FrancophonIA/ELRC3.0 huggingface dataset:
English: Volume of distribution is approximately 5,000 l. Ribavirin does not bind to plasma proteins.
Maltese: Il-volum tad-distribuzzjoni huwa ta' madwar 5,000 l. Ribavirin ma jintrabatx mal-proteini tal-plażma.
English: - anti-Human Immunodeficiency Virus (HIV) medicines - [nucleoside reverse transcriptase inhibitor (NRTI), and/or combined anti-retroviral therapy (cART)]:
Maltese: - mediċini kontra l-Virus tal-Immunodefiċjenza Umana (HIV) [inibitur nukleosid ta' reverse transcriptase (NRTI -nucleoside reverse transcriptase inhibitor), u/jew terapija b'kombinazzjoni ta' mediċini antiretrovirali (cART - combined anti-retroviral therapy)]:
English: Haemolitic anaemia, leukopenia, thrombocytopenia, lymphadenopathy, lymphopenia
Maltese: Anemija emolitika, lewkopenija, tromboċitopenija, limfadenopatija, limfopenija
English: Each Rebetol capsule contains 40 mg of lactose.
Maltese: Kull kapsula Rebetol fiha 40 mg ta' lactose.
English:  11 g/dL (females);  12 g/dL (males)
Maltese: ≥ 11 g/dL (nisa); ≥ 12 g/dL (irġiel)
English: Genotype 1/4 23.0 (182/790) 51.6 (94/182)
Maltese: Ġenotip 1/4 23.0 (182/790) 51.6 (94/182) Ġenotip 2/3 67.9 (74/109)
English: Rebetol does not inhibit cytochrome P450 enzymes.
Maltese: Rebetol ma timpedixxix l-enzimi tas-cytochrome P450.
English: This medicine is available in different pack sizes containing 84, 112, 140 or 168 capsules of 200 mg to be swallowed.
Maltese: Din il-mediċina tiġi f'pakketti ta' qisien differenti li jkun fihom 84, 112, 140 jew 168 kapsuli ta' 200 mg li għandhom jinbelgħu.
English: Rebetol capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC).
Maltese: Il-kapsuli Rebetol huma ppakkjati ġo folji li huma magħmula minn polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC).
English: EU/1/99/107/001 (84 hard capsules) EU/1/99/107/005 (112 hard capsules) EU/1/99/107/002 (140 hard capsules) EU/1/99/107/003 (168 hard capsules)
Maltese: EU/1/99/107/005 (112-il kapsula iebsa) EU/1/99/107/002 (140 kapsula iebsa) EU/1/99/107/003 (168 kapsula iebsa)
English: Rebetol 200 mg capsules
Maltese: Rebetol 200 mg kapsuli
English: 84 hard capsules 112 hard capsules 140 hard capsules 168 hard capsules
Maltese: 84 kapsula iebsa 112-il kapsula iebsa 140 kapsula iebsa 168 kapsula iebsa
English: Genotype 1 > 600,000 IU/mL
Maltese: Ġenotip 1 > 600,000 IU/mL
English: Palpitation, tachycardia
Maltese: Palpitazzjonijiet, takikardija
English: Seminal transfer of ribavirin has been studied.
Maltese: Trasferiment fil-fluwidu seminali Kien studjat it-trasferiment seminali ta' ribavirin.
English: Excipients with known effect Rebetol contains 142 mg of sorbitol and 300 mg of sucrose per mL.
Maltese: Rebetol fih 142 mg ta' sorbitol u 300 mg ta' sucrose f'kull mL.
English: METAVIR Fibrosis score F2
Maltese: METAVIR F2
English: peginterferon alfa-2b (1.5 µg/kg/ week)
Maltese: peginterferon alfa-2b (1.5 µg/kg/
English: Rebetol oral solution
Maltese: Rebetol soluzzjoni orali
English: Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis*
Maltese: Infiltrati pulmonari*, pnewmonite*, pnewmonite fl-interstizzju*
English: MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no
Maltese: Tlf: +47 32 20 73 00
English: P1.5/R Rebetol (800 mg) + peginterferon alfa-2b (1.5 micrograms/kg) P0.5/R Rebetol (1,000/1,200 mg) + peginterferon alfa-2b (1.5 to 0.5 microgram/kg) I/R
Maltese: P1.5/R Rebetol (800 mg/) + peginterferon alfa-2b (1.5 mikrogrammi/kg) P0.5/R Rebetol (1,000/1,200 mg) + peginterferon alfa-2b (1.5 sa 0.5 mikrogrammi/kg)
English: By Week 12*** (n= 915)
Maltese: (n=915)
English: Capsule imprint
Maltese: Qoxra tal-kapsula
English: Anaemia (haemoglobin < 9.4 g/dL) was reported in 12 % (23/194) of patients treated with Rebetol in combination with peginterferon alfa-2b.
Maltese: Anemija (ħemoglobina < 9.4 g/dL) kienet irrappurtata fi 12 % (23/194) tal-pazjenti kkurati b'Rebetol f'kombinazzjoni ma' peginterferon alfa-2b.
English: d: Rebetol dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Maltese: d: dożaġġ ta' Rebetol kien 800 mg għall-pazjenti < 60 kg, 1,000 mg għall-pazjenti 60-75 kg, u 1,200 mg għall-pazjenti
English: Neuralgia, lethargy, psychomotor hyperactivity
Maltese: Newralġja, letarġija, attività psikomotriċi eċċessiva
English: Endocrine disorders Common:
Maltese: Disturbi fis-sistema endokrinarja Komuni ħafna:
English: Table 9 Virologic response at treatment week 12, end of treatment response, relapse rate* and Sustained Virologic Response (SVR) Treatment group
Maltese: Tabella 9 Rispons viroloġiku fil-ġimgħa 12 ta' trattament, rispons ma' tmiem it-trattament, rata ta' rkadar * u Rispons Viroloġiku Sostnut (SVR - Sustained Virologic Response)
English: Merck Sharp & Dohme Cyprus Limited Τηλ.
Maltese: Merck Sharp & Dohme Cyprus Limited
English: Ribavirin (Rebetol) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Maltese: Ribavirin (Rebetol) huwa analogu sintetiku tan-nuklejosajd li wera attività in vitro kontra xi RNA jew
English: Sexual dysfunction (not specified)* General disorders and administration site conditions Very common:
Maltese: Disfunzjoni sesswali (mhux speċifikata)* Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna:
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of therapy.
Maltese: Arritmiji kardijaċi (primarjament supraventrikulari) normalment jirrispondu għat-terapija konvenzjonali imma għandhom mnejn ikollhom bżonn li titwaqqaf t-terapija.
English: Rebetol 40 mg/mL oral solution ribavirin
Maltese: Rebetol 40 mg/mL soluzzjoni orali ribavirin
English: Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme* Musculoskeletal and connective tissue disorders Very common:
Maltese: Sindrome ta' Stevens Johnson*, nekrolisi tossika tal-epidermide*, eritema multiforme*
English: Tabulated list of adverse reactions in paediatric population
Maltese: Lista ta' reazzjonijiet avversi fil-popolazzjoni pedjatrika miġbura f'tabella
English: Rebetol oral solution 40 mg/mL
Maltese: Rebetol soluzzjoni orali 40 mg/mL
English: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Maltese: Aplażja pura taċ-ċelluli ħomor, purpura tromboċitopenika idjopatika, purpura tromboċitopenika trombotika
English: Rebetol 200 mg capsules ribavirin
Maltese: Rebetol 200 mg kapsuli ribavirin
English: Relapse
Maltese: Kontużjoni
English: Sustained Response
Maltese: Rispons Sostnut
English: Dose modification for adults
Maltese: Ara d-doża adulta
English: Adverse Reactions
Maltese: Reazzjonijiet avversi
English: HVL (>600,000 IU/mL)
Maltese: HVL (>600,000
English: Pharmacotherapeutic group: antivirals for systemic use, antivirals for treatment of HCV infections, ATC code: J05AP01.
Maltese: Kategorija farmakoterapewtika: antivirali għall-użu sistemiku, antivirali għat-trattament talinfezzjonijiet tal-HCV, Kodiċi ATC:
English: Rebetol, by having an inhibitory effect on inosine monophosphate dehydrogenase, may interfere with azathioprine metabolism possibly leading to an accumulation of 6-methylthioinosine monophosphate (6-MTIMP), which has been associated with myelotoxicity in patients treated with azathioprine.
Maltese: Permezz ta' effett inibitorju fuq inosine monophosphate dehydrogenase, Rebetol jista' jfixkel il-metaboliżmu ta' azathioprine u possibbilment iwassal għall-akkumulazzjoni ta' 6-methylthioinosine monophosphate (6-MTIMP), li kienet assoċjata ma' majelotossiċità f'pazjenti kkurati b'azathioprine.
English: Upon discontinuation of dosing the half-life was approximately 298 hours, which probably reflects slow elimination from non-plasma compartments.
Maltese: Wara l-waqfien tad-dożaġġ, il-half-life kienet ta' madwar 298 siegħa, li probabbilment tirrifletti l-eliminazzjoni bil-mod mill-kompartamenti mhux tal-plażma.
English: Rebetol contains lactose
Maltese: Rebetol fih lactose
English: For HCV/HIV co-infected patients receiving Rebetol in combination with peginterferon alfa-2b, other adverse reactions (that were not reported in mono-infected patients) which have been reported in the studies with a frequency > 5 % were: oral candidiasis (14 %), lipodystrophy acquired (13 %), CD4 lymphocytes decreased (8 %), appetite decreased (8 %), gamma-glutamyltransferase increased (9 %), back pain (5 %), blood amylase increased (6 %), blood lactic acid increased (5 %), cytolytic hepatitis (6 %), lipase increased (6 %) and pain in limb (6 %).
Maltese: Għall-pazjenti infettati fl-istess ħin b'HCV/HIV li qed jirċievu Rebetol f'kombinazzjoni ma' peginterferon alfa-2b, effetti avversi oħra (li ma kienux irrappurtati f'pazjenti b'infezzjoni waħda) li kienu rrappurtati fl-istudji bi frekwenza ta' > 5 % kienu: kandidijażi orali (14 %), lipodistrofija akkwiżita (13 %), tnaqqis fil-limfoċiti CD4 (8 %), tnaqqis fl-aptit (8%), żieda tal-gamma-glutamyltransferase (9 %), uġigħ fid-dahar (5 %), żieda tal-amylase fid-demm (6 %), żieda tal-aċidu lattiku fid-demm (5 %), epatite ċitolitika (6 %), żieda tal-lipase (6 %) u uġigħ fir-riġel (6 %).
English: The sustained response at the end of follow-up was significantly increased by the addition of Rebetol to interferon alfa-2b (41 % vs 16 %, p < 0.001).
Maltese: Ir-rispons sostnut fit-tmiem tal-follow-up żdied b'mod sinifikanti biż-żieda ta' Rebetol ma' interferon alfa-2b (41 % vs 16 %, p < 0.001).
English: Excipient with known effect Each hard capsule contains 40 mg of lactose monohydrate.
Maltese: Kull kapsula iebsa fiha 40 mg ta' lactose monohydrate.
English: A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age.
Maltese: Total ta' 107 pazjent ingħataw kura li minnhom 52 % kienu nisa, 89 % Kawkażi, 67 % b'HCV Ġenotip 1 u 63 % < 12-il sena.
English: N/A
Maltese: (n/N)
English: Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Maltese: Sindrome ta' Vogt-Koyanagi-Harada, lupus erythematosus sistemiku, vaskulite, reazzjonijiet ta' sensittività eċċessiva inkluż urtikarja, anġjoedima, bronkokostrizzjoni, anafilassi
English: Patients with low CD4 counts
Maltese: Tnaqqis fil-limfoċiti CD4
English: Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).
Maltese: Rebetol flimkien ma' prodotti mediċinali oħra huwa indikat għat-trattament ta' epatite Ċ kronika (CHC - chronic hepatitis C) fl-adulti (ara sezzjonijiet 4.2, 4.4, u 5.1).
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 98 % [95 % CI: 95 %, 100 %] for paediatric patients treated with interferon alfa-2b and ribavirin.
Maltese: Kaplan-Meier għar-rispons sostnut li nżamm fuq 5 snin hija ta' 98 % [95 % CI: 95 %, 100 %] għal pazjenti pedjatriċi kkurati b'interferon alfa-2b u ribavirin.
English: Twenty-four % had bridging fibrosis or cirrhosis (Knodell 3/4).
Maltese: Erbgħa u għoxrin % kellhom bridging fibrosis jew ċirrożi (Knodell 3/4).
English: Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/kg in a mouse micronucleus assay.
Maltese: Attività ġenotossika kienet osservata f'assaġġ tal-limfoma tal-ġrieden, u b'doża ta' 20-200 mg/kg f'test tal-mikronukleju tal-ġurdien.
English: The bioavailability of Rebetol 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14 %.
Maltese: Il-bijodisponibbiltà ta' Rebetol 600 mg kienet imnaqqsa meta ngħata flimkien ma' antaċidu li kien fih magnesium aluminium u simethicone; l-AUCtf tnaqqas b'14 %.
English: Suicide attempts, panic attack, hallucination
Maltese: Attentati ta' suwiċidju, attakk ta' paniku, alluċinazzjoni
English: % (number) of patients
Maltese: % (numru) ta' pazjenti
English: Adult:  12 g/dL (females);  13 g/dL (males) Children and adolescents:  11 g/dL (females);  12 g/dL (males)
Maltese: Adulti: ≥ 12 g/dL (nisa); ≥ 13 g/dL (irġiel)
English: At least 5 years of long-term follow-up was completed after treatment in 462 patients and 327 patients, respectively.
Maltese: Mill-anqas 5 snin ta' follow up fit-tul intemm wara kura f'462 pazjent u 327 pazjent, rispettivament.
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week peginterferon alfa-2b and subjects ≥ 75 kg received 150 µg/week peginterferon alfa-2b .
Maltese: b: valur p ibbażat fuq it-test chi-square. c: individwi < 75 kg ħadu 100 µg/ġimgħa peginterferon alfa-2b u individwi ≥ 75 kg irċevew 150 µg/ġimgħa peginterferon alfa-2b .
English: MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
Maltese: Tlf: + 45 4482 4000
English: Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Maltese: Reazzjonijiet avversi importanti li tfaċċaw f'din il-popolazzjoni ta' pazjenti bil-kura kienu: nervożità (8 %), aggressjoni (3 %), rabja (2 %), dipressjoni/burdata ta' dipressjoni (4 %) u ipotajrojdiżmu (3 %) u 5 individwi ngħataw kura b'levothyroxine għal ipotajrodjiżmu/TSH għoli.
English: LVL (≤600,000 IU/mL)
Maltese: LVL (≤600,000
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Maltese: Pnewmonja, askarijażi, enterobijasi, herpes zoster, ċellulite Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Komuni:
English: Overall, approximately 36 % (821/2,286) of patients had undetectable plasma HCV-RNA levels at week 12 of therapy measured using a research-based test (limit of detection 125 IU/mL).
Maltese: B'mod globali, madwar 36 % (821/2.286) tal-pazjenti kellhom livelli ta' HCV-RNA fil-plażma li ma setgħux jitkejlu mat-12-il ġimgħa ta' terapija mkejla permezz ta' test ibbażat fuq riċerka (limitu li seta' jitkejjel 125 IU/mL).
English: Thrombocytopenia, lymphadenopathy
Maltese: Tromboċitopenija, limfadenopatija
English: Rebetol in combination with Direct Antiviral Agent (DAA):
Maltese: Rebetol flimkien ma' Sustanza Antivirali li taħdem b'mod Dirett (DAA - Direct Antiviral Agent):
English: 3 capsules
Maltese: 3 kapsuli a
English: : 800 00 673 (+357 22866700) cyprus_info@merck.com
Maltese: Τηλ.: 800 00 673 (+357 22866700)
English: The pharmacokinetics of Rebetol and interferon alfa-2b (dose-normalized) is similar in adults and children or adolescents.
Maltese: Il-farmakokinetika ta' Rebetol u interferon alfa-2b (doża normalizzata) hija simili fl-adulti u fit-tfal jew adolexxenti.
English: 1 bottle of 100 mL 10 mL oral dosing syringe
Maltese: siringa ta' 10 mL għall-għoti tad-doża orali
English: How to store Rebetol
Maltese: Tiħux Rebetol
English: Combination therapy with Rebetol and interferon alfa-2b resulted in a sustained virological response that was ten-fold higher than that with interferon alfa-2b alone (49 % vs 5 %, p < 0.0001).
Maltese: Terapija mħallta b'Rebetol + interferon alfa-2b irriżultat f'rispons viroloġiku sostnut li kien għaxar darbiet ogħla minn dak b'interferon alfa-2b waħdu (49 % vs 5 %, p < 0.0001).
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 multiċentriku u randomized li fih ħadu sehem 412-il pazjent adult li ma kinux ikkurati qabel, b'epatite Ċ kronika li kellhom ukoll infezzjoni b'HIV.
English: Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax= 1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively).
Maltese: Ribavirin huwa assorbit malajr wara li tingħata mill-ħalq doża waħda (il-medja Tmax= 1.5 sigħat), segwit minn distribuzzjoni mgħaġġla u fażijiet ta' eliminazzjoni mtawwla (half-lives ta' assorbiment b'dożi waħidhom, distribuzzjoni u eliminazzjoni huma 0.05, 3.73 u 79 sigħat, rispettivament).
English: In combination with interferon alfa-2b
Maltese: Interferon alfa-2b
English: A reduction in haemoglobin concentrations by > 4 g/dL was observed in 30 % of patients treated with Rebetol and peginterferon alfa-2b and 37 % of patients treated with Rebetol and interferon alfa-2b.
Maltese: Tnaqqis fil-konċentrazzjonijiet tal-emoglobina b'> 4 g/dL kien osservat fi 30 % tal-pazjenti kkurati b'Rebetol u peginterferon alfa-2b u f'37 % tal-pazjenti kkurati b'Rebetol u interferon alfa-2b.
English: Oral formulations of Rebetol monotherapy have been investigated as therapy for chronic hepatitis C in several clinical trials.
Maltese: Formulazzjonijiet orali tal-monoterapija ta' Rebetol kienu investigati bħala terapija għall-epatite Ċ kronika f'diversi provi kliniċi.
English: Study 2
Maltese: Studju 22
English: Viral infection, pharyngitis
Maltese: Infezzjonijiet virali, farinġite
English: Three trials examined the use of interferon in naïve patients, two with Rebetol + interferon alfa-2b (C95-132 and I95-143) and one with Rebetol + peginterferon alfa-2b (C/I98-580).
Maltese: interferon alfa-2b (C95-132 u I95-143) u wieħed b'Rebetol + peginterferon alfa-2b (C/I98-580).
English: • Rebetol (800 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week) (n = 511).
Maltese: • Rebetol (800 mg/jum) + peginterferon alfa-2b (1.5 mikrogrammi/kg/ġimgħa)
English: Headache, dizziness
Maltese: Rabdomajoliżi*, myożite*
English: Cardiomyopathy, arrhythmia*
Maltese: Kardjomijopatija, arritmija*
English: However, in a population pharmacokinetic study, age was not a key factor in the kinetics of ribavirin; renal function is the determining factor.
Maltese: Madankollu, fi studju farmakokinetiku dwar il-popolazzjoni, l-età ma kinetx fattur importanti fil-kinetika ta' ribavirin; il-funzjoni renali hija l-fattur determinanti.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku
English: In the treatment phase of this study, the most prevalent adverse reactions in all subjects were pyrexia (80 %), headache (62 %), neutropenia (33 %), fatigue (30 %), anorexia (29 %) and injection-site erythema (29 %).
Maltese: Fil-fażi ta' kura ta' dan l-istudju, l-aktar reazzjonijiet avversi prevalenti fl-individwi kollha kienu: temperatura għolja (80 %), uġigħ ta' ras (62 %), newtropenija (33 %), għeja (30 %), anoressija (29 %) u ħmura fis-sit tal-injezzjoni (29 %).
English: In this subgroup, there was a 92 % (89/97) sustained virological response rate.
Maltese: F'dan is-sottogrupp, kien hemm rata ta' 92 % (89/97) li kellhom rispons viroloġiku sostnut.
English: At the end of 5 years, 85 % (80/94) of all enrolled subjects and 86 % (54/63) of sustained responders completed the study.
Maltese: Fl-aħħar tal-5 snin, 85% (80/94) tal-individwi kollha rreġistrati u
English: Table 10 Predictive Value of In-Treatment Virologic Response while on peginterferon alfa-2b 1.5 µg/kg/Rebetol 800-1,400 mg Combination Therapy Negative
Maltese: Tabella 10 Valur Imbassar għar-Rispons Viroloġiku Sostnut Waqt Il-Kura waqt Terapija Kombinata bi peginterferon alfa-2b 1.5 µg/kg/ Rebetol 800-1,400 mg
English: Tel: +40 21 529 2900 msdromania@merck.com
Maltese: Tel: +40 21 529 2900
English: Tel: +48 22 549 51 00 msdpolska@merck.com
Maltese: Tel: +48 22 549 51 00
English: At the peginterferon alfa-2b 1.5 µg/kg plus Rebetol dose, sustained virologic response rates were lower in patients with cirrhosis, in patients with normal ALT levels, in patients with a baseline viral load > 600,000 IU/mL and in patients > 40 years old.
Maltese: Bid-doża ta' 1.5 µg/kg peginterferon alfa-2b ma' Rebetol, ir-rati ta' rispons viroloġiku sostnut kienu aktar baxxi f'pazjenti b'ċirrożi, f'pazjenti b'livelli ta' ALT normali, f'pazjenti ta' viral load > 600,000 IU/mL mal-linja bażi, u f'pazjenti li għandhom > 40 sena.
English: Hypertriglyceridemia, hyperuricemia
Maltese: Ipertrigliċeridemija, iperuriċemija
English: Bacterial infection (including sepsis), fungal infection, influenza, respiratory tract infection, bronchitis, herpes simplex, sinusitis, otitis media, rhinitis, urinary tract infection
Maltese: Infezzjoni bil-batterji (inkluż sepsi), infezzjoni bil-fungu, influwenza, infezzjoni tal-passaġġ tan-nifs, bronkite, herpes simplex, sinożite, otitis media, flissjoni, infezzjoni fil-passaġġ tal-awrina
English: In clinical trials C95-132 and I95-143, Rebetol + interferon alfa-2b combination therapy proved to be significantly more effective than interferon alfa-2b monotherapy (a doubling in sustained response).
Maltese: Fi studji kliniċi C95-132 u I95-143, it-terapija mħallta ta' Rebetol + interferon alfa-2b intweriet li kienet aktar effettiva b'mod sinifikanti mill-monoterapija ta' interferon alfa-2b (irduppjar fir-rispons sostnut).
English: EU/1/99/107/004
Maltese: EU/1/99/107/001 (84 kapsula iebsa)
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10), and uncommon (≥ 1/1,000 to < 1/100).
Maltese: Fost il-klassijiet tas-sistemi ta' organi, reazzjonijiet avversi huma elenkati taħt it-titli ta' frekwenza permezz tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10), u mhux komuni (≥ 1/1,000 sa' < 1/100).
English: Adult patients with moderate renal impairment (creatinine clearance 30- 50 mL/minute) should be administered alternating daily doses of 200 mg and 400 mg.
Maltese: Pazjenti adulti b'indeboliment moderat tal-kliewi (tneħħija tal-kreatinina ta' 30-50 mL/minuta) għandhom jingħataw dożi jalternaw kuljum ta' 200 mg u 400 mg.
English: Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Maltese: Dejta storika limitata tindika li kura għal 48 ġimgħa tista' tkun marbuta ma' rata ta' rispons sostnut ogħla (11/11) u ma' riskju aktar baxx li jirkadu (0/11 imqabbel ma' 7/96 fl-24 ġimgħa ta' wara l-kura).
English: • are a woman of childbearing age (see section “Pregnancy and breast-feeding”).
Maltese: • intom nisa ta' età li jista' jkollkom it-tfal (ara sezzjoni “Tqala u treddigħ”).
English: Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder, Male: testicular pain
Maltese: Mara: amenorreja, menorraġja, disturbi mestrwali, disturb vaġinali.
English: Genotype 2, 3**
Maltese: Ma' Ġimgħa 4***
English: Reduce Rebetol dose* if:
Maltese: Naqqas id-doża ta' Rebetol* jekk:
English: This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Maltese: Din l-attività tista' twassal għar-riskju ta' aċidożi lattika kkaġunata minn analogi tan-nuklejosajd tal-purina (eż. didanosine jew abacavir).
English: Propylene glycol Ammonium hydroxide Colouring agent (E 132)
Maltese: Propylene glycol Ammonium hydroxide
English: Merck Sharp & Dohme Cyprus Limited Tel.: 8007 4433 (+356 99917558) malta_info@merck.com
Maltese: Tel.: 8007 4433 (+356 99917558)
English: Information on excipients
Maltese: Informazzjoni dwar l-eċċipjenti
English: Natural and artificial bubble gum flavouring
Maltese: Togħma naturali u artifiċjali tal-bubble gum 6.2 Inkompatibbiltajiet