qanastek/EMEA-V3 huggingface dataset:
There are no data on long term effects on growth and development and on sexual maturation.
M’ hemmx tagħrif dwar l- effetti fit- tul fuq it- tkabbir u l- iżvilupp kif ukoll il- maturazzjoni sesswali.
HCV/ HIV Coinfection:
Ko- infezzjoni bl- HCV/ HIV:
Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (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 IntronA and ribavirin to HAART therapy (see ribavirin SPC).
Għandha tintuża attenzjoni meta jiżdiedu IntronA u ribavirin mat- terapija HAART (ara l- SPC ta ’ ribavirin).
Patients treated with IntronA and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia.
Pazjenti kkurati b’ IntronA u ribavirin f’ terapija kombinata u zidovudine jista ’ jkollhom riskju akbar li jiżviluppaw anemija.
Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
Pazjenti ko- infettati li għandhom ċirrosi avanzata u li qed jirċievu l- HAART jista ’ jkollhom riskju akbar ta ’ dikompensazzjoni tal- fwied u tal- mewt.
Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Iż- żieda ta ’ trattament bl- interferoni alpha waħidhom jew flimkien ma ’ ribavirin jista ’ jkabbar ir- riskju f’ dan il- grupp ta ’ pazjenti.
Concomitant chemotherapy:
Kemoterapija konkomitanti:
Administration of IntronA in combination with other chemotherapeutic agents (e. g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration), which may be life-threatening or fatal as a result of the concomitantly administered medicinal product.
L- għoti ta ’ IntronA flimkien ma ’ sustanzi kemoterapewtiċi oħra (eż., Ara- C, cyclophosphamide, doxorubicin, teniposide) jista ’ jwassal għal riskju akbar ta ’ tossiċità (severità u żmien), li jista ’ jkun ta ’ theddida għall- ħajja jew fatali minħabba l- prodott mediċinali li jkun ingħata miegħu.
The most commonly reported potentially life-threatening or fatal adverse events include mucositis, diarrhoea, neutropaenia, renal impairment, and electrolyte disturbance.
L- aktar każijiet avversi komuni li huma potenzjalment ta ’ theddida għall- ħajja jew fatali li kienu rrappurtati jinkludu mukożite, dijarrea, newtropenja, indeboliment tal- kliewi, u disturbi fl- elettroliti.
Because of the risk of increased toxicity, careful adjustments of doses are required for IntronA and for the concomitant chemotherapeutic agents (see section 4.5).
Minħabba r- riskju ta ’ tossiċità akbar, jinħtieġu aġġustamenti bir- reqqa tad- dożi ta ’ IntronA u ta ’ s- sustanzi kemoterapewtiċi mogħtija b' mod konkomitanti (ara sezzjoni 4. 5).
When IntronA is used with hydroxyurea, the frequency and severity of cutaneous vasculitis may be increased.
Meta IntronA jintuża ma ’ hydroxyurea, il- frekwenza u s- severità ta ’ vaskulite kutanja jistgħu jiżdiedu.
Dental and periodontal disorders:
Disturbi tas- snien u madwar is- snien:
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving IntronA and ribavirin combination therapy.
Mard tas- snien u madwar is- snien, li jista ’ jwassal għal telf tas - snien, kienu rrappurtati f’ pazjenti li kienu qed jirċievu IntronA 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 IntronA 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 ’ IntronA u ribavirin.
Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Il- pazjenti għandhom jaħslu snienhom sew darbtejn kuljum u jmorru għal eżamijiet tas- snien b’ mod regolari.
In addition some patients may experience vomiting.
Minbarra hekk, xi pazjenti jistgħu jirremettu.
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Jekk isseħħ din ir- reazzjoni, għandhom jingħataw parir sabiex jaħslu ħalqhom sew wara.
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 IntronA.
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’ IntronA.
During treatment for hepatitis B or C the recommended testing schedule is at weeks 1, 2, 4, 8, 12, 16, and every other month, thereafter, throughout treatment.
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’ IntronA l- ALT jogħla f’ daqqa u jilħaq jew jaqbeż id- doppju tal- livelli bażi, it- terapija b’ IntronA tista ’ titkompla sakemm ma jkunux innutati sinjali u sintomi ta ’ indebolimet qawwi tal- fwied.
ALT, prothrombin time, alkaline phosphatase, albumin and bilirubin must be monitored at two-week intervals.
Waqt il - qabża kbira fl- ALT, testijiet ta ’ kif qed jaħdem il- fwied, ALT, ħin tal- protrombina, alkaline phosphatase, albumina u bilirubin iridu jkunu mkejjla f’ intervalli ta ’ ġimagħtejn.
In patients treated for malignant melanoma, liver function and white blood cell (WBC) count and differential must be monitored weekly during the induction phase of therapy and monthly during the maintenance phase of therapy.
F 'pazjenti li qed jkunu ttrattati għall- melanoma malinna, il- funzjoni tal- fwied u l- għadd u d - differenzjal taċ- ċelluli bojod fid- demm (WBC) iridu jkunu mkejjla kull ġimgħa matul il- fażi ta ’ l - induzzjoni tat- terapija u kull xahar matul il- fażi li t- terapija qed tkun sostnuta.
Effect on fertility:
Effett fuq il- fertilità:
Interferon may impair fertility (see section 4.6 and section 5.3).
L- interferon jista ’ jkun ta ’ ħsara għall- fertilità (ara sezzjoni 4. 6 u 5. 3).
Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with IntronA.
Narkotiċi, ipnotizzanti u sedattivi għandhom jingħataw b’ attenzjoni meta jkunu użati b' mod konkomitanti ma ’ IntronA.
Interactions between IntronA and other medicinal products have not been fully evaluated.
Interazzjonijiet bejn IntronA u prodotti mediċinali oħra għadhom ma kinux evalwati għal kollox.
Caution must be exercised when administering IntronA in combination with other potentially myelosuppressive agents.
Għandu jkun hemm attenzjoni meta jingħata IntronA flimkien ma ’ sustanzi oħra li jista ’ jkollhom effett majelosuppressiv.
 9 Interferons may affect the oxidative metabolic process.
L- interferoni jistgħu jaffettwaw il- proċess metaboliku ossidattiv.
This must be considered during concomitant therapy with medicinal products metabolised by this route, such as the xanthine derivatives theophylline or aminophylline.
Dan għandu jkun ikkunsidrat waqt terapija konkomitanti ma ’ prodotti mediċinali li jkunu metabolati permezz ta ’ din ir- rotta, bħal ma 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.
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.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
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’ IntronA.
The aetiology has not been defined.
L- etjoloġija 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).
Administration of IntronA in combination with other chemotherapeutic agents (e. g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration) (see section 4.4).
L- għoti ta ’ IntronA flimkien ma ’ sustanzi kemoterapewtiċi oħra (eż., Ara- C, cyclophosphamide, doxorubicin, teniposide) jista ’ jwassal għal riskju akbar ta ’ tossiċità (severità u żmien) (ara sezzjoni 4. 4).
(Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C).
(Ara wkoll l- SPC ta ’ ribavirin jekk IntronA se jingħata flimkien ma ’ ribavirin lill- pazjenti bl- epatite Ċ kronika).
Women of childbearing potential have to use effective contraception during treatment.
Nisa li jista ’ jkollhom it- tfal għandhom jużaw kontraċezzjoni effettiva waqt il- kura.
IntronA must be used with caution in fertile men.
IntronA għandu jintuża b’ attenzjoni f’ irġiel fertili.
Decreased serum estradiol and progesterone concentrations have been reported in women treated with human leukocyte interferon.
Konċentrazzjonijiet imnaqqsa ta ’ estradajol u ta ’ proġesteron fis - serum kienu rrappurtati fin- nisa ttrattati bl- interferon tal- lewkoċiti tal- bniedem.
There are no adequate data from the use of interferon alfa-2b in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ interferon alfa- 2b f’ nisa waqt it- tqala.
The potential risk for humans is unknown.
Mhux magħruf ir- riskju potenzjali fuq in - nies.
IntronA is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
IntronA m’ għandux jintuża waqt it- tqala ħlief jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali għall- fetu.
It is not known whether the components of this medicinal product are excreted in human milk.
Mhux magħruf jekk il- komponenti ta ’ dan il- prodott mediċinali jitneħħewx mal- ħalib tal- mara.
Because of the potential for adverse reactions in nursing infants, nursing should be discontinued prior to initiation of treatment.
Minħabba l- potenzjal ta ’ reazzjonijiet avversi minn IntronA fit- trabi li qegħdin jerdgħu, it- treddigħ għandu jitwaqqaf qabel tinbeda l- kura.
Combination therapy with ribavirin:
Terapija kombinata ma ’ ribavirin:
Ribavirin causes serious birth defects when administered during pregnancy.
Ribavirin jikkawża difetti tat- twelid serji meta jingħata waqt it - tqala.
Ribavirin therapy is contraindicated in women who are pregnant.
It- terapija b’ ribavirin hija kontra- indikata f’ nisa waqt it- tqala.
Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking IntronA 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 IntronA f’ kombinazzjoni ma ’ ribavirin.
Females of childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Nisa li jista ’ jkollhom it- tfal u s- sieħba rġiel tagħhom għandhom it- tnjen li huma jużaw kontraċezzjoni effettiva waqt il- kura u fl- 4 xhur ta ’ wara t- twaqqif tal- kura.
Male patients and their female partners must each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC).
Pazjenti 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).
Patients are to be advised that they may develop fatigue, somnolence, or confusion during treatment with IntronA, and therefore it is recommended that they avoid driving or operating machinery.
Il- pazjenti għandhom ikunu avżati li jista ’ jkollhom għeja kbira, nagħas jew konfużjoni waqt it - trattament b’ IntronA, u għalhekk hu rakkomandat li jevitaw li jsuqu jew li jħaddmu xi magni.
See ribavirin SPC for ribavirin-related undesirable effects if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Ara l- SPC ta ’ ribavirin għall- effetti mhux mixtieqa konnessi ma ’ ribavirin jekk IntronA se jingħata 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 in hairy cell leukaemia up to 100 MIU/ m2/ week in melanoma), the most commonly reported undesirable effects were fever, fatigue, headache and myalgia.
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 mhux mixtieqa li kienu rrappurtati ta’ spiss kienu d- deni, għeja kbira, uġigħ ta ’ ras u uġigħ fil- muskoli.
Fever and fatigue were often reversible within 72 hours of interruption or cessation of treatment.
Id- deni u l- għeja spiss kienu riversibbli sa 72 siegħa wara l- interruzzjoni jew il- waqfien tat- trattament.
In clinical trials conducted in the hepatitis C population, patients were treated with IntronA alone or in combination with ribavirin for one year.
Fi provi kliniċi li saru bil- popolazzjoni bl- epatite Ċ fejn il- pazjenti kienu ttrattati b’ IntronA waħdu jew flimkien ma ’ ribavirin għal sena.
All patients in these trials received 3 MIU of IntronA three times a week.
Il- pazjenti kollha f’ dawn il- provi rċivew 3 MIU ta ’ IntronA tliet darbiet fil- ġimgħa.
In Table 1 the frequency of patients reporting (treatment related) undesirable effects is
F’ Tabella 1 il- frekwenza ta ’ pazjenti li rrappurtaw effetti mhux mixtieqa (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 system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rarely (≥ 1/ 10,000, < 1/ 1,000); very rarely (< 1/ 10,000); not known.
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); mhux komuni (≥1/ 1, 000, < 1/ 100); rari (≥1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000); mhux magħruf.
Table 1.
Tabella 1:
Adverse reactions reported during clinical trials or following the marketing use of IntronA alone or in combination with ribavirin System Organ Class Infections and infestations
Reazzjonijiet avversi rrappurtati waqt provi kliniċi jew bl- użu wara t- tqegħid fis- suq ta ’ IntonA waħdu jew ma ’ ribavirin Klassi tas- Sistema ta ’ l- Organi Infezzjonijiet u infestazzjonijiet
Adverse Reactions
Reazzjonijiet avversi
Rarely:
Rari:
Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Bacterial infection Pneumonia§, sepsis
Farinġite *, infezzjoni virali * Bronkite, sinusite, herpes simplex (reżistenza), flissjoni Infezzjoni tal- batteri Pnewmonja§, sepsi
Immune system disorders§
Disturbi fis- sistema immuni§
Leukopaenia Thrombocytopaenia, lymphadenopathy, lymphopenia Aplastic anaemia Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Lewkopenja Tromboċitopenja, limfadenopatija, limfopenija Anemija aplastika Aplasja taċ- ċelluli ħomor puri, purpura tromboċitopenika idjopatika, purpura trombotika tromboċitopenika
Endocrine disorders
Disturbi fis- sistema endokrinarja
Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid arthritis (new or aggravated), Vogt-Koyanagi-Harada syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis§
Sarkojdożi, tiħrax s- sarkojdożi Lupus erythematosus sistemika, vaskulite, artrite rewmatika (tibda jew taggrava), sindrome Vogt- Koyanagi- Harada, reazzjonijiet ta ’ sensittività eċċessiva akuti li jinkludu urtikarja, anġjoedema, bronkokostrizzjoni, anafilassi§
Common:
Ipotajrojdiżmu§, ipertajrojdiżmu§ Komuni:
Hypothyroidism§, hyperthyroidism§ Diabetes, aggravated diabetes
Dijabete, dijabete taggrava
Very rarely: § Psychiatric disorders
Disturbi psikjatriċi§
Anorexia Hypocalcaemia, dehydration, hyperuricemia, thirst Hyperglycaemia, hypertriglyceridaemia§, increased appetite
Anoressija Ipokalċimija, deidratazzjoni, iperuriċemija, għatx Ipergliċemija, ipertrigliċeridemija§, żieda fl- aptit
Depression, insomnia, anxiety, emotional lability*, agitation, nervousness
Dipressjoni, nuqqas ta ’ rqad, ansjetà, burdati emozzjonali *, aġitazzjoni, nervi
Nervous system disorders§
Mhux magħruf Disturbi fis- sistema nervuża§
Homicidal ideation, mental status change§, mania, bipolar disorders
Konfużjoni, disturbi ta ’ l- irqad, tnaqqis fil- libido Ħsibijiet dwar suwiċidju Suwiċidju, attentati ta’ suwiċidju, imġieba aggressiva (kulltant indirizzata lejn l- oħrajn), psikożi inklużi alluċinazzjonijiet Ħsibijiet dwar ommiċidji, tibdil fl- istat mentali§, manija, disturbi bipolari
Dizziness, headache, concentration impaired, mouth dry Tremor, paresthesia, hypoesthesia, migraine, flushing, somnolence, taste perversion
Sturdament, uġigħ ta ’ ras, telf tal- konċentrazzjoni, ħalq xott Tregħid, parasteżija, ipoesteżija, emigranja, fwawar, ngħas, perverżjoni tat- togħma
Mononeuropathies, coma§
Newropatija periferali Emorraġija ċerebrovaskulari, iskemija ċerebrovaskulari, aċċessjoni, koxjenza indebolita, enċefalopatija Mononewropatiji, koma§
Vision blurred 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), ostruzzjoni fl- arterja jew vina tar- retina§, nevrite ottika, papilledema, tnaqqis fl- akutezza viżiva jew kamp viżiv, tikek qieshom tajjar§
Rarely:
Komuni:
Vertigo, tinnitus Hearing loss, hearing disorder
Vertigo, tisfir fil- widnejn Telf tas- smigħ, disturbi tas- smigħ
Palpitation, tachycardia Cardiomyopathy Myocardial infarction, cardiac ischaemia Arrhythmia
Palpitazzjoni, takikardija Kardjomijopatija Infart majokardijaku, iskemija kardijaka Arritmija
Hypertension Peripheral ischaemia, hypotension§
Pressjoni għolja Iskemija periferali, pressjoni baxxa§
Pulmonary infiltrates§, pneumonitis§
Dispneja *, sogħla * Epistassi, disturbi respiratorji, konġestjoni fl- imnieħer, rinoreja, sogħla fil- vojt Infiltrati fil- pulmun§, pnumonite§
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
Stomatite b’ ulċera, uġigħ fil- kwadrant lemini ta ’ fuq, glossite, infjammazzjoni tal- ħanek, stitikezza, ippurgar maħlul
Periodontal disorder NOS, dental disorder NOS§
Pankrejatite, kolite iskemika, kolite b’ ulċera, fsada tal- ħanek Disturbi perjodontali NOS, disturbi fis- snien NOS§
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ ġilda
Hepatomegaly Hepatotoxicity, (including fatality)
Epatomegalija Epatotossiċità, (inkluż fatalità) taħt il -
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 bi ħmura, ekżema, ħmura, disturbi tal- ġilda
Musculoskeletal and connective tissue disorders
Disturbi muskolu- skeletrali u tal - connective tissue
Stevens Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
Sindrome Stevens Johnson, nekroliżi tossika tal- ġilda, erythema multiforme
Myalgia, arthralgia, musculoskeletal pain Arthritis Rhabdomyolysis, myositis, leg cramps, back pain
Mijalġja, artralġja, uġigħ muskoluskeletrali Artrite Rabdomajelożi, majożite, bugħawwieġ fir- riġlejn, uġigħ fid - dahar
Reproductive system and breast disorders
Disturbi fis- sistema riproduttiva u fis - sider
Micturition frequency Renal failure, renal insufficiency, nephrotic syndrome
Frekwenza ta ’ l- awrina Indeboliment renali, insuffiċjenza renali, sindrome nefrotika
Amenorrhea, breast pain, dysmenorrhea, menorrhagia, menstrual disorder, vaginal disorder
Amenorreja, uġigħ fis- sider, dismenorreja, menorraġja, disturbi mestrwali, disturbi fil- vaġina
Injection site inflammation, injection site reaction*, fatigue, rigors, fever§, flu-like symptoms§, asthenia, irritability, chest pain, malaise
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 - sider, tħossok ma tiflaħx
Injection site pain Injection site necrosis, face oedema
Uġigħ tas- sit mnejn tingħata l- injezzjoni Nekrożi tas- sit mnejn tingħata l- injezzjoni, edema tal- wiċċ
* These events were only common with IntronA alone § See section 4.4
* Dawn il- każijiet kienu komuni biss b’ IntronA waħdu § Ara sezzjoni 4. 4
These undesirable effects have also been reported with IntronA alone.
Dawn l- effetti mhux mixtieqa kienu ukoll irrappurtati b’ IntronA waħdu.
The undesirable effects seen with hepatitis C are representative of those reported when IntronA is administered in other indications, with some anticipated dose-related increases in incidence.
L- effetti mhux mixtieqa li dehru ma ’ l- epatite Ċ huma rappreżentattivi ta ’ dawk irrappurtati meta IntronA jingħata f’ indikazzjonijiet oħra, b’ xi żidiet mistennija fl- inċidenza konnessi mad- doża.
For example, in a trial of high-dose adjuvant IntronA treatment in patients with melanoma, incidences of fatigue, fever, myalgia, neutropaenia/anaemia, anorexia, nausea and vomiting, diarrhoea, chills, flu- like symptoms, depression, alopecia, altered taste, and dizziness were greater than in the hepatitis C trials.
Per eżempju, fi provi ta ’ trattament awżiljarju b’ doża għolja ta ’ IntronA f’ pazjenti bil- melanoma, inċidenzi ta ’ għeja, deni, uġigħ fil- muskoli, newtropenja/ anemija, anoreksja, tqalligħ u rimettar, dijarrea, irjiħat, sintomi li jixbħu l- influwenza, dipressjoni, alopeċja, togħma mibdula, u ta ’ sturdament kienu aktar milli fil- provi ta ’ l- epatite Ċ.
Severity also increased with high dose therapy (WHO Grade 3 and 4, in 66% and 14% of patients, respectively), in comparison with the mild to moderate severity usually associated with lower doses.
Is- severità żdiedet ukoll bit- terapija b’ doża għolja (Grad 3 u 4 tal- WHO, f’ 66% u 14% tal- pazjenti, rispettivament) imqabbla mas- severità bejn ħafifa u moderata normalment assoċjata mad- dożi baxxi.
Undesirable effects were usually managed by dose adjustment.
Effetti mhux mixtieqa kienu ġeneralment ikkontrolloti b’ aġġustament fid - doża.
Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
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 evidence of cardiac disease (see section 4.4).
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).
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 (see also section 4.4).
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 jinkludu mononewropatiji (ara wkoll sezzjoni 4. 4).
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 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, kreatinina fis- serum u tan- nitroġenu ta ’ l- urea fis- serum.
Moderate and usually reversible pancytopenia has been reported.
Panċitopenja moderata li s- soltu tkun riversibbli kienet irrappurtata.
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.
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.
For safety with respect to transmissible agents, see section 4.4.
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.
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 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%) percentile were observed during treatment (see section 4.4).
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 ’ tnaqqis ta ’ 13%) perċentwali dehret waqt il- kura (ara sezzjoni 4. 4).
Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month follow-up after treatment.
Minbarra hekk, ħsibijiet dwar suwiċidju jew attentati ta ’ suwiċidju kienu rrappurtati aktar ta ’ spiss meta mqabbla ma ’ pazjenti adulti (2. 4% vs 1%) waqt il- kura u fis- 6 xhur tal- follow- up wara l- kura.
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) (ara sezzjoni 4. 4).
In addition, injection site disorders, fever, anorexia, vomiting, and emotional lability occurred more frequently in children and adolescents compared to adult patients.
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.
Dose modifications were required in 30% of patients, most 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.
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).
Table 2 Adverse reactions very commonly and commonly reported in paediatric clinical trials  13 Very common (≥1/10) - Common (≥1/100, < 1/10) System Organ Class Infection and infestations
Reazzjonijiet avversi irrapurtati b’ mod komuni ħafna u komuni fil- provi kliniċi pedjatriċi Komuni ħafna (≥1/ 10) - Komuni (≥1/ 100, < 1/ 10)
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
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
Neoplasm (unspecified)
Neoplażmi (mhux speċifikati)
Endocrine disorders
Disturbi fis- sistema endokrinarja Komuni ħafna:
Hypothyroidism§, Hyperthyroidism§, virilism
Anemija, newtropenja Tromboċitopenja, limfadenopatija Ipotajrojdiżmu§ Ipertajrojdiżmu§, viriliżmu
Common: § Psychiatric disorders
Disturbi psikjatriċi§
Anorexia Hypertriglyceridemia§, hyperuricemia, increased appetite
Anoressija Ipertrigliċeridemika§, iperuriċemija, żieda fl- aptit
Common: § Nervous system disorders
Disturbi fis- sistema nervuża§
Depression, emotional lability, insomnia Suicidal ideation, aggressive reaction, confusion, behaviour disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy
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
Headache, dizziness Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
Uġigħ ta ’ ras, sturdament Iperkinesja, tregħid, disfonja, parasteżija, ipoesteżija, iperesteżija, telf tal- konċentrazzjoni, ngħas
Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder
Konġuntivite, uġigħ fl- għajnejn, vista anormali, disturb fil - glandola ta ’ l- għajnejn
Raynaud’s disease, flushing, pallor
Marda ta ’ Raynaud, fwawar, pallidità
Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhea, sneezing
Dispneja, takipneja, epistassi, sogħla, konġestjoni fl- imnieħer, irritazzjoni fl- imnieħer, flissjoni, għatis
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 lemini ta ’ fuq, dispepsja, glossite, ittella ’ mill- istonku, disturbi fir- rektum, disturbi gastro- intestinali, stitikezza, ippurgar maħlul, uġigħ fis- snien, disturbi fis- snien
Hepatic function abnormal
Funzjoni epatika anormali
Musculoskeletal and connective tissue disorders
Disturbi muskolu- skeletali u tal- connective tissue
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased
Alopeċja, raxx Reazzjoni ta ’ fotosensittività, raxx makulopapulari, ekżema, akne, disturbi fil- ġilda, disturbi fid- dwiefer, telf tal- lewn tal - ġilda, ħakk, ġilda xotta, ħmura, dbenġil, żieda fl- għaraq
Arthralgia, myalgia, musculoskeletal pain
Disturbi fil- kliewi u fis - sistema urinarja
 Renal and urinary disorders
Artralġja, mijalġja, uġigħ muskolskeletali
Enuresis, micturition disorder, urinary incontinence
Enureżi, disturbi ta ’ l- awrina, inkontinenza ta ’ l- awrina
Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder Male: testicular pain
Mara: amenorreja, menorraġja, disturbi mestrwali, disturbi fil - vaġina Raġel: uġigħ fit- testikoli
Injection site inflammation, injection site reaction, fatigue, rigors, fever§, influenza-like symptoms§, malaise, irritability
Infjammazzjoni tas- sit mnejn tingħata l- injezzjoni, reazzjoni tas - sit mnejn tingħata l- injezzjoni, għeja, tregħid, deni§, sintomi bħal ta ’ l- influwenza§, tħossok ma tiflaħx, irritabilità
Investigations
Investigazzjonijiet Komuni ħafna:
Chest pain, asthenia, oedema, injection site pain
Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura
Growth rate decrease (height and/or weight decrease for age)§
Uġigħ fis- sider, astenja, edema, uġigħ tas- sit mnejn tingħata l - injezzjoni Titnaqqas ir- rata ta ’ tkabbir (tul u/ jew piż aktar baxx għall- età) §
Common: § See section 4.4
Komuni: § Ara sezzjoni 4. 4
Skin laceration
Tiċrit tal- ġilda
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.
Immunostimulants, cytokines and immunomodulators, interferons, interferon alfa-2b, ATC code:
Immunostimulanti, ċitokini u immunomodulaturi, interferoni, interferon alfa- 2b, Kodiċi ATC:
IntronA is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques.
IntronA huwa formulazzjoni sterili u stabbli ta ’ interferon alfa- 2b ippurifikat sa grad għoli ħafna magħmul bit- teknika tad- DNA rikombinanti.
Recombinant interferon alfa-2b is a water-soluble protein with a molecular weight of 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.
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 IntronA 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 ’ IntronA 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 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 21, 000 dalton.
They are produced and secreted by cells in response to viral infections or various synthetic and biological inducers.
Dawn ikunu magħmula u merħijja miċ- ċelluli b’ rispons għall- infezzjonijiet virali jew għal induċenti sintetiċi u bijoloġiċi varji.
Three major classes of interferons have been identified: alpha, beta and gamma.
Kienu identifikati tliet klassijiet ewlenin ta ’ interferoni: alpha, beta u gamma.
These three main classes are themselves not homogeneous and may contain several different molecular species of interferon.
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.
Kienu identifikati aktar minn 14- il interferon alpha umani ġenetikament distinti.
IntronA has been classified as recombinant interferon alfa-2b.
IntronA 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 il- wiċċ taċ- ċellula.
Human interferon receptors, as isolated from human lymphoblastoid (Daudi) cells, appear to be highly asymmetric proteins.
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.
Huma juru selettività għall- interferoni tal - bniedem iżda mhux għal dawk tal- ġrieden, li jagħti ħjiel ta ’ speċifiċità għall- ispeċi.
Studies with other interferons have demonstrated species specificity.
Studji b’ interferoni oħra wrew speċifiċità għall- ispeċi.
However, certain monkey species, eg, rhesus monkeys, are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Madankollu, ċerti speċi ta ’ xadini, eż. ix- xadini tar - razza rhesus, huma suxxettibbli għall- istimulazzjoni farmakodinamika meta jkunu esposti għall - interferoni umani tat- tip 1.
 15 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.
Ir- riżultati ta ’ diversi studji jissuġġerixxu li, hekk kif ikun mqabbad mal- membrana taċ- ċellula, l - interferon jagħti bidu għal sekwenza kumplessa ta ’ okkorrenzi intraċellulari li jinkludu l- induzzjoni ta ’ ċerti enżimi.
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.
Huwa maħsub li dan il- proċess huwa responsabbli, għall- inqas parzjalment, għad- diversi 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 - ċelluli li huma targits.
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.
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.
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.
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.
Din l- azzjoni tfixkel ir - replikazzjoni virali jew jekk ir- replikazzjoni sseħħ, il- virjoni proġeni ma jkunux jistgħu joħorġu miċ - ċellula.
Chronic hepatitis B:
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.
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.
An improvement in liver histology has been observed.
Kien innutat titjib fl- istoloġija tal- fwied.
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.
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.
Minħabba difett fil- metodoloġija, l- effettività ma setgħetx tkun murija.
Moreover children treated with interferon alfa-2b experienced a reduced rate of growth and some cases of depression were observed.
Barra dan it- tfal ittrattati b’ interferon alfa- 2b kellhom rata mnaqqsa ta ’ tkabbir u kienu innutati xi każijiet ta ’ dipressjoni.
Chronic hepatitis C:
Epatite Ċ kronika:
In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is 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).
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).
IntronA 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.
IntronA waħdu jew flimkien ma ’ ribavirin kien studjat f’ 4 provi kliniċi ta’ Fażi III randomised f’ 2, 552 pazjent bl- epatite Ċ kronika li qatt ma ħadu l- interferon.
The trials compared the efficacy of IntronA used alone or in combination with ribavirin.
Il- provi qabblu l - effettività ta ’ IntronA użat waħdu jew flimkien ma ’ ribavirin.
Efficacy was defined as sustained virologic response, 6 months after the end of treatment.
Effettività kienet iddefinita bħala rispons viroloġiku sostnut, 6 xhur wara t- tmiem tat- trattament.
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.
Il- pazjenti eliġibbli għal dawn il- provi 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.
IntronA was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with ribavirin.
IntronA ingħata f’ doża ta ’ 3 MIU tlett darbiet fil- ġimgħa bħala monoterapija jew flimkien ma ’ ribavirin.
The majority of patients in these clinical trials were treated for one year.
Il- maġġoranza tal- pazjenti f’ dawn il- provi kliniċi kienu ittrattati għal sena.
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 viroloġiku sostnut.
Sustained virologic response rates for treatment groups treated for one year with IntronA alone or in combination with ribavirin (from two studies) are shown in Table 3.
Ir- rati ta ’ rispons viroloġiku sostnuti għall- gruppi ttrattati għal sena b’ IntronA waħdu jew flimkien ma ’ ribavirin (minn żewġ studji) huma murija f’ Tabella 3.
Co-administration of IntronA with ribavirin increased the efficacy of IntronA by at least two fold for the treatment of chronic heptatitis C in naïve patients.
L- għoti flimkien ta ’ IntronA ma ’ ribavirin żied l- effettività ta ’ IntronA f’ pazjenti naive mill- inqas bid - doppju għat- trattament - ta ’ l- epatite Ċ kronika.
HCV genotype and baseline virus load are prognostic 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 IntronA + ribavirin, compared with IntronA alone, is maintained across all subgroups.
Ir- rata ogħla ta ’ rispons għall - kumbinazzjoni ta ’ IntronA + ribavirin, imqabbla ma ’ IntronA waħdu, tibqa ’ ogħla fis- sotto- gruppi kollha.
The relative benefit of combination therapy with IntronA + 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’ IntronA + 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).
 16 Response rates in these trials were increased with compliance.
Ir- rati ta ’ rispons f’ dawn il- provi kienu ogħla meta l- pazjenti kienu konformi mal- kura.
Regardless of genotype, patients who received IntronA 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.
Irrispettiv mill - ġenotip, il- pazjenti li rċivew IntronA 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).
virologic response rates with IntronA + ribavirin (one year of treatment) by genotype and viral load
Rati ta ’ rispons viroloġiku sostnut b’ IntronA + ribavirin (sena waħda ta ’ trattament) skond il- ġenotip u l- viral load
HCV Genotype
Ġenotip ta ’ l -
I/R
HCV
N=505
C/ I98- 580
C/I98-580
C95- 132/ I95- 143
All Genotypes
Il- Ġenotipi kollha