natgillin/translations-raw huggingface dataset:
On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Ibandronic Acid Teva has no or negligible influence on the ability to drive and use machines.
Glede na farmakodinamske in farmakokinetične lastnosti ter poročane neželene učinke pričakujemo, da zdravilo Ibandronska kislina Teva nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
On the basis of the pharmacodynamic and pharmacokinetic profile, tafamidis meglumine is believed to have no or negligible influence on the ability to drive or use machines.
Na podlagi farmakodinamičnega in farmakokinetičnega profila naj tafamidis meglumin ne bi imel vpliva ali naj bi imel zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
On the basis of the scientific conclusions for aclidinium bromide / formoterol fumarate dihydrate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aclidinium bromide / formoterol fumarate dihydrate is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za aklidinijev bromid/formoterolijev fumarat dihidrat Odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) aklidinijev bromid/formoterolijev fumarat dihidrat, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for aclidinium bromide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aclidinium bromide is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za aklidinijev bromid, odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo zdravilno učinkovino aklidinijev bromid nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for aclidinium bromide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aclidinium bromide is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za aklidinijev bromid, odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo zdravilno učinkovino aklidinijev bromid nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for aflibercept (indicated for wet macular degeneration and CRVO) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aflibercept (indicated for wet macular degeneration and CRVO) is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za aflibercept (za indikacijo vlažne starostne degeneracija makule in CRVO), odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) aflibercept (za indikacijo vlažne starostne degeneracije makule in CRVO), nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for agomelatine the CHMP is of the opinion that the benefit- risk balance of the medicinal product(s) containing agomelatine is favourable subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za agomelatin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) agomelatin ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for alemtuzumab the CHMP is of the opinion that the benefit- risk balance of the medicinal product containing alemtuzumab is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za alemtuzumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebuje alemtuzumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide is favourable subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za aliskiren / aliskiren, amlodipin / aliskiren, hidroklorotiazid odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo aliskiren / aliskiren, amlodipin / aliskiren, hidroklorotiazid, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for apremilast the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing apremilast is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za apremilast odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) apremilast, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for aripiprazole the CHMP is of the opinion that the benefit-risk balance of the medicinal products containing aripiprazole is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za aripiprazolodbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zdravilno učinkovino aripiprazol ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for bimatoprost / timolol the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing bimatoprost / timolol is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za bimatoprost/timolol odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) bimatoprost/timolol nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for bimatoprost the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing bimatoprost is favourable subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov glede bimatoprosta je odbor CHMP mnenja, da je vpeljava predlaganih sprememb informacij o zdravilih zaradi razmerja med pozitivnimi učinki in tveganji zdravil, ki vsebujejo bimatoprost, smiselna.
On the basis of the scientific conclusions for brimonidine (centrally authorised product only) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing brimonidine (centrally authorised product only) is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za brimonidin (samo za zdravilo, odobreno po centraliziranem postopku) odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zdravilno učinkovino brimonidin (samo za zdravilo, odobreno po centraliziranem postopku), nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for carglumic acid the CHMP is of the opinion that the benefit-risk balance of the medicinal products containing carglumic acid is favourable subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za kargluminska kislina odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zdravilno(-e) učinkovino(-e) kargluminska kislina ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for clofarabine the CHMP is of the opinion that the benefit- risk balance of the medicinal product containing clofarabine is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za klofarabin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) klofarabin nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for Cystagon the CHMP is of the opinion that the benefit- risk balance of the medicinal product(s) containing the active substance Mercaptamine bitartrate is favourable subject to the proposed changes to the product information.
Na osnovi znanstvenih zaključkov za cystagon CHMP meni, da je razmerje med koristmi in tveganji pri medicinskem izdelku(ih), ki vsebuje(jo) aktivno snov merkaptamin bitartrat ugodno, glede na predlagane spremembe informacij o izdelku.
On the basis of the scientific conclusions for deferasirox the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing deferasirox is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za deferasiroks odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) deferasiroks, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for enfuvirtide the CHMP is of the opinion that the benefit- risk balance of the medicinal product containing enfuvirtide is favourable subject to the proposed changes to the product information
CHMP je na podlagi znanstvenih zaključkov za enfuvirtid sprejel mnenje, da je s predlaganimi spremembami informacij o zdravilu razmerje med koristmi in tveganji zdravila z enfuvirtidom ugodno.
On the basis of the scientific conclusions for eribulin the CHMP is of the opinion that the benefit- risk balance of the medicinal product containing eribulin is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za eribulin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) eribulin, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for Firmagon the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing the active substance degarelix is favourable subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za zdravilo Firmagon odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilno učinkovino degareliks ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for florbetaben (18F) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing florbetaben (18F) is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za [18F]florbetaben odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila(-a), ki vsebuje(-jo) učinkovino [18F]florbetaben, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for fondaparinux the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing fondaparinux is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za fondaparinuks odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) fondaparinuks nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za glimepirid/pioglitazon hidroklorid, metformin/pioglitazon, pioglitazon odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zdravilno(-e) učinkovinoe glimepirid/pioglitazon hidroklorid, metformin/pioglitazon, pioglitazon nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za glimepirid/pioglitazon hidroklorid, metformin/pioglitazon, pioglitazon odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zdravilno(-e) učinkovinoe glimepirid/pioglitazon hidroklorid, metformin/pioglitazon, pioglitazon{ime(- na) zdravilne(-ih) učinkovine(učinkovin)} nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for ibandronic acid, sodium ibandronate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ibandronic acid, sodium ibandronate is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za ibandronsko kislino in natrijev ibandronat odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo ibandronsko kislino in natrijev ibandronat ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for Incresync, the CHMP is of the opinion that the benefit- risk balance of the medicinal product containing the active substance alogliptin/ pioglitazone is favourable subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za zdravilo Incresync odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilni učinkovini alogliptin in pioglitazon, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for influenza vaccine (surface antigen, inactivated, prepared in cell cultures) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing influenza vaccine (surface antigen, inactivated, prepared in cell cultures) is favourable subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za cepivo proti gripi (površinski antigen, neaktiviran, pripravljen v celičnih kulturah) odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) cepivo proti gripi (površinski antigen, neaktiviran, pripravljen v celičnih kulturah), ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for ingenol mebutate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ingenol mebutate is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za ingenol mebutat (ingenoli mebutas) odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo ingenol mebutat (ingenoli mebutas) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for irbesartan the CHMP is of the opinion that the benefit- risk balance of the medicinal product(s) containing irbesartan is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za irbesartan odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(a), ki vsebuje(jo) irbesartan nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for Javlor, the CHMP is of the opinion that the benefit- risk balance of the medicinal product containing the active substance VINFLUNINE DITARTRATE is favourable subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za zdravilo Javlor odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilno učinkovino VINFLUNIN DITARTRAT, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for levetiracetam the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing levetiracetam is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za levetiracetam odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) levetiracetam nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for liraglutide the CHMP is of the opinion that the benefit­ risk balance of the medicinal products containing liraglutide is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za liraglutid odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo liraglutid, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for lomitapide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing lomitapide is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za lomitapid odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) lomitapid nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for melatonin the CHMP is of the opinion that the benefit- risk balance of the medicinal product containing melatonin is favourable subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za melatonin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje melatonin ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for METFORMIN, VILDAGLIPTIN the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing METFORMIN, VILDAGLIPTIN is favourable subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za METFORMIN in VILDAGLIPTIN odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo METFORMIN in VILDAGLIPTIN, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for mirabegron the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing mirabegron is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za mirabegron odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilno učinkovino mirabegron ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for ocriplasmin the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing ocriplasmin is favourable subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za okriplazmin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilno učinkovino okriplazmin, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for omalizumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing omalizumab is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za omalizumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) omalizumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for orlistat the CHMP is of the opinion that the benefit- risk balance of the medicinal product(s) containing orlistat is favourable subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za orlistat odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zdravilno učinkovino orlistat ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for orlistat the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing the active substance(s) orlistat is favourable subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za orlistat odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zdravilno učinkovino orlistat ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for paclitaxel albumin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing paclitaxel albumin is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za paklitaksel albumin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) paklitaksel albumin, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for para-aminosalicylic acid (centrally authorised product) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing para- aminosalicylic acid (centrally authorised product) is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za para-aminosalicilno kislino (zdravilo, za katero je bilo izdano dovoljenje za promet po centraliziranem postopku) odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) para-aminosalicilno kislino (zdravilo, za katero je bilo izdano dovoljenje za promet po centraliziranem postopku) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for pegloticase the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing pegloticase is favourable subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za peglotikazo odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilno učinkovino peglotikazo, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for pregabalin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pregabalin is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za pregabalin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje pregabalin nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for Pumarix, the CHMP is of the opinion that the benefit- risk balance of the medicinal product containing the active substance purified antigen fractions of inactivated split virion A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2 is favourable subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za cepivo Pumarix je CHMP mnenja, da je razmerje med koristjo in tveganjem za cepivo, v katerem so zdravilna učinkovina prečiščene antigenske frakcije inaktiviranega razcepljenega viriona A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2, ugodno, ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
On the basis of the scientific conclusions for ranolazine the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing ranolazine is favourable subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za ranolazin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilno učinkovino krizotinib, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.