qanastek/EMEA-V3 huggingface dataset:
154 oral contraceptives ("the Pill") any medicines used to treat diseases related to the acid in the stomach (e. g. antacids, H2- blockers and proton pump inhibitors) medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm simvastatin, lovastatin, and atorvastatin (used to lower blood cholesterol) nevirapine and efavirenz (used to treat HIV) cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune system) certain antibiotics (rifabutin, clarithromycin) ketoconazole, itraconazole, and voriconazole (antifungals) warfarin (anticoagulant, used to reduce the blood clots) irinotecan (used to treat cancer) sedative agents (e. g. midazolam administered by injection) buprenorphine (used to treat opioid addiction and pain).
158 sildenafil (jintuża mill- irgiel kontra l- impotenza (anormalità erettili)) kontraċettivi orali (“ Il- Pill ”) kull mediċina użata biex tikkura mard relatat ma ’ l- aċidu fl- istonku (eż. antaċidi, imblokkaturi ta ’ H2 u inibituri proton pump) mediċini biex inaqqsu l- aċidu fl- istonku mediċini biex ibaxxu l- pressjoni, ir- rata tat- taħbit tal- qalb, jew biex jirranġaw ir- ritmu tal- qalb simvastatin, lovastatin, u atorvastatin (biex ibaxxu l- livell tal- kolesterol fid- demm) nevirapine u efavirenz (użat biex jittratta l- HIV) cyclosporine, tacrolimus, u sirolimus (mediċini biex inaqqsu l- effetti tas- sistema ta ’ l- immunità tal- ġisem) xi antibijotiċi (rifabutin, clarithromycin) ketoconazole, itraconazole, u voriconazole (antifungali) warfarin (antikoagulanti użat biex irattab id- demm) irinotecan (użat fil- kura tal- kanċer) mediċini li jikkalmaw (eż. midazolam mogħti b' injezzjoni) buprenorphine (użat biex jittratta dipendenza fuq l- opjojde u uġigħ).
No studies on the effect of effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
If you feel dizzy or lightheaded, contact your doctor immediately.
Jekk tħossok stordut jew mhux f' postok, ikkuntattja lit- tabib tiegħek minnufih.
This medicine contains a sweetening agent called aspartame.
Il- mediċina fiha sweeteneer imsejħa aspartame.
Aspartame provides a source of phenylalanine that may not be suitable for persons with phenylketonuria.
Aspartame jipprovdi sors ta 'phenylalanine u mhux tajjeb għal persuni li jbatu minn phenylketonuria.
REYATAZ oral powder contains 7.3 g sucrose per 300 mg daily dose.
REYATAZ trab orali fih 7. 3 g ta ’ sucrose fid- doża ta ’ 300 mg li tingħata fil- ġurnata.
This should be taken into account in patients with diabetes mellitus.
Din għandha tiġi kkunsidrata f’ dawk il- pazjenti li għandhom id- dijabete.
This way, you can be sure your medicine is fully effective and you reduce the risk of the virus developing resistance to the treatment.
B’ hekk il- mediċina tkunlek effettiva u jonqos ir- riskju li l- virus jiżviluppa reżistenza għall- kura.
The usual adult dose of REYATAZ is 300 mg oral powder once daily with 100 mg ritonavir once daily and with food, in combination with other anti-HIV medicines.
Id- doża ta ’ REYATAZ li ssoltu tingħata lill- adulti hija 300 mg darba kuljum ma ’ 100 mg ritonavir darba kuljum u ma ’ l- ikel, flimkien ma ’ mediċini oħra ta ’ kontra l- HIV.
300 mg REYATAZ oral powder equals to 6 level measuring spoons of powder (each spoon makes 50 mg of atazanavir).
300 mg REYATAZ trab orali huwa ekwivalenti għal 6 imgħaref tad- doża livellati tat- trab (kull mgħarfa fiha 50 mg ta ’ atazanavir).
Your doctor may adjust the dose of REYATAZ according to your anti-HIV therapy.
It- tabib tiegħek jista ’ jaġġusta d- doża ta ’ REYATAZ skond it- terapija ta ’ kontra l- HIV li qed tieħu.
There is not enough information to recommend a dose in children.
M’ hemmx biżżejjed informazzjoni dwar id- doża rrikmandata fit- tfal.
155 Take REYATAZ with food (a meal or a substantial snack).
159 Ħu REYATAZ ma ’ l- ikel (ikla jew ikla ħafifa imma sostanzjali).
Scoop an overfilled spoon of loose powder from the bottle using the measuring spoon provided (see picture below).
Neħħi ż- żejjed tat- trab mill- imgħarfa mferra 'mill- flixkun billi tuża l- imgħarfa tad- doża ipprovduta (ara l- istampa ta ’ taħt).
Then gently level the powder in the spoon by scraping the extra powder back into the bottle using a flat edge of a knife or spatula.
Ġentilment, illivella t- trab fl- imgħarfa billi titfa 'lura l- bqija tat- trab fil- flixkun billi tuża l- parti ċatta tas- sikkina jew spatula.
Do not try to pack the powder into the spoon or attempt to level the powder by shaking or tapping the spoon.
Tippruvax tippakkja t- trab fil- kuċċarina jew tipprova tillivella t- trab billi ċċaqlaq jew ittaptap il- kuċċarina.
REYATAZ oral powder should be taken at about the same time each day with a meal.
REYATAZ trab orali għandu jittieħed bejn wieħed u ieħor fl- istess ħin kuljum waqt xi ikla.
It may be mixed with water, milk, infant formula, applesauce, or yoghurt.
Jista 'jiġi mħallat bl- ilma, ħalib, ħalib tat- trabi, applesauce, jew jogurt.
Once the powder is mixed, it must be consumed within 6 hours.
Meta t- trab jitħallat, irid jiġi kkonsmat fi żmien 6 sigħat.
Do not mix the powder inside the bottles of REYATAZ.
Tħallatax it- trab ġol - fliexken ta ’ REYATAZ.
If you take more REYATAZ than you should
Jekk tieħu REYATAZ aktar milli suppost
If you accidentally take more REYATAZ oral powder than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
Jekk tieħu REYATAZ trab tal- ħalq aktar milli għandek tieħu, kellem lit- tabib tal- HIV tiegħek jew mur l- isptar għal parir.
If you have any further questions on the use of this product, ask your doctor.
Jekk għandek aktar mistoqsijiet dwar l- użu ta 'dan il- prodott, staqsi lit- tabib tiegħek.
When treating HIV infection, it is not always easy to identify what side effects are caused by REYATAZ, by the other medicines you are taking, or by the HIV infection itself.
Waqt il- kura ta ’ l- infezzjoni tal- HIV, mhux dejjem faċli tagħraf liema effetti sekondarji huma kkawżati minn REYATAZ, minn mediċini oħra li qed tieħu, jew minħabba l- infezzjoni tal- HIV nfisha.
Common: headache ocular icterus (presence of jaundice seen in the white part of the eyes) vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia (indigestion) jaundice (yellowing of the skin and/ or eyes) rash lipodistrophy syndrome (body changes due to fat redistribution, accumulation, or loss of body fat), fatigue (extreme tiredness) Uncommon:
Komuni: uġigħ ta 'ras icterus okulari (preżenza ta' suffejra li tidher fil- parti l- bajda ta 'l- għajnejn) rimettar, dijarea, uġigħ addominali (uġigħ ta' żaqq ta 'skumditа), nawseja, dispepsja (indiġestjoni) suffejra (sfurija tal- ġilda u/ jew ta' l- għajnejn) raxx
Torsades de pointes (life threatening irregular heart beat) QTc prolongation (irregular heart beat) Diabetes mellitus (body cannot remove sugar from the blood normally) Hyperglycaemia (high sugar levels in the blood) Nephrolithiasis (kidney stones) Gallbladder disorders (gallstones and gallbladder inflammation)
Torsades de pointes (taħbit irregolari tal- qalb li jista ’ jkun ta ’ periklu għall- ħajja) Titwil tal- QTc (taħbit irregolari tal- qalb) Dijabete mellitus (il- ġisem ma jkunx jista ’ jneħħi z- zokkor mid- demm b’ mod normali) Ipergliċemija (livelli għolja ta ’ zokkor fid- demm) Nefrolitijasi (ġebel fil- kliewi) Disturbi fil- marrara (ġebel fil- marrara u infjammazzjoni fil- marrara)
Do not use REYATAZ after the expiry date stated on the package and on the bottle label.
Tużax REYATAZ wara d- data ta 'skadenza li tidher fuq it- tikketta tal- pakkett jew tal- flixkun.
Do not use REYATAZ oral powder if you notice the product has turned into a dark yellow or brown powder aggregated into one clump.
Tużax REYATAZ trab orali jekk issib li l- prodott inbidel fi trab isfar skur jew kannella maqgħud f' ċappa waħda.
157 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m' għandhomx jintremew ma 'l- ilma tad- dranaġġ jew ma' l- iskart domestiku.
What REYATAZ contains
X' fih TRADENAME
The active substance in REYATAZ is atazanavir.
Is- sustanza attiva f’ REYATAZ hija atazanavir.
One measuring spoon of 1.5 g oral powder contains 50 mg of atazanavir (as sulphate).
Mgħarfa tad- doża ta '1. 5 g trab orali fiha 50 mg ta ’ atazanavir (bħala sulfat).
The other ingredients are aspartame (E951), sucrose, and orange vanilla flavour.
Sustanzi oħra huma aspartame (E951), sucrose, u togħma tal- laring u vanilla.
REYATAZ oral powder is supplied in bottles containing 180 g of powder together with a plastic measuring spoon.
REYATAZ trab tal- ħalq jiġi fi fliexken li fihom 180 g ta ’ trab flimkien ma ’ mgħarfa bil- qies tal - plastik.
The colour of the powder is off-white to pale yellow.
Il- kulur tat- trab hu minn off- white sa isfar ċar.
REYATAZ also exists in capsules.
REYATAZ jeżisti wkoll f’ kapsuli.
However, not all pack sizes may be marketed in all countries.
Madankollu, mhux il- pakketti tad- daqsijiet kollha jkunu għall - bejgħ fil- pajjiżi kollha.
This leaflet was last approved in {MM/ YYYY}
163 Dan il- fuljett kien approvat l- aħħar f '{XX/ SSSS}.
What is Ribavirin Teva?
X’ inhu Ribavirin Teva?
Ribavirin Teva is a medicine containing the active substance ribavirin.
Ribavirin Teva huwa mediċina li fiha s- sustanza attiva ribavirin.
It is available as white capsules (200 mg).
Huwa disponibbli bħala kapsuli bojod (200 mg).
Ribavirin Teva is a ‘ generic medicine’.
Ribavirin Teva huwa ‘ mediċina ġenerika ’.
This means that it is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called Rebetol.
Dan ifisser li jixbah lill - ‘ mediċina ta ’ referenza ’ diġà awtorizzata fl- Unjoni Ewropea (UE) magħrufa bħala Rebetol.
For more information on generic medicines, see the question-and-answer document here.
Għall- aktar informazzjoni dwar il - mediċini ġeneriċi, ara d- dokument mistoqsija- u- tweġiba hawn.
What is Ribavirin Teva used for?
Għal xiex tintuża Ribavirin Teva?
Ribavirin Teva is used to treat adults and children aged three years and older who have chronic (long- term) hepatitis C (a disease of the liver due to an infection with the hepatitis C virus).
Ribavirin Teva jintuża biex jittratta adulti u tfal minn 3 snin ’ il fuq li jbatu minn epatite Ċ kronika (fuq tul ta ’ żmien) (marda tal- fwied ikkaġunata mill- virus tal- epatite Ċ).
Ribavirin Teva must never be used on its own but only together with an interferon (another type of medicine used in hepatitis).
Ribavirin Teva ma għandu qatt jintuża waħdu iżda flimkien ma ’ interferon (tip ieħor ta ’ mediċina użata fl- epatite).
In adults, Ribavirin Teva can be used in ‘ naïve’ patients (who have not been treated before) or in patients in whom previous treatment including any type of interferon alfa, with or without ribavirin, did not work.
Fl- adulti, Ribavirin Teva jista ’ jintuża f’ pazjenti ‘ safja ’ (li qatt ma ġew ikkurati qabel) jew f’ pazjenti li l- kura li ħadu fil- passat ma ħadmitx fosthom kull tip ta ’ interferon alfa, bi jew mingħajr ribavirin.
Ribavirin Teva is used either in combination with interferon alfa-2b or peginterferon alfa-2b (including for adults also infected with human immunodeficiency virus [HIV]).
Ribavirin Teva jintuża jew flimkien ma ’ interferon alfa- 2b jew peginterferon alfa- 2b (inkluż għall - adulti infettati wkoll bil- virus uman tal- immunodefiċjenza [HIV]).
In children and adolescents, Ribavirin Teva can only be used in naïve patients without HIV infection and only in combination with interferon alfa-2b.
Fit- tfal u ż- żgħażagħ, Ribavirin Teva jista ’ jintuża biss minn pazjenti safja mingħajr l- infezzjoni tal- HIV u flimkien ma ’ interferon alfa- 2b biss.
How is Ribavirin Teva used?
Kif tintuża Ribavirin Teva?
Treatment with Ribavirin Teva should be started and monitored by a doctor who has experience in the management of chronic hepatitis C.
Il- kura b’ Ribavirin Teva trid tinbeda u tiġi ssorveljata minn tabib li jkollu esperjenza fil- ġestjoni tal - epatite kronika Ċ.
The dose of Ribavirin Teva is based on the patient’ s body weight, and ranges from three to seven capsules a day.
Id- doża ta ’ Ribavirin Teva tiġi kkalkulata skont il- piż tal- pazjent u tvarja minn tlieta sa seba ’ pilloli kuljum.
It can only be taken by patients weighing at least 47 kg.
Jista ’ jittieħed biss minn pazjenti li jkunu jiżnu ’ l fuq minn 47 kg.
Ribavirin Teva is taken with food each day in two divided doses (morning and evening).
Ribavirin Teva jittieħed darbtejn kuljum mal- ikel (filgħodu u filgħaxija).
The duration of treatment depends on the patient’ s condition and response to treatment, and ranges from 24 weeks to a year.
It- tul ta ’ żmien tat- trattament jiddependi fuq il- kondizzjoni tal- pazjent u r- reazzjoni għat- trattament, u jvarja minn 24 ġimgħa sa sena.
How does Ribavirin Teva work?
Kif jaħdem Ribavirin Teva?
The active substance in Ribavirin Teva, ribavirin, is an antiviral belonging to the class ‘ nucleoside analogues’.
Is- sustanza attiva f’ Ribavirin Teva, ribavirin, hija antivirali li tappartjeni għall- klassi ‘ nucleoside analogues ’.
RNA, which are needed for viruses to survive and multiply.
Reproduction is authorised provided the source is acknowledged. virali li huma meħtieġa biex il- virusis jissopravivu u jimmultiplikaw.
Ribavirin Teva on its own has no effect on eliminating the hepatitis C virus from the body.
Ribavirin Teva waħdu ma għandu l- ebda effett li jelimina l- virus tal- epatite Ċ mill- ġisem.
How has Ribavirin Teva been studied?
Kif ġie studjat Ribavirin Teva?
Because Ribavirin Teva is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (i. e. that the two medicines produce the same levels of the active substance in the body).
Minħabba li Ribavirin Teva huwa mediċina ġenerika, l- istudji ġew limitati għal testijiet biex jintwera li hija bijoekwivalenti għall- mediċina ta ’ referenza (jiġifieri li ż- żewġ mediċini jipproduċu l- istess livelli ta ’ sustanza attiva fil- ġisem).
What are the benefit and risk of Ribavirin Teva?
X’ inhu l- benefiċċju u r- riskju ta ’ Ribavirin Teva?
Because Ribavirin Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Minħabba li Ribavirin Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall- mediċini ta ’ referenza, il- benefiċċju u r- riskju tiegħu huma meqjusa li huma l- istess bħal dawk tal- mediċina ta ’ referenza.
Why has Ribavirin Teva been approved?
Għaliex ġie approvat Ribavirin Teva?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ribavirin Teva has been shown to have comparable quality and to be bioequivalent to Rebetol.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li, b’ mod konformi mal- ħtiġijiet tal- UE, Ribavirin Teva wera li għandu kwalità komparabbli ma ’ u huwa bijoekwivlenti għal Rebetol.
Therefore, the CHMP’ s view was that, as for Rebetol, the benefit outweighs the identified risk.
Għaldaqstant, il- fehma tas- CHMP kienet li, bħal f’ Rebetol, il- benefiċċji jegħlbu r- riskji identifikati.
The Committee recommended that Ribavirin Teva be given marketing authorisation.
Il- Kumitat irrakkomanda li Ribavirin Teva jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Ribavirin Teva:
Tagħrif ieħor dwar Ribavirin Teva:
The European Commission granted a marketing authorisation valid throughout the EU for Ribavirin Teva to Teva Pharma B. V. on 31 March 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Ribavirin Teva lil Teva Pharma B. V. fil- 31 ta ’ Marzu 2009.
The full EPAR for Ribavirin Teva can be found here.
L- EPAR sħiħ għal Ribavirin Teva jista ’ jinstab hawnhekk.
EMEA Number EU/ 1/ 09/ 509/ 001 EU/ 1/ 09/ 509/ 002 EU/ 1/ 09/ 509/ 003 EU/ 1/ 09/ 509/ 004
Numru ta ’ l- EU EU/ 1/ 09/ 509/ 001 EU/ 1/ 09/ 509/ 002 EU/ 1/ 09/ 509/ 003 EU/ 1/ 09/ 509/ 004
Name Ribavirin Teva Ribavirin Teva Ribavirin Teva Ribavirin Teva
Isem Ribavirin Teva Ribavirin Teva Ribavirin Teva Ribavirin Teva
Strength 200 mg 200 mg 200 mg 200 mg
Qawwa 200 mg 200 mg 200 mg 200 mg
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Għamla Farmaċewtika Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa Kapsula, iebsa
Route of Administration Oral use Oral use Oral use Oral use
Mnejn jingħata Jittieħed mill- ħalq Jittieħed mill- ħalq Jittieħed mill- ħalq Jittieħed mill- ħalq
Packaging blister (PVC/ PE/ PVdC) blister (PVC/ PE/ PVdC) blister (PVC/ PE/ PVdC) blister (PVC/ PE/ PVdC)
Il- pakkett folja (PVC/ PE/ PVdC) folja (PVC/ PE/ PVdC) folja (PVC/ PE/ PVdC) folja (PVC/ PE/ PVdC)
Package size 84 capsules 112 capsules 140 capsules 168 capsules
Daqs tal- pakkett 84 kapsula 112- il kapsula 140 kapsula 168 kapsula
Ribavirin Teva 200 mg hard capsules
Ribavirin Teva 200 mg kapsuli iebsin
Each Ribavirin Teva capsule contains 200 mg of ribavirin For a full list of excipients, see section 6.1.
Kull kapsula ta ’ Ribavirin Teva fiha 200 mg ta ’ ribavirin Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
White, opaque and imprinted with blue ink.
Bajda, opaka u intaljata b’ linka blu.
Ribavirin Teva is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa-2b (adults) or interferon alfa-2b (adults, children (3-years of age or older), and adolescents).
Ribavirin Teva huwa indikat għal trattament tal- epatite Ċ kronika u għandu jkun użat biss bħala parti minn programm ta ’ terapija li jingħata flimkien ma ’ peginterferon alfa- 2b (adulti) jew interferon alfa - 2b (adulti, tfal (3 snin jew aktar), u adoloxxenti).
Ribavirin monotherapy must not be used.
Monoterapija b’ Ribavirin m’ għandhiex tintuża.
There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i. e., not alfa-2b), or on the use of Ribavirin with peginterferon alfa-2b in children or adolescents.
M’ hemmx informazzjoni dwar is- sigurtà jew l- effikaċja meta jintuża Ribavirin ma ’ xorta oħra ta ’ interferon (i. e. mhux alfa- 2b), jew meta Ribavirin jintuża ma ’ peginterferon alfa- 2b fi tfal jew l- adoloxxenti.
Please refer also to the peginterferon alfa-2b or interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.
Jekk jogħġbok irreferi wkoll għas- Sommarju tal- Karatteristiċi tal- Prodott (SPC) ta ’ peginterferon alfa - 2b jew interferon alfa- 2b għall- informazzjoni dwar kif ikun preskritt dak il- prodott partikulari.
Naïve patients Adult patients:
Pazjenti inkonsapevoli Pazjenti adulti:
Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA (see section 4.4).
Ribavirin Teva huwa indikat għall- użu, flimkien ma ’ interferon alfa- 2b, għal trattament f’ pazjenti adulti b’ epatite Ċ kronika, li ma kienux ikkurati qabel, mingħajr fwied mhux kompensat, b’ alanine aminotransferase (ALT) għoli, li huma pożittivi għal HCV- RNA fis- serum (ara sezzjoni 4. 4).
Additionally, Ribavirin Teva is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA, including patients with clinically stable HIV co-infection (see section 4.4).
Minbarra hekk, huwa indikat ukoll, f’ kombinazzjoni ma ’ peginterferon alfa- 2b, għal trattament f ’ pazjenti adulti b’ epatite Ċ kronika, li ma kienux ikkurati qabel, mingħajr fwied mhux kompensat, b’ alanine aminotransferase (ALT) għoli li huma pożittivi għal HCV- RNA fis- serum li jinkludu pazjenti b’ ko- infezzjoni ta ’ HIV klinikament stabbli (ara sezzjoni 4. 4).
Ribavirin Teva is intended for use, in a combination regimen with interferon alfa2b, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Ribavirin Teva huwa indikat għall- użu, fi programm ta ’ terapija kkombinat ma ’ interferon alfa2b, għal trattament fi tfal u adoloxxenti minn 3 snin ’ il fuq, li għandhom epatite Ċ kronika, li ma kienux ikkurati qabel, mingħajr fwied mhux kompensat, u li huma pożittivi għal HCV- RNA fis- serum.
The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load.
Id- deċiżjoni jekk għandux jingħata t- trattament għandha tittieħed fuq bażi individwali skont il- każ, billi jitqies kull sinjal ta ’ firxa tal- marda bħal infjammazzjoni epatika u fibrożi, kif ukoll fatturi oħra ta ’ pronjożi għar- rispons, il- ġenotip tal- HCV u l- viral- load.
The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).
Is- siwi mistenni ta ’ trattament għandu jiġi mwieżen mar- riżultati dwar is- sigurtà osservati fil- pazjenti li jkunu jidhru f’ individwi pedjatriċi fil- provi kliniċi (ara sezzjonijiet 4. 4, 4. 8 u 5. 1).
Previous treatment failure patients Adult patients:
Pazjenti li jkunu fallew it- trattament li ngħataw qabel Pazjenti adulti:
Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.
Ribavirin Teva hu indikat għall- użu biex jingħata flimkien ma ’ interferon alfa- 2b, għat- trattament ta ’ pazjenti adulti b’ epatite Ċ kronika li qabel kienu wrew rispons (bin - normalizzazzjoni ta ’ ALT fi tmiem il- kura) għal monoterapija ta ’ interferon alfa, iżda li wara rkadew.
Additionally, Ribavirin Teva is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have failed previous treatment with interferon alpha
Minbarra hekk, Ribavirin Teva hu indikat, f’ kombinazzjoni ma ’ peginterferon alfa- 2b, għal trattament f’ pazjenti adulti b’ epatite Ċ kronika li fuqhom it- trattament b’ interferon alfa (pegilata jew mhux
2 (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).
2 pegilata) u ribavirin f’ terapija kombinata jew b’ monoterapija b’ interferon alfa ma rnexxitx (ara sezzjoni 5. 1).
Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C.
It- terapija għandha tinbeda, u tkun monitorata, minn tabib li għandu esperjenza fil- ġestjoni tal- epatite Ċ kronika.
Dose to be administered The dose of Ribavirin Teva is based on patient body weight (Table 1).
Doża li trid tingħata Id- doża ta ’ Ribavirin Teva hi bażata fuq il- piż tal- ġisem tal- pazjent (Tabella 1).
Ribavirin capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Il- kapsuli Ribavirin għandhom jittieħdu mill- ħalq kuljum f’ żewġ dożi mqassmin (filgħodu u filgħaxija) mal- ikel.
Ribavirin Teva must be used in combination with either peginterferon alfa-2b (1.5 micrograms/ kg/ week) or interferon alfa-2b (3 million international units [MIU] three times a week).
Ribavirin Teva għandu jittieħed flimkien jew ma ’ peginterferon alfa- 2b (1. 5 mikrogrammi/ kg/ ġimgħa) jew interferon alfa- 2b (3 miljun unità internazzjonali [MIU] tliet darbiet kuljum fil- ġimgħa).
The choice of combination regimen is based on the characteristics of the patient.
L- għażla ta ’ programm ta ’ terapija kombinata hija bbażata fuq il- karatteristiċi tal- pazjent.
The regimen administered should be selected based on the anticipated efficacy and safety of the combination treatment for an individual patient (see section 5.1).
Il- programm ta ’ terapija amministrata għandu jiġi magħżul skont l- effikaċja u s- sigurtà mistennija mill- kura mħallta għal pazjent individwali (ara sezzjoni 5. 1).
Table 1
Piż tal- pazjent (kg)
Ribavirin dose based on body weight
Doża ta ’ kuljum ta ’ Ribavirin
Patient
Numru ta ’ kapsuli ta ’ 200 mg 4a
1,000 mg
1, 200 mg
86 – 105 > 105 2 morning, 2 evening 2 morning, 3 evening 3 morning, 3 evening 3 morning, 4 evening
2 filgħodu, 2 filgħaxija 2 filgħodu, 3 filgħaxija 3 filgħodu, 3 filgħaxija 3 filgħodu, 4 filgħaxija
Ribavirin Teva Capsules in combination with pegylated interferon alfa-2b:
Kapsuli ta ’ Ribavirin Teva f’ kombinazzjoni ta ’ interferon alfa- 2b pergilat:
Duration of treatment – Naïve patients Predictability of sustained virological response:
Żmien kemm iddum it- trattament – Pazjenti inkonsapevoli Tbassir tar- rispons viroloġiku sostnut:
Patients infected with virus genotype 1 who fail to achieve virological response at Week 12 are highly unlikely to become sustained virological responders (see also section 5.1).
Pazjenti infettati b’ virus ta ’ ġenotip 1 li ma jkollux rispons viroloġiku sostnut f’ Ġimgħa 12 x’ aktarx ma jiksbux rispons viroloġiku sostnut (ara wkoll sezzjoni 5. 1).
• Genotype 1:
Ġenotip 1:
For patients who exhibit virological response at week 12, treatment should be continued for another nine month period (i. e., a total of 48 weeks).
Għal pazjenti li juru rispons viroloġiku ma ’ Ġimgħa 12, it- trattament għandu • jitkompla għal perijodu ta ’ disa ’ xhur oħra (i. e., total ta ’ 48 ġimgħa).
In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i. e. overall 48 weeks treatment duration).
Fis- sottosett ta ’ pazjenti b’ ġenotip 1, infezzjoni u viral load baxxa (< 600, 000 IU/ ml) li jsiru negattivi għal HCV- RNA fil - ġimgħa 4 ta ’ trattament u jibqgħu negattivi sa ġimgħa 24, it- trattament jista ’ jitwaqqaf wara dan il- kors ta ’ 24 ġimgħa jew jibqa ’ għaddej għal 24 ġimgħa oħra (i. e. b’ kollox 48 ġimgħa ta ’ trattament).
However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1). • Genotypes 2 or 3:
Madankollu, meta t- trattament jingħata għal 24 ġimgħa jista ’ jkun hemm riskju ogħla li l- pazjenti jirkadi milli meta jingħata t- trattament għal 48 ġimgħa (ara sezzjoni 5. 1).
It is recommended that all patients be treated for 24 weeks, except for HCV/ HIV co-infected patients who should receive 48 weeks of treatment. • Genotype 4:
Hu rakkomandat li l- pazjenti kollha jiġu trattati għal 24 ġimgħa, ħlief pazjenti • li jkollhom infezzjoni fl- istess ħin b’ HCV/ HIV li għandhom jieħdu t- trattament għal 48 ġimgħa. • Ġenotip 4:
In general, patients infected with genotype 4 are considered harder to treat and limited study data (n=66) indicate they are compatible with a duration of treatment as for genotype 1.
B’ mod ġenerali, pazjenti infettati b’ ġenotip 4 huma meqjusa bħala aktar diffiċli biex tittratta u riżultat ta ’ studju ristrett (n=66) jindika li jkun jixraq li t- trattament iddum sejjer bħal dawk ta ’ ġenotip 1.
HCV/ HIV Co-infection The recommended duration of dosing for HCV/ HIV co-infected patients is 48 weeks, regardless of genotype.
Id- doża għal perijodu taż- żmien rakkomandat għal pazjenti infettati fl- istess ħin b’ HCV/ HIV hi ta ’ 48 ġimgħa, ikun x’ ikun il- ġenotip.
The negative predictive value for sustained response in HCV/ HIV co-infected patients treated with Ribavirin in combination with
Tbassir għar- rispons u n- nuqqas ta ’ rispons b’ infezzjoni fl- istess ħin b ’ HCV/ HIV Rispons viroloġiku bikri ma ’ Ġimgħa 12, imfisser bħala 2 log viral load jew livelli li ma jitkejlux ta ’ HCV- RNA, deher li seta ’ jservi għat- tbassir ta ’ rispons assolut.
3 peginterferon alfa-2b was 99% (67/ 68; Study 1) (see section 5.1).
Il- valur ta ’ tbassir negattiv għal rispons sostnut f’ pazjenti infettati fl- istess ħin b’ HCV/ HIV ittrattati b’ Ribavirin flimkien ma ’ peginterferon alfa- 2b kien ta ’ 99% (67/ 68; Studju 1) (ara sezzjoni 5. 1).
A positive predictive value of 50% (52/ 104; Study 1) was observed for HCV/ HIV co-infected patients receiving combination therapy.
Valur ta ’ tbassir pożittiv ta ’ 3 50% (52/ 104; Studju 1) deher għal pazjenti infettati fl- istess ħin b’ HCV/ HIV li kienu qed jirċievu terapija kombinata.
Duration of treatment - Retreatment Predictability of sustained virological response:
Kemm għandu jdum it- trattament - Trattament mill- ġdid It- tbassir għar- rispons viroloġiku sostnut:
All patients, irrespective of genotype, who have demonstrated serum HCV-RNA below the limits of detection at Week 12 should receive 48 weeks of therapy.
Il- pazjenti kollha, irrispettivament mill- ġenotip, li wrew HCV- RNA fis- serum taħt il- limiti li jistgħu jitkejjlu ta ’ Ġimgħa 12 għandhom jieħdu t- trattament għal 48 ġimgħa.
Retreated patients who fail to achieve virological response at Week 12 are unlikely to become sustained virological responders after 48 weeks of therapy (see also section 5.1).
Pazjenti trattati mill- ġdid li ma jirnexxilhomx jiksbu rispons viroloġiku mat- 12- il ġimgħa x’ aktarx li ma jiksbux rispons viroloġiku sostnut wara 48 ġimgħa ta ’ terapija (ara wkoll sezzjoni 5. 1).
Ribavirin Capsules in combination with interferon alfa-2b:
Kapsuli Ribavirin flimkien ma ’ interferon alfa- 2b:
Duration of treatment:
Kemm għandu jdum it- trattament:
Based on the results of clinical trials, it is recommended that patients be treated for at least six months.
Fuq bażi tar- riżultati mill- provi kliniċi, huwa rakkomandat li l- pazjenti jkunu trattati għal mill- anqas sitt xhur.
During those clinical trials in which patients were treated for one year, patients who failed to show a virological response after six months of treatment (HCV-RNA below lower limit of detection) were unlikely to become sustained virological responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
Waqt dawk il- provi kliniċi meta pazjenti kienu trattati għal mill- anqas sena, pazjenti li ma wrewx rispons viroloġiku wara sitt xhur ta ’ trattament (HCV- RNA taħt il- limitu ta ’ taħt li jista ’ jitkejjel) kellhom anqas probabilità li jiksbu rispons viroloġiku sostnut (HCV- RNA taħt il- limitu ta ’ taħt li jista ’ jitkejjel sitt xhur wara li twaqqaf it - trattament).
• Genotype 1:
• Ġenotip 1:
Treatment should be continued for another six month period (i. e., a total of one year) in patients who exhibit negative HCV-RNA after six months of treatment. • Genotypes Non-1:
It- trattament għandu jitkompla għal perijodu ieħor ta ’ sitt xhur (i. e., total ta ’ sena) f’ pazjenti li jkollhom HCV- RNA negattiv wara sitt xhur ta ’ trattament. • Ġenotipi Mhux 1:
The decision to extend therapy to one year in patients with negative HCV- RNA after six months of treatment should be based on other prognostic factors (e. g., age > 40 years, male gender, bridging fibrosis).
Id- deċiżjoni sabiex it- trattament jiġi estiż għal sena f’ pazjenti b’ HCV- RNA negattiv wara sitt xhur ta ’ trattament għandha tkun ibbażata fuq parametri pronjostiċi oħra (eż., età > 40 sena, ġens maskili, fibrożi li tgħaqqad).
Children aged three years and older, and adolescents:
Tfal ta ’ tliet snin u akbar, u adoloxxenti:
(for patients who weigh < 47 kg, or are unable to swallow capsules, please refer to the SPC for ribavirin 40 mg/ ml oral solution).
(għal pazjenti li jiżnu < 47 kg, jew li ma jistgħux jibilgħu kapsuli, jekk jogħġbok irreferi għal SPC ta ’ 40 mg/ ml soluzzjoni orali ta ’ ribavirin).
In clinical studies performed in this population ribavirin and interferon alfa-2b were used in doses of 2 15 mg/ kg/ day and 3 MIU/ m three times a week respectively (Table 2).
Fi studji kliniċi li saru f’ din il- popolazzjoni ribavirin u interferon alfa- 2b intużaw f’ dożi ta ’ 2 15 mg/ kg/ jum u 3 MIU/ m tliet darbiet fil- ġimgħa rispettivament (Tabella 2).
Ribavirin Teva capsules are to be administered orally each day in two divided doses with food (morning and evening).
Il- kapsuli ta ’ Ribavirin Teva huma amministrati mill- ħalq kuljum maqsumin f’ żewġ dożi mal- ikel (filgħodu u filgħaxija).
Table 2
Tabella 2 Doża pedjatrika ta ’ Ribavirin bażata fuq il- piż tal- ġisem
Ribavirin paediatric dose based on body weight
Numru ta ’ kapsuli ta ’ 200 mg 3 kapsulia
Number of 200 mg capsules 3 capsulesa 4 capsulesb
4 kapsulib
Refer to adult dosing table (Table 1)
Irreferi għat- tabella ta ’ dożaġġi tal- adulti (Tabella 1)
1 morning, 2 evening b:
1 filgħodu, 2 filgħaxija b:
2 morning, 2 evening
2 filgħodu, 2 filgħaxija
Duration of treatment in children and adolescents Genotype 1:
Kemm għandu jdum it- trattament fi tfal u l- adoloxxenti Ġenotip 1:
The recommended duration of treatment is 1 year.
Hu rakkomandat li l- kura għandha ddum għaddejja sena sħiħa.
Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%).
Pazjenti li ma jkollhomx rispons viroloġiku mat- 12- il ġimgħa għandhom ferm anqas probabilità li jiksbu rispons viroloġiku sostnut (valur negattiv imbassar 96%).
Virological response is defined as absence of detectable HCV-RNA at Week 12 of treatment.
Ir- rispons viroloġiku huwa mfisser bħala każ fejn HCV- RNA ma jkunx jista ’ jitkejjel mat- 12- il ġimgħa ta ’ trattament.
Treatment should be discontinued in these patients.
It- trattament għandu jitwaqqaf f’ dawn il- pazjenti.
Genotype 2 or 3:
Genotip 2 jew 3:
The recommended duration of treatment is 24 weeks.
Hu rakkomandat li l- kura għandha ddum 24 ġimgħa.
Virological responses after 1 year of treatment and 6 months of follow-up were 36% for genotype 1 and 81% for genotype 2/ 3/ 4.
Ir- risponsi viroloġiċi wara sena ta ’ trattament u 6 xhur follow- up kienu 36% għal ġenotip 1 u 81% għal ġenotip 2/ 3/ 4.
Dose modification for all patients If severe adverse reactions or laboratory abnormalities develop during therapy with Ribavirin and peginterferon alfa-2b or interferon alfa-2b, modify the dosages of each product if appropriate, until the adverse reactions abate.
Tibdil fid- doża għal pazjenti kollha Jekk ikun hemm reazzjonijiet avversi severi jew abnormalitajiet fir- riżultati tal- laboratorju waqt it- terapija b’ Ribavirin u peginterferon alfa- 2b jew interferon alfa- 2b, ibdel dawn id- dożaġġi ta ’ kull prodott jekk ikun xieraq, sakemm ir- reazzjonijiet avversi jbattu.
Guidelines were developed in clinical trials for dose modification (see Dosage modification guidelines, Table 3).
Ġew żviluppati linji gwida fi provi kliniċi għal tibdil fid- doża (ara Linji Gwida għal Tibdil fid- Doża, Tabella 3).
As adherence might be of importance for outcome of therapy, the dose should be kept as close as possible to the recommended standard dose.
Peress li jista ’ jkun importanti għar- riżultat tat- terapija kemm il- pazjent jieħu t- trattament, id- doża għandha tinżamm qrib id- doża rakkomandata standard.
The potential negative impact of ribavirin dose reduction on efficacy results could not be ruled out.
Mhux eskluż il- fatt li tnaqqis fid- doża ta ’ ribavirin
4 Table 3
4 jista ’ jkollu impatt negattiv fuq ir- riżultati tal- effikaċja.
Dosage modification guidelines
Tabella 3 Linji gwida għal modifikazzjonijiet fid- dożaġġ Valuri
Laboratory Values
Naqqas id- doża ta ’ Naqqas id- doża ta ’
Reduce only Ribavirin Reduce only
Waqqaf it- terapija
Discontinue
tal- Laboratorju
daily dose adult to
kuljum ta ’ Ribavirin
combination therapy
mħallta jekk:
600 mg/ day*, paediatric to 7.5 mg/ kg, if:
għal 600 mg/ jum *, dik
(adult) or interferon alfa- 2b dose (adult and paediatric) to one-half dose, if:
(adulti) jew interferon
if:
mg/ kg, jekk:
Haemoglobin in: patients with history of stable cardiac disease Paediatric: not applicable (see section 4.4)
Tnaqqis f’ emoglobina ta ’ ≥ 2 g/ dl waqt
≥ 2 g/ dl decrease in haemoglobin during any 4 week period during treatment (permanent dose reduction)
f’ pazjenti li għandhom mard tal- qalb stabbli Pedjatriċi: mhux applikabbli (ara sezzjoni 4. 4)
< 12 g/ dl after 4 weeks of dose reduction
kwalunkwe perijodu ta ’ 4 ġimgħat waqt it - trattament (tnaqqis permanenti fid- doża)
White blood cells Neutrophils
ġimgħat ta ’ tnaqqis did- doża
80 x 109/ l
Pedjatriċi < 80 x 109/ l
Paediatric < 50 x 109/ l
Pedjatriċi < 50 x 109/ l 2. 5 x ULN **
Bilirubin – Direct
Bilirubin – Dirett
Bilirubin – Indirect
Bilirubin – Indirett
Paediatric > 5 mg/ dl (for > 4 weeks) Creatinine
Pedjatriċi > 5 mg/ dl (għal > 4 ġimgħat) Kreatinina
> 2.0 mg/ dl
> 2. 0 mg/ dl
Alanine aminotransferase/ aspartate aminotransferase (ALT/ AST)
Alanine
2 x baseline and > 10 x ULN**
2 x linja bażi ta ’
* Administered in two divided doses, in the morning and in the evening. ** Upper limit of normal
aminotransferase / aspartate aminotransferase (ALT/ AST) * Mogħtija billi d- doża tinqasam fi tnejn, filgħodu u filgħaxija ** Il- limitu ta ’ fuq tan- normal
Special populations
riferiment u > 10 x ULN **
Use in renal impairment:
L- użu f’ pazjenti b’ indeboliment tal- kliewi:
The pharmacokinetics of ribavirin are altered in patients with renal dysfunction due to reduction of apparent clearance in these patients (see section 5.2).
Il- farmakokinetika ta ’ ribavirin tinbidel f’ pazjenti li għandhom il- kliewi ma jaħdimx sew minħabba li jidher tnaqqis fit- tneħħija f’ dawn il- pazjenti (ara sezzjoni 5. 2).
Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of Ribavirin.
Għalhekk, huwa rakkomandat li l- funzjoni tal- kliewi tkun valutata fil- pazjenti kollha qabel ma jinbeda Ribavirin.
Patients with creatinine clearance < 50 ml/ minute must not be treated with Ribavirin (see section 4.3).
Pazjenti li għandhom rata ta ’ tneħħija ta ’ kreatinina ta ’ < 50 ml/ minuta m’ għandhomx jiġu trattati b’ Ribavirin (ara sezzjoni 4. 3).
Subjects with impaired renal function should be more carefully monitored with respect to the development of anaemia.
Individwi li għandhom funzjoni indebolita tal- kliewi għandhom jiġu monitorati b’ attenzjoni fir- rigward tal- iżvilupp ta ’ anemija.
If serum creatinine rises to > 2 mg/ dl (Table 3), Ribavirin and peginterferon alfa- 2b/ interferon alfa-2b must be discontinued.
Jekk il - kreatinina fis- serum togħla għal > 2 mg/ dl (Tabella 3), Ribavirin u peginterferon alfa- 2b/ interferon alfa- 2b għandhom jitwaqqfu.
Use in hepatic impairment:
L- użu f’ pazjenti b’ indeboliment tal- fwied:
No pharmacokinetic interaction appears between ribavirin and hepatic function (see section 5.2).
Ma dehret ebda azzjoni farmakokinetika reċiproka bejn ribavirin u l- funzjoni tal- fwied (ara sezzjoni 5. 2).
Therefore, no dose adjustment of Ribavirin is required in patients with hepatic impairment.
Għalhekk, l- ebda aġġustament fid- doża ta ’ Rebetol m’ huwa meħtieġ f’ pazjenti b’ indeboliment tal- fwied.
Use in the elderly (≥ 65 years of age):
L- użu fl- anzjani (≥ 65 sena):
There does not appear to be a significant age-related effect on the pharmacokinetics of ribavirin.
Ma jidhirx li hemm xi effett sinifikanti konness mal- età fuq il- farmakokinetiċi ta ’ ribavirin.
However, as in younger patients, renal function must be determined prior to administration of Ribavirin (see section 5.2).
Madankollu, bħal f’ pazjenti iżgħar, il- funzjoni renali għandha tiġi determinata qabel ma Ribavirin jibda jingħata (ara sezzjoni 5. 2).
Use in patients under the age of 18 years:
5 L- użu f’ pazjenti li għandhom inqas minn 18- il sena:
Ribavirin may be used in combination with interferon alfa-2b in children (3 years of age and older) and adolescents.
Ribavirin jista ’ jintuża flimkien ma ’ interferon alfa- 2b fi tfal (3 snin jew aktar) u adoloxxenti.
Safety and effectiveness of Ribavirin
L- għażla dwar liema formulazzjoni tingħata tkun ibbażżata fuq il- karatteristiċi individwali tal- pazjent (ara sezzjoni 4. 1).
5 with pegylated or other forms of interferon (i. e. not alfa-2b) in these patients have not been evaluated.
Is- sigurtà u l- effettività ta ’ Ribavirin ma ’ interferon pegilat jew għamliet oħra ta ’ interferon (i. e. mhux alfa- 2b) f’ dawn il- pazjenti ma ġewx evalwati.
Patients taking NRTI treatment in association with ribavirin and interferon alfa-2b or peginterferon alfa-2b may be at increased risk of mitochondrial toxicity, lactic acidosis and hepatic decompensation (see section 4.4).
Pazjenti li qed jieħdu trattament b ’ NRTI flimkien ma ’ ribavirin u interferon alfa- 2b jew peginterferon alfa- 2b jista ’ jkollhom riskju akbar ta ’ tossiċità mitokondrijali, aċidosi lattika u dikompensazzjoni epatika (ara sezzjoni 4. 4).
Please refer also to the relevant product information for antiretroviral medicinal products.
Jekk jogħġbok irreferi wkoll għat- tagħrif tal- prodott għal prodotti antiretrovirali mediċinali.
- Pregnant women (see sections 4.4, 4.6 and 5.3).
- Nisa waqt it- tqala (ara sezzjonijiet 4. 4, 4. 6 u 5. 3).
Ribavirin must not be initiated until a report of
Ribavirin m’ għandux jinbeda qabel ma
a negative pregnancy test has been obtained immediately prior to initiation of therapy.
jinkiseb rapport ta ’ riżultat negattiv għat- test tat- tqala eżatt qabel tinbeda t- terapija.
- A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac
- Storja ta ’ mard kardijaku sever minn qabel li jinkludi mard kardijaku instabbli jew mhux
disease, in the previous six months (see section 4.4).
kontrollat, fis- sitt xhur ta ’ qabel (ara sezzjoni 4. 4).
- Severe, debilitating medical conditions, including patients with chronic renal failure, patients
- Kundizzjonijiet mediċi severi u li jdgħajfu, li jinkludu pazjenti b’ insuffiċjenza kronika renali,
with creatinine clearance < 50 ml/ minute and/ or on haemodialysis.
pazjenti bi tneħħija tal- kreatinina ta ’ < 50 ml/ minuta u/ jew li qegħdin fuq emodijaliżi.
- Severe hepatic dysfunction or decompensated cirrhosis of the liver.
- F’ każijiet severi fejn il- fwied ma jkunx qed jaħdem tajjeb jew ċirrosi mhux ikkumpensata
- Haemoglobinopathies (e. g., thalassemia, sickle-cell anaemia).
- Mard tad- demm (eż., talessimja, anemija tat- tip sickle cell).
- Initiation of peginterferon alfa-2b is contraindicated in HCV/ HIV patients with cirrhosis and a
- Huwa kontraindikat li jinbeda trattament bi peginterferon alfa- 2b f’ pazjenti HCV/ HIV b’ ċirrożi
Child-Pugh score ≥ 6.
u punteġġ Child- Pugh ≥6.
- Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal
- Jekk ikun hemm, jew hemm storja ta ’ kundizzjoni psikjatrika severa, l- aktar f’ każ ta ’
ideation, or suicide attempt.
dipressjoni severa, ħsibijiet ta ’ suwiċidju, jew tentattivi ta ’ suwiċidju.
Because of co-administration with peginterferon alfa-2b or interferon alfa-2b:
Minħabba l- għoti fl- istess ħin ta ’ peginterferon alfa- 2b jew interferon alfa- 2b:
- Autoimmune hepatitis; or history of autoimmune disease.
- Epatite awtoimmuni jew storja b ’ mard awtoimmuni.
Psychiatric and Central Nervous System (CNS):
Psikjatriku u Sistema Nervuża Ċentrali (SNĊ):
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Ribavirin combination therapy with peginterferon alfa-2b or interferon alfa-2b, and even after treatment discontinuation mainly during the 6-month follow-up period.
Effetti severi tas- SNĊ, b’ mod partikolari dipressjoni, ħsibijiet suwiċidali jew tentattivi ta ’ suwiċidju dehru f’ xi pazjenti waqt l- użu b’ terapija kombinata b’ Ribavirin ma ’ peginterferon alfa- 2b jew interferon alfa- 2b, u anki wara li t- trattament twaqqaf u prinċipalment fis- sitt xhur ta ’ wara.
Among children and adolescents, treated with Ribavirin in combination with interferon alfa-2b, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% versus 1%) during treatment and during the 6-month follow-up after treatment.
Fost it- tfal u l- adoloxxenti ttrattati b’ Ribavirin flimkien ma ’ interferon alfa- 2b, ħsibijiet jew tentattivi suwiċidali kienu rappurtati aktar ta ’ spiss milli f’ pazjenti adulti (2. 4% kontra 1%) waqt it- trattament u fis- 6 xhur ta ’ wara t- trattament.
As in adult patients, children and adolescents experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence).
Bħal ma ġara f’ pazjenti adulti, tfal u adoloxxenti wkoll kellhom effetti psikjatriċi avversi oħra (eż., dipressjoni, burdati emozzjonali, u ngħas).
Other CNS effects including aggressive behaviour (sometimes directed against others), confusion and alterations of mental status have been observed with alpha interferons.
Effetti oħra marbuta mas- SNĊ kienu jinkludu mġieba aggressiva (xi drabi kontra individwi oħra), konfużjoni u bidliet fl- istat mentali dehru b’ alpha interferons.
Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Il- pazjenti għandhom ikunu osservati mill- qrib għal sinjali jew sintomi ta ’ disturbi psikjatriċi.
If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Jekk jidhru dan it - tip ta ’ sintomi, it- tabib li qed jordna dawn il- mediċini għandu jżomm f’ rasu kemm jistgħu jkunu serji dawn l- effetti mhux mixtieqa, u għandu jqis il- ħtieġa għall- ġestjoni terapewtika xierqa.
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Ribavirin and peginterferon alfa-2b or interferon alfa-2b be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk sintomi psikjatriċi jippersistu jew imorru għall- agħar, jew jiġu identifikati ħsibijiet suwiċidali, huwa rakkomandat li t- trattament b’ Ribavirin u peginterferon alfa- 2b jew interferon alfa- 2b jitwaqqaf, u l - pazjent jibqa ’ taħt osservazzjoni, b’ interventi għal għajnuna psikjatrika xierqa.
Patients with existence of or history of severe psychiatric conditions:
Pazjenti b’ disturbi psikjatriċi severi eżistenti jew bi storja:
If treatment with Ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Jekk ikun meqjus li meħtieġ jinbeda trattament b’ Ribavirin flimkien ma ’ peginterferon alfa- 2b jew interferon alfa- 2b f’ pazjenti adulti li jkollhom jew xi darba kellhom kundizzjonijiet psikjatriċi severi, dan għandu jinbeda biss wara li jkun ġie żgurat li l- kundizzjoni psikjatrika ġiet dijanjostikata u kkontrollata b’ terapija individwali xierqa.
The use of Ribavirin and interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
L- użu ta ’ Ribavirin u interferon alfa- 2b fi tfal u adoloxxenti li jkollhom jew xi darba kellhom
6 Based on results of clinical trials, the use of ribavirin as monotherapy is not effective and Ribavirin must not be used alone.
Skont riżultati ta ’ studji kliniċi, l- użu ta ’ ribavirin bħala monoterapija mhux effettiv u Ribavirin m’ għandux jingħata waħdu.
The safety and efficacy of this combination have been established only using ribavirin capsules together with peginterferon alfa-2b or interferon alfa-2b solution for injection.
Is- sigurtà u l- effikaċja ta ’ din il- kombinazzjoni kienu stabbiliti biss permezz tal- kapsuli ta ’ ribavirin flimkien mas- soluzzjoni għall- injezzjoni ta ’ peginterferon alfa- 2b jew interferon alfa- 2b.
All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i. e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Il- pazjenti kollha fl- istudju dwar l- epatite Ċ kronika kellhom bijopsija tal- fwied qabel ma ’ daħlu fl - istudju, imma f’ ċertu każijiet (i. e. pazjenti b’ ġenotip 2 u 3), it- trattament jista ’ jkun possibbli mingħajr konferma istoloġika.