qanastek/EMEA-V3 huggingface dataset:
Very commonly reported side effects (at least 1 in every 10 patients): irritation or redness at the site of injection, headache, tired feeling, shaking chills, fever, flu-like symptoms, dizziness, nausea, loss of appetite, diarrhoea, stomach pain, vomiting, muscle aches, pain in joints and muscles, feeling depressed or irritable, trouble falling asleep or staying asleep, mood swings, virus infection, hair loss, rash, pharyngitis (sore throat), decrease in the number of red blood cells or decrease in certain white blood cells called neutrophils that fight infection, change in thyroid gland activity (which may make you feel tired or, less commonly, energetic), feeling unwell, and decrease in their rate of growth (height and weight).
Effetti rrappurtati komuni ħafna (mill- anqas 1 f’ kull 10 pazjenti): irritazzjoni jew ħmura fis- sit mnejn tingħata l- injezzjoni, uġigħ ta ’ ras, sensazzjoni ta ’ għeja, dehxiet ta ’ bard, deni, sintomi bħal ta ’ l- influwenza, sturdament, dardir, nuqqas ta ’ aptit, dijarea, uġigħ fl - istonku, rimettar, weġgħat fil- muskoli, uġigħ fil- ġogi u l- muskoli, tħossok depress jew irritabbli, tbati biex torqod jew biex tibqa rieqed, tibdil fil- burdati, infezzjoni b’ virus, telf tax- xagħar, raxx, farinġite (grieżem misluħa), tnaqqis fl- għadd taċ- ċelluli ħomor tad- demm jew f’ ċerti ċelluli bojod tad- demm
66 The additional following commonly reported (at least 1 in every 100 patients, but less than 1 in every 10 patients) side effects have occurred with the combination of Rebetol and an alpha interferon product in adults but not in children:
Dawn l- effetti li ġejjin seħħew ukoll b’ mod komuni (mill- anqas f’ 1 minn kull 100 pazjent, iżda anqas minn 1 f’ kull 10 pazjenti) b’ kombinazzjoni ta ’ Rebetol u prodott alfa interferon f’ adulti iżda mhux fi tfal:
rapid heart rate, low or high blood pressure, palpitations (pounding heart beat), puffy or swollen hands and ankles, feeling faint, migraine, tense muscles, arthritis, unsteady when walking, vertigo (spinning feeling), changes in your hearing, ringing in ears, earache, blurred vision, mental disorder, abnormal crying, enlarged liver, jaundice (yellow skin), change in taste, taste loss, dry mouth, bleeding gums, inflamed gums, thirst, intestinal gas (flatus), irritated colon, passing more urine than usual, abnormal urine, painful menstruation, disorder of ovary, breast pain, lack of interest in sex or inability to perform, irritation of prostate gland, sinusitis, nonproductive cough, difficult breathing, abnormal hair texture, psoriasis, cardiac murmur (abnormal heart beat sounds), excess of sugar in the blood, low calcium level in the blood, and water impairment.
qalb tħabbat mgħaġġla, pressjoni baxxa jew għolja, palpitazzjonijiet (tħabbat bil- qawwa), idejn jew għekiesi rotob jew minfuħin, ħass ħażin, attakki tal- migranja, muskoli miġbudin, artrite, mixi mhux stabbli, vertigo (tara kollox idur bik), tibdil fis- smigħ, żarżir fil- widnejn, uġigħ fil- widnejn, vista mċajpra, disturbi mentali, biki anormali, fwied imkabbar, suffejra (ġilda safra), tibdil fit- togħma, telf tat- togħma, ħalq xott, ħanek idemma, ħanek iffjammat, għatx, gas fl- imsaren (flatus), kolon irritat, tgħaddi aktar awrina mis- soltu, awrina anormali, uġigħ mestruwali, disturbi ta ’ l- ovarji, uġigħ tas - sider, nuqqas ta ’ interess fis- sess jew nuqqas ta ’ ħila li tgħamlu, irritazzjoni tal- glandola tal- prostata, sinusite, sogħla fil- vojt, tbati biex tieħu n- nifs, għamla tax- xagħar anormali, psorajiżi, ħsejjes kardijaċi (ħsejjes tat- tħabbit tal- qalb anormali), zokkor żejjed fid- demm, livell baxx ta ’ calcium fid- demm u problemi ta ’ l- ilma.
Rebetol in combination with an alpha interferon product may also cause aplastic anaemia, pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells); this causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy, seizure (convulsions), inflammation of the pancreas, severe rashes which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes (erythema multiforme, Stevens Johnson syndrome), and toxic epidermal necrolysis (blistering and peeling of the top layer of skin).
Rebetol f’ kombinazzjoni ma ’ prodott alfa interferon jista ’ jikkawża wkoll anemija aplastika, aplażja pura taċ- ċelluli ħomor, (kundizzjoni fejn il- ġisem waqaf jew naqqas il- produzzjoni ta ’ ċelluli ħomor tad- demm); dan jikkawża anemija severa, li s- sintomi tagħha jinkludu għeja mhux tas- soltu u nuqqas ta ’ enerġija), attakki ta ’ puplesija (aċċessjonijiet), infjammazzjoni tal- frixa, raxxijiet severi li jistgħu jkunu assoċjati ma ’ bżieżaq fil- ħalq, imnieħer, għajnejn jew membrani mukużi oħrajn (erythema multiforme, sindrome ta ’ Stevens Johnson), nekroliżi tossika tal- ġilda (bżieżaq u tqaxxir tas- saff ta ’ fuq tal- ġilda).
Intense pain in an appendage, loss of range of motion, stiffness, abnormal thoughts, hearing or seeing images that are not present, altered mental status, disorientation, leg or thigh pain, constant cough, trouble having bowel movement or painful bowel movement, bruises, heartburn, enlarged abdominal area, acute hypersensitivity reactions including urticaria (hives), angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing), bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction) have been reported.
Uġigħ qawwi f’ xi appendiċi, il- medda tal- moviment tonqos, ebusija, ħsibijiet anormali, tisma ’ jew tara affarijiet li ma jeżistux, stat mentali mibdul, disorjentament, uġigħ fir- riġlejn jew koxxtejn, sogħla 71 kontinwa, problemi biex tipporga jew tbatija biex tipporga, tbenġil, ħruq ta ’ stonku, żona addominali tikber, reazzjonijiet ta ’ sensittività eċċessiva akuta inkluża urtikarja (ħorriqija), anġjo- edema (nefħa ta ’ l- idejn, saqajn, għekiesi, wiċċ, xofftejn, ħalq, jew il- gerżuma li tista ’ ġġib diffikultà biex tibla ’ jew tieħu n- nifs), jingħalqu l- bronki, u anafilassi (reazzjoni allerġika severa, tal- ġisem kollu) kienu irrappurtati.
If you are receiving nucleoside reverse transcriptase inhibitor (NRTI) treatment, the addition of Rebetol and interferon alfa-2b may increase your risk of lactic acidosis and liver failure.
Jekk qed tirċievi kura b’ inibituri tan- nukleosajd rivers transkriptejż (NRTI), iż- żieda ta ’ Rebetol u interferon alfa- 2b jistgħu jżidulek ir- riskju ta ’ aċidożi lattika u insuffiċjenza tal- fwied.
Do not use Rebetol after the expiry date which is stated on the label.
Tużax Rebetol wara d- data ta ’ skadenza li tidher fuq il- kartuna.
Once the bottle has been opened, the oral solution can be used for 1 month.
Meta jkun infetaħ il- flixkun, is - soluzzjoni orali tista ’ tintuża għal xahar 1.
67 Do not use Rebetol without advice of your doctor or pharmacist if you notice any change in the appearance of the solution.
Tużax Rebetol mingħajr il- parir tat- tabib jew l- ispiżjar tiegħek jekk tinnota xi tibdil fid- dehra tas - soluzzjoni.
- The active substance is ribavirin 40 mg/ml.
- Is- sustanza attiva hi ribavirin 40 mg/ ml
Sodium citrate, citric acid, anhydrous, sodium benzoate, glycerol,
- Is- sustanzi l- oħra huma sodium citrate, citric acid, anhydrous, sodium benzoate, glycerol,
sucrose, sorbitol liquid (crystallising), propylene glycol, purified water, natural and artificial bubble gum flavouring
sucrose, sorbitol liquid (crystallising), propylene glycol, ilma purifikat, assenza tal- bubble gum naturali u artifiċjali
Rebetol 40 mg/ml oral solution is packaged in 118 ml size amber glass bottles containing 100 ml of oral solution.
Soluzzjoni orali ta ’ Rebetol 40 mg/ ml hija konfezzjonata fi fliexken tal- ħġieġ kannella fl- oranġjo tal - 118 ml li jkun fihom 100 ml tas- soluzzjoni orali.
A 10 ml oral dosing syringe is provided to measure the dose.
Hemm siringa għad- dużaġġi mill- ħalq ta ’ l- 10 ml sabiex tkejjel id- doża.
SP Europe
Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
73, rue de Stalle B-1180 Bruxelles Belgium
72 SP Europe 73, rue de Stalle B- 1180 Bruxelles Il- Belġju
2, rue Louis Pasteur F-14200 Hérouville St Clair France
2, rue Louis Pasteur F- 14200 Hérouville St Clair France
8, sector 1 RO-013682 Bucureşti Tel. + 40 21 233 35 30
73 RO- 013682 Bucureşti Tél: + 33 - (0) 1 41 06 35 00 Tel. + 40 21 233 35 30
Italia Via fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I-20090 Segrate (Milano) Tel: + 39-02 2101 8.1
Suomi/ Finland Italia PL 86/ PB 86 Via fratelli Cervi snc, FIN- 02151 Espoo/ Esbo Centro Direzionale Milano Due Puh/ Tel: + 358 - (0) 20- 7570 300 Palazzo Borromini I- 20090 Segrate (Milano) Tel: + 39- 02 21018. 1
69 This leaflet was last approved on
Dan il- fuljett kien approvat l- aħħar f ’
What is Rebif?
X’ inhu Rebif?
Rebif is a solution for injection in pre-filled syringes and cartridges.
Rebif huwa soluzzjoni biex tiġi injettata f’ siringi diġà mimlija u stoċċijiet.
The syringes contain 8.8, 22 or 44 micrograms of the active substance, interferon beta-1a.
Is- siringi fihom 8. 8, 22 jew 44 mikrogrammi tas- sustanza attiva, interferon beta- 1a.
The cartridges contain a total of 66 or 132 micrograms of interferon beta-1a and are designed for multiple dosing using an electronic injection device that delivers 8.8, 22 or 44 micrograms per dose.
L- istoċċijiet fihom total ta ’ 66 jew 132 mikrogramma ta ’ interferon beta- 1a u huma ddiżinjati għal dożaġġ multiplu bl- użu ta ’ apparat ta ’ injezzjoni elettronika li tagħti 8. 8, 22 jew 44 mikrogrammi għal kull doża.
What is Rebif used for?
Għal xiex jintuża Rebif?
Rebif is used to treat patients with relapsing multiple sclerosis (MS).
Rebif jintuża sabiex jitratta pazjenti li jkollhom sklerożi multipla reċidiva (SM).
This is the type of MS where the patient has attacks (relapses) within periods with no symptoms.
Din hija t- tip ta ’ SM fejn il- pazjent ikollu attakki (rikaduti) matul ċerti perjodi fejn ma jkunx hemm sintomi.
Its effectiveness has not been shown in patients with secondary progressive MS (the type of MS that comes after relapsing MS), when the disease is not in a relapsing phase.
L- effikaċja tiegħu ma ġietx pruvata f’ pazjenti b’ SM sekondarja progressiva (it- tip ta ’ SM li tiġi wara SM reċidivi), meta l- marda ma tkunx f’ fażi reċidiva.
Rebif should not be used in children aged below 12 years because of a lack of information on the use of the medicine in this group.
Rebif ma għandux jintuża fit- tfal ta ’ inqas minn 12- il sena minħabba nuqqas ta ’ informazzjoni dwar l- użu tal- mediċina f’ dan il- grupp.
How is Rebif used?
Kif jintuża Rebif?
Rebif treatment should be started by a doctor who has experience in the management of MS.
It- trattament ta ’ Rebif għandu jinbeda minn tabib li għandu l- esperjenza fuq kif għandha titmexxa l - kura ta ’ SM.
The recommended dose of Rebif is 44 micrograms given three times a week by injection under the skin.
Id- doża rakkomandata ta ’ Rebif hija ta ’ 44 mikrogrammi li tingħata tliet darbiet kull ġimgħa b’ injezzjoni taħt il- ġilda.
The 22– microgram dose is recommended for patients who cannot tolerate the higher dose and for adolescents aged between 12 and 16 years.
Id- doża ta ’ 22 mikrogramma huwa rakkomandat għal pazjenti li ma jifilħux doża akbar u għall- adoloxxenti ta ’ bejn it- 12 u s- 16 – il sena.
When first starting treatment with Rebif, the dose should be slowly increased to avoid side effects, starting with 8.8 micrograms three times a week for the first two weeks, followed by 22 micrograms three times a week for the next two weeks.
Meta jinbeda t- trattament b’ Rebif, id- doża għandha tiżdied bilmod sabiex jiġu evitati effetti sekondarji.
The electronic injection device used with the cartridges is programmed to deliver the correct doses of Rebif at the start of treatment and during the standard-dose phase.
Dan għandu jibda bi 8. 8 mikrogrammi tliet darbiet fil- ġimgħa għall- ewwel ġimagħtejn, imbagħad 22 mikrogramma tliet darbiet fil- ġimgħa għall- ġimagħtejn ta ’ wara.
The patients can inject Rebif themselves if they have been trained appropriately.
Meta jinbeda t- trattament, hemm pakkett speċjali li fih il- kwantitajiet eżatti ta ’ siringi u stoċċijiet biż- żewġ tipi ta ’ dożi.
The doctor may advise the patient to take a fever-reducing painkiller before each injection and for 24 hours after injection to reduce the flu-like symptoms that may occur as a side effect of treatment.
L- apparat ta ’ injezzjoni elettronika użat mal- istoċċijiet huwa pprogrammat sabiex jagħti d- dożi ġusti ta ’ Rebif fil - bidu tat- trattament u matul il- fażi ta ’ doża- standard.
How does Rebif work?
Kif jaħdem Rebif?
This is called ‘ demyelination’.
SM hija marda tas- sistema nervuża, fejn l- infjammazzjoni teqred il- kisja protettiva madwar n- nervituri, magħrufa nħala ‘ demjelinazjoni ’.
The active substance in Rebif, interferon beta-1a, belongs to the group ‘ interferons’.
Is- sustanza attiva f’ Rebif, interferon beta- 1a tagħmel parti mill - grupp ta ’ ‘ interferoni ’ (interferons).
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
L- interferoni huma sustanzi naturali prodotti mill- ġisem sabiex jgħinuh jiġġieled kontra attakki bħal infezzjonijiet ikkawżati minn virusijiet.
The exact way that Rebif works in MS is not yet known but interferon beta seems to calm the immune system down and prevent relapses of MS.
Il- mod eżatt ta ’ kif jaħdem Rebif fl- SM għadu mhux magħruf imma interferon beta jidher li jikkalma s- sistema immunitarju u jipprevjeni l- SM reċidiva.
Interferon beta-1a is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce interferon beta-1a.
Interferon beta- 1a huwa magħmul permezz ta ’ metodu magħruf bħala ‘ teknoloġija tad- DNA rikombinanti ’: huwa magħmul minn ċellula li kisbet ġene (DNA), li jagħtiha l- abbiltà li tipproduċi interferon beta- 1a.
The replacement interferon beta-1a acts in the same way as naturally produced interferon beta.
L- interferon beta li jitpoġġa jaġixxi bl- istess mod bħal interferon beta li jiġi prodott b’ mod naturali.
How has Rebif been studied?
Kif ġie studjat Rebif?
Rebif has been studied in 560 patients with relapsing MS.
Rebif ġie studjat f’ 560 pazjent b’ SM reċidiva.
The patients had experienced at least two relapses in the previous two years.
Il- pazjenti rkadu talanqas darbjetjn fis- sentejn ta ’ qabel.
Patients received either Rebif (22 or 44 micrograms) or placebo (a dummy treatment) for two years.
Il- pazjenti rċevew jew Rebif (22 jew 44 mikrogrammi) jew plaċebo (trattament finta) għal sentejn.
The study was then extended to four years.
L - istudju ġie mbagħad estiż għal erba ’ snin.
The main measure of effectiveness was the number of relapses that the patients had.
Il- miżura ewlenija tal- effikaċja kienu n- numru ta ’ drabi li rkadu l- paxjenti.
Rebif has also been studied in patients with secondary progressive MS.
Rebif ġie studjat ukoll f’ pazjenti b’ SM sekondarja progressiva.
The study looked at the effectiveness of the medicine in preventing the progression of disability over three years.
L- istudju ħares lejn l- effikaċja tal - prodott mediċinali ġiet studjata billi ġie osservat kemm dan kien ta ’ siwi fil- prevenzjoni tad- diżabilità f’ dawn il- pazjenti fuq perjodu ta ’ tliet snin.
The company has not carried out any formal studies of patients under 16 years of age.
Il- kumpannija ma wettqet l- ebda studju formali ta ’ pazjenti taħt is- 16 – il sena.
However, it presented information from published studies on the use of Rebif in children aged between 12 and 18 years.
Madanakollu, hija ppreżentat informazzjoni minn studji ppublikati dwar l- użu ta ’ Rebif fit- tfal ta ’ bejn it- 12 u t- 18 – il sena.
What benefit has Rebif shown during the studies?
Liema benefiċċju wera Rebif waqt l- istudji li ġew mwettqa?
Rebif was more effective than placebo in reducing the number of relapses in relapsing-remitting MS.
Rebif kien aktar effettiv minn plaċebo fit- tnaqqis tan- numru ta ’ reċidivi f’ SM remittenti- reċidiv.
Relapses were reduced by about 30% over two years for both Rebif 22 and 44 micrograms compared with placebo, and by 22% (Rebif 22 micrograms) and 29% (Rebif 44 micrograms) over four years.
Reċidivi tnaqqsu għal madwar 30% matul perjodu ta ’ sentejn kemm għal Rebif 22 u 44 mikrogramma meta mqabbel mal- plaċebo, u bi 22% (Rebif 22 mikrogramma) u 29% (Rebif 44 mikrogramma) fuq erba ’ snin.
In the study of patients with progressive MS, Rebif had no significant effect on the progression of disability, but the relapse rate was reduced by about 30%.
Fl- istudju ta ’ pazjenti b’ SM progressiva, Rebif ma kellu l- ebda effett sinjifikanti fuq il- progressjoni tad- diżabilità, imma r- rata tar- rikaduta ġiet imnaqqsa għal madwar 30%.
Some effect on progression of disability could be seen only in the patients who had relapses in the two years before the start of the study.
Xi effetti fuq il- progressjoni tad- diżabilità setgħu biss jiġu osservati fil- pazjenti kellhom rikaduti fis- sentejn qabel ma beda l- istudju.
In patients aged between 12 and 18, the published studies showed that the patients had a decrease in the rate of relapse.
Fil- pazjenti fl- età ta ’ bejn it- 12 u t- 18 – il sena, l- istudji ppublikati wrew li l- pazjenti kellhom tnaqqis fir- rata tar- rikaduta.
This may be due to Rebif treatment.
Dan jista ’ jkun minħabba t- trattament Rebif.
What is the risk associated with Rebif?
X’ inhu r- riskju assoċjat ma ’ Rebif?
The most common side effects with Rebif (seen in more than 1 patient in 10) are flu-like symptoms, neutropenia, lymphopenia and leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, inflammation and other reactions at the injection site, and increases in transaminases (liver enzymes).
L- iktar effetti sekondarju komuni għal Rebif (osservati f’ iktar minn pazjent wieħed fuq 10) huma sintomi bħal tal- influwenza, newtopenija, linfopenija u lewkopenija (għadd żgħir ta ’ ċelluli tad- demm bojod), tromboċitopenija (għadd żgħir ta ’ platelets tad- demm), anemija (għadd żgħir ta ’ ċelluli tad - demm ħomor), uġigħ ta ’ ras, infjammazzjoni u reazzjonijiet oħra fil- post fejn issir l- injezzjoni, u żieda fit- transaminases (enzimi tal- fwied).
The side effects are similar in children.
Fit- tfal kien hemm effetti sekondarji simili.
For the full list of all side effects reported with Rebif, see the Package Leaflet.
Għal- lista sħiħa tal - effetti sekondarji kollha rrappurtati b’ Rebuf, ara l- Fuljett ta ’ Tagħrif.
Rebif should not be used in people who have a history of hypersensitivity (allergy) to natural or recombinant interferon beta, or any of the other ingredients.
Rebif m’ għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal interferon beta naturali jew rikombinanti, jew għal xi wieħed mill- ingredjenti l- oħra.
Rebif treatment must not be started during pregnancy.
It- trattament ta ’ Rebif m’ għandux jinbeda matul it- tqala.
If a woman becomes pregnant while taking the medicine, she should consult her doctor.
Jekk mara toħroġ tqila waqt li tkun qed tieħu l- mediċina, hija għandha tikkonsulta lit - tabib.
Rebif must also not be used in patients who are suffering from severe depression or having thoughts about suicide.
Rebif m’ għandux jintuża f’ pazjenti li qed ibatu minn dipressjoni gravi jew li għandhom ħsibijiet dwar is- suwiċidju.
Why has Rebif been approved?
2/ 3 Għaliex ġie approvat Rebif?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rebif’ s benefits are greater than its risks for the treatment of relapsing MS.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Rebif jisbqu r- riskji tiegħu għat- trattament ta ’ SM reċidiva.
The Committee recommended that Rebif be given marketing authorisation.
Il- Kumitat jirrakkomanda li Rebif jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Rebif:
Informazzjoni oħra dwar Rebif:
The European Commission granted a marketing authorisation valid throughout the European Union for Rebif to Serono Europe Limited on 4 May 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea, għal Rebif lil Serono Europe Limited fl- 4 ta ’ Mejju 1998.
The marketing authorisation was renewed on 4 May 2003 and on 4 May 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 4 ta ’ Mejju 2003 u fl- 4 ta ’ Mejju 2008.
The full EPAR for Rebif is available here.
L- EPAR sħiħ dwar Rebif jista ’ jiġi kkonsultat hawn.
Pharmaceutica l Form
farmaċewtika
Route of Administratio n
Mnejn jingħata
pre-filled syringe (glass)
Għal użu taħt il - ġilda
0.5 ml (12 million IU/ ml)
Siringa waħda mimlija 0. 5 ml (12 miljun IU/ ml) lesta għal użu (ħġieġ)
1 pre-filled syringe
Siringa waħda mimlija lesta għal użu
3 pre-filled syringes
3 siringi mimlijin lesti għal użu
12 pre-filled syringes
12- il siringa mimlijin lesti għal użu
0.5 ml (24 million IU/ ml)
Siringa waħda mimlija 0. 5 ml (24 miljun IU/ ml) lesta għal użu (ħġieġ)
12 pre-filled syringes
12 siringi mimlijin lesti għal użu
8.8 µg (2.4 m IU) + 22 µg (6 m IU)
8. 8 µg (2. 4 m IU) + 22 µg (6 m IU)
0.2 ml (12 m IU/ ml) + 0.5 ml (12 m IU/ ml)
Siringa waħda mimlija 0. 2 ml (12 miljun IU) + lesta għal użu (ħġieġ) 0. 5 ml (12 miljun IU)
Initiation pack:
Pakkett għall- ewwel fażi tal- kura.
6 pre-filled syringes of 8.8 µg + 6 pre- filled syringes of 22 µg
6 siringi mimlijien lesti għal użu ta ’ Rebif 8. 8 mikrogrammi u 6 siringi mimlijien lesti għal użu ta ’ Rebif 22 mikrogrammi
Subcutaneous use
Għal użu taħt il - ġilda
cartridge (glass)
ataċ (ħġieġ)
1.5 ml (12million IU/ ml)
1, 5 ml (12 miljun IU/ ml)
4 cartridges
4 skrataċ
1.5 ml (24million IU/ ml)
1, 5 ml (24 miljun IU/ ml)
Subcutaneous use
Soluzzjoni għall - injezzjoni
cartridge (glass)
Għal użu taħt il - ġilda
1.5 ml (24 million IU/ ml)
1, 5 ml (24 miljun IU / ml)
Initiation pack:
Pakkett għall- ewwel fażi tal- kura:
2 cartridges
2 skrataċ
Rebif 22 micrograms solution for injection in pre-filled syringe
Rebif 22 mikrogrammi – soluzzjoni għall- injezzjoni b’ siringa mimlija għal- lest
Each pre-filled syringe (0.5 ml) contains 22 micrograms (6 MIU*) of interferon beta-1a**.
Kull siringa mimlija lesta (0. 5ml) fiha 22 mikrogrammi (6 MIU *) ta ’ interferon beta- 1a **.
* Million International Units, measured by cytopathic effect (CPE) bioassay against the in-house IFN beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531). ** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology.
* Miljun Unità Internazzjonali, meqjus permezz ta ’ test tal- effett kitopatiku (EKP) mqabbel ma ’ l - istandard IFN beta- 1a li jsir fil- fabbrika li jinstab wara li jitqabbel ma ’ l- istandard kurrenti internazzjonali NIH (GB- 23- 902- 531). ** magħmulin fiċ- ċelluli ta ’ l- ovarju tal- ħamster Ċiniz (CHO- K1) li għandhom materjal ġenetiku mibdul.
2.5 mg benzyl alcohol For a full list of excipients, see section 6.1.
2. 5 mg benzyl alkohol Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Solution for injection in pre-filled syringe.
Soluzzjoni għall- injezzjoni b’ siringa mimlija għal- lest.
Clear to opalescent solution, with pH 3.5 to 4.5 and osmolarity 250 to 450 mOsm/ l.
Soluzzjoni ċara għal opalexxenti, b’ pH ta ’ 3. 5 sa 4. 5 u osmolarita ta ’ 250 to 450 mOsm/ l
Rebif is indicated for the treatment of relapsing multiple sclerosis.
Rebif hu indikat għall- kura ta ’ pazjenti bi sklerożi multipla li terġa tirkadi.
In clinical trials, this was characterised by two or more acute exacerbations in the previous two years (see section 5.1).
Fi studji kliniċi, dan ġie karaterizzat bħala ripetizzjoni ta ’ 2 każi jew aktar fl- aħħar sentejn. (ara sezzjoni 5. 1).
Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity (see section 5.1).
(ara sezzjoni 5. 1).
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Il- kura għandha tinbeda taħt is- superviżjoni ta ’ tabib li jkollu l- esperjenza tal- kura tal- marda.
Rebif is available in three strengths:
Rebif jinstab fi tliet tipi:
8.8 micrograms, 22 micrograms and 44 micrograms.
8. 8 mikrogrammi, 22 mikrogrammi u 44 mikrogrammi.
For patients initiating treatment with Rebif, Rebif 8.8 micrograms and Rebif 22 micrograms are available in a package that corresponds to the patient needs for the first month of therapy.
Għal pazjienti li qegħdin jibdew il- kura ma ’ Rebif, hemm Rebif 8. 8 mikrogrammi u Rebif 22 mikrogrmmi f’ pakett li jkollhom bżonn dawn il- pazjienti għall- ewwel xgħar tal- kura.
The recommended posology of Rebif is 44 micrograms given three times per week by subcutaneous injection.
Il- posoloġija rakkomandata ta ’ Rebif hi 44 mikrogrammi tliet darbiet fil- ġimgħa permezz ta ’ injezzjoni taħt il- ġilda.
A lower dose of 22 micrograms, also given three times per week by subcutaneous injection, is recommended for patients who cannot tolerate the higher dose in view of the treating specialist.
Doża iktar baxxa ta ’ 22 mikrogramma, mogħtija wkoll tliet darbiet fil- ġimgħa permezz ta ’ injezzjoni taħt il- ġilda, hi rakkomandata għal pazjenti li ma jittollerawx l- għola doża f’ għajnejn l- ispeċjalista li jikkurahom.
When first starting treatment with Rebif, dose should be gradually escalated in order to allow tachyphylaxis to develop thus reducing adverse reactions.
Għal pazjenti li jkunu qegħdin jibdew il- kura b’ Rebif, id- doża għandha tiżdied gradwalment sabiex tkun tista ’ tiżviluppa takifilassi u b’ hekk jitnaqqsu r- reazzjonijiet avversi.
The Rebif initiation package corresponds to the patient needs for the first month of treatment.
Il- pakkett għall- ewwel fażi tal- kura ta ’ Rebif jikkorrespondi għall- ħtiġiet tal- pazjent għall- ewwel xahar ta ’ kura.
Method of administration Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with Rebif administration.
2 Qabel l- injezzjoni u għal 24- il siegħa wara kull injezzjoni, huwa rakkomandat li jingħata analġesiku li huwa ukoll kontra d- deni sabiex jitnaqqsu is- sintomi li jixbħu l- influenza li huma assoċjati ma ’ l- amministrazzjoni ta ’ Rebif.
2 At the present time, it is not known for how long patients should be treated.
S’ issa għadu mhux magħruf għal kemm tul ta ’ żmien il- pazjenti għandhom ikunu ikkurati.
Safety and efficacy with Rebif have not been demonstrated beyond 4 years of treatment.
Sigurta ’ u effikaċja b’ Rebif ma ntwerewx wara erba ’ snin ta ’ kura.
It is recommended that patients should be evaluated at least every second year in the 4-year period after initiation of treatment with Rebif and a decision for longer term treatment should then be made on an individual basis by the treating physician.
Hu rakkomandat li l- pazjenti għandhom ikunu eżaminati mill- anqas matul it- tieni sena tal- perjodu ta ’ erba ’ snin wara li tkun inbdiet il- kura b’ Rebif u d- deċiżjoni sabiex titkompla l- kura għandha ssir fuq bażi individwali mit- tabib li jikkura.
Paediatric use No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
L- użu fit- tfal Ma sarux studji kliniċi jew studji farmakokinetiċi fit- tfal jew adolexxenti.
However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Rebif 22 micrograms subcutaneously three times per week is similar to that seen in adults.
Iżda, inforamazzjoni limitata li ġie ippublikat juri li l- profil tas- sigurta ’ fl- adolexxenti ta ’ l- eta ’ ta ’ bejn 12 u 16- il sena li ħadu Rebif 22 mikrogrammi taħt il- ġilda tliet darbiet fil- ġimgħa kien simli bħal dak fl- adulti.
There is very limited information on the use of Rebif in children under 12 years of age and therefore Rebif should not be used in this population.
Hemm informazzjoni limitata ħafna fuq l- użu ta ’ Rebif fit- tfal taħt 12- il sena u għalhekk Rebif m’ għandux jintuża f’ din il- populazzjoni.
• Initiation of treatment in pregnancy (see section 4.6). • Hypersensitivity to natural or recombinant interferon-β, or to any excipients. • Current severe depression and/ or suicidal ideation (see sections 4.4 and 4.8).
• Inizjazzjoni tal- kura fin- nisa tqal (ara sezzjoni 4. 6). • Ipersensibilita ’ għal interferon beta naturali jew rikombinat jew xi sustanzi mhux attivi. • Depressjoni u/ jew b’ ideat ta ’ suwiċidju (ara sezzjonijiet 4. 4 u 4. 8).
Patients should be informed of the most frequent adverse reactions associated with interferon beta administration, including symptoms of the flu-like syndrome (see section 4.8).
Il- pazjenti għandhom ikunu mgħarrfa bir- reazzjonijiet negattivi l- aktar frekwenti assoċjati mat- teħid ta ’ l- interferon beta, li jinkludi sintomi ta ’ sindromu li jixbah lill- influwenza (ara sezzjoni 4. 8).
These symptoms tend to be most prominent at the initiation of therapy and decrease in frequency and severity with continued treatment.
Dawn is- sintomi l- aktar jidhru malli jinbeda t- teħid tat- terapija u jonqsu fil- frekwenza u s- severita ’ meta titkompla l- kura.
Rebif 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).
Rebif għandhu jintuża bil- qies fuq pazjenti li jbatu jew batew minn dipressjoni, speċjalment dawk li kellhom ideat ta ’ suwiċidju.
Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Id- dipressjoni u l- idea ta ’ suwiċidju huma magħrufa li jinstabu b’ rata aktar għolja f’ persuni li jbatu minn sklerożi multipla kif ukoll f’ persuni li jużaw l- interferon.
Patients treated with Rebif should be advised to immediately report any symptoms of depression and/ or suicidal ideation to their prescribing physician.
Pazjenti kkurati bl- interferon beta- 1a għandhom ikunu avżati sabiex jirrapurtaw immedjatament xi sintomi ta ’ dipressjoni jew ideat ta ’ suwiċidju lit- tabib li jkun jikkurahom.
Patients exhibiting depression should be monitored closely during therapy with Rebif and treated appropriately.
Pazjenti li juru sintomi ta ’ dipressjoni għandhom ikunu mħarsa mill- qrib matul it- terapija ma ’ Rebif u jkunu kkurati kif suppost.
Cessation of therapy with Rebif should be considered (see sections 4.3 and 4.8).
Il- waqfien mit- terapija ma ’ Rebif għandu jkun ikkunsidrat (ara sezzjonijiet 4. 3 u 4. 8).
Rebif 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 sections 4.5 and 4.8).
(ara sezzjonijiet 4. 5 u 4. 8).
Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during initiation of therapy with interferon beta-1a.
Pazjenti b’ mard tal- qalb, bħall- anġina, attakk tal- qalb konġestiv jew arrhythmia, għandhom ikunu mħarsa mill- qrib sabiex isir magħruf jekk il- kundizzjoni klinika tagħhom teħżienx matul it- tnedija tat - terapija bl- interferon beta- 1a.
Symptoms of the flu-like syndrome associated with interferon beta-1a therapy may prove stressful to patients with cardiac conditions.
Sintomi ta ’ sindromu li jixbah lill- influwenza asso`jati mat- terapija bl- interferon beta- 1a jistgħu jkunu ta ’ stress fuq pazjenti li jbatu bil- qalb.
Injection site necrosis (ISN) has been reported in patients using Rebif (see section 4.8).
Nekrożi fis- sit ta ’ l- injezzjoni (ISN) kien rappurtat fuq pazjenti li jużaw ir- Rebif (ara sezzjoni 4. 8).
To minimise the risk of injection site necrosis patients should be advised to: • use an aseptic injection technique, • rotate the injection sites with each dose.
Sabiex jitnaqqas ir- riskju ta ’ nekrożi fis- sit ta ’ l- injezzjoni l- pazjenti għandhom ikunu mgħarrfa sabiex: • jużaw teknika ta ’ injezzjoni asettika • jbiddlu is- sit ta ’ l- injezzjoni ma ’ kull doża.
The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
Il- proċedura għat- teħid mill- pazjent stess għandha tkun eżaminata mill- ġdid kull tant żmien speċjalment jekk reazzjonijiet fejn ikunu saru l- injezzjonijiet ikunu dehru.
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 their physician before continuing injections with Rebif.
Jekk fil- pazjent jidher xi qsim fil- ġilda, li jista ’ jkun assoċjat ma ’ nefħa jew telf ta ’ likwidu mis- sit ta ’ l- injezzjoni, il- pazjent għandu jkun mgħarraf sabiex jikkonsulta mat- tabib qabel ikompli l -
If the patient has multiple lesions, Rebif should be discontinued until healing has occurred.
Jekk il- pazjent ikollu ħafna ġrieħi, Rebif għandu jitwaqqaf sakemm il- ġrieħi ifiequ.
Patients with single lesions may continue provided that the necrosis is not too extensive.
Pazjenti bi ftit ġrieħi jistgħu jkomplu jekk in- nekrożi ma tkunx estenstiva ħafna.
3 In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
Fi provi kliniċi b’ Rebif, elevazzjonijiet mingħajr sintomi ta ’ transminases epatika (b’ mod partikolari ALT) kienu komuni u bejn 1 u 3% tal- pazjenti żviluppaw elevazzjoni ta ’ transminases epatika aktar minn 5 darbiet l- għola limitu normali (ULN- upper limit of normal).
In the absence of clinical symptoms, serum ALT levels should be monitored prior to the start of therapy, at months 1, 3 and 6 on therapy and periodically thereafter.
Jekk mahemx sintomi kliniċi, il - livelli ta ’ serum ALT għandhom ikunu monitorjati qabel tinbeda l- kura, f’ xhur 1, 3 u 6 waqt it- terapija u perjodikament wara.
Dose reduction of Rebif should be considered if ALT rises above 5 times the ULN, and gradually re-escalated when enzyme levels have normalized.
Tnaqqis tad- doża ta ’ Rebif għandu jkun ikkunsidrat jekk l- ALT togħla aktar minn ħames darbiet mill- ULN u terġa ’ tittella mill- ġdid bil- mod meta l- livelli tal- enżimi jkunu ġew għan- normal.
Rebif should be initiated with caution in patients with a history of significant liver disease, clinical evidence of active liver disease, alcohol abuse or increased serum ALT (> 2.5 times ULN).
Rebif g ħandu jinbeda b’ attenzjoni f’ pazjenti bi storja ta ’ disturbi tal- fwied sinjifikattiva, evidenza klinika ta ’ mard tal- fwied, abbuż ta ’ l- alkoħol u livell għoli ta’ serum ALT (> 2. 5 drabi ULN).
Treatment with Rebif should be stopped if icterus or other clinical symptoms of liver dysfunction appear (see section 4.8).
Il- kura b’ Rebif għandha titwaqqaf jekk jidhru ikterus jew sintomi oħra kliniċi ta ’ funżjoni ħażina tal - fwied (ara sezzjoni 4. 8).
Rebif, like other interferons beta, has a potential for causing severe liver injury (see section 4.8) including acute hepatic failure.
Rebif bħal interferons beta oħra, għandu l- potenzjal li joħloq periklu serju għall- fwied (ara sezzjoni 4. 8) li jinkludi kollass epatiku akut.
The mechanism for the rare symptomatic hepatic dysfunction is not known.
Il- mekkaniżmu għad- disfunzjoni epatika rari sintomatika mhux magħruf.
No specific risk factors have been identified.
L- ebda fatturi ta ’ riskju ma ġew identifikati.
Laboratory abnormalities are associated with the use of interferons.
Abnormalitajiet tal- laboratorju huma assoċjati ma ’ l- użu ta ’ l- interferons.
Therefore, in addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, liver enzyme monitoring and complete and differential blood cell counts and platelet counts are recommended at regular intervals (1, 3 and 6 months) following introduction of Rebif therapy and then periodically thereafter in the absence of clinical symptoms.
Għaldaqstant, flimkien ma ’ testijiet tal- laboratorju ġeneralment mitluba sabiex tinstab l- isklerożi multipla fuq il- pazjenti, u flimkien ma ’ testijiet ta ’ enżimi tal- fwied, l- għadd komplut u differenzjat ta ’ ċelluli tad- demm u l - għadd ta ’ platelets huma wkoll rakkomandati ta’ spis (1, 3 u 6 xur) wara l- introduzzjoni tal- kura ta ’ Rebif u imbagħad perjodikament jekk ma hemx sintomi kliniċi.
Patients being treated with Rebif may occasionally develop new or worsening thyroid abnormalities.
Pazjenti kkurati b’ Rebif jistgħu jiżviluppaw abnormalitajiet ġodda jew aggravati tat- tirojde.
Thyroid function testing is recommended at baseline and if abnormal, every 6-12 months following initiation of therapy.
It- test tal - funzjoni tat- tirojde hu rrakkomandat fil- bidu u jekk abnormali, kull 6- 12– il xahar wara li tinbeda t - terapija.
If tests are normal at baseline, routine testing is not needed but should be performed if clinical findings of thyroid dysfunction appear (see section 4.8).
Jekk it- testijiet huma normali fil- bidu, testijiet ta ’ rutina mhumiex bżonnjużi iżda għandhom isiru jekk tidher disfunzjoni klinika tat- tirojde (ara sezzjoni 4. 8).
Caution should be used, and close monitoring considered when administering interferon beta-1a to patients with severe renal and hepatic failure and to patients with severe myelosuppression.
Attenzjoni għandha tittieħed, u monitoraġġ mill- qrib għandu jkun ikkunsidrat meta jingħata interferon beta – 1a lil pazjenti li jbatu minn problemi tal- kliewi u epatiċi u lil pazjenti li jbatu minn myelosuppression qawwija.
Serum neutralising antibodies against interferon beta-1a may develop.
Jistgħu jinħolqu antikorpi fis- serum li jinnewtralizzaw l- interferon beta – 1a.
The precise incidence of antibodies is as yet uncertain.
L- inċidenza preċiża ta ’ antikorpi għadha mhix magħrufa.
Clinical data suggest that after 24 to 48 months of treatment with Rebif 22 micrograms, approximately 24% of patients develop persistent serum antibodies to interferon beta-1a.
Informazzjoni klinika tissuġġerixxi li wara 24 sa 28 xhar ta ’ kura b’ Rebif 22 mikrogramma, madwar 24% tal- pazjenti jiżviluppaw antikorpi persistenti fis serum għal interferon beta- 1a.
The presence of antibodies has been shown to attenuate the pharmacodynamic response to interferon beta-1a (Beta-2 microglobulin and neopterin).
Il- preżenza ta ’ antikorpi wriet li tnaqqas ir- rispons farmakodinamiku għal interferon beta – 1a (Beta 2 mikroglobulina u neopterina).
Although the clinical significance of the induction of antibodies has not been fully elucidated, the development of neutralising antibodies is associated with reduced efficacy on clinical and MRI variables.
Għalkemm it- tifsira klinika ta ’ x’ jagħmlu dawn l- antikorpi għadha mhix ċara, l- iżvilupp ta ’ antikorpi newtralizzanti hu assoċjat ma ’ effikaċja mnaqqsa kif jidher fuq diversi suġġetti kliniċi u fi riżultati ta ’ MRI.
If a patient responds poorly to therapy with Rebif, and has neutralising antibodies, the treating physician should reassess the benefit/ risk ratio of continued Rebif therapy.
Jekk pazjent jkollu rispons fqir għat- terapija b’ Rebif, u għandu antikorpi newtralizzanti, it- tabib li jikkurah għandu jerġa ’ jeżamina mill- ġdid ir- rata benefiċċju/ riskju tat- tkomplija tat- terapija b’ Rebif.
The use of various assays to detect serum antibodies and differing definitions of antibody positivity limits the ability to compare antigenicity among different products.
L- użu ta ’ testijiet varji sabiex jinstabu l- antikorpi tas- serum u sabiex tinsab id- differenza ta ’ definizzjonijiet ta ’ posittivita ’ ta ’ antikorpi tillimita l- abilità li tiġi kkumparata l- antiġeniċita ’ bejn prodotti differenti.
Only sparse safety and efficacy data are available from non-ambulatory patients with multiple sclerosis.
Xi ftit informazzjoni dwar sigurtà u effikaċja tinstab għand pazjenti li mhumiex fl- isptarijiet u jbatu minn sklerożi multipla.
Rebif has not yet been investigated in patients with primary progressive multiple sclerosis and should not be used in such patients.
Rebif għadu ma kienx investigat f’ pazjenti bi sklerosi multipla progressiva primarja u m’ għandux jintuża f’ dawn il- pazjenti.
This medicinal product contains 2.5 mg benzyl alcohol per dose.
Dan il- prodott mediċinali fih 2. 5 mg ta ’ benzyl alkohol f’ kull doża.
Must not be given to premature babies or neonates.
M’ għandux jingħata lil trabi prematuri jew lil trabi tat- twelid.
May cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Jista ’ jikkawża reazzjonijiet tossiċi u reazzjonijiet anafilattojdi fit - trabi u fi tfal sa l- età ta ’ 3 snin.
No interaction studies have been performed with interferonbeta-1a in humans.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku ta ’ interferon beta- 1a fil- bnedmin.
Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Interferons ġew rappurtati li jnaqqsu l- attività ta ’ enżimi li jiddependu minn hepatic cytochrome P450 - fil- bnedmin u l- annimali.
Caution should be exercised when administering Rebif 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. antiepileptics and some classes of antidepressants.
Għandha ssir attenzjoni meta jingħata Rebif flimkien ma ’ prodotti mediċinali oħra li għandhom indiċi terapewtiku qasir u li jiddependu] afna fuq is- sistema hepatic cytochrome P450 sabiex jitnaddfu eż:. anti- epilettiċi u xi tipi ta ’ antidipressivi.
4 The interaction of Rebif with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
L- effetti ta ’ Rebif flimkien ma ’ corticosteroids jew l- ormon adrenokortikotropiku (ACTH) ma ġewx studjati sistematikament.
Clinical studies indicate that multiple sclerosis patients can receive Rebif and corticosteroids or ACTH during relapses.
Studji kliniċi jindikaw li pazjenti li jbatu minn sklerożi multipla jistgħu jieħdu Rebif u corticosteroids jew ACTH matul l- attakki.
There is limited information on the use of Rebif in pregnancy.
Hemm informazzjoni limitata fuq l- użu ta ’ Rebif fit- tqala.
Available data indicates that there may be an increased risk of spontaneous abortion.
Informazzjoni li hemm jindika li jista ’ jkun hemm riskju akbar ta ’ abbort spontanju.
Therefore initiation of treatment is contraindicated during pregnancy (see section 4.3).
Għalhekk, l - inizjazzjoni tal- kura muwiex indikat waqt it - tqala (ara sezzjoni 4. 3).
Women of child-bearing potential should take appropriate contraceptive measures.
Nisa fertili għandhom jieħdu miżuri addattati ta ’ kontraċezzjoni.
If the patient becomes pregnant or plans to become pregnant while taking Rebif she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).
Pazjenti li qed jippjanaw għal tarbija u dawk li jinqabdu tqal waqt il- kura ma ’ Rebif għandhom ikunu mgħarrfa bil- perikli potenzjali u twaqqif tal- kura għandhu jkun ikkonsidrat (ara sezzjoni 5. 3).
In patients with a high relapse rate before treatment has started, the risk of a severe relapse following discontinuation of Rebif in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.
F’ pazjienti bi rata g] olja ta ’ marda li tirkadi qabel li nbeda l- kura, huwa importanti li wieħed jeżaminah ir- riskju ta ’ relapse severa wara li jitwaqqaf Rebif f’ kaz ta ’ tqala, kontra possibilta ’ ta ’ riskju akbar ta ’ abbort spontanju.
It is not known whether Rebif is excreted in human milk.
Mhux magħruf jekk Rebif joħroġx mal- ħalib tas- sider.
Because of the potential for serious adverse reactions in breast-fed infants, a decision should be made whether to discontinue breast-feeding or Rebif therapy.
Minħabba l- potenzjal ta ’ effetti serji negattivi fuq trabi li jerdgħu, deċiżjoni għandha tittieħed jekk jitwaqqafx it- treddiegħ jew inkella t- terapija b’ Rebif.
Central nervous system-related adverse events associated with the use of interferon beta (e. g. dizziness) might influence the patient's ability to drive or use machines (see section 4.8).
Effetti relatati mas- sistema nervuża ċentrali assoċjati ma ’ l- użu ta ’ interferon beta (e. ż. sturdament) jistgħu jinfluwenzaw il- ħila tal- pazjent biex isuq jew iħaddem magni (ara sezzjoni 4. 8).
The highest incidence of adverse reactions associated with Rebif therapy is related to flu-like syndrome.
L- ogħla inċindenza ta ’ effetti mhux mixtieqa li huma assoċjati mat- terapija ta ’ Rebif huma relatati mas- sindromu li jixbaħ l- influenza.
Flu-like symptoms tend to be most prominent at the initiation of therapy and decrease in frequency with continued treatment.
Dawn is- sintomi bħal ta ’ l- influenza huma aktar prominenti fil - bidu tal- kura u jitnaqqsu fil- frekwenza meta il- kura titkompla.
Approximately 70% of patients treated with Rebif can expect to experience the typical interferon flu-like syndrome within the first six months after starting treatment.
Madwar 70% tal- pazjenti kkurati b’ Rebif jistgħu jistennew li jħossu s- sindromu li jixbah lill- influwenza fl- ewwel sitt xhur wara li jibew il- kura.
Approximately 30% of patients will also experience reactions at the injection site, predominantly mild inflammation or erythema.
Madwar 30% tal- pazjenti jista ’ jkollhom ukoll reazzjonijiet fuq il- post fejn issir l- injezzjoni, l - aktar infjammazzjoni ħafifa jew eritema.
Asymptomatic increases in laboratory parameters of hepatic function and decreases in white blood cells (WBC) are also common.
Żidiet fil parametri tal- laboratorju tal – funzjioni epatika mingħajr sintomi u tnaqqis ta ’ ċelluli bojod tad- demm (WBC) ukoll huma komuni.
The majority of adverse reactions observed with IFN beta-1a are usually mild and reversible, and respond well to dose reductions.
Il- maġġoranza ta ’ l- effetti mhux mixtieqa osservati b’ IFN- beta- 1a huma ġeneralment ħfief u riversibbli, u jaqblu sew mar- riduzzjonijiet tad- dożi.
In case of severe or persistent undesirable effects, the dose of Rebif may be temporarily lowered or interrupted, at the discretion of the physician.
F’ każ ta ’ effetti mhux mixtieqa ħarxa jew persistenti, id- doża ta ’ Rebif tista ’ titnaqqas jew titwaqqaf għal xi żmien, skond kif jiddeċiedi t- tabib.
The adverse reactions reported below are classified according to frequency of occurrence as follows:
5 L- effetti mhux mixtieqa li jissemmew hawn taħt huma klassifikati skond il- frekwenza ta ’ kif jidhru kif ġej:
Very Common Common Uncommon Rare
Komuni ħafna Komuni Mhux komuni Rari Rari ħafna Mhux magħrufa
≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000
≥ 1/ 10 ≥1/ 100 sa < 1/ 10 ≥1/ 1, 000 sa < 1/ 100 ≥1/ 10, 000 sa < 1/ 1, 000 1/ 1, 000 < 1/ 10, 000 Ma tistax tittieħed stima mid- dejta disponibbli
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetata ’ tagħhom, bl - aktar serji jitniżżlu l- ewwel.
The data presented is obtained from pooled clinical studies in multiple sclerosis (placebo=824 patients; Rebif 22 micrograms three times per week (TIW)=398 patients; Rebif 44 micrograms TIW=727 patients) and shows the frequency of adverse reactions observed at six months (excess over
L- informazzjoni ppreżentata hi miksuba minn studji kliniċi fi sklerożi multipla (plaċebo=824 pazjienti; Rebif 22 mikrogrammi tlitt darbiet fil- ġimgħa (TIW) =398 pazjienti; Rebif 44 mikrogrammi TIW=727 pazjienti) u turi l- frekwenza ta ’ l- effetti mhux mixtieqa f’ sitt xhur (żieda fuq plaċebo).
Adverse reactions are listed below by frequency of occurrence and by MedDRA System Organ Class.
Effetti mhux mixtieqa huma mmniżżlin taħt skond il- frekwenza tal- ġrajja u minn MedDRA System Organ Class.
System Organ Class Infections and infestations
Sistema tal- klassifika tal- organi
Uncommon Injection site abscess
Abscess fis- sit ta ’ injezzjoni
Not known* Injection site infections, including cellulitis
Infezzjonijiet fis - sit ta l- injezzjoni, inkluż ċellulitis
Neutropenia, lymphopenia, leucopenia, thrombocytopenia, anaemia
Newtropenija, limfopenija, lewkopenija, thromboċitopenija, anemija
Endocrine Disorders
Disturbi fis- sistema endokrinarja