qanastek/EMEA-V3 huggingface dataset:
Tablet core Cellulose microcrystalline Povidone Sodium starch glycolate Silica, colloidal anhydrous Magnesium stearate
Qalba tal- pillola Cellulose microcrystalline Povidone Sodium starch glycolate Silica, colloidal anhydrous Magnesium stearate
14 6.2 Incompatibilities
14 Kisja tar- rita tal- pillola Titanium dioxide (E171) Macrogol Talc Hypromellose
PVC/ aluminium blisters
Folji tal- PVC/ aluminium
28 or 98 film-coated tablets
28 jew 98 pillola miksija b’ rita.
Sebivo 20 mg/ ml oral solution
Sebivo 20 mg/ ml soluzzjoni orali
One ml contains 20 mg telbivudine.
Kull ml fih 20 mg telbivudine.
A 600 mg dose (30 ml) of oral solution contains approximately 47 mg sodium.
Doża ta ’ 600 mg (30 ml) ta ’ soluzzjoni orali fiha bejn wieħed u ieħor 47 mg ta ’ sodium.
Clear, colourless to pale yellow solution.
Soluzzjoni trasparenti, minn bla kulur sa safra ċara.
Adults The recommended dose of Sebivo is 30 ml, providing a dose equivalent to 600 mg, once daily, taken orally, with or without food.
Adulti Id- doża rakkomandata ta ’ Sebivo hija ta ’ 30 ml, li tipprovdi doża ekwivalenti għal 600 mg, darba kuljum, meħuda mill- ħalq, mal- ikel jew mingħajru.
16 Renal impairment No adjustment of the recommended dose of telbivudine is necessary in patients whose creatinine clearance is ≥ 50 ml/ min.
16 Indeboliment renali M’ hemmx bżonn li jsir aġġustament tad- doża rakkomandata ta ’ telbivudine f’ pazjenti li għandhom tneħħija tal- krejatinina ≥ 50 ml/ min.
If use of the oral solution is not possible, Sebivo film-coated tablets could be used as an alternative and dosing should be adjusted by increasing the time interval between doses, as detailed in Table 1.
Jekk l- użu tas- soluzzjoni orali ma jkunx possibbli, jistgħu jintużaw pilloli Sebivo miksija b’ rita bħala alternattiva u d- doża għandha tkun aġġustata billi jitwal l - intervall bejn id- dożi, kif dettaljat fit- Tabella 1.
Dosing regimen adjustment of Sebivo in patients with renal impairment
Tabella 1 Aġġustar tal- mod kif jingħataw id- dożaġġi ta ’ Sebivo f’ pazjenti b’ indeboliment renali
Creatinine clearance (ml/ min)
Tneħħja tal - krejatinina (ml/ min)
Telbivudine 20 mg/ ml oral solution Daily dose adjustment
Soluzzjoni orali ta ’ telbivudine ta ’ 20 mg/ ml Aġġustament tad- doża ta ’ kuljum
600 mg (30 ml) once daily 400 mg (20 ml) once daily 200 mg (10 ml) once daily
600 mg (30 ml) darba kuljum 400 mg (20 ml) darba kuljum 200 mg (10 mg) darba kuljum
The safety and effectiveness of these dosing adjustment guidelines have not been clinically evaluated.
Is- sigurtà u l - effikaċja ta ’ dawn il- linji gwida fuq l- aġġustament tad- dożaġġi ma ġewx evalwati klinikament.
In patients with compensated liver disease, this elevation of serum ALT is generally not accompanied by elevated levels of serum bilirubin or by other signs of hepatic decompensation.
17 żiediet ta ’ ALT fis- serum ġeneralment ma jkunux akkompanjat b’ żiediet fil- livelli ta ’ bilirubin fis - serum jew b’ sinjali oħra ta ’ dikompensazzjoni epatika.
17 Exacerbations of hepatitis have also been reported in patients who have terminated treatment of hepatitis B.
Każijiet fejn l- epatite ħraxet kienu rappurtati wkoll f’ pazjenti li kienu temmu l- kura għall- epatite B.
Renal function Telbivudine is eliminated primarily by renal excretion, therefore dose interval adjustment is recommended in patients with creatinine clearance < 50 ml/ min, including patients on haemodialysis.
18 Funzjoni renali Telbivudine jitneħħa l- aktar mill- kliewi, għaldaqstant aġġustament ta ’ l- intervall tad- dożaġġi huwa rakkomandat f’ pazjenti bi tneħħija tal- krejatinina < 50 ml/ min, inklużi pazjenti fuq ħemodijaliżi.
18 Patients with cirrhosis without decompensation Due to the limited data available (about 3% of patients enrolled had cirrhosis), telbivudine should be used with particular caution in cirrhotic patients.
Pazjenti b’ ċirrożi mingħajr dikumpensazzjoni Minħabba t- tagħrif limitat li hemm (madwar 3% tal- pazjenti li kienu reġistrati kellhom ċirrożi), telbivudine għandu jintuża b’ attenzjoni partikolari f’ pazjenti b’ ċirrożi.
Sebivo oral solution contains approximately 47 mg sodium per 600 mg dose (30 ml), which should be taken into consideration by patients on a controlled sodium diet.
Sebivo soluzzjoni orali fiha bejn wieħed u ieħor 47 mg ta ’ sodium f’ kull doża ta ’ 600 mg (30 ml), li għandu jiġi kkunsidrat mill- pazjenti li qegħdin fuq dieta tas- sodium kkontrollata.
There are currently no efficacy and safety data for other antiviral combinations with telbivudine.
19 Bħalissa m’ hemmx tagħrif dwar l- effikaċja u s- sigurtà għal kombinazzjonijiet ta ’ anti- virali oħra ma ’ telbivudine.
The steady-state pharmacokinetics of telbivudine were unaltered following multiple dose administration in combination with lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate, 19 ciclosporin or pegylated interferon-alfa 2a.
Il- farmakokinetiċi fi stat fiss ta ’ telbivudine ma nbidlux wara li ngħataw ħafna dożi wara xulxin fl- istess ħin ma ’ lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate, ciclosporin jew interferon alfa- 2a pegilat.
No definitive conclusion could be drawn regarding the effects of telbivudine on the pharmacokinetics of pegylated interferon due to high interindividual variability of pegylated interferon alfa 2a concentrations.
Ma setgħetx tinstab konklużjoni definittiva dwar l- effetti ta ’ telbivudine fuq il - farmakokinetiċi ta ’ interferon alfa pegilat minħabba l- varjabbiltà kbira bejn individwu u ieħor fil - konċentrazzjonijiet ta ’ interferon alfa- 2a pegilat.
In the 104-week clinical studies, reported adverse reactions were usually classified as mild or moderate in severity.
20 Fl- istudji kliniċi ta’ 104 ġimgħat, reazzjonijiet avversi li kienu rrappurtati kienu s- soltu kklassifikati bħala ħfief jew moderati fis- severità tagħhom.
Table 2 lists the adverse reactions recorded in the pooled 104-week NV-02B-007 GLOBE and NV- 02B-015 studies by system organ class and by frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000).
Tabella 2 telenka r- reazzjonijiet avversi li kienu reġistrati b’ mod kollettiv fl- istudji NV- 02B- 007 GLOBE u NV- 02B- 015 ta ’ 104 ġimgħat skond il- klassi tas- sistema ta ’ l- organi u skond il- frekwenza billi ntużat il- konvenzjoni li ġejja: komuni ħafna (≥1/ 10); komuni (≥1/ 100 sa < 1/ 10); mhux komuni (≥1/ 1, 000 sa < 1/ 100); rari (≥1/ 10, 000 sa < 1/ 1, 000); rari ħafna (< 1/ 10, 000).
Clinical adverse reactions in patients with chronic hepatitis B, treated with telbivudine 600 mg in the pooled 104-week NV-02B-007 (GLOBE) and NV-02B-015 studies *
Tabella 2 Reazzjonijiet kliniċi avversi kollettivi f’ pazjenti b’ epatite B kronika, kurati b’ telbivudine 600 mg fl- istudji NV- 02B- 007 (GLOBE) u NV- 02B- 015 ta ’ 104 ġimgħat *
The incidence of on treatment alanine aminotransferase (ALT) flares in the two treatment arms according to AASLD (American Association for the Study of Liver Diseases) definition (ALT elevation > 2x baseline and > 10x ULN) are further described in Table 3 below.
21 In- numru ta ’ drabi li fihom seħħew żiediet f’ daqqa ta ’ alanine aminotransferase (ALT) waqt il- kura fiż- żewġ fergħat skond id- definizzjoni ta ’ l- AASLD (Assoċjazzjoni Amerikana għall- Istudji tal- Mard tal- Fwied) (żieda ta ’ l- ALT ta ’ > 2 darbiet mill- linja bażi u > 10 darbiet l- ULN) huma spjegati aktar f’ Tabella 3 taħt.
Summary of on treatment ALT (IU/ L) flare – Pooled NV-02B-007/ NV-02B-015
Tabella 3 Sommarju taż- żidiet f’ daqqa ta ’ l- ALT (IU/ L) – Kollettiva NV- 02B- 007/ NV- 02B- 015
21 Exacerbations of hepatitis B after discontinuation of treatment Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti- hepatitis B therapy including telbivudine (see section 4.4).
Każijiet fejn l- epatite B tiħrax wara li titwaqqaf il- kura.
Telbivudine is an inhibitor of both HBV first strand (EC50 = 0.4-1.3 μ M) and second strand (EC50 = 0.12-0.24 μ M) synthesis, and shows a distinct preference for inhibiting second strand production.
Telbivudine jinibixxi s- sinteżi kemm ta ’ l- ewwel strand (EC50 = 0. 4- 1. 3 μM) kif ukoll tat- tieni (EC50 = 0. 12- 0. 24 μM), u juri preferenza distinta għall -
The in vitro antiviral activity of telbivudine was assessed in the HBV-expressing human hepatoma cell line 2.2.15.
L- attività antivirali in vitro ta ’ telbivudine kienet stmata fil- linja ta ’ ċelluli ta ’ epatoma tal- bniedem 2. 2. 15 li jesprimu HBV.
22 NV-02B-007 GLOBE study The NV-02B-007 GLOBE study is a randomised, double-blind, multinational phase III study of telbivudine compared to lamivudine for a treatment period of 104 weeks in 1,367 nucleoside-naïve chronic hepatitis B HBeAg-positive and HBeAg-negative patients.
Studju NV- 02B- 007 GLOBE L- istudju NV- 02B- 007 GLOBE huwa studju ta ’ telbivudine randomised, double- blind, multinazzjonali ta ’ fażi III imqabbel ma ’ dak ta ’ lamivudine għal perijodu ta ’ kura ta ’ 104 ġimgħat f ’ 1, 367 pazjent li qatt ma ingħataw nucleoside u li kellhom epatite B HBeAg- posittiva u HBeAg- negattiva kronika.
Of those HBeAg positive subjects, 95% achieved non-detectable HBV DNA, 39% achieved HBeAg seroconversion, 90% achieved ALT normalisation at week 52 and 0.5% exhibited resistance at week 48.
Bl- istess mod, f’ dawk l- individwi HBeAg -
Similarly of those HBeAg-negative subjects, 96% achieved non-detectable HBV DNA, 79% achieved ALT normalisation at week 52 and 0% exhibited resistance at week 48.
23 negattivi, 96% kisbu livelli ta ’ HBV DNA li ma setgħux jitkejlu, 79% kisbu livelli normali ta ’ ALT mat- 52 ġimgħa u 0% saru reżistenti mat- 48 ġimgħa.
23 Table 5
Tabella 5 Endpoints viroloġiċi, biokimiċi u seroloġiċi fit- 52 ġimgħa (Studju NV- 02B- 007 GLOBE)
Histological improvement and change in Ishak Fibrosis Score at week 52 (NV-02B- 007 GLOBE study)
24 Tabella 6 Titjib istoloġiku u tibdil fil- Punteġġ Fibrożi Ishak mat- 52 ġimgħa (studju NV- 02B - 007 GLOBE)
24 Clinical results at week 104 Overall, clinical results at week 104 in telbivudine-treated patients were consistent with those at week 52, demonstrating durability of efficacy responses for telbivudine-treated patients with continued treatment.
Riżultati kliniċi fil- ġimgħa 104 Globalment, riżultati kliniċi fil- ġimgħa 104 f’ pazjenti kkurati b’ telbivudine kienu konsistenti ma ’ dawk tat- 52 ġimgħa, li juri li r- rispons ta ’ effikaċja għal pazjenti kkurati b’ telbivudine jservi għal żmien twil meta titkompla l- kura.
Outcome results at week 104, based on level of HBV DNA at week 24, for either HBeAg-positive or HBeAg-negative patients are presented in Table 7.
25 Ir- riżultati fil- ġimgħa 104, ibbażati fuq il- livell ta ’ HBV DNA fl- 24 ġimgħa, għal pazjenti li jew huma HBeAg- pożittivi jew HBeAg- negattivi huma ppreżentati fit- Tabella 7.
25 Study NV-02B-015 The efficacy and safety results of the 007 GLOBE study were confirmed in study NV-02B-015.
Studju NV- 02B- 015 Ir- riżultati ta ’ l- effikaċja u s- sigurtà ta ’ l- istudju 007 GLOBE kienu ikkonfermati fi studju NV- 02B - 015.
Genotypic analysis of 203 evaluable sample pairs with HBV DNA ≥ 1,000 copies/ ml at week 104 demonstrated that the primary mutation associated with telbivudine resistance was rtM204I, often associated with mutations rtL180M and rtL80I/ V and infrequently with rtV27A, rtL82M, rtV173L, rtT184I and rtA200V.
Fatturi tal- linja bażi assoċjati ma ’ l- iżvilupp ta ’ reżistenza
Baseline factors associated with development of genotypic drug resistance included: lamivudine treatment, higher baseline HBV DNA, lower baseline serum ALT, and increased body weight/ BMI.
26 ġenotipika kienu jinkludu: kura b’ lamivudine, linja bażi ogħla ta ’ HBV DNA, linja bażi aktar baxxa ta ’ ALT fis- serum, u żieda fil- piż tal- ġisem/ BMI.
26 Absorption Following oral administration of a 600 mg single dose of telbivudine to healthy subjects (n = 42), the peak plasma concentration (Cmax) of telbivudine was 3.2 ± 1.1 μ g/ ml (mean ± SD) and occurred at median 3.0 hours post dose.
Assorbiment Wara l- għotja ta ’ doża orali ta ’ 600 mg telbivudine lill- individwi b’ saħħithom (n = 42), il- quċċata tal - konċentrazzjoni fil- plażma (Cmax) ta ’ telbivudine kienet 3. 2 ± 1. 1 μg/ ml (medja ± SD) u seħħet medja ta ’ 3. 0 sigħat wara li ngħatat id- doża.
Film-coated tablets containing 600 mg telbivudine are bioequivalent to 30 ml telbivudine oral solution (20 mg/ ml).
Pilloli miksijin b’ rita li fihom 600 mg telbivudine huma bijoekwivalenti għal 30 ml ta ’ soluzzjoni orali ta ’ telbivudine (20 mg/ ml).
Renal impairment The single-dose pharmacokinetics of telbivudine (200, 400 and 600 mg) have been evaluated in patients (without chronic hepatitis B) with various degrees of renal impairment (as assessed by creatinine clearance).
Indeboliment renali Il- farmakoiknetiċi ta ’ doża waħda ta ’ telbivudine (200, 400 u 600 mg) kienu stmati f’ pazjenti (mingħajr epatite B kronika) b’ gradi varji ta ’ indeboliment renali (kif stmat mit- tneħħija tal - krejatinina).
5.3 Preclinical safety data
28 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Benzoic acid Sodium saccharin Passion fruit flavouring Sodium hydroxide Citric acid anhydrous Water, purified
Benzoic acid Sodium saccharin Passion fruit flavouring Sodium hydroxide Citrc acid anhydrous Ilma, ppurifikat
28 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Use within 2 months of opening the bottle.
Uża fi żmien xahrejn minn meta tiftaħ il- flixkun.
300 ml brown glass bottle with a child-resistant closure, including a polyethylene sealing disc and a guarantee ring and a polypropylene dosing cup with embossed graduations of 5 to 30 ml in 5 ml increments.
Flixkun ta ’ 300 ml tal- ħġieġ kannella b’ għatu li ma jinfetaħx mit- tfal, inkluż disk tal- polyethylene li tisiġilla u ċirku ta ’ garanzija u tazza tal- polypropylene tad- doża immarkata bi gradi ta ’ kejlibbuzzat ’ il barra minn 5 ml sa 30 ml b’ żidiet ta ’ 5 ml.
29 ANNEX II
30 ANNESS II
26, rue de la Chapelle F-68330 Huningue France
26, rue de la Chapelle F- 68330 Huningue Franza
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 (19 August 2008) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
L- MAH għandha tiżgura li s - sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 3. 0 (19 ta ’ Awissu 2008) ippreżentata fil- Modulu 1. 8. 1. tal- Applikazzjoni tal- Awtorizzazzjoni għat- tqegħid fis- suq tkun ġiet stabbilita u tiffunzjona qabel ma l- prodott jitqiegħed fis- suq u waqt li l- prodott ikun fis- suq.
Risk Management plan
Pjan ta ’ maniġġar tar- riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 (12 February 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
L- MAH jintrabat li jagħmel l- istudji u l- attivitajiet l- oħra ta ’ farmakoviġilanza li jissemmew fid- dettal fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 2 (12 ta ’ Frar 2008) tal- Pjan ta ’ Maniġġar tar - Riskju (RMP) ippreżentat fil- Modulu 1. 8. 2. tal- Applikazzjoni tal- Awtorizzazzjoni għat- tqegħid fis- suq u kull aġġornament sussegwenti tal- RMP li jsir bi qbil mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skont il- Linja Gwida tas- CHMP dwar is- Sistemi ta ’ Maniġġar tar- Riskju għal prodotti mediċinali għall- użu mill- bniedem, l- RMP aġġornat għandu jintbagħat fl- istess waqt flimkien mar- Rapport Perjodiku dwar l- Aġġornamenti ta ’ Sigurtà (PSUR) li jkun imiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn dan, għandu jintbagħat RMP aġġornat • Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq il- Pjan ta ’ Farmakoviġilanza, Speċifikazzjoni ta ’ Sigurtà attwali jew fuq attivitajiet għal minimizzazzjoni ta ’ riskju • Fi żmien 60 jum minn meta jseħħ avveniment (farmakoviġilanza jew minimizzazzjoni ta ’ riskju) importanti • Fuq talba tal- EMEA
32 A.
32 ANNESS III
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
Sebivo 600 mg film-coated tablets telbivudine
Sebivo 600 mg pilloli miksija b’ rita telbivudine
One tablet contains 600 mg telbivudine.
Pillola waħda fiha 600 mg telbivudine.
28 film-coated tablets 98 film-coated tablets
28 pillola miksija b’ rita 28 pillola miksija b’ rita
28 film-coated tablets 98 film-coated tablets
28 pillola miksija b’ rita 98 pillola miksija b’ rita
35 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
36 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
37 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
FOLDING BOX AND BOTTLE LABEL
KAXXA LI TINTEWA U TIKKETTA TAL- FLIXKUN
Sebivo 20 mg/ ml oral solution Telbivudine
Sebivo 20 mg/ ml soluzzjoni orali Telbivudine
Each ml contains 20 mg telbivudine.
Kull ml fih 20 mg telbivudine.
Also contains sodium.
Fih ukoll sodium.
1 bottle containing 300 ml oral solution 1 cup
Flixkun wieħed li jkun fih 300 ml ta ’ soluzzjoni orali Tazza waħda
Sebivo 20 mg/ ml [folding box only]
Sebivo 20 mg/ ml [kaxxa li tintlewa biss]
Sebivo 600 mg film-coated tablets Telbivudine
Sebivo 600 mg pilloli miksija b’ rita Telbivudine
What Sebivo is and what it is used for 2.
X’ inhu Sebivo u għalxiex jintuża 2.
Before you take Sebivo 3.
Qabel ma tieħu Sebivo 3.
How to take Sebivo 4.
Kif għandek tieħu Sebivo 4.
How to store Sebivo 6.
Kif taħżen Sebivo 6.
WHAT SEBIVO IS AND WHAT IT IS USED FOR
X’ INHU SEBIVO U GĦALXIEX JINTUŻA
Sebivo belongs to a group of medicines called antiviral medicines, which are used to treat infections caused by viruses.
Sebivo jagħmel parti minn grupp ta ’ mediċini magħrufin bħala mediċini antivirali, li jintużaw biex jikkuraw infezzjonijiet ikkawżati minn viruses.
Sebivo is used to treat adults with chronic hepatitis B.
Sebivo jintuża għal kura ta ’ adulti li jsofru minn epatite B.
Hepatitis B is caused by infection with the hepatitis B virus, which multiplies in the liver and causes liver damage.
Epatite B hija kkawżata b’ infezzjoni mill- virus ta ’ l- epatite B, li jimmultiplika fil- fwied u jikkawża ħsara fil- fwied.
Treatment with Sebivo reduces the amount of hepatitis B virus in the body by blocking its growth, resulting in less liver damage and improved liver function.
Il- kura b’ Sebivo tnaqqas l- ammont ta ’ virus ta ’ l- epatite B mill- ġisem billi jinblokka t - tkattir tagħha, u b’ hekk titnaqqas il- ħsara fil- fwied u titjieb il- funzjoni tal- fwied.
BEFORE YOU TAKE SEBIVO
QABEL MA TIEĦU SEBIVO
Do not take Sebivo
Tieħux Sebivo
- if you are allergic (hypersensitive) to telbivudine or any of the other ingredients of Sebivo
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telbivudine jew sustanzi oħra ta ’
(listed in section 6).
Sebivo (elenkati f’ sezzjoni 6).
If this applies to you, do not take Sebivo.
Jekk dan jgħodd għalik, tieħux Sebivo.
Talk to your doctor.
Kellem lit- tabib tiegħek.
If you think you may be allergic, ask your doctor for advice.
Jekk taħseb li tista ’ tkun allerġiku/ a, staqsi lit- tabib għall- parir.
Take special care with Sebivo
Oqgħod attent ħafna b’ Sebivo
- if you have or have had any kidney problems.
- jekk għandek jew kellek xi problemi bil- kliewi.
Your doctor may order laboratory tests to check
It- tabib tiegħek jista ’ jordna li jsirulek testijiet
your kidneys are working properly before and during treatment.
tal- laboratorju biex jara jekk il- kliewi hux qed jaħdmulek tajjeb qabel u waqt il- kura.
Depending on the results of these tests your doctor may advise you to change how often you take Sebivo.
Skond ir - riżultati ta ’ dawn it- testijiet, it- tabib tiegħek jista ’ jagħtik parir biex tbiddel kemm il- darba tieħu Sebivo ħdu aktar jew anqas ta ’ spiss kif jixraq.
- if you suffer from cirrhosis of the liver (a serious condition which causes liver “ scarring”).
- jekk tbati minn ċirrożi tal- fwied (kundizzjoni serja li tikkawża “ ċikatriċi ” tal- fwied).
In
F’ dan il -
this case your doctor will want to monitor you more closely.
każ it- tabib tiegħek ikun irid iżommok taħt osservazzjoni aktar mill- qrib.
- if you have had a liver transplant.
- jekk kellek trapjant tal- fwied.
- if you are taking any medicines that may cause muscle problems (talk to your doctor or
- jekk qed tieħu xi mediċini li jistgħu jikkawżaw problemi fil- muskoli (kellem lit- tabib jew spiżjar
pharmacist if you are unsure).
tieghek jekk m’ intix ċert/ a).
- if you are infected with HIV, hepatitis C or D, or are being treated with any antiviral medicines.
- jekk int infettat bl- HIV, epatite C jew D, jew jekk qed tingħata kura b’ xi mediċini antivirali.
If any of these applies to you, tell your doctor before you take Sebivo.
Jekk xi wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek qabel tieħu Sebivo.
- Sebivo can cause persistent unexplained muscle weakness or muscle pain (myopathy).
- Sebivo jista ’ jikkawża dgħjufija tal- muskoli jew uġigħ fil- muskoli (mijopatija) persistenti u
Uncommonly Sebivo can induce numbness, tingling, pain and/ or burning sensations in the arms and/ or legs (peripheral neuropathy).
Xi minn daqqiet Sebivo jista ’ jinduċi titrix, tnemnim, uġigħ u/ jew sensazzjonijiet ta ’ ħruq fid- dirgħajn u/ jew ir- riglejn (newropatija periferali).
If you experience any of these symptoms, call your doctor immediately.
Jekk tħoss xi wieħed minn dawn is- sintomi, sejjaħ lit- tabib tiegħek immedjatament.
Other effects of this type of medicine Sebivo belongs to a class of medicines (a nucleoside analogue) that can cause an excess of lactic acid in the blood (lactic acidosis) and enlargement of the liver (hepatomegaly) with fatty liver (steatosis).
Effetti oħra ta ’ din it- tip ta ’ mediċina Sebivo jappartieni lill- klassi ta ’ medicini (analogu tan- nucleoside) li jistgħu jikkawżaw eċċess ta ’ lactic acid fid- demm (aċidożi lattika) u tkabbir tal- fwied (epatomegalija) bi fwied xaħmi (stejatożi).
Lactic acidosis is a rare but serious side effect which can occasionally be fatal.
Aċidożi lattika huwa effett sekondarju rari imma serju li jista ’ f’ xi każijiet ikun fatali.
Lactic acidosis occurs more often in women, particularly if they are very overweight.
Aċidożi lattika tiġri aktar ta ’ spiss fin- nisa, partikularment jekk ikunu ħoxnin iżżejjed.
Your doctor will monitor you regularly while you are receiving Sebivo.
It- tabib tiegħek jieħu ħsiebek regolarment waqt li tkun qed tieħu s- Sebivo.
If you experience muscle pain, severe and persistent stomach pain with nausea and vomiting, severe and persistent trouble breathing and tiredness while taking Sebivo, call your doctor immediately.
Jekk tħoss uġigħ fil- muskoli, uġigħ sever u persistenti fl - istonku bi tqalligħ u rimettar, problemi severi u persistenti biex tieħu n- nifs u għeja waqt li tkun qed tieħu Sebivo, sejjaħ lit- tabib tiegħek immedjatament.
Some people may get very serious hepatitis symptoms when they stop taking medicines like Sebivo.
Xi persuni jista ’ jkollhom sintomi tal- epatite serji ħafna meta jieqfu jieħdu mediċini bħal Sebivo.
Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Sebivo.
It - tabib tiegħek se jsegwi saħħtek u jagħmillek testijiet tad- demm b’ mod regolari biex jiċċekkjalek il - fwied wara li inti twaqqaf il- kura b’ Sebivo.
Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment (see “ If you stop taking Sebivo” in section 3 of this leaflet).
Għid lit- tabib tiegħek immedjatament dwar kull sintomu ġdid jew mhux tas- soltu li inti tinnota wara li twaqqaf il- kura (ara “ Jekk tieqaf tieħu Sebivo ” f’ sezzjoni 3 ta ’ dan il- fuljett).
Take care not to infect other people Sebivo does not reduce the risk of infecting others with hepatitis B virus (HBV) through sexual contact or exposure to contaminated blood or other body fluids.
Ħu ħsieb sabiex ma tinfettax nies oħrajn Sebivo ma jnaqqasx ir- riskju li tinfetta nies oħra bil- virus ta ’ l- epatite B (HBV) permezz ta ’ kuntatt sesswali jew b’ kuntatt ma ’ demm kontaminat jew fluwidi tal- ġisem.
Never share needles.
Qatt m’ għandek tislef labar tas - siringi.
Do not share personal items that could have blood or body fluids on them, such as toothbrushes or razor blades.
Qatt m’ għandek tislef affarjiet personali tiegħek li jista ’ jkollhom id- demm jew fluwidi tal - ġisem fuqhom, bħal xkupilji tas- snien jew xfafar tal- leħja.
A vaccine is available to prevent infection with HBV.
Hemm tilqima sabiex jiġu evitati infezzjonijiet b’ HBV.
Use in children Sebivo is not recommended for use in children under 16 years of age.
L- użu fi tfal Sebivo mhux rakkomandat għall- użu fi tfal taħt is- 16- il sena.
Your doctor or pharmacist needs to know about other medicines because some medicines could affect your kidneys and because Sebivo mainly leaves the body via the kidneys in the urine.
It- tabib jew spiżjar tiegħek għandhom bżonn ikunu jafu dwar il- mediċini l- oħra għax xi mediċini jistgħu jeffettwaw il- kliewi tiegħek u dan għaliex Sebivo joħroġ mill- ġisem permezz tal- kliewi fl - awrina.
- Do not use Sebivo during pregnancy unless your doctor recommends it.
- M’ għandekx tuża Sebivo waqt it- tqala sakemm ma jkunx irrikmandahielek it- tabib tiegħek.
If you are pregnant or
Jekk
think you may be, tell your doctor before taking Sebivo.
inti ħriġt tqila jew taħseb li tista ’ tkun, għid lit- tabib tiegħek qabel ma tieħu Sebivo.
Your doctor will discuss with you the potential risks of taking Sebivo during pregnancy.
It- tabib tiegħek se jiddiskuti miegħek ir- riskji li jista ’ jkun hemm meta tieħu Sebivo waqt it- tqala.
- If you have hepatitis B and become pregnant, talk to your doctor about how you can best protect
- Jekk għandek epatite B u ħriġt tqila, tkellem mat- tabib tiegħek dwar l- aħjar mod kif tista ’
your baby.
tipproteġi it- tarbija tiegħek.
It is not known whether Sebivo reduces the risk of passing your hepatitis B virus on to your unborn baby.
Mhux mgħaruf jekk Sebivo jnaqqasx ir- riskju li tgħaddi l- virus ta ’ l - epatite B lit- tarbija li għada ma twelditx.
- Do not breast-feed during treatment with Sebivo.
- M’ għandekx tredda ’ waqt il- kura b’ Sebivo.
Tell your doctor if you are breast-feeding.
Tkellem mat- tabib tiegħek jekk qed tredda ’.
HOW TO TAKE SEBIVO
KIF GĦANDEK TIEĦU SEBIVO
Always take Sebivo exactly as your doctor has told you.
Dejjem għandek tieħu Sebivo skond il- parir eżatt tat- tabib.
How much Sebivo to take The usual dose of Sebivo is one 600 mg tablet once a day.
42 Kemm għandek tieħu Sebivo Id- doża ta ’ Sebivo s- soltu tkun pillola waħda ta ’ 600 mg darba kuljum.
Take the tablet at about the same time each day.
Ħu l- pillola bejn wieħed u ieħor fl- istess ħin kuljum.
41 The tablet can be taken with or without food.
Il- pillola tista ’ tittieħed ma l- ikel jew mhux ma l- ikel.
Swallow it whole with some water.
Iblaha sħieħa bi ftit ilma.
You may need to take Sebivo less frequently if you have kidney problems.
Jista ’ jkollok bżonn tieħu Sebivo anqas ta ’ spiss jekk ikollok problemi tal- kliewi.
Tell your doctor if you have, or have ever had, any kidney problems.
Għid lit- tabib tiegħek jekk għandek, jew qatt kellek, xi problemi tal- kliewi.
How long to take Sebivo Do not change your dose or stop taking Sebivo without talking to your doctor.
Kemm għandek iddum tieħu Sebivo M’ għandekx tibdel id- doża jew tieqaf tieħu Sebivo mingħajr ma tkellem lit- tabib tiegħek.
Take Sebivo every day and continue your treatment exactly as prescribed unless your doctor says otherwise.
Ħu Sebivo kuljum u ibqa ħu l- kura eżattament kif kienet ordnata sakemm it- tabib tiegħek ma jgħidlekx mod ieħor.
Your doctor will make regular checks to make sure that Sebivo is working.
It- tabib tiegħek ser jagħmillek testijiet regolari biex jara jekk Sebivo hux qed jaħdem.
Your hepatitis B symptoms may get worse or become very serious if you stop taking Sebivo.
Is- sintomi ta ’ l- epatite B jistgħu jiħżienu jew isiru serji ħafna jekk tieqaf tieħu Sebivo.
If you take more Sebivo than you should If you have taken too much Sebivo, or if someone else accidentally takes your tablets, go to your doctor or hospital for advice straight away.
Jekk tieħu Sebivo aktar milli suppost Jekk ħadt wisq Sebivo, jew jekk xi ħadd ieħor jieħu l- pilloli tiegħek bi żball, mur għand it- tabib jew l - isptar għall- parir minnufih.
Take the pack of tablets with you and show it to your doctor.
Ħu l- pakkett tal- pilloli miegħek u wrieh lit- tabib tiegħek.
If you forget to take Sebivo
Jekk tinsa tieħu Sebivo
- If you forget to take Sebivo, take it as soon as you remember and then take your next dose at its
- Jekk tinsa tieħu Sebivo, ħudha malli tiftakar u imbagħad ħu d- doża li jmiss fil- ħin tas- soltu.
- However, if it is almost time for your next dose, skip the dose you missed and take the next one
- Madankollu, jekk ikun sar kważi l- ħin biex tieħu d- doża li jmissek, aqbeż id- doża li nsejt u ħu
at the usual time.
dik li jmiss fil- ħin tas- soltu.
This may increase the chance of you getting unwanted side effects.
Jekk tgħamel hekk, ikollok riskju akbar li tħoss effetti sekondarji mhux mixtieqa.
Ask your doctor or pharmacist if you are not sure what to do.
Staqsi lit- tabib jew spiżjar tiegħek jekk m’ intix ċert/ a x’ għandek tgħamel.
If you stop taking Sebivo Stopping treatment with Sebivo may result in a worsening of your hepatitis B infection.
Jekk tieqaf tieħu Sebivo Jekk twaqqaf it- trattament bis- Sebivo, ir- riżultat jista ’ jkun li l- infezzjoni tiegħek tal- epatite B tmur għall- agħar.
Do not stop Sebivo unless your doctor tells you to.
Twaqqafx Sebivo sakemm ma jgħidlekx it- tabib tiegħek.
While you are taking Sebivo, make sure you do not run out of Sebivo.
Waqt li tkun qed tieħu s- Sebivo, żgura li Sebivo ma ’ jispiċċalekx.
Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Sebivo since your hepatitis B infection may get worse or become very serious after stopping treatment.
It- tabib tiegħek isegwi saħħtek u jagħmel regolarment testijiet tad- demm biex jeżamina fwiedek wara li twaqqaf il- kura bis- Sebivo minħabba li l- infezzjoni tiegħek tal- epatite B tista ’ tmur għall- agħar jew tisfa serja ħafna wara li jieqaf it- trattament.
Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment.
Għarraf lit- tabib tiegħek immedjatament dwar sintomi ġodda jew mhux tas- soltu li inti tinnota wara li twaqqaf it- trattament.
Like all medicines, Sebivo can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Sebivo jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The frequencies are defined as: very common: common: uncommon: rare: very rare: not known:
Il- frekwenzi huma definiti bħala: komuni ħafna: komuni: mhux komuni: rari: rari ħafna: mħux magħruf:
affects more than 1 patient in 10 affects 1 to 10 patients in 100 affects 1 to 10 patients in 1,000 affects 1 to 10 patients in 10,000 affects less than 1 patient in 10,000 frequency cannot be estimated from the available data.
jaffettwaw aktar minn pazjent wieħed minn kull 10 jaffettwaw minn pazjent wieħed sa 10 minn kull 100 jaffettwaw minn pazjent wieħed sa 10 minn kull 1, 000 jaffettwaw minn pazjent wieħed sa 10 minn kull 10, 000 jaffettwaw anqas minn pazjent wieħed minn kull 10, 000 ma tistax tittieħed stima mid- data disponibbli.
effects could be serious:
43 Xi effetti sekondarji mhux komuni jistgħu jkunu serji:
- Persistent muscle weakness or muscle pain
- Dgħjufija jew uġigħ persistenti fil- muskoli
- Numbness, tingling, pain and/ or burning sensation in the arms and/ or legs
- Titrix, tnemnim, uġigħ u/ jew sensazzjoni ta ’ ħruq fid- dirgħajn u/ jew fir- riġlejn
If you experience any of these, call your doctor immediately.
Jekk tħoss xi waħda minn dawn, sejjaħ lit- tabib tiegħek immedjatament.
42 Sebivo may also cause other side effects:
Sebivo jista ’ wkoll jikkawża effetti sekondarji oħra:
- Dizziness, headache
- Sturdament, uġigħ ta ’ ras
- Cough
- Sogħla
- Diarrhoea, feeling sick (nausea), stomach (abdominal) pain
- Dijarea, tħossok imdardar (tqalligħ), uġigħ fl- istonku (fl- addome)
- Skin rash
- Raxx tal- ġilda
- Blood test results show higher levels of liver enzymes, amylase, lipase or creatine kinase
- Riżultati tat- testijiet tad- demm jkunu juru livelli għoljin ta ’ l- enzimi tal- fwied, amylase, lipase
- Joint pain
- Uġigħ fil- ġogi
- Persistent muscle weakness or muscle pain (myopathy/ myositis), muscle cramp
- Dgħjufija fil- muskoli persistenti jew uġigħ fil- muskoli (mijopatija/ mijożite), bugħawwieġ
- Back, neck and flank pain
- Uġigħ fid- dar, għonq jew ‘ l fuq mill- ġenbejn
- Numbness, tingling, pain and/ or burning sensation in the arms and/ or legs or around the mouth
- Titrix, tnemnim, uġigħ u/ jew sensazzjoni ta ’ ħruq fid- dirgħajn u/ jew fir- riġlejn jew mad- dawra
- Sciatica (pain in lower back or hip and may radiate into the leg)
- Xjatika (uġigħ fin- naħa t’ isfel tad- dar jew ġenbejn u jista ’ jinfirex għar- riġel)
- Taste disturbance
- Disturb fit- togħma
- Feeling unwell (malaise)
- Tħoss li ma tkunx tajjeb (Tħoss telqa)
HOW TO STORE SEBIVO
KIF TAĦŻEN SEBIVO
Do not use Sebivo after the expiry date which is stated on the carton after EXP.
Tużax Sebivo wara d- data ta ’ skadenza li tidher fuq il- kartuna wara JIS.
Do not use if the pack is damaged or shows signs of tampering.
Tużax Sebivo jekk il- pakkett ikun danneġġat jew juri sinjali ta ’ tbagħbis.
What Sebivo contains
X’ fih Sebivo
- The active substance is telbivudine.
- Is- sustanza attiva hi telbivudine.
Each tablet contains 600 mg telbivudine.
Kull pillola fiha 600 mg telbivudine.
- The other ingredients are: cellulose, microcrystalline; povidone; sodium starch glycolate; silica,
- Is- sustanzi l- oħra huma: cellulose, microcrystalline; povidone; sodium starch glycolate; silica,
colloidal anhydrous; magnesium stearate; hypromellose; titanium dioxide (E171); talc; macrogol.
colloidal anhydrous; magnesium stearate; hypromellose; titanium dioxide (E171); talc; macrogol.
What Sebivo looks like and contents of the pack Sebivo film-coated tablets are white to slightly yellowish, oval, film-coated tablets with “ LDT” imprinted on one side.
Id- Dehra ta ’ Sebivo u l- kontenuti tal- pakkett Il- pilloli miksija b’ rita ta ’ Sebivo huma bojod jagħtu ħarira fl- isfar, ovali, pilloli miksija b’ rita b ’ “ LDT ” ittimbrata fuq naħa.
Sebivo film-coated tablets are supplied in packs of 28 or 98 tablets.
44 Il- pilloli miksija b’ rita Sebivo jiġu f’ pakketti ta ’ 28 jew 98 pillola.
Not all pack sizes may be marketed in your country.
Jista ’ jkun li mhux il- pakketti kollha jkunu għal skop kummerċjali f’ pajjiżek.
43 Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
44 Ireland Novartis Ireland Limited Tel: +353 1 260 12 55
45 Ireland Novartis Ireland Limited Tel: +353 1 260 12 55
45 PACKAGE LEAFLET:
46 FULJETT TA ’ TAGĦRIF:
Uncommonly Sebivo can cause numbness, tingling, pain and/ or burning sensations in the arms and/ or legs (peripheral neuropathy).
Xi minn daqqiet Sebivo jista ’ jinduċi titrix, tnemnim, uġigħ u/ jew sensazzjonijiet ta ’ ħruq fid- dirgħajn u/ jew ir- riglejn (newropatija periferali).
Other effects of this type of medicine Sebivo belongs to a class of medicines (a nucleoside analogue) that can cause an excess of lactic acid in the blood (lactic acidosis) and enlargement of the liver (hepatomegaly) with fatty liver (steatosis).
Effetti oħra ta ’ dan it- tip ta ’ mediċina Sebivo jappartieni lill- klassi ta ’ medicini (analogu tan- nucleoside) li jistgħu jikkawżaw eċċess ta ’ lactic acid fid- demm (aċidożi lattika) u tkabbir tal- fwied (epatomegalija) bi fwied xaħmi (stejatożi).
Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment (see “ If you stop taking Sebivo” in section 3 of this leaflet).
Għid lit- tabib tiegħek immedjatament dwar kull sintomu ġdid jew sintomi mhux tas- soltu li inti tinnota wara li twaqqaf il- kura (ara “ Jekk tieqaf tieħu Sebivo ” f’ sezzjoni 3 ta ’ dan il- fuljett).
Taking Sebivo with food and drink You can take Sebivo with or without food.
Meta tieħu Sebivo ma ’ l- ikel u max- xorb Tista ’ tieħu Sebivo mal- ikel jew mingħajru.
Important information about some of the ingredients of Sebivo Sebivo oral solution contains approximately 47 mg of sodium per 600 mg dose (30 ml).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Sebivo Is- soluzzjoni orali ta ’ Sebivo fiha bejn wieħed u ieħor 47 mg ta ’ sodium għal kull doża ta ’ 600 mg (30 ml).
If you are on a controlled sodium diet, ask your doctor for advice.
Jekk inti qiegħed/ qiegħda fuq dieta b’ sodium ikkontrollat, staqsi lit- tabib tiegħek għall- parir.
How much Sebivo to take The usual dose of Sebivo is 30 ml of oral solution (600 mg telbivudine) once a day.
Kemm għandek tieħu Sebivo Id- doża ta ’ Sebivo s- soltu tkun 30 ml ta ’ soluzzjoni orali (600 mg telbivudine) darba kuljum.
Take Sebivo at about the same time each day.
Hu Sebivo bejn wieħed u ieħor fl- istess ħin kuljum.
It can be taken with or without food.
Huwa jista ’ jittieħed mal- ikel jew mingħajru.
Remove the dosing cup and open the bottle.
Neħħi t- tazza tad- doża u iftaħ il- flixkun.
Slowly and carefully pour the solution from the bottle into the dosing cup until it reaches the prescribed amount.
Bilmod u bl- attenzjoni ferragħ s- soluzzjoni mill- flixkun għal ġot- tazza tad- doża sakemm tilħaq il- livell tal- ammont preskritt.
Swallow the entire contents of the dosing cup immediately.
Ibla ’ il- kontenut kollu tat- tazza tad - doża immedjatament.
For full instructions on how to take Sebivo, see section “ Instructions for use” at the end of this leaflet.
Għal istruzzjonijiet kompleti dwar kif tieħu Sebivo, ara sezzjoni “ Istruzzjonijiet dwar l- użu ” fi tmiem dan il- fuljett.
Your dose may be reduced if you have kidney problems.
Id- doża tiegħek tista ’ titnaqqas jekk għandek problemi fil- kliewi.
Tell your doctor if you have, or have ever had, any kidney problems.
Għid lit- tabib tiegħek jekk għandek, jew qatt kellek, problemi fil- kliewi.
If you take more Sebivo than you should If you have taken too much Sebivo, or if someone else accidentally takes your oral solution, go to your doctor or hospital for advice straight away.
Jekk tieħu Sebivo aktar milli suppost Jekk ħadt wisq Sebivo, jew jekk xi ħadd ieħor jieħu s- soluzzjoni orali tiegħek bi żball, mur għand it - tabib jew l- isptar għall- parir minnufih.
Take the pack with you and show it to the doctor.
Ħu l- pakkett miegħek u wrieh lit- tabib tiegħek.
The frequencies are defined as: very common: common: uncommon: rare: very rare: not known:
49 Il- frekwenzi huma definiti bħala: komuni ħafna: komuni: mhux komuni: rari: rari ħafna: mħux magħruf:
effects could be serious:
Xi effetti sekondarji mhux komuni jistgħu jkunu serji:
Sebivo may also cause other side effects:
Sebivo jista ’ wkoll jikkawża effetti sekondarji oħra:
- Persistent muscle weakness or muscle pain (myopathy/ myositis), muscle cramp
- Dgħjufija tal- muskoli persistenti jew uġigħ fil- muskoli (mijopatija/ mijożite), bugħawwieġ
- Back, neck and flank pain
- Uġigħ fid- dahar, għonq jew ‘ l fuq mill- ġenbejn
- Numbness, tingling, pain and/ or burning sensation in the arms and/ or legs or around the mouth
- Titrix, tnemnim, uġigħ u/ jew sensazzjoni ta ’ ħruq fid- dirgħajn u/ jew fir- riġlejn jew mad- war il -
- Sciatica (pain in lower back or hip and may radiate into the leg)
- Xjatika (uġigħ fin- naħa t’ isfel tad- dahar jew ġenbejn u jista ’ jinfirex għar- riġel)
Do not use Sebivo after the expiry date which is stated on the carton and bottle label.
Tużax Sebivo wara d- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta tal- flixkun.
30 ml oral solution contain 600 mg telbivudine.
30 ml ta ’ soluzzjoni orali fiha 600 mg telbivudine.
- The other ingredients are: benzoic acid, sodium saccharin, passion fruit flavouring, sodium
- Is- sustanzi l- oħra huma: benzoic acid, sodium saccharin, passion fruit flavouring, sodium
hydroxide, citrc acid anhydrous, water.
hydroxide, citrc acid anhydrous, ilma.
What Sebivo looks like and contents of the pack Sebivo 20 mg/ ml oral solution is supplied as 300 ml of a clear, colourless to pale yellow solution in an brown glass bottle with a child-resistant white polypropylene closure, including a polyethylene sealing disc and a guarantee ring.
Id- Dehra ta ’ Sebivo u l- kontenuti tal- pakkett Is- soluzzjoni orali Sebivo 20 mg/ ml hija fornuta bħala 300 ml ta ’ soluzzjoni trasparenti, minn bla kulur sa safra ċara fi flixkun tal- ħġieġ kannella b’ għatu abjad tal- polypropylene li ma jinfetaħx mit - tfal, inkluż disk tal- polyethylene li tisiġilla u ċirku ta ’ garanzija.
The pack contains an oral dosing cup made of polypropylene with embossed graduations of 5 to 30 ml in 5 ml increments.
Il- pakkett fih tazza tad- doża magħmula mill- polypropylene mmarkata bi gradi ta ’ kejl ibbuzzat ’ il barra minn 5 ml sa 30 ml b’ żidiet ta ’ 5 ml.
51 INSTRUCTIONS FOR USE
52 ISTRUZZJONIJIET DWAR L- UŻU
Please read these instructions carefully so that you know how to use the solution correctly.
Jekk jogħġbok aqra sew dawn l- istruzzjonijiet biex tkun taf kif għandek tuża s- soluzzjoni kif suppost.
Bottle containing the oral solution.
Il- flixkun li fih is- soluzzjoni orali.
Child-resistant screw cap with a guarantee-ring.
Għatu bil- kamin li ma jinfetaħx mit- tfal b’ ċirku ta ’ garanzija.
Always close the bottle with the cap after use.
Dejjem agħlaq il- flixkun bl- għatu wara li tużah.
Oral dosing cup for measuring out the dose.
Tazza tad- doża orali biex tkejjel id- doża.
Always put the dosing cup back onto the cap after use and cleaning.
Dejjem erġa ’ poġgi t- tazza lura fuq it- tapp wara li tużaha u taħsilha.
Preparing a dose of medicine
Kif tipprepara doża tal- mediċina
Remove the dosing cup.
Neħħi t- tazza tad- doża.
Simultaneously press down (2a) and turn the child-resistant cap (2b) to open the bottle.
Filwaqt li tagħfas l- isfel (2a) dawwar l- għatu li ma jinfetaħx mit- tfal (2b) biex tiftaħ il- flixkun.
Before pouring any solution into the cup, please check the position of the appropriate graduation to avoid any potential waste or spillage.
Qabel ma tferragħ xi soluzzjoni fit- tazza, jekk jogħġbok iċċekkja l- pożizzjoni tal- marka sa fejn suppost timla biex tevita l- ħela jew li twaqqa ’.
Holding the cup at eye level, carefully and slowly pour the prescribed amount of solution from the bottle into the dosing cup until the solution reaches the top of the appropriate graduation.
Waqt li żżomm it- tazza bi dritt għajnejk, b’ attenzjoni u bilmod ferragħ l- ammont ta ’ soluzzjoni preskritta minn ġol- flixkun għal ġot- tazza tad- doża sakemm is- soluzzjoni tmiss man- naħa ta ’ fuq tal- marka sa fejn suppost timla.
discard the excess in the sink.
Jekk l- ammont li tferragħ fit- tazza jaqbeż id- doża li hemm bżonn, armi ż- żejjed fis- sink.
Do not pour it back into the bottle.
Terġax tferrgħu lura ġol- flixkun.
Drink the solution or administer it to the patient immediately.
Ixrob is- soluzzjoni jew agħtiha lill- pazjent immedjatament.
Close the bottle by screwing the cap back on tightly.
Agħlaq il- flixkun billi tpoġġi l- għatu lura fuq il- flixkun u tissikka sewwa l- kamin.
Immediately rinse the dosing cup with water.
Laħlaħ it- tażża tad- doża bl- ilma mill- ewwel.
Remove the water from the dosing cup, wipe it with a clean tissue and place it back on top of the cap.
Neħħi l- ilma minn ġot- tazza tad- doża, imsaħha b’ tixu nadifa u erġa ’ poġġiha lura fuq l- għatu tal- flixkun.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
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 tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Sifrol?
X' inhu Sifrol?
Sifrol is a medicine containing the active substance pramipexole base.
Sifrol hu mediċina li fiha s- sustanza attiva pramipexole base.
What is Sifrol used for?
Għal xiex jintuża Sifrol?
Sifrol is used to treat the symptoms of the following diseases: • Parkinson’ s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Sifrol jintuża fit- trattament tas- sintomi ta 'dan il- mard: • il- marda ta' Parkinson, disturb progressiv tal- moħħ li jikkawża rogħda, tnaqqis fil- ħeffa taċ- ċaqliq u ebusija tal- muskoli.
Sifrol can be used either on its own or in combination with levodopa (another medicine for Parkinson’ s disease), at any stage of disease including the later stages when levodopa starts becoming less effective; • moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Sifrol jista 'jintuża waħdu jew flimkien ma' levodopa (mediċina oħra għall - marda ta 'Parkinson), fi kwalunkwe stadju tal- marda inkluż l- istadji avvanzati meta levodopa tibda jkollha inqas effett; • Sindromu tar- riġlejn li ma għandhomx kwiet (restless legs syndrome) minn moderat għal gravi, disturb li jġiegħel il- pazjent iċaqlaq riġlejh u dirgħajh bla kontroll biex itaffi sensazzjonijiet ta' skumdità, ta 'wġigħ jew sensazzjonijiet strambi fil- ġisem, ġeneralment bil- lejl.
Sifrol is used when a specific cause for the disorder cannot be identified.
Sifrol jintuża meta ma tkunx tista 'tiġi identifikata xi kawża speċifika għad- disturb.
How is Sifrol used?
Kif jintuża Sifrol?
Sifrol tablets should be swallowed with water, with or without food.
Il- pilloli ta 'Sifrol għandhom jinbelgħu ma' l- ilma, ma 'l- ikel jew mingħajru.
Sifrol must be given less frequently in patients who have problems with their kidneys.
Sifrol għandu jingħata inqas frekwentement f' pazjenti li jkollhom problemi bil- kliewi.
For restless legs syndrome, Sifrol should be taken once a day, two to three hours before going to bed.
Għas- sindromu tar- riġlejn li ma għandhomx kwiet, Sifrol għandu jittieħed darba kuljum, bejn sagħtejn u tliet sigħat qabel l- irqad.
How does Sifrol work?
Kif jaħdem Sifrol?
The active substance in Sifrol, pramipexole, is a dopamine agonist, which imitates the action of dopamine.
Is- sustanza attiva f' Sifrol, pramipexole, hi agonista tad- dopamina, li timita l- azzjoni tad- dopamina.
Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination.
Id - dopamina hi sustanza messaġġiera f' partijiet mill- moħħ li jikkontrollaw iċ- ċaqliq u l- koordinazzjoni.
In patients with Parkinson’ s disease, the cells that produce dopamine begin to die and 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Fil- pazjenti bil- marda ta 'Parkinson, iċ- ċelluli li jipproduċu d- dopamina jibdew imutu u l- ammont ta' 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. the amount of dopamine in the brain decreases.
Reproduction is authorised provided the source is acknowledged. dopamina fil- moħħ jonqos.
The patients then lose their ability to control their movements reliably.
Il- pazjenti mbagħad jitilfu l- kapaċità li jikkontrollaw iċ- ċaqliq tagħhom b' mod ta 'min toqgħod fuqu.
Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson’ s disease, such as shaking, stiffness and slowness of movement.
Pramipexole jistimula l- moħħ bħad- dopamina, u b' hekk il- pazjenti jkunu jistgħu jikkontrollaw il- moviment tagħhom u jkollhom inqas sinjali u sintomi tal- marda ta 'Parkinson, bħar- rogħda, l- ebusija u t- tnaqqis fil- ħeffa taċ- ċaqliq.
How has Sifrol been studied?
Kif ġie studjat Sifrol?