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1–14/14
associated guidelines
1 Končna redakcija
Guidelines for a risk assessment on FMD threat associated with tourism and transport agreed at the 33rd Session of the European Commission for the Control of FMD (EUFMD)
Smernice za oceno tveganja nevarnosti SIP, povezane s turizmom in prevozom, dogovorjenim na 33. seji Evropske komisije za nadzor slinavke in parkljevke (EUFMD)
2 Končna redakcija
DRUGO: TRANS
Following guidelines of the UN High Commissioner for Refugees, recourse to bad economic conditions to justify deviations from the rule is acceptable only for developing countries - a category which Slovenia, in its eagerness to be accepted by the European Union, did not want to be associated with.
Izgovarjanje na slabe ekonomske razmere, ki naj bi upravičile odstopanje od pravil, je po navodilih Visokega komisariata za begunce sprejemljivo samo v deželah v razvoju - v kategoriji torej, s katero Slovenija, ki si prizadeva priti v Evropsko unijo, noče biti povezana.
3 Pravna redakcija
CELEX: 32003D0578
In addition to the Employment guidelines and their associated Employment recommendations, Member States should fully implement the Broad economic policy guidelines and ensure that the two instruments operate in a consistent way.
Poleg smernic za zaposlovanje in z njimi povezanih priporočil za zaposlovanje, bi morale države članice v celoti izvajati širše smernice gospodarske politike in zagotoviti dosledno delovanje obeh instrumentov.
4 Pravna redakcija
DRUGO
in these guidelines the 'internalisation of costs' means the principle that all costs associated with the protection of the environment should be included in firms' production costs.
v teh smernicah "internalizacija stroškov" pomeni načelo, da je treba vse stroške, povezane z varstvom okolja, vključiti v proizvodne stroške podjetja.
5 Prevajalska redakcija
izobraževanje
CELEX: 32002D0995
The guidelines focus on the threats associated with tourism and transport and on the preparation of an awareness campaign to decrease these risks.
Smernice so osredotočene na nevarnosti, povezane s turizmom in prevozom, in na pripravo akcije ozaveščanja, s katero bi zmanjšali taka tveganja.
6 Prevajalska redakcija
izobraževanje
Guidelines for a risk assessment on FMD threat associated with tourism and transport agreed at the 33rd Session of the European Commission for the Control of FMD (EUFMD)
Smernice za oceno tveganja nevarnosti SIP, povezane s turizmom in prevozom, dogovorjenim na 33. seji Evropske komisije za nadzor slinavke in parkljevke (EUFMD)
7 Prevajalska redakcija
izobraževanje
in these guidelines the "internalisation of costs" means the principle that all costs associated with the protection of the environment should be included in firms' production costs.
v teh smernicah "internalizacija stroškov" pomeni načelo, da je treba vse stroške, povezane z varstvom okolja, vključiti v proizvodne stroške podjetja.
8 Prevajalska redakcija
RS
EMEA
CV prevention The MAH proposed the following wording based on international guidelines: “ Instead of increasing the dose above 5 mg Tritace and associated names daily, the addition of another drug, e. g. of a diuretic or a calcium-antagonist may be considered”.
Kardiovaskularna preventiva Imetnik dovoljenja za promet z zdravilom je na podlagi mednarodnih smernic predlagal naslednje besedilo: „ Namesto povečevanja odmerka nad 5 mg zdravila Tritace in z njim povezanih imen dnevno, je treba preučiti možnost dodajanja drugega zdravila, npr. diuretika ali kalcijevega antagonista “.
9 Prevajalska redakcija
izobraževanje
CELEX: 32000L0059
"ship-generated waste" shall mean all waste, including sewage, and residues other than cargo residues, which are generated during the service of a ship and fall under the scope of Annexes I, IV and V to Marpol 73/78 and cargo-associated waste as defined in the Guidelines for the implementation of Annex V to Marpol 73/78;
"ladijski odpadki" pomenijo vse odpadke, vključno z odplakami, in druge ostanke, ki niso ostanki tovora, ki nastanejo med plovbo ladje ter sodijo na področje uporabe prilog I, IV in V k Marpol 73/78, pa tudi odpadke, povezane s tovorom, kakor so opredeljeni v Smernicah za izvajanje Priloge V k Marpol 73/78;
10 Prevajalska redakcija
RS
EMEA
In assessing the benefit/ risk of Oracea, the current situation of limited treatment options for rosacea was taken into consideration, as well as the fact that Oracea is expected to provide an alternative to the international guidelines recommending off-label use of doxycycline (or other tetracycline derivates) for the treatment of rosacea, with the associated decrease in risk for adverse events.
Pri vrednotenju koristi in tveganj zdravila Oracea je bila upoštevana trenutna situacija omejenih možnosti zdravljenja rozacee ter dejstvo, da se zdravilo Oracea pričakuje kot alternativno mednarodnim smernicam, ki priporočajo uporabo doksiciklina (ali drugih tetraciklinskih derivatov) za rozaceo izven obsega indikacij ob povezanem zmanjšanju tveganja neželenih učinkov.
11 Prevajalska redakcija
RS
EMEA
the documentation submitted, the scientific discussion within the Committee and the new wording proposed in the updated Guideline on SPC dated October 2005 and the latest QRD template, the CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxastad 4 mg prolonged release tablets and associated names (see Annex I).
predlagal vlagatelj, so bili ovrednoteni na podlagi predložene dokumentacije, znanstvene razprave znotraj Odbora in novega besedila, predlaganega v posodobljenih smernicah o SPC iz oktobra 2005 ter zadnje predloge QRD, je CHMP za Doxastad 4 mg tablete s podaljšanim sproščanjem in z njim povezana imena (glejte Dodatek I) priporočil odobritev dovoljenj za promet, za katera so Povzetki glavnih značilnosti zdravila, označevanje in Navodila za uporabo opredeljeni v Dodatku III.
12 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
1–14/14
associated guidelines