natgillin/translations-raw huggingface dataset:
Side effects reported with Ivemend are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Ivemend, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
It is used in adults and children from 6 months of age who are undergoing chemotherapy known to cause moderate or severe nausea and vomiting. 
Uporablja se pri odraslih in otrocih od šestega meseca starosti naprej, ki prejemajo kemoterapijo, za katero je znano, da povzroča zmerno ali hudo slabost in bruhanje.
For more information about using Ivemend, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Ivemend glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Ivemend (seen in between 1 and 10 patients in 100) are increased liver enzymes, headache, hiccups, constipation, dyspepsia (heartburn), loss of appetite and fatigue (weakness or tiredness). 
Najpogostejši neželeni učinki zdravila Ivemend (ki se pojavijo pri 1 do 10 bolnikih od 100) so zvišane ravni jetrnih encimov, glavobol, kolcanje, zaprtost, dispepsija (zgaga), izguba teka in izčrpanost (šibkost ali utrujenost).
Ivemend must not be used at the same time as pimozide (used to treat mental illness), terfenadine and astemizole (used to treat allergy symptoms) and cisapride (used to relieve certain stomach problems). 
Zdravilo Ivemend se ne sme uporabljati sočasno s pimozidom (uporablja se za zdravljenje duševnih bolezni), terfenadinom in astemizolom (uporabljata se za zdravljenje simptomov alergije) ter cisapridom (uporablja se za lajšanje nekaterih težav z želodcem).
It stops a chemical in the body called ‘substance P' from attaching to the NK1 receptors. 
Preprečuje, da bi se kemična snov v telesu (snov P) vezala na receptorje za NK1.
When substance P attaches to these receptors, it causes nausea and vomiting. 
Če se snov P veže na te receptorje, to povzroči slabost in bruhanje.
In adults, Ivemend is given as a slow infusion into a vein on the first day of chemotherapy. 
Pri odraslih se zdravilo Ivemend daje s počasnim infundiranjem v veno prvi dan kemoterapije.
The active substance in Ivemend, fosaprepitant, is a ‘prodrug' of aprepitant. 
Učinkovina v zdravilu Ivemend, fosaprepitant, je „predzdravilo“ aprepitanta.
How is Ivemend used? 
Kako se zdravilo Ivemend uporablja?
A main study in 2,000 patients with cancer showed that Ivemend was as effective as a Emend another medicine approved for preventing nausea and vomiting. 
Glavna študija z 2 000 bolniki z rakom je pokazala, da je zdravilo Ivemend enako učinkovito kot zdravilo Emend, drugo zdravilo za preprečevanje slabosti in bruhanja.
Ivemend is a medicine for preventing nausea (feeling sick) and vomiting caused by chemotherapy cancer medicines. 
Ivemend je zdravilo za preprečevanje navzeje (slabosti) in bruhanja, ki ju povzročajo kemoterapevtska zdravila za zdravljenje raka.
Ivemend must always be given together with other medicines that prevent nausea and vomiting, including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist' (such as ondansetron). 
Zdravilo Ivemend je treba jemati z drugimi zdravili za preprečevanje slabosti in bruhanja, vključno s kortikosteroidom (kot je deksametazon) in antagonistom 5-HT3 (kot je ondansetron).
By blocking these receptors, Ivemend can prevent nausea and vomiting, which often happens during and after chemotherapy. 
Zdravilo Ivemend z zaviranjem teh receptorjev prepreči slabost in bruhanje, ki se pogosto pojavita med kemoterapijo in po njej.
Around 72% of patients treated with either medicine did not have any nausea or vomiting over the five days after receiving chemotherapy. 
V petih dneh po prejemu kemoterapije se slabost in bruhanje nista pokazala pri približno 72 % bolnikov, zdravljenih z enim ali drugim zdravilom.
A main study showed that Ivemend was as effective as Emend at preventing nausea and vomiting in patients undergoing chemotherapy and its side effects are considered to be manageable. 
Glavna študija je pokazala, da je zdravilo Ivemend pri preprečevanju slabosti in bruhanja pri bolnikih, ki prejemajo kemoterapijo, enako učinkovito kot zdravilo Emend, njegovi neželeni učinki pa so obvladljivi.
For the full list of side effects reported with Ivemend, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ivemend, glejte navodilo za uporabo.
How does Ivemend work? 
Kako zdravilo Ivemend deluje?
_ _ 1 Whole virion non-adjuvanted influenza vaccine, inactivated, containing antigen of *: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** per 0.5 ml dose * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms hemagglutinin 
_ _ 1 Cepivo proti gripi s celimi inaktiviranimi virioni brez adjuvansa, ki vsebuje antigen *: A/Vietnam/1203/2004 (H5N1) 7,5 mikrogramov** na odmerek 0,5 ml * razmnožen v celicah Vero (neprekinjena celična linija sesalskega izvora) ** izraženo v mikrogramih hemaglutinina
20 vials 
20 vial
1 syringe 
1 brizga
Immediate Packaging Content (concentration) 
Vsebina (koncentracija)
Pack size multi-dose vial (glass) 
Večodmerna viala (steklena)
Single-dose prefilled syringe (glass) without needle 
Enoodmerna napolnjena injekcijska brizga (steklena) brez igle
MA (EU) Number (Invented) name 
Številka EU
Route of Administration 
Pot uporabe Stična ovojnina
This overview was last updated in 05-2019. 
Povzetek je bil nazadnje posodobljen 05-2019.
Further information on Telzir can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Telzir. 
Nadaljnje informacije za zdravilo Telzir so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Telzir.
Telzir tablets can be taken with or without food. 
Tablete zdravila Telzir se lahko vzamejo s hrano ali brez nje.
It contains the active substance fosamprenavir. 
Vsebuje učinkovino fosamprenavir.
Telzir received a marketing authorisation valid throughout the EU on 12 July 2004. 
Za zdravilo Telzir je bilo 12. julija 2004 izdano dovoljenje za promet, veljavno po vsej EU.
Telzir has been studied in three main studies involving 1,862 adults. 
Zdravilo Telzir so proučevali v treh glavnih študijah, v katere je bilo vključenih 1 862 odraslih.
A similar benefit was also seen in one main study including 57 children aged between 2 and 18 years. 
Podobno učinkovitost so opazili tudi v eni glavni študiji, ki je vključevala 57 otrok, starih od dveh do 18 let.
What measures are being taken to ensure the safe and effective use of Telzir? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Telzir?
Similar side effects are seen in younger patients. 
Pri mlajših bolnikih so opaženi podobni neželeni učinki.
In adults, each dose of Telzir must be given with 100 mg ritonavir, twice a day. 
Odrasli morajo vsak odmerek zdravila Telzir vzeti skupaj s 100 mg ritonavirja dvakrat na dan.
However, there were too few patients aged below 6 years to support the use of Telzir in this age group. 
Vendar je bilo bolnikov, mlajših od šest let, premalo, da bi bila potrjena uporaba zdravila Telzir v tej starostni skupini.
An overview of Telzir and why it is authorised in the EU 
Pregled zdravila Telzir in zakaj je odobreno v EU
As for all medicines, data on the use of Telzir are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Telzir stalno spremljajo.
Telzir is available as tablets (700 mg) and as an oral suspension (50 mg/ml) to be taken by mouth. 
Zdravilo Telzir je na voljo v obliki tablet (700 mg) in kot peroralna suspenzija (50 mg/ml) za peroralno uporabo.
In younger patients, the dose of ritonavir depends on body weight. 
Pri mlajših bolnikih je odmerek ritonavirja odvisen od njihove telesne mase.
For more information about using Telzir, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Telzir glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Why is Telzir authorised in the EU? 
Zakaj je bilo zdravilo Telzir odobreno v EU?
As Telzir is converted into amprenavir in the body, it must not be given at the same time as other medicines containing amprenavir. 
Ker se zdravilo Telzir v telesu pretvori v amprenavir, se ne sme dajati istočasno z drugimi zdravili, ki vsebujejo amprenavir.
Telzir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. 
Zdravilo Telzir v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
What are the risks associated with Telzir? 
Kakšna tveganja so povezana z zdravilom Telzir?
Telzir is an antiviral medicine for treating patients aged 6 years or above who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). 
Telzir je protivirusno zdravilo za zdravljenje bolnikov, starejših od šest let, ki so okuženi z virusom človeške imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
What benefits of Telzir have been shown in studies? 
Kakšne koristi je zdravilo Telzir izkazalo v študijah?
Side effects reported with Telzir are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Telzir, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The oral suspension should be taken without food in adults, but in younger patients it should be taken with food in order to hide the taste and help them stick to treatment. 
Odrasli naj peroralno suspenzijo jemljejo brez hrane, mlajši bolniki pa naj jo vzamejo s hrano, da se prikrije njen okus in se jim pomaga, da se držijo režima zdravljenja.
In one study, after 48 weeks of treatment, 69% of previously untreated adults taking ritonavir-boosted Telzir (221 out of 322) and 68% of those taking nelfinavir (221 out of 327) had viral loads below 400 copies/ml (considered a low viral load). 
V eni študiji je po 48 tednih zdravljenja imelo 69 % (221 od 322) predhodno nezdravljenih bolnikov, ki so jemali z ritonavirjem ojačano zdravilo Telzir, in 68 % (221 od 327) bolnikov, ki so jemali nelfinavir, virusno breme pod 400 kopij/ml (kar velja za nizko virusno breme).
What is Telzir and what is it used for? 
Kaj je zdravilo Telzir in za kaj se uporablja?
Telzir must not be used in patients who are taking lurasidone (for schizophrenia and bipolar disorder), paritaprevir (for hepatitis C), simvastatin or lovastatin (for lowering blood cholesterol), rifampicin (for tuberculosis), St John's wort (a herbal preparation for depression and anxiety), or certain medicines that are broken down in the same way as Telzir or ritonavir as Telzir may affect their blood levels. 
Zdravila Telzir ne smejo uporabljati bolniki, ki jemljejo lurazidon (za zdravljenje shizofrenije in bipolarne motnje), paritaprevir (za zdravljenje okužbe z virusom hepatitisa C), simvastatin ali lovastatin (za znižanje ravni holesterola v krvi), rifampicin (za zdravljenje tuberkuloze), šentjanževko (rastlinski pripravek za zdravljenje depresije in tesnobe) ali določena zdravila, ki se presnavljajo enako kot zdravilo Telzir ali ritonavir, saj lahko zdravilo Telzir vpliva na njihovo koncentracijo v krvi.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Telzir have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Telzir upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The recommended dose for adults (aged 18 years or over) and for patients aged between 6 and 18 years who weigh more than 39 kg is 700 mg twice a day. 
Priporočeni odmerek za odrasle (starejše od 18 let) in za bolnike, stare od šest do 18 let, ki tehtajo več kot 39 kg, je 700 mg dvakrat na dan.
Telzir does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and the development of infections and diseases associated with AIDS. 
Zdravilo Telzir ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
In patients aged between 6 and 18 years who weigh between 25 and 39 kg, the dose depends on body weight. 
Pri bolnikih, starih od šest do 18 let, ki tehtajo med 25 in 39 kg, je odmerek odvisen od njihove telesne mase.
Other information about Telzir: 
Druge informacije o zdravilu Telzir
For patients who have taken medicines to treat their HIV infection before and did not respond to that treatment, doctors should only prescribe Telzir once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus's response to any new antiviral medicines that might be prescribed. 
Pri bolnikih, ki so že jemali zdravila za zdravljenje okužbe z virusom HIV, a se na to vrsto zdravljenja niso odzvali, lahko zdravniki predpišejo zdravilo Telzir šele, ko pregledajo, katera protivirusna zdravila je bolnik jemal pred tem in ocenijo, kakšna je verjetnost, da se bo virus odzval na zdravljenje z novimi protivirusnimi zdravili, ki jih nameravajo predpisati.
Although the Agency noted that the use of ritonavir-boosted Telzir had not been studied sufficiently in heavily pretreated patients and that studies carried out in children did not compare Telzir with a comparator medicine, it decided that Telzir's benefits are greater than its risks and it can be authorised for use in the EU. 
Čeprav je ugotovila, da uporaba zdravila Telzir, ojačanega z ritonavirjem, ni bila zadostno proučena pri bolnikih, ki so predhodno prejemali že več drugih zdravljenj, in da študije, opravljene pri otrocih, niso primerjale zdravila Telzir s primerjalnim zdravilom, je menila, da so koristi zdravila Telzir večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection. 
Zaradi zaviranja tega encima se virus ne more več normalno razmnoževati, kar zmanjša hitrost širjenja okužbe.
In a third study in patients who had been treated before, Telzir was less effective than the comparator medicine lopinavir, with patients taking lopinavir having larger reductions in viral loads over the first 48 weeks. 
V tretji študiji pri bolnikih, ki so se pred tem že zdravili, je bilo zdravilo Telzir manj učinkovito od primerjalnega zdravila lopinavir, pri čemer je pri bolnikih, ki so jemali lopinavir, prišlo do večjega zmanjšanja virusnega bremena v prvi 48 tednih zdravljenja.
Treatment with Telzir should be started by a doctor who has experience in the management of HIV infection. 
Zdravljenje z zdravilom Telzir lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
The European Medicines Agency concluded that Telzir, which contains a prodrug of amprenavir, is as effective as comparator medicines in reducing viral load. 
Evropska agencija za zdravila je zaključila, da je zdravilo Telzir, ki vsebuje predzdravilo amprenavirja, pri zmanjševanju virusnega bremena enako učinkovito kot primerjalna zdravila.
The active substance in Telzir, fosamprenavir, is a ‘prodrug' of the protease inhibitor amprenavir, which means that it is converted into amprenavir in the body. 
Učinkovina zdravila Telzir, fosamprenavir, je „predzdravilo“ zaviralca proteaze amprenavirja, kar pomeni, da se v telesu pretvori v amprenavir.
Telzir should not be used in people who are hypersensitive (allergic) to fosamprenavir, amprenavir, any of the other ingredients, or ritonavir. 
Zdravila Telzir ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) fosamprenavir, amprenavir ali katero koli drugo sestavino zdravila ali ritonavir.
The most common side effects in adults taking Telzir (seen in more than 1 patient in 10) are diarrhoea and increases in the levels of cholesterol (a type of fat) in the blood. 
Najpogostejša neželena učinka pri jemanju zdravila Telzir pri odraslih (opažena pri več kot 1 bolniku od 10) sta driska in povišana raven holesterola (vrste maščob) v krvi.
Two of the studies in previously untreated patients showed that Telzir in combination with other antiviral medicines was as effective as comparator medicines. 
Dve študiji s predhodno nezdravljenimi bolniki sta pokazali, da je zdravilo Telzir v kombinaciji z drugimi protivirusnimi zdravili enako učinkovito kot primerjalna zdravila.
Telzir is used in combination with ritonavir and other HIV medicines. 
Zdravilo Telzir se uporablja v kombinaciji z ritonavirjem in drugimi zdravili za zdravljenje okužbe z virusom HIV.
Similar results were seen in the other study comparing ritonavir-boosted Telzir with ritonavir-boosted lopinavir, with around three-quarters of both groups of previously untreated patients having viral loads below 400 copies/ml. 
Podobne rezultate so opazili tudi v drugi študiji, v kateri so z ritonavirjem ojačano zdravilo Telzir primerjali z lopinavirjem, ojačanim prav tako z ritonavirjem, pri čemer so imele približno tri četrtine predhodno nezdravljenih bolnikov v obeh skupinah virusno breme pod 400 kopij/ml.
It slows down the rate at which amprenavir is broken down, helping to increase levels of amprenavir in the blood. 
Ker upočasni hitrost razgradnje amprenavirja, s tem zviša njegove ravni v krvi.
Adults with liver problems should take a reduced dose of Telzir and be closely monitored for side effects and their response to treatment. 
Odrasli z jetrnimi obolenji naj jemljejo manjši odmerek zdravila Telzir, med jemanjem pa jih je treba skrbno spremljati zaradi neželenih učinkov in odziva na zdravljenje.
Patients in these three adult studies also took two reverse-transcriptase inhibitors (another type of antiviral medicine) in addition to Telzir or the medicine Telzir was being compared with. 
V teh treh študijah pri odraslih so bolniki poleg zdravila Telzir jemali tudi dva zaviralca reverzne transkriptaze (drugo vrsto protivirusnega zdravila) ali pa so zdravilo Telzir primerjali z njima.
For the full list of side effects of Telzir, see the package leaflet. 
Za celoten seznam neželenih učinkov zdravila Telzir glejte navodilo za uporabo.
There is no recommended dose for patients below 18 years who weigh less than 25 kg. 
Za bolnike, mlajše od 18 let, ki tehtajo manj kot 25 kg, ni priporočenega odmerka.
Ritonavir, another protease inhibitor, is used with Telzir as a ‘booster'. 
Ritonavir, drugi zaviralec proteaze, se v kombinaciji z zdravilom Telzir uporablja kot „spodbujevalec“.
How does Telzir work? 
Kako zdravilo Telzir deluje?
How is Telzir used? 
Kako se zdravilo Telzir uporablja?
blocks an enzyme that is involved in the reproduction of HIV. 
Amprenavir, ki je bil na voljo v EU že prej, zavira encim, ki sodeluje pri razmnoževanju virusa HIV.
Packaging Content Package size 
Pot uporabe Pakiranje Vsebina Velikost pakiranj a
EU (MA) number Invented name 
Številka (EU) dovoljenja za promet
EU/1/03/249/016 Vivanza 10 mg Orodispersible tablet blister (alu/alu) 4 x 1 tablets (unit dose) 
10 mg orodisperzibilna tableta peroralna uporaba pretisni omot (alu/alu) 4 x 1 tableta (enkratni odmerek)
Strength Pharmaceutical form Route of administration 
Jakost Farmacevtska oblika
MA (EU) Number Invented name 
Številka (EU) dovoljenja za promet
(Invented) name Strength Pharmaceutical Form Route of Administration 
Pot uporabe Stična ovojnina
London, June 2008 EMEA/532267/2007- Rev.1 
London, junij 2008 EMEA/532267/2007- Wer.
The CVMP concluded that, based on all available data, there was no concern regarding safety or efficacy for the product. 
CVMP je zaključil, da na podlagi vseh razpoložljivih podatkov ni zadržkov glede varnosti in učinkovitosti zdravila.
The Committee for Medicinal Products for Veterinary Use (CVMP) started the referral procedure on 19 July 2006. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je začel napotitveni postopek dne 19. julija 2006.
France notified the EMEA on 11 July 2006 of a Referral under Article 40 of Council Directive 2001/82/EC, as amended, in relation to Suvaxyn Parvo/E. 
Francija je dne 11. julija 2006 obvestila EMEA o napotitvi v skladu s členom 40 Direktive Sveta 2001/82/ES, kakor je bila spremenjena, v zvezi z zdravilom Suvaxyn Parvo/E.
However, it was important to ensure that the pass limits of the potency test do not drift from the original. 
Kljub temu pa je bilo pomembno zagotoviti, da se meje sprejemljivosti pri preskusu učinkovitosti ne oddaljijo od prvotnih meja.
The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 17 April 2007. 
Mnenje Odbora za zdravila za uporabo v veterinarski medicini (CVMP) je bilo sprejeto 17. januarja 2007, s tem povezana odločba Komisije pa 17. aprila 2007.
In addition, a more robust test for potency should be applied to the product in the future. 
Poleg tega bi bilo treba v prihodnje za učinkovitost uporabljati odpornejšo obliko preskusa.
The CVMP, therefore, recommended that the Marketing Authorisation should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum. 
CVMP je zato priporočil, da bi dovoljenje za promet morali spremeniti tako, da bi se odstopanja pri preskusu serološke učinkovitosti pri miših zmanjšala z ustreznimi ukrepi, kot je zamenjava uporabe referenčnega cepiva v preskusih serološke učinkovitosti pri miših z uporabo referenčnega seruma.
Suvaxyn Parvo/E is indicated for the active immunisation of pigs (gilts and sows) to prevent reproductive disorders caused by porcine parvovirus and to reduce clinical signs caused by Erysipelothrix rhusiopathiae infections, serotype 2 and serotype 1. 
Zdravilo Suvaxyn Parvo/E je indicirano za aktivno imunizacijo prašičev (mladic ali svinj) za preprečevanje motenj pri reprodukciji, ki jih povzroča prašičji parvovirus, in zmanjševanje kliničnih znakov, ki jih povzročajo okužbe z Erysipelothrix rhusiopathiae, serotipa 1 in serotipa 2.
OPINION FOLLOWING AN ARTICLE 40 REFERRAL FOR SUVAXYN PARVO/E 
MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 40 ZA ZDRAVILO SUVAXYN PARVO/E
The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation. 
Napotitveni postopek obravnava vprašanje enakovrednosti, ki po mnenju Francije med referenčno serijo cepiva za preskus učinkovitosti serije proti erizipelu, ki je bila potrjena v prvotni dokumentaciji, in med novimi referenčnimi serijami cepiva ni bila izkazana za ti dve seriji, zato je posledično CVMP moral razmisliti o spremembi, umiku ali preklicu dovoljenja za promet z zdravilom.
Invented Name 
Izmišljeno ime Ime
Member State EU/EEA Applicant 
Država članica EU/EGP
Three definitions of Cmin were discussed: 
Obravnavane so bile tri opredelitve vrednosti Cmin:
In addition, tmax was in the same range for both products. 
Poleg tega je bila vrednost tmax v istem razponu za obe zdravili.
Scientific conclusions and grounds for refusal 
Znanstveni zaključki in podlaga za zavrnitev
List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States 
Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, predlagateljev v državah članicah
• The risk-benefit balance is therefore not positive. 
• razmerje med koristmi in tveganji je zato negativno;
• Bioequivalence issues 
• Zadržki glede biološke enakovrednosti
However none of the 90%CI for this parameter fit into the standard bioequivalence limits. 
Vendar nobeden od 90-odstotnih intervalov zaupanja za ta parameter ne ustreza standardnim mejam biološke enakovrednosti.