qanastek/EMEA-V3 huggingface dataset:
Interferon alfa-2b 3 MIU/ m2 is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution
ux (darba kull jumejn) lill- pazjenti adulti, kemm jekk jingħata bħala monoterapija kif ukoll flimkien ma ’ ribavirin.
ge administered orally in two divided doses daily with food (morning and evening).
ad Tfal ta ’ 3 snin jew akbar u adolexxenti:
(See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination lon therapy.
Interferon alfa- 2b 3 MIU/ m2 jingħata taħt il- ġilda tliet darbiet fil- ġimgħa (darba kull jumejn) flimkien mal- kapsuli ribavirin jew soluzzjoni orali li tittieħed mill- ħalq maqsuma f’ żewġ dożi kuljum ma ’ l- ikel (filgħodu u filgħaxija). ’ għ (Ara l- SPC tal- kapsuli ribavirin u l- linji gwida għal tibdil fid- dożaġġ għal terapija kombinata.
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC).
Għal pazjenti pedjatriċi li jiżnu < 47 kg jew li ma jistgħux jibilaw kapsuli, ara l- SPC tas- soluzzjoni orali ribavirin). im
Relapse patients (adults): no
Pazjenti li jirkadu (adulti):
Viraferon is given in combination with ribavirin.
Viraferon jingħata flimkien ma ’ ribavirin. li l
Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with Viraferon in combination with ribavirin for 6 months. t uc
Skond ir- riżultati ta ’ provi kliniċi, li għandhom informazzjoni għal 6 xhur ta ’ trattament, huwa rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon flimkien ma ’ ribavirin għal 6 xhur. ina
Viraferon should be rod
L- effikaċja ta ’ Viraferon tiżdied meta jkun mogħti flimkien ma ’ ribavirin.
given alone mainly in case of intolerance or contraindication to ribavirin.
Viraferon għandu jingħata waħdu l- aktar f’ każijiet ta ’ intolleranza jew ta ’ kontra- indikazzjoni għal ribavirin. diċ
Based on the results of clinical trials, in which data are available for 12 months of treatment, it is lp
Skond ir- riżultati ta ’ provi kliniċi, li għandhom informazzjoni għal 12- il xahar ta ’ trattament, huwa me
recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months. na
rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon flimkien ma ’ ribavirin għal mill- inqas 6 xhur.
Treatment should be continued for another 6-month period (i. e., a total of 12 months) in patients who exhibit negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and high pre-treatment viral load. i dic
It- trattament għandu jitkompla għal perijodu ieħor ta ’ 6 xhur (i. e., għal total ta ’ 12- il xahar) f’ pazjenti li juru HCV- RNA negattiv f’ xahar 6, u b’ ġenotip virali 1 (kif stabbilit f’ kampjun ta ’ qabel it - trattament) u b’ viral load għoli qabel it- trattament. ott
Me
Fatturi oħra ta ’ tbassir negattiv (età > 40 sena, sess maskili, fibrożi li tgħaqqad) għandhom ikunu ikkunsidrati sabiex it- terapija tkun estiża għal 12- il xahar. od
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV- RNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
Waqt provi kliniċi, il- pazjenti li ma wrewx rispons viroloġiku wara 6 xhur ta ’ trattament (HCV- RNA inqas mil- limitu li jista ’ jkun imkejjel) ma sostnewx ir- rispons viroloġiku tagħhom (HCV- RNA inqas Pr
140 It is recommended that patients be treated with Viraferon alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Huwa rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon waħdu għal mill- inqas 3 sa 4 xhur, f’ liema punt l- istat ta ’ l- HCV- RNA għandu jkun stabbilit.
s should be discontinued in these patients.
tor Rispons viroloġiku huwa definit bħala nuqqas ta ’ HCV- RNA li jista ’ jitkejjel f’ ġimgħa 12.
uth 81% for genotype 2/ 3/ 4.
aw Rispons viroloġiku wara sena 1 ta ’ trattament u 6 xhur follow- up kienu ta ’ 36% għall- ġenotip 1 u 81% għall- ġenotip 2/ 3/ 4.
myocardial infarction, severe arrhythmic disorders. lon
mhux taħt kontroll, infart mijokardjali reċenti, disturbi arritmiċi severi ’ għ
agents excluding short term corticosteroid withdrawal.
immunosoppressivi, bl- esklużjoni tat- twaqqif għal żmien qasir tal- kortikosterojdi
t uc
konvenzjonali ina
ideation or suicide attempt. rod
ħsibijiet dwar suwiċidju jew attentati ta ’ suwiċidju. diċ
Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C. lp
Ara wkoll l- SPC ta ’ ribavirin jekk l- interferon alfa- 2b se jingħata flimkien ma ’ ribavirin fil- pazjenti bl- epatite Ċ kronika. me
4.4 Special warnings and precautions for use na
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after i dic
Effetti severi tas- CNS, l- aktar dipressjoni, ħsibijiet ta ’ suwiċidju u attentati ta ’ suwiċidju dehru f’ xi pazjenti waqt terapija b’ Viraferon, u anki wara li ott
Among children and adolescents treated with Viraferon in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6-month Me
Fost it- tfal u adolexxenti kkurati b’ Viraferon ma ’ ribavirin, ħsibijiet dwar suwiċidju u attentati ta ’ suwiċidju kienu rrappurtati aktar ta ’ spiss meta mqabbla ma ’ pazjenti adulti (2. 4% vs 1%) waqt il- kura u fil- perijodu ta ’ 6 xhur follow- up ta ’ wara l - od
follow-up after treatment.
kura.
141 Patients with existence of or history of severe psychiatric conditions:
Pazjenti li jkollhom jew fil- passat kellhom kundizzjonijiet psikjatriċi severi:
The use of interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
L- użu ta ’ interferon alfa- 2b fi tfal u
Transient rashes do not necessitate interruption of treatment.
at adolexxenti li jkollhom jew fil- passat kellhom kundizzjonijiet psikjatriċi severi huwa kontra- indikat (ara sezzjoni 4. 3).
s Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon
Jekk tiżviluppa xi reazzjoni
If such a reaction develops, discontinue the medication and institute appropriate medical therapy.
tor bħal xi waħda minn dawn, waqqaf il- medikazzjoni u applika t- terapija medika xierqa.
ra with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress.
Kull pazjent li jiżviluppa anormalitajiet fil- funzjoni tal- fwied waqt it- trattament b’ Viraferon għandu jkun osservat mill- qrib u t- trattament jitwaqqaf jekk is- sinjali u s- sintomi javvanzaw.
Hypotension may occur during Viraferon therapy or up to two days post-therapy and may require supportive
ux Pressjoni baxxa ħafna tista ’ sseħħ waqt t- terapija b’ Viraferon jew sa jumejn wara, u tista ’ teħtieġ trattament ta ’ appoġġ.
Fluid replacement may be necessary.
ad Idratazzjoni xierqa għandha tkun sostnuta fil- pazjenti li qed jagħmlu terapija b’ Viraferon billi kienet innutata f’ xi pazjenti pressjoni baxxa ħafna relatata ma’ nuqqas ta ’ fluwidu.
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out. no
Tista ’ tkun meħtieġa s - sostituzzjoni tal- fluwidi. ’ għ Filwaqt li d- deni jista ’ jkun assoċjat mas- sindrome li jixbah l- influwenza li spiss tkun rrapportata waqt it- terapija bl- interferon, kawżi oħrajn ta ’ deni persistenti għandhom ikunu esklużi. im
Caution must be observed also in patients with coagulation disorders (e. g., thrombophlebitis, uc
Attenzjoni għandha wkoll tingħata lill- pazjenti bi problemi ta ’ li l
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rod
Infiltrazzjonijiet pulmonarji, pulmonite, u pnewmonja, li kultant wasslu għall- mewt, kienu innutati ina
Any patient developing fever, cough, lp
Kwalunkwe pazjent li jiżviluppa deni, sogħla, qtugħ ta ’ nifs jew sintomi oħra respiratorji għandu jitteħidlu raġġi- X tas- sider. diċ
While this has been reported more often in patients with chronic na
Filwaqt li dan kien irrappurtat aktar ta ’ spiss fil- pazjenti bl- epatite Ċ kronika ttrattati bl- interferon alpha, kien ukoll me
Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events. i dic
It- twaqqif minnufih ta ’ l- għoti ta ’ l- interferon alpha, u t- trattament bil- kortikosterojdi jidher li jgħinu biex ifejjqu l- każijiet avversi pulmonarji.
All patients Me
Każijiet avversi okulari (ara sezzjoni 4. 8) li jinkludu emorraġiji tar- retina, tikkek bojod fl- għajn, u ott
142 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
B’ mod aktar sinifikanti jistgħu jseħħu obtundation u koma, inklużi każijiet ta ’ enċefelopatija f’ xi pazjenti, ġeneralment anzjani, ittrattati b’ dożi aktar għoljin.
143 Supplemental monitoring specific for children and adolescents Thyroid Monitoring:
Aktar monitoraġġ speċifiku għal tfal u adolexxenti Monitoraġġ tat- Tirojde:
144 Interactions between Viraferon and other medicinal products have not been fully evaluated.
at Interazzjonijiet bejn Viraferon u prodotti mediċinali oħra għadhom ma kinux evalwati għal kollox.
145 In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
at Fi provi kliniċi li saru bil- popolazzjoni bl- epatite Ċ fejn il- pazjenti kienu ttrattati b’ Viraferon waħdu jew flimkien ma ’ ribavirin għal sena.
146 Common:
Komuni:
147 Very common:
tor Komuni ħafna:
148 media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
ux Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
149 breast disorders Common:
ad Komuni:
150 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Huwa maħsub li dan il- proċess huwa responsabbli, għall- inqas parzjalment, għad- diversi im
151 response 6 months after 1 year of treatment than those who took < 80% of their treatment (56% vs.
tagħhom (56% vs.
152 All Genotype 1, 4
Kollox Ġenotip 1,
153 Genotype 1 (n=92)
Ġenotip 1 (n=92)
154 for 3 months caused no remarkable toxicity.
xhur mogħtija lil xadini tar- razza cynomolgus ma kkawżat ebda tossiċità ta ’ importanza.
6.3 Shelf life
ad 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali ’ għ Sentejn
Chemical and physical in-use stability has been demonstrated for 28 days at 2ºC – 8ºC.
L- istabilità kimika u fiżika waqt l- użu intweriet għal 28 jum f’ 2ºC – 8ºC. im
From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at Me
Mill- aspett mikrobijoloġiku, ladarba jinfetaħ, il- prodott jista ’ jinħażen għall- mhux aktar minn 28 jum bejn 2ºC – 8ºC.
Other in-use storage times and conditions are the responsibility of the user.
Perijodi u kundizzjonijiet oħra tal- ħażna jkunu r- responsabbilità ta ’ min qed jużah. li l
Store in a refrigerator (2°C – 8°C).
Aħżen fi friġġ (2°C – 8°C). ina
Within its shelf-life, for the purpose of transport, the solution can be kept at or below 25ºC for a period up to seven days before use.
Viraferon diċ
Viraferon can be put back in the refrigerator at any time during this seven-day period.
jista ’ jitpoġġa lura fil- friġġ fi kwalunkwe ħin f’ dawn is- sebat ijiem.
155 If the product is not used during the seven-day period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
Jekk il- prodott ma jintużax matul dawn is- sebat ijiem, dan għandu jintrema. Jekk il- prodott ma jkunx intuża matul il- perijodu ta ’ sebat ijiem, ma jistax jitpoġġa lura fil- friġġ għal perijodu ġdid ta ’ ħażna u għandu jintrema. me
3 ml of solution (corresponding to 18 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip- off seal (aluminium) with a bonnet (polypropylene).
soluzzjoni ta ’ 3 ml (li jikkorrispondi għal 18- il MIU) f’ kunjett (ħġieġ tat- tip I), b’ tapp (lasktu halobutyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene).
ed Pack sizes of 1, 2 or 12
Pakketti ta ’ daqsijiet b’ 1, 2 jew 12 ott
Or
u od
s ori 3 ml of solution (corresponding to 18 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip- off seal (aluminium) with a bonnet (polypropylene) with 6 injection syringes, 6 injection needles and 12 cleansing swabs.
Pr
uth Pack sizes of 1 Not all pack sizes may be marketed.
Pakketti ta ’ daqsijiet b’ 1.
ra 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Please make sure to select an
Mhux il- forom kollha tad- dożaġġi u qawwiet ikunu xierqa għal xi indikazzjonijiet.
ge appropriate dosage form and strength.
Jekk jogħġbok kun żgur li tgħażel il- forma tad- dożaġġ u qawwa xierqa.
Viraferon solution for injection, may be injected directly after withdrawal of the appropriate doses from the lon vial with a sterile injection syringe.
at Viraferon, soluzzjoni għall- injezzjoni jew infużjoni, jista ’ jkun injettat immedjatament wara li jinġibdu d- dożi xierqa mill- kunjett b’ siringa ta ’ l- injezzjoni sterili.
As with all parenteral medicinal products, prior to administration inspect Viraferon, solution for injection, visually for particulate matter and discolouration.
izz Bħal f’ kull prodott mediċinali parenterali, Viraferon, soluzzjoni għall- injezzjoni jew infużjoni, għandha tkun miflija għal xi frak u għal telf ta ’ kulur qabel tingħata.
The solution should be clear and colourless. no
Is- soluzzjoni għandha tkun ċara u
Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “ How to self inject Viraferon”). t uc
Istruzzjonijiet dettaljati dwar l- użu għal taħt il- ġilda tal- prodott qed jingħataw fil- fuljett ta ’ tagħrif (irreferi għal “ Kif tinjetta lilek innifsek b’ Viraferon ”).
MARKETING AUTHORISATION HOLDER rod
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
SP Europe 73, rue de Stalle B-1180 Bruxelles lp
ux SP Europe 73, rue de Stalle B- 1180 Bruxelles
MARKETING AUTHORISATION NUMBERS
ad Il- Belġju ’ għ NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ 8.
EU/ 1/ 99/ 128/ 021 i dic
EU/ 1/ 99/ 128/ 021 EU/ 1/ 99/ 128/ 022 im
EU/ 1/ 99/ 128/ 022 EU/ 1/ 99/ 128/ 023 EU/ 1/ 99/ 128/ 024 Me
EU/ 1/ 99/ 128/ 023 EU/ 1/ 99/ 128/ 024 li l
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI ina
23 May 2005
23 Mejju 2005 diċ
156 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija me
lp i na dic Me
Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /. ott od Pr 1.
Viraferon 25 million IU/ 2.5 ml solution for injection
Viraferon 25 miljun IU/ 2. 5 ml soluzzjoni għall- injezzjoni
ed One vial of Viraferon solution for injection, multiple dose vial, contains 25 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 2.5 ml of solution.
izz Kunjett wieħed ta ’ Viraferon soluzzjoni għall- injezzjoni, kunjett b’ doża waħda, fih 25 miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 2. 5 ml ta ’ soluzzjoni.
s One ml of solution contains 10 million IU of interferon alfa-2b.
tor Millilitru wieħed fih 10 miljun IU interferon alfa- 2b.
158 develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon.
Jekk tiżviluppa intolleranza persistenti jew rikorrenti wara aġġustament xieraq fid- dożaġġ, jew il- marda tavvanza, waqqaf it- trattament b’ Viraferon.
159 It is recommended that patients be treated with Viraferon alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Huwa rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon waħdu għal mill- inqas 3 sa 4 xhur, f’ liema punt l- istat ta ’ l- HCV- RNA għandu jkun stabbilit.
160 Patients with existence of or history of severe psychiatric conditions:
Pazjenti li jkollhom jew fil- passat kellhom kundizzjonijiet psikjatriċi severi:
161 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
B’ mod aktar sinifikanti jistgħu jseħħu obtundation u koma, inklużi każijiet ta ’ enċefelopatija f’ xi pazjenti, ġeneralment anzjani, ittrattati b’ dożi aktar għoljin.
162 Supplemental monitoring specific for children and adolescents Thyroid Monitoring:
Aktar monitoraġġ speċifiku għal tfal u adolexxenti Monitoraġġ tat- Tirojde:
163 Interactions between Viraferon and other medicinal products have not been fully evaluated.
at Interazzjonijiet bejn Viraferon u prodotti mediċinali oħra għadhom ma kinux evalwati għal kollox.
164 In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
at Fi provi kliniċi li saru bil- popolazzjoni bl- epatite Ċ fejn il- pazjenti kienu ttrattati b’ Viraferon waħdu jew flimkien ma ’ ribavirin għal sena.
166 rigors, fever§, flu-like symptoms§, asthenia, irritability, chest pain, malaise Common:
aw sider, tħossok ma tiflaħx Komuni:
167 vaginitis, gastroenteritis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
ux Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
168 Common:
ad Komuni:
169 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Huwa maħsub li dan il- proċess huwa responsabbli, għall- inqas parzjalment, għad- diversi im
170 response 6 months after 1 year of treatment than those who took < 80% of their treatment (56% vs.
tagħhom (56% vs.
171 All Genotype 1, 4
Kollox Ġenotip 1,
172 Genotype 1 (n=92)
Ġenotip 1 (n=92)
173 for 3 months caused no remarkable toxicity.
xhur mogħtija lil xadini tar- razza cynomolgus ma kkawżat ebda tossiċità ta ’ importanza.
ra No studies have been conducted in juvenile animals to examine the effects of treatment with interferon alfa- 2b on growth, development, sexual maturation, and behaviour ((see section 4.4 and Rebetol SPC if Viraferon
Ma sarux studji f’ annimali ta ’ età żgħira sabiex jiġu eżaminati l- effetti tal- kura b’ interferon alfa- 2b fuq it- tkabbir, żvilupp, maturazzjoni sesswali, u imġieba (ara sezzjoni 4. 4 u l- SPC ta ’ Rebetol jekk Viraferon ikun ser jingħata ma ’ ribavirin).
174 If the product is not used during the seven-day period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
Jekk il- prodott ma jintużax matul dawn is- sebat ijiem, dan għandu jintrema. Jekk il- prodott ma jkunx intuża matul il- perijodu ta ’ sebat ijiem, ma jistax jitpoġġa lura fil- friġġ għal perijodu ġdid ta ’ ħażna u għandu jintrema. me
s ori 2.5 ml of solution (corresponding to 25 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) with 6 injection syringes, 6 injection needles and 12 cleansing swabs.
Pr
uth Pack sizes of 1 Not all pack sizes may be marketed.
Pakketti ta ’ daqsijiet b’ 1 Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
EU/ 1/ 99/ 128/ 025 i dic
EU/ 1/ 99/ 128/ 025 EU/ 1/ 99/ 128/ 026 im
EU/ 1/ 99/ 128/ 026 EU/ 1/ 99/ 128/ 027 EU/ 1/ 99/ 128/ 028 Me
EU/ 1/ 99/ 128/ 027 EU/ 1/ 99/ 128/ 028 li l
175 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija me
Viraferon 18 million IU solution for injection, multidose pen
Viraferon 18- il miljun IU soluzzjoni għall- injezzjoni, pinna b’ ħafna dożi
ed One cartridge contains 18 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1.2 ml.
izz Kull skartoċċ fih 18- il miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 1. 2 ml.
s One ml contains 15 million IU of interferon alfa-2b.
tor Millilitru wieħed fih 15- il miljun IU interferon alfa- 2b.
ori The pen is designed to deliver its contents of 18 million IU in doses ranging from 1.5 to 6 million IU.
Il- pinna hi magħmula b’ mod li tinjetta l- kontenuti tagħha ta ’ 18- il miljun IU f’ dożi fuq medda ta bejn
uth For a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
ra 3.
ux 3.
ge Solution for injection Solution is clear and colourless.
ad Soluzzjoni għall- injezzjoni Is- soluzzjoni hi ċara u bla kulur.
Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and t
It- trattament ta ’ pazjenti adulti li għandhom l- epatite B kronika assoċjata ma ’ evidenza ta ’ replikazzjoni virali ta ’ l- epatite B (preżenza ta ’ HBV- DNA u HBeAg), alanine li l
histologically proven active liver inflammation and/ or fibrosis. uc
aminotransferase (ALT) elevat u infjammazzjoni u/ jew fibrożi attiva fil- fwied li tkun konfermata b' mod istoloġiku. ina
Adult patients: rod
Pazjenti adulti:
Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4). lp
transaminases elevati mingħajr dikompensazzjoni tal- fwied u li huma pożittivi għall- HCV- RNA jew għall- anti- HCV fis- serum (ara sezzjoni 4. 4).
The best way to use Viraferon in this indication is in combination with ribavirin. na
L- aħjar mod kif tuża Viraferon f’ din l- indikazzjoni huwa flimkien ma ’ ribavirin. me
Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver i dic
Viraferon huwa intenzjonat biex jintuża, f’ kors ta ’ kombinazzjoni ma ’ ribavirin, għall- kura ta ’ tfal u adolexxenti minn 3 snin ‘ l fuq, li għandhom epatite Ċ kronika, li ma ġietx ikkurata qabel, mingħajr ott
decompensation, and who are positive for serum HCV-RNA.
dikumpensazzjoni tal- fwied, u li huma pożittivi għall- HCV- RNA.
The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load.
Id- deċiżjoni jekk għandhiex tingħata l- kura għandha tittieħed skond il- każ, billi jkun meqjus jekk hemmx avvanz tal- marda bħal infjammazzjoni epatika u fibrożi, kif ukoll fatturi ta ’ tbassir għar- rispons, ġenotip tal- HCV u viral od
(see sections 4.4, 4.8 and 5.1).
Pr
177 Not all dosage forms and strengths are appropriate for some indications.
Mhux il- forom tad- dożaġġi u qawwiet kollha jkunu xierqa għal xi indikazzjonijiet.
If adverse events develop during the course of treatment with Viraferon for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
Jekk iseħħu każijiet avversi matul il- kors tat- trattament b’ Viraferon għal kwalunkwe indikazzjoni,
If persistent or recurrent intolerance develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon.
at ibdel id- dożaġġ jew waqqaf it- terapija temporanjament sakemm il- każijiet avversi jonqsu.
At the discretion of the physician, the patient may self-administer the dose for maintenance dosage regimens
Jekk tiżviluppa intolleranza persistenti jew rikorrenti wara aġġustament xieraq fid- dożaġġ, jew il- marda
ed administered subcutaneously.
izz tavvanza, waqqaf it- trattament b’ Viraferon.
Chronic Hepatitis B:
tor Epatite B Kronika:
s subcutaneously three times a week (every other day) for a period of 4 to 6 months.
Id- dożaġġ rakkomandat huwa bejn 5 u 10 miljun IU mogħtija taħt il- ġilda tliet darbiet fil- ġimgħa (darba kull jumejn) għal perijodu ta ’ 4 sa 6 xhur.
Treatment should be
Id- doża mogħtija għanda titnaqqas b’ 50% f' każ li jseħħu problemi ematoloġiċi (ċelluli bojod tad -
uth discontinued in case of severe leukopaenia (< 1,200/ mm3), severe neutropaenia (< 750/ mm3) or severe thrombocytopaenia (< 70,000/ mm3).
It- trattament għandu jitwaqqaf f’ każijiet ta ’ lewkopenja severa (< 1, 200/ mm3), ta ’ newtropenja severa (< 750/ mm3) jew ta ’ tromboċitopenija severa (< 70, 000/ mm3).
ra For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue Viraferon therapy.
ux Għall- pazjenti kollha, jekk ma jidhirx titjib ta ’ l- HBV- DNA fis- serum wara 3 sa 4 xhur ta ’ trattament (bid- doża massima ttollerata), waqqaf it- terapija b’ Viraferon.
ge Chronic Hepatitis C:
ad Epatite Ċ Kronika:
Viraferon is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with ribavirin. lon Children 3 years of age or older and adolescents:
Viraferon jingħata taħt il- ġilda f’ doża ta ’ 3 miljun IU tliet darbiet fil- ġimgħa (darba kull jumejn) lill- pazjenti adulti, kemm jekk jingħata bħala monoterapija kif ukoll flimkien ma ’ ribavirin.
Interferon alfa-2b 3 MIU/ m2 is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution administered orally in two divided doses daily with food (morning and evening). no
Interferon alfa- 2b 3 MIU/ m2 jingħata taħt il- ġilda tliet darbiet fil- ġimgħa (darba kull jumejn) flimkien mal- kapsuli ribavirin jew soluzzjoni orali li tittieħed mill- ħalq maqsuma f’ żewġ dożi kuljum ma ’ l- ikel (filgħodu u filgħaxija). im
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC). t uc
Għal pazjenti pedjatriċi li jiżnu < 47 kg jew li ma jistgħux jibilaw kapsuli, ara l- SPC tas- soluzzjoni orali li l
Relapse patients (adults):
Pazjenti li jirkadu (adulti): ina
Viraferon is given in combination with ribavirin. rod
Viraferon jingħata flimkien ma ’ ribavirin.
Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with Viraferon in combination with ribavirin for 6 months.
Skond ir- riżultati ta ’ provi kliniċi, li għandhom informazzjoni għal 6 xhur ta ’ trattament, huwa rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon flimkien ma ’ ribavirin għal 6 xhur. diċ
Naïve patients: lp
Pazjenti naïve:
Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin. na
jingħata waħdu l- aktar f’ każijiet ta ’ intolleranza jew ta ’ kontra- indikazzjoni għal ribavirin.
recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months. dic
Skond ir- riżultati ta ’ provi kliniċi, li għandhom informazzjoni għal 12- il xahar ta ’ trattament, huwa rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon flimkien ma ’ ribavirin għal mill- inqas 6 xhur. ott
Treatment should be continued for another 6-month period (i. e., a total of 12 months) in patients who exhibit negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and Me
It- trattament għandu jitkompla għal perijodu ieħor ta ’ 6 xhur (i. e., għal total ta ’ 12- il xahar) f’ pazjenti li juru HCV- RNA negattiv f’ xahar 6, u b’ ġenotip virali 1 (kif stabbilit f’ kampjun ta ’ qabel it - od
high pre-treatment viral load.
trattament) u b’ viral load għoli qabel it- trattament.
Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months.
Fatturi oħra ta ’ tbassir negattiv (età > 40 sena, sess maskili, fibrożi li tgħaqqad) għandhom ikunu Pr
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV- RNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
Waqt provi kliniċi, il- pazjenti li ma wrewx rispons viroloġiku wara 6 xhur ta ’ trattament (HCV- RNA inqas mil- limitu li jista ’ jkun imkejjel) ma sostnewx ir- rispons viroloġiku tagħhom (HCV- RNA inqas mil- limitu li jista ’ jkun imkejjel sitt xhur wara l- waqfien tat- trattament).
178 Viraferon alone:
Viraferon waħdu:
It is recommended that patients be treated with Viraferon alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
at Huwa rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon waħdu għal mill- inqas 3 sa 4 xhur, f’ liema punt l- istat ta ’ l- HCV- RNA għandu jkun stabbilit.
Treatment should be continued in patients who exhibit negative
It- trattament għandu jitkompla fejn il- pazjenti juru
ed HCV-RNA.
izz HCV- RNA negattiv.
The efficacy and safety of Viraferon in combination with ribavirin has been
L- effikaċja u s- sigurtà ta ’ Viraferon flimkien ma ’ ribavirin kienu studjati fi tfal u
s studied in children and adolescents who have not been previously treated for chronic hepatitis C.
tor adolexxenti li ma kienux ġew ikkurati qabel għall- epatite Ċ.
ori Genotype 1:
Ġenotip 1:
Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive
Pazjenti li ma jiksbux rispons viroloġiku mat - 12- il ġimgħa x’ aktarx li ma jiksbux rispons viroloġiku sostnut (valur ta ’ tbassir negattiv 96%).
Virological response is defined as absence of detectable HCV-RNA at Week 12.
aw Rispons viroloġiku huwa definit bħala nuqqas ta ’ HCV- RNA li jista ’ jitkejjel f’ ġimgħa 12.
ra Virological responses after 1 year of treatment and 6 months of follow-up were 36% for genotype 1 and 81% for genotype 2/ 3/ 4.
ux Rispons viroloġiku wara sena 1 ta ’ trattament u 6 xhur follow- up kienu ta ’ 36% għall- ġenotip 1 u 81% għall- ġenotip 2/ 3/ 4.
ge 4.3 Contraindications lon
ad 4. 3 Kontra- indikazzjonijiet
myocardial infarction, severe arrhythmic disorders.
mhux taħt kontroll, infart mijokardjali reċenti, disturbi arritmiċi severi
agents excluding short term corticosteroid withdrawal. uc
immunosoppressivi, bl- esklużjoni tat- twaqqif għal żmien qasir tal- kortikosterojdi li l
rod
ina
ideation or suicide attempt. lp
ħsibijiet dwar suwiċidju jew attentati ta ’ suwiċidju.
Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C. na
Ara wkoll l- SPC ta ’ ribavirin jekk l- interferon alfa- 2b se jingħata me
For all patients:
Għall- pazjenti kollha: ott
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after Me
Fost it- tfal u adolexxenti kkurati b’ Viraferon od
Among children and adolescents treated with Viraferon in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6-month follow-up after treatment.
ma ’ ribavirin, ħsibijiet dwar suwiċidju u attentati ta ’ suwiċidju kienu rrappurtati aktar ta ’ spiss meta mqabbla ma ’ pazjenti adulti (2. 4% vs 1%) waqt il- kura u fil- perijodu ta ’ 6 xhur follow- up ta ’ wara l - kura.
As in adult patients, children and adolescents experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence).
Bħal f’ pazjenti adulti, tfal u adolexxenti kellhom każijiet avversi oħra (eż dipressjoni, burdati Pr
179 symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk sintomi psikjatriċi jippersistu jew imorru għall- agħar, jew jiġi mitbuħ li hemm ħsibijiet dwar suwiċidju, huwa rakkomandat li l- kura b’ Viraferon titwaqqaf, u l- pazjent jiġi segwit, b’ intervent psikjatriku kif ikun xieraq.
If a treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
at kellhom kundizzjonijiet psikjatriċi severi, din għandha tinbeda biss wara li jkun ġie żgurat li jkun hemm maniġġar terapewtiku u dijanjostiku individwali xieraq.
ed with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
izz adolexxenti li jkollhom jew fil- passat kellhom kundizzjonijiet psikjatriċi severi huwa kontra- indikat (ara sezzjoni 4. 3).
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon
tor Reazzjonijiet ta ’ sensittività eċċessiva akuta (eż. urtikarja, anġjoedima, bronkokostrizzjoni, anafilassi) għall- interferon alfa- 2b dehru f’ każijiet rari waqt it- terapija b’ Viraferon.
ra Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases, termination of Viraferon therapy.
aw Esperjenzi avversi minn moderati sa serji jistgħu jeħtieġu bidla fir- reġimen tad- dożaġġ tal- pazjent, jew f’ xi każijiet, il- waqfien tat- terapija b’ Viraferon.
Any patient developing liver function abnormalities during treatment
Kull pazjent li jiżviluppa anormalitajiet fil- funzjoni tal- fwied waqt it- trattament b’ Viraferon għandu jkun osservat mill- qrib u t- trattament jitwaqqaf jekk
ge with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress.
ux is- sinjali u s- sintomi javvanzaw.
Hypotension may occur during Viraferon therapy or up to two days post-therapy and may require supportive lon treatment.
Pressjoni baxxa ħafna tista ’ sseħħ waqt t- terapija b’ Viraferon jew sa jumejn wara, u tista ’ teħtieġ
Adequate hydration must be maintained in patients undergoing Viraferon therapy since hypotension related to fluid depletion has been seen in some patients.
Idratazzjoni xierqa għandha tkun sostnuta fil- pazjenti li qed jagħmlu terapija b’ Viraferon billi kienet ’ għ innutata f’ xi pazjenti pressjoni baxxa ħafna relatata ma’ nuqqas ta ’ fluwidu.
Fluid replacement may be necessary. no
Tista ’ tkun meħtieġa s - sostituzzjoni tal- fluwidi.
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out. t uc
Filwaqt li d- deni jista ’ jkun assoċjat mas- sindrome li jixbah l- influwenza li spiss tkun rrapportata waqt im
Viraferon must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e. g., chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis.
it- terapija bl- interferon, kawżi oħrajn ta ’ deni persistenti għandhom ikunu esklużi.
Caution must be observed also in patients with coagulation disorders (e. g., thrombophlebitis, rod
Viraferon għandu jintuża b’ attenzjoni f’ pazjenti b’ kundizzjonijiet mediċi ta ’ indeboliment, bħal dawk li l
pulmonary embolism) or severe myelosuppression.
b’ passat mediku ta ’ mard pulmonari (eż., mard pulmonari ostruttiv kroniku) jew dijabete mellitus suxxettibbli għall- ketoaċidożi.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed lp
Attenzjoni għandha wkoll tingħata lill- pazjenti bi problemi ta ’ koagulazzjoni (eż., tromboflebite, emboliżmu pulmonari) jew majelosuppressjoni serja. ina
rarely in interferon alpha treated patients, including those treated with Viraferon.
Infiltrazzjonijiet pulmonarji, pulmonite, u pnewmonja, li kultant wasslu għall- mewt, kienu innutati f’ każijiet rari fil- pazjenti ttrattati bl- interferon alpha, inklużi dawk ittrattati b’ Viraferon.
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.5).
Dawn is- sintomi kienu rrapportati aktar ta ’ spiss meta shosaikoto, mediċina tal - diċ
dyspnea or other respiratory symptoms must have a chest X-ray taken.
ħxejjex Ċiniża, ingħatat fl- istess ħin ma ’ l- interferon alpha (ara sezzjoni 4. 5).
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.
Kwalunkwe pazjent li jiżviluppa deni, sogħla, qtugħ ta ’ nifs jew sintomi oħra respiratorji għandu jitteħidlu raġġi- X tas- sider.
While this has been reported more often in patients with chronic i dic
Jekk ir- raġġi- X juri infiltrazzjonijiet pulmonarji jew hemm evidenza ta ’ ħsara fil- funzjoni tal- pulmun, me
hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
Filwaqt li dan kien irrappurtat aktar ta ’ spiss fil- pazjenti bl- epatite Ċ kronika ttrattati bl- interferon alpha, kien ukoll irrappurtat fil- pazjenti b’ mard onkoloġiku ttrattati bl- interferon alpha.
Me
It- twaqqif minnufih ta ’ l- għoti ta ’ l- interferon alpha, u t- trattament bil- kortikosterojdi jidher li jgħinu biex ifejjqu l- każijiet avversi pulmonarji. ott
Ocular adverse events (see section 4.8) including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instance after treatment with alpha interferons.
Każijiet avversi okulari (ara sezzjoni 4. 8) li jinkludu emorraġiji tar- retina, tikkek bojod fl- għajn, u mblukkar fl- arterji jew fil- vini tar- retina, kienu irrappurtati f’ każijiet rari wara t- trattament bl - od
Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with Viraferon, must have a prompt and complete eye examination.
Eżamijiet tal - Pr
Discontinuation of Viraferon should be considered in patients who develop new or worsening ophthalmological disorders.
It - twaqqif ta ’ Viraferon għandu jkun ikkunsidrat fil- pazjenti li jitfaċċawlhom jew imorrulhom għall - agħar xi problemi oftalmoloġiċi.
180 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
B’ mod aktar sinifikanti jistgħu jseħħu obtundation u koma, inklużi każijiet ta ’ enċefelopatija f’ xi pazjenti, ġeneralment anzjani, ittrattati b’ dożi aktar għoljin.
It is recommended that
at Pazjenti b’ passat mediku ta ’ insuffiċjenza tal- qalb konġestiva, infarti mijokardjali u/ jew problemi arritmiċi passati jew attwali, li jeħtieġu t- terapija b’ Viraferon, għandhom ikunu segwiti mill- qrib.
ed those patients who have pre-existing cardiac abnormalities and/ or are in advanced stages of cancer have electrocardiograms taken prior to and during the course of treatment.
izz Huwa rakkomandat li dawk il- pazjenti li għandhom anormalitajiet kardijaċi li kienu jeżistu minn qabel u/ jew jinsabu fi stadju avanzat ta ’ kankru jieħdu elettrokardjogrammi qabel u matul il- kors tat - trattament.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of Viraferon
Arritmi kardijaċi (primarjament sopraventrikulari) ġeneralment jirrispondu għat- terapija
s therapy.
tor konvenzjonali iżda jistgħu jeħtieġu t- twaqqif tat- terapija ta ’ Viraferon.
ori Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
L- ipertrigliċeridimja u l- aggravament ta ’ l- ipertrigliċeridimja, kultant b' mod serju, kienu innutati.
Monitoring of lipid levels is, therefore, recommended.
aw Huwa għalhekk rakkomandat li l- livelli tal- lipidi jkunu sorveljati b’ attenzjoni.
uth Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of Viraferon in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the
Minħabba rapporti li l- interferon alpha jħarrax il- mard psorjatiku u s- sarkojdożi f’ pazjenti li kienu jsofru bihom minn qabel, l- użu ta ’ Viraferon fil- pazjenti bi psorajiżi jew sarkojdożi hu rakkomandat
ra potential risk.
ux biss jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali.
Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney
L- informazzjoni preliminari tindika li t- terapija bl- interferon alpha hija assoċjata ma ’ rata ikbar ta ’
ge graft rejection.
ad riġett ta ’ trapjanti tal- kliewi.
The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha lon interferons.
L- iżvilupp ta ’ awtoantikorpi u problemi ta ’ awtoimmunità kienu irrappurtati waqt it- trattament bl - ’ għ interferoni alpha.
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 Chronic hepatitis C, Monotherapy (thyroid abnormalities) and section 4.8). no
Pazjenti b’ sinjali jew b’ sintomi kompatibbli ma ’ problemi ta ’ awtoimmunità għandhom ikunu evalwati b’ attenzjoni, u l- benefiċċju- riskju tat- tkomplija tat- terapija b’ interferon għandu jitqies mill- ġdid (ara wkoll sezzjoni 4. 4 Epatite Ċ kronika, Monoterpaija (anormalitajiet tat - im
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, li l
If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8). t uc
Jekk ikun hemm suspett li hemm is- sindrome VKH, il- kura kontra l- virus għandha titwaqqaf u tiġi diskussa terapija b’ kortikosterojdi (ara sezzjoni 4. 8). ina
Discontinue treatment with Viraferon in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation. rod
Waqqaf il- kura b’ Viraferon f’ pazjenti b’ epatite kronika li jiżviluppaw titwil tal- markaturi tal - koagulazzjoni li jista ’ jindika dikumpensazzjoni tal- fwied.
Chronic Hepatitis C:
Epatite Ċ Kronika: diċ
Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C. lp
Ara wkoll l- SPC ta ’ ribavirin jekk Viraferon ser jingħata flimkien ma ’ ribavirin fil- pazjenti li għandhom epatite Ċ kronika. me
patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Il- pazjenti kollha fl- istudji dwar l- epatite Ċ kronika saritilhom bijopsija tal- fwied qabel ma kienu inklużi, iżda f’ ċerti każijiet (jiġifieri l- pazjenti bil- ġenotipi 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. i dic
Għandhom ikunu kkonsultati l- linji ta ’ gwida attwali dwar it- trattament biex ikun deċiż jekk għandiex tkun meħtieġa bijopsija tal- fwied qabel il- bidu tat- trattament. ott
Infrequently, adult patients treated for chronic hepatitis C with Viraferon developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
F’ każijiet mhux tas- soltu, pazjenti ttrattati b’ Viraferon għall- epatite Ċ kronika żviluppaw anormalitajiet fit- tirojde, ipotirojdiżmu jew ipertirojdiżmu.
In clinical trials using Viraferon therapy, 2.8% patients overall developed thyroid abnormalities.
Fi provi kliniċi bl- użu tat - terapija b’ Viraferon, 2. 8% tal- pazjenti kollha żviluppaw anormalitajiet tat- tirojde.
The abnormalities were controlled by conventional therapy Me
L- anormalitajiet od
for thyroid dysfunction.
kienu kkontrollati bit- terapija konvenzjonali għall- funzjoni ħażina tat- tirojde.
The mechanism by which Viraferon may alter thyroid status is unknown.
Il- mekkaniżmu kif Viraferon jista ’ jbiddel l- istat tat- tirojde mhuwiex magħruf.
Prior to initiation of Viraferon therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
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Any thyroid abnormality detected at that time must be treated with conventional therapy.
anormalità tat- tirojde li tinstab f’ dak l- istadju trid tkun ittrattata bit- terapija konvenzjonali.
Discontinuation of
Fil- preżenza ta ’ funzjoni ħażina tat- tirojde, it- trattament b’ Viraferon jista ’ jitkompla jekk it- TSH jista ’ jinżamm fil- livelli normali bil - medikazzjoni.
181 Viraferon therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
It- twaqqif tat- terapija ta ’ Viraferon ma reġġax lura l- funzjoni ħażina tat- tirojde li seħħet matul it- trattament (ara wkoll Tfal u adolexxenti, monitoraġġ tat- Tirojde).
Approximately 12% of children treated with interferon alfa-2b and ribavirin developed increase in TSH.
Madwar 12% tat- tfal ikkurati b’ interferon alfa- 2b u ribavirin kellhom tnaqqis
Prior to initiation of Viraferon therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be
Qabel tinbeda t - terapija b’ Viraferon, il- livelli ta ’ TSH għandhom jiġu evalwati u kwalunkwe anormalità fit- tirojde
ed treated with conventional therapy.
izz għandha tiġi kkurata b’ terapija konvenzjonali.
If thyroid abnormalities are detected, the patient’ s thyroid status should be evaluated and
Jekk jinsabu anormalitajiet tat- tirojde, l- istat tat- tirojde
s treated as clinically appropriate.
tor tal- pazjent għandu jiġi evalwat u kkurat kif ikun xieraq b’ mod kliniku.
Children and adolescents should be monitored every 3 months for evidence
Tfal u adolexxenti għandhom jiġu monitorati kull 3 xhur għal evidenza ta ’ funzjoni ħażina tat- tirojde (eż TSH).
During a 1-year course of therapy there was a decrease in the rate of linear growth
Waqt kors ta ’ terapija ta ’ sena kien hemm tnaqqis fir- rata ta ’ tkabbir linejari
uth (mean percentile decrease of 9%) and a decrease in the rate of weight gain (mean percentile decrease of 13%).
aw (perċentwali medju naqas b’ 9%) u tnaqqis fir- rata ta ’ żieda fil- piż (perċentwali medju naqas b’ 13%).
However, based on interim data from a long-term follow-up study, 12 (14%) of 84 children had a > 15 percentile
Madankollu, minn dejta interim minn studju ta ’ follow- up fuq perijodu twil, 12 (14%) ta ’ l- 84 tfal kellhom > 15 perċentwali fir- rata ta ’ tkabbir linejari, li minnhom 5 (6%) tat- tfal kellhom tnaqqis ta ’
ra decrease in rate of linear growth, of whom 5 (6%) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
ux > 30 perċentwali minkejja li kienu waqqfu l- kura għal aktar minn sena.
Therefore, the
Għalhekk ir- riskju/ benefiċċju ta ’ l -
ge risk/ benefit of the combined use of interferon alfa-2b and ribavirin should be assessed in young children prior to the initiation of therapy.
ad użu kombinat ta ’ interferon alfa- 2b u ribavirin għandu jiġi evalwat fi tfal żgħar qabel tinbeda t - terapija.
There are no data on long term effects on growth and development and lon on sexual maturation.
M’ hemmx tagħrif dwar l- effetti fit- tul fuq it- tkabbir u l- iżvilupp kif ’ għ ukoll il- maturazzjoni sesswali.
Caution should be used when adding Viraferon no
Għandha tintuża im
and ribavirin to HAART therapy (see ribavirin SPC).
attenzjoni meta jiżdiedu Viraferon u ribavirin mat- terapija HAART (ara l- SPC ta ’ ribavirin).