FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Conversion table for HALDOL 2 mg/ml oral solution mg haloperidol Number of drops of HALDOL (dropper container)
Maltese: Tabella 2: Tabella ta' konverżjoni għas-soluzzjoni orali ta' HALDOL 2 mg/ml mg haloperidol
English: 6.2 Incompatibilities [To be completed nationally]
Maltese: [Biex timtela mill-pajjiż partikolari] 6.2 Inkompatibbilitajiet
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 5 mg tablets [See Annex I - To be completed nationally] haloperidol
Maltese: HALDOL u ismijiet assoċjati (ara Anness I) 5 mg pilloli [Ara Anness I - Biex timtela mill-pajjiż partikolari] haloperidol
English: The HALDOL 2 mg/ml oral solution in a bottle with an oral syringe is intended to be used for single doses of 0.5 mg haloperidol and above (equivalent to 0.25 ml and above).
Maltese: Is-soluzzjoni orali ta' HALDOL 2 mg/ml fi flixkun b'siringa tal-ħalq qegħda biex tintuża għal dożi waħdiet ta' 0.5 mg haloperidol u aktar (ekwivalenti għal 0.25 ml u aktar).
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 4 mg tablets [See Annex I - To be completed nationally] haloperidol
Maltese: HALDOL u ismijiet assoċjati (ara Anness I) 4 mg pilloli [Ara Anness I - Biex timtela mill-pajjiż partikolari] haloperidol
English: The HALDOL 10 mg/ml oral solution in a dropper container is intended to be used for single doses up to 10 mg haloperidol (20 drops).
Maltese: Is-soluzzjoni orali ta' HALDOL 10 mg/ml f'kontenitur b'qattara qegħda biex jintuża għal dożi waħdiet sa 10 mg haloperidol (20 qatra).
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 1 mg tablets [See Annex I - To be completed nationally] haloperidol
Maltese: HALDOL u ismijiet assoċjati (ara Anness I) 1 mg pilloli [Ara Anness I - Biex timtela mill-pajjiż partikolari] haloperidol
English: Increased haloperidol plasma concentrations may result in an increased risk of adverse events, including QTc-prolongation (see section 4.4).
Maltese: avvenimenti avversi, inkluż titwil tal-intervall QTc (ara sezzjoni 4.4).
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 10 mg tablets [See Annex I - To be completed nationally] haloperidol
Maltese: HALDOL u ismijiet assoċjati (ara Anness I) 10 mg pilloli [Ara Anness I - Biex timtela mill-pajjiż partikolari] haloperidol
English: Fertility - Haldol may increase your levels of a hormone called ‘prolactin', which may affect fertility in men and women.
Maltese: Fertilità - Haldol jista' jżid il-livelli tiegħek ta' ormon imsejjaħ ‘prolaktin', li jista' jaffettwa l-fertilità fl-irġiel u n-nisa.
English: Patients with first-episode schizophrenia generally respond to 2 to 4 mg/day, whereas patients with multiple-episode schizophrenia may need doses up to 10 mg /day.
Maltese: Il-pazjenti bl-ewwel episodju ta' skiżofrenja ġeneralment jirrispondu għal 2 sa 4 mg/kuljum, filwaqt li pazjenti b'episodji multipli ta' skiżofrenja jistgħu jkunu jeħtieġu dożi sa 10 mg/kuljum.
English: Haldol is also used in adults:
Maltese: Haldol jintuża wkoll fl-adulti:
English: EXPIRY DATE EXP
Maltese: <Sorsi oħra ta' informazzjoni>
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 5 mg/ml solution for injection [See Annex I - To be completed nationally] haloperidol
Maltese: HALDOL u ismijiet assoċjati (ara Anness I) 5 mg/ml soluzzjoni għall-injezzjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari] haloperidol
English: Hypoglycaemia and syndrome of inappropriate antidiuretic hormone secretion have been reported with haloperidol (see section 4.8).
Maltese: ġinekomastja, u oligomenorrea jew amenorrea (ara sezzjoni 4.8).
English: (ml).
Maltese: {XX/SSSS}
English: Haloperidol may antagonise the action of adrenaline and other sympathomimetic medicinal products (e.g. stimulants like amphetamines) and reverse the blood pressure-lowering effects of adrenergic-blocking medicinal products such as guanethidine.
Maltese: Haloperidol jista' jantagonizza l-azzjoni tal-adrenalina u prodotti mediċinali simpatomimetiċi oħra (eż.
English: NAME OF THE MEDICINAL PRODUCT HALDOL and associated names (see Annex I) 2 mg tablets [See Annex I - To be completed nationally] haloperidol
Maltese: HALDOL u ismijiet assoċjati (ara Anness I) 2 mg pilloli [Ara Anness I - Biex timtela mill-pajjiż partikolari] haloperidol
English: The following problems may occur in newborn babies of mothers that use Haldol in the last 3 months of their pregnancy (the last trimester):
Maltese: Il-problemi li ġejjin jistgħu jseħħu fi trabi tat-twelid ta' ommijiet li jieħdu Haldol fl-aħħar 3 xhur tat tqala tagħhom (l-aħħar trimestru):
English: HALDOL should be used with caution in patients who are known poor metabolisers of cytochrome P450 (CYP) 2D6 and who are coadministered a CYP3A4 inhibitor.
Maltese: HALDOL għandu jintuża b'kawtela f'pazjenti li huma magħrufa li huma metabolizzaturi dgħajfa taċċitokrom P450 (CYP) 2D6 u li flimkien miegħu jingħataw inibitur ta' CYP3A4.
English: Heart problems are uncommon in people taking Haldol (may affect up to 1 in 100 people).
Maltese: Problemi fil-qalb mhumiex komuni f'persuni li jkunu qed jieħdu Haldol (jistgħu jaffettwaw sa persuna 1 minn kull 100).
English: Package Leaflet for 10 mg/ml oral solution - bottle with oral syringe only: The HALDOL 10 mg/ml oral solution in a bottle with an oral syringe is intended to be used for doses of 5 mg haloperidol and above (equivalent to 0.5 ml and above).
Maltese: Is-soluzzjoni orali ta' HALDOL 10 mg/ml fi flixkun b'siringa tal-ħalq qegħda biex tintuża għal dożi waħdiet ta' 5 mg haloperidol u aktar (ekwivalenti għal 0.5 ml u aktar).
English: The risk of ventricular arrhythmias, possibly associated with QTc prolongation, must be considered.
Maltese: Għandu jitqies ir-riskju ta' arritmiji talventrikulu, possibilment assoċjati ma titwil tal-intervall QTc.
English: • Adolescents up to 17 years of age being treated for schizophrenia or behavioural problems may have a higher dose, up to 5 mg each day.
Maltese: • L-adolexxenti sa 17-il sena li jkunu qed jiġu ttrattati għal skiżofrenja jew problemi ta' mġieba jistgħu jieħdu doża ogħla, sa 5 mg kuljum.
English: Your doctor will discuss the risks and benefits of breast-feeding while you are taking Haldol.
Maltese: Ittabib tiegħek se jiddiskuti r-riskji u l-benefiċċji tat-treddigħ waqt li inti tkun qed tieħu Haldol.
English: Photosensitivity reaction Urticaria Pruritus Hyperhidrosis
Maltese: Indeboliment akut tal-fwied
English: Plasma concentrations measured at various time points and after various durations of treatment, were either undetectable or ranged up to a maximum of 44.3 ng/ml.
Maltese: Konċentrazzjonijiet fil-plażma mkejla f'punti ta' żmien differenti wara tulijiet ta' żmien differenti ta' trattament, kienu jew ma jistgħux jitkejlu jew kienu fuq firxa sa massimu ta' 44.3 ng/ml.
English: Isolated cases of liver function abnormalities or hepatitis, most often cholestatic, have been reported (see section 4.8).
Maltese: Ġew irrappurtati każijiet iżolati ta' anormalitajiet fil-funzjoni tal-fwied jew epatite, il-biċċa l-kbira kolestatika (ara sezzjoni 4.8).
English: Examples of medicinal products that may increase haloperidol plasma concentrations (based on clinical experience or drug interaction mechanism) include:
Maltese: Eżempji ta' prodotti mediċinali li jistgħu jżidu l-konċentrazzjonijiet ta' haloperidol fil-plażma (abbażi ta' esperjenza klinika jew talmekkaniżmu ta' interazzjoni bejn il-mediċini) jinkludu:
English: How to store Haldol
Maltese: X'fih Haldol
English: DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
Maltese: Data tal-ewwel awtorizzazzjoni: {JJ xahar SSSS}
English: • The highest dose adults should take depends on the condition you are being treated for and varies between 5 mg and 20 mg each day.
Maltese: • L-ogħla doża li għandhom jieħdu l-adulti tiddependi fuq il-kundizzjoni li inti tkun qed tiġi ttrattat għaliha u tvarja bejn 5 mg u 20 mg kuljum.
English: Inhibition of these routes of metabolism by another medicinal product or a decrease in CYP2D6 enzyme activity may result in increased haloperidol concentrations.
Maltese: metaboliżmu permezz ta' prodott mediċinali ieħor jew tnaqqis fl-attività tal-enzima CYP2D6 jistgħu jwasslu għal żieda fil-konċentrazzjonijiet ta' haloperidol.
English: 6.1 List of excipients [To be completed nationally]
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti
English: • Muscle tremors, stiff or weak muscles
Maltese: • Depressjoni • Tensjoni mhux normali fil-muskoli
English: The most prominent symptoms are severe extrapyramidal reactions, hypotension and sedation.
Maltese: L-aktar sintomi prominenti huma reazzjonijiet ekstrapiramidali, ipotensjoni u sedazzjoni severi.
English: The safety and efficacy of HALDOL oral solution in children below the ages defined in the indications have not been established.
Maltese: Is-sigurtà u l-effikaċja tas-soluzzjoni orali ta' HALDOL fit-tfal li għandhom anqas mill-etajiet iddefiniti fl-indikazzjonijiet ma ġewx ddeterminati s'issa.
English: HALDOL and associated names (see Annex I) 2 mg/ml oral solution HALDOL and associated names (see Annex I) 10 mg/ml oral solution
Maltese: HALDOL u ismijiet assoċjati (ara Anness I) 2 mg/ml soluzzjoni orali HALDOL u ismijiet assoċjati (ara Anness I) 10 mg/ml soluzzjoni orali
English: Additionally, the antidopaminergic effect on the chemoreceptor-trigger zone of the area postrema explains the activity against nausea and vomiting.
Maltese: B'mod addizzjonali, l-effett antidopaminerġiku fuq iż-żona li tipprovoka l kimoriċettur tal-parti postrema jispjega l-attività kontra n-nawjsja u r-rimettar.
English: Therapeutic concentrations
Maltese: TAL-PRODOTT MEDIĊINALI
English: Missed dose
Maltese: Ħafna
English: However, if administered intravenously, continuous ECG monitoring must be performed for QTc interval prolongation and for ventricular arrhythmias.
Maltese: Madankollu, jekk jingħata mill-vini, għandu jsir monitoraġġ kontinwu bl-ECG għal titwil tal-intervall QTc u għal arritmiji tal-ventrikulu.
English: Electrocardiogram QT prolonged
Maltese: Tħassib dwar is-sistema endokrinarja
English: The maximum dose in elderly patients is 5 mg/day.
Maltese: Id-doża massima f'pazjenti anzjani hija 5 mg/kuljum.
English: Photosensitivity reaction Urticaria Pruritus
Maltese: Disturbi taddemm u tassistema limfatika
English: EMA/207380/2018 Rev. 2 EMEA/H/C/004398
Maltese: EMA/207380/2018 Rev.
English: Alsitek was expected to be used to treat amyotrophic lateral sclerosis (ALS).
Maltese: Alsitek kien mistenni li jintuża biex jikkura sklerosi laterali amijotrofika (ALS).
English: What is Alsitek?
Maltese: X'inhu Alsitek?
English: Alsitek was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 29 August 2016 for the treatment of ALS.
Maltese: Alsitek kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fid-29 ta' Awissu 2016, għall-kura tal-ALS.
English: ALS is a progressive disease of the nervous system, where nerve cells in the brain and spinal cord that control voluntary movement gradually deteriorate, causing loss of muscle function and paralysis.
Maltese: L-ALS hija marda progressiva tas-sistema nervuża, fejn iċ-ċelluli tan-nervituri fil-moħħ u fil-korda spinali li jikkontrollaw il-moviment volontarju jiddeterjoraw gradwalment, u jikkawżaw telfien tal-funzjoni tal-muskoli u paraliżi.
English: On 18 April 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Alsitek, intended for the treatment of amyotrophic lateral sclerosis (ALS).
Maltese: Fit-18 ta' April 2018, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Alsitek, maħsub għall-kura ta' sklerosi laterali amijotrofika (ALS).
English: Alsitek is a medicine that contains the active substance masitinib.
Maltese: Alsitek huwa mediċina li fiha s-sustanza attiva masitinib.
English: The applicant presented the results of one main study involving 394 patients with ALS, where Alsitek was compared with placebo (a dummy treatment), both taken together with riluzole.
Maltese: L-applikant ippreżenta r-riżultati ta' studju ewlieni li involva 394 pazjent bl-ALS, fejn Alsitek tqabbel ma' plaċebo (kura finta), it-tnejn jittieħdu flimkien ma' riluzole.
English: 1 June 2018
Maltese: EMA/207380/2018
English: Refusal of the marketing authorisation for Alsitek (masitinib)
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għal Alsitek (masitinib)
English: Although a positive effect on symptoms was seen in the group of patients whose disease worsened at a normal rate compared with those whose disease worsened rapidly, the CHMP considered that this way of classifying patients was arbitrary and did not reflect clinical practice.
Maltese: Għalkemm ġie osservat effett pożittiv fuq is-sintomi fil-grupp ta' pazjenti li lmarda tagħhom aggravat b'rata normali meta mqabbla ma' dawk li l-marda tagħhom aggravat malajr, is-CHMP ikkunsidra li dan il-mod ta' klassifikazzjoni tal-pazjenti kien arbitrarju u ma rriflettiex ilprattika klinika.
English: What was Alsitek expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Alsitek?
English: Microglia and mast cells may play a role in the inflammation and damage to nerves in patients with ALS.
Maltese: Microglia u ċ-ċelloli mast jista' jkollhom rwol flinfjammazzjoni u l-ħsara lin-nervituri f'pazjenti bl-ALS.
English: By reducing their activity, the medicine is expected to reduce inflammation and damage to nerves, thereby slowing down the worsening of the patient's symptoms.
Maltese: Billi tnaqqas l-attività tagħhom, il-mediċina hija mistennija li tnaqqas l-infjammazzjoni u l-ħsara lin-nervituri, u b'hekk tnaqqas l-aggravament tassintomi tal-pazjent.
English: Alsitek was to be used in combination with riluzole, another medicine for ALS.
Maltese: Alsitek kellu jintuża flimkien ma' riluzole, mediċina oħra għall-ALS.
English: Alsitek is thought to work by reducing the activity of microglia, the main immune (defence) cells of the brain, and mast cells, a type of white blood cell.
Maltese: Alsitek huwa maħsub li jaħdem billi jnaqqas l-attività ta' microglia, iċ-ċelluli immuni (difiżi) ewlenin talmoħħ, u ċelloli mast, tip ta' ċelluli bojod tad-demm.
English: Therefore, the CHMP was of the opinion that the study did not provide reliable evidence on the benefits of Alsitek and recommended that it be refused marketing authorisation.
Maltese: Fl-aħħarnett, il-Kumitat kien imħasseb dwar il-mod kif id-data minn pazjenti li rtiraw mill-kura ġiet ittrattata, li setgħet ippreġudikat ir-riżultati favur Alsitek.
English: The CHMP concluded that the main study in patients with ALS did not show that Alsitek is effective at slowing down progression of the disease.
Maltese: Is-CHMP ikkonkluda li l-istudju ewlieni f'pazjenti bl-ALS ma weriex li Alsitek huwa effettiv biex inaqqas il-progressjoni tal-marda.
English: Date of first authorisation: 16 October 1998 Date of latest renewal: 16 October 2008
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Ottubru 1998 Data tal-aħħar tiġdid: 16 ta' Ottubru 2008
English: Following oral administration of Karvezide, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Maltese: Wara li jingħata mill-ħalq Karvezide il-biodisponibilità assoluta orali hija 60-80% u 50-80% għal irbesartan u hydrochlorothiazide, rispettivament.
English: Angiotensin II Receptor Antagonists (AIIRAs):
Maltese: Antagonisti ta' Reċetturi ta' Angiotensin II (AIIRAs)
English: Tables 2 and 3 below detail the adverse reactions reported with the individual components of Karvezide.
Maltese: It-Tabelli 2 u 3 taħt jiddeskrivu fid-dettall ir-reazzjonijiet avversi rrapportati mal-komponenti individwali ta' Karvezide.
English: cardiac arrhythmias
Maltese: edema pulmonari)
English: The following changes, observed in rats and macaques receiving the irbesartan/hydrochlorothiazide combination at 10/10 and 90/90 mg/kg/day, were also seen with one of the two medicinal products alone and/or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed):  kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system;  slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit);  stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/kg/day, hydrochlorothiazide 90 mg/kg/day, and irbesartan/hydrochlorothiazide 10/10 mg/kg/day.
Maltese: It-tibdiliet li ġejjin, osservati f'firien u f'makakki li rċevew il-kombinazzjoni ta' irbesartan/hydrochlorothiazide f'dożi ta' 10/10 u 90/90 mg/kg/jum, dehru wkoll b'wieħed minn dawn iż-żewġ mediċini waħidhom u/jew kienu sekondarji għal tnaqqis tal-pressjoni (ma ġewx osservati interazzjonijiet tossikoloġiċi sinifikanti): tibdil fil-kliewi, ikkaratterizzat minn żidiet ħfief fl-urea fis-serum u tal-krejatinina, u iperplażja/ipertrofija ta' l-apparat jukstaglomerulari, li huma konsegwenza diretta ta' l-interazzjoni ta' irbesartan mas-sistema renin-angiotensin; tnaqqis żgħir fil-parametri ta' l-eritroċiti (eritroċiti, emoglobina, ematokrit); telf ta' kulur fl-istonku, ulċeri, nekrożi fokali tal-mukoża gastrika ġew osservati fi ftit firien fi studju ta' 6 xhur fuq it-tossiċità b'irbesartan 90 mg/kg/jum, hydrochlorothiazide 90 mg/kg/jum u irbesratan/hydrochlorothiazide 10/10 mg/kg/jum.
English: Karvezide is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Maltese: Karvezide huwa kombinazzjoni ta' antagonist ta' riċettur angiotensin-II, irbesartan u dijuretiku thiazide, hydrochlorothiazide.
English: Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use Karvezide with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m²) (see sections 4.5 and 5.1).
Maltese: Indeboliment epatiku sever, ċirrożi biljari u kolestażi L-użu fl-istess ħin ta' Karvezide ma' prodotti li jkun fihom aliskiren hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (rata ta filtrazzjoni mill-glomeruli (GFR) < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for Karvezide 150 mg/12.5 mg and Karvezide 300 mg/12.5 mg, respectively.
Maltese: L-effetti millinqas għal aktar mkejla mid-dirgħajn waqt il-viżti għand it-tabib kienu 68% u 76% għal Karvezide 150 mg/12.5 mg u Karvezide 300 mg/12.5 mg, rispettivament.
English: Non-melanoma skin cancer: based on available data from epidemiological studies, cumulative dose dependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
Maltese: Skont data disponibbli minn studji epidemjoloġiċi, ġiet osservata assoċjazzjoni kumulattiva dipendenti mid-doża bejn HCTZ u NMSC (ara ukoll sezzjoni 4.4 u 5.1).
English: Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel, BP 7166 F-37071, 37100 Tours France
Maltese: Sanofi Winthrop Industrie 30-36, avenue Gustave Eiffel 37100 Tours
English: Other medicines and Karvezide
Maltese: Mediċini oħra u Karvezide
English: See also information under the heading “Do not take Karvezide”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Karvezidel”.
English: Lithium: the combination of lithium and Karvezide is not recommended (see section 4.5).
Maltese: Lithium: mhux irrikmandat l-użu flimkien ta' lithium u Karvezide (ara sezzjoni 4.5).
English: Karvezide is a combination of two active substances, irbesartan and hydrochlorothiazide.
Maltese: Karvezide hu kombinazzjoni ta' żewġ sustanzi attivi, irbesartan u hydrochlorothiazide.
English: When clinically appropriate direct change from monotherapy to the fixed combinations may be considered:  Karvezide 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;  Karvezide 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Karvezide 150 mg/12.5 mg.  Karvezide 300 mg/25 mg may be administered in patients insufficiently controlled by Karvezide 300 mg/12.5 mg.
Maltese:  Karvezide 150 mg/12.5 mg jista' jingħata f' pazjenti, fejn il-pressjoni mhix qed tiġi kkontrollata sew b'hydrochlorothiazide jew irbesartan 150 mg waħidhom;  Karvezide 300 mg/12.5 mg jista' jingħata lill-pazjenti li mhux qed ikunu kkontrollati b'mod suffiċjenti b'irbesartan 300 mg jew b'Karvezide 150 mg/12.5 mg.  Karvezide 300 mg/25 mg jista' jingħata lil pazjenti li ma jkunux qed jiġu kkontrollati b'mod suffiċjenti b'Karvezide 300 mg/12.5 mg.
English: Karvezide 300 mg/12.5 mg tablets.
Maltese: Karvezide 300 mg/12.5 mg pilloli.
English: Please see section 2 “Karvezide contains lactose”.
Maltese: Jekk jogħġbok ara sezzjoni 2 “Karvezide fih lactose”.
English:  The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, red and yellow ferric oxides, carnauba wax.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, ferric oxides ħomor u sofor, carnauba wax.
English: Anaphylactic reaction including anaphylactic shock Table 3: Adverse reactions reported with the use of hydrochlorothiazide alone
Maltese: Mhux magħruf Reazzjoni anafilattika inkluż xokk anafilattiku Tabella 3: Reazzjonijiet avversi rapportati ma' l-użu ta' hydrochlorothiazide waħdu
English: Efficacy and safety of Karvezide as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
Maltese: L-effikaċja u s-sigurtà ta' Karvezide bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b'aktar minn ċentru wieħed, b'mod każwali, doubleblind, ikkontrollat b'mod attiv ta' 8 ġimgħat, parallel-arm.
English:  The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, red, yellow and black ferric oxides, pregelatinised starch, carnauba wax.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, ferric oxides ħomor, sofor u suwed, lamtu preġelatinizzat, carnauba wax.
English: Karvezide 150 mg/12.5 mg tablets.
Maltese: Karvezide 150 mg/12.5 mg pilloli.
English: When necessary, Karvezide may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Meta neċessarju, Karvezide jista jingħata ma' prodott mediċinali ieħor kontra l-pressjoni għolja (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: When measured by ambulatory blood pressure monitoring, the trough to peak effects of Karvezide 150 mg/12.5 mg were 100%.
Maltese: Meta mkejla permezz ta' osservazzjoni tal-pressjoni ambulatorja l-effetti mill-inqas għal aktar ta' Karvezide 150 mg/12.5 mg kienu 100%.
English: Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine
Maltese: Lactose: pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew assorbiment ħażin tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.