qanastek/EMEA-V3 huggingface dataset:
This study is referenced as OGT 918-018.
Dan l- istudju hu riferut bħala OGT 918- 018.
Progress and recruitment updates will be provided alongside the Annual Re -assessment/ PSURs.
Aġġornamenti dwar l- progress u r- reklutaġġ ser ikunu pprovduti flimkien ma ’ l- Evalwazzjoni Annwali mill- Ġdid/ PSURs.
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
15 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Zavesca 100 mg hard capsules
Zavesca 100 mg kapsuli iebsa
Each capsule contains 100 mg miglustat
Kull kapsula fiha 100 mg ta ’ miglustat
17 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTURTA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Zavesca 100 mg hard capsules Miglustat
Zavesca 100 mg kapsuli iebsin Miglustat
if their symptoms are the same as yours.
ħsara, anki jekk ikollhom l- istess sintomi bhal tiegħek.
What Zavesca is and what it is used for 2.
X’ inhu Zavesca u għalxiex jintuża 2.
Before you take Zavesca 3.
Qabel ma tieħu Zavesca 3.
How to take Zavesca 4.
Kif tieħu Zavesca 4.
How to store Zavesca 6.
Kif taħżen Zavesca 6.
WHAT ZAVESCA IS AND WHAT IT IS USED FOR
X’ INHU ZAVESCA U GĦALXIEX JINTUŻA
Zavesca belongs to a group of medicines that affect metabolism.
Zavesca jappartieni għal grupp ta ’ mediċini li jaffettwaw il- metaboliżmu.
It is used to treat two conditions:
Huwa wżat għall- kura ta ’ żewġ kundizzjonijiet:
• Zavesca is used to treat mild to moderate type 1 Gaucher disease.
• Zavesca huwa wżat għall- kura tal- marda ta ’ Gaucher ta ’ tip 1 ħafifa sa moderata.
In type 1 Gaucher disease, a substance called glucosylceramide is not removed from your body.
Fil- marda ta ’ Gaucher ta ’ tip 1, sustanza msejħa glucosylceramide ma titneħħiex minn ġismek.
It starts to build up in certain cells of the body’ s immune system.
Hija tibda takkumula f’ ċerti ċelluli tas- sistema immuni tal- ġisem.
This can result in liver and spleen enlargement, changes in the blood, and bone disease.
Dan jista ’ jirriżulta fit- tkabbir tal- fwied u tal- milsa, tibdil fid- demm, u mard fl- għadam.
The usual treatment for type 1 Gaucher disease is enzyme replacement therapy.
Il- kura normali għal marda ta ’ Gaucher ta ’ tip 1 hi t- terapija tat- tibdil ta ’ l- enzimi.
Zavesca is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Zavesca jintuża biss meta pazjent ikun ikkunsidrat li mhuwiex adattat għal kura bit- terapija tat- tibdil ta ’ l- enzimi.
• Zavesca is also used to treat progressive neurological symptoms in Niemann-Pick type C disease.
• Zavesca huwa wżat ukoll għall- kura ta ’ sintomi newroloġiċi progressive fil- marda ta ’ Niemann- Pick ta ’ tip Ċ.
If you have Niemann-Pick type C disease, fats such as glycosphingolipids build up in the cells of your brain.
Jekk għandek il- marda Niemann- Pick ta ’ tip Ċ, xaħmijiet bħal glycosphingolipids jinġabru fiċ- ċelluli ta ’ moħħok.
This can result in disturbances in neurological functions such as eye movements, balance, swallowing, and memory, and in seizures.
Dan jista ’ jwassal f’ disturbi fil- funzjoni newroloġika bħal disturbi fil- moviment ta ’ l - għajnejn, fil- bilanċ, biex tibla ’, u fil- memorja, u f’ aċċessjonijiet.
Zavesca works by inhibiting the enzyme called ‘ glucosylceramide synthase’ which is responsible for the first step in the synthesis of most glycosphingolipids.
Zavesca jaħdem billi jinibixxi l- enzima msejjħa ‘ glucosylceramide synthase ’ li hija responsabbli għall - ewwel pass fis- sintesi tal- biċċa l- kbira tal- glycosphingolipids.
BEFORE YOU TAKE ZAVESCA
QABEL MA ’ TIEĦU ZAVESCA
Do not take Zavesca
Tieħux Zavesca
If this
- jekk inti allerġiku/ a (għandek sensittività eċċessiva) għal miglustat jew għal xi wieħed mis -
applies to you, tell your doctor.
sustanzi ta ’ Zavesca.
Don’ t take Zavesca.
Tieħux Zavesca.
Take special care with Zavesca
Oqgħod attent ħafna b’ Zavesca
- if you suffer from kidney disease
- jekk int tbati minn mard tal- kliewi
- if you suffer from liver disease
- jekk int tbati minn mard tal- fwied
If any of these apply to you, tell your doctor before you take Zavesca.
Jekk wieħed minn dawn il- każijiet japplika għalik, kellem lit- tabib tiegħek qabel ma tieħu Zavesca.
20 Your doctor will perform the following tests before treatment and during treatment with Zavesca:
20 ee It- tabib tiegħek ser jagħmillek it- testijiet li ġejjin qabel u waqt il- kura b’ Zavesca:
- an examination to check the nerves in your arms and legs
- eżami biex jiċċekkja n- nervituri ta ’ dirgħajk u ta ’ riġlejk
- measurement of vitamin B12 levels.
- kejl tal- livelli tal- vitamina B12.
- monitoring growth if you are a child or adolescent with Niemann-Pick type C disease
- sorveljanza tat- tkabbir jekk inti tifel/ tifla bil- marda ta ’ Niemann- Pick ta ’ tip Ċ
- monitoring of blood platelet counts if you are a patient with Niemann-Pick type C disease
- sorveljanza ta ’ l- għadd ta ’ plejtlits fid- demm jekk inti pazjent bil- marda ta ’ Niemann- Pick ta ’
The reason for these tests is that some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Zavesca.
Ir- raġunijiet għal dawn it- testijiet hu li xi pazjenti kellhom tnemnim jew tmewwit f’ idejhom u f’ saqajhom, jew tnaqqis fil- piż tal- ġisem, meta kienu qed jieħdu Zavesca.
The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Zavesca (see section 4 for further details).
Dawn it- testijiet ser jgħinu lit- tabib jiddeċiedi jekk dawn l- effetti humiex ġejjin mill- marda tiegħek jew minn kundizzjonijiet eżistenti oħra, jew minħabba effetti sekondarji ta ’ Zavesca (ara sezzjoni 4 għal iktar dettalji).
If you have diarrhoea, your doctor may ask you to change your diet to reduce your lactose and carbohydrate intake, or not to take Zavesca together with food, or to temporarily reduce your dose.
Jekk għandek dijarea, it- tabib tiegħek jista ’ jgħidlek biex tbiddel id- dieta tiegħek biex tnaqqas it- teħid ta ’ lactose u karboidrati, jew biex ma tieħux Zavesca flimkien ma ’ l- ikel, jew biex tnaqqas temporanjament id- doża tiegħek.
In some cases the doctor may prescribe anti-diarrhoeal medicines such as loperamide.
F’ ċertu każijiet it- tabib jista ’ jippreskrivilek mediċini kontra d- dijarea bħal loperamide.
If your diarrhoea does not respond to these measures, or if you have any other abdominal complaint, consult your doctor.
Jekk id- dijarea tiegħek ma tirrispondix għal dawn il- miżuri, jew jekk għandek xi problemi addominali oħra, kellem lit- tabib tiegħek.
In such case, your doctor may decide to conduct further investigations.
F’ dan il- kaz, it- tabib tiegħek jista ’ jiddeċidi biex jagħmel xi investigazzjonijiet oħra.
Male patients should use reliable birth control methods during their treatment with Zavesca, and for 3 months after finishing treatment.
Il- pazjenti rġiel għandhom jużaw metodi ta ’ kontraċezzjoni affidabbli waqt il- kura b’ Zavesca, u għal 3 xhur wara li titwaqqaf il- kura.
Using other medicines Talk to your doctor if you are using Cerezyme, or other medicines containing imiglucerase, which are sometimes used at the same time as Zavesca.
Meta tieħu mediċini oħra Kellem lit- tabib tiegħek jekk qed tieħu Cerezyme jew xi mediċini oħra li fihom imiglucerase, li kultant jintużaw fl- istess ħin ta ’ Zavesca.
They may lower the amount of Zavesca in your body.
Dawn jistgħu jnaqqsu l- ammont ta ’ Zavesca fil- ġisem tiegħek.
Please tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including medicines obtained without prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew jekk dan l- aħħar ħadt xi mediċini oħra, anki dawk mingħajr riċetta.
Taking Zavesca with food and drink Zavesca can be taken with or without food.
Meta tieħu Zavesca ma ’ l- ikel u max- xorb Zavesca jista ’ jittieħed ma ’ l- ikel jew mingħajr l- ikel.
You should swallow the whole capsule with a glass of water.
Għandek tibla ’ l- kapsula sħiħa ma ’ tazza ilma.
Pregnancy and breast-feeding You should not use Zavesca if you are pregnant or thinking of becoming pregnant.
Tqala u Treddigħ M’ għandekx tuża Zavesca jekk inti tqila jew jekk qed taħseb biex toħroġ tqila.
Your doctor can give you more information.
It- tabib tiegħek jista ’ jagħtik aktar informazzjoni.
You must use effective birth control while using Zavesca.
Għandek tuża metodu ta ’ kontraċezzjoni effettiv waqt l- użu ta ’ Zavesca.
Do not breast- feed while you are using Zavesca.
Treddax waqt li qed tuża Zavesca.
Driving and using machines Zavesca may make you feel dizzy.
Sewqan u tħaddim ta ’ magni Zavesca jista ’ jikkawża sturdament.
Do not drive or use any tools or machines if you feel dizzy.
M’ għandekx issuq, tagħmel użu minn għodda jew tħaddem magni jekk tħossok sturdut.
HOW TO TAKE ZAVESCA
KIF GĦANDEK TIEĦU ZAVESCA
Always take Zavesca exactly as your doctor has told you.
Dejjem għandek tieħu Zaveca skond il- parir tat -- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure about any of the instructions.
Dejjem għandek tiaċċeerta ruħek mat - tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubji.
• For type 1 Gaucher disease:
• Għall- marda ta ’ Gaucher ta ’ tip 1:
For adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening).
Għall- adulti, id- doża tas- soltu hija kapsula (100 mg) tliet darbiet kuljum (filgħodu, wara nofsinhar u filgħaxija).
This means a daily maximum of three capsules (300 mg).
Dan ifisser massimu ta ’ tliet kapsuli kuljum (300 mg).
• For Niemann-Pick type C disease:
21 • Għall- marda ta ’ Niemann- Pick ta ’ tip Ċ:
For adults and adolescents, the usual dose is two capsules (200 mg) three times a day (morning, afternoon and evening).
Għall- adulti u adoloxxenti, id- doża tas- soltu hija żewġ kapsuli (200 mg) tliet darbiet kuljum (filgħodu, wara nofsinhar u filgħaxija).
This means a daily maximum of six capsules (600 mg).
Dan ifisser massimu ta ’ sitt kapsuli kuljum( 600 mg).
21 If you are less than 12 years old, your doctor will adjust your dose for Niemann-Pick type C disease.
Jekk inti għandek inqas minn 12- il sena, it- tabib tiegħek ser jaġġusta d- doża tiegħek għall- marda ta ’ Niemann- Pick ta ’ tip Ċ.
If you have a problem with your kidneys you may receive a lower starting dose.
Jekk inti għandek problema bil- kliewi tiegħek tista ’ tirċievi doża tal- bidu aktar baxxa.
Your doctor may reduce your dose, e. g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Zavesca (see section 4).
It- tabib tiegħek jista ’ jnaqqas id- doża tiegħek, eż., għall- kapsula waħda (100 mg) darba jew darbtejn kuljum, jekk inti ssofri minn dijarea meta tieħu Zavesca (ara sezzjoni 4).
Your doctor will tell you how long your treatment will last.
It- tabib tiegħek ser jgħidlek kemm ser iddum il- kura tiegħek.
To remove the capsule:
Biex tneħħi l- kapsula:
Separate at perforations 2.
Issepara fil- perforazzjonijiet 2.
Peel back paper at arrows 3.
Qaxxar il- karta lura fejn hemm il- vleġeġ 3.
Push product through foil
Imbotta l- prodott minn ġol- fojl
The Zavesca capsule should be swallowed whole with water.
Għandek tibla ’ kapsula Zavesca sħiħa ma ’ l- ilma.
If you take more Zavesca than you should If you take more capsules than you were told to, consult your doctor immediately.
Jekk tieħu aktar kapsuli milli suppost, kellem lit- tabib tiegħek immedjatament.
Zavesca has been used in clinical trials at doses ten times higher than the recommended dose: this caused decreases in white blood cells and other side effects similar to those described in section 4.
Zavesca ntuża fi provi kliniċi b’ dożi li kienu għaxar darbiet ogħla mid- doża rrakkomandata: dan wassal għal tnaqqis fiċ - ċelluli bojod tad- demm u effetti sekondarji oħra li kienu bħal dawk deskritti f’ sezzjoni 4.
If you forget to take Zavesca Take the next capsule at the usual time.
Jekk tinsa tieħu Zavesca
Do not take a double dose to make up for a forgotten dose.
Jekk tieqaf tieħu Zavesca
If you stop taking Zavesca Don’ t stop taking Zavesca without talking to your doctor.
Tieqafx tieħu Zavesca mingħajr ma tgħid lit- tabib tiegħek.
Like all medicines, Zavesca can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Zavesca jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common effects – likely to affect more than 1 in 10 people The most common side effects are weight loss, tremor, diarrhoea, flatulence (wind), abdominal (stomach) pain.
Effetti komuni ħafna – x’ aktarx jaffettwa 1 minn kull 10 persuni L- aktar effetti sekondarji komuni huma tnaqqis fil- piż, tregħid, dijarea, gass, uġigħ addominali (fl - istonku)
Common effects – likely to affect less than 1 in 10 people and more than 1 in 100 people Common side effects of treatment include anorexia (lack of appetite), decreased appetite, headache, dizziness, peripheral neuropathy, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets). The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Sintomi newroloġiċi u tromboċitopenja jistgħu jkunu kkawżati mill- marda li ġa hemm.
Other possible side effects are muscular spasms or weakness, fatigue, difficulty sleeping, and less libido.
Effetti sekondarji possibli oħrajn huma spażmi jew dgħjufija fil- muskoli, għeja, diffikultà biex torqod u tnaqqis fil- libido.
Most patients get one or more of these side effects, usually at the start of treatment or at intervals during treatment.
Il- biċċa l- kbira tal- pazjenti jkollhom wieħed jew aktar minn dawn l- effetti sekondarji ġeneralment fil- bidu tal- kura jew xi kultant matul il- kors tal- kura.
Most cases are mild and disappear quite quickly.
Il- biċċa l- kbira tal- każijiet huma ħfief u jgħibu pjuttost malajr.
If any of these side effects cause
Jekk xi wieħed minn dawn l- effetti sekondarji joħolqu problemi, ikkonsulta lit- tabib tiegħek.
He or she may reduce the dose of Zavesca or recommend other medicines to help control side effects.
Hu jew hi tista ’ tnaqqas id- doża ta ’ Zavesca jew jirrakkomandawlek mediċini oħra biex jgħin fil- kontroll ta ’ l- effetti sekondarji.
Some patients have had tingling or numbness in the hands and feet.
Xi pazjenti kellhom tnemnim jew tmewwit f’ idejn u s- saqajn.
They could be signs of peripheral neuropathy, due to side effects of Zavesca or they could be due to existing conditions.
Dawn jistgħu jkunu sinjali ta ’ newtropatija periferali, minħabba l- effetti sekondarji ta ’ Zavesca jew jistgħu jkunu dovuti għal kundizzjonijiet eżistenti.
Your doctor will perform some tests before and during treatment with Zavesca to assess this (see section 2).
It- tabib tiegħek ser jagħmel xi testijiet qabel u waqt it- trattament b’ Zavesca sabiex jivvaluta dan (ara sezzjoni 2).
If you do get any of these effects, please report them to your doctor as soon as possible.
Jekk ikollok xi wieħed minn dawn l- effetti, jekk jogħġbok irraporthom lit- tabib tiegħek kemm jista ’ jkun malajr.
If you do lose some weight when you start treatment with Zavesca don’ t worry.
Jekk tonqos fil- piż meta tibda l- kura b’ Zavesca, tinkwetax.
People usually stop losing weight as treatment goes on.
Dan l- effett għandu jieqaf hekk kif titkompla l- kura b’ Zavesca.
If you get a slight tremor, usually trembling hands, report it to your doctor as soon as possible.
Jekk ikollok ftit tar- rogħda, l- aktar jitregħdu l- idejn, irraporta dan lit- tabib tiegħek mill- iktar fis possibbli.
The tremor often disappears without needing to stop the treatment.
Ħafna drabi din ir- rogħda tgħib mingħajr il- bżonn li titwaqqaf il- kura.
Sometimes your doctor will need to reduce the dose or stop Zavesca treatment to stop the tremor.
Xi drabi jista ’ jkun hemm il- bżonn li t- tabib tiegħek inaqqaslek id- doża jew iwaqqaflek il- kura b’ Zavesca biex tieqaf ir- rogħda.
For storage and other information, please turn over.
Għall- informazzjoni dwar ħażna jew informazzjoni oħra, jekk jogħġbok aqleb.
HOW TO STORE ZAVESCA
KIF TAĦŻEN ZAVESCA
Do not use Zavesca after the expiry date stated on the carton.
Tużax Zavesca wara d- data ta ’ skadenza li tidher fuq il- pakkett
Store below 30 °C.
Aħżen f’ temperatura taħt 30°C.
What Zavesca contains
X’ fih Zavesca
The active substance is miglustat 100 mg.
Is- sustanza attiva hi miglustat 100 mg.
Other ingredients in the capsule are:
Is- sustanzi l- oħra fil- kapsula huma:
Other ingredients in the capsule shell are:
23 Sustanzi oħra fil- qoxra tal- kapsula huma:
Gelatin, Water, Titanium dioxide (E171).
Ġelatina, Ilma Titanium dioxide (E172)
Black iron oxide (E172) Shellac.
Sustanzi oħra fil- linka ta ’ l- istampar huma Black iron oxide Shellac.
23 What Zavesca looks like and contents of the pack
Id- dehra ta ’ Zavesca u l- kontenuti tal- pakkett
Zavesca is a white 100 mg capsule with “ OGT 918” printed in black on the cap and “ 100” printed in black on the body.
Zavesca huwa kapsula bajda ta ’ 100 mg b ’ “ OGT 918 ” stampata bl- iswed fuq l- għatu u “ 100 ” stampata bl- iswed fuq il- korp tal- kapsula.
Box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
Kaxxa ta ’ 4 strixxi tal- folji, kull strixxa tal- folji fiha 21 kapsula għal total ta ’ 84 kapsula.
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63– 65 79100 Freiburg Germany
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63- 65 79100 Freiburg Il- Ġermanja
България Actelion Pharmaceuticals Ltd Teл.: +420-2 3413 8150
420- 2 3413 8150
Č eská republika Actelion Pharmaceuticals Ltd Tel: +420-2 3413 8150
Česká republika Actelion Pharmaceuticals Ltd Tel: +420 2 3413 8150
Österreich Actelion Pharmaceuticals Austria GmbH Tel: +43-(0)1 505 4527
Österreich Actelion Pharmaceuticals Austria GmbH Tel: + 43 - (0) 1 505 4527
This leaflet was last approved in:
Dan il- fuljett kien approvat l- aħħar f ’:
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Dan ifisser li minħabba r- rarità tal- marda kien impossibbli li tinkiseb informazzjoni kompleta dwar din il- mediċina.
What is Zeffix?
X’ inhu Zeffix?
Zeffix is a medicine containing the active substance lamivudine.
Zeffix huwa mediċina li fiha s- sustanza attiva lamivudine.
It is available as yellow, capsule shaped tablets (100 mg) and a clear pale yellow solution (5 mg/ ml).
Jiġi bħala pilloli sofor forma ta ’ kapsuli (100mg) u bħala soluzzjoni safra ċara (5 mg/ ml).
What is Zeffix used for?
Għal xiex jintuża Zeffix?
Zeffix is used to treat adult patients who have chronic (long term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus).
Zeffix jintuża fit- trattament ta ’ pazjenti adulti li jkollhom epatite B kronika (fit- tul) (marda tal- fwied ikkawżata minn infezzjoni bil- virus ta ’ l- epatite B).
It is used in patients with: • compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of the liver enzyme ‘ alanine aminotransferase’ [ALT] and signs of damage when liver tissue is examined under a microscope), • decompensated liver disease (when the liver is damaged and does not function normally).
Jintuża f’ pazjenti li għandhom: • Mard tal- fwied kompensat (meta l- fwied ikollu l- ħsara iżda jibqa ’ jaħdem normalment), li juru wkoll sinjali li l- virus ikun għadu jimmultiplika, u jkollhom sinjali ta ’ ħsara fil- fwied (livelli għoljin ta ’ l- enzim 'alanina aminotransferażi' (alanine aminotransferase) [ALT] u sinjali ta ’ ħsara meta t- tessut tal- fwied jiġi eżaminat taħt mikroskopju), • Mard tal- fwied dekompensat (meta l- fwied ikollu l- ħsara u ma jaħdimx sew).
How is Zeffix used?
Kif jintuża Zeffix?
Treatment with Zeffix should be initiated by a doctor who has experience in the management of chronic hepatitis B.
It- trattament b’ Zeffix għandu jinbeda minn tabib li jkollu esperjenza fil- ġestjoni ta ’ l- epatite B kronika.
The recommended dose of Zeffix is 100 mg once a day.
Id- doża rakkomandata ta ’ Zeffix hija ta ’ 100 mg darba kuljum.
Zeffix can be taken with or without food.
Zeffix jista ’ jittieħed waħdu jew ma ’ l- ikel.
The dose needs to be lowered for patients who have problems with their kidneys, using the oral solution.
Id- doża jkollha bżonn titbaxxa għal pazjenti li jkollhom problemi bil- kliewi, meta tintuża s- soluzzjoni orali.
The duration of treatment depends on the patient’ s condition and response to treatment.
Id- dewmien tat- trattament jista ’ jiddependi mill- kundizzjoni tal- pazjenti u mir- rispons għat- trattament.
For more information, please see the Summary of Product Characteristics (also part of the EPAR).
Għal iktar tagħrif, jekk jogħġbok ara s- Sommarju tal- Karatteristiċi tal - Prodott (li huwa wkoll parti mill- EPAR).
How does Zeffix work?
Kif jaħdem Zeffix?
The active substance in Zeffix, lamivudine, is an antiviral agent belonging to the class of the nucleoside analogues.
Is- sustanza attiva f’ Zeffix, lamivudine, hija aġent antivirali li jagħmel parti mill- klassi ta ’ l- analogi tan- nukleosidi.
Lamivudine interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Lamivudine jinterferixxi ma ’ l- azzjoni ta ’ l- enzim virali, DNA polymerase, li għandu x’ jaqsam mal- formazzjoni tad- DNA virali.
Lamivudine stops the virus making DNA and prevents it from multiplying and spreading.
Lamivudine iwaqqaf il- virus milli jagħmel id- DNA u jipprevjenih milli jimmultiplika u jinfirex.
How has Zeffix been studied?
Kif ġie studjat Zeffix?
Zeffix has been studied in five main studies involving a total of 1,083 adult patients.
Zeffix ġie studjat f’ ħames studji ewlenin li fihom b’ kollox ħadu sehem 1, 083 pazjent adult.
Three studies compared the effectiveness of Zeffix to that of placebo (a dummy treatment) in patients with compensated chronic hepatitis B, including one study that looked more particularly at the effectiveness of Zeffix in ‘ HBeAg negative’ patients.
Tlieta mill- istudji qabblu l- effikaċja ta ’ Zeffix ma ’ dik tal- plaċebo (trattament finta) f’ pazjenti b’ epatite B kronika kompensata, inkluż studju wieħed li ħares b’ mod iktar partikolari lejn l - effikaċja ta ’ Zeffix f’ pazjenti ‘ negattivi għall- HBeAg ’.
These are patients infected with hepatitis B virus 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Dawn huma pazjenti infettati bil- virus ta ’ l- epatite B li jkun 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(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 that has mutated (changed), leading to a form of chronic hepatitis B that is more difficult to treat.
(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 inbidel (tkun saritlu mutazzjoni), li jwassal għal forma ta ’ epatite B kronika iktar diffiċli biex tiġi ttrattata.
Two studies looked the use of Zeffix on its own compared with alfa-interferon (another treatment used in chronic hepatitis B) either on its own or with Zeffix.
Żewġ studji minnhom ħarsu lejn l- użu ta ’ Zeffix waħdu mqabbel ma ’ alfa- interferon (trattament ieħor użat fl- epatite B kronika) jew waħdu jew ma ’ Zeffix.
There were several measures of effectiveness in the studies.
Kien hemm diversi miżuri ta ’ l - effikaċja f’ dawn l- istudji.
These included looking at how the liver damage had evolved after 52 weeks of treatment using a liver biopsy (when a small sample of liver tissue is taken and examined under a microscope), as well as measuring other signs of the disease such as the levels of ALT or of hepatitis B viral DNA circulating in the blood.
Fost dawn ġiet studjata kif evolviet il- ħsara fil- fwied wara 52 ġimgħa trattament bl- użu tal- bijopsija tal- fwied (meta jittieħed kampjun żgħir tat- tessut tal- fwied u jiġi eżaminat taħt mikroskopju), kif ukoll sinjali oħra tal- marda bħal- livelli ta ’ l- ALT jew tad- DNA virali ta ’ l- epatite B li jiċċirkola fid- demm.
A further analysis was carried out comparing patients with and without the ‘ YMDD mutation’ (a change in the hepatitis B virus ’ s DNA that is often found after treatment with lamivudine).
Saret analiżi iktar dettaljata li tqabbel pazjenti li fihom tkun saret ‘ mutazzjoni YMDD ’ (tibdil fid - DNA tal- virus ta ’ l- epatite B li tinstab b’ mod komuni wara t- trattament b’ lamivudine) ma ’ dawk li fihom din ma tkunx seħħet.
What benefit has Zeffix shown during the studies?
X’ inhu l- benefiċċju ta ’ Zeffix li ntwera f’ dawn l- istudji?
Zeffix was more effective than placebo in slowing down the progression of liver disease.
Zeffix kien iktar effikaċi mill- plaċebo fit- tnaqqis tal- progressjoni tal- mard tal- fwied.
About half of the patients taking Zeffix had an improvement in liver damage assessed in a biopsy, compared with about a quarter of the patients who took placebo.
Madwar nofs il - pazjenti li kienu qed jieħdu Zeffix kellhom titjib fil- ħsara tal- fwied kif valutata minn bijopsija, meta mqabbla ma ’ madwar kwart tal- pazjenti li kienu ngħataw il- plaċebo.
Zeffix was as effective as alfa-interferon.
Zeffix kien effikaċi daqs alfa - interferon.
The analysis showed that patients with the YMDD mutation do not respond as well to treatment with Zeffix as those without the mutation.
L- analiżi wriet li l- pazjenti bil- mutazzjoni YMDD ma jirrispondux tajjeb għat- trattament daqs dawk mingħajr il- mutazzjoni.
What is the risk associated with Zeffix?
X’ inhu r- riskju assoċjat ma ’ Zeffix?
The most common side effect with Zeffix (seen in more than 1 patient in 10) is raised ALT levels.
L- iktar effett sekondarju komuni ma ’ Zeffix (li dehru f’ iktar minn pazjent wieħed minn kull għaxra) huwa livelli għoljin ta ’ ALT.
For the full list of all side effects reported with Zeffix, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Zeffix, ara l- Fuljett ta ’ Tagħrif.
Zeffix should not be used in people who may be hypersensitive (allergic) to lamivudine or any of the other ingredients.
Zeffix m’ għandux jintuża minn persuni allerġiċi għal lamivudine jew għal kwalunkwe mill- ingredjenti l- oħra.
Why has Zeffix been approved?
Għaliex ġie approvat Zeffix?
The Committee for Medicinal products for Human Use (CHMP) decided that Zeffix’ s benefits are greater than its risks for treatment of chronic hepatitis B in adults with compensated liver disease with evidence of active viral replication, persistently elevated serum ALT levels and histological evidence of active liver inflammation and/ or fibrosis, and in adults with decompensated liver disease.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Zeffix huma ikbar mill- benefiċċji tiegħu meta użat għat- trattament ta ’ l- epatite B kronika f’ adulti b’ mard tal- fwied kompensat b’ evidenza ta ’ tkattir virali attiv, livelli ta’ ALT persistentement għoljin u evidenza istoloġika ta ’ infjammazzjoni u/ jew fibrożi attiva, u f’ adulti b’ mard tal- fwied dekompensat.
They recommended that Zeffix be given marketing authorisation.
Huma rrakkomandaw li Zeffix jingħata l- approvazzjoni għat- tqegħid fis- suq.
Zeffix was originally authorised under "Exceptional Circumstances", because, for scientific reasons, limited information was available at the time of approval.
Oriġinarjament, Zeffix kien awtorizzazzat taħt “ Ċirkustanzi ta ’ Eċċezzjoni ” minħabba li, għal raġunijiet xjentifiċi, it- tagħrif disponibbli fi żmien l- approvazzjoni kien limitat.
As the company had supplied the additional information requested, the "Exceptional Circumstances" ended on 18 May 2001.
Billi l- kumpanija kienet forniet it- tagħrif addizzjonali mitlub, iċ - ‘ Ċirkustanzi ta ’ Eċċezzjoni ’ ntemmu fit- 18 ta ’ Mejju ta ’ l- 2001.
Other information about Zeffix:
Tagħrif ieħor dwar Zeffix:
The European Commission granted a marketing authorisation valid throughout the European Union for Zeffix to Glaxo Group Ltd on 29 July 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Zeffix lil Glaxo Group Ltd fid- 29 ta ’ Lulju 1999.
The marketing authorisation was renewed on 29 July 2004.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid- 29 ta ’ Lulju 2004.
The full EPAR for Zeffix is available here.
L- EPAR sħiħ għal Zeffix huwa disponibbli minn hawnhekk.
Zeffix 100 mg film-coated tablets
Zeffix pilloli ta ’ 100 mg miksijin b’ rita
Zeffix film-coated tablets contain 100 mg lamivudine For a full list of excipients see section 6.1.
Zeffix pilloli miksijin b’ rita fihom 100 mg lamivudine Għal lista sħiħa ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Butterscotch coloured, film-coated, capsule shaped, biconvex and engraved “ GX CG5” on one face.
Lewn butterscotch, miksija b’ rita, forma ta ’ kapsula, ibbuzata fuq iż- żewġ naħat u mnaqqxa bi “ GX CG5 ” fuq naħa waħda.
Zeffix is indicated for the treatment of chronic hepatitis B in adults with:
Zeffix hu indikat għat- trattament tal- epatite B kronika f’ adulti li għandhom:
compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis.
mard kumpensat tal- fwied b’ evidenza ta ’ replikazzjoni virali attiva, b’ livelli elevati b’ persistenza ta ’ alanine aminotransferase (ALT) fis- serum u evidenza istoloġika ta 'infjammazzjoni attiva tal - fwied u/ jew fibrożi.
decompensated liver disease.
mard mhux kumpensat tal- fwied.
Therapy with Zeffix should be initiated by a physician experienced in the management of chronic hepatitis B.
It- terapija b’ Zeffix trid tinbeda minn tabib ta 'esperjenza fil- maniġġjar ta' l- epatite B kronika.
Adults: the recommended dosage of Zeffix is 100 mg once daily.
Adulti: d- doża rakkomandata ta 'Zeffix hi ta' 100mg darba kuljum.
Zeffix can be taken with or without food.
Zeffix jista 'jittieħed ma' l- ikel jew fuq xejn.
Duration of treatment:
Tul tat- trattament:
• In patients with HBeAg positive chronic hepatitis B (CHB) treatment should be administered for at least 3-6 months after HBeAg seroconversion (HBeAg and HBV DNA loss with HBeAb detection) is confirmed, to limit the risk of virological relapse, or until HBsAg seroconversion.
• F' pazjenti bl- epatite B kronika (CHB) pożittiva għall- HbeAg it- trattament għandu jiġi amministrat għallinqas għal 3- 6 xhur wara li tiġi kkonfermata s- serokonverżjoni ta 'l- HbeAg (telf ta' HbeAg u HBV DNA bi skoperta ta 'HbeAB), biex jitnaqqas ir- riskju li l- pazjent jirkadi viroloġikament jew sas- serokonverżjoni tal- HbsAg.
This recommendation is based on limited data (see section 5.1). • In patients with HBeAg negative CHB (pre-core mutant), the optimal duration of treatment is unknown.
Din ir- rakkomandazzjoni hi bbażata fuq tagħrif limitat (ara sezzjoni 5. 1). • F' pazjenti b’ CHB negattiva għall- HbeAg (mutant pre- core) it- tul ta ’ trattament ottimali mhuwiex magħruf.
Treatment discontinuation may be considered following HBsAg seroconversion. • In patients with either HBeAg positive or HBeAg negative CHB, the development of YMDD variant HBV may result in a diminished therapeutic response to lamivudine, indicated by a rise in HBV DNA and ALT from previous on-treatment levels.
Waqfien tat- trattament jista 'jiġi kkunsidrat wara s- serokonverżjoni tal - HbsAg. • F' pazjenti b’ CHB pożittiva għall- HbeAg jew negattiva għall- HbeAg, l- iżvilupp tal- varjant YMDD ta ’ l- HBV jista jirriżulta f’ rispons terapewtiku mnaqqas għal lamivudine, li jintwera b’ żieda ta ’ l- HBV DNA u ta ’ l- ALT mill- livelli preċedenti ta ’ waqt it- trattament.
In patients with extended-duration YMDD variant HBV, a switch to or addition of an alternative agent should be considered (see section 5.1). • In patients with decompensated liver disease and liver transplant recipients, treatment cessation is not recommended.
F’ pazjenti bil - varjant YMDD ta ’ l- HBV li jdum għal żmien twil, l- użu ta ’ trattament alternattiv għandu jiġi kkunsidrat flimkien jew minnflok dan it- trattament (ara sezzjoni 5. 1). • F' pazjenti b' mard mhux kumpensat tal- fwied u f’ dawk li għaddew minn trapjant tal- fwied, il - waqfien tat- trattament mhux rakkomandat.
If there is a loss of efficacy attributable to the emergence of YMDD variant HBV in these patients, additional or alternative therapies should be considered (see section 5.1).
Jekk f’ dawn il- pazjenti, hemm telf ta ’ effikaċja minħabba l- iżvilupp tal- varjant YMDD ta ’ l- HBV, l- użu ta ’ terapiji alternattivi għandhom jiġu kkunsidrati flimkien jew minnflok dan it- trattament (ara sezzjoni 5. 1).
2 If Zeffix is discontinued, patients should be periodically monitored for evidence of recurrent hepatitis (see section 4.4).
(ara sezzjoni 4. 4).
Children (less than 12 years of age) and adolescents (12 to 17 years of age):
Tfal (ta ’ inqas minn 12- il sena) u adoloxxenti (12 sa 17- il sena):
Zeffix is not recommended for use in children below age 12 and adolescents age 12 to 17 due to lack of data on safety and efficacy (see section 5.2).
Zeffix mhux indikat għall- użu fi tfal ta ’ taħt 12- il sena u fl- adoloxxenti ta ’ 12 sa 17- il- sena minħabba nuqqas ta ’ tagħrif dwar is- sigurtà u l - effikaċja (ara sezzjoni 5. 2).
Renal impairment: lamivudine serum concentrations (AUC) are increased in patients with moderate to severe renal impairment due to decreased renal clearance.
Indeboliment tal- kliewi: il- konċentrazzjonijiet ta 'lamivudine fis- serum (AUC) jiżdiedu f' pazjenti bi kliewi indeboliti b' mod moderat jew severament minħabba t- tneħħija mnaqqsa mill- kliewi.
The dosage should therefore be reduced for patients with a creatinine clearance of < 50 ml/ minute.
Id- dożaġġ għandu għalhekk jitnaqqas f' pazjenti bi tneħħija ta 'kreatinina ta < 50 ml/ minuta.
When doses below 100 mg are required Zeffix oral solution should be used (see Table 1 below).
Meta dożi ta 'inqas minn 100 mg ikunu meħtieġa għandha tintuża t- taħlita likwida orali Zeffix (ara Tabella 1 hawn taħt).
Dosage of Zeffix in patients with decreased renal clearance.
Dożaġġ ta ’ Zeffix f’ pazjenti bit- tneħħija mnaqqsa mill- kliewi.
Creatinine clearance ml/ min
Tneħħija ta 'kreatinina
First Dose of Zeffix oral solution *
L- ewwel doża ta 'taħlita
Maintenance Dose Once daily
Doża ta ’ manteniment
15 to < 30
15 to < 30
5 to < 15
5 to < 15
* Zeffix oral solution containing 5 mg/ ml lamivudine.
* Soluzzjoni li tittieħed mill- ħalq Zeffix li jkun fiha 5 mg/ ml lamivudine.
Data available in patients undergoing intermittent haemodialysis (for less than or equal to 4 hrs dialysis 2-3 times weekly), indicate that following the initial dosage reduction of lamivudine to correct for the patient’ s creatinine clearance, no further dosage adjustments are required while undergoing dialysis.
It- tagħrif disponibbli dwar pazjenti għaddejjin minn proċess intermittenti ta 'dijaliżi tad- demm (ta' inqas minn, jew ugwali għal 4 sigħat dijaliżi 2- 3 darbiet kull ġimgħa), jindikaw li wara t- tnaqqis inizjali tad- dożaġġ ta 'lamivudine biex jagħmel tajjeb għat- tneħħija tal- kreatinina mill- pazjent, ma jibqax aktar ħtieġa għal aġġustamenti tad- dożaġġ waqt li jkun għaddej il- proċess ta' dijaliżi.
Hepatic impairment: data obtained in patients with hepatic impairment, including those with end-stage liver disease awaiting transplant, show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Indeboliment fil- fwied: tagħrif miksub minn pazjenti b' indeboliment epatiku, inklużi dawk fl- aħħar fażi tal- mard fil- fwied li qed jistennew trapjant, juri li l- farmakokinetiċi ta ’ lamivudine mhumiex affettwati b' mod sinifikanti ta 'anormalita' ta 'funzjoni epatika.
Based on these data, no dose adjustment is necessary in patients with hepatic impairment unless accompanied by renal impairment.
Fuq bażi ta 'dan it- tagħrif m' hemmx il - ħtieġa ta' aġġustament f' pazjenti bil- marda tal- fwied fin- nuqqas ta 'indeboliment tal- kliewi.
Lamivudine has been administered to children (2 years and above) and adolescents with compensated chronic hepatitis B.
Lamivudine ingħata lil tfal (ta 'sentejn u aktar) u adolexxenti b' epatite B kronika kumpensata.
However, due to limitations of the data, the administration of lamivudine to this patient population is not currently recommended (see section 5.1).
Madankollu, minħabba nuqqas ta 'tagħrif, il- lamivudine mhux rakkomandat għal pazjenti ta' dawn l - etajiet (ara sezzjoni 5. 5).
The efficacy of lamivudine in patients co-infected with Delta hepatitis or hepatitis C has not been established.
L- effikaċja ta ’ lamivudine f' pazjenti ko- infettati bl- epatite Delta jew epatite C ma ġietx stabbilita.
Data are limited on the use of lamivudine in HBeAg negative (pre-core mutant) patients and in those receiving concurrent immunosuppressive regimes, including cancer chemotherapy.
Tagħrif dwar l- użu ta ’ lamivudine f' pazjenti b' HbeAg negattiv (mutant pre- core) u f' dawk li qed jirċievu concurrent immunosuppressive regimes, inkluża l- kemjoterapija għall- kanċer huwa limitat.
During treatment with Zeffix patients should be monitored regularly.
Waqt li qed jirċievu t- trattament b’ Zeffix, pazjenti għandhom jiġi monitorjati regolarment.
Serum ALT levels should be monitored at 3 month intervals and HBV DNA and HBeAg should be assessed every 6 months.
Il- livell ta ’ ALT fis- serum għandu jiġi monitorjati kull tlett xhur u l- HBV DNA u l- HbeAg għandhom jiġu assessjati kull sitt xhur.
3 Exacerbations of hepatitis
3 Attakk qawwi ta ’ l- epatite
HBV viral subpopulations with reduced susceptibility to lamivudine (YMDD variant HBV) have been identified with extended therapy.
Subpopulations ta 'HBV virali b' suxxettibilita' mnaqqsa għal lamivudine (varjant YMDD ta ’ l- HBV) ġew identifikati wara terapija fit- tul.
In some patients the development of YMDD variant HBV can lead to exacerbation of hepatitis, primarily detected by serum ALT elevations and re-emergence of HBV DNA.
F' xi pazjenti, l- iżvilupp tal- varjant YMDD ta ’ l- HBV jista 'jwassal biex titħarrax l- epatite, li titfaċċa fil- bidu b' żieda tas- serum ALT u bil- ħruġ mill- ġdid ta' HBV DNA.
In patients who have YMDD variant HBV and worsening liver disease (increasing ALT with or without decompensated cirrhosis) or recurrent hepatitis B after liver transplantation, a switch to or addition of an alternative agent should be considered.
F’ pazjenti bil- varjant YMDD ta ’ l- HBV u b’ mard tal- fwied li qed jaqleb għal- agħar (ALT li qed jiżdied bi jew mingħajr ċirrozi mhux kumpensata) jew bl- epatite B li terġa titfaċċa wara trapjant tal - fwied, l- użu ta ’ trattament alternattiv għandu jiġi kkunsidrat flimkien jew minnflok dan it- trattament.
If Zeffix is discontinued or there is a loss of efficacy due to the development of YMDD variant HBV (see section 4.2), some patients may experience clinical or laboratory evidence of recurrent hepatitis.
Jekk Zeffix ma jibqgħax jittieħed jew ikun hemm nuqqas ta 'effikaċja minħabba l- iżvilupp tal- varjant YMDD ta ’ l- HBV (ara sezzjoni 4. 2), xi pazjenti jistgħu juru evidenza klinika jew ta' laboratorju ta 'epatite rikorrenti.
If Zeffix is discontinued, patients should be periodically monitored both clinically and by assessment of serum liver function tests (ALT and bilirubin levels), for at least four months, and then as clinically indicated.
Jekk Zeffix jitwaqqaf, il- pazjenti għandhom jiġu monitorjati perjodikament kemm klinikament u kemm b' valutazzjoni permezz ta 'testijiet dwar il- funzjoni ta' serum fil- fwied (livelli ta 'ALT u bilirubin), għal erba' xhur mill- inqas, imbagħad kif klinikament indikat.
Exacerbation of hepatitis has primarily been detected by serum ALT elevations, in addition to the re-emergence of HBV DNA.
Il- peġġjorament ta 'l - epatite ġie nnotat primarjament b' żieda tas- serum ALT, barra milli terġa' titfaċċa l- HBV DNA.
See Table 3 in Section 5.1 Clinical experience for more information regarding frequency of post treatment ALT elevations.
Ara Tabella 3 fis- Sezzjoni 5. 1 Esperjenza klinika għal aktar tagħrif dwar il- frekwenza ta 'żidiet ta' ALT wara t- trattament.
Most events have been self- limited, however some fatalities have been observed.
Il- biċċa l- kbira tal- każi kienu limitati fihom infushom, madankollu ġew osservati xi fatalitajiet.
For patients who develop evidence of recurrent hepatitis post-treatment, there are insufficient data on the benefits of re-initiation of lamivudine treatment.
Għal pazjenti li jiżviluppaw sinjali ta 'epatite rikorrenti wara t- trattament, m' hemmx tagħrif biżżejjed dwar il- benefiċċji tat- trattament mill- ġdid b’ lamivudine.
Transplantation recipients and patients with advanced liver disease are at greater risk from active viral replication.
Dawk li kellhom trapjanti u pazjenti b' mard avanzat tal- fwied huma f' riskju ikbar ta 'replikazzjoni attiva virali.
Due to the marginal liver function in these patients, hepatitis reactivation at discontinuation of lamivudine or loss of efficacy during treatment may induce severe and even fatal decompensation.
Billi f' dawn il- pazjenti l- fwied jaħdem ftit wisq, il- ħruġ mill- ġdid ta 'l- epatite mat - twaqqif ta ’ lamivudine jew in- nuqqas ta' effettivita 'waqt il- kura jistgħu iwasslu għal decompensation qawwija jekk mhux fatali.
These patients should be monitored for clinical, virological and serological parameters associated with hepatitis B, liver and renal function, and antiviral response during treatment (at least every month), and, if treatment is discontinued for any reason, for at least 6 months after treatment.
Dawn il- pazjenti għandhom jiġu monitorjati għall- parametri kliniċi, viroloġiċi u seroloġiċi assoċjati ma 'l- epatite B, għall- funzjoni tal- fwied u l- kliewi, u għar- reazzjoni antivirali waqt it- trattament (għallinqas ta' kull xhar) u jekk it- trattament jitwaqqaf għal xi raġuni, għallinqas għal 6 xhur wara t- trattament.
HBV antigen/ antibody, and serum HBV DNA concentrations when possible.
Il- parametri tal- laboratorju li għandhom jiġu monitorjati għandhom jinkludu (mill- inqas) is- serum ALT, bilirubin, albumin, nitroġenu ta 'l- urea fid- demm, kreatinina, u status viroloġiku: konċentrazzjonijiet ta antiġenu/ anti- korp ta' l- HBV u ta 'serum HBV DNA meta possibbli.
Patients experiencing signs of hepatic insufficiency during or post-treatment should be monitored more frequently as appropriate.
Pazjenti li jħossu sinjali ta 'insuffiċjenza tal- fwied waqt jew wara t- trattament għandhom jiġu monitorjati aktar spiss kif xieraq.
HIV co-infection
Ko- infezzjoni bl- HIV
For the treatment of patients who are co-infected with HIV and are currently receiving or plan to receive treatment with lamivudine or the combination lamivudine-zidovudine, the dose of lamivudine prescribed for HIV infection (usually 150 mg/ twice daily in combination with other antiretrovirals) should be maintained.
Għat- trattament ta 'pazjenti ko- infettati bl- HIV u li jkunu qegħdin jiġu trattati jew qed jippjanaw trattament bil- lamivudine jew it- taħlita lamivudine/ zidovudine, id- doża ta' lamivudine preskritta għall - infezzjoni ta 'l- HIV (normalment 150 mg/ darbtejn kuljum flimkien ma' anti- retrovirali oħra) għandha tibqa 'kif inhi.
For HIV co-infected patients not requiring anti-retroviral therapy, there is a risk of HIV mutation when using lamivudine alone for treating chronic hepatitis B.
Għal pazjenti ko- infettati bl- HIV mingħajr il- bżonn ta 'terapija anti- retrovirali, hemm riskju ta' tibdil ta 'l- HIV meta jintuża lamivudine waħdu għall- kura ta' l- epatite B kronika.
Transmission of hepatitis B
Teħid tal- virus ta ’ l- epatite B
There is no information available on maternal-foetal transmission of hepatitis B virus in pregnant women receiving treatment with lamivudine.
Ma hawnx tagħrif dwar it- teħid tal- virus ta 'l- epatite B mill- fetu ta' l- omm fil- każ ta 'nisa tqal li jkunu qed jieħdu lamivudine.
The standard recommended procedures for hepatitis B virus immunisation in infants should be followed.
Il- proċeduri normali rakkomandati dwar l- immunita 'mill- virus ta' l- epatite B għat- tfal żgħar għandhom jiġu osservati.
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.
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.
Interaction studies have only been performed in adults.
Studji dwar mediċini oħra li ma jaqblux ma 'dan il- prodott saru biss fl- adulti.
The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal elimination of unchanged substance.
4 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.
4 Lamivudine is predominantly eliminated by active organic cationic secretion.
Lamivudine huwa fil- biċċa l- kbira eliminat bit- tnixxija katjonika organika attiva.
The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system e. g. trimethoprim.
Il- possibilta 'li ma jkunx jaqbel ma' prodotti mediċinali oħra li jkunu qed jittieħdu fl- istess żmien għandha titqies, partikolarment meta r- rotta ewlenija ta 'minn fejn jitneħħew hi t- tnixxija attiva tal- kliewi minn ġo s - sistema ta' trasport katjonika organika eż. trimethropin.
Other medicinal products (e. g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Prodotti mediċinali oħra (eż. ranitidine, cimetidine) jitneħħew parzjalment b' dan il- mekkaniżmu u wrew li jaqblu ma ’ lamivudine.
Substances shown to be predominately excreted either via the active organic anionic pathway, or by glomerular filtration are unlikely to yield clinically significant interactions with lamivudine.
Is- sustanzi li dehru li jitneħħew jew mill- passaġġ anjoniku organiku attiv, jew b’ filtrazzjoni glomerulari x' aktarx li mhux se jkollhom interazzjonijiet kliniċi sinifikanti ma ’ lamivudine.
Administration of trimethoprim/ sulphamethoxazole 160 mg/ 800 mg increased lamivudine exposure by about 40%.
L- amministrazzjoni ta 'trimethoprim/ sulphamethoxazole 160 mg/ 800 mg żiedet l- esponiment ta ’ lamivudine kważi b' 40%.
Lamivudine had no effect on the pharmacokinetics of trimethoprim or sulphamethoxazole.
Il- lamivudine ma 'kellu ebda effett fuq il- farmakokinetiċi tat- trimethropim jew tas- sulphamethoxazole.
However, unless the patient has renal impairment, no dosage adjustment of lamivudine is necessary.
Madankollu, sakemm il- pazjent ma jkollux indeboliment tal- kliewi, ma jkunx hemm bżonn li jinbidel id- dożaġġ ta ’ lamivudine.
A modest increase in Cmax (28%) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) was not significantly altered.
Żieda diskreta ta 'Cmax (28%) ġiet osservata għal zidovudine meta jittieħed mal- lamivudine, biss l - esponiment ġenerali (AUC) ma tbiddlitx sostanzjalment.
Zidovudine had no effect on the pharmacokinetics of lamivudine (see section 5.2).
Zidovudine ma kellu ebda effett fuq il - farmakokinetiċi ta ’ lamivudine (ara sezzjoni 5. 2).
Lamivudine has no pharmacokinetic interaction with alpha-interferon when the two medicinal products are concurrently administered.
Lamivudine m' għandu l- ebda effett ħażin farmakokinetiku ma 'alpha- interferon meta dawn iż- żewġ prodotti mediċinali jittieħdu flimkien.