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comparative trial
51 Pravna redakcija
DRUGO
For the Community comparative trials and tests lasting more than one year the parts of the trials and tests following the first year should, on condition that the necessary appropriations are available, be authorised by the Commission without further reference to the Standing Committee on Propagating Material and Plants of Fruit Genera and Species.
Za primerjalne poskuse in testiranje Skupnosti, ki traja dlje kot eno leto, mora Komisija po prvem letu, če so na voljo potrebna odobrena sredstva, odobriti delno izvajanje poskusov in testiranja brez napotitve k Stalnemu odboru za razmnoževalni material in rastline sadnih rodov in vrst.
52 Pravna redakcija
gospodarstvo
CELEX: 32003D0894
(6) For Community comparative trials and tests lasting more than one year, the parts of the trials and tests following the first year should be authorised by the Commission without further reference to the Standing Committee on Propagating Material and Plants of Fruit Genera and Species, on condition that the necessary appropriations are available.
(6) Pri primerjalnih poskusih in testih Skupnosti, ki trajajo več kot eno leto, odobri dele poskusov in testov po prvem letu Komisija brez nadaljnjega posvetovanja s Stalnim odborom za razmnoževalni material in rastline sadnih rodov in vrst, pod pogojem, da so na razpolago potrebna proračunska sredstva.
53 Pravna redakcija
gospodarstvo
CELEX: 32004D0011
(1) Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC provide for the necessary arrangements to be made by the Commission for Community comparative trials and tests of seed and propagating material.
(1) Direktive 66/401/EGS, 66/402/EGS, 68/193/EGS, 92/33/EGS, 2002/54/ES, 2002/55/ES, 2002/56/ES in 2002/57/ES predvidevajo potrebne postopke, ki jih vzpostavi Komisija za primerjalne poskuse in testiranje semen in razmnoževalnega materiala Skupnosti.
54 Pravna redakcija
gospodarstvo
CELEX: 32004D0059
Having regard to Commission Decision 2001/898/EC of 12 December 2001 setting out the arrangements for Community comparative trials and tests on propagating material of ornamental plants under Council directive 98/56/EC fn, and in particular Article 2 thereof,
ob upoštevanju Odločbe Komisije 2001/898/ES z dne 12. decembra 2001 o postopkih za primerjalne poskuse in testiranje razmnoževalnega materiala okrasnih rastlin Skupnosti v skladu z Direktivo Sveta 98/56/ES fn in zlasti člena 2 Odločbe,
55 Pravna redakcija
gospodarstvo
CELEX: 32004D0060
Having regard to Commission Decision 2002/744/EC of 5 September 2002 setting out the arrangements for Community comparative trials and tests on propagating material of ornamental plants under Council directive 98/56/EC fn, and in particular Article 3 thereof,
ob upoštevanju Odločbe Komisije 2002/744/ES z dne 5. septembra 2002 o postopkih za primerjalne poskuse in testiranje razmnoževalnega materiala okrasnih rastlin Skupnosti po Direktivi Sveta 98/56 / EGS fn in zlasti člena 3 Odločbe,
56 Pravna redakcija
DRUGO
Having regard to Commission Decision 2001/898/EC of 12 December 2001 setting out the arrangements for Community comparative trials and tests on propagating material of ornamental plants under Council Directive 98/56/EC (2), and in particular Article 2 thereof,
ob upoštevanju Odločbe Komisije 2001/898/ES z dne 12.decembra 2001 o postopkih za primerjalne poskuse in testiranje razmnoževalnega materiala okrasnih rastlin v skladu z Direktivo Sveta 98/56/ES fn ter zlasti člena 2,
57 Pravna redakcija
gospodarstvo
CELEX: 32004D0060
Community comparative trials and tests which began in 2003 on propagating material of ornamental plants of Chamaecyparis, Ligustrum vulgare, Euphorbia fulgens and bulbs of flowers ( Narcissus ) shall be continued in 2004 in accordance with Decision 2002/744/EC.
Primerjalni poskusi in testiranja Skupnosti, ki so se začeli leta 2003 z razmnoževalnim materialom okrasnih rastlin Chamaecyparis, Ligustrum vulgare, Euphorbia fulgens in cvetnih čebulic ( Narcissus ), se nadaljujejo v letu 2004 v skladu z Odločbo 2002/744/ES.
58 Pravna redakcija
DRUGO
Commission Decision of 16 December 2002 on the continuation of Community comparative trials and tests on propagating material of ornamental plants of Chamaecyparis, Ligustrum vulgare and Euphorbia fulgens under Council Directive 98/56/EC (Text with EEA relevance)
SKLEP KOMISIJE z dne 16. decembra 2002 o nadaljevanju primerjalnih poskusov in testiranja razmnoževalnega materiala okrasnih rastlin Chamaecyparis, Ligustrum vulgare in Euphorbia fulgens v skladu z Direktivo Sveta 98/56/ES (Besedilo velja za EGP) (2002/982/ES)
59 Pravna redakcija
gospodarstvo
CELEX: 32004D0060
on the continuation in the year 2004 of Community comparative trials and tests on propagating material of ornamental plants of C hamaecyparis, Ligustrum vulgare, Euphorbia fulgens and bulbs of flowers ( Narcissus ) under Council Directive 98/56/EC started in 2003
o nadaljevanju primerjalnih poskusov in testiranja Skupnosti z razmnoževalnim materialom okrasnih rastlin C hamaecyparis, Ligustrum vulgare, Euphorbia fulgens in cvetnih čebulic ( Narcissus ) na podlagi Direktive Sveta 98/56/ES, ki so se začeli leta 2003, v letu 2004
60 Pravna redakcija
gospodarstvo
CELEX: 32003D0865
(8) Member States should participate in the Community comparative trials and tests, in so far as propagating material of the plants concerned are usually reproduced or marketed in their territories, in order to ensure that proper conclusions may be drawn therefrom.
(8) Države članice bi morale sodelovati pri primerjalnih poskusih in testih Skupnosti, če se razmnoževalni material zadevnih rastlin običajno razmnožuje ali trži na njihovem ozemlju, da se zagotovi pridobitev pravilnih ugotovitev na tej podlagi.
61 Pravna redakcija
gospodarstvo
CELEX: 32004D0011
(5) For Community comparative trials and tests lasting more than one year, the parts of the trials and tests following the first year should be authorised by the Commission without further reference to the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, on condition that the necessary appropriations are available.
(5) Za primerjalne poskuse in testiranja Skupnosti, ki trajajo več kakor eno leto, bi morala Komisija dele poskusov in testiranj, ki potekajo po prvem letu, odobriti brez nadaljnjega sklicevanja na Stalni odbor za seme in razmnoževalni material za poljedelstvo, vrtnarstvo in gozdarstvo pod pogojem, da so na voljo potrebna proračunska sredstva.
62 Pravna redakcija
gospodarstvo
CELEX: 32004D0056
Having regard to Commission Decision 2001/896/EC of 12 December 2001 setting out the arrangements for Community comparative trials and tests on propagating and planting material of fruit plants under Council directive 92/34/EEC fn, and in particular Article 2 thereof,
ob upoštevanju Odločbe Komisije 2001/896/ES z dne 12. decembra 2001 o postopkih za primerjalne poskuse in testiranje razmnoževalnega in sadilnega materiala sadnih rastlin Skupnosti v skladu z Direktivo Sveta 92/34/EGS fn in zlasti člena 2 Odločbe,
63 Pravna redakcija
gospodarstvo
CELEX: 32004D0058
Having regard to Commission Decision 2002/745/EC of 5 September 2002 setting out the arrangements for Community comparative trials and tests on propagating and planting material of fruit plants under Council directive 92/34/EEC fn, and in particular Article 3 thereof,
ob upoštevanju Odločbe Komisije 2002/745/ES z dne 5. septembra 2002 o postopkih za primerjalne poskuse in testiranje razmnoževalnega in sadilnega materiala sadnih rastlin Skupnosti po Direktivi Sveta 92/34 / EGS fn in zlasti člena 3 Odločbe,
64 Pravna redakcija
gospodarstvo
CELEX: 32004D0060
(1) Decision 2002/744/EC sets out the arrangements for the comparative trials and tests to be carried out under Directive 98/56/EC as regards ornamental plants of Chamaecyparis, Ligustrum vulgare, Euphorbia fulgens and bulbs of flowers ( Narcissus ) from 2003 to 2005.
(1) Odločba 2002/744/ES določa postopke primerjalnih poskusov in testiranja, ki jih je treba opraviti na podlagi Direktive 98/56/ES v zvezi z okrasnimi rastlinami Chamaecyparis, Ligustrum vulgare, Euphorbia fulgens in cvetnimi čebulicami ( Narcissus ) v letih 2003 do 2005.
65 Pravna redakcija
DRUGO
Member States should participate in the Community comparative trials and tests, in so far as propagating and planting material of Prunus domestica are usually reproduced or marketed in their territories, in order to ensure that proper conclusions may be drawn therefrom.
Države članice bi morale sodelovati v primerjalnih poskusih in testiranju Skupnosti, če je na njihovih ozemljih ustaljeno razmnoževanje ali trženje razmnoževalnega ali sadilnega materiala vrste domača sliva ( Prunus domestica), da se zagotovi pridobitev pravilnih ugotovitev na tej podlagi.
66 Pravna redakcija
gospodarstvo
CELEX: 32003D0894
(8) Member States should participate in the Community comparative trials and tests, in so far as propagating and planting material of the plants concerned are usually reproduced or marketed in their territories, in order to ensure that proper conclusions may be drawn therefrom.
(8) Države članice bi morale sodelovati v primerjalnih poskusih in testih Skupnosti, če se razmnoževalni in sadilni material zadevnih rastlin običajno razmnožuje ali trži na njihovem ozemlju, da se zagotovi pridobitev pravilnih ugotovitev na tej podlagi.
67 Pravna redakcija
DRUGO
Whereas, in order to harmonise technical methods of examination used in the Member States and to compare propagating material produced in the Community with those produced in third countries, comparative trials should be carried out to check compliance of propagating material with the requirements of this Directive;
ker bi bilo treba za uskladitev tehničnih metod preizkušanja, ki jih uporabljajo države članice, in za primerjanje razmnoževalnega materiala, pridelanega v Skupnosti, s tistim, ki je pridelan v tretjih državah, izvesti primerjalne poskuse, s katerimi bi preverili skladnost teh proizvodov z zahtevami te direktive;
68 Pravna redakcija
gospodarstvo
CELEX: 32004D0011
setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants of agricultural and vegetable species and vine under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC for the years 2004 and 2005
o določitvi postopkov Skupnosti za primerjalne poskuse in testiranje semena in razmnoževalnega materiala nekaterih sort poljščin in zelenjadnic ter trte v skladu z direktivami Sveta 66/401/EGS, 66/402/EGS, 68/193/EGS, 92/33/EGS, 2002/54/ES, 2002/55/ES, 2002/56/ES in 2002/57/ES za leti 2004 in 2005
69 Pravna redakcija
gospodarstvo
CELEX: 32004D0057
on the continuation in the year 2004 of Community comparative trials and tests on seeds and propagating material of gramineae, Triticum aestivum, Brassica napus and Allium ascalonicum under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC started in 2003
o nadaljevanju v letu 2004 izvajanja primerjalnih poskusov Skupnosti ter testiranja semena in razmnoževalnega materiala trav, Triticum aestivum, Brassica napus in Allium ascalonicum v okviru direktiv Sveta 66/401/EGS, 66/402/EGS, 68/193/EGS, 92/33/EGS, 2002/54/ES, 2002/55/ES, 2002/56/ES in 2002/57/ES, začetimi leta 2003
70 Pravna redakcija
promet
CELEX: 22003D0003
Commission Decision 2001/897/EC of 12 December 2001 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants under Council Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 68/193/EEC, 69/208/EEC, 70/458/EEC and 92/33/EEC (OJ L 331, 15.12.2001, p. 97).
Sklep Komisije 2001/897/ES z dne 12. decembra 2001 o doloeitvi režimov za primerjalne poskuse in teste semen in sadilnega materiala doloeenih rastlin v skladu z Direktivami Sveta 66/400/EGS, 66/401/EGS, 66/402/EGS, 66/403/EGS, 68/193/EGS, 69/208/EGS, 70/458/EGS in 92/33/EGS (UL L 331, 15.12.2001, str.97).
71 Pravna redakcija
promet
CELEX: 22003D0040
Commission Decision 2002/756/EC of 16 September 2002 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/ EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC (OJ L 252, 20.9.2002, p. 33).
Odločba Komisije 2002/756/ES z dne 16. septembra 2002 o postopkih Skupnosti za primerjalne poskuse in testiranje semen in razmnoževalnega materiala okrasnih rastlin v skladu z Direktivami Sveta 66/401/EGS, 66/402/EGS, 68/193/EGS, 92/33/EGS, 2002/54/ES, 2002/55/ES, 2002/56/ES in 2002/57/ES (UL L 252, 20. 9. 2002, str. 33).
72 Pravna redakcija
promet
CELEX: 22003D0003
Commission Decision 2001/897/EC of 12 December 2001 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants under Council Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 68/193/EEC, 69/208/EEC, 70/458/EEC and 92/33/EEC fn is to be incorporated into the Agreement.
Odloeba Komisije 2001/897/ES z dne 12. decembra 2001 o režimih za primerjalne poskuse in teste semen in sadilni material doloeenih rastlin v skladu z Direktivami Sveta 66/400/EGS, 66/401/EGS, 66/402/EGS, 66/403/EGS, 68/193/EGS, 69/208/EGS, 70/458/EGS in 92/33/EGS fn, se vkljuei v Sporazum.
73 Pravna redakcija
DRUGO
Whereas, in order to harmonize technical methods of examination used in the Member States and to compare propagating and planting material and vegetable plants produced in the Community with that produced in third countries, comparative trials should be carried out to check compliance of such products with the requirements of this Directive;
ker bi bilo treba za uskladitev tehničnih metod preizkušanja, ki jih uporabljajo države članice, in za primerjanje razmnoževalnega in sadilnega materiala zelenjadnic, pridelanega v Skupnosti, s tistim, ki je pridelan v tretjih državah, izvesti primerjalne poskuse, s katerimi bi preverili skladnost teh proizvodov z zahtevami te direktive;
74 Pravna redakcija
promet
CELEX: 22003D0040
Commission Decision 2002/756/EC of 16 September 2002 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC( fn ) is to be incorporated into the Agreement.
Odločbo Komisije 2002/756/ES z dne 16. septembra 2002 o postopkih Skupnosti za primerjalne poskuse in testiranje semen in razmnoževalnega materiala okrasnih rastlin v skladu z Direktivami Sveta 66/401/EGS, 66/402/EGS, 68/193/EGS, 92/33/EGS, 2002/54/ES, 2002/55/ES, 2002/56/ES in 2002/57/ES( fn ) je treba vključiti v Sporazum.
75 Pravna redakcija
gospodarstvo
CELEX: 32004D0057
Having regard to Commission Decision 2002/756/EC of 16 September 2002 setting out the arrangements for Community comparative trials and tests on seeds and propagating material of certain plants under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC fn, and in particular Article 4 thereof,
ob upoštevanju Odločbe Komisije 2002/756/ES z dne 16. septembra 2002 o določitvi postopkov Skupnosti za primerjalne poskuse in testiranje semen in razmnoževalnega materiala določenih sort rastlin v skladu z direktivami Sveta 66/401/EGS, 66/402/EGS, 68/193/EGS, 92/33/EGS, 2002/54/ES, 2002/55/ES, 2002/56/ES in 2002/57/ES fn in zlasti člena 4 Odločbe,
76 Pravna redakcija
DRUGO
Commission Decision of 16 December 2002 on the continuation of Community comparative trials and tests on seeds and propagating material of gramineae, Triticum aestivum, Vitis vinifera, Brassica napus and Allium ascalonicum under Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/33/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC (Text with EEA relevance)
SKLEP KOMISIJE z dne 16. decembra 2002 o nadaljevanju programa Skupnosti za primerjalne poskuse in testiranja semen in razmnoževalnega materiala trav, Triticum aestivum, Vitis vinifera, Brassica napus in Allium ascalonicum, na podlagi direktiv Sveta 66/401/EGS, 66/402/EGS, 68/193/EGS, 92/33/EGS, 2002/54/ES, 2002/55/ES, 2002/56/ES in 2002/57/ES (Besedilo velja za EGP) (2002/984/ES)
77 Pravna redakcija
DRUGO
Whereas the reference laboratory will build up, store and supply when necessary to the national laboratories, diagnostic agents so that diagnosis in the said national laboratories is carried out in a uniform manner; whereas the reference laboratory must organize comparative trials, carry out further training of experts, and develop data and information systems for the use of the Commission and the Member States;
ker bo referenčni laboratorij razvijal, shranjeval in po potrebi dobavljal diagnostične agense nacionalnim laboratorijem, da bi se diagnoza v navedenih nacionalnih laboratorijih izvajala enotno; ker mora referenčni laboratorij organizirati primerjalne poskuse, izvajati izpopolnjevanje strokovnjakov ter razvijati podatkovne in informacijske sisteme, ki jih bodo uporabljali Komisija in države članice;
78 Pravna redakcija
promet
CELEX: 22004D0017
(2) Council Directive 2003/61/EC of 18 June 2003 amending Directives 66/401/EEC on the marketing of fodder plant seed, 66/402/EEC on the marketing of cereal seed, 68/193/EEC on the marketing of material for the vegetative propagation of the vine, 92/33/EEC on the marketing of vegetable propagating and planting material, other than seed, 92/34/EEC on the marketing of propagating and planting material of fruit plants, 98/56/EC on the marketing of propagating material of ornamental plants, 2002/54/EC on the marketing of beet seed, 2002/55/EC on the marketing of vegetable seed, 2002/56/EC on the marketing of seed potatoes and 2002/57/EC on the marketing of seed of oil and fibre plants as regards Community comparative tests and trials fn is to be incorporated into the Agreement.
(2) Direktivo Sveta 2003/61/ES z dne 18. junija 2003 o spremembi Direktiv 66/401/EGS o trženju semena krmnih rastlin, 66/402/EGS o trženju semena žit, 68/193/EGS o trženju materiala za vegetativno razmnoževanje vinske trte, 92/33/EGS o trženju razmnoževalnega in sadilnega materiala zelenjadnic, razen semena, 92/34/EGS o trženju razmnoževalnega in sadilnega materiala sadnih rastlin98/56/ES o trženju razmnoževalnega materiala okrasnih rastlin, 2002/54/ES o trženju semena pese, 2002/55/ES o trženju semena zelenjadnic, 2002/56/ES o trženju semenskega krompirja in 2002/57/ES o trženju semena oljnic in predivnic, glede primerjalnih testov in poskusov Skupnosti fn je treba vključiti v Sporazum.
79 Prevajalska redakcija
RS
EMEA
One randomized non-comparative trial was conducted in chronic phase patients who failed initial treatment with 400 or 600 mg imatinib.
Pri bolnikih v kroničnem obdobju, ki se na začetno zdravljenje z imatinibom v odmerku 400 mg ali 600 mg niso odzvali, je bilo izvedeno eno randomizirano neprimerjalno preskušanje.
80 Prevajalska redakcija
RS
EMEA
In a 12-week comparative trial in stable patients with schizophrenia, RISPERDAL CONSTA was shown to be as effective as the oral tablet formulation.
31 12- tedensko primerjalno preskušanje, v katerem so sodelovali stabilni bolniki s shizofrenijo, pa je pokazalo, da je zdravilo RISPERDAL CONSTA enako učinkovito kot peroralne tablete.
81 Prevajalska redakcija
RS
EMEA
In the non-comparative trial, the PFS at 6 months was 19 %, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
V neprimerjalnem preskušanju je bil PFS po 6 mesecih 19 %, mediana vrednost PFS 2, 1 meseca in mediana vrednost celotnega preživetja 5, 4 mesecev.
82 Prevajalska redakcija
RS
EMEA
One was a non-comparative trial in 138 patients (29 % received prior chemotherapy), and the other was a randomised active-controlled trial of TMZ vs procarbazine in a total of 225 patients (67 % received prior treatment with nitrosourea based chemotherapy).
Eno je bilo neprimerjalno preskušanje pri 138 bolnikih (29 % jih je pred tem že prejemalo kemoterapijo), drugo pa randomizirano, z učinkovino nadzorovano kontrolirano preskušanje TMZ in prokarbazina pri skupaj 225 bolnikih (67 % jih je pred tem že prejemalo kemoterapijo na osnovi nitrozouree).
83 Prevajalska redakcija
izobraževanje
CELEX: 32003L0061
The comparative tests and trials may include the following:
Primerjalno testi in poskusi lahko obsegajo:
84 Prevajalska redakcija
RS
EMEA
The safety and efficacy of MabCampath were evaluated in a Phase 3, open-label, randomized comparative trial of first line (previously untreated) Rai stage I-IV B-CLL patients requiring therapy (Study 4).
Ocena varnosti in učinkovitosti zdravila MabCampath je bila narejena pri randomiziranih predhodno nezdravljenih bolnikih s stadijem bolezni po Raiju I- IV B- KLL v 3. fazi, ki potrebujejo zdravljenje (4. študija).
85 Prevajalska redakcija
RS
EMEA
In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received PegIntron, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
V neporovnávacom skúšaní 235 pacientov s genotypom 1 a nízkou záťažou vírusom (< 600 000 IU/ ml) dostávalo PegIntron 1, 5 mikrogramu/ kg subkutánne raz týždenne v kombinácii s ribavirínom v dávke upravenej podľa telesnej hmotnosti.
86 Prevajalska redakcija
RS
EMEA
17 In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
V neprimerjalnem preskušanju je 235 bolnikov, ki so bili okuženi z virusom genotipa 1 in so imeli majhno virusno obremenitev (< 600. 000 i. e. / ml), prejemalo ViraferonPeg v odmerku 1, 5 mikrograma/ kg subkutano enkrat na teden, v kombinaciji z ribavirinom v odmerku, izračunanem glede na telesno maso.
87 Prevajalska redakcija
RS
EMEA
In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received peginterferon alfa-2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted Rebetol.
V neprimerjalnem preskušanju je 235 bolnikov, ki so bili okuženi z virusom genotipa 1 in so imeli majhno virusno obremenitev (< 600. 000 i. e. / ml), prejemalo peginterferon alfa- 2b v odmerku 1, 5 mikrograma/ kg subkutano enkrat na teden, v kombinaciji z zdravilom Rebetol v odmerku, izračunanem glede na telesno maso.
88 Prevajalska redakcija
RS
EMEA
In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ ml) received peginterferon alfa-2b, 1.5 microgram/ kg subcutaneously, once weekly, in combination with weight adjusted Ribavirin.
V neprimerjalnem preskušanju je 235 bolnikov, ki so bili okuženi z virusom genotipa 1 in so imeli majhno virusno obremenitev (< 600. 000 i. e. / ml), prejemalo peginterferon alfa- 2b v odmerku 1, 5 mikrograma/ kg subkutano enkrat na teden, v kombinaciji z ribavirinom v odmerku, izračunanem glede na telesno maso.
89 Prevajalska redakcija
RS
EMEA
In this comparative trial the seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
V tem primerjalnem preskušanju so ocenili stopnjo serozaščite *, serokonverzijo ali značilne stopnje povečanja ** in razmerje geometričnega povprečja titrov (GMTR) za protitelesa anti- HA (izmerjeno z uporabo metode HI) v skladu s predhodno opredeljenimi kriteriji.
90 Prevajalska redakcija
izobraževanje
CELEX: 32000R0847
In some cases direct comparative clinical trials will be necessary;
V nekaterih primerih bodo potrebni neposredni primerjalni klinični preskusi;
91 Prevajalska redakcija
RS
EMEA
In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
V tem primerjalnem preskušanju so ocenili geometrično povprečje titra (GMTs), stopnjo serozaščite *, serokonverzijo ali značilne stopnje povečanja ** in razmerje geometričnega povprečja titrov (GMTR) za protitelesa anti- HA (izmerjeno z uporabo metode HI) v skladu s predhodno opredeljenimi kriteriji.
92 Prevajalska redakcija
RS
EMEA
In this comparative trial against an egg-derived influenza vaccine the seroprotection rate*, seroconversion or significant increase rate** and the geometric mean ratio (GMR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
V tem primerjalnem preskušanju s cepivom, pridobljenim iz jajc, so bili stopnja serološke zaščite *, stopnja serološke konverzije ali pomembnega povečanja ** in razmerje geometrične srednje vrednosti (GMR – Geometric Mean Ratio) za protitelesa proti HA (izmerjeno z inhibicijo hemaglutinina) ocenjeni glede na predhodno določene kriterije.
93 Prevajalska redakcija
RS
EMEA
In a comparative trial in subjects aged 1-11 years, the incidences of local and general solicited symptoms in the Ambirix group were similar to those seen with the three-dose combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
V primerjalnem preskušanju pri osebah, starih od 1 do 11 let, je bila incidenca lokalnih in generaliziranih simptomov v skupini, ki je prejemala Ambirix, podobna tisti po prejemu treh odmerkov kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
94 Prevajalska redakcija
RS
EMEA
PegIntron/ribavirin retreatment of prior treatment failures In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with PegIntron, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Opakovaná liečba PegIntronom/ ribavirinom po zlyhaniach predchádzajúcej liečby V rámci nekomparatívneho skúšania bolo 2 293 pacientov so stredne závažnou až závažnou fibrózou, u ktorých zlyhala predchádzajúca liečba kombináciou alfa interferónu s ribavirinom, opakovane liečených podkožne aplikovaným PegIntronom v dávke 1, 5 mikrogramu/ kg 1x týždenne v kombinácii s ribavirinom, ktorého dávka bola upravená podľa telesnej hmotnosti.
95 Prevajalska redakcija
RS
EMEA
ViraferonPeg/ribavirin retreatment of prior treatment failures In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Ponovno zdravljenje z zdravilom ViraferonPeg in ribavirinom po predhodno neuspešnem zdravljenju V neprimerjalnem preskušanju so skupaj 2293 bolnikov z zmerno do hudo fibrozo, pri katerih je bilo predhodno zdravljenje s kombinacijo interferona alfa in ribavirina neuspešno, ponovno zdravili z zdravilom ViraferonPeg v odmerku 1, 5 mikrograma/ kg enkrat na teden subkutano, v kombinaciji z ribavirinom v odmerku, odvisnem od bolnikove telesne mase.
96 Prevajalska redakcija
izobraževanje
CELEX: 31998D0320
The details shall be determined in the respective technical protocols for the Community comparative trials.
Podrobnosti se določijo v ustreznih strokovnih protokolih za primerjalne poskuse Skupnosti.
97 Prevajalska redakcija
RS
EMEA
In one comparative trial, combination therapy with nucleoside analogues (triple therapy with zidovudine plus didanosine) conferred protection against the selection of virus expressing at least one resistance– 20 associated amino acid substitution to both indinavir (from 13/ 24 to 2/ 20 at therapy week 24) and to the nucleoside analogues (from 10/ 16 to 0/ 20 at therapy week 24).
V primerjalni raziskavi je kombinirano zdravljenje z nukleozidnimi analogi (trojno zdravljenje z zidovudinom in didanozinom) potrdilo zaščito pred selekcijo virusa, ki ima izraženo vsaj eno aminokislinsko substitucijo, povezano z rezistenco na indinavir (od 13/ 24 do 2/ 20 v 24. tednu zdravljenja) in na nukleozidne analoge (od 10/ 16 do 0/ 20 v 24. tednu zdravljenja).
98 Prevajalska redakcija
izobraževanje
CELEX: 32002D0280
It is also still collecting data on the samples supplied by the Member States and tested in Community comparative trials.
Še vedno tudi zbira podatke o vzorcih, ki so jih dostavile države članice in so se v Skupnosti preizkušali v primerjalnih poskusih.
99 Prevajalska redakcija
RS
EMEA
Previous treatment failure patients Retreatment of prior treatment failures (relapse and non-responder patients) with peginterferon alfa- 2b in combination with Rebetol In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with peginterferon alfa 2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted Rebetol.
Bolniki, pri katerih je bilo prejšnje zdravljenje neuspešno Ponovno zdravljenje s peginterferonom alfa- 2b v kombinaciji z zdravilom Rebetol v primeru neuspešnega prejšnjega zdravljenja (za bolnike s ponovitvijo bolezni in tiste, ki se niso odzvali na predhodno terapijo) V neprimerjalnem preskušanju so skupaj 2293 bolnikov z zmerno do hudo fibrozo, pri katerih je bilo predhodno zdravljenje s kombinacijo interferona alfa in ribavirina neuspešno, ponovno zdravili s peginterferonom alfa- 2b v odmerku 1, 5 mikrograma/ kg enkrat na teden subkutano, v kombinaciji z zdravilom Rebetol v odmerku, odvisnem od bolnikove telesne mase.
100 Prevajalska redakcija
izobraževanje
CELEX: 32002D0745
Community comparative trials and tests shall be carried out from 2003 to 2007 on propagating and planting material of Prunus domestica.
Primerjalni poskusi in testiranje Skupnosti se izvajajo v letih 2003 do 2007 na razmnoževalnem in sadilnem materialu Prunus domestica.
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