natgillin/translations-raw huggingface dataset:
Not known: acute generalised exanthematous pustulosis (AGEP)
Redki: akutna generalizirana eksantematozna pustuloza (AGEP)
Contact a doctor immediately if you experience a serious skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis).
Če se pri vas pojavi resna kožna reakcija: rdeč, luskast izpuščaj s podkožnimi bulicami in mehurji (eksantematozna pustuloza), se nemudoma obrnite na zdravnika.
This summary was last updated in 10-2014.
Povzetek je bil nazadnje posodobljen 10-2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Prezista on 12 February 2007.
Evropska komisija je dovoljenje za promet z zdravilom Prezista, veljavno po vsej Evropski uniji, izdala 12. februarja 2007.
Other information about Prezista
Druge informacije o zdravilu Prezista
What measures are being taken to ensure the safe and effective use of Prezista?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Prezista?
It is available as tablets (75, 150, 300, 400, 600, and 800 mg) and as an oral suspension (100 mg/ml).
Na voljo je v obliki tablet (75, 150, 300, 400, 600 in 800 mg) in kot peroralna suspenzija (100 mg/ml).
The full EPAR for Prezista 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 Prezista je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
In adults, Prezista has been studied in six main studies.
Pri odraslih so zdravilo Prezista proučevali v šestih glavnih študijah.
It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Zavira encim, imenovan proteaza, ki sodeluje pri razmnoževanju virusa HIV.
The oral suspension is available for patients unable to swallow the tablets.
Peroralna suspenzija je na voljo za bolnike, ki ne morejo pogoltniti tablet.
A risk management plan has been developed to ensure that Prezista is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Prezista je bil pripravljen načrt obvladovanja tveganj.
For more information about treatment with Prezista, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Prezista preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Prezista.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prezista.
What benefit has Prezista shown during the studies?
Kakšne koristi je zdravilo Prezista izkazalo med študijami?
The main measures of effectiveness were based on the change in HIV levels in the blood (viral load).
Glavna merila učinkovitosti so temeljila na spremembi ravni virusa HIV v krvi (virusnega bremena).
The CHMP decided that Prezista's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Prezista večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Side effects are similar in children and adolescents.
Pri otrocih in mladostnikih prihaja do podobnih neželenih učinkov.
The 300- and 600-mg tablets contain a colouring agent called sunset yellow (E110), which can cause allergies.
300- in 600-miligramske tablete vsebujejo oranžno rumeno barvilo (E110), ki lahko povzroči alergije.
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 Prezista.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Immune reconstitution syndrome happens when the patient's immune system starts working again and fights existing infections, causing inflammation at the site of the infection.
Sindrom imunske reaktivacije nastopi, ko začne bolnikov imunski sistem ponovno delovati in se boriti proti obstoječim okužbam, kar povzroči vnetje na okuženem mestu.
The study included both previously treated patients and those who had not received HIV medicines before.
Študija je vključevala predhodno zdravljene bolnike in tudi tiste, ki zdravil za zdravljenje okužbe z virusom HIV predhodno še niso prejemali.
In adults who had not been treated before, Prezista was as effective as lopinavir.
Pri odraslih, ki predhodno niso bili zdravljeni, je bilo zdravilo Prezista enako učinkovito kot lopinavir.
What is the risk associated with Prezista?
Kakšna tveganja so povezana z zdravilom Prezista?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Prezista, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Prezista is a medicine that contains the active substance darunavir.
Prezista je zdravilo, ki vsebuje zdravilno učinkovino darunavir.
Either ritonavir or cobicistat is used with Prezista as a ‘booster'.
Ritonavir ali kobicistat se z zdravilom Prezista uporabljata kot „spodbujevalca“.
Prezista must not be taken by patients who have severely reduced liver function, or who are taking certain other medicines which may decrease blood levels of darunavir, ritonavir or cobicistat, and therefore cause a lack of effect.
Zdravilo Prezista se ne sme uporabljati pri bolnikih, ki imajo hudo zmanjšano jetrno funkcijo ali jemljejo druga zdravila, ki lahko znižujejo ravni darunavirja, ritonavirja in kobicistata v krvi, ter tako zmanjšujejo njegov učinek.
Why has Prezista been approved?
Zakaj je bilo zdravilo Prezista odobreno?
When the enzyme is blocked, the virus does not reproduce normally and its rate of replication slows down.
Ko je encim zavrt, se virus ne razmnožuje več normalno, ampak upočasnjeno.
Patients who are allergic to this agent may need to take the lower strength tablets, which do not contain sunset yellow.
Bolniki, ki so alergični nanj, bodo morda morali jemati tablete manjše jakosti, ki tega barvila ne vsebujejo.
Prezista does not cure HIV infection or AIDS, but it may delay or reverse the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo ne ozdravi okužbe z virusom HIV ali aidsa, vendar pa lahko upočasni slabšanje imunskega sistema ali izboljša njegovo stanje ter zavira razvoj okužb in bolezni, povezanih z aidsom.
The active substance in Prezista, darunavir, is a protease inhibitor.
Zdravilna učinkovina zdravila Prezista, darunavir, je zaviralec proteaze.
For the full list of these medicines, see the package leaflet.
Za celoten seznam teh zdravil glejte navodilo za uporabo.
Prezista, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Če se zdravilo Prezista jemlje v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV, zmanjša količino tega virusa v krvi in ga ohranja na nizki ravni.
This allows a lower dose of darunavir to be used for the same antiviral effect.
Uporaba spodbujevalca omogoča uporabo manjšega odmerka darunavirja za dosego enakega protivirusnega učinka.
Prezista is used together with low-dose ritonavir and other HIV medicines to treat adults and children aged three years or over who are infected with human immunodeficiency virus (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Prezista se uporablja skupaj z nizkim odmerkom ritonavirja in drugimi zdravili za zdravljenje okužbe z virusom HIV pri odraslih in otrocih, starejših od treh let, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
In adults, Prezista is also used with another medicine, cobicistat, in combination with other HIV medicines to treat HIV-1 infection.
Pri odraslih se zdravilo Prezista uporablja tudi skupaj z drugim zdravilom, kobicistatom, v kombinaciji z drugimi zdravili proti virusu HIV za zdravljenje okužbe z virusom HIV-1.
Previously treated children may be given similar once-daily doses, provided that their disease is not resistant to Prezista, but treatment is usually with a dose between 380 and 600 mg twice daily, depending on their weight.
Otroci, ki so predhodno že bili zdravljeni, lahko prejemajo podoben dnevni odmerek, če njihova bolezen ni odporna proti zdravilu Prezista, toda običajno zdravljenje poteka z odmerkom med 380 in 600 mg dvakrat na dan, odvisno od njihove telesne mase.
Ritonavir-boosted Prezista has also been studied in 101 previously treated children aged between three and 18 years and 12 previously untreated children aged between 12 to 18 years who weighed at least 40 kg.
Zdravilo Prezista, spodbujeno z ritonavirjem, so proučevali tudi pri 101 predhodno zdravljenem otroku, starem od tri do 18 let, in 12 otrocih, starih od 12 do 18 let, ki so tehtali vsaj 40 kg in predhodno niso bili zdravljeni.
A dose of 800 mg once a day can also be taken by previously treated patients, provided that the patients are healthy enough and that the HIV virus causing their infection has been shown not to be resistant to Prezista.
Pri predhodno zdravljenih bolnikih se lahko vzame tudi 800-miligramski odmerek enkrat na dan, če to dopušča zdravstveno stanje bolnika in je bilo ugotovljeno, da virus HIV, ki je povzročil okužbo, ni odporen proti zdravilu Prezista.
In all of the studies, the patients also took other HIV medicines.
V vseh so bolniki jemali tudi druga zdravila za zdravljenje okužbe z virusom HIV.
For the full list of all side effects reported with Prezista, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Prezista, glejte navodilo za uporabo.
For previously untreated children aged from 3 to 17 years and weighing at least 15 kg, the recommended dose varies between 600 and 800 mg once daily depending on the body weight.
Pri predhodno nezdravljenih otrocih, starih od tri do 17 let in ki tehtajo najmanj 15 kg, je priporočeni odmerek med 600 in 800 mg enkrat na dan, odvisno od njihove telesne mase.
The medicine is always taken with cobicistat (in adults) or with low-dose ritonavir (in adults and children) plus other HIV medicines, and should be taken with food.
Zdravilo se vedno jemlje skupaj s kobicistatom (pri odraslih) ali nizkim odmerkom ritonavirja (pri odraslih in otrocih) ob hkratnem jemanju drugih zdravil za zdravljenje okužbe z virusom HIV.
Treatment with Prezista should be started by a healthcare professional who has experience in the management of HIV infection.
Zdravljenje z zdravilom Prezista lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
The other two studies compared ritonavir-boosted Prezista with other protease inhibitors chosen on the basis of the patient's previous treatments and predicted response, in a total of 628 patients who had taken many anti-HIV medicines in the past.
V preostalih dveh študijah so zdravilo Prezista, spodbujeno z ritonavirjem, primerjali z drugimi zaviralci proteaze, ki so bili izbrani na podlagi predhodnih zdravljenj bolnika in predvidenega odziva, pri skupno 628 bolnikih, ki so v preteklosti jemali različna zdravila za zdravljenje okužb z virusom HIV.
In adults who had been treated before, those taking Prezista achieved lower viral loads than those taking the comparator protease inhibitors.
Pri odraslih, ki so bili predhodno zdravljeni, je bilo virusno breme pri tistih, ki so jemali zdravilo Prezista, manjše kot pri tistih, ki so jemali primerjalne zaviralce proteaze.
The fifth study involved 590 adults who had been treated before and compared Prezista 800 mg once a day with Prezista 600 mg twice a day.
V peti študiji, ki je vključevala 590 predhodno zdravljenih odraslih, so primerjali 800-miligramski odmerek zdravila Prezista enkrat na dan s 600-miligramskim odmerkom dvakrat na dan.
These booster medicines slow the rate at which darunavir is broken down, increasing the levels of darunavir in the blood.
Ta upočasnita hitrost razgradnje darunavirja in s tem zvišata njegove ravni v krvi.
Prezista in combination with the booster cobicistat was evaluated in a study in 313 adult patients all of whom received 800 mg Prezista and 150 mg cobicistat once a day, in addition to two other HIV medicines.
Zdravilo Prezista je bilo v kombinaciji s kobicistatom ocenjeno v študiji z 313 odraslimi bolniki, od katerih so vsi prejemali 800-miligramski odmerek zdravila Prezista in 150-miligramski odmerek kobicistata enkrat na dan poleg dveh drugih zdravil za zdravljenje okužbe z virusom HIV.
One study compared ritonavir-boosted Prezista with ritonavir-boosted lopinavir in 604 patients who had taken some anti-HIV medicines in the past.
V eni študiji so zdravilo Prezista, spodbujeno z ritonavirjem, primerjali z lopinavirjem, spodbujenim z ritonavirjem, pri 604 bolnikih, ki so v preteklosti že jemali nekatera zdravila za zdravljenje okužbe z virusom HIV.
In adults, the most common side effects with Prezista are diarrhoea, ‘immune reconstitution syndrome', nausea (feeling sick), pyrexia (fever) and rash.
Pri odraslih so najpogostejši neželeni učinki zdravila Prezista driska, sindrom imunske reaktivacije, navzeja (slabost), povišana telesna temperatura in izpuščaji.
Prezista was also effective in previously treated children: 74% of the previously treated children aged above six years (59 out of 80) had at least a 90% reduction in viral loads after 24 weeks of treatment; 81% of those aged between three and six (17 out of 21) had viral loads below 50 copies/ml after 48 weeks.
Zdravilo Prezista je bilo učinkovito tudi pri predhodno zdravljenih otrocih: pri 74 % (59 od 80) predhodno zdravljenih otrok, starejših od šest let, je po 24 tednih zdravljenja prišlo do 90-odstotnega zmanjšanja virusnega bremena, medtem ko je 81 % (17 od 21) otrok, starih od tri do šest let, imelo po 48 tednih virusno breme pod 50 kopijami/ml.
In patients who had taken some anti-HIV medicines in the past, 77% of those taking ritonavir-boosted Prezista had viral loads below 400 copies/ml after 48 weeks, compared with 68% of those taking ritonavir-boosted lopinavir.
Pri bolnikih, ki so v preteklosti jemali nekatera zdravila za zdravljenje okužbe z virusom HIV, je imelo 77 % tistih, ki so jemali zdravilo Prezista, spodbujeno z ritonavirjem, po 48 tednih virusno breme pod 400 kopij/ml v primerjavi z 68 % tistih, ki so jemali lopinavir, spodbujen z ritonavirjem.
How has Prezista been studied?
Kako je bilo zdravilo Prezista raziskano?
What is Prezista?
Kaj je zdravilo Prezista?
Prezista 800 mg once a day was as effective as Prezista 600 mg twice a day in patients who had been treated before: after 48 weeks, 72% of the patients taking Prezista 800 mg once day had viral loads below 50 copies/ml (212 out of 294) compared with 71% of those taking Prezista 600 mg twice a day (210 out of 296).
Zdravilo Prezista v odmerku 800 mg enkrat na dan je bilo pri predhodno zdravljenih bolnikih enako učinkovito kot zdravilo Prezista v odmerku 600 mg dvakrat na dan: po 48 tednih je bilo pri 72 % (212 od 294) bolnikov, ki so jemali zdravilo Prezista v odmerku 800 mg enkrat na dan, virusno breme pod 50 kopij/ml v primerjavi z 71 % (210 od 296) bolnikov, ki so jemali zdravilo Prezista v odmerku 600 mg dvakrat na dan.
In adults who had received many anti-HIV medicines in the past, 70% of those taking the approved dose of ritonavir-boosted Prezista (92 out of 131) had at least a 90% reduction in viral load after 24 weeks, compared with 21% of those taking the comparator protease inhibitors (26 out of 124).
Pri odraslih, ki so v preteklosti prejemali številna zdravila za zdravljenje okužbe z virusom HIV, je bilo zmanjšanje virusnega bremena po 24 tednih pri 70 % (92 od 131) tistih, ki so jemali odobreni odmerek zdravila Prezista, spodbujenega z ritonavirjem , najmanj 90-odstotno v primerjavi z 21 % (26 od 124) tistih, ki so jemali primerjalne zaviralce proteaze.
For adults who have not been treated before, the recommended dose is 800 mg once a day.
Priporočeni odmerek za odrasle, ki predhodno še niso bili zdravljeni, znaša 800 mg enkrat na dan.
After 48 weeks, 84% of the patients taking ritonavir-boosted Prezista had viral loads below 50 copies/ml (287 out of 343) compared with 78% of those taking ritonavir-boosted lopinavir (271 out of 346).
Po 48 tednih je bilo pri 84 % (287 od 343) bolnikov, ki so jemali zdravilo Prezista, virusno breme pod 50 kopij/ml v primerjavi z 78 % (271 od 346) bolnikov, ki so jemali lopinavir, spodbujen z ritonavirjem.
In the study of previously untreated children, 83% (10 out of 12) had viral loads below 50 copies/ml after 48 weeks of treatment.
V študiji z otroki, ki predhodno niso bili zdravljeni, je 83 % (10 od 12) otrok po 48 tednih zdravljenja imelo virusno breme pod 50 kopijami/ml.
What is Prezista used for?
Za kaj se zdravilo Prezista uporablja?
For adults who have been treated before, the dose is 600 mg twice a day.
Pri že zdravljenih odraslih znaša odmerek 600 mg dvakrat na dan.
Three studies involved adults who had been treated before who received 600 mg Prezista twice a day.
V treh študijah so predhodno zdravljeni odrasli prejemali 600 mg zdravila Prezista dvakrat na dan.
How is Prezista used?
Kako se zdravilo Prezista uporablja?
How does Prezista work?
Kako zdravilo Prezista deluje?
In the study looking at Prezista with cobicistat, around 81% (253 out of 313) of patients had viral loads below 50 copies/ml after 48 weeks.
V študiji, ki je proučevala kombinacijo zdravila Prezista in kobicistata, je imelo po 48 tednih 81 % (253 od 313) bolnikov virusno breme pod 50 kopijami/ml.
One study compared ritonavir-boosted Prezista 800 mg once a day with ritonavir-boosted lopinavir (another protease inhibitor) in 691 adults who had not been treated for HIV before.
V eni študiji so pri 691 odraslih, ki predhodno niso bili zdravljeni zaradi okužbe z virusom HIV, z ritonavirjem spodbujeno zdravilo Prezista v odmerku 800 mg enkrat na dan primerjali z lopinavirjem (drugim zaviralcem proteaze), spodbujenim z ritonavirjem.
(Invented) name Strength Pharmaceutical Form Route of Administration
Izmišljeno ime Jakost Farmacevtska oblika
Oral use bottle (HDPE) 30 tablets
25 mg filmsko obložena tableta peroralna uporaba plastenka (HDPE)
25 mg
30 tablet
Film-coated tablet
Pot uporabe Ovojnina
This summary was last updated in 05-2014.
Povzetek je bil nazadnje posodobljen 05-2014.
This can result in loss of vision and even blindness.
To lahko povzroči izgubo vida in celo slepoto.
The European Commission granted a marketing authorisation valid throughout the European Union for Azopt on 9 March 2000.
Evropska komisija je dovoljenje za promet z zdravilom Azopt, veljavno po vsej Evropski uniji, izdala 9. marca 2000.
What measures are being taken to ensure the safe and effective use of Azopt?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Azopt?
Other information about Azopt
Druge informacije o zdravilu Azopt
The full EPAR for Azopt 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 Azopt je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What benefit has Azopt shown during the studies?
Kakšne koristi je zdravilo Azopt izkazalo med študijami?
This is a summary of the European public assessment report (EPAR) for Azopt.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Azopt.
A risk management plan has been developed to ensure that Azopt is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Azopt je bil pripravljen načrt obvladovanja tveganj.
In all of the studies, the main measure of effectiveness was the change in pressure inside the eye, measured in units called ‘millimetres of mercury' (mmHg).
V vseh študijah je bilo glavno merilo učinkovitosti sprememba tlaka v očesu, ki se meri v enotah, imenovanih „milimetri živega srebra“ (mmHg).
What is the risk associated with Azopt?
Kakšna tveganja so povezana z zdravilom Azopt?
The Committee for Medicinal Products for Human Use (CHMP) decided that Azopt's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Azopt večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
For more information about treatment with Azopt, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Azopt preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It must not be used in patients with severe kidney disease or hyperchloraemic acidosis (excess acid in the blood caused by too much chloride).
Ne smejo ga uporabljati bolniki s hudim obolenjem ledvic ali hiperkloremično acidozo (preveč kisline v krvi, ki jo povzroča preveč klorida).
The eye pressure was at least 21 mmHg in all of the patients at the start of the studies (above the normal range of 10 to 21 mmHg).
Očesni tlak je pri vseh bolnikih na začetku študij znašal vsaj 21 mmHg (kar je nad običajno vrednostjo, ki je od 10 do 21 mmHg.
Azopt has been studied in seven main studies including a total of 2,173 patients with open-angle glaucoma or ocular hypertension.
Zdravilo Azopt so raziskali v sedmih glavnih študijah z 2 173 bolniki z glavkomom odprtega zakotja ali očesno hipertenzijo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Azopt, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Azopt in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
If more than one type of eye-drop medicine is being used, each one should be given at least five minutes apart.
Če bolnik uporablja več vrst kapljic za oko, je treba zdravila dajati v razmiku najmanj pet minut.
Dorzolamide led to decreases of between 4.3 and 4.9 mmHg.
Dorzolamid je povzročil znižanje tlaka od 4,3 do 4,9 mmHg.
All of the studies lasted for three months, except for the study comparing Azopt used on its own with timolol, which lasted for 18 months.
Vse študije so trajale tri mesece, razen študije, v kateri so primerjali učinek samostojnega zdravila Azopt s timololom, ki je trajala 18 mesecev.
However, the results suggested that some patients may show a greater reduction in eye pressure when using the drops three times a day.
Vendar so rezultati pokazali, da se je pri nekaterih bolnikih tlak v očesu znižal bolj, če so kapljice jemali trikrat na dan.
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 Azopt.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Azopt, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
By lowering the pressure, Azopt reduces the risk of damage to these structures.
Zdravilo Azopt z zniževanjem tlaka zmanjša nevarnost poškodb teh struktur.