FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended starting dose is lenalidomide 10 mg orally once daily continuously (on days 1 to 28 of repeated 28-day cycles) given until disease progression or intolerance.
Maltese: Id-doża tal-bidu rakkomandata ta' lenalidomide hi ta' 10 mg mill-ħalq darba kuljum kontinwament (f'jiem 1 sa 28 ta' ċikli ripetuti ta' 28 jum) mogħtija sal-progressjoni tal-marda jew intolleranza.
English: Gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in length, grey cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “2.5 mg” printed on body in green, containing white to off white coloured powder.
Maltese: Kapsuli ibsin tal-gelatin daqs “5” ta' madwar tul ta' 11.0 mm sa 11.8mm, b'kappa griża u korp opak abjad b'“LENALIDOMIDE” stampata fuq il-kappa bl-iswed u “2.5 mg” stampata fuq il-korp bl-aħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: You must follow the Lenalidomide Pregnancy Prevention Programme 8.
Maltese: Inti trid issegwi il-Programm tal-Prevenzjoni tat-Tqala ta' Lenalidomide.
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (li jistgħu jaffettwaw sa 1 minn kull 10 persuni):
English: First fall to < 0.5 x 109/Lª
Maltese: L-ewwel jaqgħu għal < 0.5 x 109/Lª
English: The DLT in these studies was essentially haematological.
Maltese: Id-DLT f'dawn l-istudji kienet essenzjalment ematoloġika.
English: Gastrointestinal perforations may lead to septic complications and may be associated with fatal outcome.
Maltese: Perforazzjonijiet gastrointestinali jistgħu jwasslu għal kumplikazzjonijiet settiċi u jistgħu jiġu assoċjati ma riżultat fatali.
English: EU/1/18/1316/008 7x1 hard capsules EU/1/18/1316/009 21x1 hard capsules
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1316/008 7x1 kapsuli ibsin EU/1/18/1316/009 21x1 kapsuli ibsin
English: Treatment cycle
Maltese: TAL-PRODOTT MEDIĊINALI
English: Follow-up (months) Medianf (min, max): all patients Myeloma responseg n (%)
Maltese: Medjanf (min, max): il-pazjenti kollha 40.8 (0.0, 65
English: Gelatin hard capsules size “3” approximately 15.4 mm to 16.2 mm in length, leaf green cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “10 mg” printed on body in green, containing white to off white coloured powder.
Maltese: Kapsuli ibsin tal-gelatin daqs “3” ta' madwar tul ta' 15.4 mm sa 16.2mm, b'kappa ħadra kulur ilwerqa u korp abjad opak b'“LENALIDOMIDE” stampata fuq il-kappa bl-iswed u “10 mg” stampata fuq il-korp bl-aħdar, li fih trab ta' kulur abjad għal jagħti fl-abjad.
English: Lenalidomide may be continued in patients with Grade 1 or 2 tumour flare reaction (TFR) without interruption or modification, at the physician's discretion.
Maltese: Lenalidomide jista' jitkompla f'pazjenti b'reazzjoni ta' aggravament tat-tumur (TFR) ta' Grad 1 jew 2 mingħajr interruzzjoni jew modifika, fid-diskrezzjoni tat-tabib.
English: Co-administration with a high-fat and high-calorie meal in healthy volunteers reduces the extent of absorption, resulting in an approximately 20% decrease in area under the concentration versus time curve (AUC) and 50% decrease in Cmax in plasma.
Maltese: L-għoti flimkien ma' ikla b'ammont għoli ta' xaħam u ammont għoli ta' kaloriji f'voluntiera b'saħħithom inaqqas il-grad ta' assorbiment, li jirriżulta fi tnaqqis ta' madwar 20% fiż-żona taħt ilkurva konċentrazzjoni-ħin (AUC) u tnaqqis ta' 50% tas-Cmax fil-plażma.
English: This may lead to very serious infection.
Maltese: Dan jista' jwassal għal infezzjoni serja ħafna.
English: • Blurred vision
Maltese: • Telf tal-vista
English: The efficacy and safety of lenalidomide maintenance was assessed in two phase 3 multicenter, randomised, double-blind 2-arm, parallel group, placebo-controlled studies: CALGB 100104 and IFM
Maltese: L-effikaċja u s-sigurtà tal-manteniment b'lenalidomide ġie evalwat f'żewġ studji multiċentriċi ta' fażi 3, li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, b'2 partijiet, ta' grupp parallel, ikkontrollati bi plaċebo:
English: The Educational brochures for patients should be of 3 types:
Maltese: Il-pamflets edukattivi għall-pazjenti għandhom ikunu ta' 3 tipi:
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 25 mg hard capsules lenalidomide
Maltese: TAL-PRODOTT MEDIĊINALI Lenalidomide Accord 25 mg kapsuli ibsin
English: 2 D bar code carrying the unique identifier
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: The recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles.
Maltese: Id-doża tal-bidu rakkomandata ta' lenalidomide hi 25 mg mill-ħalq darba kuljum f'jiem 1 sa 21 ta' ċikli ripetuti ta' 28 jum.
English: Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with dexamethasone (see sections 4.4 and 4.8).
Maltese: Sustanzi eritropojetiċi, jew sustanzi oħrajn li jistgħu jżidu r-riskju ta' trombożi, bħat-terapija tas-sostituzzjoni ta' l-ormoni, għandhom jintużaw bl-attenzjoni f'pazjenti b'majeloma multipla li jkunu qed jirċievu lenalidomide ma' dexamethasone (ara sezzjonijiet 4.4 u 4.8).
English: Patients were stratified at randomisation by age (≤75 versus >75 years), stage (ISS Stages I and II versus Stage III), and country.
Maltese: Il-pazjenti ġew stratifikati fl-għażla b'mod każwali skont l-età (≤75 kontra >75 sena), stadju (Stadji
English: • The need to avoid foetal exposure due to teratogenicity of lenalidomide in animals and the expected teratogenic effect of lenalidomide in humans Obligations of the health care professional in relation to the prescribing of Lenalidomide Accord
Maltese: • Il-ħtieġa li tiġi evitata l-espożizzjoni tal-fetu minħabba t-teratoġeniċità ta' lenalidomide flannimali u l-effett teratoġeniku mistenni ta' lenalidomide fil-bnedmin Obbligazzjonijiet tal-professjonist fil-qasam tas-saħħa fir-rigward ta' l-għoti tar-riċetta ta' Lenalidomide Accord
English: If you are aged 75 years or older or have moderate to severe kidney problems - your doctor will check you carefully before starting treatment.
Maltese: Jekk għandek 75 sena jew aktar, jew għandek problemi moderati sa severi tal-kliewi - it-tabib tiegħek se jeżaminak b'attenzjoni qabel tibda t-trattament.
English: Newly diagnosed multiple myeloma (NDMM)
Maltese: Majeloma multipla b'mill-inqas terapija waħda fil-passat
English: Lenalidomide is primarily excreted by the kidney; patients with greater degrees of renal impairment can have impaired treatment tolerance (see section 4.4).
Maltese: Lenalidomide jitneħħa b'mod primarjament mill-kliewi; pazjenti bi gradi akbar ta' indeboliment talkliewi jista' jkollhom indeboliment fit-tolleranza għall-kura (ara sezzjoni 4.4).
English: Baseline and ongoing monitoring of thyroid function is recommended.
Maltese: Monitoraġġ tal-linja bażi u monitoraġġ kontinwu tal-funzjoni tat-tirojde huwa rakkomandat.
English: Uncommon Renal tubular necrosis
Maltese: Mhux Magħrufa Pnewmonite interstizjali
English: In vitro, lenalidomide is a substrate of P-gp, but is not a P-gp inhibitor.
Maltese: Madankollu, l-indeboliment renali ma bidilx l-assorbiment orali ta' lenalidomide.
English: Patients in the Rd and Rd18 arms took lenalidomide 25 mg once daily on days 1 to 21 of 28-day cycles according to protocol arm. Dexamethasone 40 mg was dosed once daily on days 1, 8, 15, and 22 of each 28-day cycle.
Maltese: Il-pazjenti fil-partijiet tal-istudju dwar Rd u Rd18 ħadu lenalidomide 25 mg darba kuljum f'jiem 1 sa 21 ta' ċikli ta' 28 jum skont il-parti tal-istudju TAL-protokoll.
English: Do not use this medicine after the expiry date, which is stated on the carton and blister after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara ‘JIS'.
English: Lenalidomide is present in human semen at extremely low levels during treatment and is undetectable in human semen 3 days after stopping the substance in the healthy subject (see section 5.2).
Maltese: Lenalidomide jinsab fis-semen uman f'livelli estremament baxxi matul il-kura, u ma jkunx jista' jiġi osservat fis-semen uman 3 ijiem wara li s-sustanza titwaqqaf fil-persuna b'saħħitha (ara sezzjoni 5.2).
English: ª The median is based on the Kaplan-Meier estimate ¤PFS2 (an exploratory endpoint) was defined for all patients (ITT) as time from randomisation to start of 3rd line antimyeloma therapy (AMT) or death for all randomised patients
Maltese: e Punt tat-tmiem esploratorju (PFS2). Lenalidomide riċevut minn individwi fil-parti tal-istudju dwar plaċebo, li qalbu qabel PD meta sar lunblinding tal-istudju, ma ġiex ikkunsidrat bħala terapija sekondarja.
English: The results indicate that as renal function decreases (< 50 mL/min), the total lenalidomide clearance decreases proportionally resulting in an increase in AUC.
Maltese: Ir-riżultati jindikaw li hekk kif il-funzjoni renali tonqos (< 50 mL/min), it-tneħħija totali ta' lenalidomide tonqos proporzjonalment, u tirriżulta f'żieda fl-AUC.
English: For men taking lenalidomide
Maltese: Waqqaf il-kura b'lenalidomide
English: Lenalidomide is taken on certain days over 4 weeks (28 days).
Maltese: Lenalidomide jittieħed f'ċerti jiem fuq perjodu ta' 4 ġimgħat (28 jum).
English: Thyroid disorders
Maltese: Disturbi tattirojde).
English: Overall survival (months) Mediana OS time, months (95% CI)b
Maltese: Sopravivenza globali (xhur) Medjana żmien OS, xhur (95% CI)
English: Patients were randomised in a 1:1:1 ratio to one of 3 treatment arms.
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1:1 għal waħda minn 3 partijiet tal-istudju dwar il-kura.
English: Lenalidomide maintenance in patients who have undergone autologous stem cell transplantation (ASCT)
Maltese: Majeloma multipla ddijanjostikata għall-ewwel darba (NDMM) Manteniment b'lenalidomide f'pazjenti li kellhom trapjant awtologu ta' ċelluli staminali (autologous stem cell transplantation, ASCT)
English: Gastrointestinal haemorrhage (including rectal haemorrhage, haemorrhoidal haemorrhage, peptic ulcer haemorrhage and gingival bleeding)^, Dry mouth, Stomatitis, Dysphagia
Maltese: d It-terminu AE kombinat “Trombożi tal-vini profondi” jinkludi l-PTs li ġejjin: Trombożi tal-vini profondi, Trombożi, Trombożi venuża
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: PFS2e (xhur)
English: The adverse reactions observed more frequently with MPR+R or MPR+p than MPp+p were: neutropenia (83.3%), anaemia (70.7%), thrombocytopenia (70.0%), leukopenia (38.8%), constipation (34.0%), diarrhoea (33.3%), rash (28.9%), pyrexia (27.0%), peripheral oedema (25.0%), cough (24.0%), decreased appetite (23.7%), and asthenia (22.0%).
Maltese: 0%), lewkopenija (38.8%), stitikezza (34.0%), dijarea (33.3%), raxx (28.9%), deni (27.0%), edema periferali (25.
English: Recommended dose adjustments in patients with impaired renal function are described in section 4.2.
Maltese: Aġġustamenti fid-doża rakkomandata f'pazjenti b'indeboliment fil-funzjoni renali huma deskritti f'sezzjoni 4.2.
English: Uncommon Colitis, Caecitis
Maltese: Komuni Għeja, Astenija
English: These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
Maltese: Dawn jistgħu jkunu kollha sintomi ta' kondizzjoni tal-moħħ serja u potenzjalment fatali magħrufa bħala lewkoenċefalopatija multifokali progressiva (PML).
English: • Deafness
Maltese: Dardir
English: - capsule shell: gelatin, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171) - printing ink: black and green ink (which contains shellac, propylene glycol, iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide) Lenalidomide Accord 20 mg hard capsules:
Maltese: • Is-sustanzi mhux attivi l-oħra huma: - il-kontenut tal-kapsula: lactose, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate. - qoxra tal-kapsula: gelatin, titanium dioxide (E171) linka tal-istampar: linka sewda u ħadra (li tinkludi shellac, propylene glycol, iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) u potassium hydroxide) Lenalidomide Accord 7.5 mg kapsuli ibsin:
English: - capsule shell: gelatin, indigo carmine (E132), iron oxide yellow (E172) and titanium dioxide (E171) - printing ink: black and green ink (which contains shellac, propylene glycol, iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide)
Maltese: • Is-sustanza mhux attivi l-oħra huma: - il-kontenut tal-kapsula: lactose, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate. - qoxra tal-kapsula: gelatin, indigo carmine (E132), iron oxide yellow (E172) and titanium dioxide (E171) - linka tal-istampar: linka sewda u ħadra (li tinkludi shellac, propylene glycol, iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) u potassium hydroxide)
English: EU/1/18/1316/006 7x1 hard capsules EU/1/18/1316/007 21x1 hard capsules
Maltese: EU/1/18/1316/007 21x1 kapsuli ibsin
English: Hepatitis B virus status should be established before initiating treatment with lenalidomide.
Maltese: L-istat tal-virus tal-epatite B għandu jiġi stabbilit qabel ma tinbeda l-kura b'lenalidomide.
English: Uncommon Joint swelling
Maltese: Żmien għall-avveniment
English: Pancytopenia◊, Haemolytic anaemia
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Very Common Paraesthesia Common
Maltese: Komuni Ħafna Parestesija
English: Lenalidomide Accord 7.5 mg hard capsules Each hard capsule contains 7.5 mg of lenalidomide.
Maltese: Lenalidomide Accord 7.5 mg kapsuli ibsin Kull kapsula iebsa fiha 7.5 mg ta' lenalidomide. Eċċipjent b'effett magħruf Kull kapsula iebsa fiha 50 mg ta' lactose.
English: SP (Brinny) Company Innishannon - County Cork Ireland
Maltese: SP (Brinny) Company Innishannon - County Cork L-Irlanda
English: 36, Ctra.
Maltese: Km. 36, Ctra.
English: *Number (%) of patients
Maltese: *Numru (%) ta' pazjenti
English: It has demonstrated significant immunomodulatory activity in vitro.
Maltese: Huwa wera attività immunomodulatorja sinifikattiva in vitro.
English: Laboratory Tests:
Maltese: Testijiet tal-Laboratorju:
English: Genotype 1 (n=92) Genotype 2/3/4 (n=26)
Maltese: Ġenotip 1 (n=92) Ġenotip 2/3/4 (n=26)
English: BG-София 1504 Тел.
Maltese: BG-София 1504
English: Naïve patients:
Maltese: Pazjenti naïve:
English: Date of last renewal : 23 May 2005
Maltese: Data ta' l-aħħar tiġdid: 23 Mejju 2005
English: Tmax (hr) Cmax (ng/ml) AUC* Apparent clearance l/hr/kg
Maltese: Tmax (hr) Cmax (ng/ml) AUC* Tneħħija apparenti l/hr/kg
English: *AUC12 (ng.hr/ml) for ribavirin; AUC0-24 (IU.hr/ml) for Viraferon
Maltese: *AUC12 (ng.hr/ml) għal ribavirin; AUC0-24 (IU.hr/ml) għal Viraferon
English: Via fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I-20090 Segrate (Milano)
Maltese: Via fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini
English: 1 ml
Maltese: INDIVIDWALI 1 ml
English: SP Europe 73, rue de Stalle B-1180 Bruxelles Belgium
Maltese: SP Europe 73, rue de Stalle B-1180 Bruxelles Il-Belġju
English: Genotype 1 ≤ 2 million copies/ml Genotype 1 > 2 million copies/ml
Maltese: Ġenotip 1 ≤ 2 miljun kopja/ml Ġenotip 1 > 2 miljun kopji/ml
English: Rarely:
Maltese: Rari:
English: §See section 4.4
Maltese: Ara sezzjoni 4.4
English: B-2220 Heist-op-den-Berg Belgium
Maltese: B-2220 Heist-op-den-Berg Il-Belġju
English: IS-210 Garðabær Sími: + 354 535 70 00
Maltese: Garðabær Sími: + 354 535 70 00
English: A-2514 Traiskirchen Tel: + 43-(0)2252 502-0
Maltese: Traiskirchen Tel: + 43-(0)2252 502-0
English: Al. Jerozolimskie 195a PL-02-222 Warszawa Tel.: + 48-(0)22 478 41 50
Maltese: Jerozolimskie 195a PL-02-222 Warszawa Tel.: + 48-(0)22 478 41 50
English: Hepatomegaly Hepatotoxicity, (including fatality)
Maltese: Epatomegalija Epatotossiċità, (inkluż fatalità)
English: Genotype 2,
Maltese: Ġenotip 2,
English: 3), severe neutropaenia (< 750/mm
Maltese: 3), ta' newtropenja severa (< 750/mm
English: SI-1000 Ljubljana Tel. + 386 01 3001070
Maltese: Ljubljana Tel: + 386 01 3001070
English: Diagram E
Maltese: Diagramma E
English: The aetiology has not been defined.
Maltese: L-etjoloġija ma kinetx definita.
English: Adult patients:
Maltese: Adulti:
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1,64 % ≤ 12 years of age.
Maltese: Totali ta' 118 pazjent ħadu sehem: 57 % irġiel, 80 % Kawkażi, u 78 % ġenotip 1, 64 % ≤ 12-il sena.
English: Dyspnoea*, coughing*
Maltese: Dispneja*, sogħla*
English: Micturition frequency Renal failure, renal insufficiency, nephrotic syndrome
Maltese: Frekwenza ta' l-awrina Indeboliment renali, insuffiċjenza renali, sindrome nefrotika
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation : 9 March 2000
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 9 ta' Marzu 2000
English: Overall Response
Maltese: Rispons Globali
English: Diagram F
Maltese: Diagramma F
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Glycine,
Maltese: FARMAĊEWTIKU 6.1 Lista ta' sustanzi mhux attivi Glycine,
English: Mononeuropathies, coma
Maltese: Mononewropatiji, koma§
English: 3) or severe thrombocytopaenia (< 70,000/mm
Maltese: tromboċitopenija severa (< 70,000/mm
English: Dosage indicator
Maltese: Indikatur tad-dożagg
English: Effect on fertility: Interferon may impair fertility (see section 4.6 and section 5.3).
Maltese: L-interferon jista' jkun ta' ħsara għall-fertilità (ara sezzjoni 4.6 u 5.3).
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Maltese: Studju 1 (RIBAVIC; P01017) kien studju randomized, multiċentriku li ingaġġa 412 pazjent adult li ma kienux ingħataw kura minn qabel b'epatite Ċ kronika li kienu ko-infettati b'HIV.
English: In clinical trials of 118 children or adolescents 3 to 16 years of age, 6 % discontinued therapy due to adverse events.
Maltese: Fi provi kliniċi b'118 tfal jew adolexxenti ta' 3 sa 16-il sena, 6 % waqfu t-terapija minħabba każijiet avversi.
English: Endocrine disorders Common:
Maltese: Disturbi fis-sistema endokrinarja Komuni:
English: Severity was generally mild to moderate.
Maltese: Isseverità kienet ġeneralment minn ħafifa għal moderata.
English: GR-174 55 Άλιμος Tηλ: + 30-210 98 97 300
Maltese: Άλιμος Tηλ: + 30-210 98 97 300
English: The interferons are a family of small protein molecules with molecular weights of approximately 15,000 to 21,000 daltons.
Maltese: L-interferoni huma familja ta' molekuli żgħar ta' proteina bil-piżijiet molekulari ta' madwar 15,000 sa 21,000 dalton.
English: B-1180 Bruxelles/Brüssel Belgique/Belgien
Maltese: B-1180 Bruxelles/Brüssel Belgique/Belgien Tél/Tel:
English: Be sure the solution is at room temperature up to 25°C.
Maltese: Kun ċert li s-soluzzjoni għandha t-temperatura tal-kamra ta' mhux aktar minn 25°C.
English: Solvent: water for injections 1 ml/ampoule
Maltese: - Solvent: ilma għall-injezzjonijiet 1 ml/ampulla
English: Serum levels were below the detection limit 16 and 24 hours, respectively, post-injection.
Maltese: Il-livelli fis-serum kienu inqas mil-limitu li jistgħu jitkejjlu 16 u 24 siegħa, rispettivament, wara l-injezzjoni.
English: when receiving Viraferon, you may temporarily have a greater risk of getting an infection.
Maltese: meta tirċievi Viraferon, jista' temporanjament ikollok riskju akbar li taqbdek infezzjoni.
English: 3 times a week (n = 54)
Maltese: 3 darbiet fil-ġimgħa (n = 54)
English: The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 97 % with a 95 % Confidence Interval of [95 %, 99 %].
Maltese: L-istima Kaplan-Meier għal rispons sostnut fuq 5 snin għall-pazjenti kollha huwa 97 % b'Intervall ta' Kunfidenza ta' 95 % ta' [95 %, 99 %].
English: 1 full turn (5 clicks) 6 clicks 7 clicks 8 clicks 9 clicks 2 full turns (10 clicks) 11 clicks 12 clicks 13 clicks 14 clicks 3 full turns (15 clicks) 16 clicks 17 clicks 18 clicks 19 clicks 4 full turns (20 clicks)*
Maltese: Tidwira 1 sħiħa (5 tfaqqihat) 6 tfaqqihat 7 tfaqqihat 8 tfaqqihat 9 tfaqqihat 2 dawriet sħaħ (10 tfaqqihat) 11-il tfaqqiha 12-il tfaqqiha 13-il tfaqqiha 14-il tfaqqiha 3 dawriet sħaħ (15-il tfaqqiha) 16-il tfaqqiha 17-il tfaqqiha 18-il tfaqqiha 19-il tfaqqiha 4 dawriet sħaħ (20 tfaqqiha)*
English: Treatment should be discontinued in case of severe leukopaenia (< 1,200/mm
Maltese: It-trattament għandu jitwaqqaf f'każijiet ta' lewkopenja severa (< 1,200/mm
English: Ribavirin 15 mg/kg/day as 2 divided doses (n = 17)
Maltese: Ribavirin 15 mg/kg/jum bħala 2 dożi maqsuma (n = 17)
English: Three major classes of interferons have been identified: alpha, beta and gamma.
Maltese: Kienu identifikati tliet klassijiet ewlenin ta' interferoni: alpha, beta u gamma.
English: Pulmonary infiltrates§, pneumonitis§
Maltese: Infiltrati fil-pulmun
English: Chidren and adolescents:
Maltese: Tfal u adolexxenti:
English: Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Maltese: L-interferon alfa-2b rikombinanti wkoll jiskoraġġixxi r-replikazzjoni virali in vitro u in vivo.
English: 1Carrat F, Bani-Sadr F, Pol S et al. JAMA 2004; 292(23): 2839-2848.
Maltese: JAMA 2004; 292(23): 2839-2848.
English: Myocardial infarction, cardiac ischaemia Arrhythmia
Maltese: Infart majokardijaku, iskemija kardijaka Arritmija
English: Immune system disorders§ Very rarely:
Maltese: Disturbi fis-sistema immuni Rari ħafna:
English: System Organ Class
Maltese: Klassi tas-Sistema ta' l-Organi
English: Pack sizes of 1, 2 or 8
Maltese: Pakketti ta' daqsijiet 1,2 jew 8.
English: The clinical incidence of neutralising factors developing in cancer patients treated systemically is 2.9 % and in chronic hepatitis patients is 6.2 %.
Maltese: L-inċidenza klinika ta' fatturi newtralizzanti li jiżviluppaw fil-pazjenti bil-kankru ttrattati sistemikament hi ta' 2.9 % u ta' 6.2 % filpazjenti bl-epatite kronika.
English: 3 times a week ribavirin 15 mg/kg/day
Maltese: 3 darbiet fil-ġimgħa ribavirin 15 mg/kg/jum
English: Virological responses after 1 year of treatment and 6 months of follow-up were 36 % for genotype 1 and 81 % for genotype 2/3/4.
Maltese: Rispons viroloġiku wara sena 1 ta' trattament u 6 xhur follow-up kienu ta' 36 % għall-ġenotip 1 u 81 % għall-ġenotip 2/3/4.
English: HCV/HIV Co-infected patients
Maltese: Pazjenti ko- infettati b'HCV/HIV
English: Myalgia, arthralgia, musculoskeletal pain Arthritis
Maltese: Mijalġja, artralġja, uġigħ muskoluskeletrali Artrite
English: The pharmacokinetics of Viraferon and ribavirin (dose-normalized) are similar in adults and children or adolescents.
Maltese: Il-farmakokinetika ta' Viraferon u ribavirin (normalizzata mad-doża) jixxiebhu fl-adulti u tfal jew adolexxenti.
English: Pharmacotherapeutic group: Immunostimulants, cytokines and immunomodulators, interferons, interferon alfa-2b, ATC code: L03A B05
Maltese: Immunostimulanti, ċitokini u immunomodulaturi, interferoni, interferon alfa-2b, Kodiċi ATC:
English: interferon alfa-2b (1.5 µg/kg/ week) + ribavirin (800 mg)
Maltese: interferon alfa-2b pegilat (1.5 µg/kg/ ġimgħa) + ribavirin (800 mg)
English: Pen barrel
Maltese: Barrel talpinna
English: Viraferon in combination with ribavirin:
Maltese: Terapija kombinata ma' ribavirin:
English: Viraferon (3 MIU 3 times a week) I/R Viraferon (3 MIU 3 times a week) + ribavirin (1,000/1,200 mg/day)
Maltese: I/R Viraferon (3 MIU 3 darbiet fil-ġimgħa) + ribavirin (1,000/1,200 mg/jum)
English: Thrombocytopaenia, lymphadenopathy, lymphopenia Aplastic anaemia
Maltese: Tromboċitopenja, limfadenopatija, limfopenija Anemija aplastika
English: Periodontal disorder NOS, dental disorder NOS
Maltese: NOS, disturbi fis-snien NOS
English: Very common: Common:
Maltese: Komuni ħafna: Komuni: