natgillin/translations-raw huggingface dataset:
2.2 PECsoil CALCULATION
2.2 IZRAČUN PKOtla
In this instance a number of publications were provided to substantiate the proportion of animals treated for BRD within a herd.
V tem primeru so bile predložene številne publikacije za utemeljitev deleža živali, zdravljenih zaradi respiratorne bolezni goveda znotraj črede.
Fenflor contains florfenicol, which is a broad-spectrum primarily bacteriostatic antibiotic with a range of activity, including many Gram-negative and Gram-positive organisms.
Zdravilo Fenflor vsebuje florfenikol, ki je širokospektralni, primarno bakteriostatični antibiotik s širokim spektrom delovanja, vključno naz mnogeimi gramnegativne imi in grampozitivneimi organizmei.
• Dairy calves: Sweden - 2.2-53.3% (Svensson et al 20064).
• Teleta krav molznic: Švedska - 2,2-53,3 % (Svensson et al 20064).
The dossier as submitted in the referral procedure is considered to fulfil the necessary requirements with regards to the environmental risk assessment (as established in Article 12(3)(j) of Directive 2001/82/EC, as amended by Directive 2004/28/EC) provided that the product is used only for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Dokumentacija, predložena v napotitvenem postopku, izpolnjuje potrebne zahteve glede ocene tveganja za okolje (kot je določeno v členu 12(3)(j) Direktive 2001/82/ES, kakor je bila spremenjena z Direktivo 2004/28/ES), ob upoštevanju, da se zdravilo uporablja le za terapevtsko zdravljenje okužb dihalnih poti pri govedu, ki jih povzročajo Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
However, given that the CVMP considers that no Phase II environmental risk assessment is required for this application (because the calculated PECsoil values are below the trigger value), the manure degradation study is not pivotal to the environmental risk assessment.
faza ocene tveganja za to vlogo za okolje ni potrebna za to vlogo (saj so vrednosti izračunanih PKOtla nižje od sprožitvene mejne vrednosti), pa študija razkroja v gnoju ni ključna za oceno tveganja za okolje.
place-1.y-1] (see Table 3 of the guideline)
mesto-1.leto-1] (glejte razpredelnico 3 v smernici)
• Commercial veal unit: UK - 75% (Miller et al, 19802).
• Teletina za prodajo: Združeno kraljestvo - 75 % (Miller et al, 19802).
To support the argument that the environmental risk assessment could be completed at Phase I, the Marketing Authorisation Holder also provided a manure degradation study, which was performed in accordance with the criteria laid out in the above mentioned CVMP guideline.
Imetnik dovoljenja za promet z zdravilom je v podporo trditvi, da bi lahko oceno tveganja za okolje zaključili v I. fazi, prav tako predložil študijo razkroja v gnoju, ki je bila izvedena v skladu z merili, določenimi v zgoraj omenjeni smernici CVMP.
The LOQ is equal to 11% of the dose added to manure (0.4/3.6) and the LOD is equal to 2.7% (0.1/3.6) of the dose added to manure.
Meja kvantifikacije znaša 11 % (0,4/3,6) odmerka, dodanega gnoju, meja zaznavnosti pa znaša 2,7 % (0,1/3,6) odmerka, dodanega gnoju.
• Dairy farm calves: Italy - 28.9% (Makoshey et al, 20086).
• Teleta mlečnih kmetij: Italija - 28,9 % (Makoshey et al, 20086).
In the first phase the extent of environmental exposure is determined based on the intended use of the veterinary medicinal product.
V prvi fazi se glede na predvideno uporabo zdravila za uporabo v veterinarski medicini določi obseg izpostavljenosti okolju.
• Veal calves: The Netherlands - 19.8%, Belgium - 13.3% (Catry et al, 20091).
• Klavna teleta: Nizozemska - 19,8 %, Belgija - 13,3 % (Catry et al, 20091).
The CVMP concluded that adequate evidence had been provided to demonstrate that the proportion of treated animals in a herd would not be higher than 38% for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni and that the data justified the use of this figure of 38% as the value for the proportion of treated animals in a herd, for use in calculating the PECsoil.
CVMP je zaključil, da so predloženi zadostni dokazi, da delež zdravljenih živali v čredi ne bo višji od 38 % za zdravljenje okužb dihalnih poti pri govedu, ki jih povzročajo Mannheimia haemolytica, Pasteurella multocida in Histophilus somni, in da podatki oupravičujejo uporabo vrednosti 38 % kot deleža zdravljenih živali v čredi za izračun PKOtla.
The Marketing Authorisation Holder provided data with the aim of demonstrating that the percentage of herd animals that will be treated for Bovine Respiratory Disease (BRD) is less than the default value of 50% given in the CVMP guideline mentioned above (EMEA/CVMP/ERA/418282/2005Rev.1).
Imetnik dovoljenja za promet z zdravilom je predložil podatke, da bi dokazal, da je odstotek črednih živali, ki jih bodo zdravili zaradi respiratorne bolezni goveda, manjši od privzete vrednosti 50 %, ki je navedena v zgoraj omenjenih smernici CVMP (EMEA/CVMP/ERA/418282/2005-Rev.1).
6 Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. and Cavirani S. (2008) Field Efficacy of Combination Vaccines Against Bovine Respiratory Pathogens in Calves.
Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. in Cavirani S. (2008) Field Efficacy of Combination Vaccines Against Bovine Respiratory Pathogens in Calves.
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILO ZA UPORABO
In this case a number of studies were provided to demonstrate that the proportion of treated animals in a herd would not be greater than 38% for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
V tem primeru so predložili številne študije, da bi dokazali, da delež zdravljenih živali v čredi ne bo višji od 38 % za terapevtsko zdravljenje okužb dihalnih poti pri govedu, ki jih povzročajo Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
The PECsoil for each cattle type (calves, dairy cows, cattle 0-1 year, cattle over 2 years) has been calculated using 38% as the proportion of the herd treated, according to the following formula (from the CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1).
PKOtla so za vsako posamezno vrsto goveda (teleta, krave molznice, govedo, staro 0-1 leta, govedo, starejše od 2 let) izračunali s pomočjo 38 % kot deleža zdravljene črede v skladu z naslednjo formulo (iz smernice CVMP o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1).
= Animal turnover rate per place per year [place-1.y-1] (see Table 3 of the guideline) = EU nitrogen spreading limit [kg N.ha-1]
= Menjava živali na mesto in leto [mesto-1.leto-1] (glejte razpredelnico 3 v smernici) = Meja širjenja dušika v EU [kg N.ha-1]
74:162-179 5 Godinho K., Wolf R., Sherington J., Rowan T., Sunderland S. and Evans N. (2005) Efficacy of tulathromycin in the treatment and prevention of natural outbreaks of bovine respiratory disease in European cattle.
5 Godinho K., Wolf R., Sherington J., Rowan T., Sunderland S. in Evans N. (2005) Efficacy of tulathromycin in the treatment and prevention of natural outbreaks of bovine respiratory disease in European cattle.
= Fraction of herd treated [value between 0 and 1] (see Table 2 of the guideline) = Bulk density of dry soil [kg.m-3]
= Delež zdravljene črede [vrednost med 0 in 1] (glejte razpredelnico 2 v smernici) = Specifična masa suhe prsti [kg.m-3]
• Beef calves: Spain - 31.5%, UK - 13-15% (Martin et al, 20073).
• Teleta pitanci: Španija - 31,5 %, Združeno kraljestvo - 13-15 % (Martin et al, 20073).
Svensson C., Hultgren J. and Oltenacu P. (2006) Morbidity in 3-7 month old dairy calves in south-western Sweden, and risk factors for diarrhoea and respiratory disease.
4 Svensson C., Hultgren J. in Oltenacu P. (2006) Morbidity in 3-7 month old dairy calves in south-western
This overall process is described in VICH Phase I and Phase II guidelines (VICH Topic GL6 (Ecotoxicity Phase I; Guideline on environmental impact assessment (EIAS) for veterinary medicinal products - Phase I (CVMP/VICH/592/98-FINAL) and VICH GL 38 (Environmental impact assessment for veterinary medicinal products - Phase II (CVMP/VICH/790/03-FINAL)).
fazi smernic VICH (predmet VICH GL6 (Ekotoksičnost faza I; Smernica o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje (PVO) - I. faza (CVMP/VICH/592/98-FINAL) in VICH GL 38 (Presoja vplivov zdravil za uporabo v veterinarski medicini na okolje - II.
Section 4.2 of the SPC and Section 4 of the Package Leaflet:
poglavje 4.2 povzetka glavnih značilnosti zdravila in poglavje 4 navodila za uporabo:
All PECsoil values calculated are below the Phase II trigger value of 100 μg/kg, with the highest PECsoil (88.6 μg/kg) calculated for cattle of over 2 years of age.
fazo, pri čemer je bil najvišji izračunani PKOtla (88,6 μg/kg) pri govedu, starejšem od 2 let.
The product is presented as a solution for injection containing 300 mg of florfenicol per ml solution for injection and it is intended for the therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Zdravilo je na voljo kot raztopina za injiciranje, ki vsebuje 300 mg florfenikola na ml raztopine za injiciranje in je namenjeno terapevtskemu zdravljenju okužb dihalnih poti pri govedu, ki jih povzročajo Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
In particular, concerns were raised over the adequacy of the data provided by the Marketing Authorisation Holder on the incidence of bovine respiratory disease (BRD) within an infected herd and as a consequence objections were raised over the proposal to deviate from the default value of 50% specified in CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) as the value for the proportion of infected animals for use in calculation of the Predicted Environmental Concentration in soil (PECsoil).
Zadržki so se pojavili zlasti glede primernosti podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom o pojavnosti respiratorne bolezni goveda v okuženi čredi, posledično pa so se pojavili ugovori na predlog odklona od privzete vrednosti 50 %, ki je določena v smernici CVMP o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL8 in GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) kot vrednost za delež okuženih živali, ki se uporabi za izračun predvidene okoljske koncentracije v tleh (PKOtla).
When such specific information is not available then the default values given in Table 2 of the CVMP guideline in support of VICH guidelines (Guideline on Environmental Impact Aassessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005Rev.1 - also known as the Technical Guidance Document - TGD) should be used.
Kadar tovrstne specifične informacije niso na voljo, je treba uporabiti privzete vrednosti, navedene v razpredelnici 2 smernice CVMP v podporo smernicama VICH (Smernica o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL8 in GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1 - prav tako znane kot dokumenti tehničnih smernic (TGD)).
• Commercial farms (several breeds and age): France - 15.7%, Germany - 20.3%, Italy - 15.2%, Spain - 17.1% (Godinho et al, 20055).
• Komercialne kmetije (več pasem in starosti): Francija - 15,7 %, Nemčija - 20,3 %, Italija
= Number of days of treatment [d] BW = Animal body weight [kgbw] (see Table 3 of the guideline.)
BW = Telesna masa živali [kgtm] (glejte razpredelnico 3 v smernici) P
“Diseases caused by florfenicol susceptible bacteria: therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Hisophilus somni”
„Bolezni, ki jih povzročajo za florfenikol občutljive bakterije: terapevtsko zdravljenje okužb dihalnih poti pri govedu, ki jih povzročajo Mannheimia haemolytica, Pasteurella multocida in Hisophilus somni“.
According to the CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guideline GL6 and GL38 (EMEA/CVMP/ERA/418282/2005Rev.1), complete degradation has to be demonstrated either by total mineralisation or by the presence of degradation products all representing 5% or less of the total dose.
V skladu s smernico CVMP o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) je za dokaz popolnega razkroja potrebna popolna mineralizacija ali prisotnost razkrojnih produktov, ki vsi skupaj predstavljajo 5 % celotnega odmerka ali manj.
The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) indicates that the proportion of animals in the herd which is treated may be available from information in the dossier such as field trial data or from the scientific literature.
Smernica CVMP o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) nakazuje, da je delež zdravljenih živali v čredi lahko na voljo iz informacij v dokumentaciji, kot so podatki terenskih preskušanj ali podatki iz znanstvene literature.
PECsoil = 40 x 1 x 140 x 1.8 x 170 x 0.38 x 1000 =
PKOtla = 40 x 1 x 140 x 1,8 x 170 x 0,38 x 1000 =
The value of the resulting PECsoil determines whether or not a Phase II environmental risk assessment is required.
Vrednost izračunane PKOtla določa, ali je potrebna II.
3 Martin G., Partida E., Villalobos P., López C., López-Guerrero C. and Blanco A. (2007) Evaluation of Mass and Selective Metaphylaxis Medication with Florfenicol at Feedlot entry as a tool against Bovine Respiratory Disease Under Commercial Conditions in Spain.
3 Martin G., Partida E., Villalobos P., López C., López-Guerrero C. in Blanco A. (2007) Evaluation of Mass and
The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL8 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) provides default values for the proportion of animals in a herd which is treated, for use in the calculation of PECsoil.
Smernica CVMP o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL8 in GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) podaja privzete vrednosti za delež živali v zdravljeni čredi, ki ga uporabimo pri izračunu PKOtla.
1500 x 10000 x 0.05 x 35 x 0.5 Dairy cow PECsoil = 40 x 1 x 425 x 1 x 170 x 0.38 x 1000=
1500 x 10000 x 0,05 x 35 x 0,5 Krava molznica PKOtla = 40 x 1 x 425 x 1 x 170 x 0,38 x 1000 =
1500 x 10000 x 0.05 x 18 x 0.5 Cattle (> 2 years) PECsoil = 40 x 1 x 450 x 1 x 170 x 0.38 x 1000=
1500 x 10000 x 0,05 x 18 x 0,5 Govedo (> 2 let) PKOtla = 40 x 1 x 450 x 1 x 170 x 0,38 x 1000 =
1500 x 10000 x 0.05 x 10 x 1 Cattle (0 - 1 year) PECsoil = 40 x 1 x 200 x 1 x 170 x 0.38 x 1000 =
1500 x 10000 x 0,05 x 10 x 1 Govedo (0-1 leta) PKOtla = 40 x 1 x 200 x 1 x 170 x 0,38 x 1000 =
As this is below the Phase II trigger value of 100 µg/kg no Phase II environmental risk assessment is required.
fazo, ki znaša 100 µg/kg, II.
Marixino should be given once a day at the same time every day.
Zdravilo Marixino se daje enkrat dnevno, vsak dan ob istem času.
To prevent side effects, the dose of Marixino is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Da se preprečijo neželeni učinki, se odmerek zdravila Marixino v prvih treh tednih zdravljenja postopoma povečuje: prvi teden je odmerek 5 mg; drugi teden 10 mg, tretji teden pa 15 mg. Od četrtega tedna naprej je priporočeni vzdrževalni odmerek 20 mg enkrat dnevno.
What measures are being taken to ensure the safe and effective use of Marixino?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Marixino?
The name of the medicine was changed to Marixino on 9 August 2013.
Ime zdravila je bilo Dne 9 avgusta 2013 spremenjeno v Marixino.
The full EPAR for Marixino can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Marixino je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
1 Previously known as Maruxa.
Prej znano kot Maruxa.
Marixino is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Marixino je zdravilo, ki se uporablja za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo, tj. vrsto demence (možganske bolezni), ki postopoma prizadene spomin, intelektualno sposobnost in vedenje.
Marixino is a ‘generic medicine'.
Marixino je „generično zdravilo“.
This is a summary of the European public assessment report (EPAR) for Marixino.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Marixino.
The Committee recommended that Marixino be approved for use in the EU.
Priporočil je, da se zdravilo Marixino odobri za uporabo v EU.
What are the benefits and risks of Marixino?
Kakšne so koristi in tveganja, povezani z zdravilom Marixino?
This means that Marixino is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Ebixa.
‘Bioequivalent' means that the medicines are expected to produce the same levels of the active substance in the body.
„Biološko enakovredni“ pomeni, da naj bi zdravili dosegali enake ravni zdravilne učinkovine v telesu.
Marixino is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.
Zdravilo Marixino je na voljo v obliki 10- in 20-miligramskih tablet in se izdaja le na recept.
The company provided data on the medicine's solubility, composition and absorption in the body.
Družba je predstavila podatke o topnosti in sestavi zdravila ter njegovi absorpciji v telesu.
The European Commission granted a marketing authorisation valid throughout the European Union for Maruxa on 29 April 2013.
Evropska komisija je dovoljenje za promet z zdravilom Marixino, veljavno po vsej Evropski uniji, odobrila dne 29. aprila 2013.
Because Marixino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Marixino generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Marixino by the patient.
Zdravljenje se sme uvesti samo, če je na voljo negovalec, ki bo redno spremljal bolnikovo jemanje zdravila Marixino.
It is not intended to provide practical advice on how to use Marixino.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Other information about Marixino
Druge informacije o zdravilu Marixino
It contains the active substance memantine hydrochloride.
Vsebuje zdravilno učinkovino memantinijev klorid.
What is Marixino and what is it used for?
Kaj je zdravilo Marixino in za kaj se uporablja?
No additional studies in patients were required as Marixino was shown to have comparable quality and is considered to be bioequivalent to the reference medicine, Ebixa.
Potrebne niso bile nobene dodatne študije na bolnikih, saj je bilo dokazano, da ima zdravilo Marixino primerljivo raven kakovosti, in se šteje, da je biološko enakovredno referenčnemu zdravilu Ebixa.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Marixino has been shown to have comparable quality and to be bioequivalent to Ebixa.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Marixino primerljivo raven kakovosti kot zdravilo Ebixa ter da mu je biološko enakovredno.
Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease.
Spremenjen način tega, kako glutamat prenaša signale v možganih, je povezan z izgubo spomina, kakršno je opaziti pri Alzheimerjevi bolezni.
For more information about treatment with Marixino, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Marixino preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Why is Marixino approved?
Zakaj je bilo zdravilo Marixino odobreno?
For practical information about using Marixino, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Marixino naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Safety information has been included in the summary of product characteristics and the package leaflet for Marixino, including the appropriate precautions to be followed by healthcare professionals and patients.
V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Marixino so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The active substance in Marixino, memantine, is an antidementia medicine.
Zdravilna učinkovina zdravila Marixino, memantin, je zdravilo za zdravljenje demence.
The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing
oceniti v treh mesecih od začetka zdravljenja, od takrat naprej pa je treba redno ocenjevati koristi zdravljenja z zdravilom Marixino.
How does Marixino work?
Kako zdravilo Marixino deluje?
How has Marixino been studied?
Kako je bilo zdravilo Marixino raziskano?
How is Marixino used?
Kako se zdravilo Marixino uporablja?
The company requested a re-examination of the opinion.
Predlagatelj je zahteval ponovno presojo mnenja.
How does the medicine work?
Kako zdravilo deluje?
What was the medicine expected to be used for?
Za kaj naj bi se zdravilo uporabljalo?
At the time of the initial review, the CHMP had a number of concerns.
Odbor CHMP je že ob prvotnem pregledu imel številne pomisleke.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in 14. septembra 2017 potrdil zavrnitev vloge za pridobitev dovoljenja za promet.
Secondly, at that time, there appeared to be an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care.
Drugič, takrat se je pri bolnikih, ki so jemali zdravilo, pojavilo večje tveganje za okužbo, ki ni ocenjeno kot sprejemljivo pri občutljivih bolnikih, ki bodo prejemali paliativno oskrbo.
Firstly, the study did not show clear improvements in either lean body mass or quality of life.
Prvič, študija ni pokazala jasnega izboljšanja puste telesne mase in kakovosti življenja.