qanastek/EMEA-V3 huggingface dataset:
Patients should be advised that therapy with lamivudine has not been proven to reduce the risk of transmission of hepatitis B virus to others and therefore, appropriate precautions should still be taken.
15 Il- pazjenti għandhom ikunu avżati li ma hemm ebda prova li t- terapija b’ lamivudine tnaqqas ir- riskju li l- virus ta 'l- epatite B jiġi mgħoddi lill- oħrajn u għalhekk, għandhom jibqgħu jittieħdu prekawzjonijiet xierqa.
16 Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Pazjenti li minħabba problemi ereditarji rari, ma jaqbilx magħhom il- fructose, jew għandhom problema ta ’ assorbiment ta ’ glucose u galactose jew insuffiċjenza ta ’ sucrase- isomaltase, m’ għandhomx jieħdu din il- mediċina.
Diabetic patients should be advised that each dose of oral solution (100 mg = 20 ml) contains 4 g of sucrose.
Pazjenti dijabetiċi għandhom jiġu avżati li kull doża ta ’ soluzzjoni ti tittieħed mill- ħalq (100 mg = 20 ml) fiha 4 g ta ’ sucrose.
The oral solution contains propyl and methyl parahydroxybenzoate.
Is- soluzzjoni ti tittieħed mill- ħalq fiha propyl and methyl parahydroxybenzoate.
These products may cause an allergic reaction in some individuals.
Dawn il- prodotti jistgħu jikkawżaw reazzjoni allerġika f’ xi individwi.
This reaction may be delayed.
Din ir- reazzjoni tista ’ toħroġ iżjed tard.
The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal elimination of unchanged substance.
Il- probabilta 'ta' effetti ħżiena metaboliċi hi baxxa minħabba metaboliżmu limitat u t- tagħqid ta 'proteini tal- plażma u t- tneħħija kważi totali mill- kliewi ta' sustanzi li ma nbidlux.
Lamivudine is predominantly eliminated by active organic cationic secretion.
Lamivudine huwa fil- biċċa l- kbira eliminat bit- tnixxija katjonika organika attiva.
There were no observed clinically significant adverse interactions in patients taking lamivudine concurrently with commonly used immunosuppressant medicinal products (e. g. cyclosporin A).
Ma ġewx osservati xi interazzjonijiet kliniċi sostanzjalment ħżiena f' pazjenti li kienu qed jieħdu l- lamivudine flimkien ma 'prodotti mediċinali immunosuppressant li jintużaw ħafna (eż. cyclosporin A).
Although animal reproductive studies are not always predictive of the human response, administration is not recommended during the first three months of pregnancy (see section 4.4).
16 Għalkemm studji dwar ir- riproduttivita 'fl- annimali mhux dejjem ifissru l- istess effetti fil- bniedem, din il- mediċina mhix rakkomandata fl- ewwel tlett xhur tat- tqala (ara sezzjoni 4. 4).
Adverse reactions are listed below by system organ class and frequency.
Effetti aversi huma elenkati hawn taħt skond is- sistema, l- organu, il- klassi u l- frekwenza.
The frequency categories assigned to the adverse reactions below are estimates: for most events, suitable data for calculating incidence are not available.
Il- kategoriji ta 'frekwenza marbutin ma' reazzjonijiet aversi kif jidhru hawn taħt huma bażati fuq stima: għall- biċċa l- kbira ta ’ l- eventi, m' hawnx it- tagħrif meħtieġ għall- kalkolu ta 'inċidenzi.
Very common:
Disturbi fil- fwied u fil- marrara Komuni ħafna:
In patients with chronic hepatitis B there was no observed difference in incidence of these events between placebo and lamivudine treated patients.
F' pazjenti b- epatite B kronika ma ġietx notata xi differenza fl- inċidenza ta 'dawn il - każi bejn pazjenti li ħadu plaċebo u dawk li ħadu lamivudine.
4.9 Overdose
17 4. 9 Doza eċċessiva
If overdose occurs the patient should be monitored, and standard supportive treatment applied as required.
Fil- każ ta 'overdose il- pazjent għandu jiġi monitorjat, u jingħata trattament ta' sostenn kif meħtieġ.
Lamivudine is metabolised by both infected and uninfected cells to the triphosphate (TP) derivative which is the active form of the parent compound.
Lamivudine hu metabolizzat b 'ċelluli infettati jew mhux infettati lid- derivattiv trifosfat (TP) li huwa l - forma attiva tat- taħlita parentali.
Lamivudine-TP does not interfere with normal cellular deoxynucleotide metabolism.
Lamivudine- TP ma jfixkilx il- metaboliżmu deoxynucleotide ċellulari normali.
Experience in patients with HBeAg positive CHB and compensated liver disease: in controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication (34-57% of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ ml)], normalised ALT level (40-72% of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 16-18% of patients), improved histology (38-52% of patients had a ≥ 2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17% of patients) and progression to cirrhosis.
Esperjenza f’ pazjenti b’ CHB pożittiv għall- HbeAg u mard kumpensat tal- fwied: fi studji kontrollati ta 'pazjenti pożittivi għall- HbeAg, sena waħda ta' terapija b ’ lamivudine żammet sostanzjalment ir - replikazzjoni ta 'DNA tal- HBV {34- 57% ta' pazjenti, kellhom livelli taħt il- limiti li jitkejlu fl- assay (soluzzjoni Abbott Genostics hybridization assay, LLOD < 1. 6pg/ ml)}, ġiebet għan- normal il- livell ta 'ALT (40- 72% ta' pazjenti), ikkaġunat serokonverżjoni tal- HbeAg (telf ta 'DNA tal- HbeAg u skoperta ta' HbeAb b’ telf ta ’ HBV DNA [b’ assay konvenzjonali], 16- 18% ta 'pazjenti), tejjbet l- istoloġija (38 - 52% ta' pazjenti kellhom tnaqqis ta ’ ≥ 2 punti fil- Knodell Histologic Activity Index [HAI]) u naqqset l- avanz ta 'fibrożi (f’ 3- 17% ta ’ pazjenti u l- avanz għaċ- ċirrożi.
In an extended treatment study in Asian patients (NUCB3018) the HBeAg seroconversion rate and ALT normalisation rate at the end of the 5 year treatment period was 48% (28/ 58) and 47% (15/ 32), respectively.
18 Fi studju ta 'trattament fit- tul, f’ pazjenti Asjatiċi (NUCB3018), ir- rata totali ta' serokonverżjoni tal - HbeAg u r- rata ta 'normalizzazzjoni ta' l- ALT fl- aħħar tal- perjodu ta 'ħames snin trattament kienet ta ’ 48% (28/ 58) u 47% (15/ 32) rispettivament.
Further results from the trial by YMDD variant status are summarised in Table 2.
Tabella 2:
19 Subjects,% (no.)
Suġġetti,% (no.)
- - -
(13/ 18)
All patients Baseline ALT ≤ 1 x ULN2 Baseline ALT > 2 x ULN
- Il- pazjenti kollha - Linja bażi ALT ≤ 1 x ULN2
(15/ 40) (1/ 11) (9/ 15)
(15/ 40) 72 (1/ 11) 33
72 33 100
(9/ 15) 100
positive< baseline positive> baseline
pożittiv < linja bażi
- Week 260
Ġimgħa 260
1 Patients designated as YMDD variant were those with ≥ 5% YMDD variant HBV at any annual time-point during the 5-year period.
Pazjenti meqjusa bħala varjant YMDD kienu dawk b ’ ≥5% varjant YMDD tal- HBV f’ kwalunkwe sena tul il- perjodu 5 ta ’ ħames snin.
In a long-term follow-up study of patients who had previously seroconverted and discontinued lamivudine, late virological relapse occurred in 39% of the subjects.
F’ studju ta ’ tkomplija fit- tul ta ’ pazjenti li kellhom serokonverżjoni qabel u waqqfu l- lamivudine, 39% tas - 19 suġġetti marru lura viroloġikament wara żmien twil.
In patients followed for up to 16 weeks after discontinuation of treatment at one year, post-treatment ALT elevations were observed more frequently in patients who had received lamivudine than in patients who had received placebo.
F' pazjenti li baqgħu jiġu segwiti sa 16- il ġimgħa wara l- waqfien tat- trattament fl- ewwel sena, żidiet fil- livelli ta 'l- ALT ta' wara t- trattament kienu osservati iktar ta 'spiss f' pazjenti li kienu ħadu l - lamivudine milli dawk tal- plaċebo.
A comparison of post-treatment ALT elevations between weeks 52 and 68 in patients who discontinued lamivudine at week 52 and patients in the same studies who received placebo throughout the treatment course is shown in Table 3.
Paragun taż- żidiet fl- ALT ta ’ wara t- trattament bejn il- ġimgħa 52 u l- ġimgħa 68 f' pazjenti li ma baqgħux jieħdu l- lamivudine fil- ġimgħa 52 u pazjenti fl- istes studji li kienu ħadu plaċebo matul il- kors tat- trattament kollu jidher fit- Tabella 3.
20 Table 3:
Tabella 3:
> 500 IU/ l ALT ≥ 2 x baseline value; and bilirubin > 2 x ULN
> 500 IU/ L ALT ≥2 x valur linja bażi; u bilirubin > 2 x ULN
and ≥ 2 x baseline value *Each patient may be represented in one or more category. †
and ≥2 x valur linja bażi
In a double-blind study in CHB patients with YMDD variant HBV and compensated liver disease (NUC20904), with a reduced virological and biochemical response to lamivudine (n=95), the addition of adefovir dipivoxil 10 mg once daily to ongoing lamivudine 100mg for 52 weeks resulted in a median decrease in HBV DNA of 4.6 log10 copies/ ml compared to a median increase of 0.3 log10 copies/ ml in those patients receiving lamivudine monotherapy.
F’ studju double- blind f’ pazjenti b’ CHB bil- varjant YMDD tal- HBV u b’ mard kumpensat tal- fwied (NUC20904), b’ rispons viroloġiku u bijokimiku għal lamivudine mnaqqas (n=95), iż- żieda ta ’ adefovir dipivoxil 10 mg darba kuljum ma ’ terapija għaddeja ta ’ lamivudine 100mg għal 52 ġimgħa rriżulta f’ nuqqas medju fl- HBV DNA ta ’ 4. 6 log10 kopji/ ml meta komparat ma ’ żieda medja ta ’ 0. 3
Forty patients (HBeAg negative or HBeAg positive) with either decompensated liver disease or recurrent HBV following liver transplantation and YMDD variant were also enrolled into an open label arm of the study.
Erbgħajn pazjent (negattivi għal HBeAg jew pożittivi għal HBeAg) b’ mard mhux kumpensat tal- fwied jew b’ HBV li reġa ’ tfaċċa wara trapjant tal- fwied u bil- varjant YMDD daħlu wkoll f’ parti open label ta ’ l- istudju.
Improvement in liver function was also seen after one year of therapy.
Ntwera wkoll titjib fil- funzjoni tal- fwied wara sena ta ’ terapija.
Experience in patients with decompensated liver disease: placebo controlled studies have been regarded as inappropriate in patients with decompensated liver disease, and have not been undertaken.
Esperjenza f’ pazjenti b’ mard mhux kumpensat tal- fwied: studji kontrollati bi plaċebo ġew meqjusa mhux addattati għal pazjenti b' mard mhux kumpensat tal- fwied, u għalhekk ma sarux.
21 In non-controlled studies, where lamivudine was administered prior to and during transplantation, effective HBV DNA suppression and ALT normalisation was demonstrated.
Fi studji mhux kontrollati, meta l- lamivudine ingħata qabel u waqt trapjant, deher trażżin effettiv ta ’ HBV DNA u normalizzazzjoni ta 'ALT.
When lamivudine therapy was continued post transplantation there was reduced graft re-infection by HBV, increased HBsAg loss and on one-year survival rate of 76 – 100%.
Meta tkompliet il- kura bil- lamivudine wara trapjant kien hemm tnaqqis ta 're- infezzjoni tal- graft bl- HBV, żieda f' telf ta ’ HbsAg u fuq rata ta' sena ta 'sopravivenza ta ’ 76- 100%.
Experience in children and adolescents: lamivudine has been administered to children and adolescents with compensated CHB in a placebo controlled study of 286 patients aged 2 to 17 years.
Esperjenza fit- tfal u adolexxenti: lamivudine ingħata lil tfal u adolexxenti b' CHB kumpensata fi studju kontrollat bi plaċebo f' 286 pazjenti bejn is- sentejn u 17- il sena.
The incidence of YMDD variant HBV was similar to that observed in adults, ranging from 19% at week 52 up to 45% in patients treated continuously for 24 months.
L- inċidenza tal- varjant YMDD tal- HBV kienet simili għal dik osservata fl - adulti u kienet tvarja bejn 19% (31/ 166) fil- ġimgħa 52 sa 45% (53/ 118) f' pazjenti li baqgħu kontinwament fuq it- trattament għal 24 xahar.
Distribution:
21 Distribuzzjoni:
Limited data shows lamivudine penetrates the central nervous system and reaches the cerebro-spinal fluid (CSF).
Tagħrif limitat juri li lamivudine jidħol fis- sistema ċentrali nervuża u jilħaq il- fluwidu ċerebro- spinali (CSF).
The mean lamivudine CSF/ serum concentration ratio 2-4 hours after oral administration was approximately 0.12.
Il- proporzjon medju ta 'konċentrazzjoni ta' CSF/ serum ta 'lamivudine għal minn sagħtejn sa erba' siegħat wara li tittieħed kien bejn wieħed u ieħor ta '0. 12.
22 Elimination:
Tneħħija:
In elderly patients the pharmacokinetic profile of lamivudine suggests that normal ageing with accompanying renal decline has no clinically significant effect on lamivudine exposure, except in patients with creatinine clearance of < 50 ml/ min (see section 4.2).
F' pazjenti anzjani il- profil farmakokinetiku ta ’ lamivudine jindika li l- avanz fl- eta 'bin- nuqqas li jġib fil- funzjonament tal- kliewi m' għandux xi effett partikolari fuq l- esponiment ta ’ lamivudine, ħlief f' pazjenti bi tneħħija ta' kreatinin ta < 50 ml/ min (ara sezzjoni 4. 2).
Sucrose (20% w/ v) Methyl Parahydroxybenzoate (E218) Propyl Parahydroxybenzoate (E216) Citric Acid (anhydrous) Propylene Glycol Sodium Citrate Artificial strawberry flavour Artificial banana flavour Purified water
Sucrose (20% w/ v) Methyl Parahydroxybenzoate (E218) Propyl Parahydroxybenzoate (E216) Citric Acid (anhydrous) Propylene Glycol Sodium Citrate Ingredjent artifiċjali b’ togħma tal- frawli Ingredjent artifiċjali b’ togħma tal- banana Ilma ppurifikat
1 month
Wara li jinfetaħ il- kontenitur għall- ewwel darba: xahar
Do not store above 25 ºC.
Taħżinx f' temperatura 'l fuq minn 25°C
Cartons containing 240 ml lamivudine oral solution 5 mg/ ml in an opaque, white, high-density polyethylene (HDPE) Bottle with a polypropylene child resistant closure.
Kaxxa tal- kartun li fiha flixkun abjad u opak magħmul minn polyethylene ta ’ densita ’ għolja (HDPE), b’ għatu tal- polypropylene li ma jinfetaħx mit- tfal.
The pack includes a clear polypropylene oral dosing syringe and a polyethylene syringe-adapter.
Fil- pakkett hemm ukoll siringa ċara tal - polypropylene biex tkejjel id- doża li tittieħed mill- ħalq, u adapter tal- polyethylene li tintuża mas - siringa.
The oral dosing syringe is provided for accurate measurement of the prescribed dose of oral solution.
Siringa biex tkejjel id- doża tas- soluzzjoni li tittieħed mill- ħalq, b’ mod preċiż u skond ir- riċetta medika hija pprovduta.
Instructions for use are included in the pack.
Struzzjonijiet għall- użu jinsabu fil- pakkett.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION 24 Date of first authorisation:
Data ta ’ l- ewwel awtorizzazzjoni:
25 ANNEX II
24 ANNESS II
Glaxo Wellcome Operations Priory Street, Ware Hertfordshire SG12 0DJ United Kingdom.
Glaxo Wellcome Operations Priory Street, Ware Hertfordshire SG12 0DJ Renju Unit
KG Industriestrasse 32-36 23843 Bad Oldesloe Germany
KG Industriestrasse 32- 36 23843 Bad Oldesloe Ġermanja
Not applicable.
26 ANNESS III
LABELLING
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
28 tablet box
IL- KARTUNA TA ’ BARRA GĦALL- PILLOLI: kaxxa ta '28 pillola
Zeffix 100 mg film-coated tablets Lamivudine
Zeffix 100 mg pilloli miksijin b’ rita Lamivudine
Each film-coated tablet contains lamivudine 100 mg
Kull pillola miksija b’ rita fiha 100 mg lamivudine
28 film-coated tablets
28 pilloli miksija b’ rita
Oral use
Għal użu mill- ħalq
Do not store above 30°C
Taħżinx f’ temperatura ‘ l- fuq minn 30°C
Zeffix 100 mg
Zeffix 100mg
28 tablet box
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI: kaxxa ta '28 pillola
Zeffix 100 mg tablets Lamivudine
Pilloli Zeffix 100 mg Lamivudine
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
84 tablet box
KARTUNA TA ’ BARRA GĦALL- PILLOLI; kaxxa ta ’ 84 pillola
84 film-coated tablets
84 pilloli miksijin b’ rita
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEGA
Do not store above 30°C
Taħżinx f' temperatura ‘ l- fuq minn 30°C
84 tablet box
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI: kaxxa ta '84 pillola
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON FOR ORAL SOLUTION
KARTUNA TA 'BARRA GĦAS- SOLUZZJONI LI TITTIEĦED MILL- ĦALQ
Zeffix 5 mg/ ml oral solution Lamivudine
Zeffix soluzzjoni ta '5 mg/ ml li tittieħed mill- ħalq Lamivudine
240 ml oral solution containing 5 mg/ ml lamivudine
Soluzzjoni li tittieħed mill- ħalq 240 ml li fiha 5 mg/ ml lamivudine
Contains amongst others: sugar (sucrose), preservatives: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
Fih fost oħrajn Zokkor (sucrose), priservattivi: methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216)
Oral use
Tittieħed mill- ħalq
Do not store above 25°C
Taħżinx f' temperatura ogħla minn 25°C Armih wara xahar li jkun infetaħ
Zeffix 5 mg/ ml
Zeffix 5mg/ mL
37 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR ORAL SOLUTION
TIKKETA TA 'FUQ IL- FLIXKUN GĦAS- SOLUZZJONI LI TITTIEĦED MILL- ĦALQ
Contents 240 ml oral solution containing 5 mg/ ml lamivudine
Soluzzjoni li tittieħed mill- ħalq 240 ml li fiha 5 mg/ ml lamivudine
Contains amongst others: sugar (sucrose), and preservatives: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
Fih fost oħrajn Zokkor (sucrose), priservattivi: methyl parahydroxybenzoate (E 218) u propyl parahydroxybenzoate (E216)
INSTRUCTIONS ON USE
FULJETT TA ’ TAGĦRIF
PACKAGE LEAFLET
39 FULJETT TA ’ TAGĦRIF:
It may harm them even if
Tista ’ tagħmlilhom il- ħsara,
their symptoms are the same as yours.
anki jekk ikollom l- istess sintomi bħal tiegħek.
What Zeffix is and what it is used for 2.
X’ inhu Zeffix u għalxiex jintuża 2.
Before you take Zeffix 3.
Qabel ma ’ tieħu Zeffix 3.
How to take Zeffix 4.
Kif għandek tieħu Żeffix 4.
How to store Zeffix 6.
Kif taħżen Zeffix 6.
WHAT ZEFFIX IS AND WHAT IT IS USED FOR
X’ INHU ZEFFIX U GĦALXIEX JINTUŻA
Zeffix belongs to a group of medicines called antivirals.
Zeffix huwa wieħed minn grupp ta 'mediċini msejħa antivirali.
It is used for the treatment of hepatitis B virus infection.
Jintuża għall- kura ta 'infezzjoni bil - virus ta' l- epatite B.
Zeffix is used to treat patients 18 years of age or over with long term (chronic) hepatitis B.
Zeffix jintuża għall- kura 'ta' pazjenti 'l fuq minn 18- il sena li jsofru mill- epatite B kronika (fit- tul).
Hepatitis B is a virus which infects the liver, and leads to liver damage.
L 'Epatite B hu virus li jinfetta l- fwied, u jwassal għal ħsara fil- fwied.
Treatment with Zeffix can reduce the amount of hepatitis B virus in your body.
Il- kura b’ Zeffix tista 'twassal għal tnaqqis tal- virus ta' l- epatite B minn ġo fik.
This should lead to a reduction in liver damage and an improvement in your liver function.
Dan għandu jwassal għal tnaqqis ta 'ħsara fil- fwied u titjib fil- funzjoni tal- fwied.
BEFORE YOU TAKE ZEFFIX
QABEL MA ’ TIEĦU ZEFFIX
Do not take Zeffix:
Tieħux Zeffix:
• if you are allergic (hypersensitive) to lamivudine or to any of the other ingredients of Zeffix.
• jekk inti allerġiku (tbagħti minn sensittività eċċessiva) għal lamivudine jew sustanzi oħra ta ’ Zeffix
If you are not sure please consult your doctor.
Jekk għandek xi dubju tkellem mat- tabib tiegħek
Take special care with Zeffix
Oqgħod attent ħafna b’ Zeffix
Zeffix reduces the amount of hepatitis B virus in your body, and keeps the liver disease under control, therefore reducing health problems relating to your liver in the future.
Zeffix inaqqas l- ammonti ta 'virus ta' l- epatite B minn ġo fik, u jikkontrollalek il- marda fil- fwied, u għalhekk inaqqaslek mill- problemi ta 'saħħtek li għandhom x' jaqsmu mal- fwied.
For effective treatment you will need to take Zeffix every day.
Biex jaħdem sew ikollok bżonn tieħu Zeffix kuljum.
Patients respond to the treatment differently, therefore it is not known for how long you will have to take this medicine.
Mhux kulħadd jirrispondi bl- istess mod għall- kura, għalhekk wieħed ma jistax ikun jaf kemm se jdum bil- bżonn li jieħu din il- mediċina.
Your doctor will be checking your response to treatment by taking regular blood samples.
It- tabib tiegħek jibqa 'jiċċekkja dwar l- effett ta' din il- kura billi regolarment jieħu kampjuni tad- demm.
The results of these tests will help your doctor to decide when your treatment with Zeffix can be stopped.
Ir- riżultati ta 'dawn it- testijiet jgħini lit- tabib biex jiddeċiedi meta jista' jwaqqaflek it- trattament ta ’ Zeffix.
Before treatment with Zeffix you should have discussed any additional medical problems that you have with your doctor.
Qabel tieħu Zeffix, int mistenni li tkun tkellimt mat- tabib tiegħek dwar xi problemi oħra ta 'saħħtek.
If you have kidney disease the dose of this medicine may have to be reduced, as it is your kidneys that are mainly responsible for getting rid of the medicine from your body.
Jekk ikollok xi mard tal- kliewi id- doża ta 'din il- mediċina jista' jkun li titnaqqas, għaliex huma l- kliewi
Zeffix is available as an oral solution.
Zeffix jista 'wkoll jittieħed bħala soluzzjoni mill- ħalq.
This means that your doctor can prescribe a lower dose for you if necessary.
Dan ifisser li t- tabib tiegħek jista ', jekk hemm bżonn, jippreskrivilek doża inqas.
41 Do not stop taking Zeffix without instruction from your doctor, as there is a small risk of your hepatitis getting worse.
Tieqafx tieħu Zeffix jekk ma jgħidlekx it- tabib, għax tista 'tirriskja li l- marda tiegħek ta' l- epatite B tmurlek għall- agħar.
When you stop taking Zeffix your doctor will monitor you for at least the following four months to check for any problems.
Meta tieqaf tieħu Zeffix jibqa 'jimmonitorjak mill- aqnqas gġal erba' xhur biex jara jkunx hemm xi problemi.
This will mean taking blood samples to check for any abnormal liver enzymes, indicating liver damage.
Dan ifisser li jkollu jeħodlok kampjuni tad- demm biex jiċċekkja dwar enżimi mhux normali fil- fwied li jindikaw xi mard fil- fwied.
The active substance in Zeffix is lamivudine.
Is- sustanza attiva f’ Zeffix hi lamivudine.
If you are already taking this medicinal product for HIV infection, your doctor will continue to treat you with the higher dose, usually 150 mg twice a day, as the lower dose of 100 mg lamivudine is insufficient to treat HIV infection.
Jekk diġa 'qed tieħu din is- sustanza attiva għal xi infezzjoni ta' l- HIV, it- tabib jibqa 'jtik id- doża għolja, ġeneralment 150 gm darbtejn kuljum billi d- doża l- baxxa ta' 100 mg lamivudine mhijiex biżżejjed biex tikkura infezzjoni ta 'HIV.
Because your medicine helps to control your hepatitis B and it is not yet known whether it will cure it, you are still at risk of transmitting this virus to others through sexual contact or by blood transfer, and you should use appropriate precautions to prevent this.
Billi l- mediċina tiegħek tgħin biex tikkontrollalek l- epatite B waqt li ma tkunx ċert li se tfejqek minnha, tibqa fir- riskju li dan il- virus tgħaddih lil ħaddieħor permezz ta 'xi kuntatt sesswali jew b' xi tiċpis mid- demm, u int għandek tieħu l- prekawzjonijiet xierqa biex dan ma jiġrix.
There is an effective vaccine available to protect those at risk from becoming infected with hepatitis B virus.
Hawn tilqima effettiva biex tipproteġi lil dawk f' riskju li jiġu nfettati bil- virus ta 'l- epatite B.
Taking other medicines Some medicines may affect the action of Zeffix.
Meta tieħu mediċini oħra Xi mediċini oħra jistgħu jkollhom effett fuq l- azzjoni ta ’ Zeffix.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill - ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Zeffix should not be taken with zalcitabine.
Zeffix m’ għandux jittieħed ma ’ zalcitabine.
Taking Zeffix with food and drink Zeffix can be taken with food or on an empty stomach.
Meta tieħu Zeffix ma ’ l- ikel u x- xorb Zeffix jista jittieħed ma 'l- ikel u anki fuq stonku vojt.
Tell your doctor if you are pregnant, or are planning to become pregnant, or if you are breast-feeding.
Għid lit- tabib tiegħek jekk int tqila, jew li qed tippjana biex toħroġ tqila, jew jekk qed tredda '.
Your doctor will advise whether you should continue to take Zeffix while you are pregnant.
It- tabib itik parir jekk għandekx tkompli tieħu Zeffix waqt it- tqala.
Do not stop treatment with Zeffix without your doctor’ s advice.
Twaqqafx Zeffix bla ma tgħid lit- tabib.
Since lamivudine and the virus pass into breast milk it is recommended that mothers taking Zeffix do not breast-feed their infants.
Peress li lamivudine u l- virus jidħlu fil- ħalib ta 'l- omm huwa rakkomandat li l- ommijiet li qed jieħdu Zeffix ma jreddgħux lit- trabi tagħhom.
Driving and using machines No studies on the effect of Zeffix on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effett ta ’ Zeffix fuq l- abilta 'biex issuq jew tħaddem xi makkinarju.
HOW TO TAKE ZEFFIX
KIF GĦANDEK TIEĦU ZEFFIX
Always takeZeffix exactly as your doctor has told you.
Dejjem għandek tieħu Zeffix skond il- parir tat- tabib.
The recommended dose of Zeffix is one tablet (100 mg lamivudine) once a day.
Id- doża ta 'Zeffix li ssoltu tingħata hija pillola waħda (100 mg lamivudune) darba kuljum.
The tablet should be swallowed whole with water.
Il- pillola trid tinbela 'sħiħa ma' l- ilma.
It can be taken with food or on an empty stomach.
Tista tittieħed ma 'l- ikel jew fuq stonku vojt.
Your doctor will advise you on how long you will need to take the medicine for.
It- tabib tiegħek jgħidlek hu kemm għandek iddum tieħu din il- mediċina.
Your doctor may need to reduce your dose of Zeffix if you have kidney problems.
It- tabib jista 'jġoss li għandu jnaqqaslek id- doża ta' Zeffix jekk ikollok xi problemi tal- kliewi.
It may be necessary for you to take an oral solution instead of tablets so that the dose of your medicine can be accurately reduced.
Jista 'jkollok bżonn tieħu t- taħlita likwida flok il- pilloli biex b' hekk tonqoslok bl- eżatt id- doża li għandek tieħu.
42 If you take more Zeffix than you should Accidentally taking too much of your medicine is unlikely to cause any serious problems.
Jekk bi żball tieħu aktar mediċina milli għandek bżonn mhux probabbli li se joħloqlok xi problemi serji.
However, you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Biss għandek tgħid b' dan lit- tabib jew lill- ispiżjar, jew tinforma lill- emerġenza ta 'xi sptar qrib għal xi parir li tkun teħtieġ.
If you forget to take Zeffix If you forget to take your medicine, take it as soon as you remember and then continue to take it as instructed.
Jekk tinsa tieħu l- mediċina, hudħa malli tiftakar u mbagħad kompli hudha skond il- parir li għandek.
Do not take a double dose to make up for forgotten individual doses.
M' għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop taking Zeffix You must not stop taking Zeffix without consulting your doctor.
Jekk tieqaf tieħu Zeffix M’ għandekx tieqaf tieħu Zeffix mingħajr ma tgħid lit- tabib tiegħek.
If you have any further questions on the use of this product, ask you doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqst lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Zeffix can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Zeffix jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In clinical trials, the number and type of side effects reported in patients taking Zeffix were generally similar to those reported in patients taking an inactive substance (placebo).
Fi provi kliniċi, n- numru u t- tip ta 'effetti sekondarji rappurtati f' pazjenti fuq Zeffix kienu jixbħu dawk rappurtati f' pazjenti fuq sustanza mhux attiva (plaċebo).
The most commonly reported were tiredness, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea.
L- aktar li ġew rappurtati kienu għeja, infezzjonijiet fl- apparat respiratorju, uġigħ ħafif tal- griżmejn, uġigħ ta 'ras, uġigħ fl- istonku u uġigħ, dardir, rimettar u dijarea.
However, increases in liver enzymes and enzymes produced in the muscles were sometimes more commonly reported in patients taking Zeffix (see below).
Madankollu, żidied fl- enżimi tal- fwied u fl- enżimi prodotti mill- muskoli ġew rappurtati xi drabi aktar komunement f’ pazjenti fuq Zeffix (ara hawn taħt).
Side effects thought to be caused by Zeffix are listed below:
Effetti sekondarji maħsuba li huma kawżati minn Zeffix huma msemmija hawn taħt:
Very common side effects (in more than 10 in 100 patients)
Effetti sekondarji komuni ħafna (f’ aktar minn 10 pazjenti minn kull 100)
Increases in enzymes produced by the liver called transaminases
Żidied fl- enżimi prodotti mill- fwied li jissejjħu transaminases
Common side effects (in more than 1 in 100 patients)
Effetti sekondarji komuni (f’ aktar minn pazjent 1 minn kull 100)
Increases in an enzyme called creatine phosphokinase produced in the muscles
Żieda f’ enżima prodotta fil- muskolu li tissejjaħ creatine phosphokinase
side effects (in less than 1 in 10,000 patients)
Effetti sekondarji rari ħafna (f’ anqas minn pazjent 1 minn kull 10, 000)
Reductions in platelets, blood cells important for blood clotting.
Tnaqqis ta 'platelets, ċelluli tad- demm importanti għat- tagħqid tad- demm).
If you have a low platelet count you may notice you bruise more easily
Jekk ikollok livell baxx ta 'platelets tista tinnota li titbenġel aktar faċli.
Cramps, muscle pains and breakdown of muscle Marked worsening of liver disease after Zeffix is stopped or during treatment if resistance develops.
Bugħawwieġ, uġigħ fil- muskolu u ħsara fil- muskolu Il- mard tal- fwied imur għall- agħar wara li jitwaqqaf Zeffix jew waqt it- trattament jekk tiżviluppa reżistenza.
This can be fatal in some patients.
F’ xi pazjenti dan jista ’ jikkawża l- mewt.
Some people may be allergic to medicines.
Xi wħud huma allerġiċi għall- mediċini.
If you have any of the following symptoms soon after taking Zeffix STOP taking the medicine and tell your doctor immediately:
Jekk ikollok xi sintomi bħal dawn li ġejjin ftit wara li tieħu Zeffix IEQAF mill- ewwel u għid lit- tabib mill- ewwel:
* Sudden wheeziness and chest pain or tightening. * Swelling of eyelids, face or lips. * Skin rash or ‘hives’ anywhere on the body.
* Tħarħir f' salt u uġigħ fis- sider jew tagħfis. * Infih fl- għajnejn, fil- wiċċ jew fix- xofftejn * Raxx fil- ġilda jew urtikarja fil- ġisem ikun fejn ikun.
HOW TO STORE ZEFFIX
KIF TAĦŻEN ZEFFIX
Do not store above 30 °C.
Taħżnux f' temperatura 'l fuq minn 30°C
Do not use Zeffix after the expiry date which is stated on the tablet carton and blister pack..
Tużax Zeffix wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- pilloli u fuq l- istrixxi.
Medicines should not be disposed of via wastewater or household waste.
42 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Zeffix contains
X’ fih Zeffix
The active substance is lamivudine.
Is- sustanza attiva hija lamivudine.
Each film-coated tablet contains 100 mg of lamivudine.
Kull pillola miksija b’ rita fiha 100 mg lamivudine.
The other ingredients are: microcrystalline cellulose, sodium starch glycollate, magnesium stearate, hypromellose, titanium dioxide, macrogol 400, polysorbate 80, synthetic yellow and red iron oxide.
Is- sustanzi l- oħra huma: microcrystalline cellulose, sodium starch glycollate, magnesium stearate, hypromellose, titanium dioxide, macrogol 400, polysorbate 80, synthetic yellow u red iron oxide.
What Zeffix looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
Zeffix film-coated tablets are supplied in tamper evident foil blister packs containing 28 or 84 tablets.
Il- pilloli Zeffix miksijin b’ rita jinbiegħu fi folji li juru jekk ikunu mimsusin u li jkun fihom 28 jew 84 pillola.
The tablets are butterscotch coloured, capsule shaped, biconvex and engraved “GX CG5” on one face.
Għandhom forma ta 'kapsula u ta' lewn butterscotch, ibbuzati fuq iż- żewġ naħat u mnaqqxa bi “ GX CG5 ” fuq naħa waħda.
Glaxo Wellcome Operations Priory Street Ware Herts SG12 0DJ United Kingdom
Glaxo Wellcome Operations Priory Street Ware Herts SG 12 0DJ Renju Unit
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
43 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
Ísland GlaxoSmithKline ehf.
44 Ísland GlaxoSmithKline ehf.
This leaflet was approved on
Dan il- fuljett kien approvat fil -
46 PACKAGE LEAFLET:
45 FULJETT TA ’ TAGĦRIF:
Zeffix 5 mg/ml oral solution Lamivudine
Zeffix 5 mg/ ml Soluzzjoni li tittieħed mill- ħalq Lamivudine
- If you have further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not take Zeffix: • if you are allergic (hypersensitive) to lamivudine or to any of the other ingredients of Zeffix.
• jekk inti allerġiku (tbagħti minn sensittività eċċessiva) għal lamivudine jew sustanzi oħra ta ’ Zeffix
If you are not sure please consult your doctor
Jekk għandek xi dubju tkellem mat- tabib tiegħek
Your doctor will advise you on the correct dose of Zeffix to take if required.
Dan ifisser li t- tabib tiegħek jista ', jekk hemm bżonn, jippreskrivilek doża inqas.
47 Do not stop taking Zeffix without instruction from your doctor, as there is a small risk of your hepatitis getting worse.
Tieqafx tieħu Zeffix jekk ma jgħidlekx it- tabib, għax tista 'tirriskja li l- marda tiegħek ta' l- epatite B tmurlek għall- agħar.
If you are already taking this medicinal product for HIV infection, your doctor will continue to treat you with the higher dose, usually 150 mg twice a day, as the lower dose of 100 mg of lamivudine is insufficient to treat HIV infection.
Jekk diġa 'qed tieħu din is- sustanza attiva għal xi infezzjoni ta' l- HIV, it- tabib jibqa 'jtik id- doża għolja, ġeneralment 150 gm darbtejn kuljum billi d- doża l- baxxa ta' 100 mg lamivudine mhijiex biżżejjed biex tikkura infezzjoni ta 'HIV.
If you are a diabetic, please note that each dose of Zeffix (100 mg = 20 ml) contains 4 g sugar.
Jekk tbati bid- dijabete, ftakar li kull doża ta 'Zeffix (100 mg=20 ml) fiha 4 g zokkor.
Zeffix can be taken with food or on an empty stomach.
Meta tieħu Zeffix ma ’ l- ikel u x- xorb Zeffix jista jittieħed ma 'l- ikel u anki fuq stonku vojt.
Do not stop treatment with Zeffix without your doctor’s advice.
Twaqqafx Zeffix bla ma tgħid lit- tabib.
Important information about ingredients of Zeffix oral solution This medicine contains preservatives (propyl parahydroxybenzoate:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Zeffix soluzzjoni li tittieħed mill- ħalq Din il- mediċina fiha priservattivi (propyl parahydroxybenzoate:
E216 and methyl parahydroxybenzoate:
E216 and methyl parahydroxybenzoate:
E218) which may cause allergic reactions (possibly delayed).
E218) li jistgħu jikkawzaw reazzjonijiet allerġiċi (li jistgħu joħorġu aktar tard).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek għallek li xi tip ta ’ zokkor ma jaqbilx miegħek, għid lit- tabib tiegħek qabel ma tieħu din il- mediċina.
Sucrose may be harmful to the teeth.
Sucrose jista ’ jagħmel ħsara fis- snien.
Always take Zeffix exactly as your doctor has told you.
Dejjem għandek tieħu Zeffix skond il- parir tat- tabib.
The recommended dose of Zeffix is 20 ml (100 mg lamivudine) once a day.
Id- doża ta 'Zeffix li ssoltu tingħata hija hi 20 ml (100 mg lamivudune) darba kuljum.
Your doctor may need to reduce your dose of Zeffix if you have kidney problems.
It- tabib jista 'jħoss li għandu jnaqqaslek id- doża ta' Zeffix jekk ikollok xi problemi tal- kliewi.
48 To measure your dose of medicine accurately use the oral dosing syringe supplied with the pack as follows:
47 Biex tkejjel id- doża eżatta tal- mediċina uża s- siringa tad- dożaġġ bil- ħalq li jkun hemm mal- pakkett kif ġej:
Remove the bottle cap 2.
Neħħi t- tapp tal- flixkun 2.
Push the plastic adapter into the neck of the bottle, while holding the bottle firmly 3.
Daħħal l- adapter tal- plastik f' għonq il- flixkun waqt li żżomm sod il- flixkun 3.
Insert the syringe firmly into the adapter 4.
Deffes sew is- siringa fl- adapter 4.
Turn the bottle upside down 5.
Aqleb il- flixkun rasu 'l isfel 5.
Pull out syringe plunger until the first portion of your full dose is withdrawn 6.
Oħroġ il- planġer tas- siringa sakemm tkun ġbidt l- ewwel porzjon tad- doża sħiħa 6.
Turn the bottle the correct way up and remove the syringe from the adapter 7.
Erġa dawwar il- flixkun f' postu u neħħi s- siringa mill- adapter 7.
Administer the dose into the mouth by placing the tip of the syringe against the inside of the cheek.
Poġġi d- doża f’ ħalqek billi t’ poġġi t- tarf tas- siringa man- naħa ta ’ ġewwa tal- ħadd.
Slowly depress the plunger, allowing time to swallow.
Għafas il - planġer bil- mod, biex tagħti ċans li tibla.
Forceful squirting to the back of the throat may cause choking.
Jekk tgħafas bil- goff lejn in- naħa ta ’ wara tal- gerżuma tista tifga.
Repeat steps 3 to 7 in the same way until you have taken the whole dose 9.
Irrepeti punt 3 sa 7 bl- istess mod sakemm tkun ħadt id- doża sħiħa 9.
After use the syringe must not be left in the bottle.
Wara l- użu s- siringa m’ għandiex titħalla fil- flixkun.
Take off the syringe and adapter and wash them thoroughly in clean water.
Neħħi s- siringa u l- adapter u aħsilhom sew fl- ilma nadif.
Let them dry completely before you use them again.
Ħallihom jinxfu kompletament qabel ma terġa ’ tużahom.
Replace and tighten the bottle cap
Erġa 'qiegħed it- tapp u għalqu sew.
If you take more Zeffix than you should Accidentally taking too much of your medicine is unlikely to cause any serious problems.
Jekk bi żball tieħu aktar mediċina milli għandek bżonn mhux probabbli li se joħloqlok xi problemi serji.
Very Rare side effects (in less than 1 in 10,000 patients)
Effetti sekondarji rari ħafna (f’ anqas minn pazjent 1 minn kull 10, 000)
Cramps, muscle pains and breakdown of muscle
Bugħawwieġ, uġigħ fil- muskolu u ħsara fil- muskolu
Marked worsening of liver disease after Zeffix is stopped or during treatment if resistance develops.
Il- mard tal- fwied imur għall- agħar wara li jitwaqqaf Zeffix jew waqt it- trattament jekk tiżviluppa reżistenza.
Do not store above 25 °C.
Taħżnux f' temperatura 'l fuq minn 25°C
Discard one month after first opening.
Armih xahar wara li jkun infetah
Do not use Zeffix after the expiry date which is stated on the bottle and the carton.
Tużax Zeffix wara d- data ta ’ skadenza li tidher fuq il- flixkun u fuq il- kartuna.
Each ml of oral solution contains 5 mg of lamivudine.
Kull ml ta ’ soluzzjoni li tittieħed mill- ħalq fiha 5mg ta ’ lamivudine.
Sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid, propylene glycol, sodium citrate, artificial strawberry flavour, artificial banana flavour, purified water.
Sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid, propylene glycol, sodium citrate, it- togħma ta 'frawli/ banana, ilma purifikat.
Zeffix oral solution is supplied in tamper evident cartons containing a white polyethylene bottle, with a child resistant cap.
Is- soluzzjoni Zeffix tinbiegħ f' kartuniet li juru jekk mimsusin li jkun fihom flixkun abjad tal - polyethylene, b' tapp li ma jistgħux jiftħuh it- tfal.
The solution is clear, colourless to pale yellow in colour with strawberry/banana flavouring.
Is- soluzzjoni hi ċara, bla kulur jew ta 'lewn safrani ċar b' togħma ta' frawli/ banana.
The bottle contains 240 ml of lamivudine solution (5 mg/ml).
Il- flixkun ikun fih 240 ml tas- soluzzjoni ta ’ lamivudine (5 mg/ ml).
The pack includes an oral dosing syringe and a syringe-adapter for the bottle.
Il - pakkett ikun fih siringa għal dożaġġ bil- ħalq u syringe- adapter għall- flixkun.
KG Industriestrasse 32-36 23843 Bad Oldesloe Germany
KG Industriestrasse 32- 36 23843 Bad Oldesloe Germany
50 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
49 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
ZENAPAX
at ZENAPAX
ed EPAR summary for the public
izz Sommarju ta ’ l- EPAR għall- pubbliku
s ori This document is a summary of the European Public Assessment Report (EPAR).
tor Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you want more
aw Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew spiżjar tiegħek Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll
ra information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
ux parti mill- EPAR).
What is Zenapax?
ad X’ inhu Zenapax?
Zenapax is a concentrate to be made up into a solution for infusion (drip lon active substance daclizumab (5 mg/ ml).
Fih is- sustanza attiva ’ g ħ daclizumab (5 mg/ ml).
What is Zenapax used for?
Għal xiex jintuża Zenapax? im
It is used together no
Zenapax jintuża biex jimpedixxi l- ġisem milli jirrifjuta kilwa ftit wara trapjant.
with other immunosuppressive (anti-rejection) medicines including ciclosporin and corticosteroids.
Huwa jintuża flimkien ma ’ mediċini immunosoppressivi (kontra l- irrifjutar) oħra inklużi ciclosporin u kortikosterojdi.
It is used in patients who do not have high levels of antibodies against ‘ foreign’ cells from other people.
Huwa jintuża f’ pazjenti li m’ għandhomx livelli għoljin ta ’ antikorpi kontra ċelloli ‘ barranin ’ minn nies oħra.
These antibodies can develop following blood transfusion, pregnancy or previous organ t
Dawn l- antikorpi jistgħu jiżviluppaw wara trasfużjoni tad- demm, tqala jew trapjant ta ’ organi li l
transplantation. uc
preċedenti. na
How is Zenapax used? rod
Kif jintuża Zenapax?
Zenapax should only be prescribed and given by doctors who have experience in the use of immunosuppressive treatment following organ transplant.
kura immunosoppressiva wara trapjant ta ’ l- organi.
The recommended dose for adults and children is 1 mg per kilogram body weight, diluted in 50 ml sterile saline solution and given over 15 lp
Id- doża irrikkmandata għal adulti u tfal hija 1 mg għal kull kilogramm piż korporju, dilwit f’ 50 ml soluzzjoni ta ’ salina sterili u mogħti fuq 15- il minuta.
The first infusion is given in the 24 hours before transplantation.
L- ewwel infużjoni tingħata fl- 24 siegħa ta ’ qabel it- trapjant.
The subsequent doses should be given every 14 days for a total of five doses. na
kull 14- il jum għal total ta ’ ħames dożi. me
How does Zenapax work?
Kif jaħdem Zenapax?
The active substance in Zenapax, daclizumab, is a monoclonal antibody.
Is- sustanza attiva f’ Zenapax, daclizumab, hija antikorp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called i dic
Antikorp monoklonali huwa antikorp (tip ta ’ proteina) li ġie iddisinnjat biex jagħraf u jorbot ma ’ struttura speċifika (imsejħa ott
an antigen) that is found on certain cells in the body.
antiġen) li tinsab fuq ċerti ċelloli fil- ġisem.
Daclizumab has been designed to bind to the receptor for interleukin-2 on the surface of white blood cells called T-lymphocytes.
Daclizumab ġie iddisinnjat biex jorbot mar- riċettur għal interleukin- 2 fuq il- wiċċ ta ’ ċelloli tad- demm bojod imsejjħa limfoċiti- T.
These cells are involved in recognising ‘ foreign’ cells and rejecting transplanted organs.
Dawn iċ- ċelloli huma involuti f’ li jagħrfu ċelloli ‘ barranin ’ u jirrifjutaw organi trapjantati.
By binding to and blocking Me
Billi jorbot u jimblokka r- riċettur, od
How has Zenapax been studied?
Kif ġie studjat Zenapax?
Zenapax has been studied in two main studies involving a total of 535 adults undergoing kidney transplant.
Zenapax ġie studjat f’ żewġ studji ewlenin li jinvolvu total ta ’ 535 adult li se jsirilhom trapjant tal - kilwa.
Both studies compared the effects of adding Zenapax or placebo (a dummy treatment) to other immunosuppressive medicines.
Iż- żewġ studji qabblu l- effetti taż- żieda ta ’ Zenapax jew plaċebo (kura finta) ma ’ mediċini immunosoppressivi oħra.
In the first study, the patients were receiving ciclosporin and prednisone (a corticosteroid), and in the second study, they were receiving ciclosporin, prednisone and
Il- miżura
The main measure of effectiveness was the proportion of patients who experienced rejection of the transplanted kidney in the first six months after the transplant.
(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 ewlenija ta ’ effikaċja kienet il- proporzjon ta ’ pazjenti li esperjenzaw irrifjutar tal- kilwa trapjantata fl - ewwel sitt xhur wara t- trapjant.
A further study looked at rejection rates in 60 children aged between five and 18 years who were undergoing a kidney transplant.
Studju ieħor ħares lejn ir- rati ta ’ irrifjutar f’ 60 tifel u tifla ta ’ etajiet bejn ħamsa u tmintax- il sena li kien qed isirilhom trapjant ta ’ kilwa.
In this study, Zenapax was added to the children ’ s existing immunosuppressive medicines.
F’ dan l- istudju, Zenapax kien miżjud mal- mediċini immunosoppressivi diġà eżistenti tat- tfal.
What benefit has Zenapax shown during the studies?
X’ benefiċċju wera Zenapax waqt l- istudji?
Zenapax was more effective than placebo in reducing the rate of rejection when added to immunosuppressive therapy.
Zenapax kien aktar effettiv minn plaċebo f’ li jnaqqas ir- rata ta ’ irrifjutar meta miżjud ma ’ terapija
ed In the first study, 28 (22%) of the 126 adults adding Zenapax to ciclosporin and prednisone experienced rejection, compared with 47 (35%) of the 134 adding placebo.
Fl- ewwel studju, 28 (22%) mill- 126- il adult li żiedu Zenapax ma ’ ciclosporin u prednisone
In the second study, 39 (28%) of the 141 adults adding Zenapax to ciclosporin, prednisone and
izz esperjenzaw irrifjutar, imqabbla ma ’ 47 (35%) tal- 134 li żiedu plaċebo.
s azathioprine experienced rejection of the kidney, compared with 63 (47%) of the 134 adding placebo.
Fit- tieni studju, 39 (28%) mill- 141 adult li żiedu Zenapax ma ’ ciclosporin, prednisone u azathioprine esperjenzaw irrifjutar tal- kilwa, meta mqabbla ma ’ 63 (47%) mill- 134 li żiedu plaċebo.
ori In the study of children, five (8%) experienced rejection in the first six months after the transplant.
tor Fl- istudju tat- tfal, ħamsa (8%) esperjenzaw irrifjutar fl- ewwel sitt xhur wara t- trapjant.
What is the risk associated with Zenapax?
X’ inhu r- riskju assoċjat ma ’ Zenapax?
uth In studies, side effects were seen at similar rates in patients taking Zenapax and those taking placebo, when given in combination with immunosuppressive medicines.
aw Fl- istudji, effetti sekondarji dehru f’ rati simili f’ pazjenti li qed jieħdu Zenapax u dawk li qed jieħdu plaċebo, meta mogħti f’ kombinazzjoni ma ’ mediċini immunosoppressivi.
The most common side effects (seen in more than 1 patient in 10) were insomnia (difficulty sleeping), tremor (shaking), headache,
L- aktar effetti sekondarji komuni (dehru f’ aktar minn pazjent 1 minn kull 10) kienu insomnja (diffikultà fl- irqad), rogħda, uġigħ ta ’ ras, pressjoni għolja tad- demm, dispnija (diffikultà fit- teħid tan- nifs), stitikezza, dijarea, remettar,
ra hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, diarrhoea, vomiting, nausea (feeling sick), dyspepsia (heartburn), musculoskeletal pain (pain in the muscles and joints), oedema (swelling), impaired healing and post-traumatic pain (pain after surgery).
ux nawżja (dardir), dispepsja (ħruq ta ’ stonku), uġigħ muskoloskeletali (uġigħ fil- muskoli u l- ġogi), edima (nefħa), fejqan imxekkel u uġigħ ta ’ wara t- trawma (uġigħ wara l- kirurġija).