qanastek/EMEA-V3 huggingface dataset:
Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Ara wkoll l- SPC ta ’ ribavirin jekk Viraferon ser jingħata flimkien ma ’ ribavirin fil- pazjenti li għandhom epatite Ċ kronika.
6 All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i. e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Il- pazjenti kollha fl- istudji 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.
Monotherapy:
at Monoterapija:
Infrequently, adult patients treated for chronic hepatitis C with Viraferon developed thyroid
Fi provi kliniċi bl- użu tat -
ed abnormalities, either hypothyroidism or hyperthyroidism.
izz terapija b’ Viraferon, 2. 8% tal- pazjenti kollha żviluppaw anormalitajiet tat- tirojde.
In clinical trials using Viraferon therapy, 2.8% patients overall developed thyroid abnormalities.
L- anormalitajiet kienu kkontrollati bit- terapija konvenzjonali għall- funzjoni ħażina tat- tirojde.
The abnormalities were controlled by conventional therapy for thyroid dysfunction.
Il- mekkaniżmu kif Viraferon jista ’ jbiddel l- istat tat- tirojde mhuwiex magħruf.
Prior to
Qabel tibda t- terapija b’ Viraferon għat -
s initiation of Viraferon therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating
tor trattament ta ’ l- epatite Ċ kronika, qies l- livelli ta ’ l- ormoni li jistimulaw it- tirojde (TSH) fis- serum.
Any thyroid abnormality detected at that time must be treated with conventional therapy.
Xi anormalità tat- tirojde li tinstab f’ dak l- istadju trid tkun ittrattata bit- terapija konvenzjonali.
Viraferon treatment may be initiated if TSH levels can be maintained in the normal range by medication.
It - trattament b’ Viraferon jista ’ jinbeda jekk it- TSH jista ’ jinżamm fil- livelli normali bil- medikazzjoni.
Determine TSH levels if, during the course of Viraferon therapy, a patient develops symptoms
Stabilixxi l- livelli tat- TSH jekk, matul il- kors tat- terapija b’ Viraferon, il- pazjent jiżviluppa sintomi
uth consistent with possible thyroid dysfunction.
aw konsistenti mal- possibbiltà ta ’ funzjoni ħażina tat- tirojde.
In the presence of thyroid dysfunction, Viraferon treatment may be continued if TSH levels can be maintained in the normal range by medication.
Fil- preżenza ta ’ funzjoni ħażina tat- tirojde, it- trattament b’ Viraferon jista ’ jitkompla jekk it- TSH jista ’ jinżamm fil- livelli normali bil - medikazzjoni.
Discontinuation of Viraferon therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and
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).
ra adolescents, Thyroid monitoring).
ux Aktar monitoraġġ speċifiku għal tfal u adolexxenti Monitoraġġ tat- Tirojde:
Supplemental monitoring specific for children and adolescents
Madwar 12% tat- tfal ikkurati b’ interferon alfa- 2b u ribavirin kellhom tnaqqis
ge Thyroid Monitoring:
ad fit- TSH.
Prior to initiation of Viraferon therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be lon treated with conventional therapy.
Qabel tinbeda t - terapija b’ Viraferon, il- livelli ta ’ TSH għandhom jiġu evalwati u kwalunkwe anormalità fit- tirojde għandha tiġi kkurata b’ terapija konvenzjonali.
Viraferon therapy may be initiated if TSH levels can be maintained in the normal range by medication.
Terapija b’ Viraferon tkun tista ’ tinbeda jekk il- livelli ’ għ ta ’ TSH ikunu jistgħu jinżammu fil- medda normali bil- mediċina.
If thyroid abnormalities are detected, the patient’ s thyroid status should be evaluated and treated as clinically appropriate.
Jekk jinsabu anormalitajiet tat- tirojde, l- istat tat- tirojde tal- pazjent għandu jiġi evalwat u kkurat kif ikun xieraq b’ mod kliniku.
Children and adolescents should be monitored every 3 months for evidence no
Tfal u adolexxenti għandhom jiġu monitorati kull 3 xhur għal evidenza ta ’ funzjoni ħażina tat- tirojde (eż TSH). im
During a 1-year course of therapy there was a decrease in the rate of linear growth (mean percentile decrease of 9%) and a decrease in the rate of weight gain (mean percentile decrease of t uc
Waqt kors ta ’ terapija ta ’ sena kien hemm tnaqqis fir- rata ta ’ tkabbir linejari (perċentwali medju naqas b’ 9%) u tnaqqis fir- rata ta ’ żieda fil- piż (perċentwali medju naqas b’ 13%). li l
However, based on interim data from a long-term follow-up study, 12 (14%) of 84 children had a > 15 percentile decrease in rate of linear growth, of whom 5 (6%) children had a > 30 percentile decrease despite being off rod
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 ’ ina
treatment for more than 1 year.
> 30 perċentwali minkejja li kienu waqqfu l- kura għal aktar minn sena.
Therefore, the risk/ benefit of the combined use of interferon alfa-2b and ribavirin should be assessed in young children prior lp
Għalhekk ir- riskju/ benefiċċju ta ’ l - użu kombinat ta ’ interferon alfa- 2b u ribavirin għandu jiġi evalwat fi tfal żgħar qabel tinbeda t - diċ
to the initiation of therapy.
terapija.
There are no data on long term effects on growth and development and on sexual maturation. na
M’ hemmx tagħrif dwar l- effetti fit- tul fuq it- tkabbir u l- iżvilupp kif ukoll il- maturazzjoni sesswali. me
Caution should be used when adding Viraferon i dic
Għandha tintuża attenzjoni meta jiżdiedu Viraferon u ribavirin mat- terapija HAART (ara l- SPC ta ’ ribavirin).
and ribavirin to HAART therapy (see ribavirin SPC).
jiżviluppaw anemija.
Adding treatment with alfa interferons alone or in combination with ribavirin may Me
Iż- żieda ta ’ trattament bl- interferoni alpha od
increase the risk in this patient subset.
waħidhom jew flimkien ma ’ ribavirin jista ’ jkabbar ir- riskju f’ dan il- grupp ta ’ pazjenti.
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Viraferon and ribavirin combination therapy.
snien, kienu rrappurtati f’ pazjenti li kienu qed jirċievu Viraferon u ribavirin f’ terapija kombinata.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Viraferon and ribavirin.
Minbarra hekk, ħalq xott jista ’ jgħamel ħsara lis- snien u l- membrani tal- ħalq waqt kura fuq tul ta ’ żmien bil- kombinazzjoni ta ’ Viraferon u ribavirin.
7 Laboratory Tests:
Testijiet tal- Laboratorju:
Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all patients prior to and periodically during systemic treatment with Viraferon.
Testijiet standard ematoloġiċi u tal- komponenti kimiċi tad- demm (l- għadd totali u d- differenzjal tad - demm, l- għadd tal- plejlets, l- elettroliti, l- enżimi tal- fwied, il- proteina fis- serum, il- bilirubin fis- serum u l- kreatinina fis- serum) għandhom isiru lill- pazjenti kollha qabel u b' mod perijodiku matul it -
During treatment for hepatitis B or C the recommended testing schedule is at weeks 1, 2, 4, 8, 12, 16, and
at trattament sistemiku b’ Viraferon.
ed every other month, thereafter, throughout treatment.
izz Matul it- trattament għall- epatite B jew Ċ, l- iskeda rrakkomandata għat- testijiet hija fil- ġimgħat numru 1, 2, 4, 8, 12, 16, u wara dan kull xahrejn tul iż- żmien kollu tat- trattament.
During ALT flare, liver function tests:
Jekk matul it- terapija b’ Viraferon l- ALT jogħla f’ daqqa u jilħaq jew jaqbeż id- doppju tal- livelli bażi, it- terapija b’ Viraferon
s bilirubin must be monitored at two-week intervals.
tor tista ’ titkompla sakemm ma jkunux innutati sinjali u sintomi ta ’ indebolimet qawwi tal- fwied.
ori Effect on fertility:
aw Effett fuq il- fertilità:
uth 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with
ux Narkotiċi, ipnotizzanti u sedattivi għandhom jingħataw b’ attenzjoni meta jkunu użati b' mod konkomitanti ma ’ Viraferon.
Caution must be
ad Interazzjonijiet bejn Viraferon u prodotti mediċinali oħra għadhom ma kinux evalwati għal kollox.
ge exercised when administering Viraferon in combination with other potentially myelosuppressive agents.
Għandu jkun hemm attenzjoni meta jingħata Viraferon flimkien ma ’ sustanzi oħra li jista ’ jkollhom ’ għ effett majelosuppressiv.
This must be considered during concomitant therapy lon with medicinal products metabolised by this route, such as the xanthine derivatives theophylline or aminophylline.
huma d- derivattivi ta ’ xanthine, theophylline jew aminophylline.
During concomitant therapy with xanthine agents, serum theophylline levels must be monitored and dosage adjusted if necessary. no
Matul it- terapija konkomitanti ma ’ sustanzi ta ’ xanthine, il- livelli ta ’ theophylline fis- serum iridu jkunu mkejjla, u d- dożaġġ ikun aġġustat jekk ikun meħtieġ. li l
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with Viraferon.
L- etjoloġija ina
The aetiology has not been defined.
ma kinetx mfissra.
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.4). t uc
Dawn is- sintomi kienu rrappurtati aktar ta ’ spiss meta shosaikoto, mediċina tal - ħxejjex Ċiniża, ingħatat fl- istess ħin ma ’ l- interferon alpha (ara sezzjoni 4. 4).
(Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C). rod
(Ara wkoll l- SPC ta ’ ribavirin jekk Viraferon se jingħata flimkien ma ’ ribavirin lill- pazjenti bl- epatite diċ
4.6 Pregnancy and lactation lp
4. 6 Tqala u Treddigħ me
Viraferon must be used with caution in fertile men.
Viraferon għandu jintuża b’ attenzjoni f’ irġiel fertili.
Decreased serum estradiol and progesterone concentrations have been reported in women treated with human leukocyte interferon. na
Konċentrazzjonijiet imnaqqsa ta ’ estradajol u ta ’ proġesteron fis - serum kienu rrappurtati fin- nisa ttrattati bl- interferon tal- lewkoċiti tal- bniedem. ott
There are no adequate data from the use of interferon alfa-2b in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fuq bhejjem urew ħsara fuq is- sistema riproduttiva (ara sezzjoni 5. 3).
Viraferon is to be i dic
Viraferon m’ għandux jintuża waqt it- tqala ħlief jekk il- benefiċċju potenzjali jiġġustifika r- riskju od
used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
potenzjali għall- fetu.
It is not known whether the components of this medicinal product are excreted in human milk.
Pr
Because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to initiation of Me
Minħabba l- potenzjal ta ’ reazzjonijiet avversi minn Viraferon fit- trabi li qegħdin jerdgħu, it- treddigħ għandu jitwaqqaf qabel tinbeda l- kura.
Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking Viraferon in combination with ribavirin.
Għandha tittieħed kawtela partikolari sabiex tiġi evitata t- tqala f’ pazjenti nisa jew sieħba nisa ta ’ pazjenti rġiel li jkunu qed jieħdu Viraferon f’ kombinazzjoni ma ’ ribavirin.
Male patients and their female partners must
Nisa li jista ’ jkollhom it- tfal u s- sieħba rġiel tagħhom għandhom it- tnjen li huma jużaw kontraċezzjoni effettiva waqt il- kura u fl- 4 xhur ta ’ wara t- twaqqif tal- kura.
8 each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC).
Pazjenti rġiel u s- sieħba nisa tagħhom għandhom it- tnejn li huma jużaw kontraċezzjoni effettiva waqt il- kura u għal 7 xhur wara t- twaqqif tal- kura (ara l- SPC ta ’ ribavirin).
4.7 Effects on ability to drive and use machines
at 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Patients are to be advised that they may develop fatigue, somnolence, or confusion during treatment with Viraferon, and therefore it is recommended that they avoid driving or operating machinery.
izz Il- pazjenti għandhom ikunu avżati li jista ’ jkollhom għeja kbira, nagħas jew konfużjoni waqt it - trattament b’ Viraferon, u għalhekk hu rakkomandat li jevitaw li jsuqu jew li jħaddmu xi magni.
ed 4.8 Undesirable effects
tor 4. 8 Effetti mhux mixtieqa
s See ribavirin SPC for ribavirin-related undesirable effects if Viraferon is to be administered in combination
Ara l- SPC ta ’ ribavirin għall- effetti mhux mixtieqa konnessi ma ’ ribavirin jekk Viraferon se jingħata
ori with ribavirin in patients with chronic hepatitis C.
aw flimkien ma ’ ribavirin lill- pazjenti bl- epatite Ċ kronika.
In clinical trials conducted in a broad range of indications and at a wide range of doses (from 6 MIU/ m2/ week
Fi provi kliniċi magħmula fuq firxa wiesgħa ta ’ indikazzjonijiet u b’ medda wiesgħa ta ’ dożi (minn 6 MIU/ m²/ ġimgħa għal- lewkimja tal- hairy cell sa 100 MIU/ m²/ ġimgħa għall- melanoma), l- aktar effetti
uth in hairy cell leukaemia up to 100 MIU/ m2/ week in melanoma), the most commonly reported undesirable effects were fever, fatigue, headache and myalgia.
ux mhux mixtieqa li kienu rrappurtati ta’ spiss kienu d- deni, għeja kbira, uġigħ ta ’ ras u uġigħ fil- muskoli.
ra In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
ad Fi provi kliniċi li saru bil- popolazzjoni bl- epatite Ċ fejn il- pazjenti kienu ttrattati b’ Viraferon waħdu jew flimkien ma ’ ribavirin għal sena.
All patients in these trials received 3 MIU of Viraferon three times a
Il- pazjenti kollha f’ dawn il- provi rċivew 3 MIU ta ’ Viraferon tliet darbiet fil- ġimgħa.
In Table 1 the frequency of patients reporting (treatment related) undesirable effects is presented from clinical trials in naïve patients treated for one year.
F’ Tabella 1 il- frekwenza ta ’ pazjenti li rrappurtaw effetti mhux mixtieqa ’ għ (konnessi mat- trattament) huma elenkati minn provi kliniċi f’ pazjenti naive ittrattati għal sena.
Severity was generally mild to moderate.
Is - severità kienet ġeneralment minn ħafifa għal moderata.
The adverse reactions listed in Table 1 are based on experience from clinical trials and post-marketing.
Ir- reazzjonijiet avversi elenkati f’ Tabella 1 huma bbażati fuq l- esperjenza minn provi kliniċi u ta ’ wara t- tqegħid fis- suq.
Within the organ lon system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); rarely (≥ 1/ 10,000, < 1/ 1,000); very rarely (< 1/ 10,000); not known.
li ġejjin: komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10); rari (≥1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000); mhux magħruf.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. no
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà ta ’ tagħhom.
Adverse reactions reported during clinical trials or following the marketing use of Viraferon alone or in combination with ribavirin System Organ Class
Reazzjonijiet avversi rrappurtati waqt provi kliniċi jew bl- użu wara t- tqegħid fis- suq ta ’ ina
t
Viraferon waħdu jew ma ’ ribavirin Klassi tas- Sistema ta ’ l- Organi Infezzjonijiet u infestazzjonijiet
Infections and infestations uc
Farinġite *, infezzjoni virali *
Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Pneumonia§
Bronkite, sinusite, herpes simplex (reżistenza), flissjoni Pnewmonja§
Blood and lymphatic system disorders Very common:
limfatika Komuni ħafna:
Leukopaenia Thrombocytopaenia, lymphadenopathy, lymphopenia
Lewkopenja Tromboċitopenja, limfadenopatija, limfopenija Anemija aplastika
Not known:
Disturbi fis- sistema immuni§ od
Aplastic anaemia Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Aplasja taċ- ċelluli ħomor puri, purpura tromboċitopenika idjopatika, purpura trombotika tromboċitopenika
Immune system disorders§ Very rarely:
Rari ħafna:
Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid
Sarkojdożi, tiħrax s- sarkojdożi Lupus erythematosus sistemika, vaskulite, artrite rewmatika (tibda jew taggrava), sindrome Vogt- Koyanagi- Harada,
arthritis (new or aggravated), Vogt-Koyanagi-Harada syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis§ Me
reazzjonijiet ta ’ sensittività eċċessiva akuti li jinkludu urtikarja, anġjoedema, bronkokostrizzjoni, anafilassi§ Disturbi fis- sistema endokrinarja Ipotajrojdiżmu§, ipertajrojdiżmu§ Komuni:
9 Very common:
at Rari ħafna:
Depression, insomnia, anxiety, emotional lability*, agitation, nervousness
Dipressjoni, nuqqas ta ’ rqad, ansjetà, burdati emozzjonali *,
Common:
izz aġitazzjoni, nervi Komuni:
Confusion, sleep disorder, libido decreased Suicide ideation Suicide, suicide attempts, aggressive behaviour (sometimes directed against others), psychosis including hallucinations
Konfużjoni, disturbi ta ’ l- irqad, tnaqqis fil- libido Ħsibijiet dwar suwiċidju
Not known:
tor Rari ħafna:
Mental status change§
Suwiċidju, attentati ta’ suwiċidju, imġieba aggressiva (kulltant indirizzata lejn l- oħrajn), psikożi inklużi alluċinazzjonijiet
ed Nervous system disorders§ Very common:
aw Tibdil fl- istat mentali§ Mhux magħruf Disturbi fis- sistema nervuża§ Komuni ħafna:
Dizziness, headache, concentration impaired, mouth dry Tremor, paresthesia, hypoesthesia, migraine, flushing,
Sturdament, uġigħ ta ’ ras, telf tal- konċentrazzjoni, ħalq xott Tregħid, parasteżija, ipoesteżija, emigranja, fwawar, ngħas,
ori Very rarely:
ux perverżjoni tat- togħma Rari ħafna:
Cerebrovascular haemorrhage, cerbrovascular ischaemia, seizure, impaired consciousness, encephalopathy, neuropathy, polyneuropathy
Emorraġija ċerebrovaskulari, iskemija ċerebrovaskulari, aċċessjoni, koxjenza indebolita, enċefalopatija, newropatija,
uth Not known:
ad polinewropatija Mononewropatiji, koma§ Mhux magħruf:
Mononeuropathies, coma§
’ għ
ra Common:
Rari:
Conjunctivitis, vision abnormal, lacrimal gland disorder, eye pain
Vista mċajpra Konġuntivite, vista anormali, disturbi fil- glandola tad - dmugħ, uġigħ fl- għajnejn Emoraġġiji fir- retina§, retinopatiji (inkluża edema makulari),
Rarely:
ina
Retinal haemorrhages§, retinopathies (including macular
Vertigo, tisfir fil- widnejn
Vertigo, tinnitus Hearing loss, hearing disorder no
Telf tas- smigħ, disturbi tas- smigħ
t
diċ
Palpitation, tachycardia Cardiomyopathy Myocardial infarction, cardiac ischaemia
Palpitazzjoni, takikardija Kardjomijopatija
Arrhythmia
Mhux magħruf:
Vascular disorders Common:
Disturbi vaskulari me
Hypertension Peripheral ischaemia, hypotension§
Infart majokardijaku, iskemija kardijaka Arritmija
Respiratory, thoracic and mediastinal disorders Very common:
Disturbi respiratorji, toraċiċi u medjastinali ott
Dyspnoea*, coughing*
Pressjoni għolja Iskemija periferali, pressjoni baxxa§
Common:
Komuni: od
Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive
Dispneja *, sogħla * Epistassi, disturbi respiratorji, konġestjoni fl- imnieħer, rinoreja, sogħla fil- vojt Infiltrati fil- pulmun§, pnumonite§
Nausea/ vomiting, abdominal pain, diarrhoea, stomatitis,
Tqalligħ/ rimettar, uġigħ fl- addome, dijarea, stomatite,
Common:
dispepsja Komuni:
bleeding Not known:
Mhux magħruf:
Common:
at Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ġilda Komuni ħafna:
Alopecia, pruritus*, skin dry*, rash*, sweating increased Psoriasis (new or aggravated)§, rash maculopapular, rash
Alopeċja, ħakk *, ġilda xotta *, raxx *, żieda fl- għaraq
10 erythematous, eczema, erythema, skin disorder Very rarely:
izz Psorajiżi (tibda jew taggrava) §, raxx makulopapulari, raxx Komuni: bi ħmura, ekżema, ħmura, disturbi tal- ġilda Rari ħafna:
Musculoskeletal and connective tissue disorders
Sindrome Stevens Johnson, nekroliżi tossika tal- ġilda,
Stevens Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
tor erythema multiforme Disturbi muskolu- skeletrali u tal - connective tissue
Very common:
aw Komuni ħafna:
ed Very rarely:
Rari ħafna:
Rhabdomyolysis, myositis, leg cramps, back pain
Mijalġja, artralġja, uġigħ muskoluskeletrali Artrite Rabdomajelożi, majożite, bugħawwieġ fir- riġlejn, uġigħ fid - dahar
Common:
ux Disturbi fil- kliewi u fis- sistema urinarja Komuni:
s Very rarely:
Rari ħafna:
Renal failure, renal insufficiency, nephrotic syndrome
Frekwenza ta ’ l- awrina Indeboliment renali, insuffiċjenza renali, sindrome nefrotika
ori Reproductive system and breast disorders Common:
ad Disturbi fis- sistema riproduttiva u fis - sider Komuni:
Amenorrhea, breast pain, dysmenorrhea, menorrhagia,
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
uth menstrual disorder, vaginal disorder General disorders and administration site conditions
Amenorreja, uġigħ fis- sider, dismenorreja, menorraġja, ’ għ disturbi mestrwali, disturbi fil- vaġina
ra Very common:
Komuni ħafna:
Injection site inflammation, injection site reaction*, fatigue, rigors, fever§, flu-like symptoms§, asthenia, irritability, chest pain, malaise
tas- sit mnejn tingħata l- injezzjoni *, għeja, tertir, deni§, sintomi bħal ta ’ l- influwenza§, astenja, irritabilità, uġigħ fis - sider, tħossok ma tiflaħx
ge Common:
Komuni:
Injection site pain Injection site necrosis, face oedema lon
Uġigħ tas- sit mnejn tingħata l- injezzjoni Nekrożi tas- sit mnejn tingħata l- injezzjoni, edema tal- wiċċ
*These events were only common with Viraferon alone § See section 4.4 no
* Dawn il- każijiet kienu komuni biss b’ Viraferon waħdu § Ara sezzjoni 4. 4 diċ
These undesirable effects have also been reported with Viraferon alone.
Dawn l- effetti mhux mixtieqa kienu ukoll irrappurtati ma ’ Viraferon waħdu.
Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre- t
Każijiet avversi kardjovaskulari (CVS), b' mod partikolari arritmija, dehru li kienu korrelati l- aktar me
Cardiomyopathy, that may uc
mal- mard CVS li kien jeżisti minn qabel u mat- terapija b’ sustanzi kardjotossiċi li saret qabel (ara sezzjoni 4. 4).
be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease (see section 4.4). rod
Kardjomajopatija li tista ’ tkun riversibbli bit- twaqqif ta ’ interferon alpha, kienet irrappurtata f’ każijiet rari f’ pazjenti li ma kellhomx evidenza minn qabel ta ’ mard tal- qalb (ara sezzjoni 4. 4). ott
A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies lp
Varjetà kbira ta ’ problemi awtoimmunitarji u ta ’ problemi konnessi ma ’ l- immunità kienu irrappurtati bl- interferoni alpha, u jinkludu disturbi tat- tirojde, lupus erythematosus sistemika, artrite rewmatika (tibda jew taggrava), purpura idjopatika u tromboċitopenika trombotika, vaskulite, u newropatiji li od
(see also section 4.4).
jinkludu mononewropatiji (ara wkoll sezzjoni 4. 4).
Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU na
Anormalitajiet tal- laboratorju klinikament sinifikanti, li l- aktar li jseħħu f’ dożi ta ’ aktar minn Pr
daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels. i
10 miljun IU kuljum, jinkludu t- tnaqqis fl- għadd tal- granuloċiti u taċ- ċelluli bojod tad- demm; tnaqqis fil- livell ta ’ l- emoglobina u ta ’ l- għadd tal- plejtlets; żidiet fil- livelli ta ’ alkaline phosphatase, LDH, kreatinina fis- serum u tan- nitroġenu ta ’ l- urea fis- serum.
subjects and also in some patients with chronic hepatitis B coincident with clearance of viral DNAp.
Żieda fil- livelli fis- serum ta ’ l- ALT/ AST (SGPT/ SGOT) kienu innutati bħala anormalità f’ xi suġġetti mhux bl- epatite u wkoll f’ xi pazjenti bl - epatite B kronika li kkoinċidiet mat- tneħħija tad- DNAp virali.
Me
Għas- sigurtà rigward aġenti li jistgħu jittieħdu, ara sezzjoni 4. 4
Children and adolescents – Chronic Hepatitis C In clinical trials of 118 children or adolescents 3 to 16 years of age, 6% discontinued therapy due to adverse events.
at Tfal u adolexxenti – Epatite Ċ Kronika Fi provi kliniċi b’ 118 tfal jew adolexxenti ta ’ 3 sa 16- il sena, 6% waqfu t- terapija minħabba każijiet
In general, the adverse event profile in the limited paediatric population studied was similar to that observed in adults, although there is a paediatric specific concern regarding growth inhibition as decrease in height (mean percentile decrease of growth velocity of 9%) and weight (mean percentile decrease of 13%)
B’ mod ġenerali, il- profil ta ’ każijiet avversi fil- popolazzjoni pedjatrika limitata kien jixbah lill- dak ta ’ l- adulti, għalkemm hemm tħassib speċifiku għat- tfal dwar l- inibizzjoni tat- tkabbir bħal tnaqqis fit- tul (perċentwali medja ta ’ tnaqqis fir- rata ta ’ tkabbir b’ 9%) u fil- piż (perċentwali medja ta ’
11 percentile were observed during treatment (see section 4.4).
tor tnaqqis ta ’ 13%) perċentwali dehret waqt il- kura (ara sezzjoni 4. 4).
As in adult patients, children and adolescents also experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence) (see section 4.4).
Bħal f’ pazjenti adulti, tfal u adolexxenti kellhom każijiet psikjatriċi avversi oħrajn (eż. dipressjoni, burdati emozzjonali, u ngħas)
ed The adverse reactions listed in Table 2 are based on experience from paediatric clinical trials.
ux Ir- reazzjonijiet avversi elenkati f’ Tabella 2 huma bbażati fuq esperjenza minn provi kliniċi pedjatriċi.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following
F’ kull sezzjoni ta ’ frekwenza,
s categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10).
ad l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà ta ’ tagħhom.
Within each frequency grouping, undesirable
L- effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji. ’ għ Tabella 2
ori effects are presented in order of decreasing seriousness.
Reazzjonijiet avversi irrapurtati b’ mod komuni ħafna u komuni fil- provi kliniċi pedjatriċi Komuni ħafna (≥1/ 10) - Komuni (≥1/ 100, < 1/ 10)
Table 2 Adverse reactions very commonly and commonly reported in paediatric clinical trials
Klassi tas- sistema ta ’ l -
uth Very common (≥ 1/ 10) - Common (≥ 1/ 100, < 1/ 10) System Organ Class Infection and infestations
Reazzjonijiet avversi im
Adverse Reactions
organi Infezzjonijiet u infestazzjonijiet
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection,
Infezzjoni virali, farinġite Infezzjonijiet tal- fungu, infezzjoni tal- batteri, infezzjoni fil - pulmun, otite medja, ħofra fis- snien, herpes simplex, infezzjoni
ge vaginitis, gastroenteritis Neoplasms benign, malignant and unspecified (including lon cysts and polyps) Common:
fil- passaġġ ta ’ l- awrina, gastro- enterite Neoplażmi beninni, malinni u dawk mhux speċifikati diċ
Blood and lymphatic system disorders
Disturbi tad- demm u tas - sistema limfatika me
Neoplasm (unspecified) no
Neoplażmi (mhux speċifikati)
Endocrine disorders
Disturbi fis- sistema endokrinarja ott
Anaemia, neutropaenia Thrombocytopaenia, lymphadenopathy t
Anemija, newtropenja Tromboċitopenja, limfadenopatija
Very common:
Ipotajrojdiżmu§ Komuni ħafna:
Common:
Ipertajrojdiżmu§, viriliżmu Komuni:
Metabolism and nutrition
Disturbi fil- metaboliżmu u od
disorders Very common:
n- nutrizzjoni Komuni ħafna:
Very common:
§ Disturbi psikjatriċi Komuni ħafna:
Depression, emotional lability, insomnia Suicidal ideation, aggressive reaction, confusion, behaviour disorder, agitation, somnambulism, anxiety, nervousness, sleep
Depressjoni, burdati emozzjonali, nuqqas ta ’ rqad Ħsiebijiet dwar suwiċidju, reazzjoni aggressiva, konfużjoni, disturbi fl- imġieba, aġitazzjoni, ħmar il- lejl, ansjetà, nervi, disturbi fl- irqad, ħolm anormali, apatija
Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
Uġigħ ta ’ ras, sturdament Iperkinesja, tregħid, disfonja, parasteżija, ipoesteżija,
Vascular disorders
at iperesteżija, telf tal- konċentrazzjoni, ngħas Disturbi fl- għajnejn Komuni:
Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder
Konġuntivite, uġigħ fl- għajnejn, vista anormali, disturb fil -
Respiratory, thoracic and mediastinal disorders
izz glandola ta ’ l- għajnejn Disturbi vaskulari Komuni:
Raynaud’ s disease, flushing, pallor
Marda ta ’ Raynaud, fwawar, pallidità
Gastrointestinal disorders
tor Disturbi respiratorji, toraċiċi u medjastinali Komuni:
Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhea, sneezing
Dispneja, takipneja, epistassi, sogħla, konġestjoni fl- imnieħer,
12 Very common:
aw irritazzjoni fl- imnieħer, flissjoni, għatis Disturbi gastro- intestinali Komuni ħafna:
Diarrhoea, vomiting, nausea, abdominal pain Mouth ulceration, stomatitis ulcerative, stomatitis, right upper quadrant pain, dyspepsia, glossitis, gastroesophogeal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder
Dijarea, rimettar, tqalligħ, uġigħ fl- addome Ulċeri fil- ħalq, stomatite b’ ulċera, stomatite, uġigħ fil- kwadrant
Common:
ad Disturbi fil- fwied u fil - marrara Komuni:
Hepatic function abnormal
anormali ’ għ
ed Skin and subcutaneous tissue disorders Very common:
Komuni ħafna:
s Common:
Komuni:
Photosensitivity reaction, maculopapular rash, eczema, acne, skin
Reazzjoni ta ’ fotosensittività, raxx makulopapulari, ekżema, im
ori disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased Musculoskeletal and
akne, disturbi fil- ġilda, disturbi fid- dwiefer, telf tal- lewn tal - ġilda, ħakk, ġilda xotta, ħmura, dbenġil, żieda fl- għaraq li l
uth connective tissue disorders Very common:
tal- connective tissue Komuni ħafna:
ra Common:
sistema urinarja Komuni:
ge Common:
riproduttiva u fis- sider Komuni:
General disorders and administration site conditions
me
Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder Male: testicular pain lon
Mara: amenorreja, menorraġja, disturbi mestrwali, disturbi fil - vaġina Raġel: uġigħ fit- testikoli
Very common:
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni ħafna: ott
Injection site inflammation, injection site reaction, fatigue, rigors, no
Infjammazzjoni tas- sit mnejn tingħata l- injezzjoni, reazzjoni tas -
fever§, influenza-like symptoms§, malaise, irritability
sit mnejn tingħata l- injezzjoni, għeja, tregħid, deni§, sintomi bħal ta ’ l- influwenza§, tħossok ma tiflaħx, irritabilità Komuni: od
Chest pain, asthenia, oedema, injection site pain t
Uġigħ fis- sider, astenja, edema, uġigħ tas- sit mnejn tingħata l -
Growth rate decrease (height and/ or weight decrease for age)§ uc
Pr
Injury and poisoning Common:
Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura Komuni: § Ara sezzjoni 4. 4 4. 9 Doża eċċessiva
However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close na
Madankollu, bħal f’ kull sustanza farmakoloġikament attiva, huwa indikat li jsir trattament sintomatiku
observation of the patient is indicated. i
at b’ monitoraġġi spissi tas- sinjali vitali u osservazzjoni mill- qrib tal- pazjent.
PHARMACOLOGICAL PROPERTIES dic
TAGĦRIF FARMAKOLOĠIKU
5.1 Pharmacodynamic properties Me
tor 5. 1 Tagħrif farmakodinamiku
Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques.
aw Viraferon huwa formulazzjoni sterili u stabbli ta ’ interferon alfa- 2b ippurifikat sa grad għoli ħafna magħmul bit- teknika tad- DNA rikombinanti.
It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
ux għandu ġo fih ibridu plażmidu mfassal ġenetikament imdawwar ma ’ ġene ta ’ interferon alfa- 2b minn lewkoċiti umani.
13 The activity of Viraferon is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein corresponding to 2.6 x l08 IU.
ad L- attività ta ’ Viraferon hija mfissra f’ termini ta ’ IU, u 1 mg ta ’ proteina ta ’ interferon alfa- 2b rikombinanti li tikkorrispondi għal 2. 6 x l08 IU.
International Units are determined by comparison of the activity of the recombinant interferon alfa-2b with the activity of the international reference preparation of human leukocyte interferon established by the World Health Organisation.
L- Unitajiet Internazzjonali huma stabbiliti bil- paragun bejn l- attività ta ’ l- interferon alfa- 2b rikombinanti u l- attività ta ’ preparazzjoni għar- referenza ’ għ internazzjonali ta ’ l- interferon tal- lewkoċita tal- bniedem stabbilita mill- Organizzazzjoni Dinjija tas - Saħħa.
The interferons are a family of small protein molecules with molecular weights of approximately 15,000 to 21,000 daltons.
L- interferoni huma familja ta ’ molekuli żgħar ta ’ proteina bil- piżijiet molekulari ta ’ madwar 15, 000 sa im
ed and biological inducers.
21, 000 dalton.
These three main classes are themselves not homogeneous and may contain several different molecular species of interferon.
fihom diversi speċi molekulari differenti ta ’ interferon.
s Viraferon has been classified as recombinant interferon alfa-2b.
Viraferon kienet ikklassifikata bħala interferon alfa- 2b rikombinanti. ina
ori Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface.
L- interferoni jwettqu l- attivitajiet ċellulari tagħhom billi jeħlu ma ’ reċetturi speċifiċi tal- membrana fuq il- wiċċ taċ- ċellula.
Human interferon receptors, as isolated from human lymphoblastoid (Daudi) cells, appear to be highly
Ir- reċetturi ta ’ l- interferon uman, kif iżolat miċ- ċelluli limfoblastojdi (Daudi) tal - bniedem, jidhru li huma proteini asimmetriċi ħafna.
They exhibit selectivity for human but not murine interferons, suggesting species specificity.
bniedem iżda mhux għal dawk tal- ġrieden, li jagħti ħjiel ta ’ speċifiċità għall- ispeċi.
However, certain monkey species, eg, rhesus monkeys, are susceptible to pharmacodynamic stimulation upon exposure to human type
Madankollu, ċerti speċi ta ’ xadini, eż. ix- xadini tar - razza rhesus, huma suxxettibbli għall- istimulazzjoni farmakodinamika meta jkunu esposti għall - me
ra 1 interferons.
interferoni umani tat- tip 1.
The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex
Huwa maħsub li dan il- proċess huwa responsabbli, għall- inqas parzjalment, għad- diversi ott
Any or all of these activities may contribute to interferon's therapeutic effects.
risponsi ċellulari għall- interferon, fosthom l- inibizzjoni tar- replikazzjoni tal- vajrus f 'ċelluli infettati minn vajrus, it- trażżin tal- proliferazzjoni taċ- ċelluli u attivitajiet immunomodulattivi bħal ma huma ż - żieda ta ’ l- attività fagoċitika tal- makrofaġi u ż- żieda taċ- ċitotossiċità speċifika tal- limfoċiti għaċ - od
Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and no
Pr
human cell culture systems as well as human tumour xenografts in animals.
L- interferon alfa- 2b rikombinanti wera effetti antiproliferattivi fi studji fejn intużaw kemm sistemi ta ’ kultura ta ’ ċelluli umani u ta ’ l- annimali kif ukoll xenografts ta ’ tumur uman fl- annimali.
Although the exact antiviral t uc
L- interferon alfa- 2b rikombinanti wkoll jiskoraġġixxi r- replikazzjoni virali in vitro u in vivo.
mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
Għalkemm il- metodu eżatt ta ’ l- azzjoni anti- virali ta ’ l- interferon alfa- 2b rikombinanti mhuwiex magħruf, jidher li dan ibiddel il- metaboliżmu taċ- ċellula fejn ikun.
This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell. rod
Din l- azzjoni tfixkel ir - replikazzjoni virali jew jekk ir- replikazzjoni sseħħ, il- virjoni proġeni ma jkunux jistgħu joħorġu miċ - ċellula.
Chronic hepatitis B:
at Epatite B kronika:
Current clinical experience in patients who remain on interferon alfa-2b for 4 to 6 months indicates that therapy can produce clearance of serum HBV-DNA.
izz L- esperjenza klinika attwali f’ pazjenti li jibqgħu fuq l- interferon alfa- 2b minn 4 sa 6 xhur tindika li t - terapija tista ’ tipproduċi l- eliminazzjoni ta ’ l- HBV- DNA mis- serum.
In adult patients with loss of HBeAg and HBV-DNA, a significant reduction in morbidity and mortality has lp
F’ pazjenti adulti bi tnaqqis ta ’ HBeAg u ta ’ HBV- DNA, kien innutat tnaqqis sinifikattiv fil -
been observed. na
tor morbidità u fil- mortalità.
Interferon alfa-2b (6 MIU/ m2 3 times a week for 6 months) has been given to children with chronic active hepatitis B.
Interferon alfa- 2b (6 MIU/ m² tlett darbiet fil- ġimgħa għal 6 xhur) ingħata lil tfal b’ epatite B attiva kronika.
Because of a methodological flaw, efficacy could not be demonstrated.
Barra dan it- tfal
Moreover children treated with interferon alfa-2b experienced a reduced rate of growth and some cases of depression were observed. i dic
aw ittrattati b’ interferon alfa- 2b kellhom rata mnaqqsa ta ’ tkabbir u kienu innutati xi każijiet ta ’ dipressjoni.
In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is 47%.
ux F’ pazjenti adulti li jkunu qed jirċievu interferon ma ’ ribavirin, ir- rata ta ’ rispons sostnut li nkisbet hija 47%.
Superior efficacy has been demonstrated with the combination of pegylated interferon with ribavirin Me
Effikaċja superjuri ntweriet bil- kombinazzjoni ta ’ interferon pegilat ma ’ ribavirin (rata ta ’ rispons sostnut ta ’ 61% nkisbet fi studju li sar b’ pazjenti naïve b’ doża ta ’ ribavirin > 10. 6 mg/ kg,
(sustained response rate of 61% achieved in a study performed in naïve patients with a ribavirin dose > 10.6 mg/ kg, p < 0.01).
ad p < 0. 01).
Viraferon alone or in combination with ribavirin has been studied in 4 randomised Phase III clinical trials in 2,552 interferon-naïve patients with chronic hepatitis C.
Viraferon waħdu jew flimkien ma ’ ribavirin kien studjat f’ 4 provi kliniċi ta’ Fażi III ’ għ randomised f’ 2, 552 pazjent bl- epatite Ċ kronika li qatt ma ħadu l- interferon.
The trials compared the efficacy of Viraferon used alone or in combination with ribavirin.
Il- provi qabblu l - effettività ta ’ Viraferon użat waħdu jew flimkien ma ’ ribavirin.
Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 100 copies/ ml), a liver biopsy consistent with
Il- pazjenti eliġibbli għal dawn il- provi kellhom epatite Ċ kronika kkonfermata minn analiżi pożittiva (> 100 kopji/ ml) tar- reazzjoni katina tal - im
14 a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
polimerat (PCR) HCV- RNA, bijopsija tal- fwied konsistenti ma ’ dijanjosi istoloġika ta ’ epatite kronika bla ebda kawża oħra għall- epatite kronika, u ALT fis- serum anormali. li l
Viraferon was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with ribavirin.
Viraferon ingħata f’ doża ta ’ 3 MIU tlett darbiet fil- ġimgħa bħala monoterapija jew flimkien ma ’ ribavirin.
All patients were followed for an additional 6 months after the end of treatment for the determination of sustained virologic response.
Il- pazjenti kollha kienu segwiti għal 6 xhur oħra wara t- tmiem tat- trattament biex tkun iddeterminata r- rispons ina
ed combination with ribavirin (from two studies) are shown in Table 3.
Ir- rati ta ’ rispons viroloġiku sostnuti għall- gruppi ttrattati għal sena b’ Viraferon waħdu jew flimkien ma ’ ribavirin (minn żewġ studji) huma murija f’ Tabella 3.
Co-administration of Viraferon with ribavirin increased the efficacy of Viraferon by at least two fold for the
L- għoti flimkien ta ’ Viraferon ma ’ ribavirin żied l- effettività ta ’ Viraferon f’ pazjenti naive mill- inqas diċ
s treatment of chronic heptatitis C in naïve patients.
bid- doppju għat- trattament - ta ’ l- epatite Ċ kronika.
ori factors which are known to affect response rates.
Il- ġenotip ta ’ l- HCV u l- linja bażi tal- viral load huma fatturi ta ’ pronostiċi li huma magħrufin li jaffettwaw ir- rati ta ’ rispons.
The increased response rate to the combination of Viraferon + ribavirin, compared with Viraferon alone, is maintained across all subgroups.
Ir- rata ogħla ta ’ rispons għall- kumbinazzjoni ta ’ Viraferon + ribavirin, imqabbla ma ’ Viraferon waħdu, tibqa ’ ogħla fis- sotto - me
uth (genotype 1 and high virus load) (Table 3).
gruppi kollha.
Regardless of genotype, patients who received
Irrispettiv mill - ott
ra Viraferon in combination with ribavirin and received ≥ 80% of their treatment had a higher sustained response 6 months after 1 year of treatment than those who took < 80% of their treatment (56% vs.
ġenotip, il- pazjenti li rċivew Viraferon flimkien ma ’ ribavirin u rċivew ≥ 80% tat- trattament tagħhom kellhom rispons sostnut ogħla 6 xhur wara sena ta ’ trattament minn dawk li ħadu < 80% tat- trattament tagħhom (56% vs.
32% in trial C/ I98-580).
32% fil- prova C/ I98- 580). od Pr
Sustained virologic response rates with Viraferon + ribavirin (one year of treatment) by genotype and viral load
Rati ta ’ rispons viroloġiku sostnut b’ Viraferon + ribavirin (sena waħda ta ’ trattament) skond il- ġenotip u l- viral load
HCV Genotype
at I/ R Ġenotip ta ’ l -
I/ R
HCV
C95-132/ I95-143 C95-132/ I95-143
C95- 132/ I95- 143
ed All Genotypes
izz Il- Ġenotipi kollha
s ori Genotype 1
tor Ġenotip 1
uth Genotype 1 ≤ 2 million copies/ ml Genotype 1
aw Ġenotip 1 ≤ 2 miljun kopja/ ml Ġenotip 1
ra > 2 million copies/ ml
ux > 2 miljun kopji/ ml
ge Genotype 2/ 3
ad Ġenotip 2/ 3
I Viraferon (3 MIU 3 times a week) lon I/ R Viraferon (3 MIU 3 times a week) + ribavirin (1,000/ 1,200 mg/ day)
I/ R Viraferon (3 MIU 3 darbiet fil- ġimgħa) + ribavirin (1, 000/ 1, 200 mg/ jum)
HCV/ HIV Co-infected patients Two trials have been conducted in patients co-infected with HIV and HCV.
Pazjenti ko - infettati b’ HCV/ HIV Saru żewġ provi f’ pazjenti ko- infettati b’ HIV u HCV.
Overall, in both studies, patients no
B’ mod globali, fiż- żewġ studji, il- pazjenti li im
who received Viraferon plus ribavirin, were less likely to respond than patients who received pegylated interferon alfa-2b with ribavirin.
rċievew Viraferon flimkien ma ’ ribavirin, kellhom anqas ċans li jkollhom rispons minn pazjenti li rċievew interferon alfa- 2b pegilat flimkien ma ’ ribavirin.
Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated t
Studju 1 (RIBAVIC; P01017) kien studju randomized, multiċentriku li ingaġġa 412 pazjent adult li ma kienux ingħataw kura minn qabel b’ epatite Ċ kronika li kienu ko- infettati li l
Patients were randomized to receive uc
Il- pazjenti kienu randomized biex jirċievu interferon alfa- 2b pegilat (1. 5 µg/ kg/ ġimgħa) flimkien ma ’ ribavirin (800 mg/ jum) jew inkella Viraferon (3 MIU TIW) flimkien ma ’ ribavirin ina
either pegylated interferon alfa-2b (1.5 µg/ kg/ week) plus ribavirin (800 mg/ day) or Viraferon (3 MIU TIW) plus ribavirin (800 mg/ day) for 48 weeks with a follow-up period of 6 months.
(800 mg/ jum) għal 48 ġimgħa b’ perijodu ta ’ follow- up ta ’ 6 xhur.
Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C rod
Studju 2 (P02080) kien studju randomised, f’ ċentru wieħed li ingaġġa 95 pazjent adult li ma kienux ingħataw kura minn qabel b’ epatite Ċ kronika li kienu ko- infettati b’ HIV.
The duration of therapy was 48 weeks with a lp
Il- pazjenti kienu randomised sabiex jirċievu interferon alfa- 2b pegilat (100 or 150 µg / ġimgħa skond il- piż) flimkien ma ’ ribavirin (800- 1, 200 mg/ jum skond diċ
follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
It - terapija damet 48 ġimgħa b’ perijodu ta ’ follow- up ta ’ 6 xhur ħlief għall- pazjenti li kienu infettati b’ ġenotipi 2 jew 3 u viral load < 800, 000 IU/ ml (Amplicor) li kienu kkurati għal 24 ġimgħa b’ perijodu me
dic
ta 6 xhur follow- up. ott od Pr Tabella 4
i
Rispons viroloġiku sostnut ibbażat fuq il- ġenotip wara Viraferon flimkien ma ’ ribavirin kontra interferon alfa- 2b pegilat flimkien ma ’ ribavirin f’ pazjenti ko- infettati b’ HCV/ HIV
16 Table 4
Studju 11
Study 11
interferon
Study 22 pegylated
Studju 22
interferon
izz alfa- 2b pegilat( 100
alfa-2b (100
jew 150c
alfa-2b
alfa- 2b pegilat
(1.5 µg/ kg/
(1. 5 µg/ kg /
150c µg/ week) (3 MIU TIW)
µg/ ġimgħa) +
ori
(3 MIU TIW)
(3 MIU TIW) +
MIU TIW) +
(800-
Valur
valuea
(800 mg)
1,200 mg)d 1,200 mg)d
(800 mg)
uth All Genotype 1, 4
Kollox Ġenotip 1,
ra Genotype 2, 3
Ġenotip 2, 3
MIU = million international units; TIW = three times a week.
ad MIU = miljun unit internazzjonali; TIW = tlett darbiet fil- ġmgħa. a: valur p bażat fuq test Cochran- Mantel Haenszel Chi square. b: valur p bażat fuq it- test chi- square.
ge a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/ week pegylated interferon alfa-2b and subjects ≥ 75 kg received 150 µg/ week pegylated interferon alfa-2b. lon d: ribavirin dosing was 800 mg for patients< 60 kg, 1,000 mg for patients 60- 75 kg, and 1,200 mg for patients > 75 kg.
c: individwi < 75 kg irċievew 100 µg/ ġimgħa interferon alfa- 2b pegilat u individwi ≥ 75 kg irċevew 150 µg/ week interferon alfa- 2b pegilat. d: dożi ta ’ ribavirin kien 800 mg għal pazjenti < 60 kg, 1, 000 mg għal pazjenti 60- 75 kg, u 1, 200 mg għal pazjenti > 75 kg. im
F27-F36. no
F27- F36. li l
A total of 345 interferon alpha relapse patients were treated in two clinical trials with t
Total ta ’ 345 pazjent ta ’ l- interferon alpha li rkadew kienu ittrattati f’ żewġ provi kliniċi bil- monoterapija b’ Viraferon jew flimkien ma ’ ribavirin.
In these patients, the addition of ribavirin to uc
F’ dawn il- pazjenti, meta ribavirin ingħata ma ’ Viraferon żied b ’ 10 darbiet l- effettività ta ’ Viraferon użat waħdu fit- trattament ta ’ l - ina
Viraferon increased by as much as 10-fold the efficacy of Viraferon used alone in the treatment of chronic hepatitis C (48.6% vs.
epatite Ċ kronika (48. 6% vs.
This enhancement in efficacy included loss of serum HCV (< 100 copies/ ml by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when rod
Dan it- titjib fl- effettività kien jinkludi t- tnaqqis ta ’ l- HCV fis - serum (< 100 kopja/ ml bil- PCR), it- titjib fl- infjammazzjoni epatika, u n- normalizzazzjoni ta ’ l- ALT, u kien sostnut meta mkejjel 6 xhur wara t- tmiem tat- trattament. diċ
measured 6 months after the end of treatment.
Dejta dwar l- effikaċja fuq Tul ta ’ Żmien Fi studju kbir, 1, 071 pazjent ħadu sehem wara kura fi studju b’ interferon alfa- 2b mhux pegilat jew b’ interferon alfa- 2b mhux pegilat/ ribavirin sabiex jiġi evalwat kemm idum ir- rispons viroloġiku me