qanastek/EMEA-V3 huggingface dataset:
Treatment of patients with hairy cell leukaemia.
It- trattament ta ’ pazjenti bil- lewkimja tal- Hairy cell.
Chronic Myelogenous Leukaemia:
Lewkimja tal- Mudullun Kronika:
Treatment of adult patients with Philadelphia chromosome or bcr/ abl translocation positive chronic myelogenous leukaemia.
It- trattament ta ’ pazjenti adulti li għandhom il- lewkimja tal- mudullun kronika tal - kromosoma ta ’ Philadelphia jew lewkimja kronika majeloġena pożittiva għat- traslokazzjoni bcr/ abl.
Clinical experience indicates that a haematological and cytogenetic major/ minor response is obtainable in the majority of patients treated.
L- esperjenza klinika tindika li rispons maġġuri/ minuri ematoloġiku u ċitoġenetiku jtista ’ jinkiseb fil - maġġoranza tal- pazjenti ttrattati.
A major cytogenetic response is defined by < 34% Ph+ leukaemic cells in the bone marrow, whereas a minor response is  34%, but < 90% Ph+ cells in the marrow.
Rispons ċitoġeniku maġġuri huwa mfisser bħala < 34% ċelluli Ph+ lewkimiċi fil- mudullun, filwaqt li rispons minuri huwa  34%, iżda < 90% ċelluli Ph+ fil- mudullun.
 2 Combination therapy:
Terapija kombinata:
The combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy.
L- għoti ta ’ interferon alfa- 2b ma ’ cytarabine (Ara- C) matul l- ewwel 12- il xahar ta ’ trattament kien ppruvat li jżid b’ mod sinifikanti r- rata ta ’ rispons ċitoġenetiku maġġuri u li jtawwal b’ mod sinifikanti s- sopravivenza ġenerali wara tlett snin meta mqabbel mal- monoterapija b’ interferon alfa- 2b.
Multiple Myeloma:
Mjeloma Multipla:
As maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy.
Bħala terapija ta ’ manteniment f’ pazjenti li rnexxielhom jiksbu għal remissjoni oġġettiva (aktar minn 50% tnaqqis fil- proteina tal- majeloma) wara kemoterapija ta ’ l- induzzjoni inizjali.
Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated.
L- esperjenza klinika attwali tindika li t- terapija ta ’ manteniment b’ interferon alfa- 2b ittawwal il- fażi ta ’ stabbilità; madankollu, l- effetti fuq is- sopravivenza ġenerali ma kinux murija b' mod konklużiv.
Follicular Lymphoma:
Limfoma Follikulari:
Treatment of high tumour burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen.
Trattament ta ’ tumuri tal- limfoma follikulari mgħobbija ħafna bħala kura aġġuntiva għall- kemoterapija ta ’ l- induzzjoni kombinata xierqa bħal ma hu r- reġimen li jixbaħ liċ - CHOP.
High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10%, fever > 38°C for more than 8 days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.
Tumur mgħobbi ħafna huwa definit bħala li għandu mill- inqas wieħed milli ġejjin: massa kbira ta 'tumur (> 7 cm), l- involviment ta ’ tliet siti nodali jew aktar (kull wieħed > 3 cm), sintomi sistematiċi (telf ta ’ piż > 10%, deni > 38°C għal aktar minn 8 ijiem, jew għaraq matul il- lejl), splenomegalija ’ l isfel miż- żokra, imblukkar jew sindrome ta ’ mblukkar ta ’ organu maġġuri, involviment orbitali jew epidurali, effużjoni serja, jew lewkimja.
Carcinoid Tumour:
Tumur Karċinojdi:
Treatment of carcinoid tumours with lymph node or liver metastases and with "carcinoid syndrome".
It- trattament tat- tumuri karċinojdi fin- nodi limfatiċi jew metastażi tal- fwied u bis - "sindrome karċinojde".
Malignant Melanoma:
Melanoma Malinna:
As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e. g., patients with primary or recurrent (clinical or pathological) lymph node involvement.
Bħala terapija aġġuntiva f’ pazjenti li huma ħielsa mill- mard wara l- kirurġija iżda li jinsabu f’ riskju kbir li jirkadu b’ mod sistematiku, eż., pazjenti b’ involviment primarju jew rikorrenti (kliniku jew patoloġiku) tan- nodi limfatiċi.
Treatment must be initiated by a physician experienced in the management of the disease.
It- trattament għandu jkun mibdi minn tabib li għandu l- esperjenza fl- imaniġġjar tal- marda.
Not all dosage forms and strengths are appropriate for some indications.
Mhux il- forom tad- dożaġġi u qawwiet kollha jkunu xierqa għal xi indikazzjonijiet.
Please make sure to select an appropriate dosage form and strength.
Jekk jogħġbok kun żgur li tagħżel il- forma tad- dożaġġ u qawwa li tkun xierqa.
If adverse events develop during the course of treatment with IntronA for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
Jekk iseħħu każijiet avversi matul il- kors tat- trattament b’ IntronA għal kwalunkwe indikazzjoni, ibdel id- dożaġġ jew waqqaf it- terapija temporanjament sakemm il- każijiet avversi jonqsu.
If persistent or recurrent intolerance develops following adequate dosage adjustment, or disease progresses, discontinue treatment with IntronA.
Jekk tiżviluppa intolleranza persistenti jew rikorrenti wara aġġustament xieraq fid- dożaġġ, jew il- marda tavvanza, waqqaf it- trattament b’ IntronA.
At the discretion of the physician, the patient may self-administer the dose for maintenance dosage regimens administered subcutaneously.
Skond id- diskrezzjoni tat- tabib, il- pazjent jista ’ jagħti d- doża lilu nnifsu għall- korsijiet ta ’ dożaġġi ta ’ manteniment mogħtija taħt il- ġilda.
The recommended dosage is in the range 5 to 10 million IU administered subcutaneously three times a week (every other day) for a period of 4 to 6 months.
Id- dożaġġ rakkomandat huwa bejn 5 u 10 miljun IU mogħtija taħt il- ġilda tliet darbiet fil- ġimgħa (darba kull jumejn) għal perijodu ta ’ 4 sa 6 xhur.
The administered dose should be reduced by 50% in case of occurrence of haematological disorders (white blood cells < 1,500/ mm3, granulocytes < 1,000/ mm3, thrombocytes < 100,000/ mm3).
Id- doża mogħtija għanda titnaqqas b’ 50% f' każ li jseħħu problemi ematoloġiċi (ċelluli bojod tad - demm < 1, 500/ mm3, granuloċiti < 1, 000/ mm3, tromboċiti < 100, 000/ mm3).
Treatment should be discontinued in case of severe leukopaenia (< 1,200/ mm3), severe neutropaenia (< 750/ mm3) or severe thrombocytopaenia (< 70,000/ mm3).
It- trattament għandu jitwaqqaf f’ każijiet ta ’ lewkopenja severa (< 1, 200/ mm3), ta ’ newtropenja severa (< 750/ mm3) jew ta ’ tromboċitopenija severa (< 70, 000/ mm3).
For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue IntronA therapy.
Għall- pazjenti kollha, jekk ma jidhirx titjib ta ’ l- HBV- DNA fis- serum wara 3 sa 4 xhur ta ’ trattament (bid- doża massima ttollerata), waqqaf it- terapija b’ IntronA.
IntronA is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with ribavirin.
IntronA jingħata taħt il- ġilda f’ doża ta ’ 3 miljun IU tliet darbiet fil- ġimgħa (darba kull jumejn) lill- pazjenti adulti, kemm jekk jingħata bħala monoterapija kif ukoll flimkien ma ’ ribavirin.
Children 3 years of age or older and adolescents:
Tfal ta ’ 3 snin jew akbar u adolexxenti:
Interferon alfa-2b 3 MIU/ m2 is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution administered orally in two divided doses daily with food (morning and evening).
Interferon alfa- 2b 3 MIU/ m2 jingħata taħt il- ġilda tliet darbiet fil- ġimgħa (darba kull jumejn) flimkien mal- kapsuli ribavirin jew soluzzjoni orali li tittieħed mill- ħalq maqsuma f’ żewġ dożi kuljum ma ’ l- ikel (filgħodu u filgħaxija).
 3 (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
(Ara l- SPC tal- kapsuli ribavirin u l- linji gwida għal tibdil fid- dożaġġ għal terapija kombinata.
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC).
Għal pazjenti pedjatriċi li jiżnu < 47 kg jew li ma jistgħux jibilaw kapsuli, ara l- SPC tas- soluzzjoni orali ribavirin).
Relapse patients (adults):
Pazjenti li jirkadu (adulti):
IntronA is given in combination with ribavirin.
IntronA jingħata flimkien ma ’ ribavirin.
Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with IntronA in combination with ribavirin for 6 months.
Skond ir- riżultati ta ’ provi kliniċi, li għandhom informazzjoni għal 6 xhur ta ’ trattament, huwa rakkomandat li l- pazjenti jkunu ttrattati b’ IntronA flimkien ma ’ ribavirin għal 6 xhur.
Naïve patients:
Pazjenti naïve:
The efficacy of IntronA is enhanced when given in combination with ribavirin.
L- effikaċja ta ’ IntronA tiżdied meta jkun mogħti flimkien ma ’ ribavirin.
IntronA should be given alone mainly in case of intolerance or contraindication to ribavirin.
IntronA għandu jingħata waħdu l- aktar f’ każijiet ta ’ intolleranza jew ta ’ kontra- indikazzjoni għal ribavirin.
IntronA in combination with ribavirin:
IntronA flimkien ma ’ ribavirin:
Based on the results of clinical trials, in which data are available for 12 months of treatment, it is recommended that patients be treated with IntronA in combination with ribavirin for at least 6 months.
Skond ir- riżultati ta ’ provi kliniċi, li għandhom informazzjoni għal 12- il xahar ta ’ trattament, huwa rakkomandat li l- pazjenti jkunu ttrattati b’ IntronA flimkien ma ’ ribavirin għal mill- inqas 6 xhur.
Treatment should be continued for another 6-month period (i. e., a total of 12 months) in patients who exhibit negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and high pre-treatment viral load.
It- trattament għandu jitkompla għal perijodu ieħor ta ’ 6 xhur (i. e., għal total ta ’ 12- il xahar) f’ pazjenti li juru HCV- RNA negattiv f’ xahar 6, u b’ ġenotip virali 1 (kif stabbilit f’ kampjun ta ’ qabel it - trattament) u b’ viral load għoli qabel it- trattament.
Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months.
Fatturi oħra ta ’ tbassir negattiv (età > 40 sena, sess maskili, fibrożi li tgħaqqad) għandhom ikunu ikkunsidrati sabiex it- terapija tkun estiża għal 12- il xahar.
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV-RNA below lower limit of detection) did not become sustained virologic responders (HCV- RNA below lower limit of detection six months after withdrawal of treatment).
Waqt provi kliniċi, il- pazjenti li ma wrewx rispons viroloġiku wara 6 xhur ta ’ trattament (HCV- RNA inqas mil- limitu li jista ’ jkun imkejjel) ma sostnewx ir- rispons viroloġiku tagħhom (HCV- RNA inqas mil- limitu li jista ’ jkun imkejjel sitt xhur wara l- waqfien tat- trattament).
IntronA alone:
IntronA waħdu:
The optimal duration of therapy with IntronA alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
L- aħjar tul ta ’ żmien tat- terapija b’ IntronA waħdu għadu ma kienx stabbilit għall- kollox, iżda terapija ta ’ bejn 12 u 18- il xahar hija rakkomandata.
It is recommended that patients be treated with IntronA alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Huwa rakkomandat li l- pazjenti jkunu ttrattati b’ IntronA waħdu għal mill- inqas 3 sa 4 xhur, f’ liema punt l- istat ta ’ l- HCV- RNA għandu jkun stabbilit.
Treatment should be continued in patients who exhibit negative HCV-RNA.
It- trattament għandu jitkompla fejn il- pazjenti juru HCV- RNA negattiv.
The efficacy and safety of IntronA in combination with ribavirin has been studied in children and adolescents who have not been previously treated for chronic hepatitis C.
L- effikaċja u s- sigurtà ta ’ IntronA flimkien ma ’ ribavirin kienu studjati fi tfal u adolexxenti li ma kienux ġew ikkurati qabel għall- epatite Ċ.
Genotype 1:
Ġenotip 1:
The recommended duration of treatment is one year.
It- tul ta ’ trattament rakkomandat huwa sena.
Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%).
Pazjenti li ma jiksbux rispons viroloġiku mat - 12- il ġimgħa x’ aktarx li ma jiksbux rispons viroloġiku sostnut (valur ta ’ tbassir negattiv 96%).
Virological response is defined as absence of detectable HCV-RNA at Week 12.
Rispons viroloġiku huwa definit bħala nuqqas ta ’ HCV- RNA li jista ’ jitkejjel f’ ġimgħa 12.
Treatment should be discontinued in these patients.
Il- kura għandha titwaqqaf f’ dawn il- pazjenti.
Genotype 2/ 3:
Ġenotip 2/ 3:
The recommended duration of treatment is 24 weeks.
It- tul ta ’ trattament rakkomandat huwa 24 ġimgħa.
Virological responses after 1 year of treatment and 6 months of follow-up were 36% for genotype 1 and 81% for genotype 2/ 3/ 4.
Rispons viroloġiku wara sena 1 ta ’ trattament u 6 xhur follow- up kienu ta ’ 36% għall- ġenotip 1 u 81% għall- ġenotip 2/ 3/ 4.
The recommended dosage is 2 million IU/ m2 administered subcutaneously three times a week (every other day) for both splenectomised and non-splenectomised patients.
Id- dożaġġ rakkomandat huwa ta ’ 2 miljun IU/ m2 mogħti taħt il- ġilda tliet darbiet fil- ġimgħa (darba kull jumejn) kemm għall- pazjenti splenektomizzati kif ukoll għal dawk li mhumiex.
For most patients with Hairy Cell Leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment.
Fil- biċċa l- kbira tal- pazjenti bil- Lewkimja tal- hairy cell, in- normalizzazzjoni ta ’ kwantità varjabbli ematoloġika waħda jew aktar isseħħ fi żmien xahar sa xahrejn tat- trattament b’ IntronA.
Improvement in all three haematological variables (granulocyte count, platelet count and haemoglobin level) may require six months or more.
Għal titjib fit- tliet kwantitajiet varjabbli ematoloġiċi kollha (l- għadd tal- granuloċiti, l- għadd tal- plejtlets u l - livell ta ’ l- emoglobina) jista ’ jkollhom bżonn sitt xhur jew aktar.
This regimen must be maintained unless the disease progresses rapidly or severe intolerance is manifested.
Dan il- kors għandu jitkompla sakemm il- marda ma tiggravax f’ daqqa u sakemm ma jkunx hemm intolleranza severa.
 4 Chronic Myelogenous Leukaemia:
Lewkimja tal- Mudullun Kronika:
The recommended dosage of IntronA is 4 to 5 million IU/ m2 administered daily subcutaneously.
Id- dożaġġ rakkomandat ta ’ IntronA hu ta ’ 4 sa 5 miljun IU/ m2 mogħtija kuljum taħt il- ġilda.
Some patients have been shown to benefit from IntronA 5 million IU/ m2 administered daily subcutaneously in association with cytarabine (Ara-C) 20 mg/ m2 administered daily subcutaneously for 10 days per month (up to a maximum daily dose of 40 mg).
Intwera li xi pazjenti bbenefikaw minn 5 miljun IU/ m2 IntronA mogħtija kuljum taħt il- ġilda flimkien ma ’ 20 mg/ m2 cytarabine (Ara- C) mogħtija kuljum taħt il- ġilda għal 10 ijiem kull xahar (sa doża massima ta ’ 40 mg kuljum).
When the white blood cell count is controlled, administer the maximum tolerated dose of IntronA (4 to 5 million IU/ m2 daily) to maintain haematological remission.
Meta l- għadd taċ- ċelluli bojod fid- demm ikun ikkontrollat, agħti d- doża massima tollerata ta ’ IntronA (4 sa 5 miljun IU/ m2 kuljum) biex ikun sostnut it- titjib ematoloġiku.
IntronA treatment must be discontinued after 8 to 12 weeks of treatment if at least a partial haematological remission or a clinically meaningful cytoreduction has not been achieved.
It- trattament b’ IntronA għandu jitwaqqaf wara 8 sa 12- il ġimgħa ta ’ trattament jekk ma jwassalx għal mill- inqas titjib ematoloġiku parzjali jew għal tnaqqis fiċ- ċelluli klinikament sinifikattiv.
In patients who are in the plateau phase (more than 50% reduction of myeloma protein) following initial induction chemotherapy, interferon alfa-2b may be administered as monotherapy, subcutaneously, at a dose of 3 million IU/ m2 three times a week (every other day).
Fil- pazjenti li jinsabu fil- fażi ta ’ stabbiltà (aktar minn 50% tnaqqis tal- proteina tal- majeloma) wara kemoterapija ta ’ l- induzzjoni inizjali, interferon alfa- 2b jista ’ jingħata bħala monoterapija, taħt il- ġilda, f’ doża ta ’ 3 miljun IU/ m2 tliet darbiet fil- ġimgħa (darba kull jumejn).
Follicular Lymphoma:
Limfoma follikulari:
Adjunctively with chemotherapy, interferon alfa-2b may be administered subcutaneously, at a dose of 5 million IU three times a week (every other day) for a duration of 18 months.
Bħala żieda mal- kemoterapija, interferon alfa- 2b jista ’ jingħata taħt il- ġilda, f’ doża ta ’ 5 miljun IU tliet darbiet fil- ġimgħa (darba kull jumejn) għal tul ta ’ 18- il xahar.
CHOP-like regimens are advised, but clinical experience is available only with CHVP (combination of cyclophosphamide, doxorubicin, teniposide and prednisolone).
Korsijiet li jixbħu lil dak taċ- CHOP huma rakkomandati, iżda teżisti biss esperjenza klinika bis- CHVP (kumbinazzjoni ta ’ cyclophosphamide, doxorubicin, teniposide u prednisolone).
The usual dose is 5 million IU (3 to 9 million IU) administered subcutaneously three times a week (every other day).
Normalment id- doża tkun 5 miljun IU (3 sa 9 miljun IU) mogħtija taħt il- ġilda tliet darbiet fil- ġimgħa (darba kull jumejn).
Patients with advanced disease may require a daily dose of 5 million IU.
Il- pazjenti b’ marda avvanzata jistgħu jeħtieġu doża ta ’ 5 miljun IU kuljum.
The treatment is to be temporarily discontinued during and after surgery.
It- trattament għandu jkun mwaqqaf b' mod temporanju waqt u wara l- kirurġija.
Therapy may continue for as long as the patient responds to interferon alfa-2b treatment.
It- terapija tista ’ titkompla sakemm il- pazjent jibqa ’ jirrispondi għat- trattament b’ interferon alfa- 2b.
As induction therapy, interferon alfa-2b is administered intravenously at a dose of 20 million IU/ m2 daily for five days a week for a four-week period; the calculated interferon alfa-2b dose is added to sodium chloride 9 mg/ ml (0.9%) solution for injection and administered as a 20- minute infusion (see section 6.6).
Bħala terapija ta ’ l- induzzjoni, l- interferon alfa- 2b jingħata ġol- vina b’ doża ta ’ 20 miljun IU/ m² kuljum għal ħamest ijiem fil- ġimgħa għal perijodu ta ’ erba ’ ġimgħat; id- doża kkalkulata ta ’ interferon alfa- 2b tiżdied ma ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni u tingħata bħala infużjoni ta ’ 20 minuta (ara sezzjoni 6. 6).
As maintenance treatment, the recommended dose is 10 million IU/ m2 administered subcutaneously three days a week (every other day) for 48 weeks.
Bħala trattament ta ’ manteniment, id- doża rakkomandata hi 10 miljun IU/ m² mogħtija taħt il- ġilda tliet darbiet fil- ġimgħa (darba kull jumejn) għal 48 ġimgħa.
If severe adverse events develop during interferon alfa-2b treatment, particularly if granulocytes decrease to< 500/mm3 or alanine aminotransferase/aspartate aminotransferase (ALT/AST) rises to> 5 x upper limit of normal, discontinue treatment temporarily until the adverse event abates.
Jekk iseħħu każijiet avversi severi matul it- trattament b’ interferon alfa- 2b, speċjalment jekk il - granuloċiti jonqsu għal < 500/ mm³ jew l- alanine aminotransferase/ aspartate aminotransferase (ALT/ AST) jogħlew għal > 5 darbiet l- ogħla limitu tan- normal, waqqaf it- trattament b' mod temporanju sakemm il- każ avvers ibatti.
Interferon alfa-2b treatment is to be restarted at 50% of the previous dose.
It- trattament b’ interferon alfa- 2b għandu jerġa ’ jinbeda b’ 50% tad- doża ta ’ qabel.
If intolerance persists after dose adjustment or if granulocytes decrease to< 250/mm3 or ALT/AST rises to> 10 x upper limit of normal, discontinue interferon alfa-2b therapy.
Jekk l- intolleranza tippersisti wara l- aġġustament fid- doża jew jekk il - granuloċiti jonqsu għal < 250/ mm³ jew l- ALT/ AST jogħlew għal > 10 darbiet l- ogħla limitu tan - normal, waqqaf it- terapija b’ interferon alfa- 2b.
Although the optimal (minimum) dose for full clinical benefit is unknown, patients must be treated at the recommended dose, with dose reduction for toxicity as described.
Għalkemm l- aħjar doża (minima) għal benefiċċju kliniku sħiħ mhiex magħrufa, il- pazjenti għandhom ikunu ttrattati bid- doża rakkomandata, bi tnaqqis fid- doża minħabba t- tossiċità kif deskritt.
IntronA may be administered using either glass or plastic disposable injection syringes.
IntronA jista ’ jingħata b’ siringi li jintużaw darba u jintremew tal- ħġieġ jew tal- plastik.
- Hypersensitivity to the active substance or to any of the excipients.
- Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi
- A history of severe pre-existing cardiac disease, e. g., uncontrolled congestive heart failure,
- Passat ta ’ mard tal- qalb sever li kien jeżisti minn qabel, eż., insuffiċjenza tal- qalb konġestiva
recent myocardial infarction, severe arrhythmic disorders.
mhux taħt kontroll, infart mijokardjali reċenti, disturbi arritmiċi severi
- Severe renal or hepatic dysfunction; including that caused by metastases.
- Funzjoni ħażina severa renali jew epatika; inklużi dawk ikkaġunati minn metastażi
- Epilepsy and/ or compromised central nervous system (CNS) function (see section 4.4).
- Epilessija u/ jew funzjoni kompromessa tas- sistema nervuża ċentrali (CNS) (ara sezzjoni 4. 4)
- Chronic hepatitis with decompensated cirrhosis of the liver.
- Epatite kronika b’ ċirrożi dekompensata tal- fwied
- Chronic hepatitis in patients who are being or have been treated recently with
- Epatite kronika f’ pazjenti li qegħdin jew reċentement kienu qegħdin ikunu ttrattati b’ sustanzi
immunosuppressive agents excluding short term corticosteroid withdrawal.
immunosoppressivi, bl- esklużjoni tat- twaqqif għal żmien qasir tal- kortikosterojdi
- Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant
- Epatite awtoimmuni; jew passat mediku ta ’ mard awtoimmuni; pazjenti immunosoppressi li
recipients.
rċivew trapjant
- Pre-existing thyroid disease unless it can be controlled with conventional treatment.
- Mard tat- tirojde li kien jeżisti minn qabel, sakemm ma jistax ikun ikkontrollat bi trattament
 5 Children and adolescents:
Tfal u adolexxenti:
- Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal
- Ikun hemm, jew fil- passat kien hemm kundizzjoni psikjatrika severa, l- aktar dipressjoni severa,
ideation or suicide attempt.
ħsibijiet dwar suwiċidju jew attentati ta ’ suwiċidju.
Combination therapy with ribavirin:
Terapija flimkien ma ’ ribavirin:
Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Ara wkoll l- SPC ta ’ ribavirin jekk l- interferon alfa- 2b se jingħata flimkien ma ’ ribavirin fil- pazjenti bl- epatite Ċ kronika.
For all patients:
Għall- pazjenti kollha:
Psychiatric and central nervous system (CNS):
Psikjatrika u sistema nervuża ċentrali (CNS):
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during IntronA therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Effetti severi tas- CNS, l- aktar dipressjoni, ħsibijiet ta ’ suwiċidju u attentati ta ’ suwiċidju dehru f’ xi pazjenti waqt terapija b’ IntronA, u anki wara li twaqqfet il- kura waqt is- 6 xhur fil- perijodu ta ’ follow- up.
Among children and adolescents treated with IntronA in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6-month follow-up after treatment.
Fost it- tfal u adolexxenti kkurati b’ IntronA ma ’ ribavirin, ħsibijiet dwar suwiċidju u attentati ta ’ suwiċidju kienu rrappurtati aktar ta ’ spiss meta mqabbla ma ’ pazjenti adulti (2. 4% vs 1%) waqt il- kura u fil- perijodu ta ’ 6 xhur follow- up ta ’ wara l - kura.
As in adult patients, children and adolescents experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence).
Bħal f’ pazjenti adulti, tfal u adolexxenti kellhom każijiet avversi oħra (eż dipressjoni, burdati emozzjonali, u ngħas).
Other CNS effects including aggressive behaviour (sometimes directed against others), bipolar disorders, mania, confusion and alterations of mental status have been observed with alpha interferons.
Effetti oħra fuq is- CNS inkluż imġieba aggressiva (kultant indirizzata lejn l - oħrajn), disturbi bipolari, manija, konfużjoni u tibdil fl- istat mentali dehru b’ alpha interferons.
Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Il - pazjenti għandhom ikunu monitorati mill- qrib għal kwalunkwe sinjali jew sintomi ta ’ disturbi psikjatriċi.
If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Jekk jidhru dawn is- sintomi, is- serjetà li jista ’ jkollhom dawn l- effetti għandha titqies mit - tabib li jkun qed jordnhom u l- ħtieġa ta ’ maniġġar terapewtiku xieraq għandha tkun ikkunsidrata.
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with IntronA be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk sintomi psikjatriċi jippersistu jew imorru għall- agħar, jew jiġi mitbuħ li hemm ħsibijiet dwar suwiċidju, huwa rakkomandat li l- kura b’ IntronA titwaqqaf, u l- pazjent jiġi segwit, b’ intervent psikjatriku kif ikun xieraq.
Patients with existence of or history of severe psychiatric conditions:
Pazjenti li jkollhom jew fil- passat kellhom kundizzjonijiet psikjatriċi severi:
If treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Jekk kura b’ interferon alfa- 2b tkum meqjusa neċessarja f’ pazjenti adulti li jkollhom jew fil- passat kellhom kundizzjonijiet psikjatriċi severi, din għandha tinbeda biss wara li jkun ġie żgurat li jkun hemm maniġġar terapewtiku u dijanjostiku individwali xieraq.
The use of interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
L- użu ta ’ interferon alfa- 2b fi tfal u adolexxenti li jkollhom jew fil- passat kellhom kundizzjonijiet psikjatriċi severi huwa kontra- indikat (ara sezzjoni 4. 3).
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during IntronA therapy.
Reazzjonijiet ta ’ sensittività eċċessiva akuta (eż. urtikarja, anġjoedima, bronkokostrizzjoni, anafilassi) għall- interferon alfa- 2b dehru f’ każijiet rari waqt it- terapija b’ IntronA.
If such a reaction develops, discontinue the medication and institute appropriate medical therapy.
Jekk tiżviluppa xi reazzjoni bħal xi waħda minn dawn, waqqaf il- medikazzjoni u applika t- terapija medika xierqa.
Transient rashes do not necessitate interruption of treatment.
F’ każijiet ta ’ raxx li jgħaddi malajr, m’ għandux jitwaqqaf it- trattament.
Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases, termination of IntronA therapy.
Esperjenzi avversi minn moderati sa serji jistgħu jeħtieġu bidla fir- reġimen tad- dożaġġ tal- pazjent, jew f’ xi każijiet, il- waqfien tat- terapija b’ IntronA.
Any patient developing liver function abnormalities during treatment with IntronA must be monitored closely and treatment discontinued if signs and symptoms progress.
Kull pazjent li jiżviluppa anormalitajiet fil- funzjoni tal - fwied waqt it- trattament b’ IntronA għandu jkun osservat mill- qrib u t- trattament jitwaqqaf jekk is - sinjali u s- sintomi javvanzaw.
Hypotension may occur during IntronA therapy or up to two days post-therapy and may require supportive treatment.
Pressjoni baxxa ħafna tista ’ sseħħ waqt t- terapija b’ IntronA jew sa jumejn wara, u tista ’ teħtieġ trattament ta ’ appoġġ.
Adequate hydration must be maintained in patients undergoing IntronA therapy since hypotension related to fluid depletion has been seen in some patients.
Idratazzjoni xierqa għandha tkun sostnuta fil- pazjenti li qed jagħmlu terapija b’ IntronA billi kienet innutata f’ xi pazjenti pressjoni baxxa ħafna relatata ma’ nuqqas ta ’ fluwidu.
Fluid replacement may be necessary.
Tista ’ tkun meħtieġa s - sostituzzjoni tal- fluwidi.
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out.
Filwaqt li d- deni jista ’ jkun assoċjat mas- sindrome li jixbah l- influwenza li spiss tkun rrapportata waqt it- terapija bl- interferon, kawżi oħrajn ta ’ deni persistenti għandhom ikunu esklużi.
IntronA must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e. g., chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis.
IntronA 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.
Caution must be observed also in patients with coagulation disorders (e. g., thrombophlebitis, pulmonary embolism) or severe myelosuppression.
Attenzjoni għandha wkoll tingħata lill- pazjenti bi problemi ta ’ koagulazzjoni (eż., tromboflebite, emboliżmu pulmonari) jew majelosuppressjoni serja.
 6 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 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 definita.
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.5).
Dawn is- sintomi kienu rrapportati aktar ta ’ spiss meta shosaikoto, mediċina tal- ħxejjex Ċiniża, ingħatat fl- istess ħin ma ’ l- interferon alpha (ara sezzjoni 4. 5).
Any patient developing fever, cough, dyspnea or other respiratory symptoms must have a chest X-ray taken.
Kwalunkwe pazjent li jiżviluppa deni, sogħla, qtugħ ta ’ nifs jew sintomi oħra respiratorji għandu jitteħidlu raġġi- X tas- sider.
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.
Jekk ir - raġġi- X juri infiltrazzjonijiet pulmonarji jew hemm evidenza ta ’ ħsara fil- funzjoni tal- pulmun, il - pazjent għandu jkun osservat mill- qrib, u, jekk meħtieġ, jitwaqqaf l- interferon alpha.
While this has been reported more often in patients with chronic hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
Filwaqt li dan kien irrappurtat aktar ta ’ spiss fil- pazjenti bl- epatite Ċ kronika ttrattati bl- interferon alpha, kien ukoll irrappurtat fil- pazjenti b’ mard onkoloġiku ttrattati bl- interferon alpha.
Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events.
It- twaqqif minnufih ta ’ l- għoti ta ’ l- interferon alpha, u t- trattament bil- kortikosterojdi jidher li jgħinu biex ifejjqu l- każijiet avversi pulmonarji.
Ocular adverse events (see section 4.8) including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instances after treatment with alpha interferons.
Każijiet avversi okulari (ara sezzjoni 4. 8) li jinkludu emorraġiji tar- retina, tikkek bojod fl- għajn, u mblukkar fl- arterji jew fil- vini tar- retina, kienu irrappurtati f’ każijiet rari wara t- trattament bl - interferon alpha.
All patients 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 IntronA, must have a prompt and complete eye examination.
Kwalunkwe pazjent li jilmenta dwar bidliet f’ kemm jara ċar jew fil- kamp viżiv, jew li jirrapporta sintomi oħra oftalmoloġiċi waqt it- trattament b’ IntronA, għandu minnufih jagħmel eżami komplet ta ’ l- għajnejn.
Periodic visual examinations during IntronA therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Eżamijiet tal - vista regolari waqt it- terapija b’ IntronA huma rakkomandati speċjalment f’ pazjenti li għandhom problemi li jistgħu jkunu assoċjati mar- retinopatija, bħad- dijabete mellitus u l- pressjoni għolja.
Discontinuation of IntronA should be considered in patients who develop new or worsening ophthalmological disorders.
It - twaqqif ta ’ IntronA għandu jkun ikkunsidrat fil- pazjenti li jitfaċċawlhom jew imorrulhom għall- agħar xi problemi oftalmoloġiċi.
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.
While these effects are generally reversible, in a few patients full resolution took up to three weeks.
Filwaqt li dawn l- effetti huma ġeneralment riversibbli, xi pazjenti damu sa tliet ġimgħat biex irkupraw.
Very rarely, seizures have occurred with high doses of IntronA.
F’ każijiet rari ħafna, seħħew aċċessjonijiet b’ dożi għoljin ta ’ IntronA.
Adult patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders, who require IntronA 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’ IntronA, 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 electrocardiograms taken prior to and during the course of treatment.
Huwa rakkomandat li dawk il- pazjenti li għandhom anormalitajiet kardijaċi li kienu jeżistu minn qabel u/ jew jinsabu fi stadju avanzat ta ’ kankru jieħdu elettrokardjogrammi qabel u matul il- kors tat- trattament.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of IntronA therapy.
Arritmi kardijaċi (primarjament sopraventrikulari) ġeneralment jirrispondu għat- terapija konvenzjonali iżda jistgħu jeħtieġu t- twaqqif tat- terapija ta ’ IntronA.
There are no data in children or adolescents with a history of cardiac disease.
M’ hemmx tagħrif dwar tfal jew adolexxenti li fil- passat kellhom mard kardijaku.
Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
L- ipertrigliċeridimja u l- aggravament ta ’ l- ipertrigliċeridimja, kultant b' mod serju, kienu innutati.
Monitoring of lipid levels is, therefore, recommended.
Huwa għalhekk rakkomandat li l- livelli tal- lipidi jkunu sorveljati b’ attenzjoni.
Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of IntronA in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Minħabba rapporti li l- interferon alpha jħarrax il- mard psorjatiku u s- sarkojdożi f’ pazjenti li kienu jsofru bihom minn qabel, l- użu ta ’ IntronA fil- pazjenti bi psorajiżi jew sarkojdożi hu rakkomandat biss jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali.
Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
L- informazzjoni preliminari tindika li t- terapija bl- interferon alpha hija assoċjata ma ’ rata ikbar ta ’ riġett ta ’ trapjanti tal- kliewi.
Liver graft rejection has also been reported.
Riġett tat- trapjanti tal- fwied kien rappurtat ukoll.
The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
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.
Pazjenti li huma predisposti għall- iżvilupp ta ’ problemi ta ’ awtoimmunità jista ’ jkollhom riskju akbar.
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 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 treated with interferon.
Każijiet tas- sindrome Vogt- Koyanagi- Harada (VKH) kienu rrappurtati f’ pazjenti b’ epatite Ċ kronika kkurati b’ interferon.
This syndrome is a granulomatous inflammatory disorder affecting the eyes, auditory system, meninges, and skin.
Din is- sindrome hija disturb infjammatorju granulomatus li teffettwa l- għajnejn, is- sistema tas- smigħ, il- meninġi u l- ġilda.
If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8).
Jekk ikun hemm suspett li hemm is- sindrome VKH, il- kura kontra l- virus għandha titwaqqaf u tiġi diskussa terapija b’ kortikosterojdi (ara sezzjoni 4. 8).
Discontinue treatment with IntronA in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation.
Waqqaf il- kura b’ IntronA f’ pazjenti b’ epatite kronika li jiżviluppaw titwil tal- markaturi tal - koagulazzjoni li jista ’ jindika dikumpensazzjoni tal- fwied.
 7 Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/ repeated receipt of human plasma-derived albumin.
Tilqim xieraq (Epatite A u B) għandu jkun konsidrat għal pazjenti li jirċievu b’ mod regolari/ ripetut albumina li tkun ġejja mill- plażma tal- bniedem.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
Miżuri standard biex jiġu evitati infezzjonijiet li jiġu mill- użu ta ’ prodotti mediċinali li jkunu preparati mid- demm jew plażma tal- bniedem inkluż l- għażla tad- donaturi, screening tad- donazzjonijiet individwali u ġabra tal- plażma għal markaturi speċifiċi ta ’ l- infezzjoni u l- inklużjoni ta ’ passi effettivi fil- manifattura għall- inattivazzjoni/ tneħħija ta ’ viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Minkejja dan, meta jingħataw prodotti mediċinali li jkunu ppreparati minn- demm jew plażma tal- bniedem, il- possibilità li jkunu mxerrda aġenti infettivi ma tistax tiġi eskluża għal kollox.
This also applies to unknown or emerging viruses and other pathogens.
Dan japplika wkoll għal viruses mhux magħrufa jew ġodda u patoġeni oħrajn.
There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
M’ hemmx rapporti ta ’ tixrid ta ’ virus b’ albumina manifatturata skond speċifikazzjonijiet tal- European Pharmacopoeia bi proċessi stabbiliti.
It is strongly recommended that every time that IntronA is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Huwa rakkomandat ħafna li kull darba li jingħata IntronA lill- pazjent, l- isem tan- numru tal- lott tal - prodott jiġi mniżżel sabiex tinżamm ir- rabta bejn il- pazjent u l- lott tal- prodott.
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 ser jingħata flimkien ma ’ ribavirin fil- pazjenti li għandhom epatite Ċ kronika.
All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i. e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Il- pazjenti kollha fl- istudji dwar l- epatite Ċ kronika saritilhom bijopsija tal- fwied qabel ma kienu inklużi, iżda f’ ċerti każijiet (jiġifieri l- pazjenti bil- ġenotipi 2 u 3), it- trattament jista ’ jkun possibbli mingħajr konferma istoloġika.
Current treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment.
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 IntronA developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
F’ każijiet mhux tas- soltu, pazjenti ttrattati b’ IntronA għall- epatite Ċ kronika żviluppaw anormalitajiet fit- tirojde, ipotirojdiżmu jew ipertirojdiżmu.
In clinical trials using IntronA therapy, 2.8% patients overall developed thyroid abnormalities.
Fi provi kliniċi bl- użu tat- terapija b’ IntronA, 2. 8% tal- pazjenti kollha żviluppaw anormalitajiet tat- tirojde.
The abnormalities were controlled by conventional therapy for thyroid dysfunction.
L- anormalitajiet kienu kkontrollati bit- terapija konvenzjonali għall- funzjoni ħażina tat- tirojde.
The mechanism by which IntronA may alter thyroid status is unknown.
Il- mekkaniżmu kif IntronA jista ’ jbiddel l- istat tat- tirojde mhuwiex magħruf.
Prior to initiation of IntronA therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
Qabel tibda t- terapija b’ IntronA għat- trattament ta ’ l - epatite Ċ kronika, qies l- livelli ta ’ l- ormoni li jistimulaw it- tirojde (TSH) fis- serum.
Any thyroid abnormality detected at that time must be treated with conventional therapy.
Xi anormalità tat - tirojde li tinstab f’ dak l- istadju trid tkun ittrattata bit- terapija konvenzjonali.
IntronA treatment may be initiated if TSH levels can be maintained in the normal range by medication.
It- trattament b’ IntronA jista ’ jinbeda jekk it- TSH jista ’ jinżamm fil- livelli normali bil- medikazzjoni.
Determine TSH levels if, during the course of IntronA therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
Stabilixxi l- livelli tat - TSH jekk, matul il- kors tat- terapija b’ IntronA, il- pazjent jiżviluppa sintomi konsistenti mal- possibbiltà ta ’ funzjoni ħażina tat- tirojde.
In the presence of thyroid dysfunction, IntronA treatment may be continued if TSH levels can be maintained in the normal range by medication.
Fil- preżenza ta ’ funzjoni ħażina tat- tirojde, it- trattament b’ IntronA jista ’ jitkompla jekk it- TSH jista ’ jinżamm fil- livelli normali bil- medikazzjoni.
Discontinuation of IntronA therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
It- twaqqif tat- terapija ta ’ IntronA ma reġġax lura l- funzjoni ħażina tat- tirojde li seħħet matul it- trattament (ara wkoll Tfal u adolexxenti, monitoraġġ tat- Tirojde).
Supplemental monitoring specific for children and adolescents Thyroid Monitoring:
Aktar monitoraġġ speċifiku għal tfal u adolexxenti Monitoraġġ tat- Tirojde:
Approximately 12% of children treated with interferon alfa-2b and ribavirin developed increase in TSH.
Madwar 12% tat- tfal ikkurati b’ interferon alfa- 2b u ribavirin kellhom tnaqqis fit- TSH.
Another 4% had a transient decrease below the lower limit of normal.
4% oħra kellhom tnaqqis momentanju taħt il- limitu baxx tan- normali.
Prior to initiation of IntronA 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’ IntronA, il- livelli ta ’ TSH għandhom jiġu evalwati u kwalunkwe anormalità fit- tirojde għandha tiġi kkurata b’ terapija konvenzjonali.
IntronA therapy may be initiated if TSH levels can be maintained in the normal range by medication.
Terapija b’ IntronA 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 been observed.
Dehret funzjoni ħażina tat- tirojde waqt il- kura b’ interferon alfa- 2b u ribavirin.
If thyroid abnormalities are detected, the patient’ s thyroid status should be evaluated and treated as clinically appropriate.
Jekk jinsabu anormalitajiet tat- tirojde, l- istat tat- tirojde tal - pazjent għandu jiġi evalwat u kkurat kif ikun xieraq b’ mod kliniku.
TSH).
Tfal u adolexxenti għandhom jiġu monitorati kull 3 xhur għal evidenza ta ’ funzjoni ħażina tat- tirojde (eż TSH).
Growth and Development:
Tkabbir u Żvilupp:
During a 1-year course of therapy there was a decrease in the rate of linear growth (mean percentile decrease of 9%) and a decrease in the rate of weight gain (mean percentile decrease of 13%).
Waqt kors ta ’ terapija ta ’ sena kien hemm tnaqqis fir- rata ta ’ tkabbir linejari (perċentwali medju naqas b’ 9%) u tnaqqis fir- rata ta ’ żieda fil- piż (perċentwali medju naqas b’ 13%).
A general reversal of these trends was noted during the 6 months follow- up post treatment.
Kien nutat li dawn it- tendenzi reġgħu lura b’ mod ġenerali waqt is- 6 xhur ta ’ follow- up wara l- kura.
However, based on interim data from a long-term follow-up study, 12 (14%) of 84 children had a > 15 percentile decrease in rate of linear growth, of whom 5 (6 %)children had a > 30 percentile decrease despite being off treatment for more than 1 year.
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, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3).
Minbarra hekk, riżultati ta ’ qabel l- użu kliniku dwar tossiċità fiż- żgħażagħ wrew tnaqqis minuri, relatat mad- doża fit- tkabbir globali fil- firien tat- twelid li ngħataw ribavirin (ara sezzjoni 5. 3).
Therefore, the risk/ benefit of the combined use of  8 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 combination with interferon alfa-2b.
It- tobba huma konsiljati dsabiex jimmonitoraw it- tkabbir ta ’ tfal li jkunu qed jieħdu ribavirin flimkien ma ’ interferon alfa- 2b.