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Prevodi: en > sl
1–18/18
medical guidelines
1 Objavljeno
RS
DRUGO: TRANS
The Helsinki-Tokyo Declaration and the Code of Practice of Medical Workers have served as guidelines for the decisions of the Committee.
Kot osnova za delo je Komisiji služila Helsinško- Tokijska deklaracija in nacionalni Kodeks etike zdravstvenih delavcev.
2 Končna redakcija
CELEX: 32004L0027
Acting in accordance with the guidelines, marketing authorisation holders shall use internationally agreed medical terminology for the reporting of adverse reactions.
V skladu z navodili, imetniki dovoljenj za promet z zdravili za poročanje o neželenih učinkih uporabijo mednarodno sprejeto medicinsko terminologijo.
3 Končna redakcija
CELEX: 32004L0028
in Article 77(1), the second subparagraph shall be replaced by the following:"In accordance with those guidelines, the marketing authorisation holder shall use internationally agreed veterinary medical terminology for the transmission of reports on adverse reactions.
v členu 77(1) se drugi odstavek nadomesti z naslednjim besedilom: "V skladu s temi smernicami imetnik dovoljenja za promet uporablja mednarodno dogovorjeno izrazje veterinarske medicine pri pošiljanju poročil o neželenih škodljivih učinkih.
4 Končna redakcija
CELEX: 32004L0027
In order to facilitate the exchange of information on pharmacovigilance within the Community, the Commission, after consulting the Agency, the Member States and interested parties, shall draw up guidelines on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of pharmacovigilance information in accordance with internationally agreed formats, and shall publish a reference to an internationally agreed medical terminology.
Za lažjo izmenjavo informacij o farmakovigilanci v Skupnosti, Komisija, po posvetovanju z Agencijo, državami članicami in zainteresiranimi strankami, izdela navodila za zbiranje, preverjanje in predstavitev poročil o neželenih učinkih, vključno s tehničnimi zahtevami za elektronsko izmenjavo podatkov o farmakovigilanci v skladu z mednarodno dogovorjenimi oblikami ter objavi napotilo na mednarodno sprejeto medicinsko terminologijo.
5 Pravna redakcija
finance
CELEX: 32003L0063
The safety data shall be reviewed taking into account guidelines published by the Commission, with particular attention to events resulting in changes of dose or need for concomitant medication, serious adverse events, events resulting in withdrawal, and deaths.
Pregledajo se podatki o varnosti ob upoštevanju smernic, ki jih je objavila Komisija, posebna pozornost pa se posveti učinkom, ki so posledica sprememb odmerka ali potrebe po hkratnem zdravljenju, resnim neželenim učinkom, učinkom, ki imajo za posledico umik zdravila in smrti.
6 Prevajalska redakcija
RS
EMEA
The available medical guidelines should also be taken into account.
Upoštevati je treba tudi razpoložljive medicinske smernice.
7 Prevajalska redakcija
RS
EMEA
To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving Soliris and must be re-vaccinated according to current medical guidelines for vaccination use.
Za zmanjšanje tveganja okužbe morajo biti vsi bolniki cepljeni najmanj 2 tedna pred pričetkom jemanja zdravila Soliris ter prejeti obnovitveno cepljenje v skladu z veljavnimi medicinskimi smernicami za cepljenje.
8 Prevajalska redakcija
izobraževanje
CELEX: 31998L0024
Practical guidelines for biological monitoring and medical surveillance must be developed in accordance with Article 12(2).
Praktične smernice za biološko spremljanje in nadzorovanje zdravja je treba oblikovati v skladu s členom12(2).
9 Prevajalska redakcija
RS
EMEA
It must be in line with authoritative international guidelines and supported by evidence published in peer reviewed medical journals.
Program mora biti v skladu z verodostojnimi mednarodnimi smernicami in podprt z navedbami v strokovni medicinski periodiki.
10 Prevajalska redakcija
izobraževanje
CELEX: 32004L0027
Acting in accordance with the guidelines, marketing authorisation holders shall use internationally agreed medical terminology for the reporting of adverse reactions.
V skladu z navodili, imetniki dovoljenj za promet z zdravili za poročanje o neželenih učinkih uporabijo mednarodno sprejeto medicinsko terminologijo.
11 Prevajalska redakcija
izobraževanje
CELEX: 32004L0028
in Article 77(1), the second subparagraph shall be replaced by the following:"In accordance with those guidelines, the marketing authorisation holder shall use internationally agreed veterinary medical terminology for the transmission of reports on adverse reactions.
v členu 77(1) se drugi odstavek nadomesti z naslednjim besedilom: "V skladu s temi smernicami imetnik dovoljenja za promet uporablja mednarodno dogovorjeno izrazje veterinarske medicine pri pošiljanju poročil o neželenih škodljivih učinkih.
12 Prevajalska redakcija
izobraževanje
CELEX: 31992L0029
the captain and any worker or workers to whom he delegates the use of the medical supplies pursuant to Article 4 (1) (b) have received special training updated periodically, at least every five years, taking into account the specific risks and needs connected with the different categories of vessel and in accordance with the general guidelines set out in Annex V.
so kapitan in častniki, na katere kapitan prenese pooblastila za uporabo sanitetnega materiala v skladu s členom 4(1)b posebej usposobljeni in svoje znanje občasno, to je vsaj vsakih pet let, obnavljajo glede na posebna tveganja in potrebe, povezane z različnimi kategorijami ladij in v skladu s splošnimi smernicami, navedenimi v Prilogi V.
13 Prevajalska redakcija
RS
EMEA
The Applicant provided further reassurances on the use of Rapinyl in patiens with mucositis, based on publications and guidelines, concluding that patients with mild/ moderate mucositis can use oral medication, while transmucosal forms of fentanyl are not suitable for use in patients with severe mucositis where other routes of analgesia administration are preferable.
Predlagatelj je ponudil dodatna zagotovila o uporabi zdravila Rapinyl pri bolnikih z mukozitisom, zasnovana na podlagi publikacij in smernic, iz katerih izhaja, da bolniki z rahlim/ zmernim mukozitisom lahko uporabljajo peroralna zdravila, medtem ko oblike fentanila, ki prehajajo skozi sluznico niso primerne za bolnike z močnim mukozitisom in se priporočajo druge oblike dajanja analgetikov.
14 Prevajalska redakcija
izobraževanje
CELEX: 32004L0027
In order to facilitate the exchange of information on pharmacovigilance within the Community, the Commission, after consulting the Agency, the Member States and interested parties, shall draw up guidelines on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of pharmacovigilance information in accordance with internationally agreed formats, and shall publish a reference to an internationally agreed medical terminology.
Za lažjo izmenjavo informacij o farmakovigilanci v Skupnosti, Komisija, po posvetovanju z Agencijo, državami članicami in zainteresiranimi strankami, izdela navodila za zbiranje, preverjanje in predstavitev poročil o neželenih učinkih, vključno s tehničnimi zahtevami za elektronsko izmenjavo podatkov o farmakovigilanci v skladu z mednarodno dogovorjenimi oblikami ter objavi napotilo na mednarodno sprejeto medicinsko terminologijo.
15 Prevajalska redakcija
RS
EMEA
• To submit a Risk Management Plan, according to the current guideline, including: o Detailed strategies for educating physicians including appropriate injection techniques, dosing and lack of interchangeability between products as well as programmes for continued and improved monitoring of spread reactions in clinical use and in clinical trials. o Information on usage patterns and on types of prescribers/ users of Xeomin in order to identify if and at what type of clinics off-label cosmetic use is taking place, especially in the EU. o Steps to be taken to ensure that patients are adequately informed of the safety issues associated with these products, e. g. adequate labelling and patient brochures. Specifically this information should include advice to seek immediate medical help in the event of swallowing, speech or respiratory difficulties arise. o Specifically include toxin spread events in their sentinel list of events for active monitoring. o Evaluation of the spread reactions, specifically as part of future studies. o Commitment to alert the National Competent Authorities if there is a significant change in reporting rate.
• Predložitev načrta za obvladovanje tveganj v skladu z veljavno smernico, vključno s: podrobno strategijo za izobraževanje zdravnikov, ki vključuje ustrezno tehniko injiciranja, o odmerjanje in neobstoj medsebojne zamenljivosti med izdelki, kakor tudi programe za kontinuiran in izboljšan nadzor širjenja pri klinični uporabi in kliničnih preizkušanjih; informacijami o vzorcih uporabe in tipih predpisovalcev/ uporabnikov zdravila Xeomin, da o bi tako identificirali ali in v kakšnem tipu klinik prihaja do " off- label " uporabe (za namene, ki niso navedeni v registraciji zdravila) za kozmetične namene, zlasti v EU; potrebnimi koraki, da bi zagotovili, da so bolniki ustrezno informirani o vidikih varnosti o pri teh izdelkih, npr. ustrezno označevanje in brošure za bolnike; te informacije morajo vključevati izrecen napotek, naj bolniki takoj poiščejo zdravniško pomoč v primeru nastopa težav s požiranjem, govorom ali dihanjem; dogodke, povezane s širjenjem toksina, je treba izrecno vključiti v seznam dogodkov za o aktivno spremljanje; ovrednotenjem reakcij, povezanih s širjenjem, specifično kot del prihodnjih študij; o zavezo k opozorilu pristojnih nacionalnih organov v primeru pomembne spremembe v o pogostosti poročil.
Prevodi: en > sl
1–18/18
medical guidelines