natgillin/translations-raw huggingface dataset:
ART-experienced paediatric patients from the age of 6 to < 18 years and weighing at least 20 kg DELPHI is an open-label, Phase II trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with low dose ritonavir in 80 ART-experienced HIV-1 infected paediatric patients aged 6 to 17 years and weighing at least 20 kg.
DELPHI je otvoreno ispitivanje faze II, koje procjenjuje farmakokinetiku, sigurnost, podnošljivost i djelotvornost darunavira s niskom dozom ritonavira u 80 pedijatrijskih bolesnika prethodno liječenih ART-om inficiranih s HIV-1, u dobi od 6 do 17 godina i težine najmanje 20 kilograma.
675 mg darunavir/100 mg ritonavir once daily
675 mg darunavir/100 mg ritonavir jedanput na dan
Second trimester of pregnancy (n=12)
Drugo tromjesečje trudnoće (n=12)
It is not recommended to coadminister darunavir with low dose ritonavir and boceprevir.
Ne preporučuje se istodobna primjena darunavira s niskom dozom ritonavira i boceprevira.
Boosted darunavir and raltegravir can be used without dose adjustments.
Pojačan darunavir i raltegravir mogu se primijeniti bez prilagodbe doze.
Co-administration of boosted darunavir with these anticoagulants may increase concentrations of the anticoagulant, which may lead to an increased bleeding risk.
Istodobna primjena pojačanog darunavira s ovim antikoagulansima može povećati koncentracije antikoagulansa, što može povećati rizik od krvarenja. (CYP3A i/ili P-gp inhibicija)
Dabigatran Ticagrelor
tikagreloru.
Ethinylestradiol Norethindrone 35 μg/1 mg once daily
35 μg/1 mg jedanput na dan
Each film-coated tablet contains 800 mg darunavir.
Jedna filmom obložena tableta sadrži 800 mg darunavira.
Co-administration of darunavir with these anticoagulants may increase concentrations of the anticoagulant, which may lead to an increased bleeding risk.
Istodobna primjena darunavira s ovim antikoagulansima može povećati koncentracije antikoagulansa, što može povećati rizik od krvarenja. (CYP3A i/ili P-gp inhibicija)
Rare side effects (may affect up to 1 in 1,000 people) areaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung] heart attack, slow heart beating, palpitations visual disturbance chills, feeling abnormal a feeling of confusion or disorientation, altered mood, restlessness fainting, epileptic fits, changes or loss of taste mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue running nose skin lesions, dry skin stiffness of muscles or joints, joint pain with or without inflammation changes in some values of your blood cells or chemistry.
umorom, oticanjem lica ili limfnih čvorova, povišenjem eozinofila (vrsta bijelih krvnih stanica), učincima na jetru, bubreg ili pluća] - srčani udar, spori otkucaji srca, osjećaj lupanja srca - poremećaj vida - zimica, nenormalno osjećanje - osjećaj smetenosti ili dezorijentacije, promijenjeno raspoloženje, nemir - nesvjestica, epileptički napadaji, promjene ili gubitak okusa - ranice u ustima, povraćanje krvi, upala usnica, suhe usnice, obložen jezik - curenje nosa - oštećenja kože, suha koža - ukočenost mišića ili zglobova, bolovi u zglobovima s ili bez upale - promjene nekih vrijednosti stanica ili kemijskih nalaza u Vašoj krvi.
With baseline CD4+ cell count ≥
S početnim brojem CD4+ stanica ≥ 200
Darunavir dose is
Drugi lijekovi i Darunavir Krka
ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
ritonavira, primjena bi morala biti u jedinici intenzivnog liječenja ili sličnom odjelu gdje je sigurano pomno kliničko praćenje, te primjereno medicinsko zbrinjavanje u slučaju respiratorne depresije i/ili produljene sedacije.
Co administration of darunavir coadministered with cobicistat and bosentan is not recommended.
Primjena darunavira istodobno primijenjenog s kobicistatom i bosentanom se ne preporučuje.
Edoxaban
Nuspojava
For clinical trial results in ART-naïve adult patients, refer to the Summary of Product Characteristics for Darunavir Krka 400 mg and 800 mg tablets.
Za rezultate kliničkog ispitivanja u odraslih bolesnika koji nisu prethodno liječeni ART-om, vidjeti sažetak opisa svojstava lijeka za Darunavir Krka 400 mg i 800 mg tablete.
Pharmacokinetic results of total darunavir after administration of darunavir/cobicistat 800/150 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy, and postpartum Pharmacokinetics of total darunavir (mean ± SD)
800/150 mg jedanput na dan kao dijela antiretrovirusnog režima, tijekom drugog tromjesečja trudnoće, trećeg tromjesečja trudnoće i u postpartalnom razdoblju Farmakinetika ukupnog darunavira (srednja vrijednost
Concomitant use of boosted darunavir and elbasvir/grazoprevir is contraindicated (see section 4.3).
darunavira s elbasvirom/grazoprevirom je kontraindicirana (vidjeti dio 4.3).
The use of carbamazepine with darunavir co-administered with cobicistat is contraindicated (see section 4.3).
Primjena karbamazepina s darunavirom istodobno primijenjenog s kobicistatom je kontraindicirana (vidjeti dio 4.3).
Clotrimazole
Klotrimazol
ANTIBIOTIC Clarithromycin 500 mg twice daily clarithromycin AUC ↑ 57% clarithromycin Cmin ↑ 174% clarithromycin Cmax ↑ 26% darunavir AUC ↓ 13% darunavir Cmin ↑ 1% darunavir Cmax ↓ 17%
ANTIBIOTICI Klaritromicin 500 mg dvaput na dan klaritromicin AUC ↑ 57% klaritromicin Cmin ↑ 174% klaritromicin Cmax ↑ 26% darunavir AUC ↓ 13% darunavir Cmin ↑ 1% darunavir Cmax ↓ 17% Koncentraciju 14-OHklaritromicina nije bilo moguće odrediti kada se kombinirao s darunavirom/ritonavirom. (↑klaritromicina zbog inhibicije CYP3A i moguće P-gp inhibicije)
silica, colloidal anhydrous ) and magnesium stearate (E470b)in the tablet core and poly(vinyl alcohol), macrogol, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172) in film coating.
- Drugi sastojci su mikrokristalična celuloza, krospovidon, hidroksipropilceluloza, koloidni bezvodni silicijev dioksid, silicificirana mikrokristalična celuloza (mikrokristalična celuloza, koloidni bezvodni silicijev dioksid) i magnezijev stearat (E470b) u jezgri tablete te poli(vinilni alkohol), makrogol, titanijev dioksid (E171), talk (E553b), žuti željezov oksid (E172) i crveni željezov oksid (E172) u film ovojnici tablete.
Lovastatin and simvastatin are expected to have markedly increased plasma concentrations when coadministered with boosted darunavir.
Za lovastatin i simvastatin se očekuje značajno povišenje koncentracija u plazmi kada se primjenjuju istodobno s pojačanim darunavirom. (inhibicija CYP3A)
Darunavir co-administered with low dose ritonavir can be used with these NRTIs without dose adjustment.
Darunavir istodobno primijenjen s niskom dozom ritonavira može se primijeniti s ovim NRTI lijekovima bez prilagodbe doze.
Darunavir co-administered with cobicistat lowers the creatinine clearance.
Darunavir istodobno primijenjen s kobicistatom snižava klirens kreatinina.
The pharmacokinetics of darunavir in combination with ritonavir taken once daily in 12 ART-naïve paediatric patients, aged 12 to < 18 years and weighing at least 40 kg, showed that darunavir/ritonavir 800/100 mg once daily results in darunavir exposure that was comparable to that achieved in adults receiving darunavir/ritonavir 800/100 mg once daily.
Farmakokinetika darunavira u kombinaciji s ritonavirom uzetih jedanput na dan, u 12 pedijatrijskih bolesnika koji nisu prethodno liječeni, u dobi od 12 do < 18 godina s težinom najmanje 40 kg, pokazala je da darunavir/ritonavir 800/100 mg jedanput na dan rezultira izloženošću darunaviru koja je usporediva s onom u odraslih koji primaju darunavir/ritonavir od 800/100 mg jedanput na dan.
Each film-coated tablet contains 600 mg darunavir.
Jedna filmom obložena tableta sadrži 600 mg darunavira.
Darunavir Krka 800 mg film-coated tablets:
Darunavir Krka 800 mg filmom obložene tablete:
Hence, concomitant use of boosted darunavir and the combination product lopinavir/ritonavir is contraindicated (see section 4.3).
Odavde proizlazi da je istodobna primjena pojačanog darunavira i kombiniranog lijeka lopinavir/ritonavir kontraindicirana (vidjeti dio 4.3).
These active substances include e.g.: alfuzosin amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine astemizole, terfenadine colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) elbasvir/grazoprevir cisapride dapoxetine domperidone naloxegol lurasidone, pimozide, quetiapine, sertindole (see section 4.5) triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5) sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil simvastatin, lovastatin and lomitapide (see section 4.5) dabigatran, ticagrelor (see section 4.5).
(vidjeti dio 4.5) - ergot derivate (npr. dihidroergotamin, ergometrin, ergotamin, metilergonovin) - elbasvir/grazoprevir - cisaprid - dapoksetin - domperidon - naloksegol - lurasidon, pimozid, kvetiapin, sertindol (vidjeti dio 4.5) - triazolam, peroralno primijenjen midazolam (mjere opreza za parenteralnu primjenu midazolama, vidjeti dio 4.5) - sildenafil -kada se primjenjuje za liječenje plućne arterijske hipertenzije,
Do not combine Darunavir Krka with any of the following medicines If you are taking any of these, ask your doctor about switching to another medicine.
Nemojte kombinirati Darunavir Krka ni s jednim od sljedećih lijekova
Number of baseline mutations
Broj mutacija na početu liječenja
Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,968 treatment-experienced patients receiving darunavir co-administered with ritonavir 600/100 mg twice daily, 236 patients were co-infected with hepatitis B or C. Co-infected patients were more likely to have baseline and treatment emergent hepatic transaminase elevations than those without chronic viral hepatitis (see section 4.4).
Bolesnici istodobno inficirani virusom hepatitisa B i/ili hepatitisa C Od 1968 prethodno liječenih bolesnika, a primali su darunavir primijenjen istodobno s ritonavirom od 600/100 mg dvaput na dan, 236 bolesnika bilo je istodobno inficirano hepatitisom B ili C.
Other medicines and Darunavir Krka Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
30 film-coated tablets: EU/1/17/1249/001 60 film-coated tablets: EU/1/17/1249/002 90 film-coated tablets: EU/1/17/1249/003 180 film-coated tablets: EU/1/17/1249/004
30 filmom obloženih tableta: EU/1/17/1249/001 60 filmom obloženih tableta: EU/1/17/1249/002 90 filmom obloženih tableta: EU/1/17/1249/003 180 filmom obloženih tableta: EU/1/17/1249/004
375 mg darunavir /50 mg ritonavir twice daily
375 mg darunavir /50 mg ritonavir dvaput na dan
600 mg darunavir/100 mg ritonavir once daily
600 mg darunavir/100 mg ritonavir jedanput na dan
Imputations according to the TLOVR algorithm.
Pripisane vrijednosti izračunate prema TLOVR algoritmu
800 mg darunavir /100 mg ritonavir once daily
800 mg darunavir /100 mg ritonavir jedanput na dan
These active substances include e.g.: alfuzosin amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine astemizole, terfenadine colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) elbasvir/grazoprevir cisapride dapoxetine domperidone naloxegol lurasidone, pimozide, quetiapine, sertindole (see section 4.5) triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5) sildenafil -when used for the treatment of pulmonary arterial hypertension, avanafil simvastatin, lovastatin and lomitapide (see section 4.5) dabigatran, ticagrelor (see section 4.5).
(vidjeti dio 4.5) - ergot derivate (npr. dihidroergotamin, ergometrin, ergotamin, metilergonovin) - elbasvir/grazoprevir - cisaprid - dapoksetin - domperidon - naloksegol - lurasidon, pimozid, kvetiapin, sertindol (vidjeti dio 4.5) - triazolam, peroralno primijenjen midazolam (mjere opreza za parenteralnu primjenu midazolama, vidjeti dio 4.5)
Boosted darunavir with triazolam or oral midazolam is contraindicated (see section 4.3)
Pojačan darunavir s triazolamom ili peroralnim midazolamom je kontraindiciran (vidjeti dio 4.3).
Co-administration of boosted darunavir with clonazepam may increase concentrations of clonazepam.
Istodobna primjena pojačanog darunavira s klonazepamom može povećati koncentracije klonazepama. (CYP3A inhibicija)
United Kingdom Consilient Health (UK) Ltd. Tel: +44 (0)203 751 1888
Tel: +44 (0)203 751 1888
30 film-coated tablets: EU/1/17/1249/005 60 film-coated tablets: EU/1/17/1249/006 90 film-coated tablets: EU/1/17/1249/007 180 film-coated tablets: EU/1/17/1249/008
30 filmom obloženih tableta: EU/1/17/1249/005 60 filmom obloženih tableta: EU/1/17/1249/006 90 filmom obloženih tableta: EU/1/17/1249/007 180 filmom obloženih tableta: EU/1/17/1249/008
darunavir AUC24h ↑ 33% (based on population pharmacokinetic model)
Istodobna sistemska primjena klotrimazola i pojačanog darunavira može povisiti koncentracije darunavira i/ili klotrimazola u plazmi. darunavir AUC24h ↑ 33% (na temelju populacijskog farmakokinetičkog modela)
Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg twice daily in combination with atazanavir 300 mg once daily.
Darunavir: usporedba darunavira/ritonavira 400/100 mg dvaput na dan naspram darunavira/ritonavira 400/100 mg dvaput na dan u kombinaciji s atazanavirom 300 mg jedanput na dan.
Co-administration of darunavir with low dose ritonavir and alfuzosin is contraindicated (see section 4.3).
Istodobna primjena darunavira s niskom dozom ritonavira i alfuzozinom je kontraindicirana (vidjeti dio 4.3).
median CD4+ cell count change from baseline (x 10
Medijan promjene broja CD4+ stanica od početne vrijednosti (x 10
once daily N=294
razlike) jedanput na dan N=343
Each film-coated tablet contains 400 mg darunavir.
Jedna filmom obložena tableta sadrži 400 mg darunavira.
EU/1/17/1249/005 30 film-coated tablets EU/1/17/1249/006 60 film-coated tablets EU/1/17/1249/007 90 film-coated tablets EU/1/17/1249/008 180 film-coated tablets
EU/1/17/1249/005 30 filmom obloženih tableta EU/1/17/1249/006 60 filmom obloženih tableta EU/1/17/1249/007 90 filmom obloženih tableta EU/1/17/1249/008 180 filmom obloženih tableta
ART-naïve paediatric patients (3 to 17 years of age and weighing at least 40 kg) The recommended dose regimen is 800 mg once daily with ritonavir 100 mg once daily taken with food.
Odrasli bolesnici koji nisu prethodno liječeni antiretrovirusnom terapijom (ART-om) Preporučeni režim doziranja je 800 mg jedanput na dan uz 100 mg ritonavira jedanput na dan uzeto s hranom.
Musculoskeletal and connective tissue disorders uncommon myalgia, osteonecrosis, muscle spasms, muscular weakness, arthralgia, pain in extremity, osteoporosis, increased blood creatine phosphokinase rare musculoskeletal stiffness, arthritis, joint stiffness
DRESS, Stevens-Johnsonov sindrom, multiformni eritem, dermatitis, seboroični dermatitis, kožne lezije, kseroderma nepoznato toksična epidermalna nekroliza, akutna generalizirana egzantematozna pustuloza Poremećaji mišićno-koštanog sustava i vezivnog tkiva manje često mialgija, osteonekroza, mišićni spazmi, mišićna slabost, artralgija, bol u ekstremitetima, osteoporoza, povišena kreatin-fosfokinaza u krvi rijetko mišićno-koštana ukočenost, artritis, ukočenost zglobova
Third trimester of pregnancy (n=12)
Treće tromjesečje trudnoće (n=12)
Clinical monitoring is recommended when co-administering darunavir with low dose ritonavir with these analgesics.
Preporučeno je kliničko praćenje kada se istodobno primjenjuju ovi analgetici s darunavirom s niskom dozom ritonavira.
EU/1/17/1249/001 30 film-coated tablets EU/1/17/1249/002 60 film-coated tablets EU/1/17/1249/003 90 film-coated tablets EU/1/17/1249/004 180 film-coated tablets
EU/1/17/1249/001 30 filmom obloženih tableta EU/1/17/1249/002 60 filmom obloženih tableta EU/1/17/1249/003 90 filmom obloženih tableta EU/1/17/1249/004 180 filmom obloženih tableta
not known toxic epidermal necrolysis*, acute generalised exanthematous pustulosis*
nepoznato toksična epidermalna nekroliza*, akutna generalizirana egzantematozna pustuloza* Poremećaji mišićno-koštanog sustava i vezivnog tkiva često mijalgija manje često osteonekroza*
Darunavir Krka 600 mg film-coated tablets darunavir
Darunavir Krka 600 mg filmom obložene tablete darunavir
Outcomes darunavir / ritonavir 600/100 mg twice daily n=131
Ishodi darunavir/ritonavir 600/100 mg dvaput na dan n=131
Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis) Saquinavir (HIV infection).
fenobarbital, fenitoin (sprječavaju epileptičke napadaje) deksametazon (kortikosteroid) efavirenz (HIV infekcija) boceprevir (infekcija hepatitisom C) rifapentin, rifabutin (lijekovi za liječenje nekih infekcija poput tuberkuloze) sakvinavir (HIV infekcija).
Darunavir/ritonavir 800/100 mg once daily in ART-experienced patients should not be used in patients with one or more darunavir resistance associated mutations (DRV-RAMs) or HIV-1 RNA ≥ 100,000 copies/ml or CD4+ cell count < 100 cells x 10
Među bolesnicima prethodno liječenim ART-om, darunavir/ritonavir od 800/100 mg jedanput na dan ne smije se primjenjivati u bolesnika s jednom ili više mutacija povezanih s rezistencijom na darunavir (DRV-RAM) ili s HIV-1 RNK ≥ 100 000 kopija/ml ili brojem CD4+ stanica < 100 stanica x 10
Hence, concomitant use of darunavir coadministered with low dose ritonavir and the combination product lopinavir/ritonavir is contraindicated (see section 4.3).
Odavde proizlazi da je istodobna primjena darunavira s niskom dozom ritonavira i kombiniranog lijeka lopinavira/ritonavira kontraindicirana (vidjeti dio 4.3).
darunavir/ ritonavir 600/100 mg twice daily N=298
darunavir/ritonavir 600/100 mg dvaput na dan N=298
Darunavir co-administered with low dose ritonavir and amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine is contraindicated (see section 4.3).
Istodobna primjena darunavira istodobno primijenjenog s niskom dozom ritonavira i amiodarona, bepridila, dronedarona, ivabradina, kinidina ili ranolazina je kontraindicirana (vidjeti dio
General disorders and administration site conditions common asthenia, fatigue uncommon pyrexia, chest pain, peripheral oedema, malaise, feeling hot, irritability, pain rare chills, abnormal feeling, xerosis
Nuspojava manje često pireksija, bol u prsištu, periferni edem, malaksalost, osjećaj vrućine, iritabilnost, bol rijetko zimica, nenormalno osjećanje, kseroza
Concomitant use of colchicine and darunavir co-administered with low dose ritonavir may increase the exposure to colchicine.
Istodobna primjena kolhicina i darunavira primijenjenog istodobno s niskom dozom ritonavira može povećati izloženost kolhicinu. (inhibicija CYP3A i/ili P-gp-a)
It is not recommended to combine darunavir co-administered with low dose ritonavir with saquinavir.
Ne preporučuje se istodobna primjena darunavira primijenjenog istodobno s niskom dozom ritonavira u kombinaciji sa sakvinavirom.
Abacavir Emtricitabine Lamivudine Stavudine Zidovudine
Abakavir Emtricitabin Lamivudin Stavudin Zidovudin
Co-administration of boosted darunavir with dapoxetine is contraindicated.
Istodobna primjena pojačanog darunavira s dapoksetinom je kontraindicirana.
Darunavir Krka 400 mg and 800 mg tablets can be used to construct the once daily 800 mg regimen.
Tablete Darunavir Krka od 400 mg i 800 mg mogu se uzimati za dostizanje jednokratne doze od 800 mg.
Darunavir co-administered with low dose ritonavir and atazanavir can be used without dose adjustments.
Darunavir istodobno primijenjen s niskom dozom ritonavira i atazanavirom može se primijeniti bez prilagodbe doze.
concomitantly administered with boosted darunavir.
Istodobna primjena kolhicina i pojačanog darunavira
The strong CYP3A inducers rifampicin and herbal preparations containing St John's wort (Hypericum perforatum).
- kombinacija lijekova lopinavir/ritonavir (vidjeti dio 4.5). - snažni CYP3A induktori, rifampicin i biljni pripravci koji sadrže gospinu travu (Hypericum perforatum).
Darunavir Krka 400 mg film-coated tablets Darunavir Krka 800 mg film-coated tablets darunavir
Darunavir Krka 400 mg filmom obložene tablete Darunavir Krka 800 mg filmom obložene tablete darunavir
Clinical monitoring is recommended when co-administering boosted darunavir with these analgesics.
Preporučeno je kliničko praćenje kada se istodobno primjenjuju ovi analgetici s pojačanim darunavirom.
Darunavir Krka 400 mg film-coated tablets darunavir
Darunavir Krka 400 mg filmom obložene tablete darunavir
The pharmacokinetics of darunavir in combination with ritonavir taken once daily in 10 treatmentexperienced paediatric patients, aged 3 to < 6 years and weighing at least 14 kg to < 20 kg, showed that weight-based dosages resulted in darunavir exposure that was comparable to that achieved in adults receiving darunavir/ritonavir 800/100 mg once daily (see section 4.2).
Farmakokinetika darunavira u kombinaciji s ritonavirom uzetih jedanput na dan, u 10 pedijatrijskih prethodno liječenih bolesnika, u dobi od 3 do < 6 godina i težine najmanje 14 kg do < 20 kg, pokazala je da je doziranje temeljeno na težini rezultiralo izloženošću darunaviru, sličnoj onoj postignutoj u odraslih koji su uzimali darunavir/ritonavir 800/100 mg jedanput na dan (vidjeti dio 4.2).
Boosted darunavir and dolutegravir can be used without dose adjustment.
Pojačan darunavir i dolutegravir mogu se uzimati bez prilagodbe doze.
Darunavir Krka 800 mg film-coated tablets darunavir
Darunavir Krka 800 mg filmom obložene tablete darunavir
Darunavir is expected to increase these β-blocker plasma concentrations.
Očekuje se da će darunavir povećati koncentracije tih β-blokatora u plazmi. (CYP2D6 inhibicija)
Concomitant use of everolimus and darunavir co-administered with low dose ritonavir is not recommended.
Istodobna primjena everolimusa i darunavira istodobno primijenjenog s niskom dozom ritonavira se ne preporučuje.
Darunavir used in combination with cobicistat or low dose ritonavir once daily in ART-experienced patients should not be used in patients with one or more darunavir resistance associated mutations (DRV-RAMs) or HIV-1 RNA ≥ 100,000 copies/ml or CD4+ cell count < 100 cells x 10
Darunavir koji se uzima u kombinaciji s kobicistatom ili niskom dozom ritonavira jedanput na dan, u ART-om prethodno liječenih bolesnika, ne smije se primjenjivati u onih bolesnika koji imaju jednu ili više mutacija povezanih s rezistencijom na darunavir (DRV-RAM, od engl. darunavir resistance associated mutations) ili HIV-1 RNK ≥ 100 000 kopija/ml ili broj CD4+ stanica < 100 stanica x 10
Dose for children 3 years of age and above, weighing more than 40 kilograms who have not taken antiretroviral medicines before (your child's doctor will determine this) The usual dose of Darunavir Krka is 800 milligram (2 tablets containing 400 milligram of Darunavir Krka or 1 tablet containing 800 milligram of Darunavir Krka) together with 100 milligram ritonavir once daily.
Doza za djecu u dobi od 3 godine i više, težine najmanje 40 kilograma koja nisu prethodno uzimala antiretrovirusne lijekove (to će odrediti liječnik Vašeg djeteta) - Uobičajena doza lijeka Darunavir Krka je 800 miligrama (2 tablete koje sadrže
Concomitant use of salmeterol and darunavir co-administered with low dose ritonavir is not recommended.
Ne preporučuje se istodobna primjena salmeterola i darunavira primijenjenog istodobno s niskom dozom ritonavira.
Sildenafil to treat high blood pressure in the pulmonary circulation
- sildenafil - kada se primjenjuje za liječenje plućne arterijske hipertenzije,
darunavir/ ritonavir 800/100 mg once daily N=294
darunavir/ritonavir 800/100 mg jedanput na dan N=294