natgillin/translations-raw huggingface dataset:
Progress and recruitment updates will be provided alongside the Annual Re-assessment/ PSURs.
Zadnji podatki o napredku in vključevanju oseb v raziskavo bodo na voljo skupaj z letno ponovno presojo in dopolnili periodičnih poročil o varnosti zdravila.
Actelion will conduct a natural history observational study of 100 patients with type 1 Gaucher disease taking the Scientific Advice provided in November 2003 into consideration.
Actelion bo opravil opazovalno študijo pojava in poteka Gaucherjeve bolezni tipa 1 pri 100 bolnikih in pri tem upošteval znanstveno mnenje, predloženo novembra 2003.
The study will be conducted in conjunction with the European Working Group for Gaucher disease (EWGGD).
Študija bo potekala v sodelovanju z Evropsko delovno skupino za Gaucherjevo bolezen – EWGGD.
This study will aim to enhance the knowledge of the neurological aspects of type 1 Gaucher disease.
Cilj študije bo izvedeti več o nevroloških vidikih Gaucherjeve bolezni tipa 1.
Longitudinal data will then be gathered on the patient cohort over a 2-year period.
Longitudinalni podatki bodo nato zbrani na vzorcu bolnikov v obdobju dveh let.
This study is referenced as OGT 918-018.
Oznaka te študije je OGT 918- 018.
Progress and recruitment updates will be provided alongside the Annual Re -assessment/ PSURs.
Zadnji podatki o napredku in vključevanju oseb v raziskavo bodo predloženi skupaj z letno ponovno presojo in dopolnili periodičnih poročil o varnosti.
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
15 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ZUNANJA ŠKATLA
Zavesca 100 mg hard capsules
Zavesca 100 mg trde kapsule miglustat
Each capsule contains 100 mg miglustat
Vsaka kapsula vsebuje 100 mg miglustata
EXP MM/ YYYY
MM/ LLLL
What Zavesca is and what it is used for 2.
Kaj je zdravilo Zavesca in za kaj ga uporabljamo 2.
Before you take Zavesca 3.
Kaj morate vedeti, preden boste vzeli zdravilo Zavesca 3.
How to take Zavesca 4.
Kako jemati zdravilo Zavesca 4.
How to store Zavesca 6.
Shranjevanje zdravila Zavesca 6.
WHAT ZAVESCA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ZAVESCA IN ZA KAJ GA UPORABLJAMO
Zavesca belongs to a group of medicines that affect metabolism.
Zdravilo Zavesca spada v skupino zdravil, ki vplivajo na presnovo.
• Zavesca is used to treat mild to moderate type 1 Gaucher disease.
• Zdravilo Zavesca se uporablja za zdravljenje blage do zmerne Gaucherjeve bolezni tipa 1.
In type 1 Gaucher disease, a substance called glucosylceramide is not removed from your body.
Pri Gaucherjevi bolezen tipa 1 se snov, imenovana glukozilceramid, ne odstranjuje iz telesa.
It starts to build up in certain cells of the body’ s immune system.
Namesto tega se kopiči v določenih celicah imunskega sistema.
• Zavesca is also used to treat progressive neurological symptoms in Niemann-Pick type C disease.
• Zdravilo Zavesca se uporablja tudi za zdravljenje progresivnih nevroloških simptomov pri Niemann- Pickovi bolezni tipa C.
If you have Niemann-Pick type C disease, fats such as glycosphingolipids build up in the cells of your brain.
Če imate Niemann- Pickovo bolezen tipa C, se v celicah vaših možganov kopičijo maščobe kot so glikosfingolipidi.
This can result in disturbances in neurological functions such as eye movements, balance, swallowing, and memory, and in seizures.
To lahko povzroči motnje nevroloških funkcij kot so gibanje očesa, ravnotežje, požiranje, spomin in epileptične napade.
Zavesca works by inhibiting the enzyme called ‘ glucosylceramide synthase’ which is responsible for the first step in the synthesis of most glycosphingolipids.
Zdravilo Zavesca deluje tako, da zavira delovanje encima, ki se imenuje 'glukozilceramid sintaza', ki je odgovoren za prvi korak sinteze večine glikosfingolipidov.
BEFORE YOU TAKE ZAVESCA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ZAVESCA
Do not take Zavesca
Ne jemljite zdravila Zavesca:
- if you are allergic (hypersensitive) to miglustat or any of the other ingredients of Zavesca.
- če ste alergični na (preobčutljivi za) miglustat ali katerokoli sestavino zdravila Zavesca.
If this
Če to
applies to you, tell your doctor.
velja za vas, povejte zdravniku.
Don’ t take Zavesca.
Ne uporabljajte zdravila Zavesca.
Take special care with Zavesca
Bodite posebno pozorni pri jemanju zdravila Zavesca:
- if you suffer from kidney disease
- če imate ledvično bolezen,
- if you suffer from liver disease
- če imate jetrno bolezen
20 Your doctor will perform the following tests before treatment and during treatment with Zavesca:
20 Če karkoli od zgoraj navedenega velja za vas, o tem obvestite svojega zdravnika preden začnete jemati zdravilo Zavesca.
- an examination to check the nerves in your arms and legs
- pregled živcev v vaših rokah in nogah,
- measurement of vitamin B12 levels.
- meritev ravni vitamina B12,
- monitoring growth if you are a child or adolescent with Niemann-Pick type C disease
- nadziranje rasti, če ste otrok ali mladostnik z Niemann- Pickovo boleznijo tipa C
- monitoring of blood platelet counts if you are a patient with Niemann-Pick type C disease
- nadziranje števila trombocitov v krvi, če ste bolnik z Niemann- Pickovo boleznijo tipa C
If you have diarrhoea, your doctor may ask you to change your diet to reduce your lactose and carbohydrate intake, or not to take Zavesca together with food, or to temporarily reduce your dose.
Če boste imeli drisko, vam bo morda zdravnik svetoval, da spremenite svojo prehrano tako, da zmanjšate vnos laktoze in ogljikovih hidratov, ali ne jemljete zdravila Zavesca skupaj s hrano ali začasno znižate svoj odmerek.
Male patients should use reliable birth control methods during their treatment with Zavesca, and for 3 months after finishing treatment.
Bolniki moškega spola morajo v času jemanja ter 3 mesece po prenehanju jemanja zdravila Zavesca uporabljati zanesljive kontracepcijske metode.
Using other medicines Talk to your doctor if you are using Cerezyme, or other medicines containing imiglucerase, which are sometimes used at the same time as Zavesca.
Jemanje drugih zdravil Obvestite svojega zdravnika, če jemljete zdravilo Cerezyme ali druga zdravila, ki vsebujejo imiglucerazo, ki se včasih jemljejo skupaj z zdravilom Zavesca.
Please tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including medicines obtained without prescription.
Obvestite svojega zdravnika ali farmacevta, če uporabljate ali ste pred kratkim uporabljali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Taking Zavesca with food and drink Zavesca can be taken with or without food.
Jemanje zdravila Zavesca skupaj s hrano in pijačo Zdravilo Zavesca lahko jemljete skupaj s hrano ali brez nje.
You should swallow the whole capsule with a glass of water.
Celo kapsulo pogoltnite s kozarcem vode.
Pregnancy and breast-feeding You should not use Zavesca if you are pregnant or thinking of becoming pregnant.
Nosečnost in dojenje Če ste noseči ali nameravate zanositi, zdravila Zavesca ne smete jemati.
You must use effective birth control while using Zavesca.
V času jemanja zdravila Zavesca morate uporabljati učinkovite metode preprečitve zanositve.
Do not breast- feed while you are using Zavesca.
V času jemanja zdravila Zavesca ne smete dojiti.
Male patients should use reliable birth control methods during their treatment with Zavesca, and for 3 months after finishing treatment.
Moški bolniki morajo med jemanjem zdravila Zavesca in 3 mesece po končanju zdravljenja uporabljati zanesljivo zaščito proti zanositvi (glejte poglavji 4. 4 in 5. 3).
Driving and using machines Zavesca may make you feel dizzy.
Vpliv na sposobnost upravljanja vozil in strojev Zaradi zdravila Zavesca ste lahko omotični.
HOW TO TAKE ZAVESCA
KAKO JEMATI ZDRAVILO ZAVESCA
Always take Zavesca exactly as your doctor has told you.
Pri jemanju zdravila Zavesca natančno upoštevajte zdravnikova navodila.
You should check with your doctor or pharmacist if you are not sure about any of the instructions.
Če ste negotovi glede kateregakoli od navodil, se posvetujte s svojim zdravnikom ali farmacevtom.
• For type 1 Gaucher disease:
• Za 1 Gaucherjevo bolezen tipa 1:
For adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening).
Za odrasle je običajni odmerek ena kapsula (100 mg) trikrat dnevno (zjutraj, popoldne, zvečer).
• For Niemann-Pick type C disease:
21 • Za Niemann- Pickovo bolezen tipa C:
For adults and adolescents, the usual dose is two capsules (200 mg) three times a day (morning, afternoon and evening).
Za odrasle in mladostnike je običajni odmerek dve kapsuli (200 mg) trikrat dnevno (zjutraj, popoldan in zvečer).
21 If you are less than 12 years old, your doctor will adjust your dose for Niemann-Pick type C disease.
Če ste stari manj kot 12 let, bo zdravnik vaš odmerek prilagodil za Niemann- Pickovo bolezen tipa C.
Your doctor may reduce your dose, e. g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Zavesca (see section 4).
Vaš zdravnik lahko zmanjša vaš odmerek, npr. na eno kapsulo (100 mg) enkrat ali dvakrat dnevno, če imate med jemanjem zdravila Zavesca drisko (glejte poglavje 4).
The Zavesca capsule should be swallowed whole with water.
Kapsule zdravila Zavesca morate pogoltniti cele, z vodo.
If you take more Zavesca than you should If you take more capsules than you were told to, consult your doctor immediately.
V kliničnih preskušanjih so zdravilo Zavesca jemali v odmerkih, ki so bili 10- krat višji kot priporočen odmerek.
If you forget to take Zavesca Take the next capsule at the usual time.
Če ste pozabili vzeti zdravilo Zavesca
Do not take a double dose to make up for a forgotten dose.
Če ste prenehali jemati zdravilo Zavesca
If you stop taking Zavesca Don’ t stop taking Zavesca without talking to your doctor.
Ne prenehajte uporabljati zdravila Zavesca, ne da se o tem pogovorite z zdravnikom.
Like all medicines, Zavesca can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Zavesca neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very common effects – likely to affect more than 1 in 10 people The most common side effects are weight loss, tremor, diarrhoea, flatulence (wind), abdominal (stomach) pain.
Zelo pogosti neželeni učinki – pojavijo se pri več kot 1 od 10 ljudi Najbolj pogosti neželeni učinki so izguba telesne mase, tresavica, driska, flatulenca (vetrovi), bolečine v trebuhu.
Common effects – likely to affect less than 1 in 10 people and more than 1 in 100 people Common side effects of treatment include anorexia (lack of appetite), decreased appetite, headache, dizziness, peripheral neuropathy, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets). The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Nevrološki simptomi in trombocitopenija so lahko posledica bolezni, zaradi katere se zdravite.
Other possible side effects are muscular spasms or weakness, fatigue, difficulty sleeping, and less libido.
Drugi možni neželeni učinki so mišični krči ali slabost, utrujenost, težave s spanjem in zmanjšan libido.
If any of these side effects cause
Večina neželenih učinkov je blagih in kmalu izzvenijo.
Some patients have had tingling or numbness in the hands and feet.
Nekateri bolniki izkusijo mravljinčenje ali otrplost rok ali nog.
Your doctor will perform some tests before and during treatment with Zavesca to assess this (see section 2).
Vaš zdravnik bo z nekaj preskusi pred zdravljenjem z zdravilom Zavesca stanje ocenil (glejte poglavje 2).
If you do get any of these effects, please report them to your doctor as soon as possible.
Če opazite katerega koli od teh učinkov, čim prej obvestite svojega zdravnika.
If you do lose some weight when you start treatment with Zavesca don’ t worry.
Če po začetku zdravljenja z zdravilom Zavesca izgubite nekaj telesne mase, to ni vzrok za zaskrbljenost.
If you get a slight tremor, usually trembling hands, report it to your doctor as soon as possible.
Če med zdravljenjem z zdravilom Zavesca izkusite blag tremor, običajno tresenje rok, to čim prej sporočite svojemu zdravniku.
The tremor often disappears without needing to stop the treatment.
Tresenje pogosto izgine brez potrebe, da se prekine zdravljenje z zdravilom Zavesca.
Sometimes your doctor will need to reduce the dose or stop Zavesca treatment to stop the tremor.
Lahko se zgodi, da bo moral vaš zdravnik, da bi odpravil tresenje, znižati vaš odmerek zdravila Zavesca ali prekiniti zdravljenje z njim.
For storage and other information, please turn over.
Za shranjevanje in druge informacije obrnite stran.
HOW TO STORE ZAVESCA
SHRANJEVANJE ZDRAVILA ZAVESCA
Do not use Zavesca after the expiry date stated on the carton.
Zdravila Zavesca ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
What Zavesca contains
Kaj vsebuje zdravilo Zavesca
The active substance is miglustat 100 mg.
Zdravilna učinkovina je miglustat 100 mg.
Sodium starch glycollate, Povidone (K30), Magnesium stearate.
23 Pomožne snovi v kapsuli so: natrijev karboksimetilškrob, povidon (K30), magnezijev stearat.
Gelatin, Water, Titanium dioxide (E171).
Pomožne snovi v ovoju kapsule so: želatina, voda, titanov dioksid (E171).
Black iron oxide (E172) Shellac.
Druge sestavine v tiskarskem črnilu so: črn železov oksid (E172), šelak.
23 What Zavesca looks like and contents of the pack
Izgled zdravila Zavesca in vsebina pakiranja
Zavesca is a white 100 mg capsule with “ OGT 918” printed in black on the cap and “ 100” printed in black on the body.
Zdravilo Zavesca je bela 100 mg kapsula, ki ima v črni barvi na pokrovčku natisnjeno "OGT 918", na ovoju pa "100".
Manufacturer responsible for batch release:
Izdelovalec, odgovornega za sproščanje serije:
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63– 65 79100 Freiburg Germany
Actelion Pharmaceuticals Deutschland GmbH Basler Strasse 63- 65 79100 Freiburg Nemčija
Österreich Actelion Pharmaceuticals Austria GmbH Tel: +43-(0)1 505 4527
24 Eesti Österreich Actelion Pharmaceuticals Austria GmbH Nycomed SEFA AS Tel: +43 - (0) 1 505 4527 Tel: +372 6112 569
Ireland Actelion Pharmaceuticals UK Ltd Tel: +353 1890 771 648
Actelion Pharmaceuticals UK Ltd Tel: +353 1890 771 648
Slovenija Medis d. o. o.
Medis d. o. o.
This medicine has been authorised under “ Exceptional Circumstances”.
Zdravilo je pridobilo dovoljenje za promet v » izjemnih okoliščinah «.
Zeffix is a medicine containing the active substance lamivudine.
Zeffix je zdravilo, ki vsebuje zdravilno učinkovino lamivudin.
It is available as yellow, capsule shaped tablets (100 mg) and a clear pale yellow solution (5 mg/ ml).
Na voljo je v obliki rumenih tablet, ki so podobne kapsulam (100 mg), in v obliki bistre bledo rumene raztopine (5 mg/ ml).
Zeffix is used to treat adult patients who have chronic (long term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus).
Zdravilo Zeffix se uporablja za zdravljenje odraslih bolnikov s kroničnim (dolgotrajnim) hepatitisom B (boleznijo jeter zaradi okužbe z virusom hepatitisa B).
It is used in patients with: • compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of the liver enzyme ‘ alanine aminotransferase’ [ALT] and signs of damage when liver tissue is examined under a microscope), • decompensated liver disease (when the liver is damaged and does not function normally).
Uporablja se za zdravljenje: • kompenzirane bolezni jeter (jetra so poškodovana, a delujejo normalno) pri bolnikih, ki kažejo tudi znake še vedno potekajočega razmnoževanja virusa in znake poškodb jeter (povišane ravni jetrnega encima „ alanin aminotransferaze “ [ALT] in znaki poškodb, ki so vidni pod mikroskopom), • dekompenzirane bolezni jeter (jetra so poškodovana in ne delujejo normalno).
Treatment with Zeffix should be initiated by a doctor who has experience in the management of chronic hepatitis B.
Zdravljenje z zdravilom Zeffix mora uvesti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B.
Zeffix can be taken with or without food.
Bolnik lahko zdravilo Zeffix vzame s hrano ali brez nje.
The dose needs to be lowered for patients who have problems with their kidneys, using the oral solution.
Odmerek zdravila je treba znižati pri bolnikih, ki imajo težave z ledvicami, ter v ta namen uporabiti peroralno raztopino.
For more information, please see the Summary of Product Characteristics (also part of the EPAR).
Za več informacij glejte Povzetek glavnih značilnosti zdravila, ki je prav tako del EPAR.
The active substance in Zeffix, lamivudine, is an antiviral agent belonging to the class of the nucleoside analogues.
Zdravilna učinkovina zdravila Zeffix, lamivudin, je protivirusno sredstvo, ki spada v razred nukleozidnih analogov.
Lamivudine interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Lamivudin ovira delovanje virusnega encima, DNA polimeraze, ki sodeluje pri tvorjenju virusne DNA.
Lamivudine stops the virus making DNA and prevents it from multiplying and spreading.
Lamivudin zaustavi tvorjenje virusne DNA ter prepreči razmnoževanje in razširjanje virusa.
Zeffix has been studied in five main studies involving a total of 1,083 adult patients.
Zdravilo Zeffix so raziskovali v petih glavnih študijah, ki so vključevale skupaj 1. 083 odraslih bolnikov.
Three studies compared the effectiveness of Zeffix to that of placebo (a dummy treatment) in patients with compensated chronic hepatitis B, including one study that looked more particularly at the effectiveness of Zeffix in ‘ HBeAg negative’ patients.
V treh študijah so primerjali učinkovitost zdravila Zeffix z učinkom placeba (zdravila brez zdravilne učinkovine) pri bolnikih s kompenziranim kroničnim hepatitisom B, v eni od teh študij pa so bolj natančno primerjali tudi učinkovitost zdravila Zeffix pri „ HBeAg negativnih “ bolnikih.
These are patients infected with hepatitis B virus 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
To so 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged that has mutated (changed), leading to a form of chronic hepatitis B that is more difficult to treat.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged bolniki, ki so okuženi z virusom hepatitisa B, ki je mutiral (se je spremenil), kar povzroči obliko kroničnega hepatitisa B, ki jo je težje zdraviti.
Two studies looked the use of Zeffix on its own compared with alfa-interferon (another treatment used in chronic hepatitis B) either on its own or with Zeffix.
V dveh študijah so preučevali uporabo zdravila Zeffix kot samostojnega zdravila v primerjavi z interferonom alfa (drugim zdravilom, ki se uporablja pri kroničnem hepatitisu B), uporabljenim kot samostojno zdravilo ali skupaj z zdravilom Zeffix.
There were several measures of effectiveness in the studies.
V študijah so imeli več meril učinkovitosti.
These included looking at how the liver damage had evolved after 52 weeks of treatment using a liver biopsy (when a small sample of liver tissue is taken and examined under a microscope), as well as measuring other signs of the disease such as the levels of ALT or of hepatitis B viral DNA circulating in the blood.
Merila so vključevala opazovanje razvoja poškodb jeter po 52 tednih zdravljenja z biopsijo jeter (odvzame se majhen vzorec jetrnega tkiva, ki ga pregledajo pod mikroskopom), kakor tudi merjenje drugih znakov bolezni, kot so ravni encima ALT ali virusne DNA hepatitisa B, ki kroži v krvi.
A further analysis was carried out comparing patients with and without the ‘ YMDD mutation’ (a change in the hepatitis B virus ’ s DNA that is often found after treatment with lamivudine).
Izvedli so tudi dodatno analizo, v kateri so primerjali bolnike z „ mutacijo YMDD “ in brez nje (spremembo virusne DNA hepatitisa B, do katere pogosto pride po zdravljenju z lamivudinom).
What benefit has Zeffix shown during the studies?
Kakšne koristi je zdravilo Zeffix izkazalo med raziskavami?
Zeffix was more effective than placebo in slowing down the progression of liver disease.
Zdravilo Zeffix je bilo pri upočasnitvi napredovanja bolezni jeter bolj učinkovito od placeba.
About half of the patients taking Zeffix had an improvement in liver damage assessed in a biopsy, compared with about a quarter of the patients who took placebo.
Približno polovica bolnikov, ki so jemali zdravilo Zeffix, je pokazala izboljšanje poškodb jeter, ocenjenih z biopsijo, v primerjavi z izboljšanjem pri četrtini bolnikov, ki so jemali placebo.
Zeffix was as effective as alfa-interferon.
Zdravilo Zeffix je bilo enako učinkovito kot interferon alfa.
The analysis showed that patients with the YMDD mutation do not respond as well to treatment with Zeffix as those without the mutation.
Analiza je pokazala, da se bolniki z mutacijo YMDD ne odzivajo tako dobro na zdravljenje z zdravilom Zeffix kot tisti, pri katerih mutacija ni prisotna.
The most common side effect with Zeffix (seen in more than 1 patient in 10) is raised ALT levels.
Najpogostejši neželeni učinek pri jemanju zdravila Zeffix (opažen pri več kot 1 bolniku od 10) je povečana raven encima ALT.
For the full list of all side effects reported with Zeffix, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zeffix, glejte Navodilo za uporabo.
Zeffix should not be used in people who may be hypersensitive (allergic) to lamivudine or any of the other ingredients.
Zdravila Zeffix ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) lamivudin ali katerokoli drugo sestavino zdravila.
The Committee for Medicinal products for Human Use (CHMP) decided that Zeffix’ s benefits are greater than its risks for treatment of chronic hepatitis B in adults with compensated liver disease with evidence of active viral replication, persistently elevated serum ALT levels and histological evidence of active liver inflammation and/ or fibrosis, and in adults with decompensated liver disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristni učinki zdravila Zeffix večji od z njim povezanih tveganj pri zdravljenju kronične oblike hepatitisa B pri odraslih s kompenzirano boleznijo jeter, pri katerih obstajajo dokazi aktivnega razmnoževanja virusov, stalno povišanih nivojev encima ALT v serumu in histološki dokazi aktivnega jetrnega vnetja in/ ali fibroze, kakor tudi pri odraslih z dekompenzirano boleznijo jeter.
They recommended that Zeffix be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Zeffix.
Zeffix was originally authorised under "Exceptional Circumstances", because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Zeffix je bilo prvotno odobreno „ v izjemnih okoliščinah “, ker vsi podatki zaradi znanstvenih razlogov v času odobritve niso bili na razpolago.
As the company had supplied the additional information requested, the "Exceptional Circumstances" ended on 18 May 2001.
Ko je družba predložila dodatne zahtevane podatke, je bila odobritev „ v izjemnih okoliščinah “ preklicana dne 18. maja 2001.
The European Commission granted a marketing authorisation valid throughout the European Union for Zeffix to Glaxo Group Ltd on 29 July 1999.
Evropska komisija je dovoljenje za promet z zdravilom Zeffix, veljavno po vsej Evropski uniji, odobrila družbi Glaxo Group Ltd. dne 29. julija 1999.
The marketing authorisation was renewed on 29 July 2004.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 29. julija 2004.