natgillin/translations-raw huggingface dataset:
• Keep out of the reach and sight of children. • Do not use EXJADE after the expiry date which is stated on the blister and the carton.
• Zdravilo shranjujte nedosegljivo otrokom! • Zdravila EXJADE ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli.
The expiry date refers to the last day of that month. • Store in the original package in order to protect from moisture. • Do not use any pack that is damaged or shows signs of tampering.
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca. • Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago. • Zdravila ne uporabljajte, če je ovojnina poškodovana ali opazite, da je bila že odprta.
What EXJADE contains The active substance is deferasirox.
Kaj vsebuje zdravilo EXJADE Zdravilna učinkovina je deferasiroks.
Each tablet of EXJADE 125 mg contains 125 mg deferasirox.
Ena tableta zdravila EXJADE 125 mg vsebuje 125 mg deferasiroksa.
Each tablet of EXJADE 250 mg contains 250 mg deferasirox.
Ena tableta zdravila EXJADE 250 mg vsebuje 250 mg deferasiroksa.
Each tablet of EXJADE 500 mg contains 500 mg deferasirox.
Ena tableta zdravila EXJADE 500 mg vsebuje 500 mg deferasiroksa.
The other ingredients are lactose monohydrate, crospovidone type A, povidone, sodium lauryl sulphate, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.
Pomožne snovi so laktoza monohidrat, krospovidon tipa A, povidon, natrijev lavrilsulfat, mikrokristalna celuloza, brezvoden koloidni silicijev dioksid in magnezijev stearat.
What EXJADE looks like and contents of the pack EXJADE is supplied as dispersible tablets.
Izgled zdravila in vsebina pakiranja EXJADE je na voljo v obliki disperzibilnih tablet.
The tablets are off-white, round and flat.
Vsaka tableta vsebuje 125 mg, 250 mg ali 500 mg deferasiroksa:
Each tablet contains 125 mg, 250 mg or 500 mg deferasirox: • EXJADE 125 mg tablets are stamped on each tablet with “J 125”. • EXJADE 250 mg tabletsare stamped on each tablet with “J 250”. • EXJADE 500 mg tablets are stamped on each tablet with “J 500”.
Vsaka tableta EXJADE 125 mg ima vtisnjeno oznako “ J 125 ”. • Vsaka tableta EXJADE 250 mg ima vtisnjeno oznako “ J 250 ”. • Vsaka tableta EXJADE 500 mg ima vtisnjeno oznako “ J 500 ”. •
Each blister pack contains 28, 84 or 252 dispersible tablets.
Vsak pretisni omot vsebuje 28, 84 ali 252 disperzibilnih tablet.
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0
56 Deutschland Novartis Pharma GmbH Tel: +49 911 273 0
It contains 250 micrograms (8 million international units - MIU) per millilitre of the active substance interferon beta-1b.
Vsebuje 250 mikrogramov (8 milijonov mednarodnih enot – milijonov i. e.) zdravilne učinkovine interferon beta- 1b na mililiter pripravljene raztopine.
The company that makes Betaferon has agreed that its scientific data can be used for Extavia.
Družba, ki proizvaja zdravilo Betaferon, je privolila v to, da se znanstveni podatki tega zdravila uporabljajo tudi za zdravilo Extavia.
What is Extavia used for?
Za kaj se zdravilo Extavia uporablja?
Extavia is used to treat adult patients who have multiple sclerosis (MS).
Zdravilo Extavia se uporablja za zdravljenje odraslih z multiplo sklerozo (MS).
MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
Multipla skleroza je obolenje živcev, pri kateri vnetje uniči zaščitni ovoj okoli živcev.
This is called ‘ demyelination’.
Ta proces se imenuje „ demielinizacija “.
It is used in patients: • who have experienced the signs of MS (‘ demyelination event ’) for the first time, and these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines).
Zdravilo se uporablja pri bolnikih: • ki prvič doživijo znake multiple skleroze („ demielinizacijski dogodek “), če so ti znaki dovolj resni, da je potrebno zdravljenje z injiciranjem kortikosteroidov (protivnetnih zdravil).
It is used when the patient is considered to be at high risk of developing MS.
Zdravilo se uporabi, če je ugotovljeno, da je tveganje za razvoj multiple skleroze veliko.
Before using it, doctors need to exclude other causes for the symptoms. • who have MS of the type known as ‘ relapsing-remitting ’, when the patient has attacks (relapses) within periods with no symptoms (remissions), and with at least two relapses within the last two years. • who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
Pred uporabo mora zdravnik izključiti možnost kakršnega koli drugega vzroka za te simptome; • z vrsto multiple skleroze, imenovane „ recidivno- remitentna “ multipla skleroza, pri kateri bolnik doživlja napade (recidive) v obdobjih brez simptomov (remisije), in sicer vsaj dva recidiva v zadnjih dveh letih; • s sekundarno progresivno multiplo sklerozo (vrsto multiple skleroze, ki nastopi po recidivno- remitentni multipli sklerozi), pri katerih je bolezen aktivna.
The treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 19 days to reach the recommended dose of 250 micrograms (8 MIU) given every other day.
Zdravljenje se začne z 62, 5 mikrograma (četrtina odmerka), ki se injicira vsak drugi dan, ta odmerek pa se v naslednjih 19 dneh postopoma povečuje do priporočenega odmerka 250 mikrogramov (8 milijonov i. e.), ki se daje vsaki drugi dan.
The patients can inject Extavia themselves, provided that they have been trained.
Zdravljenje z zdravilom Extavia je treba prekiniti pri bolnikih, pri katerih ni odziva na zdravilo.
Extavia treatment should be stopped in patients who fail to respond.
Zdravilna učinkovina zdravila Extavia, interferon beta- 1b, spada v skupino „ interferonov “.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Natančen način delovanja zdravila Extavia pri multipli sklerozi še ni znan, vendar se zdi, da 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
How does Extavia work?
Reproduction is authorised provided the source is acknowledged. beta- interferon pomirja imunski sistem (naravno obrambo telesa) in preprečuje recidive multiple skleroze.
The active substance in Extavia, interferon beta-1b, belongs to the group ‘ interferons’.
Interferon beta- 1b proizvajajo z metodo, znano kot „ tehnologija rekombinantne DNK “.
The interferon beta-1b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
Interferon beta- 1b proizvede bakterija, ki je prejela gen (DNK), s katerim lahko tvori ta interferon.
The replacement interferon beta-1b acts in the same way as naturally produced interferon beta.
Nadomestni interferon beta- 1b deluje na enak način kot naravno proizvedeni interferon beta.
Extavia was studied over a two year period in 338 patients with relapsing remitting MS and able to walk unaided, where its effectiveness was compared with placebo (a dummy treatment).
Zdravilo Extavia so preučevali v obdobju dveh let pri 338 bolnikih z recidivno- remitentno multiplo sklerozo, sposobnih hoje brez pomoči, pri čemer so učinkovitost zdravila primerjali z učinkovitostjo placeba (zdravila brez zdravilne učinkovine).
Extavia has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with placebo.
Zdravilo Extavia so preučevali tudi v okviru dveh študij pri 1657 bolnikih s sekundarno progresivno multiplo sklerozo, sposobnih hoje, pri čemer so ga primerjali s placebom.
The study of Extavia in patients with a single demyelinating event involved 487 patients, who received either Extavia or placebo for two years.
Študija zdravila Extavia pri bolnikih z enkratnim demielinizacijskim dogodkom je vključevala 487 bolnikov, ki so v obdobju dveh let prejemali bodisi zdravilo Extavia ali placebo.
In patients with relapsing remitting MS, Extavia was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27 relapses.
Pri bolnikih z recidivno- remitentno multiplo sklerozo je bilo pri zmanjševanju števila letnih recidivov zdravilo Extavia učinkovitejše od placeba: bolniki, ki so prejemali zdravilo, so v povprečju doživeli 0, 84 recidiva letno, bolniki, zdravljeni s placebom, pa 1, 27.
One of the two studies in patients with secondary progressive MS showed a significant delay in the time to disability progression (31% risk reduction due to Extavia) and in the time to becoming wheelchair bound (39%).
Ena od dveh študij pri bolnikih s sekundarno progresivno multiplo sklerozo je pokazala pomemben odlog do napredovanja invalidnosti (31% zmanjšanje tveganja zaradi zdravila Extavia) in do priklenjenosti na voziček (39%).
In both trials, Extavia showed a reduction in the number (30%) of clinical relapses.
V obeh študijah so pri uporabi zdravila Extavia ugotovili zmanjšanje števila (30%) kliničnih recidivov.
28% of the patients who received Extavia developed MS, against 45% of those who received placebo.
V študiji z bolniki z enkratnim demielinizacijskim dogodkom so ugotovili, da je zdravilo Extavia zmanjšalo tveganje za razvoj klinično dokončne multiple skleroze: multipla skleroza se je razvila pri 28% bolnikov, ki so prejemali zdravilo Extavia, v primerjavi s 45% tistih, ki so prejemali placebo.
Very common side effects with Extavia (seen more than 1 patients in 10) are flu-like symptoms, fever, chills and injection site reactions (inflammation and pain at the site of injection).
Najpogostejši neželeni učinki zdravila Extavia (opaženi pri več kot 1 bolniku izmed 10) so gripi podobni simptomi, povišana telesna temperatura, mrzlica in reakcije na mestu injiciranja (vnetje in bolečina na mestu injiciranja).
For the full list of all side effects reported with Extavia, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Extavia, glejte navodilo za uporabo.
Extavia should not be used in people who have a history of hypersensitivity (allergy) to natural or recombinant interferon beta, human albumin or any of the other ingredients.
Zdravila Extavia ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) naravni ali rekombinantni interferon beta, humani albumin ali katero koli drugo sestavino zdravila.
Extavia treatment should not be started during pregnancy.
Zdravljenje z zdravilom Extavia se ne sme pričeti med nosečnostjo.
Extavia should not be used in patients who are currently suffering from severe depression and/ or have thoughts of suicide.
Zdravila Extavia prav tako ne smejo uporabljati bolniki, ki trpijo za depresijo in/ ali imajo samomorilne misli.
Extavia should not be used in patients who have decompensated liver disease (when the liver does not function normally).
Zdravila Extavia ne smejo uporabljati bolniki z dekompenzirano boleznijo jeter (pri kateri jetra ne delujejo normalno).
The Committee for Medicinal Products for Human Use (CHMP) decided that Extavia’ s benefits are greater than its risks for the treatment of patients with a single demyelinating event, if it is severe enough to justify treatment with intravenous corticosteroids, patients with relapsing-remitting MS and patients with secondary progressive MS with active disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Extavia večje od z njim povezanih tveganj pri zdravljenju bolnikov z enkratnim demielinizacijskim dogodkom, ki je dovolj resen, da je potrebno zdravljenje z injiciranjem kortikosteroidov, bolnikih z recidivno- remitentno multiplo sklerozo ter bolnikih s sekundarno progresivno multiplo sklerozo, pri katerih je bolezen aktivna.
They recommended that Extavia be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Extavia odobri dovoljenje za promet.
Other information about Extavia:
Druge informacije o zdravilu Extavia:
The European Commission granted a marketing authorisation valid throughout the European Union, for Extavia to Novartis Europharm Limited on 20 May 2008.
Evropska komisija je dovoljenje za promet z zdravilom Extavia, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 20. maja 2008.
The full EPAR for Extavia can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Extavia je na voljo tukaj.
EU/ 1/ 08/ 454/ 001
Številka EU EU/ 1/ 08/ 454/ 001
Extavia
Izmišljeno ime Extavia
250 µg / ml
Jakost 250 µg/ ml
Powder and solvent for solution for injection
Farmacevtska oblika Prašek in vehikel za raztopino za injiciranje
Subcutaneous use
Pot uporabe Subkutana uporaba
powder: vial (glass); solvent: pre-filled syringe (glass)
Ovojnina Prašek: viala (steklena) Vehikel: napolnjena injekcijska brizga (steklena)
powder:
Vsebina prašek:
3 ml; solvent:
3 ml; vehikel:
5 vials + 5 pre-filled syringes
Velikost pakiranja 5 vial + 5 napolnjenih injekcijskih brizg
powder: vial (glass); solvent: pre-filled syringe (glass)
Prašek: viala (steklena) Vehikel: napolnjena injekcijska brizga (steklena)
3 ml; solvent:
3 ml vehikel:
3 x 15 vials + 3 x 15 pre- filled syringes
3 x 15 vial + 3 x 15 napolnjenih injekcijskih brizg
Extavia 250 microgram/ ml powder and solvent for solution for injection.
Extavia 250 mikrogramov/ ml prašek in vehikel za raztopino za injiciranje
Extavia contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial.
Zdravilo Extavia vsebuje 300 mikrogramov (9, 6 milijonov i. e.) rekombinantnega interferona beta- 1b na vialo.
Recombinant interferon beta-1b* 250 microgram (8.0 million IU) per ml when reconstituted.
Rekombinantni interferon beta- 1b *, 250 mikrogramov (8, 0 milijonov i. e.) na mililiter po pripravi.
Extavia is indicated for the treatment of • Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1). • Patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years. • Patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Zdravilo Extavia je indicirano za zdravljenje • bolnikov z enkratnim demielinizacijskim dogodkom, z aktivnim vnetnim procesom, če je dovolj resen, da je potrebno intravensko zdravljenje s kortikosteroidi, če je bila alternativna diagnoza izključena in če je ugotovljeno, da je tveganje za razvoj klinično dokončne multiple skleroze veliko (glejte poglavje 5. 1); • bolnikov z recidivno- remitentno multiplo sklerozo, ki so v zadnjih dveh letih doživeli dva recidiva ali več. • bolnikov s sekundarno progresivno multiplo sklerozo, pri katerih je bolezen aktivna, kar se kaže z recidivi.
Adults The recommended dose of Extavia is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day.
Odrasli Priporočeni odmerek zdravila Extavia je 250 mikrogramov (8, 0 milijonov i. e.), kolikor ga vsebuje 1 ml pripravljene raztopine (glejte poglavje 6. 6), ki ga je treba injicirati subkutano vsak drugi dan.
Children and adolescents No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Otroci in mladostniki Formalnih kliničnih preskušanj ali farmakokinetičnih študij pri otrocih ali mladostnikih niso opravili.
However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Extavia 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Vendar pomankljivi objavljeni podatki kažejo, da je varnostni profil pri mladostnikih, starih od 12 do 16 let, ki so vsak drugi dan subkutano prejemali 8, 0 milijonov i. e. zdravila Extavia, podoben varnostnemu profilu, ki so ga opazili pri odraslih.
There is no information on the use of Extavia in children under 12 years of age and therefore Extavia should not be used in this population.
Informacij o uporabi zdravila Extavia pri otrocih, mlajših od 12 let, ni, zato se ga pri tej populaciji ne sme uporabljati.
2 Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
2 Zdravljenje je treba začeti z odmerkom 62, 5 mikrogramov (0, 25 ml) subkutano vsak drugi dan, nato pa ga večati do 250 mikrogramov (1, 0 ml) vsak drugi dan (glejte Preglednico A).
In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.
Za doseganje ustrezne učinkovitosti je treba doseči odmerek 250 mikrogramov (1, 0 ml) vsak drugi dan.
Treatment day
dan zdravljenja
Volume
prostornina
There are follow-up data under controlled clinical conditions for patients with relapsing-remitting multiple sclerosis for up to 5 years and for patients with secondary progressive multiple sclerosis for up to 3 years.
Za bolnike z recidivno - remitentno multiplo sklerozo obstajajo podatki o spremljanju v kontroliranih kliničnih pogojih za obdobje do 5 let, za bolnike s sekundarno progresivno multiplo sklerozo za obdobje do 3 let.
For relapsing-remitting multiple sclerosis, efficacy has been demonstrated for therapy for the first two years.
Pri recidivno- remitentni multipli sklerozi je dokazana učinkovitost zdravljenja za prvi dve leti.
Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.
Zdraviti ni priporočljivo bolnikov z recidivno- remitentno multiplo sklerozo, ki so v zadnjih 2 letih doživeli manj kot 2 recidiva, in bolnikov s sekundarno progresivno multiplo sklerozo, ki v zadnjih 2 letih niso imeli aktivne bolezni.
− Initiation of treatment in pregnancy (see section 4.6). − Patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients. − Patients with current severe depression and/ or suicidal ideation (see sections 4.4 and 4.8). − Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
− Uvajanje zdravljenja med nosečnostjo (glejte poglavje 4. 6). − Pri bolnikih z znano preobčutljivostjo za naravni ali rekombinantni interferon beta, humani albumin ali katerokoli od pomožnih snovi. − Bolniki s hudimi depresivnimi motnjami in/ ali samomorilnimi mislimi (glejte poglavji 4. 4 in 4. 8). − Bolniki z dekompenzirano boleznijo jeter (glejte poglavja 4. 4, 4. 5 in 4. 8).
Immune system disorders The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Bolezni imunskega sistema Uporaba citokinov pri bolnikih z obstoječo monoklonsko gamopatijo je povezana z razvojem sindroma sistemske kapilarne krvavitve s simptomi, podobnimim šoku in smrtnim izidom.
Gastrointestinal disorders In rare cases, pancreatitis was observed with Extavia use, often associated with hypertriglyceridaemia.
Bolezni prebavil V redkih primerih so pri uporabi zdravila Extavia opazili pankreatitis, ki je bil pogosto povezan s hipertrigliceridemijo.
3 Nervous system disorders Extavia should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
3 Bolezni živčevja Zdravilo Extavia morate previdno uporabljati pri bolnikih s predhodnimi ali trenutnimi depresivnimi motnjami, zlasti pri tistih, ki so že imeli samomorilna razmišljanja (glejte poglavje 4. 3).
Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Znano je, da sta depresija in samomorilno razmišljanje med bolniki z multiplo sklerozo in v povezavi z uporabo interferona pogostejša.
Patients treated with Extavia should be advised to immediately report any symptoms of depression and/ or suicidal ideation to their prescribing physician.
Bolnikom, ki dobivajo zdravilo Extavia, je treba naročiti, naj o morebitnih simptomih depresije ali samomorilnega razmišljanja nemudoma obvestijo zdravnika, ki je predpisal zdravilo.
Cessation of therapy with Extavia should be considered (see also sections 4.3 and 4.8).
V poštev pride prekinitev zdravljenja z zdravilom Extavia (glejte tudi poglavji 4. 3 in 4. 8).
Extavia should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti- epileptics (see sections 4.5 and 4.8).
Zdravilo Extavia je treba previdno uporabljati pri bolnikih z anamnezo epileptičnih napadov in bolnikih, ki dobivajo antiepileptična zdravila, zlasti če njihova epilepsija z antiepileptičnimi zdravili ni ustrezno obvladana (glejte poglavji 4. 5 in 4. 8).
This product contains human albumin and hence carries a potential risk for transmission of viral diseases.
Zdravilo vsebuje človeški albumin in zato obstaja potencialno tveganje za prenos virusnih bolezni.
Laboratory tests Thyroid function tests are recommended regularly in patients with a history of thyroid dysfunction or as clinically indicated.
Laboratorijski testi Pri bolnikih z anamnezo motenega delovanja ščitnice so priporočljive redne preiskave delovanja ščitnice, kot je klinično indicirano.
In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e. g. aspartate aminotransferase serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase serum glutamate pyruvate transaminase (SGPT) and gamma glutamyltransferase), are recommended prior to initiation and at regular intervals following introduction of Extavia therapy, and then periodically thereafter in the absence of clinical symptoms.
Poleg laboratorijskih preiskav, ki se običajno uporabljajo pri spremljanju bolnikov z multiplo sklerozo, je pred začetkom zdravljenja z zdravilom Extavia, ob rednih presledkih med zdravljenjem ter, če ni kliničnih simptomov, občasno po zdravljenju, priporočljivo opraviti celotno krvno sliko, diferencialno krvno sliko levkocitov, število trombocitov in biokemične krvne preiskave, vključno s preizkusi delovanja jeter (npr. aspartat- aminotransferaza (AST), alanin- aminotransferaza (ALT), in γ- glutamiltransferaza).
Hepatobiliary disorders Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Extavia during clinical trials.
Bolezni jeter, žolčnika in žolčevodov Med kliničnimi preskušanji so se pri bolnikih, ki so dobivali zdravilo Extavia, zelo pogosto pojavila asimptomatska zvišanja serumskih transaminaz, ki so bila večinoma blaga in prehodna.
As for other beta interferons, severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking Extavia.
Tako kot pri drugih interferonih beta so bili tudi pri prejemnikih zdravila Extavia opisani redki primeri hude okvare jeter, vključno s primeri odpovedi jeter.
The most serious events often occurred in patients exposed to other medicinal products or substances known to be associated with hepatotoxicity or in the presence of co-morbid medical conditions (e. g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
Najresnejši učinki so se pogosto pojavili pri bolnikih, ki so dobivali še druga zdravila ali snovi z znanimi hepatotoksičnimi učinki in pri bolnikih s sočasnimi boleznimi (npr. metastatsko maligno boleznijo, hudo okužbo in sepso, zlorabo alkohola).
Withdrawal of Extavia should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundices.
Če se transaminaze pomembno zvišajo ali če jih spremljajo klinični simptomi zlatenice, je treba premisliti o prekinitvi zdravljenja z zdravilom Extavia.