qanastek/EMEA-V3 huggingface dataset:
Cardiac status must be assessed before start of therapy and monitored clinically during therapy; if any deterioration occurs, therapy must be stopped.
L- istat kardijaku għandu jkun eżaminat qabel tinbeda t- terapija u osservat klinikament waqt it- terapija; jekk iseħħ xi deterjorament, it- terapija għandha titwaqqaf (ara sezzjoni 4. 2).
Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders must be closely monitored.
Pazjenti adulti li kellhom insuffiċjenza konġestiva tal- qalb, infart mijokardijaku, u/ jew irregolaritajiet fit- taħbit tal- qalb preżenti jew fil- passat, għandhom ikunu osservati mill- qrib.
It is recommended that those patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment.
Hu rrakkomandar li dawk il- pazjenti li għandhom anormalitajiet kardijaċi li kienu jeżistu minn qabel jittieħdu elettrokardjogrammi qabel qabel u waqt il- kors tal- kura.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of therapy.
Arritmiji kardijaċi (primarjament supraventrikulari) normalment jirrispondu għat- terapija konvenzjonali imma għandhom mnejn ikollhom
There are no data in children and adolescents with a history of cardiac disease.
M’ hemmx tgħarif dwar tfal u adolexxenti li xi darba kellhom mard kardijaku.
If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Rebetol must be discontinued immediately and appropriate medical therapy instituted.
Jekk tiżvillupa reazzjoni minħabba sensittività eċċessiva akuta (eż., urtikarja, anġoedema,, jingħalqu l -- bronki, anafilassi), Rebetol għandu jitwaqqaf minnufih u tinbeda terapija medika xierqa.
29 Supplemental monitoring specific for children and adolescents
Monitoraġġ supplimentari speċifiku għat- tfal u adolexxenti
A general reversal of these trends was noted during the 6 months follow-up post treatment.
Fil- perijodu ta ’ 6 xhur ta ’ wara li twaqqfet il- kura kienu reġistrati tendenzi ġenerali jieqfu jikbru.
However, based on interim data from a long-term follow-up study, 12 (14%) of 84 children had a > 15 percentile decrease in rate of linear growth, of whom 5 (6%) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
Madankollu, minn tgħarif li nġabar filwaqt li kien qed isir studju follow up fit - tul, 12 (14%) minn 84 tifel u tifla kellhom > 15% perċentwali ta ’ tnaqqis fir- rata ta ’ żieda fit- tul, li minnhom, 5- itfal (6%) kellhom > 30 perċentwali ta ’ tnaqqis minkejja li kienu ilhom aktar minn sena li waqfu mill- kura.
Therefore, the risk/benefit of the combined use of Rebetol and interferon alfa-2b should be assessed in young children prior to the initiation of therapy.
Għaldaqstant għandu jitqies ir- riskju/ benefiċċju ta ’ l- użu kombinat ta’ Rebetol ma ’ interferon alfa- 2b fi tfal żgħar qabel ma tinbeda t- terapija.
There are no data on long term effects on growth and development and on sexual maturation.
M’ hemmx tgħarif dwar l- effetti li jkun hemm bl- użu fit- tul fuq it- tkabbir u żviluppsesswali.
Thyroid Monitoring:
Monitoraġġ tat- tirojde:
Prior to initiation of interferon alfa-2b therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Qabel ma tinbeda terapija b’ interferon alfa- 2b, il- livelli ta ’ TSH għandhom jitqiesu u kwalunkwe anormalitàjiet fit - tirojdi li jinstabu f’ dak il- ħin għandhom ikun kurati b’ terapiji konvenzjonali.
If thyroid abnormalities are detected, the patient’s thyroid status should be evaluated and treated as clinically appropriate.
Jekk jinstabu anormalitajiet tat- tirojdi, l- istat tat- tirojdi tal- pazjent għandu jitqies u jiġi kkurat kif ikun klinikament xieraq.
TSH).
It- tfal u l- adolexxenti għandhom ikunu monitorati kull 3 xhur għal sinjali li jistgħu juru funzjoni ħażina tat- tirojdi (eż TSH).
HCV/HIV Co-infection:
Ko- infezzjoni ta ’ l- HCV/ HIV:
Caution should be taken in HIV-positive subjects co-infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa-2b/ribavirin treatment.
Għandha tingħata attenzjoni lill- pazjenti pożittivi għall- HIV li huma ko - infettati bl- HCV li qed jirċievu kura bl- impedituri ta ’ nucleoside reverse transcriptase (NRTI) (l- aktar ddI u d4T) u l- kura assoċjata interferon alfa- 2b/ ribavirin.
In particular, co-administration of Rebetol and didanosine is not recommended due to the risk of mitochondrial toxicity (see section 4.5).
L- aktar, l- użu ta ’ Rebetol flimkien ma ’ didanosine mhuwiex rakkomandat minħabba riskju ta ’ tossiċità mitokondrijali (ara sezzjoni 4. 5).
Moreover, co-administration of Rebetol and stavudine should be avoided to limit the risk of overlapping mitochondrial toxicity.
Minbarra hekk, l- użu ta ’ Rebetol ma ’ stavudine għandu jiġi evitat sabiex r- riskju ta ’ tossiċità mitokondrijali miż- żewġ mediċini f’ daqqa jkun limitat.
Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
32 Pazjenti ko- infettati li jkollhom ċirrożi fi stat avvanzat u li jkunu qed jirċievu HAART jista ’ jkollhom riskju akbar ta ’ nuqqas ta ’ kumpens epatiku u mewt.
Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Iż- żieda ta ’ alfa interferons waħidhom jew flimkien ma ’ ribavirin mal- kura tista ’ żżid ir- riskju f’ dan is- sottogrupp ta ’ pazjenti.
Haematological abnormalities in HCV/HIV co-infected patients:
Anormalitajiet ematoloġiċi f’ pazjenti li jkollhom fl- istess ħin HCV/ HIV:
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Rebetol and interferon alfa-2b combination therapy.
Mard tas- snien u tal- ħalq li minħabba fihom jistgħu jaqgħu is- snien, kienu rappurtati f’ pazjenti li kienu qed jieħdu terapija kombinata b’ Rebetol u interferon alfa- 2b.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Rebetol and interferon alfa-2b.
Minbarra hekk, ħalq xott jista ’ jgħamel ħsara lis- snien u ’ l- membrani tal- mukoża fil- ħalq waqt kura kombinata fit- tul b’ Rebetol u interferon alfa- 2b.
Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Il- pazjenti għandhom jaħslu snienhom sew darbtejn kuljum u jkollhom snienhom eżaminati b’ mod regolari.
Standard haematological tests and blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) must be conducted in all patients prior to initiating therapy.
Qabel ma tinbeda t- terapija fil- pazjenti kollha għandhom isiru testijiet tad- demm kemm dawk standard kif ukoll kimiċi (għadd komplet tad- demm [CBC] u differenzjali, l- għadd tal - plejtlets, elettroliti, krejatinina fis- serum, testijiet tal- funzjoni tal- fwied, uric acid).
Acceptable baseline values that may be considered as a guideline prior to initiation of Rebetol therapy in children and adolescents:
Valuri aċċettabbli tal- linja bażi li jistgħu jitqiesu bħala linji gwida qabel tinbeda t- terapija b’ Rebetol:
≥ 11 g/dl (females); ≥ 12 g/dl (males) ≥ 100,000/mm3 ≥ 1,500/mm3
• Adulti: ≥ 11 g/ dl (nisa); ≥ 12 g/ dl (irġiel) Emoglobina ≥ 100, 000/ mm3 • Plejtlets ≥ 1, 500/ mm3 • Għadd tan- Newtrofili
30 Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
Evalwazzjonijiet tal- laboratorju għandhom isiru fit- 2 u fir- 4 ġimgħa tat- terapija, u kultant żmien wara dan, kif ikun klinikament xieraq.
This product contains sucrose and sorbitol.
Dan il- prodott fih sucrose u sorbitol.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal fructose, sindrome ta ’ malassorbiment ta ’ glucose- galaktose jew insuffiċjenza ta ’ sucrase- isomaltase m’ għandhomx jieħdu din il- mediċina.
Therefore, there is a minimal potential for P450 enzyme-based interactions.
Għalhekk, hemm probabbilita ’ minima li jseħħu interazzjonijiet bażati fuq l- enzima P450.
No interaction studies have been conducted with Rebetol and other medicinal products, except for interferon alfa-2b and antacids.
Ma saru l- ebda studji dwar l- interazzjoni bejn Rebetol u prodotti mediċinali oħra, ħlief għall- interferon alfa- 2b u mediċini kontra l- aċidu fl- istonku.
No pharmacokinetic interactions were noted between Rebetol and interferon alfa-2b in a multiple-dose pharmacokinetic study.
L- ebda interazzjonijiet farmakokinetiċi ma kienu nnotati bejn Rebetol u interferon alfa- 2b fi studju dwar il- farmakokinetika b’ dożi multipli.
The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium, aluminium and simethicone; AUCtf decreased 14%.
Il- biodisponibbiltà ta ’ ribavirin 600 mg kienet imnaqqsa meta ngħata flimkien ma ’ mediċini kontra l- aċidu fl- istonku li kien fihom magnesium aluminium u simethicone; l- AUCtf tnaqqas b’ 14%.
It is possible that the decreased bioavailability in this study was due to delayed transit of ribavirin or modified pH.
33 Jista ’ jkun li l- biodisponibilità kienet imnaqqsa f' dan l- istudju minħabba l- ittardjar tal- ġarr ta ’ ribavirin jew tal- bdil fil- pH.
Nucleoside analogues:
Analogi tan- Nuklejosajd:
This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Din l- attività tista ’ twassal għar- riskju ta ’ aċidożi lattika kkaġunata minn analogi tan- nuklejosajd tal- purina (eż. didanosine jew abacavir).
Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see section 4.4).
Rapporti ta ’ tossiċità mitokondrijali, l- aktar aċidożi lattika u pankrejatite, ftit minnhom fatali, kienu rappurtati (ara sezzjoni 4. 4).
The exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Kien irrapportat li l- anemija ħraxet minħabba ribavirin meta zidovudine ikun parti mill- kors li jintuża għall- kura ta ’ l- HIV għalkemm il- mekkaniżmu eżatt għad irid jiġi ċċarat.
Consideration should be given to replacing zidovudine in a combination anti-retroviral treatment (ART)regimen if this is already established.
Għandu jiġi kkonsidrat il- bidla ta ’ zidovudine bħala parti mill- kors ta ’ kura kontra r- retrovirus (ART) jekk dan kien diġa qed jingħata.
31
Informazzjoni ta ’ qabel l- użu kliniku:
In animal studies, ribavirin produced reversible effects on spermatogenesis (see
sezzjoni 5. 3).
Ribavirin induces genotoxicity (see section 5.3).
Ribavirin jikkawża effett tossiku fuq il- ġeni.
Females of childbearing potential and their partners must each use an effective contraceptive during treatment and for four months after treatment has been concluded; routine monthly pregnancy tests must be performed during this time (see section 4.4).
Nisa li jista ’ jkollhom it- tfal u s - sieħeb tagħhom, għandhom it- tnejn jużaw mezzi kontraċettivi effettivi waqt il- kura u għal erba ’ xhur wara li l- kura tkun spiċċat; testijiet tat- tqala ta ’ rutina kull xahar għandhom isiru matul dan iż- żmien (ara sezzjoni 4. 6).
Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, male patients and their female partners of childbearing age must be counseled to each use an effective contraceptive during treatment with Rebetol and for seven months after treatment.
Għalkemm tagħrif minn madwar 300 tqala b’ missirijiet li ġew esposti għal ribavirin li kienu segwiti b’ mod prospettiv, ma wrewx żieda fir- riskji ta ’ malformazzjonijiet meta mqabbla mal- popolazzjoni ġenerali, jew xi forma ta ’ malformazzjoni oħra, pazjenti rġiel u s- sieħba tagħhom nisa li jista ’ jkollhom it- tfal għandhom jingħataw parir sabiex it- tnejn jużaw kontraċettiv effettiv waqt il- kura b’ Rebetol u sa seba ’ xhur wara l- kura.
Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
Irġiel li s- sieħba tagħhom ħargu tqal għandhom jingħataw istruzzjonijiet sabiex jużaw kondom biex inaqqsu kemm jista ’ jkun ir- riskjulili jgħaddu ribavirin lis- sieħba.
4.7 Effects on ability to drive and use machines
34 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Rebetol has no or negligible influence on the ability to drive or use machines; however, interferon alfa-2b used in combination may have an effect.
Rebetol m’ għandu l- ebda effett, jew ftit li xejn għandu effett fuq il- ħila biex issuq u tħaddem magni; madankollu, interferon alfa- 2b użati b’ mod kombinat għandu mnejn ikollhom effett.
Children and adolescents in clinical trials:
Tfal u adolexxenti fi provi kliniċi:
In clinical trials of 118 children or adolescents 3 to 16 years of age, 6% discontinued therapy due to adverse events.
Fi provi kliniċi b’ 118 tifel u tifla jew adolexxenti ta ’ età minn 3 sa 16- il sena, 6% waqfu t- terapija minħabba effetti avversi.
In general, the adverse event profile in the limited paediatric population studied was similar to that observed in adults, although there is a paediatric specific concern regarding growth inhibition as decrease in height (mean percentile decrease of growth velocity of 9%) and weight (mean percentile decrease of 13%) percentile were observed during treatment (see section 4.4).
B’ mod ġenerali, il- profil ta ’ l- effetti avversi fil- popolazzjoni pedjatrika limitata li kienet studjata kienet simili għal dik li ġiet osservata fl- adulti, għalkemm l- inibizzjoni ta ’ tkabbir hija ta ’ tħassib speċifiku għall- popolazzjoni pedjatrika, peress li tnaqqis fit- tul (tnaqqis medju perċentwali tar- rata ta ’ tkabbir b’ 9%) u piż (tnaqqis medju perċentwali ta ’ 13%) perċentwali kienu osservati waqt il- kura (ara sezzjoni 4. 4).
Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month follow-up after treatment.
Minbarra hekk, każijiet ta ’ fissazzjoni ta ’ suwiċidju jew attantati ta ’ suwiċidju kienu rappurtati b’ mod aktar frekwenti meta mqabbla mal- pazjenti adulti (2. 4% vs 1%) waqt il- kura u fis- 6 xhur ta ’ wara l- kura.
As in adult patients, children and adolescents also experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence) (see section 4.4).
Bħal ma ġralhomil- pazjenti adulti, it- tfal u l - adolexxenti kellhom ukoll effetti psikjatriċi oħra (eż dipressjoni, burdati emozzjonali u tħeddil) (ara sezzjoni 4. 4).
Reported adverse reactions listed in Table 3 are based on experience from paediatric clinical trials.
Reazzjonijiet avversi elenkati f’ Tabella 3 huma ibbażati fuq esperjenza minn provi kliniċi pedjatriċi.
Adverse reactions reported at a ≥ 10% incidence in paediatric trials were previously reported in adults (Table 4) and are not repeated in the paediatric table.
Reazzjonijiet avversi irrappurtati bi frekwenza ta ’ ≥ 10% fi provi pedjatriċi kienu irrappurtati qabel fl - adulti (Tabella 4) u mhux qed ikunu ripetuti fit- tabella pedjatrika.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10);
Fost il- klassijiet tas- sistemi ta ’ organi, reazzjonijiet avversi huma elenkati taħt it- titli ta ’ frekwenza permezz tal- kategoriji li ġejjin: komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10).
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
Infezzjoni virali, farinġite Infezzjoni tal- fungu, infezzjoni tal- batteri, infezzjoni pulmonari, otitis media, snien jitħaffru, herpes simplex, infezzjoni fil- passaġġ ta’ l- awrina, vaġinite, gastroenterite
Common:
Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Komuni:
Very common:
35 Komuni ħafna:
Gastro-intestinal disorders
Disturbi gastro- intestinali
Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhea, sneezing
Qtugħ ta ’ nifs, nifs imgħaġġel, epistassi, sogħla, konġestjoni nasali, irritazzjoni nasali, rajnorreja, għatis
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased 33
Alopeċja, raxx Reazzjoni ta ’ fotosensittività, raxx makulopapulari, ekżema, akne, disturbi tal- ġilda, disturbi fid- dwiefer, il- ġilda titlef il - kulur, ħakk, ġilda xotta, erytema, tbenġil, żieda fl- għaraq
Very common:
Disturbi muskolu- skeltrali u tal- connective tissue Komuni ħafna:
Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder.
Mara: amenorreja, menorraġja, disturbi mestrwali, disturb vaġinali.
Male: testicular pain
Raġel: uġigħ fit- testikoli
Very common:
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni ħafna:
Injection site inflammation, injection site reaction, fatigue, rigors, fever, influenza-like symptoms, malaise, irritability
Infjammazzjoni tas- sit mnejn tingħata l- injezzjoni, reazzjoni tas- sit ta ’ l- injezzjoni, għeja, tertir, deni, sintomi bħal ta ’ l - influwenza, tħossok ma tiflaħx, irritabilità
Chest pain, asthenia, oedema, injection site pain
Uġigħ tas- sider, astenja, edema, uġigħ fis- sit ta ’ l- injezzjoni
Common:
Korriment, avvelenament u komplikazzjonijiet ta ’ Komuni:
Adverse reactions reported with a > 10% incidence in adult patients treated with ribavirin capsules in combination with interferon alfa-2b or pegylated interferon alfa-2b for one year have also been reported in children and adolescents.
Reazzjonijiet avversi irrappurtati bi frekwenza ta ’ > 10% f’ pazjenti adulti kurati b’ kapsuli ta ’ ribavirin flimkien ma ’ interferon alfa- 2b jew interferon alfa- 2b pegilat għal sena kienu irrappurtati wkoll fit- tfal u fl- adolexxenti.
The side effect profile was also similar at the lower incidences.
Il- profil ta ’ l- effetti sekondarji kien simili anki f’ dawk l- effetti li seħħew b’ rati aktar baxxi.
Also, refer to peginterferon alfa-2b and interferon alfa-2b SPCs for adverse reactions that may be attributable to interferon monotherapy.
Minbarra hekk, irreferi għall- SPC’ s ta ’ peginterferon alfa- 2b u interferon alfa- 2b għar- reazzjonijiet avversi li jistgħu jiġu attribwiti għal 36 monoterapija b’ interferon.
Adverse reactions reported during clinical trials or following the marketing use of Rebetol with pegylated interferon alfa-2b or interferon alfa-2b injection
Reazzjonijiet avversi irrapurtati waqt provi kliniċi jew wara l- użu ta ’ wara t- tqegħid fis - suq ta ’ Rebetol ma ’ interferon alfa- 2b pegilat jew injezzjoni ta ’ interferon alfa- 2b.
Anaemia, neutropenia Thrombocytopenia, lymphadenopathy, lymphopenia Aplastic anaemia* Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Anemija, newtropenja Tromboċitopenja, limfadenopatija, limfopenja Anemija aplastika * Aplażja pura taċ- ċelluli ħomor, purpura tromboċitopenika idjopatika, purpura tromboċitopenika trombotika
Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Sarkojdożi * Sindrome ta ’ Vogt- Koyanagi- Harada, lupus erythematosus sistemiku, arthrite rewmatika (toħroġ mill- ġdid jew taggrava), vaskulite, reazzjonijiet ta ’ sensittività eċċessiva inkluża urtikarja, anġjo- edema, bronkokostrizzjoni, anafilassi
Anorexia Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite, thirst
Anoressija Ipergliċemija, iperuriċemija, ipokalċemija, deidrazzjoni, żieda fl- aptit, għatx
Suicide attempts Hallucination Suicide* Mental status change
Attentati ta ’ suwiċidju Alluċinazzjoni Suwiċidju * Bidla fl- istat mentali
Seizure (convulsion)*, peripheral neuropathy* Cerebrovascular haemorrhage*, cerebrovascular ischaemia*, encephalopathy*, polyneuropathy*
Emorraġija ċerebrovaskulari *, iskemija ċerebrovaskulari *, enċefalopatija *, polinewropatija *
Hypotension, hypertension, syncope, flushing Peripheral ischaemia*
Pressjoni baxxa, pressjoni għolja, sinkope, fwawar Iskemija periferika *
Dyspnoea, coughing Sinusitis, bronchitis, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough
Dispneja, sogħla Sinużite, bronkite, epistassi, flissjoni, disturb respiratorju, konġestjoni nażali, rajnorreja, sogħla fil- vojt
Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis* 35
Infiltrati pulmonari *, pnewmonite *, pnewmonite fl - interstizzju *
Hepatomegaly, jaundice, hyperbilirubinemia* Hepatotoxicity (including fatalities)*
Fwied kbir,, suffejra, iperbilirubinimja * Epatotossiċità (inklużi imwiet) *
Alopecia, pruritus, skin dry, rash Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, dermatitis, acne, furunculosis*, erythema, skin disorder, bruise, sweating increased, abnormal hair texture, nail disorder*
Alopeċja, ħakk, ġilda xotta, raxx Psorajiżi, psorajiżi taggrava, ekżema, reazzjoni ta ’ fotosensittività, raxx makulopapulari, raxx ħamrani, dermatite, akne, furunkulożi *, eritema, disturbi tal- ġilda, tbenġil, żieda fl- għaraq, għamla tax- xagħar anormali, disturbi fid- dwiefer *
Renal and urinary disorders Common:
Frekwenza ta ’ l- awrina, awrina tiżdied
Micturition frequency, polyuria Renal failure*, renal insufficiency* Nephrotic syndrome*
Indeboliment tal- kliewi *, insuffiċjenza tal- kliewi * Rari ħafna:
Reproductive system and breast disorders
Sindrome nefrotika *
General disorders and administration site Very common:
Komuni ħafna:
conditions Injection site inflammation, injection site reaction, fatigue, rigors, fever, flu-like symptoms, asthenia, irritability
Infjammazzjoni tas- sit mnejn tingħata l- injezzjoni, reazzjoni tas- sit ta ’ l- injezzjoni, għeja, tertir ta ’ bard, deni, sintomi bħal ta ’ l- influwenza, astenija, irritabilità
* Since ribavirin is always prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or nonpegylated).
* Minħabba li ribavirin dejjem jiġi ordnat ma ’ prodott alfa interferon, u r- reazzjonijiet avversi tal- mediċina elenkati li kienu inklużi kienu jirriflettu esperjenza ta ’ wara t- tqegħid fis- suq li ma tippermettix li tiġi kwantifikata b’ mod preċiż il- frekwenza, il- frekwenza irrappurtata hawn fuq inkisbet minn provi kliniċi fejn intuża ribavirin f’ taħlita ma ’ interferon alfa- 2b (pegilat jew mhux pegilat)
An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with Rebetol used in combination with interferon alfa-2b in clinical trials, but values returned to baseline levels by four weeks after the end of therapy.
Żieda fil- uric acid u valuri indiretti ta ’ bilirubin assoċjati ma ’ ħemoliżi kienet osservata f’ xi pazjenti kurati b’ Rebetol użat flimkien ma ’ interferon alfa- 2b fi provi kliniċi, iżda il- valuri marru lura għal dawk tal- livelli fil- linja bażi wara erba ’ ġimgħat minn meta ntemmet it- terapija.
In clinical trials with Rebetol used in combination with interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of Rebetol (50 x 200 mg capsules) and 39 MIU of interferon alfa-2b (13 subcutaneous injections of 3 MIU each) taken in one day by a patient in an attempt at suicide.
Fi studji kliniċi b’ Rebetol użat flimkien ma ’ interferon alfa- 2b, id- doża eċċessiva massima rrappurtata kienet doża totali ta ’ 10 g ta ’ Rebetol (50 kapsula ta ’ 200 mg) u 39 MIU ta ’ interferon alfa- 2b (13 injezzjonijiet taħt il- ġilda ta ’ 3 MIU kull waħda) meħuda f’ ġurnata waħda minn pazjent f’ tentattiv ta ’ suwiċidju.
The mechanism by which Rebetol in combination with interferon alfa-2b exerts its effects against HCV is unknown.
Il- mekkaniżmu li bih Rebetol flimkien ma ’ interferon alfa- 2b jeżerċita l- effetti tiegħu kontra HCV mhuwiex magħruf.
Results of these investigations showed that Rebetol monotherapy had no effect on eliminating hepatitis virus (HCV-RNA) or improving hepatic histology after six to 12 months of therapy and six months of follow-up.
Ir- riżultati ta ’ dawn l- investigazzjoniet urew li l - monoterapija ta ’ Rebetol ma kellha l- ebda effett fuq l- eliminazzjoni tal- vajrus ta ’ l- epatite (HCV- RNA) jew fit- titjib ta ’ l- istoloġija epatika wara sitt sa tnax- il xahar ta ’ terapija u sitt xhur ta ’ follow- up.
Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received Rebetol 15 mg/kg per day plus interferon alfa-2b 3 MIU/m2 three times a week for 1 year followed by 6 months follow-up after-treatment.
Tfal u adolexxenti 3 sa 16- il sena b’ epatite C kronika kumpensata u HCV- RNA li setgħu jitkejjlu (imkejjel minn laboratorju ċentrali bl- użu ta ’ assay RT- PCR li jintuża għar- riċerka) kienu reklutati f’ żewġ provi multiċentriċi u rċevew Rebetol 15 mg/ kg kull jum ma ’ interferon alfa- 2b 3 MIU/ m2 3 darbiet fil- ġimgħa għal sena 1 segwit b’ 6 xhur follow- up wara l- kura.
A total of 118 patients were enrolled:
Kienu reklutati totall ta ’
Sustained virological response rates in children and adolescents were similar to those in adults (see Table 5).
Rati ta ’ rispons viroloġiku sostnut fi tfal u adolexxenti kienu simili għal dawk ta ’ l- adulti (ara Tabella 5).
Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Minħabba nuqqas ta ’ tagħrif fi tfal b’ avvanz sever tal- marda, u l- possibilità ta ’ effetti mhux mixtieqa, il- benefiċju/ riskju f’ din il - popolazzjoni tat- taħlita ta ’ ribavirin u interferon alfa- 2b għandu jiġi kkonsidrat b’ attenzjoni (ara sezzjonijiet 4. 1, 4. 4 u 4. 8).
Table 5
Tabella 5.
Virological response: previously untreated children and adolescents Rebetol 15 mg/kg/day + interferon alfa-2b 3 MIU/m2 3 times a week
u adolexxenti li ma kienux kurati qabel Rebetol 15 mg/ kg/ jum + interferon alfa- 2b 3 MIU/ m2 3 darbiet fil- ġimgħa
Genotype 2/3/4 (n=26) *Number (%) of patients
Ġenotip 2/ 3/ 4 (n=26) * Numru (%) ta ’ pazjent
Defined as HCV RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period
Definit bħala HCV- RNA taħt il- limitu li jista ’ jitkejjel b’ assay bażat fuq RT- PCR fl- aħħar tal- kura u fil- perijodu ta ’ follow- up.
Multiple-dose pharmacokinetic properties for Rebetol capsules and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 6.
Il- karatteristiċi tal- farmakokinetiċi b’ ħafna dożi għall- kapsuli Rebetol u interferon alfa- 2b fi tfal u adolexxenti b’ epatite C kronika ta ’ età bejn 5 u 16- il sena qed jintwerew fil- qosor f’ Tabella 6.
The pharmacokinetics of Rebetol and interferon alfa-2b (dose-normalized) are similar in adults and children or adolescents.
Il- farmakokinetiċi ta ’ Rebetol u interferon alfa- 2b (doża normalizzata) huma simili fl - adulti u fit- tfal jew adolexxenti.
37 Table 6
Tabella 6.
Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and
Medja (% CV) parametri tal- farmakokinetiċi b’ ħafna dożi għal interferon alfa- 2b u kapsuli Rebetol meta jingħataw lit- tfal jew adolexxenti b’ epatite C kronika
Rebetol capsules when administered to children or adolescents with chronic hepatitis C PARAMETER
Parametru
Apparent
29, 774 (26)
AUC* clearance l/hr/kg
622 (48) Ma sarx
29,774 (26) 0.27 (27)
apparenti l/ hr/ kg
622 (48) Not done
0. 27 (27)
Ribavirin transport in non-plasma compartments has been most extensively studied in red cells, and has been identified to be primarily via an es-type equilibrative nucleoside transporter.
40 It- trasport ta ’ ribavirin f’ kompartamenti mhux tal- plażma kien studjat bl- aktar mod estensiv fiċ- ċelluli ħomor, u kien identifikat li jseħħ primarjament permezz tat- trasportatur ekwilibrattiv tan- nuklejosajd tat - tip es.
Both ribavirin and its triazole, carboxamide and triazole carboxylic acid metabolites are also excreted renally.
Kemm Ribavirin u l- metaboli tiegħu triazole carboxymide u triazole carboxylic acids jitneħħew ukoll mill- kliewi.
Upon multiple dosing, ribavirin accumulates extensively in plasma with a six-fold ratio of multiple-dose to single-dose AUC12hr.
Wara dożaġġ multiplu, ribavirin jakkumula b’ mod estensiv fil- plażma bi proporzjon ta ’ sitt darbiet ta ’ dożaġġ multiplu għal doża waħidha ta ’ AUC12hr.
Upon discontinuation of dosing the half-life was approximately 298 hours, which probably reflects slow elimination from non-plasma compartments.
Wara l- waqfien tad- dożaġġ, il- half- life kienet ta ’ madwar 298 siegħa, li probabbilment tirrifletti l- eliminazzjoni bil- mod mill- kompartamenti mhux tal- plażma.
It is possible that the increased bioavailability in this study was due to delayed transit of ribavirin or modified pH.
Jista ’ jkun li ż- żieda fil - biodisponibbilita f’ dan l- istudju kienet minħabba dewmien fil- ġarr ta ’ ribavirin jew bidla tal- pH modifikat.
The clinical relevance of results from this single dose study is unknown.
Ir- relevanza klinika tar- riżultati minn dan l- istudju ta ’ doża waħda mhix magħrufa.
In the pivotal clinical efficacy trial, patients were instructed to take ribavirin with food to achieve the maximal plasma concentration of ribavirin.
Fi studju pivitali dwar l- effikaċja klinika, il- pazjenti kienu istruwiti biex jieħdu ribavirin ma ’ l- ikel biex tintlaħaq il- konċentrazzjoni massima ta ’ ribavirin fil- plażma.
Ribavirin is embryotoxic or teratogenic, or both, at doses well below the recommended human dose in all animal species in which studies have been conducted.
Ribavirin huwa tossiku għall- embriju jew teratoġeniku, jew it- tnejn, f’ dożi ħafna inqas mid - dożi irrakkomandata fil- bniedem, fl- ispeċi kollha ta ’ annimali li dwarhom saru studji.
In a juvenile rat toxicity study, pups dosed from postnatal day 7 to 63 with 10, 25 and 50 mg/kg of ribavirin demonstrated a dose-related decrease in overall growth, which was subsequently manifested as slight decreases in body weight, crown-rump length and bone length.
Fi studju dwar firien ta ’ età żgħira, frieħ li ngħataw doża bejn 7 u 63 jum wara t- twelid b ’ 10, 25 u 50 mg/ kg ta ’ ribavirin urew tnaqqis ġenerali fit- tkabbir skond id - doża, li wara deher bħala tnaqqis żgħir fil- piż tal- ġisem, it- tul tal- crown rump u t- tul ta ’ l- għadam.
At the end of the recovery period, tibial and femoral changes were minimal although generally statistically significant compared to controls in males at all dose levels and in females dosed with the two highest doses compared to controls.
Fi tmiem il- perijodu ta konvalexxenza, bidliet fit- tibja u fil- femori kienu żgħar ħafna għalkemm statitistikament sinifikanti b’ mod ġenerali meta mqabbla ma ’ dawk maskili li ntużaw bħala kontroll fid- dożi kollha u f’ dawk femminili li ngħataw l- ogħla żewġ dożi meta mqabbla mal- kontrolli.
Erythrocytes are a primary target of toxicity for ribavirin in animal studies.
L- eritroċiti huma l- aktar li ntlaqtu mit- tossiċità għal ribavirin fi studji dwar l- annimali.
Anaemia occurs shortly after initiation of dosing,but is rapidly reversible upon cessation of treatment.
L- anemija sseħħ ftit wara l- bidu tad- dożaġġ, iżda hija riversibbli malajr wara l- waqfien tal- kura.
In 3-and 6-month studies in mice to investigate ribavirin-induced testicular and sperm effects, abnormalities in sperm occurred at doses of 15 mg/kg and above.
41 Fi studji ta ’ 3 u 6 xhur fuq il- ġrieden biex ikunu investigati l- effetti testikulari u ta ’ l- isperma kkaġunati minn ribavirin, anormalitajiet fl- isperma seħħew f’ dożi ta ’ 15 mg/ kg u aktar.
Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity occurred within one or two spermatogenic cycles.
Wara l- waqfien tal- kura, l- irkupru tista tgħid totali mit- tossiċità testikulari kkaġunata minn ribavirin seħħet fi żmien wieħed jew żewġ ċikli spermatoġeniċi (ara sezzjoni 4. 6).
Conventional carcinogenicity rodent studies with low exposures compared to human exposure under therapeutic conditions (factor 0.1 in rats and 1 in mice) did not reveal tumorigenicity of ribavirin.
Studji konvenzjonali dwar il- karċinoġeneċità f’ annimali gerriema f’ espożizzjonijiet baxxi meta mqabbla ma ’ espożizzjonijiet fil- bniedem skond kondizzjonijiet terawpewtiċi (fattur 0. 1 fil- firien u 1 fil- ġrieden) ma wrewx tumoriġeneċità ta ’ ribavirin.
In addition, in a 26 week carcinogenicity study using the heterozygous p53(+/-) mouse model, ribavirin did not produce tumours at the maximally tolerated dose of 300 mg/kg (plasma exposure factor approximately 2.5 compared to human exposure).
Ma ’ dan, fi studju dwar il- karċinoġeneċità ta ’ 26 ġimgħa bl- użu tal- mudell heterozygous p53( + / -) tal- ġurdien, ribavirin ma kkawżax tumuri fid- doża massima ttolerata ta ’ 300 mg/ kg (fattur ta ’ l- espożizzjoni fil- plażma ta ’ madwar 2. 5 meta mqabbel ma ’ l- espożizzjoni umana).
When used in combination with interferon alfa-2b, ribavirin did not cause any effects not previously seen with either active substance alone.
Meta intuża flimkien ma ’ interferon alfa- 2b, ribavirin ma kkawżax xi effetti li ma kinux innotati qabel b’ xi waħda miż- żewġ sustanzi attivi waħidhom.
Oral solution contents:
Il- kontenut tas- soluzzjoni:
Sodium citrate Citric acid, anhydrous Sodium benzoate Glycerol Sucrose Sorbitol liquid (crystallising) Propylene glycol Purified Water Natural and artificial bubble gum flavouring.
Sodium citrate Citric acid, anhydrous Sodium benzoate Glycerol Sucrose Sorbitol liquid (crystallising) Propylene glycol Ilma purifikat Essenza naturali u artifiċjali tal- bubble gum.
39 6.2 Incompatibilities
6. 2 Inkompatibbilitajiet
3 years In use:
3 snin Waqt l- użu:
After first opening the medicinal product should be used within one month.
Wara li tiftaħ l- ewwel darba l- prodott mediċinali għandu jintuża fi żmien xahar.
Rebetol oral solution 100 ml is packaged in 118 ml amber glass bottles (coloured EP Type IV glass, Ph Eur.).
Eur.).
The child-resistant cap has inner and outer polypropylene shells.
L- għatu li ma jinfetaħx mit- tfal għandu qoxra minn barra u minn ġewwa ta ’ polypropylene.
The 10 ml oral dosing syringe consists of a natural polyethylene barrel, with a white polystyrene plunger rod.
Is- siringa ta ’ 10 ml li tintuża għall- kejl tad- doża hija magħmula minn tubu ta ’ polyethylene naturali, bi planġer ta ’ polystyrene abjad.
Calibrations are marked at 0.5 m1 increments from 1.5 ml to 10 ml.
Il- marki tal- kejl huma mmarkati kull 0. 5 ml minn 1. 5 ml sa 10 ml.
25 January 2005
25 Jannar 2005
40 ANNEX II
43 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT B.
MANUFACTURING AUTHORISATION HOLDERS RE SPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release for the hard capsules
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott tal- kapsuli ibsin.
Industriepark 30 2220 Heist op den Berg Belgium
Industriepark 30 2220 Heist op den Berg Il- Belġju
Name and address of the manufacturer responsible for batch release for the oral solution
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott tas- soluzzjoni orali.
2, rue Louis Pasteur 14200 Hérouville St Clair France
2, rue Louis Pasteur 14200 Hérouville St Clair Franza
The holder of this marketing authorisation must submit 6-month PSURs for the medicinal product authorised by this decision until further review by CHMP.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jissottometti PSUR’ s kull 6 xhur għall- prodott mediċinali awtorizzat b’ din id- deċiżjoni sakemm ikompli jiġi rivedut mis- CHMP.
42 ANNEX III
45 ANNESS III
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
REBETOL – 84, 112, 140, 168 hard capsules
REBETOL – 84, 112, 140, 168 kapsuli ibsin
Rebetol 200 mg hard capsules ribavirin
Kapsuli ibsin ta ’ Rebetol ta ’ 200 mg ribavirin
Each capsule contains 200 mg of ribavirin.
Kull kapsula fiha 200 mg ta ’ ribavirin.
Contains lactose
Fih lactose
84 hard capsules 112 hard capsules 140 hard capsules 168 hard capsules 200 mg
84 kapsuli ibsin 112 kapsuli ibsin 140 kapsuli ibsin 168 kapsuli ibsin 200 mg
SP Europe 73, rue de Stalle B-1180 Bruxelles Belgium
Id- Detentur Ta ’ L- Awtorizzazzjoni Għat- Tqegħid Fis- Suq SP Europe Rue de Stalle 73 B- 1180 Bruxelles, Il- Belġju
EU/1/99/107/001 (84 hard capsules) EU/1/99/107/005 (112 hard capsules) EU/1/99/107/002 (140 hard capsules) EU/1/99/107/003 (168 hard capsules)
EU/ 1/ 99/ 107/ 001 (48 kapsuli ibsin) EU/ 1/ 99/ 107/ 005 (112 kapsuli ibsin) EU/ 1/ 99/ 107/ 002 (140 kapsuli ibsin) EU/ 1/ 99/ 107/ 003 (168 kapsuli ibsin)
Immediate packaging (blister foil)
Il- pakkett ta ’ ġewwa (Il- folja)
Rebetol ribavirin 200 mg
Rebetol 200 mg ta ’ ribavirin
Rebetol oral solution 40 mg/ml
Rebetol soluzzjoni orali 40 mg/ ml
Rebetol 40 mg/ml oral solution ribavirin
Rebetol soluzzjoni orali 40 mg/ ml ribavirin
Each one ml of oral solution contains 40 mg of ribavirin.
Kull ml tas- soluzzjoni orali fih 40 mg ta ’ ribavirin.
Glycerol, propylene glycol, sorbitol liquid (crystallising), sucrose.
Glycerol, propylene glycol, sorbitol liquid (crystallising), sucrose.
oral solution 100 ml
100 ml soluzzjoni orali
Store in the original package.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
Rebetol 40 mg/ml oral solution ribavirin
Rebetol 40 mg/ ml soluzzjoni orali ribavirin
51 PACKAGE LEAFLET:
54 FULJETT TA ’ TAGĦRIF:
Rebetol 200 mg hard capsules ribavirin
Rebetol 200 mg kapsuli ibsin ribavirin
What Rebetol is and what it is used for 2.
X’ inhu Rebetol u għalxiex jintuża 2.
Before you take Rebetol 3.
Qabel ma tieħu Rebetol 3.
How to take Rebetol 4.
Kif għandek tieħu Rebetol 4.
How to store Rebetol 6.
Kif taħżen Rebetol 6.
WHAT REBETOL IS AND WHAT IT IS USED FOR
X’ INHU REBETOL U GĦALXHIEX JINTUŻA
Rebetol (ribavirin) inhibits the multiplication of many types of viruses.
Rebetol (ribavirin) jimpedixxi l- multiplikazzjoni ta ’ ħafna tipi ta ’ vajrusis.
Combining Rebetol and peginterferon alfa-2b or interferon alfa-2b has been shown to be a more effective treatment for hepatitis C virus infection than peginterferon alfa-2b or interferon alfa-2b alone.
Intwera li meta Rebetol u peginterferon alfa- 2b jew interferon alfa- 2b jingħataw b’ mod kombinat, jipprovdu kura aktar effettiva għall- infezzjoni virali ta ’ l- epatite C minn peginterferon alfa- 2b jew interferon alfa- 2b waħidhom.
Rebetol is used in combination with interferon alfa-2b to treat patients 18 years of age or older who have chronic hepatitis C.
Rebetol huwa wżat flimkien ma’ interferon alfa- 2b biex jikkura pazjenti ta ’ 18- il sena jew aktar li għandhom l- epatite C kronika.
The combination of Rebetol with peginterferon alfa-2b is also used to treat patients 18 years of age or older who have chronic hepatitis C, including in patients who are co- infected with clinically stable HIV.
Il- kombinazzjoni ta ’ Rebetol ma ’ peginterferon alfa- 2b tintuża wkoll għall- kura ta ’ pazjenti li għandhom minn 18- il sena ’ l fuq li għandhom l- epatite C kronika, inkluż f’ pazjenti li huma ko- infettati b’ HIV li tkun klinikament stabbli.
Both combinations (Rebetol with peginterferon alfa-2b and Rebetol with interferon alfa-2b) can be used in previously untreated patients and patients who have previously responded to treatment with an alpha interferon, but whose condition has recurred.
Iż- żewġ kombinazzjonijiet (Rebetol ma ’ peginterferon alfa- 2b u Rebetol ma ’ interferon alfa- 2b) jistgħu jintużaw f’ pazjenti li ma kinux ikkurati qabel u pazjenti li qabel kienu wrew rispons għall- kura b’ alfa interferon, imma li l - kondizzjoni tagħhom reġgħet tfaċċat.
Additionally, Rebetol in combination with peginterferon alfa-2b can be used for the treatment of adult patients with chronic hepatitis C who have previously relapsed following treatment with alpha interferon (pegylated or nonpegylated) and ribavirin combination therapy, or have not responded to previous treatment with alpha interferon (pegylated or nonpegylated) and ribavirin combination therapy or alpha interferon monotherapy.
Minbarra hekk, Rebetol flimkien ma ’ peginterferon alfa- 2b jista ’ jintuża għall- kura ta ’ pazjenti adulti b’ epatite C kronika li kienu rkadew qabel wara kura b’ alfa interferon (pegilat jew mhux pegilat) u terapija kkombinata ma ’ ribavirin, jew ma wrewx rispons għall- kura li ngħatat qabel b’ alfa interferon (pegilat jew mhux pegilat) u terapija kkombinata b’ ribavirin jew monoterapija b’ alfa interferon.
Rebetol is used in combination with interferon alfa-2b for injection in children 3 years of age and older who have previously untreated chronic hepatitis C.
Rebetol jintuża kombinat ma ’ interferon alfa- 2b għall- injezzjoni fi tfal ta ’ età minn 3 snin ‘ l fuq li jkollhom minn qabel epatite C kronika.
For children weighing less than 47 kg a solution formulation is available.
Għal tfal li jiżnu anqas minn 47 kg, tiġi formulazzjoni fil - forma ta ’ soluzzjoni.
Rebetol must not be used alone.
Rebetol m’ għandux jintuża waħdu.
BEFORE YOU TAKE REBETOL
QABEL MA TIEĦU REBETOL
- You may need to have your kidneys tested before starting your treatment, especially if you are
- Għandu mnejn ikollok bżonn tagħmel test tal- kliewi qabel tibda l- kura, speċjalment jekk
older than 65 years or if you have problems with your kidneys.
għandek aktar minn 65 sena jew jekk għandek problemi tal- kliewi.
- Rebetol capsules are not recommended for use in children weighing less than 47 kg.
- Il- kapsuli Rebetol mhumiex kunsiljati għall- użu fi tfal li jiżnu anqas minn 47 kg.
- Tell your doctor if you have or have had any serious illness.
- Għid lit- tabib tiegħek jekk inti għandek jew kellek xi marda serja.
Perhaps Rebetol treatment will not
Għandu mnejn li l- kura b ’
be suitable for you.
Rebetol ma tkunx tgħodd għalik.
- Tell your doctor if you ever had a heart attack or a heart problem, severe liver diseases
- Għid lit- tabib tiegħek jekk inti qatt kellek xi attakk tal- qalb jew xi problema tal- qalb, mard serju
excluding chronic hepatitis C, thyroid problems; if you have ever been treated for depression or any other psychiatric disorder, confusion, unconsciousness, or have had thoughts of suicide or have attempted suicide.
tal- fwied minbarra l- epatite C kronika, problemi tat- tirojde; jekk xi darba ngħatajt kura għad - dipressjoni jew xi mard psikjatriku ieħor, konfużjoni, intlift minn sensik, jew jekk kellek ħsibijiet ta ’ suwiċidju jew jekk ippruvajt tagħmel suwiċidju.
Be sure to read the Package Leaflet for peginterferon alfa -2b or interferon alfa-2b before you begin treatment with Rebetol and peginterferon alfa-2b or interferon alfa-2b.
Kun żgur li taqra l- Fuljett ta ’ Tagħrif għal peginterferon alfa- 2b jew interferon alfa- 2b qabel tibda l - kura b’ Rebetol u peginterferon alfa- 2b jew interferon alfa- 2b.
Do not take Rebetol
Tieħux Rebetol
- if you are allergic (hypersensitive) to ribavirin or any of the other ingredients of Rebetol.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal ribavirin jew sustanzi oħra ta ’
- if you are pregnant or planning to become pregnant.
- jekk inti ħriġt tqila jew jekk qed tippjana li toħroġ tqila.
Rebetol can cause harm to the unborn child
Rebetol jista ’ jikkaġuna ħsara lit- tarbija
if a pregnant woman takes Rebetol herself during pregnancy or has unprotected sex (sex without using a condom) with a man who is taking Rebetol.
mhux imwielda jekk mara tqila tieħu Rebetol waqt it- tqala jew ikollha x’ taqsam sesswalment mingħajr protezzjoni (sess mingħajr ma ’ tuża l- kondom) ma ’ raġel li qed jieħu Rebetol.
Rebetol can damage the sperm and the embryo (unborn child).
Rebetol jista ’ jagħmel ħsara lill- isperma u lill- embriju (it- tarbija mhux imwielda).
Therefore, if you are a female patient, it is very important to avoid becoming pregnant during treatment and during the 4 months after treatment.
Għalhekk, jekk inti pazjenta mara, huwa importanti ħafna li tevita li toħroġ tqila waqt il- kura u fl- 4 xhur ta ’ wara l- kura.
If you are a male patient, it is very important for your female partner to avoid becoming pregnant during your Rebetol treatment and during the 7 months after treatment (see “Take special care with Rebetol”).
(ara “ Oqgħod attent ħafna b’ Rebetol ”).
- if you had a problem with your heart during the past six months or any previous serious heart
- jekk kellek xi problema tal- qalb fl- aħħar sitt xhur jew xi kundizzjoni serja tal- qalb qabel.
- if you have severe medic al conditions that leave you very weak, including severe kidney
- jekk għandek xi kundizzjoni medika serja li tħallik dgħajjef ħafna, li tinkludi mard serju tal -
disease.
kliewi.
- if you have a serious problem with your liver other than chronic hepatitis C.
- jekk għandek xi problema serja tal- kliewi minbarra l- epatite C kronika.
- if you have a blood disorder, including anaemia (low number of red blood cells), thalassemia
- jekk għandek xi mard tad- demm, inkluża l- anemija (għadd baxx ta ’ ċelluli ħomor tad- demm),
(Mediterranean anaemia), sickle-cell anaemia.
talessimja (anemija Mediterranja), anemija tat tip sickle- cell.
- if you have autoimmune hepatitis or any other problem with your immune system; if you are
- jekk għandek epatite awtoimmuni jew xi problema oħra tas- sistema immunitarja; jekk qed tieħu
taking medicine that suppresses your immune system (Your immune system protects you against infection and some diseases).
(Is- sistema immunitarja tiegħek tipproteġik kontra l- infezzjoni u xi mard).
- if you have had serious nervous or mental problems, such as severe depression or thoughts of
- jekk kellek problemi serji ta ’ nervi jew problemi mentali, bħal dipressjoni jew ħsibijiet ta ’
Rebetol is also not suitable for patients with certain other past or present serious illnesses.
Rebetol ukoll mhuwiex adattat għall- pazjenti li kellhom ċertu mard serju fl- imgħoddi jew fil- preżent.
Mention any past or present serious illness to your doctor.
Għid lit- tabib tiegħek b’ kull mard serju li kellek fl- imgħoddi jew li għandek issa.
Also, be sure to read the “Do not take” section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b.
Barra dan il- fuljett, kun żgur li taqra is- sezzjoni “ Tieħux ” tal- Fuljett ta ’ Tagħrif għall- peginterferon alfa- 2b jew interferon alfa- 2b.
Take special care with Rebetol • If you have had a severe or mental disorder.
adolexxenti li jkollhom jew fl- imgħoddi kellhom kundizzjonijiet severi psikjatriċi huwa kontra - indikat (ara “ Tieħux Rebetol ”).
The use of Rebetol and interferon alfa -2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see “Do not take Rebetol”). • If you have ever had depression or develop symptoms associated with depression (e.g. feeling of sadness, dejection, etc.) while on treatment with Rebetol (see section 4).
- jekk qatt xi darba kellek dipressjoni jew tiżviluppa sintomi assoċjati mad- dipressjoni (eż tħoss id -