natgillin/translations-raw huggingface dataset:
When it was added to paclitaxel, the average progression-free survival was 11.4 months, compared with 5.8 months in those receiving paclitaxel alone.
Če je bilo zdravilo dodano paklitakselu, je povprečni čas brez napredovanja bolezni znašal 11,4 meseca, v primerjavi s 5,8 meseca pri tistih, ki so jemali samo paklitaksel.
When it was compared with dolasetron, these values were 63% for Aloxi (119 patients out of 189) and 53% for dolasetron (101 patients out of 191).
Primerjava z dolasetronom je pokazala, da ta vrednost znaša 63 % za zdravilo Aloxi (119 bolnikov od 189) oziroma 53 % za dolasetron (101 bolnik od 191).
When it was used in combination with ribavirin in adults, Pegasys was more effective than when it was used on its own (45% responders at follow-up compared with 24%), and was as effective as the combination of interferon alfa-2a and ribavirin (39% responders).
Zdravilo Pegasys je bilo pri uporabi v kombinaciji z ribavirinom učinkovitejše kot pri samostojni uporabi (45 % odzivnih bolnikov ob kontrolnem pregledu v primerjavi s 24 %) ter je bilo najmanj tako učinkovito kot kombinacija interferona alfa-2a in ribavirina (39 % odzivnih bolnikov).
When Jakavi is administered with strong CYP3A4 inhibitors or dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole) the unit dose of Jakavi should be reduced by approximately 50%, to be administered twice daily (see section 4.5).
Pri sočasnem odmerjanju zdravila Jakavi z močnimi zaviralci CYP3A4 ali z dvojnimi zaviralci CYP2C9 in CYP3A4 (na primer s flukonazolom), je treba posamezen odmerek zdravila Jakavi znižati za približno 50 % in ga odmerjati dvakrat na dan (glejte poglavje 4.5).
When judged necessary, the doctor may monitor the level of caffeine in the baby’s blood and adjust the dose accordingly.
Zdravnik se lahko po potrebi odloči nadzirati ravni kofeina v krvi novorojenčka in skladno z njimi prilagajati odmerke.
When Keppra is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Kadar se zdravilo Keppra uporablja kot samostojno zdravilo, je začetni odmerek 250 mg dvakrat na dan, ki se dva tedna pozneje poveča na 500 mg dvakrat na dan.
When laboratory abnormalities and adverse reactions were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic reactions were observed in 8% of the patients.
Ko so bile laboratorijske nenormalnosti in neželeni dogodki združeni po fazi sočasnega zdravljenja in fazi monoterapije, so bile pri 8 % bolnikov opažene anomalije nevtrofilcev stopnje 3 ali 4, vključno z nevtropeničnimi dogodki.
When lamivudine therapy was continued post transplantation there was reduced graft re-infection by HBV, increased HBsAg loss and on one-year survival rate of 76 – 100 %.
Če se je zdravljenje z lamivudinom nadaljevalo po transplantaciji, je prišlo do zmanjšanja reinfekcij presadka s HBV, izginotje HBsAg je poraslo, stopnja enoletnega preživetja pa je bila med 76 in 100 %.
When lamivudine therapy was continued post transplantation there was reduced graft re-infection by HBV, increased HBsAg loss and on one-year survival rate of 76-100 %.
Če se je zdravljenje z lamivudinom nadaljevalo po presaditvi, se je stopnja reinfekcij presadka z virusom HBV zmanjšala, izginotje HBsAg je naraslo, stopnja enoletnega preživetja pa je bila med 76 in 100 %.
When lamivudine was discontinued, the majority of patients (70 %) had a return of viral replication.
Pri večini bolnikov (70 %) se je po ukinitvi zdravljenja z lamivudinom ponovila virusna replikacija.
When Letifend is given to dogs the immune system recognises the Leishmania protein as ‘foreign’ and makes defences against it.
Ko pes prejme zdravilo Letifend, imunski sistem prepozna protein parazita Leishmania kot tujek in proti njemu tvori protitelesa.
When Levemir is used as part of a basal-bolus insulin regimen Levemir should be administered once or twice daily depending on patients’ needs.
Če je zdravilo Levemir uporabljeno kot del bazalno-bolusne sheme zdravljenja z insulinom, ga je treba aplicirati enkrat ali dvakrat na dan, odvisno od bolnikovih potreb.
When Levemir is used as part of a basal-bolus insulin regimen, Levemir should be administered once or twice daily depending on patients’ needs.
Če je zdravilo Levemir uporabljeno kot del bazalno-bolusne sheme zdravljenja z insulinom, ga je treba aplicirati enkrat ali dvakrat na dan, odvisno od bolnikovih potreb.
When Levetiracetam Hospira is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Kadar se zdravilo Levetiracetam Hospira uporablja samostojno, je začetni odmerek 250 mg dvakrat na dan, ki se dva tedna pozneje poveča na 500 mg dvakrat na dan.
When linagliptin and metformin were administered in combination with a sulphonylurea, hypoglycaemia was the most frequently reported adverse event (linagliptin plus metformin plus sulphonylurea 23.9% and 16.0% in placebo plus metformin plus sulphonylurea).
Če so linagliptin in metformin dajali v kombinaciji s sulfonilsečnino, je bila hipoglikemija najpogostnejši neželeni dogodek, o katerem so poročali (linagliptin, metformin in sulfonilsečnina 23,9 % in 16,0 % pri placebu, metforminu in sulfonilsečnini).
When linagliptin and metformin were administered in combination with insulin, constipation was identified as an additional adverse reaction under these conditions.
Če so linagliptin in metformin dajali v kombinaciji z insulinom, je bilo v teh pogojih zaprtje opredeljeno kot dodatni neželeni učinek.
When lomitapide 60 mg was administered to steady state prior to atorvastatin 20 mg, atorvastatin acid AUC and Cmax increased 52% and 63%, respectively.
Ko se je lomitapid 60 mg dajal do stanja dinamičnega ravnovesja pred dajanjem atorvastatina 20 mg, se vrednost AUC atorvastatinske kisline poveča za 52 %, Cmax pa za 63 %.
When looking at certain abnormalities in the brain, Optimark may need to be used at three times the usual dose in one injection in adults.
Pri ogledovanju nekaterih abnormalnosti v možganih bo morda pri odraslih treba uporabiti trikratni običajni odmerek zdravila Optimark.
When Lynparza is bound to the active site of DNA-associated PARP it prevents the dissociation of PARP and traps it on the DNA, thus blocking repair.
Če je zdravilo Lynparza vezano na aktivno mesto z DNA povezane PARP, prepreči sprostitev PARP in jo ohrani vezano na DNA ter tako onemogoči popravilo.
When Lyrica is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel).
Ob sočasni uporabi zdravila Lyrica z ostalimi zdravili, ki lahko povzročijo zaprtost (kot so nekatera zdravila proti bolečinam), obstaja možnost pojava prebavnih težav (npr. zaprtje, zaprto ali paralizirano črevo).
When Lyxumia was given with a sulphonylurea and a basal insulin, symptomatic hypoglycaemia occurred in 47.2% of lixisenatide treated patients compared to 21.6% with placebo (25.6% absolute difference).
Če je bilo zdravilo Lyxumia uporabljeno s sulfonilsečnino in bazalnim insulinom, se je simptomatska hipoglikemija pojavila pri 47,2 % prejemnikov zdravila Lyxumia in pri 21,6 % prejemnikov placeba (absolutna razlika 25,6 % ).
When Lyxumia was given with a sulphonylurea and a basal insulin, symptomatic hypoglycaemia occurred in 47.2% of lixisenatide treated patients compared to 21.6% with placebo (25.6% absolute difference).
Če je bilo zdravilo Lyxumia uporabljeno s sulfonilsečnino in bazalnim insulinom, se je simptomatska hipoglikemija pojavila pri 47,2 % prejemnikov zdravila Lyxumia in pri 21,6 % prejemnikov placeba (absolutna razlika 25,6 %) .
When made up into a solution, SonoVue contains sulphur hexafluoride gas as ‘microbubbles’ in suspension in a liquid.
Ko se zdravilo SonoVue pripravi v obliki raztopine, vsebuje plin žveplovega heksafluorida v obliki mikromehurčkov v tekoči suspenziji.
When Matever is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Kadar se zdravilo Matever uporablja kot samostojno zdravilo, je začetni odmerek 250 mg dvakrat na dan, ki se dva tedna pozneje poveča na 500 mg dvakrat na dan.
When measured, CK levels should be interpreted in the context of other potential factors that can cause transient muscle damage, such as strenuous exercise or muscle trauma and repeated if necessary.
drugimi potencialnimi dejavniki, ki lahko povzročijo prehodno poškodbo mišic, npr. z naporno telesno dejavnostjo, in merjenje po potrebi ponoviti.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Kadar so zdravila izdelana iz humane krvi ali plazme, se uporabljajo nekateri ukrepi, ki preprečujejo, da bi se okužbe prenašale na bolnike.
When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients.
Pri zdravilih, ki se izdelajo iz humane krvi ali plazme, se izvajajo določeni ukrepi za preprečevanje prenosa okužb na bolnike.
When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients.
Pri zdravilih, ki se izdelajo iz človeške krvi ali plazme, se izvajajo določeni ukrepi za preprečevanje prenosa okužb na bolnike.
When Mekinist is taken in combination with dabrafenib the most common side effects (seen more than 1 in 5 people) are fever, tiredness, nausea, headache, chills, diarrhea, rash, joint pain, high blood pressure, vomiting and cough.
Kadar se zdravilo Mekinist jemlje v kombinaciji z dabrafenibom, so najpogostejši neželeni učinki (opaženi pri več kot 1 osebi od 5) povišana telesna temperatura, utrujenost, navzeja (slabost), glavobol, mrzlica, driska, izpuščaj, bolečine v sklepih, visok krvni tlak, bruhanje in kašelj.
When mixed with Ingelvac MycoFLEX:
Kadar cepivo mešate s cepivom Ingelvac MycoFLEX,
When mixed with these Nobivac vaccines, the demonstrated safety and efficacy claims for Nobivac L4 are no different from those described for Nobivac L4 alone.
Kadar se cepivo meša s temi cepivi Nobivac, se podatki o varnosti in učinkovitosti za Nobivac L4 ne razlikujejo od tistih, ki so opisane za samo cepivo Nobivac L4.
When mixing the product and handling the final feed containing the product, direct contact with the skin and mucous membranes should be avoided.
Pri mešanju zdravila za uporabo v veterinarski medicini in rokovanju s krmo, ki vsebuje zdravilo za uporabo v veterinarski medicini, se je treba izogibati neposrednemu stiku s kožo in sluznicami.
When mixing the product and handling the final feed containing the product, direct contact with the skin and mucous membranes should be avoided.
Pri pripravi krmne mešanice in pri hranjenju živali je potrebna previdnost, da zdravilo ne pride v direkten stik s kožo ali sluznicami.
When mixing the product and handling the final feed containing the veterinary medicinal product, direct contact with the skin and mucous membranes should be avoided.
Pri mešanju zdravila za uporabo v veterinarski medicini in rokovanju s krmo, ki vsebuje zdravilo za uporabo v veterinarski medicini, se je treba izogibati neposrednemu stiku s kožo in sluznicami.
When mixing the product directly into the drinking water system, the contents of the sachet should be sprinkled onto the surface of the water and mixed thoroughly until a clear solution is produced (usually within 3 minutes).
Kadar izdelek umešamo neposredno v sistem pitne vode, moramo vsebino vrečke potresti na površino vode, ki jo nato temeljito mešamo, dokler ne nastane bistra raztopina (navadno v 3 minutah).
When mixing the product directly into the drinking water system, the contents of the sachet should be sprinkled onto the surface of the water and mixed thoroughly until a clear solution is produced (usually within 3 minutes).
Kadar izdelek umešate neposredno v sistem vode za pitje, morate vsebino vrečke potresti na površino vode, ki jo nato temeljito mešate, dokler ne nastane bistra raztopina (navadno v 3 minutah).
When mixing the veterinary medicinal product and handling the final feed containing the product, direct contact with the skin and mucous membranes should be avoided.
Pri mešanju zdravila za uporabo v veterinarski medicini in rokovanju s krmo, ki vsebuje zdravilo za uporabo v veterinarski medicini, se je treba izogibati neposrednemu stiku s kožo in sluznicami.
When mixing the veterinary medicinal product and handling the final feed containing the veterinary medicinal product, direct contact with the skin and mucous membranes should be avoided.
Pri mešanju zdravila za uporabo v veterinarski medicini in rokovanju s krmo, ki vsebuje zdravilo za uporabo v veterinarski medicini, se je treba izogibati neposrednemu stiku s kožo in sluznicami.
When mixing the veterinary medicinal product and handling the medicated water, direct contact, with eyes, skin and mucous membranes should be avoided.
Pri mešanju zdravila za uporabo v veterinarski medicini in pri rokovanju z medicinirano predmešanico se je treba izogibati direktnemu stiku z očmi, kožo in sluznicami.
When mixing the veterinary medicinal product and handling the medicatedoral powder, direct contact, with eyes, skin and mucous membranes should be avoided.
Pri mešanju zdravila za uporabo v veterinarski medicini in pri rokovanju z mediciniranim peroralnim praškom se je treba izogibati direktnemu stiku z očmi, kožo in sluznicami.
When mixing the veterinary medicinal product directly into the drinking water system, the contents of the sachet should be sprinkled onto the surface of the water and mixed thoroughly until a clear solution is produced (usually within 3 minutes).
Kadar izdelek umešate neposredno v sistem pitne vode, morate vsebino vrečice potresti na površino vode, ki jo nato temeljito mešate, dokler ne nastane bistra raztopina (navadno v 3 minutah).
When mixing the veterinary medicinal product directly into the drinking water system, the contents of the sachet should be sprinkled onto the surface of the water and mixed thoroughly until a clear solution is produced (usually within 3 minutes).
Kadar zdravilo za uporabo v veterinarski medicini umešamo neposredno v sistem pitne vode, moramo vsebino vrečice potresti na površino vode, ki jo nato temeljito mešamo, dokler ne nastane bistra raztopina (navadno v 3 minutah).
When Mozobil is used in conjunction with G-CSF for haematopoietic stem cell mobilisation in patients with lymphoma or multiple myeloma‚ tumour cells may be released from the marrow and subsequently collected in the leukapheresis product.
Kadar se zdravilo Mozobil uporablja skupaj z G-CSF za mobilizacijo krvotvornih matičnih celic pri bolnikih z limfomom ali multiplim mielomom, se lahko tumorske celice sprostijo iz kostnega mozga in nato zberejo v levkafereznem pripravku.
When MS-H Vaccine is given to chickens the immune system recognises the weakened strain as ‘foreign’ and makes defences against it.
Po cepljenju piščancev s cepivom MS-H imunski sistem prepozna oslabljeni sev kot „tujek“ in proti njemu vzpostavi obrambo.
When Myocet is administered in combination with cyclophosphamide (600 mg/m2) the initial recommended dose of Myocet is 60-75 mg/m2 every three weeks.
Pri uporabi v kombinaciji s ciklofosfamidom (600 mg/m2) je začetni priporočeni odmerek zdravila Myocet 60–75 mg/m2 vsake tri tedne.
When naltrexone / bupropion was given with a high-fat meal the AUC and Cmax for naltrexone increased 2.1-fold and 3.7-fold and the AUC and Cmax for bupropion increased 1.4-fold and 1.8-fold, respectively.
Pri uporabi kombinacije naltrekson/bupropion skupaj z obrokom z veliko vsebnostjo maščob sta se vrednosti AUC in Cmax za naltrekson povečali 2,1-kratno oziroma 3,7-kratno, vrednosti AUC in Cmax za bupropion pa sta se povečali 1,4-kratno oziroma 1,8-kratno.
When necessary Humalog can be given soon after meals.
Po potrebi se lahko zdravilo Humalog daje tudi kmalu po obrokih.
When necessary Liprolog can be given soon after meals.
Po potrebi se lahko zdravilo Liprolog daje tudi kmalu po obrokih.
When necessary NovoRapid can be given soon after a meal.
Če je potrebno, pa ga je mogoče injicirati kmalu po obroku.
When necessary, Humalog Mix25 can be given soon after meals.
Po potrebi se lahko zdravilo Humalog Mix25 daje tudi kmalu po obrokih.
When necessary, Humalog Mix50 can be given soon after meals.
Po potrebi se lahko zdravilo Humalog Mix50 daje tudi kmalu po obrokih.
When necessary, Irbesartan Hydrochlorothiazide Zentiva may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Kadar je nujno, smejo bolniki poleg zdravila Irbesartan Hydrochlorothiazide Zentiva jemati tudi drug antihipertenziv (glejte poglavje 4.5).
When necessary, Liprolog Mix25 can be given soon after meals.
Po potrebi se lahko zdravilo Liprolog Mix25 daje tudi kmalu po obrokih.
When necessary, Liprolog Mix50 can be given soon after meals.
Po potrebi se lahko zdravilo Liprolog Mix50 daje tudi kmalu po obrokih.
When necessary, NovoMix 30 can be given soon after a meal.
Če je potrebno, se zdravilo NovoMix 30 lahko uporabi tudi kmalu po obroku.
When necessary, NovoMix 50 can be given soon after a meal.
Če je potrebno, se zdravilo NovoMix 50 lahko uporabi tudi kmalu po obroku.
When necessary, NovoMix 70 can be given soon after a meal.
Če je potrebno, se zdravilo NovoMix 70 lahko uporabi tudi kmalu po obroku.
When necessary, NovoRapid can be given soon after a meal.
Če je treba, je mogoče zdravilo NovoRapid injicirati kmalu po obroku.
When needed (for example when you are travelling), a single Humira pre-filled pen may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light.
Če je potrebno (na primer, kadar potujete), lahko posamezen napolnjen injekcijski peresnik zdravila Humira hranite pri sobni temperaturi (do 25 ºC) za največ do 14 dni – zagotovite, da bo zaščiten pred svetlobo.
When needed (for example when you are travelling), a single Humira pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light.
Če je potrebno (na primer, kadar potujete), lahko posamezno napolnjeno injekcijsko brizgo zdravila Humira hranite pri sobni temperaturi (do 25 ºC) za največ do 14 dni – zagotovite, da bo zaščitena pred svetlobo.
When needed (for example, when you are travelling), a single Humira pre-filled pen may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light.
Če je potrebno (na primer kadar potujete), lahko posamezen napolnjen injekcijski peresnik zdravila Humira hranite pri sobni temperaturi (do 25 ºC) za največ do 14 dni – zagotovite, da bo zaščiten pred svetlobo.
When needed, inject yourself using a second pen, dialing your remaining dose written in the ‘’Amount Displayed After Injection’’ section (8).
Po potrebi uporabite za injiciranje drugi injekcijski peresnik in izberite preostali odmerek zabeležen v poglavju "Količina, prikazana po injiciranju" (8).
When needed, the patient can change the time of administration as long as Ryzodeg is dosed with the largest meal when taken once daily.
Po potrebi lahko bolnik spremeni čas apliciranja zdravila Ryzodeg, pod pogojem, da si ga aplicira ob največjem obroku, če ga uporablja enkrat dnevno.
When needed, Toujeo can be injected up to 3 hours before or after the time you usually inject it.
Če je treba, lahko zdravilo Toujeo injicirate do 3 ure pred ali po času, ko ga injicirate po navadi.
When needed, you can inject it up to 3 hours before or after the usual time that you use it.
Če je treba, ga lahko injicirate do 3 ure pred ali po času, ko ga uporabite po navadi.
When Neofordex is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with Neofordex.
Če se bo zdravilo Neofordex uporabljalo v kombinaciji z drugimi zdravili, je treba pred uvedbo zdravila Neofordex prebrati povzetek glavnih značilnosti zdravila za ta druga zdravila.
When Neoplastin PT was used, baseline PT was about 13 s and the slope was around 3 to 4 s/(100 µg/l).
Kadar je bil uporabljen Neoplastin, je bil izhodiščni PČ približno 13 sekund in naklon krivulje približno 3 do 4 s/(100 mikrogramov/l).
When Nespo therapy is absolutely indicated women must stop breast-feeding.
Če je Nespo absolutno indiciran, mora ženska nehati dojiti.
When neutrophils Recommended course
Ko se število nevtrofilcev Priporočen potek zdravljenja
When neutrophils Recommended Course
Ko se število nevtrofilcev Priporočeni potek zdravljenja
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
< po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja,
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
kadar imetnik dovoljenja za promet prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali aktivnosti za zmanjšanje tveganja.
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Kadar imetnik dovoljenja za promet z zdravilom prejeme nove informacije, ki lahko vplivajo na veljavne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja;
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja,
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja;
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
kadar imetnik dovoljenja za uporabo z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja,
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
kadar imetnik dovoljenja za uporabo z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja,
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
kadar se pridobijo nove informacije, ki bi lahko vplivale na trenutne varnostne specifikacije, farmakovigilančni načrt ali na dejavnosti za zmanjšanje tveganja;
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
ko se pridobijo novi podatki, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali aktivnosti za zmanjševanje tveganja.
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
ko so znane nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja