natgillin/translations-raw huggingface dataset:
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
- pogosti (več kot 1, a manj kot 10 od 100 živali) - občasni (več kot 1, a manj kot 10 od 1.000 živali) - redki (več kot 1, a manj kot 10 od 10.000 živali)
Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate. 
Enkratna podkožna injekcija odmerka po 0,5 mg meloksikama na kilogram telesne mase (to je 10,0 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
PACKAGE LEAFLET FOR Melovem 30 mg/ml solution for injection for cattle and pigs 
NAVODILO ZA UPORABO Melovem 30 mg/ml raztopina za injiciranje za govedo in prašiče
Excipient(s): 
INDIKACIJA(E) Govedo:
Muscle Liver Kidney 
Steklena viala
Cardboard box with 1 colourless glass injection vial of 50 ml, 100 ml or 250 ml. 
Kartonska škatla z 1 brezbarvno stekleno vialo tipa I po 50 ml, 100 ml ali 250 ml. Ni nujno, da so v prometu vsa navedena pakiranja.
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 30 mg/ml solution for injection for cattle and pigs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melovem 30 mg/ml raztopina za injiciranje za govedo in prašiče
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 20 mg/ml solution for injection for cattle, pigs and horses 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melovem 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje
PACKAGE LEAFLET FOR Melovem 20 mg/ml solution for injection for cattle, pigs and horses 
NAVODILO ZA UPORABO Melovem 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/006 (100 ml) 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/006 (100 ml)
Manufacturer responsible for batch release: Dopharma B.V. 
Imetnik dovoljenja za promet z zdravilom: Dopharma Research B.V.
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/005 (50 ml) 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/005 (50 ml)
Cattle: meat and offal: 15 days. 
Govedo: meso in organi: 15 dni
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 20 mg/ml solution for injection for cattle, pigs and horses Meloxicam 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melovem 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje Meloksikam
Cattle: meat and offal: 15 days; milk: 5 days. 
Meso in organi: 15 dni Mleko: 5 dni
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/003 (100 ml) 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/003 (100 ml)
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic properties. 
Meloksikam je nesteroidno protivnetno zdravilo (NSAID) iz skupine oksikamov.
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 30 mg/ml solution for injection for cattle and pigs Meloxicam 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Melovem 30 mg/ml raztopina za injiciranje za govedo in prašiče Meloksikam
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/001 
ŠTEVILKA DOVOLJENJ(A) ZA PROMET EU/2/09/098/001
PACKAGE LEAFLET FOR: Melovem 5 mg/ml solution for injection for cattle and pigs 
Melovem 5 mg/ml, raztopina za injiciranje za govedo in prašiče
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/002 (50 ml) 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/002 (50 ml)
Protect from frost. 
Zdravilo ne sme zmrzniti.
In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies. 
NEŽELENI UČINKI Govedo in prašiči podkožno, intramuskularno in intravensko dajanje dobro prenašajo; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije, in sicer pri manj kot 10 % goved.
To obtain the best possible pain relieving effect post surgery Melovem should be administered 30 minutes before surgical intervention. 
Najboljše možno lajšanje bolečine po operaciji boste dosegli, če boste zdravilo Melovem uporabili
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/005 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/005
In cattle and pigs, subcutaneous and intramuscular administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies. 
NEŽELENI UČINKI Govedo in prašiči podkožno in intramuskularno dajanje dobro prenašajo; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije, in sicer pri manj kot 10 % goved.
4.8 Interaction with other medicinal products and other forms of interaction 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
Benzyl alcohol Hydrochloric acid Sodium chloride Macrogol 400 
6.1 Seznam pomožnih snovi benzilalkohol klorovodikova kislina natrijev klorid makrogol 400 makrogol 1500 meglumin voda za injekcije
WITHDRAWAL PERIOD Cattle: 
KARENCA Govedo:
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/002 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/098/002
QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 30 mg/ml 
Meloksikam 20 mg Pomožna(e) snov(i): Etanol 150 mg
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects. 
Meloksikam je nesteroidno protivnetno zdravilo iz skupine oksikamov.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 20 mg/ml 
Meloksikam 20 mg Pomožna(pomožne) snov(i): Etanol 150 mg
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) each ml contains: 
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI
SPECIAL STORAGE CONDITIONS Keep the injection vial in the outer carton in order to protect from light. 
POSEBNA NAVODILA ZA SHRANJEVANJE Zdravilo shranjujte nedosegljivo otrokom.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Meloxicam 30 mg/ml 
Meloksikam 30 mg/ml
Immediate Packaging Pack size 
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
Strength Pharmaceutical Form Route of Administration 
Številka EU zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Date of first authorisation: 3 March 2017 
Datum prve odobritve: 3. marec 2017
Assessment was undertaken by a blinded observer. 
Oceno je izvedel slepi opazovalec.
The safety profile observed in elderly patients was consistent with that in the overall patient population. 
Varnostni profil, opažen pri starejših bolnikih, je bil konsistenten s tistim pri celotni populaciji bolnikov.
Cutaneous hypersensitivity reactions were reported in 2.3% of the treated patients. 
O kožnih preobčutljivostnih reakcijah so poročali pri 2,3 % zdravljenih bolnikov.
The response criteria were the same as for CAILS. 
Merila za odziv so bila enaka kot pri CAILS.
Do not give this medicine to children and adolescents under the age of 18 years because the safety and effectiveness have not been established for this age group. 
Tega zdravila ne dajajte otrokom in mladostnikom, mlajšim od 18 let, saj varnost in učinkovitost pri tej starostni skupini nista bili dokazani.
Your doctor may restart the treatment upon improvement of your symptoms. 
Zdravnik bo zdravljenje morda znova uvedel po izboljšanju vaših simptomov.
- Tell your doctor if you have ever had an allergic reaction to chlormethine. 
- Povejte svojemu zdravniku, če ste že kdaj imeli alergijskoreakcijo na klormetin.
The safety and efficacy of Ledaga in children aged 0 to 18 years have not been established. 
Varnost in učinkovitost zdravila Ledaga pri otrocih, starih 0 do 18 let, še nista bili dokazani.
In the controlled clinical trial, 31% (79/255) of the study population were aged 65 years or older. 
Pri nadzorovanem kliničnem preskušanju je bilo 31 % (79/255) študijske populacije starih 65 let ali starejših.
• The opening of the tube is covered with a foil safety seal. 
• Odprtina tube je zaprta z varnostno tesnilno folijo.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Results in other secondary endpoints (response in percentage of body surface area affected, time to first confirmed CAILS response, duration of first confirmed CAILS response and time to disease progression) were consistent with those for CAILS and SWAT. 
Rezultati pri drugih sekundarnih opazovanih dogodkih (odziv glede na odstotek prizadete telesne površine, čas do prvega potrjenega odziva po CAILS, trajanje prvega potrjenega odziva po CAILS in čas do napredovanja bolezni) so bili konsistentni s tistimi iz CAILS in SWAT.
• Fire, flame, and smoking must be avoided until Ledaga has dried. 
• Ognju, plamenom in kajenju se je treba izogibati, dokler se zdravilo Ledaga ne posuši.
Do not stop using your medicine until your doctor advises you to do so. 
Ne prenehajte uporabljati zdravila, dokler vam tako ne naroči zdravnik.
Local skin reactions 
Lokalne reakcije na koži
A small number of subjects (6.3%, 8/128) treated with Ledaga utilised topical corticosteroids. 
Manjše število preskušancev (6,3 %, 8/128), zdravljenih z zdravilom Ledaga, je uporabljalo lokalne kortikosteroide.
Do not use this medicine after the expiry date, which is stated on the tube label and box after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na tubi in škatli poleg oznake »EXP«.
The ratio of response and the 95% confidence interval in the ITT population were 1.226 (0.974-1.552) for CAILS and 1.017 (0.783-1.321) for SWAT and therefore consistent with those in the EE population for both the overall CAILS and SWAT responses. 
Razmerje odzivov in 95-% interval zaupanja pri populaciji ITT sta bila 1,226 (0,974-1,552) za CAILS in 1,017 (0,783-1,321) za SWAT, tako da sta konsistentna s tistima pri populaciji EE za celotno vrednost odzivov po CAILS in SWAT.
Response rates (%) 
Stopnja odziva (v %)
If reintroduction of treatment is tolerated for at least 1 week, the frequency of application can be increased to every other day for at least 1 week and then to once-daily application if tolerated. 
Če bolnik nadaljevanje zdravljenja prenaša vsaj 1 teden, se lahko pogostnost nanašanja poveča na vsak drugi dan za vsaj 1 teden in nato na enkrat na dan, če bolnik to prenese.
• medical care should be obtained immediately (including ophthalmological consultation if there is eye exposure). 
• takoj je treba poiskati medicinsko pomoč (vključno s posvetom z oftalmologom v primeru izpostavljenosti očesa).
- Contact with your eyes must be avoided. 
- Stiku zdravila z očmi se je treba izogniti.
- Remove the cap from the tube just before use. 
- Pokrovček s tube odstranite tik pred uporabo.
In the EE population, the percentage of patients who achieved a confirmed response by CAILS was similar between disease stages IA (79.6 %) and IB-IIA (73.2%). 
Pri populaciji EE je bil odstotek bolnikov, ki so dosegli potrjeni odziv po CAILS, za stopnjo IA (79,6 %) in stopnjo IB-IIA (73,2 %) podoben.
If you apply more than recommended, talk to your doctor. 
Če ste ga nanesli več, kot je priporočeno, se posvetujte z zdravnikom.
Study medicinal product was to be applied topically once daily for 12 months. 
Zdravilo v preskušanju je bilo treba nanašati lokalno enkrat na dan 12 mesecev.
Comparator N=95 
N = 95
- if you are allergic (hypersensitive) to chlormethine or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični (preobčutljivi) na klormetin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
CAILS = Composite Assessment of Index Lesion Severity; CI = confidence interval; CR = Complete Response; PR = Partial Response; SWAT = Severity Weighted Assessment Tool. 
CAILS = Sestavljena ocena indeksa resnosti poškodb; IZ = interval zaupanja; PO= popolni odziv; DO = delni odziv; SWAT = Orodje za ocenjevanje ovrednotene resnosti.
The tube should be returned to the refrigerator immediately after each use. 
Tubo je treba spraviti v hladilnik takoj po vsaki uporabi.
Thus, the safety of the concomitant use of Ledaga with topical corticosteroids has not yet been established. 
Zato varnost sočasne uporabe zdravila Ledaga in lokalnih kortikosteroidov še ni bila dokazana.
- Rash - Difficulty breathing 
- težave pri dihanju.
The dosing recommendation for elderly patients ( ≥ 65 years old) is the same as for younger adult patients (see section 4.8). 
Priporočilo za odmerjanje pri starostnikih (starih ≥ 65 let) je enako kot pri mlajših odraslih bolnikih (glejte poglavje 4.8).
The recommended application instructions should be followed (see section 4.2). 
Upoštevati je treba priporočena navodila za nanašanje (glejte poglavje 4.2).
As the main secondary endpoint, patients were also evaluated using the Severity Weighted Assessment Tool (SWAT), which was based on an assessment of all lesions. 
Kot glavni sekundarni opazovani dogodek so bolnike ocenili tudi z Orodjem za ocenjevanje ovrednotene resnosti (v nadaljevanju SWAT - Severity Weighted Assessment Tool), ki je temeljil na oceni vseh poškodb.
For dose modification information in case of skin reactions, see section 4.2. 
Za informacijo o prilagajanju odmerka v primeru reakcij na koži glejte poglavje 4.2.
The CAILS score was adjusted by removal of the pigmentation score and simplification of the plaque elevation scale. 
Ocena po CAILS je bila prilagojena z odstranitvijo ocene za pigmentacijo in poenostavitvijo lestvice za povečanje števila plakov.
Complete Response (CR) Partial Response (PR) 
Popolni odziv (PO) Delni odziv (PR)
o Instruction on how to accurately use, open and dispose a plastic bag should be printed on the plastic bag. 
o navodila o pravilni uporabi, odpiranju in odstranjevanju plastične vrečke morajo biti natisnjena na plastični vrečki.
Rinse the affected area right away for at least 15 minutes with large amounts of water, and seek medical assistance as soon as possible. 
Takoj si vsaj 15 minut izpirajte prizadeti del z velikimi količinami vode in čim prej poiščite zdravniško pomoč.
- Caregivers must wear disposable nitrile gloves when applying this medicine to patients (this is a special type of glove; ask your doctor or pharmacist if you have questions). 
- Negovalci morajo pri nanašanju zdravila Ledaga bolnikom nositi nitrilne rokavice za enkratno uporabo (to so rokavice posebne vrste; če imate vprašanja, se posvetujte z zdravnikom ali farmacevtom).
Chlormethine is a bifunctional alkylating agent that inhibits rapidly proliferating cells. 
Klormetin je difunkcionalna alkilirajoča učinkovina, ki zavira hitro deleče se celice.
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). 
Dermalna uporaba klormetina pri miših v odmerku 15 mg/kg do 33 tednov je povzročila kožne tumorje (karcinome skvamoznih celic in kožne papilome).
Ledaga N=90 
Zdravilo Ledaga N = 90
Remove and wash contaminated clothing. 
Onesnažena oblačila je treba odstraniti in oprati.
Upon improvement, treatment with Ledaga can be restarted at a reduced frequency of once every 3 days. 
Ko se stanje izboljša, se lahko zdravljenje z zdravilom Ledaga nadaljuje z manjšo pogostnostjo, enkrat vsake 3 dni.
Other findings in animals included embryo-lethality and growth retardation when administered as a single injection. 
Ostale ugotovitve pri živalih so vključevale smrtnost zarodkov in upočasnitev rasti pri dajanju v obliki enkratne injekcije.
The relevance to humans receiving topical chlormethine is unknown. 
Pomen tega za ljudi, ki prejemajo lokalni klormetin, ni znan.
A complete response was defined as a confirmed CAILS score of 0. 
Popolni odziv je bil opredeljen kot potrjena ocena 0 po CAILS.
What Ledaga is and what it is used for What you need to know before you use Ledaga How to use Ledaga 
Kaj je zdravilo Ledaga in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ledaga Kako uporabljati zdravilo Ledaga
For storage conditions after defrosting Ledaga, see section 6.3. 
Za pogoje shranjevanja po odmrzovanju zdravila Ledaga glejte poglavje 6.3.
Ledaga has no or negligible influence on the ability to drive or use machines. 
Zdravilo Ledaga nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Do not apply the medicine near the eyes, to the inside of the nostrils, the inside of the ear or on the lips. 
Zdravila ne nanašajte v bližini oči, v nosnicah, v ušesu ali na ustnice.
A response was defined as an at least 50% improvement in the baseline CAILS score, confirmed at a subsequent visit at least 4 weeks later. 
Odziv je bil opredeljen kot vsaj 50-% izboljšanje glede na izhodiščno oceno po CAILS, potrjeno ob naknadnem obisku po vsaj 4 tednih.
This medicine is not expected to have any effect on your ability to drive or to use machines. 
Ni pričakovati, da bo to zdravilo imelo kakršen koli vpliv na sposobnost upravljanja vozil in strojev.
The primary efficacy endpoint in Study 201 was the Composite Assessment of Index Lesion Severity (CAILS) response rate. 
Primarni opazovani dogodek učinkovitosti v študiji 201 je bila stopnja odziva po Sestavljeni oceni indeksa resnosti poškodb (v nadaljevanju CAILS - Composite Assessment of Index Lesion Severity).
Blindness and severe irreversible anterior eye injury may occur. 
Pride lahko do slepote in nepovratnih poškodb sprednjega dela očesa.
Patients should be monitored for development of skin cancers during and after discontinuation of treatment with chlormethine. 
Bolnike je treba spremljati glede razvoja kožnega raka med zdravljenjem s klormetinom in po njem.
Frequencies were defined 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). 
Pogostnost je bila opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000),
Ledaga is for use in adults only. 
Zdravilo Ledaga se uporablja samo pri odraslih.
Within each frequency grouping, adverse reactions are presented in order of decreasing severity. 
V vsaki skupini pogostnosti so neželeni učinki navedeni po padajočem vrstnem redu resnosti.
Other medicines and Ledaga 
Druga zdravila in zdravilo Ledaga
• The active substance is chlormethine. 
• Učinkovina je klormetin.
Contents of the pack and other information What Ledaga contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ledaga
It is unknown whether chlormethine is excreted in human milk. 
Ni znano, ali se klormetin izloča v materino mleko.
Table 1 CAILS and SWAT-confirmed response rates by 12 months in Study 201 (efficacy evaluable population) 
Stopnje odziva, potrjene s CAILS in SWAT za dvanajst mesecev v študiji 201 (populacija EE)
A decision must be made whether to discontinue breast-feeding or to discontinue Ledaga therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the breastfeeding mother. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z zdravilom Ledaga, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za doječo mater.
Chlormethine caused foetal malformations in mice and rats when given as single injections of 1-2.5 mg/kg. 
Klormetin je povzročil malformacije plodov pri miših in podganah, ki so prejele enkratno injekcijo z odmerkom 1-2,5 mg/kg.
Unused refrigerated Ledaga should be discarded after 60 days, together with the plastic bag. 
Neuporabljeno zdravilo Ledaga je treba po 60 dneh zavreči, skupaj s plastično vrečko.
It attaches to the DNA of dividing cells, like cancer cells, which stops them from multiplying and growing. 
Pritrdi se na DNK delečih se celic, kot so rakave celice, zaradi česar se ne morejo več deliti in razraščati.
Patients were stratified based on stage (IA vs IB and IIA) and then randomised to receive either Ledaga (equivalent to 0.02% chlormethine HCl) or the comparator (a petroleum-based 0.02% chlormethine HCl ointment). 
Bolniki so bili razdeljeni po stopnjah (IA v primerjavi z IB in IIA) in nato randomizirani za prejemanje zdravila Ledaga (enakovrednega 0,02 % klormetinijevega klorida) ali primerjalnega zdravila (mazila z 0,02 % klormetinijevega klorida na osnovi nafte).
Hypersensitivity to chlormethine or to any of the excipients listed in section 6.1. 
Preobčutljivost na klormetin ali katero koli pomožno snov, navedeno v poglavju 6.1.
After defrosting 60 days in the refrigerator (+2 °C to +8 °C). 
Po odmrznjenju 60 dni v hladilniku (od +2 °C do +8 °C).
Skin-directed therapies for MF-type CTCL have been associated with secondary skin cancers, although the specific contribution of chlormethine has not been established. 
Zdravljenja CTLC vrste MF na koži so povezana s sekundarnimi oblikami kožnega raka, čeprav specifični prispevek klormetina k temu še ni bil dokazan.
Get medical help right away if Ledaga gets into your eyes, mouth, or nose. 
Takoj poiščite zdravniško pomoč, če zdravilo Ledaga dobite v oči, usta ali nos.
Ledaga is a clear, colourless gel. 
Zdravilo Ledaga je bister brezbarvni gel.
Treatment with Ledaga should be initiated by an appropriately experienced physician. 
Zdravljenje z zdravilom Ledaga sme uvesti zdravnik z ustreznimi izkušnjami.
Non-inferiority was considered to have been demonstrated if the lower bound of the 95% confidence interval around the ratio of response rates (Ledaga/comparator) was greater than or equal to 0.75. 
Neinferiornost zdravljenja je bila opredeljena kot dokazana, če je bila spodnja meja 95-% intervala zaupanja po razmerju stopenj odziva (zdravilo Ledaga/primerjalno zdravilo) 0,75 ali več.
Chlormethine was shown to be genotoxic in bacterial, plant, and mammalian cells. 
Ugotovljena je bila genotoksičnost klormetina za bakterijske, rastlinske in sesalske celice.
Each tube contains 10.5 grams of propylene glycol and 6 micrograms of butylhydroxytoluene. 
Ena tuba vsebuje 10,5 gramov propilenglikola in 6 mikrogramov butilhidroksitoluena.
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. 
o Plastične vrečke ni dovoljeno uporabljati za druge namene in jo je treba po 60 dneh zavreči, skupaj z neuporabljenim zdravilom Ledaga, shranjenim v hladilniku, in vsakršnim drugim odpadnim materialom, vključno z nitrilnimi rokavicami, v skladu z lokalnimi predpisi.
Caregivers should remove gloves carefully (turning them inside out during the removal to avoid contact with Ledaga) and wash hands thoroughly with soap and water after removal of gloves. 
Negovalci morajo rokavice sneti previdno (tako da jih med odstranjevanjem obrnejo navzven, da se izognejo stiku z zdravilom Ledaga) in si po odstranitvi rokavic roke dobro umiti z milom in vodo.
• Ledaga should be applied to completely dry skin at least 4 hours before or 30 minutes after showering or washing. 
• Zdravilo Ledaga je treba nanesti na povsem suho kožo vsaj 4 ure pred ali 30 minut po tuširanju ali umivanju.
Contact with mucous membranes, especially those of the eyes, must be avoided. 
Stiku s sluznicami, zlasti očesnimi, se je treba izogniti.
- If this medicine gets in your mouth or nose, it can cause pain, redness, and ulcers that may be severe. 
- Če dobite to zdravilo v usta ali nos, lahko povzroči bolečino, pordelost in razjede, ki so lahko hude.