency categories used in the SPC of Vascace Plus had been harmonised with the ones of the SPC for Vascace.
Maltese: Is-CHMP awtorizza l-proposta tal-MAH wara li l-kategoriji tal-frekwenzi użati fl-SPC ta' Vascace Plus ġew armonizzati ma' dawk tal-SPC għal Vascace.
English: The ADR `headache' has been included in the list of ADRs attributable to cilazapril, as requested by the CHMP, in the category `common'.
Maltese: L-ADR ‘uġigħ ta' ras' kien inkluż fil-lista tal-ADRs li jistgħu jiġu attribwiti għal cilazapril, kif mitlub mis-CHMP, fil-kategorija `komuni'.
English: From these patients 108 patients had initially been treated with cilazapril and 106 patients with hydrochlorothiazide.
Maltese: Minn dawn il-pazjenti 108 kienu ikkurati inizjalment b'cilazapril u 106 pazjenti b'hydrochlorothiazide.
English: The proposed text was consistent with the wording used in current local SPCs for Vascace Plus, and was the same as that proposed for the revised version of the EU harmonized SPC for Vascace.
Maltese: It-test propost kien konsistenti mal-formolazzjoni tal-kliem użata fl-SPCs lokali attwali għal Vascace Plus, u kien l-istess għal dak propost għall-verżjoni riveduta tal-SPC armonizzat għall-UE għal Vascace.
English: Several clinical trials showed that doses of 5 mg cilazapril and 12.5 mg hydrochlorothiazide generated a greater reduction in blood pressure than either of the individual components in patients with mild to moderate hypertension whose blood pressure could not be normalized with cilazapril alone.
Maltese: Diversi provi kliniċi urew li dożi ta' 5 mg cilazapril u ta' 12.5 mg hydrochlorothiazide iġġeneraw tnaqqis akbar fil-pressjoni tad-demm milli kull wieħed mill-komponenti individwali f'pazjenti bi pressjoni għolja ħafifa sa moderata li l-pressjoni tad-demm tagħhom ma setgħetx tiġi normalizzata b'cilazapril waħdu.
English: The text proposed by the MAH was based on Meyler's reviews of ACE inhibitors and thiazide diuretics, and it is consistent with the CDS and most current SPCs for Vascace Plus.
Maltese: It-test propost mill-MAH kien ibbażat fuq ir-reviżjonijiet ta' Meyler ta' inibituri ta' ACE u dijuretiċi ta' thiazide, u huwa konsistenti mas-CDS u mal-aktar SPCs attwali għal Vascace Plus.
English: Patients with liver cirrhosis
Maltese: Pazjenti b'ċirrożi tal-fwied
English: The number of products for Vascace Plus is considerably higher than for cilazapril alone, since numerous molecules had been added where a potential interaction with hydrochlorothiazide was suspected.
Maltese: Innumru ta' prodotti għal Vascace Plus huwa ferm ogħla minn dak għal cilazapril waħdu, minħabba li bosta molekuli żdiedu fejn kien hemm suspett ta' interazzjoni potenzjali ma' hydrochlorothiazide.
English: The CHMP, considering that there is plausible effect based on the pharmacologic action of the drug to affect the ability to drive, endorsed the following: “When driving and operating machines, it should be taken into account that occasionally dizziness and fatigue may occur during treatment with Vascace Plus (see sections 4.4 and 4.8)”.
Maltese: Is-CHMP, minħabba li hemm effett plawsibbli fuq il-bażi tal-azzjoni farmakoloġika tal-mediċina li taffettwa l-ħila biex issuq, awtorizza li ġej: “Waqt is-sewqan jew it-tħaddim ta' magni, għandu jkun ikkunsidrat li kultant jista' jkun hemm sturdamenti u għejja waqt il-kura b'Vascace Plus (ara taqsimiet 4.4 u 4.8)”
English: However, the MAH did not propose to include such a warning as considered that this is implied in the warning that patients should have regular monitoring of renal function and electrolytes which is included in the proposed SPC.
Maltese: Madankollu, il-MAH ma pproponiex li jinkludi tali twissija għaliex qies li dan huwa implikat fittwissija li l-pazjenti għandu jkollhom monitoraġġ regolari tal-funzjoni renali u tal-eletroliti li huma inklużi fl-SPC propost.
English: The CHMP agreed the following: “Because significant hypotension may occur in patients with liver cirrhosis treated with standard doses of ACE inhibitors, cautious dose titration of each individual component is needed if patients with liver cirrhosis should require treatment with cilazapril and hydrochlorothiazide (see section 4.4)”.
Maltese: Is-CHMP adotta dan li ġej: “Minħabba li jista' jkun hemm pressjoni ferm baxxa f'pazjenti b'ċirrożi tal-fwied ikkurati b'dożi standard ta' inibituri ACE, hemm bżonn ta' titrazzjoni tad-doża b'attenzjoni ta' kull komponent individwali jekk il-pazjenti b'ċirrożi tal-fwied ikunu jeħtieġu kura b'cilazapril u b'hydrochlorothiazide (ara taqsima 4.4)”.
English: Apart from some additional information which is provided on the distribution of cilazapril and hydrochlorothiazide the text suggested for this section of the harmonized label was identical to the wording in the CDS of the MAH.
Maltese: Apparti xi informazzjoni addizzjonali li hija pprovduta dwar id-distribuzzjoni ta' cilazapril u hydrochlorothiazide, it-test issuġġerit għal din is-sezzjoni tat-tikketta armonizzata kien identiku għallformolazzjoni fis-CDS tal-MAH.
English: The MAH's initially proposed SPC and CDS included some additional information concerning the use of ACE inhibitors in the 1st trimester of pregnancy as a contraindication to ACE inhibitors.
Maltese: L-SPC u CDS inizjalment proposti mill-MAH kienu jinkludu xi informazzjoni addizzjonali dwar l-użu tal-inibituri ACE fl-ewwel trimestru tat-tqala bħala kontra-indikazzjoni għall-inibituri ACE.
English: • contraindications were sometimes relative rather than absolute.
Maltese: • xi kultant, kontra-indikazzjonijiet kienu relattivi aktar milli assoluti.
English: The MAH proposed text also included an additional comment concerning the use of ACE inhibitors in patients with liver cirrhosis and ascites, as suggested by the CHMP for the EU harmonized Vascace SPC.
Maltese: It-test propost mill-MAH inkluda wkoll kumment addizzjonali dwar l-użu ta' inibituri ta' ACE f'pazjenti b'ċirrożi tal-fwied u axxite, kif issuġġerit mis-CHMP għall-SPC ta' Vascace armonizzat fl-UE.
English: Information on pharmacokinetics of hydrochlorothiazide in special populations has been added to section 5.2.
Maltese: Informazzjoni dwar il-farmakokinetiċi ta' hydrochlorothiazide f'popolazzjonijiet speċjali ġiet miżjuda mas-sezzjoni 5