PRAC in English translation

Stoga je PRAC suglasan da je potrebno dodati„Noćnu moru

Therefore, the PRAC agreed that‘Nightmare and Insomnia' should be

Shodno tome, na temelju dostupnih podataka vezano za konfuzno stanje, PRAC smatra da su izmjene informacija o lijeku opravdane.

Therefore, in view of available data regarding confusional state, the PRAC considered that changes to the product information were warranted.

PRAC smatra da postoji dovoljno dokaza koji dovode do zaključka da teške infekcije za vrijeme liječenja terifulnomidom mogu dovesti do sepse.

The PRAC is of the opinion that there is enough evidence leading to the conclusion that severe infections during teriflunomide treatment can result to sepsis.

PRAC preporučio nove mjere kako bi se umanjio rizik od srčanih nuspojava u bolesnika liječenih ivabradinom(Corlentor/Procoralan.

PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan(ivabradine.

Stoga, s obzirom na dostupne podatke o vrućici u djece, PRAC smatra da su izmjene informacija o lijeku opravdane.

Therefore, in view of the available data regarding fever in children, the PRAC considered that changes to the product information were warranted.

PRAC je osnovan u srpnju 2012. godine.

The PRAC was established in July 2012.

PRAC preporučuje ograničavanje primjene lijekova koji sadrže flupirtin.

PRAC recommends the restriction of use of flupirtine-containing medicines.

Ocjenom svih dostupnih podataka PRAC je zaključio sljedeće.

Having assessed all the available data, the PRAC concluded that.

Opširnije PRAC preporučio stroža ograničenja primjene valproata u žena i djevojaka.

PRAC recommends strengthening the restrictions on the use of valproate in women and girls.

PRAC za diklofenak preporučuje jednake mjere opreza kao i za selektivne COX-2 inhibitore.

PRAC recommends the same precautions for diclofenac as for selective COX-2 inhibitors.

Osnovne informacije o PRAC-u- Povjerenstvo za ocjenu rizika na području farmakovigilancije(PRAC)- poveznice Farmakovigilancija.

Basic Information on the PRAC- Pharmacovigilance and Risk Assessment Committee(PRAC)- Links Pharmacovigilance.

PRAC je započeo procjenu valproata

The PRAC has started a review of valproate

Obavijest o osnivačkom sastanku PRAC-a- Povjerenstvo za ocjenu rizika na području farmakovigilancije(PRAC)- poveznice Farmakovigilancija.

Information About the First Meeting of the PRAC- Pharmacovigilance and Risk Assessment Committee(PRAC)- Links Pharmacovigilance.

PRAC preporučuje suspenziju odobrenja za stavljanje u promet otopina za infuziju koje sadrže hidroksietil škrob.

PRAC recommends the suspension of infusion solutions containing hydroxyethyl starch.

PRAC se također usredotočio na široki spektar svojih odgovornosti, koji obuhvaća sve aspekte upravljanjem rizicima lijekova.

The PRAC also focused on the broad spectrum of its responsibilities which cover all aspects of the risk management of the use of medicines.

Nositelji odobrenja na koje se odnosi ova ocjena imaju pravo zatražiti da PRAC preispita svoju preporuku.

The companies concerned by this review have the right to request the PRAC to re-examine its recommendations.

Na temelju toga, PRAC može odlučiti proširiti ovu ocjenu kako bi se obuhvatilo cijelu skupinu lijekova.

Based on this, the PRAC may decide to extend the scope of the review to cover these medicines.

Pregled novog zakonodavstva na području farmakovigilancije- Povjerenstvo za ocjenu rizika na području farmakovigilancije(PRAC)- poveznice Farmakovigilancija.

Overview of the New Pharmacovigilance Legislation- Pharmacovigilance and Risk Assessment Committee(PRAC)- Links Pharmacovigilance.

PRAC je započeo novu ocjenu primjene lijekova koji sadrže valproat u liječenju žena

The PRAC has started a new review of the use of valproate-containing medicines in the treatment of women

Osim toga, PRAC je zatražio provođenje dodatnih studija o primjeni ovih lijekova tijekom elektivnih operacija i kod bolesnika u traumi.

In addition, the PRAC requested that further studies be carried out on the use of these medicines in elective surgery and trauma patients.

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