natgillin/translations-raw huggingface dataset:
The main measures of the effectiveness of the vaccine were viraemia (levels of BTV8 in the blood) and clinical signs of bluetongue virus infection.
Glavna merila učinkovitosti cepiva so bila viremija (količina virusa BTV8 v krvi) in klinični znaki okužbe z virusom modrega jezika.
The studies showed that the vaccine prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8.
Študije so pokazale, da cepivo preprečuje viremijo pri ovcah in govedu ter zmanjšuje klinične znake pri ovcah, okuženih s serotipom 8 virusa modrega jezika.
For the full list of restrictions and all side effects reported with Bovilis Blue-8, see the package leaflet.
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Bovilis Blue-8, glejte navodilo za uporabo.
bluetongue virus vaccine, serotype 8 (inactivated)
cepivo z virusom modrega jezika, serotip 8 (inaktivirano)
This authorisation was based on the authorisation granted to Bluevac BTV8 in 2011 (‘informed consent').
Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Bluevac BTV8, ki je bilo izdano leta 2011 („uporaba dokumentacije s soglasjem“).
Bovilis Blue-8 is a vaccine.
Zdravilo Bovilis Blue-8 je cepivo.
Bovilis Blue-8 contains bluetongue viruses of one type (‘serotype 8').
Zdravilo Bovilis Blue-8 vsebuje en tip virusov modrega jezika („serotip 8“).
The company that makes Bluevac BTV8 has agreed that its scientific data can be used for Bovilis Blue-8 (‘informed consent').
Družba, ki proizvaja zdravilo Bluevac BTV8, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Bovilis Blue-8 („uporaba dokumentacije s soglasjem“).
The vaccine is used to prevent viraemia (the presence of viruses in the blood) and to reduce clinical signs caused by bluetongue virus in sheep and to prevent viraemia in cattle.
Cepivo se uporablja pri ovcah za preprečevanje viremije (prisotnosti virusov v krvi) in zmanjšanje kliničnih znakov, ki jih povzroča virus modrega jezika, ter pri govedu za preprečevanje viremije.
Bovilis Blue-8 is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Zdravilo Bovilis Blue-8 je cepivo, ki se uporablja pri govedu in ovcah za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo prenašajo trzače, povzroča pa jo virus modrega jezika.
Other information about Bovilis Blue-8:
Druge informacije o zdravilu Bovilis Blue-8:
For practical information about using Bovilis Blue-8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Bovilis Blue-8 naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with Bovilis Blue-8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Bovilis Blue-8 naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
The vaccine contains inactivated (killed) bluetongue virus, serotype 8.
Cepivo vsebuje inaktivirane (uničene) viruse modrega jezika, serotip 8.
What are the risks associated with Bovilis Blue-8?
Kakšna tveganja so povezana z zdravilom Bovilis Blue-8?
Bovilis Blue-8 contains a bluetongue virus that has been inactivated so that it cannot cause the disease.
Cepivo Bovilis Blue-8 vsebuje inaktivirani virus modrega jezika, ki ne povzroča bolezni.
What benefits of Bovilis Blue-8 have been shown in studies?
Kakšne koristi je zdravilo Bovilis Blue-8 izkazalo v študijah?
What is Bovilis Blue-8 and what is it used for?
Kaj je zdravilo Bovilis Blue-8 in za kaj se uporablja?
Why is Bovilis Blue-8 approved?
Zakaj je bilo zdravilo Bovilis Blue-8 odobreno?
How does Bovilis Blue-8 work?
Kako zdravilo Bovilis Blue-8 deluje?
How is Bovilis Blue-8 used?
Kako se zdravilo Bovilis Blue-8 uporablja?
The recommended dose is one tablet taken once a day.
Priporočeni odmerek zdravila je ena tableta enkrat dnevno.
The tablets must always be taken after the patient has fasted overnight for at least six hours and at least 30 minutes before the first food or drink of the day.
Tableto mora bolnik vedno vzeti zjutraj na tešče, ko ni jedel vsaj šest ur, in vsaj 30 minut pred prvim obrokom ali pijačo.
This leads to less bone loss.
Zaradi tega je izgubljanje kostne mase manjše.
The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Zmanjšano izgubljanje kostnine pripomore k manjši verjetnosti zloma, kar je koristno za preprečevanje zlomov pri bolnikih z rakom in metastazami v kosteh.
The patient must also not lie down for one hour after taking the tablets.
Eno uro po tem bolnik ne sme ležati.
The full EPAR for Ibandronic Acid Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ibandronic Acid Sandoz je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It stops the action of osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Ta zavira delovanje osteoklastov, tj. celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
Ibandronic Acid Sandoz is used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Zdravilo Ibandronic Acid Sandoz se uporablja za preprečevanje z okostjem povezanih dogodkov (zlomov kosti ali z okostjem povezanih zapletov, ki zahtevajo zdravljenje) pri bolnikih z rakom dojke in metastazami v kosteh (ko se je rak razširil v kosti).
This means that Ibandronic Acid Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU).
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU).
For more information about treatment with Ibandronic Acid Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Ibandronic Acid Sandoz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This document is a summary of the European public assessment report (EPAR) for Ibandronic Acid Sandoz.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ibandronic Acid Sandoz.
Ibandronic Acid Sandoz must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed.
Zdravilo Ibandronic Acid Sandoz je treba vzeti v stoječem ali sedečem položaju in popiti poln kozarec navadne (ne mineralne) vode; tableta se ne sme žvečiti, lizati ali zdrobiti.
Because Ibandronic Acid Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Ibandronic Acid Sandoz generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Sandoz on 26 July 2011.
Evropska komisija je dovoljenje za promet z zdravilom Ibandronic Acid Sandoz, veljavno po vsej Evropski uniji, izdala 26. julija 2011.
Because Ibandronic Acid Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine.
Ker je zdravilo Ibandronic Acid Sandoz generično zdravilo, so bile študije na ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu.
The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Sandoz has been shown to have comparable quality and to be bioequivalent to Bondronat.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ibandronic Acid Sandoz primerljivo raven kakovosti kot zdravilo Bondronat in da mu je biološko enakovredno.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ibandronic Acid Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What measures are being taken to ensure the safe and effective use of Ibandronic Acid Sandoz?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ibandronic Acid Sandoz ?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ibandronic Acid Sandoz.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Ibandronic Acid Sandoz, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Ibandronic Acid Sandoz ibandronic acid
Ibandronic Acid Sandoz ibandronska kislina
Other information about Ibandronic Acid Sandoz:
Druge informacije o zdravilu Ibandronic Acid Sandoz:
The Committee recommended that Ibandronic Acid Sandoz be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Ibandronic Acid Sandoz izda dovoljenje za promet.
Ibandronic Acid Sandoz is a ‘generic medicine'.
Ibandronic Acid Sandoz je „generično zdravilo“.
What are the benefits and risks of Ibandronic Acid Sandoz?
Kakšne so koristi in tveganja, povezani z zdravilom Ibandronic Acid Sandoz?
A risk management plan has been developed to ensure that Ibandronic Acid Sandoz is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Ibandronic Acid Sandoz je bil pripravljen načrt obvladovanja tveganj.
Ibandronic Acid Sandoz is a medicine that contains the active substance ibandronic acid.
Ibandronic Acid Sandoz je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
The reference medicine for Ibandronic Acid Sandoz is Bondronat.
Referenčno zdravilo za Ibandronic Acid Sandoz je zdravilo Bondronat.
Why has Ibandronic Acid Sandoz been approved?
Zakaj je bilo zdravilo Ibandronic Acid Sandoz odobreno?
The active substance in Ibandronic Acid Sandoz, ibandronic acid, is a bisphosphonate.
Zdravilna učinkovina v zdravilu Ibandronic Acid Sandoz, ibandronska kislina, je difosfonat.
What is Ibandronic Acid Sandoz?
Kaj je zdravilo Ibandronic Acid Sandoz?
How has Ibandronic Acid Sandoz been studied?
Kako je bilo zdravilo Ibandronic Acid Sandoz raziskano?
How does Ibandronic Acid Sandoz work?
Kako zdravilo Ibandronic Acid Sandoz deluje?
What is Ibandronic Acid Sandoz used for?
Za kaj se zdravilo Ibandronic Acid Sandoz uporablja?
How is Ibandronic Acid Sandoz used?
Kako se zdravilo Ibandronic Acid Sandoz uporablja?
17 December 2009 EMA/830685/2009 EMEA/H/C/1020
17. december 2009 EMEA/830685/2009 EMEA/H/C/1020
Idiopathic means that the disease has no obvious cause.
Idiopatsko pomeni, da bolezen nima nikakršnega očitnega vzroka.
The 210 patients who completed the first 12 weeks were also offered the opportunity to continue treatment in an extension study.
Prav tako so 210 bolnikom, ki so zaključili prvih 12 tednov zdravljenja, ponudili možnost nadaljevanja zdravljenja v podaljšku študije.
The company had also provided results on studies involving patients with Parkinson's disease.
Družba je prav tako priložila rezultate študij, ki so vključevale bolnike s Parkinsonovo boleznijo.
The effects of Nenad were first tested in experimental models before being studied in humans.
Učinki zdravila Nenad so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
There were also problems with the patches not sticking well enough to the skin.
Prav tako so se pojavljale težave, ker se obliž ni dovolj dobro prilepil na kožo.
What is Nenad?
Kaj je zdravilo Nenad?
Restless legs syndrome is a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Sindrom nemirnih nog je motnja, pri kateri ima bolnik nenadzorovano potrebo po premikanju okončin, da prepreči neprijetne, boleče ali nenavadne občutke v telesu, najpogosteje ponoči.
The company presented results of one main study of 309 patients with moderate-to-severe restless legs syndrome.
Družba je predložila rezultate ene glavne študije, ki je vključevala 309 bolnikov z zmernim do hudim sindromom nemirnih nog.
On 30 November 2009, Axxonis Pharma AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Nenad, for the treatment of the signs and symptoms of moderate-to-severe idiopathic restless legs syndrome in adults.
Družba Axxonis Pharma AG je dne 30. novembra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Nenad, namenjenim zdravljenju znakov in simptomov zmernega do hudega idiopatskega sindroma nemirnih nog pri odraslih.
The Committee was also concerned that a large proportion of patients in the study stopped treatment with Nenad because of skin irritation, making the patch unsuitable for long-term use.
Odbor je prav tako izrazil zaskrbljenost nad tem, da je velik delež bolnikov v študiji prekinil zdravljenje z zdravilom Nenad zaradi draženja kože, zaradi česar je obliž neprimeren za dolgotrajno uporabo.
What documentation did the company present to support its application to the Agency?
Katero dokumentacijo je družba predložila Evropski agenciji za zdravila v podporo svoji vlogi?
Since restless legs syndrome is often a lifelong disease, long-term data were considered essential.
Ker je sindrom nemirnih nog pogosto doživljenjska bolezen, so podatki o dolgotrajnih učinkih bistveni.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Nenad?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Nenad?
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation for Nenad be refused.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil negativno mnenje in priporočil zavrnitev dovoljenja za promet z zdravilom Nenad.
This means that it imitates the action of dopamine, a messenger substance in the parts of the brain that control movement and co ordination.
To pomeni, da posnema delovanje dopamina, sporočilne snovi v delih možganov, ki nadzorujejo gibanje in koordinacijo.
What was Nenad expected to be used for?
Za kaj naj bi se zdravilo Nenad uporabljalo?
The patients were given Nenad, ropinirole (another medicine for restless legs syndrome) or placebo (a dummy medicine).
Bolniki so prejeli zdravilo Nenad, ropinirol (drugo zdravilo za sindrom nemirnih nog) ali placebo (zdravilo brez zdravilne učinkovine).
The active substance in Nenad, lisuride, is a dopamine agonist.
Zdravilna učinkovina zdravila Nenad, lizurid, je agonist dopamina.
The CHMP noted that, while the short-term effectiveness of Nenad for the treatment of restless legs syndrome had been shown, there was not enough evidence to demonstrate its long-term effectiveness.
CHMP je upošteval, da kljub temu, da so bili kratkoročni učinki zdravila Nenad za zdravljenje sindroma nemirnih nog dokazani, ni bilo zadostnih dokazov za njegovo dolgotrajno učinkovitost.
However, during the CHMP evaluation, the company withdrew its application for Nenad to be used for this disease.
Vendar pa je med postopkom ocenjevanja CHMP družba umaknila vlogo za zdravilo Nenad za uporabo pri tej bolezni.
However, the syndrome is thought to be caused by problems in the way dopamine works in the brain, which was expected to be corrected by lisuride.
Vendar pa se domneva, da sindrom nastane zaradi motenj delovanja dopamina v možganih, ki naj bi se odpravile z lizuridom.
The company withdrew before the European Commission had issued a decision on this opinion.
Družba je podala zahtevek za umik, še preden je Evropska komisija odobrila dovoljenje.
The company informed the CHMP that there are no consequences for patients using Nenad in clinical trials or compassionate use programmes.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki jemljejo zdravilo Nenad v kliničnih preskušanjih ali programih sočutne uporabe.
Nenad was expected to be used in adults with moderate-to-severe idiopathic restless legs syndrome.
Zdravilo Nenad naj bi se uporabljalo pri odraslih z zmernim do hudim idiopatskim sindromom nemirnih nog.
The way lisuride was expected to work in restless legs syndrome is not fully understood.
Način delovanja lizurida pri simptomu nemirnih nog ni popolnoma znan.
Nenad is a transdermal patch (patch that delivers a medicine across the skin) that contains the active substance lisuride.
Zdravilo Nenad je transdermalni obliž (obliž, ki dovaja zdravilo skozi kožo), ki vsebuje zdravilno učinkovino lizurid.
How was Nenad expected to work?
Kako naj bi zdravilo Nenad delovalo?
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Nenad in the treatment of restless legs syndrome did not outweigh its risks.
CHMP je menil, da koristi zdravila Nenad pri zdravljenju sindroma nemirnih nog ne odtehtajo z njim povezanih tveganj.
The main measure of effectiveness was the change in the rating of the
Glavno merilo učinkovitosti je bila sprememba ocene bolnikovih simptomov po 12 tednih glede na mednarodno ocenjevalno lestvico
patients' symptoms after 12 weeks using the International Restless Legs Syndrome rating scale (IRLS) score.
sindroma nemirnih nog (IRLS).
Date of first authorisation: 19 November 2008 Date of latest renewal: 28 November 2013
Datum prve odobritve: 19. november 2008 Datum zadnjega podaljšanja: 28. november 2013
(type A) and magnesium stearate.
(tipa A) in magnezijev stearat.
Your doctor will tell you exactly how many tablets of Xiliarx to take.
Zdravnik vam bo natančno povedal, koliko tablet zdravila Xiliarx morate jemati.
EU/1/08/486/001 7 tablets EU/1/08/486/002 14 tablets EU/1/08/486/003 28 tablets EU/1/08/486/004 30 tablets EU/1/08/486/005 56 tablets EU/1/08/486/006 60 tablets EU/1/08/486/007 90 tablets EU/1/08/486/008 112 tablets EU/1/08/486/009 180 tablets EU/1/08/486/010 336 tablets
EU/1/08/486/001 7 tablet EU/1/08/486/002 14 tablet EU/1/08/486/003 28 tablet EU/1/08/486/004 30 tablet EU/1/08/486/005 56 tablet EU/1/08/486/006 60 tablet EU/1/08/486/007 90 tablet EU/1/08/486/008 112 tablet EU/1/08/486/009 180 tablet EU/1/08/486/010 336 tablet
EU/1/08/486/011 336 tablets (3 packs of 112)
EU/1/08/486/011 336 tablet (3 pakiranja po 112 tablet)
How to take Xiliarx • Swallow the tablets whole with some water.
Kako jemati zdravilo Xiliarx - Tablete pogoltnite cele z malo vode.
Xiliarx is not a substitute for insulin in insulin-requiring patients.
Zdravilo Xiliarx ne more nadomestiti zdravljenja z insulinom pri bolnikih, ki potrebujejo insulin.
Xiliarx should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Zdravila Xiliarx se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
If you think you may be allergic to vildagliptin or any of the other ingredients of Xiliarx, do not take this medicine and talk to your doctor.
Če menite, da bi lahko bili alergični na vildagliptin ali katerokoli sestavino zdravila Xiliarx, ne jemljite tega zdravila in se posvetujte z zdravnikom.
The amount of Xiliarx people have to take varies depending on their condition.
Koliko zdravila Xiliarx morajo ljudje jemati, je odvisno od njihovega stanja.
Your doctor will prescribe Xiliarx either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.
Zdravnik vam bo predpisal zdravilo Xiliarx bodisi za samostojno uporabo ali skupaj z določenimi drugimi zdravili, ki jih že jemljete, če ta zdravila do zdaj niso bila dovolj učinkovita za urejanje sladkorne bolezni.
The active substance of Xiliarx, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Zdravilna učinkovina zdravila Xiliarx, vildagliptin, sodi v skupino zdravil, ki se imenujejo “peroralni antidiabetiki”.
It is not known if Xiliarx passes into breast milk.
Ni znano, ali zdravilo Xiliarx prehaja v materino mleko.
What Xiliarx is and what it is used for
Kaj je zdravilo Xiliarx in za kaj ga uporabljamo
Your doctor may wish to alter your dose of Xiliarx if you are taking other medicines such as: - thiazides or other diuretics (also called water tablets) - corticosteroids(generally used to treat inflammation) - thyroid medicines - certain medicines affecting the nervous system.
Zdravnik vam bo morda svetoval spremembo odmerka zdravila Xiliarx, če jemljete druga zdravila kot so - tiazidi ali drugi diuretiki (imenovani tudi tablete za odvajanje vode) - kortikosteroidi (običajno se jih uporablja za zdravljenje vnetij) - hormoni ščitnice - nekatera zdravila, ki vplivajo na živčevje.
The safety and efficacy of Xiliarx in children and adolescents (< 18 years) have not been established.
Varnost in učinkovitost zdravila Xiliarx pri otrocih in mladostnikih (< 18 let) nista bili dokazani.
Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Xiliarx for 10 days.
Podatki o verjetnih simptomih prevelikega odmerjanja temeljijo na študiji prenašanja naraščajočih odmerkov, izvedeni na zdravih osebah, ki so prejemale zdravilo Xiliarx 10 dni.
Do not stop taking Xiliarx unless your doctor tells you to.
Ne prenehajte jemati zdravila Xiliarix, če vam tega ne naroči zdravnik.
No studies on the effect on human fertility have been conducted for Xiliarx (see section 5.3).
Študij o vplivu zdravila Xiliarx na plodnost pri ljudeh niso izvajali (glejte poglavje 5.3).
Driving and using machines If you feel dizzy while taking Xiliarx, do not drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Če ste med jemanjem zdravila Xiliarx omotični, ne vozite in ne upravljajte strojev.
What you need to know before you take Xiliarx
Kaj morate vedeti, preden boste vzeli zdravilo Xiliarx
Xiliarx contains lactose (milk sugar).
Zdravilo Xiliarx vsebuje laktozo (mlečni sladkor).
Oral use Xiliarx can be administered with or without a meal (see also section 5.2).
Zdravilo Xiliarx se lahko jemlje z obrokom ali brez njega (glejte tudi poglavje 5.2).
• Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
• bolezen jeter (hepatitis) (redko); simptomi vključujejo rumeno kožo in oči, slabost, izgubo apetita ali temno obarvan urin, kar lahko kaže na bolezen jeter (hepatitis) ;
Following withdrawal of treatment with Xiliarx and LFT normalisation, treatment with Xiliarx should not be reinitiated.
Po prekinitvi zdravljenja z zdravilom Xiliarx in normalizaciji vrednosti jetrnih testov se zdravljenja z zdravilom Xiliarx ne sme ponovno uvesti.
Other medicines and Xiliarx
Druga zdravila in zdravilo Xiliarx
Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of Xiliarx therapy is recommended.
Če zvišanje AST ali ALT na ali nad 3-kratno zgornjo mejo normalnih vrednosti vztraja, je priporočena prekinitev zdravljenja z zdravilom Xiliarx.