qanastek/EMEA-V3 huggingface dataset:
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 t
Viraferon għandu jintuża b’ attenzjoni f’ pazjenti b’ kundizzjonijiet mediċi ta ’ indeboliment, bħal dawk b’ passat mediku ta ’ mard pulmonari (eż., mard pulmonari ostruttiv kroniku) jew dijabete mellitus suxxettibbli għall- ketoaċidożi.
pulmonary embolism) or severe myelosuppression.
Attenzjoni għandha wkoll tingħata lill- pazjenti bi problemi ta ’ koagulazzjoni (eż., tromboflebite, emboliżmu pulmonari) jew majelosuppressjoni serja. li l
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rod
L- etjoloġija ina
The aetiology has not been defined.
ma kinetx definita.
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.
dyspnea or other respiratory symptoms must have a chest X-ray taken.
il- pazjent għandu jkun osservat mill- qrib, u, jekk meħtieġ, jitwaqqaf l- interferon alpha.
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.
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.
While this has been reported more often in patients with chronic na
It- twaqqif minnufih ta ’ l- għoti me
Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events. i dic
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 mblukkar fl- arterji jew fil- vini tar- retina, kienu irrappurtati f’ każijiet rari wara t- trattament bl - ott
should have a baseline eye examination.
Kull pazjent għandu jsirlu eżami tal- linja bażi ta ’ l- għajnejn.
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 - od
Periodic visual examinations during Viraferon therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
vista regolari waqt it- terapija b’ Viraferon huma rakkomandati speċjalment f’ pazjenti li għandhom problemi li jistgħu jkunu assoċjati mar- retinopatija, bħad- dijabete mellitus u l- pressjoni għolja.
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 - Pr
85 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.
Adult patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders, who require Viraferon therapy, must be closely monitored.
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.
It is recommended that those patients who have pre-existing cardiac abnormalities and/ or are in advanced stages of cancer have
at 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 -
ed electrocardiograms taken prior to and during the course of treatment.
izz trattament.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of Viraferon therapy.
Arritmi kardijaċi (primarjament sopraventrikulari) ġeneralment jirrispondu għat- terapija konvenzjonali iżda jistgħu jeħtieġu t- twaqqif tat- terapija ta ’ Viraferon.
s ori Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
tor L- ipertrigliċeridimja u l- aggravament ta ’ l- ipertrigliċeridimja, kultant b' mod serju, kienu innutati.
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 potential risk.
aw 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 biss jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali.
ra Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
ux L- informazzjoni preliminari tindika li t- terapija bl- interferon alpha hija assoċjata ma ’ rata ikbar ta ’ riġett ta ’ trapjanti tal- kliewi.
ge The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
ad L- iżvilupp ta ’ awtoantikorpi u problemi ta ’ awtoimmunità kienu irrappurtati waqt it- trattament bl - interferoni alpha.
Patients predisposed to the development of autoimmune disorders may be at increased risk. lon 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).
Pazjenti b’ sinjali jew b’ sintomi kompatibbli ma ’ problemi ta ’ awtoimmunità ’ għ 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 - tirojde) u sezzjoni 4. 8).
Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C no
Każijiet tas- sindrome Vogt- Koyanagi- Harada (VKH) kienu rrappurtati f’ pazjenti b’ epatite Ċ kronika im
treated with interferon.
kkurati b’ interferon.
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. diċ
Current na
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 me
treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment. i
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.
Infrequently, adult patients treated for chronic hepatitis C with Viraferon developed thyroid dic
Fi provi kliniċi bl- użu tat - ott
abnormalities, either hypothyroidism or hyperthyroidism.
terapija b’ Viraferon, 2. 8% tal- pazjenti kollha żviluppaw anormalitajiet tat- tirojde.
Prior to Me
Qabel tibda t- terapija b’ Viraferon għat - od
initiation of Viraferon therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
trattament ta ’ l- epatite Ċ kronika, qies l- livelli ta ’ l- ormoni li jistimulaw it- tirojde (TSH) fis- serum.
Viraferon treatment may be initiated if TSH levels can be maintained in the normal range by medication.
Pr
Determine TSH levels if, during the course of Viraferon therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
Stabilixxi l- livelli tat- TSH jekk, matul il- kors tat- terapija b’ Viraferon, il- pazjent jiżviluppa sintomi konsistenti mal- possibbiltà ta ’ funzjoni ħażina tat- tirojde.
Discontinuation of 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).
86 Supplemental monitoring specific for children and adolescents Thyroid Monitoring:
Aktar monitoraġġ speċifiku għal tfal u adolexxenti Monitoraġġ tat- Tirojde:
Prior to initiation of Viraferon therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Qabel tinbeda t - terapija b’ Viraferon, il- livelli ta ’ TSH għandhom jiġu evalwati u kwalunkwe anormalità fit- tirojde
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 ta ’ TSH ikunu jistgħu jinżammu fil- medda normali bil- mediċina.
Thyroid dysfunction during treatment with interferon alfa-2b and ribavirin has
Dehret funzjoni ħażina tat- tirojde
ed been observed.
izz waqt il- kura b’ interferon alfa- 2b u ribavirin.
s ori Growth and Development:
tor Tkabbir u Żvilupp:
However,
Kien nutat li dawn it- tendenzi reġgħu lura b’ mod ġenerali waqt is- 6 xhur ta ’ follow- up wara l- kura.
uth 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 treatment for more than 1 year.
aw 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 ’ > 30 perċentwali minkejja li kienu waqqfu l- kura għal aktar minn sena.
In addition, preclicinal juvenile toxicity results have demonstrated a minor,
Minbarra hekk, riżultati ta ’ qabel l- użu kliniku dwar tossiċità fiż- żgħażagħ wrew tnaqqis minuri, relatat mad- doża fit- tkabbir
ra dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3).
ux globali fil- firien tat- twelid li ngħataw ribavirin (ara sezzjoni 5. 3).
Therefore, the risk/ benefit of the combined use of interferon alfa-2b and ribavirin should be assessed in young children prior to the initiation of therapy.
Għalhekk ir- riskju/ benefiċċju ta ’ l - użu kombinat ta ’ interferon alfa- 2b u ribavirin għandu jiġi evalwat fi tfal żgħar qabel tinbeda t - terapija.
Physicians are advised to monitor the growth of children taking ribavirin in
It- tobba huma konsiljati dsabiex jimmonitoraw it- tkabbir ta ’ tfal li jkunu qed jieħdu ribavirin
ge combination with interferon alfa-2b.
ad flimkien ma ’ interferon alfa- 2b.
Patients co-infected with HIV and
M’ hemmx tagħrif dwar l- effetti fit- tul fuq it- tkabbir u l- iżvilupp kif ukoll il- maturazzjoni sesswali. ’ għ Ko- infezzjoni bl- HCV/ HIV:
(HAART) may be at increased risk of developing lactic acidosis.
Pazjenti ko- infettati bl- HIV u li qed jirċievu Terapija Anti- Retrovirali Attiva Ħafna (HAART) jista ’ jkollhom riskju akbar li jiżviluppaw l- aċidożi lattika.
Caution should be used when adding Viraferon and ribavirin to HAART therapy (see ribavirin SPC).
Għandha tintuża attenzjoni meta jiżdiedu Viraferon u ribavirin mat- terapija HAART (ara l- SPC ta ’ ribavirin).
Patients treated with Viraferon and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia. no
Pazjenti kkurati b’ Viraferon u ribavirin f’ terapija kombinata u zidovudine jista ’ jkollhom riskju akbar li im
Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset. t uc
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.
Mard tas- snien u madwar is- snien, li jista ’ jwassal għal telf tas - ina
combination of Viraferon and ribavirin.
snien, kienu rrappurtati f’ pazjenti li kienu qed jirċievu Viraferon u ribavirin f’ terapija kombinata.
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards. lp
din ir- reazzjoni, għandhom jingħataw parir sabiex jaħslu ħalqhom sew wara.
Laboratory Tests:
Testijiet tal- Laboratorju: me
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. i dic
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 - trattament sistemiku b’ Viraferon. ott
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 od
bilirubin must be monitored at two-week intervals.
tista ’ titkompla sakemm ma jkunux innutati sinjali u sintomi ta ’ indebolimet qawwi tal- fwied.
Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with Viraferon.
Narkotiċi, ipnotizzanti u sedattivi għandhom jingħataw b’ attenzjoni meta jkunu użati b' mod konkomitanti ma ’ Viraferon.
87 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.
Caution must be exercised when administering Viraferon in combination with other potentially myelosuppressive agents.
izz Għandu jkun hemm attenzjoni meta jingħata Viraferon flimkien ma ’ sustanzi oħra li jista ’ jkollhom effett majelosuppressiv.
Interferons may affect the oxidative metabolic process.
tor L- interferoni jistgħu jaffettwaw il- proċess metaboliku ossidattiv.
During concomitant therapy with xanthine agents, serum theophylline levels must be
Matul it- terapija konkomitanti ma ’ sustanzi ta ’ xanthine, il- livelli ta ’ theophylline fis- serum iridu jkunu mkejjla, u d- dożaġġ ikun aġġustat
ed monitored and dosage adjusted if necessary.
aw jekk ikun meħtieġ.
s rarely in interferon alpha treated patients, including those treated with Viraferon.
Infiltrazzjonijiet pulmonarji, pulmonite, u pnewmonja, li xi kultant wasslu għall- mewt, kienu innutati f’ każijiet rari fil- pazjenti ttrattati bl- interferon alpha, inklużi dawk ittrattati b’ Viraferon.
The aetiology has not been
L- etjoloġija
ori defined.
ux 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).
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).
uth (Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C).
ad (Ara wkoll l- SPC ta ’ ribavirin jekk Viraferon se jingħata flimkien ma ’ ribavirin lill- pazjenti bl- epatite Ċ kronika). ’ għ Tqala u Treddigħ 4. 6
ra 4.6 Pregnancy and lactation
Viraferon għandu jintuża b’ attenzjoni f’ irġiel fertili.
Viraferon must be
serum kienu rrappurtati fin- nisa ttrattati bl- interferon tal- lewkoċiti tal- bniedem.
Decreased serum estradiol and progesterone concentrations have been reported in women treated with human leukocyte interferon. lon There are no adequate data from the use of interferon alfa-2b in pregnant women.
Studji fuq bhejjem li l
Studies in animals have shown reproductive toxicity (see section 5.3).
urew ħsara fuq is- sistema riproduttiva (ara sezzjoni 5. 3).
Viraferon is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. no
Viraferon m’ għandux jintuża waqt it- tqala ħlief jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali għall- fetu. ina
Because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to initiation of treatment. t uc
Minħabba l- potenzjal ta ’ reazzjonijiet avversi minn Viraferon fit- trabi li qegħdin jerdgħu, it- treddigħ għandu jitwaqqaf qabel tinbeda l- kura. diċ
Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking Viraferon in combination with rod
Għandha tittieħed kawtela me
ribavirin.
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 each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see lp
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). ott
4.7 Effects on ability to drive and use machines na
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni od
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. i dic
Pr
See ribavirin SPC for ribavirin-related undesirable effects if Viraferon is to be administered in combination Me
Ara l- SPC ta ’ ribavirin għall- effetti mhux mixtieqa konnessi ma ’ ribavirin jekk Viraferon se jingħata flimkien ma ’ ribavirin lill- pazjenti bl- epatite Ċ kronika.
88 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.
All patients in these trials received 3 MIU of Viraferon three times a week.
Il- pazjenti kollha f’ dawn il- provi rċivew 3 MIU ta ’ Viraferon
The adverse reactions listed in Table 1 are based on experience from clinical trials and post-marketing.
tor huma bbażati fuq l- esperjenza minn provi kliniċi u ta ’ wara t- tqegħid fis- suq.
Within the organ 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
Fost il- klassijiet tas - sistemi ta ’ l- organi, ir- reazzjonijiet avversi huma elenkati taħt it- titli tal- frekwenza skond il- kategoriji 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.
ed known.
aw skond is- serjetà ta ’ tagħhom.
Adverse reactions reported during clinical trials or following the marketing use of Viraferon
Reazzjonijiet avversi rrappurtati waqt provi kliniċi jew bl- użu wara t- tqegħid fis- suq ta ’
s alone or in combination with ribavirin
ux Viraferon waħdu jew ma ’ ribavirin Klassi tas- Sistema ta ’ l- Organi Infezzjonijiet u infestazzjonijiet
Very common:
ad Komuni ħafna:
uth Common:
Komuni:
Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Pneumonia§
Farinġite *, infezzjoni virali * Bronkite, sinusite, herpes simplex (reżistenza), flissjoni Pnewmonja§ ’ għ
Very rarely:
Lewkopenja
Leukopaenia Thrombocytopaenia, lymphadenopathy, lymphopenia Aplastic anaemia
im
ge Not known:
Komuni:
Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid arthritis (new or aggravated), Vogt-Koyanagi-Harada syndrome, acute hypersensitivity reactions including no
Tromboċitopenja, limfadenopatija, limfopenija Anemija aplastika Aplasja taċ- ċelluli ħomor puri, purpura tromboċitopenika idjopatika, purpura trombotika tromboċitopenika
Endocrine disorders
Disturbi fis- sistema immuni§ Rari ħafna:
urticaria, angioedema, bronchoconstriction, anaphylaxis§
Sarkojdożi, tiħrax s- sarkojdożi
Common:
Mhux magħruf:
Hypothyroidism§, hyperthyroidism§
Disturbi fis- sistema endokrinarja Ipotajrojdiżmu§, ipertajrojdiżmu§ Komuni:
Diabetes, aggravated diabetes
Dijabete, dijabete taggrava
Metabolism and nutrition disorders Very common:
Disturbi fil- metaboliżmu u n - nutrizzjoni Komuni ħafna:
Very rarely:
Rari ħafna: ott
Hypocalcaemia, dehydration, hyperuricemia, thirst Hyperglycaemia, hypertriglyceridaemia§, increased appetite
Anoressija Ipokalċimija, deidratazzjoni, iperuriċemija, għatx Ipergliċemija, ipertrigliċeridemija§, żieda fl- aptit
Very common:
Disturbi psikjatriċi§ Komuni ħafna: od
Depression, insomnia, anxiety, emotional lability*,
Dipressjoni, nuqqas ta ’ rqad, ansjetà, burdati emozzjonali *, aġitazzjoni, nervi
agitation, nervousness Common:
Komuni:
Suicide, suicide attempts, aggressive behaviour (sometimes directed against others), psychosis including hallucinations
Konfużjoni, disturbi ta ’ l- irqad, tnaqqis fil- libido Ħsibijiet dwar suwiċidju Suwiċidju, attentati ta’ suwiċidju, imġieba aggressiva
§ Nervous system disorders Very common:
(kulltant indirizzata lejn l- oħrajn), psikożi inklużi alluċinazzjonijiet 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, perverżjoni tat- togħma
somnolence, taste perversion Very rarely:
Rari ħafna:
Not known:
at polinewropatija Mononewropatiji, koma§ Mhux magħruf:
Very common:
izz Komuni ħafna:
Vision blurred Conjunctivitis, vision abnormal, lacrimal gland disorder, eye
Vista mċajpra Konġuntivite, vista anormali, disturbi fil- glandola tad - dmugħ, uġigħ fl- għajnejn
Retinal haemorrhages§, retinopathies (including macular oedema), retinal artery or vein obstruction§, optic neuritis, papilloedema, loss of visual acuity or visual field, cotton- wool spots§
tor Emoraġġiji fir- retina§, retinopatiji (inkluża edema makulari), Rari: ostruzzjoni fl- arterja jew vina tar- retina§, nevrite ottika, papilledema, tnaqqis fl- akutezza viżiva jew kamp viżiv,
Common:
aw tikek qieshom tajjar§ Disturbi fil- widnejn u fis- sistema labirintika Komuni:
Vertigo, tinnitus
Vertigo, tisfir fil- widnejn
ed Very rarely:
ux Rari ħafna:
Hearing loss, hearing disorder
Telf tas- smigħ, disturbi tas- smigħ
s Rarely:
ad Rari:
ori Very rarely:
Kardjomijopatija Rari ħafna:
Myocardial infarction, cardiac ischaemia Arrhythmia
Infart majokardijaku, iskemija kardijaka Arritmija ’ għ
Respiratory, thoracic and mediastinal
Disturbi respiratorji, toraċiċi u
ra disorders Very common:
Komuni ħafna:
Dyspnoea*, coughing* Epistaxis, respiratory disorder, nasal congestion, rhinorrhea,
Dispneja *, sogħla * Epistassi, disturbi respiratorji, konġestjoni fl- imnieħer,
ge cough nonproductive Very rarely:
rinoreja, sogħla fil- vojt Infiltrati fil- pulmun§, pnumonite§ Rari ħafna:
Gastrointestinal disorders
Disturbi gastro- intestinali ina
Nausea/ vomiting, abdominal pain, diarrhoea, stomatitis, dyspepsia
Tqalligħ/ rimettar, uġigħ fl- addome, dijarea, stomatite, dispepsja
Stomatitis ulcerative, right upper quadrant pain, glossitis, gingivitis, constipation, loose stools no
Stomatite b’ ulċera, uġigħ fil- kwadrant lemini ta ’ fuq,
Pancreatitis, ischaemic colitis, ulcerative colitis, gingival bleeding
glossite, infjammazzjoni tal- ħanek, stitikezza, ippurgar maħlul Rari ħafna:
t
me
Hepatobiliary disorders uc
Disturbi fil- fwied u fil- marrara Komuni:
Skin and subcutaneous tissue disorders Very common:
ġilda Komuni ħafna:
Alopecia, pruritus*, skin dry*, rash*, sweating increased Psoriasis (new or aggravated)§, rash maculopapular, rash erythematous, eczema, erythema, skin disorder
Alopeċja, ħakk *, ġilda xotta *, raxx *, żieda fl- għaraq Psorajiżi (tibda jew taggrava) §, raxx makulopapulari, raxx
Musculoskeletal and connective tissue na
Pr
disorders Very common:
Disturbi muskolu- skeletrali u tal - connective tissue Komuni ħafna:
Rhabdomyolysis, myositis, leg cramps, back pain
Mijalġja, artralġja, uġigħ muskoluskeletrali Artrite Rabdomajelożi, majożite, bugħawwieġ fir- riġlejn, uġigħ fid -
Me
dahar Disturbi fil- kliewi u fis- sistema urinarja Komuni:
Common:
at Disturbi fis- sistema riproduttiva u fis - sider Komuni:
General disorders and administration site conditions
Amenorreja, uġigħ fis- sider, dismenorreja, menorraġja,
Amenorrhea, breast pain, dysmenorrhea, menorrhagia, menstrual disorder, vaginal disorder
izz disturbi mestrwali, disturbi fil- vaġina Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
Very common:
tor Komuni ħafna:
Injection site inflammation, injection site reaction*, fatigue,
Infjammazzjoni tas- sit mnejn tingħata l- injezzjoni, reazzjoni tas- sit mnejn tingħata l- injezzjoni *, għeja, tertir, deni§, sintomi bħal ta ’ l- influwenza§, astenja, irritabilità, uġigħ fis -
90 rigors, fever§, flu-like symptoms§, asthenia, irritability, chest pain, malaise Common:
aw sider, tħossok ma tiflaħx Komuni:
Very common:
ux Komuni ħafna
*These events were only common with Viraferon alone
* Dawn il- każijiet kienu komuni biss b’ Viraferon waħdu § Ara sezzjoni 4. 4
These undesirable effects have also been reported with Viraferon alone.
ad Dawn l- effetti mhux mixtieqa kienu ukoll irrappurtati ma ’ Viraferon waħdu. ’ għ Każijiet avversi kardjovaskulari (CVS), b' mod partikolari arritmija, dehru li kienu korrelati l- aktar mal- mard CVS li kien jeżisti minn qabel u mat- terapija b’ sustanzi kardjotossiċi li saret qabel (ara sezzjoni 4. 4).
Cardiomyopathy, that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior
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 im
uth evidence of cardiac disease (see section 4.4).
sezzjoni 4. 4).
A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons
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 li l
ra including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies (see also section 4.4).
(tibda jew taggrava), purpura idjopatika u tromboċitopenika trombotika, vaskulite, u newropatiji li jinkludu mononewropatiji (ara wkoll sezzjoni 4. 4). ina
ge Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and lon platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
Anormalitajiet tal- laboratorju klinikament sinifikanti, li l- aktar li jseħħu f’ dożi ta ’ aktar minn 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, diċ
Increase in serum ALT/ AST (SGPT/ SGOT) levels have been noted as an abnormality in some non-hepatitis subjects and also in some patients with chronic hepatitis B coincident with clearance of viral DNAp. no
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
Children and adolescents – Chronic Hepatitis C t
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 ott
events.
avversi.
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%) rod
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 ’ od
percentile were observed during treatment (see section 4.4).
tnaqqis ta ’ 13%) perċentwali dehret waqt il- kura (ara sezzjoni 4. 4).
As in adult patients, children and adolescents also experienced other psychiatric lp
Bħal f’ pazjenti adulti, tfal u Pr
adverse events (e. g., depression, emotional lability, and somnolence) (see section 4.4).
adolexxenti kellhom każijiet psikjatriċi avversi oħrajn (eż. dipressjoni, burdati emozzjonali, u ngħas) (ara sezzjoni 4. 4).
Dose modifications were required in 30% of patients, most na
Minbarra hekk, disturbi fis- sit mnejn tingħata l- injezzjoni, deni, anoressija, rimettar u burdati emozzjonali seħħew aktar ta ’ spiss fi tfal u adolexxenti meta mqabbla ma ’ pazjenti adulti.
commonly for anaemia and neutropaenia.
Tibdil fid- dożi kienu meħtieġa fi 30% tal- pazjenti, l- aktar għal anemija u newtropenija.
The adverse reactions listed in Table 2 are based on experience from paediatric clinical trials. i dic
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 categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10).
Bil- klassijiet tas- sistemi ta ’ l- organi, ir- reazzjonijiet avversi huma elenkati taħt it- titli tal- frekwenza bil- kategoriji li ġejjin: komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10).
Me
at Tabella 2
Table 2 Adverse reactions very commonly and commonly reported in paediatric clinical trials Very common (≥ 1/ 10) - Common (≥ 1/ 100, < 1/ 10) System Organ Class Infection and infestations
izz pedjatriċi Komuni ħafna (≥1/ 10) - Komuni (≥1/ 100, < 1/ 10) Klassi tas- sistema ta ’ l -
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 fil- passaġġ ta ’ l- awrina, gastro- enterite
91 vaginitis, gastroenteritis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
ux Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
ed Very common:
sistema limfatika Komuni ħafna:
Anaemia, neutropaenia Thrombocytopaenia, lymphadenopathy
’ għ Anemija, newtropenja Tromboċitopenja, limfadenopatija im
s Very common:
Komuni ħafna:
ori Common:
Komuni:
Metabolism and nutrition
Disturbi fil- metaboliżmu u
Hyperthyroidism§, virilism
Ipotajrojdiżmu§ Ipertajrojdiżmu§, viriliżmu li l
uth disorders Very common:
n- nutrizzjoni Komuni ħafna:
ra 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,
ge disorder, abnormal dreaming, apathy Nervous system disorders§ Very common:
disturbi fl- irqad, ħolm anormali, apatija Disturbi fis- sistema nervuża§ me
Headache, dizziness lon
Komuni ħafna:
Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
Uġigħ ta ’ ras, sturdament Iperkinesja, tregħid, disfonja, parasteżija, ipoesteżija, iperesteżija, telf tal- konċentrazzjoni, ngħas
Common:
Komuni: ott
Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder no
Konġuntivite, uġigħ fl- għajnejn, vista anormali, disturb fil -
Vascular disorders
glandola ta ’ l- għajnejn Disturbi vaskulari od
Respiratory, thoracic and
Disturbi respiratorji, toraċiċi u medjastinali Pr
Raynaud’ s disease, flushing, pallor t
Marda ta ’ Raynaud, fwawar, pallidità
Gastrointestinal disorders Very common:
Komuni ħafna:
Diarrhoea, vomiting, nausea, abdominal pain Mouth ulceration, stomatitis ulcerative, stomatitis, right upper quadrant pain, dyspepsia, glossitis, gastroesophogeal reflux, rectal
Dijarea, rimettar, tqalligħ, uġigħ fl- addome Ulċeri fil- ħalq, stomatite b’ ulċera, stomatite, uġigħ fil- kwadrant lemini ta ’ fuq, dispepsja, glossite, ittella ’ mill- istonku, disturbi fir- rektum, disturbi gastro- intestinali, stitikezza, ippurgar maħlul, uġigħ fis- snien, disturbi fis- snien
Hepatobiliary disorders Common:
at marrara Komuni:
Skin and subcutaneous tissue i
Disturbi fil- ġilda u fit- tessuti
Very common:
izz ta ’ taħt il- ġilda Komuni ħafna:
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin,
Alopeċja, raxx Reazzjoni ta ’ fotosensittività, raxx makulopapulari, ekżema,
erythema, bruise, sweating increased Musculoskeletal and connective tissue disorders Very common:
tor akne, disturbi fil- ġilda, disturbi fid- dwiefer, telf tal- lewn tal - ġilda, ħakk, ġilda xotta, ħmura, dbenġil, żieda fl- għaraq Disturbi muskolu- skeletali u
Common:
ux Komuni:
92 Common:
ad Komuni:
Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder Male: testicular pain
Mara: amenorreja, menorraġja, disturbi mestrwali, disturbi fil - vaġina Raġel: uġigħ fit- testikoli ’ għ
Injection site inflammation, injection site reaction, fatigue, rigors,
Infjammazzjoni tas- sit mnejn tingħata l- injezzjoni, reazzjoni tas - im
ed fever§, influenza-like symptoms§, malaise, irritability Common:
sit mnejn tingħata l- injezzjoni, għeja, tregħid, deni§, sintomi bħal ta ’ l- influwenza§, tħossok ma tiflaħx, irritabilità
Investigations
Komuni:
Chest pain, asthenia, oedema, injection site pain
Uġigħ fis- sider, astenja, edema, uġigħ tas- sit mnejn tingħata l - li l
s Very common:
injezzjoni Investigazzjonijiet Titnaqqas ir- rata ta ’ tkabbir (tul u/ jew piż aktar baxx għall- età) § Komuni ħafna: ina
Growth rate decrease (height and/ or weight decrease for age)§
Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura diċ
ori Injury and poisoning Common: §
Komuni: § Ara sezzjoni 4. 4
uth See section 4.4
4. 9 Doża eċċessiva me
ra No case of overdose has been reported that has led to acute clinical manifestations.
Ma kien rrappurtat l- ebda każ ta ’ doża eċċessiva li wasslet għal manifestazzjonijiet kliniċi akuti.
However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close observation of the patient is indicated.
Madankollu, bħal f’ kull sustanza farmakoloġikament attiva, huwa indikat li jsir trattament sintomatiku b’ monitoraġġi spissi tas- sinjali vitali u osservazzjoni mill- qrib tal- pazjent. ott
PHARMACOLOGICAL PROPERTIES ge lon 5.1 Pharmacodynamic properties
5. 1 Tagħrif farmakodinamiku
Immunostimulants, cytokines and immunomodulators, interferons, interferon no
Immunostimulanti, ċitokini u immunomodulaturi, interferoni, Pr
alfa-2b, ATC code:
interferon alfa- 2b, Kodiċi ATC:
Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA t
Viraferon huwa formulazzjoni sterili u stabbli ta ’ interferon alfa- 2b ippurifikat sa grad għoli ħafna magħmul bit- teknika tad- DNA rikombinanti.
approximately 19,300 daltons.
L- interferon alfa- 2b rikombinanti huwa proteina li tinħall fl- ilma u għandu piż molekulari ta ’ madwar 19, 300 dalton.
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. rod
Huwa jinkiseb minn klonu ta ’ E. coli, li għandu ġo fih ibridu plażmidu mfassal ġenetikament imdawwar ma ’ ġene ta ’ interferon alfa- 2b minn lewkoċiti umani.
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.
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 lp
at bejn l- attività ta ’ l- interferon alfa- 2b rikombinanti u l- attività ta ’ preparazzjoni għar- referenza internazzjonali ta ’ l- interferon tal- lewkoċita tal- bniedem stabbilita mill- Organizzazzjoni Dinjija tas -
interferon established by the World Health Organisation.
izz Saħħa.
The interferons are a family of small protein molecules with molecular weights of approximately 15,000 to na
L- interferoni huma familja ta ’ molekuli żgħar ta ’ proteina bil- piżijiet molekulari ta ’ madwar 15, 000 sa
21,000 daltons.
tor 21, 000 dalton.
These three main classes are themselves not homogeneous and may contain several different molecular i dic
Dawn it- tliet klassijiet ewlenin fihom infushom mhumiex omoġeni u jista ’ jkun fihom diversi speċi molekulari differenti ta ’ interferon.
More than 14 genetically distinct human alpha interferons have been identified.
aw alpha umani ġenetikament distinti.
Me
Viraferon kienet ikklassifikata bħala interferon alfa- 2b rikombinanti.
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
They exhibit selectivity for human but not murine interferons, suggesting species specificity.
Studji
Studies with other interferons have demonstrated species specificity.
ad b’ interferoni oħra wrew speċifiċità għall- ispeċi.
93 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
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
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 - li l
Any or all of these activities may contribute to interferon's therapeutic effects.
Kull waħda minn dawn l- attivitajiet, jew kollha kemm huma, jistgħu jikkontribwixxu għall- effetti terapewtiċi ta ’ l- interferon. ina
ed Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and 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.
It has demonstrated significant immunomodulatory activity in vitro.
Huwa wera attività immunomodulatorja sinifikattiva in vitro. diċ
s ori Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
L- interferon alfa- 2b rikombinanti wkoll jiskoraġġixxi r- replikazzjoni virali in vitro u in vivo.
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
Din l- azzjoni tfixkel ir - me
This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell.
replikazzjoni virali jew jekk ir- replikazzjoni sseħħ, il- virjoni proġeni ma jkunux jistgħu joħorġu miċ - ċellula.
uth Chronic hepatitis B:
Epatite B kronika:
Current clinical experience in patients who remain on interferon alfa-2b for 4 to 6 months indicates that
L- esperjenza klinika attwali f’ pazjenti li jibqgħu fuq l- interferon alfa- 2b minn 4 sa 6 xhur tindika li t - ott
ra therapy can produce clearance of serum HBV-DNA.
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 been observed.
F’ pazjenti adulti bi tnaqqis ta ’ HBeAg u ta ’ HBV- DNA, kien innutat tnaqqis sinifikattiv fil - morbidità u fil- mortalità. od
ge 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.
Moreover children treated lon with interferon alfa-2b experienced a reduced rate of growth and some cases of depression were observed.
ittrattati b’ interferon alfa- 2b kellhom rata mnaqqsa ta ’ tkabbir u kienu innutati xi każijiet ta ’ dipressjoni.
47%.
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 (sustained response rate of 61% achieved in a study performed in naïve patients with a ribavirin dose > 10.6 mg/ kg, p < 0.01). t uc
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, p < 0. 01).
Adult patients:
at Pazjenti adulti:
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
Efficacy was defined as sustained virologic response, rod
Effettività kienet iddefinita bħala rispons viroloġiku sostnut, 6 xhur wara t- tmiem tat- trattament.
6 months after the end of treatment.
Il- pazjenti eliġibbli għal dawn il- provi
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 a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT. lp
tor kellhom epatite Ċ kronika kkonfermata minn analiżi pożittiva (> 100 kopji/ ml) tar- reazzjoni katina tal - 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.
Viraferon was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with na
aw Viraferon ingħata f’ doża ta ’ 3 MIU tlett darbiet fil- ġimgħa bħala monoterapija jew flimkien ma ’ ribavirin.
Sustained virologic response rates for treatment groups treated for one year with Viraferon alone or in i dic
Ir- rati ta ’ rispons viroloġiku sostnuti għall- gruppi ttrattati għal sena b’ Viraferon
combination with ribavirin (from two studies) are shown in Table 3.
ux 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 treatment of chronic heptatitis C in naïve patients.
L- għoti flimkien ta ’ Viraferon ma ’ ribavirin żied l- effettività ta ’ Viraferon f’ pazjenti naive mill- inqas
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 - ’ għ gruppi kollha.
The relative benefit of combination therapy with Viraferon + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3).
Il- benefiċċju relattiv tat- terapija kombinata b’ Viraferon + ribavirin hi b’ mod partikulari sinifikattiva fis- sotto- grupp ta ’ pazjenti li huma l- aktar diffiċli biex ikunu ttrattati (ġenotip 1 u piż għoli ta ’ vajrus) (Tabella 3). im
Regardless of genotype, patients who received Viraferon in combination with ribavirin and received ≥ 80% of their treatment had a higher sustained
Irrispettiv mill - 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 li l
94 response 6 months after 1 year of treatment than those who took < 80% of their treatment (56% vs.
tagħhom (56% vs.
32% in trial C/ I98-580).
32% fil- prova C/ I98- 580).
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 ’ ina
HCV Genotype
I/ R Ġenotip ta ’ l -
ed
diċ
s All Genotypes
Il- Ġenotipi
ori Genotype 1
Ġenotip 1 ott
uth Genotype 1 ≤ 2 million
Ġenotip 1 ≤ 2 miljun kopja/ ml od
ra copies/ ml Genotype 1 > 2 million
Ġenotip 1 > 2 miljun kopji/ ml Pr
I Viraferon (3 MIU 3 times a week) I/ R Viraferon (3 MIU 3 times a week) + ribavirin (1,000/ 1,200 mg/ day) no
I Viraferon (3 MIU 3 darbiet fil- ġimgħa) I/ R Viraferon (3 MIU 3 darbiet fil- ġimgħa) + ribavirin (1, 000/ 1, 200 mg/ jum) Pazjenti ko - infettati b’ HCV/ HIV Saru żewġ provi f’ pazjenti ko- infettati b’ HIV u HCV.
Overall, in both studies, patients who received Viraferon plus ribavirin, were less likely to respond than patients who received pegylated t
B’ mod globali, fiż- żewġ studji, il- pazjenti li rċievew Viraferon flimkien ma ’ ribavirin, kellhom anqas ċans li jkollhom rispons minn pazjenti li rċievew interferon alfa- 2b pegilat flimkien ma ’ ribavirin.
interferon alfa-2b with ribavirin.
Ir- rispons għall- kura f’ dawn iż- żewġ provi qed jidher f’ Tabella 4.
The response to treatment in both of these trials is presented in Table 4. uc
Studju 1 (RIBAVIC; P01017) kien studju randomized, multiċentriku li ingaġġa
Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
at 412 pazjent adult li ma kienux ingħataw kura minn qabel b’ epatite Ċ kronika li kienu ko- infettati b’ HIV.
Patients were randomized to receive either pegylated interferon alfa-2b (1.5 µg/ kg/ week) plus ribavirin (800 mg/ day) or Viraferon (3 MIU TIW) rod
Il- pazjenti kienu randomized biex jirċievu interferon alfa- 2b pegilat (1. 5 µg/ kg/ ġimgħa)
plus ribavirin (800 mg/ day) for 48 weeks with a follow-up period of 6 months.
izz flimkien ma ’ ribavirin (800 mg/ jum) jew inkella Viraferon (3 MIU TIW) flimkien ma ’ ribavirin (800 mg/ jum) għal 48 ġimgħa b’ perijodu ta ’ follow- up ta ’ 6 xhur.