FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Phase 3 trial in suppressed treatment-experienced patients (EMERALD Study TMC114IFD3013), 5.1% (39/763) of patients receiving Symtuza experienced rash (most of which were grade 1), none discontinued treatment due to rash.
Croatian: U ispitivanju faze 3 u virološki suprimiranih bolesnika koji su primali terapiju (EMERALD ispitivanje TMC114IFD3013), 5,1% (39/763) bolesnika koji su uzimali lijek Symtuza doživjelo je osip (većinom 1. stupnja), nitko nije prekinuo liječenje radi osipa.
English: Over 96 weeks of treatment in the Phase 3 studies TMC114FD2HTX3001 (AMBER) in treatmentnaïve patients and TMC114IFD3013 (EMERALD) in virologically suppressed treatment-experienced patients, resistance testing was performed on samples from patients experiencing protocol-defined virologic failure (PDVF) and who had HIV-1 RNA ≥400 copies/mL at failure or at later time points.
Croatian: Tijekom 96 tjedana liječenja u ispitivanjima faze 3: TMC114FD2HTX3001 (AMBER) u bolesnika koji prethodno nisu bili liječeni i TMC114IFD3013 (EMERALD) u prethodno liječenih virološki suprimiranih bolesnika, provedeno je testiranje rezistencije na uzorcima bolesnika koji su doživjeli protokolom definiran virološki neuspjeh i koji su imali HIV-1 RNK ≥ 400 kopija/ml u trenutku utvrđivanja neuspjeha liječenja ili pri kasnijem mjerenju.
English: When Symtuza is coadministered with a drospirenone-containing product, clinical monitoring is recommended due to the potential for hyperkalaemia.
Croatian: Kada se Symtuza istodobno primjenjuje s lijekovima koji sadrže drospirenon preporučuje se kliničko praćenje, radi rizika nastanka hiperkalemije.
English: The most frequent (> 5%) adverse reactions reported in suppressed treatment-experienced patients (EMERALD Study TMC114IFD3013, Week 96 analysis) were diarrhoea (10.5%), headache (10.4%), arthralgia (7.7%), abdominal pain (7.5%), fatigue (5.9%), and rash (5.1%).
Croatian: Najčešće nuspojave (> 5%) prijavljene u prethodno liječenih virološki suprimiranih bolesnika (ispitivanje EMERALD, TMC114IFD3013, analiza podataka u 96. tjednu) bile su proljev (10,5%), glavobolja (10,4%), artralgija (7,7%), bol u abdomenu (7,5%), umor (5,9%) i osip (5,1%).
English: An open-label, Phase 2 trial (TMC114-C230) was conducted for evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with low dose ritonavir in 12 ART-naïve HIV-1 infected paediatric patients aged 12 to less than 18 years and weighing at least 40 kg.
Croatian: Provedeno je otvoreno ispitivanje faze 2 (TMC114-C230) radi ocjenjivanja farmakokinetike, sigurnosti, podnošljivosti i djelotvornosti darunavira u kombinaciji s niskom dozom ritonavira u 12 pedijatrijskih bolesnika zaraženih virusom HIV-1 u dobi od 12 do manje od 18 godina i tjelesne težine od najmanje 40 kg koji se prethodno nisu liječili antiretrovirusnom terapijom.
English: Co-administration of Symtuza and these anticoagulants is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka Symtuza i ovih antikoagulansa.
English: At Week 96, the median change in eGFRCG was -5.2 mL/min with D/C/F/TAF.
Croatian: Medijan promjene vrijednosti eGFRCG u 96. tjednu iznosio je -5,2 ml/min uz D/K/F/TAF.
English: Clinical monitoring is recommended when co-administering Symtuza with these sedatives/hypnotics and a lower dose of the sedative/hypnotic should be considered.
Croatian: Kod istodobne primjene lijeka Symtuza i ovih sedativa/hipnotika preporučuje se kliničko praćenje te treba razmotriti nižu dozu ovih sedativa/hipnotika.
English: It is important not to stop taking Symtuza without talking to your doctor first.
Croatian: Važno je da ne prestanete uzimati lijek Symtuza ako prethodno o tome niste razgovarali s liječnikom.
English: Baseline CD4+ cell count < 200 cells/mm ≥ 200 cells/mm
Croatian: Početna vrijednost broja CD4+ stanica <200 stanica/mm ≥200 stanica /mm
English: Metabolism and nutrition disorders common diabetes mellitus, anorexia, hypercholesterolaemia, low density lipoprotein increased, hypertriglyceridaemia, hyperlipidaemia, dyslipidaemia uncommon hyperglycaemia
Croatian: Poremećaji metabolizma i prehrane često dijabetes melitus, anoreksija, hiperkolesterolemija, povišeni lipoproteini niske gustoće, hipertrigliceridemija, hiperlipidemija, dislipidemija manje često hiperglikemija
English: Patients with pre-existing liver dysfunction, including chronic hepatitis B or C, have an increased risk for liver function abnormalities including severe and potentially fatal hepatic adverse reactions.
Croatian: Bolesnici s postojećom disfunkcijom jetre, uključujući kronični hepatitis B ili C, izloženi su povećanom riziku od poremećaja jetrene funkcije, uključujući potencijalno smrtonosne jetrene nuspojave.
English: 2 consecutive HIV-1 RNA ≥ 50 copies/mL, or in case of discontinuation or at Week 48/96 for any reason, (single) HIV-1 RNA ≥ 50 copies/mL as of baseline (included)
Croatian: 2 uzastopna mjerenja HIV-1 RNK ≥ 50 kopija/mL, ili u slučaju prekida ili u 48./96. tjednu radi bilo kojeg razloga, (jedno mjerenje) HIV-1 RNK ≥ 50 kopija/mL od početka liječenja (uključeno)
English: Table 7: Virologic Outcome in ART- naïve Adolescents at Week 48 (TLOVR algorithm) TMC114-C230
Croatian: Tablica 7: Virološki ishod u adolescenata prethodno neliječenih antiretrovirusnom terapijom u 48. tjednu (algoritam vremena do gubitka virološkog odgovora [engl. time to loss of virological response, TLOVR]) TMC114-C230
English: Patients with severe (Child-Pugh Class C) hepatic impairment.
Croatian: Bolesnici s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).
English: The exposure to darunavir and cobicistat administered as the Symtuza was 30-45% lower and 16-29% lower, respectively, in fasted compared to fed condition.
Croatian: Izloženost darunaviru i kobicistatu nakon primjene lijeka Symtuza bila je 30 - 45% odnosno 16 - 29% niža natašte nego nakon obroka.
English: Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Croatian: Tenofoviralafenamid je nukleotidni inhibitor reverzne transkriptaze (engl. nucleotide reverse transcriptase inhibitor, NtRTI) i fosforoamidatni predlijek tenofovira (analog 2'-deoksiadenozin monofosfata).
English: Rash is a common adverse drug reaction in patients treated with darunavir.
Croatian: Osip je česta nuspojava u bolesnika liječenih darunavirom.
English: Median Increase From Baseline at Week 48 D/C/F/TAF
Croatian: Medijani povišenja od početne vrijednosti 48. tjedan D/K/F/TAF
English: Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chain-termination.
Croatian: Tenofovirdifosfat inhibira replikaciju HIV-a ugradnjom u virusnu DNK uz pomoć RT HIV-a, što dovodi do prekida lanca DNK.
English: Symtuza can be co-administered with proton pump inhibitors without dose adjustments.
Croatian: Symtuza se može primjenjivati istodobno s inhibitorima protonske pumpe bez prilagodbe doze.
English: Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human PBMCs and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to 5.0 ng/mL).
Croatian: Darunavir pokazuje aktivnost protiv laboratorijskih sojeva i kliničkih izolata virusa HIV-1 te laboratorijskih sojeva virusa HIV-2 u akutno zaraženim linijama T-stanica, ljudskim mononuklearnim stanicama iz periferne krvi i ljudskim monocitima/makrofagima, uz medijan vrijednosti EC50 u rasponu od 1,2 do 8,5 nM (0,7 - 5,0 ng/ml).
English: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Croatian: U bolesnika zaraženih HIV-om s teškom imunodeficijencijom u vrijeme uvođenja KART-a može doći do upalne reakcije na asimptomatski prisutne ili na rezidualne oportunističke patogene, koja može uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
English: ERGOT DERIVATIVES e.g.
Croatian: DERIVATI ERGOTA npr.
English: In HIV infected patients with severe immune deficiency at the time of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Croatian: U bolesnika s HIV infekcijom i teškom imunodeficijencijom u trenutku uvođenja KART-a može se razviti upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
English: In double-blind Phase 3 Trial TMC114FD2HTX3001 (AMBER), treatment-naïve patients were randomised to receive either Symtuza (N = 362) or a combination of fixed-dose combination of darunavir and cobicistat and fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (F/TDF) (N = 363) once daily.
Croatian: U dvostuko slijepom ispitivanju faze 3 TMC114FD2HTX3001 (AMBER), bolesnici koji prethodno nisu bili liječeni bili su randomizirani tako da prime ili lijek Symtuza (N = 362) ili kombinaciju fiksne kombinacije darunavira i kobicistata i fiksne kombinacije emtricitabina i tenofovirdizoproksilfumarata (F/TDF) (N = 363) jedanput na dan.
English: In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 mcg/mL.
Croatian: In vitro se za proteine u plazmi ljudi vezalo < 0,7% tenofovira; vezivanje je je bilo neovisno o koncentraciji u rasponu od 0,01 do 25 µg/ml.
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 15 and 40 times greater, respectively, than those expected after administration of Symtuza.
Croatian: Primijećena je minimalna infiltracija histiocita u oku pasa kod izloženosti tenofoviralafenamidu i tenofoviru koja je bila približno 15 odnosno 40 puta veća od one očekivane nakon primjene lijeka Symtuza.
English: • allergic reactions such as nettle rash (urticaria), itching, decreased appetite (anorexia)
Croatian: • alergijske reakcije kao što su koprivnjača (urtikarija), svrbež
English: Patients had a median age of 46 years (range 19-78), 82% were male, 75.5% White, 20.9% Black, and 2.3% Asian.
Croatian: Medijan dobi bolesnika bio je 46 godina (raspon 19-78), 82% bilo je muškog spola, 75,5% bijele rase, 20,9% crne rase i 2,3% azijskog porijekla.
English: A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Croatian: Ispitivanje farmakokinetike kobicistata provedeno je u ispitanika s umjerenim oštećenjem jetrene funkcije koji nisu bili zaraženi virusom HIV-1 (Child-Pugh stadij B).
English: A safe and effective dose of sildenafil for the treatment of pulmonary arterial hypertension co-administered with Symtuza has not been established.
Croatian: Nije utvrđena sigurna i učinkovita doza sidenafila za liječenje plućne arterijske hipertenzije kada se primjenjuje istodobno s lijekom Symtuza.
English: Co-administration of Symtuza and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and cobicistat and may result in increased plasma concentrations of darunavir and cobicistat (e.g. azole antifungals like clotrimazole).
Croatian: Istodobna primjena lijeka Symtuza i drugih lijekova koji inhibiraju CYP3A može smanjiti klirens darunavira i kobicistata te uzrokovati povišenje plazmatskih koncentracija darunavira i kobicistata (npr. antifungalni azoli poput klotrimazola).
English: • cobicistat, a booster (enhancer) of darunavir
Croatian: • kobicistat, pojačivač darunavira
English: Following administration of tenofovir alafenamide, plasma [
Croatian: Nakon primjene tenofoviralafenamida, [
English: During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Croatian: Tijekom antiretrovirusne terapije može doći do povećanja tjelesne težine i povišenja razine lipida i glukoze u krvi.
English: Symtuza is, therefore, contraindicated in patients with severe hepatic impairment.
Croatian: Stoga je lijek Symtuza kontraindiciran u bolesnika s teškim oštećenjem jetrene funkcije.
English: Virologic Response, % HIV-1 RNA < 50 copies/mL
Croatian: Virološki odgovor, % HIV-1 RNK <50 kopija/mL Razlika liječenja
English: Co-administration of amiodarone, dronedarone, ivabradine, quinidine, or ranolazine and Symtuza is contraindicated (see section 4.3).
Croatian: Istodobna primjena amiodarona, dronedarona, ivabradina, kinidina ili ranolazina i lijeka Symtuza je kontraindicirana (vidjeti dio 4.3).
English: In the Phase 2/3 trials in treatment-naïve patients, 12.7% (59/465) of patients receiving Symtuza experienced rash (most of which were grade 1), 1.5% (7/465) of patients discontinued treatment due to rash, of whom one for rash and hypersensitivity.
Croatian: U ispitivanjima faze 2/3 u bolesnika koji prethodno nisu bili liječeni, 12,7% (59/465) bolesnika koji uzimaju lijek Symtuza doživjelo je osip (većinom 1.stupnja), 1,5% (7/465) bolesnika prekinulo je liječenje radi osipa, od čega jedan radi osipa i prosjetljivosti.
English: Cobicistat is a mechanism based inhibitor of CYP3A, and a weak CYP2D6 inhibitor.
Croatian: Kobicistat je inhibitor mehanizma djelovanja CYP3A i slab inhibitor CYP2D6.
English: Darunavir is an inhibitor of CYP3A, a weak inhibitor of CYP2D6 and an inhibitor of P-gp.
Croatian: Darunavir je inhibitor CYP3A, slab inhibitor CYP2D6 i inhibitor P-glikoproteina.
English: Changes in measures of renal function
Croatian: Promjene u mjerama funkcije bubrega
English: Virologic Outcomes in AMBER at Week 48 and 96 (FDA Snapshot) Week 48
Croatian: Tablica 5: Virološki ishodi u ispitivanju AMBER u 48. i 96. tjednu (FDA Snapshot) 48. tjedan
English: Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Croatian: Glavni put eliminacije tenofoviralafenamida u ljudi je metabolizam, kojim se razgradi > 80% peroralno primijenjene doze.
English: Mexiletine
Croatian: Meksiletin
English: These can include, but are not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Croatian: Oni uključuju, između ostaloga, težak osip ili osip praćen vrućicom, opću malaksalost, umor, bolove u mišićima ili zglobovima, mjehuriće na koži, oralne lezije, konjunktivitis, hepatitis i/ili eozinofiliju.
English: A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Symtuza is required.
Croatian: U bolesnika s normalnom bubrežnom ili jetrenom funkcijom preporučuje se smanjenje doze kolhicina ili prekid liječenja kolhicinom ako je potrebno liječenje lijekom Symtuza.
English: No human data on the effect of darunavir, cobicistat, emtricitabine, or tenofovir alafenamide on fertility are available.
Croatian: Nema dostupnih podataka o učinku darunavira, kobicistata, emtricitabina ni tenofoviralafenamida na plodnost u ljudi.
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of tenofovir alafenamide has not been studied.
Croatian: Utjecaj teškog oštećenja jetrene funkcije (Child-Pugh stadij C) na farmakokinetiku tenofoviralafenamida nije ispitivan.
English: Co-administration of Symtuza with rifabutin and rifapentine is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka Symtuza s rifabutinom i rifapentinom.
English: Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended.
Croatian: Preporučuje se se uzimanje drugog antitrombocitnog lijeka na kojeg ne utječe CYP inhibicija ili indukcija (npr. prasugrela).
English: Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Croatian: Bolesnici s kroničnim hepatitisom B ili C koji primaju antiretrovirusnu terapiju izloženi su povećanom riziku od razvoja teških jetrenih nuspojava s mogućim smrtnim ishodom.
English: Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of Symtuza treatment.
Croatian: U bolesnika s podležećim kroničnim hepatitisom, cirozom, ili u bolesnika koji su prije liječenja imali povišene vrijednosti transaminaza potrebno je razmotriti pojačano praćenje vrijednosti AST-a/ALT-a, osobito u prvih nekoliko mjeseci liječenja lijekom Symtuza.
English: Following oral administration of Symtuza, the median terminal elimination half-life of emtricitabine is 17.2 hours.
Croatian: Medijan terminalnog poluvijeka eliminacije emtricitabina nakon peroralne primjene lijeka Symtuza iznosi 17,2 sata.
English: Lipid disorders should be managed as clinically appropriate.
Croatian: Poremećaje vrijednosti lipida treba liječiti prema kliničkoj potrebi.
English: Co-administration of cobicistat with medicinal products that are substrates of these transporters can result in increased plasma concentrations of the co-administered medicinal products.
Croatian: Istodobna primjena kobicistata s lijekovima koji su supstrati ovih prijenosnika može uzrokovati povišenje plazmatskih koncentracija istodobno primijenjenih lijekova.
English: A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (eGFRCG below 30 mL/min).
Croatian: Ispitivanje farmakokinetike kobicistata provedeno je u ispitanika s teškim oštećenjem bubrežne funkcije koji nisu bili zaraženi virusom HIV-1 (eGFRCG ispod 30 ml/min).
English: No virologic data
Croatian: Nema viroloških podatka Razlozi
English: Patients should be informed that dizziness may occur when treated with Symtuza (see section 4.8).
Croatian: Bolesnike treba upozoriti da se tijekom liječenja lijekom Symtuza može javiti omaglica (vidjeti dio 4.8).
English: It is not recommended to co-administer Symtuza with glecaprevir/pibrentasvir.
Croatian: Ne preporučuje se istodobna primjena lijeka Symtuza s glekaprevirom/pibrentasvirom.
English: Using Cyst C as filtration marker, the median changes in estimated glomerular filtration rate calculated using the CKD-EPI (eGFRCKD-EPI CystC) formula were respectively 4.0 mL/min/1.73 m² and 1.6 mL/min/1.73 m² (p<0.001).
Croatian: Koristeći cistatin C kao biljeg filtracije utvrđeno je da je medijan promjene procijenjene brzine glomerularne filtracije izračunate jednadžbom CKD-EPI (eGFRCKD-EPI CystC) iznosio 4,0 ml/min/1,73 m² odnosno 1,6 ml/min/1,73 m² (p = 0,001).
English: C]-cobicistat, 86% and 8.2% of the dose were recovered in feces and urine, respectively.
Croatian: C]-kobicistata 86% doze pronađeno je u fecesu, a 8,2% u mokraći.
English: The safety of Symtuza in paediatric patients has not been investigated.
Croatian: Sigurnost lijeka Symtuza nije se ispitivala u pedijatrijskih bolesnika.
English: The median terminal elimination half-life of tenofovir alafenamide was 0.3 hours when administered as Symtuza.
Croatian: Medijan terminalnog poluvijeka eliminacije tenofoviralafenamida nakon primjene lijeka Symtuza iznosio je 0,3 sata.
English: The most frequent (> 5%) adverse reactions reported in treatment-naïve patients in the Phase 2 (GSUS-299-0102) and Phase 3 Study (AMBER, TMC114FD2HTX3001, Week 96 analysis) were diarrhoea (22.6%), headache (13.1%), rash (12.7%), nausea (9.7%), fatigue (8.0%), and abdominal pain (5.8%).
Croatian: Najčešće nuspojave (> 5%) prijavljene u bolesnika koji prethodno nisu bili liječeni u ispitivanju faze 2 (GS-US-299-0102) i ispitivanju faze 3 (AMBER, TMC114FD2HTX3001, analiza u 96. tjednu) bile su proljev (22,6%), glavobolja (13,1%), osip (12,7%), mučnina (9,7%), umor (8,0%) i bol u abdomenu
English: However,the safety of components of Symtuza was evaluated through the clinical study TMC114-C230 (N = 12) for darunavir with ritonavir and GS-US-292-0106 (N = 50) for a fixed dose combination containing elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
Croatian: Međutim, sigurnost pojedinačnih sastavnica lijeka Symtuza ocjenjivala se u kliničkom ispitivanju TMC114-C230 (N = 12), u kojem se ocjenjivao darunavir u kombinaciji s ritonavirom, te u ispitivanju GS-US-292-0106 (N = 50), u kojem se ocjenjivala fiksna kombinacija doza elvitegravira, kobicistata, emtricitabina i tenofoviralafenamida.
English: What Symtuza looks like and contents of the pack Yellow to yellowish-brown capsule shaped film-coated tablet, mentioning “8121” on one side and “JG” on the other side.
Croatian: Žuta do žućkasto-smeđa filmom obložena tableta u obliku kapsule, s utisnutom oznakom “8121” na jednoj strani i “JG” na drugoj strani.
English: In some patients with advanced HIV infection and who had unusual infections due to a weakened immune system (opportunistic infection), signs and symptoms of inflammation from previous infections may occur soon after you start HIV treatment.
Croatian: U nekih bolesnika s uznapredovalom HIV infekcijom koji su zbog oslabljenog imunološkog sustava već imali neuobičajene infekcije (oportunističke infekcije) mogu se ubrzo nakon početka liječenja HIV-a pojaviti znakovi i simptomi upale od prijašnjih infekcija.
English: One film-coated tablet of Symtuza once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10
Croatian: Bolesnici koji su prethodno primali antiretrovirusnu terapiju Jednu filmom obloženu tabletu lijeka Symtuza uzetu jedanput dnevno s hranom mogu koristiti bolesnici koji su prethodno bili izloženi antiretrovirusnim lijekovima, ali bez mutacija povezanih s rezistencijom na darunavir (DRV-RAM-ovi)* i s HIV-1 RNK < 100 000 kopija/ml te brojem stanica CD4+ ≥ 100 stanica x 10
English: Simeprevir may increase darunavir and/or cobicistat plasma concentrations.
Croatian: Simeprevir može povisiti plazmatske koncentracije darunavira i/ili kobicistata.
English: The median terminal plasma half-life of darunavir following administration of Symtuza is 5.5 hours.
Croatian: Medijan terminalnog poluvijeka darunavira u plazmi nakon primjene lijeka Symtuza iznosi 5,5 sati.
English: INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by therapeutic areas
Croatian: INTERAKCIJE I PREPORUKE ZA DOZIRANJE KOD PRIMJENE S DRUGIM LIJEKOVIMA
English: Tell your doctor if you take: - Alfentanil (injectable, strong and short-acting, painkiller that is used for surgical procedures) - Carvedilol, metoprolol, timolol (for heart disease) - Warfarin (to reduce clotting of the blood) as its therapeutic effect or side effects may be altered;
Croatian: Obavijestite liječnika ako uzimate: - alfentanil (u obliku injekcije, jaki i kratkodjelujući lijek za liječenje boli koji se koristi u kirurškim zahvatima) - karvedilol, metoprolol, timolol (za srčanu bolest) - varfarin (za smanjenje zgrušavanja krvi), zbog mogućih promjena njegova terapijskog učinka ili nuspojava; liječnik će Vam možda trebati provjeriti krvnu sliku.
English: • If you notice 12 hours or more after the time you usually take Symtuza, then do not take the missed dose and take the next doses with food at your usual time.
Croatian: • Ako primijetite da ste propustili uzeti lijek 12 ili više sati nakon uobičajenog vremena uzimanja lijeka Symtuza, preskočite propuštenu dozu i uzmite iduću dozu s hranom prema uobičajenom rasporedu.
English: Therefore, co-administration of Symtuza and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Croatian: Stoga je kontraindicirana istodobna primjena lijeka Symtuza i sildenafila kada se primjenjuje za liječenje plućne arterijske hipertenzije (vidjeti dio 4.3).
English: ANTACIDS Aluminium/magnesium hydroxide
Croatian: Aluminijev/magnezijev hidroksid Kalcijev karbonat
English: • muscle pain, muscle cramps or weakness
Croatian: • bol u mišićima, grčenje ili slabost u mišićima