qanastek/EMEA-V3 huggingface dataset:
An unborn baby has a blood vessel called the ductus arteriosus near the heart which allows the baby ’ s blood to bypass the lungs and circulate to the rest of the body.
Tarbija mhux mwielda għandha blood vessel imsejjaħ ductus arteriosus qrib il- qalb li jippermetti d- demm li jaqbeż il- pulmun u jiċċirkola mal- bqija tal- ġisem.
When the baby is born and starts using its lungs the ductus arteriosus normally closes.
Meta t- tarbija titwieled u tibda tuża l- pulmun tagħha d- ductus arteriosus ġeneralment jagħlaq.
However, in some cases this does not happen.
Madankollu, xi minn daqqiet dan ma jseħħx.
The medical term for this condition is ‘ patent ductus arteriosus’, i. e. an open ductus arteriosus.
It- terminoloġija medika għal din is- sitwazzjoni tissejjaħ ‘ patent ductus arteriosus ’, jiġifieri ductus arteriosus miftuħ.
This can cause heart problems in your baby.
Din tista ’ tikkawża problemi tal- qalb fit - tarbija tiegħek.
This condition is much more frequent in premature newborn than in full-term newborn infants.
Din il- kondizzjoni hija aktar frekwenti fi trabi li għadhom kif twieldu meta jitwieldu qabel iż- żmien milli fi trabi li jkunu għadhom kif twieldu u li għamlu l- perijodu ta ’ ġestazzjoni kollu.
Pedea, when given to your baby, can help to close the ductus arteriosus.
Pedea, meta tingħata lit- tarbija tiegħek, tista ’ tgħin sabiex jingħalaq id- ductus arteriosus.
Pedea closes the ductus arteriosus by inhibiting the production of prostaglandin, a naturally occurring chemical in the body which keeps the ductus arteriosus open.
Pedea jagħlaq id- ductus arteriosus billi jimpedixxi l- produzzjoni ta ’ prostaglandin, li hija sustanza naturali li tinsab fil- ġisem tiegħek li qed iżżomm id- ductus arteriosus miftuħ.
BEFORE PEDEA IS ADMINISTERED TO YOUR BABY
QABEL MA PEDEA TIĠI MOGĦTIJA LIT- TARBIJA TIEGĦEK
Pedea must not be given to babies:
Pedea m’ għandhiex tingħata lit- trabi:
- if they have a life-threatening infection which has not been treated;
- jekk ikollhom infezzjoni li tista ’ tkun fatali li għadha ma ġietx ittrattata;
- if they are bleeding, especially if the bleeding is inside the skull or in the intestines;
- jekk ikollhom fsada attiva, speċjalment jekk il- fsada tinsab fil- kranju jew fl- imsaren;
- if they have problems with their blood clotting;
- jekk għandhom problemi bil- koagulazzjoni tad- demm;
- if they have kidney problems.
- jekk għandhom problemi fil- kliewi;
- if they have certain problems with their intestines;
- jekk ikun hemm ċertu problemi fl- imsaren tagħhom;
- if they are hypersensitive (allergic) to ibuprofen or any of the excipients.
- jekk għandhom sensittività eċċessiva (allerġija) għal ibuprofen jew għal xi wieħed mis- sustanzi
Special care should be taken with Pedea
Attenzjoni speċjali għandha tingħata b’ Pedea
Before Pedea is given to your baby, your baby’ s heart will be examined to confirm that the ductus arteriosus is open.
Qabel ma ’ Pedea tingħata lit- tarbija tiegħek, il- qalb tat- tarbija ser tiġi eżaminata sabiex jiġi konfermat li d- ductus arteriosus huwa miftuħ.
Pedea should not be given in the first 6 hours of life.
Pedea m’ għandhiex tingħata fl- ewwel 6 sigħat ta ’ ħajja.
Treatment with Pedea should not be used if your baby is suspected of having liver disease, signs and symptoms of which include yellowing of the skin and eyes.
It- trattament b’ Pedea m’ għandux jingħata jekk hemm suspett li t- tarbija tiegħek għandha xi mard tal - fwied, li jista ’ jkun indikat permezz ta ’ sinjali u sintomi li jindikaw sfurija tal- ġilda u ta ’ l- għajnejn.
If your baby is already suffering from an infection that is being treated, the doctor will treat your baby with Pedea only after careful consideration of your baby’ s condition.
Jekk it- tarbija tiegħek diġà qed tbati minn infezzjoni li qed tiġi trattata, it- tabib tiegħek ser jagħti t - trattament lit- tarbija tiegħek b’ Pedea wara li jqis sew il- kundizzjoni tat- tarbija.
Pedea should be carefully administered to your baby by the healthcare professional, to avoid damage to the skin and surrounding tissues.
Pedea għandha tingħata b’ attenzjoni mill- professjonist fil- kura tas- saħħa, sabiex ikun evitat ħsara lill - ġilda u tessut ta ’ madwar.
Ibuprofen may reduce the ability of your baby ’ s blood to clot.
Ibuprofen jista ’ jnaqqas il- ħila tad- demm tat- tarbija tiegħek li jgħaqqad.
Your baby should therefore be watched for signs of prolonged bleeding.
It- tarbija tiegħek għandha għalhekk tiġi osservata għal sinjali ta ’ fsada fit- tul.
Your baby may develop some bleeding from the intestines and the kidneys.
It- tarbija tiegħek tista ’ tiżviluppa xi fsada mill- imsaren jew mill- kliewi.
To detect this, your baby ’ s stools and urine may be tested to determine if there is any blood present in them.
Sabiex jintebħu b’ dan, l - ippurgar tat- tarbija u l- awrina jistgħu jiġu eżaminati sabiex jiġi stabbilit jekk hemmx demm fihom.
Pedea may reduce the amount of urine your baby passes.
Pedea tista ’ tnaqqas l- ammont ta ’ awrina li t- tarbija tgħaddi.
If this is significant, your baby’ s treatment may be stopped until the volume of urine returns to normal.
Jekk dan ikun sinifikanti, it- trattament fuq it- tarbija jista ’ jitwaqqaf sakemm il- volum ta ’ awrina jiġi għan- normal.
Pedea may be less effective in very premature babies.
Pedea tista ’ tkun inqas effettiva fi trabi li huma prematuri ħafna.
Certain medicines, if given together with Pedea, may cause side effects.
Ċertu mediċini, jekk jingħataw flimkien ma ’ Pedea, jistgħu jikkawżaw effetti oħra.
These are detailed below:
Dawn huma spjegati fid- dettal hawn taħt:
Ibuprofen
- it- tarbija tiegħek jista ’ jkollha problemi biex tgħaddi l- awrina u jista ’ jkun li ngħatat riċetta biex
may reduce the effect of these medicines.
Ibuprofen jista ’ jnaqqas l- effett ta ’ dawn il- mediċini.
Ibuprofen may
- it- tarbija tiegħek tista ’ tingħata mediċina kontra l- koagulazzjoni (mediċina li timpedixxi d- demm
increase the anti-clotting effect of this product.
Ibuprofen jista ’ jżid l- effett ta ’ kontra l- koagulazzjoni ta ’ dan il- prodott.
- your baby may be given nitric oxide to improve blood oxygenation.
- it- tarbija tiegħek tista ’ tingħata nitric oxide sabiex ittejjeb l- ammont ta ’ ossiġenu fid- demm.
Ibuprofen may increase the
Ibuprofen jista ’ iżid ir- riskju ta ’ fsada.
- your baby may be given corticosteroids to prevent inflammation.
- it- tarbija tiegħek tista ’ tingħata kortikosterojdi sabiex tiġi evitata l- infjammazzjoni.
Ibuprofen may increase the
Ibuprofen
risk of bleeding in the stomach and intestines.
jista ’ jżid ir- riskju ta ’ fsada fl- istonku u fl- imsaren.
Ibuprofen may
- it- tarbija tiegħek tista ’ tingħata aminosides (familja ta ’ antibijotiċi) sabiex tittratta l- infezzjoni.
increase blood concentrations and thus increase the risk of toxicity on kidney and ear
Ibuprofen jista ’ jgħolli l- konċentrazzjonijiet taghhom fid- demm u b’ hekk iżid ir- risku ta ’ tossiċità fuq il- kliewi u l- widnejn.
HOW PEDEA IS USED
KIF TINTUŻA PEDEA
Pedea will only be given to your baby in a special neonatal intensive care unit by qualified healthcare professional.
Pedea ser jingħata biss fit- taqsima ta ’ kura intensiva ta ’ trabi li għadhom kif twieldu minn professjonista kkwalifikat fil- kura tas- saħħa.
17 A course of therapy is defined as three intravenous injections of Pedea given at 24 hour intervals.
Kors ta ’ terapija huwa mfisser bħala tliet dożi ta ’ Pedea mogħtija ġol- vina f’ intervalli ta ’ 24 siegħa.
The dose to be administered will be calculated from the weight of your baby.
Id- doża li trid tiġi mogħtija ser tiġi kkalkulata skond il- piż tat- tarbija tiegħek:
It is 10 mg/ kg for the first administration and 5 mg/ kg for the second and the third administrations.
Din hija 10 mg/ kg għall - ewwel doża u 5 mg/ kg għat- tieni u t- tielet amministrazzjoni.
This calculated amount will be given by infusion in a vein over a period of 15 minutes.
Dan l- ammont ikkalkulat ser jingħata b’ infużjoni ġol- vina fuq perijodu ta ’ 15- il minuta.
If after this first course of treatment, the ductus arteriosus is not closed or re-opens, your baby ’ s doctor may decide to give a second course of treatment.
Jekk wara dan l- ewwel kors ta ’ trattament, id- ductus arteriosus ma jingħalaqx jew jerġa ’ jinfetaħ mill - ġdid, it- tabib tat- tarbija tiegħek jista ’ jiddeċiedi li jagħti t- tieni kors ta ’ trattament.
POSSIBLE SIDE EFFECTS
X’ EFFETTI OĦRA JISTA ’ JKOLLHA
Like all medicines, Pedea may cause side effects.
Bħal kull mediċina oħra, Pedea jista ’ jkollha effetti oħra.
However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease.
Madankollu, huwa diffiċli tgħarafhom minn kumplikazzjonijiet li jseħħu ta ’ spiss f’ trabi li jitwieldu qabel iż- żmien u dawk li jseħħu minħabba l - marda.
The following side effects have been reported with Pedea:
L- effetti oħra li ġejjin ġew rapportati b’ Pedea:
- problems with blood clotting resulting in bleeding disorders such as bleeding from the intestines,
- problemi bit- tagħqid tad- demm li jirriżultaw f’ problemi ta ’ fsada bħal fsada fl- imsaren, fsada fil -
bleeding inside the skull;
kranju;
- breathing problems and bleeding in the lungs;
- problemi bin- nifs u fsada fil- pulmun;
- problems with the digestive system such as obstruction and perforation of the intestine;
- problemi fis- sistema diġestiva bħal imblukkar u perforazzjoni ta ’ l- imsaren;
- kidney problems such as reduced volume of urine passed, blood in the urine and acute failure of
- problemi tal- kliewi bħal tnaqqis fil- volum tal- awrina, demm fl- awrina u insuffiċjenza akuta fil -
the kidneys’ functions.
funzjonijiet tal- kliewi.
If you notice any side effects not mentioned in this leaflet, please inform your baby ’ s doctor or your pharmacist.
Jekk tinduna b’ xi effetti li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib tat- tarbija tiegħek jew l- ispiżjar tiegħek.
STORING PEDEA
KIF TAĦŻEN PEDEA
Do not use after the expiry date stated on the label.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq it- tikketta
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This leaflet was last approved on
Dan il- fuljett kien approvat l- aħħar f ’ 24 ta ’ Novembru 2006
Treatment with Pedea can only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.
Trattament b’ Pedea għandu jsir biss fit- taqsima tal- kura intensiva ta ’ trabi li għadhom kif twieldu, taħt is- superviżjoni ta ’ neonatoloġista b’ esperjenza.
A course of therapy is defined as three intravenous doses of Pedea given at 24-hour intervals.
Kors ta ’ terapija jfisser tliet dożi ta ’ Pedea ġol- vina mogħtija f’ intervalli ta ’ 24 siegħa.
If the ductus arteriosus does not close 48 hours after the last injection or if it re-opens, a second course of 3 doses, as above, may be given.
Kemm- il darba d- ductus arteriosus ma jagħlaqx fi żmien 48 siegħa mill- aħħar injezzjoni jew jekk jerġa ’ jinfetaħ, jista ’ jingħata t- tieni kors ta ’ 3 dożi kif indikat hawn fuq.
20 If the condition is unchanged after the second course of therapy, surgery of the PDA may then be necessary.
20 Metodu ta ’ kif għandha tingħata:
To facilitate the administration an infusion pump may be used.
Sabiex jiġi faċilitat l- għoti tista ’ tintuża pompa ta ’ l- infużjoni.
If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution for injection.
Jekk ikun hemm bżonn, il- volum ta ’ l- injezzjoni jista ’ jiġi mibdul jew b’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride għall- injezzjoni jew soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glukożju għall- injezzjoni.
Any unused portion of the solution should be discarded.
Kull fdal tal- prodott li ma jiġix użat għandu jintrema.
The total volume of solution injected to preterm infants should take into account the total daily fluid volume administered.
Għandu jitqies il- volum ta ’ fluwidu kollu li jingħata kuljum fil- volum kollu ta ’ soluzzjoni injettatat fi trabi mwielda qabel iż- żmien.
A maximal volume of 80 ml/ kg/ day on the first day of life should usually be respected; this should be progressively increased in the following 1-2 weeks (about 20 ml/ kg birthweight/ day) up to a maximal volume of 180 ml/ kg birthweight/ day.
Għandu ġeneralment jingħata volum massimu ta ’ 80 ml/ kg/ jum fl - ewwel jum. ta ’ ħajja; dan għandu jiżdid b’ mod progressiv fil- ġimgħa jew ġimgħatejn ta ’ wara (madwar 20 ml/ kg piż ta ’ twelid / jum) sa volum massimu ta ’ 180 ml/ kg piż ta ’ twelid/ jum.
This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride soluzzjoni għall- injezzjoni jew 50 mg/ ml (5%) soluzzjoni ta ’ glukożju.
In order to avoid any substantial variation of pH due to the presence of acidic medicinal products that could remain in the infusion line, the latter must be rinsed before and after administration of Pedea with 1.5 to 2 ml of either sodium chloride 9 mg/ ml (0.9%) solution for injection or glucose 50 mg/ ml (5%) solution.
Sabiex ma jkunx hemm bidla sostanzjali fil- pH minħabba l- preżenza ta ’ prodotti mediċinali aċidużi li jistgħu jibqgħu fil- pajp ta ’ l- infużjoni, dan ta ’ l- aħħar irid jiġi mlaħlaħ qabel u wara l- għoti ta ’ Pedea jew b’ 1. 5 sa 2 ml ta ’ soluzzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride għall- injezzjoni jew 50 mg/ ml (5%) soluzzjoni ta ’ glukożju.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar- rakkomandazzjonijiet ta 'CHMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Pegasys?
X' inhu Pegasys?
Pegasys is a medicine that contains the active substance peginterferon alfa-2a.
Pegasys huwa mediċina li fiha s- sustanza attiva peginterferon alfa- 2a.
It is available as a solution for injection in a vial and as a pre-filled syringe (135 and 180 micrograms).
Huwa disponibbli f' soluzzjoni għall- injezzjoni f' kunjett u bħala siringa mimlija minn qabel (135 u 180 mikrogramma).
What is Pegasys used for?
Għal xiex jintuża Pegasys?
Pegasys is used to treat adult patients with the following diseases: • chronic (long-term) hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Pegasys jintuża għat- trattamet ta 'pazjenti adulti li jbatu mill- mard li ġej: • epatite kronika B (fit- tul) (marda tal- fwied ikkawżata minn infezzjoni bil- vajrus tal- epatite B).
It is used in patients who have compensated liver disease (when the liver is damaged but works normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of alanine aminotransferase [ALT], a liver enzyme, and signs of damage when liver tissue is examined under a microscope); • chronic hepatitis C (a disease of the liver due to infection with the hepatitis C virus).
Jintuża f' pazjenti li jbatu minn mard tal- fwied kompensat (meta l- fwied ikollu l- ħsara iżda jibqa 'jaħdem normalment), li juru wkoll sinjali li l- vajrus ikun għadu qed jimmultiplika, u li jkollhom sinjali ta' ħsara fil- fwied (żieda fil- livelli ta 'alanina aminotransferażi [ALT], enzima tal- fwied, u sinjali ta' ħsara meta t- tessut tal- fwied jiġi eżaminat b' mikroskopju); • epatite kronika Ċ (marda tal- fwied minħabba infezzjoni mil- vajrus tal- epatite Ċ).
It can be used in patients with liver cirrhosis (scarring) and in patients also infected with human immunodeficiency virus (HIV).
Jista 'jintuża f' pazjenti b' ċirrożi epatika (ċikatriċi), u f' pazjenti infettati wkoll bil- vajrus tal- immunodefiċjenza umana (HIV).
The best way to use Pegasys is with ribavirin (an antiviral medicine).
L- aħjar mod kif jintuża Pegasys hu ma 'ribavirin (mediċina antivirali).
This combination is suitable for treatment-naïve patients (who have not been treated before) and for patients in whom previous treatment including any type of interferon alfa, with or without ribavirin, did not work.
Din il - kombinazzjoni hi adatta għal pazjenti li ma jkunux ingħataw trattament qabel, kif ukoll għal pazjenti li qabel ma jkunx ħadem fuqhom trattament li jkun jinkludi kwalunkwe tip ta ’ interferon alfa bi jew mingħajr ribavirin.
Pegasys can be used on its own if the patient does not tolerate or must not receive ribavirin.
Pegasys jista 'jintuża waħdu jekk il- pazjent ma jkunx jittollera jew mgħandux jingħata ribavirin.
How is Pegasys used?
Kif jintuża Pegasys?
Treatment with Pegasys should be started by a doctor who has experience in the treatment of hepatitis B or C.
It- trattament b' Pegasys għandu jinbeda minn tabib li jkollu esperjenza fit- trattament tal- epatite B jew Ċ.
Pegasys is given by injection under the skin in the abdomen (tummy) or thigh.
Pegasys jingħata b' injezzjoni taħt il- ġilda fiż- żaqq jew fil- koxxa.
It is usually given as 180 micrograms once a week for 48 weeks, although some hepatitis C patients may need 16, 24 or 72 weeks of treatment.
Normalment jingħata f' doża ta '180 mikrogramma darba f' ġimgħa għal 48 ġimgħa, għalkemm xi pazjenti bl- epatite Ċ jista' jkollhom bżonn trattament ta '16, 24 jew 72 ġimgħa.
The dose may need to be adjusted for patients who experience side effects.
Id- doża jista 'jkollha bżonn tiġi aġġustata għal pazjenti li jkollhom xi effetti sekondarji.
For full dosing information, see the Summary of Product Characteristics (also part of the EPAR).
Għal tagħrif sħiħ dwar id- doża, ara s- Sommarju tal- Karatteristiċi tal - Prodott (li wkoll hu parti mill- EPAR).
How does Pegasys work?
Kif jaħdem Pegasys?
The active substance in Pegasys, peginterferon alfa-2a, belongs to the group ‘ interferons’.
Is- sustanza attiva f' Pegasys, peginterferon alfa- 2a, tagħmel parti mill- grupp ta '' interferoni '.
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
L - interferoni huma sustanzi naturali prodotti mill- ġisem biex jgħinuh jiġġieled kontra attakki bħal infezzjonijiet ikkawżati mill- vajrusis.
The exact way alpha interferons work in viral diseases in not fully understood, but it is 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Il- mod eżatt ta 'kif jaħdmu l- interferoni alfa fil- mard virali mhux 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. thought that they act as immunomodulators (substances that modify how the immune system, the body’ s defence system, works).
Reproduction is authorised provided the source is acknowledged. kompletament magħruf, iżda hu maħsub li jaħdmu bħala immunomodulaturi (sustanzi li jimmodifikaw il- mod ta 'kif taħdem is- sistema immunitarja: is- sistema ta' difiża tal- ġisem).
Alpha interferons may also block the multiplication of viruses.
L- interferoni alfa jistgħu wkoll jimblukkaw il- proliferazzjoni tal- vajrusis.
Peginterferon alfa-2a is very similar to interferon alfa-2a, which is already available in the European Union (EU) as Roferon.
Peginterferon alfa- 2a huwa simili ħafna għal interferon alfa- 2a, li diġà huwa disponibbli fl- Unjoni Ewropea (UE) bħala Roferon.
In Pegasys, the interferon alfa-2a has been ‘ pegylated’ (coated with a chemical called polyethylene glycol).
F' Pegasys, l- interferon alfa- 2a hu 'pegylated' (jiġifieri miksi b' sustanza kimika magħrufa bħala polietilene glikol [polyethylene glycol]).
The interferon alfa-2a in Pegasys is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2a.
L- interferon alfa- 2a f' Pegasys huwa prodott b' metodu magħruf bħala 'teknoloġija tad- DNA rikombinanti': jiġifieri jinkiseb minn batterju li jkun irċieva ġene (DNA), li jagħmlu kapaċi jipproduċi l- interferon alfa- 2a.
The replacement acts in same way as naturally produced interferon alpha.
Is- sostituzzjoni taħdem bl- istess mod bħal interferon alfa prodott b' mod naturali.
How has Pegasys been studied?
Kif ġie studjat Pegasys?
In chronic hepatitis C, Pegasys has been studied on its own in three studies involving a total of 1,441 patients, and in combination with ribavirin in one study involving 1,149 patients.
Fl- epatite kronika Ċ, Pegasys ġie studjat waħdu fi tliet studji li fihom, b' kollox ħadu sehem 1, 441 pazjent, kif ukoll flimkien ma 'ribavirin fi studju ieħor li kien jinvolvi 1, 149 pazjent.
All of these studies lasted 48 weeks, and compared the effectiveness of Pegasys with that of interferon alfa-2a.
Dawn l - istudji kollha damu 48 ġimgħa, u qabblu l- effikaċja ta 'Pegasys ma' dik ta 'interferon alfa- 2a.
Additional studies looking at the combination of Pegasys and ribavirin included one study comparing two doses and two durations of treatment (24 or 48 weeks) in 1,285 patients, one study comparing 16 and 24 weeks of treatment in 1,469 patients, one study in 514 patients with normal ALT levels, one study in 860 patients who were also infected with HIV, and a final study in 950 patients who did not respond to previous treatment with peginterferon alfa-2b and ribavirin.
Fost l - istudji addizzjonali li eżaminaw il- kombinazzjoni ta 'Pegasys u ribavirin hemm wieħed li qabbel iż - żewġ dożi u ż- żewġ perjodi ta' żmien tat- trattament (24 jew 48 ġimgħa) f' 1, 285 pazjent, studju minnhom qabbel it- trattament ta '16 u 24 ġimgħa ta' trattament f' 1, 469 pazjent, studju ieħor li involva 514- il pazjent b' livelli ta 'ALT normali, u studju ta' 860 pazjent li kienu wkoll infettati bl- HIV, u studju finali ta ’ 950 pazjent li ma kinux irrispondew għal trattament preċedenti b’ peginterferon alfa- 2b u ribavirin.
In chronic hepatitis B, two studies have been carried out comparing Pegasys with lamivudine (another antiviral medicine) in 820 ‘ HBeAg-positive’ patients (infected with the common type of the hepatitis B virus) and in 552 ‘ HBeAg-negative ’ patients (infected with a virus that has mutated [changed], leading to a form of chronic hepatitis B that is more difficult to treat).
Fl- epatite kronika B, iż- żewġ studji li saru qabblu Pegasys ma 'lamivudine (mediċina antivirali oħra) fi 820 pazjent' pożittivi għall- HBeAg '(infettati bit- tip komuni tal- vajrus tal- epatite B) u f' 552 pazjent' negattivi għall- HBeAg '(infettati b' vajrus li jkun għadda minn mutazzjoni [bidla], li jwassal għal forma ta' epatite kronika B li hi iktar diffiċli biex tiġi ttrattata).
In all cases, the main measure of effectiveness was the disappearance of the markers of hepatitis virus infection from the blood after treatment and at ‘ follow-up’ six months later.
Fil- każijiet kollha, il- mezz ewlieni tal- kejl tal- effikaċja kien l- għajbien ta 'markaturi tal- infezzjoni tal - vajrus tal- epatite mid- demm fl- aħħar tat- trattament u f' vista ta' kontroll wara sitt xhur.
What benefit has Pegasys shown during the studies?
X' inhu l- benefiċċju ta 'Pegasys li ntwera matul dawn l- istudji?
In chronic hepatitis C, Pegasys on its own was more effective than interferon alfa-2a.
Fl- epatite kronika Ċ, Pegasys waħdu rriżulta aktar effikaċi mill- interferon alfa- 2a.
More patients responded to treatment, with 28 to 39% of patients in the Pegasys group having no markers of hepatitis virus infection in their blood at follow-up, compared with 8 to 19% in the interferon alfa-2a group.
Iktar pazjenti rrispondew għat- trattament, b' bejn 28 u 39% tal- pazjenti fil- grupp ta 'Pegasys ma jkollhom l- ebda markatur tal- infezzjoni bil- vajrus tal- epatite fid- demm meta reġa' ġew invistati, imqabbla ma 'bejn 8 u 19% fil- grupp tal- interferon alfa- 2a.
When it was used in combination with ribavirin, Pegasys was more effective than when it was used on its own (45% responders at follow-up compared with 24%), and was as effective as the combination of interferon alfa-2a and ribavirin (39% responders).
Meta ntuża flimkien ma 'ribavirin, Pegasys kien aktar effikaċi milli meta ntuża waħdu (45% tal- pazjenti rrispondew b' mod favorevoli fil- vista ta' kontroll meta pparagunat mal- 24% qabel), u kien effikaċi daqs il- kombinazzjoni ta 'interferon alfa- 2a u ribavirin (39% rrispondew).
The additional studies confirmed the effectiveness of Pegasys, including in patients with HIV and those who did not respond to previous treatment.
L- istudji addizzjonali kkonfermaw l- effikaċja ta 'Pegasys, inkluż f' pazjenti bl- HIV u dawk li ma rrispondewx għal trattament preċedenti.
In chronic hepatitis B, Pegasys was more effective than lamivudine in both HBeAg-positive and -negative patients.
Fl- epatite kronika B, Pegasys kien iktar effikaċi minn lamivudine kemm fil- pazjenti pożittivi għall - HbeAg u kemm f' dawk negattivi għall- HBeAg.
The proportions of patients with no signs of viral activity in their blood at follow- up were 32% with Pegasys and 22% with lamivudine in the HBeAg-positive patients, and 43% with Pegasys and 29% with lamivudine in the HBeAg-negative patients.
Il- perċentwali ta 'pazjenti mingħajr sinjali ta' attività virali fid- demm waqt il- vista ta 'kontroll kienu 32% fil- każ ta' Pegasys u 22% fil- każ ta 'lamivudine fil - pazjenti pożittivi għall- HbeAg, u 43% fil- każ ta' Pegasys u 29% fil- każ ta 'lamivudine fil- pazjenti negattivi għall- HBeAg.
What is the risk associated with Pegasys?
X' inhu r- riskju assoċjat ma 'Pegasys?
The most common side effects with Pegasys (seen in more than 1 patient in 10) are anorexia (loss of appetite), headache, insomnia (difficulty sleeping), irritability, depression, dizziness, nausea (feeling sick), diarrhoea, abdominal (tummy) pain, alopecia (hair loss), pruritus (itching), myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness), pyrexia (fever), rigors (shaking chills), reactions at the site of the injection and pain.
L- effetti sekondarji l- aktar komuni b' Pegasys (li dehru f' iktar minn pazjent wieħed minn kull għaxra) kienu anoressija (nuqqas ta 'aptit), uġigħ ta' ras, insonnja (tbatija fl- irqad), irritabilità, depressjoni, sturdament, nawżea (dardir), dijarrea, uġigħ addominali (ta 'żaqq), alopeċja (waqgħa tax- xagħar), ħakk, mijalġija (uġigħ muskolari), artralġija (uġigħ fil- ġogi), għeja kbira, piressija (deni), tkexkix ta' bard (tertir), reazzjonijiet fil- punt tal- injezzjoni u wġigħ.
For the full list of all side effects reported with Pegasys, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati b 'Pegasys, ara l- Fuljett ta' Tagħrif.
Pegasys should not be used in people who may be hypersensitive (allergic) to alpha interferons or any of the other ingredients.
Pegasys ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għall- interferoni alfa jew għal xi ingredjenti ieħor.
Pegasys should not be used in: • patients with auto-immune hepatitis (when the body attacks the liver); • patients with severe liver problems; • patients with a history of severe heart disease; • HIV-infected patients with signs of serious liver disease.
Pegasys ma għandux jintuża minn: • pazjenti b' epatite awtoimmuni (meta l- ġisem jattakka l- fwied); • pazjenti bi problemi gravi fil- fwied; • pazjenti bi storja ta 'mard tal- qalb gravi; • pazjenti infettati bl- HIV b' sinjali ta' mard gravi tal- fwied.
For a list of all restrictions with Pegasys, see the Package Leaflet.
Għal- lista sħiħa ta 'restrizzjonijiet għal Pegasys, ara l- Fuljett ta' Tagħrif.
2/ 3 Why has Pegasys been approved?
2/ 3 Għaliex ġie approvat Pegasys?
The Committee for Medicinal Products for Human Use (CHMP) decided that Pegasys’ s benefits are greater than its risks for treatment of chronic hepatitis B and C.
Il- Kumitat għall- prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Pegasys huma ikbar mir- riskji tiegħu fit- trattament tal- epatite kronika B u Ċ.
The Committee recommended that Pegasys be given marketing authorisation.
Il- Kumitat irrakkomanda li Pegasys jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Pegasys:
Aktar tagħrif dwar Pegasys:
The European Commission granted a marketing authorisation valid throughout the EU for Pegasys to Roche Registration Limited on 20 June 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Pegasys lil Roche Registration Limited fl- 20 ta 'Ġunju 2002.
The marketing authorisation was renewed on 20 June 2007.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fl- 20 ta 'Ġunju 2007.
The full EPAR for Pegasys is available here.
L- EPAR sħiħ għal Pegasys jista 'jiġi kkonsultat hawn.
Pegasys 135 micrograms solution for injection
Pegasys 135 mikrogramma soluzzjoni għall- injezzjoni
peginterferon alfa-2a*.................................................................................... .135 micrograms Each vial of 1 ml solution contains 135 micrograms peginterferon alfa-2a*.
peginterferon alfa- 2a *............................................................................... 135 mikrogramma Kull kunjett ta ’ 1 ml ta ’ soluzzjoni fih 135 mikrogramma peginterferon alfa- 2a *.
The strength indicates the quantity of the interferon alfa-2a moiety of peginterferon alfa-2a without consideration of the pegylation.
Il- qawwa tindika l - kwantità tal- parti ta ’ interferon alfa- 2a ta ’ peginterferon alfa- 2a mingħajr konsiderazzjoni tal - pegilazzjoni.
*The active substance, peginterferon alfa-2a, is a covalent conjugate of the protein interferon alfa-2a produced by recombinant DNA technology in Escherichia coli with bis-[monomethoxy polyethylene glycol].
Is- sustanza attiva, peginterferon alfa- 2a, hija konjugat kovalenti tal- proteina interferon alfa- 2a magħmula permezz ta ’ teknoloġija ta ’ DNA rikombinanti f’ Escherichia coli u kkonjugata ma ’ bis - [monomethoxy polyethylene glycol].
The potency of this product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class.
Il- qawwa ta ’ dan il- prodott m’ għandiex titqabbel ma ’ dik ta ’ proteina pegilata (pegylated) jew mhux pegilata oħra ta ’ l- istess klassi terapewtika.
For more information, see section 5.1.
Għal aktar informazzjoni, ara sezzjoni 5. 1.
Benzyl alcohol (10 mg/ 1 ml)
Benzyl alcohol (10 mg / 1 ml)
The solution is clear and colourless to light yellow.
Is- soluzzjoni hija ċara u mingħajr kulur għal isfar ċar.
Pegasys is indicated for the treatment of HBeAg-positive or HBeAg-negative chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, increased ALT and histologically verified liver inflammation and/ or fibrosis (see sections 4.4 and 5.1).
Pegasys huwa indikat għall- kura ta ’ epatite B kronika pożittiva għal HBeAg jew negattiva għal HBeAg f’ pazjenti adulti b’ mard kumpensat tal- fwied u b’ evidenza ta ’ replikazzjoni virali, żieda fl- ALT u infjammazzjoni tal- fwied verifikata b’ mod istoloġiku u/ jew fibrożi (ara sezzjonijiet 4. 4 u 5. 1).
Pegasys is indicated for the treatment of chronic hepatitis C in adult patients who are positive for serum HCV-RNA, including patients with compensated cirrhosis and/ or co-infected with clinically stable HIV (see section 4.4).
Pegasys huwa indikat għall- kura ta ’ epatite Ċ kronika f’ pazjenti adulti li huma pożitivi għal HCV- RNA fis- serum, inkluż pazjenti b’ ċirrożi kumpensata u/ jew infezzjoni fl- istess waqt b’ HIV klinikament stabbli (ara sezzjoni 4. 4).
The optimal way to use Pegasys in patients with chronic hepatitis C is in combination with ribavirin.
L- aħjar mod ta ’ kif jintuża Pegasys f’ pazjenti li jbagħtu minn epatite Ċ kronika huwa meta jintuża flimkien ma ’ ribavirin.
The combination of Pegasys and ribavirin is indicated in naive patients and patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination therapy with ribavirin.
It- taħlita ta ’ Pegasys u ribavirin hija ndikata għall- pazjenti li qatt ma ħadu kura qabel u għall- pazjenti li fallew kura ta ’ qabel b’ interferon alpha (pegylated jew mhux pegylated) waħdu jew bħala terapija kombinata ma ’ ribavirin.
Monotherapy is indicated mainly in case of intolerance or contraindication to ribavirin.
Monoterapija hija indikata l- aktar f’ każ ta ’ intolleranza jew fejn hemm kontra- indikazzjoni għal ribavirin.
2 4.2 Posology and method of administration
2 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
Treatment should be initiated only by a physician experienced in the treatment of patients with hepatitis B or C.
Il- kura għandha tinbeda biss minn tabib li għandu esperjenza fil- kura ta ’ pazjenti li għandhom l- epatite B jew Ċ.
Please refer also to the ribavirin Summary of Product Characteristics (SPC) when Pegasys is to be used in combination with ribavirin.
Jekk jogħġbok irreferi wkoll għas- Sommarju tal- Karatteristiċi tal- Prodott (SPC) ta ’ ribavirin meta Pegasys jkun ser jintuża ’ flimkien ma ’ ribavirin.
Dose to be administered and duration of treatment
Doża li għandha tingħata u t- tul tal- kura
The recommended dosage and duration of Pegasys for both HBeAg-positive and HBeAg-negative chronic hepatitis B is 180 micrograms once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh.
Id- doża rakkomandata u t- tul ta ’ kura ta ’ Pegasys kemm għal epatite B kronika pożittiva għal HBeAg kif ukoll għal dik negattiva għal HBeAg hija ta ’ 180 mikrogramma darba fil- ġimgħa għal 48 ġimgħa amministrata minn taħt il- ġilda fl- addome jew fil- koxxa.
Chronic hepatitis C – treatment-naïve patients:
Epatite Ċ kronika – pazjenti li qatt ma jkunu ħadu kura qabel:
The recommended dose for Pegasys is 180 micrograms once weekly by subcutaneous administration in the abdomen or thigh given in combination with oral ribavirin or as monotherapy.
Id- doża ta ’ Pegasys rakkomandata hija ta ’ 180 mikrogrammi darba fil- ġimgħa li tingħata minn taħt il - ġilda fl- addome jew fil- koxxa flimkien ma ’ ribavirin li jittieħed mill- ħalq, jew bħala monoterapija.
The dose of ribavirin to be used in combination with Pegasys is given in Table 1.
Id- doża ta ’ ribavirin li għandha tintuża meta tingħata flimkien ma ’ Pegasys tidher f’ Tabella 1.
The ribavirin dose should be administered with food.
Id- doża ta ’ ribavirin għandha tingħata ma ’ l- ikel.
Duration of treatment
Tul tal- kura
The duration of combination therapy with ribavirin for chronic hepatitis C depends on viral genotype.
It- tul tat- terapija imħallta ma ’ ribavirin għall- epatite Ċ kronika tiddependi fuq il- ġenotip tal- virus.
Patients infected with HCV genotype 1 who have detectable HCV RNA at week 4 regardless of pre- treatment viral load should receive 48 weeks of therapy.
Pazjenti infettati b’ HCV ġenotip- 1 li għandhom HCV RNA li jista ’ jiġi osservat fir- raba ’ ġimgħa irrespettivament mill- viral load ta ’ qabel il- kura għandhom jirċievu terapija għal 48 ġimgħa.
Treatment for 24 weeks may be considered in patients infected with
Kura għal 24 ġimgħa tista ’ tkun ikkunsidrata jekk il- pazjenti huma infetti b ’
- genotype 1 with low viral load (LVL) (≤ 800,000 IU/ mL) at baseline or
- ġenotip 1 b’ viral load baxxa (LVL) (≤ 800, 000 IU/ mL) fil- linja bażi jew
- genotype 4
- ġenotip 4
who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24.
li jsiru negattivi għal HCV RNA mar- raba ’ ġimgħa u jibqgħu negattivi għal HCV RNA f’ ġimgħa 24.
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).
Iżda, tul ta ’ kura totali ta ’ 24 ġimgħa jista ’ jkun assoċjat ma ’ riskju ogħla li l- pazjent jirkadi meta mqabbel ma ’ tul ta ’ kura ta ’ 48 ġimgħa (ara sezzjoni 5. 1).
In these patients, tolerability to combination therapy and additional prognostic factors such as degree of fibrosis should be taken into account when deciding on treatment duration.
F’ dawn il- pazjenti, għandha tiġi kkunsidrata t- tollerabilità għal terapija kombinata u fatturi pronjostiċi oħra bħall- grad ta ’ fibrożi, meta tittieħed deċiżjoni dwar it- tul ta ’ kura.
Shortening the treatment duration in patients with genotype 1 and high viral load (HVL) (> 800, 000 IU/ ml) at baseline who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24 should be considered with even more caution since the limited data available suggest that this may significantly negatively impact the sustained virologic response.
Tqassir tat- tul tal- kura f’ pazjenti b’ ġenotip 1 u viral load għolja (HVL) (> 800, 000 IU/ ml) fil- linja bażi li jsiru negattivi għal HCV RNA fir- raba ’ ġimgħa u jibqgħu negattivi għal HCV RNA f’ ġimgħa 24 għandu jiġi kkunsidrat b’ aktar kawtela minħabba t- tagħrif limitat disponibbli li jissuġġerixxi li dan jista ’ jkollu effett negattiv b’ mod sinifikanti fuq ir- rispons viroloġiku sostenut.
Patients infected with HCV genotype 2 or 3 who have detectable HCV RNA at week 4, regardless of pre-treatment viral load should receive 24 weeks of therapy.
Pazjenti infettati b’ HCV ġenotip 2 jew 3 li għandhom HCV RNA li jista ’ jiġi osservat fir- raba ’ ġimgħa, irrispettivament mill- viral load ta ’ qabel il- kura għandhom jirċievu terapija għal 24 ġimgħa.
Treatment for only 16 weeks may be considered in selected patients infected with genotype 2 or 3 with LVL (≤ 800,000 IU/ mL) at baseline who become HCV negative by week 4 of treatment and remains HCV negative by week 16.
Kura għal 16- il ġimgħa biss tista ’ tiġi kkunsidrata f’ pazjenti magħżula infetti b’ ġenotip 2 jew 3 b’ LVL (≤ 800, 000 IU/ mL) fil- linja bażi li saru negattivi għal HCV mar- raba ’ ġimgħa ta ’ kura u baqgħu negattivi għal HCV sa ġimgħa 16.
Overall 16 weeks of treatment may be associated with a lower chance of response and is associated with a higher risk of relapse than a 24 week treatment duration (see section 5.1).
Kura totali ta ’ 16- il ġimgħa tista ’ tiġi assoċjata ma ’ ċans aktar baxx ta ’ rispons u ma ’ riskju ogħla ta ’ rkadar minn kura ta ’ tul ta ’ 24 ġimgħa (ara sezzjoni 5. 1).
In these patients, tolerability to combination therapy and the presence of additional clinical or prognostic factors such as degree of fibrosis should be taken into account when considering deviations from standard 24 weeks treatment duration.
F’ dawn il- pazjenti, meta jiġu kkunsidrati devjazzjonijiet mit- tul stàndard ta ’ kura ta ’ 24 ġimgħa, għandhom jitqiesu t- tollerabilità għall- kura kombinata u l- preżenza ta ’ fatturi kliniċi jew pronjostiċi oħra bħall- grad ta ’ fibrożi.
Shortening the treatment duration in patients infected with genotype 2 or 3 with HVL (> 800,000 IU/ mL) at baseline who become HCV negative by week 4 should be considered with more caution as this may significantly negatively impact the sustained virological response (see Table 1).
Tnaqqis fit- tul tal- kura f’ pazjenti infetti b’ ġenotip 2 jew 3 b’ HVL (> 800, 000 IU/ mL) fil- linja bażi li saru negattivi għal HCV mar- raba ’ ġimgħa għandu jiġi kkunsidrat b’ aktar attenzjoni minħabba li dan jista ’ jkollu impatt negattiv sinifikanti fuq ir- rispons viroloġiku sostenut (ara Tabella 1).
Available data for patients infected with genotype 5 or 6 are limited; therefore combination treatment with 1000/ 1200 mg of ribavirin for 48 weeks is recommended.
Tagħrif disponibbli għal pazjenti infetti b’ ġenotip 5 jew 6 huwa limitat; għalhekk kura kombinata b’ 1000/ 1200 mg ta ’ ribavirin għal 48 ġimgħa hija rakkomandata.
3 Table 1:
3 Tabella 1:
Dosing Recommendations for Combination Therapy for HCV Patients Genotype
Dożaġġi Rakkomandati għal Terapija Kombinata għall- Pazjenti b’ HCV Ġenotip Ġenotip 1 LVL
Pegasys Dose
Doża ta ’ Pegasys 180 mikrogramma
Ribavirin Dose
Doża ta ’ Ribavirin Tul < 75 kg = 1000 mg 24 ġimgħa jew ≥75 kg = 1200 mg
Duration
b’ RVR *
Genotype 1 LVL with RVR*
Ġenotip 1 HVL b’ RVR *
180 micrograms
180 mikrogramma
< 75 kg = 1000 mg ≥ 75 kg = 1200 mg
< 75 kg = 1000 mg 48 ġimgħa ≥75 kg = 1200 mg
24 weeks or 48 weeks
Ġenotip 4
< 75 kg = 1000 mg ≥ 75 kg = 1200 mg
< 75 kg = 1000 mg 24 ġimgħa jew ≥75 kg = 1200 mg
48 weeks
48 ġimgħa
Genotype 4 with RVR*
Ġenotip 1 jew 4
Genotype 1 or 4 without RVR*
mingħajr RVR *
Genotype 2 or 3 without RVR**
Ġenotip 2 jew 3 mingħajr RVR **
24 weeks
800 mg 24 ġimgħa
Genotype 2 or 3 LVL with RVR**
Ġenotip 2 jew 3 LVL b’ RVR **
weeks or 24 weeks
800 mg 16- il ġimgħa jew 24 ġimgħa
Genotype 2 or 3 HVL with RVR**
Ġenotip 2 jew 3 HVL b’ RVR **
800 mg
800 mg 24 ġimgħa
24 weeks
* RVR = Rispons virali rapidu (HCV RNA mhix osservata) fir- raba ’ ġimgħa u HCV RNA mhix osservata f’ ġimgħa 24;
*RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24; **RVR = rapid viral response (HCV RNA negative) by week 4 LVL= ≤ 800,000 IU/ mL; HVL= > 800,000 IU/ mL
** RVR = rispons virali rapidu (negattiv għal HCV RNA) fir- raba ’ ġimgħa LVL= ≤800, 000 IU/ mL; HVL= > 800, 000 IU/ mL
The ultimate clinical impact of a shortened initial treatment of 16 weeks instead of 24 weeks is unknown, taking into account the need for retreating non-responding and relapsing patients.
Mhux magħruf l- impatt kliniku finali ta ’ kura inizjali mqassra ta ’ 16- il ġimgħa minflok 24 ġimgħa, meta wieħed jikkunsidra l- bżonn li tikkura mill- ġdid pazjenti li ma rrispondewx għall- kura u li rkadew.
The recommended duration of Pegasys monotherapy is 48 weeks.
It- tul rakkomandat ta ’ monoterapija b’ Pegasys huwa ta ’ 48 ġimgħa.
Chronic hepatitis C – treatment-experienced patients:
Epatite Ċ kronika – pazjenti b’ esperjenza ta ’ kura:
The recommended dose of Pegasys in combination with ribavirin is 180 mcg once weekly by subcutaneous administration.
Id- doża rrakkomandata ta ’ Pegasys flimkien ma ’ ribavirin hija 180 mcg darba fil- ġimgħa permezz ta ’ għoti minn taħt il- ġilda.
For patients < 75 kg and ≥ 75 kg, 1000 mg daily and 1200 mg daily of ribavirin, respectively, should be administered.
Għall- pazjenti < 75 kg u ≥75 kg, għandhom jingħataw 1000 mg kuljum u 1200 mg kuljum ta ’ ribavirin rispettivament.
Patients who have detectable virus at week 12 should stop therapy.
Pazjenti li għandhom virus li jista ’ jiġi osservat fit- 12- il ġimgħa għandhom iwaqqfu t- terapija.
The recommended total duration of therapy is 48 weeks.
It- tul totali rrakkomandat ta ’ terapija huwa 48 ġimgħa.
If patients infected with virus genotype 1, not responding to prior treatment with PEG-IFN and ribavirin are considered for treatment, the recommended total duration of therapy is 72 weeks (see section 5.1).
Jekk pazjenti nfettati b’ virus ta ’ ġenotip 1, li ma rrispondewx għall- kura minn qabel b’ PEG- IFN u ribavirin huma kkunsidrati għall- kura, it- tul totali rrakkomandat ta ’ terapija huwa 72 ġimgħa (ara sezzjoni 5. 1).
HIV-HCV co-infection The recommended dosage for Pegasys, alone or in combination with 800 milligrams of ribavirin, is 180 micrograms once weekly subcutaneously for 48 weeks, regardless of genotype.
Infezzjoni fl- istess waqt b’ HIV- HCV Id- dożaġġ rakkomandat ta ’ Pegasys, waħdu jew f’ taħlita ma ’ 800 milligramma ribavirin, huwa ta ’ 180 mikrogramma darba fil- ġimgħa minn taħt il- ġilda għal 48 ġimgħa, indipendenti mill- ġenotip.
The safety and efficacy of combination therapy with ribavirin doses greater than 800 milligrams daily is currently being studied.
Is- sigurtà u l- effikaċja ta ’ terapija kombinata ma ’ dożi ta ’ ribavirin akbar minn 800 milligramma kuljum qed jiġu studjati.
A duration of therapy less that 48 weeks has not been adequately studied.
Tul ta ’ terapija ta ’ anqas minn 48 ġimgħa ma ġietx studjata biżżejjed.
Predictability of response and non-response – treatment-naïve patients 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 (see Tables 2 and 6).
Tbassir ta ’ rispons u ta ’ nuqqas ta ’ rispons – pazjenti li qatt ma jkunu ħadu kura qabel Effett viroloġiku bikri sat- 12- il ġimgħa, definit bħala tnaqqis ta ’ 2 log fil- viral load jew livelli ta ’ HCV RNA li ma jitkejlux kien meqjus bħala indikattiv għal rispons sostenut (ara Tabelli 2 u 6).