qanastek/EMEA-V3 huggingface dataset:
HCV/ HIV Co-infection The recommended duration of dosing for HCV/ HIV co-infected patients is 48 weeks, regardless of genotype.
Infezzjoni fl- istess ħin b’ HCV/ HIV It- tul tad- dużaġġ rakkomandat għall- pazjenti li jkollhom infezzjoni fl- istess ħin b’ HCV/ HIV huwa ta ’ 48 ġimgħa, ikun x’ ikun il- ġenotip.
Predictability of response and non-response in HCV/ HIV Co-infection Early virological response by Week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RNA, has been shown to be predictive for sustained response.
Kemm jista ’ jkun imbassar ir- rispons jew in- nuqqas tiegħu f ’ infezzjonijiet fl- istess ħin b’ HCV/ HIV Rispons viroloġiku bikri ma ’ Ġimgħa 12, definit bħala 2 log tal- viral load jew livelli li ma jitkejlux ta ’ HCV- RNA, deher li setgħa jservi għat- tbassir ta ’ rispons sostnut.
The negative predictive value for sustained response in HCV/ HIV co-infected patients treated with PegIntron in combination with ribavirin 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 ikkurati b’ PegIntron f’ kombinazzjoni ma ’ ribavirin kien 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 ’ 50% (52/ 104; Studju 1) deher għal pazjenti infettati fl- istess ħin b’ HCV/ HIV li kienu qed jirċievu terapija kombinata.
3 Duration of treatment - Retreatment Predictability of sustained virological response:
Kemm għandha ddum il- kura – Trattament mill- ġdid Kemm jista ’ jiġi mbassar r- 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- ġinotip, li wrew HCV- RNA fis- serum taħt il- limiti li jistgħu jitkejjlu mat- 12- il Ġimgħa għandhom jieħdu kura 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 ikkurati 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).
Retreatment duration greater than 48 weeks in non-responder patients with genotype 1 has not been studied with pegylated interferon alfa-2b and ribavirin combination therapy.
Kura mill- ġdid għal aktar minn 48 ġimgħa f’ pazjenti b’ ġenotip 1 li ma wrewx rispons ma ġietx studjata b’ terapija kombinata ta ’ interferon alfa- 2b pegilat u ribavirin.
PegIntron monotherapy As monotherapy the PegIntron regimen is 0.5 or 1.0 microgram/ kg/ week.
Monoterapija b’ PegIntron Bħala monoterapija l- kors ta ’ PegIntron huwa ta ’ 0. 5 jew 1. 0 mikrogramma/ kg/ ġimgħa.
The lowest vial or pen strength available is 50 μ g/ 0.5 ml; therefore for patients prescribed 0.5 μ g/ kg/ week, doses must be adjusted by volume as shown in Table 2.
L- iktar qawwa baxxa disponibbli ta ’ kunjett jew pinna hija ta ’ 50 μg/ 0. 5 ml; għaldaqstant għal pazjenti li ġew mogħtija preskrizzjoni ta ’ 0. 5 μg/ kg/ ġimgħa, id- dożi għandhom jiġu regolati bil- volum kif muri fi Tabella 2.
For the 1.0 μ g/ kg dose, similar volume adjustments can be made or alternate vial strengths can be used as shown in Table 2.
Għad - doża ta ’ 1. 0 μg/ kg, aġġustamenti fil- volum bħal dawn jistgħu jsiru jew inkella jistgħu jintużaw kunjetti b’ qawwiet oħra kif muri f’ Tabella 2.
PegIntron monotherapy was not studied in HCV/ HIV co-infected patients.
Monoterapija b’ PegIntron ma kienitx studjata f’ pazjenti ko- infettati b’ HCV/ HIV.
Table 2- Monotherapy Dosing
Tabella 2 - Dożaġġ tal- Monoterapija
Body Weight (kg)
Piż tal- Ġisem
Vial/ Pen Strength
Qawwa tal -
Administer Vial/ Pen Once Weekly Strength
Amministra Qawwa tal -
Administer Once Weekly
Amministra
(μ g/ 0.5ml)
(kg)
(ml) (μ g/ 0.5ml)
Darba fil - Pinna/ Kunjett Ġimgħa (μg/ 0. 5ml) (ml)
(ml)
Darba fil - Ġimgħa (ml)
0.3 0.4 0.5 0.4 0.5 0.5 0.5
0. 5 0. 5
* Must use vial.
* Għandha tintuża l- kunjett.
Minimum delivery for pen is 0.3 ml. ** For patients > 120 kg, use 80 μ g/ 0.5 ml vial
L- inqas ammont mogħti mill- pinna huwa ta ’ 0. 3 ml. ** Għal pazjenti > 120 kg, uża kunjett ta ’ 80 μg/ 0. 5 ml
Duration of treatment For patients who exhibit virological response at Week 12, treatment should be continued for at least another three-month period (i. e., a total of six months).
Tul tat- trattament Għal pazjenti li juru reazzjoni viroloġika f’ Ġimgħa 12, it- trattament għandu jitkompla għal perijodu ieħor ta ’ mill- inqas tliet xhur (i. e., total ta ’ sitt xhur).
The decision to extend therapy to one year of treatment should be based on prognostic factors (e. g., genotype, age > 40 years, male gender, bridging fibrosis).
Id- deċiżjoni biex it- terapija tkun estiża għal sena ta ’ trattament għandha tkun ibbażata fuq fatturi pronostiċi (eż., ġenotip, età > 40 sena, sess maskil, fibrożi li tgħaqad).
Dose modification for all patients If severe adverse reactions or laboratory abnormalities develop during treatment with PegIntron monotherapy or PegIntron in combination with ribavirin, modify the dosages of each product as appropriate, until the adverse reactions abate.
Tibdil fid- doża għal pazjenti kollha Jekk reazzjonijiet akuti mhux mixtieqa jew anormalitajiet tal- laboratorju jiżviluppaw waqt it- trattament bil - monoterapija ta ’ PegIntron jew PegIntron flimkien ma 'ribavirin, id- dożi għandhom jiġu regolati għal kull prodott kif jixraq, sakemm ir- reazzjonijiet mhux mixtieqa jbattu.
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 kemm jiġu segwiti l- istruzzjonijiet jista ’ jkun importanti għar- riżultati tat- terapija, id- doża għandha tinżamm kemm jista ’ jkun viċin id- doża standard irrikkmandata.
Guidelines were developed in clinical trials for dose modification.
Linji gwida ġew żviluppati fi provi kliniċi għall- modifikazzjoni tad- doża.
4 Combination Therapy Dose Reduction Guidelines
Linji Gwida Dwar it- Tnaqqis fid- Doża tat- Terapija Kombinata
Table 2a Dose modification guidelines for combination therapy (with ribavirin)
Tabella 2a Linji gwida dwar il- modifikazzjoni tad- doża għal terapija kombinata (b 'ribavirin)
Laboratory values
Tkomplix it -
Reduce only
Laboratorju
Reduce only PegIntron
ribavirin għal
Discontinue
terapija konġunta
ribavirin dose to 600 mg/ day* if:
600 mg/ kuljum * biss jekk:
dose to one-half dose if:
għal nofs- doża biss jekk:
combination therapy if:
jekk:
Haemoglobin Haemoglobin in:
Emoglobina Emoglobina fi:
< 8.5 g/ dl
< 8. 5 g/ dl
Patients with history of stable cardiac disease White blood cells Neutrophils
mard tal- qalb stabbli
≥ 2
ta ’
g/ dl decrease in haemoglobin during any four week period during treatment (permanent dose reduction) - < 1.5 x 109/ l - < 0.75 x 109/ l 9
erba ’ ġimgħat waqt it- trattament (tnaqqis permanenti fid- doża)
<
< 0. 75 x 109/ l - 9
12 g/ dl after four weeks of dose reduction < 1.0 x 109/ l < 0.5 x 109/ l
< 0. 5 x 109/ l < 25 x 109/ l
Platelets Bilirubin – direct Bilirubin - indirect
Bilirubin – dirett
< 25 x 109/l 2.5 x ULN** > 4 mg/ dl (for > 4 weeks)
> 4 mg/ dl > 4 ġimgħat)
> 2.0 mg/ dl 2 x baseline and > 10 x ULN**
2 x linja bażi u > 10 x ULN **
Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening. ** Upper limit of normal
Pazjenti li d- doża tagħhom ta ’ ribavirin hija mnaqqsa għal 600 mg kuljum jieħdu kapsula waħda ta ’ 200 mg filgħodu u żewġ kapsuli ta ’ 200 mg filgħaxija. ** Limitu ta ’ fuq tan- normal
Dose reduction of PegIntron may be accomplished by either reducing the prescribed volume by one- half or by utilizing a lower dose strength as shown in Table 2b.
Tnaqqis fid- doża ta ’ PegIntron jista ’ jinkiseb jew billi jitnaqqas il- volum preskritt bin- nofs jew billi tintuża doża anqas qawwija kif muri f 'Tabella 2b.
Table 2b – Reduced PegIntron Dosing for Combination Therapy
Tabella 2b – Tnaqqis fid- Doża ta ’ PegIntron għal Terapija Kombinata
Body Weight
Piż tal- Ġisem
Target Reduced
Tnaqqis Mixtieq
Vial/ Pen
Saħħa tal -
Administer
Amministra
Amount
Ammont Mogħti
Dose (μ g)
fid- Doża (μg)
(μ g/ 0.5 ml)
Kunjett/ Pinna (μg/ 0. 5 ml)
0.4 0.5 0.4 0.4
0. 4
*Must use vial.
* Għandha tintuża kunjett.
Minimum delivery for pen is 0.3 ml.
L- inqas ammont mogħti mill- pinna huwa ta ’ 0. 3 ml.
PegIntron Monotherapy Dose Reduction Guidelines
Linji Gwida għat- Tnaqqis fid- Doża ta ’ Monoterapija b 'PegIntron
Dose modification guidelines for patients who use PegIntron monotherapy are shown in Table 3a.
Il- linji gwida għat- tibdil fid- doża għal pazjenti li jużaw il- monoterapija b 'PegIntron huma indikati f' Tabella 3a.
Table 3a Dose modification guidelines for PegIntron monotherapy
Tabella 3a Linji gwida għat- tibdil fid- doża tal- monoterapija b 'PegIntron Valuti tal -
Laboratory values
Naqqas PegIntron
Reduce PegIntron to one-half dose if:
Waqqaf PegIntron jekk:
Discontinue PegIntron if:
għal nofs doża jekk:
Neutrophils
Newtrofili
< 0.75 x 109/ l
< 0. 75 x 109/ l
< 0.5 x 109/ l
< 0. 5 x 109/ l
Platelets
Plejtlets
5 Dose reduction for patients who use 0.5 μ g/ kg PegIntron monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ PegIntron 0. 5 μg/ kg għandu jinkiseb billi jitnaqqas il- volum preskritt bin- nofs.
The 50 μ g/ 0.5 ml vial must be used if necessary since the pen can only deliver a minimum volume of 0.3 ml.
Il- kunjett ta ’ 50 μg/ 0. 5 ml għandha tintuża jekk meħtieġ billi l- pinna tista ’ biss twassal volum minimu ta ’ 0. 3 ml.
For patients who use 1.0 μ g/ kg PegIntron monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half or by utilizing a lower dose strength as shown in Table 3b.
Għal pazjenti illi jużaw il- monoterapija ta ’ PegIntron 1. 0 μg/ kg, tnaqqis fid- doża jista ’ jinkiseb billi jitnaqqas il- volum li ġie miktub mit- tabib bin- nofs jew billi tintuża doża anqas qawwija kif muri f 'Tabella 3b.
Table 3b – Reduced PegIntron Dose for the 1.0 μ g/ kg Monotherapy Regimen
Tabella 3b – Tnaqqis fid- Doża ta ’ PegIntron għall- Kors ta ’ Monoterapija 1. 0 μg/ kg
Target Reduced
Tnaqqis fid -
Dose (μ g)
Doża
Strength
Kunjett/ Pinna
Once Weekly
Darba fil - Ġimgħa
(μ g/ 0.5ml)
Intenzjonat (μg)
(ml)
(μg/ 0. 5ml)
0.3 0.4 0.5 0.4
0. 3 0. 4 0. 5 0. 4
Minimum delivery for pen is 0.3 ml.
L- inqas ammont li jista ’ jingħ ata bil- pinna huwa 0. 3 ml.
Use in renal impairment:
Użu f' indeboliment tal- kliewi:
PegIntron should be used with caution in patients with moderate to severe renal impairment.
Monoterapija: PegIntron għandu jintuża b’ attenzjoni f’ pazjenti b’ indeboliment renali moderat għal sever.
In patients with moderate renal dysfunction (creatinine clearance 30- 50 ml/ minute), the starting dose of PegIntron should be reduced by 25%.
F’ pazjenti li jkollhom il- funzjoni renali ħażina b’ mod moderat (tneħħija tal- krejatinina 30- 50 ml/ minuta), id- doża tal- bidu ta ’ PegIntron għandha titnaqqas b’ 25%.
Patients with severe renal dysfunction (creatinine clearance 15-29 ml/ minute) should have the starting dose of PegIntron reduced by 50%.
Pazjenti li jkollhom funzjoni renali ħażina b’ mod sever (tneħħija tal- krejatinina 15- 29 ml/ min) għandhom jieħdu d- doża tal- bidu ta ’ PegIntron imnaqqsa b’ 50%.
Data are not available for the use of PegIntron in patients with creatinine clearance < 15 ml/ minute (see section 5.2).
M’ hemmx tagħrif dwar l- użu ta ’ PegIntron f’ pazjenti bi tneħħija tal - krejatinina < 15 ml/ min (ara sezzjoni 5. 2).
Patients with severe renal impairment, including those on hemodialysis, should be closely monitored.
Pazjenti b’ indeboliment renali sever, inklużi dawk fuq il - ħemodijaliżi, għandhom ikunu monitorati mill- qrib.
If renal function decreases during treatment, PegIntron therapy should be discontinued.
Jekk il- funzjoni renali tonqos waqt il- kura, it- terapija b’ PegIntron għandha titwaqqaf.
Patients with creatinine clearance < 50 ml/ minute must not be treated with PegIntron in combination with ribavirin (see ribavirin SPC).
Terapija kombinata: Pazjenti bit- tneħħija tal- krejatinina < 50 ml/ minuta m’ għandhom jiġu kkurati b’ PegIntron f’ taħlita ma ’ ribavirin (ara SPC ta ’ ribavirin).
When administered in combination with ribavirin, subjects with impaired renal function should be more carefully monitored with respect to the development of anaemia.
Meta jingħata f’ kombinazzjoni ma ’ ribavirin, individwi li jkollhom indeboliment fil- funzjoni renali għandhom ikunu monitorati aktar b’ kawtela għall- iżvilupp ta ’ anemija.
Use in hepatic impairment:
Użu f' indeboliment tal- fwied:
The safety and efficacy of PegIntron therapy has not been evaluated in patients with severe hepatic dysfunction, therefore PegIntron must not be used for these patients.
Is- sigurtà u l- effikaċja ta ’ PegIntron ma ġewx evalwati f’ pazjenti b’ funzjoni ħ aż ina serja fil- fwied, għalhekk PegIntron m’ għandux jintuża f’ dawn il- pazjenti.
Use in the elderly (≥ 65 years of age):
Użu fl- anzjani (≥ 65 sena):
There are no apparent age-related effects on the pharmacokinetics of PegIntron.
Jidher li ma hemm l- ebda effetti relatati ma ’ l- età fuq il- farmakokinetiċi ta ’ PegIntron.
Data from elderly patients treated with a single dose of PegIntron suggest no alteration in PegIntron dose is necessary based on age (see section 5.2).
Informazzjoni minn pazjenti anzjani li ngħataw doża waħda ta ’ PegIntron tissuġġerixxi li m’ hemmx bżonn ta ’ tibdil fid- doża minħabba l- età (ara sezzjoni 5. 2).
Use in patients under the age of 18 years:
Użu f’ pazjenti taħt it- 18- il sena:
There is no experience in children (see section 5.2).
M’ hemmx esperjenza fi tfal (ara sezzjoni 5. 2).
- Hypersensitivity to the active substance or to any interferon or to any of the excipients;
- Sensittività eċċessiva għas- sustanza attiva jew għal xi interferon jew għal xi sustanzi mhux attivi;
- A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease
- Passat ta ’ mard tal- qalb sever pri- eżistenti, inkluż mard tal- qalb mhux stabbli jew mhux kontrollat fis -
in the previous six months (see section 4.4);
sitt xhur ta ’ qabel (ara sezzjoni 4. 4);
- Severe, debilitating medical conditions;
- Kundizzjonijiet mediċi severi li jinkapaċitaw;
- Autoimmune hepatitis or a history of autoimmune disease;
- Epatite awto- immuni jew passat ta ’ mard awto- immuni;
- Severe hepatic dysfunction or decompensated cirrhosis of the liver;
- Fwied ma jaħdimx normali b’ mod sever jew ċirrożi mhux kumpensata tal- fwied;
- Pre-existing thyroid disease unless it can be controlled with conventional treatment;
- Mard pri- eżistenti tat- tirojde kemm- il darba ma jkunx jista ’ jiġi kkontrollat bi trattament konvenzjonali;
- Epilepsy and/ or compromised central nervous system (CNS) function;
- Epilessija u/ jew funzjoni kompromessa tas- sistema nervuża ċentrali (CNS);
- Initiation of PegIntron is contraindicated in HCV/ HIV patients with cirrhosis and a Child-Pugh
- Huwa kontra- indikat li tinbeda kura bi PegIntron f’ pazjenti HCV/ HIV b’ ċirrożi u punteġġ Child- Pugh
score ≥ 6.
≥ 6.
Also see ribavirin Summary of the Product Characteristics (SPC) if PegIntron is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Ara wkoll is- Sommarju tal- Karatteristiċi tal- Prodott (SPC) ta ’ ribavirin jekk PegIntron ikun ser jingħata flimkien ma ’ ribavirin f’ pazjenti b’ epatite C kronika.
Psychiatric and Central Nervous System (CNS):
Psikjatrika u Sistema Nervuża Ċentrali (CNS):
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during PegIntron therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Effetti CNS sekondarji severi, l- aktar dipressjoni, ħsibijiet ta ’ suwiċidju u attentati ta ’ suwiċidju dehru f’ xi pazjenti waqt terapija b’ PegIntron, u anki wara twaqqfet il - kura l- aktar fil- perijodu follow- up tas- sitt xhur ta ’ wara.
Other CNS effects including aggressive behaviour (sometimes directed against others), bipolar disorders, mania, confusion and alterations of mental status have been observed with alpha interferons.
Effetti CNS oħrajn inklużi mġieba aggressive (kulltant indirizzata lil persuni oħrajn), disturbi bipolari, manija, konfużjoni u alterazzjoni fl- istat mentali dehru b’ interferoni alfa.
Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Il- pazjenti għandhom jiġu monitorati mill- qrib għal xi 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 dawn is- sintomi, is- serjetà li jistgħu jkollhom dawn l- effetti mhux mixtieqa għandhom jitqiesu mit- tabib li jkun qed jordnahom u l- bżonn għall- immaniġġjar terapewtiku xieraq għandu jitqies.
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with PegIntron be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk is- sintomi psikjatriċi jibqgħu jew imorru għall- agħar, jew jidher le jkun hemm ħsibijiet ta ’ suwiċidju, huwa irrikkmandat li l- kura b’ PegIntron titwaqqaf, u l- pazjent jiġi segwit, b’ interventi psikjatriċi kif ikun jixraq.
If treatment with peginterferon alfa-2b is judged necessary in 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.
Pazjenti li jkollhom, jew kellhom xi darba kundizzjonijiet psikjatriċi serji: Jekk il- kura b’ peginterferon alfa- 2b titqies neċessarja f’ pazjenti li jkollhom jew kellhom xi darba kundizzjonijiet psikjatriċi severi, dan għandu jinbeda biss wara li jkun ġie żgurat maniġġar individwali dijanjostiku u terapewtiku tal- kundizzjoni psikjatrika.
More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses for oncology indications.
Ottudazzjoni aktar sinifikanti u koma, inklużi każijiet ta ’ enċefalopatija, dehru f’ xi pazjenti, l- aktar fl- anzjani, ikkurati b’ dożi ogħla għall- indikazzjonijiet onkoloġiċi.
While these effects are generally reversible, in a few patients full resolution took up to three weeks.
Filwaqt li dawn l- effetti ġeneralment ikunu riversibbli, xi wħud mill- pazjenti damu sa tlett ġimgħat biex jirkupraw għall- kollox.
Very rarely, seizures have occurred with high doses of interferon alpha.
F’ każijiet rari ħafna, seħħew aċċessjonijiet b’ dożi għoljin ta ’ interferon alpha.
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- istudji li saru dwar epatite Ċ kronika saritilhom bijopsija tal- fwied qabel ma ġew inklużi, iżda f’ ċertu każijiet (jiġifieri pazjenti b’ ġenotip 2 u 3), it- trattament jista ’ jkun possibbli mingħajr konferma istoloġika.
Current treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment.
Il- linji gwida attwali dwar it- trattament għandhom jiġu kkonsultati dwar jekk bijopsija tal- fwied hiex meħtieġa qabel ma jinbeda t- trattament.
Acute hypersensitivity:
Sensittività eċċessiva akuta:
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed rarely during interferon alfa-2b therapy.
Reazzjonijiet rari ta ’ sensittività eċċessiva akuta (eż urtikarja, anġjo- edema, bronko- kostrizzjoni, anafilassi) ġew osservati rarament waqt it- terapija ta ’ interferon alfa- 2b.
If such a reaction develops during treatment with PegIntron, discontinue treatment and institute appropriate medical therapy immediately.
Jekk reazzjoni bhal din tiżviluppa waqt it- trattament b 'PegIntron, tkomplix it- trattament u għandek tibda terapija medika xierqa minnufih.
Transient rashes do not necessitate interruption of treatment.
Mhux meħtieġ li jitwaqqaf it- trattament jekk joħroġ xi raxx temporanju.
Cardiovascular system:
Sistema kardjovaskulari:
As with interferon alfa-2b, patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders, receiving PegIntron therapy require close monitoring.
Bħalma jiġri b 'interferon alfa- 2b, pazjenti li għandhom passat ta ’ insuffiċjenza tal - qalb konġestiva, attakk tal- qalb kif ukoll/ jew li kellhom jew għandhom problemi arritmiċi u li qed jingħataw terapija b’ PegIntron jeħtieġu sorveljanza mill- qrib.
It is recommended that patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment.
Huwa rakkomandat illi dawk il- pazjenti li għandhom problemi pri- eżistenti fil- qalb jitteħdulhom elettrokardjogrammi tal- qalb (ECG) qabel kif ukoll waqt il- kors tat- trattament.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of PegIntron therapy.
Arritmiji kardijaċi (l- aktar dawk supraventrikulari) ġeneralment jirrispondu ghal terapija konvenzjonali iżda jistgħu jkunu jeħtieġu li t- terapija b’ PegIntron ma titkompliex.
As with all interferons, discontinue treatment with PegIntron in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Bħal ma huwa l- każ b 'interferoni kollha, waqqaf it- trattament b' PegIntron f’ pazjenti li jiżviluppaw żjieda fl- indikaturi tal- koagulazzjoni tad- demm, peress li dan jista ’ jkun qed jindika mard mhux kumpensat tal- fwied.
Fever:
Deni:
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out.
Għalkemm deni jista ’ jkun assoċjat ma ’ sindrome bħal ta ’ l- influwenza li ta ’ spiss jiġi rapportat waqt it- terapija b 'interferon, kawżi oħra ta ’ deni persistenti għandhom jiġu esklużi.
7 Hydration:
Idratazzjoni:
Adequate hydration must be maintained in patients undergoing PegIntron therapy since hypotension related to fluid depletion has been seen in some patients treated with alpha interferons.
Idratazzjoni xierqa għandha tinżamm f’ pazjenti li qed jingħataw it- terapija b 'PegIntron billi l - pressjoni baxxa konnessa ma ’ nuqqas ta ’ likwidi ġiet osservata f’ xi pazjenti ttrattati b' alfa interferoni.
Fluid replacement may be necessary.
Is - sostituzzjoni tal- likwidi tista ’ tkun meħtieġa
Pulmonary changes:
Bidliet fil- pulmun:
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients.
F’ każijiet rari f’ pazjenti li kienu qed jingħataw interferon alfa ġew osservati infiltrazzjonijiet tal- pulmun, infjammazzjoni tal- pulmun u pnewmonja, li xi drabi wasslet għall- mewt.
Any patient developing fever, cough, dyspnea or other respiratory symptoms must have a chest X-ray taken.
Kull pazjent li jiżviluppa deni, sogħla, qtugħ ta ’ nifs jew sintomi respiratorji oħra għandu jitteħidlu X- ray ta ’ sidru.
If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.
Jekk l- X- ray tas- sider juri xi infiltrazzjoni fil- pulmun jew jekk hemm xi sinjali ta ’ tnaqqis fil- funzjoni tal - pulmun, il- pazjent għandu jiġi sorveljat mill- qrib u, jekk meħtieġ, għandu jitwaqqaflu l- interferon alfa.
Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events.
It - twaqqif fil- pront ta ’ l- amministrazzjoni ta’ interferon alpha u t- trattament b 'kortikosterojdi jidher illi huwa assoċjat mar- riżoluzzjoni ta ’ l- effetti avversi fil- pulmun.
Autoimmune disease:
Mard awtoimmuni:
The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
L- iżvilupp ta ’ awto- antikorpi u mard awto- immuni ġie rappurtat waqt it- trattament b 'alfa interferoni.
Patients predisposed to the development of autoimmune disorders may be at increased risk.
Pazjenti jista ’ jkollhom riskju akbar ta ’ dan jekk ikollhom tendenza li jiżviluppaw mard awtoimmuni.
Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Thyroid changes and 4.8).
Pazjenti b’ sinjali jew sintomi kompatibbli ma ’ mard awto- immuni għandhom ikunu eżaminati bir- reqqa, u għandhom jintiżnu l- benefiċċji mar- riskji tal- kura b’ interferon jekk din titkompla (ara wkoll sezzjoni 4. 4 Bidliet fit- tirojde u 4. 8).
Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C treated with interferon.
Każijiet tas- sindrome Vogt- Koyanagi- Harada (VKH) kienu rrappurtati f’ pazjenti b’ epatite C kronika kkurati b’ interferon.
This syndrome is a granulomatous inflammatory disorder affecting the eyes, auditory system, meninges, and skin.
Din is- sindrome hija disturb infjammatorju granulomatus li teffettwa l- għajnejn, is - sistema tas- smigħ, il- meninġi u l- ġilda.
Ocular changes:
Bidliet okulari:
Ophthalmologic disorders, including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instances after treatment with alpha interferons (see section 4.8).
Mard oftalmoloġiku, li jinkludi emorraġiji fir- retina, vista b’ tikkek bojod, kif ukoll imblokk ta ’ l- arterja jew tal- vina tar- retina ġew rrapportati f’ każijiet rari wara t- trattament b 'alfa interferoni (ara sezzjoni 4. 8).
All patients should have a baseline eye examination.
Il- pazjenti kollha għandhom jagħmlu eżami tal- għajnejn bħala linja bażi ta ’ referenza.
Any patient complaining of ocular symptoms, including loss of visual acuity or visual field must have a prompt and complete eye examination.
Kull pazjent illi jilmenta b’ sintomi f’ għajnejh, bħal telf fil- vista jew fil- kamp viżiv, għandu jiġi mill- ewwel eżaminat b’ mod komplet f’ għajnejh.
Periodic visual examinations are recommended during PegIntron therapy, particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Huwa rakkomandat illi jsiru eżamijiet ta ’ l- għajnejn kull tant żmien waqt li qed jingħata PegIntron, l- aktar f’ dawk il- pazjenti b’ mard illi jista ’ jkun konness mar - retinopatija, bħal zokkor għoli fid- demm jew pressjoni għolja.
Discontinuation of PegIntron should be considered in patients who develop new or worsening ophthalmological disorders.
F’ pazjenti illi jiżviluppaw mard f’ għajnejhom, jew li l- mard f’ għajnejhom imur għall- agħar, wieħed għandu jikkunsidra li PegIntron jitwaqqaf.
Thyroid changes:
Bidliet fit- tirojde:
Infrequently, patients treated for chronic hepatitis C with interferon alpha have developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
Mhux ta ’ spiss, pazjenti b’ epatite Ċ li ngħataw interferon alfa żviluppaw bidliet fit - tirojde, b’ mod li jew bdiet taħdem aktar mgħaġġla jew inkella aktar bil- mod.
Determine thyroid stimulating hormone (TSH) levels if, during the course of therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
Wieħed għandu jkejjel il - livelli ta ’ l- ormoni li jistimulaw it- tirojde - (TSH) jekk, matul il- kors tat- terapija, pazjent jiżviluppa sintomi li jistgħu jkunu konnessi ma ’ funzjoni ħażina tat- tirojde.
In the presence of thyroid dysfunction, PegIntron treatment may be continued if TSH levels can be maintained in the normal range by medication.
Jekk it- tirojde ma tkunx qed taħdem tajjeb, xorta jista ’ jitkompla t- trattament b 'PegIntron jekk il- livelli tat- TSH jinżammu fil- livell normali permezz ta ’ mediċini.
Metabolic disturbances:
Disturbi fil- metaboliżmu:
Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
Ipertrigliċeridemija u żjieda fl- ipertrigliceridemija, kultant ukoll gravi, ġew osservati.
Monitoring of lipid levels is, therefore, recommended.
Sorveljanza tal- livelli tal- lipidi hija, għaldaqstant, rakkomandata.
HCV/ HIV Co-infection Mitochondrial toxicity and lactic acidosis:
Infezzjoni fl- istess ħin b’ HCV/ HIV Tossiċità mitokondrijali u aċidożi lattika:
Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Pazjenti li għandhom ukoll l- infezzjoni ta ’ l- HIV u li qed jingħataw Terapija Anti- Retrovirali Attiva Ħafna (Highly Active Anti- Retroviral Therapy) (HAART) jista ’ jkollhom riskju akbar illi taqbadhom aċidożi lattika.
Caution should be used when adding PegIntron and ribavirin to HAART therapy (see ribavirin SPC).
Wieħed għandu joqgħod attent meta jżid PegIntron u ribavirin ma 'terapija HAART (ara l- SPC ta ’ ribavirin).
Hepatic decompensation in HCV/ HIV co-infected patients with advanced cirrhosis:
Pazjenti infettati fl- istess ħin 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 u li jkunu qed jirċievu HAART jista ’ jkollhom riskju akbar ta ’ dikumpens 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 waħidhom jew f’ taħlita ma ’ ribavrin 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 concentration.
Fatturi mal- linja bażi oħrajn f’ pazjenti infettati fl- istess ħin li jistgħu jkunu assoċjati ma ’ riskju akbar ta ’ dikumpens epatiku jinkludu kura b’ didanosine u konċentrazzjoni għolja 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 kura antiretrovrali (ARV) kif ukoll kura kontra l- epatite għandhom ikunu monitorati mill- qrib, jiġi evalwat il- punteġġ Child- Pugh tagħhom waqt il- kura.
Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
Pazjenti li javvanzaw għal nuqqas ta ’ kumpens epatiku għandu jkollhom il- kura tagħhom kontra l- epatite mwaqqfa mill - ewwel u l- kura ARV terġa tiġi evalwata mill- ġdid.
8 Haematological abnormalities in HCV/ HIV co-infected patients:
Anormalitajiet ematoloġiċi f’ pazjenti li jkollhom fl- istess ħin 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.
F’ pazjenti li jkollhom fl- istess ħin HCV/ HIV li jkunu qed jirċievu kura bi peginterferon alfa- 2b/ ribavirin u HAART jista ’ jkollhom riskju akbar li jiżviluppaw anormalitajiet ematoloġiċi (bħal newtropenja, tromboċitopenja u anemija) meta mqabbla ma ’ pazjenti infettati b’ HCV waħdu.
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- parti l- kbira tagħhom jistgħu jkunu mmaniġġjati bi tnaqqis fid- doża, monitoraġġ mill- qrib ta ’ parametri ematoloġiċi għandu jsir f’ din il- popolazzjoni ta ’ pazjenti (ara sezzjonijiet 4. 2 u hawn taħt “ Testijiet tal- Laboratorju ” u sezzjoni 4. 8).
Patients treated with PegIntron and ribavirin combination therapy and zidovudine are at increased risk of developing anaemia and therefore the concomitant use of this combination with zidovudine is not recommended (see section 4.5).
Pazjenti kkurati b’ terapija bit- taħlita ta ’ PegIntron u ribavrin ma ’ zidovudine għandhom riskju akbar li jiżviluppaw anemija u għalhekk l- użu ta ’ din it- taħlita ma ’ zidovudine mhux rakkomandata (ara sezzjoni 4. 5).
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.
F’ pazjenti li jkollhom fl- istess ħin HCV/ HIV, dejta dwar l- effikaċja u s- sigurtà limitata (N=25) huma disponibbli f’ individwi b’ għadd tas- CD4 anqas minn 200 cellula/ µl.
Caution is therefore warranted in the treatment of patients with low CD4 counts.
Għalhekk għandha ssir kawtela meta jkunu qed jiġu kkurati pazjenti b’ għadd tas- CD4 baxx.
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 PegIntron and ribavirin.
Jekk jogħġbok irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott tal- prodotti mediċinali antiretrovirali li jkollhom jittieħdu fl- istes ħin ma’ terapija HCV għall- għarfien u maniġġjar tat- tossiċitajiet speċifiċi għal kull prodott u l- potenzjal li jista ’ jkun hemm tossiċitajiet f ’ daqqa b’ PegIntron u ribavirin.
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving PegIntron and ribavirin combination therapy.
Disturbi tas- snien u tal- ħanek: Disturbi tas- snien u tal- ħanek, li jistgħu jwasslu għal telf ta ’ snien, kienu rrappurtati f’ pazjenti li kienu qed jirċievu PegIntron u ribavirin f’ terapija kombinata.
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 PegIntron and ribavirin.
Minbarra hekk, ħalq xott jista ’ jgħamel il- ħsara fis- snien u l- membrani mukużi tal- ħalq waqt kura għal tul ta ’ żmien bil- kombinazzjoni ta ’ PegIntron u ribavirin.
Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Il- pazjenti għandhom jaħslu snienhom sew darbtejn kuljum u jmorru għall viżti regolari għal snienhom.
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Jekk jiġri hekk, għandhom jingħataw parir sabiex ilaħalħu ħalqhom sew wara.
Organ transplant recipients:
Pazjenti li jirċievu trapjanti ta ’ organi:
The safety and efficacy of PegIntron alone or in combination with ribavirin for the treatment of hepatitis C in liver or other organ transplant recipients have not been studied.
Is- sigurtà u l- effikaċja ta ’ PegIntron waħdu jew f’ kombinazzjoni ma’ ribavirin għall- kura ta ’ epatite C f’ pazjenti li jkunu rċevew trapjant tal- fwied jew ta ’ xi organu ieħor ma ġewx studjati.
Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
Dejta preliminari jindika li terapija b’ interferon alpha tista ’ tkun assoċjata ma ’ żieda fir- rata ta ’ riġett ta ’ trapjant tal- kliewi.
Liver graft rejection has also been reported.
Riġett tat- trapjant tal- fwied kienet irrappurtata wkoll.
Other:
Oħ rajn:
Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of PegIntron in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Minħabba rapporti illi interferon alpha jista ’ jħarrax il- mard tal- psorajiżi u tas- sarkojdożi, l- użu ta ’ PegIntron f’ pazjenti bi psorajiżi jew sarkojdożi huwa rakkomandat biss jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali.
Laboratory tests:
Testijiet tal- laboratorju:
Standard haematologic tests, blood chemistry and a test of thyroid function must be conducted in all patients prior to initiating therapy.
Testijiet ematoloġiċi standard, kimika tad- demm u test tal- funzjoni tat- tirojde għandhom isiru fil- pazjenti kollha qabel ma tinbdilhom it- terapija.
Acceptable baseline values that may be considered as a guideline prior to initiation of PegIntron therapy are:
Riżultati ta ’ referenza bażi aċċettati li jistgħu jkunu kkunsidrati bħala linja gwida qabel ma tinbeda t- terapija ta ’ PegIntron huma:
• • •
≥ 100, 000/ mm3 • Plejtlets ≥ 1, 500/ mm3 • Għadd tan- newtrofili •
Platelets Neutrophil count TSH level
Livell TSH
≥ 100,000/mm3 ≥ 1,500/mm3 must be within normal limits
għandu jkun fil- limiti normali
Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
L- evalwazzjonijiet tal- laboratorju għandhom isiru f’ ġimgħat 2 u 4 tat- terapija, u kull tant żmien minn hemm ’ l quddiem skond kif klinikament xieraq.
Important information about some of the ingredients of PegIntron:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ PegIntron:
This medicinal product contains less than 1 mmol sodium (23 mg) per 0.7 ml, i.e., essentially "sodium-free".
Dan il- prodott mediċinali fih anqas minn 1 mmol (23 mg) sodium għal kull 0. 7 ml, ie tista ’ titqies “ ħielsa mis- sodium ”.
Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal fructose, malassorbiment tal- glucose galactose jew insuffiċjenza ta ’ sucrase- isomaltase m’ għandhomx jieħdu din il- mediċina.
Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly PegIntron (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of
Riżultati minn studju bi probe b’ ħafna dożi li evalwa is- sottostrati P450 f’ pazjenti b’ epatite C kronika likienu qed jirċievu PegIntron darba fil- ġimgħa (1. 5 µg/ kg) għal 4 ġimgħat wrew żieda fl- attività ta ’ CYP2D6 u CYP2C8/ 9.
No change in activity of CYP1A2, CYP3A4, or N-acetyltransferase was observed.
Ma dehret l- ebda bidla fl- attività ta ’ CYP1A2, CYP3A4, jew N- acetyltransferase.
Caution should be used when administering peginterferon alfa-2b with medicines metabolised by CYP2D6 and CYP2C8/9, especially those with narrow therapeutic window, such as warfarin and phenytoin (CYP2C9) and flecainide (CYP2D6).
Għandha ssir attenzjoni meta jingħata peginterferon alfa- 2b ma ’ mediċini metabolizzati b’ CYP2D6 u CYP2C8/ 9, l- aktar dawk b’ firxa terapewtika dejqa, bħal warfarin u phenytoin (CYP2C9) u flecainide (CYP2D6).
These findings may partly relate to improved metabolic capacity due to reduced hepatic inflammation in patients undergoing treatment with PegIntron.
Dawn is- sejbiet jistgħu jgħinu xi ftit sabiex titjieb il- ħila metabolika minħabba tnaqqid fl- infjammazzjoni epatika f’ pazjenti li jkunu taħt kura b’ PegIntron.
Caution is therefore advised when PegIntron treatment is initiated for chronic hepatitis in patients treated with medication with a narrow therapeutic window and sensitive to mild metabolic impairment of the liver.
Il- kawtela għalhekk hija konsiljata meta tinbeda l- kura b’ PegIntron f’ pazjenti b’ epatite C kronika kkurati b’ mediċini li għandhom firxa terapewtika dejqa u li jkunu sensittivi għal indeboliment ħafif tal- fwied.
No pharmacokinetic interactions were noted between PegIntron and ribavirin in a multiple-dose pharmacokinetic study.
Ma kienx hemm interazzjonijiet farmakokinetiċi sinifikanti bejn PegIntron u ribavirin fi studju farmakokinetiku fejn ingħataw ħafnadożi.
In patients with chronic hepatitis C that were on stable methadone maintenance therapy and naïve to peginterferon alfa-2b, addition of 1.5 microgram/kg/week of PegIntron subcutaneously for 4 weeks increased R-methadone AUC by approximately 15% (95% Cl for AUC ratio estimate 103 – 128%).
F’ pazjenti b’ epatite C kronika li kienu ġew stabbiliti fuq terapija ta ’ manteniment b’ methadone u naïve għal peginterferon alfa- 2b, iż- żieda ta ’ 1. 5 mikrogramma/ kg/ ġimgħa ta ’ PegIntron minn taħt il- ġilda għal 4 ġimgħat żied l- AUC ta ’ R- methadone b’ madwar 15% (95% Cl għall- istima tal- proporzjon AUC 103 – 128%).
The clinical significance of this finding is unknown; however, patients should be monitored for signs and symptoms of increased sedative effect, as well as respiratory depression.
Is- sinifikat kliniku ta ’ din is- sejba mhux magħruf, madankollu, il- pazjenti għandhomikunu monitorati għal sinjali u sintomi ta ’ żieda fl- effett sedattiv, kif ukoll għal dipressjoni respiratorja.
Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.
L- aktar f’ pazjenti fuq doża għolja ta ’ methadone, ir- riskju ta ’ titwil tal- QTc għandu jitqies.
HCV/HIV Co-infection Nucleoside analogs:
Infezzjoni fl- istess ħin b’ HCV/ HIV Analogi tan- nuklejosajd:
Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis.
L- użu ta ’ l- analogi tan- nuklejosajd waħidhom jew flimkien ma ’ nuklejosidi oħra, irriżulta f’ aċidożi lattika.
Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Farmakoloġikament, ribavirin iżid il- metaboli fosforilati tan- nuklejosajd tal- purina 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 għar- riskju akbar ta ’ aċidożi lattika kkaġunata minn analogi tan - nukejosajd 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 irrikkmandat.
Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see ribavirin SPC).
Rapporti ta ’ tossiċità mitokondrijali, l- aktar aċidożi lattika u pankrejatite, ftit minnhom fatali, kienu rrappurtati (ara l- SPC ta ’ ribavirin).
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 irrapportat li l- anemija ħraxet minħabba ribavirin meta zidovudine ikun parti mill- kors li jintuża għall- kura ta ’ l- 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 irrakkomandat minħabba żieda fir- riskju 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.
Għandu jiġi kkonsidrat il- bidla ta ’ zidovudine bħala parti mill- kors ta ’ kura kontra r- retrovirus (ART) jekk dan kien diġa qed jingħata.
This would be particularly important in patients with a known history of zidovudine-induced anaemia.
Dan ikun importanti b’ mod partikolari f’ pazjenti li fil- passat kellhom anemija minħabba li ħadu zidovudine.
PegIntron is recommended for use in fertile women only when they are using effective contraception during the treatment.
L- użu ta ’ PegIntron f’ nisa fertili huwa irrikkmandat biss meta jkunu qed jużaw metodi ta ’ kontraċezzjoni effettiva waqt il- kura.
There are no adequate data from the use of interferon alfa-2b in pregnant women.
M’ hemmx tagħrif xieraq dwar l- użu ta ’ interferon alfa- 2b f’ nisa waqt it- tqala.
Interferon alfa-2b has been shown to be abortifacient in primates.
Interferon alfa- 2b wera li kellu effett abortiv fi primati.
PegIntron is likely to also cause this effect.
X’ aktarx li PegIntron jikkawża dan l- effett.
The potential risk in humans is unknown.
Mhux magħruf ir- riskju potenzjali fuq in- nies.
PegIntron is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
PegIntron għandu jintuża waqt it- tqala biss jekk il- benefiċċju li jista ’ jkun hemm jiġġustifika r- riskju li jista ’ jkun hemm għall- fetu.
It is not known whether the components of this medicinal product are excreted in human milk.
Mhux magħruf jekk il- komponenti ta ’ dan il- prodott mediċinali joħ orġux mal- ħalib tal - bniedem.
Because of the potential for adverse reactions in breast-fed infants, breast-feeding should be discontinued prior to initiation of treatment.
Peress li jista ’ jkun hemm reazzjonijiet avversi fi tfal li jkunu qed jieħdu l- ħalib tas- sider, it - treddigħ għandu jitwaqqaf qabel tibda l- kura.
Combination therapy with ribavirin:
Terapija kombinata b’ ribavirin:
Ribavirin causes serious birth defects when administered during pregnancy.
Ribavirin jista ’ jikkawża difetti tat- twelid serji meta jingħata waqt it- tqala.
Females of
Għandha tittieħed kawtela estrema sabiex tiġi evtata t- tqala f’ pazjenti nisa jew fis- sieħba ta ’ pazjenti rġiel li jkunu qed jieħdu PegIntron flimkien ma ’ ribavirin.
10 childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Nisa li jista ’ jkollhom it- tfal u s- sieħba tagħhom għandhom jużaw kontraċezzjoni effettiva kull wieħed waqt il- kura u għal 4 xhur wara li tkun intemmet il- kura.
Male patients and their female partners must each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see Ribavirin SPC).
Pazjenti irġiel u s- sieħba tagħhom għandhom jużaw kull wieħed kontraċezzjoni effettiva waqt il- kura u għal 7 xhur wara li tkun intemmet il- kura (ara l- SPC ta ’ ribavirin).
Patients who develop fatigue, somnolence or confusion during treatment with PegIntron are cautioned to avoid driving or operating machinery.
Pazjenti li jiżviluppaw għejja, ħedla jew konfużjoni matul it- trattament b 'PegIntron huma mwissija sabiex jevitaw li jsuqu jew iħaddmu magni.
The most common treatment-related adverse reactions reported during clinical trials with PegIntron in combination with ribavirin, seen in more than half of the study subjects, were headache, fatigue, and injection site reaction.
L- aktar reazzjonijiet avversi komuni relatati mal- kura irrappurtata waqt provi kliniċi b’ PegIntron flimkien ma ’ ribavirin, li dehret f’ aktar minn- nofs l- individwi li kienu qed jieħdu sehem fl- istudju, kienu uġigħ ta ’ ras, għeja, u reazzjoni fis- sit mnejn tingħata l- injezzjoni.
Additional important adverse reactions reported in more than 25% of subjects included myalgia, fever, asthenia, alopecia, nausea, anorexia, weight decrease, depression, irritability and insomnia.
Reazzjonijiet avversi importanti oħrajn irrappurtati f’ aktar minn 25% ta ’ l- individwi kienu jinkludu mijalġja, deni, astenja, alopeċja, nawsja, anoressija, telf tal- piż, dipressjoni, irritabilità u nuqqas ta ’ rqad.
The most frequently reported adverse reactions were mostly mild to moderate in severity and were manageable without the need for modification of doses or discontinuation of therapy.
Ir- reazzjonijiet avversi irrappurtati b’ mod l- aktar frekwenti kienu fil- parti l- kbira tagħhom ħfief għal moderati fis- severità tagħhom u setgħu jiġu mmaniġġati mingħajr ma kien hemm bżonn li jinbidlu d- dożi jew titwaqqaf it- terapija.
Fatigue, alopecia, pruritus, nausea, anorexia, weight decrease, irritability and insomnia occur at a notably lower rate in patients treated with PegIntron monotherapy compared to those treated with combination therapy (see Table 4).
Għeja, alopeċja, ħakk, nawsja, anoressija, telf tal- piż, irritabilità u nuqqas ta ’ rqad iseħħu b’ rata ferm aktar baxxa f’ pazjenti kkurati b’ PegIntron bħala monoterapija meta mqabbel ma ’ dawk ikkurati b’ terapija kkombinata (ara Tabella 4).
The following treatment-related adverse reactions were reported during therapy with PegIntron.
Ir- reazzjonijiet avversi li ġejjin relatati mal- kura kienu rrappurtati waqt terapija b’ PegIntron.