FrancophonIA/ELRC3.0 huggingface dataset:
English: In an embryotoxicity study in rats, developmental toxicity (decreased fetal body weight and delayed skeletal ossification) and maternal toxicity were observed at oral doses of ≥ 150 mg/kg/day
Croatian: U ispitivanjima embriotoksičnosti na štakorima, razvojna toksičnost (smanjena tjelesna težina fetusa te zakašnjelo okoštavanje) i toksičnost za majku utvrđene su pri dozama na usta od ≥ 150 mg/kg/dan
English: Do not use in the eyes or on mucous membranes.
Croatian: Nemojte primjenjivati u oči ili na sluznice.
English: There was no treatment-related effect on embryofetal development.
Croatian: Nije bilo učinaka na fetalni razvoj embrija vezanih za terapiju.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar određene učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Nevertheless, the highest plasma concentrations recorded were low (< 10.5 ng/ml in the absence of ketoconazole and < 17 ng/ml in the presence of ketoconazole.
Croatian: Ipak, najviše zabilježene koncentracije u plazmi su bile niske (< 10,5 ng/ml bez ketokonazola i < 17 ng/ml s ketokonazolom).
English: In vitro, retapamulin was shown to be a P-glycoprotein (Pgp) substrate and inhibitor.
Croatian: In vitro, pokazano je da je retapamulin supstrat i inhibitor P-glikoproteina (Pgp).
English: Any signs or symptoms of overdose, either topically or by accidental ingestion, should be treated
Croatian: Sve znakove ili simptome predoziranja, bilo putem kože ili slučajnim uzimanjem na usta, potrebno je liječiti simptomatski.
English: Your doctor will decide if this
Croatian: Liječnik će odlučiti o tome je li ova terapija odgovarajuća za Vas.
English: Of the samples that had measurable concentrations 90% had retapamulin concentrations less than 2.5 ng/ml.
Croatian: Od uzoraka koji su imali mjerljive koncentracije, kod 90% je imalo koncentraciju retapamulina manju od 2,5 ng/ml.
English: The effect of concurrent application of retapamulin and other topical medicinal products to the same area of skin has not been studied, and is not recommended.
Croatian: Učinak istodobne primjene retapamulina i drugih topikalnih lijekova na istom području kože nije ispitan pa se ne preporučuje istodobna primjena.
English: In the event of a sensitisation or severe local irritation from the use of retapamulin ointment, treatment should be discontinued, the ointment carefully wiped off, and appropriate alternative therapy for the
Croatian: U slučaju senzibilizacije ili teške lokalne iritacije zbog primjene retapamulin masti, potrebno je prekinuti liječenje, pažljivo obrisati mast te započeti s alternativnom terapijom infekcije.
English: In a study conducted in healthy adult subjects, 10 mg/g retapamulin ointment was applied daily to intact and to abraded skin under occlusion for up to 7 days.
Croatian: U ispitivanju provedenom na zdravim odraslim ispitanicima, 10 mg/g retapamulin mast je svakodnevno primijenjena na zdravu i na abradiranu kožu pod okluzijom tijekom najviše 7 dana.
English: Maternal toxicity was demonstrated at dosages of ≥ 7.2 mg/kg/day corresponding to ≥ 8 times the estimated human exposure (see above).
Croatian: Toksičnost za majku utvrđena je pri dozama ≥ 7,2 mg/kg/dan koje odgovaraju ≥ 8 puta većoj dozi izloženosti od one procijenjene za ljude (vidjeti gore).
English: Retapamulin was given as a continuous intravenous infusion to pregnant rabbits from day 7 to day 19 of gestation.
Croatian: Retapamulin je davan skotnim kunićima u obliku intravenske infuzije od 7. do 19. dana gestacije.
English: Butylated hydroxytoluene (E321)
Croatian: Bijeli vazelin Butilhidroksitoluen (E321)
English: Altargo contains butylated hydroxytoluene (E321) It may cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucous
Croatian: Altargo sadrži butilhidroksitoluen (E321) On može izazvati lokalne kožne reakcije (npr. kontaktni dermatitis), ili iritaciju očiju i sluznica.
English: $ In vitro, retapamulin was equally active against methicillin-susceptible and methicillin-resistant strains of S. aureus.
Croatian: In vitro, retapamulin je bio jednako učinkovit protiv meticilin-osjetljivih i meticilin-rezistentnih sojeva S. aureus.
English: Altargo ointment contains an antibiotic called retapamulin, which is used on the skin.
Croatian: Što je Altargo i za što se koristi Altargo mast sadrži antibiotik nazvan retapamulin, koji se koristi na koži.
English: Retapamulin should not be used to treat abscesses.
Croatian: Retapamulin se ne smije koristiti za liječenje apscesa.
English: No treatment-related effects on male or female fertility have been shown in animal studies (see section 5.3).
Croatian: U ispitivanjima na životinjama nisu pronađeni učinci povezani s liječenjem na plodnost muških ili ženskih jedinki (vidjeti dio 5.3).
English: Your doctor will decide if Altargo can be used for a child aged less than 2 years old who is taking other medicines.
Croatian: Vaš liječnik će odlučiti može li dijete koje ima manje od 2 godine i uzima druge lijekove koristiti Altargo.
English: It is unknown whether retapamulin is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se retapamulin u majčino mlijeko u ljudi.
English: Sampling occurred pre-dose for adult subjects on days 3 or 4, and between 0-12 hours after the last application for paediatric subjects on days 3 or 4.
Croatian: U odraslih je uzorak uzet prije primjene doze 3. ili 4. dan, a kod pedijatrijskih ispitanika 0-12 sati nakon posljednje primjene 3. ili 4. dan.
English: $: the response rate for MRSA due to PVL+ MRSA was 8/13 (62%)
Croatian: Točan CI se računa korištenjem metode F-distribucije. $: stopa odgovora za MRSA uslijed PVL+ MRSA bila je 8/13 (62%)
English: Infections that may be treated include impetigo (which causes crusting scabs on infected areas), cuts, grazes and stitched wounds.
Croatian: Infekcije koje se mogu liječiti uključuju impetigo (koji na zahvaćenom području uzrokuje kraste koje se gule), porezotine,
English: However by the Follow-up visit this difference was less pronounced, (88.6% vs, 81% for retapamulin and placebo treated subjects respectively).
Croatian: Međutim, do kontrolne posjete razlika je bila manje izražena (88,6% u odnosu na 81% za bolesnike liječene retapamulinom
English: Very few MRSA were isolated in studies in impetigo and all were clinical successes (100%: 8/8).
Croatian: Svega je nekoliko MRSA izolirano pri ispitivanjima impetiga i sve su bile klinički uspješne (100%:
English: However, since plasma concentrations of retapamulin during topical application have been low (see section 5.2), it is not expected that concurrent systemic administration of CYP3A4 substrates will result in clinically important inhibition of their metabolism by retapamulin.
Croatian: Međutim, zbog niskih koncentracija retapamulina u plazmi pri topikalnoj primjeni (vidjeti dio 5.2), ne očekuje se da će istodobna sistemska primjena supstrata CYP3A4 uzrokovati klinički značajnu inhibiciju njihovog metabolizma retapamulinom.
English: The study failed to meet the primary end point which was the clinical success rate at follow-up (day 12 - 14) for subjects in the Intent to Treat Clinical
Croatian: Ispitivanje nije dostiglo primarni ishod koji je bio stopa kliničke uspješnosti (engl. rate) na kontrolnom pregledu (12. - 14. dan) za ispitanike u
English: 0.5 g aluminium foil sachet.
Croatian: Vrećica od 0,5 g od aluminijske folije.
English: No development of resistance was observed during treatment with retapamulin in the clinical study programme and all clinical isolates were inhibited by retapamulin concentrations of <2 µg/ml.
Croatian: Tijekom programa kliničkog ispitivanja nije uočen razvoj rezistencije za vrijeme liječenja retapamulinom i svi su klinički izolati bili inhibirani koncentracijama retapamulina od <2 µg/ml.
English: Contact your doctor or pharmacist for advice.
Croatian: Za savjet se obratite svom liječniku ili ljekarniku.
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza ‘Rok valjanosti'.
English: n/N Success rate
Croatian: n/N Stopa uspješnosti
English: Keep using Altargo for as long as your doctor advises.
Croatian: Nastavite koristiti Altargo onoliko dugo koliko Vam to
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infection is questionable.
Croatian: U slučaju potrebe, kada je lokalna prevalencija rezistencije takva da je korisnost lijeka za barem neke vrste infekcija upitna, treba potražiti stručan savjet.
English: Systemic exposure following topical application of retapamulin through intact skin was very low.
Croatian: Sistemska izloženost nakon topikalne primjene retapamulina kroz zdravu kožu je bila vrlo niska.
English: See package leaflet for further information
Croatian: Sadržaj pakiranja i dodatne informacije
English: Therefore caution is advised if retapamulin 10 mg/g ointment is administered to children in this age group who are also receiving CYP3A4 inhibitors, as further increase in systemic exposure to retapamulin may occur upon CYP3A4 inhibition.
Croatian: Prema tome, ako se retapamulin 10 mg/g mast primjenjuje djeci te dobne skupine, koja istodobno primaju inhibitore CYP3A4, preporučuje se oprez, s obzirom da je moguć daljnji porast sistemske izloženosti retapamulinu nakon inhibicije CYP3A4.
English: Check with your doctor or pharmacist if
Croatian: Provjerite sa svojim liječnikom ili ljekarnikom ako niste sigurni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains 10 mg retapamulin (1% w/w).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan gram masti sadrži 10 mg retapamulina (1% m/m).
English: Co-administration of oral ketoconazole 200mg twice daily increased mean retapamulin AUC(0-24) and Cmax by 81% after topical application of retapamulin 10 mg/g ointment on the abraded skin of healthy adult males.
Croatian: Istodobna peroralna primjena ketokonazola 200 mg dva puta dnevno povećala je srednju vrijednost AUC(0-24) i Cmax retapamulina za 81% nakon topikalne primjene retapamulin 10 mg/g masti na abradiranu kožu zdravih odraslih muškaraca.
English: No differences were observed in the in vitro activity of retapamulin versus S. aureus whether the isolates were susceptible or resistant to methicillin.
Croatian: Nisu primijećene razlike u in vitro aktivnosti retapamulina na S. aureus bez obzira jesu li su izolati bili osjetljivi ili rezistentni na meticilin.
English: There were no treatment
Croatian: Ako nema poboljšanja
English: GlaxoSmithKline (Malta) Limited Tel: + 356 21 238131
Croatian: GlaxoSmithKline Malta (Malta) Limited Tel: + 356 21 238131
English: Due to its distinct mode of action, target specific cross-resistance with other classes of antibacterial agents is rare.
Croatian: Zahvaljujući posebnom mehanizmu djelovanja, ciljno specifična križna rezistencija s ostalim klasama
English: Susceptibility to pleuromutilins can also be affected by the Cfr rRNA methyltransferase, which confers cross-resistance to phenicols, lincosamides and streptogramin A in staphylococci.
Croatian: Cfr rRNA metiltransferaza također može utjecati na osjetljivost na pleuromutiline, čime se stiče križna rezistencija na fenikole, linkozamide i streptogramin
English: Among the children aged from 9 months to 2 years plasma concentrations of retapamulin were measurable in 32% (16/50) of samples.
Croatian: Među djecom u dobi od 9 mjeseci do 2 godine, koncentracija retapamulina u plazmi mogla se izmjeriti u 32% (16/50) uzoraka.
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
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V*.
English: Cephalexin n/N Success
Croatian: Cefaleksin n/N Stopa uspješnosti
English: See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus.
Croatian: Vidjeti dijelove 4.4 i 5.1 za važne informacije o kliničkoj aktivnosti retapamulina protiv različitih
English: Placebo n/N Success rate (%)
Croatian: Placebo n/N Stopa uspješnosti
English: In monkeys dosed orally (50, 150 or 450 mg/kg) for 14 days there was dose-related emesis.
Croatian: Kod majmuna koji su primali doze na usta (50, 150 ili 450 mg/kg) tijekom 14 dana, primijećeno je
English: Clinical Success Rates at Follow up for SIOW patients with S. aureus Phenotype/PFGE type
Croatian: Stope kliničke uspješnosti na kontrolnom pregledu bolesnika sa SIOR i S. aureus Fenotip/PFGE tip
English: If you forget to use Altargo
Croatian: Ako ste zaboravili primijeniti Altargo
English: Retapamulin is predominantly bacteriostatic against S. aureus and S. pyogenes.
Croatian: Retapamulin djeluje pretežno bakteriostatski na S. aureus i S. pyogenes.
English: • Impetiginous lesions >10 in number and exceeding 100 cm2 in total surface area.
Croatian: • Više od 10 impetiginoznih lezija i ukupne površine područja veće od 100 cm2.
English: In the case of treatment failure associated with S. aureus, the presence of strains possessing additional virulence factors (such as PantonValentine Leukocidin) should be considered.
Croatian: aureus, treba razmotriti prisutnost sojeva koji posjeduju dodatne faktore virulencije (poput Panton
English: Retapamulin ointment contains butylated hydroxytoluene, which may cause local skin reaction (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Croatian: Retapamulin mast sadrži butilhidroksitoluen koji može izazvati lokalne kožne reakcije (npr. kontaktni dermatitis) ili iritacije očiju i sluznica.
English: The geometric mean Cmax value in plasma after application to 200 cm2 of abraded skin was 9.75 ng/ml on day 1 and 8.79 ng/ml on day 7, and the maximum individual systemic exposure (Cmax) recorded was 22.1 ng/ml.
Croatian: Geometrijska srednja vrijednost Cmax u plazmi nakon primjene na 200 cm2 abradirane kože bila je 9,75 ng/ml 1. dan i 8,79 ng/ml 7. dan, a maksimalna zabilježena pojedinačna sistemska izloženost
English: While the S. aureus epidemiological cut off value for retapamulin is 0.5 µg/ml, the clinical significance of isolates with elevated retapamulin MICs is unknown due to the potential for high local concentrations (20,000 µg/ml) of retapamulin on the skin.
Croatian: klinički značaj izolata s povišenim vrijednostima MIC-a za retapamulin nije poznat zbog potencijalno visokih lokalnih koncentracija (20 000 µg/ml) retapamulina na koži.
English: However, retapamulin showed no advantage over placebo in subjects with SIOW due to S. pyogenes.
Croatian: retapamulin nije pokazao prednost nad placebom u ispitanika sa SIOR uzrokovanog S. pyogenes-om.
English: The reason for the reduced clinical efficacy observed in
Croatian: Nije poznat uzrok smanjene kliničke djelotvornosti opažene kod ovih bolesnika.
English: Frequency, type and severity of adverse reactions in the paediatric population are the same as in adults.
Croatian: U pedijatrijskoj populaciji su učestalost, vrsta i težina nuspojava isti kao i u odraslih.
English: Four plasma retapamulin concentrations (26.9, 80.3, 174.3, and 177.3 ng/ml) exceeded the highest concentration observed in patients aged 2-17 years (18.5 ng/ml).
Croatian: Četiri koncentracije retapamulina u plazmi (26,9; 80,3; 174,3 i 177,3 ng/ml) prelazile su najveću izmjerenu koncentraciju u ispitanika u dobi od 2 do 17 godina (18,5 ng/ml).
English: Single plasma samples were obtained from 516 adult and paediatric patients who received topical treatment with retapamulin 10 mg/g ointment twice daily for 5 days for the treatment of secondarily infected traumatic lesions.
Croatian: Od 516 odraslih i pedijatrijskih ispitanika kojima je topikalno primjenjivana retapamulin 10 mg/g mast dva puta dnevno tijekom 5 dana za liječenje sekundarno inficirane traumatske lezije, uzet je po jedan uzorak plazme.
English: Glaxo Operations UK, Ltd, (trading as Glaxo Wellcome Operations)
Croatian: Glaxo Operations UK, Ltd, (posluje pod imenom Glaxo Wellcome Operations) Harmire Road
English: Immune system disorders
Croatian: Inherentno rezistentni organizmi
English: Single plasma samples were obtained approximately 4-8 hours after the first application on days 3 or 4 from patients aged from 2 months to 2 years with impetigo or with secondarily infected traumatic lesions or dermatoses (note that retapamulin is not indicated for use in secondarily infected dermatoses).
Croatian: Prikupljen je po jedan uzorak plazme od ispitanika u dobi od 2 mjeseca do 2 godine s impetigom ili sa sekundarno inficiranim traumatskim lezijama ili dermatozama (retapamulin nije indiciran za primjenu kod sekundarno inficiranih dermatoza) 3. ili 4. dan, 4 do 8 sati nakon prve primjene lijeka.
English: If you stop using Altargo
Croatian: Ako prestanete primjenjivati Altargo
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 5 g, 10 g 15 g TUBE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE 5 g, 10 g 15 g TUBA
English: OTHER CONDITIONS AND REQUIREMENTS OF THE
Croatian: OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE LIJEKA U
English: In children aged from 2 months to 9 months plasma concentrations of retapamulin were measurable in 69% (20/29) of samples.
Croatian: mjeseca do 9 mjeseci, koncentracija retapamulina u plazmi bila je mjerljiva u 69% (20/29) uzoraka.
English: A single retapamulin concentration (95.1 ng/ml) exceeded the highest concentration observed in patients aged 2-17 years (18.5 ng/ml).
Croatian: Samo je jedna koncentracija (95,1 ng/ml) prelazila najveću izmjerene koncentraciju kod ispitanika u dobi od 2 do 17 godina (18,5 ng/ml).
English: Alternative therapy should be considered if there is no improvement or a worsening in the infected area after 2-3 days of treatment.
Croatian: Ako nakon 2-3 dana liječenja nema poboljšanja ili se uoči pogoršanje inficiranog područja potrebno je uzeti u obzir alternativnu terapiju.
English: Prolonged use and overgrowth of non-susceptible micro-organisms Prolonged use of retapamulin may result in overgrowth of non-susceptible micro-organisms, including fungi.
Croatian: Produljena primjena retapamulina može dovesti do prekomjernog rasta neosjetljivih mikroorganizama, što uključuje gljivice.
English: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Croatian: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com Sverige
English: Each gram contains 10 mg retapamulin (1% w/w)
Croatian: Jedan gram sadrži: 10 mg retapamulina (1% m/m)
English: However, the maximum individual systemic exposure in humans following topical application of 10 mg/g ointment on 200 cm2 of abraded skin (Cmax= 22 ng/ml; AUC(0-24) = 238 ng.h/ml) was 660-fold lower than the retapamulin IC50 for Pgp inhibition.
Croatian: 200 cm2 abradirane kože (Cmax= 22 ng/ml; AUC(0-24) = 238 ng•h/ml) bila je 660 puta niža nego retapamulin IC50 za inhibiciju Pgp.
English: Retapamulin ointment must be kept away from the eyes and mucous membranes.
Croatian: Mora se izbjegavati kontakt retapamulin masti s očima ili sluznicama.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 5 g, 10 g, 15 g TUBE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA TUBE OD 5 g, 10 g i 15 g
English: Retapamulin is for cutaneous use only.
Croatian: Retapamulin se primjenjuje samo za kožu.
English: In children aged from 9 months to 2 years it is possible that higher plasma concentrations may occasionally occur during treatment with retapamulin 10 mg/g ointment compared to older children and adults.
Croatian: Tijekom liječenja djece u dobi od od 9 mjeseci do 2 godine s retapamulin 10 mg/g masti, u usporedbi sa starijom djecom i odraslima, moguća je povremena pojava viših koncentracija u plazmi.
English: Retapamulin elimination in humans has not been investigated.
Croatian: U ljudi nije ispitivana eliminacija retapamulina.
English: If you accidentally swallow Altargo
Croatian: Ako slučajno progutate Altargo
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU
English: Do not apply other ointments, creams or lotions to the area being treated with Altargo unless specifically instructed to do so by your doctor.
Croatian: Na područje na koje nanosite Altargo nemojte stavljati nikakve druge masti, kreme ili losione ako Vam tako nije preporučio Vaš liječnik.
English: Retapamulin concentrations were measurable in 46% (36/79) of samples (range 0.52 to 177.3 ng/ml) but the majority of these samples (27/36; 75%) contained < 5.0 ng/ml.
Croatian: 177,3 ng/ml), ali je većina ovih uzoraka (27/36; 75%) sadržavala < 5,0 ng/ml.
English: Uncommon side effects (may affect up to 1 in 100 people): - pain, itching, redness or rash (contact dermatitis) Other side effects (frequency not known, cannot be estimated from the available data):
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): - bol, svrbež, crvenilo ili osip (kontaktni dermatitis)
English: 4.4 Special warnings and precautions for use
Croatian: 6.6 Posebne mjere za zbrinjavanje
English: 5 g, 10 g and 15 g aluminium tubes with a plastic screw cap. Carton of 1 tube.
Croatian: Aluminijske tube od 5 g, 10 g i 15 g s plastičnim zatvaračem na navoj.
English: Severe skin reactions or allergies (frequency not known) If you develop a severe skin reaction or an allergy: (e.g. severe itching or severe rash, swelling of the
Croatian: Ako razvijete jaku kožnu reakciju ili alergiju: (npr. jaki svrbež ili teški osip, oticanje lica, usana, ili • prestanite koristiti Altargo
English: See section 5.2 regarding plasma concentrations of retapamulin observed in patients in different age groups.
Croatian: Za koncentracije retapamulina izmjerenih u plazmi bolesnika različitih dobnih skupina, vidjeti dio 5.2.
English: - The active substance is retapamulin.
Croatian: Što Altargo sadrži - Djelatna tvar je retapamulin.
English: Methicillin-resistant Staphylococcus aureus (MRSA) Retapamulin should not be used to treat infections known or thought likely to be due to MRSA (see In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was inadequate in patients with infections caused by MRSA.
Croatian: Meticilin-rezistentan Staphylococcus aureus (MRSA) Retapamulin se ne smije koristiti za liječenje infekcija za koje se zna ili se pretpostavlja da su uzrokovane MRSA-om (vidjeti dio 5.1).
English: GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com
Croatian: GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com lv-epasts@gsk.com
English: Package leaflet: Information for the patient Altargo 10 mg/g ointment Retapamulin
Croatian: Uputa o lijeku: Informacija za bolesnika Altargo 10 mg/g mast retapamulin
English: Carcinogenesis, mutagenesis, reproductive toxicity Long-term studies in animals to evaluate carcinogenic potential have not been conducted with
Croatian: U životinja nisu provedena dugotrajna ispitivanja za procjenu karcinogenog potencijala retapamulina.
English: Systemic exposure to retapamulin has been low following topical application of 10 mg/g ointment in adult and paediatric patients aged 2 years and older (maximum plasma concentration < 20 ng/mL).
Croatian: Nakon topikalne primjene 10 mg/g masti u odraslih i pedijatrijskih bolesnika u dobi od 2 i više godina, sistemska izloženost retapamulinu bila je niska (maksimalna koncentracija u plazmi < 20 ng/ml).
English: In clinical studies in which 2150 patients with superficial skin infections applied Altargo, the most commonly reported adverse reaction was application site irritation, which affected approximately 1%
Croatian: Altargo, najčešće prijavljena nuspojava koja je zabilježena kod približno 1% ispitanika, bila je iritacija
English: If you get any side effects, talk to your doctor, nurse or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ili ljekarnika ili medicinsku sestru.