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Podjetje Chiesi Farmaceutici ima vzpostavljen sistem farmakovigilance, s katerim prevzema odgovornost za svoja zdravila (tako tista, ki so na trgu, kot tista, ki so v kliničnem razvoju) in ustrezno ukrepa, če je potrebno. Skrbimo, da se vse informacije, pomembne za oceno razmerja med koristmi in tveganji naših zdravil, stalno vrednotijo. Če se pojavijo pomembna obvestila o varnosti, v skladu z veljavno zakonodajo takoj obvestimo zadevne zdravstvene delavce, bolnike in regulatorne agencije.

Kaj je farmakovigilanca?

Svetovna zdravstvena organizacija (SZO) opredeljuje farmakovigilanco kot znanost in dejavnosti, povezane z odkrivanjem, ocenjevanjem, razumevanjem in preprečevanjem neželenih učinkov ali katerih koli drugih z zdravili povezanih težav (ref. SZO. Pomen farmakovigilance: varnostni nadzor zdravil, Ženeva, SZO 2002).
V skladu s to splošno definicijo so glavni cilji farmakovigilance po veljavni zakonodaji EU:
  • preprečevanje škodljivih posledic neželenih učinkov pri ljudeh,
  • spodbujanje varne in učinkovite uporabe zdravil, zlasti z zagotavljanjem pravočasnih informacij o varnosti zdravil bolnikom, zdravstvenim delavcem in javnosti.
Farmakovigilanca je torej dejavnost, ki pomaga pri varovanju bolnika in javnega zdravja.

Kaj je neželeni učinek?

Škodljiv in nenameren odziv na zdravilo (odziv v tem primeru pomeni, da je vzročna povezanost med zdravilom in neželenim učinkom vsaj smiselno možna).
Neželeni učinki se lahko pojavijo ob upoštevanju ali neupoštevanju pogojev dovoljenja za promet z zdravilom ali pa zaradi poklicne izpostavljenosti. Pogoji uporabe zunaj okvira dovoljenja za promet vključujejo neodobreno uporabo, preveliko odmerjanje, nepravilno uporabo, zlorabo ali napako pri uporabi zdravila.

Informacije o tem, kako poročati o neželenih učinkih

Če ste v Sloveniji

O vsakem neželenem učinku, ki se pojavi ob zdravljenju, morate takoj obvestiti svojega zdravnika ali farmacevta.
Če morate poročati o neželenem učinku katerega od zdravil podjetja Chiesi, prosimo, da ne uporabljate tega spletnega mesta ali elektronske pošte, temveč da upoštevate navodila, navedena na spodnji povezavi:

https://www.jazmp.si/zdravila_za_uporabov_humani_medicini/farmakovigilanca/porocanje_o_nezelenih_ucinkih_zdravil/

Če se želite obrniti neposredno na oddelek za farmakovigilanco podjetja Chiesi Slovenija, lahko:
pokličete +386/0/1 43 00 901
pošljete faks +386/0/1 43 00 900
pišete na elektronski naslov: farmakovigilanca.si@chiesi.com

Če ste zunaj Slovenije

Vsaka država ima zakonodajo, ki ureja poročanje o neželenih učinkih zdravil. Če se vam pojavijo neželeni učinki ob uporabi naših zdravil vas prosimo, da se obrnete na lokalno zdravstveno osebje – tako boste lahko pravilno izvedli postopek poročanja.



Chiesi Farmaceutici has a system of pharmacovigilance in order to assume liability for our medicinal products (whether marketed or under clinical development) and to take appropriate actions when necessary. We ensure that all information relevant to the benefit-risk ratio of our medicinal products is continuously evaluated. When important safety issues arise, if applicable, we promptly notify healthcare the professionals, patients and regulatory agencies concerned in accordance with current legislation.

What is Pharmacovigilance?

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem (Ref. World Health Organization, WHO. The importance of pharmacovigilance: safety monitoring of medicinal products, Genève, WHO, 2002).
In line with this general definition, the main objectives of pharmacovigilance in accordance with the applicable EU legislation are:
  • preventing harm from adverse reactions in humans;
  • promoting the safe and effective use of medicinal products, in particular by providing timely information about the safety of medicinal products for patients, healthcare professionals and the public.
Pharmacovigilance is therefore an activity contributing to the protection of patient and public health.

What is an Adverse Drug Reaction?

A response to a medicinal product which is harmful and unintended (response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility).
Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Conditions of use outside the marketing authorisation include off-label use, overdose, misuse, abuse and medication errors.

Information on how to report adverse drug reactions

If you are in Slovenia

Any untoward event that occurs following medical treatment must be promptly reported either to the family doctor or to the pharmacist.
If you need to report an adverse drug reaction related to Chiesi drugs, we kindly request that you follow the instructions indicated in the link below instead of using the website or email:

https://www.jazmp.si/zdravila_za_uporabov_humani_medicini/farmakovigilanca/porocanje_o_nezelenih_ucinkih_zdravil/

If you need to contact the Chiesi pharmacovigilance department directly you can:
call +386/0/1 43 00 901
send a fax to +386/0/1 43 00 900
send an e-mail to: farmakovigilanca.si@chiesi.com

If you are outside Slovenia

Every country has laws governing the reporting of adverse drug reactions, therefore if you experience adverse drug reactions with our medicinal products, you are asked to contact local health personnel to rightly follow the notification procedure.