FrancophonIA/ELRC3.0 huggingface dataset:
English: Ibandronic acid Accord ibandronic acid
Maltese: Ibandronic acid Accord aċidu ibandroniku
English: In the prevention of skeletal events in patients with breast cancer and bone metastases, Ibandronic acid Accord is given into a vein as a 6 mg infusion lasting at least 15 minutes every three to four weeks.
Maltese: Fil-prevenzjoni ta' episodji skeletali f'pazjenti b'kanċer tas-sider u metastasi fl-għadam, Ibandronic acid Accord jingħata fil-vina bħala infużjoni ta' 6 mg li ddum mill-inqas 15-il minuta kull tlieta sa erba' ġimgħat.
English: The active substance in Ibandronic acid Accord, ibandronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Ibandronic acid Accord, l-aċidu ibandroniku, hija bisfosfonat.
English: The reference medicines for Ibandronic acid Accord are Bondronat and Bonviva.
Maltese: Il-mediċini ta' referenza għal Ibandronic acid Accord huma Bondranat u Bonviva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ibandronic acid Accord on 19 November 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ibandronic acid Accod fid-19 ta' Novembru 2012.
English: Ibandronic acid Accord contains the active substance ibandronic acid and is a ‘generic medicine'.
Maltese: Ibandronic acid Accord fih is-sustanza attiva aċidu ibandroniku u huwa “mediċina ġenerika”.
English: Ibandronic acid Accord concentrate for solution for infusion (drip) is used in adults to:
Maltese: Il-konċentrat Ibandronic acid Accord għal soluzzjoni għall-infużjoni (dripp) jintuża fuq l-adulti:
English: This is a summary of the European public assessment report (EPAR) for Ibandronic acid Accord.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ibandronic acid Accord.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicines, Bondronat and Bonviva, and do not need to be repeated for Ibandronic acid Accord.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat bil-mediċini ta' referenza, Bondronat u Bonviva, u ma għandhomx għalfejn jiġu ripetuti għal Ibandronic acid Accord.
English: • prevent ‘skeletal events' (fractures or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
Maltese: • għall-prevenzjoni ta' “episodji skeletali” (fratturi jew kumplikazzjonijiet fl-għadam li jeħtieġu kura) f'pazjenti b'kanċer tas-sider u b'metastasi fl-għadam (meta l-kanċer ikun infirex fl-għadam);
English: • treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Maltese: • għall-kura ta' iperkalċemija (livelli għolja ta' kalċju fid-demm) ikkawżata minn tumuri.
English: Other information about Ibandronic acid Accord
Maltese: Aktar informazzjoni dwar Ibandronic acid Accord
English: There was no need for ‘bioequivalence' studies to investigate whether Ibandronic acid Accord is absorbed similarly to the reference medicines to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' “bijoekwivalenza” biex jiġi investigat jekk Ibandronic acid Accord jiġix assorbit b'mod simili bħall-mediċini ta' referenza biex jipproduċi l-istess livell tas-sustanza attiva fiddemm.
English: The company that markets Ibandronic acid Accord will provide a card to inform patients receiving Ibandronic acid Accord infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they get symptoms.
Maltese: Il-kumpanija li tqiegħed Ibandronic acid Accord fis-suq ser tipprovdi kard biex tinforma lill-pazjenti li jirċievu l-infużjoni ta' Ibandronic acid Accord dwar ir-riskju ta' osteonekrożi tax-xedaq u tagħtihom parir jikkuntattjaw lit-tabib tagħhom jekk jesperjenzaw sintomi.
English: Why is Ibandronic acid Accord approved?
Maltese: Għaliex ġie approvat Ibandronic acid Accord?
English: Because Ibandronic acid Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicines'.
Maltese: Billi Ibandronic acid Accord huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu huma meqjusa listess bħal dawk tal-mediċini ta' referenza.
English: The Agency recommended that Ibandronic acid Accord be approved for use in the EU.
Maltese: LAġenzija rrakkomandat li Ibandronic acid Accord ikun approvat għall-użu fl-UE.
English: Therefore, the Agency's view was that, as for Bondronat and Bonviva, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tal-Aġenzija kienet li, bħal fil-każ ta' Bondronat u Bonviva, il-benefiċċju huwa akbar mir-riskju identifikat.
English: For the prevention of skeletal events or the treatment of hypercalcaemia in cancer patients, treatment with this medicine should only be started by a doctor who has experience in the treatment of cancer.
Maltese: Għall-prevenzjoni ta' episodji skeletali jew il-kura ta' iperkalċemija f'pazjenti li għandhom kanċer, ilkura b'din il-mediċina għandha tinbeda biss minn tabib li jkollu esperjenza fil-kura tal-kanċer.
English: Patients should also take vitamin D and calcium supplements.
Maltese: Il-pazjenti għandhom jieħdu wkoll supplimenti tal-vitamina D u tal-kalċju.
English: Ibandronic acid Accord solution for injection is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Maltese: Is-soluzzjoni għal injezzjoni ta' Ibandronic Acid Accord tintuża fil-kura tal-osteoporożi (marda li ddgħajjef l-għadam) f'nisa li jkunu għaddew mill-menopawża u li hemm ir-riskju li jiżviluppaw fratturi (ksur fl-għadam).
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ibandronic acid Accord has been shown to be comparable to Bondronat and Bonviva.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, f'konformità mar-rekwiżiti tal-UE, Ibandronic acid Accord intwera li huwa komparabbli ma' Bondronat u Bonviva.
English: The reduction of bone loss helps to make bones less likely to break in cancer patients with bone metastases and in women with osteoporosis.
Maltese: It-tnaqqis ta' telf tal-għadam jgħin biex ikun hemm inqas probabbiltà li l-għadam jinkiser f'pazjenti bil-kanċer tal-metastasi fl-għadam u f'nisa b'osteoporożi.
English: Periodontal disorder, dental disorder
Maltese: Disturbi periodontali, disturbi dentali
English: Adults: ≥ 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) Tfal u adolexxenti: ≥ 11 g/dl (nisa); ≥ 12 g/dl (irġiel)
English: Packs of 84, 112, 140 and 168 film-coated tablets.
Maltese: Pakketti ta' 84, 112, 140 u 168 pillola miksija b'rita.
English: EU/1/10/626/001 (84 film-coated tablets) EU/1/10/626/002 (112 film-coated tablets) EU/1/10/626/003 (140 film-coated tablets) EU/1/10/626/004 (168 film-coated tablets)
Maltese: EU/1/10/626/001 (84 pillola miksija b'rita) EU/1/10/626/002 (112-il pillola miksija b'rita) EU/1/10/626/003 (140 pillola miksija b'rita) EU/1/10/626/004 (168 pillola miksija b'rita)
English: < 50 x 109/l (adults) < 70 x 109/l (children and adolescents)
Maltese: < 50 x 109/l (adulti) < 70 x 109/l (tfal u adolexxenti)
English: • tablet coating: hypromellose, macrogol, titanium dioxide.
Maltese: • il-kisja tal-pillola: hypromellose, macrogol, titanium dioxide.
English: 3 tablets a
Maltese: 3 pilloli a 4 pilloli b
English: BioPartners if CrCl < 50 ml/minute
Maltese: Waqqaf Ribavirin BioPartners jekk CrCl < 50 ml/minuta
English: *AUC12 (ng.hr/ml) for Ribavirin; AUC0-24 (IU.hr/ml) for interferon alfa-2b
Maltese: *AUC12 (ng.hr/ml) għal Ribavirin; AUC0-24 (IU.hr/ml) għal interferon alfa-2b
English: d interferon alfa-2b (3 MIU TIW)
Maltese: + interferon alfa-2b (3 MIU TIW)
English: 4 tablets b Refer to adult dosing table (Table 1)
Maltese: Irreferi għat-tabella ta' dożaġġi tal-adulti (Tabella 1)
English: 1 Carrat F, Bani-Sadr F, Pol S et al. JAMA 2004; 292(23): 2839-2848.
Maltese: JAMA 2004; 292(23): 2839-2848.
English: Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Maltese: Farmakoloġikament, ribavirin iżid il-metaboliti fosforilati ta' nukleosidi purini in vitro.
English: Discontinue Ribavirin
Maltese: Ribavirin
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 April 2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 6 ta' April 2010
English: Serum Creatinine
Maltese: Kreatinina fis-Serum
English: Ribavirin (800-1,200 mg /day)
Maltese: Ribavirin (800-1,200 mg /jum)d
English: p value b
Maltese: Valur pb
English: < 25 x 109/l (adults) < 50 x 109/l (children and adolescents) 2.5 x ULN* > 4 mg/dl (adults) > 5 mg/dl (for > 4 weeks) (children and adolescents treated with interferon alfa-2b),
Maltese: < 25 x 109/l (adulti) < 50 x 109/l (tfal u adolexxenti) 2.5 x ULN* > 4 mg/dl (adulti) > 5 mg/dl (għal > 4 ġimgħat) (tfal u adolexxenti ikkurati b'interferon alfa-2b),
English: Psychiatric and Central Nervous System (CNS):
Maltese: Psikjatriku u Sistema Nervuża Ċentrali (SNĊ):
English: • tablet core: microcrystalline cellulose, crospovidone, povidone K25, silica colloidal, magnesium stearate
Maltese: • il-qalba tal-pillola: microcrystalline cellulose, crospovidone, povidone K25, silica colloidal,
English: In clinical trials of 118 children and adolescents 3 to 16 years of age treated with combination therapy of interferon alfa-2b and ribavirin, 6 % discontinued therapy due to adverse reactions.
Maltese: Fi provi kliniċi b'118 tfal u adolexxenti ta' 3 sa 16-il sena kkurati b'terapija kombinata b'interferon alfa-2b u ribavirin, 6 % waqqfu t-terapija minħabba reazzjonijiet avversi.
English: Biopartners GmbH Kaiserpassage 11 D-72764 Reutlingen Germany
Maltese: Biopartners GmbH Kaiserpassage 11
English: 2 x baseline and > 10 x ULN*
Maltese: 2 x linja bażi u > 10 x ULN* jew 2 x linja bażi u > 10 x ULN*
English: Transfer into seminal fluid: Seminal transfer of ribavirin has been studied.
Maltese: Kien studjat it-trasferiment seminali ta' ribavirin.
English: Creatinine
Maltese: Epatomegalija
English: 2 tablets in the morning and 2 tablets in the evening 2 tablets in the morning and 3 tablets in the evening 3 tablets in the morning and 3 tablets in the evening 3 tablets in the morning and 4 tablets in the evening
Maltese: 2 pilloli filgħodu u 2 pilloli filgħaxija 2 pilloli filgħodu u 3 pilloli filgħaxija 3 pilloli filgħodu u 3 pilloli filgħaxija 3 pilloli filgħodu u 4 pilloli filgħaxija
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: 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 siegħa, rispettivament).
English: Anaemia (haemoglobin < 9.4 g/dl) was reported in 12 % (23/194) of patients treated with ribavirin in combination with peginterferon alfa-2b.
Maltese: Anemija (emoglobina < 9.4 g/dl) kienet irrappurtata fi 12 % (23/194) tal-pazjenti trattati b'ribavirin f'kombinazzjoni ma' peginterferon alfa-2b.
English: Psychiatric and Central Nervous System:
Maltese: Sistema Psikjatriku u Sistema Nervuża Ċentrali:
English: The pharmacokinetics of ribavirin and interferon alfa-2b (dose-normalized) are similar in adults and
Maltese: Il-farmakokinetika ta' ribavirin u interferon alfa-2b (doża normalizzata) huma simili fl-adulti jew
English: - Haemoglobinopathies (e.g., thalassemia, sickle-cell anaemia).
Maltese: − Mard tad-demm (eż., talessimja, anemija tat-tip sickle cell).
English: P1.5/R Ribavirin (800 mg) + peginterferon alfa-2b (1.5 micrograms/kg) P0.5/R Ribavirin (1,000/1,200 mg) + peginterferon alfa-2b (1.5 to 0.5 microgram/kg) I/R Ribavirin (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
Maltese: P1.5/R Ribavarin (800 mg/) + peginterferon alfa-2b (1.5 mikrogrammi/kg) P0.5/R Ribavarin (1,000/1,200 mg) + peginterferon alfa-2b (1.5 sa 0.5 mikrogrammi/kg)
English: Number of 200 mg tablets 1 tablet in the morning and 2 tablets in the evening
Maltese: Numru ta' pilloli ta' 200 mg 1 pillola filgħodu u 2 pilloli filgħaxija
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); uncommon (≥ 1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known.
Maltese: Fil-klassifika tas-sistema tal-organi, ir-reazzjonijiet avversi huma elenkati taħt titli ta' frekwenzi bil-kategoriji li ġejjin: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥ 1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħuf.
English: Ribavirin was active in the Balb/3T3 in vitro Transformation Assay.
Maltese: Ribavirin kien attiv fl-Assaġġ tat-Trasformazzjoni tal-Balb/3T3 in vitro.
English: In
Maltese: A.
English: - Genotoxicity: Ribavirin induces genotoxicity (see section 5.3).
Maltese: Ribavirin jinduċi l-ġenotossiċità (ara sezzjoni 5.3).
English: Stevens Johnson syndrome*, toxic epidermal necrolysis*, Musculoskeletal and connective tissue disorders Very common:
Maltese: Sindromu ta' Stevens Johnson*, nekrolisi epidermali tossika*, eritema multiforme*
English: Clearance
Maltese: MANIFATTURA
English: NAME OF THE MEDICINAL PRODUCT Ribavirin BioPartners 200 mg
Maltese: Ribavirin BioPartners 200 mg
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 d: Ribavirin 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: 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 d: dożaġġ ta' Ribavirin kien 800 mg għal pazjenti < 60 kg, 1,000 mg għal pazjenti 60-75 kg, u 1,200 mg għal pazjenti > 75 kg.
English: For HCV/HIV co-infected patients receiving ribavirin 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: Għal pazjenti infettati fl-istess ħin b'HCV/HIV li qed jirċievu ribavirin f'kombinazzjoni ma' peginterferon alfa-2b, reazzjonijiet avversi oħra (li ma kienux irrappurtati f'pazjenti b'infezzjoni waħda) li kienu rrappurtati fl-istudji bi frekwenza > 5 % kienu: kandidijażi orali (14 %), lipodistrofija akkwiżita (13 %), tnaqqis fil-linfoċiti CD4 (8 %), tnaqqis fl-aptit (8 %), żieda fil-gamma-glutamyltransferase i (9 %), uġigħ fid-dahar (5 %), żieda tal-amylase fid-demm (6 %),
English: Three trials examined the use of interferon in naïve patients, two with ribavirin + interferon alfa-2b (C95-132 and I95-143) and one with ribavirin + peginterferon alfa-2b (C/I98-580).
Maltese: Tliet provi eżaminaw l-użu ta' interferon f'pazjenti inkonsapevoli, tnejn b'ribavirin + interferon alfa-2b (C95-132 u I95-143) u wieħed b'ribavirin + peginterferon alfa-2b (C/I98-580).
English: • are older than 65 years or if you have problems with your kidneys.
Maltese: • għandek iżjed minn 65 sena jew jekk għandek problemi tal-kliewi.
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 %  12 years of age.
Maltese: 118-il pazjent ingħataw kura li minnhom 57 % kienu rġiel, 80 % Kawkażi, u 78 % b'HCV Ġenotip 1 u 64 % < 12-il sena.
English: Number of 200 mg tablets
Maltese: Numru ta' pilloli ta' 200 mg
English: Both ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are also excreted
Maltese: Kemm ribavirin u l-metaboliti tiegħu triazole carboxamide u triazole carboxylic acid jiġu eliminati permezz tal-kliewi.
English: Pharmacotherapeutic group: Direct acting antivirals, nucleosides and nucleotides (excl. reverse transcriptase inhibitors), ATC code: J05AB04.
Maltese: Antivirali li jaġixxu direttament, nukleosidi u nukleotidi (li jeskludu reverse transcriptase inhibitors), Kodiċi ATC:
English: Elderly patients (≥ 65 years of age): Specific pharmacokinetic evaluations for elderly subjects have not been performed.
Maltese: Pazjenti anzjani (≥ 65 sena): Ma sarux evalwazzjonijiet farmakokinetiċi speċifiċi f'pazjenti anzjani.
English: A reduction in haemoglobin concentrations by > 4 g/dl was observed in 30 % of patients treated with ribavirin and peginterferon alfa-2b and 37 % of patients treated with ribavirin and interferon alfa-2b.
Maltese: Tnaqqis fil-konċentrazzjoni ta' emoglobulina b' > 4 g/dl kien osservat fi 30 % tal-pazjenti trattati b' ribavirin u peginterferon alfa-2b u 37 % tal-pazjenti trattati b'ribavirin u interferon alfa-2b.
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 filkinetika ta' ribavirin; il-funzjoni renali hija l-fattur determinanti.
English: There were some cases of more severe neutropenia in patients treated with ribavirin in combination with peginterferon alfa-2b (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]); WHO grade 3 leukopenia was also reported in 7 % of this treatment group.
Maltese: Kien hemm xi każijiet ta' newtropenja aktar severa f'pazjenti ttrattati b'ribavirin flimkien ma' peginterferon alfa-2b (grad 3 tal-WHO: 39 minn 186 [21 %]; u grad 4 tal-WHO: 13 ta' 186 [7 %]); lewkopenja grad 3 tal-WHO kienet rapportata wkoll f'7 % ta' dan il-grupp ta' trattament.
English: Male: impotence, prostatitis, erectile dysfunction, Sexual dysfunction (not specified)*
Maltese: Rġiel: impotenza, prostatite, funzjoni ħażina ta' lerezzjoni, nuqqas ta' funzjoni sesswali (mhux
English: Interferon alfa-2b: No pharmacokinetic interactions were noted between ribavirin and peginterferon alfa-2b or interferon alfa-2b in a multiple-dose pharmacokinetic study.
Maltese: Interferon alfa-2b: L-ebda interazzjonijiet farmakokinetiċi ma kienu nnotati bejn ribavirin u peginterferon alfa-2b jew interferon alfa-2b fi studju farmakokinetiku b'dożi multipli.
English: 2 Laguno M, Murillas J, Blanco J.L et al. AIDS 2004; 18(13): F27-F36.
Maltese: AIDS 2004; 18(13): F27-F36.
English: There are no data on long term effects on sexual maturation.
Maltese: M'hemmx dejta dwar l-effetti fit-tul fuq il-maturità
English: Another approximately 4 % had a transient decrease below the lower limit of normal.
Maltese: Madwar 4 % oħra kellhom tnaqqis momentarju taħt l-aktar limitu normali baxx.
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: L-istima Kaplan-Meier ghar-rispons sostnut li inżamm fuq il-5 snin huwa 98 % [95 % CI: 95 %, 100 %] għal pazjenti pedjatriċi ikkurati b'interferon alfa-2b u ribavirin.
English: Facial palsy, mononeuropathies
Maltese: Puplesija fil-wiċċ, mononewropatiji
English: Ribavirin, 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, ribavirin jista' jfixkel ilmetaboliżmu ta' azathioprine u possibbilment iwassal għall-akkumulazzjoni ta' 6-methylthioinosine monophosphate (6-MTIMP), li kienet assoċjata ma' majelotossiċità f'pazjenti kkurati b'azathioprine.
English: In 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: F'dan l-istudju, l-aktar reazzjonijiet avversi li ħarġu fl-individwi kollha kienu: temperatura għolja (80 %), uġigħ ta' ras (62 %), newtropenija (33 %), għeja (30 %), anoressija (29 %) u ħmura fis-sit ta'
English: Table 9 Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and Ribavirin when administered to children or adolescents with chronic Interferon alfa-2b 3 MIU/m2 3 times a week (n = 54)
Maltese: Tabella 9 Medja (% CV) ta' parametri farmakokinetiċi b'ħafna dożi għal for interferon alfa-2b u Ribavirin meta jingħataw lil tfal u adoloxxenti b'epatite C kronika Interferon alfa-2b 3 MIU/m2 3 darbiet fil-ġimgħa (n = 54)
English: Ribavirin BioPartners film-coated tablets are packaged in blisters consisting of polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) and aluminium foil.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-pilloli miksija b'rita Ribavirin BioPartners huma ppakkjati ġo folji li jikkonsistu minn polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) u fojl tal-aluminju.
English: Ribavirin clinical trials in children and adolescents:
Maltese: Provi kliniċi b'Ribavarin fi tfal u adolexxenti:
English: In general, the adverse reaction profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition, as decrease in height percentile (mean percentile decrease of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment.
Maltese: B'mod ġenerali, il-profil ta' reazzjoni avversa fil-popolazzjoni limitata tat-tfal u adolexxenti li kienet studjata kien simili għal dak osservat fl-adulti, għalkemm l-impediment ta' żvilupp huwa ta' tħassib speċifiku għall-popolazzjoni pedjatrika, peress li tnaqqis perċentwali fit-tul (perċentwali medja ta' tnaqqis ta'9 fil-mija) u filperċentwali tal-piż (tnaqqis perċentwali medju ta' 13 %) kienu osservati waqt it-trattament.
English: • are a woman of childbearing age (see section “Pregnancy and breast-feeding”).
Maltese: • int mara ta' età li jista' jkollok it-tfal (ara sezzjoni “Tqala u treddigħ”).
English: Patients co-infected with HCV/HIV: Patients taking nucleoside reverse transcriptase inhibitor (NRTI) treatment in association with ribavirin and interferon alfa-2b may be at increased risk of mitochondrial toxicity, lactic acidosis and hepatic decompensation (see section 4.4).
Maltese: Pazjenti li qed jieħdu trattament b'inibitur ta' nucleoside reverse transcriptase (NRTI) flimkien ma' ribavirin u interferon alfa-2b jista' jkollhom riskju akbar ta' tossiċità mitokondrijali, aċidosi lattika u dikompensazzjoni epatika (ara sezzjoni 4.4).
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 97 % (95 % CI: 95-99 %) for patients receiving non-pegylated interferon alfa-2b (with or without ribavirin), and is 99 % (95 % CI: 98-100 %) for patients receiving pegylated interferon alfa-2b (with or without ribavirin).
Maltese: L-istima Kaplan-Meier għal rispons sostnut fuq tul ta' 5 snin hija 97 % (95 % CI: 95-99 %) għal pazjenti li kienu qed jirċievu interferon alfa-2b mhux pegilat (bi jew mingħajr ribavirin), u hija 99 % (95 % CI: 98-100 %) għal pazjenti li kienu qed jirċievu interferon alfa-2b pegilat (bi jew mingħajr ribavirin).
English: • are a male and your female partner is of childbearing age (see section “Pregnancy and
Maltese: • int raġel u l-partner femminili tiegħek jista' jkollha t-tfal (ara sezzjoni “Tqala u treddigħ”)