natgillin/translations-raw huggingface dataset:
Based upon the safety profile of darunavir/ritonavir, the increase in darunavir exposure in the presence of rifabutin does not warrant a dose adjustment for darunavir/ritonavir.
Na temelju sigurnosnog profila darunavira/ritonavira, povišena izloženost darunaviru u prisustvu rifabutina ne zahtijeva prilagodbu doze darunavira/ritonavira.
drospirenone Cmax ↑ 15% ethinylestradiol AUC  30% ethinylestradiol Cmin ND€
drospirenon Cmax ↑ 15% etinilestradiol AUC  30% etinilestradiol Cmin NO€
Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone for intranasal or inhalational use should be considered, particularly for long term use.
Trebalo bi razmotriti primjenu alternativnih kortikosteroida koji manje ovise o metabolizmu CYP3A, kao što je beklometazon, za intranazalnu ili inhalacijsku upotrebu, posebice za dugotrajnu upotrebu.
There are currently inadequate data to determine whether co-administration of tenofovir disoproxil and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil without cobicistat.
Trenutno nema prikladnih podataka pomoću kojih bi se odlučilo je li istodobna primjena tenofovirdizoproksila i kobicistata povezana s povećanim rizikom za bubrežne nuspojave u usporedbi s režimima koji uključuju tenofovirdizoproksil bez kobicistata.
Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone.
Sistemski učinci kortikosteroida uključujući Cushingov sindrom i adrenalnu supresiju bili su prijavljeni kod bolesnika koji su primali ritonavir i inhalirali ili intranazalno primijenili flutikazon.
DRESS, Stevens-Johnson syndrome, erythema multiforme, dermatitis, seborrhoeic dermatitis, skin lesion, xeroderma toxic epidermal necrolysis, acute generalised exanthematous pustulosis
DRESS, Stevens-Johnsonov sindrom, multiformni eritem, dermatitis, seboroični dermatitis, kožne lezije, kseroderma toksična epidermalna nekroliza, akutna generalizirana egzantematozna pustuloza
Before prescribing darunavir tablets, young children should be assessed for the ability to swallow intact tablets.
Prije propisivanja tableta darunavira, potrebno je procijeniti mogu li mala djeca progutati cijele tablete.
Saquinavir 1,000 mg twice daily
Sakvinavir 1000 mg dva puta na dan
Darunavir cannot work properly without cobicistat or ritonavir and food.
Darunavir ne može pravilno djelovati bez kobicistata ili ritonavira i hrane.
administered with H2-receptor antagonists without dose adjustments.
H2-receptora bez prilagodbe doze.
- Clarithromycin (antibiotic) - Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
- klaritromicin (antibiotik) - ciklosporin, everolimus, takrolimus, sirolimus (za prigušivanje imunološkog sustava), s obzirom na mogućnost pojačanog terapijskog učinka ili nuspojava tih lijekova.
C-darunavir with ritonavir showed that approximately 7.7% of the administered dose of darunavir is excreted in the urine unchanged.
C-darunavirom s ritonavirom pokazali su da se približno 7,7% primijenjene doze darunavira izluči u mokraći u nepromijenjenom obliku.
Rifabutin 150 mg once every other day rifabutin AUC** ↑ 55% rifabutin Cmin
150 mg jedanput svaki drugi dan rifabutin AUC** ↑ 55% rifabutin Cmin
The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range (not determined as “ND”).
Smjer strelice za svaki farmakokinetički parametar utemeljen je na 90%-tnom intervalu pouzdanosti omjera geometrijskih srednjih vrijednosti unutar granice (↔), ispod (↓) ili iznad (↑) raspona 80-125% (nije određeno, označeno kao „NO“).
● antiretroviral therapy (ART)-naïve (see section 4.2).
● nisu prethodno liječeni antiretrovirusnom terapijom (ART) (vidjeti dio 4.2).
Endocrine disorders Uncommon hypothyroidism, increased blood thyroid stimulating hormone
Endokrini poremećaji manje često hipotireoza, povišen tiroidni stimulirajući hormon u krvi
- Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
- kortikosteroide uključujući betametazon, budesonid, flutikazon, mometazon, prednizon, triamcinolon.
Instructions for adults - Take one 800 milligram tablet at the same time, once a day, every day.
Upute za odrasle - Uzimite jednu tabletu od 800 miligrama u isto vrijeme, jedanput na dan, svaki dan.
Midazolam (oral) Triazolam
Midazolam (peroralni) Triazolam
Methadone individual dose ranging from 55 mg to 150 mg once daily
Metadon pojedinačna doza u rasponu od 55 mg do 150 mg jednput na dan
The recommendations given for concomitant use of darunavir and other medicinal products may therefore differ depending on whether darunavir is boosted with ritonavir or cobicistat (see sections 4.3 and 4.4), and caution is also required during the first time of treatment if switching the pharmacoenhancer from ritonavir to cobicistat (see section 4.4).
Preporuke za istodobnu primjenu darunavira i drugih lijekova mogu se stoga razlikovati, ovisno o tome je li darunavir pojačan ritonavirom ili kobicistatom (vidjeti dijelove 4.3 i 4.4), a oprez je također potreban tijekom prvog liječenja, ako se mijenja farmakokinetički pojačivač s ritonavira na kobicistat (vidjeti dio 4.4).
Week 48
48. tjedana
Digoxin 0.4 mg single dose digoxin AUC ↑ 61% digoxin Cmin ND digoxin Cmax ↑ 29% (↑ digoxin from probable inhibition of P-gp)
Digoksin 0,4 mg jednokratna doza digoksin AUC ↑ 61% digoksin Cmin ND digoksin Cmax ↑ 29% (↑digoksina zbog vjerojatne inhibicije P-gp)
Darunavir cannot work properly without ritonavir.
Darunavir ne može pravilno djelovati bez ritonavira.
Cobicistat as a pharmacokinetic enhancer of darunavir should, therefore, not be initiated in patients with creatine clearance less than 70 ml/min if any co-administered agent requires dose adjustment based on creatinine clearance: e.g. emtricitabine, lamivudine, tenofovir disoproxil (as fumarate, phosphate or succinate) or adefovir dipovoxil.
Prema tome, kobicistat koji se koristi kao farmakokinetički pojačivač darunavira se ne smije se početi davati bolesnicima s klirensom kreatinina manjim od 70 ml/min, ako bilo koji od istodobno primijenjenih lijekova zahtjeva prilagodbu doze temeljenu na klirensu kreatinina: npr. emtricitabin, lamivudin, tenofovirdizoproksil (u obliku fumarata, fosfata ili sukcinata) ili adefovirdipovoksil.
The table below shows the development of HIV-1 protease mutations and resistance to PIs in virologic failures at endpoint in the GS-US-216-130 trial.
Tablica ispod pokazuje razvoj mutacija HIV-1 proteaza i rezistenciju na IP u virološkom neuspjehu na ishodu ispitivanja GS-US-216-130.
What Darunavir Mylan contains - The active substance is darunavir.
Što Darunavir Mylan sadrži - Djelatna tvar je darunavir.
However, when HIV genotypic testing is not feasible, the darunavir/ritonavir once daily dosing regimen is recommended in HIV protease inhibitor-naïve paediatric patients and the twice daily dosing regimen is recommended in HIV protease inhibitor-experienced patients.
Međutim, kada testiranje genotipa HIV-a nije moguće provesti, preporučeni režim doziranja lijeka darunavir/ritonavir je jedanput na dan u pedijatrijskih bolesnika koji prethodno nisu uzimali inhibitore proteaze HIV-a i dva puta na dan, preporučeni režim doziranja u bolesnika koji su prethodno uzimali inhibitore proteaze HIV-a.
The film-coating contains polyvinyl alcohol partially hydrolysed, titanium dioxide (E171), macrogol and talc.
Film-ovojnica sadrži poli(vinilni alkohol) - djelomično hidroliziran, titanijev dioksid (E171), makrogol i talk.
100 milligram between 30 and 40 kilograms
100 miligrama između 30 i 40 kilograma
Therefore, no special precautions or dose adjustments are required in these patients (see sections 4.2 and 5.2).
Prema tome, kod takvih bolesnika nisu potrebne posebne mjere opreza ili prilagodbe doze (vidjeti dijelove 4.2 i 5.2).
Up to same dose levels, there was no teratogenicity with darunavir in rats and rabbits when treated alone nor in mice when treated in combination with ritonavir.
Pri istim razinama doza, nije bilo teratogenosti s liječenjem darunavirom kod štakora i kunića, a niti kod miševa uz liječenje kombinacijom s ritonavirom.
The most frequent adverse reactions reported in clinical trials and as spontaneous reports are diarrhoea, nausea, rash, headache and vomiting.
Najčešće nuspojave prijavljene u kliničkim ispitivanjima i spontano prijavljene su proljev, mučna, osip, glavobolja i povraćanje.
What Darunavir Mylan looks like and contents of the pack
Kako Darunavir Mylan izgleda i sadržaj pakiranja
- Tell your doctor if you have haemophilia.
- Upozorite liječnika ako imate hemofiliju.
The dosage of other medicines might need to be changed since either their own or darunavir's therapeutic effect or side effects may be influenced when combined.
Postoji mogućnost da će biti potrebno promijeniti doziranje drugih lijekova, s obzirom na mogućnost promjene terapijskog učinka ili nuspojava tih lijekova ili darunavira kada se primjenjuju u kombinaciji.
Cobicistat inhibits the tubular secretion of creatinine and may cause modest increases in serum creatinine and modest declines in creatinine clearance.
Kobicistat inhibira tubularnu sekreciju kreatinina i može uzrokovati blagi porast kreatinina u serumu i blagi pad klirensa kreatinina.
The increased exposure to darunavir in HIV-1 infected patients compared to healthy subjects may be explained by the higher concentrations of α1-acid glycoprotein (AAG) in HIV-1 infected patients, resulting in higher darunavir binding to plasma AAG and, therefore, higher plasma concentrations.
Povišena izloženost darunaviru kod bolesnika inficiranih s HIV-1 u usporedbi sa zdravim ispitanicima može se objasniti višim koncentracijama α1-kiselog glikoproteina (AAG, od engl. α1-acid glycoprotein) kod bolesnika inficiranih s HIV-1, što može rezultirati višim vezivanjem darunavira na AAG u plazmi i stoga višim koncentracijama u plazmi.
Tablets of other strengths are available and your doctor may have prescribed a certain combination of tablets to construct the appropriate dosing regimen.
Dostupne su i tablete drugih jačina, pa Vam liječnik može propisati određenu kombinaciju tableta kojom će biti dosegnut odgovarajući režim doziranja.
Even when you feel better, do not stop taking darunavir.
Čak i ako se osjećate bolje, nemojte prestati uzimati darunavir.
Tell your doctor if you take: - Phenobarbital, phenytoin (to prevent seizures) - Dexamethasone (corticosteroid) - Efavirenz (HIV infection) - Boceprevir (hepatitis C infection) - Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis) - Saquinavir (HIV infection).
Upozorite svog liječnika ako uzimate: - fenobarbital, fenitoin (sprečavaju epileptičke napadaje) - deksametazon (kortikosteroid) - efavirenz (HIV infekcija) - boceprevir (infekcija virusom hepatitisa C) - rifapentin, rifabutin (lijekovi za liječenje nekih infekcija poput tuberkuloze) - sakvinavir (HIV infekcija).
One ritonavir a dose is between 15 and 30 kilograms
Jedna doza ritonavira a je između 15 i 30 kilograma
NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)].
NRTI (nukleozidni inhibitori reverzne transkriptaze), NNRTI (ne-nukleozidni inhibitori reverzne transkriptaze), antagonisti receptora CCR5 i IF (inhibitori fuzije)].
Even when you feel better, do not stop taking Darunavir Mylan.
Čak i ako se osjećate bolje, nemojte prestati uzimati Darunavir Mylan.
Darunavir is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection.
Darunavir je antiretrovirusni lijek koji se koristi za liječenje infekcije uzrokovane virusom humane imunodeficijencije (HIV).
Strong CYP3A inducers include e.g. carbamazepine, phenobarbital and phenytoin (see sections 4.4 and 4.5).
Snažni induktori CYP3A uključuju npr. karbamazepin, fenobarbital i fenitoin (vidjeti dijelove 4.4 i
As limited information is available on the use of darunavir in patients aged 65 and over, caution should be exercised in the administration of darunavir in elderly patients, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
S obzirom da su dostupni ograničeni podaci o primjeni darunavira kod bolesnika u dobi od 65 godina i više, nužan je oprez kod primjene darunavira u starijih bolesnika zbog povećane učestalosti smanjene funkcije jetre, te istodobne bolesti ili druge terapije (vidjeti dijelove 4.2 i 5.2).
Given that digoxin has a narrow therapeutic index, it is recommended that the lowest possible dose of digoxin should initially be prescribed in case digoxin is given to patients on darunavir/ritonavir therapy.
Budući da digoksin ima uzak terapijski indeks, preporučuje se inicijalno propisati najnižu moguću dozu digoksina u slučaju kada se digoksin daje bolesnicima koji su na terapiji darunavirom/ritonavirom.
Therefore, concomitant treatment with such medicinal products for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (applies to darunavir boosted with either ritonavir or cobicistat).
Stoga je istodobno liječenje s takvim lijekovima čije su povišene koncentracije u plazmi povezane s ozbiljnim i/ili po život opasnim događajima kontraindicirano (odnosi se na darunavir pojačan bilo ritonavirom ili bilo kobicistatom.
Darunavir may therefore have different contraindications and recommendations for concomitant medications depending on whether the compound is boosted with ritonavir or cobicistat (see sections 4.3, 4.4 and 4.5).
Stoga, darunavir može imati različite kontraindikacije i preporuke za istodobno primijenjene lijekove, ovisno o tome je li djelatna tvar pojačana ritonavirom ili kobicistatom (vidjeti dijelove 4.3, 4.4 i 4.5).
Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 ml/min, n=20) (see sections 4.2 and 4.4).
Iako darunavir nije ispitivan kod bolesnika s oštećenjem bubrega, analiza populacijskih farmakokinetičkih podataka pokazala je da kod bolesnika inficiranih HIV-om s umjerenim oštećenjem bubrega nije bilo značajnog utjecaja na farmakokinetiku darunavira (CrCl između 30-60 ml/min, n=20) (vidjeti dijelove 4.2 i 4.4).
PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction
INHIBITORI FOSFODIESTERAZE, TIP 5 (PDE-5) Za liječenje erektilne disfunkcije Avanafil Sildenafil Tadalafil Vardenafil
Investigations Common increased blood creatinine these adverse drug reactions have not been reported in clinical trial experience with darunavir/cobicistat but have been noted with darunavir/ritonavir treatment and could be expected with darunavir/cobicistat too.
Pretrage često povišen kreatinin u krvi * ove nuspojave nisu prijavljene tijekom iskustva iz kliničkih ispitivanja s darunavirom/kobicistatom ali su zabilježene tijekom liječenja s darunavirom/ritonavirom, te se također mogu očekivati s darunavirom/kobicistatom.
When the recommendation is the same for darunavir when co-administered with a low dose ritonavir or cobicistat, the term “boosted darunavir” is used.
Kada je preporuka ista za darunavir istodobno primijenjen s niskom dozom ritonavira ili kobicistatom, korišten je termin „pojačani darunavir“.
Darunavir Mylan should be used with caution in patients with a known sulphonamide allergy.
Darunavir Mylan mora se primjenjivati s oprezom kod bolesnika s poznatom alergijom na sulfonamide.
Cobicistat has not been studied in patients receiving dialysis, and, therefore, no recommendation can be made for the use of darunavir/cobicistat in these patients.
Kobicistat nije ispitan u bolesnika na dijalizi, stoga se ne mogu dati preporuke za primjenu darunavira/kobicistata u ovih bolesnika.
ART-experienced paediatric patients from the age of 3 to < 6 years
Pedijatrijski bolesnici prethodno liječeni ART-om u dobi od 3 do < 6 godina
zoldipem (sedative agents) - Perphenazine, risperidone, thioridazine (to treat psychiatric conditions) - Metformin (to treat type 2 diabetes).
- perfenazin, risperidon, tioridazin ( za liječenje psihijatrijskih stanja) - metformin (za liječenje šećerne bolesti tipa 2).
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Kod bolesnika inficiranih HIV-om s teškom imunodeficijencijom u vrijeme započinjanja kombinirane antiretrovirusne terapije (KART), može se pojaviti upalna reakcija na asimptomatske ili rezidualne oportunističke patogene te uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
Repeated administration of darunavir to rats caused hepatic microsomal enzyme induction and increased thyroid hormone elimination, which predispose rats, but not humans, to thyroid neoplasms.
Ponovljena primjena darunavira štakorima uzrokovala je indukciju mikrosomalnih enzima jetre te povećanu eliminaciju hormona štitnjače, što je kod štakora predispozicija za razvoj neoplazmi štitnjače, ali ne i kod ljudi.
Vinblastine
Vinblastin
This guidance is based on the half-life of darunavir in the presence of cobicistat or ritonavir and the recommended dosing interval of approximately 24 hours.
Ova smjernica temeljena je na poluvijeku darunavira u prisutnosti kobicistata ili ritonavira te preporučenom intervalu doziranja od približno 24 sata.
Some side effects are typical for anti-HIV medicines in the same family as darunavir.
Neke su nuspojave tipične za lijekove protiv HIV-a koji spadaju u istu skupinu kao i darunavir.
The combination of darunavir and artemether/lumefantrine can be used without dose adjustments; however, due to the increase in lumefantrine exposure, the combination should be used with caution.
Kombinacija darunavira i artemeter/lumefantrina može se primijeniti bez prilagodbe doze, međutim, zbog povećane izloženosti lumefantrinu, tu kombinaciju se mora primjenjivati s oprezom.
Darunavir might increase the risk for elevated potassium levels by drospirenone.
Darunavir može povećati rizik od nastanka povišenih razina kalija zbog drospirenona.
Alternative or additional contraceptive measures are recommended when oestrogen-based contraceptives are coadministered with boosted darunavir.
Preporučuju se druge ili zamjenske kontracepcijske mjere kada se kontraceptivi na bazi estrogena primjenjuju istodobno s pojačanim darunavirom.
Uncommon side effects (may affect up to 1 in 100 people) - chest pain, changes in electrocardiogram, rapid heart beating - decreased or abnormal skin sensitivity, pins and needles, attention disturbance, loss of memory,
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) - bol u prsnom košu, promjene u elektrokardiogramu, brzi otkucaji srca - smanjena ili nenormalna osjetljivost kože, mravci i trnci, poremećaj pažnje, gubitak pamćenja,
Darunavir should be used with caution in patients with a known sulphonamide allergy.
Darunavir se mora primjenjivati s oprezom kod bolesnika s poznatom alergijom na sulfonamide.
AUC24h, ng.h/mL 47,293 ± 19,058
AUC24h, ng.h/mL 47 293 ± 19 058 Cmin, ng/mL
Darunavir/cobicistat may, in contrast, increase methadone plasma concentrations (see cobicistat SmPC).
Nasuprot tome, darunavir/kobicistat može povećati koncentracije metadona u plazmi (vidjeti SmPC za kobicistat).
Treatment-experienced darunavir/cobicistat 800/150 mg once daily N=18 Number of subjects with virologic failurea and genotype data that develop mutationsb at endpoint, n/N
Prethodno liječeni darunavir/kobicistat 800/150 mg jedanput na dan N=18 Broj ispitanika s virološkim neuspjehoma i podaci o genotipu koji je razvio mutacijeb na ishodu ispitivanja, n/N
The observed hepatocellular and thyroid tumours in rodents are considered to be of limited relevance to humans.
Smatra se da su opaženi hepatocelularni tumori i tumori štitnjače kod glodavaca od ograničenog značaja za ljude.
The combination of boosted darunavir and artemether/lumefantrine can be used without dose adjustments; however, due to the increase in lumefantrine exposure, the combination should be used with caution.
Kombinacija pojačanog darunavira i artemeter/lumefantrina može se primijeniti bez prilagodbe doze, međutim, zbog povećane izloženosti lumefantrinu, tu kombinaciju se mora primjenjivati s oprezom.
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Kod bolesnika inficiranih HIV-om s teškom imunodeficijencijom u vrijeme početka liječenja kombiniranom antiretrovirusnom terapijom (KART) može nastati upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents.
Pri donošenju odluke o početku liječenja darunavirom primijenjenim istodobno s niskom dozom ritonavira, mora se pažljivo razmotriti dosadašnje liječenje pojedinog bolesnika i obrasce mutacija povezanih s različitim lijekovima.
Applicable to darunavir boosted with cobicistat, not when boosted with ritonavir: - Darunavir boosted with cobicistat is more sensitive for CYP3A induction than darunavir boosted with ritonavir.
Primjenjivo na darunavir pojačan s kobicistatom, ne kada je pojačan ritonavirom: - Darunavir pojačan s kobicistatom osjetljiviji je na CYP3A indukciju, nego darunavir pojačan s ritonavirom.
400/100 mg twice daily
400/100 mg dva puta na dan
MedDRA system organ class Frequency category
Klasifikacija organskih sustava prema MEDRA-i Kategorija učestalosti
Ritonavir inhibits the transporters P-glycoprotein, OATP1B1 and OATP1B3, and co-administration with substrates of these transporters can result in increased plasma concentrations of these compounds (e.g. dabigatran etexilate, digoxin, statins and bosentan; see the Interaction table below).
Ritonavir blokira prijenosnike glikoproteina P, OATP1B1 i OATP1B3 i zajednička primjena sa supstratima tih prijenosnika može dovesti do povećanja koncentracije tih tvari u plazmi (npr. dabigatran-eteksilata, digoksina, statina i bosentana; vidjeti Tablicu interakcija u nastavku).
Low rates of developing resistant HIV-1 virus were observed in ART-naïve patients who are treated for the first time with darunavir/cobicistat once daily in combination with other ART, and in ARTexperienced patients with no darunavir RAMs receiving darunavir/cobicistat in combination with other ART.
Niske stope razvijanja rezistentnog HIV-1 virusa bile su uočene u bolesnika koji prethodno nisu liječeni ART-om i koji su liječeni prvi put s darunavirom/kobicistatom jedanput na dan u kombinaciji s drugim ART, i u bolesnika koji su prethodno liječeni ART-om bez mutacija povezanih s rezistencijom (RAM) na darunavir koji primaju darunavir/kobicistat u kombinaciji s drugim ART.
Darunavir/ritonavir should not be used in children below 3 years of age because of safety concerns (see sections 4.4 and 5.3).
Darunavir/ritonavir se ne smiju primjenjivati u djece uzrasta ispod 3 godine zbog sigurnosnih pitanja (vidjeti dijelove 4.4 i
For bottles: Once opened, use within 90 days.
Za boce: Nakon otvaranja, iskoristiti u roku od 90 dana.
Therefore, protein displacement of medicinal products highly bound to α1-acid glycoprotein cannot be ruled out (see section 4.5).
Stoga se ne može isključiti istiskivanje proteina lijekovima koji imaju visoki afinitet vezanja na α1-kiseli glikoprotein (vidjeti dio 4.5).