FrancophonIA/ELRC3.0 huggingface dataset:
English: No special dose adjustment is required in patients over 75 years.
Croatian: Nije potrebna posebna prilagodba doze u bolesnika starijih od 75 godina.
English: It is not known whether GIAPREZA can pass into breast milk.
Croatian: Nije poznato izlučuje li se GIAPREZA u majčino mlijeko.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER La Jolla Pharmaceutical II B.V.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET La Jolla Pharmaceutical II B.V.
English: In order to minimise the risk of adverse events derived from prolonged vasoconstriction, treatment with GIAPREZA should be withdrawn once underlying shock is sufficiently improved (see section 4.4 and 4.8).
Croatian: Kako bi se minimizirao rizik od štetnih događaja nastalih zbog produžene vazokonstrikcije, liječenje lijekom GIAPREZA treba prekinuti kada se osnovni šok dostatno poboljša (vidjeti dijelove 4.4 i 4.8).
English: Concurrent venous thromboembolism prophylaxis (VTE) should be used unless contraindicated during treatment with GIAPREZA.
Croatian: Potrebno je primjenjivati istodobnu profilaksu venske tromboembolije (VTE), osim ako je kontraindicirana tijekom liječenja lijekom GIAPREZA.
English: If you are given more GIAPREZA than you should GIAPREZA will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose.
Croatian: Lijek GIAPREZA dat će Vam liječnik ili medicinska sestra, tako da je malo vjerojatno da ćete dobiti pogrešnu dozu.
English: It is important to administer GIAPREZA at the lowest compatible dose to achieve or maintain adequate mean arterial pressure and tissue perfusion.
Croatian: Važno je primijeniti lijek GIAPREZA u najnižoj kompatibilnoj dozi kako bi se postigla ili održala odgovarajuća srednja vrijednost arterijskog krvnog tlaka i perfuzija tkiva.
English: Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/10,000 to < 1/100), rare (≥ 1/10,000
Croatian: Kategorije učestalosti određene su kao: vrlo često (≥ 1/10), često (≥ 1/100 i
English: There is limited information about the effects of GIAPREZA during pregnancy.
Croatian: O učincima lijeka GIAPREZA tijekom trudnoće postoje ograničeni podatci.
English: Tell your doctor or nurse immediately if you experience a change of colour (redness or paleness), pain, numbness in any of your limbs, or if any of your limbs are cold to the touch, as these could be signs that a blood clot has blocked blood flow to a part of the body.
Croatian: osjetite bol, utrnulost u nekom od udova ili ako Vam je neki od udova hladan na dodir, jer to mogu biti znakovi da je krvni ugrušak blokirao dotok krvi u dio tijela.
English: One or two millilitres of GIAPREZA must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection to achieve a final concentration of 5,000 ng/mL or 10,000 ng/mL (see Table 1).
Croatian: Jedan ili dva mililitra lijeka GIAPREZA mora se razrijediti u otopini natrijeva klorida od 9 mg/ml (0,9 %) za injekciju radi postizanja konačne koncentracije od 5000 ng/ml ili 10 000 ng/ml (vidjeti tablicu 1).
English: No trials have been conducted to investigate the pharmacokinetics of angiotensin II in patients with hepatic impairment since the liver is not a major organ for angiotensin II metabolism or excretion.
Croatian: Nisu provedena ispitivanja u svrhu istraživanja farmakokinetike angiotenzina II u bolesnika s oštećenjem funkcije jetre jer jetra nije glavni organ za metabolizam ili izlučivanje angiotenzina II.
English: Of the 321 patients treated in the Phase 3 study, 195 patients were male (60.7%), 257 (80%) patients were White, 33 (10%) were Black, and 31 (10%) were Other.
Croatian: Od 321 bolesnika liječenog u ispitivanju faze 3, 195 bolesnika bili su muškarci (60,7 %), 257 (80 %)
English: There are limited efficacy and safety data of GIAPREZA in patients > 75 years.
Croatian: Podatci o djelotvornosti i sigurnosti lijeka GIAPREZA u bolesnika starijih od 75 godina su ograničeni.
English: Dilute 1 or 2 ml of GIAPREZA in sodium chloride 9 mg/ml (0.9%) solution for injection to achieve a final concentration of 5,000 ng/ml or 10,000 ng/ml.
Croatian: Razrijedite 1 ili 2 ml lijeka GIAPREZA u otopini natrijeva klorida od 9 mg/ml (0,9 %) za injekciju radi postizanja konačne koncentracije od 5000 ng/ml ili 10 000 ng/ml.
English: Doses as low as 1.25 ng/kg per minute may be used.
Croatian: Mogu se primjenjivati male doze od 1,25 ng/kg u minuti.
English: Store in a refrigerator (2 - 8 °C).
Croatian: Uvjeti čuvanja Čuvati u hladnjaku (2 - 8 °C).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Croatian: PODATCI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: - Angiotensin II receptor blockers (medicines used to lower blood pressure, with active substances whose names usually end in -sartan) may lessen the effect of GIAPREZA.
Croatian: ACE inhibitori mogu pojačati učinak lijeka GIAPREZA. - blokatori receptora angiotenzina II (lijekovi koji se koriste za snižavanje krvnog tlaka, s djelatnim tvarima čiji nazivi obično završavaju na -sartan) mogu smanjiti učinak lijeka GIAPREZA.
English: Of the 321 patients, 227 (71%) were receiving a baseline norepinephrine equivalent dose (NED) < 0.5 mcg/kg/min, 73 patients (23%) were receiving baseline NED ≥ 0.5 to
Croatian: Od 321 bolesnika, 227 (71 %) primalo je početnu dozu ekvivalentnu norepinefrinu (engl. norepinephrine equivalent dose, NED) od < 0,5 µg/kg/min, 73 bolesnika (23 %) primalo je početnu NED vrijednost od ≥ 0,5 do < 1 µg/kg/min i 21 (6 %) bolesnik primao je visoke doze vazopresora (NED ≥ 1,0 µg/kg/min).
English: Stopping GIAPREZA treatment
Croatian: Prekid terapije lijekom GIAPREZA
English: No trials have been conducted to investigate the pharmacokinetics of angiotensin II in renally impaired patients since the kidneys are not a major organ for angiotensin II metabolism or excretion.
Croatian: Nisu provedena ispitivanja u svrhu istraživanja farmakokinetike angiotenzina II u bolesnika s oštećenjem funkcije bubrega jer bubrezi nisu glavni organ za metabolizam ili izlučivanje angiotenzina II.
English: Mortality through day 28 was 46% on GIAPREZA and 54% on placebo (hazard ratio 0.78; 95% confidence interval 0.57-1.07).
Croatian: (omjer hazarda 0,78; 95 %-tni interval pouzdanosti 0,57-1,07).
English: A total of 37 patients (23%) experienced transient hypertension with the angiotensin II 20 ng/kg/min starting dose.
Croatian: Ukupno 37 bolesnika (23 %) razvilo je prolaznu hipertenziju uz početnu dozu angiotenzina II od
English: More patients experienced peripheral ischaemia in the GIAPREZA arm compared to the placebo arm (7 [4.3%] vs 4 [2.5%]).
Croatian: Perifernu ishemiju razvilo je više bolesnika u skupini koja je primala lijek GIAPREZA (7 [4,3 %]) nego u skupini koja je primala placebo (4 [2,5 %]).
English: If you notice any of these symptoms, seek medical advice immediately.
Croatian: odmah potražite savjet liječnika.
English: Intravenous use only after dilution.
Croatian: Intravenska primjena isključivo nakon razrjeđivanja.
English: must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection prior to use.
Croatian: Prije upotrebe mora se razrijediti u otopini natrijeva klorida od 9 mg/ml (0,9 %) za injekciju.
English: What is in this leaflet
Croatian: Što se nalazi u ovoj uputi 1.
English: La Jolla Pharmaceutical II B.V. Herengracht 500
Croatian: La Jolla Pharmaceutical II B.V.
English: The recommended starting rate of GIAPREZA is 20 nanograms (ng) per kilogram of your body weight per minute.
Croatian: 20 nanograma (ng) po kilogramu Vaše tjelesne težine u minuti.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains angiotensin II acetate equivalent to 2.5 mg angiotensin II.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadrži angiotenzin II acetat ekvivalentan 2,5 mg angiotenzina II.
English: More patients experienced venous and arterial thromboembolic events in the GIAPREZA arm compared to placebo arm in the Phase 3 (ATHOS-3) study (21 [12.9%] vs 8 [5.1%]).
Croatian: U ispitivanju faze 3 (ATHOS-3) venske i arterijske tromboembolijske događaje imalo je više bolesnika u skupini koja je primala lijek GIAPREZA (21 [12,9 %]) nego u skupini koja je primala placebo (8 [5,1 %]).
English: vasodilatory shock and associated severe acute kidney injury requiring renal replacement therapy to provide: (1) data on the effect of the product on morbidity events and organ perfusion with and adequate representation of European patients, (2) reassurance that there is no detrimental effect on mortality at day 28, (3) additional safety data about ischemic and thromboembolic events associated with the use of the product and to record clinical global impression of the response to treatment.
Croatian: Ispitivanje djelotvornosti nakon davanja odobrenja za stavljanje lijeka u promet (PAES): Kako bi se dodatno istražila djelotvornost i sigurnost lijeka Giapreza u liječenju refraktorne hipotenzije u odraslih osoba sa septičkim ili drugim distributivnim šokom, nositelj odobrenja treba provesti i dostaviti rezultate randomiziranog, dvostruko slijepog placebom kontroliranog multicentričnog ispitivanja u odraslih bolesnika s vazodilatornim šokom i povezanom teškom akutnom ozljedom bubrega koja zahtijeva nadomjesnu terapiju bubrega, koje će osigurati sljedeće: (1) podatke o učinku lijeka na morbiditet i perfuziju organa s odgovarajućom zastupljenošću europskih bolesnika, (2) potvrdu da nema štetnog učinka na smrtnost do 28. dana, (3) dodatne podatke o sigurnosti u vezi s ishemijom i tromboembolijskim događajima povezanima s upotrebom lijeka i kako bi se zabilježio klinički opći dojam odgovora na liječenje.
English: The major imbalance compared to placebo was in venous thromboembolism (6.1% vs 0%) (see section 4.8).
Croatian: Najveća neravnoteža u usporedbi s placebom bila je u venskoj tromboemboliji (6,1 % naspram 0 %)
English: This medicine contains less than 1 mmol sodium (23 mg) per 2.5 mg/1 ml, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija na 2,5 mg/1 ml, tj. zanemarive količine natrija.
English: Down-titrate by gradual decrements of up to 15 ng/kg per minute, as needed, based on blood pressure, in order to avoid hypotension due to abrupt withdrawal (see section 4.4).
Croatian: Postupno smanjujte dozu u koracima od najviše 15 ng/kg u minuti, prema potrebi, na temelju krvnog tlaka, kako bi se izbjegla hipotenzija zbog naglog prekida (vidjeti dio 4.4).
English: CLINICAL PARTICULARS
Croatian: KLINIČKI PODATCI
English: Inspect each vial for particulate matter prior to dilution.
Croatian: Prije razrjeđivanja provjerite svaku bočicu radi krutih čestica.
English: Diluted solution
Croatian: Razrijeđena otopina
English: No special dose adjustment is required in patients with renal insufficiency or those with hepatic impairment (see section 5.2).
Croatian: U bolesnika s insuficijencijom bubrega ili oštećenjem funkcije jetre nije potrebna posebna prilagodba doze (vidjeti dio 5.2).
English: When initiating GIAPREZA, it is important to closely monitor blood pressure response and adjust dose accordingly.
Croatian: Na početku terapije lijekom GIAPREZA, važno je pažljivo pratiti promjene krvnog tlaka i u skladu s time prilagoditi doziranje.
English: For critically ill patients, the usual target mean arterial pressure is 65 - 75 mmHg.
Croatian: Uobičajena ciljna srednja vrijednost arterijskog tlaka u teško oboljelih bolesnika iznosi 65
English: Approximately one in every four patients experienced transient hypertension with the angiotensin II 20 ng/kg per minute starting dose in clinical trials (see section 4.8), thus needing dose down-titration.
Croatian: U kliničkim ispitivanjima, otprilike jedan od četiri bolesnika razvio je prolaznu hipertenziju pri početnoj dozi angiotenzina II od 20 ng/kg u minuti (vidjeti dio 4.8), zbog čega je bila potrebna titracija na nižu dozu.
English: GIAPREZA 2.5 mg/ml concentrate for solution for infusion angiotensin II
Croatian: GIAPREZA 2,5 mg/ml koncentrat za otopinu za infuziju angiotenzin II
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 2.5 mg/ml, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po 2,5 mg/ml, tj. zanemarive količine natrija.
English: No in vitro metabolism studies have been performed with GIAPREZA.
Croatian: S lijekom GIAPREZA nisu provedena in vitro ispitivanja metabolizma.
English: 1 ml solution in a Type I glass vial with an aluminium over-seal, stopper (elastomeric), and plastic cap.
Croatian: I s 1 ml otopine, zatvorena aluminijskim prstenom, čepom (elastomernim) i plastičnom kapicom.
English: Thromboembolic events have been reported with the use of angiotensin II in clinical trials.
Croatian: U kliničkim su ispitivanjima pri primjeni angiotenzina II zabilježeni tromboembolijski događaji.
English: Down-titration of therapy, careful observation, and initiation of appropriate supportive measures are the indicated treatment of overdose of angiotensin II.
Croatian: Indicirano liječenje predoziranja angiotenzinom II jest postupno smanjivanje doze liječenja, pažljivo promatranje i uvođenje odgovarajućih potpornih mjera.
English: Your doctor or nurse should be told if any of the above applies to you before this medicine is used.
Croatian: Ako se bilo što od prethodno navedenog odnosi na Vas, morate to reći liječniku ili medicinskoj sestri prije primjene ovog lijeka.
English: Tachycardia
Croatian: Tahikardija
English: 2 ml solution in a Type I glass vial with an aluminium over-seal, stopper (elastomeric), and plastic cap.
Croatian: I s 2 ml otopine, zatvorena aluminijskim prstenom, čepom (elastomernim) i plastičnom kapicom.
English: As for other patient populations, it is important to closely monitor blood pressure response and adjust dose accordingly.
Croatian: Kao i u ostalim populacijama bolesnika, važno je pažljivo pratiti promjene krvnog tlaka i u skladu s time prilagoditi doziranje.
English: There are no dose adjustments needed for patients with impairment of the function of the liver or kidneys.
Croatian: U bolesnika s oštećenjem funkcije jetre ili bubrega nije potrebno prilagoditi dozu.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION GIAPREZA 2.5 mg/mL sterile concentrate angiotensin II
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA GIAPREZA 2,5 mg/ml sterilni koncentrat angiotenzin II
English: Each ml contains angiotensin II acetate equivalent to 2.5 mg angiotensin II.
Croatian: Jedan ml sadrži angiotenzin II acetat ekvivalentan 2,5 mg angiotenzina II.
English: Posology and method of administration
Croatian: Doziranje i način primjene
English: NAME OF THE MEDICINAL PRODUCT GIAPREZA 2.5 mg/ml concentrate for solution for infusion
Croatian: NAZIV LIJEKA GIAPREZA 2,5 mg/ml koncentrat za otopinu za infuziju
English: Down-titrate by gradual decrements of up to 15 ng/kg per minute, as needed, based on blood pressure in order to avoid hypotension due to abrupt withdrawal (see section 4.4).
Croatian: Prema potrebi, postupno smanjujte dozu u koracima do najviše 15 ng/kg u minuti na temelju krvnog tlaka, kako bi se izbjegla hipotenzija zbog naglog prekida primjene (vidjeti dio 4.4).
English: In order to minimise the risk of side effects to this medicine, GIAPREZA will be withdrawn as soon as your condition improves.
Croatian: Kako bi se smanjio rizik od nuspojava ovog lijeka, prekinut će se primjena lijeka
English: Approximately one in every four patients experienced transient hypertension with the angiotensin II 20 ng/kg/min starting dose in clinical trials (see section 4.8), thus needing dose downtitration.
Croatian: U kliničkim ispitivanjima, otprilike jedan od četiri bolesnika razvio je prolaznu hipertenziju pri početnoj dozi angiotenzina II od 20 ng/kg/min (vidjeti dio 4.8), zbog čega je bila potrebna titracija na nižu dozu.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single-dose.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: GIAPREZA response rate
Croatian: Stopa odgovora na lijek GIAPREZA
English: How to store GIAPREZA
Croatian: Kako čuvati lijek GIAPREZA
English: Patients with active bleeding, mesenteric ischaemia, liver failure and MELD score of ≥ 30, CV SOFA score ≤ 3 and patients with extensive burns were also excluded.
Croatian: Sequential Organ Failure Assessment, SOFA) ≤ 3 i bolesnici s opsežnim opeklinama također su bili isključeni.
English: PHARMACEUTICAL PARTICULARS
Croatian: FARMACEUTSKI PODATCI
English: ≥ 10 mmHg increase in MAP without an increase in baseline vasopressor therapy at 3 hours.
Croatian: Mjera primarnog ishoda bila je postotak ispitanika koji su postigli MAP ≥ 75 mmHg ili povećanje MAP-a od ≥ 10 mmHg bez povećanja osnovne terapije vazopresorom za 3 sata.
English: For intravenous use only after dilution.
Croatian: Namijenjeno za intravensku primjenu isključivo nakon razrjeđivanja.
English: Discard unused portions.
Croatian: Bacite neiskorišteni sadržaj.
English: One vial of 2 ml concentrate for solution for infusion contains 5 mg of angiotensin II.
Croatian: Jedna bočica od 2 ml koncentrata za otopinu za infuziju sadrži 5 mg angiotenzina II.
English: Two (1.2%) patients in the GIAPREZA arm experienced a fatal thromboembolic event compared with no patients in the placebo arm. Concurrent venous thromboembolism prophylaxis should be used unless contraindicated during treatment with GIAPREZA (see section 4.4).
Croatian: U dva (1,2 %) bolesnika u skupini koja je primala lijek GIAPREZA došlo je do tromboembolijskog događaja sa smrtnim ishodom, dok se to nije dogodilo ni u jednog bolesnika iz skupine koja je primala placebo.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V..
English: Table 2:
Croatian: PRILOG II.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 2.5 mg of angiotensin II (as acetate)
Croatian: Jedan ml sadrži 2,5 mg angiotenzina II (u obliku acetata)
English: As for other age groups, it is important to closely monitor blood pressure response and adjust dose accordingly.
Croatian: Kada je riječ o ostalim dobnim skupinama, važno je pažljivo pratiti promjene krvnog tlaka i u skladu s time prilagoditi doziranje.
English: One vial of 1 ml concentrate for solution for infusion contains 2.5 mg of angiotensin II.
Croatian: Jedna bočica od 1 ml koncentrata za otopinu za infuziju sadrži 2,5 mg angiotenzina II.
English: Fluid Restricted?
Croatian: Tablica 1: Priprema razrijeđene otopine Tekućina ograničena?
English: Your doctor or nurse should be told before GIAPREZA is used if you or someone else in your family have a history of blood clots, as this medicine has been associated with the formation of blood clots.
Croatian: Liječniku ili medicinskoj sestri treba reći prije primjene lijeka GIAPREZA ako ste Vi ili netko drugi u
English: Marketing Authorisation Holder La Jolla Pharmaceutical II B.V. Herengracht 500
Croatian: Nositelj odobrenja za stavljanje lijeka u promet La Jolla Pharmaceutical II B.V.
English: Common side effects (may affect up to 1 in 10 people) are: - Rapid heartbeat - Poor circulation to your hands, feet, or other bodily areas which can be severe and cause tissue damage.
Croatian: - loša cirkulacija u rukama, stopalima ili drugim područjima tijela koja može biti teška i uzrokovati oštećenje tkiva
English: Instructions for dilution
Croatian: Prijavljivanje nuspojava
English: Hepatic impairment
Croatian: Krvožilni poremećaji
English: Baseline MAP < 65 mmHg 10/50 patients
Croatian: < 65 mmHg
English: Once an infusion has been established, the dose may be titrated as frequently as every 5 minutes in steps of up to 15 ng/kg per minute, as needed, depending on the patient's condition and target mean arterial pressure.
Croatian: 15 ng/kg u minuti, prema potrebi, ovisno o stanju bolesnika i ciljnoj srednjoj vrijednosti arterijskog tlaka.
English: Vial strength
Croatian: Jačina bočice
English: Thromboembolic eventsa Transient hypertensionb
Croatian: Opis odabranih nuspojava Prolazna hipertenzija
English: Withdrawal of therapy
Croatian: Prekid liječenja
English: NAME OF THE MEDICINAL PRODUCT GIAPREZA 2.5 mg/ml concentrate for solution for infusion angiotensin II
Croatian: Uputa o lijeku: Informacije za bolesnika GIAPREZA 2,5 mg/ml koncentrat za otopinu za infuziju angiotenzin II
English: - If you get any side effects, talk to your doctor.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: 5 mg/2 mL 2
Croatian: 2,5 mg/ml 5 mg/2 ml
English: Your doctor will continue to assess your response and will adjust the dose accordingly up to a maximum of 80 ng per kilogram each minute during the first 3 hours of treatment.
Croatian: Liječnik će nastaviti procjenjivati Vašu reakciju i u skladu s tim prilagođavati dozu do maksimalno
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Samo za jednu dozu.
English: METHOD OF ADMINISTRATION IV use only after dilution
Croatian: NAČIN PRIMJENE LIJEKA Intravenska primjena isključivo nakon razrjeđivanja
English: PHARMACEUTICAL FORM AND CONTENTS
Croatian: OZNAČIVANJE I UPUTA O LIJEKU
English: pH: 5.0 to 6.0
Croatian: Koncentrat za otopinu za infuziju (sterilni koncentrat) Bistra i bezbojna otopina. pH: od 5,0 do 6,0
English: Your doctor should be told if you are breast-feeding before this medicine is given.
Croatian: Prije nego što primite ovaj lijek, svojeg liječnika trebate obavijestiti ako dojite.
English: Concentrate for solution for infusion 1 vial
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju
English: BATCH NUMBER Lot:
Croatian: 13. BROJ SERIJE Broj serije:
English: One vial of 1 ml concentrate for solution for infusion contains 2.5 mg of angiotensin II One vial of 2 ml concentrate for solution for infusion contains 5 mg of angiotensin II - The other ingredients are mannitol and water for injections adjusted with sodium hydroxide and/or hydrochloric acid (see section 2 under ‘Sodium').
Croatian: - Drugi sastojci su manitol i voda za injekcije podešeni natrijevim hidroksidom i/ili kloridnom kiselinom (pogledajte dio 2. pod „Natrij”).
English: The type of food is not important.
Croatian: Vrsta hrane nije bitna.
English: This is not an exclusive list.
Croatian: Ovo nije isključivi popis.
English: Your doctor will tell you how long your treatment will last.
Croatian: Liječnik će Vam reći koliko će dugo liječenje trajati.
English: Yes (for all three parameters listed above)
Croatian: Da (po sva tri navedena parametra)
English: Use with caution.
Croatian: Primjenjivati s oprezom.
English: It is important that both men and women read the information.
Croatian: Važno je da i muški i ženski partner pročitaju te informacije.
English: Keep the medicine pack with you so you can easily describe what you have taken.
Croatian: Ponesite sa sobom pakiranje lijeka kako biste lako mogli opisati što ste uzeli.
English: • Anaemia (low number of red blood cells).
Croatian: • anemija (nizak broj crvenih krvnih stanica)
English: Sex or body weight
Croatian: Spol ili tjelesna težina
English: It is very important that you complete the full course of treatment.
Croatian: Vrlo je važno da završite cijeli ciklus liječenja.
English: You will take Exviera for 8, 12 or 24 weeks.
Croatian: Lijek Exviera uzimat ćete tijekom 8, 12 ili 24 tjedna.
English: There is no pharmacokinetic information in patients >75 years.
Croatian: Nema farmakokinetičkih ipodataka u bolesnika >75 godina.
English: Ask your doctor about the best contraception for you.
Croatian: Upitajte Vašeg liječnika koja je najbolja metoda kontracepcije za Vas.
English: EFFECT Cmax
Croatian: UČINAK Cmax
English: Depression or psychiatric illness
Croatian: Depresija ili psihijatrijska bolest
English: The doctor may need to change your dose of these medicines.
Croatian: Liječnik će možda morati promijeniti dozu tih lijekova.
English: • You or your partner must use an effective method of contraception during treatment.
Croatian: • Vi ili Vaš partner morate koristiti učinkovitu metodu kontracepcije tijekom liječenja.