Iskalni niz je ali predolg ali pa vsebuje preveč besed.
Prevodi: sl > en
1–20/20
nadzor trga zdravil
1 Pravna redakcija
gospodarstvo
CELEX: 32003D0721
(4) Skladno z Uredbo (ES) št. 999/2001 Evropskega parlamenta in Sveta z dne 22. maja 2001 o predpisih za preprečevanje, nadzor in izkoreninjenje določenih transmisivnih spongiformnih encefalopatij fn, kakor je bila nazadnje spremenjena z Uredbo Komisije (ES) št. 1234/2003 fn, omejitve pri dajanju na trg ne veljajo za kože v smislu Direktive 92/118/EGS, ki se pridobivajo iz zdravih prežvekovalcev in za kolagen, pridobljen iz takih kož.
(4) Under Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies fn, as last amended by Commission Regulation (EC) No 1234/2003 fn, hides and skins within the meaning of Directive 92/118/EEC, derived from healthy ruminants and collagen derived from such hides and skins are not subject to restrictions on placing on the market.
2 Prevajalska redakcija
RS
EMEA
28 V nadzoru po uvedbi zdravila na trg so pri bolnikih, ki so jih zdravili s pemetreksedom, poročali o naslednjih neželenih učinkih:
During post marketing surveillance, the following adverse reactions have been reported in patients treated with pemetrexed:
3 Prevajalska redakcija
RS
EMEA
Program vzorčenja in preizkušanja za zdravila, odobrena po centraliziranem postopku, se bo nadaljeval v letu 2006 z uporabo strokovnega znanja mreže EGP uradnih laboratorijev za nadzor zdravil, ki omogočajo nadzor kakovosti zdravil na trgu EGP.
The sampling and testing programme for centrally authorised products will continue in 2006, using the expertise of the EEA’ s network of official medicines-control laboratories, enabling the quality of medicinal products on the market in the EEA to be controlled.
4 Prevajalska redakcija
RS
EMEA
Redki neželeni učinki, ki so jih opažali v kliničnih preizkušanjih (< 0, 1 %) ali o njih spontano poročali med nadzorom po prihodu zdravila na trg, so:
Rare undesirable effects in clinical trials (< 0.1 %) or spontaneously reported during post-marketing surveillance included:
5 Prevajalska redakcija
RS
EMEA
V kliničnih preskušanjih ni bilo poročano o klinično pomembni aktivaciji komplementa, vendar je med nadzorom po prihodu zdravila na trg poročano o anafilaktičnih reakcijah.
No clinically relevant complement activation was reported in clinical trials but anaphylactic reactions have been reported during post-marketing surveillance.
6 Prevajalska redakcija
RS
EMEA
Zbirka podatkov o varnosti je na prvi pogled omejena, vendar pa niti nadzor po uvedbi zdravila na trg v Ameriki niti preizkušanja niso razkrila nobenih nepričakovanih varnostnih zadržkov.
The safety database seems limited, but no unexpected safety issues have occurred nor in the American post marketing surveillance neither in the trials.
7 Prevajalska redakcija
izobraževanje
CELEX: 31989L0105
ker takšni ukrepi vključujejo neposreden in posreden nadzor cen zdravil kot posledico neustreznosti ali odsotnosti konkurence na trgu zdravil in omejitev obsega izdelkov, ki ga vključujejo nacionalni sistemi zdravstvenega zavarovanja;
whereas such measures include direct and indirect controls on the prices of medicinal products as a consequence of the inadequacy or absence of competition in the medicinal products market and limitations on the range of products covered by national health insurance systems;
8 Prevajalska redakcija
RS
EMEA
c) Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bo material, ki ga bodo prejeli zdravniki, vseboval informacije o programu spremljanja zdravila po dajanju na trg in o programu imunskega nadzora.
c) The MAH will ensure that material provided to physicians provides information on the post-marketing surveillance programme and the immunosurveillance programme.
9 Prevajalska redakcija
RS
EMEA
Podatki iz nadzora po uvedbi na trg pri omejenem številu nosečnic, ki so bile izpostavljene zdravilu, ne kažejo na možnost škodljivih vplivov insulina glargin na nosečnost ali zdravje zarodka in novorojenca.
A limited number of exposed pregnancies from Post Marketing Surveillance indicate no adverse effects of insulin glargine on pregnancy or on the health of the foetus and newborn child.
10 Prevajalska redakcija
RS
EMEA
„ Po doseženem nadzoru epilepsije med dopolnilnim zdravljenjem je mogoče prenehati s sočasno uporabo drugih antiepileptičnih zdravil (AED), zdravljenje bolnikov pa se nadaljuje kot monoterapija z zdravilom trgovsko ime zdravila “.
“ After epileptic control has been achieved during adjunctive therapy, concomitant antiepileptic drugs (AEDs) may be withdrawn and patients continued on Tradename monotherapy”.
11 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Po vzpostavitvi notranjega trga se je mogoče odreči posebnemu nadzoru za zagotavljanje kakovosti zdravil, ki se uvažajo iz tretjih držav samo, če se Skupnost ustrezno dogovori in zagotovi, da bo država izvoznica izvajala potrebni nadzor.
Following the establishment of the internal market, specific controls to guarantee the quality of medicinal products imported from third countries can be waived only if appropriate arrangements have been made by the Community to ensure that the necessary controls are carried out in the exporting country.
12 Prevajalska redakcija
RS
EMEA
Države članice se morajo tudi dogovoriti z imetnikom dovoljenja za promet z zdravili pred lansiranjem zdravila na trg: • o možnosti zbiranja podrobnih podatkov v zvezi z indikacijo, da bi skrbno nadzorovali nenamensko uporabo znotraj nacionalega teritorija; • o vzpostavitvi nacionalnih ukrepov za določanje učinkovitosti in soglasje s PPN- jem.
The Member States should also agree with the MAH prior to the launch of the product: • The feasibility of collecting detailed data relating to the indication in order to monitor closely the off-label use within the national territory. • The set-up of national measures to assess the effectiveness of and compliance with the PPP
13 Prevajalska redakcija
RS
EMEA
Imetnik dovoljenja za promet z zdravili se mora tudi dogovoriti v vsaki državi članici pred lansiranjem zdravila na trg: • o možnosti zbiranja podrobnih podatkov v zvezi z indikacijo, da bi skrbno nadzorovali nenamensko uporabo znotraj nacionalega teritorija; • o vzpostavitvi nacionalnih ukrepov za določanje učinkovitosti in soglasje s PPN- jem.
The MAH should also agree with each Member State prior to the launch of the product: • The feasibility of collecting detailed data relating to the indication in order to monitor closely the off-label use within the national territory • The set-up of national measures to assess the effectiveness of and compliance with the PPP.
14 Prevajalska redakcija
RS
EMEA
Države članice se bodo z imetnikom dovoljenja za promet z zdravilom pred uvedbo zdravila na trg dogovorile o: o najustreznejših strategijah za nadzor nenamenske uporabe zdravila znotraj nacionalnega območja, o zbiranju podrobnih podatkov z vsaj demografijo in indikacijo bolnika, da bi skrbno nadzorovali nenamensko uporabo znotraj nacionalnega območja, o vzpostavitvi nacionalnih ukrepov za določanje učinkovitosti in skladnosti s PPN.
The Member State should agree with the Marketing Authorisation Holder prior to the launch of the product: o The most appropriate strategies to monitor the off label use within national territory o The collection of detailed data with at least patient demographics and indication in order to monitor closely the off-label use within national territory o The set-up of national measures to assess the effectiveness of and compliance with the PPP.
15 Prevajalska redakcija
RS
EMEA
6. Imetnik dovoljenja za promet z zdravilom se mora prav tako v vsaki državi članici pred uvedbo zdravila na trg dogovoriti o: o najustreznejših strategijah za nadzor nenamenske uporabe zdravila znotraj nacionalnega območja, o zbiranju podrobnih podatkov z vsaj demografijo in indikacijo bolnika, da bi skrbno nadzorovali nenamensko uporabo znotraj nacionalnega območja, o vzpostavitvi nacionalnih ukrepov za določanje učinkovitosti in skladnosti s PPN.
16 o The collection of detailed data with at least patient demographics and indication in order to monitor closely the off-label use within national territory o The set-up of national measures to assess the effectiveness of and compliance with the PPP.
16 Prevajalska redakcija
izobraževanje
CELEX: 32003D0721
Skladno z Uredbo (ES) št. 999/2001 Evropskega parlamenta in Sveta z dne 22. maja 2001 o predpisih za preprečevanje, nadzor in izkoreninjenje določenih transmisivnih spongiformnih encefalopatij [6], kakor je bila nazadnje spremenjena z Uredbo Komisije (ES) št. 1234/2003 [7], omejitve pri dajanju na trg ne veljajo za kože v smislu Direktive 92/118/EGS, ki se pridobivajo iz zdravih prežvekovalcev in za kolagen, pridobljen iz takih kož.
Under Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(6), as last amended by Commission Regulation (EC) No 1234/2003(7), hides and skins within the meaning of Directive 92/118/EEC, derived from healthy ruminants and collagen derived from such hides and skins are not subject to restrictions on placing on the market.
17 Prevajalska redakcija
RS
EMEA
Imetnik dovoljenja za promet z zdravilom se mora o podrobnostih sistema za nadzorovani sistem distribucije dogovoriti s pristojnimi nacionalnimi organi in izvajati ta program na nacionalni ravni, da tako zagotovi naslednje: o Pred uvedbo zdravila na trg morajo vsi zdravniki in farmacevti, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, prejeti Pismo za zdravstvene delavce, kot je opisano spodaj; o Pred predpisovanjem prejmejo vsi zdravstveni delavci, ki nameravajo predpisovati (in v skladu z dogovorom s pristojnimi nacionalnimi organi izdajati) zdravilo Thalidomide Celgene, izobraževalni paket za zdravstvene delavce, ki vsebuje naslednje: o Brošura za zdravstvene delavce o Izobraževalne brošure za bolnike o Kartice za bolnike o Povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje
The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that: o Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below. o Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional’ s Kit containing the following: o Healthcare professional booklet o Patient booklets o Patient cards o Summary of Product Characteristics, Package Leaflet and Labelling
18 Prevajalska redakcija
RS
EMEA
Države članice se morajo o podrobnostih sistema za nadzorovano distribucijo dogovoriti z imetnikom dovoljenja za promet z zdravili in izvajati ta program na državni ravni, da tako zagotovi naslednje: • pred lansiranjem zdravila na trg morajo vsi zdravniki, ki nameravajo predpisovati zdravilo Revlimid, in vsi farmacevti, ki bodo izdajali zdravilo Revlimid, prejeti Neposredno obvestilo zdravstvenim delavcem, kot je opisano spodaj; • pred predpisovanjem (kjer je ustrezno, in v skladu s pristojnimi nacionalnimi organi, pred izdajanjem) bodo vsi zdravstveni delavci, ki nameravajo predpisovati (in izdajati) zdravilo Revlimid, prejeli paket s podatki za zdravnike, ki vsebuje naslednje: o izobraževalni paket za zdravstvene delavce, o izobraževalne brošure za bolnike, o kartice bolnika, o povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje.
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare system and must implement such programme nationally to ensure that: • Prior to launch, all doctors who intend to prescribe Revlimid and all pharmacists who may dispense Revlimid receive a Direct Healthcare Professional Communication as described below. • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) Revlimid are provided with a physician information pack containing the following: o Educational Health Care Professional’ s kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SPC) and Package Leaflet and Labelling.
19 Prevajalska redakcija
RS
EMEA
Države članice se morajo z imetnikom dovoljenja za promet z zdravilom dogovoriti o podrobnostih za nadzorovani sistem distribucije v skladu z nacionalno ureditvijo in zdravstvenim sistemom in izvajati ta program na nacionalni ravni ter tako zagotoviti naslednje: o Pred uvedbo zdravila na trg morajo vsi zdravniki in farmacevti, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, prejeti Pismo za zdravstvene delavce, kot je opisano spodaj o Pred predpisovanjem vsi zdravstveni delavci, ki nameravajo predpisovati (in v skladu z dogovorom s pristojnimi nacionalnimi organi izdajati) zdravilo Thalidomide Celgene, prejmejo izobraževalni paket za zdravstvene delavce, ki vsebuje naslednje:
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and must implement such programme nationally to ensure that: o Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below. o Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional’ s Kit containing the following:
20 Prevajalska redakcija
RS
EMEA
Imetnik dovoljenja za promet z zdravili se mora o podrobnostih sistema za nadzorovano distribucijo dogovoriti s pristojnimi nacionalnimi organi in izvajati ta program na državni ravni, da tako zagotovi naslednje: • pred lansiranjem zdravila na trg morajo vsi zdravniki, ki nameravajo predpisovati zdravilo Revlimid, in vsi farmacevti, ki bodo izdajali zdravilo Revlimid, prejeti Neposredno obvestilo zdravstvenim delavcem, kot je opisano spodaj; • pred predpisovanjem (kjer je ustrezno, in v skladu s pristojnimi nacionalnimi organi, pred izdajanjem) bodo vsi zdravstveni delavci, ki nameravajo predpisovati (in izdajati) zdravilo Revlimid, prejeli paket s podatki za zdravnike, ki vsebuje naslednje: o izobraževalni paket za zdravstvene delavce, o izobraževalne brošure za bolnike, o kartice bolnika, o povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje.
The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that: • Prior to launch, all doctors who intend to prescribe Revlimid and all pharmacists who may dispense Revlimid receive a Direct Healthcare Professional Communication as described below. • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) Revlimid are provided with a physician information pack containing the following: o Educational Health Care Professional’s kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SPC) and Package Leaflet and Labelling.
Prevodi: sl > en
1–20/20
nadzor trga zdravil