qanastek/EMEA-V3 huggingface dataset:
Control blood tests will be performed regularly.
Għandhom jitwettqu testijiet tad - demm ta ’ kontroll b’ mod regolari.
The common (up to 1 in 10 patients) side-effects are:
22 L- effetti sekondarji komuni (sa 1 minn kull 10 pazjenti) huma:
A general feeling of being unwell including feeling tired, sleepy or dizzy.
Sensazzjoni ġenerali li ma tħossokx tajjeb fosthom li tħossok għajjien, bi ngħas jew stordut.
Furthermore there can be inflammation of the blood vessel where the treatment is given (phlebitis), diarrhoea, dry mouth, hair
Barra minn hekk jista ’ jkun hemm infjammazzjoni tal- vina fejn tingħata t- trattament (flebite), dijarea, ħalq xott, twaqqigħ tax- xagħar.
At the site of injection you may get a reaction, where the skin may be red, swollen or hurt when touched.
Fil- post ta ’ l- injezzjoni jista ’ jkollok reazzjoni, fejn il- ġilda tista ’ tkun ħamra, minfuħa jew tuġgħek meta tmissha.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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 tiegħek.
HOW TO STORE SAVENE
KIF TAĦŻEN SAVENE
Do not use Savene after the expiry date stated on the label.
Tużax Savene wara d- data ta ’ skadenza indikata fuq it- tikketta.
Savene should be stored below 25oC.
Savene għandu jinħażen f’ temperatura taħt 25 oC.
Keep Savene in the outer carton in order to protect from light.
Żomm Savene fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Chemical and physical in-use stability has been demonstrated for 4 hours when stored at 2 to 8oC after reconstitution and subsequent dilution in the diluent.
Intweriet stabbiltà kimika u fiżika waqt l- użu ta ’ 4 sigħat meta Savene inħażen f’ temperatura ta ’ 2 sa 8 oC wara r- rikonstituzzjoni u t- taħlit suċċessiv fid- dilwent.
If not used immediately, in-use storage times and conditions prior to use are at the responsibility of the user and would normally not be longer than 4 hours at 2 to 8°C.
Jekk ma jintużax minnufih, il- ħinijiet tal- ħażna waqt l- użu u l- kondizzjonijiet ta ’ qabel l- użu jkunu r - responsabbiltà ta ’ l- utent u ġeneralment ma jkunux aktar minn 4 sigħat f’ temperatura ta ’ bejn 2 sa 8 °C.
Do not use Savene if you notice that the vial is damaged or show signs of tampering.
Tużax Savene jekk tinnota li l- kunjett ikun miksur jew juri sinjali ta ’ tbagħbis.
What Savene contains The active substance is dexrazoxane.
X' fih Savene Is- sustanza attiva hija dexrazoxane.
Each vial contains 500 mg dexrazoxane as 589 mg dexrazoxane hydrochloride.
Kull kunjett fih 500 mg dexrazoxane bħala 589 mg dexrazoxane hydrochloride.
The other ingredients are hydrochloric acid.
L- ingredjenti l- oħra huma hydrochloric acid.
The diluent contains sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium hydroxide and water for injections.
Id- dilwent fih sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium hydroxide u ilma għall- injezzjonijiet.
What Savene looks like and contents of the pack Savene consists of Savene powder and Savene diluent.
Id- dehra ta 'Savene u l- kontenut tal- pakkett Savene jikkonsisti fit- trab ta ’ Savene u d- dilwent ta ’ Savene.
Savene powder is presented as a single glass vial containing a white to off-white powder called dexrazoxane (the active substance).
It- trab ta ’ Savene huwa ppreżentat bħala kunjett wieħed tal- ħġieġ li fih trab abjad għal abjad fl- isfar imsejjaħ dexrazoxane (is- sustanza attiva).
Savene is also supplied with an infusion bag containing the Savene diluent.
Savene jiġi pprovdut ukoll b’ borża ta ’ l- infużjoni li fiha d- dilwent ta ’ Savene.
The concentration of the active ingredient following reconstitution with sterile water is 20 mg dexrazoxane per ml.
Il- konċentrazzjoni ta ’ l- ingredjent attiv wara r- rikonstituzzjoni b’ ilma sterilizzat hija 20 mg dexrazoxane għal kull ml.
Savene is supplied in a box containing 10 vials of Savene powder and 3 infusion bags of Savene diluent.
Savene huwa fornut f’ kaxxa li fiha 10 kunjetti Savene trab u 3 boroż ta ’ infużjoni ta ’ Savene dilwent.
Marketing Authorisation Holder and Manufacturer:
23 Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur:
TopoTarget A/ S Fruebjergvej 3 DK-2100 Copenhagen Denmark Tel: +45 39 17 83 92 Fax: +45 39 17 94 92
TopoTarget A/ S Fruebjergvej 3 DK- 2100 Copenhagen Id- Danimarka Tel: +45 39 17 83 92 Fax: +45 39 17 94 92
23 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq:
France Topotarget A/ S Fruebjergvej 3, DK – 2100 Copenhague Tél: + 45 39 17 83 92 Ireland TopoTarget A/ S Fruebjergvej 3 DK – 2100 Copenhagen Tel: + 45 39 17 83 92
24 France Topotarget A/ S Fruebjergvej 3, DK – 2100 Copenhague Tél: + 45 39 17 83 92 Ireland TopoTarget A/ S Fruebjergvej 3 DK – 2100 Copenhagen Tel: + 45 39 17 83 92 Ísland TopoTarget A/ S Fruebjergvej 3 DK- 2100 Kaupmannahöfn Sími: + 45 39 17 83 92 Italia ADIENNE S. r. l.
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. eu. int /
25 The following information is intended for medical or healthcare professionals only.
25 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku.
Preparation guide for use with Savene powder for concentrate and diluent for solution for infusion
Gwida ta ’ preparazzjoni għall- użu ma ’ Savene trab għall- konċentrat u dilwent għal soluzzjoni għall- infużjoni
It is important that you read the entire content of this procedure prior to the preparation of Savene.
Huwa importanti li taqra l- kontenut kollu ta ’ din il- proċedura qabel il- preparazzjoni ta ’ Savene.
FORMULATION
FORMOLAZZJONI
Savene is supplied as:
Savene huwa pprovdut bħala:
Savene powder 2.
Savene trab 2.
Savene diluent
Savene dilwent
Savene powder must be reconstituted in 25 ml sterile water and diluted in 500 ml diluent prior to administration.
Savene trab għandu jiġi rikonstitwit f’ 25 ml ilma sterilizzat u dilwit f’ 500 ml ta ’ dilwent qabel l- għoti.
RECOMMENDATION FOR THE SAFE HANDLING
RAKKOMANDAZZJONI GĦAL MANIĠĠ BLA PERIKLU
Savene is an anti-cancer agent and the normal procedures for proper handling and disposal of anticancer medicines should be adopted, namely:
Savene huwa aġent kontra l- kanċer u l- proċeduri normali għal maniġġ u rimi xieraq ta ’ mediċini kontra l- kanċer għandhom jiġu adottati, b’ mod partikolari:
- Personnel should be trained to reconstitute the medicine
- Il- personal għandu jitħarreġ biex jirrikonstitwixxi l- mediċina
- Pregnant staff should be excluded from working with this medicine
- Nisa tqal parti mill- personal għandhom ikunu esklużi milli jaħdmu b’ din il- mediċina
- Personnel handling this medicine during reconstitution should wear protective clothing including
- Il- personal li jimmaniġġja din il- mediċina matul ir- rikonstituzzjoni għandu jilbes ħwejjeġ ta ’
mask, goggles and gloves
protezzjoni inkluż maskla, gogils u ingwanti
- Accidental contact with the skin or eyes should be treated immediately and thoroughly with
- Kuntatt aċċidentali mal- ġilda jew ma ’ l- għajnejn għandu jiġi ttrattat minnufih u sewwa
copious amounts of water
b’ abbundanza ta ’ ilma
3.1 Reconstitution of Savene powder 3.1.1 Using a syringe fitted with a needle, aseptically withdraw 25 ml of sterile water.
3. 1 Rikonstituzzjoni ta ’ Savene trab 3. 1. 1 Permezz ta ’ siringa mlibbsa bil- labra, islet b’ mod asettiku 25 ml ta ’ ilma sterilizzat.
3.1.2 Inject the entire contents of the syringe into the vial containing the Savene powder.
3. 1. 2 Injetta l- kontenut kollu tas- siringa fil- kunjett li fih Savene trab.
3.1.3 Remove the syringe and needle and mix manually by repeated inversions until the powder is fully dissolved.
3. 1. 3 Neħħi s- siringa u l- labra u ħallat manwalment permezz ta ’ qlib ripetut sakemm it- trab idub għal kollox.
3.1.4 Allow the vial with the reconstituted solution to stand for 5 minutes at room temperature and check if the solution is homogenous and clear.
3. 1. 4 Ħalli l- kunjett bis- soluzzjoni rikonstitwita joqgħod għal 5 minuti f’ temperatura ambjentali u ara jekk is- soluzzjoni hijiex omoġenja u ċara.
The reconstituted solution contains 20 mg dexrazoxane per ml and should be used immediately after preparation.
Is- soluzzjoni rikonstitwita fiha 20 mg dexrazoxane għal kull ml u għandha tintuża minnufih wara l- preparazzjoni.
It contains no antibacterial preservative.
Ma fiha ebda preservattiv antibatteriku.
3.2 Dilution of the infusion concentrate 3.2.1 More than one vial containing reconstituted solution may be necessary to obtain the required dose for the patient.
3. 2 Dilwizzjoni tal- konċentrat għall- infużjoni 3. 2. 1 Jista ’ jkun hemm bżonn ta ’ aktar minn kunjett wieħed li fih soluzzjoni rikonstitwita sabiex tinkiseb id- doża meħtieġa għall- pazjent.
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding reconstituted volume containing 20 mg dexrazoxane per ml from the appropriate number of vials containing reconstituted solution.
Fuq il- bażi tad- doża meħtieġa għall- pazjent imfissra f’ mg, iġbed b’ mod asettiku l- volum rikonstitwit korrispondenti li fih 20 mg dexrazoxane għal kull ml minn numru ta ’ kunjetti xierqa li fihom is- soluzzjoni rikonstitwita.
Use a graduated syringe filled with a needle.
Uża siringa bil- marki mimlija b’ labra.
3.2.2 Inject the required reconstituted volume into the infusion bag with 500 ml diluent.
3. 2. 2 Injetta l- volum rikonstitwit fil- borża ta ’ infużjoni b’ 500 ml dilwent.
The solution must not be mixed with any other medicines.
Is- soluzzjoni ma għandhiex titħallat ma ’ xi mediċini oħra.
3.2.3 Mix the infusion bag manually using a rocking motion 3.2.4 Savene should be aseptically administered as a 1-2 hours infusion under room temperature and normal light conditions.
3. 2. 3 Ħallat il- borża ta ’ infużjoni manwalment permezz ta ’ movement ’ l hinn u ’ l hawn 3. 2. 4 Savene għandu jingħata b’ mod asettiku bħala infużjoni għal siegħa- sagħtejn f’ temperatura ambjentali u taħt kundizzjonijiet ta ’ dawl normali.
3.2.5 As with all parenteral products, Savene reconstituted solution and infusion solution should be inspected visually for particulate matter and discoloration prior to administration.
3. 2. 5 Bħal fil- każ tal- prodotti parenterali kollha, soluzzjoni rikonstitwita ta ’ Savene u soluzzjoni għall- infużjoni ta ’ Savene għandhom jiġu spezzjonati viżwalment għal trab u telf fil- kulur qabel l- għoti.
Solutions containing a precipitate should be discarded.
Soluzzjonijiet li fihom preċipitat għandhom jintremew.
26 All items for preparation, administration or cleaning, including gloves, as well as liquid waste should be disposed of in accordance with local requirements.
26
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Sebivo?
X’ inhu Sebivo?
Sebivo is a medicine that contains the active substance telbivudine.
Sebivo huwa mediċina li fiha s- sustanza attiva telbivudine.
It is available as yellow, oval tablets (600 mg) and as an oral solution (20 mg/ ml).
Jiġi bħala pilloli ovali sofor (600 mg) u bħala soluzzjoni orali (20 mg/ ml).
What is Sebivo used for?
Għalxiex jintuża Sebivo?
Sebivo is used to treat adults with chronic (long-term) hepatitis B, a disease of the liver caused by infection with the hepatitis B virus.
Sebivo jintuża għall- kura ta ’ pazjenti adulti li jkollhom epatite B kronika (fit- tul), marda tal- fwied dovuta għal infezzjoni bil- virus tal- epatite B.
It is used in patients who have 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 liver enzymes or signs of damage when liver tissue is examined under a microscope).
Huwa jintuża f’ pazjenti li jkollhom mard tal- fwied ikkumpensat (meta l- fwied ikollu l- ħsara iżda jaħdem b’ mod normali), li juru wkoll sinjali li l- virus għadu jimmultiplika ruħu, u jkollhom sinjali ta ’ ħsara fil- fwied (enzimi għolja tal- fwied jew sinjali ta ’ ħsara meta t- tessut tal- fwied jiġi eżaminat taħt mikroskopju).
How is Sebivo used?
Kif jintuża Sebivo?
Treatment with Sebivo should be started by a doctor who has experience in the management of chronic hepatitis B.
Il- kura b’ Sebivo għandha tinbeda minn tabib li għandu esperjenza fil- ġestjoni tal- epatite B kronika.
The recommended dose of Sebivo is one tablet once a day, with or without food.
Id- doża rakkomandata ta ’ Sebivo hija pillola waħda darba kuljum, bi jew mingħajr ikel.
The oral solution can be considered for patients who have difficulty swallowing tablets.
Għal pazjenti li jsibu diffikultà biex jibilgħu l- pilloli, tista ’ tiġi kkunsidrata s- soluzzjoni orali.
Patients who have problems with their kidneys may need to take a lower daily dose using the oral solution.
Il- pazjenti li għandhom problemi fil- kliewi tagħhom jistgħu jieħdu doża inqas kuljum permezz tas- soluzzjoni orali.
If this is not possible, they should take the tablets less often.
Jekk dan ma jkunx possibbli, dawn il- pazjenti għandhom jieħdu l- pilloli inqas frekwenti.
Patients with kidney problems should be closely monitored.
Il- pazjenti li għandhom problemi fil- kliewi għandhom jiġu mmonitorjati iktar mill- qrib.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Ara s- Sommarju tal - Karatteristiċi tal- Prodott (parti mill- EPAR ukoll) għad- dettalji kollha.
How does Sebivo work?
Kif jaħdem Sebivo?
The active substance in Sebivo, telbivudine, is an antiviral medicine that belongs to the class ‘ nucleoside analogues’.
Is- sustanza attiva f’ Sebivo, telbivudine, hija mediċina antivirali li tappartjeni għall- klassi tal - ‘ analogi nucleoside ’.
Telbivudine interferes with the action of a viral enzyme called DNA polymerase, which is involved in the formation of viral DNA.
Telbivudine jostakola l- azzjoni ta ’ enzima virali msejħa polimerażi tad- DNA, li hija involuta fil- formazzjoni tad- DNA virali.
By stopping the virus making DNA, telbivudine prevents it from multiplying and spreading.
Permezz ta ’ dan it- twaqqif telbivudine jwaqqaf il- virus li jagħmel id- DNA, u ma jħallihx jimmultiplika u jinfirex.
How has Sebivo been studied?
Kif ġie studjat Sebivo?
The effects of Sebivo were first tested in experimental models before being studied in humans.
L- effetti ta ’ Sebivo l- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma kienu studjati fil- bniedem.
Sebivo tablets were compared with lamivudine (another medicine used in chronic hepatitis B) in a two-year study involving 1,367 patients.
Il- pilloli Sebivo ġew ikkomparati ma ’ lamivudine (mediċina oħra użata fl- epatite B kronika) fi studju ta ’ sentejn li kien jinvolvi 1, 367 pazjent.
The patients were mainly of Asian origin and had an average age of 36 years.
Il- pazjenti kienu fil- biċċa l- kbira ta ’ oriġini Ażjatika u kellhom età medja ta ’ 36 sena.
None of the patients had been treated with nucleoside analogues before.
Ħadd minn dawn il- pazjenti ma kien ġie kkurat b’ analogi nucleoside
Reproduction is authorised provided the source is acknowledged. measure of effectiveness was the number of patients who had responded to treatment after a year.
L- effikaċja ewlenija kienet imkejla billi ġie osservat kemm pazjenti rrispondew għall- kura wara sena.
A response was defined as low levels of viral DNA in the blood, together with either the levels of a liver enzyme called alanine aminotransferase (ALT) returning to normal or the marker for the hepatitis B virus disappearing from the blood.
Dan ir- rispons tkejjel fuq il- livelli baxxi tad- DNA virali fid- demm, flimkien mar- ritorn għal - livelli normali ta ’ enzima tal- fwied imsejjaħ alanine aminotransferase (ALT), jew mal- għibien tal - indikatur għall- virus tal- epatite B mid- demm.
The company also presented the results of a study showing that the oral solution produced the same levels of the active substance in the blood as the tablets.
Il- kumpanija ppreżentat ukoll ir- riżultati ta ’ studju li wera li s- soluzzjoni orali produċiet l- istess livelli ta ’ sustanza attiva fid- demm daqs il- pilloli.
What benefit has Sebivo shown during the studies?
X’ benefiċċju wera Sebivo matul l- istudji?
Overall, Sebivo was as effective as lamivudine, with about three-quarters of the patients responding to treatment after a year.
B’ mod ġenerali, Sebivo kien effettiv daqs lamivudine, b’ madwar tliet kwarti tal- pazjenti jirrispondu għall- kura wara sena.
The results were also calculated separately between ‘ HBeAg-positive’ patients (infected with the common hepatitis B virus) and ‘ HBeAg-negative ’ patients (infected with a virus that has mutated, leading to a form of chronic hepatitis B that is more difficult to treat).
Ir- riżultati kienu kkalkulati wkoll separatament bejn il- pazjenti ‘ HBeAg pożittivi ’ (infettati bil- virus komuni tal- epatite B) u l- pazjenti ‘ HBeAg negattivi ’ (infettati b’ virus li nbidel, li wassal għal forma ta ’ epatite B kronika li hija aktar diffiċli biex tiġi kkurata).
Sebivo was more effective than lamivudine in the HBeAg-positive patients, with 75% responding to Sebivo and 67% to lamivudine.
Sebivo kien aktar effettiv minn lamivudine fil- grupp tal- pazjenti ‘ HBeAg pożittivi ’, b’ 75% li rrispondew għal Sebivo u 67% li rrispondew għal lamivudine.
In the HBeAg-negative patients, Sebivo was as effective as lamivudine (75 and 77% responding, respectively).
Fil- grupp tal- pazjenti ‘ HbeAg negattivi ’, Sebivo kien effettiv daqs lamivudine (75 u 77% li rrispondew, rispettivament).
What is the risk associated with Sebivo?
X’ inhu r- riskju assoċjat ma ’ Sebivo?
The most common side effects with Sebivo (seen in between 1 and 10 patients in 100) are dizziness, headache, cough, increased levels of some enzymes in the blood (amylase, lipase, creatine phosphokinase and alanine aminotransferase), diarrhoea, nausea (feeling sick), abdominal (tummy) pain, skin rash and fatigue (tiredness).
L- aktar effetti sekondarji komuni b’ Sebivo (dehru f’ bejn 1 u 10 pazjenti minn kull 100) huma sturdament, uġigħ ta ’ ras, sogħla, livelli aktar għoljin ta ’ xi enzimi (amylase, lipase, creatine phosphokinase u alanine aminotransferase), dijarrea, nawżea (dardir), uġigħ addominali (fiż- żaqq), raxx tal- ġilda u għeja kbira.
Because creatine phosphokinase is an enzyme that is raised when muscles are damaged, doctors need to monitor all muscle-related side effects closely.
Minħabba li l- creatine phosphokinase hija enzima li togħla meta jkun hemm ħsara fil- muskoli, it- tobba jridu jimmonitorjaw l- effetti sekondarji kollha li huma relatati mal - muskoli mill- qrib.
For the full list of all side effects reported with Sebivo, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati b’ Sebivo, ara l- Fuljett ta ’ Tagħrif.
Sebivo should not be used in people who may be hypersensitive (allergic) to telbivudine or to any of the other ingredients.
Sebivo m’ għandux jintuża f’ persuni li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal telbivudine jew xi sustanzi oħra.
Why has Sebivo been approved?
Għaliex ġie approvat Sebivo?
The Committee for Medicinal Products for Human Use (CHMP) decided that Sebivo’ s benefits are greater than its risks for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/ or fibrosis.
Il- Kumitat dwar il- Prodotti Mediċinali għall- Użu fil- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Sebivo huma akbar mir- riskji tiegħu għall- kura tal- epatite B kronika f’ pazjenti adulti b’ mard tal- fwied ikkumpensat u evidenza ta ’ riproduzzjoni virali, kostantement għoli fil- livelli tas- serum ALT u evidenza istoloġika ta ’ infjammazzjoni attiva u/ jew fibrożi.
As the studies were mainly carried out in Asia and included fewer Caucasian patients than the Committee would have liked to see, the Committee asked the company to carry out a further study in Europe.
Billi l- istudji saru prinċipalment fl- Ażja, u kienu jinkludu anqas pazjenti Kawkasi milli l- kumitat xtaq li jara studjati, il- kumitat talab li jitwettaq studju ieħor fl- Ewropa.
The Committee recommended that Sebivo be given marketing authorisation.
Il- kumitat irrakkomanda li Sebivo għandu jingħata l- awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Sebivo:
Tagħrif ieħor dwar Sebivo:
The European Commission granted a marketing authorisation valid throughout the European Union for Sebivo to Novartis Europharm Limited on 24 April 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Sebivo lil Novartis Europharm Limited fl- 24 ta ’ April 2007.
The full EPAR for Sebivo can be found here.
L- EPAR sħiħ għal Sebivo jista ’ jinstab hawn.
This summary was last updated in 02-2009.
Dan is- sommarju kien approvat l- aħħar f’ 02- 2009.
EU Number EU/ 1/ 07/ 388/ 001 EU/ 1/ 07/ 388/ 002
Numru tal- UE EU/ 1/ 07/ 388/ 001 EU/ 1/ 07/ 388/ 002
Invented name Sebivo Sebivo
Isem inventat Sebivo Sebivo
Strength 600 mg 600 mg
Qawwa 600 mg 600 mg
Pharmaceutical Form Film-coated tablet Film-coated tablet
Għamla farmaċewtika Pillola miksija b’ rita Pillola miksija b’ rita
Packaging Blister (PVC/ alu) Blister (PVC/ alu)
Il- pakkett Blister (PVC/ alu) Blister (PVC/ alu)
Package size 28 tablets 98 tablets
Daqs tal- pakkett 28 pillola 98 pillola
20 mg/ ml
20 mg/ m
Bottle (glass)
Flixkun (tal- ħġieġ)
1 bottle + 1 Cup
Flixkun wieħed + Tazza waħda
Sebivo 600 mg film-coated tablets
Sebivo 600 mg pilloli miksija b’ rita
Each film-coated tablet contains 600 mg telbivudine.
Kull pillola miksija b’ rita fiha 600 mg telbivudine.
White to slightly yellowish, oval film-coated tablet, imprinted with “ LDT” on one side.
Bajda tagħti ħarira fl- isfar, pillola miksija b’ rita ovali, ittimbrata b ’ “ LDT ” fuq naħa waħda.
Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/ or fibrosis.
Sebivo huwa indikat għall- kura ta ’ epatite B kronika f’ pazjenti adulti b’ mard tal- fwied kompensat u evidenza ta ’ replikazzjoni virali, livelli ta ’ alanine aminotransferase (ALT) li jibqgħu għoljin b’ mod persistenti u evidenza istoloġika ta ’ infjammazzjoni attiva u/ jew fibrożi.
See section 5.1 for details of the study and specific patient characteristics on which this indication is based.
Ara sezzjoni 5. 1 għad- dettalji ta ’ l- istudju u l- karatteristiċi speċifiċi tal- pazjent li fuqhom din l- indikazzjoni hija bbażata.
Therapy must be initiated by a physician experienced in the management of chronic hepatitis B infection.
It- terapija għandha tinbeda minn speċjalista li għandu esperjenza fl- immaniġġar ta ’ infezzjoni ta ’ epatite B kronika.
Adults The recommended dose of Sebivo is 600 mg (one tablet) once daily, taken orally, with or without food.
Adulti Id- doża rakkomandata ta ’ Sebivo hija 600 mg (pillola waħda) darba kuljum, li tittieħed b’ mod orali, ma ’ jew mingħajr l- ikel.
Sebivo oral solution may be considered for patients who have difficulties swallowing tablets.
Is- soluzzjoni orali ta ’ Sebivo tista ’ titqies għal pazjenti li jsibu diffikultà biex jibilgħu l- pilloli.
Duration of therapy The optimal treatment duration is unknown.
Tul tat- terapija Mhux magħruf it- tul ta ’ terapija idejali.
Treatment discontinuation should be considered as follows: • In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or there is evidence of loss of efficacy.
Il- waqfien tal- kura għandu jitqies kif ġej: • F’ pazjenti mingħajr ċirrożi, posittivi għall- HBeAg, il- kura għandha tibqa ’ tingħata għal mill - anqas 6- 12 il xahar wara li serokonverżjoni ta ’ l- HBe (telf ta ’ HBeAg u telf ta ’ HBV DNA b’ sejba ta ’ anti- HBe) tkun konfermata jew sakemm ikun hemm serokonverżjoni ta ’ HBs jew ikun hemm evidenza ta ’ tnaqqis ta ’ l- effikaċja.
Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse. • In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or until there is evidence of loss of efficacy.
Il- livelli ta ’ l- ALT u ta ’ l- HBV DNA fis- serum għandhom jiġu segwiti b’ mod regolari wara li titwaqqaf il- kura sabiex ikun magħruf kwalunkwe każ ta ’ rkadar viroloġiku li jkun dam biex iseħħ. • F’ pazjenti mingħajr ċirrożi, negattivi għall- HBeAg, il- kura għandha tibqa ’ tingħata mill- anqas sakemm ikun hemm HBs serokonverżjoni jew sakemm ikun hemm evidenza li l- effikaċja naqset.
With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuation of the selected therapy remains appropriate for the patient.
Meta l- kura ddum tingħata għal aktar minn sentejn, evalwar b’ mod regolari huwa rakkomandat sabiex ikun konfermat li t- tkomplija tat- terapija magħżula tibqa ’ l- aktar waħda xierqa għall- pazjent.
On-treatment response at week 24 has been shown to be predictive of longer-term response (see Table 7 in section 5.1) and might be useful for driving the management of patients treated with telbivudine monotherapy.
Ir- rispons waqt il- kura f’ ġimgħa 24 intwera li jista ’ jintuża sabiex jiġi mbassar ir- rispons għal aktar fit - tul (ara t- Tabella 7 fis- sezzjoni 5. 1) u jista ’ jkun utli għall- imaniġġar ta ’ pazjenti ikkurati b’ monoterapija ta ’ telbivudine.
2 Renal impairment No adjustment of the recommended dose of telbivudine is necessary in patients whose creatinine clearance is ≥ 50 ml/ min.
2 Indeboliment renali M’ hemmx bżonn li jsir aġġustament tad- doża rakkomandata ta ’ telbivudine f’ pazjenti li għandhom tneħħija tal- krejatinina ≥ 50 ml/ min.
Adjustment of the dose is required in patients with creatinine clearance < 50 ml/ min, including those with end-stage renal disease (ESRD) on haemodialysis.
Ikun hemm bżonn li d- doża tkun aġġustata meta t- tneħħija tal - krejatinina tkun < 50 ml/ min, inklużi dawk li jsofru minn mard renali ta ’ l- aħħar fażi (ESRD) fuq ħemodijaliżi.
A reduction of the daily dose using Sebivo oral solution, as detailed in Table 1 below, is recommended.
Huwa rrakkomandat tnaqqis fid- doża ta ’ kuljum bl- użu ta ’ soluzzjoni orali ta ’ Sebivo, kif dettaljat fit- Tabella 1 hawn taħt.
If use of the oral solution is not possible, Sebivo film-coated tablets could be used as an alternative and dosing should be adjusted by increasing the time interval between doses, as detailed in Table 1.
Jekk l- użu tas- soluzzjoni orali ma jkunx possibbli, jistgħu jintużaw pilloli Sebivo miksijin b’ rita bħala alternattiva u d- doża għandha tkun aġġustata billi jitwal l - interval bejn id- dożi, kif dettaljat fit- Tabella 1.
Dosing regimen adjustment of Sebivo in patients with renal impairment
Tabella 1 Aġġustar tal- mod kif jingħataw id- dożaggi ta ’ Sebivo f’ pazjenti b’ indeboliment renali
Creatinine clearance (ml/ min)
Tneħħija tal - krejatinina (ml/ min)
Telbivudine 20 mg/ ml oral solution Daily dose adjustment
Soluzzjoni orali ta ’ telbivudine 20 mg/ ml Aġġustament tad- doża ta ’ kuljum
Telbivudine 600 mg film-coated tablet Alternative** dose adjustment with increased dose intervals
Pillola telbivudine ta ’ 600 mg miksija b’ rita Aġġustament tad- doża alternattiv ** b’ żieda fl- intervalli ta ’ dożi
≥ 50 30-49 < 30 (not requiring dialysis)
≥ 50 30- 49 < 30 (ma tinħtieġx dijalisi)
600 mg (30 ml) once daily 400 mg (20 ml) once daily 200 mg (10 ml) once daily
600 mg (30 ml) darba kuljum 400 mg (20 ml) darba kuljum 200 mg (10 ml) darba kuljum
600 mg once daily 600 mg once every 48 hours 600 mg once every 72 hours
600 mg darba kuljum 600 mg darba kull 48 siegħa 600 mg darba kull 72 siegħa
120 mg (6 ml) once daily
120 mg (6 ml) darba kuljum
600 mg once every 96 hours
600 mg darba kull 96 siegħa
* End stage renal disease ** In case use of the oral solution is not possible
* Mard renali fl- aħħar fażi ** F’ każ li l- użu tas- soluzzjoni orali ma jkunx possibbli
The proposed dose modifications are based on extrapolation and may not be optimal.
It- tibdiliet fid- doża proposti huma bbażati fuq estrapolazzjoni u jista ’ ma ’ jkunx idejali.
The safety and effectiveness of these dosing adjustment guidelines have not been clinically evaluated.
Is- sigurtà u l - effikaċja ta ’ dawn il- linji gwida fuq l- aġġustament tad - dożaġġi ma ġewx evalwati klinikament.
Therefore, close clinical monitoring is recommended in these patients.
Għaldaqstant, huwa rrakkomandat monitoraġġ kliniku mill- qrib ta ’ dawn il- pazjenti.
End-stage renal disease patients For patients with ESRD, Sebivo should be administered after haemodialysis (see section 5.2).
Pazjenti b’ mard renali fl- aħħar fażi Għal pazjenti b’ ESRD, Sebivo għandu jingħata wara l- ħemodijaliżi (ara sezzjoni 5. 2).
Hepatic impairment No adjustment to the recommended dose of Sebivo is necessary in patients with hepatic impairment (see section 5.2).
Indeboliment tal- fwied M’ hemmx bżonn ta ’ tibdil tad- doża rakkomandata ta ’ Sebivo f’ pazjenti b’ indeboliment tal- fwied (ara sezzjoni 5. 2).
Children and adolescents Sebivo is not recommended for use in children and adolescents below 16 years of age due to a lack of data on safety and efficacy.
Tfal u adoloxxenti Sebivo mhux irrakkomandat għall- użu fit- tfal u adoloxxenti ta ’ taħt is- 16- il sena peress li m’ hemmx informazzjoni dwar is- sigurtà u l- effikaċja.
Elderly patients (age above 65 years) No data are available to support a specific dose recommendation for patients over the age of 65 years (see section 4.4).
Pazjenti anzjani (età ’ l fuq minn 65 sena) M’ hemmx informazzjoni disponibbli li fuqha tista ’ tkun ibbażata rakkomandazzjoni għall- pazjenti ’ l fuq minn 65 sena (ara sezzjoni 4. 4).
Severe acute exacerbations of chronic hepatitis B are relatively frequent, and are characterised by transient elevation of serum ALT.
Każijiet ta ’ epatite B kronika li tiħrax f’ daqqa b’ mod sever huma relattivament spissi, u huma karatterizzati b’ żieda momentanja ta ’ ALT fis- serum.
Following initiation of antiviral treatment, serum ALT may rise in some patients while serum levels of HBV DNA fall (see section 4.8).
Wara li tibda l- kura antivirali, f’ xi pazjenti jista ’ jkun hemm żieda ta ’ ALT fis- serum filwaqt li l- livelli ta ’ HBV DNA fis- serum jaqaw (ara sezzjoni 4. 8).
On average, 4-5 weeks elapsed prior to the occurrence of an exacerbation in patients treated with telbivudine.
Bħala medja, 4- 5 ġimgħat għaddew qabel ma seħħew il- każijiet fejn il- mard ħrax f’ pazjenti kurati b’ telbivudine.
Overall, ALT flares occurred more frequently in HBeAg-positive patients than in HBeAg-negative patients.
B’ mod ġenerali, żiediet f’ daqqa ta ’ ALT seħħew aktar ta ’ spiss f’ pazjenti HBeAg- posittivi milli f’ pazjenti HBeAg- negattivi.
In patients with compensated liver disease, this elevation of serum ALT is generally not accompanied by elevated levels of serum bilirubin or by other signs of hepatic decompensation.
3 żiediet ta ’ ALT fis- serum ġeneralment ma jkunux akkompanjat b’ żiediet fil- livelli ta ’ bilirubin fis - serum jew b’ sinjali oħra ta ’ dikompensazzjoni epatika.
The risk of hepatic decompensation – and of a subsequent exacerbation of hepatitis – may be elevated in patients with cirrhosis.
Ir- riskju ta ’ dikompensazzjoni epatika – u wara b’ hekk, epatite aktar ħarxa - jista ’ jkun għoli f’ pazjenti b’ ċirrożi.
Such patients should therefore be closely monitored.
Dawn il- pazjenti għaldaqstant għandhom jiġu monitorati mill- qrib.
3 Exacerbations of hepatitis have also been reported in patients who have terminated treatment of hepatitis B.
Każijiet fejn l- epatite ħraxet kienu rappurtati wkoll f’ pazjenti li kienu temmu l- kura għall- epatite B.
Post-treatment ALT flares are normally associated with increases in serum HBV DNA levels, and the majority of such cases have proven to be self-limiting.
Każijiet fejn ikun hemm żiediet f’ daqqa fl- ALT wara li tkun intemmet il- kura huma normalment assoċjati ma ’ żiediet tal- livelli ta’ l- HBV DNA fis- serum, u fil- parti l- kbira tagħhom, dawn il- każijiet urew li normalment jgħaddu waħidhom.
Nonetheless, there have also been reports of severe – and sometimes fatal – post-treatment disease exacerbations.
Madankollu, kien hemm ukoll rapporti ta ’ każijiet severi – kultant fatali fejn il- mard ħrax wara l- kura.
Therefore, hepatic function should be monitored at regular intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Għaldaqstant, il- funzjoni epatika għandha tkun monitorata f’ intervalli regolari kemm b’ mod kliniku kif ukoll permezz ta ’ follow- up fil- laboratorju għal mill - anqas 6 xhur wara li titwaqqaf it- terapija għall- epatite B.
Occurrence of lactic acidosis (in the absence of hypoxaemia) sometimes fatal, and usually associated with severe hepatomegaly with steatosis have been reported with the use of nucleoside/ nucleotide analogues.
Każijiet ta ’ aċidożi lattika (mingħajr ipoksja) kultant fatali, u normalment assoċjati ma ’ epatomegalija severa bi stejatożi kienu rappurtati bl- użu ta ’ analogi nuklejosidi/ nuklejotidi.
As telbivudine is a nucleoside analogue, this risk cannot be excluded.
Peress li telbivudine huwa analogu nuklejosida, dan ir- riskju ma jistax jiġi eskluż.
Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/ lactic acidosis of unknown aetiology occur.
Il- kura bl- analogi nuklejosidi għandha titwaqqaf meta jkun hemm żieda mgħaġġla fil- livelli ta ’ aminotransferase, avvanz ta ’ epatomegalija jew aċidożi metabolika/ lattika ta ’ oriġini mhux magħrufa.
Benign digestive symptoms, such as nausea, vomiting and abdominal pain, may be indicative of lactic acidosis development.
Sintomi ħfief tas- sistema diġestiva, bħall - tqalligħ, rimettar u uġigħ addominali, jistgħu jindikaw li tkun qed tiżviluppa aċidożi lattika.
Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/ hepatic steatosis, renal failure and higher levels of serum lactate.
Każijiet severi, kulltant fatali, kienu assoċjati ma ’ pankrejatite, insuffiċjenza tal- fwied/ stejatożi epatika, insuffiċjenza renali, u livelli ogħla 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 ssir attenzjoni meta jkun se jiġi ordnat xi analogu tan- nucleosides lil kwalunkwe pazjent (l- aktar lil nisa obeżi) b’ epatomegalija, epatite jew fatturi oħrajn magħrufin li jistgħu jkunu fatturi ta ’ riskju għall- mard tal- fwied.
These patients should be followed closely.
Dawn il - pazjenti għandhom jibqgħu taħt osservazzjoni mill- qrib.
Muscular effects Cases of myopathy and myalgia have been reported with telbivudine use several weeks to months after starting therapy (see section 4.8).
Effetti muskolari Każijiet ta ’ mijopatija u majalġja kienu rappurtati bl- użu ta ’ telbivudine għall- perjodu bejn numru ta ’ ġimgħat għall- numru ta ’ xhur wara li tibda t- terapija (ara sezzjoni 4. 8).
Myopathy, defined as persistent unexplained muscle aches and/ or muscle weakness regardless of the degree of increases in creatine kinase levels, should be considered in any patient with diffuse unexplained myalgias, muscle tenderness, muscle weakness or myositis (defined as myopathy with histological evidence of muscle damage).
Mijopatija, definita bħala weġgħat fil- muskoli persistenti u mingħajr spjegazzjoni u/ jew dgħjufija fil - muskoli mhux relatata ma ’ żiediet fil- livelli ta ’ creatine kinase abnormali, għandu jitqies f’ kull pazjenti li jsofri b’ majalġji mifrux mingħajr spjegazzjoni, tenerezza tal- muskoli, dgħjufija tal- muskoli jew mijożite (definita bħala mijopatija b’ evidenza istoloġika ta ’ ħsara tal- muskoli).
Patients should be advised to report promptly any persistent unexplained muscle aches, pain, tenderness or weakness.
Il- pazjenti għandhom jiġu kunsiljati sabiex jirrapurtaw mill- ewwel weġgħat fil- muskoli persistenti mingħajr spjegazzjoni, uġigħ, tenerezza jew dgħjufija.
If any of these symptoms are reported, a detailed muscle examination should be performed in order to evaluate muscle function.
Jekk xi wieħed minn dawn is- sintomi jiġu rrappurtati, għandu jsir eżami dettaljat tal- muskoli sabiex tiġi evalwata l- funzjoni tal- muskoli.
Telbivudine therapy should be discontinued if myopathy is diagnosed.
It- terapija b’ telbivudine għandha titwaqqaf jekk tiġi dijanjostikata mijopatija.
It is not known whether the risk of myopathy during treatment with telbivudine is increased with concurrent administration of other medicinal products associated with myopathy (e. g. statins, fibrates, or ciclosporin).
Mhux magħruf jekk ir- riskju ta ’ mijopatija waqt kura b’ telbivudine jiżdiedx bl- għotja fl- istess ħin ta ’ prodotti mediċinali oħrajn li huma assoċjati ma ’ mijopatija (eż statini, fibrati, jew ciclosporin).
Physicians considering concomitant treatment with other agents associated with myopathy should weigh carefully the potential benefits and risks and should monitor patients for any signs or symptoms suggestive of myopathy.
It - tobba li jkunu qed jikkonsidraw l- għotja fl- istess ħin ma ’ mediċini oħra assoċjati ma ’ mijopatija għandhom iqisu sew il- benefiċċji potenzjali u r- riskji u għandhom jimmonitoraw il- pazjenti għal kwalunkwe sinjali jew sintomi li jindikaw li hemm mijopatija.
Peripheral neuropathy Peripheral neuropathy has been uncommonly reported in telbivudine-treated patients.
Newropatija periferali Newropatija periferali kienet irrappurtata b’ mod mhux komuni f’ pazjenti ikkurati b’ telbivudine.
If peripheral neuropathy is suspected, treatment with telbivudine should be reconsidered (see section 4.8).
Jekk ikun hemm suspett li hemm newropatija periferali, il- kura b’ telbivudine għandha tiġi ikkonsidrata mill- ġdid (ara sezzjoni 4. 8).
An increased risk of peripheral neuropathy has been observed when telbivudine and pegylated interferon alfa-2a are co-administered (see section 4.5).
Żieda fir- riskju ta ’ newropatija periferali dehret meta telbivudine u interferon alfa- 2a ingħataw flimkien (ara sezzjoni 4. 5).
Such increased risk cannot be excluded for other interferons alfa (pegylated or standard).
Żieda bħal din ma tistax tiġi eskluża għal interferons alfa orħrajn (pegilati jew standard).
Moreover, the benefit of this combination of telbivudine with interferon alfa (pegylated or standard) is not currently established.
Minbarra hekk, il benefiċċju ta ’ din it- taħlita ta ’ telbivudine ma ’ interferon alfa (pegilat jew standard) s’ issa mhux stabbilita.
Renal function Telbivudine is eliminated primarily by renal excretion, therefore dose interval adjustment is recommended in patients with creatinine clearance < 50 ml/ min, including patients on haemodialysis.
4 Funzjoni renali Telbivudine jitneħħa l- aktar mill- kliewi, għaldaqstant aġġustament ta ’ l- intervall tad- dożaġġi huwa rakkomandat f’ pazjenti bi tneħħija tal- krejatinina < 50 ml/ min, inklużi pazjenti fuq ħemodijaliżi.
The effectiveness of dosing interval adjustment has not been clinically evaluated.
Ma kienx evalwat b’ mod kliniku kemm hu effettiv l- aġġustament ta ’ l- intervall tad- dożaġġi.
Therefore, virological response should be closely monitored in patients with increased dosage interval (see sections 4.2 and 5.2).
Għaldaqstant, ir- rispons viroloġiku għandu jkun monitorat mill- qrib f’ pazjenti li jkollhom l- intervall fid- dożaġġi imtawwal (ara sezzjonijiet 4. 2 u 5. 2).
4 Patients with cirrhosis without decompensation Due to the limited data available (about 3% of patients enrolled had cirrhosis), telbivudine should be used with particular caution in cirrhotic patients.
Pazjenti b’ ċirrożi mingħajr dikumpensazzjoni Minħabba t- tagħrif limitat li hemm (madwar 3% tal- pazjenti li kienu reġistrati kellhom ċirrożi), telbivudine għandu jintuża b’ attenzjoni partikolari f’ pazjenti b’ ċirrożi.
These patients should be closely monitored for clinical, biochemical and virological parameters associated with hepatitis B during treatment and after treatment is discontinued.
Dawn il- pazjenti għandhomjinżammu taħt osservazzjoni mill- qrib għal parametri kliniċi, bijokimiċi u viroloġiċi assoċjati ma ’ epatite B waqt u wara li l- kura titwaqqaf.
Patients with cirrhosis with decompensation There are no efficacy and safety data in patients with decompensated cirrhosis.
Pazjenti b’ ċirrożi b’ dikumpensazzjoni M’ hemmx tagħrif ta ’ effikaċja u sigurtà f’ pazjenti b’ ċirrożi dikumpensata.
Patients with antiviral resistant HBV infection Available evidence does not support the use of telbivudine monotherapy in patients with established lamivudine-resistant hepatitis B virus infection.
Pazjenti b’ infezzjoni ta ’ HBV resistenti għall- mediċini kontra l- virus L- evidenza li hemm ma turix li jaqbel li telbivudine għandu jintuża waħdu f’ pazjenti li jkollhom infezzjoni b’ virus ta ’ l- epatite B li jkun ġie stabbilit li huwa reżistenti għal telbivudine.
In vitro, telbivudine was not active against the HBV strains containing rtM204V/ rtL180M or rtM204I mutations (see section 5.1).
Telbivudine ma kienx attiv in vitro kontra r- razez ta ’ HBV li fihom il- mutazzjonijiet rtM204V/ rtL180M jew rtM204I (ara sezzjoni 5. 1).
The efficacy of telbivudine against HBV harbouring the M204V mutation has not been established in clinical trials.
L- effikaċja ta ’ telbivudine kontra HBV li jkollha fiha mutazzjoni M204V ma ġietx stabbilita waqt il- provi kliniċi.
There are no data on telbivudine treatment in patients with established adefovir-resistant hepatitis B virus single mutations of rtN236T or A181V.
M’ hemmx tagħrif dwar il- kura b’ telbivudine f’ pazjenti li jkollhom virus ta ’ l- epatite B li jkun ġie stabilit li huwa reżistenti għal adefovir b’ mutazzjonijiet waħdiet ta ’ rtN236T jew A181V.
The preliminary results from the cell-based assay showed that the adefovir resistance-associated substitution A181V had 3.7 fold reduced susceptibility to telbivudine.
Ir- riżultati preliminari mill- analiżi bbażata fuq iċ- ċellula wriet li s- sostituzzjoni A181V assoċjata mar- reżistenza ta ’ adefovir kellha suxxettibbilità mnaqqsa bi 3. 7 drabi għal telbivudine.
The rate of genotypically confirmed telbivudine resistance in the pivotal study at 48 weeks was 2.7%.
Ir- rata ta ’ reżistenza għal telbivudine li ġiet konfermata b’ mod ġenotopiku fi studju pivitali fit - 48 ġimgħa kienet 2. 7%.
Liver transplant recipients The safety and efficacy of telbivudine in liver transplant recipients are unknown.
Pazjenti li jkunu rċevew trapjant tal- fwied Is- sigurtà u l- effikaċja f’ pazjenti li jkunu rċevew trapjant tal- fwied mhumiex magħrufa.
Elderly patients Clinical studies of telbivudine did not include sufficient numbers of patients ≥ 65 years of age to determine whether they respond differently from younger subjects.
Pazjenti anzjani L- istudji kliniċi li saru fuq telbivudine ma kienux jinkludu numru biżżejjed ta ’ pazjenti li kellhom età ta’ ≥ 65- sena sabiex jiġi stabbilit jekk ir- rispons tagħhom hux differenti minn dak ta ’ pazjenti aktar żgħar fl- età.
In general, caution must be exercised when prescribing Sebivo to elderly patients in view of the greater frequency of decreased renal function due to concomitant disease or concomitant use of other medicinal products.
B’ mod ġenerali, għandha ssir kawtela meta Sebivo jinkiteb għall- pazjenti anzjani minħabba li jista ’ jkun hemm numru aktar frekwenti li jsofru minn tnaqqis fil- funzjoni renali minħabba mard ieħor fl- istess ħin jew użu fl- istess ħin ta ’ mediċini oħra.
Other special populations Sebivo has not been investigated in co-infected hepatitis B patients (e. g. patients co-infected with human immunodeficiency virus [HIV], hepatitis C virus [HCV] or hepatitis D virus [HDV]).
Popolazzjonijiet speċjali oħra Sebivo ma kienx investigat f’ pazjenti bl- epatite B koinfettati (eż. pazjenti li fl- istess ħin kienu infettati bil- virus ta ’ l- immunodefiċjenza umana [HIV], bil- virus tal- epatite C [HCV] jew bil- virus tal- epatite D [HDV].
General Patients should be advised that treatment with Sebivo has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
Ġenerali Pazjenti għandhom jiġu kunsiljati li l- kura b’ Sebivo ma wrietx li tnaqqas ir- riskju li HBV jinxtered lil persuni oħra permezz ta ’ kuntatt sesswali jew kontaminazzjoni tad- demm.
Telbivudine is not recommended to be used with lamivudine because in a phase II study, the treatment response observed with combination therapy of telbivudine and lamivudine was lower than with telbivudine alone.
Telbivudine mhux rakkomandat biex jintuża ma ’ lamivudine għax fi studju ta ’ fażi II, ir- rispons tal - kura li deher bil- kombinazzjoni tat- terapija ta ’ telbivudine u lamivudine kien aktar baxx minn dak b’ telbivudine waħdu.
There are currently no efficacy and safety data for other antiviral combinations with telbivudine.
Bħalissa m’ hemmx tagħrif dwar l- effikaċja u s- sigurtà għal kombinazzjonijiet ta ’ anti- virali oħra ma ’ telbivudine.
4.5 Interaction with other medicinal products and other forms of interaction
5 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Since telbivudine is eliminated primarily by renal excretion, co-administration of Sebivo with substances that affect renal function (such as aminoglycosides, loop diuretics, platinum compounds, vancomycin, amphotericin B) may affect plasma concentrations of telbivudine and/ or the co- administered substance.
Peress li telbivudine jitneħħa mill- ġisem l- aktar permezz tal- kliewi, l- għotja ta ’ Sebivo fl- istess ħin ma ’ sustanzi li jeffettwaw il- funzjoni renali (bħal aminoglycosides, dijurtiċi loop, sustanzi li fihom platinum, vancomycin, amphotericin B) jistgħu jaffettwaw l- konċentrazzjonijiet ta ’ telbivudine fil - plażma u/ jew tas- sustanza li tkun qed tiġi mogħtija fl- istess ħin.
The combination of telbivudine with these medicinal products should be used with caution.
Il- kombinazzjoni ta ’ telbivudine ma ’ dawn il- prodotti mediċinali għandha tintuża b’ attenzjoni.
The steady-state pharmacokinetics of telbivudine were unaltered following multiple dose administration in combination with lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate, ciclosporin or pegylated interferon alfa-2a.
Il- farmakokinetiċi fi stat fiss ta ’ telbivudine ma nbidlux wara li ngħataw ħafna dożi wara xulxin fl- istess ħin ma ’ lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate, ciclosporin jew interferon alfa- 2a pegilat.
In addition, telbivudine does not alter the pharmacokinetics of lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate or ciclosporin.
Flimkien ma ’ dan, telbivudine ma jibdilx il- farmakokinetika ta ’ lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate jew ciclosporin.