FrancophonIA/ELRC3.0 huggingface dataset:
English: Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Croatian: Ako Vam se tjelesna težina poveća, obavijestite o tome
English: There was no tumorigenic response in mice of either sex. Hyperplasia of the urinary bladder was not seen in dogs or monkeys treated with pioglitazone for up to 12 months.
Croatian: Hiperplazija mokraćnog mjehura nije opažena u pasa i majmuna liječenih pioglitazonom u trajanju do 12 mjeseci.
English: Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10 people) in patients taking pioglitazone in combination with insulin.
Croatian: Lokalizirano oteknuće (edemi) također su vrlo često (mogu se javiti u više od 1 od 10 osoba) nastajali u bolesnika koji su uzimali pioglitazon u kombinaciji s inzulinom.
English: Pioglitazone Teva 30 mg tablets EU/1/12/757/011-020
Croatian: Pioglitazon Teva 30 mg tablete EU/1/12/757/011-020
English: Pioglitazone Teva 15 mg tablets EU/1/12/757/001-010
Croatian: Pioglitazon Teva 15 mg tablete EU/1/12/757/001-010
English: It is recommended, therefore, that patients treated with pioglitazone undergo periodic monitoring of liver enzymes.
Croatian: Stoga se u bolesnika liječenih pioglitazonom preporučuje povremeno određivati jetrene enzime.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.
English: In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
Croatian: U toksikološkim ispitivanjima nakon ponavljanja doziranja u miševa, štakora, pasa i majmuna dosljedno su primijećeni povećanje volumena plazme hemodilucijom, anemija i reverzibilna ekscentrična hipertrofija srca.
English: Pioglitazone Teva 45 mg tablets EU/1/12/757/021-030
Croatian: Pioglitazon Teva 45 mg tablete EU/1/12/757/021-030
English: Pioglitazone Teva 15 mg tablets Pioglitazone Teva 30 mg tablets Pioglitazone Teva 45 mg tablets
Croatian: Pioglitazon Teva 15 mg tablete Pioglitazon Teva 30 mg tablete Pioglitazon Teva 45 mg tablete
English: General disorders and administration site conditions oedema5
Croatian: Opći poremećaji i reakcije na mjestu primjene edem5
English: Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking pioglitazone.
Croatian: Karcinom mokraćnog mjehura manje je često (mogu se javiti do 1 od 100 osoba) nastao u bolesnika koji uzimaju pioglitazon.
English: How to take Pioglitazone Teva
Croatian: Kako uzimati Pioglitazon Teva
English: Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5).
Croatian: Zabilježeno je da istovremena primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8) povećava, a s rifampicinom (induktor citokroma P450 2C8) snižava koncentracije pioglitazona u plazmi (vidjeti dio 4.5).
English: Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Croatian: Zatajenje srca uz primjenu pioglitazona zabilježeno je nakon stavljanja lijeka u promet, i bilo je češće kad se pioglitazon primjenjivao u kombinaciji s inzulinom ili u bolesnika sa zatajenjem srca u anamnezi.
English: No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Croatian: Nije bilo primijećeno povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,3%) u odnosu na usporedni lijek (1,5%).
English: Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency.
Croatian: Tablični prikaz nuspojava Nuspojave koje su bile zabilježene češće (> 0,5%) nego uz placebo ili kao izolirani slučaj u bolesnika koji su primali pioglitazon u dvostruko slijepim ispitivanjima navedene su niže prema MedDRA
English: 31-546, Krakow Poland
Croatian: Teva Operations Poland Sp z.o.o. ul. Mogilska 80. 31-546, Krakow Poljska
English: A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%).
Croatian: Viša stopa prijeloma bila je primijećena u žena koje su uzimale pioglitazon (2,6%) u odnosu na usporedni lijek (1,7%).
English: How to store Pioglitazone Teva
Croatian: Kako čuvati Pioglitazon Teva
English: Carmellose calcium Hydroxypropylcellulose Magnesium stearate
Croatian: 6.1 Popis pomoćnih tvari manitol karmelozakalcij hidroksipropilceluloza magnezijev stearat
English: Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Teva.
Croatian: Liječnik će tražiti da za vrijeme liječenja lijekom Pioglitazon Teva povremeno napravite krvne pretrage, da bi se provjerilo radi li Vaša jetra normalno.
English: Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon
Croatian: Poremećaji živčanog sustava hipoestezija glavobolja manje često omaglica nesanica manje često manje često manje često manje često manje često
English: Pioglitazone
Croatian: Nuspojava
English: No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Croatian: Nije bilo primijećeno povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,7%) u odnosu na one liječene usporednim lijekom (2,1%).
English: There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Croatian: Nakon stavljanja lijeka u promet zabilježeni su slučajevi zatajenja srca kad se pioglitazon primjenjivao u kombinaciji s inzulinom i u bolesnika sa zatajenjem srca u anamnezi.
English: Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Croatian: Ako razvijete znakove zatajenja srca kao što su neuobičajeni nedostatak zraka, brzo povećanje tjelesne težine ili lokalizirana nateknuća (edemi), čim prije obavijestite o tome svog liječnika.
English: A higher number of bone fractures was seen in patients, particularly women taking pioglitazone.
Croatian: U bolesnika, naročito u žena koje uzimaju pioglitazon primijećen je povećan broj prijeloma kostiju.
English: Teva Pharmaceutical Works Private Limited Company Pallagi út 13
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Teva Pharmaceutical Works Private Limited Company Pallagi út 13
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Teva.
Croatian: Za vrijeme liječenja lijekom Pioglitazon Teva obično možete nastaviti uzimati druge lijekove.
English: not known (frequency cannot be estimated from the available data) - increase in liver enzymes - allergic reactions
Croatian: - povišenje vrijednosti jetrenih enzima - alergijske reakcije
English: Cardiac disorders heart failure3
Croatian: Srčani poremećaji zatajenje srca3
English: - Pioglitazone Teva 45 mg tablets are white to off white, round, convex with the number ‘45' on one side and ‘TEVA' on the other side.
Croatian: - Pioglitazon Teva 45 mg tablete su bijele do gotovo bijele boje, okrugle, konveksne, s oznakom ‘45' na jednoj strani i ‘TEVA' na drugoj.
English: - Pioglitazone Teva 30 mg tablets are white to off white, round, convex with the number ‘30' on one side and ‘TEVA' on the other side.
Croatian: - Pioglitazon Teva 30 mg tablete su bijele do gotovo bijele boje, okrugle, konveksne, s oznakom ‘30' na jednoj strani i ‘TEVA' na drugoj.
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 0070
Croatian: Österreich ratiopharm Arzneimittel Vertriebs-GmbH
English: Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Teva.
Croatian: Kad uzimate Pioglitazon Teva možete ponovno imati ovulaciju pa mogućnost trudnoće može biti povećana.
English: Teva UK Ltd Brampton Road, Hampden Park, Eastbourne,
Croatian: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Ujedinjeno Kraljevstvo
English: Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon
Croatian: Infekcije gornjih dišnih puteva bronhitis sinusitis manje često manje često manje često manje često manje često
English: - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea as triple oral therapy in combination with
Croatian: - u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) u kojih se kontrola ne postiže dijetom i tjelovježbom i u kojih metformin nije prikladan zbog kontraindikacija ili nepodnošenja kao dvojna peroralna terapija u kombinaciji s
English: - Pioglitazone Teva 15 mg tablets are white to off white, round, convex with the number ‘15' on one side and ‘TEVA' on the other side.
Croatian: - Pioglitazon Teva 15 mg tablete su bijele do gotovo bijele boje, okrugle, konveksne, s oznakom ‘15' na jednoj strani i ‘TEVA' na drugoj.
English: However, certain medicines are especially likely to affect the amount of sugar in your blood: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections) Tell your doctor or pharmacist if you are taking any of these.
Croatian: - rifampicin (primjenjuje se za liječenje tuberkuloze i drugih infekcija) Obavijestite svog liječnika ili ljekarnika ako uzimate te lijekove.
English: Respiratory, thoracic and mediastinal disorders dyspnoea common
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja
English: Pioglitazone Teva 45 mg tablets
Croatian: Pioglitazon Teva 45 mg tablete
English: Blurred vision due to swelling (or fluid) at the back of the eye (frequency cannot be estimated from the available data) has also been reported in patients taking pioglitazone.
Croatian: U bolesnika koji uzimaju pioglitazon zabilježen je i zamagljen vid zbog oticanja (ili tekućine) stražnje strane oka (učestalost se ne može procijeniti iz dostupnih podataka).
English: Each Pioglitazone Teva 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta lijeka Pioglitazon Teva od 30 mg sadrži 30 mg pioglitazona (u obliku pioglitazonklorida).
English: Pioglitazone Teva 30 mg tablets
Croatian: Pioglitazon Teva 30 mg tablete
English: Ear and labyrinth disorders vertigo uncommon
Croatian: Poremećaji uha i labirinta vrtoglavica manje često
English: Pioglitazone Teva 45 mg tablets Pioglitazone
Croatian: Pioglitazon Teva 45 mg tablete pioglitazon
English: This is to check that your liver is working normally.
Croatian: Trebate provjeravati tjelesnu težinu u redovitim vremenskim razmacima.
English: Each Pioglitazone Teva 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta lijeka Pioglitazon Teva od 45 mg sadrži 45 mg pioglitazona (u obliku pioglitazonklorida).
English: No dose adjustment is necessary in patients with impaired renal function (creatinine clearance > 4 ml/min) (see section 5.2).
Croatian: > 4 ml/min) (vidjeti dio 5.2).
English: Each tablet contains 45 mg pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 45 mg pioglitazona (u obliku pioglitazonklorida).
English: Pioglitazone Teva 30 mg tablets Pioglitazone
Croatian: Pioglitazon Teva 30 mg tablete pioglitazon
English: Pioglitazone Teva 15 mg tablets
Croatian: Pioglitazon Teva 15 mg tablete
English: Each tablet contains 30 mg pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 30 mg pioglitazona (u obliku pioglitazonklorida).
English: The other side effects that have been experienced by some patients when pioglitazone is taken with other antidiabetic medicines are:
Croatian: Druge nuspojave koje su neki bolesnici osjetili kod uzimanja pioglitazona s drugim antidijabetičkim lijekovima su: vrlo često (mogu se javiti u više od 1 od 10 osoba)
English: If you experience any of these, talk to your doctor as soon as possible.
Croatian: Ako primijetite ovu nuspojavu, čim prije razgovarajte s Vašim liječnikom.
English: - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
Croatian: - oštećenjem funkcije jetre - dijabetičkom ketoacidozom - postojećim ili preboljenim karcinomom mokraćnog mjehura
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Croatian: Zabilježeno je da istodobna primjena pioglitazona s rifampicinom (induktor citokroma P450 2C8) rezultira smanjenjem
English: Metabolism and nutrition disorders hypo-glycaemia uncommon very common
Croatian: Poremećaji metabolizma i prehrane hipoglikemija manje često vrlo često pojačan apetit manje često
English: The tablets are white to off-white, round, convex and debossed with the number ‘45' on one side and ‘TEVA' on the other side.
Croatian: Tablete su bijele do gotovo bijele boje, okrugle, konveksne i imaju oznaku ‘45' s jedne strane i ‘TEVA' s druge strane.
English: Each Pioglitazone Teva 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta lijeka Pioglitazon Teva od 15 mg sadrži 15 mg pioglitazona (u obliku pioglitazonklorida).
English: Each tablet contains 15 mg pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 15 mg pioglitazona (u obliku pioglitazonklorida).
English: Pioglitazone Teva 15 mg tablets Pioglitazone
Croatian: Pioglitazon Teva 15 mg tablete pioglitazon
English: The tablets are white to off-white, round, convex and debossed with the number ‘30' on one side and ‘TEVA' on the other side.
Croatian: Tablete su bijele do gotovo bijele boje, okrugle, konveksne i imaju oznaku ‘30' s jedne strane i ‘TEVA' s druge strane.
English: In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDLcholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Croatian: HDL-kolesterola u usporedbi s placebom, uz mala ali ne i klinički značajna povišenja razine LDL
English: Marketing Authorisation Holder:
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet:
English: nausea or vomiting).
Croatian: - osjećaj vrtnje (vrtoglavica)
English: If you experience this side effect, talk to your doctor as soon as possible.
Croatian: Ako razvijete ovu nuspojavu, čim prije razgovarajte s Vašim liječnikom.
English: very common (may affect more than 1 in 10 people) - decreased blood sugar (hypoglycaemia)
Croatian: - utrnulost manje često (mogu se javiti do 1 od 100 osoba) - upala sinusa (sinusitis)
English: It is not known whether pioglitazone is secreted in human milk.
Croatian: Nije poznato izlučuje li se pioglitazon u majčino mlijeko u ljudi pa se stoga pioglitazon ne smije primjenjivati u dojilja.
English: The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
Croatian: Opaženo povećanje rizika od prijeloma u žena u ovom sklopu podataka o pioglitazonu stoga iznosi
English: Mon. Tue.
Croatian: - znojenje - umor
English: The tablets are white to off-white, round, convex and debossed with the number ‘15' on one side and ‘TEVA' on the other side.
Croatian: Tablete su bijele do gotovo bijele boje, okrugle, konveksne i imaju oznaku ‘15' s jedne strane i ‘TEVA' s druge strane.
English: Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience.
Croatian: Nakon stavljanja lijeka u promet bilo je rijetkih slučajeva povišenih jetrenih enzima i poremećaja funkcije jetre.
English: България Тева Фармасютикълс България ЕООД
Croatian: UAB “Sicor Biotech” Eesti filiaal
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine
English: Tel: +421 2 57 26 79 11
Croatian: TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 2 57 26 79 11
English: Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone.
Croatian: Zabilježeno je da istodobna primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8)
English: common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Croatian: Ostale nuspojave koje su osjetili neki bolesnici koji uzimaju pioglitazon su: često (mogu se javiti do 1 od 10 osoba) - infekcija dišnih putova - abnormalni vid
English: ul.
Croatian: SN:
English: Pliva Hrvatska d.o.o.
Croatian: artralgija križobolja
English: Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin.
Croatian: Kad se pioglitazon primjenjuje u kombinaciji s inzulinom, bolesnike treba nadzirati zbog znakova i simptoma zatajenja srca, povećanja tjelesne težine i pojave edema.
English: Renal and urinary disorders haematuria common glycosuria uncommon proteinuria uncommon
Croatian: Poremećaji bubrega i mokraćnog sustava hematurija glikozurija manje često proteinurija manje često
English: It is especially important to mention these:
Croatian: Osobito je važno da spomenete sljedeće:
English: Your doctor will test for these changes.
Croatian: Vaš liječnik će obaviti provjere u vezi tih promjena.
English: Your child's doctor will decide this.
Croatian: To će odlučiti liječnik Vašeg djeteta.
English: Date of first authorisation: 22 August 2016
Croatian: Datum prvog odobrenja: 22 kolovoz 2016
English: During the second and third trimesters of pregnancy
Croatian: Tijekom drugog i trećeg tromjesečja trudnoće
English: 15 to less than 35
Croatian: 15 do manje od 35
English: These could be symptoms of a serious heart problem.
Croatian: To mogu biti simpotmi ozbiljnog srčanog problema.
English: Such changes may in part be linked to the disease control and life style.
Croatian: Te promjene mogu biti djelomično povezane s kontrolom bolesti i stilom života.
English: The clinical relevance of these non-clinical data is unknown.
Croatian: Klinička važnost ovih nekliničkih podataka nije poznata.
English: No deaths were reported.
Croatian: Nije prijavljen niti jedan smrtni slučaj.
English: An alternate reliable method of contraception is recommended.
Croatian: Preporučuje se neka druga pouzdana metoda kontracepcije.
English: In some patients additional factor VIII was given.
Croatian: Nekim se bolesnicima dodatno davao faktor VIII.
English: Confidence interval.
Croatian: Interval pouzdanosti.
English: Difference estimate e
Croatian: Procjena razlike e
English: Do not open the capsules.
Croatian: Ne otvarajte kapsule.
English: Wait and take the next dose at its regular time.
Croatian: Pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
English: If genotyping is not feasible, full monitoring of safety and efficacy should be performed.
Croatian: Ako se ne može provesti genotipizacija, potrebno je provoditi cjelovit nadzor sigurnosti i djelotvornosti.
English: Biosciences, South San Francisco, California, USA)
Croatian: (Monogram Biosciences, South San Francisco, California, USA)
English: Didanosine (with food)
Croatian: Didanozin (s hranom)
English: Week 48
Croatian: 48. tjedan
English: Without tenofovir
Croatian: Bez tenofovira
English: The same recommendations for drug drug interactions would apply except:
Croatian: Vrijede iste preporuke za interakcije između lijekova, osim sljedećega:
English: Week 96
Croatian: 96. tjedan
English: Some patients required hospitalization for additional management and some had complications.
Croatian: Neki bolesnici su radi daljnjeg liječenja trebali hospitalizaciju, a neki su imali komplikacije.
English: You may continue to develop infections or other illnesses linked to HIV infection.
Croatian: I dalje se u Vas mogu razviti infekcije ili druge bolesti povezane s HIV-infekcijom.
English: Cmin is concentration 24 hours post-dose.
Croatian: Cmin je koncentracija 24 sata nakon doze.
English: If it is almost time for your next dose, do not take the missed dose.
Croatian: Ako je uskoro vrijeme za sljedeću dozu, nemojte uzeti propuštenu dozu.
English: • absence of prior virologic failure
Croatian: • izostanak prethodnog virološkog neuspjeha
English: It is important to note that at time of the 96-week analysis, 48 % of patients overall remained on study.
Croatian: Važno je primijetiti da je u vrijeme analize podataka iz 96. tjedna u ispitivanju ostalo ukupno 48% bolesnika.
English: • Changes in the way your heart beats (heart rhythm change) may occasionally happen.
Croatian: • Promjenje u načinu na koje Vaše srce kuca (promjena srčanog ritma) mogu se povremeno dogoditi.
English: • hypersensitivity (allergic reaction)
Croatian: • preosjetljivost (alergijska reakcija)
English: In the prepartum period, additional monitoring should be considered.
Croatian: U pretpartalnom razdoblju, potrebno je razmotriti mogućnost dodatnog nadzora.
English: • undetectable viral load during the last 6 months under current regimen
Croatian: • nemjerljivo virusno opterećenje tijekom posljednjih 6 mjeseci liječenja trenutnim režimom
English: Single doses up to 1,200 mg have been taken by healthy volunteers without symptomatic untoward effects.
Croatian: Zdravi dobrovoljci uzimali su jednokratne doze do 1200 mg bez simptomatskih neželjenih učinaka.
English: 100 mg at least 35
Croatian: 100 mg najmanje 35
English: • if you have hepatitis B or C
Croatian: • ako imate hepatitis B ili C
English: This side effect is usually not dangerous in adults and infants older than 3 months of age; but it might be a symptom of a serious problem.
Croatian: Ta nuspojava obično nije opasna u odraslih i dojenčadi starijoj od 3 mjeseca ali može biti i simptom ozbiljnog problema.
English: Analyses of data through 96 weeks of treatment demonstrated durability of antiviral activity (Table 5).
Croatian: Analize podataka prikupljenih tijekom 96 tjedana liječenja pokazala je trajnost antivirusnog djelovanja (tablica 5).
English: Caution should be exercised.
Croatian: Potreban je oprez.
English: There were no clinically important pharmacokinetic differences based on age or gender.
Croatian: Nije bilo klinički značajnih farmakokinetičkih razlika na temelju dobi ili spola.
English: There was no evidence of pathologic jaundice and six of 40 infants in this study received phototherapy for a maximum of 4 days.
Croatian: Nije bilo znakova patološke žutice, a šestero od 40 dojenčadi u ovom ispitivanju primilo je fototerapiju u trajanju od najviše 4 dana.
English: Therefore if the combination is unavoidable, the following recommendations are made according to the CYP2C19 status:
Croatian: Stoga se, ako je ova kombinacija neizbježna, donose sljedeće preporuke sukladno statusu CYP2C19: