natgillin/translations-raw huggingface dataset:
Melovem alone will not provide adequate pain relief during the dehorning procedure. 
Ako se primjenjuje sam, Melovem neće dovoljno smanjiti bolove za vrijeme postupka odrožnjavanja.
150 mg A clear yellow solution. 
150 mg Bistra žuta otopina.
In the case of overdosage symptomatic treatment should be initiated. 
U slučaju predoziranja potrebno je započeti simptomatsko liječenje.
MANUFACTURER'S BATCH NUMBER Lot: {number} 
BROJ PROIZVODNE SERIJE Lot: {broj}
People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAID) should avoid contact with the veterinary medicinal product. 
Osobe preosjetljive na nesteroidne protuupalne lijekove (NSAID) moraju izbjegavati doticaj s ovim veterinarsko-medicinskim proizvodom.
Meglumine Water for injection 
Meglumin Voda za injekcije
When treating groups of animals, use a draw-off needle to avoid excessive broaching of the stopper. 
Kad liječite skupinu životinja, koristite iglu za izvlačenje tekućine iz spremnika da biste izbjegli prekomjerno probadanje čepa.
Do not use this veterinary medicinal product after the expiry date (EXP) stated on the carton and bottle. 
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i bočici poslije EXP.
Benzyl alcohol Hydrochloric acid Sodium chloride Macrogol 400 
Benzil alkohol Kloridna kiselina Natrijev hidroksid Macrogol 400
Comparatively low concentrations are detectable in skeletal muscle and fat. 
Relativno niske koncentracije mogu se naći u poprečno-prugastim mišićima (skeletni mišići) i masnom tkivu.
EXPIRY DATE EXP {month/year} Once broached use by… 
ROK VALJANOSTI EXP {mjesec/godina} Jednom otvoren upotrijebiti do…
To obtain the best possible pain relieving effect post surgery Melovem should be administered 30 minutes before surgical intervention. 
Da bi se poslije operacije postigao najbolji učinak u olakšavanju bolova, Melovem treba primijeniti 30 minuta prije kirurškog zahvata.
4.2 Indications for use, specifying the target species 
4.2 Indikacije za primjenu, navesti ciljne vrste životinja Goveda:
Cattle: SC or IV 
Goveda: s.c. ili i.v.
Hydrochloric acid/sodium hydroxide Macrogol 1500 
Hidroklorna kiselina/natrijev hidroksid Makrogol 1500
Benzyl alcohol 20 mg 
Benzil alkohol 20 mg
In pigs, after intramuscular administration, the mean plasma biological elimination half-life is approximately 2.5 hours. 
U svinja, nakon intramuskularne primjene, prosječni poluživot uklanjanja iz plazme iznosi približno
Bovine, caprine 
Goveda, Koze
Hydrochloric acid/sodium hydroxide Macrogol 300 
Hidroklorna kiselina/natrijev hidroksid Makrogol 300
Treatment of piglets with Melovem before castration reduces post operative pain. 
Primjena Melovema u prasadi prije kastracije smanjuje bol poslije zahvata.
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 nesteroidni protuupalni lijek (NSAID) iz skupine oksikama koji djeluje kočenjem sinteze prostaglandina, čime se postižu protuupalna, antieksudativna, analgetička i antipiretička svojstva.
Transient swelling at the injection site was observed in clinical studies following intramuscular administration in pigs. 
Prolazno oticanje na mjestu uboda opaženo je u kliničkim ispitivanjima nakon intramuskularne primjene u svinja.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Glass vial 100 ml and 250 ml 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Staklena bočica 100 ml i 250 ml
Cardboard box with 1 colourless glass injection vial of 50 ml, 100 ml or 250 ml. 
15. OSTALE INFORMACIJE Kartonska kutija sadrži 1 bezbojnu staklenu bočicu od 50 ml, 100 ml ili 250 ml.
Treatment of calves with Melovem 20 minutes before dehorning reduces post-operative pain. 
Primjena Melovema u goveda 20 minuta prije odrožnjavanja smanjuje bol poslije kirurškog zahvata.
SPECIAL STORAGE CONDITIONS Keep the injection vial in the outer carton in order to protect from light. 
11. POSEBNI UVJETI ČUVANJA Držati bočicu u vanjskom kartonu radi zaštite od svjetla.
Clear, greenish yellow solution. 
Jasno, zelenkasto žuta otopina.
TARGET SPECIES Cattle and pigs 
CILJNE VRSTE ŽIVOTINJA Goveda i svinje
Meat and offal: 15 days Milk: 
Meso i jestive iznutrice: 15 dana Mlijeko:
After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs. 
Nakon dvije intramuskularne doze od 0,4 mg meloksikama/kg, vrijednost Cmax od 1,9 μg/ml dosegnuta je u svinja nakon 1 sata.
TARGET SPECIES Cattle (calves and young cattle) and pigs 
CILJNE VRSTE ŽIVOTINJA Goveda (telad i junad) i svinje
Cattle: Subcutaneous or intravenous use Pigs: Intramuscular use Horses: Intravenous use Read the package leaflet before use. 
Goveda: Potkožno ili intravenski Svinje: Intramuskularno Konji: Intravenski
Transient swelling at the injection site was commonly reported in clinical studies following subcutaneous administration in cattle. 
Prolazno oticanje na mjestu uboda opaženo je u kliničkim ispitivanjima nakon subkutane primjene u stoke.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, If APPLICABLE 
13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVETI ILI OGRANIČENJA U
ROUTE(S) OF ADMINISTRATION Cattle: SC or IV 
PUT(EVI) PRIMJENE Goveda: s.c. ili i.v.
Meloxicam 30 mg 
Meloksikam 30 mg
ROUTE(S) OF ADMINISTRATION Cattle: SC 
PUT(EVI) PRIMJENE Goveda: s.c.
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml and 2.7 μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively. 
Nakon jedne subkutane doze od 0,5 mg meloksikama/kg, vrijednosti Cmax od 2,1 μg/ml postignute su nakon 7,7 sati u junadi, a od 2,7 μg/ml nakon 4 sata u krava u razdoblju laktacije.
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively. 
Nakon subkutane injekcije, poluživot izlučivanja meloksikama iznosi 26 sati u junadi, a 17,5 sati u krava u razdoblju laktacije.
Cardboard box with 1 colourless, type I glass injection vial of 50 ml, 100 ml and 250 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap. 
Kartonska kutija sadrži 1 bezbojnu staklenu bočicu, tip I, od 50 ml, 100 ml ili 250 ml, zatvorenu gumenim bromobutil čepom i zapečaćenu aluminijskom kapicom.
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight). 
Jedna intravenska injekcija u dozi od 0,6 mg meloksikama/kg tjelesne mase (tj. 3,0 ml/100 kg tjelesne mase).
Overdose (symptoms, emergency procedures, antidotes): In the case of overdosage, symptomatic treatment should be initiated. 
Predoziranje (simptomi, hitni postupci, antidoti)
WITHDRAWAL PERIOD Cattle: 
INDIKACIJE Goveda:
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) 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) 
Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja)
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. 
U goveda i svinja dobro podnosi subkutana i intramuskularna primjena; samo lagano prolazno oticanje na mjestu uboda nakon subkutane primjene opaženo je u manje od 10% goveda liječenih u sklopu kliničkih ispitivanja.
4941 VX Raamsdonksveer THE NETHERLANDS 
4941 VX Raamsdonksveer Nizozemska
Cattle: meat and offal: 15 days; milk: 5 days Pigs, horses: meat and offal: 5 days 
Goveda: meso i jestive iznutrice: 15 dana; mlijeko: 5 dana Svinje, konji: meso i jestive iznutrice: 5 dana Nije odobrena primjena u konja koji proizvode mlijeko za ljudsku uporabu.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Dopharma Research B.V. 
15. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Dopharma Research B.V.
Meloxicam 5 mg 
Djelatna tvar: Meloksikam 5 mg
Manufacturer responsible for batch release: Dopharma B.V. 
Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet: Dopharma B.V.
Cardboard box with 1 colourless type I glass injection vial of 100 ml, which is closed with a bromobutyl rubber stopper and sealed with an aluminium cap. 
Kartonska kutija sadrži 1 bezbojnu staklenu bočicu od 100 ml, zatvorenu gumenim bromobutl čepom i osiguranih aluminijskom kapicom.
Meat and offal: 5 days 
Meso i jestive iznutrice: 5 dana
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). 
- rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
For animal treatment only.To be supplied only on veterinary prescription. 
Veterinarsko-medicinski proizvod se izdaje na veterinarski recept.
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) 
- rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve)
MARKETING AUTHORISATION HOLDER Dopharma Research B.V. 
NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET Dopharma Research B.V.
PACKAGE LEAFLET FOR: Melovem 5 mg/ml solution for injection for cattle and pigs 
UPUTA O VMP ZA: Melovem 5 mg/ml otopina za injekcije za goveda i svinje
Manufacturer responsible for the batch release Dopharma B.V. 
Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet Dopharma B.V.
Pigs: Meat and offal: 5 days 
Svinje: meso i jestive iznutrice: 5 dana
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 20 mg/ml solution for injection for cattle, pigs and horses 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Melovem 20 mg/ml otopina za injekcije za goveda, svinje i konje
STATEMENT OF ACTIVE SUBSTANCE Meloxicam 5 mg/ml 
Meloksikam 5 mg/ml
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/006 (100 ml) 
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/098/006 (100 ml)
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 20 mg/ml solution for injection for cattle, pigs and horses Meloxicam 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Melovem 20 mg/ml otopina za injekcije za goveda, svinje i konje Meloksikam
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Meloxicam 30 mg/ml 
I DRUGIH TVARI Meloksikam 30 mg/ml
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. 
U goveda i svinja dobro se podnosi subkutana, intramuskularna a također i intravenska primjena; samo lagano prolazno oticanje na mjestu uboda nakon subkutane primjene opaženo je u manje od 10%
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/005 (50 ml) 
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/098/005 (50 ml)
250 ml 
150 mg
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Meloxicam 20 mg/ml 
I DRUGIH TVARI Meloksikam 20 mg/ml
PACKAGE LEAFLET FOR Melovem 20 mg/ml solution for injection for cattle, pigs and horses 
UPUTA O VMP ZA: Melovem 20 mg/ml otopina za injekcije za goveda, svinje i konje
OTHER INFORMATION 
Nema podataka
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 30 mg/ml solution for injection for cattle and pigs 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Melovem 30 mg/ml otopina za injekcije za goveda i svinje
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 5 mg/ml solution for injection for cattle and pigs 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Melovem 5 mg/ml otopina za injekcije za goveda i svinje
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/003 (100 ml) 
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/098/003 (100 ml)
Meat and offal: 15 days. 
Meso i jestive iznutrice: 15 dana.
Do not use in pregnant or lactating mares. 
Ne primjenjivati u kobila za vrijeme graviditeta ili laktacije.
Not permitted for use in lactating animals producing milk for human consumption. 
Nije odobrena primjena na životinjama u laktaciji koje proizvode mlijeko za ljudsku uporabu.
NO ENTRY Antiinflammatory agents/ Nonsteroidal antiinflammatory agents 
Protuupalna sredstva/neste roidna protuupalna sredstva
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 5 mg/ml solution for injection for cattle and pigs Meloxicam 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Melovem 5 mg/ml otopina za injekcije za goveda i svinje Meloksikam
Elimination Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle. 
Nakon subkutane injekcije u junadi, poluživot izlučivanja meloksikama iznosi 26 sati.
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/002 (50 ml) 
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/098/002 (50 ml)
NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 30 mg/ml solution for injection for cattle and pigs Meloxicam 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Melovem 30 mg/ml otopina za injekcije za goveda i svinje Meloksikam
PACKAGE LEAFLET FOR Melovem 30 mg/ml solution for injection for cattle and pigs 
UPUTA O VMP ZA: Melovem 30 mg/ml otopina za injekcije za goveda i svinje
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/098/001
Pigs: Meat and offal: 5 days. 
Svinje: meso i jestive iznutrice: 5 dana.
Pigs: meat and offal: 5 days. 
Svinje: Meso i jestive iznutrice: 5 dana.
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. 
Jedna subkutana injekcija u dozi od 0,5 mg meloksikama/kg tjelesne težine (tj. 10,0 ml/100 kg tjelesne težine) u kombinaciji s antibiotskom terapijom ili oralnom rehidracijskom terapijom, kako je odgovarajuće.
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate. 
Svinje: Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne mase (tj. 2,0 ml/100 kg tjelesne mase) u kombinaciji s antibiotskom terapijom, kako je odgovarajuće.
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/150 kg body weight) in combination with antibiotic therapy, as appropriate. 
Svinje: Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne mase (tj. 2,0 ml/150 kg tjelesne mase) u kombinaciji s antibiotskom terapijom, kako je odgovarajuće.
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/002 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/098/002
MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/005 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/098/005
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate. 
Jedna subkutana ili intravenska injekcija u dozi od 0,5 mg meloksikama/kg tjelesne mase (tj. 2,5 ml/100 kg tjelesne mase) u kombinaciji s antibiotskom terapijom ili oralnom rehidracijskom terapijom, kako je odgovarajuće.
Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/150 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate. 
Jedna subkutana injekcija u dozi od 0,5 mg meloksikama/kg tjelesne mase (tj. 2,5 ml/150 kg tjelesne mase) u kombinaciji s antibiotskom terapijom ili oralnom rehidracijskom terapijom, kako je odgovarajuće.
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml were reached after 7.7 hours in young cattle. 
U junadi, nakon jedne subkutane doze od 0,5 mg meloksikama/kg, vrijednost Cmax od 2,1 µg/ml postignuta je za 7,7 sati.
Equidae 
konji (Equidae)
Date of first authorisation: 3 March 2017 
Datum prvog odobrenja: 3. ožujka 2017
- Contact with your eyes must be avoided. 
- Mora se izbjegavati kontakt s očima.
The response criteria were the same as for CAILS. 
Kriteriji odgovora bili su isti kao i za CAILS.
Response rates (%) 
Stope odgovora (%)
Ratio 95% CI 
Omjer 95 % CI
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. 
Nemojte davati ovaj lijek djeci i adolescentima mlađima od 18 godina jer sigurnost i djelotvornost za ovu dobnu skupinu nisu još ustanovljene.
Cutaneous hypersensitivity reactions were reported in 2.3% of the treated patients. 
Kutane reakcije preosjetljivosti zabilježene su u 2,3 % liječenih bolesnika.
The safety and efficacy of Ledaga in children aged 0 to 18 years have not been established. 
Sigurnost i djelotvornost gela Ledaga u djece u dobi od 0 do 18 godina nisu još ustanovljene.
The safety profile observed in elderly patients was consistent with that in the overall patient population. 
Sigurnosni profil uočen u starijih bolesnika odgovarao je onom u ukupnoj populaciji bolesnika.
Your doctor may restart the treatment upon improvement of your symptoms. 
Vaš liječnik može ponovo započeti liječenje nakon što dođe do poboljšanja simptoma.
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. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
Ask your pharmacist how to throw away used nitrile gloves, the plastic bag and the medicine you no longer use. 
Pitajte svog ljekarnika kako baciti korištene nitrilne rukavice, plastičnu vrećicu i lijek koji više ne koristite.
• The opening of the tube is covered with a foil safety seal. 
• Otvor tube pokriven je sigurnosnom pokrovnom folijom.
Ledaga is for use in adults only. 
Ledaga se koristi samo u odraslih.
What Ledaga is and what it is used for 
Što je Ledaga i za što se koristi
Do not apply Ledaga more than once per day. 
Nemojte primjenjivati gel Ledaga češće od jednom na dan.
- Tell your doctor if you have ever had an allergic reaction to chlormethine. 
- Obavijestite svog liječnika jeste li ikada imali alergijsku reakciju na klormetin.
Other medicines and Ledaga 
Drugi lijekovi i Ledaga
A small number of subjects (6.3%, 8/128) treated with Ledaga utilised topical corticosteroids. 
Mali broj ispitanika (6,3 %, 8/128) liječenih gelom Ledaga koristio je topikalne kortikosteroide.
If you use Ledaga more than you should 
Ako primijenite više gela Ledaga nego što ste trebali
Contents of the pack and other information What Ledaga contains 
Sadržaj pakiranja i druge informacije Što Ledaga sadrži
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). 
(≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
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%). 
U EE populaciji je postotak bolesnika koji su postigli potvrđen odgovor prema CAILS bio sličan za stadije IA (79,6 %) i IB-IIA (73,2 %).
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. 
Omjer odgovora i 95 %-tni interval pouzdanosti u ITT populaciji iznosio je 1,226 (0,974-1,552) za CAILS i 1,017 (0,783-1,321) za SWAT te je tako konzistentan s onim u EE populaciji za oba ukupna odgovora, CAILS i SWAT.
What Ledaga looks like and contents of the pack 
Kako Ledaga izgleda i sadržaj pakiranja
o Instruction on how to accurately use, open and dispose a plastic bag should be printed on the plastic bag. 
o Upute o tome kako točno upotrijebiti, otvoriti i zbrinuti plastičnu vrećicu trebaju biti otisnute na plastičnoj vrećici.
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 drugih sekundarnih mjera ishoda (odgovor u postotku zahvaćene površine tijela, vrijeme do prvog potvrđenog odgovora CAILS, trajanje prvog potvrđenog odgovora CAILS i vrijeme do progresije bolesti) bili su u skladu s onima za CAILS i SWAT.
In order to minimise and prevent the Important Identified Risk of “Toxicity to mucous membranes / eye” and the Important Potential Risk of “Secondary exposure to someone other than the patient”, the MAH shall ensure that, the following additional risk minimisation measures are fulfilled in each Member State (MS) where Ledaga is marketed: 
Kako bi se umanjio i spriječio važan identificirani rizik “toksičnost za sluznice / oči” te važan potencijalni rizik “sekundarna izloženost drugih osoba osim bolesnika”, nositelj odobrenja će osigurati da se u svakoj državi članici u kojoj će Ledaga biti stavljena tržište, ispune sljedeće dodatne mjere minimizacije rizika:
- if you are allergic (hypersensitive) to chlormethine or any of the other ingredients of this medicine (listed in section 6). 
- ako ste alergični (preosjetljivi) na klormetin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Do not use an opened or unopened tube of Ledaga after 60 days of storage in the refrigerator. 
Nemojte koristiti otvorenu ili neotvorenu tubu gela Ledaga nakon što je 60 dana čuvana u hladnjaku.
EXP Discard 60 days after defrosting: ../../.... 
EXP Baciti 60 dana nakon odmrzavanja: ../../....
Store and transport frozen. 
POSEBNE MJERE ČUVANJA Čuvati i prevoziti zamrznuto.
- 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). 
Njegovatelji moraju nositi jednokratne nitrilne rukavice pri nanošenju ovog lijeka bolesniku (to je posebna vrsta rukavica; ako imate kakvih pitanja, obratite se liječniku ili ljekarniku).
It attaches to the DNA of dividing cells, like cancer cells, which stops them from multiplying and growing. 
On se veže za DNK stanica koje se dijele, kao što su stanice raka, i tako sprječava njihovo umnožavanje i rast.
Tell your doctor if you get any new damaged areas or ulcers on your skin. 
Obavijestite svog liječnika ako Vam se pojave nova zahvaćena područja ili ulceracije na koži.
Ledaga contains alcohol and is therefore considered flammable. 
Ledaga sadrži alkohol te se stoga smatra zapaljivim.