FrancophonIA/ELRC3.0 huggingface dataset:
English: Contact with mucous membranes, especially those of the eyes, must be avoided.
Croatian: Kontakt sa sluznicama, osobito sluznicom očiju, mora se izbjegavati.
English: Dermatitis, skin infections, pruritus
Croatian: Vrlo često dermatitis, infekcije kože, pruritus
English: STOP taking Ledaga and tell your doctor immediately if you experience allergic reactions (hypersensitivity).
Croatian: PRESTANITE primjenjivati gel Ledaga i odmah se obratite liječniku u slučaju pojave alergijske reakcije (preosjetljivost).
English: Dermal application of chlormethine to mice at a dose of 15 mg/kg for up to 33 weeks resulted in skin tumours (squamous cell carcinomas and skin papilloma).
Croatian: Primjena klormetina na koži miša u dozi od 15 mg/kg tijekom najviše 33 tjedna imala je za posljedicu nastanak kožnih tumora (planocelularnih karcinoma i papiloma).
English: Pharmacotherapeutic group: Antineoplastic agents, nitrogen mustard analogues, ATC code: L01AA05.
Croatian: Farmakoterapijska skupina: antineoplastični lijekovi, analozi dušikovog plikavca, ATK oznaka: L01AA05.
English: - Apply a thin layer of this medicine to completely dry skin at least 4 hours before or 30 minutes after showering or washing.
Croatian: - Nanesite tanak sloj lijeka na potpuno suhu kožu najmanje 4 sata prije ili 30 minuta nakon tuširanja ili pranja.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing severity.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
English: The medicinal product contains propylene glycol and butylhydroxytoluene, which may cause skin irritation (e.g., contact dermatitis).
Croatian: Lijek sadrži propilenglikol i butilhidroksitoluen koji mogu uzrokovati iritaciju kože (npr. kontaktni dermatitis).
English: Patients who received Ledaga in Study 201 had no measurable concentrations of chlormethine in blood collected 1, 3 and 6 hours post-application on Day 1, and at the first month visit.
Croatian: Bolesnici koji su u Ispitivanju 201 primjenjivali gel Ledaga nisu imali mjerljive koncentracije klormetina u krvi uzetoj 1, 3 i 6 sati nakon nanošenja prvog dana primjene niti pri prvom mjesečnom posjetu.
English: It is not known whether Ledaga passes into breast milk, and there may be a risk that the breast-feeding baby is exposed to Ledaga via contact with the mother's skin.
Croatian: Nije poznato izlučuje li se Ledaga u majčino mlijeko te može postojati rizik od izloženosti dojenčeta gelu Ledaga putem kontakta s majčinom kožom.
English: Reductions in mean CAILS scores were observed as early as at 4 weeks, with further reductions observed with continuing therapy.
Croatian: Smanjenja srednjih vrijednosti rezultata CAILS uočena su već nakon 4 tjedna, s daljnjim smanjenjima tijekom nastavka liječenja.
English: • Ledaga should be applied to completely dry skin at least 4 hours before or 30 minutes after showering or washing.
Croatian: • Gel Ledaga treba primijeniti na potpuno suhu kožu najmanje 4 sata prije ili 30 minuta nakon tuširanja ili pranja.
English: • Emollients (moisturisers) or other topical products may be applied to the treated areas 2 hours before or 2 hours after application of Ledaga.
Croatian: • Emolijensi (hidratantna sredstva) ili drugi topikalni proizvodi mogu se primijeniti na liječena područja 2 sata prije ili 2 sata poslije nanošenja gela Ledaga.
English: Unused refrigerated Ledaga should be discarded after 60 days, together with the plastic bag.
Croatian: Neiskorišten gel Ledaga čuvan u hladnjaku treba baciti nakon 60 dana, zajedno s plastičnom vrećicom.
English: The face, genitalia, anus, and intertriginous skin are at increased risk of skin reactions to topical chlormethine.
Croatian: Koža lica, genitalija, analnog područja te intertriginoznih područja pod povećanim je rizikom od nastanka kožnih reakcija na topikalnu primjenu klormetina.
English: Mucosal or eye exposure
Croatian: Izloženost sluznice ili oka
English: Patients were not required to be refractory to or intolerant of prior therapies.
Croatian: Uvjet nije bio da je bolest refrakterna ili da bolesnici ne podnose prethodna liječenja.
English: This is an anti-cancer medicine used on the skin to treat mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL).
Croatian: To je lijek protiv raka koji se koristi na koži za liječenje kožnog T-staničnog limfoma tipa mycosis fungoides (CTCL (od engl. cutaneous T-cell lymphoma) tipa MF).
English: o The plastic bag should not be used for any other purposes and must be disposed after 60 days, together with unused refrigerated Ledaga and any waste material, including nitrile gloves in accordance with local requirements.
Croatian: o Plastičnu se vrećicu ne smije upotrijebiti ni u koje druge svrhe i vrećica se mora baciti nakon 60 dana, zajedno s neupotrijebljenim gelom Ledaga čuvanim u hladnjaku i bilo kojim otpadnim materijalom uključujući nitrilne rukavice, u skladu s nacionalnim propisima.
English: Skin ulceration and blistering, skin hyperpigmentation
Croatian: Često ulceracije i plikovi na koži, hiperpigmentacija kože
English: Ledaga is an alcohol-based product and is flammable.
Croatian: Ledaga je lijek na bazi alkohola i zapaljiv je.
English: Any unused medicinal product or waste material, including the plastic bag and the nitrile gloves used for application, must be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal, uključujući plastičnu vrećicu i nitrilne rukavice korištene za nanošenje, moraju se zbrinuti sukladno nacionalnim propisima.
English: Caregivers who accidentally come into contact with Ledaga must wash the affected area right away for at least 15 minutes.
Croatian: Njegovatelji koji nehotice dođu u doticaj s gelom Ledaga moraju odmah ispirati zahvaćena područja tijekom najmanje 15 minuta.
English: Risks of direct skin contact include inflammation of the skin (dermatitis), injury to their eyes, mouth, or nose, and skin cancers.
Croatian: Rizici izravnog doticaja s kožom uključuju upalu kože (dermatitis), ozljedu očiju, usta ili nosa te rak kože.
English: In animals, adverse effects of chlormethine on male fertility after systemic administration have been documented (see section 5.3).
Croatian: U životinja su zapaženi štetni učinci klormetina na plodnost mužjaka nakon sistemske primjene (vidjeti dio 5.3).
English: Do not use this medicine after the expiry date, which is stated on the tube label and box after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici tube i kutiji iza oznake „Rok valjanosti“.
English: Risks of secondary exposure may include skin reactions, mucosal injury, and skin cancers.
Croatian: Rizici pri sekundarnoj izloženosti uključuju kožne reakcije, ozljedu sluznica i rak kože.
English: Remove and wash contaminated clothing.
Croatian: Kontaminiranu odjeću treba skinuti i oprati.
English: Ledaga is not recommended during pregnancy.
Croatian: Ne preporučuje se koristiti lijek Ledaga tijekom trudnoće.
English: Return it to the refrigerator after each use.
Croatian: Nakon svake upotrebe vratite ga u hladnjak.
English: The median daily usage of Ledaga was 1.8 g. The maximum individual daily usage in the trial was 10.5 g of gel (i.e., 2.1 mg of chlormethine HCl).
Croatian: Najveća individualna dnevna potrošnja u ispitivanju bila je 10,5 g gela (tj. 2,1 mg klormetina HCl).
English: Recommended application instructions should be followed to prevent secondary exposure (see section 4.2).
Croatian: Kako bi se izbjegla sekundarna izloženost, potrebno je pridržavati se preporučenih uputa za primjenu (vidjeti dio 4.2).
English: In addition, butylhydroxytoluene may also cause irritation to the eyes and mucous membranes (i.e., mouth and nose).
Croatian: Osim toga, butilhidroksitoluen može uzrokovati iritaciju očiju i sluznica (npr. sluznice usta i nosa).
English: The tube should be returned to the refrigerator immediately after each use.
Croatian: Nakon svake upotrebe tubu treba odmah vratiti u hladnjak.
English: - Skin cancers (abnormal growth of the cells in the skin) have been reported after application of chlormethine to the skin, although it is not known whether chlormethine causes this.
Croatian: - Nakon nanošenja klormetina na kožu zabilježena je pojava raka kože (nenormalan rast stanica u koži), iako nije poznato uzrokuje li to klormetin.
English: The primary efficacy endpoint in Study 201 was the Composite Assessment of Index Lesion Severity (CAILS) response rate.
Croatian: Primarna mjera ishoda djelotvornosti u Ispitivanju 201 bila je stopa odgovora prema kompozitnoj procjeni indeksa težine lezija CAILS (od engl.
English: Very common side effects on the treatment area (may affect more than 1 in 10 people): - Skin inflammation - Infections of the skin - Itching (pruritus)
Croatian: Vrlo česte nuspojave na liječenom području (mogu se javiti u više od 1 na 10 osoba): - upala kože - infekcije kože - svrbež (pruritus)
English: Exposure of the eyes to chlormethine causes pain, burns, inflammation, photophobia, and blurred vision.
Croatian: Izloženost očiju klormetinu uzrokuje bol, opekline, upalu, fotofobiju i zamagljen vid.
English: Ledaga is a clear, colourless gel.
Croatian: Ledaga je proziran, bezbojan gel.
English: Treatment with Ledaga should be stopped for any grade of skin ulceration or blistering, or moderately severe or severe dermatitis (e.g., marked skin redness with oedema).
Croatian: Liječenje gelom Ledaga treba prekinuti ako se pojave ulceracije ili plikovi na koži bilo kojeg stupnja, ili ako dođe do pojave umjereno teškog ili teškog dermatitisa (npr. značajnog crvenila kože s edemom).
English: Blindness and severe irreversible anterior eye injury may occur.
Croatian: Može doći do teške ireverzibilne ozljede prednjeg oka i sljepoće.
English: Contact your doctor or seek immediate medical attention if you experience allergic reactions to Ledaga (see section
Croatian: Obratite se svom liječniku ili potražite hitnu medicinsku pomoć ako Vam se javi alergijska reakcija na gel Ledaga
English: Treatment with Ledaga should be initiated by an appropriately experienced physician.
Croatian: 4.2 Doziranje i način primjene Liječenje gelom Ledaga treba započeti liječnik s odgovarajućim iskustvom.
English: Ledaga 160 micrograms/g gel
Croatian: Ledaga 160 mikrograma/g gel
English: Dispose of the tube, plastic bag and nitrile gloves in accordance with local requirements.
Croatian: Tubu, plastičnu vrećicu i nitrilne rukavice zbrinite sukladno nacionalnim propisima.
English: Your doctor may stop your treatment if you develop severe inflammation of the skin (i.e., redness and swelling), blisters and ulcers.
Croatian: Vaš liječnik može prekinuti liječenje ako dođe do razvoja teške upale kože (tj. crvenila i oticanja), plikova i ulceracija.
English: Secondary exposure to Ledaga
Croatian: Sekundarna izloženost gelu Ledaga
English: Caregivers must wear nitrile gloves when handling Ledaga.
Croatian: Njegovatelji moraju nositi nitrilne rukavice kada rukuju gelom Ledaga.
English: - If Ledaga gets in your eyes, it can cause pain, burning, swelling, redness, sensitivity to light, and blurred vision.
Croatian: - Ako Vam Ledaga dospije u oči može uzrokovati bol, pečenje, oticanje, crvenilo, osjetljivost na svjetlo i zamagljen vid.
English: Ledaga is intended only for use on the skin.
Croatian: Gel Ledaga namijenjen je samo za primjenu na koži.
English: Ledaga is a cytotoxic medicinal product.
Croatian: Ledaga je citotoksičan lijek.
English: If Ledaga gets in your eyes, rinse your eyes right away for at least 15 minutes with large amounts of water, a solution known as “0.9% sodium chloride solution” or an eye-wash solution, and seek medical assistance (including an eye doctor) as soon as possible.
Croatian: Ako Vam gel Ledaga dospije u oči, odmah ih isperite velikim količinama vode, otopine poznate pod nazivom „fiziološka otopina ” ili otopine za ispiranje očiju i to tijekom najmanje 15 minuta, te potražite liječničku pomoć (uključujući oftalmologa) što je prije moguće.
English: The following instructions should be followed by patients or caregivers when applying Ledaga:
Croatian: Pri nanošenju gela Ledaga bolesnici ili njegovatelji moraju se držati sljedećih uputa:
English: If there is accidental skin exposure to Ledaga, caregivers must immediately wash exposed areas thoroughly with soap and water for at least 15 minutes.
Croatian: Ako dođe do nehotične izloženosti kože gelu Ledaga, njegovatelji moraju odmah temeljito ispirati izložena područja sapunom i vodom tijekom najmanje 15 minuta.
English: Your doctor will check your skin for skin cancers during and after your treatment with Ledaga.
Croatian: Vaš će Vam liječnik pregledati kožu tijekom i nakon liječenja gelom Ledaga kako bi se otkrila pojava raka.
English: Each aluminium tube contains 60 grams of gel and has a white screw cap.
Croatian: Svaka aluminijska tuba sadrži 60 grama gela i ima bijeli zatvarač s navojem.
English: - Do not apply moisturisers or any other skin products (including medicines applied to the skin) for 2 hours before or 2 hours after the daily application of Ledaga.
Croatian: Ne nanosite hidratantna sredstva ili bilo koje druge proizvode za kožu (uključujući lijekove koji se nanose na kožu) 2 sata prije ili 2 sata poslije nanošenja gela Ledaga.
English: It is unknown whether chlormethine is excreted in human milk.
Croatian: Nije poznato izlučuje li se klormetin u majčino mlijeko.
English: Ledaga should be removed from the refrigerator just prior to application and returned to the refrigerator immediately after each use in its box inside the child-resistant, transparent, sealable, plastic bag.
Croatian: Gel Ledaga treba izvaditi iz hladnjaka neposredno prije primjene i vratiti ga u hladnjak odmah nakon svake primjene u pripadajuću kutiju u prozirnoj plastičnoj vrećici sa zatvaračem, sigurnoj za djecu.
English: Ledaga contains propylene glycol and butylhydroxytoluene
Croatian: Ledaga sadrži propilenglikol i butilhidroksitoluen
English: Studies in animals have shown reproductive toxicity after systemic administration (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost nakon sistemske primjene (vidjeti dio
English: The recommended dose is application as a thin film once a day to the affected areas.
Croatian: Preporučena doza je nanošenje tankog sloja na zahvaćena područja jednom dnevno.
English: Ledaga is not recommended in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Ledaga u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Store in a refrigerator (+2 °C to +8 °C) at all times, ensuring the tube is in the box inside the childresistant, transparent, sealable, plastic bag.
Croatian: Uvijek čuvati u hladnjaku (+2 °C do +8 °C), pazeći da je tuba gela u kutiji u prozirnoj plastičnoj vrećici sa zatvaračem, sigurnoj za djecu.
English: • Ledaga should be applied immediately or within 30 minutes after removal from the refrigerator.
Croatian: • Gel Ledaga treba nanijeti odmah ili unutar 30 minuta nakon vađenja iz hladnjaka.
English: There is limited experience of chlormethine in pregnant women.
Croatian: Iskustvo s primjenom klormetina u trudnica je ograničeno.
English: Propylene glycol and butylhydroxytoluene may also cause skin irritation.
Croatian: Propilenglikol i butilhidroksitoluen mogu uzrokovati iritaciju kože.
English: Chlormethine is a type of anti-cancer medicine called an ‘alkylating agent'.
Croatian: Klormetin je vrsta lijeka protiv raka koja se naziva
English: Cytotoxic: Handle with caution Flammable: Avoid fire, flame, and smoking
Croatian: Zapaljivo: izbjegavati vatru, plamen i pušenje
English: No dedicated animal studies on the effects of chlormethine on female fertility have been reported in the literature.
Croatian: U literaturi nema izvještaja o ispitivanjima utjecaja klormetina na plodnost ženki životinja.
English: A partial response was defined as an at least 50% reduction in the baseline CAILS score.
Croatian: Djelomični odgovor definiran je kao smanjenje rezultata CAILS od početnog za najmanje 50 %.
English: Ledaga contains the active substance chlormethine.
Croatian: Ledaga sadrži djelatnu tvar klormetin.
English: Common side effects on the treatment area (may affect up to 1 in 10 people): - Skin ulcers - Blisters - Darkening of the skin
Croatian: Česte nuspojave na liječenom području (mogu se javiti u manje od 1 na 10 osoba): - ulceracije na koži - plikovi - tamnjenje kože
English: - Keep away from children and contact with food by storing Ledaga in its box and inside the plastic bag.
Croatian: - Čuvajte gel Ledaga izvan dosega djece i izbjegavajte kontakt s hranom držanjem gela Ledaga u pripadajućoj kutiji te u plastičnoj vrećici.
English: The relevance to humans receiving topical chlormethine is unknown.
Croatian: Značaj te činjenice za ljude koji klormetin primjenjuju topikalno nije poznat.
English: Chlormethine was carcinogenic in rat and mouse carcinogenicity studies after subcutaneous and intravenous administration.
Croatian: Klormetin se pokazao kancerogenim nakon supkutane i intravenske primjene u ispitivanju kancerogenog potencijala u štakora i miševa.
English: Store and transport frozen (−15 °C to −25 °C).
Croatian: Čuvati i prevoziti zamrznuto (-15 °C do -25 °C).
English: Complete Response (CR) Partial Response (PR)
Croatian: Djelomični odgovor (PR)
English: In a randomised-controlled trial (n=128 exposed to Ledaga for a median duration of 52 weeks), the most frequent adverse reactions to Ledaga were skin related: dermatitis (54.7%; e.g., skin irritation, erythema, rash, urticaria, skin-burning sensation, pain of the skin), pruritus (20.3%), skin infections (11.7%), skin ulceration and blistering (6.3%), and skin hyperpigmentation (5.5%).
Croatian: Sažetak sigurnosnog profila U randomiziranom kontroliranom ispitivanju (n=128 izloženih gelu Ledaga s medijanom trajanja izloženosti 52 tjedna) najučestalije nuspojave primjene gela Ledaga bile su povezane s kožom: dermatitis (54,7 %; npr., iritacija kože, eritem, osip, urtikarija, osjećaj pečenja kože, bolnost kože),
English: If you forget to use Ledaga
Croatian: Ako ste zaboravili primijeniti gel Ledaga
English: If you stop using Ledaga
Croatian: Ako prestanete primjenjivati gel Ledaga
English: - With clean hands, place Ledaga back in the box it came in and the box in the plastic bag.
Croatian: - Gel Ledaga čistim rukama vratite u kutiju u kojoj je isporučen, a kutiju spremite u plastičnu vrećicu.
English: Package leaflet: Information for the patient Ledaga 160 micrograms/g gel chlormethine
Croatian: Uputa o lijeku: Informacije za bolesnika Ledaga 160 mikrograma/g gel klormetin
English: Panel 2
Croatian: PRILOG II.
English: In addition, butylhydroxytoluene has been reported to cause irritation to the eyes and mucous membranes.
Croatian: Dodatno je za butilhidroksitoluen zabilježeno da uzrokuje iritaciju očiju i sluznica.
English: Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients (see section 5.1).
Croatian: (CTCL (od engl. cutaneous T-cell lymphoma) tipa MF) u odraslih bolesnika (vidjeti dio 5.1).
English: Intravenously administered chlormethine impaired male fertility in rats at a daily dose of ≥ 0.25 mg/kg for 2 weeks.
Croatian: Intravenski primijenjen klormetin u dnevnoj dozi od ≥ 0,25 mg/kg tijekom 2 tjedna uzrokovao je oštećenje plodnosti mužjaka štakora.
English: The risk for inflammation of the skin is increased if you apply Ledaga to your face, genital area, anus or skin folds.
Croatian: Rizik od upale kože veći je ako se gel Ledaga nanosi na lice, područje genitalne i analne regije ili u pregibima.
English: In case of Ledaga exposure to non-affected areas of the skin, wash the exposed area with soap and water.
Croatian: U slučaju da gelu Ledaga izložite područja kože koja nisu zahvaćena, operite ta izložena područja sapunom i vodom.
English: - Apply Ledaga immediately or within 30 minutes of removing it from the refrigerator.
Croatian: - Nanesite gel Ledaga odmah ili unutar 30 minuta nakon vađenja iz hladnjaka.
English: Panel 3
Croatian: PRILOG III.
English: Qualifying prior therapies included topical corticosteroids, phototherapy, topical bexarotene, and topical nitrogen mustard.
Croatian: Prethodno primljeno liječenje koje je omogućavalo uključenje u ispitivanje obuhvaćalo je topikalne kortikosteroide, fototerapiju, topikalni beksaroten i topikalni dušikov plikavac.
English: How to store Ledaga
Croatian: Kako čuvati gel Ledaga
English: Unopened tube 3 years in the freezer (-15 °C to -25 °C).
Croatian: 3 godine u zamrzivaču (-15 °C do -25 °C).
English: • irrigation should be performed immediately for at least 15 minutes with copious amounts of water (or sodium chloride 9 mg/ml (0.9%) solution for injection, or a balanced salt ophthalmic irrigating solution may be used if there is eye exposure), and
Croatian: Bolesnike treba savjetovati da u slučaju izloženosti bilo koje sluznice: • odmah počnu s ispiranjem velikim količinama vode (ili 9 mg/ml (0,9 %) otopine natrijeva klorida za injekciju, odnosno uravnotežene otopine soli za ispiranje oka, u slučaju izloženosti oka) tijekom najmanje 15 minuta te da
English: - For patients applying the gel, wash your hands with soap and water immediately after applying.
Croatian: - Za bolesnike koji sami nanose gel: odmah nakon nanošenja operite ruke sapunom i vodom.
English: Hypersensitivity reactions, including isolated cases of anaphylaxis, have been reported in the literature after the use of topical formulations of chlormethine (see sections 4.3 and 4.8).
Croatian: uključujući izolirane slučajeve anafilaksije (vidjeti dijelove 4.3 i 4.8).
English: Exposure of mucous membranes such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, and these may be severe.
Croatian: Izloženost sluznica, kao što su sluznica usne ili nosne šupljine, uzrokuje bol, crvenilo i ulceracije koje mogu biti teške.
English: Ledaga is provided in a white aluminium tube with an inner lacquer and an aluminium seal and a white polypropylene screw cap. Each tube contains 60 g of gel.
Croatian: Ledaga se isporučuje u bijeloj aluminijskoj tubi koja je lakirana iznutra i ima aluminijski pokrov i bijeli polipropilenski zatvarač s navojem.
English: With clean hands, the tube should be placed back into the original box and the box should be placed in the supplied transparent, sealable, plastic bag for storage in the refrigerator.
Croatian: Za čuvanje u hladnjaku tubu treba čistim rukama vratiti u originalnu kutiju, a kutiju spremiti u isporučenu prozirnu plastičnu vrećicu sa zatvaračem.
English: In case of Ledaga exposure to non-affected areas of the skin, patients should wash the exposed area with soap and water.
Croatian: Ledaga izložena područja kože koja nisu zahvaćena, bolesnici moraju oprati ta izložena područja sapunom i vodom.
English: Topical use.
Croatian: Topikalna primjena.
English: - Ledaga is supplied within a child-resistant transparent, sealable, plastic bag.
Croatian: - Gel Ledaga isporučuje se u prozirnoj plastičnoj vrećici sa zatvaračem, sigurnoj za djecu.
English: There are limited data from the use of chlormethine in pregnant women.
Croatian: Podaci o primjeni klormetina u trudnica su ograničeni.
English: • The other ingredients are: diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerol, lactic acid, hydroxypropylcellulose, sodium chloride, menthol racemic, disodium edetate, and butylhydroxytoluene.
Croatian: • Pomoćne tvari su: dietilenglikolmonoetileter, propilenglikol, izopropilni alkohol, glicerol, laktatna kiselina, hidroksipropilceluloza, natrijev klorid, mentol racemični, dinatrijev edetat i butilhidroksitoluen.
English: • Caregivers must wear disposable nitrile gloves when applying Ledaga to patients.
Croatian: • Njegovatelji moraju nositi jednokratne nitrilne rukavice za vrijeme nanošenja gela Ledaga bolesnicima.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati gel Ledaga Lijek čuvajte izvan pogleda i dohvata djece.
English: Ledaga 160 micrograms/g gel chlormethine
Croatian: Ledaga 160 mikrograma/g gel klormetin