natgillin/translations-raw huggingface dataset:
A total of 197 patients aged 15 years or older with severe active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicentre, non-inferiority trial. 
V randomiziranem, dvojno slepem, s placebom kontroliranem multicentričnem preskušanju neinferiornosti z aktivnim primerjalnim zdravilom so vključili in v njej zdravili skupno 197 bolnikov, starih 15 let ali več s hudo, aktivno granulomatozo s poliangiitisom (75%) in mikroskopskim poliangiitisom (24 %).
Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients from clinical study up to month 24 
Neželeni učinki iz klinične študije pri bolnikih z navadnim pemfigusom, zdravljenih z zdravilom Rituksimab do 24. meseca
The recommended dose of Blitzima used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 375 mg/m2 body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total). 
• Ponovitev folikularnih limfomov ali neodzivna bolezen Priporočeni odmerek zdravila Blitzima za vzdrževalno zdravljenje bolnikov s ponovitvijo folikularnih limfomov ali neodzivno boleznijo, ki so se odzvali na indukcijsko zdravljenje, je: 375 mg/m telesne površine enkrat na 3 mesece (z začetkom 3 mesece po zadnjem odmerku indukcijskega zdravljenja) do napredovanja bolezni ali največ dve leti (skupaj 8 infuzij).
Table 10a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for rituximab plus FC vs. FC alone - 48.1 months median observation time Efficacy Parameter 
Pregled rezultatov o učinkovitosti za rituksimab v kombinaciji s kemoterapijo FC v primerjavi s samo kemoterapijo FC - mediana opazovanja 48,1 meseca.
General disorders and administratio n site conditions fever, chills, asthenia, headache tumour pain, flushing, malaise, cold syndrome, +fatigue, +shivering, +multi-organ failure4 
Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura, mrzlica, astenija, glavobol tumorska bolečina, zardevanje, splošno slabo počutje, prehladni sindrom, +utrujenost, +drgetanje, +
Blitzima is used for the treatment of patients with moderate to severe pemphigus vulgaris. 
Zdravilo Blitzima se uporablja za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
Rituximab was administered as an intravenous infusion at a first-cycle dose of 375 mg/m2 increased to 500 mg/m2 each cycle for 5 doses in combination with fludarabine and cyclophosphamide in CLL patients. 
Kronična limfocitna levkemija Rituksimab so bolnikom s KLL dajali v obliki intravenske infuzije v odmerku 375 mg/m telesne površine v prvem ciklu zdravljenja, odmerek pa se je v naslednjih 5 ciklih zdravljenja povečal na 500 mg/m telesne površine (v kombinaciji s fludarabinom in ciklofosfamidom).
Blitzima 500 mg concentrate for solution for infusion 
Blitzima 500 mg koncentrat za raztopino za infundiranje
You must also do this for 12 months after your last treatment with Blitzima. 
Učinkovito kontracepcijsko zaščito morate nadaljevati še 12 mesecev po zadnjem odmerku zdravila Blitzima.
Table 5 Adverse drugs reactions for rituximab-treated pemphigus vulgaris patients in the clinical study up to month 24 System Organ Class 
Neželeni učinki iz klinične študije pri bolnikih z navadnim pemfigusom, zdravljenih z zdravilom Rituksimab do 24. meseca Organski sistem Neželeni učinek
Nervous system disorders 
Bolezni živčevja omotica tremor
Experience from granulomatosis with polyangiitis and microscopic polyangiitis 
Izkušnjeprigranulomatoza s poliangiitisom in mikroskopski poliangiitis
Complete response (CR/CRu) rate* 48% 67% 53% 67% chi-squared test p value odds ratio (95% CI) 
Delež popolnega odgovora (CR/CRu)* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ)
Table 4 Adverse drug reactions occurring in ≥ 5% of patients receiving rituximab for maintenance treatment of GPA and MPA, and at a higher frequency than the comparator group 
Neželeni učinki, ki so se pojavili pri ≥ 5 % bolnikov, ki so prejeli rituksimab za vzdrževalno zdravljenje GPA in MPA in pogosteje kot v primerjalni skupini
Skin and Subcutaneous tissue disorders pruritus, rash, +alopecia urticaria, sweating, night sweats, +skin disorder severe bullous skin reactions, StevensJohnson syndrome toxic epidermal necrolysis (Lyell's syndrome)7 
Bolezni kože in podkožja srbenje, izpuščaj, +alopecija urtikarija, znojenje, nočno znojenje, +bolezen kože hude bulozne kožne reakcije, Stevens
Influenza-like illness Oedema peripheral 
Splošne težave in spremembe na mestu aplikacije periferni edemi
At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32%. 
Nadaljnja analiza trajanja celokupnega preživetja, ki so jo izvedli po mediani časa sledenja 60 mesecev, je potrdila prednost zdravljenja z R-CHOP pred CHOP (p = 0,0071), kar pomeni zmanjšanje tveganja za dogodke za 32 %.
The overall rate of infection was approximately 94 per 100 patient years in rituximab treated patients. 
Pri bolnikih, ki so se zdravili z rituksimabom, je bil celokupni delež okužb približno 94 na 100 bolnik-let.
Blitzima is a clear, colourless solution, supplied as a concentrate for solution for infusion in a glass vial. 
Na voljo je v obliki koncentrata za raztopino za infundiranje v stekleni viali.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
In a multicentre, single-arm trial, 37 patients with relapsed or chemoresistant, low grade or follicular B cell NHL received 375 mg/m2 of rituximab as intravenous infusion weekly for eight doses. 
V multicentričnem preskušanju brez primerjalne skupine je 37 bolnikov, pri katerih se je nizko maligni ne-Hodgkinov limfom ali folikularni B-celični ne-Hodgkinov limfom ponovil ali pa so bili bolniki neodzivni na kemoterapijo, prejemalo osem odmerkov po 375 mg/m rituksimaba v obliki intravenske infuzije enkrat na teden.
For retreatment with Blitzima monotherapy for patients who have responded to previous treatment with Blitzima monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks (see section 5.1). 
Priporočeni odmerek zdravila Blitzima za ponovno samostojno zdravljenje bolnikov s folikularnim limfomom, ki so se odzvali na prejšnje samostojno zdravljenje z zdravilom Blitzima po tem, ko se na predhodno zdravljenje niso odzvali ali se je pri njih bolezen ponovila, je: 375 mg/m telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne (glejte poglavje 5.1).
Table 9 Maintenance phase: overview of efficacy results rituximab vs. observation (28 months median observation time) 
Vzdrževalno zdravljenje: pregled učinkovitosti zdravljenja z rituksimabom v primerjavi z opazovanjem (mediana časa opazovanja 28 mesecev) Parameter učinkovitosti
Blitzima 100 mg concentrate for solution for infusion 
Blitzima 100 mg koncentrat za raztopino za infundiranje
You will always be given Blitzima as a drip (intravenous infusion). 
Zdravilo Blitzima boste dobili v intravenski infuziji.
For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Blitzima to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome. 
9/l, je za zmanjšanje pogostnosti in resnosti akutnih reakcij, povezanih z infuzijo, in/ali sindroma sproščanja citokinov priporočljivo intravensko dati 100 mg prednizona/prednizolona malo pred infuzijo zdravila Blitzima.
Gastrointesti nal disorders nausea vomiting , diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation abdominal enlargement gastro-intestin al perforation7 
Bolezni prebavil navzea bruhanje, driska, bolečine v trebuhu, disfagija, stomatitis, zaprtost, dispepsija, neješčnost, draženje žrela povečanje trebuha perforacija prebavil7
Treatment with Blitzima uses four separate infusions given at weekly intervals. 
c) Če se zdravite zaradi granulomatoze s poliangiitisom ali mikroskopskega poliangiitisa Zdravljenje z zdravilom Blitzima obsega štiri ločene infuzije, ki jih dobite v presledkih enega tedna.
Baseline CD19-positive cell counts and size of measurable tumour lesions contributed to some of the variability in CL2 of rituximab in data from 161 patients given 375 mg/m2 as an intravenous infusion for 4 weekly doses. 
K variabilnosti Cl2 rituksimaba pri 161 bolnikih, ki so v štirih tednih enkrat na teden dobili 375 mg/m rituksimaba z intravensko infuzijo, je prispevalo začetno število CD19 pozitivnih celic in velikost izmerljivih tumorskih lezij.
The MAH must ensure that all physicians who are expected to prescribe Blitzima are provided with the following: 
Imetnik dovoljenja za promet mora zagotoviti, da zdravniki, ki lahko predpišejo zdravilo Blitzima, prejmejo: povzetek glavnih značilnosti zdravila, gradivo za zdravnika
PFS 
(DFS)
OS 
IZ
• If you are having Blitzima alone Blitzima will be given to you once a week for 4 weeks. 
Koliko zdravila boste dobili in kako pogosto a) Če se zdravite zaradi ne-Hodgkinovega limfoma Če prejemate samo zdravilo Blitzima, ga boste prejeli enkrat na teden 4 tedne.
A total of 23/99 (23%) rituximab-treated patients from the induction of remission trial tested positive for ADA by 18 months. 
Do 18. meseca je imelo pozitiven izvid ADA skupno 23 od 99 (23 %) bolnikov, ki so bili v preskušanju zdravljeni z rituksimabom.
Do not breast-feed while you are being treated with Blitzima. 
Med zdravljenjem z zdravilom Blitzima ne smete dojiti.
PATIENT ALERT CARD TEXT FOR NON-ONCOLOGY INDICATIONS Blitzima (Rituximab) Alert Card for patients with non-oncology diseases Why have I been given this card? 
Opozorilna kartica za bolnike, ki prejemajo zdravilo Blitzima (rituksimab) za neonkološke bolezni
Rituximab + Prednisone N=38 
Rituksimab + majhen odmerek prednizona (n = 38)
The recommended dose of Blitzima monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for 4 weeks. 
• Bolniki, ki se na prejšnje zdravljenje niso odzvali ali se je pri njih bolezen ponovila Priporočeni odmerek zdravila Blitzima za samostojno indukcijsko zdravljenje odraslih bolnikov s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se je pri njih bolezen po kemoterapiji drugič ali že večkrat ponovila, je: 375 mg/m telesne površine v obliki intravenske infuzije enkrat na teden 4 tedne.
This medicine may make you more likely to get infections. 
Ker prejemate zdravilo Blitzima, je večja verjetnost, da dobite okužbo.
Blitzima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV). 
Navadni pemfigus (pemphigus vulgaris) Zdravilo Blitzima je indicirano za zdravljenje bolnikov z zmernim do hudim navadnim pemfigusom.
• low mood and loss of interest or enjoyment in doing things, feeling nervous 
- zmedenost, izgubo spomina ali težave pri mišljenju,
Blitzima 500 mg concentrate for solution for infusion Rituximab 
Blitzima 500 mg koncentrat za raztopino za infundiranje rituksimab
Complete response (CR/CRu) rate* 48% 67% 53% 67% chi-squared test p value odds ratio (95% CI) * at end of maintenance/observation; final analysis results based on median follow-up of 73 months. 
vrednost p v testu log-rang razmerje ogroženosti (95-% IZ) zmanjšanje tveganja Delež celokupnega odgovora* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ) Delež popolnega odgovora (CR/CRu)* vrednost p v testu hi-kvadrat razmerje obetov (95-% IZ)
Very rare disorders 
Organski sistem Zelo pogosti
• heart problems - such as reduced heart rate or chest pain (angina) 
težave s srcem - na primer upočasnjen srčni utrip ali bolečina v prsih (angina pektoris), astma, telesne organe doseže premalo kisika, oteklost trebuha.
This is because side effects can develop several months after you have had treatment. 
Kartico pri sebi hranite še 2 leti po zadnjem odmerku zdravila Blitzima, ker se lahko neželeni učinki pojavijo več mesecev po zdravljenju.
Blitzima 100 mg concentrate for solution for infusion Rituximab 
Blitzima 100 mg koncentrat za raztopino za infundiranje rituksimab
Psychiatric Disorders 
Psihiatrične motnje nespečnost
Posology 
Rituksimab
Medicines given before each Blitzima administration 
Shranjevanje zdravila Blitzima
Pemphigus vulgaris 
Deutschland Mundipharma GmbH
Physician information 
FARMAKOLOŠKE LASTNOSTI
Hypertension Flushing 
Žilne bolezni hipertenzija napadi rdečice
Patient Alert card 
BESEDILO OPOZORILNE KARTICE ZA BOLNIKA Z NEONKOLOŠKO INDIKACIJO
• blood clotting problems, decrease of red blood cell production and increase of red blood cell destruction (aplastic haemolytic anaemia), swollen or enlarged lymph nodes 
Občasni neželeni učinki (pojavijo se lahko pri do 1 od 100 bolnikov): motnje strjevanja krvi, zmanjšano nastajanje rdečih krvnih celic in povečano propadanje rdečih krvnih celic (aplastična hemolitična anemija), oteklost ali povečanje bezgavk, slabo razpoloženje in izguba zanimanja ali veselja za početje stvari, živčnost, motnje okušanja - na primer spremenjen okus stvari,
The Ph. Eur. 
Ph. Eur.
At the conclusion of the assessment phase of the procedure the concerned Member State Poland was prepared to grant an authorisation. 
Ob koncu faze vrednotenja v postopku je bila zadevna država članica Poljska pripravljena odobriti dovoljenje.
In addition, reports of the field studies were provided. 
Poleg tega so bila predložena poročila o terenskih študijah.
The product has been authorised in the reference Member State (Slovak Republic) for 7 years. 
Zdravilo je bilo 7 let odobreno v referenčni državi članici (Slovaški).
Murgašova 5 949 01 Nitra Slovak 
Murgašova 5 949 01 Nitra Slovaška
Assessment of Quality and Efficacy issues 
Vrednotenje vprašanj glede kakovosti in učinkovitosti
Pigs Intramuscularly deep into the neck muscle. 
Prašiči Intramuskularno, globoko v vratno mišico.
(0062) allows levels residual formaldehyde above 0.5 g/L provided the level has been shown to be safe. 
(0062) dovoljuje ravni preostanka formaldehida nad 0,5 g/L pod pogojem, da je ta raven dokazano varna.
In addition to these quality points Spain also considered that the permitted level of residual formaldehyde was too high. 
Poleg teh vprašanj glede kakovosti je Španija menila, da so dovoljene ravni preostanka formaldehida previsoke.
The present referral follows an application for mutual recognition of the product in Poland and Spain. 
Ta napotitveni postopek sledi vlogi za medsebojno priznavanje zdravila na Poljskem in v Španiji.
The conditions for lifting the suspension are set out in Annex III. 
Pogoji za preklic zadržanja so določeni v Dodatku III.
Since formaldehyde is listed in Annex II of the MRL Council Regulation (EEC) No 2377/90 it has been accepted that it is not necessary for the protection of public health to establish a maximum residue limit. 
Ker je formaldehid naveden v Dodatku II Uredbe Sveta o MRL (EGS) št. 2377/90, je bilo sprejeto, da za zaščito javnega zdravja ni potrebno določiti največje mejne vrednosti ostankov.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF APPM RESPIPHARM 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA APPM RESPIPHARM
The National Competent Authority of the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holder: 
Pristojni nacionalni organ referenčne države članice zagotovi, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
There were no details of the statistical methods used, nor were there full reports of the field trials. 
Predložene niso bile niti podrobnosti o uporabljenih statističnih metodah niti popolna poročila o terenskih preskušanjih.
In particular, it was requested to confirm that this vaccine covered the whole range of Apx toxins. 
Še posebej je bila zahtevana potrditev, da to cepivo pokriva celoten razpon toksinov Apx.
It is considered that the principle requirements for the demonstration of efficacy are laid down by the Ph. Eur. 
Šteje se, da so osnovne zahteve za dokaz učinkovitosti določene v Ph. Eur.
Quality issues: 
Vprašanja glede kakovosti:
Slovak Republic1 
Slovaška 1
This was considered important as pathological changes caused by P.multocida are not specific for infection with this organism. 
To se je štelo za pomembno, saj patološke spremembe, ki jih povzroča P. multocida, niso specifične za okužbo s tem organizmom.
(*) Mean titre of agglutination antibodies after vaccination in rabbits 
(*) Povprečni titer aglutinacijskih protiteles po cepljenju kuncev
The onset of immunity is stated as 14 days and the duration of immunity as 6 months. 
Navedeno je, da imunost nastopi v 14 dneh in traja 6 mesecev.
In addition, it was considered that the field studies were not adequate and lacked direct confirmation of the presence of APP or appropriate monitoring of clinical signs or other efficacy parameters. 
Poleg tega je bilo izraženo mnenje, da terenske študije niso bile zadostne in ni bilo neposredne potrditve prisotnosti APP ali ustreznega spremljanja kliničnih znakov ali drugih parametrov učinkovitosti.
The significance of toxigenic group is supported by the specific monograph (2008/1360) which states (Section 2.2.2 Immunogenicity) that “The challenge strain for the following test is chosen to ensure challenge with each Ap toxin produced by the serotypes to be stated on the label…”. 
Pomen toksigenske skupine podpira specifična monografija (2008/1360), ki določa (razdelek 2.2.2 Imunogenost), da „Stimulacijski sev za v nadaljevanju opisani preskus se izbere tako, da se zagotovi stimulacija z vsemi toksini Ap, ki jih tvorijo serotipi, navedeni na označevanju…“.
It was noted by the Committee that the lack of compliance with the GCP requirements weakened the content of the surveillance study essentially. 
Odbor je izpostavil, da neskladnost z zahtevami GCP v osnovi zmanjša jakost vsebine študije spremljanja organizmov.
Consequently, there do not appear to be additional safety concerns relating to the levels of formaldehyde that may result from administration of product containing formaldehyde at the levels proposed. 
Posledično je videti, da ni drugih varnostnih zadržkov glede ravni formaldehida, ki bi lahko nastali pri dajanju zdravila, ki vsebuje formaldehid v predlaganih ravneh.
The data have been collected over a number of years (at least 2004-2008) and included a total of 163,061 pigs, of which 93,460 had been vaccinated with APPM Respipharm, 37,541 had been treated with an APP vaccine without P.multocida, and 32,060 pigs had not been vaccinated. 
V podatke, zbrane v več letih (vsaj v obdobju 2004-2008), je vključenih skupno 163 061 prašičev, od tega 93 460 cepljenih s cepivom APPM Respipharm, 37 541 cepljenih s cepivom APP brez komponente P. multocida in 32 060 necepljenih prašičev.
In addition, Spain considered that an adequate justification had not been provided for including the different serotypes of A.pleuropneumoniae and P. multocida into the same vaccine. 
Poleg tega je Španija menila, da ni bila predložena ustrezna utemeljitev vključitve posameznih serotipov A.pleuropneumoniae in P. multocida v isto cepivo.
Consequently it was agreed that the APP serotypes in the product are relevant and therefore inclusion of the APP components in the vaccine was adequately justified. 
Zaradi tega je bilo sklenjeno, da so serotipi APP v zdravilu pomembni, zato je bila vključitev komponent APP v cepivo ustrezno utemeljena.
The applicant has provided supporting opinions from EDQM and the Chairman of Group 15V which supports this interpretation. 
Predlagatelj je v podporo predložil mnenji Evropskega direktorata za kakovost zdravil in predsednika skupine 15V, ki podpirata to interpretacijo.
The Note for Guidance on field trials with veterinary vaccines3 indicates “The environment in which the two groups of animals are housed shall be as equivalent as possible (i.e. same farm/barn/batch) or at least as similar as possible (e.g. same farm/different barn/same batch).” It was confirmed that according to the study protocol the groups of pigs vaccinated with the different vaccines had been housed at the same farm in different halls (barns) which is acceptable. 
Navodila o terenskih preskušanjih s cepivi za uporabo v veterinarski medicini3 določajo: „Okolje, v katerem sta nastanjeni obe skupini živali, mora biti čimbolj enakovredno (tj. ista kmetija/hlev/serija) ali vsaj čimbolj podobno (npr. ista kmetija/drug hlev/ista serija).“ Potrjeno je bilo, da so bile po protokolu študije skupine prašičev, ki so bile cepljene z različnimi cepivi, nastanjene na isti kmetiji v različnih halah (hlevih), kar je sprejemljivo.
Requirements for combined veterinary vaccines http://www.emea.europa.eu/pdfs/vet/iwp/005297en.pdf CVMP Note for guidance: Field trials with veterinary vaccines - http://www.emea.europa.eu/pdfs/vet/iwp/085299en.pdf 
Navodilo CVMP: Terenska preskušanja s cepivi za uporabo v veterinarski medicinihttp://www.emea.europa.eu/pdfs/vet/iwp/085299en.pdf
It was noted that all three Apx toxigenic groups are represented in the vaccine. 
Izpostavljeno je bilo, da so v cepivu zastopane vse tri toksigenske skupine Apx.
The field data were deficient and it was not clear that the presence of PMA in the vaccine had any specific benefit. 
Terenski podatki so bili pomanjkljivi in ni bilo jasno, ali ima prisotnost PMA v cepivu specifičen koristni učinek.
This differentiation is based on identification of characteristic lesions by experienced veterinary staff at slaughterhouses. 
Ta razlika temelji na identifikaciji značilnih lezij s strani izkušenih veterinarjev v klavnicah.
Spain raised objections which have led to the present referral procedure as it was considered that the authorisation of this veterinary medicinal product may present a potential serious risk to human or animal health or to the environment on the grounds of concerns over Quality and Efficacy. 
Španija pa je ugovarjala, kar je sprožilo ta napotitveni postopek, saj je menila, da lahko odobritev tega zdravila za uporabo v veterinarski medicini predstavlja možno resno tveganje za javno zdravje ljudi, živali in okolje na osnovi zadržkov glede kakovosti in učinkovitosti.
In brief, concerns were raised that the composition of Actinobacillus pleuropneumoniae serotypes in the vaccine (2, 9 and 11) were not based on the epizoological situation in Spain, where the most prevalent serotypes are 2, 4 and 7. 
Na kratko: do zadržkov je prišlo, ker sestava serotipov Actinobacillus pleuropneumoniae v cepivu (2, 9 in 11) ne temelji na epizoološki situaciji v Španiji, kjer so najpogostejši serotipi 2, 4 in 7.
However, in view of the deficiencies in these data (see below) a justification for inclusion of PMA in the product could not be accepted. 
Vendar z vidika pomanjkljivosti teh podatkov (glejte nadaljevanje) utemeljitve za vključitev PMA v cepivo ni bilo mogoče sprejeti.
In addition, it is considered that on animal welfare grounds, additional challenge studies with APP Serotype 11 are unnecessary and should not be requested. 
Poleg tega se šteje, da so z vidika dobrobiti živali dodatne študije z APP serotipa 11 nepotrebne in naj se ne zahtevajo.
Therefore, in view of the fact that APPM Respipharm has met the efficacy requirements of the Ph.Eur. 
Zato se z vidika dejstva, da je zdravilo APPM Respipharm izpolnilo zahteve glede učinkovitosti iz Ph.