FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone.
Maltese: Sorveljanza mill-viċin tal-kontroll gliċemiku għandha tiġi kkunsidrata (ara sezzjoni 4.4). ġie rrappurtat li l-għotja ta' pioglitazone flimkien ma' rifampicin (induttur taċ-ċitokromju P450 2C8) twassal għal tnaqqis ta' 54% fl-AUC ta' pioglitazone.
English: EU/1/12/755/008 EU/1/12/755/009 EU/1/12/755/010 EU/1/12/755/011 EU/1/12/755/012 EU/1/12/755/013 EU/1/12/755/014 EU/1/12/755/015 EU/1/12/755/016 EU/1/12/755/017 EU/1/12/755/018 EU/1/12/755/019 EU/1/12/755/020 EU/1/12/755/021 EU/1/12/755/022 EU/1/12/755/023 EU/1/12/755/024 EU/1/12/755/025 EU/1/12/755/026 EU/1/12/755/027
Maltese: EU/1/12/755/016 EU/1/12/755/017 EU/1/12/755/018 EU/1/12/755/019 EU/1/12/755/020
English: Pioglitazone Actavis 45 mg tablets are white, round, flat, bevelled, 8 mm in diameter and engraved with ‘TZ45' on one side.
Maltese: Il-pilloli huma bojod, tondi, bbużżati b'dijametru ta'8 mm u mmarkati b'TZ45 fuq naħa waħda.
English: Postmarketing, bone fractures have been reported in both male and female patients (see section 4.4).
Maltese: Wara t-tqegħid fis-suq, fratturi fl-għadam kienu rrappurtati kemm f'pazjenti rġiel kif ukoll nisa (ara sezzjoni 4.4).
English: Do not take Pioglitazone Actavis - if you are hypersensitive (allergic) to pioglitazone or any of the other ingredients of
Maltese: Tieħux Pioglitazone Actavis - jekk inti tbati minn sensittività eċċessiva (allerġiku/a) għal pioglitazone jew sustanzi oħra ta'
English: An increased incidence of hyperplasia (males and females) and tumours (males) of the urinary bladder epithelium was apparent in rats treated with pioglitazone for up to 2 years.
Maltese: Neoplasmi beninni, malinni u mhux speċifikati (inklużi ċesti u polipi)
English: Sun.
Maltese: Sinusite
English: Gonorrhoea
Maltese: Gonorreja
English: • Intra-abdominal infections (see section 4.4).
Maltese: • Infezzjonijiet intra-addominali (ara sezzjoni 4.4).
English: Intra-abdominal infections
Maltese: Infezzjonijiet intra-addominali
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC,
Maltese: • Il-kumitat ikkunsidra l-proċedura ta' referenza taħt l-Artikolu 30 tad-Direttiva 2001/83/KE,
English: • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic,
Maltese: • Profilassi kontra l-infezzjoni fil-kirurġija gastrointestinali (inkluża esofagali), ortopedika,
English: In conclusion, the CHMP adopted a harmonised wording for Section 4.2.
Maltese: B'konklużjoni, is-CHMP adotta kliem armonizzat għasSezzjoni 4.2.
English: The CHMP agreed that the commonly used intravenous and intramuscular dosing regimens (e.g., 750 mg to 1500 mg given every 8 hours) are expected to provide efficacy for organisms with minimum inhibitory concentrations (MICs) up to, and including, 8 μg/mL.
Maltese: Is-CHMP qabel li l-iskemi ta' dożar minn ġol-vini u minn ġol-muskoli użati normalment (eż., 750 mg sa 1500 mg mogħtija kull 8 sigħat) huma mistennija li jipprovdu effikaċja għall-organiżmi b'konċentrazzjonijiet inibitorji minimi (MICs) sa, u inklużi, 8 μg/mL.
English: • Soft-tissue infections: cellulitis, erysipelas and wound infections.
Maltese: • Infezzjonijiet fit-tessuti rotob: ċellulite, erysipelas u infezzjonijiet ta' feriti.
English: • The committee reviewed the data submitted by the MAH, including data from clinical trials, published literature and clinical documentation, justifying the proposed harmonised Product Information,
Maltese: • Il-kumitat irreveda d-dejta ppreżentata mill-MAH, inkluża dejta minn provi kliniċi, letteratura ppubblikata u dokumentazzjoni klinika, li tiġġustifika l-Informazzjoni armonizzata dwar il-Prodott,
English: Having reviewed all submitted data to support the various prophylaxis indications proposed for cefuroxime, the CHMP considered the indication “Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular and gynaecological surgery (including caesarean section)” to be acceptable.
Maltese: Wara li rreveda d-dejta kollha ppreżentata b'appoġġ għad-diversi indikazzjonijiet ta' profilassi proposti għal sefuroksima, is-CHMP ikkunsidra l-indikazzjoni “Profilassi kontra l-infezzjoni f'kirurġija gastrointestinali (inkluża esofagali), ortopedika, kardjovaskolari u ġinekoloġika (inkluża ċeżarja)” bħala aċċettabbli.
English: Section 4.2 - Posology and method of administration
Maltese: Sezzjoni 4.2 - Posoloġija u metodu ta' kif għandu jingħata
English: The CHMP also noted that although the most common coexisting pathogen in patients with gonorrhoea is Chlamydia trachomatis, no data on combination therapy (cefuroxime with other antibiotic) for treatment of patients co-infected by N. gonorrhoeae and C. trachomatis, or by N. gonorrhoeae and anaerobic bacteria, was submitted.
Maltese: Is-CHMP innota wkoll li għalkemm il-patoġenu koeżistenti l-aktar komuni f'pazjenti bil-gonorreja huwa Chlamydia trachomatis, ma ġiet ippreżentata l-ebda dejta dwar terapija kkombinata (sefuroksima ma' antibijotiku ieħor) għall-kura ta' pazjenti infettati fl-istess ħin b'N. gonorrhoeae u C. trachomatis, jew b'N. gonorrhoeae u batterji anerobiċi.
English: • Complicated urinary tract infections, including pyelonephritis.
Maltese: • Infezzjonijiet ikkumplikati tal-apparat urinarju, inkluża pajelonefrite.
English: cardiovascular, and gynaecological surgery (including caesarean section).
Maltese: kardjovaskolari, u ġinekoloġika (inkluża ċeżarja).
English: Regarding meningitis, the CHMP noted that the majority of the studies identified H. influenzae, N. meningitidis, S. pneumonia and S. aureus (non-MRSA) as the predominant bacterial species, which does not reflect the present EU situation, where aerobic Gram-negative bacilli are increasingly important as causative agents.
Maltese: Rigward il-meninġite, is-CHMP innota li l-parti l-kbira tal-istudji identifikaw H. influenzae, N. meningitidis, S. pneumonia u S. aureus (mhux MRSA) bħala l-ispeċji batterjali predominanti, li ma jirriflettix issitwazzjoni preżenti fl-UE, fejn baċilli Gram-negattivi erobiċi qegħdin ikunu dejjem aktar aġenti kawżattivi importanti.
English: “Zinacef is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth) (see sections 4.4 and 5.1).
Maltese: “Zinacef huwa indikat għall-kura tal-infezzjonijiet elenkati hawn taħt fl-adulti u fit-tfal, inklużi t-trabi tattwelid (mit-twelid) (ara sezzjonijiet 4.4 u 5.1).
English: In conclusion, the CHMP considered the indication “complicated urinary tract infections, including pyelonephritis” to be acceptable.
Maltese: Bħala konklużjoni, is-CHMP ikkunsidra l-indikazzjoni “infezzjonijiet fl-apparat urinarju kkumplikati, inkluża pajelonefrite” aċċettabbli.
English: Regarding the method of administration, the CHMP stated that Zinacef should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60 minutes, or by deep intramuscular injection.
Maltese: Rigward ilmetodu ta' kif għandu jingħata, is-CHMP iddikjara li Zinacef għandu jingħata b'injezzjoni minn ġol-vina fuq perjodu ta' 3 sa 5 minuti direttament f'vina jew permezz ta' tubu tad-dripp jew infużjoni fi 30 sa 60 minuta, jew b'injezzjoni fil-fond tal-muskolu.
English: A referral under Article 30(2) of Directive 2001/83/EC was therefore triggered to resolve these divergences and thus to harmonise the Product Information (PI) across the EU.
Maltese: Għaldaqstant ingħata bidu għal proċedura ta' referenza taħt l-Artikolu 30(2) tad-Direttiva 2001/83/KE sabiex jissolvew dawn id-diverġenzi u b'hekk tiġi armonizzata l-Informazzjoni dwar il-Prodott (PI) madwar l-UE.
English: The CHMP considered the indication to be acceptable for all populations.
Maltese: Is-CHMP ikkunsidra li l-indikazzjoni hija aċċettabbli għall-popolazzjonijiet kollha.
English: The CHMP reviewed the studies on septicaemia which were old, non-comparative and included small numbers of patients.
Maltese: Is-CHMP irreveda l-istudji dwar is-settiċemija li kienu antiki, mhux komparattivi u kienu jinkludu numri żgħar ta' pazjenti.
English: Zinacef was included in the list of products for Summary of Product Characteristics (SmPC) harmonisation, due to divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product.
Maltese: Zinacef kien inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC), minħabba deċiżjonijiet nazzjonali diverġenti meħuda mill-Istati Membri rigward l-awtorizzazzjoni talprodott imsemmi hawn fuq.
English: Overall summary of the scientific evaluation of Zinacef and associated names (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Zinacef u ismijiet assoċjati (ara Anness I)
English: The CHMP also adopted a harmonised wording for the remaining sections of the Zinacef SmPC and brought the labelling and the package leaflet in line with the adopted harmonised SmPC.
Maltese: Is-CHMP adotta wkoll kliem armonizzat għas-sezzjonijiet l-oħrajn tal-SmPC ta' Zinacef u kkonforma ttikketta u l-fuljett ta' tagħrif mal-SmPC armonizzat adottat.
English: The CHMP reviewed the submitted data and agreed that staphylococci and streptococci, the bacterial species most frequently involved in skin and soft tissue infections, are sensitive to cefuroxime.
Maltese: Is-CHMP irreveda d-dejta sottomessa u qabel li stafilokokki u streptokokki, l-ispeċji batterjali involuti laktar spiss fl-infezzjonijiet tal-ġilda u tat-tessuti rotob, huma sensittivi għal sefuroksima.
English: The CHMP agreed that neonates may be given a similar total daily dose as recommended for infants (30 to 100 mg/kg/day) but at a reduced daily frequency of 2 or 3 divided doses, due to the longer serum half-life.
Maltese: Is-CHMP qabel li t-trabi tat-twelid jistgħu jingħataw doża totali ta' kuljum simili għal dik irrakkomandata għat-tfal żgħar (30 sa 100 mg/kg/kuljum) iżda fi frekwenza mnaqqsa kuljum ta' 2 jew 3 dożi mqassma, minħabba nofs ħajja itwal fis-serum.
English: Having reviewed the available data, consisting of small non-comparative studies, the CHMP considered it to be very limited and of questionable methodology.
Maltese: Wara li rreveda d-dejta disponibbli, li kienet tikkonsisti fi studji żgħar mhux komparattivi, is-CHMP ikkunsidra li hija limitata ħafna u ta' metodoloġija dubjuża.
English: In conclusion, the CHMP adopted the following harmonised indications and wording for Section 4.1:
Maltese: Bħala konklużjoni, is-CHMP adotta dawn l-indikazzjonijiet u l-kliem armonizzat li ġej għas-Sezzjoni 4.1:
English: The CHMP therefore concluded that there is enough data to support the indication in adults and that the adult efficacy data could be extrapolated to the paediatric population.
Maltese: Is-CHMP għaldaqstant ikkonkluda li hemm dejta suffiċjenti li tappoġġja l-indikazzjoni fl-adulti u li d-dejta dwar l-effikaċja fl-adulti tista' tkun estrapolata għall-popolazzjoni pedjatrika.
English: Septicaemia and meningitis
Maltese: Indikazzjoni fit-trabi tat-twelid
English: Regarding patients with hepatic impairment, the CHMP stated that hepatic dysfunction is not expected to affect the pharmacokinetics of cefuroxime.
Maltese: Rigward il-pazjenti bl-indeboliment tal-fwied, is-CHMP iddikjara li nnuqqas ta' funzjoni tal-fwied mhijiex mistennija li taffettwa l-farmakokinetika ta' sefuroksima.
English: Skin and soft-tissue infections
Maltese: Infezzjonijiet tal-ġilda u tat-tessuti rotob
English: The CHMP considered that for parenteral cefuroxime, the less susceptible bacteria include mainly Enterobacteriaceae (i.e. E. coli, P. mirabilis and Klebsiella spp).The CHMP therefore followed the EUCAST breakpoints for Enterobactariaceae at 8ug/mL to recommend a dosing regimen of 1500 mg every 8 hours for the treatment of infections caused by the above bacteria.
Maltese: Is-CHMP iddefinixxa t-trabi tat-twelid bħala trabi ta' inqas minn tliet ġimgħat, inklużi trabi li jkunu għadhom kemm twieldu u qabel li sefuroksima intuża fit-trabi tat-twelid għal bosta snin mingħajr ebda tħassib serju dwar is-sigurtà.
English: Zinacef contains cefuroxime sodium, a second generation cephalosporin antibacterial agent.
Maltese: Is-CHMP innota l-ammont kbir ta' esperjenza klinika li tappoġġja l-użu ta' sefuroksima f'din l-indikazzjoni.
English: The CHMP concluded that the clinical data and the data from the European Committee on Antimicrobial Susceptibility Testing (EUCAST) did not support the treatment of meningitis.
Maltese: Is-CHMP ikkonkluda li d-dejta klinika u d-dejta mill-Kumitat Ewropew dwar l-Ittestjar tasSuxxettibbiltà Antimikrobjali (EUCAST) ma kinitx tappoġġja l-kura tal-meninġite.
English: In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents.
Maltese: Fil-kura u l-prevenzjoni ta' infezzjonijiet fejn huwa probabbli ħafna li jinstabu organiżmi anerobiċi, sefuroksima għandu jingħata ma' aġenti antibatterjali xierqa oħrajn.
English: Based on the provided data, the CHMP considered the indication “soft-tissue infections: cellulitis, erysipelas and wound infections” to be acceptable.
Maltese: Skont id-dejta pprovduta, is-CHMP ikkunsidra li l-indikazzjoni “infezzjonijiet tat-tessuti rotob: ċellulite, erysipelas u infezzjonijiet ta' feriti” hija aċċettabbli.
English: Obstetric and gynaecological infections
Maltese: Konklużjonijiet xjentifiċi
English: Hypromellose, substitution type 2910 (3 mPa.s) Macrogol 4000
Maltese: Ipromelloża, sostituzzjoni tip 2910 (3 mPa.s) Makrogol 4000
English: Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Macrogol 4000
Maltese: Ipromelloża, sostituzzjoni tip 2910 (3 mPa.s) Dijossidu tat-titanju (E171) Makrogol 4000
English: Frequency Exforge HCT
Maltese: Frekwenza Exforge HCT
English: 56 x 1 film-coated tablet (unit dose) 98 x 1 film-coated tablet (unit dose) 280 x 1 film-coated tablet (unit dose)
Maltese: 56 x pillola 1 miksija b'rita (doża waħda) 98 x pillola 1 miksija b'rita (doża waħda) 280 x pillola 1 miksija b'rita (doża waħda)
English: Date of first authorisation: 16 October 2009 Date of latest renewal: 30 June 2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 Ottubru 2009
English: Exforge HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single perforated dose blisters.
Maltese: Exforge HCT huwa disponibbli f'pakketti li fihom 14, 28, 30, 56, 90, 98 jew 280 pillola miksija b'rita, f'pakketti multipli ta' 280 pillola (magħmulin minn 4 kartuniet, li kull waħda minnhom fiha 70 pillola, jew 20 kartuna, li kull waħda minnhom fiha 14-il pillola), u f'pakketti tal-isptar li fihom 56, 98 jew 280 pillola f'folji pperforati bid-dożi.
English: Due to the hydrochlorothiazide component, Exforge HCT is contraindicated for use in patients with anuria (see section 4.3) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2).
Maltese: Minħabba l-komponent hydrochlorthiazide, Exforge HCT huwa kontraindikat għall-użu f'pazjenti b'nuqqas ta' produzzjoni ta' awrina (ara sezzjoni 4.3) u f'pazjenti b'indeboliment renali sever (rata talfiltrazzjoni fil-glomeruli (GFR)<30 ml/min/1.73 m2) (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Exforge HCT with food, drink and alcohol
Maltese: Exforge HCT ma' ikel, xorb u alkoħol
English: See also information under the heading “Do not take Exforge HCT”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Exforge HCT”.
English: At week 8, the mean reductions in systolic/diastolic blood pressure were 39.7/24.7 mmHg with Exforge HCT, 32.0/19.7 mmHg with valsartan/hydrochlorothiazide, 33.5/21.5 mmHg with amlodipine/valsartan, and 31.5/19.5 mmHg with amlodipine/hydrochlorothiazide.
Maltese: Fit-8 ġimgħa, it-tnaqqis medju fil-pressjoni sistolika/dijastolika kien ta' 39.7/24.7 mmHg b'Exforge HCT, 32.0/19.7 mmHg b'valsartan/hydrochlorthiazide, 33.5/21.5 mmHg b'amlodipine/valsartan, u 31.5/19.5 mmHg b'amlodipine/hydrochlorthiazide.
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets Exforge HCT 5 mg/160 mg/25 mg film-coated tablets Exforge HCT 10 mg/160 mg/25 mg film-coated tablets Exforge HCT 10 mg/320 mg/25 mg film-coated tablets
Maltese: Exforge HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita Exforge HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita Exforge HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita Exforge HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita Exforge HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita
English: Exforge HCT 5 mg/160 mg/12.5 mg film-coated tablets Exforge HCT 10 mg/160 mg/12.5 mg film-coated tablets Exforge HCT 5 mg/160 mg/25 mg film-coated tablets Exforge HCT 10 mg/160 mg/25 mg film-coated tablets Exforge HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Maltese: Exforge HCT 5 mg/160 mg/12.5 mg pilloli miksijin b'rita Exforge HCT 10 mg/160 mg/12.5 mg pilloli miksijin b'rita Exforge HCT 5 mg/160 mg/25 mg pilloli miksijin b'rita Exforge HCT 10 mg/160 mg/25 mg pilloli miksijin b'rita Exforge HCT 10 mg/320 mg/25 mg pilloli miksijin b'rita amlodipine/valsartan/hydrochlorthiazide
English: Due to the hydrochlorothiazide component, Exforge HCT is contraindicated in symptomatic hyperuricaemia.
Maltese: Minħabba l-komponent ta' hydrochlorothiazide, Exforge HCT hu kontraindikat f'iperurikemija sintomatika.
English: Due to the valsartan component, Exforge HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Minħabba l-komponent valsartan, Exforge HCT huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3).
English: Statistically greater proportions of patients achieved blood pressure control (<140/90 mmHg) with Exforge HCT (71%) compared to each of the three dual combination therapies (45-54%) (p<0.0001).
Maltese: Statistikament proporzjon akbar ta' pazjenti kisbu kontroll tal-pressjoni (<140/90 mmHg) b'Exforge HCT (71%) meta mqabbel ma' kull wieħed mit-tliet terapiji l-oħra b'taħlita ta' żewġ mediċini (45-54%) (p<0.
English: No dose adjustment of Exforge HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m
Maltese: M'hemmx bżonn ta' aġġustar tad-doża ta' Exforge HCT għall-pazjenti li għandhom indeboliment renali minn ħafif għal moderat (GFR ≥30 ml/min/1.73 m
English: Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Exforge HCT (10 mg/320 mg/25 mg) compared to 1.8% of valsartan/hydrochlorothiazide (320 mg/25 mg) patients, 0.4% of amlodipine/valsartan (10 mg/320 mg) patients, and 0.2% of hydrochlorothiazide/amlodipine (25 mg/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension.
Maltese: Pressjoni baxxa eċċessiva, li tinkludi pressjoni baxxa mal-waqqaf, dehret f'1.7% tal-pazjenti kkurati bl-ogħla doża ta' Exforge HCT (10 mg/320 mg/25 mg) meta mqabbla ma' 1.8% tal-pazjenti fuq valsartan/hydrochlorthiazide (320 mg/25 mg), 0.4% tal-pazjenti fuq amlodipine/valsartan (10 mg/320 mg), u 0.2% tal-pazjenti fuq hydrochlorthiazide/amlodipine (25 mg/10 mg) fi prova kkontrollata f'pazjenti bi pressjoni minn moderata sa qawwija mhux ikkumplikata.
English: Exforge HCT combines three antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines and hydrochlorothiazide belongs to the thiazide diuretics class of medicines.
Maltese: Exforge HCT jikkombina tliet sustanzi kontra l-pressjoni għolja b'mekkaniżmi kumplimentari sabiex tkun ikkontrollata l-pressjoni tad-demm f'pazjenti bi pressjoni għolja essenzjali: amlodipine huwa membru tal-klassi ta' antagonisti tal-kalċju u l-valsartan tal-klassi ta' mediċini li huma antagonisti ta' anġjotensin II u hydrochlorthiazide huwa membru tal-klassi ta' mediċini li huma dijuretiċi thiazide.
English: Concomitant use of Exforge HCT with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Maltese: L-użu fl-istess ħin ta' Exforge HCT ma' prodotti li jkun fihom aliskiren f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR <60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: In a variety of preclinical safety studies conducted in several animal species with amlodipine, valsartan, hydrochlorothiazide, valsartan/hydrochlorothiazide, amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide (Exforge HCT), there was no evidence of systemic or target organ toxicity that would adversely affect the development of Exforge HCT for clinical use in humans.
Maltese: F'varjetà ta' studji ta' sigurtà qabel l-istudju kliniku, magħmula f'diversi speċi ta' annimali b' amlodipine, valsartan, hydrochlorthiazide, valsartan/hydrochlorthiazide, amlodipine/valsartan u amlodipine/valsartan/hydrochlorthiazide (Exforge HCT), ma kien hemm l-ebda evidenza ta' tossiċità sistemika jew ta' organi fil-mira li jaffettwaw b'mod avvers l-iżvilupp ta' Exforge HCT għall-użu kliniku fil-bniedem.
English: Multipack: 280 (20 packs of 14) film-coated tablets.
Maltese: Pakkett b'ħafna: 280 (20 pakkett ta' 14)pilloli miksija b'rita.
English: In this active controlled clinical trial, the most common reasons for discontinuation of therapy with Exforge HCT were dizziness and hypotension (0.7%).
Maltese: F'din il-prova kkontrollata b'mod attiv, l-aktar raġunijiet komuni għalfejn kellha titwaqqaf it-terapija b'Exforge HCT kienu sturdament u pressjoni baxxa (0.7%).
English: an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Maltese: inibitur ta' ACE (pereżempju enalapril, lisinopril, ramipril), b'mod partikulari jekk għandek problemi tal-kliewi relatati mad-dijabete.
English: Do not take Exforge HCT with grapefruit or grapefruit juice.
Maltese: Tiħux Exforge HCT ma' grejpfrut jew ma' meraq tal-grejpfrut.
English: The following adverse reactions, listed by MedDRA System Organ Class and frequency, concern Exforge HCT (amlodipine/valsartan/HCT) and amlodipine, valsartan and HCT individually.
Maltese: Ir-reazzjonijiet avversi li ġejjin, elenkati skont il-Klassi tas-Sistemi u Organi MedDRA u l-frekwenza, jikkonċernaw Exforge HCT (amlodipine/valsartan/HCT) u amlodipine, valsartan u HCT waħedhom.
English: No formal interaction studies with other medicinal products have been performed with Exforge HCT.
Maltese: Ma twettaq l-ebda studju formali ta' interazzjoni ma' prodotti mediċinali oħrajn b'Exforge HCT.
English: The reductions in systolic/diastolic blood pressure with Exforge HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide, 6.2/3.3 mmHg greater than with amlodipine/valsartan, and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide.
Maltese: It-tnaqqis fil-pressjoni sistolika/dijastolika b'Exforge HCT kien 7.6/5.0 mmHg aktar minn dak b'valsartan/hydrochlorthiazide, 6.2/3.3 mmHg aktar minn dak b'amlodipine/valsartan, u 8.2/5.3 mmHg aktar minn dak b'amlodipine/hydrochlorthiazide.
English: The safety profile of Exforge HCT presented below is based on clinical studies performed with Exforge HCT and the known safety profile of the individual components amlodipine, valsartan and hydrochlorothiazide.
Maltese: Il-profil ta' sigurtà ta' Exforge HCT ppreżentat hawn taħt huwa bbażat fuq studji kliniċi magħmulin b'Exforge HCT u fuq il-profil ta' sigurtà magħruf tal-komponenti individwali amlodipine, valsartan u hydrochlorthiazide.