natgillin/translations-raw huggingface dataset:
It must not be used in women who are more than three months pregnant.
Ne smejo ga uporabljati nosečnice, ki so noseče več kot tri mesece.
The company presented information from scientific literature as well as results from studies with the medicine.
Družba je predstavila podatke iz objavljene znanstvene literature in rezultate študij z zdravilom.
This medicine is the same as Twynsta, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Twynsta, ki je že odobreno v Evropski uniji (EU).
The European Commission granted a marketing authorisation valid throughout the European Union for Onduarp on 24 November 2011.
Evropska komisija je dovoljenje za promet z zdravilom Onduarp, veljavno po vsej Evropski uniji, odobrila dne 24. novembra 2011.
The maximum dose is one tablet of the highest strength (80/10 mg) once a day.
Največji odmerek je ena tableta največje jakosti (80/10 mg) enkrat na dan.
The full EPAR for Onduarp can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Onduarp je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It is available as tablets (40 mg telmisartan/10 mg amlodipine, 40 mg telmisartan/5 mg amlodipine, 80 mg telmisartan/10 mg amlodipine and 80 mg telmisartan/5 mg amlodipine).
Na voljo je v obliki tablet (40 mg telmisartana/10 mg amlodipina, 40 mg telmisartana/5 mg amlodipina, 80 mg telmisartana/10 mg amlodipina in 80 mg telmisartana/5 mg amlodipina).
Both are medicines to lower the blood pressure that have been available in the European Union (EU) since the 1990s.
Obe zdravili sta namenjeni zniževanju krvnega tlaka in sta v Evropski uniji (EU) na voljo od 1990-ih.
Other information about Onduarp
Druge informacije o zdravilu Onduarp
This is a summary of the European public assessment report (EPAR) for Onduarp.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Onduarp.
For more information about treatment with Onduarp, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Onduarp preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
EPAR summary for the public telmisartan / amlodipine
Povzetek EPAR za javnost telmisartan/amlodipin
The main measure of effectiveness in the three studies was the fall in diastolic blood pressure (blood pressure measured between two heartbeats) after eight weeks.
Glavno merilo učinkovitosti v teh treh študijah je bilo znižanje diastoličnega krvnega tlaka (krvnega tlaka, izmerjenega med dvema srčnim utripoma) po osmih tednih.
Onduarp is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over).
Zdravilo Onduarp se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih (starih 18 let ali več).
What is the risk associated with Onduarp?
Kakšna tveganja so povezana z zdravilom Onduarp?
Onduarp is taken by mouth as one tablet once a day and is used for long-term treatment.
Zdravilo Onduarp se jemlje peroralno, in sicer ena tableta enkrat na dan, uporablja pa se za dolgotrajno zdravljenje.
When appropriate, direct switch to Onduarp may be considered.
Če je primerno, se lahko presodi o neposrednem prehodu na zdravljenje z zdravilom Onduarp.
The company that makes Twynsta has agreed that its scientific data can be used for Onduarp (‘informed consent')
Družba, ki proizvaja zdravilo Twynsta, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Onduarp („privolitev po pojasnilu“).
By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Z znižanjem krvnega tlaka se zmanjšajo tveganja, ki jih povzroča visok krvni tlak, kot je na primer kap.
Onduarp must also not be used in patients who have severe liver or bile problems, shock (a steep fall in blood pressure), severe hypotension (low blood pressure), obstruction to blood flow from the left side of their heart or in patients with heart failure after having a myocardial infarction (heart attack).
Zdravila Onduarp ne smejo uporabljati bolniki s hudimi obolenji jeter ali žolčnika, bolniki v šoku (velik padec krvnega tlaka), s hudo hipotenzijo (nizkim krvnim tlakom), oviranim krvnim pretokom iz leve strani srca ali s srčnim popuščanjem po miokardnem infarktu (srčna kap).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Onduarp.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Onduarp, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Onduarp shown during the studies?
Kakšne koristi je zdravilo Onduarp izkazalo med študijami?
The most common side effects with Onduarp (seen in between 1 and 10 patients in 100) are dizziness and peripheral oedema (swelling, especially of the ankles and feet).
Najpogostejši neželeni učinki zdravila Onduarp (opaženi pri 1 do 10 bolnikov od 100) so omotica in periferni edem (otekanje, zlasti gležnjev in stopal).
Onduarp must not be used in people who are hypersensitive (allergic) to telmisartan, amlodipine, other medicines in the ‘dihydropyridine derivatives' class or to any of the other ingredients.
Zdravila Onduarp ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) telmisartan, amlodipin, druga zdravila iz razreda „derivatov dihidropiridina“ ali katero koli drugo sestavino zdravila.
The Committee decided that Onduarp's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Onduarp večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
In the two other studies, Onduarp was more effective at reducing diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Onduarp and amlodipine, the fall in diastolic blood pressure was greater in patients taking Onduarp by between 1.4 mmHg and 4.9 mmHg.
V dveh drugih študijah je bilo zdravilo Onduarp učinkovitejše pri zniževanju diastoličnega krvnega tlaka kot nadaljnje zdravljenje z amlodipinom kot samostojnim zdravilom: odvisno od jakosti zdravila Onduarp in amlodipina, se je diastolični krvni tlak bolj znižal pri bolnikih, ki so jemali zdravilo Onduarp, in sicer za 1,4 mmHg do 4,9 mmHg.
Studies were also carried to show that Onduarp tablets are absorbed in the same way in the body as separate tablets of amlodipine and telmisartan.
Izvedene so bile tudi študije, s katerimi so želeli dokazati, da telo tablete zdravila Onduarp absorbira na enak način kot ločene tablete amlodipina in telmisartana.
In two other main studies, 1,978 adults whose hypertension had not responded adequately to amlodipine were either given Onduarp or continued to take amlodipine at the same or a higher dose.
V dveh drugih glavnih študijah, v katerih je sodelovalo 1 978 odraslih s hipertenzijo, ki se niso ustrezno odzvali na amlodipin, so bolniki prejemali zdravilo Onduarp ali pa so nadaljevali zdravljenje z enakim ali večjim odmerkom amlodipina kot samostojnega zdravila.
Onduarp can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets.
Zdravilo Onduarp lahko nadomesti zdravljenje s telmisartanom in amlodipinom pri bolnikih, ki jemljejo obe zdravili z dvema ločenima tabletama.
When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Ko kalcijevi ioni vstopijo v celice mišic v stenah žil, se začnejo te krčiti.
By blocking the receptors to which angiotensin II normally attaches, Telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Ker telmisartan zavira receptorje, na katere se angiotenzin II običajno veže, hormonu prepreči delovanje, zaradi česar se krvne žile lahko razširijo.
Onduarp is used in patients whose blood pressure is not adequately controlled by amlodipine alone.
Zdravilo Onduarp se uporablja pri bolnikih, pri katerih se krvni tlak ne uravnava ustrezno samo z amlodipinom.
In one main study, 1,461 adults with hypertension were treated with combinations of telmisartan and amlodipine, with telmisartan or amlodipine alone, or with placebo (a dummy treatment).
V eni glavni študiji je bilo 1 461 odraslih bolnikov s hipertenzijo zdravljenih s kombinacijo telmisartana in amlodipina, s telmisartanom ali amlodipinom kot samostojnim zdravilom ali s placebom (zdravilom brez zdravilne učinkovine).
Why has Onduarp been approved?
Zakaj je bilo zdravilo Onduarp odobreno?
In the first study, the falls in diastolic blood pressure seen in patients taking combinations of telmisartan and amlodipine were greater than those seen in patients taking only one of the active substances or placebo.
V prvi študiji so opazili, da je bilo znižanje diastoličnega krvnega tlaka pri bolnikih, ki so jemali kombinacijo telmisartana in amlodipina, večje kot znižanje pri bolnikih, ki so jemali samo eno od zdravilnih učinkovin ali placebo.
For the full list of all side effects reported with Onduarp, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Onduarp, glejte navodilo za uporabo.
The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to adhere to their treatment if prescribed Onduarp.
CHMP je menil, da bi bolniki, ki že jemljejo obe zdravilni učinkovini z ločenima tabletama, pri prehodu na zdravljenje z zdravilom Onduarp, lažje upoštevali režim zdravljenja.
Onduarp is a medicine that contains two active substances, telmisartan and amlodipine.
Onduarp je zdravilo, ki vsebuje dve zdravilni učinkovini, telmisartan in amlodipin.
For a patient who has been taking telmisartan and amlodipine as separate tablets, the dose of Onduarp to be taken depends on the doses of telmisartan and amlodipine that he or she was taking before.
Pri bolnikih, ki so jemali telmisartan in amlodipin v dveh ločenih tabletah, se odmerek zdravila Onduarp določi na podlagi odmerka telmisartana in amlodipina, ki ga je ta oseba jemala pred tem.
In addition, studies showed that the medicine was effective in patients whose blood pressure is not adequately controlled by amlodipine alone.
Študije so tudi pokazale, da je zdravilo učinkovito pri bolnikih, pri katerih se krvni tlak ustrezno ne uravnava z amlodipinom kot samostojnim zdravilom.
By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.
Amlodipin zmanjša pretok kalcija v celice in tako prepreči njihovo krčenje ter pomaga pri sproščanju napetosti žil.
For a patient whose blood pressure is not adequately controlled by amlodipine, separate tablets of amlodipine and telmisartan should be used to adjust the doses before switching to Onduarp.
Bolniki, pri katerih se krvni tlak ustrezno ne uravnava samo z amlodipinom, naj najprej pričnejo jemati ločeni tableti amlodipina in telmisartana za prilagoditev odmerkov pred uporabo zdravila Onduarp.
Onduarp contains two active substances, telmisartan and amlodipine.
Zdravilo Onduarp vsebuje dve zdravilni učinkovini, telmisartan in amlodipin.
They work in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Obe na podoben način sproščata napetost žil in tako nižata krvni tlak.
How has Onduarp been studied?
Kako je bilo zdravilo Onduarp raziskano?
How does Onduarp work?
Kako zdravilo Onduarp deluje?
What is Onduarp used for?
Za kaj se zdravilo Onduarp uporablja?
What is Onduarp?
Kaj je zdravilo Onduarp?
How is Onduarp used?
Kako se zdravilo Onduarp uporablja?
Under these circumstances vision loss may be rapid and severe.
V takšnih okoliščinah je izgubljanje vida lahko hitro in hudo.
Distribution, biotransformation and elimination:
Porazdelitev, biotransformacija in izločanje:
It is important to identify and treat these types of conditions as soon as possible.
Zelo pomembno je, da takšna stanja čim prej prepoznamo in zdravimo.
These finding are therefore considered to be of limited clinical relevance.
Zato velja, da so te ugotovitve omejenega kliničnega pomena.
Please do not forget to tell your doctor if you are known to be allergic to any substance.
Ne pozabite obvestiti zdravnika, če veste, da ste alergični na katerokoli snov.
The following information is intended for healthcare professionals only:
V nadaljevanju navedene informacije so namenjene le zdravstvenemu osebju:
Soon after the injection serious allergic reactions may occur.
Kmalu po injiciranju se lahko pojavi resna alergijska reakcija.
At the end of the first year (week 54), 1053 patients were re-randomized to either continue or discontinue treatment through week 102.
Na koncu prvega leta (54. teden) so približno 1.053 bolnikov ponovno randomizirali, bodisi na nadaljevanje zdravljenja ali na njegovo prekinitev do 102. tedna.
This will reduce or prevent any pain you might have with the injection.
To bo zmanjšalo ali preprečilo kakršnokoli bolečino, ki bi se lahko pojavila med injiciranjem.
Frequency of these side effects cannot be estimated from the data available.
Pogostnosti teh neželenih učinkov iz razpoložljivih podatkov ne moremo oceniti.
Investigations Uncommon increased gamma-glutamyltransferase activity
Preiskave občasni zvišanje aktivnosti gama-glutamiltransferaze
The symptoms you might experience are described in section 2 of this leaflet ("Warnings and precautions").
Simptomi, ki se vam lahko pojavijo, so opisani v 2. poglavju tega navodila („Opozorila in previdnostni ukrepi“).
Your doctor will also give you some local anaesthetic (numbing medicine).
Zdravnik vam bo dal tudi lokalni anestetik (sredstvo za omrtvičenje).
* Post-marketing experience; see “Description of selected adverse reactions”
* Izkušnje v obdobju trženja zdravila; glejte „Opis izbranih neželenih učinkov“.
The symptoms you might experience and the instruction what to do in such cases are described in section 4 of this leaflet.
Simptomi, ki se lahko pojavijo, in navodila, kaj storiti v takem primeru, so opisani v poglavju 4 tega navodila.
Data over a two-year period indicate that Macugen treatment should be initiated as early as possible.
Podatki iz dveletnega obdobja kažejo, da je treba zdravljenje z zdravilom Macugen začeti čim prej.
MARKETING AUTHORISATION NUMBER(S) EU/1/05/325/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/325/002
Elderly No special considerations are needed.
Posebna pazljivost ni potrebna.
If your doctor cannot be reached for any reason, an alternate doctor should be contacted immediately.
Če zaradi kakršnegakoli razloga ne morete priti do svojega zdravnika, se morate nemudoma obrniti na drugega zdravnika.
Patients had up to one prior PDT and baseline visual acuity in the study eye between 20/40 and 20/320.
Bolniki so imeli do eno predhodno PDT in izhodiščno ostrino vida na proučevanem očesu med 20/40 in 20/320.
Patients should be instructed not to drive or use machines until this has resolved.
Bolnikom je treba naročiti, da ne smejo voziti ali upravljati strojev, dokler to ne mine.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Date of latest renewal: 19/11/2015
Datum prve odobritve: 31.1.2006 Datum zadnjega podaljšanja: 19.11.2015
Read all of this leaflet carefully before you start your treatment with this medicine because it contains important information for you.
Pred začetkom zdravljenja natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Children and adolescents Macugen should not be used in children and adolescents under 18 years old.
Zdravila Macugen se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
The plunger stopper should not be pulled back.
Gumijastega tesnila ne smete potegniti nazaj.
On average, the treatment benefit was maintained at 102 weeks with continuing preservation of visual acuity for patients re-randomized to continue pegaptanib.
V povprečju se je korist zdravljenja ohranila do 102. tedna z nadaljnjo ohranitvijo ostrine vida pri bolnikih, ponovno randomiziranih na nadaljevanje zdravljenja s pegaptanibom.
The European Medicines Agency has waived the obligation to submit the results of studies with Macugen in all subsets of the paediatric population in age-related macular degeneration.
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Macugen pri vseh podskupinah pediatrične populacije s starostno degeneracijo makule.
Before the treatment is given your doctor may ask you to use antibiotic eye drops, or to wash your eyes carefully.
Preden boste prejeli zdravilo, vam bo zdravnik morda naročil, da uporabite antibiotične kapljice za oko ali da si oči dobro umijete.
Store in a refrigerator (2ºC to 8ºC).
Shranjujte v hladilniku (2-8 °C).
Your doctor will monitor your condition and recommend how long you should be treated with Macugen.
Zdravnik bo spremljal vaše stanje in vam svetoval, kako dolgo naj traja zdravljenje z zdravilom Macugen.
• There is no experience of using Macugen in pregnant women.
• Ni podatkov o uporabi zdravila Macugen pri nosečih ženskah.
Other possible side effects are as follows:
Drugi možni neželeni učinki so:
Mean Change in VA from Week 0 (Letters)
povprečna sprememba VA od tedna 0 (črke)
Pegaptanib pharmacokinetics is similar in female and male patients and within the age range 50 to 90 years.
Farmakokinetika pegaptaniba je podobna pri bolnikih ženskega in moškega spola, starih od 50 let do 90 let.
Animal studies are insufficient, but have shown reproductive toxicity at high systemic exposure levels (see section 5.3).
Študije na živalih niso bile zadostne, vendar so pokazale toksične učinke na sposobnost razmnoževanja pri veliki sistemski izpostavljenosti (glejte poglavje 5.3).
The odds of increased IOP was increased by a factor of 1.128 for each additional injection (p= 0.0003).
Obeti za zvišan očesni tlak so se po vsakem dodatnem injiciranju povečali za faktor 1,128 (p = 0,0003).
The macula enables the eye to provide the fine central vision that is needed for activities such as driving a car, reading fine print and other similar tasks.
Makula je del, s katerim oko omogoča podroben osrednji vid, potreben za dejavnosti, kakršne so vožnja avta, branje drobnega tiska in podobno.
Nevertheless, Macugen should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Kljub temu je dovoljeno zdravilo Macugen med nosečnostjo uporabiti le, če možna korist za mater upravičuje potencialno tveganje za plod.
Treating physician should always expel excess volume of solution according to instructions under the section 6.6.
Zdravnik mora vedno odstraniti odvečni volumen raztopine v skladu z navodili v poglavju 6.6.
What Macugen is and what it is used for
Kaj je zdravilo Macugen in za kaj ga uporabljamo
At one year, pegaptanib 0.3 mg exhibited a statistically significant treatment benefit for the primary efficacy endpoint; proportion of patients losing less than 15 letters of visual acuity (prespecified pooled analysis, pegaptanib 0.3 mg 70% versus Sham 55%, p = 0.0001; EOP1003 pegaptanib 0.3 mg 73% versus Sham 59%, p = 0.0105; EOP1004 pegaptanib 0.3 mg 67% versus Sham 52%, p = 0.0031).
Po enem letu je pegaptanib v odmerku 0,3 mg v obeh preskušanjih pokazal statistično pomembno korist zdravljenja, kar zadeva učinkovitost kot primarni opazovani dogodek, tj. delež bolnikov, ki se jim je ostrina vida zmanjšala za manj kot 15 črk (vnaprej določena kumulativna analiza, pegaptanib 0,3 mg 70 %, placebo 55 %, p = 0,0001; EOP1003 pegaptanib 0,3 mg 73 %, placebo 59 %, p = 0,0105; EOP1004 pegaptanib 0,3 mg 67 %, placebo 52 %, p = 0,0031).
What you need to know before you are given Macugen
Kaj morate vedeti, preden boste prejeli zdravilo Macugen
A direct relationship to Macugen or any of the various treatments administered as part of the injection preparation procedure, or to other factors has not been established in these cases.
Direktna povezava z zdravilom Macugen, drugimi zdravljenji, ki se uporabljajo pri postopku priprave na injiciranje, ali z drugimi faktorji v teh primerih ni bila dokazana.
Please read section 2.
Preberite 2. poglavje.
A decrease in creatinine clearance down to 20 ml/min may be associated with up to a 2.3-fold increase in pegaptanib AUC.
Zmanjšanje očistka kreatinina do 20 ml/min lahko spremlja do 2,3-kratno povečanje AUC pegaptaniba.
Other medicines and Macugen
Druga zdravila in zdravilo Macugen
Caution should be exercised when treating such patients (see section 4.8, heading ‘Product-class-related adverse reactions').
Pri zdravljenju takih bolnikov je potrebna previdnost (glejte poglavje 4.8, pod naslovom „Na skupino zdravil vezani neželeni učinki“).
In mice, rats, rabbits, dogs and monkeys, pegaptanib distributes primarily into plasma volume and is not extensively distributed to peripheral tissues after intravenous administration.
Pri miših, podganah, kuncih, psih in opicah se pegaptanib porazdeli predvsem v plazemski volumen in se po intravenski uporabi ne porazdeli izdatno v periferna tkiva.
• Macugen is not recommended during breastfeeding as it is not known whether Macugen passes into human milk.
• Uporaba zdravila Macugen med dojenjem ni priporočljiva, ker ni znano, ali zdravilo Macugen prehaja v materino mleko.
If you are affected, do not drive or use machines until this resolves.
Če se to zgodi, ne upravljajte vozil in strojev, dokler ne mine.
Summary of Mean Changes in Visual Acuity from Baseline to Weeks 6, 12, 54 and 102 (LOCF) EOP 1004
Povzetek povprečne spremembe VA od začetka do tedna 6, 12, 54 in 102 (zadnje izvedeno opazovanje) EOP 1003
A total of 1190 patients were treated (892 pegaptanib, 298 sham (control)) with a median age of 77 years.
Skupaj je bilo zdravljenih 1.190 bolnikov (892 jih je dobivalo zdravilo Macugen in 298 placebo (kontrolno snov)); mediana starost je bila 77 let.
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih občasni
Reduced body weight (5%) and minimal delayed ossification in forepaw phalanges were observed, only at exposure levels based on AUC of over 300 fold greater than that expected in humans.
Opažali so zmanjšanje telesne mase (5 %) in minimalno zamudo pri osifikaciji falang sprednjih tac, a le pri izpostavljenostih, ki so bile na podlagi AUC več kot 300-krat večje, kot so pričakovane pri človeku.
The safety and efficacy of Macugen beyond two years has not been demonstrated.
Varnost in učinkovitost zdravila Macugen pri terapiji, daljši od dveh let, nista bili dokazani.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Macugen treatment.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se pred zdravljenjem z zdravilom Macugen posvetujte z zdravnikom.
All injections of Macugen will be administered by your doctor.
Vse injekcije zdravila Macugen vam bo dal zdravnik.
At this point, the remaining content of the syringe should be injected.
Preostalo vsebino injekcijske brizge se sedaj lahko injicira.
After each injection you might be asked to use antibiotic eye drops (or another type of antibiotic treatment) to guard against eye infection.
Po vsakem injiciranju vam bo zdravnik morda naročil, da za zaščito pred okužbo uporabite antibiotične kapljice za oko (ali kakšno drugo vrsto antibiotičnega zdravila).