qanastek/EMEA-V3 huggingface dataset:
Other medicines that cannot be taken with VIRACEPT include rifampicin (used for treating bacterial infections), terfenadine or astemizole (commonly used to treat allergy symptoms), cisapride (for heart burn or problems with the digestive system), amiodarone or quinidine (used to treat an irregular heart beat), triazolam or oral midazolam (used to relieve anxiety and/or trouble with sleeping), omeprazole (used in the treatment of gastrointestinal ulcers), ergot derivatives (used to treat migraine), and pimozide (for psychiatric problems).
Mediċini oħra li ma jistgħux jittieħdu ma ’ VIRACEPT jinkludu rifampicin (użat għall- kura ta ’ infezzjonijiet mill- batterji), terfenadine jew astemizole (użati b’ mod komuni ħafna għall- kura ta ’ sintomi allerġiċi), cisapride (għall- ħruq ta ’ stonku jew problemi fis- sistema diġestiva), amiodarone jew quinidine (użat għall- kura ta ’ taħbit tal- qalb irregolari), triazolam jew midazolam orali (użat biex itaffi l- ansjetà u/ jew problemi fl- irqad), omerprazole (użat fil- kura ta ’ ulċeri gastro- intestinali), derivati ta ’ l - ergot (użati għall- kura ta ’ l- emigranja), u pimozide (għall- problemi psikjatriċi).
Consult your doctor if you are taking the following medicines.
57 Kellem lit- tabib tiegħek jekk qed tieħu l- mediċini li ġejjin.
55 rifabutin (used for treating bacterial infections), birth control pills (may not prevent pregnancy when given with VIRACEPT so other birth control methods should be used), calcium channel blockers including bepridil (for the treatment of heart conditions), immunosuppressants including tacrolimus and ciclosporin, sildenafil (for male impotence), statins (used to lower lipid levels in the blood), phenobarbital, phenytoin or carbamazepine (used in the treatment of epilepsy), methadone (used in the treatment of opiate dependence), lansoprazole and other medicines which reduce stomach acid, sedative agents (i.e. midazolam administered by injection).
F’ każijiet oħra, jista ’ jkun hemm bżomm ta ’ żjieda fis - sorveljanza u/ jew bidla fid- doża ta ’ dawn il- mediċini jew ta ’ VIRACEPT: ritonavir, indinavir, saquinavir u delavirdine (użati fil- kura ta ’ infezzjoni ta ’ l- HIV), rifabutin (użat fil- kura ta ’ infezzjonijiet mill- batterji), pilloli għall- kontroll tat- twelid (jistgħu ma jwaqqfux it- tqala meta jingħataw ma ’ VIRACEPT għalhekk għandhom jintużaw metodi ta ’ kontroll tat- twelid oħra), blokkaturi tal- kanali tal- kalċju inkluż bepridil (għal- kura ta ’ kundizzjonijiet tal- qalb), immunosoppressanti inkluż tacrolimus u ciclosporin, sildenafil (għal impotenza ta ’ l- irġiel), statins (użati biex ibaxxu l- livelli tax- xaħam fid- demm), phenobarbital, phenytoin jew carbamazepine (użati fil- kura ta ’ l- epilessija), methadone (użat fil- kura tad- dipendenza mill- opojdi), sedattivi (jiġifieri midazolam mogħti b’ injezzjoni). lansoprazole u mediċini oħra li jnaqqsu l- aċtu tal- istonku.
Severe interactions with other medicines would not be expected with the following medicines but the possibility cannot be excluded: amprenavir, efavirenz and nevirapine (used in the treatment of HIV infection); ketoconazole, itraconazole and fluconazole (used for treating fungal infections); erythromycin and clarithromycin (used for treating bacterial infections); fluoxetine, paroxetine, imipramine and amitriptyline (used in the treatment of depression), diazepam (used to relieve anxiety and/or trouble with sleeping).
Interazzjonijiet serji ma ’ mediċini oħra mhux mistennija mal- mediċini li ġejjin iżda l- possibilità ma tistax tiġi eskluża: amprenavir, efavirenz u nevirapine (użati fil- kura ta ’ infezzjoni ta ’ l- HIV); ketoconazole, itraconazole u fluconazole (użati fil- kura ta ’ infezzjonijiet mill- moffa); erythromycin u clarithromycin (użati fil- kura ta ’ infezzjonijiet mill- betterji); fluoxetine, paroxetine, imipramine u amitriptyline (użati fil- kura tad- depressjoni), (użat biex itaffi l- ansjetà u/ jew problemi biex torqod).
To obtain the full benefit of VIRACEPT, the tablets should be taken with a meal.
Biex tieħu l- benefiċċju kollu ta ’ VIRACEPT, il- pilloli għandhom jittieħdu ma ’ ikla.
HOW TO TAKE VIRACEPT
KIF TIEĦU VIRACEPT
The tablet form of VIRACEPT must be taken by mouth.
Il- pilloli VIRACEPT għandhom jittieħdu mill- ħalq.
VIRACEPT film-coated tablets should be swallowed whole and should be taken with a meal.
Il- pilloli miksija b’ rita VIRACEPT għandhom jinbelgħu sħaħ u għandhom jittieħdu ma ’ ikla.
For adults and children older than 13 years, the recommended dose of VIRACEPT 250 mg film-coated tablets is 1250 mg given as five 250 mg tablets twice daily (BID) or 750 mg given as three 250 mg tablets three times daily (TID).
Għal adulti u tfal li għandhom aktar minn 13- il sena, id- doża rakkomandata tal- pilloli miksija b’ rita ta ’ VIRACEPT ta ’ 250 mg hija ta ’ 1250 mg bħala ħames pilloli ta ’ 250 mg mogħtija darbtejn kuljum (BID) jew ta ’ 750 mg bħala tliet pilloli mogħtija tliet darbiet kuljum (TID).
For children, aged 3 to 13 years, the recommended dose is either 50-55 mg/kg body weight if VIRACEPT is taken twice daily (BID) or 25-30 mg per kg of body weight if VIRACEPT is taken three times daily (TID) as follows:
Għat- tfal li għandhom minn 3 snin sa 13- il sena, id- doża rakkomandata hija ta ’ 50- 55 mg / kg ta ’ piż tal- ġisem jekk VIRACEPT jingħata darbtejn kuljum (BID) jew ta ’ 25- 30 mg/ kg ta ’ piż korporju jekk VIRACEPT jingħata tliet darbiet kuljum (TID) kif ġej:
If you are receiving VIRACEPT film-coated tablets twice a day
58 Jekk qed tirċievi l- pilloli miksija b’ rita ta ’ VIRACEPT darbtejn kuljum
Body Weight (kg)
Piż
Number
tal- Ġisem (kg)
of film-coated tablets twice daily*
Numru ta ’ pilloli miksija b’ rita BID *
18 to < 22 ≥ 22
18 sa < 22 ≥ 22
56 If you are receiving VIRACEPT film-coated tablets three times a day
Jekk qed tirċievi l- pilloli ta ’ VIRACEPT miksija b’ rita tliet darbiet
Number of film-coated tablets three times daily*
Numru ta ’ pilloli miksija b’ rita TID *
18 to < 23 ≥ 23
18 sa < 23 ≥ 23
*see Package Leaflet for VIRACEPT oral powder for patients less than 18 kg body weight.
* Ara Fuljett ta ’ Tagħrif ta ’ VIRACEPT trab orali għall- pazjenti li għandhom piż tal- ġisem ta ’ inqas minn 18 kg.
For adults or children unable to take tablets, VIRACEPT 50 mg/g oral powder may be administered (see Package Leaflet for VIRACEPT 50 mg/g oral powder).
Għal adulti u tfal li ma jistgħux jieħdu l- pilloli, VIRACEPT 50 mg/ g trab orali jista ’ jingħata (ara l - Fuljett ta ’ Tagħrif għal VIRACEPT 50 mg/ g trab orali).
If you cannot reach your doctor, go to the nearest emergency room and take your VIRACEPT tablets with you.
Jekk ma tkunx tista ’ tikkuntattja lit- tabib tiegħek, mur fl- eqreb taqsima ta ’ l- emergenza ta ’ l - isptar u ħu l- pilloli VIRACEPT miegħek.
If you stop taking VIRACEPT Continue to take this medicine until your doctor tells you otherwise.
Kompli ħu din il- mediċina sakemm it- tabib tiegħek jgħidlek mod ieħor.
Allergic reactions including difficulty in breathing, fever, itching, swelling of the face and skin rashes that can sometimes form blisters, being sick, inflammation of the pancreas.
Reazzjonijiet allerġiċi inkluż diffikultà biex tieħu n- nifs, deni, ħakk, nefħa fil- wiċċ u raxx tal- ġilda li xi kultant jifforma l- infafet,
Sometimes there are no symptoms of this and the problem appears only in blood tests.
Xi kultant ma jkunx hemm sintomi ta ’ din u l- problema tidher biss mit - testijiet tad- demm.
57 New onset diabetes mellitus, high blood sugar or an increase in severity of existing diabetes mellitus has been rarely reported in patients receiving protease inhibitors.
Il- bidu ġdid ta ’ dijabete mellitus, zokkor tad- demm għoli jew żjieda fis- severità ta ’ dijabete mellitus eżistenti kien irrappurtat b’ mod rari f’ pazjenti li qed jirċievu l- PIs.
Do not store above 30°C.
Taħżinx f’ temperatura ’ l fuq minn 30oC.
What VIRACEPT contains:
X’ fiħ VIRACEPT:
The active substance is nelfinavir.
Is- sustanza attiva hija nelfinavir.
VIRACEPT 250 mg film-coated tablets contain 292.25 mg of nelfinavir mesilate corresponding to 250 mg of nelfinavir.
VIRACEPT 250 mg pilloli miksija b’ rita fiħ 292. 25 mg ta ’ nelfinavir mesilate li jikkorrispondi għal 250 mg ta ’ nelfinavir.
The other ingredients are calcium silicate, crospovidone, magnesium stearate, indigo carmine (E132), as powder, hypromellose and glycerol triacetate.
Is- sustanzi l- oħra huma calcium silicate, crospovidone, magnesium stearate, indigo carmine (E132), bħala trab, hypromellose u glycerol triacetate.
What VIRACEPT looks like and contents of the pack:
60 Id- Dehra ta ’ VIRACEPT u l- kontenuti tal- pakkett:
VIRACEPT film-coated tablets are provided in HDPE plastic bottles containing either 270 or 300 tablets, fitted with HDPE child resistant closures with polyethylene liners.
VIRACEPT pilloli miksija b’ rita huwa pprovdut fi fliexken tal- plastik HDPE, magħluqa b’ għotjien tal- HDPE reżistenti għat- tfal b’ kisja ta ’ polyethylene, li fihom 270 jew 300 pillola.
58 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
France Roche Tél: +33 (0) 1 46 40 50 00
61 France Roche Tél: +33 (0) 1 46 40 50 00
d se EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
at RAPPORT TA ’ VALUTAZZJONI PUBBLIKA EWROPEW (EPAR)
VIRAFERON
izz VIRAFERON
ori EPAR summary for the public
Sommarju ta ’ l- EPAR għall- pubbliku
uth This document is a summary of the European Public Assessment Report (EPAR).
Huwa
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
aw jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
ra If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ukoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
ux Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
ge of the EPAR).
ad X’ inhu Viraferon?
What is Viraferon? lon Viraferon is a medicine containing the active substance interferon alfa-2b.
Viraferon huwa mediċina li fiha s- sustanza attiva interferon alfa- 2b.
It is available as a powder and solvent to be made up into a solution for injection or infusion, as a ready-to-use solution for injection and as a multidose pen for injection.
Tiġi bħala trab u solvent sabiex ’ għ isiru soluzzjoni għal injezzjoni jew infużjoni, bħala soluzzjoni lesta għall- użu għal injezzjoni u bħala pinna li fiha aktar minn doża waħda għall- injezzjoni.
These contain from 1 to 50 million IU (international units) per millilitre. no
Dawn fihom minn 1 sa 50 miljun IU (unitajiet internazzjonali) kull millilitru. im
What is Viraferon used for?
Għal x’ hiex jintuża Viraferon?
Viraferon is used for the treatment of: • chronic (long-term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus) t
Viraferon jintuża għat- trattament ta ’: • epatite B kronika (fit- tul) (marda tal- fwied dovuta għal infezzjoni bil- vajrus ta ’ l- epatite B) fl - li l
in adults; uc
Fl- adulti, ina
In adults Viraferon can be used on its own but is best used in combination with ribavirin (an antiviral medicine).
Viraferon jista ’ jintuża waħdu iżda l- aħjar li jintuża flimkien ma ’ ribavirin (mediċina antivirali).
In children it is used with ribavirin. rod
Fit- tfal jintuża ma ’ ribavirin, Il- mediċina tista tingħata biss b’ riċetta ta ’ tabib. diċ
How is Viraferon used?
Kif jintuża Viraferon?
Treatment with Viraferon should be initiated by a doctor who has experience in the management of lp
Trattament b’ Viraferon għandu jinbeda minn tabib li jkollu esperjenza fil- ġestjoni tal- marda li għaliha jkun qiegħed jintuża.
Viraferon is given three times per week (every other day) by subcutaneous injection (under the skin).
tista ’ tingħata subkutanja (taħt il- ġilda) iżda f’ melanoma, jista ’ jingħata wkoll b’ infużjoni ġol- vini (drip fil- vini).
The dose and duration of treatment depend on the disease being treated and the response of the patient, with doses ranging from 3 to 10 million IU per square metre of body surface area.
Id- doża u t- tul tat- trattament jiddependu fuq il- marda li tkun qegħda tiġi ttrattata u fuq ir- rispons tal- pazjent, b’ dożaġġi li jvarjaw minn 3 għal 10 miljun IU kull metru kwadru ta ’ l- erja tas - superfiċje tal- ġisem.
For more information, see the Package Leaflet. ina
Għal aktar informazzjoni, ara l- Fuljett ta ’ Tagħrif. ott
Viraferon has to be stored in a refrigerator (2°C-8°C).
Viraferon għandu jinħażen fi friġġ (2°C- 8°C).
How does Viraferon work?
Kif jaħdem Viraferon? od
Interferons dic
Is- sustanza attiva f’ Viraferon, interferon alfa- 2b, tappartieni għall- grupp ‘ interferons ’.
are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Interferons huma sustanza naturali prodotti mill- ġisem li jgħinuh jiġġieled attakki bħal infezzjonijiet ikkawżati minn vajrusijiet.
The exact way alpha interferons work in viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system, the Me
Il- mod eżatt kif jaħdmu l- alfa interferons f’ mard virali għadu mhux mifhum għal Pr
body ’ s defence system, works).
kollox, iżda huwa maħsub li huma jaġixxu bħala immunomodulaturi (sustanzi li jimmodifikaw il- mod kif taħdem is- sistema ta ’ immunità, s- sistema ta ’ difiża tal- ġisem).
Alpha interferons may also block the multiplication of viruses.
Alpha interferons jistgħu jimblokkaw ukoll il- multiplikazzjoni tal- vajrusijiet.
The replacement interferon alfa-2b acts in same way as naturally produced interferon alpha.
L- interferon alfa- 2b f’ Viraferon huwa prodott b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad - DNA ’: l- interferon alfa- 2b huwa magħmul minn batterju li jkun irċieva ġene (DNA), li bih ikun jista ’ jipproduċih.
How has Viraferon been studied?
Kif ġie studjat Viraferon?
d Because interferon alfa-2b has been used to treat a number of diseases in the European Union (EU) before, the company that makes Viraferon supplied data from the scientific literature and from studies
at Minħabba li interferon alfa- 2b intuża biex jittratta numru ta ’ mard fl- Unjoni Ewropea (UE) qabel, il - kumpanija li tagħmel Viraferon ipprovdiet dejta mid- dokumentazzjoni xjentifika u minn studji u l- użu
se of its use in children with chronic hepatitis B.
izz tiegħu fuq tfal b’ epatite kronika B.
The company also supplied information from a number of studies of Viraferon used alone or with ribavirin for the treatment of chronic hepatitis C.
Il- kumpanija tat ukoll informazzjoni minn numru ta ’ studji ta ’ Veraferon użat waħdu jew ma ’ ribavirin għat- trattament ta ’ epatite Ċ kronika.
These included a total of 2,552 treatment-naïve patients (who had not been treated before) and a total of 345
Dawn inkludew 2, 552 pazjent naïve għat- trattament (qatt ma ġew ittratti qabel) u total ta ’ 345 pazjent li l- marda tagħhom
ori patients whose disease had relapsed (returned) after previous treatment with interferon.
tor reġgħet feġġet (irritornat) wara trattament preċedenti b’ interferon.
The use of Viraferon in combination with ribavirin has also been studied in 118 hepatitis C treatment-naïve children aged between three and 16 years.
L- użu ta ’ Viraferon flimkien ma ’ ribavirin ġie studjat ukoll fuq 118- il tifel/ tifla naïve għat- trattament b’ epatite Ċ t’ età bejn 3 u 16- il sena.
The main measure of effectiveness was response rates.
Il- miżuri prinċipali ta ’ l- effettività kien ir- rata ta ’ rispons fl- istudji ta ’ l- epatite u l- ħin ta ’ sopravivenza
uth What benefit has Viraferon shown during the studies?
X’ benefiċċju wera Viraferon matul l- istudji?
The studies showed that Viraferon is effective in the diseases for which it can be used.
L- istudji wrew li Viraferon huwa effettiv fil- mard li jintuża għalihom.
Viraferon was also shown to have a benefit in children with chronic hepatitis B.
Intwera wkoll li Viraferon
Viraferon, with or without ribavirin,
Intwera li Viraferon, bi jew mingħajr ribavirin, huwa effettiv fit- trattament ta ’ l- epatite Ċ kemm f’ adulti naïve għat- trattamenti kif ukoll f’ adulti li rkadew.
ra was shown to be effective in treating hepatitis C in both treatment-naïve and relapsed adults.
ad Ġiet osservata wkoll reazzjoni għat- trattament waqt il- vista ta ’ kontroll li saret sitt xhur wara sena ta ’ trattament f’ 46% tat- tfal, meta IntronA kienet użata flimkien ma ribavirin. ’ għ X’ inhu r- riskju assoċjat ma ’ Viraferon?
It was also effective in children when used with ribavirin, with 46% of the children having responded to treatment at the six-month follow up visit following a year’ s treatment.
L- aktar effetti sekondarju komuni b’ Viraferon f’ adulti (muri f’ aktar minn pazjent 1 minn 10) huma leucopenia (rata baxxa ta ’ ċelloli bojod fid- demm), anoressija (nuqqas ta ’ aptit), depressjoni, insomnja (diffikultà fl- irqad), ansjetà, aġitazzjoni, nervożiżmu, sturdament, uġigħ ta ’ ras, konċentrazzjoni im
The most common side effects with Viraferon in adults (seen in more than 1 patient in 10) are leucopenia (low white blood cell counts), anorexia (loss of appetite), depression, insomnia (difficulty lon sleeping), anxiety, agitation, nervousness, dizziness, headache, impaired concentration, dry mouth, blurred vision, nausea (feeling sick) or vomiting, abdominal (tummy) pain, diarrhoea, stomatitis (inflammation of the lining of the mouth), dyspepsia (indigestion), alopecia (hair loss), increased sweating, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), inflammation at the site of the injection, fatigue (tiredness), rigors (shaking chills), fever, flu- no
mnaqqsa, ħalq niexef, vista baxxa, nawżja (tħossok mdardar) jew remettar, uġigħ addominali (taż - żaqq), dijarea, stomatitis (fjammazzjoni tad- dawra tal- ħalq), dyspepsia (indiġestjoni), alopeċja (telf ta ’ xagħar), jegħraq aktar, mijalġja (uġigħ fil- muskoli), artralġja (uġigħ fil- ġogi), uġigħ muskuloskeletali li l
like symptoms, asthenia (weakness), irritability, chest pain, malaise (feeling unwell) and weight loss.
Effetti sekondarji simili ina
Similar side effects have been seen in children receiving Viraferon, as well as inhibition of growth.
instabu fi tfal li jużaw Viraferon, kif ukoll tnaqqis fit- tkabbir.
For the full list of all side effects reported with Viraferon, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji irrapportati b’ Viraferon, ara l- Fuljett ta ’ Tagħrif.
Viraferon should not be used in people who may be hypersensitive (allergic) to interferon alfa-2b or t
Viraferon m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal interferon alfa- 2b diċ
Viraferon should not be used in: uc
jew għal xi sustanza oħra tiegħu.
• patients with a history of severe heart disease, • patients with severe kidney or liver disease including that caused by cancer, • patients with epilepsy or other central nervous system problems, rod
Viraferon m’ għandux jintuża fuq: • pazjenti bi storja ta ’ mard serju tal- qalb, • pazjenti b’ mard serju tal- kliewi u tal- fwied inkluż dak ikkawżat mill- kanċer, • pazjenti b’ epilepsja jew bi problemi oħra tas- sistema nervuża ċentrali, me
• patients with thyroid disease unless it is controlled, • hepatitis patients who have liver cirrhosis (scarring) that is causing symptoms or who have recently received medicines that affect the immune system, • patients with a history of certain disorders of the immune system, or who have had an organ lp
• pazjenti b’ mard tat- tirojde jekk mhux ikkontrollati, • pazjenti li jbatu minn epatite b’ ċirrożi tal- fwied (tbajja) li jikkawwżaw sintomi jew li dan l- aħħar irċevew mediċini li jaffettwaw is- sistema ta ’ l- immunità, • pazjenti bi storja ta ’ ċerti disturbi tas- sistema immunitarja, jew li kellhom trapjant ta ’ organu u ott
transplant and are taking medicines that suppress the immune system, • children and adolescents with a history of severe mental illness, particularly severe depression, suicidal thoughts or suicide attempts. ina
qegħdin jieħdu mediċina li trażżan is- sistema immunitarja • tfal u adoloxxenti bi storja ta ’ mard mentali serju, b’ mod partikolari depressjoni qawwija, od
For a list of all restrictions with Viraferon, see the Package Leaflet.
ħsibijiet ta ’ suwiċidju jew attentati ta ’ suwiċidju.
Because Viraferon can be associated with side effects such as depression, patients must be closely monitored during treatment. dic
Peress li Viraferon jista ’ jiġi assoċjat ma ’ effetti sekondarji bħal dipressjoni, pazjenti għandhom jiġu Pr
Why has Viraferon been approved?
sorveljati mill- qrib matul it- trattament.
Other information about Viraferon:
Għaliex Viraferon ġie approvat?
The marketing authorisation was renewed on 9 March 2005.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Viraferon jisbqu r- riskji għat- trattament ta ’ epatite B jew Ċ kronika, lewkimija biċ- ċelloli muswafa, CML, mijeloma multipla, limfoma follikulari, tumur karċinojde u melanoma malinja.
The full EPAR for Viraferon is available here.
Il- Kumitat irrakkomanda li Viraferon jingħata awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 This summary was last updated in 02-2008.
2/ 3 Informazzjoni oħra dwar Viraferon:
d se ori uth ra ge lon
at L- EPAR sħiħ għal Viraferon huwa disponibbli minn hawn.
dic
izz Dan is- sommarju ġie aġġornat l- aħħar f’ 02- 2008.
ina
tor aw ux ad ’ għ im li l ina diċ me ott od Pr
ori uth ra ge lon ANNEX I
at izz tor aw ux ad ANNESS I ’ għ SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT im li l ina diċ me ott od Pr 1.
SUMMARY OF PRODUCT CHARACTERISTICS t no uc rod lp nai dic Me
ISEM TAL- PRODOTT MEDIĊINALI
NAME OF THE MEDICINAL PRODUCT
Viraferon 1 miljun IU trab u solvent għal soluzzjoni għall- injezzjoni
ed One vial of powder contains 1 million IU of interferon alfa-2b produced in E. coli by recombinant DNA technology.
izz Kull kunjett ta ’ trab fih 1 miljun IU ta ’ interferon alfa- 2b mgħamul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti.
s ori For a full list of excipients, see section 6.1.
tor Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
uth 3.
aw 3.
ra White to cream coloured powder.
ux Trab abjad għal lewn il- krema.
ge 4.
ad 4.
CLINICAL PARTICULARS lon 4.1 Therapeutic indications
TAGĦRIF KLINIKU Indikazzjonijiet terapewtiċi
Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B no
It- trattament ta ’ pazjenti adulti li għandhom l- epatite B kronika assoċjata ma ’ im
viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/ or fibrosis. t
evidenza ta ’ replikazzjoni virali ta ’ l- epatite B (preżenza ta ’ HBV- DNA u HBeAg), alanine aminotransferase (ALT) elevat u infjammazzjoni u/ jew fibrożi attiva fil- fwied li tkun konfermata b' mod istoloġiku. li l
Chronic Hepatitis C: uc
Epatite Ċ Kronika:
Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see rod
Viraferon huwa ndikat għat- trattament ta ’ pazjenti adulti li għandhom l- epatite Ċ kronika u għandhom ina
section 4.4).
transaminases elevati mingħajr dikompensazzjoni tal- fwied u li huma pożittivi għall- HCV- RNA jew għall- anti- HCV fis- serum (ara sezzjoni 4. 4). diċ
The best way to use Viraferon in this indication is in combination with ribavirin. lp
L- aħjar mod kif tuża Viraferon f’ din l- indikazzjoni huwa flimkien ma ’ ribavirin.
Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and na
Viraferon huwa intenzjonat biex jintuża, f’ kors ta ’ kombinazzjoni ma ’ ribavirin, għall- kura ta ’ tfal u me
adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
adolexxenti minn 3 snin ‘ l fuq, li għandhom epatite Ċ kronika, li ma ġietx ikkurata qabel, mingħajr dikumpensazzjoni tal- fwied, u li huma pożittivi għall- HCV- RNA.
The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and i dic
Id- deċiżjoni jekk għandhiex tingħata l- kura għandha tittieħed skond il- każ, billi jkun meqjus jekk hemmx avvanz tal- marda bħal infjammazzjoni epatika u fibrożi, kif ukoll fatturi ta ’ tbassir għar- rispons, ġenotip tal- HCV u viral ott
fibrosis, as well as prognostic factors for response, HCV genotype and viral load.
load.
Me
Il- benefiċċju mistenni mill- kura għandu jintiżen mas- sejbiet tas- sigurtà li jkunu dehru għal individwi pedjatriċi fil- provi kliniċi (ara sezzjonijiet 4. 4, 4. 8 u 5. 1). od
2 If adverse events develop during the course of treatment with Viraferon for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
Jekk iseħħu każijiet avversi matul il- kors tat- trattament b’ Viraferon għal kwalunkwe indikazzjoni, 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 Viraferon.
Jekk tiżviluppa intolleranza persistenti jew rikorrenti wara aġġustament xieraq fid- dożaġġ, jew il- marda tavvanza, waqqaf it- trattament b’ Viraferon.
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.
Chronic Hepatitis B:
at Epatite B Kronika:
The recommended dosage is in the range 5 to 10 million IU administered
Id- dożaġġ rakkomandat huwa bejn 5 u 10 miljun IU mogħtija taħt il- ġilda tliet
ed subcutaneously three times a week (every other day) for a period of 4 to 6 months.
izz 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
Id- doża mogħtija għanda titnaqqas b’ 50% f' każ li jseħħu problemi ematoloġiċi (ċelluli bojod tad -
s blood cells < 1,500/ mm3, granulocytes < 1,000/ mm3, thrombocytes < 100,000/ mm3).
tor demm < 1, 500/ mm3, granuloċiti < 1, 000/ mm3, tromboċiti < 100, 000/ mm3).
ori 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).
uth For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue Viraferon therapy.
aw Għall- pazjenti kollha, jekk ma jidhirx titjib ta ’ l- HBV- DNA fis- serum wara 3 sa 4 xhur ta ’ trattament (bid- doża massima ttollerata), waqqaf it- terapija b’ Viraferon.
ra Chronic Hepatitis C:
Epatite Ċ Kronika:
Viraferon is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with ribavirin.
ux (darba kull jumejn) lill- pazjenti adulti, kemm jekk jingħata bħala monoterapija kif ukoll flimkien ma ’ ribavirin.
ge Children 3 years of age or older and adolescents:
ad 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). lon (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
Interferon alfa- 2b 3 MIU/ m2 jingħata taħt il- ġilda tliet darbiet fil- ġimgħa (darba kull jumejn) flimkien mal- kapsuli ribavirin jew soluzzjoni orali li tittieħed mill- ħalq maqsuma f’ żewġ dożi kuljum ma ’ l- ikel (filgħodu u filgħaxija). ’ għ (Ara l- SPC tal- kapsuli ribavirin u l- linji gwida għal tibdil fid- dożaġġ għal terapija kombinata.
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC). no
Għal pazjenti pedjatriċi li jiżnu < 47 kg jew li ma jistgħux jibilaw kapsuli, ara l- SPC tas- soluzzjoni orali ribavirin). im
Viraferon is given in combination with ribavirin. t uc
Viraferon jingħata flimkien ma ’ ribavirin. li l
Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with Viraferon in combination with ribavirin for 6 months. rod
Skond ir- riżultati ta ’ provi kliniċi, li għandhom informazzjoni għal 6 xhur ta ’ trattament, huwa rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon flimkien ma ’ ribavirin għal 6 xhur. ina
The efficacy of Viraferon is enhanced when given in combination with ribavirin.
L- effikaċja ta ’ Viraferon tiżdied meta jkun mogħti flimkien ma ’ ribavirin.
Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin. lp
Viraferon għandu jingħata waħdu l- aktar f’ każijiet ta ’ intolleranza jew ta ’ kontra- indikazzjoni għal ribavirin. diċ
Viraferon in combination with ribavirin:
Viraferon flimkien ma ’ ribavirin:
Based on the results of clinical trials, in which data are available for 12 months of treatment, it is na
Skond ir- riżultati ta ’ provi kliniċi, li għandhom informazzjoni għal 12- il xahar ta ’ trattament, huwa me
recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months.
rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon flimkien ma ’ ribavirin għal mill- inqas 6 xhur.
Treatment should be continued for another 6-month period (i. e., a total of 12 months) in patients who exhibit i
It- trattament għandu jitkompla għal perijodu ieħor ta ’ 6 xhur (i. e., għal total ta ’ 12- il xahar) f’ pazjenti li juru HCV- RNA negattiv f’ xahar 6, u b’ ġenotip virali 1 (kif stabbilit f’ kampjun ta ’ qabel it - trattament) u b’ viral load għoli qabel it- trattament. ott
Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into Me
Fatturi oħra ta ’ tbassir negattiv (età > 40 sena, sess maskili, fibrożi li tgħaqqad) għandhom ikunu ikkunsidrati sabiex it- terapija tkun estiża għal 12- il xahar. od
account in order to extend therapy to 12 months.
Waqt provi kliniċi, il- pazjenti li ma wrewx rispons viroloġiku wara 6 xhur ta ’ trattament (HCV- RNA inqas mil- limitu li jista ’ jkun imkejjel) ma sostnewx ir- rispons viroloġiku tagħhom (HCV- RNA inqas Pr
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).
mil- limitu li jista ’ jkun imkejjel sitt xhur wara l- waqfien tat- trattament).
Viraferon alone:
Viraferon waħdu:
3 The optimal duration of therapy with Viraferon 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’ Viraferon 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 Viraferon alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Huwa rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon waħdu għal mill- inqas 3 sa 4 xhur, f’ liema punt l- istat ta ’ l- HCV- RNA għandu jkun stabbilit.
ed Children and adolescents:
at Tfal u adolexxenti:
The efficacy and safety of Viraferon 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 ’ Viraferon flimkien ma ’ ribavirin kienu studjati fi tfal u adolexxenti li ma kienux ġew ikkurati qabel għall- epatite Ċ.
s Genotype 1:
izz Ġenotip 1:
Patients who fail to achieve virological
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.
tor Rispons viroloġiku huwa definit bħala nuqqas ta ’ HCV- RNA li jista ’ jitkejjel f’ ġimgħa 12.
uth Genotype 2/ 3:
Ġenotip 2/ 3:
ra 81% for genotype 2/ 3/ 4.
aw Rispons viroloġiku wara sena 1 ta ’ trattament u 6 xhur follow- up kienu ta ’ 36% għall- ġenotip 1 u 81% għall- ġenotip 2/ 3/ 4.
Viraferon may be administered using either glass or plastic disposable injection syringes.
Viraferon jista ’ jingħata b’ siringi li jintużaw darba u jintremew tal- ħġieġ jew tal- plastik.
ge 4.3 Contraindications lon
ux 4. 3 Kontra- indikazzjonijiet
- A history of severe pre-existing cardiac disease, e. g., uncontrolled congestive heart failure, recent
- Passat ta ’ mard tal- qalb sever li kien jeżisti minn qabel, eż., insuffiċjenza tal- qalb konġestiva
myocardial infarction, severe arrhythmic disorders.
mhux taħt kontroll, infart mijokardjali reċenti, disturbi arritmiċi severi ’ għ
- Chronic hepatitis in patients who are being or have been treated recently with immunosuppressive
- Epatite kronika f’ pazjenti li qegħdin jew reċentement kienu qegħdin ikunu ttrattati b’ sustanzi
agents excluding short term corticosteroid withdrawal. t uc
immunosoppressivi, bl- esklużjoni tat- twaqqif għal żmien qasir tal- kortikosterojdi
- Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant recipients.
- Epatite awtoimmuni; jew passat mediku ta ’ mard awtoimmuni; pazjenti immunosoppressi li
rod
konvenzjonali ina
ideation or suicide attempt. lp
ħsibijiet dwar suwiċidju jew attentati ta ’ suwiċidju. diċ
Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C. na
Ara wkoll l- SPC ta ’ ribavirin jekk l- interferon alfa- 2b se jingħata flimkien ma ’ ribavirin fil- pazjenti bl- epatite Ċ kronika. me
4.4 Special warnings and precautions for use i dic
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after Me
Effetti severi tas- CNS, l- aktar dipressjoni, ħsibijiet ta ’ suwiċidju u attentati ta ’ suwiċidju dehru f’ xi pazjenti waqt terapija b’ Viraferon, u anki wara li ott
treatment discontinuation mainly during the 6-month follow-up periodand in the follow-up period.
twaqqfet il- kura waqt is- 6 xhur fil- perijodu ta ’ follow- up.
Among children and adolescents treated with Viraferon in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6-month follow-up after treatment.
Fost it- tfal u adolexxenti kkurati b’ Viraferon ma ’ ribavirin, ħsibijiet dwar suwiċidju u attentati ta ’ suwiċidju kienu rrappurtati aktar ta ’ spiss meta mqabbla ma ’ pazjenti adulti (2. 4% vs 1%) waqt il- kura u fil- perijodu ta ’ 6 xhur follow- up ta ’ wara l - od
Other CNS effects including aggressive behaviour (sometimes directed against others), confusion and alterations of mental status have been observed with alpha interferons.
Il- pazjenti għandhom ikunu Pr
Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
monitorati mill- qrib għal kwalunkwe sinjali jew sintomi ta ’ disturbi psikjatriċi.
If psychiatric
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.
4 symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk sintomi psikjatriċi jippersistu jew imorru għall- agħar, jew jiġi mitbuħ li hemm ħsibijiet dwar suwiċidju, huwa rakkomandat li l- kura b’ Viraferon titwaqqaf, u l- pazjent jiġi segwit, b’ intervent psikjatriku kif ikun xieraq.
If a treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
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
L- użu ta ’ interferon alfa- 2b fi tfal u
ed with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
at 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 Viraferon therapy.
izz Reazzjonijiet ta ’ sensittività eċċessiva akuta (eż. urtikarja, anġjoedima, bronkokostrizzjoni, anafilassi) għall- interferon alfa- 2b dehru f’ każijiet rari waqt it- terapija b’ Viraferon.
If such a reaction develops, discontinue the
Jekk tiżviluppa xi reazzjoni
Transient rashes do not necessitate interruption of
tor bħal xi waħda minn dawn, waqqaf il- medikazzjoni u applika t- terapija medika xierqa.
Any patient developing liver function abnormalities during treatment
aw Esperjenzi avversi minn moderati sa serji jistgħu jeħtieġu bidla fir- reġimen tad- dożaġġ tal- pazjent, jew f’ xi każijiet, il- waqfien tat- terapija b’ Viraferon.
ge with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress.
Kull pazjent li jiżviluppa anormalitajiet fil- funzjoni tal- fwied waqt it- trattament b’ Viraferon għandu jkun osservat mill- qrib u t- trattament jitwaqqaf jekk is- sinjali u s- sintomi javvanzaw.
Hypotension may occur during Viraferon therapy or up to two days post-therapy and may require supportive lon treatment.
ux Pressjoni baxxa ħafna tista ’ sseħħ waqt t- terapija b’ Viraferon jew sa jumejn wara, u tista ’ teħtieġ trattament ta ’ appoġġ.
Fluid replacement may be necessary. no
ad Idratazzjoni xierqa għandha tkun sostnuta fil- pazjenti li qed jagħmlu terapija b’ Viraferon billi kienet innutata f’ xi pazjenti pressjoni baxxa ħafna relatata ma’ nuqqas ta ’ fluwidu.
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out. t uc
Tista ’ tkun meħtieġa s - sostituzzjoni tal- fluwidi. ’ għ Filwaqt li d- deni jista ’ jkun assoċjat mas- sindrome li jixbah l- influwenza li spiss tkun rrapportata waqt it- terapija bl- interferon, kawżi oħrajn ta ’ deni persistenti għandhom ikunu esklużi. im
Viraferon must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e. g., chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis.
Viraferon għandu jintuża b’ attenzjoni f’ pazjenti b’ kundizzjonijiet mediċi ta ’ indeboliment, bħal dawk b’ passat mediku ta ’ mard pulmonari (eż., mard pulmonari ostruttiv kroniku) jew dijabete mellitus suxxettibbli għall- ketoaċidożi.
Caution must be observed also in patients with coagulation disorders (e. g., thrombophlebitis, rod
Attenzjoni għandha wkoll tingħata lill- pazjenti bi problemi ta ’ li l
pulmonary embolism) or severe myelosuppression.
koagulazzjoni (eż., tromboflebite, emboliżmu pulmonari) jew majelosuppressjoni serja.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed lp
Infiltrazzjonijiet pulmonarji, pulmonite, u pnewmonja, li kultant wasslu għall- mewt, kienu innutati ina
rarely in interferon alpha treated patients, including those treated with Viraferon.
f’ każijiet rari fil- pazjenti ttrattati bl- interferon alpha, inklużi dawk ittrattati b’ Viraferon.
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.5).
Dawn is- sintomi kienu rrapportati aktar ta ’ spiss meta shosaikoto, mediċina tal - ħxejjex Ċiniża, ingħatat fl- istess ħin ma ’ l- interferon alpha (ara sezzjoni 4. 5).
Any patient developing fever, cough, na
Kwalunkwe pazjent li jiżviluppa deni, sogħla, qtugħ ta ’ nifs jew sintomi oħra respiratorji għandu jitteħidlu raġġi- X tas- sider. diċ
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 i dic
Filwaqt li dan kien irrappurtat aktar ta ’ spiss fil- pazjenti bl- epatite Ċ kronika ttrattati bl- interferon alpha, kien ukoll me
hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
irrappurtat fil- pazjenti b’ mard onkoloġiku ttrattati bl- interferon alpha.
Me
It- twaqqif minnufih ta ’ l- għoti ta ’ l- interferon alpha, u t- trattament bil- kortikosterojdi jidher li jgħinu biex ifejjqu l- każijiet avversi pulmonarji.
Ocular adverse events (see section 4.8) including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instance after treatment with alpha interferons.
Każijiet avversi okulari (ara sezzjoni 4. 8) li jinkludu emorraġiji tar- retina, tikkek bojod fl- għajn, u ott
Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with Viraferon, must have a prompt and complete eye examination.
waqt it- trattament b’ Viraferon, għandu minnufih jagħmel eżami komplet ta ’ l- għajnejn.
Periodic visual examinations during Viraferon therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
It - Pr
Discontinuation of Viraferon should be considered in patients who develop new or worsening ophthalmological disorders.
twaqqif ta ’ Viraferon għandu jkun ikkunsidrat fil- pazjenti li jitfaċċawlhom jew imorrulhom għall - agħar xi problemi oftalmoloġiċi.
5 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.
Very rarely, seizures have occurred with high doses of Viraferon.
F’ każijiet rari ħafna, seħħew aċċessjonijiet b’ dożi għoljin ta ’ Viraferon.
It is recommended that
Pazjenti b’ passat mediku ta ’ insuffiċjenza tal- qalb konġestiva, infarti mijokardjali u/ jew problemi arritmiċi passati jew attwali, li jeħtieġu t- terapija b’ Viraferon, għandhom ikunu segwiti mill- qrib.
ed those patients who have pre-existing cardiac abnormalities and/ or are in advanced stages of cancer have electrocardiograms taken prior to and during the course of treatment.
at Huwa rakkomandat li dawk il- pazjenti li għandhom anormalitajiet kardijaċi li kienu jeżistu minn qabel u/ jew jinsabu fi stadju avanzat ta ’ kankru jieħdu elettrokardjogrammi qabel u matul il- kors tat -
s therapy.
izz trattament.
ori Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
tor L- ipertrigliċeridimja u l- aggravament ta ’ l- ipertrigliċeridimja, kultant b' mod serju, kienu innutati.
uth Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of Viraferon in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the
aw Minħabba rapporti li l- interferon alpha jħarrax il- mard psorjatiku u s- sarkojdożi f’ pazjenti li kienu jsofru bihom minn qabel, l- użu ta ’ Viraferon fil- pazjenti bi psorajiżi jew sarkojdożi hu rakkomandat biss jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali.
Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney
ux L- informazzjoni preliminari tindika li t- terapija bl- interferon alpha hija assoċjata ma ’ rata ikbar ta ’ riġett ta ’ trapjanti tal- kliewi.
The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha lon interferons.
ad L- iżvilupp ta ’ awtoantikorpi u problemi ta ’ awtoimmunità kienu irrappurtati waqt it- trattament bl - interferoni alpha.
Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Chronic hepatitis C, Monotherapy (thyroid abnormalities) and section 4.8). no
Pazjenti b’ sinjali jew b’ sintomi kompatibbli ma ’ problemi ta ’ awtoimmunità ’ għ għandhom ikunu evalwati b’ attenzjoni, u l- benefiċċju- riskju tat- tkomplija tat- terapija b’ interferon għandu jitqies mill- ġdid (ara wkoll sezzjoni 4. 4 Epatite Ċ kronika, Monoterpaija (anormalitajiet tat - tirojde) u sezzjoni 4. 8).
Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C treated with interferon.
kkurati b’ interferon.
If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8). t uc
Jekk ikun hemm suspett li hemm is- sindrome VKH, il- kura kontra l- virus għandha titwaqqaf u tiġi diskussa terapija b’ kortikosterojdi (ara sezzjoni 4. 8). li l
Discontinue treatment with Viraferon in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation. rod
Waqqaf il- kura b’ Viraferon f’ pazjenti b’ epatite kronika li jiżviluppaw titwil tal- markaturi tal - koagulazzjoni li jista ’ jindika dikumpensazzjoni tal- fwied. ina
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/ repeated receipt of human plasma-derived albumin. lp
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. diċ
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 na
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 me
markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
fil- manifattura għall- inattivazzjoni/ tneħħija ta ’ viruses.
This also applies to unknown or i dic
Dan japplika wkoll għal viruses mhux magħrufa jew ġodda u patoġeni oħrajn. ott
Me
M’ hemmx rapporti ta ’ tixrid ta ’ virus b’ albumina manifatturata skond speċifikazzjonijiet tal- European Pharmacopoeia bi proċessi stabbiliti. od
It is strongly recommended that every time that Viraferon 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.
Pr