qanastek/EMEA-V3 huggingface dataset:
Current treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment.
Il- linji gwida għal trattament attwali għandhom jiġu kkonsultati biex ikun stabbilit jekk il- bijopsija tal- fwied hiex meħtieġa qabel ma tinbeda l- kura.
Ribavirin must not be used by women who are pregnant (see section 4.3).
Ribavirin m’ għandux jintuża minn nisa li huma tqal (ara sezzjoni 4. 3).
Extreme care must be taken to avoid pregnancy in female patients (see sections 4.6 and 5.3).
Għandha tingħata attenzjoni kbira biex it- tqala tkun evitata f’ pazjenti nisa (ara sezzjonijiet 4. 6 u 5. 3).
Male patients and their female partners:
Pazjenti rġiel u l- imsieħba nisa tagħhom:
Extreme care must be taken to avoid pregnancy in partners of male patients taking Ribavirin (see sections 4.6 and 5.3).
Għandha tingħata attenzjoni kbira biex ma jkunx hemm tqala fis- sieħba ta ’ pazjenti rġiel li qed jieħdu Ribavirin (ara sezzjonijiet 4. 6 u 5. 3).
A decrease in haemoglobin levels to < 10 g/ dl was observed in up to 14% of adult patients and 7% of children and adolescents treated with Ribavirin in combination with peginterferon alfa-2b (adults only) or interferon alfa-2b (adults and children or adolescents) in clinical trials.
Tnaqqis fil- livelli ta ’ emoglobina għal < 10 g/ dl kien osservat f’ sa 14% ta ’ pazjenti adulti u 7% ta ’ tfal u adoloxxenti ttrattati b’ Ribavirin flimkien ma ’ peginterferon alfa- 2b (adulti biss) jew interferon alfa- 2b (adulti u tfal jew adoloxxenti) fi provi kliniċi.
Although ribavirin has no direct cardiovascular effects, anaemia associated with Ribavirin may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both.
Għalkemm ribavirin m’ għandux effetti kardjovaskulari diretti, l- anemija assoċjata ma ’ Ribavirin tista ’ tirriżulta f’ peġġorament tal - funzjoni kardijaka, jew tħarrix tas- sintomi ta ’ mard koronarju, jew it- tnejn.
Thus, Ribavirin must be administered with caution to patients with pre-existing cardiac disease (see section 4.3).
Għalhekk, Ribavirin għandu jingħata b’ attenzjoni lil pazjenti li ġa għandhom mard kardijaku (ara sezzjoni 4. 3).
Adult patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders must be closely monitored.
Pazjenti adulti li kellhom storja ta ’ insuffiċjenza konġestiva tal- qalb, infart mijokardijaku, u/ jew disturbi arritmiċi attwali jew fil- passat, għandhom ikunu osservati mill- qrib.
It is recommended that those patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment.
Hu rakkomandat li dawk il- pazjenti li għandhom anormalitajiet kardijaċi li kienu jeżistu minn qabel jittieħdulhom elettrokardjogrammi qabel u waqt il- kors tal- kura.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of therapy.
Arritmiji kardijaċi (prinċipalment supraventrikulari) ġeneralment jirrispondu għal terapija konvenzjonali imma għandu mnejn ikun hemm bżonn li titwaqqaf it- terapija.
There are no data in children or adolescents with a history of cardiac disease.
M’ hemmx tagħrif dwar tfal u adoloxxenti bi storja ta ’ mard kardijaku.
If an acute hypersensitivity reaction (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Ribavirin must be discontinued immediately and appropriate medical therapy instituted.
Jekk tiżviluppa reazzjoni ta ’ sensittività eċċessiva akuta (eż. urtikarja, anġjodema, jidjiequ l- bronki, anafilassi), Ribavirin għandu jitwaqqaf minnufih u tinbeda terapija medika xierqa.
Transient rashes do not necessitate interruption of treatment.
F’ każijiet ta ’ raxx tal- ġilda momentarja m’ hemmx għalfejn jitwaqqaf it- trattament.
Ribavirin is used in combination therapy with alpha interferons.
Ribavirin jintuża fi trattament flimkien ma ’ alfa interferons.
Retinopathy including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction which may result in loss of vision have been reported in rare instances with combination therapy with alpha interferons.
Retinopatija, li tinkludi emorraġiji retinali, dbabar bħal tajjar, papilloedema, newropatija ottika u sadd tal- arterja jew vina tar - retina li tista ’ twassal għal telf tal- vista kienu rappurtati f’ xi każijiet ta ’ terapija kkombinata ma ’ alfa interferons.
All patients should have a baseline eye examination.
Il- pazjenti kollha għandhom jkollhom eżami tal- għajnejn fil- bidu.
Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Kull pazjent li jilmenta minn tnaqqis jew telf tal- vista għandu jiġi eżaminat bir- reqqa minnufih.
Patients with preexisting ophthalmologic disorders (e. g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during combination therapy with alpha interferons.
Pazjenti li jkollhom disturbi tal- għajnejn minn qabel (eż. dijabete jew retinopatija ta ’ sensittività eċċessiva) għandu jkollhom eżamijiet tal- għajnejn waqt terapija kkombinata b’ alfa interferons.
Combination therapy with alpha interferons should be discontinued in patients who develop new or worsening ophthalmologic disorders
It- terapija kkombinata b’ alfa interferons għandha titwaqqaf f’ pazjenti li jkollhom disturbi ġodda tal- għajnejn jew li jaggravaw.
Any patient developing significant liver function abnormalities during treatment must be monitored closely.
Kull pazjent li jiżviluppa b’ mod sinifikanti anormalitajiet fil- funzjoni tal- fwied waqt it- trattament għandu jkun osservat mill- qrib.
Discontinue treatment in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Waqqaf it- trattament f’ dawk il- pazjenti li jiżviluppaw dewmien fil- markers ta ’ koagulazzjoni tad- demm li jista ’ jindika nuqqas ta ’ kumpens tal - fwied.
Supplemental monitoring specific for children and adolescents
Monitoraġġ supplimentari speċifiku għal tfal u adoloxxenti
7 Growth and Development:
7 Tkabbir u Żvilupp:
During a 1-year course of therapy there was a decrease in the rate of linear growth (mean percentile decrease of 9%) and a decrease in the rate of weight gain (mean percentile decrease of 13%).
Waqt kors ta ’ terapija ta ’ sena kien hemm tnaqqis fir- rata ta ’ tkabbir lineari (perċentwal medju ta ’ tnaqqis ta ’ 9%) u tnaqqis fir- rata ta ’ żieda fil- piż tal- ġisem (perċentwal medju ta ’ tnaqqis ta ’ 13%).
A general reversal of these trends was noted during the 6 months follow-up post treatment.
Dawn ix- xejriet kienu ġeneralment riversjati fis- sitt xhur ta ’ wara li jkun waqaf it- trattament.
However, based on interim data from a long-term follow-up study, 12 (14%) of 84 children had a > 15 percentile decrease in rate of linear growth, of whom 5 (6%) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
Madankollu, skont tagħrif interim waqt sudju ta ’ follow- ups fuq perijodu ta ’ żmien twil, 12 (14%) minn 84 tifel u tifla kellhom tnaqqis ta ’ > 15 perċentwali fir- rata ta ’ tkabbir lineari, li minnhom 5 (6%) itfal kellhom tnaqqis perċentwali ta ’ > 30 minkejja li kienu ilhom aktar minn sena li waqfu t- trattament.
In addition, preclinical juvenile toxicity results have demonstrated a minor, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3).
Barra minn hekk, riżultati tossikoloġiċi fuq żgħażagħ qabel l- użu kliniku wrew tnaqqis żgħir, marbut mad- doża fil- mod ġenerali ta ’ tkabbir ta ’ firien tat- twelid li ngħataw dożi b’ ribavirin (ara sezzjoni 5. 3).
Therefore, the risk/ benefit of the combined use of Ribavirin and interferon alfa-2b should be assessed in young children prior to the initiation of therapy.
Għalhekk, għandu jitqies ir- riskju/ benefiċċju tal- użu kombinat ta ’ Ribavirin u interferon alfa- 2b fi tfal żgħar qabel ma tinbeda t- terapija.
Physicians are advised to monitor the growth of children taking Ribavirin in combination with interferon alfa-2b.
Huwa rakkomandat li t- tobba għandhom isegwu l- mod kif kienu qed jikbru tfal li kienu qed jieħdu Ribavirin u interferon alfa- 2b flimkien.
There are no data on long term effects on growth and development and on sexual maturation.
M’ hemmx tagħrif dwar l- effetti li jkun hemm bl- użu fuq perijodu ta ’ żmien twil fuq it - tkabbir u żvilupp sesswali.
Approximately 12% of children treated with Ribavirin and interferon alfa-2b developed increase in TSH.
Madwar 12% tat- tfal trattati b’ Ribavirin u interferon alfa- 2b żviluppaw żieda f’ TSH.
Another 4% had a transient decrease below the lower limit of normal.
4% oħra kellhom tnaqqis momentarju taħt l- aktar limitu normali baxx.
Prior to initiation of interferon alfa-2b therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Qabel ma tinbeda terapija b’ interferon alfa- 2b, il- livelli ta ’ TSH għandhom jiġu valorizzati u kull abormalità li tinstab f’ dak il- ħin għandha tiġi trattata b’ terapija konvenzjonali.
Interferon alfa-2b therapy may be initiated if TSH levels can be maintained in the normal range by medication.
It- terapija b’ interferon alfa- 2b tista ’ tinbeda jekk il- livelli ta ’ TSH ikunu jistgħu jinżammu fil- medda normali permezz tal- mediċini.
Thyroid dysfunction during treatment with Ribavirin and interferon alfa-2b has been observed.
Funzjoni ħażina tat- tirojdi waqt it- trattament b’ Ribavirin u interferon alfa- 2b kienet innutata.
If thyroid abnormalities are detected, the patient ’ s thyroid status should be evaluated and treated as clinically appropriate.
Jekk jinstabu abnormalitajiet tat- tirojdi, l- istat tat- tirojdi tal- pazjent għandu jitqies u jiġi kkurat kif ikun klinikament xieraq.
Children and adolescents should be monitored every 3 months for evidence of thyroid dysfunction (e. g.
It- tfal u adoloxxenti għandhom ikunu monitorati kull 3 xhur għal sinjali li jistgħu juru funzjoni ħażina tat- tirojdi (eż.
HCV/ HIV Co-infection:
Infezzjoni fl- istess ħin b’ HCV/ HIV:
Mitochondrial toxicity and lactic acidosis:
Tossiċità mitokondrijali u aċidożi lattika:
Caution should be taken in HIV-positive subjects co- infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa-2b/ ribavirin treatment.
Kawtela għandha tittieħed f’ individwi li rriżultaw pożittivi għal HIV u li huma ko- infettati b’ HCV li qed jirċievu trattament bl- impedituri ta ’ nucleoside reverse transcriptase (NRTI) (l- aktar ddI u d4T) u t- trattament assoċjat b’ interferon alfa- 2b/ ribavirin.
In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when ribavirin is administered.
Fil- popolazzjoni pożittiva għal HIV li qed jirċievu programm ta ’ trattament ta ’ NRTI, it- tobba għandhom josservaw b’ attenzjoni l- markers ta ’ tossiċità mitokondrijali u aċidosi lattika meta jingħata ribavirin.
In particular:
B’ mod partikulari:
- co-administration of Ribavirin and didanosine is not recommended due to the risk of
- it- teħid ta ’ Ribavirin ma ’ didanosine mhux rakkomandat minħabba r- riskju ta ’ tossiċità
- co-administration of Ribavirin and stavudine should be avoided to limit the risk of overlapping
- it- teħid ta ’ Ribavirin ma ’ stavudine għandu jiġi evitat sabiex ir- riskju ta ’ tossiċità mitokondrijali
mitochondrial toxicity.
miż- żewġ mediċini jkun limitat.
Hepatic decompensation in HCV/ HIV co-infected patients with advanced cirrhosis:
Pazjenti infettati fl- istess ħin b’ HCV/ HIV li jkollhom ċirrożi fi stat avvanzat:
Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
Pazjenti infettati fl- istess ħin li jkollhom ċirrożi avvanzata li jkunu qed jirċievu HAART jista ’ jkollhom riskju akbar ta ’ dikompens epatiku u mewt.
Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Iż- żieda ta ’ trattament b’ interferoni alfa jew f’ taħlita ma ’ ribavirin jista ’ jżid ir- riskju f’ dan is- sottogrupp ta ’ pazjenti.
Other baseline factors in co-infected patients that may be associated with a higher risk of hepatic decompensation include treatment with didanosine and elevated bilirubin serum concentrations.
Fatturi mal- linja bażi oħrajn f’ pazjenti infettati fl- istess ħin li jistgħu jkunu assoċjati ma ’ riskju akbar ta ’ dikompens epatiku jinkludu trattament b’ didanosine u konċentrazzjonijiet ogħla ta ’ bilirubin fis- serum.
Co-infected patients receiving both antiretroviral (ARV) and anti-hepatitis treatment should be closely monitored, assessing their Child-Pugh score during treatment.
Pazjenti infettati fl- istess ħin li qed jirċievu kemm trattament antiretrovirali (ARV) u kontra l- epatite għandhom jiġu osservati mill- qrib, u jkollhom il- punteġġ Child- Pugh ikkalkulat waqt it- trattament.
Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
Pazjenti li jgħaddu għal nuqqas ta ’ kumpens epatiku għandu jkollhom it- trattament tagħhom kontra l- epatite mwaqqaf minnufih u t- trattament ARV assessjat mill- ġdid.
Haematological abnormalities in HCV/ HIV co-infected patients:
Abnormalitajiet ematoloġiċi f’ pazjenti infettati fl- istess ħin b’ HCV/ HIV:
HCV/ HIV co-infected patients receiving peginterferon alfa-2b/ ribavirin treatment and HAART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
Pazjenti li jkollhom HCV/ HIV fl- istess ħin li jkunu qed jirċievu trattament b’ peginterferon alfa - 2b/ ribavirin u HAART jistgħu jkunu f’ riskju akbar li jiżviluppaw anormalitajiet ematoloġiċi (bħala neutropenja, tromboċitopenja u anemija) meta mqabbla ma ’ pazjenti infettati b’ HCV biss.
Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “ Laboratory tests” and section 4.8).
Għalkemm, il- biċċa l- kbira jistgħu jkunu ġestiti bi tnaqqis fid- doża, monitoraġġ mill- qrib ta ’ parametri ematoloġiċi għandu jsir f’ dan il- grupp ta ’ pazjenti (ara sezzjoni 4. 2 u hawn isfel “ Testijiet tal- laboratorju ” u sezzjoni 4. 8).
Patients treated with ribavirin and zidovudine are at increased risk of developing anaemia; therefore, the concomitant use of ribavirin with zidovudine is not recommended (see section 4.5).
8 Patients trattati b’ ribavirin u zidovudine jinsabu f’ riskju ogħla li jiżviluppaw anemija, għalhekk l- użu ta ’ ribavirin flimkien ma ’ zidovuline mhux rakkomandat (ara sezzjoni 4. 5).
8 Patients with low CD4 counts:
Pazjenti b’ għadd baxx ta ’ CD4:
In patients co-infected with HCV/ HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/ µl.
Hemm tagħrif limitat disponibbli dwar l- effikaċja u s- sigurtà (N = 25) f’ pazjenti li huma infettati fl- istess ħin b’ HCV/ HIV, b’ għadd ta ’ CD4 ta ’ anqas minn 200 ċellula/ µl.
Caution is therefore warranted in the treatment of patients with low CD4 counts.
Kawtela hija meħtieġa fit- trattament għal pazjenti b’ għadd baxx ta ’ CD4.
Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Ribavirin and peginterferon alfa-2b.
Jekk jogħġbok irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott tal- prodotti mediċinali antiretrovirali li jkollhom jittieħdu fl- istess ħin ma ’ terapija għal HCV għal għarfien u ġestjoni minħabba t- tossiċitajiet speċifiċi għal kull prodott u l- potenzjal li jista ’ jkun hemm tossiċitajiet f’ daqqa b’ Ribavirin u peginterferon alfa- 2b.
Dental and periodontal disorders:
Disturbi dentali u periodontali:
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Ribavirin and peginterferon alfa-2b or interferon alfa-2b combination therapy.
Disturbi dentali u periodentali li minħabba fihom jistgħu jaqgħu s - snien, kienu rapportati f’ pazjenti li kienu qed jieħdu terapija kombinata ta ’ Ribavirin u peginterferon alfa- 2b jew interferon alfa- 2b.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Ribavirin and peginterferon alfa-2b or interferon alfa-2b.
Barra minn hekk, il- ħalq xott jista ’ jagħmel ħsara lis- snien u r- riti mukużi fil- ħalq waqt trattament kombinat fit- tul b’ Ribavirin u peginterferon alfa- 2b jew interferon alfa- 2b.
Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Il- pazjenti għandhom jaħslu snienhom darbtejn kuljum sew u jkollhom eżamijiet mediċi b’ mod regolari.
In addition some patients may experience vomiting.
Barra minn hekk, xi pazjenti jistgħu jirrimettu.
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Jekk jiġri dan għandhom ilaħalħu ħalqhom sew wara.
Standard haematologic tests and blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) must be conducted in all patients prior to initiating therapy.
Qabel ma tinbeda t- terapija fil- pazjenti kollha għandhom isiru t- testijiet ematoloġiċi standard u kimiċi tad- demm (għadd sħiħ u divrenzjali ta ’ ċelluli tad- demm [CBC], l- għadd ta ’ plejtlits, elettroliti, kreatinin fis- serum, testijiet tal- funzjoni tal- fwied u tal- aċidu uriku).
Acceptable baseline values that may be considered as a guideline prior to initiation of Ribavirin therapy:
Livelli aċċettabbli tal- linja bażi li jistgħu jitqiesu bħala linji gwida qabel tinbeda t- terapija b’ Ribavirin huma:
Haemoglobin
Emoglobina Plejtlets Għadd ta ’ Newtrofili
Adult: ≥ 12 g/ dl (females); ≥ 13 g/ dl (males) Paediatric: ≥ 11 g/ dl (females); ≥ 12 g/ dl (males)
Adulti: ≥ 12 g/ dl (nisa); ≥ 13 g/ dl (irġiel) Pedjatriċi: ≥ 11 g/ dl (nisa); ≥ 12 g/ dl (irġiel) ≥ 100, 000/ mm3 ≥ 1, 500/ mm3
Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
Evalwazzjonijiet tal- laboratorju għandhom isiru fit- 2 u r- 4 ġimgħa tat- terapija, u kultant żmien wara dan, kif ikun xieraq.
Female patients must have a routine pregnancy test performed monthly during treatment and for four months thereafter.
Pazjenti nisa għandu jkollhom testijiet tat- tqala ta ’ rutina kull xahar waqt it- tqala u għal 4 xhur wara.
Female partners of male patients must have a routine pregnancy test performed monthly during treatment and for seven months thereafter (see section 4.6).
L- imsieħba nisa ta ’ pazjenti rġiel għandu jkollhom testijiet ta ’ tqala ta ’ rutina kull xahar waqt il- kura u għal seba ’ xhur wara (ara sezzjoni 4. 6).
Uric acid may increase with Ribavirin due to haemolysis; therefore, the potential for development of gout must be carefully monitored in pre-disposed patients.
L- aċidu uriku għandu mnejn jiżdied b’ Ribavirin minħabba l- emoliżi; għalhekk, il- potenzjal għall- iżvilupp ta ’ gotta għandu jkun osservat b’ attenzjoni f’ pazjenti predisposti.
Results of in vitro studies using both human and rat liver microsome preparations indicated no cytochrome P450 enzyme mediated metabolism of ribavirin.
Ir- riżultati minn studji in vitro li fihom intużaw preparazzjonijiet ta ’ mikrożomi tal- fwied kemm tal- bniedem kif ukoll tal- firien ma indikaw l- ebda metaboliżmu ta ’ ribavirin medjat mill- enżima ta ’ cytochrome P450.
Ribavirin does not inhibit cytochrome P450 enzymes.
Ribavirim ma jimpedixxix l- enżimi ta ’ cytochrome P450.
There is no evidence from toxicity studies that ribavirin induces liver enzymes.
M’ hemm l- ebda evidenza minn studji dwar it- tossiċità li ribavirin jinduċi l- enżimi tal- fwied.
Therefore, there is a minimal potential for P450 enzyme-based interactions.
Għalhekk, hemm probabilità minima li jseħħu interazzjonijiet bażati fuq l- enżima P450.
No interaction studies have been conducted with Ribavirin and other medicinal products, except for peginterferon alfa-2b, interferon alfa-2b and antacids.
Ma saru l- ebda studji dwar l- interazzjoni bejn Ribavirin u prodotti mediċinali oħra, ħlief għal peginterferon alfa- 2b, interferon alfa- 2b u antaċidi.
No pharmacokinetic interactions were noted between Ribavirin and peginterferon alfa-2b or interferon alfa-2b in a multiple-dose pharmacokinetic study.
L- ebda interazzjonijiet farmakokinetiċi ma kienu nnotati bejn Ribavirin u peginterferon alfa- 2b jew interferon alfa- 2b fi studju farmakokinetiku b’ dożi multipli.
Antacid:
9 Antaċidi:
The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14%.
Il- bijodisponibilità ta ’ ribavirin 600 mg kienet imnaqqsa meta ngħata flimkien ma ’ antaċidu li kien fih manjesju aluminju u simethicone; AUCtf tnaqqas b’ 14%.
It is possible that the decreased bioavailability in this study was due to delayed transit of ribavirin or modified pH.
Jista ’ jkun li l- bijodisponibilità tnaqqset f’ dan l- istudju minħabba l- ittardjar tal- ġarr ta ’ ribavirin jew pH modifikata.
This interaction is not considered to be clinically relevant.
Din l- azzjoni reċiproka mhix ikkonsidrata klinikament rilevanti.
9 Nucleoside analogs:
Analogi ta ’ nukleoside:
Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis.
L- użu ta ’ analogi ta ’ nukleoside, waħidhom jew flimkien ma ’ nukleosides oħra, irriżulta f’ aċidożi lattika.
Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Farmakoloġikament, ribavirin iżid il- metaboliti fosforilati ta ’ nukleosidi purini in vitro.
This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e. g. didanosine or abacavir).
Din l- attività tista ’ twassal għal riskju akbar ta ’ aċidożi lattika kkaġunata minn analogi ta ’ nucleoside tal- purina (eż. didanosine jew abacavir).
Co-administration of Ribavirin and didanosine is not recommended.
L- użu fl- istess ħin ta ’ Ribavirin u didanosine mhux rakkomandat.
Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see section 4.4).
Rapporti ta ’ tossiċità mitokondrijali, l- aktar aċidożi lattika u pankreatite, li minnhom ftit kienu letali, kienu rapportati (ara sezzjoni 4. 4).
The exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Kien rapportat li l- anemija ħraxet minħabba ribavirin meta zidovudine ikun parti mill- programm ta ’ terapija li jintuża biex jittratta HIV għalkemm il- mekkaniżmu eżatt għad irid jiġi ċċarat.
The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
L- użu ta ’ ribavirin flimkien ma ’ zidovudine mhux rakkomandat minħabba r- riskju ogħla ta ’ anemija (ara sezzjoni 4. 4).
Consideration should be given to replacing zidovudine in a combination anti-retroviral treatment (ART) regimen if this is already established.
Konsiderazzjoni għandha tingħata sabiex zidovudine jitbiddel fil- kombinazzjoni antiretrovirali tat- trattament (ART) jekk dan kien qed jingħata bħala parti mill- programm ta ’ trattament.
This would be particularly important in patients with a known history of zizovudine induced anaemia.
Dan ikun importanti b’ mod partikolari f’ pazjenti bi storja ta ’ anemija minħabba li ħadu zidovudine.
Any potential for interactions may persist for up to two months (five half-lives for ribavirin) after cessation of Ribavirin therapy due to the long half-life (see section 5.2).
Kull possibilità ta ’ interazzjoni tista ’ tippersisti sa xaharejn (ħames half- lives għal ribavirin) wara l- waqfien tat- terapija b’ Ribavirin minħabba l- half- life twil (ara sezzjoni 5. 2).
There is no evidence that ribavirin interacts with non-nucleoside reverse transcriptase inhibitors or protease inhibitors.
M’ hemm l- ebda evidenza li ribavirin jagħmel xi interazzjonijiet ma ’ l- impedituri ta ’ reverse transcriptase mhux nucleosides jew impedituri ta ’ protease.
The use of Ribavirin is contraindicated during pregnancy.
L- użu ta ’ Ribavirin hu kontraindikat waqt it- tqala.
Preclinical data:
Tagħrif ta ’ qabel l- użu kliniku:
In animal studies, ribavirin produced reversible effects on spermatogenesis (see section
Fi studji fuq l- annimali, ribavirin ikkaġuna effetti riversibbli fuq l- ispermatoġenesi (ara
- Teratogenicity:
- Teratogeniċità:
Significant teratogenic and/ or embryocidal potential have been demonstrated for
Possibilità ta ’ effetti teratoġeniċi u/ jew embrijoċidali ġew murija għal ribavirin
ribavirin in all animal species in which adequate studies have been conducted, occurring at doses as low as one twentieth of the recommended human dose (see section 5.3).
fl- ispeċi tal- annimali kollha li fuqhom saru studji xierqa, b’ dożi baxxi daqs ta ’ frazzjoni waħda ekwivalenti għall- waħda f’ għoxrin tad- doża rakkomandata fil- bniedem (ara sezzjoni 5. 3).
- Genotoxicity:
- Ġenotossiċità:
Ribavirin induces genotoxicity (see section 5.3).
Ribavirin jinduċi l- ġenotossiċità (ara sezzjoni 5. 3).
Ribavirin must not be used by females who are pregnant (see sections 4.3, 4.4 and 5.3).
Ribavirin m’ għandux jintuża minn nisa waqt it- tqala (ara sezzjonijiet 4. 3, 4. 4 u 5. 3).
Ribavirin therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
It- terapija b’ Ribavirin m’ għandhiex tinbeda qabel ma jinkiseb riżultat negattiv ta ’ test tat- tqala preċiż qabel tinbeda t- terapija.
Females of childbearing potential and their partners must each use an effective contraceptive during treatment and for four months after treatment has been concluded; routine monthly pregnancy tests must be performed during this time (see section 4.4).
Nisa li jista ’ jkollhom it- tfal u s- sieħeb tagħhom, għandhom it- tnejn jużaw mezzi kontraċettivi effettivi waqt it- trattament u għal erba ’ xhur wara li jkun spiċċa t- trattament; testijiet tat- tqala ta ’ rutina kull xahar għandhom isiru matul dan iż- żmien (ara sezzjoni 4. 4).
If pregnancy does occur during treatment or within four months from stopping treatment, the patient must be advised of the significant teratogenic risk of ribavirin to the foetus.
Jekk it- tqala sseħħ waqt it- trattament, jew sa erba ’ xhur minn wara li jintemm it- trattament, il- pazjenta għandha tkun infurmata bir- riskju sinifikanti għal teratoġeniċità tal- fetu.
Male patients and their female partners:
Pazjenti rġiel u n- nisa msieħba tagħhom:
Extreme care must be taken to avoid pregnancy in partners of male patients taking Ribavirin (see sections 4.3, 4.4 and 5.3).
Għandha tingħata attenzjoni kbira biex it- tqala tkun evitata f’ imsieħba nisa ta ’ pazjenti rġiel li jkunu qed jieħdu Ribavirin (ara wkoll sezzjonijiet 4. 3, 4. 4 u 5. 3).
Ribavirin accumulates intracellularly and is cleared from the body very slowly.
Ribavirin jakkumula fiċ- ċelluli u jiġi eliminat minn ġol- ġisem bil- mod ħafna.
It is unknown whether the ribavirin that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/ foetus.
Mhux magħruf jekk ir- ribavirin li jinsab fl- isperma jeżerċitax l- effetti teratoġeniċi possibbli jew dawk fuq il- ġeni fuq l- embriju/ fetu tal- bniedem.
Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, male patients and their female partners of childbearing age must be counseled to each use an effective contraceptive during treatment with Ribavirin and for seven months after treatment Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
Għalkemm tagħrif minn madwar 300 tqala b’ missirijiet li ġew esposti għal ribavirin kienu segwiti b’ mod prospettiv, ma wrewx żieda fir- riskji ta ’ malformazzjonijiet meta mqabbla mal- popolazzjoni ġenerali, u lanqas xi skema speċifika ta ’ malformazzjoni, pazjenti rġiel u l - imsieħba nisa tagħhom li għad jista ’ jkollhom it- tfal għandhom jingħataw parir sabiex it- tnejn jużaw
It is not known whether ribavirin is excreted in human milk.
Mhux magħruf jekk ribavirin jitnixxix fil- ħalib tal- bniedem.
10 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Ribavirin has no or negligible influence on the ability to drive and use machines; however, peginterferon alfa-2b or interferon alfa-2b used in combination may have an effect.
Ribavirin m’ għandu l- ebda effett jew ftit li xejn għandu fuq il- ħila biex issuq u tħaddem magni; madankollu, peginterferon alfa- 2b jew interferon alfa- 2b użati b’ mod kombinat għandu mnejn ikollhom effett.
Thus, patients who develop fatigue, somnolence, or confusion during treatment must be cautioned to avoid driving or operating machinery.
Għalhekk, pazjenti li jiżviluppaw għeja kbira, ħedla jew konfużjoni waqt it- trattament għandhom ikunu avżati biex jevitaw li jsuqu jew li jħaddmu l- magni.
The safety of Ribavirin capsules is evaluated from data from three clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied Ribavirin in combination with interferon alfa-2b, one trial studied Ribavirin in combination with peginterferon alfa-2b.
Is- sigurtà tal- kapsuli Ribavirin hija evalwata minn tagħrif miġbur minn tliet studji kliniċi f’ pazjenti li ma kellhom ebda esponiment għal interferon (pazjenti inkonsapevoli dwar interferon): żewġ provi studjaw Ribavirin flimkien ma ’ interferon alfa- 2b, prova oħra studjat Ribavirin flimkien ma ’ peginterferon alfa- 2b.
Patients who are treated with interferon alfa-2b and ribavirin after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below.
Pazjenti trattati b’ interferon alfa- 2b u ribavirin wara li rkadew minn terapija b’ interferon jew li huma trattati għal perijodu iqsar x’ aktarx li jkollhom profil ta ’ sigurtà itjeb minn dak li huwa deskritt hawn taħt.
The adverse reactions listed in Table 4 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.
Ir- reazzjonijiet avversi elenkati f’ Tabella 4 huma bażati fuq l- esperjenza ta ’ provi kliniċi f’ pazjenti li kienu inkonsapevoli ttrattati għal sena sħiħa u wara t- tqegħid fis- suq.
A certain number of adverse reactions, generally attributed to interferon therapy but that have been reported in the context of hepatitis C therapy (in combination with ribavirin) are also listed for reference in Table 4.
Għadd ta reazzjonijiet avversi, ġeneralment attribwiti għal terapija b’ interferon imma li ġew irraportati fil- kuntest ta ’ terapija ta ’ epatite Ċ (f’ kombinazzjoni ma ’ ribavirin) huma wkoll elenkati f’ Tabella 4.
Also, refer to peginterferon alfa-2b and interferon alfa-2b SPCs for adverse reactions that may be attributable to interferon monotherapy.
Ukoll, irreferi għal Sommarju tal- Karatteristiċi tal- Prodott ta ’ peginterferon alfa- 2b u interferon 2b għal reazzjonijiet avversi li jistgħu jkunu attribwiti għal monoterapija tal- interferon.
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.
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.
Adverse reactions reported during clinical trials or following the marketing use of ribavirin with pegylated interferon alfa-2b or interferon alfa-2b injection
Reazzjonijiet avversi rapportati b’ ribavirin ma ’ injezzjoni ta ’ interferon alfa- 2b pergilat jew interferon alfa- 2b waqt provi kliniċi jew wara t- tqegħid fis- suq
System Organ Class and infestations
Klassifika tas- Sistema tal- Organi
Viral infection, pharyngitis Fungal infection, otitis media, herpes simplex, urinary tract infection
Infezzjoni virali, farinġite Infezzjoni tal- fungu, otitis media, herpes simplex, infezzjoni fil- passaġġ awrinarju
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Neoplażmi beninni, malinni u mhux speċifikati (li jinkludu ċisti u polipi)
Blood and lymphatic system disorders
Disturbi tad- demm u tas- sistema linfatika
Neoplasm unspecified
Neoplażmu mhux speċifikat
Immune system disorders
Disurbi fis- sistema immuni
Anaemia, neutropenia Thrombocytopenia, lymphadenopathy, lymphopenia Aplastic anaemia* Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Anemija, newtropenja Tromboċitopenija, limfadenopatija, limfopenja Anemija aplastika * Aplasja pura taċ- ċellula ħamra, purpura tromboċitopenika idjopatika, purpura tromboċitopenika trombotika
Endocrine disorders
Disturbi fis- sistema endokrina
Sarcoidosis* Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Sarkoijdosi * Sindromu Vogt- Koyanagi- Harada, lupus eritematosi sistemiku, artrite rewmatojdi (ġdida jew aggravata), vaskulite, reazzjonijiet ta ’ sensittività eċċessiva li jinkludu urikarja, anġjodema, tidjieq tal- bronki, anafilassi
Hypothyroidism, hyperthyroidism Diabetes
Ipotajrojdiżmu, Ipertajrojdiżmu Dijabete
Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite, thirst
Anoreksja Ipergliċemija, iperurikemija, ipokalċemija, diżidrazzjoni, żieda fl- aptit, għatx
Hypertriglyceridemia*
Ipertrigliċridemija *
Depression, insomnia, anxiety, emotional lability Suicidal ideation, psychosis, aggressive behaviour, confusion, agitation, nervousness, sleep disorder, abnormal dreaming, abnormal crying, apathy, decreased libido
Dipressjoni, insomnija, ansjetà, burdati emozzjonali Ħsibijiet suwiċidali, psikosi, mġieba aggressiva, konfużjoni, aġitazzjoni, nervożità, disturbi fl- irqad, ħolm mhux normali, biki mhux normali, apatija, tnaqqis ta ’ xewqa sesswali
Suicide attempts Hallucination Suicide* Mental status change
Tenattivi ta ’ suwiċidju Alluċinazzjoni Suwiċidju * Tibdil fl- istat mentali
Headache, dizziness, dry mouth, concentration impaired Ataxia, tremor, paresthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, somnolence, migraine, hypertonia, dysgeusia
Atassja, tregħid, parestesija, disfonja, telf fit- togħma, ipoestesija, iperestesija, ngħas, emigranja, ipertonja, disgewsja
Seizure (convulsion)*, peripheral neuropathy* Cerebrovascular haemorrhage*, cerebrovascular ischaemia*, encephalopathy*, polyneuropathy*
Attakki ta ’ puplesja (konvulsjoni) *, newropatija periferali * Emorraġija ċerebrovaskulari *, iskemija ċerebrovaskulari *, enċefalopatija *, polinewropatija *
Facial palsy, neuropathies (including mononeuropathies)
Puplesija fil- wiċċ, newropatiji (li jinkludu mononewropatiji)
Blurred vision, conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder
Vista mċajpra, konġuntivite, uġigħ fl- għajnejn, vista abnormali, disturb ital- glandola lakrimali
Retinal haemorrhages*, retinopathies (including macular oedema)*, retinal artery obstruction*, retinal vein obstruction*, optic neuritis*, papilloedema*, loss of visual acuity or visual field*, cotton wool spots*
Emorraġiji retinali *, retinopatiji (li jinkludu edema makulari) *, impediment tal- arterja retinali *, impediment tal - vina retinali *, newrite ottika *, papilloedema *, tnaqis fl - akuwita viżwali jew fil- kamp viżwali *, dbabar tat- tajjar *
Common:
Disturbi fil- widnejn u fis- sistema labirintika Komuni:
Vertigo, hearing impairment/ loss, tinnitus, earache
Vertiġini, impediment/ telf tas- smiegħ, tinnite, uġigħ fil- widnejn
Palpitation, tachycardia Cardiomyopathy*, arrhythmia* Myocardial infarction*, cardiac ischaemia*
Palpitazzjoni, takikardja Kardjomijopatija *, arrithmija * Infart mijokardjali *, iskemija kardijaka *
Vascular disorders Common:
Disturbi vaskulari
Respiratory, thoracic and mediastinal disorders
Pressjoni baxxa, pressjoni għolja, sinkope, fwawar Iskemija periferali *
Very common:
Dispnea, sogħla
Dyspnoea, coughing Sinusitis, bronchitis, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough
Sinusite, bronkite, epistassi, rinite, disturbi respiratorji, konġestjoni nażali, rinorrea, sogħla mhix produttiva
Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis*
Infiltrati pulmonari *, pnewmonite *, pnewmonite interstizzjali *
Gastro-intestinal disorders
Disturbi gastrointestinali Komuni ħafna:
Diarrhoea, vomiting, nausea, abdominal pain Ulcerative stomatitis, stomatitis, colitis, upper right quadrant pain, dyspepsia, gastroesophogeal reflux*, glossitis, gingival bleeding, gingivitis, loose stools, constipation, flatulence
Dijarea, remettar, tqalligħ, uġigħ addominali Stomatite ulċerattiva, stomatite, kolite, uġigħ fil- kwadrant lemini ta ’ fuq, dispepsja, rifluss gastroesofogeali *, glossite, ħanek bid- demm, ġinġivite, ippurgar maħlul, stitikezza, gass
12 Very rare:
Rari ħafna:
Ischaemic colitus*, ulcerative colitus* Periodontal disorder, dental disorder
Pankreatite * Kolitus iskemiku *, kolite ulċerattiva * Disturbi periodontali, disturbi dentali
Hepatomegaly, jaundice, hyperbilirubinemia* Hepatotoxicity (including fatalities)*
Epatomegalija, suffejra, iperbilirubinemija * Epatotossiċita (li jinkludi mewt) *
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessut ta ’ taħt il- ġilda
Common:
Komuni ħafna Komuni:
Alopecia, pruritus, skin dry, rash Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, dermatitis, acne, furunculosis*, erythema, skin disorder, bruise, sweating increased, abnormal hair texture, nail disorder*
Alopeċja, ħakk, ġilda xotta, raxx Psorjasi, psorjasi aggravat, ekżema, reazzjoni ta ’ fotosensittività, raxx makulopapulari, raxx eritematsi, dermatite, akne, furunkulosi *, eritema, disturb ital- ġilda, tbenġil, żieda fl- għaraq, tessut tax- xagħar mhux normali, disturbi fid- dwiefer *
Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme*
Sindromu ta ’ Stevens Johnson *, nekrolisi epidermali tossika *, eritema multiforme *
Musculoskeletal and connective tissue disorders Very common:
Disturbi muskoluskeletriċi u tat- tessut konnettiv Komuni ħafna:
Arthralgia, myalgia, musculoskeletal pain Arthritis Rhabdomyolysis*, myositis*
Artralġja, uġigħ fil- muskoli, uġigħ muskoluskeletriku Artrite Rabdomijolisi *, mijositi *
Common:
Disturbi fil- kliewi u fis- sistema awrinarja Komuni:
Micturition frequency, polyuria Renal failure*, renal insufficiency* Nephrotic syndrome*
Frekwenza biex tgħaddi l- awrina, poliurja Indebiliment renali *, insuffiċjenza tal- kliewi * Sindromu nefrotiku *
Reproductive system and breast disorders Common:
Disturbi fis- sistema riproduttiva u tas- sider Komuni:
Female: amenorrhea, menorrhagia, menstrual disorder, dysmenorrhea, breast pain, ovarian disorder, vaginal disorder.
Nisa: amenorrea, menorragja, disturbi menstruwali, dismenorrea, uġigħ fis- sider, disturb ovarjan, disturb vaġinali.
Male: impotence, prostatitis Sexual dysfunction (not specified)*
Rġiel: impotenza, prostatite Nuqqas ta ’ funzjoni sesswali (mhux speċifikata) *
Very common:
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Komuni ħafna:
Injection site inflammation, injection site reaction, fatigue, rigors, fever, flu-like symptoms, asthenia, irritability
Infjammazzjoni tas- sit mnejn tingħata l- injezzjoni, reazzjoni fis- sit tal- injezzjoni, għeja, tregħid, deni, sintomi bħal tal - influwenza, astenja, irritabilità
Chest pain, peripheral oedema, malaise, injection site pain, face oedema*
Uġigħ fis- sider, edema periferali, tħossok mitluq, uġigħ fis - sit tal- injezzjoni, edema fil- wiċċ *
Injection site necrosis
Nekrosi fis- sit tal- injezzjoni
Weight decrease Cardiac murmur, urine abnormal
Tnaqqis fil- piż Qalb tgedwed, awrina mhix normali
* Since ribavirin is always prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or nonpegylated).
13 esperjenza ta ’ wara t- tqegħid fis- suq ma tippermettix kwantifikazzjoni preċiża tal- frekwenzi, il- frekwenza rapportata haw fuq hi mill- provi kliniċi meta ribavirin intuża flimkien ma ’ interferon alfa- 2b (pergilat jew mhux pergilat)
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 + interferon alfa-2b.
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 + interferon alfa- 2b.
Haemoglobin levels dropped below 10 g/ dl in up to 14% of adult patients and 7% of children and adolescents treated with Ribavirin in combination with either peginterferon alfa-2b (adults only) or interferon alfa-2b.
Il- livelli ta ’ emoglobina niżlu għal inqas minn 10 g/ dl f’ 14% ta ’ pazjenti adulti u 7% fi tfal u adoloxxenti ttrattati b’ Ribavirin flimkien ma ’ jew peginterferon alfa- 2b (adulti biss) jew interferon alfa- 2b.
Most cases of anaemia, neutropaenia, and thrombocytopaenia were mild (WHO grades 1 or 2).
Il- maġġoranza tal- każijiet ta ’ anemija, newtropenija, u tromboċitopenija kienu ħfief (gradi 1 jew 2 tal- WHO).
There were some cases of more severe neutropenia in patients treated with Ribavirin in combination with 13 peginterferon alfa-2b (WHO grade 3:
Kien hemm xi każijiet ta ’ newtropenja aktar severa f’ pazjenti ttrattati b’ Ribavirin flimkien ma ’ peginterferon alfa- 2b (grad 3 tal- WHO:
13 of 186 [7%]); WHO grade 3 leukopenia was also reported in 7% of this treatment group.
13 ta ’ 186 [7%]); lewkopenja grad 3 tal- WHO kienet rapportata wkoll f’ 7% ta ’ dan il- grupp ta ’ trattament.
An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with Ribavirin used in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials, but values returned to baseline levels by four weeks after the end of therapy.
Żieda fl- aċidu uriku u fil- valuri indiretti ta ’ bilirubin assoċjati ma ’ emoliżi kienet osservata f’ xi pazjenti trattati b’ Ribavirin flimkien ma ’ peginterferon alfa- 2b jew interferon alfa- 2b fi provi kliniċi, imma l- valuri marru lura għal dawk tal- livelli bażi ta ’ riferiment wara erba ’ ġimgħat minn meta ntemmet it- terapija.
Among those patients with elevated uric acid levels, very few patients treated with the combination developed clinical gout, none of which required treatment modification or discontinuation from the clinical trials.
Fost dawk il- pazjenti b’ livelli ta ’ aċidu uriku għoli li kienu ttrattati bil - kombinazzjoni, kien hemm għadd żgħir ħafna ta ’ pazjenti li żviluppaw gotta klinika, iżda ħadd minnhom ma kellu bżonn tibdil fit- trattament jew kellu jitwaqqaf milli jipprosegwi bil- provi kliniċi.
HCV/ HIV co-infected patients:
Pazjenti infettati fl- istess ħin b’ HCV/ HIV:
For HCV/ HIV co-infected patients receiving Ribavirin in combination with peginterferon alfa-2b, other undesirable effects (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%).
Għal pazjenti infettati fl- istess ħin b’ HCV/ HIV li qed jirċievu Ribavirin f’ kombinazzjoni ma ’ peginterferon alfa- 2b, effetti mhux mixtieqa 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%), żieda fl- aċidu lattiku fid- demm (5%), epatite ċitolitika (6%), żieda fil- lipase (6%) u uġigħ fir - riġel/ driegħ (6%).
Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated-ribavirin for co-HCV infection (see section 4.4).
Tossiċità mitokondrijali u aċidożi lattika kienu rrappurtati f’ pazjenti pożittivi għall- HIV li kienu qed jirċievu kors ta ’ NRTI flimkien ma ’ ribavirin għall- infezzjoni fl- istess ħin b’ HCV (ara sezzjoni 4. 4).
Laboratory values for HCV/ HIV co-infected patients:
Valuri tal- laboratorju għal pazjenti infettati fl- istess ħin b’ HCV/ HIV:
Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/ HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Għalkemm tossiċitajiet ematoloġiċi ta ’ newtropenja, tromboċitopenija u anemija seħħew b’ mod aktar ta ’ spiss f’ pazjenti li kellhom infezzjoni b’ HCV/ HIV fl- istess ħin, il- maġġoranza setgħu jiġu ġestiti b’ tibdil fid- doża u rari kien meħtieġ li jitwaqqaf it- trattament qabel iż- żmien (ara sezzjoni 4. 4).
Haematological abnormalities were more frequently reported in patients receiving Ribavirin in combination with peginterferon alfa- 2b when compared to patients receiving Ribavirin in combination with interferon alfa-2b.
Anormalitajiet ematoloġiċi kienu rappurtati b’ mod aktar frekwenti f’ pazjenti li kienu qed jirċievu Ribavirin f’ kombinazzjoni ma ’ peginterferon alfa- 2b meta mqabbla ma ’ pazjenti li kienu qed jirċievu Ribavirin f’ kombinazzjoni ma ’ interferon alfa- 2b.
In Study 1 3 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/ mm was observed in 3 4% (8/ 194) of patients and decrease in platelets below 50,000/ mm was observed in 4% (8/ 194) of patients receiving Ribavirin in combination with peginterferon alfa-2b.
Fi Studju 1 (ara sezzjoni 5. 1), tnaqqis fl- għadd 3 assolut tan- newtrofili taħt il- 500 ċellula/ mm3 deher f’ 4% (8/ 194) tal- pazjenti u tnaqqis fl- għadd 3 tal- plejtlets għal taħt 50, 000/ mm3 deher f’ 4% (8/ 194) tal- pazjenti li kienu jiċievu Ribavirin f’ kombinazzjoni ma ’ peginterferon alfa- 2b.
Anaemia (haemoglobin < 9.4 g/ dl) was reported in 12% (23/ 194) of patients treated with Ribavirin in combination with peginterferon alfa-2b.
Anemija (emoglobina < 9. 4 g/ dl) kienet irrappurtata fi 12% (23/ 194) tal- pazjenti trattati b’ Ribavirin f’ kombinazzjoni ma ’ peginterferon alfa- 2b.
Treatment with Ribavirin in combination with peginterferon alfa-2b was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Trattament b’ Ribavirin f’ kombinazzjoni ma ’ peginterferon alfa- 2b kien assoċjat ma ’ tnaqqis fl- għadd assolut ta ’ ċelluli CD4+ fl- 4 ġimgħat mingħajr tnaqqis fil- perċentwali ċellulari ta ’ CD4+.
The use of Ribavirin in combination with peginterferon alfa-2b had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
L- użu ta ’ Ribavirin f’ kombinazzjoni ma ’ peginterferon alfa- 2b ma deherx li kellu impatt negattiv fuq il- kontroll ta ’ viraemja bl- HIV waqt it- terapija jew fiż- żmien ta ’ follow- up.