| Abstract | Cilj istraživanja:
Cilj specijalističkog rada je analizirati lijekove na tržištu Republike Hrvatske / Europske unije koji
uzrokuju nuspojave dišnog sustava i klasificirati ih unutar definiranih granica učestalosti korištenjem
HALMED baze lijekova. Rad pregledno prikazuje lijekove odobrene u RH/EU koji uzrokuju
nuspojave specifično dišnog sustava, klasificiranih unutar definiranih granica učestalosti.
Materijal i metode:
Kao materijal za izradu specijalističkog rada korišteni su relevantni znanstveni članci koji obrađuju
problematiku zabilježenih i opisanih respiratornih nuspojava te načina za njihovu detekciju.
Analiza lijekova koji uzrokuju nuspojave specifično dišnog sustava odobrenih u Republici Hrvatskoj
/EU bila je provođena:
- pretraživanjem internet stranice http://www.pneumotox.com/news/view/21/ (internet stranica koja se
ažurira na dnevnoj bazi i na kojoj je dostupan popis lijekova koji su prijavljeni da uzrokuju nuspojave
specifično dišnog sustava);
- pretraživanjem HALMED-ove baze podataka;
- korištenjem registra lijekova u RH za 2016. godinu.
Rezultati:
U tablicama su korišteni hrvatski nazivi djelatnih tvari. Tablice su struktuirane na način kako se
lijekovi nalaze u HALMED bazi lijekova. Ako je lijek odobren od strane HALMED-a svaka doza ili
oblik je prikazan zasebno; ako je lijek odobren od strane EMA-e sve doze i oblici se nalaze unutar iste
čelije.
Ukupno je analizirano 4873 lijeka (A skupina 422, B skupina 297, C skupina 784, D skupina 149, G
skupina 219, H skupina 93, J skupina 626, L skupina 541, M skupina 234, N skupina 1039, P skupina
1, R skupina 344, S skupina 74 i V skupina 50).
Zaključak:
Ukupno je analizirano 4873 lijeka. Broj lijekova s vrlo čestom učestalosti respiratornih nuspojava
iznosi 284, čestom učestalosti respiratornih nuspojava iznosi 1435, manje čestom učestalosti
respiratornih nuspojava iznosi 1573, rijetkom učestalosti respiratornih nuspojava iznosi 881, vrlo
rijetkom učestalosti respiratornih nuspojava iznosi 562 te nepoznatom učestalosti respiratornih
nuspojava iznosi 972.
Najčešće nuspojave kroz svih 6 kategorija učestalosti respiratornih nuspojava su: dispneja, kašalj,
epistaksa i rinitis. Unutar svih skupina anatomsko-terapijske klasifikacije lijekova opisane su
respiratorne nuspojave. Najviše vrlo čestih nuspojava ima unutar skupina L - Citostatici (162
nuspojave). Najviše čestih nuspojava ima unutar skupine N – Živčani sustav (373 nuspojave). Najviše
manje čestih nuspojava ima unutar skupine C – Kardiovaskularni sustav (449 nuspojava). Najviše
rijetkih nuspojava ima unutar skupine N – Živčani sustav (251 nuspojava). Najviše vrlo rijetkih
nuspojava ima unutar skupine C – Kardiovaskularni sustav (205 nuspojava). Najviše nepoznatih
nuspojava ima unutar skupine C – Kardiovaskularni sustav (270 nuspojave). |
| Abstract (english) | Objectives:
The aim of this this specialist work was to analyze medicinal products on the Croatian market /
European Union that cause adverse reactions of respiratory system and classify them within defined
limits of the frequency by using HALMED medicinal product base. This work gives an overview of
medicinal products approved in Croatia / EU which cause adverse reactions specific respiratory system,
classified within defined limits of the frequency.
Material and methods:
As materials for the preparation of this work several relevant scientific articles were used, that
provides an overview so far recorded and describe respiratory adverse reactions and ways for their
detection.
Analysis of medicinal products that can cause adverse reactions specific respiratory system approved
in Croatia / EU has been conducted:
- Searching the internet site http://www.pneumotox.com/news/view/21/ (web site that is updated on a
daily basis and on which can be find available list of medicinal products that have been reported to
cause adverse reactions of specific respiratory system);
- Searching HALMED medicinal product base;
- The use of the register of medicinal product in Croatia for 2016.
Results:
In the tables were used Croatian names of active substances. The tables are structured in a way that
medicines are in HALMED medicinal product base. If the drug is approved by the HALMED any
dose or form is separetaly shown; if the drug is approved by the EMA all doses and forms are located
within the same cell.
A total of 4873 medicinal product were analysed (group A 422 medicinal product, group B 297
medicinal product, group C 784 medicinal product, group D 149 medicinal product, group G 219
medicinal product, group H 93 medicinal product, J group 626 medicinal product, group L 541
medicinal product, group M 234 medicinal product, group N 1039 medicinal product, group P 1
medicinal product, group R 344 medicinal product, group 74 medicinal product and group V 50
medicinal product).
Conclusion:
A total of 4873 medicinal product were analysed. Number of medicinal products with very common
incidence of respiratory adverse reactions is 284, with common incidence of respiratory adverse
reactions is 1435, with uncommon incidence of respiratory adverse reactions is 1573, with a rare
incidence of respiratory adverse reactions is 881, with a very rare incidence of respiratory adverse
reactions is 562, with not known frequency of respiratory adverse reactions is 972.
Most common respiratory adverse reactions in all six categories of the incidence of adverse reactions
were: dyspnoea, cough, epistaxis and rhinitis. Within all groups anatomical therapeutic classification
of drugs, respiratory adverse reactions were described. The most very common respiratory adverse
reactions were in a group L - Cytostatics (162 respiratory adverse reaction). The most common
respiratory adverse reactions were in a group N - Nervous System (373 respiratory adverse reaction).
The most uncommon respiratory adverse reactions were in the group C - Cardiovascular system (449
respiratory adverse reaction). The most rare respiratory adverse reactions were in the group N -
Nervous System (251 respiratory adverse reaction). Most very rare respiratory adverse reactions were
in the group C - Cardiovascular system (205 respiratory adverse reaction). Most of not known
respiratory adverse reactions were in the group C - Cardiovascular system (270 respiratory adverse
reaction). |
