qanastek/EMEA-V3 huggingface dataset:
Ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Ratiograstim huwa indikat għat- tnaqqis fid- dewmien ta ’ newtropenja u fl- inċidenza ta ’ newtropenja bid- deni f’ pazjenti kkurati b’ kimoterapija ċitotossika stabbilita kontra malinni (bl- eċċezzjoni ta ’ lewkimja majelojde kronika u sindromi majelodisplastiċi) u għat- tnaqqis fid- dewmien ta ’ newtropenja f’ pazjenti, taħt kura majeloablativa u segwita bit- trapjant tal- mudullun, li huma meqjusa li għandhom riskju għola ta ’ newtropenja qawwija u mdewma.
Ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Ratiograstim huwa indikat għall- mobilizzazzjoni taċ- ċelluli proġenitriċi tad- demm periferali( PBPC).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/ l, and a history of severe or recurrent infections, long term administration of Ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
F’ pazjenti, tfal jew adulti, li għandhom newtropenja severa, konġenita, ċiklika, jew idjopatika bl- Għadd Assolut ta ’ Newtrofili (ANC) ta ’ 0. 5 x 109/ l, u storja ta ’ infezzjonijiet qawwija jew li jirkadu, it- terapija fit- tul b’ Ratiograstim huwa indikat biex jiżdied l- għadd ta ’ newtrofili u sabiex l- inċidenza u t- tul ta ’ ġrajjiet avversi relatati ma ’ infezzjonijiet jonqsu.
Ratiograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/ l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Ratiograstim huwa indikat għal kura ta ’ newtropenja persistenti (ANC ta ’ 1. 0 x 109/ l jew inqas) f’ pazjenti b’ infezzjoni avvanzata ta ’ l- HIV, sabiex jitnaqqas ir- riskju ta ’ infezzjonijiet batteriċi, dan meta għażliet oħra għall- immaniġġjar ta ’ newtropenja ma jkunux addattati.
Ratiograstim contains sorbitol.
Ratiograstim fih sorbitol.
4.8 Undesirable effects
10 4. 8 Effetti mhux mixtieqa
During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Ratiograstim.
Fi studji kliniċi, 541 pazjenti b’ kanċer u 188 volontiera f’ saħħithom ġew esposti għal Ratiograstim.
The safety profile of Ratiograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Il- profil ta ’ sigurta ’ ta ’ Ratiograstim li ġie osservat f’ dawn l- istudji kliniċi kien konsistenti ma dak tal- prodott ta ’ referenza li ntuża f’ dawn l- istudji.
≥ 1/ 10 ≥ 1/ 100, < 1/ 10 ≥ 1/ 1,000, < 1/ 100 ≥ 1/ 10,000, < 1/ 1,000 < 1/ 10,000 cannot be estimated from the available data
≥1/ 10 ≥1/ 100, < 1/ 10 ≥1/ 1, 000, < 1/ 100 ≥1/ 10, 000, < 1/ 1, 000 < 1/ 10, 000
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom; l- effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel.
Rare pulmonary undesirable effects including interstitial pneumonia, pulmonary oedema and pulmonary infiltrates have been reported in some cases with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS) which may be fatal (see section 4.4).
11 Effetti mhux mixtieqa rari tal- pulmun, fosthom pulmonite interstizjali, edema pulmonari, ġew irrapportati fejn ftit minnhom irriżultaw f 'inkapaċità respiratorja jew sindromu tat- tbatija respiratorja fl- adulti (ARDS), li setgħu jkunu fatali (ara sezzjoni 4. 4)
Isolated cases of sickle cells crises have been reported in patients with sickle cell disease (see section 4.4).
Każijiet iżolati ta ’ kriżi tal- marda taċ- ċelluli Sickle ġew rapportati f’ pazjenti bil- marda taċ- ċelluli Sickle (ara sezzjoni 4. 4).
Headaches, believed to be caused by filgrastim, have been reported in PBPC donor studies.
12 Uġigħ ta ’ ras, maħsub li ġej minħabba l- filgrastim, ġie rapportat f’ studji fuq donaturi ta ’ PBPC.
Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs (see section 4.4).
(ara sezzjoni 4. 4).
System organ class Blood and lymphatic system disorders Metabolism and nutrition disorders
Disturbi tad- demm u tas- sistema limfatika Disturbi fil- metaboliżmu u n - nutrizzjoni
Frequency Very common Uncommon Common Uncommon
Komuni ħafna Mhux komuni Komuni Mhux komuni
Undesirable effect Leukocytosis, thrombocytopenia Spleen disorder Elevated alkaline phosphatase, elevated LDH SGOT increased, hyperuricaemia
Lewkoċitosi, tromboċitopenja Disturbi fil- milza Żjieda fl- alkaline phosphatase, żjieda fil- LDH Żjieda fl- SGOT, iperurikemija
Nervous system disorders Musculoskeletal and connective tissue disorders
Disturbi fis- sistema nervuża Disturbi muskolu- skeltrali u tat- tessut Konnettiv
Very common Very common Uncommon
Komuni ħafna Komuni ħafna Mhux komuni
Headache Musculoskeletal pain Rheumatoid arthritis exacerbation
Uġigħ ta ’ ras Uġigħ muskolu- skeltrali Aggravament ta ’ l- artrite rewmatika
Severe allergic reaction
Reazzjoni allerġiku qawwija
12 In SCN patients
F ’ pazjenti b’ SCN
System organ class Blood and lymphatic system disorders
Effett mhux mixtieq Sistema tal- klassifika tal - organi
Nervous system disorders Respiratory, thoracic and mediastinal disorders
13 Disturbi respiratorji, toraċiċi u medjastinali
Common Very common
Komuni ħafna
Headache Epistaxis
Epitassi
Musculoskeletal and connective tissue disorders Renal and urinary disorders
Disturbi muskolu- skeltrali u tat - tessut Konnettiv Disturbi fil- kliewi u fis- sistema urinarja
In patients with HIV
F’ pazjenti b’ HIV
In clinical studies, the only undesirable effects that were consistently considered to be related to filgrastim administration were musculoskeletal pain, predominantly mild to moderate bone pain and myalgia.
F’ studji kliniċi, l- uniċi effetti mhux mixtieqa li kontinwament kienu meqjusa li huma relatati ma ’ l- amministrazzjoni ta ’ filgrastim kienu l- uġigħ muskolu- skeletrali, l- uġigħ l- aktar ħafif għal moderat fl- għadam, u majalġja.
The incidence of these events was similar to that reported in cancer patients.
L- inċidenza ta ’ dawn il- każi kienet komparabbli ma dik irraportata f’ pazjenti b’ kanċer.
Splenic enlargement was reported to be related to filgrastim therapy in < 3% of patients.
Żjieda fid- daqs tal- milza relatat ma ’ kura b’ filgrastim ġiet irraportata f ’ < 3% tal- pazjenti.
In all cases this was mild or moderate on physical examination and the clinical course was benign; no patients had a diagnosis of hypersplenism and no patients underwent splenectomy.
Fil- każi kollha, din iż- żjieda nħasset ħafifa jew moderata taħt eżaminazzjoni fiżika u kellha konsegwenza beninni; l- ebda pazjent ġie djanjostikat b’ ipersplenismu u fl- ebda pazjent ma tneħħiet il- milza.
As splenic enlargement is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to filgrastim treatment is unclear.
Peress li żjieda fid- daqs tal- milza hi komuni f’ pazjenti b’ infezzjoni ta ’ HIV u tinstab b’ diversi gradi fil- maġġoranza ta ’ pazjenti b’ AIDS, ir- relazzjoni ma ’ terapija ta ’ filgrastim mhijiex ċara.
13 System organ class Blood and lymphatic system disorders
Effett mhux mixtieq Sistema tal- klassifika tal - organi
Frequency Common
Frekwenza
Undesirable effect Spleen disorder
Disturbi tad- demm u tas- sistema Komuni limfatika
Ratiograstim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Ratiograstim, li fih r- metHuG- CSF (filgrastim), jikkawża żjieda sinifikanti fl- għadd ta ’ newtrofili fid- demm periferali fi żmien 24 siegħa, b’ żjidiet minuri fil- monoċiti.
Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Wara il- waqfien mill- kura ta ’
Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
14 filgrastim, l- għadd ta ’ newtrofili fid- demm jonqos b ’ 50% fiż- żmien ġurnata 1 jew 2, b’ ritorn għall- livelli normali fiż- żmien 1 sa 7 ijiem.
Use of filgrastim, either alone or after chemotherapy, mobilises haematopoietic progenitor cells into peripheral blood.
L- użu ta ’ filgrastim, waħdu jew wara kimoterapija, jimmobilizza ċ- celluli proġenitriċi ematopojetiċi għal ġod- demm periferiku.
14 Use of filgrastim in patients, children or adults, with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in absolute neutrophil counts in peripheral blood and a reduction of infection and related events.
L- użu ta ’ filgrastim f’ pazjenti, tfal u adulti, b’ SCN (newtropenja qawwija, konġenitali, ċiklika, u idjopatika) iwassal għal żjieda sostenibbli fl- għadd assolut ta ’ newtrofili fid- demm periferali u tnaqqis fin- numru ta ’ infezzjonijiet u ġrajjiet relatati.
Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/ or other myelosuppressive medicinal product.
L’ użu ta ’ filgrastim f’ pazjenti b’ infezzjoni ta ’ HIV iżomm l- għadd ta ’ newtrofili normali sabiex jippermetti id- dożaġġ skedat tat- terapija antivirali u/ jew mediċina majelosoppressiva oħra.
The efficacy and safety of Ratiograstim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
L- effikaċja u s- sigurta ’ ta ’ Ratiograstim ġew stmati fi studji ta ’ fażi III, randomised u kontrollati bi placebo, f’ pazjenti b’ kanċer tas- sider, kanċer tal- pulmun u Non- Hodgkin- Limfoma.
There were no relevant differences between Ratiograstim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Ma kienx hemm differenzi rilevanti bejn Ratiograstim u l- prodott ta ’ referenza fir- rigward ta ’ dewmien ta ’ newtropenja qawwija u l- inċidenza ta ’ newtropenja bid- deni.
Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Ratiograstim was comparable to that of the reference product after subcutaneous and intravenous administration.
Studji randomised, single- blind, b’ doża waħda u crossover li saru fuq 196 voluntiera b’ saħħithom urew li l- profil farmakokinetiku ta’ Ratiograstim kien komparabbli ma ’ dak tal- prodott ta ’ referenza kemm wara amministrazzjoni taħt il- ġilda kif ukoll ġol- vina.
Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ ml for 8 to 16 hours.
Wara l- amministrazzjoni taħt 15 il- ġilda tad- doża rakkomandata, il- konċentrazzjoni fis- serum nżammet il- fuq minn 10 ng/ ml għal 8 sa16- il siegħa.
In cancer patients, the pharmacokinetic profile of Ratiograstim and the reference product was comparable after single and repeated subcutaneous administration.
F’ pazjenti b’ kanċer, il- profil farmacokinetiku ta ’ Ratiograstim u dak tal- prodott ta ’ referenza kienu komparabbli wara amministrazzjoni taħt il- ġilda ta ’ doża waħda jew dożi ripetuti.
Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
Tagħrif ta ’ qabel l- użu kliniku miġbur minn studji konvenzjonali fuq l- effett tossiku minn dożi riptetuti, ikkonferma l- effetti mistennija, fosthom żjidiet fl- għadd ta ’ lewkoċiti, iperplasija majelojde fil- mudullun, ematopojesi ekstramedullari u tkabbir tal- milza.
Acetic acid, glacial Sodium hydroxide Sorbitol (E420)
Acetic acid, glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80 Ilma għall- injezzjoni
Ratiograstim should not be diluted with sodium chloride solution.
Ratiograstim m’ għandux jiġi dilwit ma ’ soluzzjoni ta ’ sodium chloride.
For storage conditions of the diluted medicinal product, see section 6.3.
16 Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali dilwit, ara sezzjoni 6. 3.
If required, Ratiograstim may be diluted in glucose 50 mg/ ml (5%) solution for infusion.
Jekk ikun hemm il- ħtieġa, Ratiograstim jista ’ jiġi dilwit f’ soluzzjoni għal infużjoni ta ’ glucose 50 mg/ ml (5%).
When diluted in glucose 50 mg/ ml (5%) solution for infusion, Ratiograstim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Meta jiġi dilwit ġo soluzzjoni għal infużjoni ta’ glucose 50 mg/ ml (5%), Ratiograstim huwa kompatibbli mal- ħġieġ u varji tipi ta ’ plastik, fosthom il- PVC, polyolefin (co- polymer ta ’ polypropylene u polyethylene) u polypropylene.
16 Ratiograstim does not contain any preservative.
Ratiograstim ma fih l- ebda preservattiv.
In view of the possible risk of microbial contamination, Ratiograstim syringes are for single use only.
Minħabba r- riskju potenzjali ta ’ kontaminazzjoni b’ mikrobi, is- siringi ta ’ Ratiograstim iridu jintużaw darba biss.
Accidental exposure to freezing temperatures does not adversely affect the stability of Ratiograstim.
L- esposizzjoni bi żball għal temperatura ta ’ friża ma jeffettwax ħażin l- istabilita` ta ’ Ratiograstim.
Ratiograstim 48 MIU/ 0.8 ml solution for injection or infusion
Ratiograstim 48 MIU/ 0. 8ml soluzzjoni għall- injezzjoni jew infużjoni
18 collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
19 ma 'ċentru ta ’ l- onkoloġija u ematoloġija b’ esperjenza xierqa f’ dan il- qasam u fejn il- monitoraġġ taċ- ċelluli proġenitriċi ematopojetiċi jista ’ jsir korrettament.
For infusions, filgrastim should be diluted in 20 ml of glucose 50 mg/ ml (5%) solution for infusion (see section 6.6 for instructions on dilution).
Għal l- infużjoni, id- doża ta ’ filgrastim 20 trid tkun miżjuda ma ’ 20ml soluzzjoni ta ’ glucose 50 mg/ ml (5%) (ara sezzjoni 6. 6 għall- istruzzjonijiet fuq id- dilwit).
In clinical studies, dosing with 30 MIU (300 μ g)/ day on 1 to 7 days per week was required to maintain the ANC
21 jkun hemm bżonn ta ’ aktar aġġustament fid- dożaġġ, li trid tiġi iddeterminata mill- ANC tal- pazjent, bl- għan li l- għadd ta ’ newtrofili jinżamm > 2. 0 x 109/ l.
20 > 2.0 x 109/ l, with the median dose frequency being 3 days per week.
F’ studji kliniċi, dożaġġ ta’ 30 MIU (300 μg) / jum għal ġurnata sa sebgħat ijiem fil- gimgħa kien meħtieġ biex jinżamm ANC > 2. 0 x 109/ l, bil- frekwenza medja tad- dożaġġ tkun ta ’ tlett ijiem fil- ġimgħa.
In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
22 Minħabba tagħrif limitat dwar is- sigurta 'u l- effikaċja assoċjat mal- użu f’ pazjenti b’ Lewkimja Majelojde Akuta (AML) sekondarja, filgrastim għandu jingħata b’ kawtela f’ dawn il- każi.
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings.
23 Żjieda fl- attività ematopojetika fil- mudullun f' rispons għal terapija ta 'fattur tat- tkabbir ġiet assoċjata ma' sejbiet transitorja posittivi fl- istampi tal- għadam.
Transient thrombocytopenia (platelets < 100 x 109/ l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
24 Wara l- amministrazzjoni ta ’ filgrastim u proċedura ta ’ lewkafereżi, ġiet osservata tromboċitopenja transitorja (plejtlits < 100 x 109/ l) f’ 35% tas- suġġeti li ġew studjati.
Special precautions in sickle cell disease
26 Prekawzjonijiet speċjali f’ pazjenti bil- marda taċ- ċelluli Sickle
4.8 Undesirable effects
27 4. 8 Effetti mhux mixtieqa
Rare pulmonary undesirable effects including interstitial pneumonia, pulmonary oedema and pulmonary infiltrates have been reported in some cases with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS) which may be fatal (see section 4.4).
28 Effetti mhux mixtieqa rari tal- pulmun, fosthom pulmonite interstizjali, edema pulmonari, ġew irrapportati fejn ftit minnhom irriżultaw f 'inkapaċità respiratorja jew sindromu tat- tbatija respiratorja fl- adulti (ARDS), li setgħu jkunu fatali (ara sezzjoni 4. 4)
Headaches, believed to be caused by filgrastim, have been reported in PBPC donor studies.
29 Uġigħ ta ’ ras, maħsub li ġej minħabba l- filgrastim, ġie rapportat f’ studji fuq donaturi ta ’ PBPC.
28 In SCN patients
F ’ pazjenti b’ SCN
Nervous system disorders Respiratory, thoracic and mediastinal disorders
30 Disturbi respiratorji, toraċiċi u medjastinali
29 System organ class Blood and lymphatic system disorders
Effett mhux mixtieq Sistema tal- klassifika tal - organi
Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
31 filgrastim, l- għadd ta ’ newtrofili fid- demm jonqos b ’ 50% fiż- żmien ġurnata 1 jew 2, b’ ritorn għall- livelli normali fiż- żmien 1 sa 7 ijiem.
30 Use of filgrastim in patients, children or adults, with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in absolute neutrophil counts in peripheral blood and a reduction of infection and related events.
L- użu ta ’ filgrastim f’ pazjenti, tfal u adulti, b’ SCN (newtropenja qawwija, konġenitali, ċiklika, u idjopatika) iwassal għal żjieda sostenibbli fl- għadd assolut ta ’ newtrofili fid- demm periferali u tnaqqis fin- numru ta ’ infezzjonijiet u ġrajjiet relatati.
Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ ml for 8 to 16 hours.
Wara l- amministrazzjoni taħt 32 il- ġilda tad- doża rakkomandata, il- konċentrazzjoni fis- serum nżammet il- fuq minn 10 ng/ ml għal 8 sa16- il siegħa.
For storage conditions of the diluted medicinal product, see section 6.3.
33 Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali dilwit, ara sezzjoni 6. 3.
32 Ratiograstim does not contain any preservative.
Ratiograstim ma fih l- ebda preservattiv.
33 ANNEX II
35 ANNESS II
Ratiograstim 30 MIU/ 0.5 ml
Ratiograstim 30 MIU/ 0. 5ml
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
41 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Ratiograstim 48 MIU/ 0.8 ml
Ratiograstim 48 MIU/ 0. 8ml
46 PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Ratiograstim 30 MIU/ 0.5 ml
Ratiograstim 30 MIU/ 0. 5 ml
48 PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Ratiograstim 48 MIU/ 0.8 ml
Ratiograstim 48 MIU/ 0. 8 ml
50 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
51 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
51 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
52 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
53 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
Ratiograstim 30 MIU/ 0.5 ml solution for injection or infusion Ratiograstim 48 MIU/ 0.8 ml solution for injection or infusion
Ratiograstim 30 MIU/ 0. 5ml soluzzjoni għall- injezzjoni jew infużjoni Ratiograstim 48 MIU/ 0. 8ml soluzzjoni għall- injezzjoni jew infużjoni
What Ratiograstim is and what it is used for 2.
X’ inhu Ratiograstim u għalxiex jintuża 2.
Before you use Ratiograstim 3.
Qabel ma tuża Ratiograstim 3.
How to use Ratiograstim 4.
Kif għandek tuża Ratiograstim 4.
How to store Ratiograstim 6.
Kif taħżen Ratiograstim 6.
WHAT Ratiograstim IS AND WHAT IT IS USED FOR
X’ INHU Ratiograstim U GĦALXIEX JINTUŻA
What Ratiograstim is Ratiograstim contains the active substance filgrastim.
X’ inhu Ratiograstim Ratiograstim fih is- sostanza attiva filgrastim.
What Ratiograstim is used for Your doctor has prescribed Ratiograstim for you to help your body make more white blood cells.
Għalxiex jintuża Ratiograstim It- tabib tiegħek tak Ratiograstim biex jgħin il- ġismek jipproduċi aktar ċelluli bojod.
Your doctor will tell you why you are being treated with Ratiograstim.
It- tabib tiegħek ser jgħidlek il- għaliex qed tingħata kura b’ Ratiograstim.
Ratiograstim is useful in several different conditions which are:
Ratiograstim huwa ta ’ benefiċju f’ ħafna kundizzjonijiet differenti li huma:
BEFORE YOU USE Ratiograstim
QABEL MA TUŻA Ratiograstim
Do not use Ratiograstim
Tużax Ratiograstim
- if you are allergic (hypersensitive) to filgrastim or to any of the other ingredients of
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal filgrastim jew sustanzi oħra ta ’
Take special care with Ratiograstim
Oqgħod attent ħafna b’ Ratiograstim
You will need to have regular blood tests whilst being treated with Ratiograstim to count the number of neutrophils and other white blood cells in your blood.
Ikollok bżonn tagħmel analiżi tad- demm regolari waqt il- kura b’ Ratiograstim biex isir magħruf l- għadd ta ’ newtrofili u l- għadd ta ’ celluli bojod oħra ġo demmek.
Ratiograstim has not been tested in pregnant women.
Ratiograstim ma ġiex ittestjat f’ nisa tqal.
Important information about some of the ingredients of Ratiograstim This medicine contains sorbitol (a type of sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ratiograstim Din il- mediċina fiha sorbitol (tip ta ’ zokkor).
HOW TO USE Ratiograstim
KIF GĦANDEK TUŻA Ratiograstim
Always use Ratiograstim exactly as your doctor has told you.
Dejjem għandek tuża Ratiograstim skond il- parir tat- tabib.
The amount of Ratiograstim you need will depend on the condition you are taking Ratiograstim for and on your bodyweight.
Id- doża li ssoltu tingħata hija … L- ammont ta ’ Ratiograstim li għandek bżonn ser jiddependi fuq il- kundizzjoni tiegħek, ir- raġuni għaliex trid tieħu Ratiograstim, u fuq il- piz ta’ ġismek.
Your doctor will tell you when to stop using Ratiograstim.
It- tabib tiegħek jgħidlek meta għandek tieqaf tieħu Ratiograstim.
It is quite normal to have a number of courses of Ratiograstim treatment.
Hija ħaġa normali li jkollok bżonn numru ta ’ korsijiet ta ’ kura b’ Ratiograstim
Ratiograstim and chemotherapy The usual dose is 0.5 million international units (MIU) per kilogram of bodyweight each day.
Ratiograstim u kimoterapija Id- doża li tintuża normali hija 0. 5 miljun international units (MIU) għal kull kilogramm ta ’ piż tal - ġisem, kuljum.
Ratiograstim and bone marrow transplantation The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day.
Ratiograstim u trapjant tal- mudullun Id- doża tal- bidu li tintuża normali hija 1 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.
You will normally receive your first dose of Ratiograstim at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transfusion.
Normalment, tirċievi l- ewwel doża tiegħek ta ’ Ratiograstim mill- inqas 24 siegħa wara l- kimoterapija imma qabel 24 hours li tirċievi t- trasfużjoni tal- mudullun.
Ratiograstim and severe chronic neutropenia The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram bodyweight each day in a single or divided dose.
56 Ratiograstim u newtropenja severa u kronika Id- doża tal- bidu li tintuża normali hija bejn 0. 5 miljun u 1. 2 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum, mogħtija bħala doża waħda jew ħafna.
Long-term treatment with Ratiograstim is required for neutropenia.
Għat- trattament ta ’ newtropenja, ikun hemm bżonn ta ’ kura b’ Ratiograstim fit- tul.
55 Ratiograstim and neutropenia in patients with HIV infection The usual starting dose is between 0.1 and 0.4 million international units (MIU) per kilogram bodyweight each day.
Ratiograstim u newtropenja f’ pazjenti bl- infezzjoni ta ’ HIV Id- doża tal- bidu li tintuża normali hija bejn 0. 1 u 0. 4 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.
Long term treatment with Ratiograstim may be required to maintain a normal number of white cells in your blood.
Jista ’ jkun hemm bżonn ta ’ kura b’ Ratiograstim fit- tul sabiex jinżammu livelli normali ta ’ l- għadd ta ’ ċelluli bojod f’ demmek.
Ratiograstim and peripheral blood stem cell mobilisation If you are donating stem cells for yourself, the usual dose is 0.5 million to 1 million international units (MIU) per kilogram bodyweight each day.
Ratiograstim u mobilizzazzjoni ta ’ ċelluli proġenitriċi tad- demm periferali Jekk inti donatur ta ’ PBPC għalik innifsek, id- doża li tintuża komunement hija 0. 5 miljun sa 1 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.
Ratiograstim treatment will last for up to 2 weeks and in exceptional cases longer.
Kura b’ Ratiograstim ser idum sa ġimgħatejn jew, f’ każijiet eċċezzjonali, anki iktar.
Ratiograstim treatment will last for 4 to 5 days.
Kura b’ Ratiograstim ser jieħu minn 4 sa 5 ijiem.
If you use more Ratiograstim than you should If you use more Ratiograstim than you should, contact your doctor or pharmacist as soon as possible.
Jekk tuża Ratiograstim aktar milli suppost Jekk tuża Ratiograstim aktar milli suppost, għandek tgħarraf lit- tabib jew l- ispiżjar tiegħek mill- iktar fis possibbli.
If you forget to use Ratiograstim Do not use a double dose to make up for a forgotten injection.
Jekk tinsa tuża Ratiograstim M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using Ratiograstim Before you stop using Ratiograstim, talk to your doctor.
Jekk tieqaf tuża Ratiograstim Qabel ma tieqaf tuża Ratiograstim, tkellem mat- tabib tiegħek.
Like all medicines, Ratiograstim can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Ratiograstim jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you think you are having this type of reaction, stop your Ratiograstim injection and get medical help immediately.
Jekk taħseb li qed ikollok xi reazzjoni minn dawn, waqqaf l- injezzjoni ta ’ Ratiograstim u fittex għajnuna medika immedjatament.
If you have Sickle Cell Disease, make sure that you tell your doctor before you start taking Ratiograstim.
Jekk tbati mill- marda ta ’ Sickle Cell, kun żgur li tgħarraf it- tabib tiegħek qabel ma tibda kura b’ Ratiograstim.
HOW TO STORE Ratiograstim
KIF TAĦŻEN Ratiograstim
Do not use Ratiograstim after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Tużax Ratiograstim wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq is- siringa mimlija għal- lest wara “ JIS ”.
Do not use Ratiograstim if you notice it is cloudy or there are particles in it.
Tużax Ratiograstim jekk tinnota li s- soluzzjoni mhix ċara jew jekk hemm xi frak fiha.
What Ratiograstim contains
X’ fih Ratiograstim:
Ratiograstim 30 MIU/ 0.5 ml:
Ratiograstim 30 MIU/ 0. 5ml:
Ratiograstim 48 MIU/ 0.8 ml:
Ratiograstim 48 MIU:
You will find detailed information about the ingredient sorbitol (a sugar) in section 2. under the heading “ Important information about some of the ingredients of Ratiograstim”.
Tista ’ ssib informazzjoni dettaljata dwar l- ingredjent sorbitol (tip ta ’ zokkor) f’ sezzjoni 2 taħt it - titlu “ Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ratiograstim ”.
What Ratiograstim looks like and contents of the pack Ratiograstim is a solution for injection or infusion in a pre-filled syringe.
Ratiograstim huwa soluzzjoni għall- injezzjoni jew infużjoni ġo siringa mimlija għal- lest.
Ratiograstim is a clear and colourless solution.
Ratiograstim huwa soluzzjoni ċar u mingħajr kulur.
Ratiograstim are supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Ratiograstim jiġi f’ pakketti ta ’ 1, 5 jew 10 siringi mimlijin għal- lest jew f’ pakkett multiplu ta’ 10 (2 pakketti ta ’ 5).
België/ Belgique/ Belgien ratiopharm Belgium S. A.
België/ Belgique/ Belgien
Luxembourg/ Luxemburg ratiopharm S. A.
ratiopharm S. A.
Lietuva ratiopharm atstovas Lietuvoje Tel: + 370 5 212 3295
60 Lietuva ratiopharm atstovas Lietuvoje Tel: + 370 5 212 3295
59 This section contains information on how to give yourself an injection of Ratiograstim.
Din il- parti tal- fuljett fiha tagħrif dwar kif tagħti injezzjoni ta ’ Ratiograstim lilek innifsek.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Huwa importanti li ma tippruvax tagħti l- injezzjoni lilek innifsek jekk ma tkunx irċevejt taħriġ speċjali mingħand it- tabib jew infermiera tiegħek.
How do I inject Ratiograstim myself?
Kif ninjetta Ratiograstim lili innifsi?
- a pre-filled syringe of Ratiograstim,
- siringa mimlija għal- lest b’ Ratiograstim;
What should I do before I give myself a subcutaneous injection of Ratiograstim?
X’ għandi nagħmel qabel ma ninjetta lili nnifsi taħt il- ġilda b’ Ratiograstim?
Take your Ratiograstim pre-filled syringe out of the refrigerator.
Oħroġ s- siringa mimlija għal- lest b’ Ratiograstim mill- friġġ.
Check the appearance of Ratiograstim.
Iċċekkja d- dehra ta ’ Ratiograstim.
Do not warm Ratiograstim in any other way (for example, do not warm it in a microwave or in hot water).
Issaħħanx Ratiograstim bl’ ebda mod ieħor (eżempju: issaħħanx fil- forn majkrowejv jew f’ ilma jaħraq).
Find a comfortable, well-lit place and put everything you need where you can reach them (the Ratiograstim pre-filled syringe, alcohol wipes and the puncture-proof container).
(is- siringa mimlija għal- lest b’ Ratiograstim, msielaħ ta ’ l- alkoħol u r- reċipjent li ma jitaqqabx).
How do I prepare my Ratiograstim injection?
Kif nipprepara l- injezzjoni ta ’ Ratiograstim?
Before you inject Ratiograstim you must do the following:
Qabel ma tinjetta ratiogratim trid tagħmel dan li ġej:
Push the plunger up to the number (ml) on the syringe that matches the dose of Ratiograstim that your doctor prescribed.
Imbotta l- planġer san- numru (ml) fuq it- tubu tas- siringa li jikkorispondi mad- doża ta ’ Ratiograstim preskritta mit- tabib tiegħek.
Check again to make sure the correct dose of Ratiograstim is in the syringe.
Erġa iċċekkja li hemm id- doża preskritta ta’ Ratiograstim fis- siringa.
It is better to change the injection site every day to avoid the risk of soreness at any one site.
62 Tajjeb li kuljum tibdel is- sit fejn tingħata l- injezzjoni sabiex tnaqqas ir- riskju ta ’ uġigħ f’ xi sit partikolari.
Do not use any Ratiograstim that is left in the syringe.
M’ għandekx tuża xi Ratiograstim li jkun baqa ’ fis- siringa.
Ratiograstim does not contain any preservative.
Ratiograstim ma fihx l- ebda preservattiv.
In view of the possible risk of microbial contamination, Ratiograstim syringes are for single use only.
Minħabba r- riskju potenzjali ta ’ kontaminazzjoni bil- mikrobi, is- siringi ta ’ Ratiograstim iridu jintużaw darba biss.
Ratiograstim should not be diluted with sodium chloride solution.
63 Ratiograstim m’ għandux jiġi dilwit ma ’ soluzzjoni ta ’ sodium chloride.
If required, Ratiograstim may be diluted in glucose 50 mg/ ml (5%) solution for infusion.
Jekk ikun hemm bżonn, Ratiograstim jista ’ jiġi dilwit f’ soluzzjoni għal infużjoni ta ’ glucose 50 mg/ ml (5%).
When diluted in glucose 50 mg/ ml (5%) solution for
Meta l- volum finali ta ’ l- injezzjoni huwa 20 ml, id- dożi kollha ta ’ filgrastim li fihom inqas minn 30 MIU (300 μg) iridu jingħataw b’ 0. 2 ml soluzzjoni ta ’ 20% albumina umana miżjuda.
62 infusion, Ratiograstim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Meta jiġi dilwit ġo soluzzjoni għal infużjoni ta’ glucose 50 mg/ ml (5%), Ratiograstim huwa kompatibbli mal- ħġieġ u varji tipi ta ’ plastik, fosthom il- PVC, polyolefin (co- polymer ta ’ polypropylene u polyethylene) u polypropylene.
What is Rebetol?
X’ inhu Rebetol?
Rebetol is a medicine containing the active substance ribavirin.
Rebetol huwa mediċina li fiha s- sustanza attiva ribavirin.
It is available as capsules (200 mg) and as an oral solution (40 mg/ ml).
Huwa disponibbli bħala kapsuli (200 mg) u bħala soluzzjoni orali (40 mg/ ml).
What is Rebetol used for?
Għalxiex jintuża Rebetol?
Rebetol is used to treat adults and children aged 3 years and older who have chronic (long term) hepatitis C (a disease of the liver due to an infection by the hepatitis C virus).
Rebetol jintuża biex jittratta adulti u tfal ta ’ età ta ’ 3 snin jew akbar li għandhom epatite Ċ kronika (fuq tul ta ’ żmien) (marda tal- fwied ikkaġunata mill- virus tal- epatite Ċ).
Rebetol must never be used on its own but only together with an interferon (another type of medicine used in hepatitis).
Rebetol m’ għandux jintuża waħdu iżda flimkien ma ’ interferon (tip ieħor ta ’ mediċina użata fl- epatite) biss.
In adults, Rebetol can be used in ‘ naïve’ patients (who have not been treated before) or in patients who have relapsed after treatment with interferon, either in combination with interferon alfa-2b or peginterferon alfa-2b (including for patients also infected with human immunodeficiency virus [HIV]).
Fl- adulti, Rebetol jista ’ jintuża f’ pazjenti ‘ naive ’ (li ma ġewx ittrattati qabel) jew f’ pazjenti li rkadew wara t- trattament b’ interferon, jew b’ kumbinazzjoni ma ’ interferon alfa- 2b jew peginterferon alfa- 2b (inklużi għal pazjenti infettati ukoll bil- virus uman ta ’ l- immunodefiċjenza [HIV]).
In children and adolescents, Rebetol can only be used in combination with interferon alfa-2b to treat naïve patients.
Fit- tfal u fl - adolexxenti, Rebetol jista ’ jintuża biss f’ kumbinazzjoni ma ’ interferon alfa- 2b biex jittratta pazjenti naive.
How is Rebetol used?
Kif inhu użat Rebetol?
Treatment with Rebetol should be initiated and monitored by a doctor who has experience in the management of chronic hepatitis C.
Trattament b’ Rebetol għandu jinbeda u jiġi sorveljat minn tabib li għandu l- esperjenza fil- kura ta ’ l - epatite Ċ kronika.
The dose of Rebetol is based on the patient’ s body weight, and ranges from 3 to 6 capsules a day in patients weighing more than 47 kg.
Id- doża ta ’ Rebetol hija bbażata fuq il- piż korporali tal- pazjent, u tvarja minn 3 sa 6 kapsuli kuljum f’ pazjenti li jiżnu aktar minn 47 kg.
For patients of a lower weight, the oral solution is used to provide a dose of 15 mg per kilogram body weight a day.
Għal pazjenti ta ’ piż aktar baxx, is- soluzzjoni orali hija użata biex tagħti doża ta ’ 15 mg kull kilogramm piż korporali.
Rebetol is taken with food each day in two divided doses (morning and evening).
Rebetol jittieħed ma ’ l- ikel kuljum f’ żewġ dożi maqsuma (filgħodu u filgħaxija).
The duration of treatment depends on the patient’ s condition and response to treatment, and ranges from 24 weeks to a year.
It- tul ta ’ żmien tat- trattament jiddependi fuq il - kondizzjoni tal- pazjent u r- reazzjoni għat- trattament, u jvarja minn 24 ġimgħa sa sena.
The dose may need to be adjusted for patients who experience side effects.
Id- doża tista ’ teħtieġ li tkun aġġustata għal pazjenti li jesperjenzaw effetti sekondarji.
How does Rebetol work?
Kif jaħdem Rebetol?
The active substance in Rebetol, ribavirin, is an antiviral belonging to the class ‘ nucleoside analogues’.
Is- sustanza attiva f’ Rebetol, ribavirin, hija antivirali li tappartieni għall- klassi ‘ nucleoside analogues ’.
Rebetol is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
Rebetol huwa maħsub li jostakola l- produzzjoni jew l- azzjoni ta ’ DNA u RNA virali li huma meħtieġa biex il- virusis jissopravivu u jimmultiplikaw.
Rebetol on its own has no effect on eliminating the hepatitis C virus from the body.
Rebetol waħdu m’ għandu l- ebda effett li jelimina l- virus ta ’ l- epatite Ċ mill- ġisem.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Rebetol been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Rebetol?
In adults, the use of Rebetol with interferon alfa-2b has been studied in four main studies, two in a total of 1,744 treatment-naïve patients and two in a total of 345 patients who had relapsed after previous treatment with interferon.
Fl- adulti, l- użu ta ’ Rebetol ma ’ interferon alfa- 2b ġie studjat f’ erba ’ studji ewlenin, tnejn f’ total ta ’ 1, 744- il pazjent naive għat- trattament u tnejn f’ total ta ’ 354- il pazjent li rkadew wara trattament ta ’ qabel b’ interferon.
All of these studies compared the effectiveness of adding either Rebetol or placebo (a dummy treatment) to interferon alfa-2b with using the interferon alone.
Dawn l- istudji kollha qabblu l- effettività taż- żieda jew ta ’ Rebetol jew ta ’ plaċebo (trattament finta) ma ’ interferon alfa- 2b ma ’ l- użu ta ’ interferon waħdu.
The use of Rebetol with peginterferon alfa-2b has been studied in 1,580 treatment-naïve patients, comparing two schedules of Rebetol added to peginterferon alfa-2b with Rebetol added to interferon alfa-2b.
L- użu ta ’ Rebetol ma ’ peginterferon alfa- 2b ġie studjat f ’ 1, 580- il pazjent naive għat- trattament, iqabbel żewġ skedi jew ta ’ Rebetol miżjud f’ kumbinazzjoni ma ’ peginterferon alfa- 2b jew ma ’ Rebetol miżjud ma ’ interferon alfa- 2b.
In addition, a further two studies have looked at its use in 565 patients also infected with HIV, where it was used in combination with either interferon alfa-2b or peginterferon alfa-2b.
Barra minn hekk, żewġ studji ħarsu lejn l- użu tiegħu f’ 565- il pazjent infettati ukoll bl- HIV, fejn intuża jew ma ’ interferon alfa- 2b jew ma ’ peginterferon alfa- 2b.
Rebetol used in combination with interferon alfa-2b has also been studied in 70 treatment-naïve children aged 3 to 16 years.
Rebetol użat f’ kumbinazzjoni ma ’ interferon alfa- 2b ġie studjat ukoll f’ 70 tifel u tifla naive għat - trattament ta ’ etajiet 3 sa 16- il sena.
In most studies, the main measure of effectiveness was the level of viral RNA circulating in the blood before and after 24 or 48 weeks of treatment, and at follow up (24 weeks later).
Fil- parti l- kbira ta ’ l- istudji, il- miżura ewlenija ta ’ l- effettività kienet il- livell ta ’ RNA virali li iċċirkola fid- demm qabel u wara 24 sa 48- il ġimgħa ta ’ trattament, u fil- vista segwenti (24- il ġimgħa wara).
Some studies also looked at signs of improvement of the condition of the liver.
Xi studji ħarsu wkoll lejn is- sinjali ta ’ titjib fil- kondizzjoni tal- fwied.
What benefit has Rebetol shown during the studies?
X’ benefiċċju wera Rebetol waqt l- istudji?
Rebetol used with interferon alfa-2b was more effective than interferon alfa-2b used on its own.
Rebetol użat ma ’ interferon alfa- 2b kien aktar effettiv minn interferon alfa- 2b użat waħdu.
In treatment-naïve adult patients, 41% had responded to treatment when checked at follow up (48 weeks) compared with 16% of those who received only interferon alfa-2b.
F’ pazjenti adulti naive għat- trattament, 41% kienu irrispondew għat- trattament meta iċċekkjati fil- follow up (ġimgħa 48) imqabbla ma ’ 16% ta ’ dawk li rċievew interferon alfa- 2b biss.
In relapsed patients, the responder rates at the follow up visit were 37% in the patients who received the combination, compared with 3.5% of the patients who only received interferon alfa-2b.
F’ pazjenti li irkadew, ir - rati ta ’ dawk li irrispondew fil- viżta ta ’ follow- up kienu 37% fil- pazjenti li irċievew il- kumbinazzjoni, imqabbla ma ’ 3. 5% tal- pazjenti li irċievew interferon alfa- 2b biss.
The effectiveness of Rebetol used with peginterferon alfa-2b (as a once weekly 1.5 micrograms per kg bodyweight) was more effective than the combination with interferon alfa-2b.
L- effettività ta ’ Rebetol użat ma ’ peginterferon alfa- 2b (bħala 1. 5 mikrogrammi kull kg piż korporali) kienet aktar effettiva mill - kumbinazzjoni ma ’ interferon alfa- 2b.
Rebetol used in combination with peginterferon alfa-2b has also shown its effectiveness in the treatment of hepatitis C infection inpatients also infected with HIV.
Rebetol użat f’ kumbinazzjoni ma ’ peginterferon alfa- 2b wera ukoll l- effettività tiegħu fit- trattament ta ’ inpatients b’ infezzjoni ta ’ epatite Ċ infettati b’ HIV ukoll.
In children, Rebetol combined with interferon alfa-2b was effective with 49% of the patients having responded to treatment at the 48-week follow-up visit.
Fit- tfal, Rebetol ikkumbinat ma ’ interferon alfa- 2b kien effettiv f’ 49% tal- pazjenti li kienu rrispondew għat- trattament fil- viżta ta ’ segwitu fit- 48 ġimgħa.
What is the risk associated with Rebetol?
X’ inhu r- riskju assocjat ma ’ Rebetol?
The most common side effects with Rebetol used in combination with interferon alfa-2b or peginterferon alfa-2b (seen in more than 1 patient in 10) are viral infections, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low white blood cell counts), hypothryroidism (underactive thyroid gland), anorexia (loss of appetite), depression, insomnia (difficulty sleeping), emotional lability (mood swings), anxiety, dry mouth, headache, dizziness, impaired concentration, cough, dyspnoea (difficulty breathing), nausea, diarrhoea, abdominal (tummy) pain, vomiting, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection including inflammation, fatigue (tiredness), fever, rigors (shaking chills), flu-like symptoms, asthenia (weakness), malaise (feeling unwell), irritability, weight loss and decreased growth rate.
L- aktar effetti sekondarji komuni b’ Rebetol użat f’ kumbinazzjoni ma ’ interferon alfa- 2b jew peginterferon alfa- 2b (irrapportati f’ aktar minn pazjent 1 f’ 10) huma infezzjonijiet virali, farinġite (uġigħ fil- griżmejn), anemija (għadd baxx taċ- ċelloli ħomor tad- demm), newtropinja (għadd baxx taċ - ċelloli bojod tad- demm), ipotirojdiżmu (glandola tirojde taħdem bil- mod), anoressja (telf ta ’ l- aptit), depressjoni, insomnja (diffikultà fl- irqad), instabbilità emozzjonali (tibdil fil- burdata), ansjetà, ħalq xott, uġigħ ta ’ ras, sturdament, ħsara fil- konċentrazzjoni, sogħla, dispneja (diffikultà fit- teħid tan- nifs), nawsja (dardir), dijarea, uġigħ addominali (taż- żaqq), remettar, alopeċija (telf ta ’ xagħar), prurite (ħakk), ġilda xotta, raxx, mijalġja (uġigħ fil- muskoli), artralġja (uġigħ fil- ġogi), uġigħ muskoluskeletali (uġigħ fil- muskoli u l- għadam), reazzjonijiet fis- sit ta ’ l- injezzjoni inklużi infjammazzjoni, għeja kbira, deni, rigors (tertir bil- bard), sintomi simili għal dawk ta ’ l- influwenza, astenja (dgħjufija), malaise (tħossok ma tiflaħx), irritabbilità, telf fil- piż u tnaqqis fir- rata ta ’ l - iżvilupp.
For the full list of all side effects reported with Rebetol, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Rebetol, ara l- Fuljett ta ’ Tagħrif.
Rebetol should not be used in people who may be hypersensitive (allergic) to ribavirin or any of the other ingredients.
Rebetol m’ għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal ribavirin jew għal xi sustanza oħra tiegħu.
Rebetol should not be used in: • pregnant women, • women who are breast-feeding, • patients with severe heart disease, • patients with a severe medical condition, including kidney failure and severe liver disease. • patients with certain blood disorder that affect haemoglobin, • patients with a history of certain disorders of the immune system, or are taking medicine that suppress the immune system, • children and adolescents with a history of severe mental illness, particularly severe depression, suicidal thoughts or suicide attempts.
Rebetol m’ għandux jintuża f ’: • nisa tqal, • nisa li qed ireddgħu, • pazjenti b’ mard serju tal- qalb, • pazjenti b’ kondizzjoni medika serja, inklużi ħsara fil- kliewi u mard serju tal- fwied. • pazjenti b’ ċertu disturb tad- demm li jaffettwa l- emoglobina, • pazjenti bi storja ta ’ ċerti disturbi tas- sistema immunitarja, jew li qed jieħdu mediċina li trażżan is- sistema immunitarja, • tfal u adolexxenti bi storja ta ’ mard mentali serju, b’ mod partikolari depressjoni serja, ħsibijiet ta ’ suwiċidju jew attentati ta ’ suwiċidju.
For the full list of all restrictions, see the Package Leaflet.
Għal- lista sħiħa tar- restrizzjonijiet kollha, ara l- Fuljett ta ’ Tagħrif.
Why has Rebetol been approved?
Għaliex ġie approvat Rebetol?
The Committee for Medicinal products for Human Use (CHMP) decided that Rebetol’ s benefits are greater than its risks for treatment of chronic hepatitis C, as part of a combination regimen with peginterferon alfa-2b (adults) including naïve patients with clinically stable HIV co-infection, or
Il- Kumitat għal Prodotti Mediċinali għal Użu tal- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Rebetol huma akbar mir- riskji tiegħu għat- trattament ta ’ pazjenti adulti b’ epatite Ċ kronika, bħala parti mir- reġimen ta ’ kumbinazzjoni ma ’ peginterferon alfa- 2b (adulti) inklużi pazjenti naive b’ ko -
interferon alfa-2b (adults, children of 3 years and older and adolescents).
infezzjoni b’ HIV klinikament stabbli, jew interferon alfa- 2b (adulti, tfal ta ’ 3 snin jew akabr u adolexxenti).
The Committee recommended that Rebetol be given marketing authorisation.
Il- Kumitat irrakkomanda li Rebetol jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Rebetol:
Tagħrif ieħor dwar Rebetol:
The European Commission granted a marketing authorisation valid throughout the European Union for Rebetol to SP Europe on 7 May 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Rebetol valida madwar l - Unjoni Ewropea kollha lil SP Europe fis- 7 ta ’ Mejju 1999.
The full EPAR for Rebetol is available here.
L- EPAR sħiħ għal Rebetol huwa disponibbli minn hawn.
Rebetol 200 mg hard capsules
Kapsuli ibsin ta ’ Rebetol ta ’ 200 mg
Each Rebetol capsule contains 200 mg of ribavirin.
Kull kapsula ta ’ Rebetol fiha 200 mg ta ’ ribavirin.
Rebetol contains 40 mg of lactose monohydrate.
Rebetol fih 40 mg ta ’ lactose monohydrate.
Hard capsule White, opaque and imprinted with blue ink.
Kapsula iebsa Bajda, opaka u ttimbrata b’ linka ċelesti.
Rebetol is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa-2b (adults) or interferon alfa-2b (adults, children (3-years of age or older), and adolescents).
Rebetol huwa indikat għall- kura ta ’ l- epatite C kronika u għandu jkun użat biss bħala parti mir- reġimen flimkien ma ’ peginterferon alfa- 2b (adulti) jew interferon alfa- 2b (adulti, tfal (3- snin jew akbar), u adolexxenti).
Rebetol monotherapy must not be used.
Monoterapija b’ Rebetol m’ għandhiex tintuża.
There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i. e., not alfa-2b), or on the use of Rebetol with peginterferon alfa-2b in children or adolescents.
M’ hemmx informazzjoni dwar is- sigurtà jew l- effikaċja dwar l- użu ta ’ Rebetol ma ’ xorta oħra ta ’ interferon (i. e., mhux alfa- 2b), jew fuq l- użu ta ’ Rebetol ma ’ peginterferon alfa- 2b fi tfal jew adolexxenti.
Please refer also to the peginterferon alfa-2b or interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.
Jekk jogħġbok irreferi wkoll għas- Sommarju tal- Karatteristiċi Tal- Prodott (SPC) ta ’ peginterferon alfa- 2b jew interferon alfa- 2b għall- informazzjoni dwar kif ikun preskritt dak il- prodott partikulari.