What is the translation of " CHANGES TO THE PRODUCT INFORMATION " in Slovenian?

• spremembe informacij o zdravilu
• do sprememb informacij o izdelkih

Examples of using Changes to the product information in English and their translations into Slovenian

In view of available data regarding orlistat, the PRAC considered that changes to the product information were warranted.
V luči razpoložljivih podatkov za orlistat je PRAC smatral, da so spremembe v informacijah o zdravilu utemeljene.

The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 and requested further changes..
CHMP je potrdil spremembe Informacij o zdravilu, že vnešene z variacijo tipa II, sprejeto maja 2005 in zahteval še nadaljne spremembe..

Therefore, in view of available data regarding orlistat, the PRAC considered that changes to the product information were warranted.
Zato PRAC v skladu z dostopnimi podatki o orlistatu meni, da so spremembe informacij o zdravilu utemeljene.

The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 further to the February USR and requested further changes..
CHMP je potrdil spremembe informacij o zdravilu, že vnešene z variacijo tipa II, sprejeto maja 2005, po februarskem nujnem varnostnem ukrepu in zahteval še nadaljnje spremembe..

In view of available data regarding temozolomide, the PRAC considered that changes to the product information were warranted.
Glede na razpoložljive podatke o temozolomidu tako odbor PRAC meni, da so spremembe v informacijah o zdravilu utemeljene.

JFB9 We reserve the right to make changes to the product information contained on this site at any time without notice, including with respect to equipment, specifications, models, colors, and materials.
Pridržujemo si pravico do sprememb informacij o izdelkih na tej strani, kar se lahko zgodi kadarkoli in brez predhodnega obvestila, vse to pa velja tudi za opremo, specifikacije, modele, barve in materiale.

Therefore, in view of available data regarding teriflunomide, the PRAC considered that changes to the product information were warranted.
Odbor PRAC zato glede na dostopne podatke glede teriflunomida meni, da so spremembe v informacijah o zdravilu utemeljene.

However the Committee adopted recommendations for changes to the product information, or so called“ key elements” during this review which reflect a common position on well known safety issues in the product information of the non-selective NSAIDs.
Vendar pa je Odbor med tem pregledom sprejel priporočila za spremembe informacij o zdravilu oziroma tako imenovanih„ ključnih elementov“, ki odražajo skupno stališče o dobro znanih varnostnih vidikih v informacijah o zdravilu za neselektivne NSAID-e.

Therefore, in view of available data regarding hyponatremia, the PRAC considered that changes to the product information were warranted.
Skladno z razpoložljivimi podatki glede hiponatriemije odbor PRAC zato meni, da je potrebna posodobitev informacij o zdravilu.

EMA has recommended changes to the product information of metamizole, to ensure that advice on the maximum daily doses and warnings not to use the medicine during the last 3 months of pregnancy or during breastfeeding are consistent across the EU.
EMA je priporočila spremembo informacij o zdravilih z metamizolom, s čimer zagotavlja, da so navodila glede največjega dovoljenega dnevnega odmerka in opozorila, da se zdravilo ne uporablja v zadnjem tromesečjem nosečnosti in med dojenjem, poenotena in usklajena po celotni Evropski uniji.

Therefore, in view of available data regarding Fuzeon, the PRAC considered that changes to the product information were warranted.
Zato je glede na razpoložljive podatke o zdravilu Fuzeon PRAC menil, da so bile spremembe informacij o zdravilu utemeljene.

Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information and conditions of the marketing authorisation of medicinal products containing vismodegib were warranted.
Zato je, glede na podatke, navedene v obravnavanem PSUR-u, PRAC menil, da so bile spremembe informacij o zdravilu in pogojev za izdajo dovoljenja za promet z zdravili, ki vsebujejo vismodegib, utemeljene.

Although no new safety concerns have been identified, the MAH proposed two changes to the product information.
Čeprav novi varnostni zadržki niso bili ugotovljeni, je imetnik dovoljenja za promet z zdravilom predlagal dve spremembi informacij o zdravilu.

In view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing ingenol mebutate were warranted.
Glede na podatke, predstavljene v pregledani oceni rednih posodobljenih poročil o varnosti zdravila(PSUR), odbor PRAC meni, da je sprememba informacij o zdravilu za zdravila, ki vsebujejo ingenol mebutat(ingenoli mebutas), upravičena.

Therefore, in view of available data regarding hypersensitivity reactions and interference with Magnetic Resonance Imaging(MRI), the PRAC considered that changes to the product information were warranted.
V luči razpoložljivih podatkov v zvezi s preobčutljivostnimi reakcijami in vplivom na magnetnoresonančno slikanje(MRI) je zato odbor PRAC presodil, da so spremembe informacij o zdravilu utemeljene.

Therefore, in view of available data regarding regadenoson, the PRAC considered that changes to the product information were warranted.
Torej odbor PRAC glede na razpoložljive podatke o regadenozonu meni, da so spremembe informacij o zdravilu utemeljene.

In view of available data regarding anaphylaxis and infusion reactions, the Pharmacovigilance Risk Assessment Committee considered that changes to the product information were warranted.
Ob upoštevanju razpoložljivih podatkov glede anafilakse in reakcij zaradi infundiranja je Odbor za oceno tveganja na področju farmakovigilance ocenil, da so ocene za spremembo informacij za zdravilo utemeljene.

Therefore, in view of available data regarding degarelix, the PRAC considered that changes to the product information were warranted.
Odbor PRAC je zato, na podlagi razpoložljivih podatkov o degareliksu, menil, da so spremembe informacij o zdravilu upravičene.

Therefore, in view of available data regarding gastrointestinal haemorrhages with the use of apremilast, the PRAC considered that changes to the product information were warranted.
Zato je spričo razpoložljivih podatkov glede gastrointestinalnih krvavitev pri uporabi apremilasta PRAC menil, da so upravičene spremembe informacij o zdravilu.

Therefore, in view of available data regarding overdose the PRAC considered that changes to the product information were warranted.
Glede na razpoložljive podatke o prevelikem odmerjanju je bil Odbor za oceno tveganja na področju farmakovigilance zato mnenja, da so bile spremembe informacij o zdravilu utemeljene.

Therefore, in view of available data regarding pallor and over-whitening, the PRAC considered that changes to the product information are warranted.
Odbor PRAC je zato na podlagi razpoložljivih podatkov o bledici in čezmernem obeljenju menil, da so potrebne spremembe informacij o zdravilu.

Therefore, in view of the available data regarding fever in children, the PRAC considered that changes to the product information were warranted.
PRAC zato glede na dostopne podatke o zvišani telesni temperaturi pri otrocih meni, da so spremembe v informacijah o zdravilu utemeljene.

In view of available data regarding the use of Focetria during pregnancy, the PRAC considered that changes to the product information were warranted.
Odbor PRAC meni, da so z vidika razpoložljivih podatkov o uporabi cepiva Focetria med nosečnostjo te spremembe informacij o zdravilu potrebne.

Therefore, in view of available data regarding rash and cases of incorrect route of administration, the PRAC considered that changes to the product information were warranted.
Zato glede na razpoložljive podatke o izpuščaju in primerih nepravilne poti uporabe odbor PRAC meni, da so spremembe informacij o zdravilu upravičene.

Therefore, in view of available data regarding next day effects on driving and mental alertness, the PRAC considered that changes to the product information were warranted.
Zato je bil PRAC glede na razpoložljive podatke v zvezi z vplivom na sposobnost vožnje in miselno zbranost, ki se pojavi naslednji dan, mnenja, da so spremembe informacij o zdravilu upravičene.