FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Aripiprazol Sandoz 10 mg
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 15 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Aripiprazol Sandoz 15 mg
English: Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Red iron oxide (E172)
Slovenian: Aripiprazol Sandoz 10 mg tablete laktoza monohidrat koruzni škrob mikrokristalna celuloza hidroksipropilceluloza magnezijev stearat rdeči železov oksid (E172)
English: What Aripiprazole Sandoz tablets contain
Slovenian: Kaj vsebuje zdravilo Aripiprazol Sandoz
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/061
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1029/061
English: Aripiprazole Sandoz 10 mg tablets EU/1/15/1029/015 (10 tablets) EU/1/15/1029/016 (14 tablets) EU/1/15/1029/017 (16 tablets) EU/1/15/1029/018 (28 tablets) EU/1/15/1029/019 (30 tablets) EU/1/15/1029/020 (35 tablets) EU/1/15/1029/021 (56 tablets) EU/1/15/1029/022 (70 tablets) EU/1/15/1029/023 (14 x 1 tablets) EU/1/15/1029/024 (28 x 1 tablets) EU/1/15/1029/025 (49 x 1 tablets) EU/1/15/1029/026 (56 x 1 tablets) EU/1/15/1029/027 (98 x 1 tablets) EU/1/15/1029/028 (100 tablets)
Slovenian: Aripiprazol Sandoz 10 mg tablete EU/1/15/1029/015 (10 tablet) EU/1/15/1029/016 (14 tablet) EU/1/15/1029/017 (16 tablet) EU/1/15/1029/018 (28 tablet) EU/1/15/1029/019 (30 tablet) EU/1/15/1029/020 (35 tablet) EU/1/15/1029/021 (56 tablet) EU/1/15/1029/022 (70 tablet) EU/1/15/1029/023 (14 x 1 tablet) EU/1/15/1029/024 (28 x 1 tablet) EU/1/15/1029/025 (49 x 1 tablet) EU/1/15/1029/026 (56 x 1 tablet) EU/1/15/1029/027 (98 x 1 tablet) EU/1/15/1029/028 (100 tablet)
English: INFORMATION IN BRAILLE Outer carton:Aripiprazole Sandoz 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanji ovoj: Aripiprazol Sandoz 5 mg
English: EU/1/15/1029/015 10 tablets EU/1/15/1029/016 14 tablets EU/1/15/1029/017 16 tablets EU/1/15/1029/018 28 tablets EU/1/15/1029/019 30 tablets EU/1/15/1029/020 35 tablets EU/1/15/1029/021 56 tablets EU/1/15/1029/022 70 tablets EU/1/15/1029/023 14 x 1 tablets EU/1/15/1029/024 28 x 1 tablets EU/1/15/1029/025 49 x 1 tablets EU/1/15/1029/026 56 x 1 tablets EU/1/15/1029/027 98 x 1 tablets
Slovenian: EU/1/15/1029/015 10 tablet EU/1/15/1029/016 14 tablet EU/1/15/1029/017 16 tablet EU/1/15/1029/018 28 tablet EU/1/15/1029/019 30 tablet EU/1/15/1029/020 35 tablet EU/1/15/1029/021 56 tablet EU/1/15/1029/022 70 tablet EU/1/15/1029/023 14 x 1 tablet EU/1/15/1029/024 28 x 1 tablet EU/1/15/1029/025 49 x 1 tablet EU/1/15/1029/026 56 x 1 tablet EU/1/15/1029/027 98 x 1 tablet
English: Aripiprazole Sandoz 20 mg tablets Lactose monohydrate Maize starch
Slovenian: Aripiprazol Sandoz 20 mg tablete laktoza monohidrat koruzni škrob mikrokristalna celuloza hidroksipropilceluloza magnezijev stearat
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1029/028
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 10 mg tablets aripiprazole
Slovenian: IME ZDRAVILA Aripiprazol Sandoz 10 mg tablete aripiprazol
English: INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanji ovoj: Aripiprazol Sandoz 10 mg
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets aripiprazole
Slovenian: IME ZDRAVILA Aripiprazol Sandoz 5 mg tablete aripiprazol
English: INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 15 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanji ovoj: Aripiprazol Sandoz 15 mg
English: Aripiprazole Sandoz 30 mg tablets EU/1/15/1029/048 (10 tablets) EU/1/15/1029/049 (14 tablets) EU/1/15/1029/050 (16 tablets) EU/1/15/1029/051 (28 tablets) EU/1/15/1029/052 (30 tablets) EU/1/15/1029/053 (35 tablets) EU/1/15/1029/054 (56 tablets) EU/1/15/1029/055 (70 tablets) EU/1/15/1029/056 (14 x 1 tablets) EU/1/15/1029/057 (28 x 1 tablets) EU/1/15/1029/058 (49 x 1 tablets) EU/1/15/1029/059 (56 x 1 tablets) EU/1/15/1029/060 (98 x 1 tablets) EU/1/15/1029/061 (100 tablets)
Slovenian: Aripiprazol Sandoz 30 mg tablete EU/1/15/1029/048 (10 tablet) EU/1/15/1029/049 (14 tablet) EU/1/15/1029/050 (16 tablet) EU/1/15/1029/051 (28 tablet) EU/1/15/1029/052 (30 tablet) EU/1/15/1029/053 (35 tablet) EU/1/15/1029/054 (56 tablet) EU/1/15/1029/055 (70 tablet) EU/1/15/1029/056 (14 x 1 tablet) EU/1/15/1029/057 (28 x 1 tablet) EU/1/15/1029/058 (49 x 1 tablet) EU/1/15/1029/059 (56 x 1 tablet) EU/1/15/1029/060 (98 x 1 tablet) EU/1/15/1029/061 (100 tablet)
English: EU/1/15/1029/001 10 tablets EU/1/15/1029/002 14 tablets EU/1/15/1029/003 16 tablets EU/1/15/1029/004 28 tablets EU/1/15/1029/005 30 tablets EU/1/15/1029/006 35 tablets EU/1/15/1029/007 56 tablets EU/1/15/1029/008 70 tablets EU/1/15/1029/009 14 x 1 tablets EU/1/15/1029/010 28 x 1 tablets EU/1/15/1029/011 49 x 1 tablets EU/1/15/1029/012 56 x 1 tablets EU/1/15/1029/013 98 x 1 tablets
Slovenian: EU/1/15/1029/001 10 tablet EU/1/15/1029/002 14 tablet EU/1/15/1029/003 16 tablet EU/1/15/1029/004 28 tablet EU/1/15/1029/005 30 tablet EU/1/15/1029/006 35 tablet EU/1/15/1029/007 56 tablet EU/1/15/1029/008 70 tablet EU/1/15/1029/009 14 x 1 tablet EU/1/15/1029/010 28 x 1 tablet EU/1/15/1029/011 49 x 1 tablet EU/1/15/1029/012 56 x 1 tablet EU/1/15/1029/013 98 x 1 tablet
English: Aripiprazole Sandoz 15 mg tablets EU/1/15/1029/029 (10 tablets) EU/1/15/1029/030 (14 tablets) EU/1/15/1029/031 (16 tablets) EU/1/15/1029/032 (28 tablets) EU/1/15/1029/033 (30 tablets) EU/1/15/1029/034 (35 tablets) EU/1/15/1029/035 (56 tablets) EU/1/15/1029/036 (70 tablets) EU/1/15/1029/037 (14 x 1 tablets) EU/1/15/1029/038 (28 x 1 tablets) EU/1/15/1029/039 (49 x 1 tablets) EU/1/15/1029/040 (56 x 1 tablets) EU/1/15/1029/041 (98 x 1 tablets) EU/1/15/1029/042 (100 tablets)
Slovenian: Aripiprazol Sandoz 15 mg tablete EU/1/15/1029/029 (10 tablet) EU/1/15/1029/030 (14 tablet) EU/1/15/1029/031 (16 tablet) EU/1/15/1029/032 (28 tablet) EU/1/15/1029/033 (30 tablet) EU/1/15/1029/034 (35 tablet) EU/1/15/1029/035 (56 tablet) EU/1/15/1029/036 (70 tablet) EU/1/15/1029/037 (14 x 1 tablet) EU/1/15/1029/038 (28 x 1 tablet) EU/1/15/1029/039 (49 x 1 tablet) EU/1/15/1029/040 (56 x 1 tablet) EU/1/15/1029/041 (98 x 1 tablet)
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 15 mg tablets aripiprazole
Slovenian: IME ZDRAVILA Aripiprazol Sandoz 15 mg tablete aripiprazol
English: EU/1/15/1029/029 10 tablets EU/1/15/1029/030 14 tablets EU/1/15/1029/031 16 tablets EU/1/15/1029/032 28 tablets EU/1/15/1029/033 30 tablets EU/1/15/1029/034 35 tablets EU/1/15/1029/035 56 tablets EU/1/15/1029/036 70 tablets EU/1/15/1029/037 14 x 1 tablets EU/1/15/1029/038 28 x 1 tablets EU/1/15/1029/039 49 x 1 tablets EU/1/15/1029/040 56 x 1 tablets EU/1/15/1029/041 98 x 1 tablets
Slovenian: EU/1/15/1029/029 10 tablet EU/1/15/1029/030 14 tablet EU/1/15/1029/031 16 tablet EU/1/15/1029/032 28 tablet EU/1/15/1029/033 30 tablet EU/1/15/1029/034 35 tablet EU/1/15/1029/035 56 tablet EU/1/15/1029/036 70 tablet EU/1/15/1029/037 14 x 1 tablet EU/1/15/1029/038 28 x 1 tablet EU/1/15/1029/039 49 x 1 tablet EU/1/15/1029/040 56 x 1 tablet EU/1/15/1029/041 98 x 1 tablet
English: Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Yellow iron oxide (E172)
Slovenian: Aripiprazol Sandoz 15 mg tablete laktoza monohidrat koruzni škrob mikrokristalna celuloza hidroksipropilceluloza magnezijev stearat rumen železov oksid (E172)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1029/014
English: EU/1/15/1029/048 10 tablets EU/1/15/1029/049 14 tablets EU/1/15/1029/050 16 tablets EU/1/15/1029/051 28 tablets EU/1/15/1029/052 30 tablets EU/1/15/1029/053 35 tablets EU/1/15/1029/054 56 tablets EU/1/15/1029/055 70 tablets EU/1/15/1029/056 14 x 1 tablets EU/1/15/1029/057 28 x 1 tablets EU/1/15/1029/058 49 x 1 tablets EU/1/15/1029/059 56 x 1 tablets EU/1/15/1029/060 98 x 1 tablets
Slovenian: EU/1/15/1029/048 10 tablet EU/1/15/1029/049 14 tablet EU/1/15/1029/050 16 tablet EU/1/15/1029/051 28 tablet EU/1/15/1029/052 30 tablet EU/1/15/1029/053 35 tablet EU/1/15/1029/054 56 tablet EU/1/15/1029/055 70 tablet EU/1/15/1029/056 14 x 1 tablet EU/1/15/1029/057 28 x 1 tablet EU/1/15/1029/058 49 x 1 tablet EU/1/15/1029/059 56 x 1 tablet EU/1/15/1029/060 98 x 1 tablet
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 30 mg aripiprazola.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 15 mg aripiprazola.
English: The European Commission granted a marketing authorisation valid throughout the EU for PegIntron on 25 May 2000.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom PegIntron, veljavno po vsej Evropski uniji, odobrila dne 25. maja 2000.
English: In adults, the most common side effects with PegIntron (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss.
Slovenian: Pri odraslih bolnikih so bili najpogostejši neželeni učinki zdravila PegIntron (opaženi pri več kot 1 bolniku od 10) virusne okužbe, faringitis (vneto žrelo), anemija (nizke ravni rdečih krvnih celic), nevtropenija (nizke ravni nevtrofilcev, vrste belih krvnih celic), izguba teka, depresija, anksioznost, čustvena labilnost (nihanje razpoloženja), motnje koncentracije, nespečnost (težave s spanjem), glavobol, omotica, dispneja (oteženo dihanje), kašelj, bruhanje, navzeja (občutek slabosti), bolečine v trebuhu, driska, suha usta, alopecija (izpadanje las), pruritus (srbenje), suha koža, izpuščaji, mialgija (bolečine v mišicah), artralgija (bolečine v sklepih), mišično-skeletne bolečine (bolečine v mišicah in kosteh), reakcije na mestu injiciranja, vnetje na mestu injiciranja, utrujenost, astenija (šibkost), razdražljivost, mrzlica, pireksija (povišana telesna temperatura), gripi podobna bolezen in izguba telesne mase.
English: Other information about PegIntron:
Slovenian: Druge informacije o zdravilu PegIntron:
English: The full EPAR for PegIntron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo PegIntron je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This document is a summary of the European Public Assessment Report (EPAR) for PegIntron.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo PegIntron.
English: For more information about treatment with PegIntron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom PegIntron preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: The CHMP decided that PegIntron's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila PegIntron večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Because PegIntron is linked to side effects such as depression, patients must be closely monitored during treatment.
Slovenian: Ker je zdravilo PegIntron povezano z neželenimi učinki, kot je depresija, je treba bolnike med zdravljenjem pozorno spremljati.
English: What benefit has PegIntron shown during the studies?
Slovenian: Kakšne koristi je zdravilo PegIntron izkazalo med študijami?
English: 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 PegIntron.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo PegIntron, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: PegIntron is also linked to weight loss and reduced growth in children and adolescents.
Slovenian: Zdravilo PegIntron je povezano z izgubljanjem telesne mase in zmanjšano telesno rastjo pri otrocih in mladostnikih.
English: Treatment with PegIntron should be started and supervised by a doctor who has experience in the management of patients with hepatitis C. PegIntron is given once a week as an injection under the skin.
Slovenian: Zdravljenje z zdravilom PegIntron mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hepatitisom C. Zdravilo PegIntron se daje enkrat tedensko z injekcijo v podkožje.
English: What is the risk associated with PegIntron?
Slovenian: Kakšna tveganja so povezana z zdravilom PegIntron?
English: PegIntron must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central nervous system problems.
Slovenian: Zdravilo PegIntron se ne sme uporabljati pri bolnikih z resnim obolenjem, s hudimi težavami z jetri, z nenadzorovanim obolenjem ščitnice, epilepsijo ali drugimi motnjami delovanja osrednjega živčnega sistema.
English: The combination of PegIntron with ribavirin was effective in patients with cirrhosis and in patients infected with HIV.
Slovenian: Kombinacija zdravila PegIntron in ribavirina je bila učinkovita pri bolnikih s cirozo in bolnikih, okuženih z virusom HIV.
English: PegIntron must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients.
Slovenian: Zdravila PegIntron ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) katero koli vrsto interferona ali katero drugo sestavino zdravila.
English: In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), PegIntron is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
Slovenian: Ostalim odraslim z virusom hepatitisa C v krvi, vključno z bolniki, ki so okuženi tudi z virusom humane imunske pomanjkljivosti (HIV), se PegIntron daje bodisi z ribavirinom (dvotirno zdravljenje) bodisi kot samostojno zdravilo, če bolniki ne morejo jemati ribavirina.
English: The combination of PegIntron and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before.
Slovenian: Kombinacijo zdravila PegIntron in ribavirina so proučevali tudi v študiji s 1 354 odraslimi bolniki, pri katerih predhodno zdravljenje ni bilo uspešno, in študiji s 107 otroki in mladostniki, starimi od 3 do 17 let, ki pred tem še niso bili zdravljeni.
English: PegIntron can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease).
Slovenian: Zdravilo PegIntron se lahko daje v okviru trotirnega zdravljenja v kombinaciji z ribavirinom in boceprevirjem odraslim bolnikom s hepatitisom C tipa 1, katerih jetra so poškodovana, vendar še vedno normalno delujejo (kompenzirana bolezen jeter).
English: For the full list of all side effects reported with PegIntron, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila PegIntron, glejte navodilo za uporabo.
English: PegIntron, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
Slovenian: Zdravilo PegIntron, uporabljeno sočasno z ribavirinom ali brez njega, so primerjali z interferonom alfa-2b v petih glavnih študijah s skupno več kot 6 000 odraslih bolnikov s hepatitisom C, ki predhodno še niso bili zdravljeni, vključno s 328 bolniki s cirozo in 507 bolniki, ki so bili okuženi tudi z virusom HIV.
English: In children and adolescents receiving PegIntron in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Slovenian: Pri otrocih in mladostnikih, ki so prejemali kombinacijo zdravila PegIntron in ribavirina, so bili neželeni učinki podobni kot pri odraslih, čeprav je bila pri več kot 1 bolniku od 10 opažena tudi manjša telesna rast.
English: The interferon alfa-2b in PegIntron is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
Slovenian: Interferon alfa-2b, ki ga vsebuje zdravilo PegIntron, se proizvaja po metodi, imenovani „tehnologija rekombinantne DNK“, pri kateri bakterija prejme gen (DNK), s katerim lahko tvori interferon alfa-2b.
English: Why has PegIntron been approved?
Slovenian: Zakaj je bilo zdravilo PegIntron odobreno?
English: PegIntron is a medicine that contains the active substance peginterferon alfa-2b.
Slovenian: PegIntron je zdravilo, ki vsebuje zdravilno učinkovino peginterferon alfa-2b.
English: In adults (aged 18 years and older), PegIntron can be used in patients who have not been treated before or whose previous treatment failed.
Slovenian: Zdravilo PegIntron se lahko uporablja pri odraslih bolnikih (starih vsaj 18 let), ki še niso bili zdravljeni oziroma pri katerih predhodno zdravljenje ni bilo uspešno.
English: Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of PegIntron in a triple therapy combination with ribavirin and boceprevir compared with PegIntron and ribavirin alone.
Slovenian: V dveh glavnih študijah, v katerih so sodelovali 1 503 odrasli bolniki s hepatitisom C tipa 1 in kompenzirano boleznijo jeter, so preučevali učinek zdravila PegIntron v trotirnem zdravljenju z ribavirinom in boceprevirjem v primerjavi z njegovim učinkom v kombinaciji zgolj z ribavirinom.
English: PegIntron is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Slovenian: Zdravilo PegIntron se uporablja za zdravljenje bolnikov, starejših od treh let, z dolgotrajnim hepatitisom C (boleznijo jeter, ki je posledica okužbe z virusom hepatitisa C).
English: In adults, PegIntron was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to PegIntron alone and around a half responding to the combination of PegIntron and ribavirin.
Slovenian: Pri odraslih bolnikih, ki predhodno še niso bili zdravljeni, je bilo zdravilo PegIntron učinkovitejše od interferona alfa-2b, pri čemer se jih je približno četrtina odzvala na zdravilo, vzeto samostojno, približno polovica pa na kombinacijo zdravila PegIntron in ribavirina.
English: In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, PegIntron in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of PegIntron with ribavirin alone.
Slovenian: V študijah trotirnega zdravljenja bolnikov s hepatitisom C tipa 1 in kompenzirano boleznijo jeter se je zdravljenje z zdravilom PegIntron v kombinaciji z ribavirinom in boceprevirjem izkazalo za učinkovitejše od dvotirnega zdravljenja z zdravilom PegIntron in ribavirinom.
English: Triple therapy led to an increase of about 30% in the number of previously untreated early responders who were cured.
Slovenian: Pri trotirnem zdravljenju se je število predhodno nezdravljenih bolnikov, ki so se zgodaj odzvali na zdravljenje in so bili ozdravljeni, povečalo za približno 30 %.
English: There is also a marked increase in cure rates in patients with long-term type 1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
Slovenian: Opaziti je tudi znatno povečanje deleža ozdravljenih bolnikov z dolgotrajno okužbo s hepatitisom C tipa 1 pri trotirnem zdravljenju z zdravilom PegIntron v kombinaciji z ribavirinom in boceprevirjem.
English: Depending on the severity of the side effects treatment may have to be stopped altogether (including boceprevir).Patients can inject themselves once they have been trained appropriately.
Slovenian: Glede na resnost neželenih učinkov bo morda treba z zdravljenjem (tudi z boceprevirjem) popolnoma prenehati.
English: In PegIntron, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Slovenian: V zdravilu PegIntron je interferon alfa-2b „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
English: What is PegIntron used for?
Slovenian: Za kaj se zdravilo PegIntron uporablja?
English: The active substance in PegIntron, peginterferon alfa-2b, belongs to the group ‘interferons'.
Slovenian: Zdravilna učinkovina zdravila PegIntron, peginterferon alfa-2b, spada v skupino interferonov.
English: How does PegIntron work?
Slovenian: Kako zdravilo PegIntron deluje?
English: What is PegIntron?
Slovenian: Kaj je zdravilo PegIntron?
English: How has PegIntron been studied?
Slovenian: Kako je bilo zdravilo PegIntron raziskano?
English: How is PegIntron used?
Slovenian: Kako se zdravilo PegIntron uporablja?
English: Around a quarter of the adults whose previous treatment had failed and around two-thirds of the children and adolescents responded to treatment with PegIntron and ribavirin.
Slovenian: Na zdravljenje s kombinacijo zdravila PegIntron in ribavirina se je odzvala približno četrtina odraslih bolnikov, pri katerih predhodno zdravljenje ni bilo uspešno, in okoli dve tretjini otrok in mladostnikov.
English: The doses of ribavirin and PegIntron may need to be adjusted for patients who experience side effects.
Slovenian: Pri bolnikih, pri katerih se pojavijo neželeni učinki, bo odmerek ribavirina in zdravila PegIntron morda treba prilagoditi.
English: The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Tamiflu a Direct Healthcare Professional Communication (DHPC) letter, the text of which is appended to the CHMP assessment report.
Slovenian: Države članice morajo zagotoviti, da bo imetnik dovoljenja za promet vsem zdravnikom, za katere se pričakuje, da bodo predpisovali zdravilo Tamiflu, razposlal pomembno obvestilo zdravstvenim delavcem (Direct Healthcare Professional Communication letter - DHPC) z vsebino, ki je priložena poročilu CHMP.
English: The Member States shall agree with the MAH the communication plan for the DHPC letter.
Slovenian: Države članice se morajo z imetnikom dovoljenja za promet dogovoriti glede komunikacijskega načrta v zvezi z DHPC obvestilom.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented.
Slovenian: Države članice morajo zagotoviti, da so vsi pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila opisani spodaj implementirani.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORA IMPLEMENTIRATI DRŽAVA ČLANICA