FrancophonIA/ELRC3.0 huggingface dataset:
English: - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle)
Croatian: - intravenski docetaksel - 75 mg/m u intravenskoj infuziji tijekom 1 sata, svaka 3 tjedna u 6 ciklusa (2. dan 1. ciklusa, a potom 1. dan svakog sljedećeg ciklusa)
English: AUCss, 0-21days (μg.day/mL)
Croatian: ASCss0 - 21 dan (μg.dan/ml)
English: Herzuma should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
Croatian: Lijek Herzuma treba davati samo onim bolesnicima s metastatskim rakom želuca čije tumorske stanice pokazuju povećanu ekspresiju HER2 određenu imunohistokemijski kao 2+ i potvrđenu SISH-om ili FISH-om, ili određenu imunohistokemijski kao 3+.
English: Chemo only (n=116)
Croatian: Samo kemoterapija (n = 116)
English: A 20 mL clear glass type I vial with fluroTec-coated butyl rubber stopper containing 150 mg of trastuzumab.
Croatian: I s butilnim gumenim čepom obloženim fluro-Tecom sadrži 150 mg trastuzumaba.
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive analysis of DFS* are summarised in Table 7.
Croatian: Rezultati djelotvornosti iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831 u trenutku konačne analize preživljenja bez bolesti prikazani su sažeto u Tablici 7.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: 1 hour) with or without trastuzumab, 60% of the patients had received prior anthracycline-based adjuvant chemotherapy.
Croatian: U pivotalnom ispitivanju docetaksela (100 mg/m u jednosatnoj infuziji) u kombinaciji s trastuzumabom ili bez njega, 60% bolesnica prethodno je liječeno antraciklinskom adjuvantnom kemoterapijom.
English: fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache (see section 4.4).
Croatian: Te reakcije uključuju zimicu, vrućicu, dispneju, hipotenziju, piskanje pri disanju, bronhospazam, tahikardiju, smanjenu zasićenost kisikom, respiratorni distres, osip, mučninu i povraćanje i glavobolju (vidjeti dio 4.4).
English: Death (OS event) No. patients with event p=0.0024
Croatian: Smrt (događaj ukupnog preživljenja) broj bolesnica s događajem p = 0,0024
English: Herzuma 150 mg powder for concentrate for solution for infusion Herzuma 420 mg powder for concentrate for solution for infusion
Croatian: Herzuma 150 mg prašak za koncentrat za otopinu za infuziju Herzuma 420 mg prašak za koncentrat za otopinu za infuziju
English: In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831
Croatian: Dodatno je provedena post-hoc eksplorativna analiza podataka dobivenih iz skupne analize ispitivanja NSABP B-31/NCCTG N9831
English: No. patients with event
Croatian: Ukupno preživljenje Broj bolesnica s događajem
English: - in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
Croatian: - u kombinaciji s paklitakselom u liječenju bolesnika koji prethodno nisu primali kemoterapiju za metastatsku bolest i onih koji nisu pogodni za liječenje antraciklinom. - u kombinaciji s docetakselom u liječenju bolesnika koji nisu prethodno primali kemoterapiju za metastatsku bolest.
English: Strong complete membrane staining is detected in > 10% of the tumour cells.
Croatian: Jaka obojenost cijele membrane otkrivena u > 10% tumorskih stanica.
English: Distant recurrence No. patients with event p=0.0008
Croatian: Pojava udaljenih metastaza broj bolesnica s događajem p = 0,0008
English:  Paclitaxel 175 mg/m administered 3-weekly for 4 cycles,
Croatian: • paklitaksel 175 mg/m 2, svaka 3 tjedna u 4 ciklusa,
English: The recommended weekly maintenance dose of Herzuma is 2 mg/kg body weight, beginning one week after the loading dose.
Croatian: Preporučena doza održavanja lijeka Herzuma koja se primjenjuje u tjednim intervalima iznosi 2 mg/kg tjelesne težine, a počinje se primjenjivati tjedan dana nakon udarne doze.
English: A faint/barely perceptible membrane staining is detected in > 10% of the tumour cells.
Croatian: Blijeda, jedva uočljiva obojenost membrane u > 10% tumorskih stanica.
English: Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Croatian: Tablica 16 Vrijednosti farmakokinetičkih parametara u stanju dinamičke ravnoteže predviđene za populaciju uz režime doziranja intravenske formulacije trastuzumaba u bolesnika s metastatskim rakom dojke, ranim rakom dojke i uznapredovalim rakom želuca
English: Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value < 0.0001).
Croatian: (stratificirani omjer hazarda = 0,64; 95% CI [0,55; 0,74]; log-rang p-vrijednost < 0,0001).
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, obavijestite svog liječnika, ljekarnika ili medicinsku sestru.
English: Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in Table 14 (Cycle 1), Table 15 (steady-state), and Table 16 (PK parameters).
Croatian: Vrijednosti farmakokinetičke izloženosti predviđene za populaciju (medijan i 5. do 95. percentil) i vrijednosti farmakokinetičkih parametara pri klinički značajnim koncentracijama (Cmax i Cmin) za bolesnike s metastatskim rakom dojke, ranim rakom dojke i uznapredovalim rakom želuca koji se liječe odobrenim režimima doziranja jedanput na tjedan i jedanput svaka 3 tjedna prikazane su u nastavku, u Tablici 14 (1. ciklus), Tablici 15 (stanje dinamičke ravnoteže) i Tablici 16 (farmakokinetički parametri).
English: Sepsis
Croatian: Norge
English: Herzuma and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Croatian: Kod adjuvantnog liječenja ne smiju se istodobno davati Herzuma i antraciklini.
English: Pleural effusion
Croatian: Trastuzumab s paklitakselom
English: - intravenous paclitaxel - 80 mg/m as a continuous intravenous infusion, given every week for 12 weeks.
Croatian: Paklitaksel je u kombinaciji s trastuzumabom primjenjivan na sljedeći način: - intravenski paklitaksel - 80 mg/m u kontinuiranoj intravenskoj infuziji, jednom tjedno tijekom 12 tjedana ili
English: - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
Croatian: Lijek Herzuma je indiciran u liječenju odraslih bolesnika s HER2 pozitivnim ranim rakom dojke: - nakon kirurškog zahvata, kemoterapije (neoadjuvantne ili adjuvantne) i radioterapije (ako su provedeni) (vidjeti dio 5.1)
English: Hazard ratio versus AC→P (95% CI)
Croatian: Omjer hazarda naspram AC→P (95% CI)
English: A weak to moderate complete membrane staining is detected in > 10% of the tumour cells.
Croatian: Slaba do umjerena obojenost cijele membrane u > 10% tumorskih stanica.
English: Each vial of Herzuma is reconstituted with 7.2 mL of sterile water for injection (not supplied).
Croatian: Sadržaj jedne bočice lijeka Herzuma rekonstituira se sa 7,2 ml sterilne vode za injekcije (nije priložena u pakiranju).
English: Disease-free survival No. patients with event p=0.0003
Croatian: Preživljenje bez bolesti broj bolesnica s događajem p = 0,0003
English: Trastuzumab washout
Croatian: Trastuzumab plus docetaksel
English: AGC 274
Croatian: Block 7
English: The recommended maintenance dose of Herzuma at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Croatian: Preporučena doza održavanja lijeka Herzuma koja se primjenjuje u trotjednim intervalima iznosi 6 mg/kg tjelesne težine, a počinje se primjenjivati 3 tjedna nakon udarne doze.
English: Each vial of Herzuma is reconstituted with 20 mL of sterile water for injection (not supplied).
Croatian: Sadržaj jedne bočice lijeka Herzuma rekonstituira se sa 20 ml sterilne vode za injekcije (nije priložena u pakiranju).
English: Death (OS event): No. patients with event p=0.014
Croatian: Smrt (događaj ukupnog preživljenja): broj bolesnica s događajem p = 0,014**
English: Tel: +385 1 6595 777
Croatian: Oktal Pharma d.o.o. Tel: +385 1 6595 777
English: Trastuzumab may persist in the circulation for up to 7 months after stopping Herzuma treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Croatian: Na temelju populacijske farmakokinetičke analize svih dostupnih podataka (vidjeti dio 5.2), trastuzumab može biti prisutan u cirkulaciji do 7 mjeseci nakon prestanka liječenja lijekom Herzuma.
English: Cmax (μg/mL)
Croatian: Cmax (µg/ml)
English: Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule 3.
Croatian: Ispitivanje WO16229: udarna doza 8 mg/kg, zatim 6 mg/kg u trotjednim ciklusima Ispitivanje MO16982: udarna doza 6 mg/kg tjedno kroz 3 tjedna, zatim 6 mg/kg u trotjednim ciklusima Ispitivanje BO15935
English: Cmin (μg/mL)
Croatian: Cmin (µg/ml)
English: Each vial of Herzuma is reconstituted with 7.2 mL of water for injections (not supplied).
Croatian: Sadržaj jedne bočice lijeka Herzuma rekonstituira se u 7,2 ml vode za injekcije (nije priložena u pakiranju).
English: Hazard ratio vs AC→P (95% CI) p-value
Croatian: Omjer hazarda naspram AC→P (95% CI) p-vrijednost
English: The median overall survival for the high HER2 expressing group was 11.8 months versus 16 months, HR 0.65 (95% CI 0.51 - 0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95% CI 0.51 - 0.79) for FP versus FP + H, respectively.
Croatian: Medijan ukupnog preživljenja u skupini s visokom ekspresijom HER2 koja nije primala trastuzumab iznosio je 11,8 mjeseci u usporedbi sa 16 mjeseci u skupini koja je primala trastuzumab, omjer hazarda (HR) 0,65 (95% CI 0,51 - 0,83).
English: Primary efficacy analysis DFS hazard ratios (95% CI) p-value p<0.0001
Croatian: Analiza djelotvornosti tijekom dugoročnog praćenja Omjeri hazarda za preživljenje bez bolesti (95% CI) p-vrijednost p < 0,0001
English: Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer
Croatian: Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi nalazi se u Tablici 3: Tablica 3 Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi u raku želuca
English: Table 2 Recommended scoring system to evaluate the IHC staining patterns in breast cancer
Croatian: Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi nalazi se u Tablici 2: Tablica 2: Preporučena ljestvica vrednovanja rezultata bojanja preparata po IHC metodi kod raka dojke
English: Thrombocytopenia
Croatian: Ispiranje trastuzumaba
English: Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Croatian: za udarnu dozu trastuzumaba od 8 mg/kg tjelesne težine ili daljnje trotjedne doze održavanja od 6 mg/kg tjelesne težine na sljedeći način: volumen (ml) = tjelesna težina (kg) x doza (8 mg/kg udarna doza ili 6 mg/kg doze održavanja) 21 (mg/ml, koncentracija rekonstituirane otopine)
English: analysis DFS hazard ratios (95% CI) p-value p<0.0001
Croatian: bez bolesti (95% CI) p-vrijednost p < 0,0001
English: Only an accurate and validated assay should be used to detect HER2 over expression or HER2 gene amplification.
Croatian: Za otkrivanje pojačane ekspresije HER2 ili HER2 genske amplifikacije potrebno je primjenjivati samo precizne i validirane metode.
English: Weekly dosing in metastatic breast cancer
Croatian: Trotjedni ciklusi u liječenju metastatskog raka dojke
English: Hazard ratio vs AC→D (95% CI) p-value
Croatian: Omjer hazarda naspram AC→D (95% CI) p-vrijednost
English: Surgical specimen - staining pattern
Croatian: Kirurški uzorakkarakteristika obojenja
English: Distant recurrence No. patients with event p<0.0001
Croatian: Pojava udaljenih metastaza broj bolesnica s događajem p < 0,0001
English: Determine the volume of the solution required:  based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight:
Croatian: • za udarnu dozu trastuzumaba od 4 mg/kg tjelesne težine ili tjedne doze održavanja od 2 mg/kg tjelesne težine na sljedeći način:
English: Each vial of Herzuma is reconstituted with 20 mL of water for injections (not supplied).
Croatian: Sadržaj jedne bočice lijeka Herzuma rekonstituira se u 20 ml vode za injekcije (nije priložena u pakiranju).
English:  additional cycles of adjuvant trastuzumab (to complete 1 year of treatment) The efficacy results from Study MO16432 are summarised in Table 12.
Croatian: Podaci o djelotvornosti liječenja iz ispitivanja MO16432 sažeto su prikazani u Tablici 12.
English: Herzuma 420 mg powder for concentrate for solution for infusion
Croatian: Herzuma 420 mg prašak za koncentrat za otopinu za infuziju
English: Medical Logistics Ltd. Tel: +356 2755 9990
Croatian: Tel: +356 2755 9990
English:  based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight:
Croatian: • za udarnu dozu trastuzumaba od 4 mg/kg tjelesne težine ili daljnje tjedne doze održavanja od 2 mg/kg tjelesne težine na sljedeći način:
English: Disease-free survival No. patients with event p<0.0001
Croatian: Preživljenje bez bolesti broj bolesnica s događajem p < 0,0001
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI)
English: Herzuma 420 mg powder for concentrate for solution for infusion trastuzumab
Croatian: Herzuma 420 mg prašak za koncentrat za otopinu za infuziju trastuzumab
English: Tel.: +386 1 519 29 22
Croatian: OPH Oktal Pharma d.o.o. Tel.: +386 1 519 29 22
English: It may take up to 7 months for Herzuma to be removed from the body.
Croatian: Da bi se lijek Herzuma uklonio iz tijela, potrebno je i do 7 mjeseci.
English: Tel.: + 48 22 417 9200
Croatian: EGIS Polska Sp. z o.o. Tel.: + 48 22 417 9200
English: Herzuma 150 mg powder for concentrate for solution for infusion
Croatian: Herzuma 150 mg prašak za koncentrat za otopinu za infuziju
English: Herzuma 150 mg powder for concentrate for solution for infusion trastuzumab
Croatian: Herzuma 150 mg prašak za koncentrat za otopinu za infuziju trastuzumab
English: Median duration of response (months) (95% CI)
Croatian: Stopa odgovora (95%CI) Medijan trajanja odgovora (mjeseci) (raspon) Medijan TTP (mjeseci) (95%CI)
English: If left ventricular ejection fraction (LVEF) percentage drops ≥ 10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Croatian: Ako postotak LVEF-a padne za ≥ 10 bodova ispod početne vrijednosti
English: United Kingdom NAPP Pharmaceuticals Ltd. Tel: +44 (0) 1223 424444
Croatian: Tel: +44 (0) 1223 424444
English: Hepatobiliary disorders
Croatian: Parametar Monoterapija
English: Patients with MBC or MGC should be treated with Herzuma until progression of disease.
Croatian: U bolesnika s metastatskim rakom dojke ili metastatskim rakom želuca liječenje lijekom Herzuma traje do progresije bolesti.
English: Tel: +34 93 700 2525
Croatian: Kern Pharma, S.L. Tel: +34 93 700 2525
English: What you need to know before you use Herzuma 3.
Croatian: Što je Herzuma i za što se koristi Što morate znati prije nego počnete primati lijek Herzuma Kako ćete primati lijek Herzuma Moguće nuspojave
English: Tel: + 372 6 644 550
Croatian: Orion Pharma Eesti OÜ Tel: + 372 6 644 550
English: Kern Pharma, S.L.
Croatian: United Kingdom NAPP Pharmaceuticals Ltd.
English: The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Croatian: Tjedni ciklusi u liječenju metastatskog raka dojke Rezultati djelotvornosti iz ispitivanja monoterapije i kombinirane terapije prikazani su u Tablici 4:
English: Hyperkalaemia
Croatian: Učestalost hiperkalijemija nepoznato
English: 8mg/kg + 6mg/kg q3w
Croatian: 4 mg/kg + 2 mg/kg jedanput na tjedan metastatski rak dojke rani rak dojke 390
English: Staining pattern
Croatian: Tablični prikaz nuspojava
English: A 50 mL clear glass type I vial with butyl rubber stopper containing 420 mg of trastuzumab.
Croatian: I s butilnim gumenim čepom sadrži 420 mg trastuzumaba.
English: Herzuma and anthracyclines should not be given concurrently in combination in the MBC setting.
Croatian: Kod liječenja metastatskog raka dojke ne smiju se istodobno davati Herzuma i antraciklini.
English: Posology
Croatian: Rezultat
English: Table 11 Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831 and BCIRG 006 clinical studies combining DFS events and symptomatic cardiac events
Croatian: Tablica 7 Sažetak rezultata djelotvornosti iz skupne analize ispitivanja NSABP B-31 i NCCTG N9831 u trenutku konačne analize preživljenja bez bolesti
English: Lung infiltration
Croatian: Prijavljivanje nuspojava
English: One case of tumour lysis syndrome with trastuzumab administration as monotherapy lends further support.
Croatian: Tomu u prilog govori i činjenica da je jedan slučaj sindroma tumorske lize zabilježen kod primjene trastuzumaba u monoterapiji.
English: You must check with your doctor first.
Croatian: Najprije morate provjeriti sa svojim liječnikom.
English: This leaflet was last revised in Other sources of information
Croatian: Ova je uputa je zadnji put revidirana u Ostali izvori informacija
English: Risk to the infant cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenče.
English: Gender, race, elderly
Croatian: Spol, rasa, starije osobe
English: Your doctor will give you instructions for proper dosing.
Croatian: Liječnik će Vam dati upute o prikladnom doziranju.
English: It is used by adults, adolescents and children 3 years of age and older.
Croatian: Uzimaju ga odrasli, adolescenti i djeca u dobi od 3 godine i starija.
English: any signs of inflammation or infection.
Croatian: o bilo kakve znakove upale ili infekcije.
English: - If any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
Croatian: • ako je netko od članova Vaše obitelji (roditelji, bake i djedovi, braća ili sestre) iznenada umro zbog tegoba sa srcem ili su rođeni s bolešću srca.
English: 10000 Zagreb, Croatia
Croatian: 10000 Zagreb, Hrvatska
English: Date of first authorisation: 9 January 2012 Date of latest renewal: 9 September 2016
Croatian: Datum posljednje obnove odobrenja: 9. rujna 2016.
English: If you do miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for a forgotten dose.
Croatian: Ako ipak propustite uzeti dozu, sljedeću dozu uzmite što je prije moguće, ali nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Adults and adolescents over 40 kg
Croatian: Odrasli i adolescenti tjelesne težine veće od 40 kg
English: - It is recommended that the tablet be swallowed whole with water.
Croatian: - Preporučuje se tabletu progutati cijelu s vodom.
English: - If you have severe liver disease.
Croatian: • ako imate tešku bolest jetre.
English: Not recommended as the exposure to both PIs is expected to be significantly decreased.
Croatian: Ne preporučuje se jer se za oba IPa očekuje značajno smanjena izloženost
English: (CYP3A induction - effect on boceprevir) *0-8 hours
Croatian: (indukcija CYP3A - učinak na boceprevir) *0-8 sati
English: a 90% confidence intervals unless otherwise noted.
Croatian: a 90% intervali pouzdanosti, osim ako nije drukčije navedeno.
English: - Efavirenz Teva must be taken every day.
Croatian: - Efavirenz Teva morate uzimati svaki dan.
English: ** Based on historical comparison
Croatian: ** na temelju retrospektivne usporedbe
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate ili ste nedavno uzimali ili biste mogli uzeti bilo koje druge lijekove.
English: Check with your doctor or pharmacist if you are not sure.
Croatian: Provjerite sa svojim liječnikom ili ljekarnikom ako u nešto niste sigurni.
English: - If you are allergic to efavirenz or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na efavirenz ili bilo koji drugi sastojak ovoga lijeka (naveden u dijelu 6).
English: It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Croatian: Preporučuje se da žene zaražene HIV virusom ni u kojem slučaju ne doje svoju djecu kako bi izbjegle prenošenje HIV virusa.
English: if you have a history of liver disease, including active chronic hepatitis.
Croatian: o ako ste imali bolest jetre, uključujući aktivni kronični hepatitis.
English: If available, 90% or 95% confidence intervals are shown in parentheses.
Croatian: Ako postoje, podaci o intervalima pouzdanosti od 90% ili 95%, navedeni su u zagradama.
English: Skin and subcutaneous tissue disorders Very common Rash (11.6%)*
Croatian: Poremećaji kože i potkožnog tkiva vrlo često osip (11,6%)*
English: - You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Croatian: • HIV virus možete prenijeti čak i dok uzimate ovaj lijek, iako je tada rizik od prijenosa manji zbog učinkovite antiretrovirusne terapije.
English: (UDP-G induction)
Croatian: (indukcija UDP-G)
English: Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms.
Croatian: Pojedini bolesnici koji su slučajno uzeli dozu od 600 mg dvaput na dan prijavili su pojačane simptome živčanog sustava.
English: Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Croatian: Teva B.V., Swensweg 5, 2031GA Haarlem, Nizozemska
English: EXP {MM/YYYY}
Croatian: EXP {MM/GGGG}
English: (induction of metabolism)
Croatian: (indukcija metabolizma)
English: - If your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
Croatian: • ako Vam je liječnik rekao da imate visoke ili niske razine elektrolita u krvi, kao što su kalij ili magnezij.
English: Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.
Croatian: Bolesnike treba uputiti da, ukoliko se pojave navedeni simptomi, moraju izbjegavati obavljanje potencijalno opasnih radnji kao što su vožnja ili rad na strojevima.
English: This proportion is approximately 3-fold higher than the non-protein-bound (free) fraction of efavirenz in plasma.
Croatian: Taj je udio približno 3 puta veći od slobodne frakcije efavirenza (nevezane na proteine) u plazmi.
English: Increases in bupropion dosage should be guided by clinical response, but the maximum recommended dose of bupropion should not be exceeded.
Croatian: Dozu bupropiona treba povećati u skladu s kliničkim odgovorom, ali se ne smije prekoračiti maksimalna preporučena doza bupropiona.
English: Efavirenz concentrations not measured, no effect is expected.
Croatian: Nisu izmjerene koncentracije efavirenza, ne očekuje se nikakav učinak.
English: Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see section 4, Possible side effects).
Croatian: Odmah obavijestite liječnika ako se osjećate deprimirano, razmišljate o samoubojstvu ili imate neuobičajene misli (vidjeti dio 4. Moguće nuspojave).