qanastek/EMEA-V3 huggingface dataset:
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
77 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE Helixate NexGen 1000 IU
KIF TAĦŻEN Helixate NexGen 1000 IU
Do not use Helixate NexGen 1000 IU after the expiry date which is stated on labels and cartons.
M' għandekx tuża Helixate NexGen 1000 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l- kartun.
Do not use Helixate NexGen 1000 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża Helixate NexGen 1000 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
What Helixate NexGen 1000 IU contains
X’ fih Helixate NexGen 1000 IU
What Helixate NexGen 1000 IU looks like and content of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Helixate NexGen 1000 IU is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake.
Helixate NexGen 1000 IU jiġi bħala trab u solvent għall- soluzzjoni għal injezzjoni u huwa trab xott jew kejk ta ’ lewn bajdani li jkanġi ftit fl- isfar.
Medical devices for reconstitution and administration are provided with each package of Helixate NexGen 1000 IU.
Wara r- rikostituzzjoni s- soluzzjoni hija ċara. Tagħmir mediku għar- rikostituzzjoni u l- għoti jiġu ma ’ kull pakkett ta ’ Helixate NexGen 1000 IU.
78 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
78 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
79 PACKAGE LEAFLET:
79 FULJETT TA 'TAGĦRIF:
Helixate NexGen 2000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Helixate NexGen 2000 IU trab u solvent għal soluzzjoni għall- injezzjoni Fattur VIII tal- koagulazzjoni rikombinanti (octocog alfa)
What Helixate NexGen 2000 IU is and what it is used for 2.
X' inhu Helixate NexGen 2000 IU u għalxiex jintuża 2.
Before you use Helixate NexGen 2000 IU 3.
Qabel ma tieħu Helixate NexGen 2000 IU 3.
How to use Helixate NexGen 2000 IU 4.
Kif għandek tieħu Helixate NexGen 2000 IU 4.
How to store Helixate NexGen 2000 IU 6.
Kif taħżen Helixate NexGen 2000 IU 6.
WHAT Helixate NexGen 2000 IU IS AND WHAT IT IS USED FOR
X' INHU Helixate NexGen 2000 IU U GĦALXIEX JINTUŻA
One vial with powder for solution for injection nominally contains 2000 IU octocog alfa (IU equals International Units).
Kunjett wieħed bit- trab għal soluzzjoni għall- injezzjoni li b' mod nominali fih 2000 IU octocog alfa (IU tfisser Unitajiet Internazzjonali).
BEFORE YOU USE Helixate NexGen 2000 IU
QABEL MA TIEĦU Helixate NexGen 2000 IU
Do not use Helixate NexGen 2000 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of Helixate NexGen 2000 IU.
Tużax Helixate NexGen 2000 IU jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal octocog alfa, proteini tal- ġurdien jew għal proteini tal- ħemster jew għal xi wieħed mis- sustanzi l- oħra ta 'Helixate NexGen 2000 IU.
Take special care with Helixate NexGen 2000 IU as there is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction).
Oqgħod attent ħafna b' Helixate NexGen 2000 IU billi hemm ċans rari li jista jkollok reazzjoni anafilattika (reazzjoni allerġika f' daqqa u serja).
If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing an allergic reaction to Helixate NexGen 2000 IU.
Jekk int tħoss għafsa fis- sider, sturdamenti, tħossok dgħajjef jew ma tiflaħx, tħossok stordut waqt li int bil- wieqfa, jista 'jkun li qed tbati minn reazzjoni allerġika għal Helixate NexGen 2000 IU.
Your doctor may wish to carry out tests to ensure that your current dose of Helixate NexGen 2000 IU is sufficient to reach and maintain adequate factor VIII levels.
It- tabib tiegħek għandu mnejn ikun irid iwettaq xi testijiet biex jiżgura li d- doża attwali ta 'Helixate NexGen 2000 IU hija biżżejjed biex tilħaq u żżomm livelli xierqa ta' Fattur VIII.
If your bleeding is not being controlled with Helixate NexGen 2000 IU, consult your doctor immediately.
Jekk il- fsada tiegħek mhux qed tiġi kkontrollata b' Helixate NexGen 2000 IU, ikkonsulta mat- tabib tiegħek minnufih.
80 If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.
80 Jekk qabel tkun żviluppajt inibitur ta ’ fattur VIII u taqleb il- prodotti ta ’ fattur VIII, tista ’ tkun f’ riskju li l- inibitur jerġa ’ jitfaċċa.
Pregnancy and breast-feeding Based on the rare occurrence of haemophilia A in women, experience regarding the use of Helixate NexGen 2000 IU during pregnancy and breast-feeding is not available.
Tqala u Treddigħ Minħabba każijiet rari ta ’ emofilija A fin- nisa, l- esperjenza dwar l- użu ta ’ Helixate NexGen 2000 IU fit- tqala u t- treddigħ m' hiex disponibbli.
Important information about some of the ingredients of Helixate NexGen 2000 IU This medicinal product contain less than 1 mmol sodium (23 mg) per vial, i. e. essentially “ sodium- free”.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Helixate NexGen 2000 IU Dan il- prodott mediċinali fih inqas minn 1 mmol sodju (23 mg) kull kunjett, i. e essenzjalment huwa “ ħieles mis- sodju ”.
HOW TO USE Helixate NexGen 2000 IU
KIF GĦANDEK TIEĦU Helixate NexGen 2000 IU
Helixate NexGen 2000 IU is intended for intravenous administration only and must be administered immediately after reconstitution.
Helixate NexGen 2000 IU huwa intiż għall- użu ġol- vina biss u għandu jiġi mogħti eżatt wara li jiġi rikostitwit.
Use only the medical devices for reconstitution and administration provided with each package of Helixate NexGen 2000 IU.
Uża biss it- tagħmir għar- rikostituzzjoni u l- għotja provduti fil- pakkett ta 'Helixate NexGen 2000 IU.
Helixate NexGen 2000 IU must not be mixed with other infusion solutions.
Helixate NexGen 2000 IU m' għandux jiġi mħallat ma 'soluzzjonijiet oħra ta' l- infużjoni.
The amount of Helixate NexGen 2000 IU you should use and how often you use it depends on many factors such as your weight, the severity of your haemophilia, the site and extent of bleeding, the
Fl- aħħar, qiegħed ġbajra tal- pressjoni għal fuq il- ferita.
11 82 amount of factor VIII inhibitors that you may have and the factor VIII level required.
11 82 L- ammont ta ’ Helixate NexGen 2000 IU li għandek tuża jiddependi fuq ħafna fatturi bħal piż tal - ġisem, kemm hija severa l- emofilja, kemm hi kbira u minn fejn hi l- fsada, l- għadd ta ’ sustanzi inibituri tal- fattur VIII li jista ’ jkollok, u l- livell tal- fattur VIII meħtieġ.
Your doctor will calculate the dose of Helixate NexGen 2000 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
It- tabib tiegħek ser jikkalkula d- doża ta ’ Helixate NexGen 2000 IU u kemm- il darba trid tużah sabiex jkollok il- livell ta ’ l- attività meħtieġa tal- fattur VIII fid- demm tiegħek.
Your doctor should always adapt the amount of Helixate NexGen 2000 IU to be administered and the frequency of administration according to the clinical effectiveness in your individual case.
83 It- tabib tiegħek għandu dejjem jadatta l- ammont ta 'Helixate NexGen 2000 IU li jiġi mogħti u l - frekwenza ta' l- għotja skond l- effettività klinika fil- każ tiegħek.
83 If you are using Helixate NexGen 2000 IU to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Jekk qed tuża Helixate NexGen 2000 IU biex tevita l- fsada (profilassi), it- tabib tiegħek ser jikkalkula d- doża għalik.
If you have the impression that the effect of Helixate NexGen 2000 IU is too strong or too weak, talk to your doctor.
Jekk inti tal- fehma li l- effett ta 'Helixate NexGen 2000 IU huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
Helixate NexGen 2000 IU should be injected intravenously over several minutes.
Helixate NexGen għandu jingħata b’ injezzjoni ġol- vina fuq medda ta ’ numru ta ’ minuti.
Your doctor will tell you, how often and at what intervals Helixate NexGen 2000 IU is to be administered.
It- tabib tiegħek għandu jgħidlek, kemm ta 'spiss u wara kemm Helixate NexGen 2000 IU għandu jiġi meħud.
Usually, the substitution therapy with Helixate NexGen 2000 IU is a life-time treatment.
Ġeneralment, it- terapija ta 'sostituzzjoni b' Helixate NexGen 2000 IU huwa trattament tul il- ħajja kollha tal- pazjent.
If you use more Helixate NexGen 2000 IU than you should:
Jekk tieħu aktar Helixate NexGen 2000 IU milli suppost għandek:
If you have used more Helixate NexGen 2000 IU than you should, please inform your doctor.
Jekk tuża aktar Helixate NexGen 2000 IU milli għandek bżonn, għarraf it- tabib tiegħek.
If you forget to use Helixate NexGen 2000 IU: • Proceed with the next administration immediately and continue at regular intervals as advised by your doctor. • Do not take a double dose to make up for a forgotten doses.
Jekk tinsa tieħu Helixate NexGen 2000 IU: • Kompli bl- għotja li jmiss minnufih u ssokta f' intervalli regolari kif rakkomandat mit- tabib tiegħek • M' għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using Helixate NexGen 2000 IU Do not stop using Helixate NexGen 2000 IU without consulting your doctor.
Jekk tieqaf tieħu Helixate NexGen 2000 IU Tieqafx tieħu Helixate NexGen 2000 IU mingħajr ma tikkonsulta t- tabib tiegħek.
Like all medicines, Helixate NexGen 2000 IU can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, Helixate NexGen 2000 IU jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In rare cases, you may notice any of the following side effects after administration of Helixate NexGen 2000 IU: • rash/ itchy rash, local reactions at the injection site (e. g. burning sensation, temporary redness) • hypersensitivity reactions (e. g. tightness of the chest/ general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing) • unusual taste in the mouth • fever.
F' każijiet rari, tista tinnota xi wieħed mill- effetti oħra li jista jkollu li ġejjin wara l- għotja ta 'Helixate NexGen 2000 IU: • raxx/ ħakk tal- ġilda, reazzjonijiet fil post ta ’ l- injezzjoni (eż. ħruq, eritema temporanja) • reazzjonijiet ta' sensittività eċċessiva (eż. għafsa tas- sider/ tħossok ma tiflaħx, sturdament u dardir u pressjoni tad- demm kemmxejn baxxa, li tista 'tagħmlek dgħajjef waqt li tkun bil - wieqfa) • togħma mhux tas- soltu fil- ħalq • deni.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
85 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE Helixate NexGen 2000 IU
KIF TAĦŻEN Helixate NexGen 2000 IU
Do not use Helixate NexGen 2000 IU after the expiry date which is stated on labels and cartons.
M' għandekx tuża Helixate NexGen 2000 IU wara d- data ta ’ skadenza li tidher fuq it- tikketti u l- kartun.
Do not use Helixate NexGen 2000 IU if you notice any particles or the solution is cloudy.
M’ għandekx tuża Helixate NexGen 2000 IU jekk tinnota xi frak jew s- soluzzjoni tidher imdardra.
What Helixate NexGen 2000 IU contains
X’ fih Helixate NexGen 2000 IU
What Helixate NexGen 2000 IU looks like and content of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
Helixate NexGen 2000 IU is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake.
Helixate NexGen 2000 IU jiġi bħala trab u solvent għall- soluzzjoni għal injezzjoni u huwa trab xott jew kejk ta ’ lewn bajdani li jkanġi ftit fl- isfar.
Medical devices for reconstitution and administration are provided with each package of Helixate NexGen 2000 IU.
Wara r- rikostituzzjoni s- soluzzjoni hija ċara. Tagħmir mediku għar- rikostituzzjoni u l- għoti jiġu ma ’ kull pakkett ta ’ Helixate NexGen 2000 IU.
86 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
86 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
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 ta' CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Hepsera?
X' inhu Hepsera?
Hepsera is a medicine containing the active substance adefovir dipivoxil.
Hepsera hu mediċina li fiha s- sustanza attiva adefovir dipivoxil.
It is available as white round tablets (10 mg).
Tiġi bħala pilloli tondi bojod (10 mg).
What is Hepsera used for?
Għalxiex jintuża Hepsera?
Hepsera is used to treat adult patients with chronic (long-term) hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Hepsera jintuża fit- trattament ta 'pazjenti adulti bl- epatite B kronika (fuq tul ta' żmien) (marda tal - fwied ikkawżata minn vajrus 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 għal pazjenti bi: • mard tal- fwied ikkompensat (meta l- fwied ikollu ħsara iżda jibqa 'jaħdem sew), li jkollhom ukoll sinjali li l- vajrus ikun għadu qed jimmultiplika, u li jkollhom sinjali ta' ħsara fil- fwied (żieda fil - livelli ta 'l- enzim tal- fwied' alanina aminotransferażi '[ALT - alanine aminotransferase] u sinjali ta' ħsara meta t- tessut tal- fwied jiġi analizzat taħt il- mikroskopju, • mard tal- fwied dekompensat (meta l- fwied issirlu l- ħsara u ma jaħdimx kif suppost).
How is Hepsera used?
Kif jintuża Hepsera?
Treatment with Hepsera should be initiated by a doctor who has experience in the management of chronic hepatitis B.
It- trattament b' Hepsera għandu jiġi preskritt minn tabib li jkollu esperjenza fil- ġestjoni ta 'l- epatite B kronika.
The recommended dose is 10 mg once a day, taken with or without food.
Id- doża rakkomandata hi 10 mg darba kuljum, meħuda ma 'l- ikel jew weħedha.
The duration of treatment depends on the patient’ s condition and response to treatment.
Kemm idum it- trattament jiddependi mill- kundizzjoni tal- pazjent u minn kemm jirrispondi għat- trattament.
These should be monitored every six months.
Dawn għandhom jiġu sorveljati kull 6 xhur.
Patients who have problems with their kidneys should take Hepsera less frequently.
Pazjenti bi problemi fil- kliewi għandhom jieħdu Hepsera inqas spiss.
Hepsera is not recommended for use in patients with severe kidney disease or who are on dialysis (a blood clearing technique) – its use should only be considered in these patients if its potential benefits are greater than its potential risks.
Hepsera mhuwiex rakkomandat għall- użu minn pazjenti b' mard gravi fil- kliewi jew li qegħdin f' dijaliżi (teknika ta 'purifikazzjoni tad- demm) - l- użu tiegħu għandu jiġi kkunsidrat f' dawn il- pazjenti jekk il- benefiċċji potenzjali tiegħu huma ogħla mir- riskji potenzjali.
Patients whose disease is caused by a virus that is resistant (does not respond) to lamivudine (another antiviral medicine) should not take Hepsera on its own, but should take it in combination with lamivudine.
Dawk il- pazjenti li l- marda tagħhom hija kkawżata minn vajrus li huwa reżistenti (ma jirrispondix) għal lamivudine (mediċini antivirali oħra) ma għandhomx jieħdu Hespera waħdu, iżda f' kombinazzjoni ma 'lamivudine.
This may reduce the risk of resistance to Hepsera developing.
Dan jista 'jnaqqas l- iżvilupp tar- reżistenza għal Hepsera.
A change to treatment should also be considered if levels of the virus remain high after a year of treatment with Hepsera on its own.
Għandha titqies ukoll bidla fit- trattament f' każ li l- livelli tal- vajrus jibqgħu għoljin wara sena ta 'trattament b' Hepsera meħud waħdu.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal iktar tagħrif, ara s- Sommarju tal- Karatteristiċi tal- Prodott (li hu wkoll parti mill- EPAR).
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Adefovir hu sustanza antivirali li tappartjeni għall- klassi ta 'l- analogi nukleosidiċi (nucleoside 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
How does Hepsera work?
Reproduction is authorised provided the source is acknowledged. analogues).
Adefovir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Adefovir jinterferixxi ma 'l- azzjoni ta' enzima virali, DNA polimerażi, li għandha x' taqsam mal- formazzjoni ta 'DNA virali.
Adefovir stops the virus making DNA and prevents it from multiplying and spreading.
Adefovir ma jħallix lill- vajrus jipproduċi DNAu ma jħallihx jimmultiplika ruħu u jinfirex.
How has Hepsera been studied?
Kif ġie studjat Hepsera?
Hepsera has been studied in two main studies, in which it was compared with placebo (a dummy treatment).
Hepsera ġie studjat f' żewġ studji ewlenin, li fihom tqabbel mal- plaċebo (trattament finta).
The first study included 511 patients who were ‘ HBeAg positive ’ (infected with the common type of the hepatitis B virus) and the second included 184 patients who were ‘ HBeAg negative ’ (infected with a virus that has mutated [changed], leading to a form of chronic hepatitis B that is more difficult to treat).
Fl- ewwel studju ħadu sehem 511- il pazjent li kienu 'pożittivi għall- HBeAg' (infettati bit- tip komuni ta 'vajrus ta' l- epatite B) u fit- tieni wieħed ħadu sehem 184 pazjent li kienu 'negattivi għall- HBeAg' (infettati b' vajrus mutat [mibdul], li jwassal għal forma ta 'epatite B kronika iktar diffiċli biex tiġi ttrattata).
In both studies, the effectiveness was measured by looking at how the liver damage had evolved after 48 weeks of treatment using a liver biopsy (when a sample of liver tissue is taken and examined under a microscope).
Fiż - żewġ studji, l- effikaċja tkejlet b' ħarsa lejn kif evolviet il- ħsara fil- fwied wara 48 ġimgħa trattament permezz ta 'bijopsija tal- fwied (meta jittieħed kampjun tat- tessut tal- fwied u dan jiġi analizzat taħt il - mikroskopju).
Studies have also examined the effectiveness of Hepsera in patients whose disease was resistant to lamivudine.
Saru studji li eżaminaw ukoll l- effikaċja ta 'Hepsera f' pazjenti li l- marda tagħhom kienet reżistenti għal lamivudine.
What benefit has Hepsera shown during the studies?
X' inhuma l- benefiċċji ta 'Hepsera li ntwerew f' dawn l- istudji?
Hepsera was more effective than placebo in slowing down the progression of liver disease.
Hepsera kien iktar effikaċi mill- plaċebo biex ibatti l- progressjoni tal- mard tal- fwied.
Among those who took Hepsera, 53% of the HBeAg positive and 64% of the HBeAg negative patients had an improvement in liver damage assessed in a biopsy, compared with 25% and 33%, respectively, in the patients who took placebo.
Fost dawk li ħadu Hepsera, 53% tal- pazjenti pożittivi għall- HBeAg u 64% ta 'dawk negattivi għall- HBeAg kellhom titjib fil- ħsara fil- fwied valutata b' bijopsija, meta mqabbla ma' 25% u 33%, rispettivament, fost pazjenti li kienu ħadu l- plaċebo.
In the studies with lamivudine-resistant patients, treatment with Hepsera led to a decrease in the levels of viral DNA circulating in the blood.
Fl- istudji b' pazjenti reżistenti għal lamivudine, it- trattament b' Hepsera wassal għal tnaqqis fil- livelli ta 'DNA virali li jiċċirkula fid- demm.
What is the risk associated with Hepsera?
X' riskji huma assoċjati ma 'Hepsera?
The most common side effects with Hepsera (seen in more than 1 patient in 10) are raised creatinine (a marker of kidney problems) and asthenia (weakness).
L- iktar effetti sekondarji komuni ma 'Hepsera (li dehru f' iktar minn pazjent wieħed minn kull 10) huma żieda fil- kreatinina (markatur tal- problemi tal- kliewi) u l- astenija (dgħufija).
For the full list of all side effects reported with Hepsera, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrapportati ma' Hepsera, ara l- Fuljett ta 'Tagħrif.
Hepsera should not be used in people who may be hypersensitive (allergic) to adefovir dipivoxil or any of the other ingredients.
Hepsera m' għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal adefovir dipivoxil jew għal xi ingredjent ieħor tiegħu.
Why has Hepsera been approved?
Għaliex ġie approvat Hepsera?
The Committee for Medicinal Products for Human Use (CHMP) decided that Hepsera’ s benefits are greater than its risks for the 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 fibrosis, and in adults with decompensated liver disease.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Hepsera għandu iktar benefiċċji milli riskji fit- trattament ta 'l- epatite B f' adulti b' mard tal- fwied kompensat b' evidenza ta' replikazzjoni virali attiva, livelli persistentament għoljin ta 'alanina aminotransferażi (ALT) fid - demm, u evidenza istoloġika ta' infjammazzjoni u fibrożi attivi fil- fwied, u f' adulti b' mard tal- fwied dekompensat.
The Committee recommended that Hepsera be given marketing authorisation.
Il- kumitat irrakkomanda li Hepsera jingħata awtorizzazzjoni għat- tqegħid fis- suq
Other information about Hepsera:
Tagħrif ieħor dwar Hepsera:
The European Commission granted a marketing authorisation valid throughout the European Union for Hepsera to Gilead Sciences International Limited on 6 March 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Hepsera valida għall- Unjoni Ewropea kollha lil Gilead Sciences International Limited fis- 6 ta 'Marzu 2003.
The marketing authorisation was renewed on 6 March 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fis- 6 ta 'Marzu 2008.
The full EPAR for Hepsera is available here.
L- EPAR sħiħ għal Hepsera jista 'jiġi kkonsultat hawn.
Hepsera 10 mg tablets
Hepsera 10 mg pilloli
Each tablet contains 10 mg adefovir dipivoxil.
Kull pillola fiha 10 mg ta ’ adefovir dipivoxil.
Each tablet contains 113 mg lactose monohydrate.
Sustanza( i) mhux attiva( i) Kull pillola fiha 113 mg ta ’ lactose monohydrate.
White to off-white, round, flat-faced, bevelled-edge tablets, debossed with “ GILEAD” and “ 10” on one side and a stylised shape of a liver on the other side.
Pilloli bojod għal abjad jagħti fil- griz, tondi, b’ wiċċ ċatt u bi xfar immolati, b ’ “ GILEAD ” u “ 10 ” imnaqqxa fuq naħa waħda u b’ forma stilizzata ta ’ fwied fuq in- naħa l- oħra.
Hepsera is indicated for the treatment of chronic hepatitis B in adults with:
Hepsera hija indikata għat- trattament ta ’ epatite B kronika f’ adulti b ’:
• compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis
• mard tal- fwied kumpensat u b’ evidenza ta ’ replikazzjoni virali attiva, b’ livelli ta ’ serum alanine aminotransferase (ALT) għolja b’ mod persistenti b’ evidenza istoloġika ta ’ infjammazzjoni tal - fwied attiva u fibrożi
• decompensated liver disease.
• mard tal- fwied mhux kumpensat.
Therapy should be initiated by a physician experienced in the management of chronic hepatitis B.
It- terapija għandha tinbeda minn tabib b’ esperjenza fl- immaniġġjar ta ’ l- epatite B kronika.
The recommended dose of Hepsera is 10 mg (one tablet) once daily taken orally with or without food.
Id- doża rakkomandata ta ’ Hepsera hija ta ’ 10 mg (pillola waħda) darba kuljum li tittieħed mill - ħalq ma ’ l- ikel jew mingħajr ikel.
Higher doses must not be administered.
M’ għandhomx jingħataw dożi ogħla.
The optimum duration of treatment is unknown.
L- aħjar tul ta ’ trattament mhux magħruf.
The relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis is not known.
Ir- relazzjoni bejn ir- rispons għat- trattament u effetti fit- tul bħalma huma karċinoma epatoċellulari u ċirrożi mhux kumpensata mhix magħrufa.
Patients should be monitored every six months for hepatitis B biochemical, virological and serological markers.
Il- pazjenti għandhom ikunu mmonitorjati kull sitt xhur għall- markers bijokemikali, viroloġiċi u seroloġiċi ta ’ l- epatite B.
Treatment discontinuation may be considered as follows:
Il- waqfien tat- trattament jista ’ jkun ikkunsidrat kif ġej:
In HBeAg positive patients, treatment should be administered at least until HBeAg seroconversion (HBeAg and HBV DNA loss with HBeAb detection on 2 consecutive serum samples at least 3 months apart) or until HBsAg seroconversion or in case of evidence of loss of efficacy (see section 4.4).
F’ pazjenti pożittivi għal HBeAg, it- trattament għandu jingħata mill- anqas sakemm isseħħ serokonverżjoni ta ’ HBeAg (telfien ta ’ HBeAg u DNA tal- HBV, b’ HBeAb li jista ’ jkun osservat f’ żewġ kampjuni konsekuttivi fis- serum ta ’ l- anqas bi tliet xhur bejniethom) jew sakemm isseħħ serokonverżjoni HBsAg jew f’ każ ta ’ evidenza ta ’ telfien ta ’ l- effikaċja (ara sezzjoni 4. 4).
In HBeAg negative (pre-core mutant) patients, treatment should be administered at least until HBsAg seroconversion or in case of evidence of loss of efficacy (see section 4.4).
F’ pazjenti HBeAg negattivi (pre- core mutant), it- trattament għandu jingħata mill- anqas sakemm isseħħ serokonverżjoni ta ’ HBsAg jew f’ każ ta ’ evidenza ta ’ telfien ta ’ l- effikaċja (ara sezzjoni 4. 4).
2 In patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended (see section 4.4).
2 F’ pazjenti b’ mard tal- fwied mhux kumpensat jew b’ ċirrożi, il- waqfien tat- trattament mhuwiex irrakkomandat (ara sezzjoni 4. 4).
Hepsera is not recommended for use in children below the age of 18 years due to insufficient data on safety and efficacy (see section 5.1).
Hepsera mhix irrakkomandata għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 1).
No data are available to support a dose recommendation for patients over the age of 65 years (see section 4.4).
M’ hemmx informazzjoni biex tissapportja rakkomandazzjoni ta ’ doża għall- pazjenti ta ’ età ta ’ ’ l fuq minn 65 sena (ara sezzjoni 4. 4).
Adefovir is eliminated by renal excretion and adjustments of the dosing interval are required in patients with a creatinine clearance < 50 ml/ min or on dialysis.
Adefovir huwa eliminat permezz ta ’ tneħħija renali u aġġustamenti fl- intervall tad- dożaġġ huma meħtieġa f’ pazjenti bi tneħħija tal- krejatinina ta ’ < 50 ml/ min jew li qegħdin fuq id - dijaliżi.
The recommended dosing frequency according to renal function must not be exceeded (see sections 4.4 and 5.2).
Il- frekwenza ta ’ dożaġġ rrakkomandat skond il- funzjoni renali m’ għandux jinqabeż (ara sezzjonijiet 4. 4 u 5. 2).
The proposed dose interval modification is based on extrapolation of limited data in patients with end stage renal disease (ESRD) and may not be optimal.
It- tibdil ta ’ l- intervall tad- doża propost hu bbażat fuq estrapolazzjoni ta ’ informazzjoni limitata miksuba minn pazjenti b’ mard renali fl- aħħar stadju (end stage renal disease, ESRD) u jista ’ ma jkunx mill- aħjar.
Patients with creatinine clearance between 30 and 49 ml/ min:
Pazjenti bi tneħħija tal- krejatinina ta ’ bejn 30 u 49 ml/ min:
It is recommended to administer adefovir dipivoxil (one 10 mg tablet) every 48 hours in these patients.
Hu rakkomandat li tagħti adefovir dipivoxil (pillola waħda ta ’ 10 mg) kull 48 siegħa f’ dawn il - pazjenti.
There are only limited data on the safety and efficacy of this dosing interval adjustment guideline.
Hemm informazzjoni limitata biss dwar is- sigurtà u l- effikaċja ta ’ din il- gwida dwar l- aġġustament ta ’ l- intervall tad- dożaġġ.
Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see section 4.4).
Għalhekk, ir- rispons kliniku għat- trattament u l- funzjoni renali għandhom ikunu mmonitorjati, mill- qrib f’ dawn il- pazjenti (ara sezzjoni 4. 4).
Patients with creatinine clearance < 30 ml/ min and dialysis patients:
Pazjenti bi tneħħija tal- krejatinina ta ’ < 30 ml/ min u pazjenti li qegħdin fuq id- dijaliżi:
There are no safety and efficacy data to support the use of adefovir dipivoxil in patients with a creatinine clearance < 30 ml/ min or on dialysis.
M’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja li tissapportja l- użu ta ’ adefovir dipivoxil f’ pazjenti bi tneħħija tal- krejatinina ta ’ < 30 ml/ min jew li qegħdin fuq id- dijaliżi.
Therefore, use of adefovir dipivoxil is not recommended in these patients and should only be considered if the potential benefits outweigh the potential risks.
Għalhekk, l- użu ta ’ adefovir dipivoxil mhux rakkomandat f’ dawn il- pazjenti u għandu jkun ikkunsidrat biss jekk il - benefiċċji potenzjali jegħlbu r- riskji potenzjali.
In that case, the limited data available suggest that for patients with creatinine clearance between 10 and 29 ml/ min, adefovir dipivoxil (one 10 mg tablet) may be administered every 72 hours; for haemodialysis patients, adefovir dipivoxil (one 10 mg tablet) may be administered every 7 days following 12 hours continuous dialysis (or 3 dialysis sessions, each of 4 hours duration).
F’ dak il- każ, l- informazzjoni limitata disponibbli tissuġġerixxi li għal pazjenti bi tneħħija tal- krejatinina ta ’ bejn 10 u 29 ml/ min, adefovir dipivoxil (pillola waħda ta ’ 10 mg) jista ’ jingħata kull 72 siegħa; għall- pazjenti fuq dijaliżi tad- demm, adefovir dipivoxil (pillola waħda ta ’ 10 mg) jista ’ jingħata kull 7 ijiem wara 12- il siegħa ta ’ dijaliżi kontinwa (jew 3 seduti ta ’ dijaliżi, kull waħda ta ’ 4 sigħat).
These patients should be closely monitored for possible adverse reactions and to ensure efficacy is maintained (see sections 4.4 and 4.8).
Dawn il- pazjenti għandhom ikunu mmonitorjati mill- qrib għal reazzjonijiet avversi possibbli u biex ikun żgurat li tinżamm l- effikaċja (ara sezzjonijiet 4. 4 u 4. 8).
No dosing interval recommendations are available for other dialysis patients (e. g. ambulatory peritoneal dialysis patients) or non-haemodialysed patients with creatinine clearance less than 10 ml/ min.
L- ebda rakkomandazzjonijiet dwar l- intervall tad- dożaġġ m’ huma disponibbli għal pazjenti oħrajn li qegħdin fuq id- dijaliżi (eż. pazjenti ambulatorji li qegħdin fuq dijaliżi peritoneali) jew pazjenti li mhux qegħdin fuq dijaliżi tad- demm bi tneħħija tal- krejatinina ta ’ inqas minn 10 ml/ min.
No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Mhux meħtieġ aġġustament tad- doża għall- pazjenti b’ indeboliment tal- fwied (ara sezzjoni 5. 2).
Clinical resistance:
Reżistenza klinika:
Lamivudine-refractory patients and patients harbouring HBV with evidence of resistance to lamivudine (mutations at rtL180M, rtA181T and/ or rtM204I/ V) should not be treated with adefovir dipivoxil monotherapy in order to reduce the risk of resistance to adefovir.
Pazjenti li mhux qed jirrispondu għat- trattament bil- lamivudine u pazjenti bl- HBV li għandhom evidenza ta ’ reżistenza għal lamivudine (mutazzjonijiet f’ rtL180M, rtA181T u/ jew rtM204I/ V) m’ għandhomx jiġu ttratati b’ monoterapija b’ adefovir dipivoxil sabiex tnaqqas ir- riskju ta ’ reżistenza għal adefovir.
Adefovir may be used in combination with lamivudine in lamivudine-refractory patients and in patients harbouring HBV with mutations at rtL180M and/ or rtM204I/ V.
Adefovir jista ’ jintuża flimkien ma ’ lamivudine f’ pazjenti li mhux qed jirrispondu għat- trattament bil- lamivudine u f’ pazjenti bl- HBV b’ mutazzjonijiet f’ rtL180M u/ jew rtM204I/ V.
However, for patients harbouring HBV that contains the rtA181T mutation, consideration should be given to alternative treatment regimens due to the risk of reduced susceptibility to adefovir (see section 5.1).
Madankollu, għal pazjenti bl- HBV li jkun fiha l- mutazzjoni rtA181T, għandha tingħata konsiderazzjoni lil korsijiet ta ’ kuri alternattivi minħabba r- riskju ta ’ tnaqqis fis- suxxettibilità għal adefovir (ara sezzjoni 5. 1).
In order to reduce the risk of resistance in patients receiving adefovir dipivoxil monotherapy, a modification of treatment should be considered if serum HBV DNA remains above 1,000 copies/ ml at or beyond 1 year of treatment.
Sabiex tnaqqas ir- riskju ta ’ reżistenza f’ pazjenti li jkunu qed jirċievu monoterapija b’ adefovir dipivoxil, għandu jkun ikkunsidrat tibdil fil- kura jekk id- DNA tal- HBV fis- serum tibqa ’ iktar minn 1, 000 kopja/ ml wara sena jew iktar ta ’ kura.
• Hypersensitivity to the active substance or to any of the excipients.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Adefovir is excreted renally, by a combination of glomerular filtration and active tubular secretion.
Adefovir jitneħħa mill- ġisem permezz tal- kliewi b’ kumbinazzjoni ta ’ filtrazzjoni glomerulari u sekrezzjoni tubulari attiva.
While the
Trattament b’ adefovir dipivoxil jista ’ jwassal għal indeboliment renali.
3 overall risk of renal impairment in patients with adequate renal function is low, this is of special importance in patients at risk of, or having underlying renal dysfunction and in patients receiving medicinal products that may affect renal function.
Waqt li r- riskju, meta wieħed iqis kollox, ta ’ indeboliment renali f’ pazjenti b’ funzjoni renali adegwata huwa baxx, dan hu ta ’ importanza partikulari f’ pazjenti li huma f’ riskju ta ’ dan, jew li għandhom disfunzjoni renali prinċipali u f’ pazjenti li jkunu qegħdin jieħdu prodotti mediċinali li jaffettwaw il- funzjoni renali.
It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with adefovir dipivoxil.
Hu rakkomandat li t- tneħħija tal- krejatinina tiġi kkalkulata fil- pazjenti kollha qabel jinbeda t - trattament b’ adefovir dipivoxil.
In patients who develop renal insufficiency and have advanced liver disease or cirrhosis, dosing interval adjustment of adefovir or switch to an alternative therapy for hepatitis B infection should be considered.
F’ pazjenti li jiżviluppaw insuffiċjenza renali u li għandhom mard tal- fwied avvanzat jew ċirrożi, l- aġġustament ta ’ l- intervall tad- dożaġġ ta ’ adefovir jew il- qlib għal terapija alternattiva għall- epatite B għandu jiġi kkunsidrat.
Treatment cessation for chronic hepatitis B in these patients is not recommended.
It- twaqqif tat- trattament għall- epatite B kronika f’ dawn il - pazjenti mhuwiex irrakkomandat.
Patients with normal renal function:
Pazjenti b’ funzjoni renali normali:
Patients with normal renal function should be monitored for changes in serum creatinine every 3 months and creatinine clearance calculated.
Pazjenti b’ funzjoni renali normali għandhom ikunu mmonitorjati għal tibdil fis- serum tal- krejatinina kull 3 xhur u bi tneħħija tal- krejatinina kkalkulata.
In patients at risk of renal impairment (see section 4.8), consideration should be given to more frequent monitoring of renal function.
F’ pazjenti f’ riskju ta ’ indeboliment renali (ara sezzjoni 4. 8), għandha tingħata konsiderazzjoni għal monitoraġġ iktar frekwenti tal- funzjoni renali.
The dosing interval of adefovir dipivoxil should be adjusted in these patients (see section 4.2).
L- intervall tad- dożaġġ ta ’ adefovir dipivoxil għandu jkun aġġustat f’ dawn il- pazjenti (ara sezzjoni 4. 2).
In addition, renal function should be closely monitored with a frequency tailored to the individual patient’ s medical condition.
Flimkien ma ’ dan, il- funzjoni renali għandha tiġi mmonitorjata mill- qrib bi frekwenza mfassla skond il- kundizzjoni medika tal- pazjent individwali.
Adefovir dipivoxil is not recommended in patients with a creatinine clearance of < 30 ml/ min or on dialysis.
Adefovir dipivoxil mhux rakkomandat f’ pazjenti bi tneħħija tal- krejatinina ta ’ < 30 ml/ min jew li qegħdin fuq id- dijaliżi.
Administration of adefovir dipivoxil in these patients should only be considered if the potential benefits outweigh the potential risks.
L- għoti ta ’ adefovir dipivoxil f’ dawn il- pazjenti għandu jkun ikkunsidrat biss jekk il- benefiċċji potenzjali jegħlbu lir- riskji potenzjali.
If treatment with adefovir dipivoxil is considered essential, then the dosing interval should be adjusted (see section 4.2).
Jekk il- kura b’ adefovir dipivoxil hi kkunsidrata essenzjali, allura l- intervall tad- dożaġġ għandu jkun aġġustat (ara sezzjoni 4. 2).
These patients should be closely monitored for possible adverse reactions and to ensure efficacy is maintained.
Dawn il - pazjenti għandhom ikunu mmonitorjati mill- qrib għal reazzjonijiet avversi possibbli u biex ikun żgurat li tinżamm l- effikaċja.
Patients receiving medicinal products that may affect renal function:
Pazjenti li jkunu qegħdin jirċievu prodotti mediċinali li jistgħu jaffettwaw il- funzjoni renali:
Adefovir dipivoxil should not be administered concurrently with tenofovir disoproxil fumarate (Viread).
Adefovir dipivoxil m’ għandux jingħata fl- istess ħin ma ’ tenofovir disoproxil fumarate (Viread).
Caution is advised in patients receiving other medicinal products that may affect renal function or are excreted renally (e. g. cyclosporin and tacrolimus, intravenous aminoglycosides, amphotericin B, foscarnet, pentamidine, vancomycin, or medicinal products which are secreted by the same renal transporter, human Organic Anion Transporter 1 (hOAT1), such as cidofovir).
Hi rakkomandata kawtela f’ pazjenti li jkunu qegħdin jirċievu prodotti mediċinali oħrajn li jistgħu jaffettwaw il- funzjoni renali jew li jitneħħew mill- ġisem permezz tal- kliewi (eż. cyclosporin u tacrolimus, aminoglycosides ġol- vini, amphotericin B, foscarnet, pentamidine, vancomycin, jew prodotti mediċinali li joħroġu mill- istess trasportatur renali, it- Trasportatur Enajoniku Organiku uman 1 (human Organic Anion Transporter, hOAT 1) bħal cidofovir).
Co-administration of 10 mg adefovir dipivoxil with medicinal products in these patients may lead to an increase in serum concentrations of either adefovir or a co-administered medicinal product.
L- għoti ta ’ 10 mg ta ’ adefovir dipivoxil flimkien ma ’ prodotti mediċinali f’ dawn il- pazjenti jista ’ jwassal għal żieda fil - konċentrazzjonijiet fis- serum jew ta ’ adefovir jew ta ’ prodott mediċinali mogħti miegħu.
The renal function of these patients should be closely monitored with a frequency tailored to the individual patient’ s medical condition.
Il- funzjoni renali f’ dawn il- pazjenti għandha tiġi mmonitorjata mill- qrib bi frekwenza mfassla skond il - kundizzjoni medika tal- pazjent individwali.
For renal safety in patients pre- and post-transplantation with lamivudine-resistant HBV, see section 4.8.
Għas- sigurtà renali f’ pazjenti ta ’ qabel u wara li kellhom it- trapjant, b’ HBV reżistenti għal lamivudine, ara sezzjoni 4. 8.
Hepatic function:
Funzjoni epatika:
Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT.
Epatite B kronika b’ aggravar spontanju hija relattivament komuni u din tkun ikkaratterizzata minn żieda temporanja fl- ALT fis- serum.
After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline.
Wara li tinbeda t- terapija antivirali, l- ALT fis- serum jista ’ jiżdied f’ xi pazjenti, hekk kif il- livelli fis- serum tad- DNA tal- HBV jinżlu.
In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation (see section 4.8).
F’ pazjenti b’ mard tal- fwied kumpensat, dawn iż- żidiet fl- ALT fis- serum ġeneralment ma jkunux akkumpanjati minn żieda fil- konċentrazzjonijiet ta ’ bilirubina fis- serum jew dikumpensazzjoni epatika (ara 4 sezzjoni 4. 8).
Patients with advanced liver disease or cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation which may be fatal.
Pazjenti b’ mard tal- fwied avvanzat jew ċirrożi jistgħu jkunu f’ riskju akbar ta ’ dikumpensazzjoni epatika wara li l- epatite tmur għall- agħar li tista ’ tkun fatali.
In these patients, including patients with decompensated liver disease, treatment cessation is not recommended and these patients should be monitored closely during therapy.
F’ dawn il- pazjenti, li jinkludu pazjenti b’ mard tal- fwied dikumpensat, il- waqfien tat- trattament mhuwiex irrakkomandat u dawn il- pazjenti għandhom ikunu mmonitorjati mill- qrib waqt it- terapija.
In the event of these patients developing renal insufficiency, see above Renal function.
F’ każ li dawn il- pazjenti jiżviluppaw insuffiċjenza renali, are Funzjoni renali hawn fuq.
If treatment cessation is necessary, patients should be closely monitored for several months after stopping treatment as exacerbations of hepatitis have occurred after discontinuation of 10 mg adefovir
Jekk il- waqfien tat- trattament ikun meħtieġ, il- pazjenti għandhom ikunu mmonitorjati mill- qrib għal bosta xhur wara li jitwaqqaf it- trattament peress li każi ta ’ epatite li tmur għall- agħar wara l- waqfien ta ’ 10 mg ta ’ adefovir dipivoxil seħħew.
These exacerbations occurred in the absence of HBeAg seroconversion and presented as serum ALT elevations and increases in serum HBV DNA.
L- aggravar seħħ fin- nuqqas ta ’ serokonverżjoni ta ’ HBeAg u ħareġ bħala żieda ta ’ l- ALT fis- serum u żieda fis- serum tad- DNA ta ’ l- HBV.
Elevations in serum ALT that occurred in patients with compensated liver function treated with 10 mg adefovir dipivoxil were not accompanied by clinical and laboratory changes associated with liver decompensation.
Żieda ta ’ l- ALT fis - serum li seħħet f’ pazjenti b’ funzjoni tal- fwied kumpensata li kienu ttrattati b’ 10 mg ta ’ adefovir dipivoxil ma kinetx akkumpanjata minn tibdil kliniku jew tal- laboratorju assoċjati ma ’ dikumpensazzjoni epatika.
Patients should be closely monitored after stopping treatment.
Pazjenti għandhom jiġu mmonitorjati mill- qrib wara l- waqfien tat - trattament.
Most post-treatment exacerbations of hepatitis were seen within 12 weeks of discontinuation of 10 mg adefovir dipivoxil.
Il- biċċa l- kbira ta ’ l- aggravar ta ’ l- epatite wara t- trattament seħħ sa 12- il ġimgħa wara li twaqqfu l- 10 mg ta ’ adefovir dipivoxil.
Lactic acidosis and severe hepatomegaly with steatosis:
Aċidożi lattika u l- epatomegalija gravi bi stejatożi:
Occurrences of lactic acidosis (in the absence of hypoxaemia), sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues.
Bl- użu ta ’ l- analogi tan- nukleosidi ġew irrappurtati inċidenti ta ’ aċidożi lattika (fin- nuqqas ta ’ ipoeksemija) xi kultant fatali, ġeneralment assoċjata ma ’ epatomegalija gravi u stejatożi epatika.
As adefovir is structurally related to nucleoside analogues, this risk cannot be excluded.
Peress li adefovir huwa strutturalment relatat ma ’ analogi tan - nukleosidi, dan ir- riskju ma jistax ikun eskluż.
Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/ lactic acidosis of unknown aetiology occur.
It- trattament b’ analogi tan- nukleosidi għandu jitwaqqaf meta l- livelli ta ’ aminotransferase jiżdiedu malajr, meta sseħħ epatomegalija progressiva jew aċidożi lattika/ metabolika ta ’ etjoloġija mhux magħrufa.
Benign digestive symptoms, such as nausea, vomiting and abdominal pain, might be indicative of lactic acidosis development.
Sintomi diġestivi beninji bħal tqalligħ, rimettar u uġigħ addominali jistgħu jkunu evidenza ta ’ żvilupp ta ’ aċidożi lattika.
Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/ hepatic steatosis, renal failure and higher levels of serum lactate.
Każi gravi, xi kultant b’ riżultati fatali, kienu assoċjati ma ’ pankreatite, kollass tal- fwied/ stejatożi epatika, kollass tal- kliewi, livelli għolja ta ’ lactate fis- serum.
Caution should be exercised when prescribing nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease.
Għandha tingħata attenzjoni meta jingħataw analogi tan- nukleosidi lil kwalunkwe pazjent (partikularment nisa obeżi) b’ epatomegalija, epatite jew fatturi oħra ta ’ riskju magħrufa għall- mard tal- fwied.
These patients should be followed closely.
Dawn il- pazjenti għandhom ikunu segwiti mill- qrib.
To differentiate between elevations in transaminases due to response to treatment and increases potentially related to lactic acidosis, physicians should ensure that changes in ALT are associated with improvements in other laboratory markers of chronic hepatitis B.
Biex ikunu jistgħu jagħrfu bejn żidiet fit- transaminases minħabba rispons għat- trattament u żidiet possibbilment assoċjati ma ’ aċidożi lattika, it- tobba għandhom jiżguraw li t- tibdil fl- ALT ikun assoċjat ma ’ titjib f’ markers oħrajn tal- laboratorju ta ’ l- epatite B kronika.
Co-infection with hepatitis C or D:
Infezzjoni ukoll bl- epatite Ċ jew D:
There are no data on the efficacy of adefovir dipivoxil in patients co-infected with hepatitis C or hepatitis D.
M’ hemmx informazzjoni dwar l- effikaċja ta ’ adefovir dipivoxil f’ pazjenti li huma infettati ukoll bl- epatite Ċ jew epatite D.
Co-infection with HIV:
Infezzjoni ukoll bl- HIV:
Limited data are available on the safety and efficacy of 10 mg adefovir dipivoxil in patients with chronic hepatitis B, co-infected with HIV.
Hemm informazzjoni limitata dwar is- sigurtà u l- effikaċja ta ’ 10 mg ta ’ adefovir dipivoxil f’ pazjenti b’ epatite B kronika, li huma infettati ukoll bl- HIV.
To date there is no evidence that daily dosing with 10 mg adefovir dipivoxil results in emergence of adefovir-associated resistance mutations in the HIV reverse transcriptase.
Sa llum m’ hemmx prova li d- dożaġġ ta ’ kuljum b’ 10 mg ta ’ adefovir dipivoxil iwassal għall- formazzjoni ta ’ mutazzjonijiet assoċjati mar- reżistenza għal adefovir fir- reverse transcriptase ta ’ l- HIV.
Nonetheless, there is a potential risk of selection of HIV strains resistant to adefovir with possible cross-resistance to other antiviral medicinal products.
Madankollu hemm riskju potenzjali ta ’ selezzjoni ta ’ strejns tal- HIV reżistenti għal adefovir bil- possibbiltà ta ’ cross- resistance għall- prodotti mediċinali antivirali oħra.
As far as possible, treatment of hepatitis B by adefovir dipivoxil in an HIV co-infected patient should be reserved for patients whose HIV RNA is controlled.
Sa fejn hu possibbli, it- trattament ta ’ l- epatite B b’ adefovir dipivoxil f’ pazjent li huma infettat ukoll bl - HIV għandu jinżamm għall- pazjenti li l- RNA ta ’ l- HIV tagħhom hi kkontrollata.
Treatment with 10 mg adefovir dipivoxil has not been shown to be effective against HIV replication and therefore should not be used to control HIV infection.
It- trattament b’ 10 mg ta ’ adefovir dipivoxil ma ġiex ippruvat li hu effettiv kontra r- replikazzjoni ta ’ l- HIV u għalhekk m’ għandux jintuża biex jikkontrolla infezzjoni bl- HIV.
The clinical experience in patients > 65 years of age is very limited.
L- esperjenza klinika f’ pazjenti ta ’ > 65 sena hi limitata ħafna.