qanastek/EMEA-V3 huggingface dataset:
The exact way that TNF α works against certain types of cancer is not fully understood, but it is thought that it can kill tumour cells directly, as well as destroy the blood vessels supplying tumours and stimulate the immune system to attack them.
Il- mod eżatt li bih jaħdem it- TNF kontra ċerti tipi ta ’ kankru għadu mhux mifhum għal kollox, iżda hu maħsub li jista ’ joqtol iċ- ċelloli tat- tumur direttament, kif ukoll jeqred l- arterji u vini li jissupplixxu lit- tumuri u jistimula s- sistema immunitarja li tattakkahom.
This leads to the tumour dying back and getting smaller, particularly when the medicine is combined with other cytotoxic (cell- killing) medicines and raised temperature.
Dan iwassal biex it- tumur imut u jiċkien, partikolarment meta l- mediċina tiġi kombinata ma ’ mediċini oħra ċitotossiċi (li joqtlu liċ- ċelloli) u żieda fit- temperatura.
The active substance in Beromun, tasonermin, is produced by a method known as ‘ recombinant DNA technology’: it is made by bacteria that have received a gene (DNA), which makes them able to produce TNFα.
Is- sustanza attiva f’ Beromun, tasonermin, tiġi prodotta b’ metodu magħruf bħala ‘ teknoloġija rikombinanati tad- DNA ’: jiġi magħmul minn batterji li jkunu diġà rċevew ġene (DNA).
The replacement TNFα acts in same way as the naturally produced protein.
Li jagħmilhom kapaċi jipproduċu t- TNFα.
How has Beromun been studied?
Kif ġie studjat Beromun?
Beromun has been studied in four main studies involving a total of 188 patients, in which it was given in combination with melphalan.
Beromun ġie studjat f’ erba ’ studji ewlenin li fihom b’ kollox ħadu sehem 188 pazjent, li fihom Beromun ingħata flimkien ma ’ melphalan.
Sixty-two of the patients also received interferon-gamma (another anticancer medicine).
Tnejn u sittin mill- pazjenti ngħataw ukoll interferon - gamma (mediċina oħra ta ’ kontra l- kankru).
A review of the studies by three independent experts found that only 145 of these patients were candidates for amputation or surgical removal of the tumour that would have resulted in significant loss of function (disability).
Meta dawn l- istudji ġew riveduti minn tliet esperti indipendenti ħareġ li 145 biss minn dawn il- pazjenti kienu kandidati għal amputazzjoni jew għat - tneħħija kirurġika tat- tumur li tirriżulta f’ telf sinjifikanti fil- funzjoni (diżabilità).
Therefore, the main measure of effectiveness was based on the experts’ assessment of the outcome of these 145 patients, in comparison with the outcome that would be expected without using Beromun.
Għalhekk, il- mezz ewlieni tal- kejl tal- effikaċja kien ibbażat fuq il- valutazzjoni tal- esperti tar- riżultati f’ dawn il- 145 pazjent, imqabbla mar- riżultati li kienu mistennija mingħajr l- użu ta ’ Beromun.
What benefit has Beromun shown during the studies?
X’ inhu l- benefiċċju ta ’ Beromun li ntwera f’ dawn l- istudji?
The independent reviewers agreed that 62% of the patients receiving Beromun and melphalan (90 out of 145) had a better outcome than predicted, since their limb was saved without surgery to remove the tumour or their tumour was removed without causing significant loss of function.
Dawn l- esperti indipendenti qablu li 62% tal- pazjent li kienu qed jingħataw Beromun u melphalan (90 minn 145) kellhom riżultati aħjar milli kien imbassar, billi r- riġel jew id- driegħ tagħhom ġie salvat mingħajr intervent kirurġiku għat- tneħħija tat- tumur jew billi t- tumur tneħħa mingħajr telf sinifikanti fil- funzjoni.
There were too few patients also receiving interferon-gamma to determine whether this improved the patients ’ outcome further.
Kien hemm ftit wisq pazjenti li kienu qed jieħdu wkoll interferon- gamma biex jiġi determinat jekk dan wassalx għal iktar titjib fil- kundizzjoni tal- pazjent.
What is the risk associated with Beromun?
X’ inhu r- riskju assoċjat ma ’ Beromun?
Most patients taking Beromun experience fever, which is usually mild to moderate.
Ħafna mill- pazjenti li jieħdu Beromun ikollhom deni, li ġeneralment ikun ħafif jew moderat.
Other side effects seen very commonly (in more than 1 patient in 10) are infection, cardiac arrhythmia (unstable heartbeat), nausea (feeling sick), vomiting, liver damage, fatigue (tiredness), chills, pain in the limb, nerve injury, skin reactions, oedema (swelling) and wound infection.
Effetti sekondarji oħra komuni ħafna (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma infezzjonijiet, aritmija kardijaka (taħbit instabbli tal- qalb), nawżea (dardir), rimettar, ħsara fil- fwied, għeja, tkexkix ta ’ bard, uġigħ fid- driegħ jew fir- riġel, leżjonijiet fin- nervituri, reazzjonijiet fil- ġilda, edema (nefħa) u infezzjoni f’ feriti.
Some side effects of Beromun are serious and could require a patient to spend time in an intensive care unit after treatment.
Xi effetti sekondarji ta ’ Beromun huma serji u jistgħu jwasslu biex pazjent iqatta ’ xi ħin f’ taqsima tal- kura intensiva wara t- trattament.
For a more complete list of the side effects reported with Beromun, see the Package Leaflet.
Għal lista iktar kompleta tal- effetti sekondarji rrappurtati ma ’ Beromun, ara l- Fuljett ta ’ Tagħrif.
Beromun should not be used in people who may be hypersensitive (allergic) to tasonermin or any of the other ingredients.
Beromun m’ għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal tasonermin jew għal xi sustanza oħra tiegħu.
It must not be used in patients with significant cardiovascular (heart and blood vessel) disease, severe lung disease, a recent or active stomach ulcer, severe ascites (fluid accumulation in the abdomen), blood disorders, kidney or liver disease, or hypercalcaemia (high blood calcium levels), or in women who are pregnant or breast-feeding.
Lanqas ma għandu jintuża minn pazjenti b’ mard kardjovaskulari sinifikanti (tal- qalb u tal- vini u l- arterji), mard tal- pulmuni gravi, ulċera tal- istonku attiva jew reċenti, axxite (akkumulu gravi ta ’ fluwidu fl- addomi), problemi fid- demm, mard tal- kliewi jew tal- fwied, jew iperkalċemija (livelli għoljin tal- kalċju fid- demm), jew f’ nisa tqal jew li jkunu qed ireddgħu.
It must also not be used in patients who cannot receive vasopressors (medicines to increase the blood pressure), anticoagulants (medicines to prevent blood clotting) or medicines that can harm the heart.
Lanqas ma għandu jintuża f’ pazjenti li ma jkunux jistgħu jieħdu vasopressors (mediċini li jgħollu l- pressjoni tad- demm), antikoagulanti (mediċini użati biex iraqqu d- demm) jew mediċini li jistgħu jagħmlu ħsara lill- qalb.
Beromun must not be used in patients who cannot receive melphalan or who cannot undergo ILP.
Beromun m’ għandux jintuża f’ pazjenti li ma jistgħux jirċievu jew ma jkunx jista ’ jsirilhom ILP.
See the Summary of Product Characteristics (also part of the EPAR) for the full list of restrictions.
Ara s- Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR) għal- lista sħiħa ta ’ restrizzjonijiet.
Why has Beromun been approved?
Għaliex ġie approvat Beromun?
The Committee for Medicinal Products for Human Use (CHMP) decided that Beromun’ s benefits are greater than its risks as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic ILP.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Beromun huma ikbar mir- riskji tiegħu meta użat bħala żieda mal- intervent kirurġiku għat- tneħħija sussegwenti tat- tumur sabiex tiġi evitata jew posposta amputazzjoni, jew f’ sitwazzjoni paljattiva, għal sarkoma fit- tessut artab fir- riġel jew fid- driegħ li ma tkunx tista ’ titneħħa b’ operazzjoni, użat flimkien ma ’ melphalan permezz ta ’ ILP ħafif ipertermiku.
The Committee recommended that Beromun be given marketing authorisation.
Il- Kumitat irrakkomanda li Beromun jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Beromun:
2/ 3 Tagħrif ieħor dwar Beromun:
The European Commission granted a marketing authorisation valid throughout the European Union for Beromun to Boehringer Ingelheim International GmbH on 13 April 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Beromun lil Boehringer Ingelheim International GmbH fit- 13 ta ’ April 1999.
The marketing authorisation was renewed on 13 April 2004 and on 13 April 2009.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 13 ta ’ April 2004 u t- 13 ta ’ April 2009.
The full EPAR for Beromun can be found here.
L- EPAR sħiħ għal Beromun jista ’ jinstab hawnhekk.
2/ 3 This summary was last updated in 04-2009.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Powder: vial (glass); solvent: pre-filled syringe (glass)
Trab: kunjett (ħġieġ); Solvent: siringa mimlija għal- lest (ħġieġ)
5 vials + 5 pre-filled syringes
5 kunjetti + 5 siringi mimlija għal - lest
15 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
15 x (kunjett 1 + siringa mimlija għal - lest 1 + adattatur għall - kunjett b ’ labra 1 + 2 imsielaħ ta ’ l- alkoħol)
5 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
5 x (kunjett 1 + siringa mimlija għal - lest 1 + adattatur b ’ labra għall- kunjett 1 + 2 imsielaħ ta ’ l- alkoħol)
3 x 15 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
3 x 15 x (kunjett 1 + siringa mimlija għal - lest 1 + adattatur għall - kunjett b’ labra 1 + 2 imsielaħ ta ’ l- alkoħol)
12 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
12 x (kunjett 1 + siringa mimlija għal- lest 1 + adattatur għall- kunjett b’ labra 1 + 2 imsielaħ ta ’ l- alkoħol)
14 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
14 x (kunjett 1 + siringa mimlija għal- lest 1 + adattatur għall- kunjett b’ labra 1 + 2 imsielaħ ta ’ l- alkoħol)
3 x 14 x (1 vial + 1 pre-filled syringe + 1 vial adapter with needle + 2 alcohol wipes)
3 x 14 x (kunjett 1 + siringa mimlija għal - lest 1 + adattatur għall - kunjett b’ labra 1 + 2 imsielaħ ta ’ l- alkoħol)
Betaferon 250 microgram/ ml, powder and solvent for solution for injection.
Betaferon 250 mikrogramma/ ml, trab u solvent għas- soluzzjoni għall- injezzjoni.
Recombinant interferon beta-1b * 250 microgram (8.0 million IU) per ml when reconstituted.
250 mikrogramma (8. 0 miljun IU) Interferon beta- 1b * rikombinanti f’ kull ml meta rikostitwit.
Betaferon contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial.
Betaferon fih 300 mikrogramma (9. 6 miljun IU) interferon beta- 1b rikombinanti f’ kull kunjett.
Sterile white to off-white powder.
Trab sterili ta ’ lewn abjad jew abjad jagħti fil- griż.
Betaferon is indicated for the treatment of • patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1). • patients with relapsing remitting multiple sclerosis and two or more relapses within the last two years, • patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Betaferon huwa indikat għall- kura ta ’ • pazjenti b’ każ wieħed ta ’ demajlinazzjoni bi proċess ta ’ infjammazzjoni attiva, jekk ikun serju biżżejjed li jeħtieġ kura b’ kortikosterojdi fil- vini, jekk dijanjosi alternattiva ġiet eskluża, u jekk jiġi stabbilit li jinsabu f’ riskju għoli li jiżviluppaw sklerożi multipla klinikament definittiva (ara sezzjoni 5. 1). • pazjenti bi sklerożi multipla li tirkadi u tbatti b’ żewġ episodji ta ’ rkadar jew iktar fl- aħħar sentejn, • pazjenti bi sklerożi multipla progressiva sekondarja bil- marda attiva, kif muri mill- irkadar.
The treatment with Betaferon should be initiated under the supervision of a physician experienced in the treatment of the disease.
Il- kura b’ Betaferon għandha tinbeda taħt is- superviżjoni ta ’ tabib b’ esperjenza fil- kura ta ’ din il- marda.
The recommended dose of Betaferon is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day.
Id- doża rrakkomandata ta ’ Betaferon hija 250 mikrogrammi (8. 0 miljun IU), li jinsabu f’ 1 ml tas - soluzzjoni rikostitwita (ara sezzjoni 6. 6), li trid tiġi injettata taħt il- ġilda ġurnata iva u oħra le.
No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Ma saru l- ebda provi kliniċi formali jew studji farmakokinetiċi fit- tfal jew fl- adoloxxenti.
However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Betaferon 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Madankollu, informazzjoni limitata li kienet ippubblikata tissuġġerixxi li l- profil tas- sigurtà f’ adoloxxenti minn 12 sa 16- il sena li kienu qed jirċievu Betaferon 8. 0 miljun IU minn taħt il- ġilda kull jumejn huwa simili għal dak li kien osservat fl- adulti.
There is no information on the use of Betaferon in children under 12 years of age and therefore Betaferon should not be used in this population.
M’ hemm l- ebda informazzjoni dwar l- użu ta ’ Betaferon fi tfal taħt 12- il sena u għalhekk Betaferon m’ għandux jintuża f’ din il- popolazzjoni.
Generally, dose titration is recommended at the start of treatment.
Ġeneralment fil- bidu tal- kura hija rrakkomandata tittrazzjoni tad- doża.
* produced by genetic engineering from strain of Escherichia coli.
* magħmul permezz ta ’ inġinerija ġenetika minn razza ta ’ Escherichia coli.
The titration period may be adjusted, if any significant adverse reaction occurs.
2 jiġi aġġustat.
In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.
Sabiex tintlaħaq effikaċja adegwata, għandha tintlaħaq doża ta ’ 250 mikrogramma (1. 0 ml) ġurnata iva u ġurnata le.
treatment day
jum ta ’ kura
dose
doża
62.5 microgram
62. 5 mikrogrammi
125 microgram
125 mikrogramma
187.5 microgram 250 microgram
187. 5 Mikrogrammi 250 mikrogramma
* The titration period may be adjusted, if any significant adverse reaction occurs.
* Jekk isseħħ xi reazzjoni avversa sinifikanti l- perijodu ta ’ titrazzjoni jista ’ jiġi aġġustat.
The optimal dose has not been fully clarified.
L- aħjar doża għada mhix ċara għal kollox.
There are follow-up data under controlled clinical conditions for patients with relapsing-remitting MS for up to 5 years and for patients with secondary progressive MS for up to 3 years.
Għall- pazjenti bi sklerożi multipla li tirkadi u tbatti hemm tagħrif meħud wara l- bidu tal- kura taħt kundizzjonijiet kliniċi kkontrollati sa 5 snin u għal pazjenti bi sklerożi multipla progressiva sekondarja hemm tagħrif sa 3 snin.
For relapsing-remitting MS, efficacy has been demonstrated for therapy for the first two years.
Għal sklerożi multipla li tirkadi u tbatti l- effikaċja tat- terapija ġiet murija għall- ewwel sentejn.
The available data for the additional three years are consistent with sustained treatment efficacy of Betaferon over the whole time period.
It - tagħrif disponibbli għat- tliet snin l- oħra huwa konsistenti ma ’ effikaċja tal- kura sostenuta tul il- perijodu kollu.
In patients with a single clinical event suggestive of multiple sclerosis, efficacy has been demonstrated over a period of three years.
F’ pazjenti b’ avveniment kliniku wieħed li jissuġġerixxi sklerożi multipla, l- effikaċja ġiet dimostrata fuq perijodu ta ’ tliet snin.
Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.
Din il- kura mhux irrakkomandata f’ pazjenti bi sklerożi multipla li tirkadi u tbatti li kellhom inqas minn 2 episodji ta ’ rkadar fl- aħħar sentejn jew f’ pazjenti bi sklerożi multipla progressiva sekondarja li ma kellhomx mard attiv fl- aħħar sentejn.
If the patient fails to respond, for example a steady progression in EDSS for 6 months occurs or treatment with at least 3 courses of ACTH or corticosteroids during a one year period is required despite Betaferon therapy, treatment with Betaferon should be stopped.
Jekk il- pazjent ma jirrispondix għall- kura, per eżempju, jekk iseħħ progress regolari fl- EDSS għal 6 xhur jew ikun hemm il- ħtieġa ta ’ kura b’ ta ’ l- anqas 3 korsijiet ta ’ ACTH jew kortikosterojdi waqt perijodu ta ’ sena minnkejja terapija ta ’ Betaferon, il- kura b’ Betaferon għandha titwaqqaf.
− Initiation of treatment in pregnancy (see section 4.6 Pregnancy and lactation). − Patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin or to any excipients. − Patients with current severe depression and/ or suicidal ideation (see section 4.4 Special warnings and special precautions for use and 4.8 Undesirable effects). − Patients with decompensated liver disease (see sections 4.4, 4.5, 4.8).
− Bidu ta ’ kura waqt it- tqala (ara sezzjoni 4. 6 Tqala u treddigħ). − Pazjenti b’ passat ta ’ sensittività eċċessiva għal interferon- beta naturali jew rikombinanti, albumina umana jew għal xi wieħed mis- sustanzi mhux attivi. − Pazjenti li bħalissa għandhom depressjoni qawwija u/ jew ħsibijiet ta ’ suwiċidju (ara sezzjoni 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu u 4. 8 Effetti mhux mixtieqa) − Pazjenti b’ mard tal- fwied dekompensat (ara sezzjonijiet 4. 4, 4. 5, 4. 8)
The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
L- għoti ta ’ ċitokini lill- pazjenti b’ gammopatija monoklonali eżistenti minn qabel kienet assoċjata ma ’ l- iżvilupp tas- sindrome sistemika ta ’ tnixxija tal- kapillari, b’ sintomi li jixbhu lil dawk ta ’ xokk u b’ konsegwenzi fatali.
In rare cases, pancreatitis was observed with Betaferon use, often associated with hypertriglyceridaemia.
F’ każijiet rari, bl- użu ta ’ Betaferon, kienet osservata pankreatite, li ta ’ spiss kienet assoċjata ma ’ ipertrigliċeridimja.
3 Nervous system disorders
Betaferon għandu jingħata b’ attenzjoni lil pazjenti li kellhom jew għandhom disturbi depressivi, b’ mod partikolari dawk bi ħsibijiet ta ’ suwiċidju (ara sezzjoni 4. 3).
Betaferon should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
Depressjoni u ħsibijiet ta ’ suwiċidju huwa magħruf li jseħħu bi frekwenza akbar fil- popolazzjoni bi sklerosi multipla u f’ assoċjazzjoni ma ’ l- użu ta ’ interferon.
Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Pazjenti kkurati b’ Betaferon għandhom jingħataw parir biex jirrapportaw sintomi ta ’
Patients treated with Betaferon should be advised to immediately report any symptoms of depression and/ or suicidal ideation to their prescribing physician.
3 depressjoni u/ jew ta ’ ħsibijiet ta ’ suwiċidju lit- tabib tagħhom minnufih.
Patients exhibiting depression should be monitored closely during therapy with Betaferon and treated appropriately.
Pazjenti li għandhom depressjoni għandhom jiġu sorveljati mill- qrib waqt it- terapija b’ Betaferon u kkurati skond il- bżonn.
Cessation of therapy with Betaferon should be considered (see also section 4.3 and section 4.8).
Għandu jiġi kkunsidrat waqfien tat- terapija b’ Betaferon (ara wkoll sezzjoni 4. 3 u sezzjoni 4. 8).
Betaferon should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti- epileptics (see section 4.5 and section 4.8).
Betaferon għandu jingħata b’ attenzjoni lil pazjenti b’ passat ta ’ aċċessjonijiet, lil dawk li qed jirċievu kura b’ anti- epilettiċi, speċjalment jekk l- epilessija tagħhom mhux ikkontrollata b’ mod adegwat b’ anti - epilettiċi (ara sezzjoni 4. 5 u sezzjoni 4. 8).
This product contains human albumin and hence carries a potential risk for transmission of viral diseases.
Dan il- prodott fih albumina umana u għalhekk għandu riskju potenzjali għat- trasmissjoni ta ’ mard ikkawżat minn virusis.
A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded.
Ma jistax jiġi eskluż ir- riskju ta ’ trasmissjoni tal- marda ta ’ Creutzfeld- Jacob (CJD).
Laboratory test
Test tal- laboratorju
Thyroid function tests are recommended regularly in patients with a history of thyroid dysfunction or as clinically indicated.
Huwa rrakkomandat li jsiru eżamijiet tal- funzjoni tat- tirojde regolari f’ pazjenti b’ passat ta ’ funzjoni tat - tirojde ħażina jew hekk kif indikat kilinkament.
In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e. g.
Flimkien ma ’ dawk it- testijiet tal- laboratorju li ġeneralment huma meħtieġa biex jiġu sorveljati pazjenti bi sklerożi multipla, l- għadd sħiħ ta ’ ċelluli tad- demm u l- għadd divrenzjali ta ’ ċelluli bojod tad- demm, l- għadd ta ’ plejtlits, u kimiċi tad- demm inkluż testijiet tal- funzjoni tal- fwied (e. ż.
AST (SGOT), ALT (SGPT) and γ -GT), are recommended prior to initiation and at regular intervals following introduction of Betaferon therapy, and then periodically thereafter in the absence of clinical symptoms.
AST (SGOT), ALT (SGPT) u γ- GT) huma rrakkomandati qabel il- bidu tal- kura b’ Betaferon, u f’ intervalli regolari wara l - introduzzjoni ta ’ terapija b’ Betaferon, u kull tant żmien wara dan fin- nuqqas ta ’ sintomi kliniċi.
Patients with anemia, thrombocytopenia, leukopenia (alone or in any combination) may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Pazjenti li għandhom anemija, tromboċitopenija, lewkopenija (waħedha jew fi kwalunkwe taħlita) għandu mnejn jeħtieġu sorveljanza aktar intensiva ta ’ l- għadd sħiħ ta ’ ċelluli tad- demm, flimkien ma ’ l - għadd divrenzjali u l- għadd tal- plejtlits.
Patients who develop neutropenia should be monitored closely for the development of fever or infection.
Pazjenti li jiżviluppaw newtropenija għandhom jiġu sorveljati mill- qrib għall- iżvilupp ta ’ deni jew infezzjonijiet.
There have been reports of thrombocytopenia, with profound decreases in platelet count.
Kien hemm rapporti ta ’ tromboċitopenija bi tnaqqis sostanzjali fl- għadd ta ’ plejtlits.
Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Betaferon during clinical trials.
Waqt provi kiniċi f’ pazjenti kkurati b’ Betaferon, seħħew każijiet komuni ħafna ta ’ żjidiet bla sintomi fit- transaminases fis- serum, li fil- biċċa l- kbira kienu ħfief u mhux permanenti.
As for other beta interferons, severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking Betaferon.
Bħal b’ beta interferoni oħrajn, f’ pazjenti li kienu qed jieħdu Betaferon, kien hemm rapporti ta ’ każijiet rari ta ’ ħsara severa fil - fwied, inkluż każijiet ta ’ insuffiċjenza tal- fwied.
The most serious events often occurred in patients exposed to other drugs or substances known to be associated with hepatotoxicity or in the presence of comorbid medical conditions (e. g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
Ħafna drabi l- aktar avvenimenti serji, seħħew f’ pazjenti li kienu esposti għal mediċini jew sustanzi oħra magħrufa li huma assoċjati ma ’ epatotossicità jew fil- preżenża ta ’ aktar minn kundizzjoni medika morbiduża waħda (e. ż. mard malinn b’ metastasi, infezzjoni qawwija u sepsi, abbuż ta ’ l- alkoħol).
Patients should be monitored for signs of hepatic injury.
Pażjenti għandhom jiġu sorveljati għal sinjali ta ’ ħsara fil- fwied.
The occurrence of elevations in serum transaminases should lead to close monitoring and investigation.
L- okkorrenza ta ’ żjidiet fit - transaminases fis- serum għandha twassal għal sorveljanza mill- viċin u investigazzjoni bir- reqqa.
Withdrawal of Betaferon should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundices.
Jekk il- livelli jogħlew b’ mod sinifikanti jew jekk ikunu assoċjati ma ’ sintomi kliniċi bħal suffejra, għandu jiġi kkunsidrat li titwaqqaf il- kura b’ Betaferon.
In the absence of clinical evidence for liver damage and after normalisation of liver enzymes a reintroduction of therapy could be considered with appropriate follow-up of hepatic functions.
Jekk ma jkunx hemm evidenza klinika ta ’ ħsara fil - fwied u wara li l- livelli ta ’ enżimi tal- fwied jerġgħu għan- normal jista ’ jiġi kkunsidrat bidu mill- ġdid tal- kura b’ sorveljanza xierqa tal- funzjonijiet tal- fwied.
Caution should be used and close monitoring considered when administering Interferon beta to patients with severe renal failure.
Għandu jkun hemm attenzjoni u sorveljanza mill- qrib għandha tiġi kkunsidrata meta Interferon beta jingħata lil pazjenti b’ insuffiċjenza severa tal- kliewi.
4 Cardiac disorders
4 Waqt li Betaferon mhux magħruf li għandu xi tossiċità kardijaka li taġixxi direttament, sintomi tas - sindrome li tixbaħ lill- influwenza assoċjati ma ’ interferoni beta jistgħu jkunu ta ’ stress għall- pazjenti b’ mard tal- qalb sinifikanti li kien jeżisti minn qabel.
While Betaferon does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease.
Waqt il- perijodu ta ’ wara t- tqegħid fis- suq waslu rapporti rari ħafna ta ’ aggravar fl- istat kardijaku ta ’ pazjenti b’ mard tal- qalb sinifikanti li kien jeżisti minn qabel, temporanjament assoċjat ma ’ bidu ta ’ terapija b’ Betaferon.
Rare cases of cardiomyopathy have been reported.
Kienu rrapportati każijiet rari ta ’ kardjomijopatija.
If this occurs and a relationship to Betaferon is suspected, treatment should be discontinued.
F’ każ li jiġri dan u jkun hemm suspett ta ’ assoċjazzjoni ma ’ Betaferon, il- kura għandha titwaqqaf.
Serious hypersensitivity reactions (rare but severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Jistgħu jseħħu reazzjonijiet serji ta ’ sensittività eċċessiva (reazzjonijiet rari iżda severi u akuti bħal bronkospasżmu, anafilassi u urtikarja).
If reactions are severe, Betaferon should be discontinued and appropriate medical intervention instituted.
Jekk ir- reazzjonijiet ikunu severi, Betaferon għandu jitwaqqaf u għandu jinbeda intervent mediku xieraq.
Injection site necrosis has been reported in patients using Betaferon (see section 4.8).
Nekrożi fil- lok ta ’ l- injezzjoni kienet irrapportata f’ pazjenti li kienu qed jużaw Betaferon (ara sezzjoni 4. 8).
It can be extensive and may involve muscle fascia as well as fat and therefore can result in scar formation.
Din tista ’ tkun estensiva u tista ’ tinvolvi l- fascia tal- muskoli kif ukoll ix- xaħam u għalhekk tista ’ twassal għall- formazzjoni ta ’ ċikatriċi.
Occasionally debridement and, less often, skin grafting are required and healing may take up to 6 months.
Xi kultant ikun meħtieġ it- tneħħija ta ’ tessut mejjet/ marid u inqas ta ’ spiss, trapjant tal- ġilda, u l- fejqan jista ’ jieħu sa 6 xhur.
If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with his/ her physician before continuing injections with Betaferon.
Jekk il- pazjent ikollu xi qsim fil- ġilda, li jista ’ jkun assoċjat ma ’ nefħa jew ħruġ ta ’ fluwidu minn fejn tingħata l- injezzjoni, il- pazjent għandu jingħata l- parir biex ikellem lit- tabib tiegħu/ tagħha qabel ikompli bl- injezzjonijiet ta ’ Betaferon.
If the patient has multiple lesions Betaferon should be discontinued until healing has occurred.
Jekk il- pazjent ikollu feriti multipli, Betaferon għandu jitwaqqaf sakemm ikun hemm fejqan.
Patients with single lesions may continue on Betaferon provided the necrosis is not too extensive, as some patients have experienced healing of injection site necrosis whilst on Betaferon.
Pazjenti b’ ferita waħda jistgħu jkomplu b’ Betaferon sakemm in- nekrosi ma tkunx estensiva ħafna, peress li xi pazjenti kellhom fejqan tan- nekrosi tal- parti minn fejn tingħata l- injezzjoni waqt li kienu qed jieħdu Betaferon.
To minimise the risk of injection site necrosis patients should be advised to:
Biex jitnaqqas ir- riskju ta ’ nekrożi fil- lok ta ’ l- injezzjoni, l- pazjenti għandhom jingħataw parir sabiex:
− use an aseptic injection technique − rotate the injection sites with each dose.
− jużaw teknika ta ’ injezzjoni mhux settika − jibdlu l- lok ta ’ injezzjoni ma ’ kull doża.
The incidence of injection site reactions may be reduced by the use of an autoinjector.
L- inċidenza ta ’ reazzjonijiet fil- lok ta ’ l- injezzjoni tista ’ titnaqqas bl- użu ta ’ awto- injettatur.
In the pivotal study of patients with a single clinical event suggestive of multiple sclerosis an autoinjector was used in the majority of patients.
Fl- istudju pivitali ta ’ pazjenti b’ avveniment kliniku wieħed li jissuġġerixxi sklerożi multipla intuża awto- injettur fil- maġġoranza tal- pazjenti.
Injection site reactions as well as injection site necroses were observed less frequently in this study than in the other pivotal studies.
Reazzjonijiet fil- lok ta ’ l- injezzjoni kif ukoll nekrosi fil- lok ta ’ l- injezzjoni kienu osservati b’ mod inqas frekwenti f’ dan l- istudju meta mqabbel ma ’ studji pivitali oħra
The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
Il- proċedura ta ’ l- għoti tal- mediċina mill- pazjent stess għandha tiġi riveduta kull tant żmien speċjalment jekk kien hemm xi reazzjonijiet fil- lok ta ’ l- injezzjoni.
As with all therapeutic proteins, there is a potential for immunogenicity.
Bħal proteini terapewtiċi kollha, hemm potenzjal għal immunoġeniċità.
Serum samples in controlled clinical trials were collected every 3 months for monitoring of development of antibodies to Betaferon.
Kampjuni tas- serum fi provi kliniċi kkontrollati kienu miġbura kull 3 xhur għal sorveljanza ta ’ żvilupp ta ’ antikorpi għal Betaferon.
In the different controlled clinical trials, between 23% and 41% of the patients developed serum interferon beta-1b neutralising activity confirmed by at least two consecutive positive titres; of these patients, between 43% and 55% converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the respective study.
Fil- provi kliniċi kkontrollati differenti, bejn 23% u 41% tal- pazjenti żviluppaw attività newtralizzanti għal interferon beta 1- b fis- serum li kienet ikkonfermata b’ minn ta ’ l- anqas żewġ titri konsekuttivi pożittivi; minn dawn il- pazjenti, bejn 43% u 55% qalbu għal stat negattiv ta ’ anti- korpi stabbli (skond żewġ titri negattivi konsekuttivi) matul il- perijodu ta ’ osservazzjoni sussegwenti ta ’ l- istudju rispettiv.
Some analyses suggest that this effect might be larger in patients with higher titre levels of neutralising activity.
Fl- istudju ta ’ pazjenti b’ avveniment kliniku wieħed li jissuġġerixxi sklerożi multipla, l- attività newtralizzanti li kienet imkejla kull 6 xhur kienet osservata ta ’ l- inqas darba f’ 32% (88) tal- pazjenti
In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (88) of the patients treated immediately with Betaferon; of these, 47% (41) returned to negative status over a 3 year period.
5 kkurati mmedjatament b’ Betaferon; minn dawn, 47% (41) marru lura għal stat negattiv fuq perijodu ta ’ 3 snin.
Within this period, the development of neutralising activity was not associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS), and time to confirmed EDSS progression).
Matul dan il- perijodu, l- iżvilupp ta ’ attività newtralizzanti ma kienx assoċjat ma ’ tnaqqis fl - effikaċja klinika (rigward iż- żmien għall- sklerożi multipla klinikament definita (CDMS), u ż- żmien sa progressjoni kkonfermata fl- EDSS).
New adverse events have not been associated with the development of neutralising activity.
Avvenimenti avversi ġodda ma kienux assoċjati ma ’ l- iżvilupp ta ’ attività li tinnewtralizza.
It has been demonstrated in vitro that Betaferon cross reacts with natural interferon beta.
Minn provi li saru in vitro intwera li Betaferon jirreaġixxi ma ’ interferon beta naturali.
However, this has not been investigated in vivo and its clinical significance is uncertain.
Madankollu dan ma kienx investigat in vivo u s- sinifikanza klinika tiegħu għadha mhux aċċertata.
There are sparse and inconclusive data on patients who have developed neutralising activity and have completed Betaferon therapy.
It- tagħrif li hemm dwar pazjenti li żviluppaw attività li tinnewtralizza u li spiċċaw it- terapija b’ Betaferon huwa skars u mhux konklussiv.
The decision to continue or discontinue treatment should be based on clinical disease activity rather than on neutralising activity status.
Id- deċiżjoni biex titkompla jew jitwaqqaf il- kura għandha tkun ibbażata fuq l- attività tal- marda klinika u mhux fuq l- istat ta ’ l- attività li tinnewtralizza.
The effect of alternate-day administration of 250 microgram (8.0 million IU) of Betaferon on drug metabolism in multiple sclerosis patients is unknown.
L- effett ta ’ għoti ta ’ 250 mikrogramma (8. 0 miljun IU) Betaferon ġurnata iva u oħra le fuq il - metaboliżmu tal- mediċina f’ pazjenti bi sklerożi multipla mhux magħruf.
Corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been well tolerated in patients receiving Betaferon.
Tul ta ’ kura sa 28 ġurnata b’ kortikosterojdi jew b’ ACTH f’ każijiet ta ’ rkadar kienu ttollerati sew f’ pazjenti li kienu qed jirċievu Betaferon.
Due to the lack of clinical experience in multiple sclerosis patients, the use of Betaferon together with immunomodulators other than corticosteroids or ACTH is not recommended.
Minħabba nuqqas ta ’ esperjenza klinika f’ pazjenti bi sklerożi multipla, l- użu ta ’ Betaferon flimkien ma ’ immunomodulaturi għajr kortikosterojdi jew ACTH, mhux irrakkomandat.
Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
L- interferoni kienu rrapportati li jnaqqsu l- attività ta ’ enżimi tal- fwied li jiddependu fuq ic- ċitokromju P- 450 fil- bnedmin u l- annimali.
Caution should be exercised when Betaferon is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e. g. anti-epileptics.
Għandu jkun hemm attenzjoni meta Betaferon jingħata flimkien ma ’ prodotti mediċinali li għandhom indiċi terapewtiċi dojoq u li huma dipendenti ħafna fuq is- sistema taċ - ċitokromju P450 tal- fwied għat- tneħħija, e. ż. anti- epilettiċi.
Additional caution should be exercised with any co-medication which has an effect on the haematopoetic system.
Għandu jkun hemm aktar attenzjoni meta Betaferon jingħata flimkien ma ’ mediċini li għandhom effett fuq is- sistema tad- demm.
No interaction studies with anti-epileptics have been carried out.
Ma sarux studji dwar l- interazzjoni b’ anti- epilettiċi.
• Pregnancy
• Tqala
There is limited information on the use of Betaferon in pregnancy.
Hemm informazzjoni limitata dwar l- użu ta ’ Betaferon waqt it- tqala.
Available data indicates that there may be an increased risk of spontaneous abortion.
Tagħrif disponibbli jindika li jista ’ jkun hemm riskju akbar ta ’ korriment spontanju.
Initiation of treatment is contraindicated during pregnancy (see section 4.3).
Bidu ta ’ kura huwa kontra- indikat waqt it- tqala (ara sezzjoni 4. 3).
• Women of child-bearing potential
• Nisa li jistgħu joħorġu tqal
Women of child-bearing potential should take appropriate contraceptive measures.
Nisa li jistgħu joħorġu tqal għandhom jużaw metodu kontraċettiv xieraq.
If the patient becomes pregnant or plans to become pregnant while taking Betaferon, she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).
Jekk il- pazjenta toħroġ tqila jew qed tippjana biex toħroġ tqila waqt il- kura b’ Betaferon, għandha tiġi nfurmata dwar il- possibbiltà ta ’ ħsara u għandu jiġi kkunsidrat li titwaqqaf il- kura (ara sezzjoni 5. 3).
In patients with a high relapse rate before treatment started, the risk of a severe relapse following discontinuation of Betaferon in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.
F’ pazjenti b’ rata għolja ta ’ rkadar qabel inbdiet il- kura, ir- riskju ta ’ rkadar serju wara l- waqfien ta ’ Betaferon f’ każ ta ’ tqala għandu jitqies kontra l- possibbiltà ta ’ riskju ogħla ta ’ korriment spontanju
6 • Lactation
6 • Treddigħ
It is not known whether interferon beta-1b is excreted in human milk.
Mhux magħruf jekk interferon beta- 1b jitneħħiex fil- ħalib tas- sider tal- bniedem.
Because of the potential for serious adverse reactions in nursing infants a decision should be made whether to discontinue breast- feeding or Betaferon therapy.
Minħabba l - possibbiltà ta ’ reazzjonijiet avversi fi trabi li qed jerdgħu, għandha tittieħed deċiżjoni jekk jitwaqqafx it- treddigħ jew jekk titwaqqafx il- kura b’ Betaferon.
Central nervous system-related adverse events associated with the use of Betaferon might influence the ability to drive and use machines in susceptible patients.
Effetti avversi fuq is- sistema nervuża ċentrali assoċjati ma ’ l- użu ta ’ Betaferon jista ’ jkollhom effett fuq il- ħila biex issuq u tħaddem magni f’ pazjenti suxxettibli.
a) At the beginning of treatment adverse reactions are common but in general they subside with further treatment.
a) Fil- bidu tal- kura, reazzjonijiet avversi huma komuni iżda normalment dawn ibattu wara ftit żmien ta ’ kura.
The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia) and injection site reactions, which is mainly due to the pharmacological effects of the medicinal product and injection site reactions.
L- aktar reazzjonijiet avversi osservati b’ mod komuni huma numru ta ’ sintomi jixbħu lill- influwenza (deni, kesħa, artralġja, telqa ġenerali, għaraq, uġigħ ta ’ ras, jew uġigħ fil - muskoli), u reazzjonijiet fil- lok ta ’ l- injezzjoni, li huma dovuti prinċipalment għall- effetti farmakoloġiċi tal- prodott mediċinali u reazzjonijiet fil- lok ta ’ l- injezzjoni.
Injection site reactions occurred frequently after administration of Betaferon.
Reazzjonijiet fil- lok ta ’ l- injezzjoni seħħew b’ mod frekwenti wara l- għoti ta ’ Betaferon.
Redness, swelling, discoloration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8 million IU) Betaferon treatment.
Ħmura, nefħa, bidla fil - kulur, infjammazzjoni, uġigħ, sensittività eċċessiva, nekrosi u reazzjonijiet mhux speċifiċi kienu assoċjati b’ mod sinifikattiv ma ’ kura b’ 250 mikrogramm (8 miljun IU) Betaferon.
Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Betaferon (see section 4.2).
Ġeneralment, tittrazzjoni tad- doża hija rrakkomandata fil- bidu tal- kura biex iżżid it- tollerabbiltà ta ’ Betaferon (ara sezzjoni 4. 2).
Flu-like symptoms may also be reduced by administration of non- steroidal anti-inflammatory drugs.
Sintomi jixbħu lill- influwenza jistgħu jitnaqqsu wkoll bl- għoti ta ’ mediċini anti- infjammatorji mhux sterojdi.
The incidence of injection site reactions may be reduced by the use of an autoinjector.
L- inċidenza ta ’ reazzjonijiet fil- lok ta ’ l- injezzjoni jistgħu jitnaqqsu bl- użu ta ’ awto- injettatur.
b) The following adverse event listing is based on reports from clinical trials (table 1, adverse events and laboratory abnormalities) and from the post marketing surveillance (table 2, reporting rates based on spontaneous adverse drug reaction reports classified as very common ≥ 1/ 10, common ≥ 1/ 100 to < 1/ 10, uncommon ≥ 1/ 1,000 to < 1/ 100, rare ≥ 1/ 10,000 to < 1/ 1,000, very rare < 1/ 10,000) of Betaferon use.
b) Il- lista ta ’ avvenimenti avversi li ġejja hija bażata fuq rapporti minn provi kliniċi (tabella 1, avvenimenti avversi u anormalitajiet tal- laboratorju) u mis- sorveljanza ta ’ wara it- tqegħid fis - suq (tabella 2, li turi r- rati bbażati fuq rapporti spontanji ta ’ reazzjonijiet avversi tal- mediċina ikklassifikati bħala komuni ħafna ≥ 1/ 10, komuni ≥ 1/ 100 sa < 1/ 10, mhux komuni ≥ 1/ 1, 000 sa < 1/ 100, rari ≥ 1/ 10, 000 sa < 1/ 1, 000 u rari ħafna < 1/ 10, 000 bl- użu ta ’ Betaferon.
Experience with Betaferon in patients with MS is limited, consequently those adverse events which occur very rarely may not yet have been observed.
L- esperjenza b’ Betaferon f’ pazjenti li jbatu minn sklerożi multipla hija limitata, għalhekk avvenimenti avversi li jseħħu b’ mod rari ħafna jista ’ jkun li għadhom ma ġewx osservati.
7 Table 1 (adverse events and laboratory abnormalities with incidence rates ≥ 10% and the respective percentages under placebo; significantly associated side effects < 10%).
7 Tabella 1 (avvenimenti avversi u anormalitajiet tal- laboratorju li seħħew b’ rata ta ’ ≥ 10% u l - perċentwali rispettivi għall- plaċebo; effetti sekondarji assoċjati b’ mod sinnifikattiv < 10%)
SystemOrganClass
Progressiva
Single Event suggestive of
Tirkadi u Tbatti
Secondary Secondary Progressive Progressive
jissuġġerixxi
Relapsing Remitting
Avveniment Avvers
Adverse Event and Laboratory Abnormalities
u Amerika ta ’ Fuq)
Multiple Sclerosis (BENEFIT) #
(BENEFIT) # Anormalitajiet
Multiple Multiple Sclerosis Sclerosis (European (North Study) American Study)
Ewropew)
Multiple Sclerosis
tal- Laboratorju
microgram microgram
mikrogramma
(Placebo)
mikrogramma
microgram
mikrogramma
(Placebo) (Placebo)
mikrogramma
n=317 (n=308)
(Plaċebo)
(Placebo)
(Plaċebo)
Infections and infestations
(Plaċebo)
n=292 (n=176)
(Plaċebo)
n=360 (n=358)
n=317 (n=308)
Infection Abscess
n=360 (n=358)
Blood and lymphatic system disorders Lymphocyte count decreased (< 1500/ mm³) Λ °
Disturbi tad- demm u tas- sistema limfatika Għadd ta ’ limfoċiti mnaqqas (< 1500/ mm³) × Λ °
Absolute neutrophil count × decreased (< 1500/ mm³) Λ *°
Għadd assolut ta ’ newtrofili mnaqqas (< 1500/ mm³) × Λ * °
White blood cell count × decreased (< 3000/ mm³) Λ *°
Għadd ta ’ ċelluli bojod tad- demm imnaqqas (< 3000/ mm³) × Λ * °
Metabolism and nutrition disorders Blood glucose decreased (< 55 mg/ dl) × Psychiatric disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni Glukosju fid- demm imnaqqas (< 55 mg/ dl) × Disturbi psikjatriċi
Depression Anxiety Nervous system disorders
Depressjoni Ansjetà Disturbi fis- sistema nervuża
Headache Λ Dizziness Insomnia Migraine Paresthesia Eye disorders
Uġigħ ta ’ ras Λ Sturdament Nuqqas ta ’ rqad Emigranja Parasteżija Disturbi fl- għajnejn
Conjunctivitis Abnormal vision Λ Ear and labyrinth disorders
Konġuntivite Vista mhux normali Λ
Ear pain Cardiac disorders
Disturbi fil- widnejn u fis- sistema labirintika Uġigħ fil- widna Disturbi fil- qalb
Palpitation * Vascular disorders
Palpitazzjoni * Disturbi vaskulari
Respiratory, thoracic and mediastinal disorders Upper respiratory infection
Disturbi respiratorji, toraċiċi u medjastinali Infezzjoni fl- apparat respiratorju ta ’ fuq
Sinusitis
Sinożite
Secondary Progressive
jissuġġerixxi
Multiple Sclerosis (BENEFIT) #
(Studju
Multiple Sclerosis (European Study)
(BENEFIT) # Anormalitajiet tal- Laboratorju
Multiple Sclerosis (North American Study)
Ewropew) Betaferon
microgram
mikrogramma (Plaċebo) mikrogramma mikrogramma (Plaċebo) n=317 (n=308) (Plaċebo) (Plaċebo) n=124 (n=123) n=360 (n=358) n=292 9n=176 _ Żjieda fis- sogħla Qtugħ ta ’ nifs * Disturbi gastro- intestinali
(Placebo)
5% (10%) 3% (2%)
n=292 (n=176)
11% (15%) 8% (6%)
n=360 (n=358)
31% (23%) 8% (2%)
n=124 (n=123)
Dijarea
Diarrhoea Constipation Nausea Vomiting Λ Abdominal pain ° Hepatobiliary disorders
Stitikezza Tqalligħ Rimettar Λ Uġigħ addominali Disturbi fil- fwied u fil- marrara
Alanine aminotransferase increased (SGPT > 5 times baseline) × Λ * °
Alanine aminotransferase miżjud (SGPT > 5 darbiet il- linja bażi) × Λ * °
Aspartate aminotransferase increased (SGOT > 5 times baseline) × Λ * °
Aspartate aminotransferase miżjud (SGOT > 5 darbiet il- linja bażi) × Λ * °
Skin and subcutaneous tissue disorders Skin disorder Λ
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Disturbi fil- ġilda Λ
Musculoskeletal and connective tissue disorders Hypertonia° Myalgia * ° Myasthenia
Disturbi muskolu- skeltrali u tal- connective tissue Ipertonija° Uġigħ fil- muskoli * ° Debbulizza fil- muskoli
Back pain Pain in extremity Renal and urinary disorders
Uġigħ fid- dahar Uġigħ fl- estremitajiet Disturbi fil- kliewi u fis- sistema
10% (7%) 6% (3%)
10% (7%) 6% (3%) urinarja
Urinary retention
Diffikultà biex tgħaddi l - awrina
Urinary protein positive (> 1+)×
Test għall- proteini fl - awrina pożittiv (> 1+) ×
Urinary frequency
Awrina frekwenti
Urinary incontinence Urinary urgency
Inkontinenza ta ’ l- awrina Awrina b’ urġenza
Reproductive system and breast disorders Dysmenorrhea Menstrual disorder *
Disturbi fis- sistema riproduttiva u fis- sider Uġigħ waqt il - mestrwazzjoni
Metrorrhagia Impotence
Disturbi fil - mestrwazzjoni *
General disorders and administration site conditions Injection site reaction Λ § (various kinds) * °
9 Sklerożi Multipla li Sklerożi Multipla Sistema tal- Klassifika
52% (11%)
Avveniment
78% (20%)
Sklerożi
89% (37%)
Progressiva
85% (37%)
Tirkadi u Tbatti
Injection site necrosis * ° & Λ
tal- Organi
1% (0%)
Wieħed li
6% (0%)
Sekondarja
5% (0%)
jissuġġerixxi
Flu-like symptoms *° Fever Λ * °
Progressiva
44% (18%) 13% (5%)
(Studju fl -
61% (40%) 40% (13%)
Avveniment Avvers
43% (33%) 29% (24%)
Sklerożi
52% (48%) 59% (41%)
Sekondarja
9 SystemOrganClass
u Amerika ta ’ Fuq)
Single Event suggestive of
Multipla
Secondary Secondary Progressive Progressive
(Studju
Relapsing Remitting
(BENEFIT) # Anormalitajiet tal- Laboratorju
Adverse Event and Laboratory Abnormalities
Betaform
Multiple Sclerosis (BENEFIT) #
Ewropew) Betaferon
Pain Chest pain ° Peripheral edema Asthenia * Chills Λ * ° Sweating * Malaise * × Laboratory abnormality Λ
Astenja * Kesħa Λ * ° Għaraq * Telqa *
4% (4%) 1% (0%) 0% (0%) 22% (17%) 5% (1%) 2% (1%) 0% (1%)
22% (17%) 5% (1%) 2% (1%) 0% (1%)
31% (25%) 5% (4%) 7% (7%) 63% (58%) 23% (7%) 6% (6%) 8% (5%)
63% (58%) 23% (7%) 6% (6%) 8% (5%)
59% (59%) 15% (8%) 21% (18%) 64% (58%) 22% (12%) 10% (10%) 6% (2%)
64% (58%) 22% (12%) 10% (10%) 6% (2%)
52% (48%) 15% (15%) 7% (8%) 49% (35%) 46% (19%) 23% (11%) 15% (3%)
49% (35%) 46% (19%) 23% (11%) 15% (3%)