natgillin/translations-raw huggingface dataset:
Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 testicular cancer patients, the mean (± SD) increase in plasma concentration from Day 1 to Day 5 was 42 ± 34%.
Po intravenskem dajanju palonosetrona v odmerku 0, 25 mg vsak drugi dan je po 3 odmerkih pri 11 bolnikih z rakom mod koncentracija v plazmi od 1. do 5. dne povprečno (± SD) zrasla za 42 ± 34%.
After intravenous administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy subjects, the mean (± SD) increase in plasma palonosetron concentration from Day 1 to Day 3 was 110 ± 45%.
Po intravenskem dajanju palonosetrona 12 zdravim osebam v odmerku 0, 25 mg enkrat na dan 3 dni je koncentracija palonosetrona v plazmi od 1. do 3. dne povprečno (± SD) zrasla za 110 ± 45%.
Pharmacokinetic simulations indicate that the overall exposure (AUC0-∞) of 0.25 mg intravenous palonosetron administered once daily for 3 consecutive days was similar to a single intravenous dose of 0.75 mg, although Cmax of the 0.75 mg single dose was higher.
8 Farmakokinetične simulacije kažejo, da je bila celotna izpostavljenost (AUC0- ∞) po 0, 25 mg intravenskega palonosetrona, dajanega enkrat na dan 3 zaporedne dni, podobna kot po enkratnem intravenskem odmerku 0, 75 mg, češrav je bila Cmax enkratnega odmerka 0, 75 mg višja.
Distribution Palonosetron at the recommended dose is widely distributed in the body with a volume of distribution of approximately 6.9 to 7.9 l/ kg.
Porazdelitev Palonosetron se v priporočenem odmerku v telesu v veliki meri porazdeli, z volumnom porazdelitve približno 6, 9 do 7, 9 l/ kg.
Approximately 62% of palonosetron is bound to plasma proteins.
Približno 62% palonosetrona je vezanega na plazemske proteine.
Metabolism Palonosetron is eliminated by dual route, about 40% eliminated through the kidney and with approximately 50% metabolised to form two primary metabolites, which have less than 1% of the 5HT3 receptor antagonist activity of palonosetron.
Približno 40% se ga izloči preko ledvic, 50% pa se ga metabolizira v dva primarna metabolita, ki imata manj kot 1% aktivnosti antagonista receptorja 5HT3 palonosetrona. Študije metabolizma in vitro so pokazale, da so v metabolizem palonosetrona vključeni CYP2D6 in v manjši meri CYP3A4 in CYP1A2 izoencimi.
In vitro metabolism studies have shown that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 isoenzymes are involved in the metabolism of palonosetron.
Vendar pa klinični farmakokinetični parametri niso pomembno različni med bolj in manj učinkovitimi substancami, ki metabolizirajo CYP2D6 substrate.
Elimination After a single intravenous dose of 10 micrograms/ kg [14C]-palonosetron, approximately 80% of the dose was recovered within 144 hours in the urine with palonosetron representing approximately 40% of the administered dose, as unchanged active substance.
Izločanje Po enojnem intravenskem odmerku 10 mikrogramov/ kg [14C] - palonosetrona, se 80% odmerka v 144 urah izloči v urinu, kjer je 40% danega odmerka palonosetrona aktivna nespremenjena substanca.
After a single intravenous bolus administration in healthy subjects the total body clearance of palonosetron was 173 ± 73 ml/ min and renal clearance was 53 ± 29 ml/ min.
Po enkratnem intravenskem bolusu danem zdravim preiskovancem je očistek palonosetrona 173 ± 29 ml/ min in ledvični očistek 53 ± 29 ml/ min.
Elderly: age does not affect the pharmacokinetics of palonosetron.
Starejši: starost ne vpliva na farmakokinetiko palonosetrona.
8 Gender: gender does not affect the pharmacokinetics of palonosetron.
Spol bolnika ne vpliva na farmakokinetiko palonosetrona.
Paediatric patients: no pharmacokinetic data are available in patients below 18 years of age.
Pri bolnikih pod 18 let starosti ni na voljo farmakokinetičnih podatkov.
Renal impairment: mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Blaga do zmerna ledvična okvara bistveno ne vpliva na farmakokinetične parametre palonosetrona.
Hepatic impairment: hepatic impairment does not significantly affect total body clearance of palonosetron compared to the healthy subjects.
Jetrna okvara v primerjavi z zdravimi preiskovanci ne vpliva pomembno na celotni očistek palonosetrona.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Učinke v nekliničnih študijah so opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
Nonclinical studies indicate that palonosetron, only at very high concentrations, may block ion channels involved in ventricular de- and re-polarisation and prolong action potential duration.
Predklinične študije kažejo na to, da palonosetron lahko blokira ionske kanalčke udeležene pri ventrikularni de in repolarizaciji, ter s tem podaljša trajanje akcijskega potencijala le v zelo visokih koncentracijah.
6 PHARMACEUTICAL PARTICULARS
O prehodu skozi placento je na voljo le malo podatkov iz študij na živalih (glejte poglavje 4. 6).
6.1 List of excipients
FARMACEVTSKI PODATKI
Mannitol Disodium edetate Sodium citrate Citric acid monohydrate Water for injections Sodium hydroxide solution Hydrochloric acid solution
manitol dinatrijev edetat natrijev citrat monohidrat citronske kisline voda za injekcije raztopina natrijevega hidroksida raztopina klorovodikove kisline
3 years.
6. 3 Rok uporabnosti
Upon opening of the vial, any unused solution should be discarded.
3 leta Po odprtju viale vso neporabljeno raztopino zavrzite.
Type I glass vial with chlorobutyl siliconised rubber stopper and aluminium cap.
Tip I steklena viala s klorobutil silikoniziranim gumijastim zamaškom in aluminijastim pokrovčkom.
9 Available in packs of 1 vial containing 5 ml of solution.
Na voljo je v pakiranju po 1 vialo, ki vsebuje 5 ml raztopine.
6.6 Special Precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje
Damastown Mulhuddart Dublin 15 Republic of Ireland
Damastown Mulhuddart Dublin 15 Irska
11 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
11 A.
Damastown, Mulhuddart, Dublin 15 Republic of Ireland
Damastown Mulhuddart Dublin 15 Irska
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING:
14 PODATKI NA ZUNANJI OVOJNINI ALI STIČNI OZ.
CARTON
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
One vial of 5 ml contains 250 micrograms of palonosetron 50 micrograms/ ml (as hydrochloride)
50 mikrogramov/ ml (v obliki palonosetronijevega klorida)
Also contains mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide solution and hydrochloric acid solution
Vsebuje tudi manitol, dinatrijev edetat, natrijev citrat, monohidrat citronske kisline, vodo za injekcije, raztopino natrijevega hidroksida in raztopino klorovodikove kisline.
1 vial - 5 ml
1 viala - 5 ml
For intravenous use Single use only Any unused solution should be discarded
Vso neuporabljeno raztopino je potrebno zavreči.
EXP {MM/ YYYY}
EXP {MM/ LLLL}
16 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING:
PODATKI V BRAILLOVI PISAVI
VIAL
16 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Aloxi 250 micrograms solution for injection Palonosetron (as hydrochloride) IV use
Aloxi 250 mikrogramov raztopina za injiciranje palonosetron (v obliki palonosetronijevega klorida) Za intravensko uporabo.
18 PACKAGE LEAFLET:
18 NAVODILO ZA UPORABO:
INFORMATION FOR THE USER
INFORMACIJE ZA UPORABNIKA
Read all of this leaflet carefully before you start using this medicine. • Keep this leaflet.
Pred uporabo natančno preberite navodilo. • Navodilo shranite.
• If you have further questions, please ask your doctor or your pharmacist.
Morda ga boste želeli ponovno prebrati. • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom. • Zdravilo je bilo predpisano vam.
Do not pass it on to others.
Ne dajajte ga drugim.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim. • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
What Aloxi is and what it is used for.
Kaj je Aloxi in za kaj ga uporabljamo.
Before you use Aloxi.
Kaj morate vedeti, preden boste uporabili Aloxi.
How to use Aloxi.
Kako uporabljati Aloxi.
Possible side effects.
Možni neželeni učinki.
5 How to store Aloxi.
Shranjevanje Aloxia.
WHAT ALOXI IS AND WHAT IT IS USED FOR
KAJ JE ALOXI IN ZA KAJ GA UPORABLJAMO
• Aloxi is a clear colourless solution for injection into a vein. • The active ingredient (palonosetron) belongs to a group of medicines known as serotonin (5HT3) antagonists. • These have the ability to block the action of the chemical, serotonin, which can cause nausea and vomiting. • Aloxi is used for the prevention of nausea and vomiting associated with cancer chemotherapy.
• Aloxi je bistra, brezbarvna raztopina za injiciranje v veno. • Zdravilna učinkovina (palonosetron) spada v skupino zdravil, znanih pod imenom antagonisti serotonina (5HT3). • Ta zdravila so sposobna blokirati delovanje kemijske snovi, ki se imenuje serotonin in ki lahko povzroča slabost s siljenjem na bruhanje (navzeo) in bruhanje. • Aloxi se uporablja za preprečevanje slabosti in bruhanja pri kemoterapiji raka.
BEFORE YOU USE ALOXI
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ALOXI
Do not take Aloxi:
Ne uporabljajte Aloxia: − če ste alergični na zdravilno učinkovino palonosetron ali katerokoli sestavino Aloxia.
- If you are allergic to the active ingredient, palonosetron or any of the other ingredients of Aloxi.
Bodite posebno pozorni pri uporabi Aloxia: − če imate akutno zaporo črevesa ali anamnezo ponavljajočih se zaprtij, − če poleg Aloxia jemljete druga zdravila, ki lahko povzročijo motnje srčnega ritma, − če imate osebno ali rodbinsko anamnezo podaljšanega intervala QT.
Take special care with Aloxi:
Uporaba drugih zdravil:
- If you have acute bowel obstruction or a history of repeated constipation.
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
- If you are taking Aloxi in addition to other medicines that may induce an abnormal heart
Nosečnost Če ste noseči ali mislite da ste, bo vaš zdravnik uporabil Aloxi le v primeru, da je to nujno potrebno.
- If you have a personal or family history of QT prolongation.
Ni znano, ali bo Aloxi povzročil škodljive učinke med uporabo v nosečnosti.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
V primeru, da ste noseči ali mislite da ste, se pred uporabo katerega koli zdravila posvetujte z vašim zdravnikom ali farmacevtom.
19 It is not known whether Aloxi will cause any harmful effects when used during pregnancy.
19 Dojenje Ni znano, ali Aloxi prehaja v materino mleko.
You should always ask your doctor or pharmacist for advice before using any medicine if you are pregnant or think you might be.
Če dojite, se pred uporabo Aloxia posvetujte z vašim zdravnikom ali farmacevtom.
You should ask your doctor or pharmacist for advice before using Aloxi if you are breast-feeding.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Aloxi lahko povzroča vrtoglavost ali utrujenost.
Driving and using machines Aloxi may cause dizziness or tiredness.
Če se vam to zgodi, ne upravljajte motornih vozil in ne uporabljajte strojev.
HOW TO USE ALOXI
KAKO UPORABLJATI ALOXI
A doctor or nurse will normally inject Aloxi about 30 minutes before the start of chemotherapy.
Zdravnik ali medicinska sestra bosta običajno Aloxi injicirala 30 minut pred začetkom kemoterapije.
The usual dose of Aloxi is 250 micrograms given as a rapid injection into a vein.
Običajen odmerek Aloxia 250 mikrogramov se daje kot hitra injekcija v veno.
Like all medicines, Aloxi can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi Aloxi neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most common side effects are: headache, dizziness, constipation and diarrhoea.
Najpogostejši neželeni učinki so: glavobol, vrtoglavost, zaprtje in driska.
Between 1 and 10 out of every 100 patients will experience these side effects.
Ti neželeni učinki se bodo pojavili pri 1 do 10 bolnikih od vsakih 100 bolnikov.
Other uncommon side effects are: high or low blood pressure abnormal heart rate or lack of blood flow to the heart discolouration or widening of the veins abnormally high or low levels of potassium in the blood high levels of sugar in the blood or sugar in the urine low levels of calcium in the blood high levels of the pigment bilirubin in the blood high levels of certain liver enzymes elevated moods or feelings of anxiousness sleepiness or trouble sleeping decrease or loss of appetite weakness, tiredness, fever or flu like symptoms numbness, burning, prickling or tingling sensations on the skin itchy skin rash impaired vision or eye irritation motion sickness ringing in the ear hiccups, flatulence, dry mouth or indigestion, abdominal (stomach) pain difficulty urinating joint pain electrocardiogram abnormalities (QT prolongation)
Drugi občasni neželeni učinki so: zvišan ali znižan krvni tlak nenormalna frekvenca srca ali premajhen dotok krvi v srce sprememba barve ali razširitev ven nenormalno visoka ali nizka koncentracija kalija v krvi zvišana koncentracija sladkorja v krvi ali sladkor v urinu znižana koncentracija kalcija v krvi visoka koncentracija barvila bilirubina v krvi visoke koncentracije nekaterih jetrnih encimov obdobja vznesenega razpoloženja ali občutki zaskrbljenosti zaspanost ali nespečnost zmanjšanje ali izguba teka šibkost, utrujenost, vročina ali gripi podobni simptomi odrevenelost, občutek pečenja, zbadanja ali mravljinčenja na koži srbeč kožni izpuščaj motnje vida ali draženje oči potovalna bolezen zvonjenje v ušesih kolcanje, vetrovi, suha usta ali slaba prebava bolečine v trebuhu (želodcu) oteženo odvajanje vode bolečine v sklepih nenormalnosti elektrokardiograma (podaljšanje intervala QT)
Between 1 and 10 out of every 1,000 patients will experience these side effects.
Ti neželeni učinki se bodo pojavili pri 1 do 10 bolnikih od vsakih 1. 000 bolnikov.
In some very rare cases, patients have experienced allergic reactions to Aloxi, or burning or pain at the site of injection.
V nekaterih zelo redkih primerih so bolniki dobili alergijske reakcije na zdravilo Aloxi ali občutek pečenja ali bolečino na mestu injekcije.
20 If you notice any side effects not mentioned in this leaflet, please tell your doctor..
Če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
HOW TO STORE ALOXI
SHRANJEVANJE ALOXIA
This medicinal product does not require any special storage conditions Do not use after the expiry date stated on the label.
Za shranjevanje zdravila niso potrebna posebna navodila.
The expiry date refers to the last day of that month.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki.
Single use only, any unused solution should be disposed of..
Za enkratno uporabo, vso preostalo raztopino zavrzite.
What Aloxi contains:
Kaj vsebuje zdravilo Aloxi
- The active substance is palonosetron (as hydrochloride).
- Zdravilna učinkovina je palonosetron (v obliki palonosetronijevega klorida).
One ml of solution contains 50 micrograms palonosetron.
En ml raztopine vsebuje 50 mikrogramov palonosetrona.
- The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate,
- Pomožne snovi so manitol, dinatrijev edetat, natrijev citrat, monohidrat citronske kisline in voda
and water for injections, sodium hydroxide solution and hydrochloric acid solution.
za injekcije, raztopina natrijevega hidroksida in raztopina klorovodikove kisline.
What Aloxi looks like and the contents of the pack Aloxi solution for injection is a clear, colourless solution and is supplied in a pack of one glass vial, which contains 5 ml of the solution.
Izgled zdravila Aloxi in vsebina pakiranja Raztopina za injiciranje Aloxi je bistra, brezbarvna raztopina, na voljo je v pakiranju, v katerem je ena steklena viala, ki vsebuje 5 ml raztopine.
Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Ireland.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Irska.
España Italfarmaco S. A. c/ San Rafael 3 E-28108 Alcobendas (Madrid) Tel: + 34 91 657 23 23
22 España Italfarmaco S. A. c/ San Rafael 3
Ref.
London, 28. junij 2006 Sklic dok.
EMEA/ 190896/ 2006
EMEA/ 462570/ 2006
QUESTIONS AND ANSWERS ON RECOMMENDATION FOR REFUSAL OF MARKETING APPLICATION for ALPHEON
VPRAŠANJA IN ODGOVORI GLEDE PRIPOROČILA ZA ZAVRNITEV VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo ALPHEON
International Non-proprietary Name (INN): interferon alfa-2a
Mednarodno nelastniško ime (INN): interferon alfa- 2a
On 28 June 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Alpheon 6 million IU/ ml solution for injection intended for the treatment of hepatitis C.
Odbor za zdravila za uporabo v humani medicini (CHMP) je dne 28. junija 2006 sprejel negativno mnenje, s katerim je priporočil zavrnitev dovoljenja za promet z zdravilom Alpheon, raztopino za injiciranje s 6 milijonov i. e. / ml, namenjeno za zdravljenje hepatitisa C.
The company that applied for authorisation is BioPartners GmbH.
Podjetje, ki je podalo vlogo za odobritev dovoljenja za promet z zdravilom, je BioPartners GmbH.
They may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Podjetje lahko v roku 15 dni od prejema uradnega obvestila o tem negativnem mnenju zahteva ponovno presojo mnenja.
What is Alpheon?
Kaj je zdravilo Alpheon?
Alpheon is a solution for injection that contains the active substance interferon alfa-2a.
Zdravilo Alpheon je raztopina za injiciranje, ki vsebuje zdravilno učinkovino interferon alfa- 2a.
Alpheon was developed as a ‘ biosimilar’ medicine.
Zdravilo Alpheon je bilo razvito kot » biogenerično « zdravilo.
This means that Alpheon was intended to be similar to a biological medicine already authorised in the EU which contains the same active substance (also known as the ‘ reference medicine’), Roferon-A.
To pomeni, da je zdravilo Alpheon podobno biološkemu zdravilu Roferon- A (imenovanemu tudi » referenčno zdravilo «), ki je že odobreno v EU in vsebuje isto zdravilno učinkovino.
What was Alpheon expected to be used for?
Za kaj naj bi se zdravilo Alpheon uporabljalo?
Alpheon was expected to be used to treat adult patients who have chronic (long-term) hepatitis C (a disease of the liver due to an infection by a virus).
Zdravilo Alpheon bi se naj uporabljalo za zdravljenje odraslih bolnikov s kroničnim (dolgotrajnim) hepatitisom C (boleznijo jeter, ki je posledica okužbe z virusom).
The patients must have signs of liver damage: their liver tissues show some damage when observed with a microscope, and they have higher than normal levels of a liver enzyme (ALT) in their blood.
Taki bolniki imajo znake poškodb jeter: njihova jetrna tkiva pri pregledu z mikroskopom kažejo določene poškodbe, v krvi pa imajo raven jetrnega encima (ALT), ki je višja od normalne.
They must also show signs of being infected by the hepatitis C virus.
Nadalje izkazujejo znake okužbe z virusom hepatitisa C.
Alpheon was to be used with an antiviral medicine, ribavirin, except when patients could not take ribavirin.
Zdravilo Alpheon bi se naj uporabljalo s protivirusnim zdravilom ribavirin, razen pri bolnikih, ki ne morejo jemati ribavirina.
How is Alpheon expected to work?
Kako naj bi zdravilo Alpheon delovalo?
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Interferoni so naravne spojine, ki jih proizvaja telo z namenom obrambe proti napadom, kot so okužbe, ki jih povzročajo virusi.
The interferon in Alpheon, interferon alfa-2a, is made by a method known as ‘ recombinant DNA technology’: it is made by a yeast that has received a gene (DNA) that makes it able to produce it.
Interferon v zdravilu Alpheon, interferon alfa- 2a, se proizvaja z metodo, imenovano » tehnologija rekombinantne DNA «: tvori ga kvasovka, ki je prejela gen (DNA), s katerim postane sposobna tvoriti interferon.
What documentation has been presented by the company to support the application to the CHMP?
Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi?
The company that makes Alpheon presented information showing that Alpheon had been compared to Roferon-A (structure of the active substance, composition and purity of the medicine, the way it works, safety and effectiveness in hepatitis C).
Podjetje, ki proizvaja zdravilo Alpheon, je predložilo informacije, ki dokazujejo, da so zdravilo Alpheon primerjali z zdravilom Roferon- A (strukturo zdravilne učinkovine, sestavo in čistost zdravila, način njegovega delovanja, varnost in učinkovitost pri hepatitisu C).
The study in patients with hepatitis C compared the efficacy of Alpheon with that of the reference medicine in 455 patients.
V okviru raziskave z bolniki s hepatitisom C so pri 455 bolnikih učinkovitost zdravila Alpheon primerjali z učinkovitostjo referenčnega zdravila.
The study measured how many patients responded (no sign of virus in their blood) after 12 out of the 48 weeks of treatment and 6 months after stopping treatment.
V raziskavi so merili, koliko bolnikov je izkazalo odziv (ni imelo znakov virusa v krvi) po 12 od skupno 48 tednov zdravljenja in 6 mesecev po zaključku zdravljenja.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What were the major concerns which led the CHMP to recommend the refusal of the marketing authorisation?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kateri so bili glavni zadržki, zaradi katerih je CHMP predlagal zavrnitev dovoljenja za promet?
The CHMP had major concerns regarding the comparability of Alpheon and Roferon-A, because of differences identified between the two medicines (such as impurities).
CHMP je imel velike zadržke glede primerljivosti zdravil Alpheon in Roferon- A, in sicer zaradi ugotovljenih razlik med zdraviloma (kot so npr. nečistoče).
They also had concerns that there was not enough data on the stability of the active substance and of the medicine that was going to be marketed.
Ravno tako so imeli pomisleke, da ni na voljo dovolj podatkov o stabilnosti zdravilne učinkovine in zdravila, ki bi se naj tržilo.
Also, the process used for making the finished medicine had not been adequately validated.
Poleg tega postopek, po katerem naj bi zdravilo proizvajali, ni bil ustrezno potrjen.
The number of patients with hepatitis C responding to treatment with Alpheon and Roferon-A was similar in the clinical study.
Število bolnikov s hepatitisom C, ki so se v okviru klinične raziskave odzvali na zdravljenje z zdravilom Alpheon in Roferon- A je bilo podobno.
However, some differences were seen between the two medicines: more patients experienced a return of the disease after treatment with Alpheon was stopped than with the reference medicine, and there were more side effects with Alpheon.
Vendar pa so med obema zdraviloma zaznali določene razlike: bolezen se je po zaključku zdravljenja v večjem številu primerov ponovila pri bolnikih, zdravljenih z zdravilom Alpheon, kot pri bolnikih, zdravljenih z referenčnim zdravilom, poleg tega pa so pri zdravilu Alpheon opazili več neželenih učinkov.