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51–100/833
klinično preskušanje zdravil
51 Pravna redakcija
promet
CELEX: 21999A1009(01)
Direktiva Komisije 91/507/EGS z dne 19. julija 1991 o spremembi priloge k Direktivi Sveta 75/318/EGS o približevanju zakonodaje držav članic v zvezi z analitskimi, farmakotoksikološkimi in kliničnimi standardi in protokoli za preskušanje lastniških zdravil (UL L 270, 26.9.1991, str. 32).
Commission Directive 91/507/EEC of 19 July 1991 modifying the Anenx to Council Directive 75/318/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (OJ L 270, 26.9.1991, p. 32).
52 Pravna redakcija
finance
CELEX: 32003L0063
Kadar je zdravilo predvideno za drugačno terapevtsko uporabo ali je v drugi farmacevtski obliki, ali se bo dajalo po različnih poteh ali v različnih odmerkih ali z različnim odmerjanjem, se predložijo rezultati ustreznih toksikoloških in farmakoloških preskusov in/ali kliničnih preskušanj.
Where a medicinal product is intended for a different therapeutic use or presented in a different pharmaceutical form or to be administered by different routes or in different doses or with a different posology, the results of appropriate toxicological and pharmacological tests and/or of clinical trials shall be provided.
53 Pravna redakcija
promet
CELEX: 22001A1029(01)
Direktiva Komisije 91/507/EGS z dne 19. julija 1991 o spremembi Priloge k Direktivi Sveta 75/318/EGS o približevanju zakonodaj držav članic, ki se nanašajo na analitične, farmakološko-toksikološke in klinične standarde in protokole za preskušanje lastniških zdravil, ter spremembe Direktive
Commission Directive 91/507/EEC of 19 July 1991 modifying the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products and amendments thereto
54 Pravna redakcija
promet
CELEX: 22001A1029(01)
Direktiva Komisije 92/18/EGS z dne 20. marca 1992 o spremembi Priloge k Direktivi Sveta 81/852/EGS o približevanju zakonodaj držav članic, ki se nanašajo na analitične, farmakološko-toksikološke in klinične standarde in protokole za preskušanje veterinarskih zdravil, ter spremembe Direktive
Commission Directive 92/18/EEC of 20 March 1992 modifying the Annex to Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products and amendments thereto
55 Pravna redakcija
DRUGO
Direktiva Sveta z dne 22. decembra 1986, ki spreminja Direktivo 75/318/EGS o približevanju zakonov držav članic v zvezi z analitičnimi, farmakotoksikološkimi in kliničnimi standardi in protokoli pri preskušanju zdravil, ki jih je moč dobiti brez recepta (87/19/EGS) (UL L 15, 17. 1. 1987, str. 31)
Council Directive of 22 December 1986 amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (87/19/EEC) (OJ L 15, 17.1.1987, p. 31)
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ki so bile uvedene z Direktivo Komisije 92/18/EGS z dne 20. marca 1992 o spremembi Priloge k Direktivi Sveta 81/852/EGS o približevanju zakonodaj držav članic v zvezi z analiznimi, farmako-toksikološkimi in kliničnimi standardi ter protokoli za preskušanje zdravil za uporabo v veterinarski medicini;
products introduced by Commission Directive 92/18/EEC of 20 March 1992 modifying the Annex to Council Directive 81/852/EEC on the approximation of laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products;
57 Pravna redakcija
finance
CELEX: 32003L0063
(8) Vsa klinična preskušanja, ki se izvajajo znotraj Evropske skupnosti, morajo izpolnjevati zahteve Direktive 2001/20/ES Evropskega parlamenta in Sveta o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi fn.
(8) All clinical trials, conducted within the European Community, must comply with the requirements of Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(3).
58 Pravna redakcija
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Direktiva Komisije z dne 20. marca 1992, ki spreminja Prilogo k Direktivi Sveta 81/852/EGS o približevanju zakonov držav članic v zvezi z analitičnimi, farmakotoksikološkimi in kliničnimi standardi in protokoli pri preskušanju zdravil za veterinarsko uporabo (92/18/EGS) (UL L 97, 10. 4. 1992, str. 1)
Commission Directive of 20 March 1992 modifying the Annex to Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (92/18/EEC) (OJ L 97, 10.4.1992, p. 1)
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Direktiva Sveta z dne 20. maja 1975 o približevanju zakonov držav članic v zvezi z analitičnimi, farmakotoksikološkimi in kliničnimi standardi in protokoli pri preskušanju zdravil (76/319/EGS), kakor je bila nazadnje spremenjena z Direktivo Sveta 89/341/EGS z dne 3. maja 1989 (UL L 142, 25. 5. 1989, str. 11)
Council Directive of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (76/319/EEC) as last amended by Council Directive 89/341/EEC of 3 May 1989 (OJ L 142, 25.5.1989, p. 11)
60 Pravna redakcija
finance
CELEX: 32003L0063
V glavni dokumentaciji o plazmi se navede seznam zdravil, za katere glavna dokumentacija o plazmi velja, če so zdravila že pridobila dovoljenje za promet ali so v postopku pridobivanja dovoljenja, vključno z zdravili, navedenimi v členu 2 Direktive 2001/20/ES Evropskega parlamenta in sveta o izvajanju dobre klinične prakse pri vodenju kliničnih preskušanj zdravil za ljudi.
In addition, the Plasma Master File shall provide a list of the medicinal products for which the Plasma Master File is valid, whether the medicinal products have been granted a marketing authorisation or are in the process of being granted such an authorisation, including medicinal products referred to in Article 2 of Directive 2001/20/EC of the European Parliament and of the Council relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
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Namen kliničnih preskušanj je dokazati ali podkrepiti učinek zdravila za uporabo v veterinarski medicini po dajanju zdravila v priporočenih odmerkih. S tem se določijo indikacije in kontraindikacije glede na živalsko vrsto, starost, pasmo in spol, navodila za uporabo, škodljivi učinki, ki bi jih proizvod lahko imel ter varnost proizvoda in toleranca v normalnih pogojih uporabe.
The purposes of clinical trials are to demonstrate or substantiate the effect of the veterinary medicinal product after administration of the recommended dosage, to specify its indications and contra-indications according to species, age, breed and sex, its directions for use, any adverse reactions which it may have and its safety and tolerance under normal conditions of use.
62 Pravna redakcija
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Zaželeno je točneje predpisati primere, v katerih za pridobitev dovoljenja za promet z zdravili za uporabo v veterinarski medicini, ki je bistveno podobno inovativnemu zdravilu rezultati farmakoloških in toksikoloških preskusov ali kliničnih preskušanj niso potrebni, pri tem pa je treba zagotoviti, da inovativne oblike niso postavljene v slabši položaj.
It is advisable to stipulate more precisely the cases in which the results of pharmacological and toxicological tests or clinical trials do not have to be provided with a view to obtaining authorization for a veterinary medicinal product which is essentially similar to an innovative product, while ensuring that innovative forms are not placed at a disadvantage.
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finance
CELEX: 32003L0063
Da bi se med ocenjevanjem vloge upoštevala klinična preskušanja, opravljena izven Evropske skupnosti, ki pa se nanašajo na zdravila, predvidena za uporabo v Evropski skupnosti, se ta načrtujejo, izvajajo in se o njih poroča, po katerikoli zadevni dobri klinični praksi in etičnih načelih, na podlagi načel, ki so enakovredna določbam Direktive 2001/20/ES.
To be taken into account during the assessment of an application, clinical trials, conducted outside the European Community, which relate to medicinal products intended to be used in the European Community, shall be designed, implemented and reported on what good clinical practice and ethical principles are concerned, on the basis of principles, which are equivalent to the provisions of Directive 2001/20/EC.
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v primeru novih zdravil za uporabo v veterinarski medicini, ki vsebujejo znane sestavine, ki dotlej v predlagani kombinaciji še niso bile uporabljane za terapevtske namene, je treba predložiti rezultate toksikoloških in farmakoloških preskusov ter kliničnih preskušanj, ki se nanašajo na zadevno kombinacijo, ni pa jih treba predložiti za vsako sestavino posebej.
in the case of new veterinary medicinal products containing known constituents not hitherto used in combination for therapeutic purposes, the results of toxicological and pharmacological tests and of clinical trials relating to that combination must be provided, but it shall not be necessary to provide the relevant documentation for each individual constituent.
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Država članica lahko uvede ali zadrži na svojem ozemlju posebna pravila za farmakološke in toksikološke preskuse ter klinično preskušanje za homeopatska zdravila za uporabo v veterinarski medicini, namenjena hišnim živalim in eksotičnim vrstam, ki niso namenjene za proizvodnjo živil, razen tistih iz člena 17(1), v skladu z načeli in značilnostmi homeopatije, ki se izvajajo v tej državi članici.
A Member State may introduce or retain in its territory specific rules for the pharmacological and toxicological tests and clinical trials of homeopathic veterinary medicinal products intended for pet animals and exotic species which are non food-producing other than those referred to in Article 17(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State.
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ker je pri zdravilih za uporabo v veterini doseženo enako z direktivo Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic v zvezi z zdravili za uporabo v veterini fn ektivo Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic v zvezi z analiznimi, farmakološko-toksikološkimi in kliničnimi standardi in protokoli, ki se nanašajo na preskušanje zdravil za uporabo v veterini fn
Whereas in the case of veterinary medicinal products, the same results have been achieved by Council Directive 81/85 I/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (1) and by Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (2);
67 Pravna redakcija
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ker je treba upoštevati predpise Skupnosti o veterinarskih zdravilih in zlasti Direktivo Sveta 81/851/EGS z dne 28. septembra 1981 o približevanju zakonov držav članic o veterinarskih zdravilih fn in Direktivo Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonov držav članic o analitskih, farmako-toksikoloških in kliničnih standardih ter protokolih o preskušanju veterinarskih zdravil fn, kakor je bila spremenjena z Direktivo 87/20/EGS fn;
Whereas Community rules regarding veterinary medicinal products, and in particular Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of Member States relating to veterinary medicinal products fn, and Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products fn, as amended by Directive 87/20/EEC fn, should be taken into account;
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Glede na nekatere značilnosti teh homeopatskih zdravil za uporabo v veterinarski medicini, kot so nizka raven učinkovin, ki jih vsebujejo ter da je pri teh izdelkih težko uporabljati standardne statistične metode v zvezi s kliničnimi preskušanji, je zaželeno, da se določi poseben, poenostavljen postopek registracije za tista tradicionalna homeopatska zdravila, ki so bila dana v promet brez terapevtskih indikacij, v farmacevtski obliki ter odmerkih, ki ne predstavljajo tveganja za živali.
Having regard to the particular characteristics of these homeopathic veterinary medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials, it is desirable to provide a special, simplified registration procedure for those traditional homeopathic medicinal products which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not present a risk for the animal.
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Za izboljšanje zaščite javnega zdravja je treba jasno navesti, da živila za prehrano ljudi ne smejo izvirati iz živali, ki so bile uporabljene v kliničnih preskušanjih zdravil za uporabo v veterinarski medicini, razen če so najvišje dovoljene količine zaostankov za zaostanke zadevnega zdravila za uporabo v veterinarski medicini določene v skladu z določili Uredbe Sveta (EGS) št. 2377/90 z dne 26. junija 1990 o določitvi postopka Skupnosti za določanje najvišjih dovoljenih količin zaostankov zdravil za uporabo v veterinarski medicini v živilih živalskega izvora( fn ).
In order to improve the protection of public health, it is necessary to specify that foodstuffs for human consumption may not be taken from animals which have been used in clinical trials of veterinary medicinal products unless a maximum residue limit has been laid down for residues of the veterinary medicinal product concerned in accordance with the provisions of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (2).
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ker je treba po znanstveni presoji, ki jo opravi Odbor za zdravila za uporabo v veterinarski medicini, sprejeti najvišje dovoljene količine zaostankov po hitrem postopku, ki zagotavlja tesno sodelovanje med Komisijo in državami članicami v odboru, ustanovljenim na podlagi Direktive Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonodaj držav članic v zvezi z analiznimi, farmako-toksikološkimi in kliničnimi standardi ter protokoli za preskušanje zdravil za uporabo v veterinarski medicini fn, kakor je bila nazadnje spremenjena z Direktivo 87/20/EGS fn;
Whereas, after scientific assessment by the Committee for Veterinary Medicinal Products, maximum residue levels must be adopted by a rapid procedure which ensures close cooperation between the Commission and the Member States through the Committee set up under Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (4), as last amended by Directive 87/20/EEC (5);
71 Pravna redakcija
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ker so pri zdravilih za ljudi merila kakovosti, varnosti in učinkovitosti v znatni meri usklajena z direktivo Sveta 65/65/EGS z dne 26. januarja 1965 o približevanju določb zakonov ali drugih predpisov, ki se nanašajo na zdravila fn ugo direktivo Sveta 75/319/EGS z dne 20. maja 1975 o približevanju določb zakonov in drugih predpisov, ki se nanašajo na lastniška zdravila fn rektivo Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaje držav članic v zvezi z analiznimi farmakološko-toksikološkimi in kliničnimi standardi in protokoli, ki se nanašajo na preskušanje zdravil za uporabo v veterini fn
Whereas, in the case of medicinal products for human use, the criteria of quality, safety and efficacy have been extensively harmonized by Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (5), and the Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation and administrative action relating to proprietary medicinal products (6), and by Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products (7);
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Direktiva Sveta 81/851/EGS z dne 28. septembra 1981 o prilagajanju zakonodaj držav članic, ki se nanaša na zdravila za uporabo v veterinarski medicini( fn ), Direktiva Sveta 81/852/EGS z dne 28. Septembra 1981 o prilagajanju zakonodaj držav članic, ki se nanaša na analitske, farmakološko-toksikološke in klinične standarde ter protokole v zvezi s preskušanjem zdravil za uporabo v veterinarski medicini( fn ), Direktiva Sveta 90/677/EGS z dne 13. decembra 1990 o razširitvi področje uporabe Direktive 81/851/EGS o prilagajanju zakonodaj držav članic, ki se nanaša na zdravila za uporabo v veterinarski medicini in o določitvi dodatnih določb za imunološka zdravila za uporabo v veterinarski medicini( fn ), in Direktiva Sveta 92/74/EGS z dne 22. septembra 1992 o razširitvi področje uporabe Direktive 81/851/EGS o prilagajanju zakonov in drugih predpisov, ki se nanašajo na zdravila za uporabo v veterinarski medicini in ki določa dodatne predpise za homeopatska zdravila za uporabo v veterinarski medicini( fn ), so bile pogosto in znatno spremenjene;
Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (3), Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (4), Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products (5), and Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products (6) have been frequently and substantially amended;
73 Prevajalska redakcija
RS
EMEA
Skladno s smernicami za klinično preskušanje zdravil za hormonsko nadomestno zdravljenje simptomov pomanjkanja estrogena pri ženskah v obdobju postmenopavze (EMEA/ CHMP/ 021/ 97 Rev.
According to the guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women (EMEA/ CHMP/ 021/ 97 Rev.
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EMEA
Klinična preskušanja zdravila Viani pri KOPB
Viani COPD clinical trials
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EMEA
Klinična preskušanja zdravila Seretide pri KOPB
Seretide COPD clinical trials
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EMEA
Incidenco napak z zdravilom v kliničnih preskušanjih.
The incidence of medication errors in clinical trials.
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EMEA
V kliničnih preskušanjih so bolnike zdravili 16 tednov.
In clinical trials patients were treated for 16 weeks.
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EMEA
Varnost zdravila Mycamine so ocenili v kliničnih preskušanjih.
The safety of Mycamine has been assessed in clinical trials.
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EMEA
Klinična preskušanja zdravila Rebetol otrocih in mladostnikih:
Rebetol clinical trials in children and adolescents:
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EMEA
Zdravilo Levitra je v kliničnih preskušanjih jemalo več kot 9500 bolnikov.
Over 9,500 patients have received Levitra in clinical trials.
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EMEA
Zdravilo Vivanza je v kliničnih preskušanjih jemalo več kot 9500 bolnikov.
Over 9,500 patients have received Vivanza in clinical trials.
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EMEA
Preveliko odmerjanje v kliničnih preskušanjih zdravila Macugen ni bilo opisano.
Overdosage with Macugen has not been reported in clinical trials.
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izobraževanje
CELEX: 32001L0020
posameznik, ki sodeluje v kliničnem preskušanju kot prejemnik zdravila v preskušanju ali kot član kontrolne skupine;
an individual who participates in a clinical trial as either a recipient of the investigational medicinal product or a control;
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EMEA
Za indikacijo specifične neželene reakcije na zdravilo v kliničnih preskušanjih
Indication-specific adverse drug reactions from clinical trials
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izobraževanje
CELEX: 32001L0020
Preverjanje skladnosti zdravil v preskušanju z dobro klinično in proizvodno prakso
Verification of compliance of investigational medicinal products with good clinical and manufacturing practice
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EMEA
Klinična preskušanja pri ljudeh niso odkrile z zdravilom izzvanih sprememb na očeh.
However, clinical trials revealed no evidence of drug-induced ocular changes in humans.
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EMEA
Zdravila EMADINE niso raziskovali v kliničnih preskušanjih, daljših od šest tednov.
EMADINE has not been studied in clinical trials beyond six weeks.
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EMEA
V kliničnih preskušanjih za registracijo zdravila Efient zdravilo ni bilo povezano s TTP.
Efient was not associated with TTP in clinical trials supporting registration.
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EMEA
V kliničnih preskušanjih so v enem mesecu aplicirali največ 8 injekcij zdravila Firazyr.
In the clinical trials, not more than 8 injections of Firazyr per month have been administered.
90 Prevajalska redakcija
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EMEA
Zdravilo Thymanax je v kliničnih preskušanjih jemalo več kot 3. 900 bolnikov z depresijo.
In clinical trials, over 3,900 depressed patients have received Thymanax.
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EMEA
Zdravilo Valdoxan je v kliničnih preskušanjih jemalo več kot 3. 900 bolnikov z depresijo.
In clinical trials, over 3,900 depressed patients have received Valdoxan.
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EMEA
V kliničnih preskušanjih so pri uporabi zdravila IDflu opazili naslednje neželene učinke.
During clinical trials, the following side effects were reported with the use of IDflu.
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EMEA
V kliničnih preskušanjih so pri uporabi zdravila INTANZA opazili naslednje neželene učinke.
During clinical trials, the following side effects were reported with the use of INTANZA.
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EMEA
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila MULTAQ?
What are the consequences of the withdrawal for patients undergoing clinical trials with MULTAQ?
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EMEA
Zdravilo Actos so preučevali v raziskavah klinične farmakologije in v kliničnih preskušanjih.
Actos has been studied in clinical pharmacology studies and in clinical trials.
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EMEA
Neželeni učinki, ki so jih opazili v kliničnih preskušanjih z zdravilom Efient, vključujejo:
Side effects seen in clinical trials with Efient include:
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EMEA
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila EXULETT?
What are the consequences of the withdrawal for patients undergoing clinical trials with EXULETT?
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EMEA
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Tygacil?
What are the consequences of the refusal for patients in clinical trials using Tygacil?
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RS
EMEA
Preglednica 2 spodaj prikazuje pogostnost neželenih učinkov zdravila v kliničnih preskušanjih:
The following table 2 provides the frequency of adverse drug reactions in clinical trials:
100 Prevajalska redakcija
RS
EMEA
Na podlagi izsledkov kliničnih preskušanj je priporočljivo zdraviti bolnike vsaj šest mesecev.
Based on the results of clinical trials, it is recommended that patients be treated for at least six months.
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klinično preskušanje zdravil