FrancophonIA/ELRC3.0 huggingface dataset:
English: The maximum daily dose is 3000 mg metformin and should preferably be divided into 2 - 3 daily doses.
Maltese: Id-doża massima ta' kuljum hija ta' 3000 mg ta' metformin u preferibbilment għandha tinqasam fi 2 - 3 dożi kuljum.
English: Other medicines and Ebymect
Maltese: Mediċini oħra u Ebymect
English: Metformin is excreted by the kidney, and moderate to severe renal insufficiency increases the risk of lactic acidosis (see section 4.4).
Maltese: Metformin jiġi eliminat mill-kliewi, u insuffiċjenza renali minn moderata għal qawwija żżid ir-riskju ta' aċidożi lattika (ara sezzjoni 4.4).
English: Ebymect 5 mg/850 mg tablets dapagliflozin/metformin HCl
Maltese: Ebymect 5 mg/850 mg pilloli dapagliflozin/metformin HCl
English: • The active substances are dapagliflozin and metformin hydrochloride (metformin HCl).
Maltese: X'fih Ebymect • Is-sustanzi attivi huma dapagliflozin u metformin hydrochloride (metformin HCl).
English: •Ebymect5mg/850mg are 9.5x20mm oval, brown film-coated tablets.
Maltese: • Ebymect 5 mg/850 mg huma 9.5 x 20 mm pilloli miksijin b'rita ovali, kannella.
English: No dose adjustment is recommended for patients with mild renal impairment, GFR 60 - 89 mL/min.
Maltese: Mhuwiex rakkomandat aġġustament tad-doża għal pazjenti b'indeboliment renali ħafif, GFR 6089 mL/min.
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo c
Maltese: HbA1c (%) Linja bażi (medja)
English: When Ebymect is used in combination with insulin or an insulin secretagogue such as sulphonylurea, a lower dose of insulin or sulphonylurea may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).
Maltese: Meta Ebymect jintuża f'kombinazzjoni mal-insulina jew ma' sekretagoga tal-insulina bħal sulphonylurea, tista' tiġi kkunsidrata doża iktar baxxa ta' insulina jew ta' sulphonylurea biex jitnaqqas ir-riskju ta' ipogliċemija (ara sezzjonijiet 4.5 u 4.8).
English: Ebymect is not recommended for use in patients with GFR < 60 mL/min (see section 4.4).
Maltese: Ebymect mhuwiex rakkomandat biex jintuża fuq pazjenti b'GFR < 60 ml/min (ara sezzjoni 4.4).
English: The following statements reflect the preclinical safety data of the individual active substances of Ebymect.
Maltese: Id-dikjarazzjonijiet li ġejjin jirriflettu linformazzjoni disponibbli dwar is-sustanzi attivi individwali.
English: Each Ebymect 5 mg/850 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg metformin hydrochloride.
Maltese: Kull Ebymect 5 mg/850 mg pillola miksija b'rita (pillola) fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin u 850 mg metformin hydrochloride.
English: Ebymect 5 mg/850 mg film-coated tablets Ebymect 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Maltese: Ebymect 5 mg/850 mg pilloli miksijin b'rita Ebymect 5 mg/1,000 mg pilloli miksijin b'rita dapagliflozin/metformin hydrochloride
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni kienet atipika b'żieda moderata biss fil-valuri tal-glucose fiddemm, inqas minn 14 mmol/l (250 mg/dl).
English: Ebymect 5 mg/850 mg film-coated tablets Ebymect 5 mg/1,000 mg film-coated tablets
Maltese: Ebymect 5 mg/850 mg pilloli miksijin b'rita Ebymect 5 mg/1,000 mg pilloli miksijin b'rita
English: Each Ebymect 5 mg/1,000 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg metformin hydrochloride.
Maltese: Kull Ebymect 5 mg/1,000 mg pillola miksija b'rita (pillola) fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin u 1,000 mg metformin hydrochloride.
English: • in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1
Maltese: • f'kombinazzjoni ma' prodotti mediċinali oħra li jbaxxu l-glukożju, inkluża l-insulina, f'pazjenti mhux ikkontrollati adegwatament b'metformin u b'dawn il-prodotti mediċinali (ara sezzjonijiet 4.4, 4.5 u 5.1 għat-tagħrif disponibbli dwar kombinazzjonijiet differenti)
English: Ebymect 5 mg/850 mg film-coated tablets and Ebymect 5 mg/1,000 mg film-coated tablets are available in PVC/PCTFE/Alu blister.
Maltese: Ebymect 5 mg/850 mg pilloli miksijin b'rita u Ebymect 5 mg/1,000 mg pilloli miksijin b'rita jiġu f'folja tal-PVC/PCTFE/Alu.
English: Haematocrit values > 55 % were reported in 1.3 % of the subjects treated with dapagliflozin 10 mg versus 0.4 % of placebo subjects.
Maltese: Valuri tal-ematokrit >55 % ġew irrapportati f'1.3 % tal-individwi kkurati b'10 mg dapagliflozin meta mqabbel ma' 0.4 % tal-individwi fuq plaċebo Il-kura fit-tul b'metformin ġiet assoċjata ma' tnaqqis fl-assorbiment tal-vitamina
English: Avoid excessive alcohol intake while taking Ebymect since this may increase the risk of lactic acidosis (see “Warnings and precautions”).
Maltese: Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu Ebymect peress li dan jista' jżid ir-riskju ta' aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: Ebymect combination tablets are considered to be bioequivalent to coadministration of corresponding doses of dapagliflozin and metformin hydrochloride administered together as individual tablets.
Maltese: Il-pilloli kombinati Ebymect huma kkunsidrati bijoekwivalenti għall-amministrazzjoni konġunta ta' dożi korrispondenti ta' dapagliflozin u metformin hydrochloride mogħtija flimkien bħala pilloli individwali.
English: Insulin and insulin secretagogues, such as sulphonylureas, cause hypoglycaemia.
Maltese: L-insulina u s-segretagogi tal-insulina, bħalma huma sulphonylureas, jikkaġunaw l-ipogliċemija.
English: Ebymect 5 mg/850 mg film-coated tablets
Maltese: Ebymect 5 mg/850 mg pilloli miksijin b'rita
English: Ebymect 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride
Maltese: Ebymect 5 mg/850 mg pilloli miksijin b'rita dapagliflozin/metformin hydrochloride
English: LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Maltese: HbA1c (%) Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo (95 % CI) Piż tal-ġisem (kg) Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo (95 % CI) Doża medja ta' insulina kuljum (IU) Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo (95 % CI) Individwi bi tnaqqis medju fid-doża tal-insulina ta' millinqas 10 % kuljum (%) LOCF: L-aħħar osservazzjoni (qabel id-data jew dakinhar tal-ewwel żieda fid-doża tal-insulina, jekk meħtieġ) miġjuba 'l quddiem L-individwi kollha magħżula b'mod każwali li ħadu mill-inqas doża waħda ta' prodott mediċinali ta' studju double-blind matul il-perjodu double-blind ta' terminu qasir Il-medja tal-inqas kwadri aġġustata għall-valur tal-linja bażi u l-preżenza ta' prodott mediċinali orali li jbaxxi l-glukożju valur-p < 0.0001 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukożju valur-p < 0.05 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukożju Żieda fid-dożi tal-insulina (inkluż insulina li taħdem għal żmien qasir, intermedja jew bażali) kienet permessa biss jekk il-pazjenti kienu jissodisfaw il-kriterji FPG definiti minn qabel Ħamsin fil-mija tal-pazjenti kienu fuq monoterapija bl-insulina fil-linja bażi; 50 % kienu fuq prodott jew żewġ prodotti mediċinali orali li jbaxxu l-glukożju miżjuda mal-insulina:
English: Therefore, this medicinal product is not recommended for use in patients with moderate to severe renal impairment (patients with GFR < 60 mL/min) (see section 4.2).
Maltese: Għaldaqstant, dan il-prodott mediċinali mhuwiex rrakkomandat biex jintuża f'pazjenti b'indeboliment renali moderat sa sever (pazjenti b'GFR < 60 ml/min) ( ara sezzjoni 4.2).
English: The efficacy of dapagliflozin, a component of this medicinal product, is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment.
Maltese: L-effikaċja ta' dapagliflozin, li huwa komponent ta' dan il-prodott mediċinali, tiddependi mill-funzjoni renali, u l-effikaċja tonqos f'pazjenti li jkollhom indeboliment renali moderat u aktarx li tkun assenti f'pazjenti b'indeboliment renali sever.
English: The safety and efficacy of Ebymect in children and adolescents aged 0 to < 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Ebymect fit-tfal u l-adolexxenti minn età ta' 0 sa < 18-il sena ma ġewx determinati s'issa.
English: Fifty percent of subjects were on insulin monotherapy at baseline; 50 % were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80 % were on metformin alone, 12 % were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Maltese: Minn dan il-grupp tal-aħħar, 80 % kienu fuq metformin waħdu, 12 % kienu fuq terapija ta' metformin flimkien ma' sulphonylurea, u lbqija kienu fuq prodotti mediċinali orali oħrajn li jbaxxu l-glukożju.
English: • by delaying intestinal glucose absorption.
Maltese: - billi jittardja l-assorbiment intestinali tal-glukożju.
English: Ebymect 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Maltese: Ebymect 5 mg/1,000 mg pilloli miksijin b'rita dapagliflozin/metformin hydrochloride
English: Consumption of alcohol and medicinal products containing alcohol should be avoided.
Maltese: Għandu jiġi evitat il-konsum talalkoħol u ta' prodotti mediċinali li fihom l-alkoħol.
English: The table shows adverse reactions identified from up to 24-week (short-term) data regardless of glycaemic rescue, except those marked with §, for which adverse reaction and frequency categories are based on information from the metformin Summary of Product Characteristics available in the European Union.
Maltese: It-tabella turi reazzjonijiet avversi identifikati minn dejta sa 24 ġimgħa (perjodu qasir) irrispettivament mis-salvataġġ gliċemiku, ħlief dawk immarkati b'§, li għalihom il-kategoriji tar-reazzjonijiet avversi u talfrekwenza huma bbażati fuq informazzjoni mis-Sommarju tal-Karatterisiċi tal-prodott ta' metformin disponibbli fl-Unjoni Ewropea.
English: • diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Maltese: - sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1 - kull tip ta' aċidożi metabolika akuta (bħal aċidożi lattika, ketoaċidożi dijabetika); - stat dijabetiku ta' qabel il-koma; - insuffiċjenza renali severa (GFR <30 mL/min) (ara sezzjonijiet 4.4 u 5.2); - kundizzjonijiet akuti li potenzjalment jistgħu jbiddlu l-funzjoni tal-kliewi bħalma huma: deidratazzjoni, infezzjoni severa, xokk; - mard akut jew kroniku li jista' jikkawża ipoksja tat-tessut bħalma huwa: insuffiċjenza kardijaka jew respiratorja, infart mijokardijaku reċenti, xokk; - indeboliment tal-fwied (ara sezzjonijiet 4.2, 4.4 u 5.2); - intossifikazzjoni akuta bl-alkoħol, alkoħoliżmu (ara sezzjoni 4.5).
English: Ebymect 5 mg/1,000 mg film-coated tablets
Maltese: Ebymect 5 mg/1,000 mg pilloli miksijin b'rita
English: There have been no therapeutic clinical trials conducted with Ebymect tablets.
Maltese: Ma saret ebda prova klinika terapewtika bil-pilloli Ebymect.
English: For patients switching from separate tablets of dapagliflozin and metformin Patients switching from separate tablets of dapagliflozin (10 mg total daily dose) and metformin to Ebymect should receive the same daily dose of dapagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
Maltese: Għal pazjenti li jaqilbu minn pilloli separati ta' dapagliflozin u metformin Pazjenti li jaqilbu minn pilloli separati ta' dapagliflozin (doża totali ta' kuljum ta' 10 mg) u metformin għal Ebymect għandhom jirċievu l-istess doża ta' kuljum ta' dapagliflozin u metformin li diġà tkun qiegħda tittieħed jew l-eqreb doża terapewtikament xierqa ta' metformin.
English: Body weight (kg) Baseline (mean) Change from baseline Difference from placebo c
Maltese: Linja bażi (medja) Bidla mil-Linja Bażi Differenza minn Plaċebo c
English: Uncommon (may affect up to 1 in 100 people) • thirst
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100)
English: in adults;
Maltese: Fl-adulti,
English: The marketing authorisation was renewed on 9 March 2005.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fid-9 ta' Marzu 2005.
English: These contain from 1 to 50 million IU (international units) per millilitre.
Maltese: Dawn fihom minn 1 sa 50 miljun IU (unitajiet internazzjonali) kull millilitru.
English: The most common side effects with Viraferon in adults (seen in more than 1 patient in 10) are leucopenia (low white blood cell counts), anorexia (loss of appetite), depression, insomnia (difficulty sleeping), anxiety, agitation, nervousness, dizziness, headache, impaired concentration, dry mouth, blurred vision, nausea (feeling sick) or vomiting, abdominal (tummy) pain, diarrhoea, stomatitis (inflammation of the lining of the mouth), dyspepsia (indigestion), alopecia (hair loss), increased sweating, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), inflammation at the site of the injection, fatigue (tiredness), rigors (shaking chills), fever, flulike symptoms, asthenia (weakness), irritability, chest pain, malaise (feeling unwell) and weight loss.
Maltese: L-aktar effetti sekondarju komuni b'Viraferon f'adulti (muri f'aktar minn pazjent 1 minn 10) huma leucopenia (rata baxxa ta' ċelloli bojod fid-demm), anoressija (nuqqas ta' aptit), depressjoni, insomnja (diffikultà fl-irqad), ansjetà, aġitazzjoni, nervożiżmu, sturdament, uġigħ ta' ras, konċentrazzjoni mnaqqsa, ħalq niexef, vista baxxa, nawżja (tħossok mdardar) jew remettar, uġigħ addominali (tażżaqq), dijarea, stomatitis (fjammazzjoni tad-dawra tal-ħalq), dyspepsia (indiġestjoni),alopeċja (telf ta' xagħar), jegħraq aktar, mijalġja (uġigħ fil-muskoli), artralġja (uġigħ fil-ġogi), uġigħ muskuloskeletali (uġigħ fil-muskoli u fl-għadam), fjammazzjoni fis-sit ta' l-injezzjoni inkluż infjammazzjoni, għejja, rigors (rogħda qawwija bil-bard), deni, sintomi simili għal ta' l-influwenza, astenja (djgħufija), irritabilità uġiegħ fis-sider, malaise (meta wieħed iħossu ħażin) u telf fil-piż.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VIRAFERON EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) VIRAFERON Sommarju ta' l-EPAR għall-pubbliku
English: Other information about Viraferon:
Maltese: Informazzjoni oħra dwar Viraferon:
English: The European Commission granted a marketing authorisation valid throughout the EU for Viraferon to SP Europe on 9 March 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Viraferon lil SP Europe fid-9 ta' Marzu 2000.
English: Viraferon has to be stored in a refrigerator (2°C-8°C).
Maltese: Viraferon għandu jinħażen fi friġġ (2°C-8°C).
English: • patients with epilepsy or other central nervous system problems,
Maltese: • pazjenti b'epilepsja jew bi problemi oħra tas-sistema nervuża ċentrali,
English: Viraferon is a medicine containing the active substance interferon alfa-2b.
Maltese: Viraferon huwa mediċina li fiha s-sustanza attiva interferon alfa-2b.
English: The active substance in Viraferon, interferon alfa-2b, belongs to the group ‘interferons'.
Maltese: Is-sustanza attiva f'Viraferon, interferon alfa-2b, tappartieni għall-grupp ‘interferons'.
English: The interferon alfa-2b in Viraferon is produced by a method known as ‘recombinant DNA technology': the interferon alfa-2b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
Maltese: L-interferon alfa-2b f'Viraferon huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tadDNA': l-interferon alfa-2b huwa magħmul minn batterju li jkun irċieva ġene (DNA), li bih ikun jista' jipproduċih.
English: The use of Viraferon in combination with ribavirin has also been studied in 118 hepatitis C treatment-naïve children aged between three and 16 years.
Maltese: L-użu ta' Viraferon flimkien ma' ribavirin ġie studjat ukoll fuq 118-il tifel/tifla naïve għat-trattament b'epatite Ċ t'età bejn 3 u 16-il sena.
English: • chronic (long-term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus)
Maltese: • epatite B kronika (fit-tul) (marda tal-fwied dovuta għal infezzjoni bil-vajrus ta' l-epatite B) fl adulti,
English: What is Viraferon?
Maltese: X'inhu Viraferon?
English: Because interferon alfa-2b has been used to treat a number of diseases in the European Union (EU) before, the company that makes Viraferon supplied data from the scientific literature and from studies of its use in children with chronic hepatitis B. The company also supplied information from a number of studies of Viraferon used alone or with ribavirin for the treatment of chronic hepatitis C. These included a total of 2,552 treatment-naïve patients (who had not been treated before) and a total of 345 patients whose disease had relapsed (returned) after previous treatment with interferon.
Maltese: Dawn inkludew 2,552 pazjent naïve għat-trattament (qatt ma ġew ittratti qabel) u total ta' 345 pazjent li l-marda tagħhom reġgħet feġġet (irritornat) wara trattament preċedenti b'interferon.
English: The replacement interferon alfa-2b acts in same way as naturally produced interferon alpha.
Maltese: L-interferon alfa-2b sostitut jaġixxi bl-istess mod bħal interferon alfa prodotti b'mod naturali.
English: Similar side effects have been seen in children receiving Viraferon, as well as inhibition of growth.
Maltese: Effetti sekondarji simili instabu fi tfal li jużaw Viraferon, kif ukoll tnaqqis fit-tkabbir.
English: • chronic hepatitis C (a disease of the liver due to an infection by the hepatitis C virus).
Maltese: • epatite Ċ kronika (marda tal-fwied dovuta għal infezzjoni bil-vajrus ta' l-epatite Ċ).
English: • children and adolescents with a history of severe mental illness, particularly severe depression,
Maltese: • tfal u adoloxxenti bi storja ta' mard mentali serju, b'mod partikolari depressjoni qawwija,
English: Why has Viraferon been approved?
Maltese: Għaliex Viraferon ġie approvat?
English: Viraferon is used for the treatment of:
Maltese: Viraferon jintuża għat-trattament ta':
English: suicidal thoughts or suicide attempts.
Maltese: ħsibijiet ta' suwiċidju jew attentati ta' suwiċidju.
English: Viraferon was also shown to have a benefit in children with chronic hepatitis B. Viraferon, with or without ribavirin, was shown to be effective in treating hepatitis C in both treatment-naïve and relapsed adults.
Maltese: Intwera li Viraferon, bi jew mingħajr ribavirin, huwa effettiv fit-trattament ta' l-epatite Ċ kemm f'adulti naïve għat-trattamenti kif ukoll f'adulti li rkadew.
English: How has Viraferon been studied?
Maltese: Kif ġie studjat Viraferon?
English: • patients with a history of certain disorders of the immune system, or who have had an organ transplant and are taking medicines that suppress the immune system,
Maltese: • pazjenti bi storja ta' ċerti disturbi tas-sistema immunitarja, jew li kellhom trapjant ta' organu u qegħdin jieħdu mediċina li trażżan is-sistema immunitarja
English: Alpha interferons may also block the multiplication of viruses.
Maltese: Alpha interferons jistgħu jimblokkaw ukoll il-multiplikazzjoni tal-vajrusijiet.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Viraferon's benefits are greater than its risks for the treatment of chronic hepatitis B and C. The Committee recommended that Viraferon be given marketing authorisation.
Maltese: Peress li Viraferon jista' jiġi assoċjat ma' effetti sekondarji bħal dipressjoni, pazjenti għandhom jiġu sorveljati mill-qrib matul it-trattament.
English: What is the risk associated with Viraferon?
Maltese: X'inhu r-riskju assoċjat ma' Viraferon?
English: Viraferon can be used on its own but is best used in combination with ribavirin (an antiviral medicine).
Maltese: Viraferon jista' jintuża waħdu iżda l-aħjar li jintuża flimkien ma' ribavirin (mediċina antivirali).
English: • patients with thyroid disease unless it is controlled,
Maltese: • pazjenti b'mard tat-tirojde jekk mhux ikkontrollati,
English: The dose and duration of treatment depend on the disease being treated and the response of the patient, with doses ranging from 3 to 10 million IU per square metre of body surface area.
Maltese: Id-doża u t-tul tat-trattament jiddependu fuq il-marda li tkun qegħda tiġi ttrattata u fuq ir-rispons tal-pazjent, b'dożaġġi li jvarjaw minn 3 għal 10 miljun IU kull metru kwadru ta' l-erja tassuperfiċje tal-ġisem.
English: It was also effective in children when used with ribavirin, with 46% of the children having responded to treatment at the six-month follow up visit following a year's treatment.
Maltese: Ġiet osservata wkoll reazzjoni għat-trattament waqt il-vista ta' kontroll li saret sitt xhur wara sena ta' trattament f'46% tat-tfal, meta IntronA kienet użata flimkien ma ribavirin.
English: For a list of all restrictions with Viraferon, see the Package Leaflet.
Maltese: Il-Kumitat irrakkomanda li Viraferon jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Maltese: Interferons huma sustanza naturali prodotti mill-ġisem li jgħinuh jiġġieled attakki bħal infezzjonijiet ikkawżati minn vajrusijiet.
English: • P-gp inhibitors (e.g. ciclosporin, verapamil)
Maltese: • Inibituri P-gp (eŜ., ciclosporin, verapamil)
English: • Have ever had an abnormal electrocardiogram (ECG)
Maltese: • Qatt kellu xi elettrokardjogramma (ECG) anormali
English: • Potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone)
Maltese: • Inibituri CYP3A4 qawwijin (eŜ. itraconazole, ketoconazole, voriconazol, posaconazol, inibituri tal-protease tal-HIV, clarithromycin, telithromycin, nefazodone)
English: • Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than Amiodarone
Maltese: • Antiarrittmiëi ta' Kategorija Ia (eŜ. quinidine) jew ta' Kategorija III (eŜ., dofetilide,sotalol) għajr amiodarone
English: • Kidney problems
Maltese: • Problemi fil-kliewi
English: • Is taking the herbal remedy St John's Wort
Maltese: • Jekk hux qiegħed jieħu r-rimedju erbali St John's Wort
English: • Not drink Grapefruit Juice
Maltese: • Ma jixrobx meraq tal-grapefruit
English: • Moderate CYP3A4 inhibitors (e.g. diltiazem, erythromycin, fluconazole)
Maltese: (eŜ., diltiazem, erythromycin, fluconazole)
English: • Is taking medications to treat epilepsy, bacterial or fungal infections, HIV infection, depression or heart rhythm disorders
Maltese: • Infezzjoni ta' l-HIV, depressjoni jew disturbi fir-rittmu tal-qalb
English: • A dose reduction of Ranexa may be needed in combination with:
Maltese: • Jista' jkun hemm bŜonn ta' tnaqqis fid-doŜa ta' Ranexa f'kombinazzjoni ma':