FrancophonIA/ELRC3.0 huggingface dataset:
English: - Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body's immune system attacks the body.
Croatian: - Sistemski lupus eritematozus (također zvan «lupus» ili «SLE»), bolest u kojoj imunološki sustav napada tijelo.
English: - Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Croatian: - Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4 i 4.6).
English: - Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
Croatian: - Povišene vrijednosti aldosterona (zadržavanje soli i vode u tijelu zajedno s neravnotežom raznih minerala u krvi).
English: This medicinal product does not require any special temperature storage conditions.
Croatian: Lijek ne zahtijeva posebne temperaturne uvjete čuvanja.
English: 3: For further description, please see sub-section “Description of selected adverse reactions”
Croatian: Za dodatni opis, molimo pogledajte odlomak „Opis izabranih nuspojava“
English: Tolucombi with food and alcohol
Croatian: Tolucombi s hranom i alkoholom
English: Date of first authorisation: 13 March 2013 Date of latest renewal: 8 January 2018
Croatian: Datum posljednje obnove odobrenja: 8. siječnja, 2018.
English: See also information under the heading “Do not take Tolucombi”.
Croatian: Vidjeti također informacije pod naslovom “Nemojte uzimati Tolucombi“.
English: After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours.
Croatian: Nakon prve doze telmisartana antihipertenzivna aktivnost postupno postaje vidljiva unutar 3 sata.
English: You can take Tolucombi with or without food.
Croatian: Možete uzimati Tolucombi sa ili bez hrane.
English: - Amantadine (medicine used to treat Parkinson's disease and also used to treat or prevent certain illnesses caused by viruses).
Croatian: - Amantadin (lijek koji se primjenjuje za liječenje Parkinsonove bolesti te se također primjenjuje u liječenju ili prevenciji određenih bolesti uzrokovanih virusima).
English: Renal clearance is about 250 - 300 ml/min.
Croatian: Renalni klirens je oko 250 - 300 ml/min.
English: - Medicines to increase blood pressure, such as noradrenaline.
Croatian: - Lijekovi za povišenje krvnog tlaka kao što je noradrenalin.
English: - Calcium supplements and/or vitamin D supplements.
Croatian: - Nadomjesci kalcija i/ili nadomjesci vitamina D.
English: - If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Tolucombi” and “Warnings and precautions”).
Croatian: - Ako uzimate ACE inhibitor ili aliskiren (vidjeti također informacije pod naslovima „Nemojte uzimati Tolucombi“ i „Upozorenja i mjere opreza“).
English: C-labelled telmisartan the glucuronide represents approximately 11 % of the measured radioactivity in plasma.
Croatian: C-označenog telmisartana glukuronid predstavlja oko 11% mjerene radioaktivnosti u plazmi.
English: - Lithium containing medicines to treat some types of depression.
Croatian: - Lijekovi koji sadrže litij za liječenje određenih oblika depresije.
English: Plasma concentrations of telmisartan are generally 2 - 3 times higher in females than in males.
Croatian: Koncentracije telmisartana u plazmi su općenito 2 - 3 puta veće kod žena nego kod muškaraca.
English: This applies especially to the medicines listed below taken at the same time with Tolucombi:
Croatian: Ovo se osobito odnosi na lijekove navedene u nastavku koji se uzimaju istodobno uz Tolucombi:
English: The terminal elimination half-life of hydrochlorothiazide is 10 - 15 hours.
Croatian: Poluvrijeme eliminacije hidroklorotiazida je 10 - 15 sati.
English: Tolucombi can have influence on the ability to drive and use machines.
Croatian: Tolucombi može utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: The recommended dose of Tolucombi is one tablet a day.
Croatian: Preporučena doza lijeka Tolucombi je jedna tableta dnevno.
English: Your doctor may need to change the dose of these other medications or take other precautions.
Croatian: Liječnik će Vam možda morati promijeniti doziranje i/ili poduzeti druge mjere opreza.
English: - If you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Croatian: - Ako ste imali rak kože ili ako Vam se pojavi neočekivana lezija (promjena) na koži tijekom liječenja.
English: By 3 hours after administration plasma concentrations are similar whether telmisartan is taken fasting or with food.
Croatian: Tri sata nakon primjene koncetracije u plazmi su slične bez obzira je li telmisartan uzet sa ili bez hrane.
English: The maximum reduction in blood pressure is generally attained 4-8 weeks after the start of treatment and is sustained during long-term therapy.
Croatian: Maksimalno smanjenje krvnog tlaka se općenito postiže 4-8 tjedana nakon početka liječenja te se održava tijekom dugotrajnog liječenja.
English: Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
Croatian: Nakon naglog prekida liječenja telmisartanom krvni tlak se postupno vraća na vrijednosti prije liječenja tijekom perioda od nekoliko dana, bez dokaza o rebound hipertenziji.
English: The incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups.
Croatian: Incidencija primarnog ishoda bila je slična u skupini na telmisartanu (16,7%) i ramiprilu (16,5%).
English: A clear cumulative dose-response relationship was observed for both BCC and SCC.
Croatian: Primijećena je jasna povezanost odgovora i kumulativne doze i za BCC i za SCC.
English: This can lead to permanent vision impairment, if not treated.
Croatian: Ovo može dovesti do trajnog oštećenja vida ako se ne liječi.
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Croatian: respiratorni distres (uključujući pneumonitis i plućni edem)
English: Rare cases have also been reported with angiotensin II receptor antagonists (including Tolucombi).
Croatian: Rijetki slučajevi također su zabilježeni uz antagoniste receptora angiotenzina II (uključujući Tolucombi).
English: Tolucombi is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Croatian: Tolucombi se ne preporučuje majkama koje doje, a liječnik može odabrati drugo liječenje za Vas ako želite dojiti.
English: Hydrochlorothiazide is 68 % protein bound in the plasma and its apparent volume of distribution is 0.83 - 1.14 l/kg.
Croatian: Hidroklorotiazid se 68% veže na proteine u plazmi, a njegov prividni volumen distribucije je 0,831,14 l/kg.
English: The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Croatian: Kombinacija ovih sastojaka ima aditivni antihipertenzivni učinak koji snižava krvni tlak u većoj mjeri nego što to čini svaka od komponenti zasebno.
English: Very rare: Interstitial lung disease
Croatian: Vrlo rijetko: intersticijska bolest pluća
English: Protect your skin from sun exposure and UV rays while taking Tolucombi.
Croatian: Zaštitite svoju kožu od izlaganja suncu i UV zrakama za vrijeme uzimanja lijeka Tolucombi.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Tolucombi.
Croatian: Ovo bi mogli biti simptomi povećanja tlaka u oku, a može se dogoditi unutar nekoliko sati do nekoliko tjedana nakon uzimanja lijeka Tolucombi.
English: Telmisartan is highly bound to plasma proteins (>99.5 %) mainly albumin and alpha l-acid glycoprotein.
Croatian: Telmisartan se uvelike veže na proteine plazme (>99,5%), uglavnom albumin i alfa 1 kiseli glikoprotein.
English: Based on cumulative renal excretion of hydrochlorothiazide the absolute bioavailability was about 60 %.
Croatian: Na osnovi kumulativne renalne ekskrecije hidroklorotiazida, apsolutna bioraspoloživost bila je oko 60%.
English: - if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
Croatian: - ako liječnik ustanovi da imate niske vrijednosti kalija ili visoke vrijednosti kalcija u krvi, a stanje se ne poboljšava s liječenjem.
English: - Cholestasis and biliary obstructive disorders.
Croatian: - Kolestaza i bilijarni opstruktivni poremećaji.
English: What Tolucombi is and what it is used for
Croatian: Što je Tolucombi i za što se koristi
English: - if you have severe kidney disease.
Croatian: - ako imate tešku bolest bubrega.
English: Your doctor will normally advise you to stop taking Tolucombi before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Tolucombi.
Croatian: Liječnik će Vam, u redovnom slučaju, savjetovati prekid primjene lijeka Tolucombi prije nego postanete trudni ili čim saznate da ste trudni te će Vam preporučiti drugi lijek umjesto lijeka Tolucombi.
English: Blisters (OPA/Al/PVC foil//Al foil): 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1 and 100 x 1 tablet in a box.
Croatian: Blisteri (OPA/Al/PVC folija//Al folija): 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1 i 100 x 1 tableta u kutiji.
English: Patients weighing 58.8 kg or less must take into consideration that sorbitol is a source of fructose and if your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Croatian: Bolesnici s tjelesnom težinom 58,8 kg ili manjom moraju uzeti u obzir da je sorbitol izvor fruktoze te da se, ako Vam je liječnik rekao da Vi (ili Vaše dijete) ne podnosite neke šećere ili ako imate dijagnosticiran nasljedno nepodnošenje fruktoze, rijetki genetski poremećaj u kojem osobe ne mogu razgraditi fruktozu, obratite liječniku prije nego Vi (ili Vaše dijete) počne uzimati ovaj lijek.
English: There was a trend towards higher plasma concentrations of hydrochlorothiazide in female than in male subjects.
Croatian: Postojao je trend prema većim koncetracijama hidroklorotiazida u plazmi kod žena nego kod muškaraca.
English: The apparent volume of distribution for telmisartan is approximately 500 litres indicating additional tissue binding.
Croatian: Prividni volumen distribucije za telmisartan je oko 500 litara, upućujući na dodatno vezanje u tkivima.
English: - Cholestyramine and colestipol, medicines for lowering blood fat levels.
Croatian: - Kolestiramin i kolestipol, lijekovi za snižavanje vrijednosti masnoća u krvi.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake “EXP”.
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
Croatian: Farmakokinetičke studije na bolesnicima s oštećenjem jetrene funkcije pokazale su povećanje u apsolutnoj bioraspoloživosti do gotovo 100%.
English: Depression
Croatian: depresija
English: Holjevca 20/E, 10 450 Jastrebarsko, Croatia
Croatian: Holjevca 20/E, 10450 Jastrebarsko, Hrvatska
English: Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su klasificirane po učestalosti koristeći sljedeću podjelu: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i <1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Exacerbation or activation of systemic lupus erythematosus
Croatian: egzacerbacija ili aktivacija sistemskog lupus eritematozusa
English: Tolucombi once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
Croatian: Tolucombi jedanput dnevno dovodi do učinkovitog i ujednačenog sniženja krvnog tlaka u rasponu terapijskih doza.
English: If any of the above applies to you, tell your doctor or pharmacist before taking Tolucombi.
Croatian: Ako se nešto od gore navedenog odnosi na Vas, obratite se liječniku ili ljekarniku prije nego počnete uzimati Tolucombi.
English: - Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1.
Croatian: - Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: You should consult with your doctor if you need to adjust the dose of your other medicine while taking Tolucombi.
Croatian: Morate se savjetovati s liječnikom ako trebate prilagođavanje doze drugog lijeka dok uzimate Tolucombi.
English: Elimination Telmisartan: Following either intravenous or oral administration of
Croatian: Eliminacija Telmisartan: nakon i intravenske ili peroralne primjene
English: If Tolucombi is used during breast feeding, doses should be kept as low as possible.
Croatian: Ako se Tolucombi primjenjuje tijekom dojenja, mora se primijeniti najniža moguća doza.
English: An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in Tolucombi, minimal or no effects were reported.
Croatian: Povećanje razine kolesterola i triglicerida povezano je s tiazidnom diuretskom terapijom, međutim, pri dozi od 12,5 mg koja je sadržana u lijeku Tolucombi, zabilježen je minimalan ili nikakav učinak.
English: Równoległa 5, 02-235 Warszawa, Poland TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany KRKA - FARMA d.o.o.,V.
Croatian: Równoległa 5, 02-235 Warszawa, Poljska TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Njemačka KRKA - FARMA d.o.o.,V.
English: Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Croatian: Reakcije preosjetljivosti na hidroklorotiazid mogu se pojaviti kod bolesnika s ili bez anamneze alergija ili bronhalne astme, ali su izglednije kod bolesnika s takvom anamnezom.
English: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Croatian: Kao kod svih bolesnika liječenih diureticima, serumski elektroliti se moraju periodično određivati u odgovarajućim intervalima.
English: This is confirmed by measurements made at the point of maximum effect and immediately prior to the next dose (through to peak ratios consistently above 80 % after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies).
Croatian: Ovo je potvrđeno mjerenjima napravljenima pri maksimalnom učinku i neposredno prije sljedeće doze (omjer između najnižih i vršnih vrijednosti neprekidno iznad 80% nakon doza od 40 i 80 mg telmisartana u placebom kontroliranim kliničkim studijama).
English: Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of medicinal product initiation.
Croatian: Simptomi uključuju akutni nastup smanjene oštrine vida ili bol u očima te se obično pojavljuju unutar nekoliko sati do tjedana od početka primjene lijeka.
English: As with all other angiotensin II receptor antagonists telmisartan is apparently less effective in lowering blood pressure in black patients than in non blacks, possibly because of higher prevalence of low renin states in the black hypertensive population.
Croatian: Kao i kod svih drugih antagonista receptora angiotenzina II, telmisartan je očigledno manje učinkovit u snižavanju krvnog tlaka kod ljudi crne rase nego kod ljudi koji nisu crne rase, vjerojatno zbog veće prevalencije niskih razina renina kod populacije crne rase s hipertenzijom.
English: Food slightly reduces the bioavailability of telmisartan with a reduction in the area under the plasma concentration time curve (AUC) of about 6 % with the 40 mg tablet and about 19 % after a 160 mg dose.
Croatian: Hrana u vrlo maloj mjeri reducira bioraspoloživost telmisartana s redukcijom površine ispod krivulje plazmatske koncentracije u odnosu na vrijeme (AUC) od oko 6% uz tabletu od 40 mg i oko 19% nakon doze od 160 mg.
English: Insomnia, sleep disorders
Croatian: nesanica, poremećaji spavanja
English: What Tolucombi is and what it is used for What you need to know before you take Tolucombi How to take Tolucombi
Croatian: Što je Tolucombi i za što se koristi Što morate znati prije nego počnete uzimati Tolucombi Kako uzimati Tolucombi
English: No additional preclinical studies have been performed with the Fixed Dose Combination product 80 mg/25 mg.
Croatian: Nisu izvedene dodatne pretkliničke studije s fiksnom kombinacijom 80 mg/25 mg.
English: Telmisartan is metabolised by conjugation to form a pharmacologically inactive acylglucuronide.
Croatian: Telmisartan: telmisartan se metabolizira konjugacijom kako bi se formirao farmakološki neaktivni acilglukuronid.
English: - The active substance hydrochlorothiazide can cause an unusual reaction, resulting in a decrease in vision and eye pain.
Croatian: - Djelatna tvar hidroklorotiazid može uzrokovati neuobičajenu reakciju rezultirajući smanjenjem vida i boli u očima.
English: Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of Tolucombi, hyperkalaemia might occur.
Croatian: Nasuprot tome, zahvaljujući antagonizmu receptora angiotenzina II (AT1) putem telmisartanske komponente lijeka Tolucombi, može doći do pojave hiperkalemije.
English: Bronchitis, pharyngitis, sinusitis
Croatian: bronhitis, faringitis i sinusitis
English: - Muscle relaxing medicines, such as tubocurarine.
Croatian: - Lijekovi za opuštanje mišića kao što je tubokurarin.
English: Beta-blockers and diazoxide The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Croatian: Beta-blokatori i diazoksid Hiperglikemijski učinak beta-blokatora i diazoksida može se pojačati tiazidima.
English: An updated RMP shall be submitted by CHMP agreed deadline.
Croatian: Ažurirani RMP treba dostaviti prema dogovorenom vremenskom rasporedu CHMP-a.
English: The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42 % and 58 %, respectively.
Croatian: Apsolutna bioraspoloživost telmisartana pri dozama od 40 mg i 160 mg bila je 42%, odnosno 58%.
English: The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively.
Croatian: Stopa smrtnosti od svih uzroka bila je 11,6% među bolesnicima liječenih telmisartanom i 11,8% među bolesnicima liječenih ramiprilom.
English: Other medicines and Tolucombi
Croatian: Drugi lijekovi i Tolucombi
English: The safety and efficacy of Tolucombi in children and adolescents aged below 18 have not been established.
Croatian: Sigurnost i djelotvornost lijeka Tolucombi u djece i adolescenata u dobi do 18 godina starosti nisu ustanovljene.
English: Investigations Not known: Triglycerides increased
Croatian: Nepoznato: povišeni trigliceridi
English: If you take more Tolucombi than you should
Croatian: Ako uzmete više Tolucombi tableta nego što ste trebali
English: - Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product).
Croatian: - Preosjetljivost na druge derivate sulfonamida (s obzirom da je hidroklorotiazid derivat sulfonamida).
English: If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.
Croatian: Ako dođe do pojave hipotenzije, bolesnik se mora staviti u ležeći položaj, a nadoknada soli i volumena mora biti brza.
English: C-labelled telmisartan most of the administered dose (>97 %) was eliminated in faeces via biliary excretion.
Croatian: C označenog telmisartana većina primijenjene doze (>97%) eliminira se u fecesom putem bilijarne ekskrecije.
English: High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness.
Croatian: Visoki krvni tlak, ako se ne liječi, može oštetiti krvne žile različitih organa, što ponekad može dovesti do srčanog udara, zatajenja srca ili bubrega, moždanog udara ili sljepoće.
English: See section 2 "Tolucombi contains lactose, sorbitol and sodium".
Croatian: Pogledajte dio 2 „Tolucombi sadrži laktozu, sorbitol i natrij“.
English: Tolucombi may be less effective in lowering the blood pressure in black patients.
Croatian: Tolucombi može biti manje učinkovit u snižavanju krvnog tlaka kod bolesnika crne rase.
English: Risk factors for developing acute angleclosure glaucoma may include a history of sulfonamide or penicillin allergy.
Croatian: Čimbenici rizika razvoja akutnog glaukoma zatvorenog kuta mogu uključivati anamnezu alergije na sulfonamid ili penicilin.
English: Therefore, it is not expected to potentiate bradykinin-mediated adverse effects.
Croatian: Stoga se ne očekuje potenciranje nuspojava posredovanih bradikininom.
English: Other antihypertensive agents Telmisartan may increase the hypotensive effect of other antihypertensive agents.
Croatian: Ostali antihipertenzivni lijekovi Telmisartan može povećati hipotenzivni učinak ostalih antihipertenzivnih lijekova.
English: The effect of Tolucombi may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicyl acid or ibuprofen).
Croatian: Učinak lijeka Tolucombi se može smanjiti dok uzimate NSAIL (nesteroidne protuupalne lijekove, npr. acetilsalicilatnu kiselinu ili ibuprofen).
English: Sepsis* (often called "blood poisoning"), is a severe infection with whole-body inflammatory response, rapid swelling of the skin and mucosa (angioedema); blistering and peeling of the top layer of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Croatian: Sepsa* (često se naziva “trovanje krvi”) je teška infekcija s upalnom reakcijom cijelog tijela, brzo oticanje kože i sluznice (angioedem), stvaranje mjehura i ljuštenje gornjeg sloja kože (toksična epidermalna nekroliza); ove nuspojave su rijetke (mogu se javiti u do 1 na 1 000 osoba) ili su nepoznate učestalosti (toksična epidermalna nekroliza), ali izuzetno ozbiljne te bolesnici moraju prekinuti s primjenom lijeka i odmah se javiti liječniku.
English: Because no information is available regarding the use of Tolucombi during breast-feeding, Tolucombi is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Croatian: S obzirom da ne postoje raspoloživi podaci u vezi primjene lijeka Tolucombi tijekom dojenja, Tolucombi se ne preporučuje te se preferiraju zamjenski lijekovi s utemeljenijim profilima sigurnosti tijekom dojenja, osobito u slučaju novorođenčeta ili prijevremeno rođenog djeteta.
English: Based on the pharmacological mechanism of action of hydrochlorothiazide its use during the second and third trimester may compromise foeto-placental perfusion and may cause foetal and neonatal effects like icterus, disturbance of electrolyte balance and thrombocytopenia.
Croatian: Na osnovi farmakološkog mehanizma djelovanja hidroklorotiazida, njegova primjena tijekom drugog i trećeg tromjesečja može kompromitirati feto-placentalnu perfuziju te može izazvati fetalne i neonatalne učinke poput ikterusa, poremećaja ravnoteže elektrolita i trombocitopenije.