natgillin/translations-raw huggingface dataset:
The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11-15 months of age.
Prvi odmerek se lahko da od starosti 2 mesecev naprej, drugega vsaj 2 meseca pozneje, tretji (poživitveni) odmerek pa v starosti 11- 15 mesecev.
Infants aged 7 - 11 months: two doses, each of 0.5 ml, with an interval of at least 1 month between doses.
Dojenčki, stari od 7 do 11 mesecev: dva odmerka po 0, 5 ml; presledek med njima mora bit najmanj 1 mesec.
Children aged 12 - 23 months: two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
50 Otroci, stari od 12 do 23 mesecev: dva odmerka po 0, 5 ml; presledek med odmerkoma naj bo najmanj 2 meseca.
Safety and immunogenicity data are not yet available for children in other specific high-risk groups for invasive pneumococcal disease (e. g. children with another congenital or acquired splenic dysfunction, HIV- infected, malignancy, nephrotic syndrome).
Podatki o varnosti in imunogenosti tega cepiva pri otrocih v drugih posebnih skupinah z visokim tveganjem za invazivne pnevmokokne okužbe še niso na voljo (kot so: otroci z drugo prirojeno ali pridobljeno motnjo delovanja vranice, otroci z okužbo s HIV, otroci z malignomi, nefrotskim sindromom).
The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children ≥ 24 months of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness or who are immunocompromised) placing them at higher risk for invasive disease due to Streptococcus pneumoniae.
Uporaba konjugiranega pnevmokoknega cepiva ne nadomesti uporabe 23- valentnega pnevmokoknega polisaharidnega cepiva pri otrocih, starih ≥ 24 mesecev z večjim tveganjem (kot so otroci z anemijo srpastih celic, asplenijo, okužbo s HIV, kroničnimi boleznimi ali drugače imunsko kompromitirani); pri njih kljub vsemu ostaja večje tveganje za invazivno okužbo z bakterijo Streptococcus pneumoniae.
Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Prevenar should receive 23-valent pneumococcal polysaccharide vaccine.
Otroci s povečanim tveganjem, stari ≥ 24 mesecev, ki so bili cepljeni s cepivom Prevenar, naj prejmejo 23- valentno pnevmokokno polisaharidno cepivo kadarkoli je to potrebno.
The interval between the pneumococcal conjugate vaccine (Prevenar) and the 23- valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
Presledek med konjugiranim pnevmokoknim cepivom (Prevenar) in 23- valentnim pnevmokoknim polisaharidnim cepivom mora biti najmanj 8 tednov.
There are no data available to indicate whether the administration of 23-valent pneumococcal polysaccharide vaccine to unprimed
Ni podatkov, ki bi kazali, ali uporaba 23- valentnega pnevmokoknega polisaharidnega cepiva pri otrocih, ki še niso bili cepljeni, ali pri otrocih, že cepljenih s cepivom Prevenar, lahko povzroči zmanjšano odzivnost na nadaljnje odmerke cepiva Prevenar.
52 children or to children primed with Prevenar might result in hyporesponsiveness to further doses of Prevenar.
Profilaktično dajanje zdravil proti zvišani temperaturi je priporočljivo:
- for all children receiving Prevenar simultaneously with vaccines containing whole cell pertussis because
- pri otrocih, ki istočasno prejmejo cepivo Prevenar in cepivo proti oslovskemu kašlju, ki vsebuje
of higher rate of febrile reactions
celotne celice, ker se pri njih pogosteje pojavi zvišana telesna temperatura.
- for children with seizure disorders or with a prior history of febrile seizures.
- pri otrocih s konvulzijami ali pri otrocih z vročinskimi krči v anamnezi.
Additionally, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease.
51 da bo zaščita pred vnetjem srednjega ušesa znatno manjša kot zaščita pred invazivnimi boleznimi.
INFORMATION FOR THE USER
52 NAVODILO ZA UPORABO
Prevenar helps protect your child against diseases such as: meningitis, sepsis or bacteraemia (bacteria in blood stream), pneumonia and ear infection caused by seven types of the bacteria Streptococcus pneumoniae.
Prevenar pomaga zaščititi vašega otroka pred boleznimi, kot so: meningitis, sepsa ali bakteriemija (bakterije v krvi), pljučnica in okužbe ušesa, ki jih povzroča sedem tipov bakterije Streptococcus pneumoniae.
Prevenar will be injected into your child's muscle.
53 Cepivo Prevenar bo otrok dobil v mišico.
The meaning of the terms used to describe the frequency of side effects is as follows:
Pomen izrazov, s katerimi opisujemo pogostost neželenih učinkov, je sledeč:
enlarged lymph nodes (lymphadenopathy) in the region of the injection site
povečanje bezgavk (limfadenopatija) v predelu mesta injiciranja.
rash/ hives (urticaria) erythema multiforme
izpuščaj/ koprivnica (urtikarija) multiformni eritem
55
redki:
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
54 Pri zelo nedonošenih dojenčkih (rojenih po 28 tednih gestacije ali prej) se lahko pojavijo daljši premori med vdihi dva do tri dni po cepljenju.
The vaccine is a suspension for injection and provided in a single-dose pre-filled syringe (0.5 ml).
Prevenar je cepivo v obliki suspenzije za injiciranje; v vsaki napolnjeni injekcijski brizgi je en odmerek (0, 5 ml).
56 Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet z zdravilom in izdelovalec
Manufacturing Authorisation Holder responsible for batch release:
55 Imetnik dovoljenja za promet z zdravilom, odgovoren za sproščanje serije:
Eesti Wyeth-Lederle Pharma GmbH Tel: + 43 1 89 1140 Faks: + 43 1 89 114600
Österreich Eesti Wyeth- Lederle Pharma GmbH Wyeth- Lederle Pharma GmbH Tel: + 43 1 891140 Tel: + 43 1 89 1140 Fax: + 43 1 89 114600 Faks: + 43 1 89 114600
Österreich Wyeth-Lederle Pharma GmbH Tel: + 43 1 891140 Fax: + 43 1 89 114600
Polska Ελλάδα Wyeth Sp. z o. o.
Ελλάδα Wyeth Hellas Α .Ε .Β .Ε.
Wyeth Hellas Α. Ε. Β. Ε.
Τηλ: + 30 2 10 99 81 600 Φαξ: + 30 2 10 99 21 994
Tel: + 48 22 457 1000 Τηλ: + 30 2 10 99 81 600 Fax: + 48 22 457 1001 Φαξ: + 30 2 10 99 21 994
Ireland Wyeth Vaccines Tel: + 353 1 449 3500 Fax: + 353 1 679 3773
56 Slovenská Republika Ireland Wyeth Whitehall Export GmbH, organizačná Wyeth Vaccines zložka Tel: + 353 1 449 3500 Tel: + 42 1 2 654 128 16 Fax: + 353 1 679 3773 Fax: + 42 1 2 654 128 17
58 This vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration.
Cepiva ne dajemo dojenčkom ali otrokom s trombocitopenijo ali kako drugo motnjo strjevanja krvi, pri kateri je intramuskularna aplikacija kontraindicirana, razen v primerih, ko je korist cepljenja očitno večja od potencialnega tveganja.
Infants aged 2 - 6 months: the primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Dojenčki od 2. do 6. meseca starosti: primarno zaporedje za dojenčke sestavljajo trije odmerki po 0, 5 ml; prvi odmerek damo običajno pri 2 mesecih starosti; med naslednjima odmerkoma mora biti najmanj enomesečni presledek.
Children aged 12 - 23 months: two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
57 Otroci, stari od 12 do 23 mesecev: dva odmerka po 0, 5 ml; presledek med odmerkoma naj bo najmanj 2 meseca.
59 children or to children primed with Prevenar might result in hyporesponsiveness to further doses of Prevenar.
Profilaktično dajanje zdravil proti zvišani telesni temperaturi je priporočljivo:
Additionally, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease.
58 da bo zaščita pred vnetjem srednjega ušesa znatno manjša kot zaščita pred invazivnimi boleznimi.
Prezista is a medicine that contains the active substance darunavir.
Zdravilo Prezista vsebuje zdravilno učinkovino darunavir.
It is available as oval tablets (orange:
Na voljo je v obliki ovalnih tablet (oranžnih:
300 and 600 mg; light orange:
300 in 600 mg; svetlo oranžnih:
Prezista is an antiviral medicine.
Zdravilo Prezista je protivirusno zdravilo.
It is used together with low-dose ritonavir (another antiviral medicine) and other antiviral medicines to treat adults who are infected with human immunodeficiency virus (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Uporablja se v kombinaciji z nizkim odmerkom ritonavirja (drugega protivirusnega zdravila) in drugih protivirusnih zdravil za zdravljenje odraslih bolnikov, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV- 1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
Doctors should prescribe Prezista to patients who have been treated before, only once they have looked at the antiviral medicines that the patient has taken before and considered the likelihood of the virus responding to the medicine.
Zdravnik lahko predpiše zdravilo Prezista bolnikom, ki so že bili zdravljeni, le ko prouči protivirusno zdravljenje posameznega bolnika v preteklosti in verjetnost odziva virusa na zdravilo.
Treatment with Prezista should be started by a doctor who has experience in the management of HIV infection.
Zdravljenje z zdravilom Prezista mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe s HIV.
For patients who have not been treated before, the recommended dose is 800 mg once a day.
Pri bolnikih, ki še niso bili zdravljeni, priporočeni odmerek znaša 800 mg enkrat dnevno.
For patients who have been treated before, it is 600 mg twice a day.
Pri bolnikih, ki so že bili zdravljeni, pa 600 mg dvakrat dnevno.
Each dose of Prezista must be taken with 100 mg ritonavir and food.
Vsak odmerek zdravila Prezista mora bolnik vzeti skupaj s 100 mg ritonavirja in hrano.
Prezista should be used with caution by patients with mild or moderate problems with their liver.
Zdravilo Prezista je treba uporabljati previdno pri bolnikih z blagimi ali zmernimi težavami z jetri.
It must not be used by patients who have severe liver problems.
Pri bolnikih s hudimi težavami z jetri pa se ne sme uporabljati.
It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Zavira encim (imenovan proteaza), ki sodeluje pri razmnoževanju HIV.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the rate of replication.
Če je encim zavrt, se virus ne razmnožuje normalno, ampak upočasnjeno.
Ritonavir is another protease inhibitor that is used as a ‘ booster’.
Ritonavir je drugi zaviralec proteaze in se uporablja kot „ ojačevalec “.
It slows down the rate at which darunavir is broken down, increasing the levels of darunavir in the blood.
Upočasni hitrost razgradnje darunavirja in s tem zviša ravni darunavirja v krvi.
The use of the booster allows a lower dose of darunavir to be used for the same antiviral effect.
Uporaba ojačevalca omogoča uporabo nižjega odmerka darunavirja, da dosežemo enak protivirusni učinek.
Prezista does not cure HIV infection or AIDS, but it may delay or reverse the damage to the immune system and reduce the risk of developing illnesses associated with HIV infection or AIDS.
Zdravilo Prezista ne ozdravi okužbe s HIV ali AIDS- a, lahko pa upočasni ali odpravi poškodbe imunskega sistema ter zmanjša tveganje za nastanek bolezni, povezanih z okužbo s HIV ali z AIDS- om.
One study compared ritonavir-boosted Prezista with ritonavir-boosted lopinavir (another protease inhibitor) in 691 adults who had not been treated for HIV before.
V eni študiji so zdravilo Prezista, ojačano z ritonavirjem, primerjali z lopinavirjem (drugim zaviralcem proteaze), ojačanim z ritonavirjem pri 691 odraslih, ki pred tem še niso bili zdravljeni zaradi okužbe z virusom HIV.
All of the patients also took tenofovir disoproxil and emtricitabine (other antiviral medicines); The other three studies involved adults who were already receiving HIV treatment but were not responding to it: • one study compared ritonavir-boosted Prezista with ritonavir-boosted lopinavir in 604 patients who had taken some anti-HIV medicines in the past; • two studies involved 628 patients who had taken many anti-HIV medicines in the past and compared ritonavir-boosted Prezista with other protease inhibitors chosen on the basis of the patient’ s previous treatments and predicted response.
V preostale tri študije so bili vključeni odrasli bolniki, ki so že prejemali zdravila proti okužbi z virusom HIV, vendar se nanje niso odzivali: • v eni študiji so zdravilo Prezista, ojačano z ritonavirjem, primerjali z lopinavirjem (drugim zaviralcem proteaze), ojačanim z ritonavirjem, pri 604 bolnikih, ki so v preteklosti jemali nekaj zdravil proti virusu HIV; • v dveh študijah, v kateri je bilo vključenih 628 bolnikov, ki so se v preteklosti že zdravili z veliko zdravili proti virusu HIV, so primerjali z ritonavirjem ojačano zdravilo Prezista z drugimi zaviralci proteaze, ki so jih izbrali na osnovi predhodnih zdravljenj bolnika ter predvidenega odziva.
In these three studies, the patients also took a combination of other anti-HIV medicines that were chosen because they had the best chances of reducing the levels of HIV in their blood.
V teh treh študijah so bolniki jemali tudi kombinacijo drugih zdravil proti virusu HIV, ki so bila izbrana kot najboljša možnost za znižanje ravni HIV v krvi.
In all four studies, the main measures of effectiveness were based on the change in HIV levels in the blood (viral load).
V vseh štirih študijah so glavna merila učinkovitosti temeljila na spremembi ravni HIV v krvi (virusno breme).
In patients who had not been treated before, Prezista was as effective as lopinavir.
Pri predhodno nezdravljenih bolnikih je bilo zdravilo Prezista učinkovitejše od lopinavirja.
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 imelo 84% bolnikov, ki so jemali z ritonavirjem ojačano zdravilo Prezista, virusno breme pod 50 kopij/ ml (287 od 343) v primerjavi s 78% tistih, ki so jemali lopinavir, ojačan z ritonavirjem (271 od 346).
In patients who had been treated before, those taking Prezista achieved lower viral loads than those taking the comparator protease inhibitors.
Pri bolnikih, ki so bili predhodno zdravljeni, so tisti, ki so jemali zdravilo Prezista dosegli manjše virusno breme kot tisti, ki so jemali primerjalne zaviralce proteaze.
In the study of patients who had taken some anti-HIV medicines in the past, 77% of those taking ritonavir-boosted Prezista and 68% of those taking ritonavir-boosted lopinavir had viral loads below 400 copies/ ml after 48 weeks.
V študiji bolnikov, ki so v preteklosti jemali nekaj zdravil proti virusu HIV, jih je imelo po 48 tednih 77% tistih, ki so jemali z ritonavirjem ojačano zdravilo Prezista, in 68% tistih, ki so jemali z ritonavirjem ojačani lopinavir, virusno breme pod 400 kopij/ ml.
In the two studies of patients 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) and 21% of the patients taking the comparator protease inhibitors (26 out of 124) had at least a 90% reduction in viral load after 24 weeks.
V dveh študijah bolnikov, ki so v preteklosti jemali veliko zdravil proti virusu HIV, se je pri 70% bolnikov, ki so jemali odobreni odmerek zdravila Prezista, ojačanega z ritonavirjem, (92 izmed 131), in 21% bolnikov, ki so jemali primerljive zaviralce proteaze (26 od 124), virusno breme v 24 tednih zmanjšalo najmanj za 90%.
The most common side effect with Prezista (seen in more than 1 patient in 10) is diarrhoea.
Najpogostejši neželeni učinek zdravila Prezista (opažen pri več kot 1 bolniku od 10) je driska.
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.
As with other anti-HIV medicines, patients taking Prezista may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Kot pri drugih zdravilih proti virusu HIV, se lahko pri bolnikih, ki jemljejo zdravilo Prezista, pojavijo lipodistrofija (spremembe razporeditve maščevja), osteonekroza (odmiranje kostnega tkiva) ali sindrom imunske reaktivacije (simptomi okužbe zaradi okrevanja imunskega sistema).
Patients who have problems with their liver (including hepatitis B or C infection) may be at a higher risk of liver damage when taking anti-HIV medicines such as Prezista.
Pri bolnikih, ki imajo težave z jetri (vključno z okužbo z virusom hepatitisa B ali C), se zaradi jemanja zdravil proti HIV, kot je zdravilo Prezista, lahko poveča tveganje za poškodbe jeter.
Prezista should not be taken by patients who may be hypersensitive (allergic) to darunavir or any of the other ingredients.
Zdravila Prezista ne smejo jemati osebe, ki utegnejo biti preobčutljive za (alergični na) darunavir ali katero koli drugo sestavino zdravila.
It must not be taken by patients who have severe problems with their liver, or who are taking the following medicines: • rifampicin (used to treat tuberculosis); • ritonavir-boosted lopinavir; • St John’ s wort (a herbal preparation used to treat depression); • medicines that are broken down in the same way as Prezista and are harmful at high levels in the blood.
Ne smejo ga jemati bolniki s hudimi težavami z jetri ali bolniki, ki jemljejo naslednja zdravila: • rifampicin (zdravilo za tuberkulozo), • ritonavir, ojačan z lopinavirjem, • šentjanževko (rastlinski pripravek za zdravljenje depresije), • zdravila, ki se presnavljajo na enak način kot Prezista in katerih visoke ravni v krvi so škodljive.
Caution is also needed by patients taking Prezista at the same time as some other medicines.
Bolniki, ki jemljejo zdravilo Prezista, morajo bili previdni tudi pri sočasnem jemanju nekaterih drugih zdravil.
See the Package Leaflet for full details.
Za vse podrobnosti glejte navodilo za uporabo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Prezista’ s benefits, when taken in combination with ritonavir and other antiretroviral medicinal products, were greater than its risks for the treatment of HIV-1 infection.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so za zdravljenje okužbe z virusom HIV- 1 koristi zdravila Prezista, ki se uporablja skupaj z ritonavirjem ali drugimi protiretrovirusnimi zdravili, večje od z njim povezanih tveganj.
The Committee recommended that Prezista be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Prezista odobri dovoljenje za promet.
Prezista was originally given ‘ Conditional Approval’.
2/ 3 Zdravilo Prezista je bilo prvotno „ pogojno odobreno “.
This means that there was more evidence to come about the medicine, in particular its safety.
To pomeni, da so pričakovali več dokazov o zdravilu, zlasti o njegovi varnosti.
As the company had supplied the additional information necessary, the authorisation was switched from ‘ conditional ’ to ‘ normal’ approval on 16 December 2008.
Ker je družba priskrbela dodatne potrebne informacije, je bil dne 16. decembra 2008 status dovoljenja spremenjen iz „ pogojne “ v „ običajno “ odobritev.
2/ 3 Other information about Prezista:
Druge informacije o zdravilu Prezista:
The European Commission granted a marketing authorisation valid throughout the European Union for Prezista to Janssen-Cilag International NV on 12 February 2007.
Evropska komisija je dovoljenje za promet z zdravilom Prezista, veljavno po vsej Evropski uniji, odobrila družbi Janssen- Cilag International NV dne 12. februarja 2007.
The full EPAR for Prezista can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Prezista je na voljo tukaj.
EU Number EU/ 1/ 06/ 380/ 001 EU/ 1/ 06/ 380/ 002 EU/ 1/ 06/ 380/ 003
Številka EU EU/ 1/ 06/ 380/ 001 EU/ 1/ 06/ 380/ 002 EU/ 1/ 06/ 380/ 003
Invented name Prezista Prezista Prezista
Izmišljeno ime Prezista Prezista Prezista
Strength 300 mg 600 mg 400 mg
jakost 300 mg 600 mg 400 mg
Pharmaceutical Form Film-coated tablet Film-coated tablet Film-coated tablet
farmacevtska oblika Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta
Route of administration Oral use Oral use Oral use
pot uporabe Za peroralno uporabo Za peroralno uporabo Za peroralno uporabo
Packaging bottle (HDPE) bottle (HDPE) bottle (HDPE)
ovojnina HDPE plastenka HDPE plastenka HDPE plastenka
Package size 120 tablets 60 tablets 60 tablets
velikost pakiranja 120 tablet 60 tablet 60 tablet
PREZISTA 300 mg film-coated tablets.
PREZISTA 300 mg filmsko obložene tablete
Each film-coated tablet contains 300 mg of darunavir (as ethanolate).
Vsaka filmsko obložena tableta vsebuje 300 mg darunavirja (v obliki etanolata).
Each tablet contains 1.375 mg sunset yellow FCF (E110).
Vsaka tableta vsebuje 1, 375 mg barvila oranžno FCF (E110).
Orange oval shaped tablet, debossed with “ 300MG” on one side and “ TMC114” on the other side.
Oranžna ovalna tableta z vtisnjeno oznako “ 300MG ” na eni strani in “ TMC114 ” na drugi.
PREZISTA, co-administered with 100 mg ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients, including those that have been highly pre-treated.
4. 1 Terapevtske indikacije
In deciding to initiate treatment with PREZISTA co-administered with 100 mg ritonavir careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents.
Zdravilo PREZISTA je v kombinaciji s 100 mg ritonavirja in z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje okužbe z virusom humane imunske pomanjkljivosti (HIV- 1), pri odraslih bolnikih, ki imajo izkušnje s protiretrovirusnim zdravljenjem, vključno s tistimi, ki so prejeli že več različnih vrst zdravljenj.
Therapy should be initiated by a physician experienced in the management of HIV infection.
Terapijo naj uvede zdravnik z izkušnjami iz vodenja okužbe s HIV.
PREZISTA must always be given orally with 100 mg ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products.
Zdravilo PREZISTA je treba vedno dajati peroralno skupaj s 100 mg ritonavirja kot sredstva za farmakokinetično okrepitev in v kombinaciji z drugimi protiretrovirusnimi zdravili.
The Summary of Product Characteristics of ritonavir must therefore be consulted prior to initiation of therapy with PREZISTA.
Pred uvedbo terapije z zdravilom PREZISTA morate torej prebrati tudi Povzetek glavnih značilnosti zdravila za ritonavir.
The recommended dosage of PREZISTA is 600 mg twice daily (b. i. d.) taken with ritonavir 100 mg b. i. d. and with food.
Priporočeni odmerek zdravila PREZISTA je 600 mg dvakrat na dan, zaužit skupaj s 100 mg ritonavirja dvakrat na dan in s hrano.
The type of food does not affect the exposure to darunavir (see sections 4.4, 4.5 and 5.2).
Vrsta hrane ne vpliva na izpostavljenost darunavirju (glejte poglavja 4. 4, 4. 5 in 5. 2).
PREZISTA is not recommended for use in children and adolescents because there are no data on safety, efficacy and pharmacokinetics.
Zaradi pomanjkanja podatkov o varnosti, učinkovitosti in farmakokinetiki uporaba zdravila PREZISTA pri otrocih in mladostnikih ni priporočljiva.
Limited information is available in this population (see sections 4.4 and 5.2).
Podatki, ki so pri tej populaciji na voljo, so omejeni (glejte poglavji 4. 4 in 5. 2).