natgillin/translations-raw huggingface dataset:
In this study, Riarify was as effective as tiotropium plus a combination of beclometasone and formoterol at reducing the number of exacerbations.
V tej študiji je bilo zdravilo Riarify pri zmanjševanju števila izbruhov enako učinkovito kot tiotropij in kombinacija beklometazona in formoterola.
Riarify contains the active substances beclometasone, formoterol and glycopyrronium bromide.
Zdravilo Riarify vsebuje učinkovine beklometazon, formoterol in glikopironijev bromid.
Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Ker ti receptorji pomagajo pri nadzoru krčenja mišic dihalnih poti, se mišice z zaviranjem receptorjev sprostijo, kar pomaga ohranjati dihalne poti prehodne in bolniku omogoča lažje dihanje.
The three active substances in Riarify work in different ways to reduce inflammation and keep the airways open, allowing the patient to breathe more easily.
Tri učinkovine v zdravilu Riarify na različne načine zmanjšujejo vnetje in ohranjajo prehodnost dihalnih poti, kar bolniku omogoča lažje dihanje.
By attaching to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Z vezavo na te receptorje sprošča mišice, kar ohranja dihalne poti prehodne in bolniku olajša dihanje.
Riarify has been shown to be effective at relieving symptoms of COPD in three main studies involving over 5,500 patients whose symptoms were not controlled well enough either by combinations of two other COPD medicines or by a muscarinic receptor antagonist alone.
V treh glavnih študijah, ki so vključevale več kot 5 500 bolnikov, pri katerih simptomi s kombinacijo dveh drugih zdravil za zdravljenje KOPB ali samostojnim antagonistom muskarinskih receptorjev niso bili ustrezno nadzorovani, so dokazali, da je zdravilo Riarify učinkovito pri lajšanju simptomov KOPB.
By comparison, the FEV1 increased by 1 and 145 ml before and after dosing in patients treated with a medicine containing only 2 of the active substances found in Riarify (beclometasone plus formoterol).
Za primerjavo se je pri bolnikih, zdravljenih z zdravilom, ki vsebuje le dve od učinkovin, ki jih vsebuje zdravilo Riarify (beklometazon in formoterol), FEV1 izboljšal za 1 ml pred prejetim odmerkom in 145 ml po prejetem odmerku.
This overview was last updated in September 2019.
Ta povzetek je bil nazadnje posodobljen septembra 2019.
These usually disappear without any treatment.
Vse te spremembe običajno izginejo brez zdravljenja.
Treated cats should not be permitted to sleep with their owners, especially children, on the day of treatment.
Zdravljene mačke na dan zdravljenja ne smejo spati pri svojih lastnikih, zlasti ne pri otrocih.
Further information on Vectra Felis can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/vectra-felis.
Nadaljnje informacije o zdravilu Vectra Felis so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/vectra-felis.
Contact with the skin, eyes or mouth should be avoided.
Izogibati se je treba stiku s kožo, očmi ali usti.
The need to re-treat cats and the time interval between treatments requires veterinary assessment.
Potrebo po ponovnem zdravljenju mačk in časovnem intervalu med zdravljenjem mora oceniti veterinar.
Vectra Felis received a marketing authorisation valid throughout the EU on 6 June 2014.
Zdravilo Vectra Felis je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 6. junija 2014.
People with known hypersensitivity (allergy) to any of the ingredients should avoid contact with the product.
Osebe z znano preobčutljivostjo za (alergijo na) katero koli sestavino naj se izogibajo stiku z zdravilom.
Used applicators should be disposed of immediately and not left within the sight or reach of children.
Uporabljene aplikatorje je treba takoj zavreči in jih ne puščati na mestu, ki je vidno ali dosegljivo otrokom.
This means that it kills parasites that occur on the skin or in the fur of animals, such as fleas that feed on the animal's skin.
To pomeni, da uniči parazite, ki živijo na koži ali v dlaki živali, kot so bolhe, ki se hranijo s kožo živali.
The European Medicines Agency decided that Vectra Felis' benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Vectra Felis večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Vectra Felis must not be used in cats or kittens weighing less than 0.6 kg.
Zdravilo Vectra Felis se ne sme uporabljati pri mačkah ali muckah, ki tehtajo manj kot 0,6 kg.
Hands should be thoroughly washed immediately after use.
Takoj po uporabi zdravila si je treba temeljito umiti roke.
The effectiveness of Vectra Felis against fleas was investigated in a large number of laboratory studies and in one field study.
Učinkovitost zdravila Vectra Felis proti bolham so raziskali v številnih laboratorijskih študijah in eni terenski študiji.
Dinotefuran is an insecticide which kills insects by acting on receptors (targets) in their nervous system called nicotinic acetylcholine receptors.
Dinotefuran je insekticid, ki uničuje žuželke z delovanjem na receptorje (prijemališča) v njihovem živčnem sistemu, ki se imenujejo nikotinski acetilholinski receptorji.
It also prevents fleas from hatching and developing in the cat's environment.
Poleg tega preprečuje, da bi se bolhe izvalile in razvile v okolju mačke.
Other information about Vectra Felis
Druge informacije o zdravilu Vectra Felis
The field study involved 129 cats with flea infestations that were treated once a month for three consecutive months either with Vectra Felis or with another spot-on product containing two different substances, fipronil and (S)-methoprene, that control fleas.
V terensko študijo je bilo vključenih 129 mačk z bolhami, ki so jih tri zaporedne mesece enkrat na mesec zdravili bodisi z zdravilom Vectra Felis bodisi z drugim zdravilom za kožni nanos, ki vsebuje dve različni zdravilni učinkovini, fipronil in (S)-metopren, ki se uporabljata za nadzor bolhavosti.
People must not handle treated cats for at least eight hours after application of the veterinary medicine.
Ljudje se morajo stiku z zdravljeno živaljo izogibati vsaj osem ur po nanosu zdravila za uporabo v veterinarski medicini.
Vectra Felis was as effective as the comparator product and reduced flea counts by 91% over the 84 day study period.
Zdravilo Vectra Felis je bilo enako učinkovito kot primerjalno zdravilo in je v 84 dneh trajanja študije zmanjšalo število bolh za 91 %.
Why is Vectra Felis authorised in the EU?
Zakaj je zdravilo Vectra Felis odobreno v EU?
Vectra Felis acts as an ectoparasiticide.
Zdravilo Vectra Felis deluje kot ektoparaziticid.
An overview of Vectra Felis and why it is authorised in the EU
Pregled zdravila Vectra Felis in zakaj je odobreno v EU
In case of accidental spillage onto skin, the area should be washed off immediately with soap and water.
V primeru nenamernega razlitja po koži je treba površino nemudoma sprati z milom in vodo.
Vectra Felis is a veterinary medicine used to treat and prevent flea infestations in cats.
Vectra Felis je zdravilo za uporabo v veterinarski medicini za zdravljenje in preprečevanje infestacij z bolhami pri mačkah.
The most common side effects with Vectra Felis (which may affect up to 1 in 1000 cats) are a slight scaling of the skin, temporary redness and itching or temporary hair loss at the application site.
Najpogostejši neželeni učinki zdravila Vectra Felis (ki lahko prizadenejo največ eno mačko od 1 000) so rahlo luščenje kože, prehodna rdečina in srbenje ali prehodna izguba dlake na mestu nanosa.
If accidental exposure to the eyes occurs, the eyes should be rinsed with water with the eyelids open and for a sufficient length of time.
Če pride do nenamernega stika z očmi, jih je treba dovolj dolgo spirati z vodo in pri tem držati veke odprte.
What benefits of Vectra Felis have been shown in studies?
Kakšne koristi je zdravilo Vectra Felis izkazalo v študijah?
If skin or eye irritation persists, or if the veterinary medicine is accidentally swallowed, immediate medical advice should be sought and the package leaflet or label shown to the doctor.
Če je draženje kože ali oči prisotno dalj časa ali če je prišlo do nenamernega zaužitja zdravila, se je treba takoj posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali ovojnino.
What are the risks associated with Vectra Felis?
Kakšna tveganja so povezana z zdravilom Vectra Felis?
For a full list of all side-effects reported with Vectra Felis, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vectra Felis, glejte navodilo za uporabo.
What is Vectra Felis and what is it used for?
Kaj je zdravilo Vectra Felis in za kaj se uporablja?
Pyriproxyfen is an insect growth regulator which stops the flea life cycle by causing production of infertile eggs as well as by blocking the development of immature flea stages into adults.
Piriproksifen je regulator rasti žuželk, ki prekine življenjski cikel bolh, tako da povzroči nastajanje neplodnih jajčec in zavira preobrazbo nezrelih bolh v odrasle bolhe.
Vectra Felis is available as a spot-on solution in an applicator and can be obtained without a prescription.
Zdravilo Vectra Felis je na voljo v obliki raztopine za kožni nanos v aplikatorju in se lahko izda brez recepta.
The content of one full Vectra Felis applicator is applied directly to the cat's skin, after parting its fur, at the base of the cat's head.
Vsebina enega polnega aplikatorja zdravila Vectra Felis se nanese neposredno na mačkino kožo med razmaknjeno dlako na zatilju njene glave.
After a single treatment, Vectra Felis prevents fleas for one month and blocks the flea life cycle so preventing infestation in the cat's environment for three months.
Zdravilo Vectra Felis po enkratnem nanosu še en mesec preprečuje infestacijo z bolhami in zavira njihov življenjski cikel, s čimer tri mesece zavira pojavljanje bolh v okolju mačke.
How does Vectra Felis work?
Kako zdravilo Vectra Felis deluje?
How is Vectra Felis used?
Kako se zdravilo Vectra Felis uporablja?
0.5 milligram Al3+
0,5 miligrama Al3+
* adsorbed on aluminium phosphate
* adsorbiran na aluminijev fosfat
1 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
1 konjugiran na nosilno beljakovino D (pridobljena iz netipiziranega Haemophilus influenzae)
--1 1 dose (0.5 ml) contains: Pneumococcal polysaccharide serotype 1* 1
--1 1 odmerek (0,5 ml) vsebuje: Pnevmokokni polisaharid serotip 1* 1
Pneumococcal polysaccharide serotype 18C* 2
Pnevmokokni polisaharid serotip 18C* 2
2 conjugated to tetanus toxoid carrier protein
2 konjugiran na nosilno beljakovino tetanusnega toksoida
Pneumococcal polysaccharide serotype 9V* 1
Pnevmokokni polisaharid serotip 9V* 1
Pneumococcal polysaccharide serotype 6B* 1
Pnevmokokni polisaharid serotip 6B* 1
1 pre-filled syringe + 1 needle
1 napolnjena injekijska brizga + 1 igla
3 conjugated to diphtheria toxoid carrier protein
3 konjugiran na nosilno beljakovino davičnega toksoida
10 pre-filled syringes + 10 needles
10 napolnjenih injekcijskih brizg + 10 igel
Strength Pharmaceutical form
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
Outcome of a procedure under Article 30 of Directive 2001/83/EC
Rezultat postopka v skladu s členom 30 Direktive 2001/83/ES
The European Commission issued a decision on 13 July 2010.
Evropska komisija je odločbo izdala 13. julija 2010.
• essential hypertension;
• esencialno hipertenzijo;
Dr Alar Irs (Estonia)
dr. Alar Irs (Estonija)
Dr Pieter de Graeff (The Netherlands)
dr. Pieter de Graeff (Nizozemska)
Why was Atacand reviewed?
Zakaj je bilo zdravilo Atacand pregledano?
The companies that market these medicines are AstraZeneca and Takeda.
Družbi, ki ta zdravila tržita, sta AstraZeneca in Takeda.
Atacand is authorised in the EU via national procedures.
Zdravilo Atacand je v EU odobreno z nacionalnimi postopki.
The European Medicines Agency has completed a review of Atacand and associated names.
Evropska agencija za zdravila je zaključila pregled zdravila Atacand in povezana imena.
There were little differences among Member States in the special warnings section.
Pri posebnih opozorilih so bile med državami članicami majhne razlike.
Atacand is also available in the EU under other trade names: Amias, Blopress, Kenzen, Parapres, Racanda and Ratacand.
Zdravilo Atacand je na voljo v EU tudi pod drugimi imeni: Amias, Blopress, Kenzen, Parapres, Racanda in Ratacand.
The CHMP recommended that Atacand should be used to treat adult patients with:
CHMP je priporočil, da se zdravilo Atacand uporablja za zdravljenje odraslih bolnikov z:
Some Member States had not approved the 32 mg dose for treating hypertension and there were differences in how heart failure was defined.
Nekatere države članice niso odobrile odmerka 32 mg za zdravljenje hipertenzije, poleg tega so bila prisotna razhajanja glede opredelitve srčnega popuščanja.
This helps blood pressure to drop, which also makes it easier for the heart to pump out blood.
To pomaga znižati krvni tlak in omogoča, da srce laže črpa kri.
Atacand is a medicine used to treat essential hypertension (high blood pressure) in adults.
Atacand je zdravilo, ki se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
For heart failure, the starting dose is 4 mg once a day, which can also be increased at intervals of at least two weeks up to a maximum of 32 mg once daily.
Pri srčnem popuščanju je začetni odmerek 4 mg enkrat dnevno, ki ga je mogoče povečati v najmanj dvotedenskih intervalih na največ 32 mg enkrat dnevno.
The recommended starting dose for treating hypertension is 8 mg once a day, which can be increased to a maximum of 32 mg once a day, depending on how the patient's blood pressure responds.
Priporočeni začetni odmerek pri zdravljenju hipertenzije je 8 mg enkrat dnevno in ga je mogoče povečati na največ 32 mg enkrat dnevno, odvisno od odziva krvnega tlaka bolnika.
This has led to divergences among Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
To je v različnih državah članicah privedlo do razhajanj glede uporabe zdravila, kakor je razvidno iz povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo v državah, v katerih je zdravilo v prometu.
It must also not be given to women in their second or third trimesters of pregnancy or to patients with severe liver impairment or cholestasis (problems with the elimination of bile).
Prav tako ga ni dovoljeno dajati ženskam v drugem ali tretjem trimesečju nosečnosti ali bolnikom s hudo okvaro jeter ali holestazo (težavami z izločanjem žolča).
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Atacand in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Atacand.
The Committee recommend that Atacand must not be used in patients who are hypersensitive (allergic) to candesartan cilexetil or to any of the ingredients.
Odbor je priporočil, da se zdravilo Atacand ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) kandesartan cileksetil ali katero koli drugo sestavino zdravila.
The Committee harmonised the warning on hyperkalaemia (high blood potassium levels) across all Member States' SmPCs.
Odbor je uskladil opozorilo glede hiperkalemije (visokih ravni kalija v krvi) v povzetkih glavnih značilnosti zdravil v vseh državah članicah.
On 16 July 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Atacand in the EU.
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Atacand v EU, je 16. julija 2009 zadevo napotila na CHMP.
The active substance in Atacand, candesartan cilexetil, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Zdravilna učinkovina zdravila Atacand, kandesartan cileksetil, je „antagonist človeškega receptorja za angiotenzin II“, ki zavira delovanje hormona angiotenzin II v telesu.
By blocking the receptors to which angiotensin II normally attaches, candesartan cilexetil stops the hormone having an effect, allowing the blood vessels to widen.
Kandesartan cileksetil z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, preprečuje učinek hormona in omogoča širjenje krvnih žil.
It is also used to treat heart failure in adult patients with impaired left ventricular systolic function who are receiving treatment with ‘angiotensin converting enzyme (ACE) inhibitors' or who cannot be given ACE inhibitors.
Uporablja se tudi za zdravljenje srčnega popuščanja pri odraslih bolnikih z oslabljeno sistolično funkcijo levega prekata, ki prejemajo „zaviralce angiotenzijske konvertaze (zaviralce ACE)“ ali ki teh zaviralcev ne morejo prejemati.
• heart failure and impaired left ventricular systolic function as ‘add-on' therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
• srčnim popuščanjem in oslabljeno sistolično funkcijo levega prekata kot dodatno zdravljenje poleg zaviralcev ACE ali kadar bolniki teh zaviralcev ne prenašajo.
Company responses provided on: 8 October 2009, 12 February 2010 Opinion date:
8. oktobra 2009, 12. februarja 2010
What is Atacand?
Kaj je zdravilo Atacand?
Atacand was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Atacand potrebno usklajevanje.
Darunavir Krka may be given to adults or children from 3 years of age and weighing at least 15 kg.
Zdravilo Darunavir Krka se lahko daje odraslim ali otrokom, starejšim od treh let, ki tehtajo najmanj 15 kg.
The full EPAR for Darunavir Krka 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 Darunavir Krka je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Darunavir Krka.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Darunavir Krka.
What measures are being taken to ensure the safe and effective use of Darunavir Krka?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Darunavir Krka?
As for every medicine, the company provided studies on the quality of Darunavir Krka.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Darunavir Krka.
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Krka.
Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Prezista, zato jih ni treba ponoviti za zdravilo Darunavir Krka.
The European Medicines Agency concluded that, in accordance with EU requirements, Darunavir Krka has been shown to have comparable quality and to be bioequivalent to Prezista.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Darunavir Krka primerljivo raven kakovosti kot referenčno zdravilo Prezista ter da mu je biološko enakovredno.
Because Darunavir Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Darunavir Krka generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
What are the benefits and risks of Darunavir Krka?
Kakšne so koristi in tveganja, povezani z zdravilom Darunavir Krka?
This means that Darunavir Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Prezista.
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“ Prezista, ki je že odobreno v Evropski uniji (EU).
Darunavir Krka is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Darunavir Krka je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV pri bolnikih, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
For more information about treatment with Darunavir Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Darunavir Krka preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Krka have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Darunavir Krka upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Darunavir Krka, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Darunavir Krka v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
What is Darunavir Krka and what is it used for?
Kaj je zdravilo Darunavir Krka in za kaj se uporablja?
Darunavir Krka does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Darunavir Krka ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
For practical information about using Darunavir Krka, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Darunavir Krka naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
It is not intended to provide practical advice on how to use Darunavir Krka.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Other information about Darunavir Krka
Druge informacije o zdravilu Darunavir Krka
The active substance in Darunavir Krka, darunavir, is a protease inhibitor.
Zdravilna učinkovina zdravila Darunavir Krka, darunavir, je zaviralec proteaze.
Darunavir Krka is a ‘generic medicine'.
Zdravilo Darunavir Krka je „generično zdravilo“.
The medicine is always taken with low-dose ritonavir and with other HIV medicines, and should be taken with food.
Zdravilo Darunavir Krka se vedno jemlje v kombinaciji z nizkimi odmerki ritonavirja in drugimi zdravili za zdravljenje okužbe s HIV, jemati pa ga je treba sočasno s hrano.
Darunavir Krka is available as tablets.
Zdravilo Darunavir Krka je na voljo v obliki tablet.
Darunavir Krka can only be obtained with a prescription and treatment should be started by a healthcare professional who has experience in the management of HIV.
Predpisovanje in izdaja zdravila Darunavir Krka je le na recept, zdravljenje z njim pa mora uvesti zdravnik specialist, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
Why is Darunavir Krka approved?
Zakaj je bilo zdravilo Darunavir Krka odobreno?