FrancophonIA/ELRC3.0 huggingface dataset:
English: Retapamulin is approximately 94% bound to human plasma proteins.
Croatian: Približno 94% retapamulina veže se za ljudske proteine plazme.
English: Altargo is not expected to affect your ability to drive or use machines.
Croatian: Ne očekuje se da će Altargo utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: If you are allergic to retapamulin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični na retapamulin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Exact CI is calculated using the F-distribution method
Croatian: Točan CI se računa korištenjem metode F-distribucije
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, ili u roku od 60 dana od ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja
English: Patients aged from 2 months to 24 months
Croatian: Ispitanici u dobi od 2 mjeseca do 24 mjeseca
English: Carton of 12 sachets.
Croatian: Kartonska kutija s 12 vrećica.
English: Short term treatment of the following superficial skin infections in adults, adolescents, infants and children (aged from nine months) (see section 5.1):
Croatian: Za kratkotrajno liječenje sljedećih površinskih kožnih infekcija u odraslih, adolescenata, dojenčadi i djece (starijih od devet mjeseci) (vidjeti dio 5.1):
English: This might lead to side effects.
Croatian: To može prouzročiti nuspojave.
English: (corresponding to ≥ 3 times the human estimated exposure (see above).
Croatian: (odgovara ≥ 3 puta većoj dozi izloženosti od one procijenjene za ljude (vidjeti gore)).
English: • Infected small lacerations, abrasions, or sutured wounds.
Croatian: • Inficirane male razderotine, ogrebotine ili šivane rane.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
Croatian: Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove: http://www.ema.europa.eu/.
English: Adults (aged 18-65 years), adolescents (aged 12-17 years), infants and children (aged from nine
Croatian: Odrasli (u dobi od 18 do 65 godina), adolescenti (u dobi od 12 do 17 godina), dojenčad i djeca (u dobi od devet mjeseci do 11 godina)
English: Talk to your doctor or pharmacist before using Altargo.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Altargo.
English: Altargo is used to treat bacterial infections affecting small areas of skin.
Croatian: Altargo se koristi za liječenje bakterijskih infekcija na malim područjima kože.
English: If super-infection with a non-susceptible organism is suspected, treatment should be guided by clinical and microbiological assessments.
Croatian: Ako se sumnja na superinfekciju neosjetljivim organizmima, u liječenju se treba voditi kliničkim i mikrobiološkim procjenama.
English: The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections.
Croatian: Prevalencija stečene rezistencije može se geografski i vremenski razlikovati za određene vrste, pa su poželjne lokalne informacije o rezistenciji, posebice pri liječenju teških infekcija.
English: However, due to the low systemic plasma levels that have been observed, no safety problems are foreseen.
Croatian: Međutim, s obzirom na opažene niske sistemske koncentracije u plazmi, ne očekuju se problemi u sigurnosti.
English: Read all of this leaflet carefully before you start using this medicine because it contains
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: Do not throw away any medicines via household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Date of first authorisation: 24 May 2007 Date of latest renewal: 20 April 2012
Croatian: Datum posljednje obnove odobrenja: 20. travnja 2012
English: Any remaining ointment at the end of treatment should be discarded.
Croatian: Sva mast koja ostane nakon završetka terapije treba se baciti.
English: Consideration should be given to official guidance on the appropriate use of antibacterial medicinal
Croatian: Treba uzeti u obzir službene smjernice o odgovarajućoj primjeni antibiotika.
English: Not all pack sizes may be marketed in your country.
Croatian: Na tržištu u Vašoj državi se ne moraju nalaziti sve veličine pakiranja.
English: Altargo is for adults and children aged nine months and older.
Croatian: Altargo se koristi za odrasle i djecu u dobi od devet mjeseci i stariju.
English: In vitro, three mechanisms have been identified which reduce susceptibility to retapamulin.
Croatian: In vitro su identificirana tri mehanizma kojima se smanjuje osjetljivost na retapamulin.
English: 4.7 Effects on ability to drive and use machines Altargo has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Altargo ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Patients not showing a clinical response within two to three days should be re-evaluated and alternative therapy should be considered (see section 4.4).
Croatian: Ako se kod bolesnika unutar dva do tri dana ne pojavi klinički odgovor, potrebno ih je ponovo procijeniti i razmisliti o alternativnoj terapiji (vidjeti dio 4.4).
English: Minimal systemic exposure is observed in adults, therefore exposure of the breast-feeding infant is likely to be negligible.
Croatian: Kod odraslih je ustanovljena minimalna sistemska izloženost pa je prema tome vjerojatnost izloženosti dojenčeta zanemariva.
English: If you notice any worsening of the infection or develop increased redness, irritation or other signs and symptoms at the site of application you should stop using Altargo and tell your doctor.
Croatian: Ako primijetite pogoršanje infekcije ili pojačano crvenilo, nadraženost ili druge znakove i simptome na mjestu nanošenja, prestanite koristiti Altargo i obratite se svom liječniku.
English: No dosage adjustment is necessary.
Croatian: Nema potrebe za prilagođavanjem doze.
English: What Altargo is and what it is used for What you need to know before you use Altargo
Croatian: Što je Altargo i za što se koristi Što morate znati prije nego što počnete primjenjivati Altargo
English: They should not be kept for future use.
Croatian: Ne smiju se čuvati za daljnju primjenu.
English: The safety and efficacy of retapamulin ointment in infants less than nine months of age has not been established.
Croatian: Sigurnost i djelotvornost retapamulin masti u dojenčadi mlađe od devet mjeseci nije ustanovljena.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku
English: It is possible that using Altargo in children who are taking certain medicines (such as some medicines used to treat fungal infections) could result in blood concentrations of Altargo that are higher than usual.
Croatian: Kod djece koja uzimaju određene lijekove (poput nekih lijekova koji se koriste za liječenje gljivičnih infekcija) pri korištenju lijeka Altargo može doći do viših koncentracija lijeka Altargo u krvi nego što je to uobičajeno.
English: • Infected lesions that exceed 10 cm in length or a total surface area >100 cm2.
Croatian: • Inficirane lezije koje duljinom prelaze 10 cm ili im je ukupna površina >100 cm2.
English: This non-target specific efflux mechanism has also been demonstrated to reduce the in vitro activity of streptogramin A.
Croatian: Za ovaj ciljno nespecifični mehanizam efluksa se također pokazalo da smanjuje in vitro aktivnost streptogramina A.
English: Altargo is for use on the skin only.
Croatian: Altargo se primjenjuje samo na koži.
English: The explanation for lower clinical efficacy against MRSA in SIOW is unclear and it may have been influenced by the presence of a particular MRSA clone.
Croatian: Objašnjenje za slabiju kliničku djelotvornost protiv MRSA kod SIORa je nejasno, a može biti povezano s prisutnošću određenog klona MRSA.
English: ITTC- Intent to Treat Clinical Primary Efficacy Population; PPC -Per Protocol Clinical Primary Efficacy population; ITTB- Intent to Treat Bacteriological evaluable, Primary Efficacy Population; PPB - Per Protocol Bacteriologically evaluable, Primary Efficacy Population.
Croatian: ITTC - Klinička populacija koja se namjerava liječiti, za procjenu primarne djelotvornosti (Intent to Treat Clinical Primary Efficacy Population); PPC - Klinička populacija za primarnu djelotvornost prema planu ispitivanja (Per Protocol Clinical Primary Efficacy population); ITTB - Bakteriološki ocjenjiva populacija koja se namjerava liječiti, za primarnu djelotvornost (Intent to Treat Bacteriological evaluable, Primary Efficacy Population); PPB - Bakteriološki ocjenjiva populacija za primarnu djelotvornost prema planu ispitivanja (Per Protocol Bacteriologically evaluable, Primary
English: However, in the two studies that enrolled patients with SIOW the efficacy of retapamulin in infections due to MRSA was inadequate (75.7%).
Croatian: Međutim, u dva ispitivanja koja su uključila ispitanike sa SIOR, djelotvornost retapamulina na infekcije izazvane MRSA-om nije bila zadovoljavajuća (75,7%).
English: After applying your ointment, you may cover the treated area with a sterile bandage or gauze dressing, unless your doctor has told you to leave it uncovered.
Croatian: Nakon primjene masti, tretirano područje možete pokriti sterilnim zavojem ili gazom, osim ako Vam liječnik nije rekao da ga ostavite nepokrivenog.
English: In studies in impetigo and in two studies of secondarily infected open wounds (SIOW), clinical success rates were high for retapamulin in patients with mupirocin-resistant S. aureus (100%: 11/11) or fusidic acid-resistant S. aureus (96.7%: 29/30).
Croatian: U ispitivanjima impetiga i u dva ispitivanja sekundarno inficiranih otvorenih rana (SIOR), klinički uspjeh terapije bio je visok za retapamulin u bolesnika sa S. aureus rezistentnim na mupirocin (100%: 11/11) ili S. aureus rezistentnim na fusidičku kiselinu (96,7%: 29/30).
English: If there is no improvement in your infection after two to three days of treatment contact your doctor.
Croatian: Vaše infekcije nakon dva do tri dana liječenja, o tome obavijestite svog liječnika.
English: Clinical Response at Follow-up (day 12-14), by Analysis population Difference in success rates (%)
Croatian: Klinički odgovor na kontrolnom pregledu (12. - 14. dan), prema analiziranoj populaciji Razlika u stopama uspješnosti
English: This plasma concentration was observed in a child with a secondary infected dermatosis, for which retapamulin is not indicated
Croatian: Ta koncentracija u plazmi izmjerena je kod djeteta sa sekundarno inficiranom dermatozom za koju retapamulin nije indiciran.
English: S. aureus (all) MRSA
Croatian: S. aureus (svi) MRSA $
English: The majority of samples (89%) were below the lower limit of quantitation (0.5 ng/ml).
Croatian: Većina je uzoraka (89%) bila ispod donje granice određivanja (0,5 ng/ml).
English: Lesions of subjects treated with retapamulin healed more quickly by the End of therapy visit (day 7-9), with a reduction in size of the lesions by 77.3% compared to 43.5% for placebo treated subjects.
Croatian: Lezije ispitanika koji su liječeni retapamulinom brže su zarastale do posjeta na kraju terapije (7. do 9. dan), sa smanjenjem veličine lezije od 77,3% u usporedbi s 43,5% u ispitanika koji su primali placebo.
English: Do not stop using this medicine before talking to your doctor or pharmacist.
Croatian: Nemojte prestati primjenjivati ovaj lijek prije nego što se savjetujete sa svojim liječnikom ili ljekarnikom.
English: Therefore the pleuromutilins appear to inhibit bacterial protein synthesis by multiple
Croatian: Prema tome, čini se da pleuromutilini inhibiraju bakterijsku sintezu proteina koristeći više mehanizama.
English: If you accidentally use Altargo inside your nose you could have a nose bleed.
Croatian: Ako slučajno nanesete Altargo u nos, možete imati
English: It is supplied in an aluminium tube with a plastic cap, containing either 5, 10 or 15 grams of ointment, or in an aluminium foil sachet containing 0.5 g of ointment.
Croatian: Dolazi u aluminijskoj tubi sa plastičnim čepom koja sadrži 5, 10 ili 15 grama masti, ili u vrećici od aluminijske folije koja sadrži 0,5 g masti.
English: Data indicate that the binding site involves ribosomal protein L3 and is in the region of the ribosomal P site and peptidyl transferase centre.
Croatian: Podaci pokazuju da vezno mjesto uključuje ribosomalni protein L3 te da se nalazi u regiji ribosomalnog P mjesta i centra za peptidil transferazu.
English: The following convention has been used for the classification of frequency: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available
Croatian: Za klasifikaciju učestalosti koristila su se sljedeća pravila: vrlo često (>1/10), često (>1/100 i <1/10), manje često (>1/1000 i <1/100),
English: In the Intent to Treat Bacteriological evaluable population, the clinical success rate of retapamulin (76.4%: 139/182) was statistically superior to that of placebo (64.3%; 54/84).
Croatian: U bakteriološki ocjenjivoj populaciji koja se namjerava liječiti, stopa kliničke uspješnosti retapamulina (76,4%: 139/182) bila je statistički veća nego kod placeba (64,3%; 54/84).
English: No studies to evaluate effects of retapamulin on pre-/postnatal development were performed.
Croatian: Nisu provedena ispitivanja procjene učinka retapamulina na pre-/postnatalni razvoj.
English: The in vitro oxidative metabolism of retapamulin in human liver microsomes was primarily mediated by CYP3A4 with minor contributions from CYP2C8 and CYP2D6 (see section 4.5).
Croatian: Oksidativni metabolizam retapamulina in vitro na mikrosomima ljudske jetre primarno je posredovan CYP3A4 s manjim udjelom CYP2C8 i CYP2D6 (vidjeti dio 4.5).
English: Retapamulin is a semi-synthetic derivative of the compound pleuromutilin, which is isolated through fermentation from Clitopilus passeckerianus (formerly Pleurotus passeckerianus).
Croatian: Retapamulin je polusintetski derivat spoja pleuromutilina, koji se izolira fermentacijom iz Clitopilus passeckerianus (ranije Pleurotus passeckerianus).
English: In 14-day (50, 150 or 450 mg/kg) oral toxicity studies in rats there was evidence of adaptive hepatic and thyroid changes.
Croatian: U 14. danu (50, 150 ili 450 mg/kg) ispitivanja oralne toksičnosti u štakora postoje dokazi o adaptivnim promjenama jetre i štitnjače.
English: If the ointment accidentally gets on to these areas, wash the area with water and consult your doctor if you experience discomfort.
Croatian: Ako mast slučajno dospije na neko od tih područja, isperite područje vodom i ako osjetite neku tegobu, konzultirajte svog liječnika.
English: Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, Antibiotics for
Croatian: Farmakoterapijska skupina: Antibiotici i kemoterapeutici - dermatici, antibiotici za topikalnu primjenu.
English: Retapamulin ointment should only be used in pregnancy when topical antibacterial therapy is clearly indicated and the use of retapamulin is considered to be preferable to administration of a systemic antibacterial medicinal product.
Croatian: U trudnoći se retapamulin mast smije koristiti samo kada je jasno indicirana topikalna antibakterijska terapija i kada se smatra da je korištenje retapamulina bolje nego korištenje sistemskog antibiotika.
English: Altargo should not be used on children who are less than nine months old.
Croatian: Altargo se ne smije koristiti u djece koja su mlađa od devet mjeseci.
English: However, when adjusted for baseline wound characteristics including pathogen, wound size and severity, the clinical success rate of retapamulin was superior to placebo for the primary efficacy endpoint (p=0.0336).
Croatian: Međutim, nakon prilagodbe prema ishodišnim karakteristikama rane uključujući patogen, veličinu rane i težinu infekcije, stopa kliničke uspješnosti retapamulina kao primarne mjere ishoda djelotvornosti (p=0,0336) bila je veća u odnosu na placebo.
English: There are no data on the effects of retapamulin on human fertility.
Croatian: Ne postoje podaci o učincima retapamulina na plodnost ljudi.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not use in the eyes or on mucous membranes.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Nemojte primjenjivati u oči ili na sluznice.
English: A thin layer of ointment is usually put on the infected skin twice a day for five days.
Croatian: Tanki sloj masti obično se stavlja na inficiranu kožu dva puta dnevno tijekom pet dana.
English: By virtue of binding to this site, pleuromutilins inhibit peptidyl transfer, partially block P-site interactions, and prevent normal formation of active 50S ribosomal subunits.
Croatian: Mogućnošću vezanja za to mjesto, pleutomutilini inhibiraju transfer peptidila, djelomično blokirajući interakcije na P-mjestu i sprječavaju normalno stvaranje aktivne 50S podjedinice ribosoma.
English: Animal studies have shown reproductive toxicity after oral administration and are insufficient with respect to effects on parturition and fetal/postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost nakon peroralne primjene i nisu dostatne za procjenu učinka na porođaj te fetalni/postnatalni razvoj (vidjeti dio 5.3).
English: Retapamulin selectively inhibits bacterial protein synthesis by interacting at a unique site on the 50S subunit of the bacterial ribosome that is distinct from the binding sites of other non-pleuromutilin antibacterial agents that interact with the ribosome.
Croatian: Retapamulin selektivno inhibira sintezu proteina u bakterijama djelovanjem na jedinstveno mjesto na 50S podjedinici bakterijskog ribosoma, koje se razlikuje od veznog mjesta ostalih nepleuromutilinskih antibakterijskih agensa koji reagiraju s ribosomima.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Altargo should be made taking into account the benefit of breast-feeding to the child and the benefit of Altargo therapy to the
Croatian: Odluku da li nastaviti/prekinuti dojenje ili nastaviti/prekinuti terapiju lijekom Altargo treba donijeti uzevši u obzir koristi dojenja za dijete i koristi terapije lijekom Altargo za ženu.
English: One involves mutations in ribosomal protein L3, the second is a non-specific efflux mechanism (ABC transporter vgaAv).
Croatian: Jedan uključuje mutaciju ribosomskog proteina L3, drugi je nespecifični mehanizam efluksa (ABC
English: In human liver microsomes, retapamulin was shown to be a strong inhibitor of CYP3A4.
Croatian: Na mikrosomima ljudske jetre se pokazalo da je retapamulin snažni inhibitor CYP3A4.
English: See also section 4 of this leaflet.
Croatian: Pogledajte također dio 4.
English: This difference was primarily due to the higher success rate observed in retapamulin-treated subjects with infections caused by S. aureus in comparison to placebo treated subjects (see Table below).
Croatian: Ova je razlika primarno posljedica veće stope uspješnosti u ispitanika s infekcijama uzrokovanima S. aureus i liječenih retapamulinom u odnosu na one liječene placebom (vidjeti tablicu niže).
English: There was no evidence of genotoxicity when evaluated in vitro for gene mutation and/or chromosomal effects in the mouse lymphoma cell assay, in cultured human peripheral blood lymphocytes, or when evaluated in vivo for chromosomal effects in a rat micronucleus test.
Croatian: Znakovi genotoksičnosti nisu pronađeni pri in vitro procjeni mutacije gena i/ili učinaka na kromosome u testu na stanicama limfoma u miša, na uzgojenim ljudskim limfocitima iz periferne krvi, ili pri in vivo procjenama kromosomskih učinaka koristeći mikronukleus test u štakora.
English: A multicentre, randomised, double-blind, study compared the efficacy of retapamulin ointment to placebo ointment for the treatment of SIOW.
Croatian: Multicentričnim, randomiziranim, dvostruko slijepim ispitivanjem uspoređivana je djelotvornost retapamulin masti u odnosu na placebo mast za liječenje SIOR.
English: • contact your doctor or pharmacist immediately.
Croatian: • odmah se obratite svom liječniku ili ljekarniku.
English: Any unused medicinal product or waste material should be disposed of in accordance with local
Croatian: Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima.
English: What you need to know before you use Altargo
Croatian: Što morate znati prije nego što počnete primjenjivati Altargo
English: Retapamulin is not recommended for use in children aged less than 9 months.
Croatian: Retapamulin se ne preporučuje za primjenu u djece mlađe od 9 mjeseci.
English: There was no evidence of impaired fertility in male or female rats at oral doses of 50, 150, or 450 mg/kg/day, resulting in exposure margins of up to 5-times the highest human estimated exposure (topical application to 200 cm2 abraded skin: AUC 238 ng.h/ml).
Croatian: Nisu nađeni dokazi oštećenja plodnosti muških ni ženskih štakora pri dozama na usta od 50, 150, ili 450 mg/kg/dan, što je rezultiralo rasponom izloženosti do 5 puta većoj od najveće procijenjene izloženosti za ljude (topikalna primjena na 200 cm2 abradirane kože: AUC 238 ng•h/ml).
English: For S. aureus isolates with laboratorygenerated mutations in ribosomal protein L3, retapamulin MICs were 0.25-4 µg/ml.
Croatian: Kod izolata S. aureus s laboratorijski induciranim mutacijama ribosomalnog proteina L3, vrijednosti MIK za retapamulin su bile 0,25-4 µg/ml.
English: Due to the very low systemic exposures, tissue distribution of retapamulin has not been investigated in humans.
Croatian: S obzirom na vrlo nisku sistemsku izloženost, distribucija retapamulina u tkivima nije ispitivana u ljudi.
English: * Activity has been satisfactorily demonstrated in clinical studies
Croatian: * Zadovoljavajuća aktivnost pokazana je u kliničkim ispitivanjima Klinička djelotvornost i sigurnost
English: Each gram of ointment contains up to 20 micrograms of butylated hydroxytoluene (E321).
Croatian: Jedan gram masti sadrži do 20 mikrograma butilhidroksitoluena (E321).
English: A thin layer of ointment should be applied to the affected area twice daily for five days.
Croatian: Tanak sloj masti potrebno je nanositi na zahvaćeno područje dva puta dnevno tijekom pet dana.
English: No pharmacokinetic data are available in patients with renal or hepatic impairment.
Croatian: Nisu dostupni farmakokinetički podaci za bolesnike s oštećenjem bubrega ili jetre.
English: Glaxo Operations UK Ltd. (trdg as Glaxo Wellcome Operations) Harmire Road
Croatian: Glaxo Operations UK Ltd. (posluje pod imenom Glaxo Wellcome Operations) Harmire Road
English: The area treated may be covered with sterile bandage or gauze dressing.
Croatian: Liječeno područje može se pokriti sterilnim zavojem ili gazom.
English: Therefore it is not expected that clinically important increases in plasma concentrations of retapamulin will occur in patients aged 2 years and older who are also receiving CYP3A4 inhibitors.
Croatian: Prema tome, ne očekuje se klinički značajan porast koncentracije retapamulina u plazmi kod bolesnika u dobi od 2 i više godina koji također primaju inhibitore CYP3A4.