natgillin/translations-raw huggingface dataset:
Rare aspartate aminotransferase increased, blood uric acid increased, liver function test abnormal, transaminases increased, blood alkaline phosphatase increased, platelet count increased, body temperature increased, hepatic enzyme increased, gamma-glutamyl transferase increased, 
povišena mokraćna kiselina u krvi, poremećeni testovi funkcije jetre, povišene transaminaze, povišena alkalna fosfataza u krvi, povećan broj trombocita, povišena tjelesna temperatura, povišeni jetreni enzimi, povišena gama-glutamil transferaza,
(≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000). 
rijetko (≥ 1/10 000 i < 1/1000).
Frequency categories are derived according to the following conventions: very common (≥ 1/10), common 
Kategorije učestalosti proizlaze iz sljedeće konvencije: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100),
Xydalba powder for concentrate for solution for infusion is provided in a 48 ml glass vial with a green flip off seal. 
Xydalba prašak za koncentrat za otopinu za infuziju dolazi u staklenoj bočici od 48 ml sa zelenim flip-off zatvaračem.
Following a single dose of 500 mg or 1,000 mg dalbavancin, the mean plasma clearance (CLT) was reduced 11 %, 35 %, and 47 % in subjects with mild (CLCR 50 - 79 ml/min), moderate (CLCR 30 - 49 ml/min), and severe (CLCR < 30 ml/min) renal impairment, respectively, compared to subjects with normal renal function. 
Nakon jednokratne doze od 500 mg ili 1000 mg dalbavancina, srednja vrijednost klirensa u plazmi (CLT) smanjena je 11 %, 35 %, i 47 % u ispitanika s blagim (CLCR 50 - 79 ml/min), umjerenim (CLCR 30 - 49 ml/min)
The most common adverse reactions occurring in ≥ 1 % of patients treated with dalbavancin were nausea (2.4 %), diarrhoea (1.9 %), and headache (1.3 %) and were generally of mild or moderate severity. 
(2,4 %), proljev (1,9 %) i glavobolja (1,3 %), te su uglavnom bile blage ili umjerene težine.
Antibacterial-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life threatening. 
Kolitis i pseudomembranozni kolitis povezani s antibakterijskim lijekovima prijavljeni su pri primjeni gotovo svih antibiotika te mogu varirati u težini od blagih do po život opasnih.
Xydalba contains sodium 
Xydalba sadrži natrij
• Viridans group streptococci (Streptococcus anginosus group only): Susceptible ≤ 0.125 mg/l; Resistant > 0.125 mg/l. 
• Viridans streptokoki (samo skupina Streptococcus anginosus): Osjetljiv ≤ 0,125 mg/l; Rezistentan > 0,125 mg/l.
is mediated by VanA, a genotype that results in modification of the target peptide in nascent cell wall. 
genotipom koji rezultira modifikacijom ciljnog peptida u nastajućoj staničnoj stijenci.
• The other ingredients are mannitol (E421), lactose monohydrate, hydrochloric acid and/or sodium hydroxide (for pH adjustment only). 
• Drugi sastojci su manitol (E421), laktoza hidrat, kloridna kiselina i/ili natrijev hidroksid (za podešavanje pH).
Before you are given this medicine, tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. 
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovaj lijek.
It is not known if Xydalba passes into breast milk in humans. 
Nije poznato prelazi li Xydalba u majčino mlijeko u ljudi.
Clinical drug-drug interaction studies with dalbavancin have not been conducted. 
Nisu provedena klinička ispitivanja interakcija lijekova s dalbavancinom.
Mixed infections 
Mješovite infekcije
The content of each vial must be reconstituted by slowly adding 25 ml of water for injections. 
Sadržaj jedne bočice mora se rekonstituirati polaganim dodavanjem 25 ml vode za injekcije.
Dalbavancin is not metabolised by CYP enzymes in vitro, therefore co-administered CYP inducers or inhibitors are unlikely to influence the pharmacokinetics of dalbavancin. 
Dalbavancin se ne metabolizira putem enzima CYP in vitro, stoga nije vjerojatno da istodobna primjena s induktorima ili inhibitorima CYP utječe na farmakokinetiku dalbavancina.
• Beta-haemolytic streptococci of Groups A, B, C, G: Susceptible ≤ 0.125 mg/l; Resistant > 0.125 mg/l, 
• Beta-hemolitički streptokoki skupine A, B, C, G: Osjetljiv ≤ 0,125 mg/l; Rezistentan > 0,125 mg/l,
A total of 10 paediatric patients with ages 12 to 16 years who had resolving infections were given single doses of either dalbavancin 1,000 mg (body weight ≥ 60 kg) or dalbavancin 15 mg/kg (body weight < 60 kg). 
Ukupno je 10 pedijatrijskih bolesnika u dobi od 12 do 16 godina s infekcijama u izlječenju, primilo jednokratnu dozu dalbavancina od 1000 mg (tjelesna težina ≥ 60 kg) ili dozu dalbavancina od 15 mg/kg (tjelesna težina < 60 kg).
Infection of the bowel has been reported as an uncommon side effect. 
Infekcija crijeva zabilježena je kao manje česta nuspojava.
Bactericidal activity against staphylococci in vitro is time-dependent at serum concentrations of dalbavancin similar to those obtained at the recommended dose in humans. 
Odnos farmakokinetika/farmakodinamika (PK/PD) Baktericidna aktivnost protiv stafilokoka in vitro ovisna je o vremenu pri serumskim koncentracijama dalbavancina sličnim onima dobivenim pri preporučenim dozama u ljudi.
Clostridioides (formerly Clostridium) difficile-associated diarrhoea 
Clostridioides (ranije Clostridium) difficile, oralna kandidijaza
In Phase 3 studies, patients have been administered single doses of up to 1,500 mg. 
ispitivanjima faze 3 bolesnici su primili jednokratne doze do 1500 mg.
Single-use 48 ml type I glass vial with an elastomeric stopper and a green flip off seal. 
I od 48 ml za jednokratnu uporabu, s elastomernim čepom i zelenim flip-off zatvaračem.
Koprska ulica 108 A SI-1000 Ljubljana Tel: +386 1 544 65 79 info@angelini.si 
Angelini Pharma d.o.o. Koprska ulica 108 A SI-1000 Ljubljana Tel: +386 1 544 65 79 info@angelini.si
Dalbavancin Plasma Concentrations versus time in a typical ABSSSI patient (simulation using population pharmacokinetic model) for both the single and the two-dose regimens. 
Slika 1. Koncentracije dalbavancina u plazmi u odnosu na vrijeme u tipičnog bolesnika s bakterijskom infekcijom kože i kožnih struktura (simulacija korištenjem populacijskog farmakokinetičkog modela) za režim jednokratnog doziranja i režim doziranja u dvije doze.
Xydalba may cause dizziness. 
Xydalba može uzrokovati omaglicu.
Adverse reactions are classified according to System Organ Class and frequency. 
Nuspojave su klasificirane prema klasifikaciji organskih sustava i učestalosti.
Description of selected adverse reactions 
Opis odabranih nuspojava Nuspojave skupine lijekova
In the major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only. 
U glavnim ispitivanjima akutnih bakterijskih infekcija kože i kožnih struktura, vrste liječenih infekcija bile su ograničene samo na celulitis/erizipel, apscese i infekcije rana.
In patients with chronic renal impairment whose creatinine clearance is < 30 ml/min and who are not receiving regularly scheduled haemodialysis, the recommended dose is reduced to either 1,000 mg administered as a single infusion or 750 mg followed one week later by 375 mg (see section 5.2). 
U bolesnika s kroničnim oštećenjem bubrega čiji je klirens kreatinina < 30 ml/min i koji se redovito ne podvrgavaju hemodijalizi, preporučena doza se smanjuje na 1000 mg dalbavancina u obliku jednokratne infuzije ili 750 mg nakon koje tjedan dana kasnije slijedi doza od 375 mg (vidjeti dio 5.2).
Skin and subcutaneous tissue disorders pruritus, urticaria, rash 
Poremećaji kože i potkožnog tkiva pruritus, urtikarija, osip
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
Dose-dependent toxicity included serum chemistry and histological evidence of renal and hepatic injury, reduced red blood cell parameters and injection site irritation. 
Toksičnost ovisna o dozi uključila je dokaze biokemijske pretrage seruma i histološke dokaze bubrežnog i jetrenog oštećenja, smanjene parametre eritrocita i nadražaj na mjestu primjene.
The experience with dalbavancin in elderly is limited: 276 patients ≥ 75 years of age were included in the Phase 2/3 clinical studies, of which 173 received dalbavancin. 
≥ 75 godina bilo je uključeno u klinička ispitivanja faze 2/3, od kojih je 173 primilo dalbavancin.
Efficacy has been demonstrated in clinical studies against the pathogens listed for ABSSSI that were susceptible to dalbavancin in vitro: 
Djelotvornost je dokazana u kliničkim ispitivanjima protiv patogena navedenih za akutne bakterijske infekcije kože i kožnih struktura koji su bili osjetljivi na dalbavancin in vitro:
The vial contains white to off-white to pale yellow powder. 
Bočica sadrži prašak bijele ili gotovo bijele do blijedo žute boje.
In Phase 2 / 3 clinical studies, 2,473 patients received dalbavancin administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg. 
U kliničkim ispitivanjima faze 2/3, 2473 bolesnika su primila dalbavancin u obliku jednokratne infuzije od 1500 mg ili kao 1000 mg nakon čega je tjedan dana kasnije slijedila doza od 500 mg.
• Inflammation and swelling of surface veins, flushing 
• Upala i otjecanje površinskih vena, navale crvenila
After reconstitution each ml contains 20 mg dalbavancin. 
Nakon rekonstitucije jedan ml sadrži 20 mg dalbavancina.
Clinically significant gender-related differences in dalbavancin pharmacokinetics have not been observed in healthy subjects or in patients with infections. 
Spol Nisu uočene klinički značajne razlike povezane sa spolom u farmakokinetici dalbavancina u zdravih ispitanika ili bolesnika s infekcijom.
Sodium chloride containing solutions can cause precipitation and should NOT be used for reconstitution or dilution. 
Otopine koje sadrže natrijev klorid mogu uzrokovati taloženje i NE SMIJU se koristiti za rekonstituciju ili razrjeđivanje.
Mean plasma exposures for dalbavancin, based on AUCinf (17,495 µg•h/ml and 16,248 µg •h/ml) and Cmax (212 µg/ml and 191 µg/ml) were similar when administered as 1,000 mg to paediatric subjects (12-16 years) weighing > 60 kg (61.9 - 105.2 kg) or as 15 mg/kg to paediatric subjects weighing < 60 kg (47.9-58.9 kg). 
248 µg •h/ml) i Cmax (212 µg/ml i 191 µg/ml) bile su slične kad je primijenjeno 1000 mg u pedijatrijskih ispitanika (12-16 godina) težine > 60 kg (61,9 - 105,2 kg) i kad je primijenjeno 15 mg/kg u pedijatrijskih ispitanika težine < 60 kg (47,9-58,9 kg).
Intravenous use after reconstitution and dilution. 
Za intravensku primjenu nakon rekonstitucije i razrjeđivanja.
Nervous system disorders headache dysgeusia, dizziness 
Poremećaji živčanog sustava glavobolja disgeuzija, omaglica
General disorders and administration site conditions infusion-related reactions 
Opći poremećaji i reakcije na mjestu primjene reakcije povezane s infuzijom
constipation, abdominal pain, dyspepsia, abdominal discomfort, vomiting 
konstipacija, bol u abdomenu, dispepsija, nelagoda u abdomenu, povraćanje
This has been reported as a side effect with a similar medicine. 
• Promjene sluha zabilježene su kao nuspojava sličnog lijeka.
Estimated pharmacokinetic parameters of dalbavancin following the two-dose regimen and the single-dose regimen, respectively, are shown in Table 2 below. 
Procijenjeni farmakokinetički parametri dalbavancina nakon dvokratne i jednokratne primjene doza prikazani su u Tablici 2. u nastavku.
The reconstituted concentrate in the vial contains 20 mg/ml dalbavancin. 
Rekonstituirani koncentrat u bočici sadrži 20 mg/ml dalbavancina.
It is unknown whether dalbavancin is excreted in human milk. 
Nije poznato izlučuje li se dalbavancin u majčino mlijeko u ljudi.
For dosing instructions in subjects with hepatic impairment refer to section 4.2. 
Za upute o doziranju u ispitanika s oštećenjem bubrega vidjeti dio 4.2.
Resistance to dalbavancin in Staphylococcus spp. 
Rezistencija na dalbavancin kod Staphylococcus spp. i Enterococcus spp. posredovana je s VanA,
Do not use this medicine after the expiry date which is stated on the vial after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici iza oznake „Rok valjanosti“.
To dilute the reconstituted concentrate, the appropriate volume of the 20 mg / ml concentrate must be transferred from the vial to an intravenous bag or bottle containing 50 mg/ml (5 %) glucose solution for infusion. 
Za razrjedivanje rekonstituiranog koncentrata, odgovarajući volumen koncentrata od 20 mg/ml mora se iz bočice prebaciti u vrećicu ili bocu za intravensku infuziju koja sadrži 5%-tnu (50 mg/ml) otopinu glukoze za infuziju.
It is not known if dalbavancin is a substrate for hepatic uptake and efflux transporters. 
Nije poznato je li dalbavancin supstrat jetrenih transportera unosa i efluksa.
: Susceptible ≤ 0.125 mg/l; Resistant > 0.125 mg/l, 
• Staphylococcus spp.: Osjetljiv ≤ 0,125 mg/l; Rezistentan > 0,125 mg/l,
Ototoxicity has been associated with glycopeptide use (vancomycin and teicoplanin); patients who are receiving concomitant therapy with an ototoxic medicinal product, such as an aminoglycoside, may be at increased risk. 
Bolesnici koji primaju istodobnu terapiju ototoksičnim lijekom, kao što je aminoglikozid, mogu biti pod povećanim rizikom.
Aseptic technique must be used for reconstitution and dilution of Xydalba. 
Za rekonstituciju i razrjeđivanje Xydalbe mora se koristiti aseptička tehnika.
Dalbavancin toxicity has been evaluated after daily intravenous administration for durations of up to 
Toksičnost dalbavancina procijenjena je nakon svakodnevne intravenske primjene u trajanju do 3 mjeseca kod štakora i pasa.
Xydalba must be reconstituted with sterile water for injections and subsequently diluted with 50 mg/ml (5 %) glucose solution for infusion. 
Xydalba se mora rekonstituirati sterilnom vodom za injekcije i nakon toga razrijediti 5%-tnom (50 mg/ml) otopinom glukoze za infuziju.
The dalbavancin plasma concentration-time following the two-dose and the single-dose regimens, respectively, are shown in Figure 1. 
Vrijeme dostignute koncentracije dalbavancina u plazmi nakon dvokratne i jednokratne doze prikazano je na Slici 1.
Recommended dose and duration of treatment for adults The recommended dose of dalbavancin in adult patients with ABSSSI is 1,500 mg administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg (see sections 5.1 and 5.2). 
Preporučena doza dalbavancina u odraslih bolesnika s akutnom bakterijskom infekcijom kože i kožnih struktura je ili 1500 mg u obliku jednokratne infuzije ili 1000 mg u infuziji nakon koje tjedan dana kasnije slijedi druga infuzija u dozi od 500 mg (vidjeti dijelove 5.1 i 5.2).
• Peptostreptococcus spp. 
• Clostridium perfringens, • Peptostreptococcus spp.
Xydalba is not recommended during pregnancy unless clearly necessary. 
Xydalba se ne preporučuje u trudnoći osim ako to nije neophodno, zbog toga što nije poznat učinak lijeka na nerođeno dijete.
Respiratory, thoracic and mediastinal disorders cough bronchospasm 
Poremećaji dišnog sustava, prsišta i sredoprsja kašalj bronhospazam
Single-dose regimen3 
Jednokratna doza3
Package leaflet: Information for the patient Xydalba 500 mg powder for concentrate for solution for infusion dalbavancin 
Uputa o lijeku: Informacija za bolesnika Xydalba 500 mg prašak za koncentrat za otopinu za infuziju dalbavancin
RO-București 050451 
Dr. Carol Davila, Nr. 9, Sector 5 RO-București 050451
The compatibility of reconstituted Xydalba concentrate has only been established with 50 mg/ml (5 %) glucose solution for infusion. 
Kompatibilnost rekonstituiranog koncentrata lijeka Xydalba ustanovljena je samo s 5%-tnom (50 mg/ml) otopinom glukoze za infuziju.
White to off-white to pale yellow powder. 
Prašak bijele ili gotovo bijele do blijedo žute boje.
Xydalba vials are for single-use only. 
Bočice s Xydalbom namijenjene su samo za jednokratnu uporabu.
A decision must be made whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Xydalba taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Potrebno je odlučiti da li nastaviti/prekinuti dojenje ili nastaviti/prekinuti liječenje lijekom
The mean AUC was unchanged in subjects with mild hepatic impairment compared to subjects with normal hepatic function; however, the mean AUC decreased by 28 % and 31 %, respectively, in subjects with moderate and severe hepatic impairment. 
Međutim, srednja vrijednost AUC smanjena je za 28 % kod ispitanika s umjerenim, odnosno 31 % kod ispitanika s teškim oštećenjem jetre.
Cross-resistance between dalbavancin and other classes of antibiotics was not seen in in vitro studies. 
Križna rezistencija između dalbavancina i drugih skupina antibiotika nije primijećena u in vitro ispitivanjima.Rezistencija na meticilin ne utječe na aktivnost dalbavancina.
Xydalba must be reconstituted and then further diluted prior to administration by intravenous infusion over a 30 - minute period. 
Intravenska primjena Xydalba se mora rekonstituirati i nakon toga razrijediti prije primjene intravenskom infuzijom tijekom
Tell your doctor or nurse immediately if you are concerned that you may have been given too much Xydalba. 
Odmah obavijestite svog liječnika ili medicinsku sestru ako ste zabrinuti da ste primili previše lijeka
In Phase 1 studies, healthy volunteers have been administered single doses of up to 1,500 mg, and cumulative doses up to 4,500 mg over a period of up to 8 weeks, with no signs of toxicity or laboratory results of clinical concern. 
U ispitivanjima faze 1, zdravi dobrovoljci primili su jednokratne doze do 1500 mg i kumulativne doze do 4500 mg tijekom razdoblja do
If particulate matter or discoloration is identified, the solution must be discarded. 
Ako otopina sadrži čestice ili promijeni boju, mora se baciti.
The reconstituted concentrate must be further diluted with 50 mg/ml (5 %) glucose solution for infusion. 
Rekonstituirani koncentrat mora se dodatno razrijediti 5 %-tnom (50 mg/ml) otopinom glukoze za infuziju.
For dosing instructions in subjects with renal impairment refer to section 4.2. 
Za upute o doziranju u ispitanika s oštećenjem jetre vidjeti dio 4.2.
Infections and infestations vulvovaginal mycotic infection, urinary tract infection, fungal infection, Clostridioides (formerly Clostridium) difficile colitis, oral candidiasis 
Infekcije i infestacije vulvovaginalna gljivična infekcija, infekcija mokraćnog trakta, gljivična infekcija, kolitis uzrokovan bakterijom
• Abdominal pain (stomach ache) and/or watery diarrhoea. 
• Bol u trbuhu i/ili vodenasti proljev.
Lactose monohydrate Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) 
6.1 Popis pomoćnih tvari manitol (E421) laktoza hidrat kloridna kiselina (za podešavanje pH ) natrijev hidroksid (za podešavanje pH )
Xydalba 500 mg powder for concentrate for solution for infusion 
Xydalba 500 mg prašak za koncentrat za otopinu za infuziju
Vascular disorders flushing, phlebitis 
Krvožilni poremećaji navale crvenila, flebitis
Intravenous infusions with these types of antibiotics can cause flushing of the upper body, hives, itching and/or rashes. 
Reakcije povezane s infuzijom Intravenske infuzije s ovim vrstama antibiotika mogu uzrokovati navale crvenila gornjeg dijela tijela,
Xydalba 500 mg powder for concentrate for solution for infusion dalbavancin 
Xydalba 500 mg prašak za koncentrat za otopinu za infuziju dalbavancin
Angelini Pharma Slovenská republika s.r.o. 
Angelini Pharma Slovenská republika s.r.o. Júnová 33
Uncommon - may affect up to 1 in 100 people: Vaginal infections, fungal infections, oral thrush Urinary tract infections Anaemia (low levels of red blood cells), high blood platelet counts (thrombocytosis), increased blood counts of a type of white blood cell called eosinophils (eosinophilia), low levels of other types of white blood cell (leucopenia, neutropenia) Changes in other blood tests Decreased appetite 
povećani broj bijelih krvnih stanica zvanih eozinofili (eozinofilija), niska razina drugih vrsta bijelih krvnih stanica (leukopenija, neutropenija)
Each vial contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin. 
Jedna bočica sadrži dalbavancinklorid što odgovara 500 mg dalbavancina.
EXP 
• Osip
Angelini Pharmaceuticals România SRL Str. Dr. Carol Davila, Nr. 9, Sector 5 
Angelini Pharmaceuticals România SRL Str.
Sodium hydroxide and/or hydrochloric acid (for pH adjustment) 
manitol (E421), laktoza hidrat, natrijev hidroksid i/ili kloridna kiselina (za podešavanje pH)
Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži dalbavancinklorid što odgovara 500 mg dalbavancina.
Lactose monohydrate, 
Nakon jednokratne intravenske doze od
Teл. 
Xydalbe.
Powder for concentrate for solution for infusion 1 vial 
Prašak za koncentrat za otopinu za infuziju.
• Abdominal pain and discomfort, indigestion, constipation 
• Bol i nelagoda u trbuhu, probavne tegobe, zatvor
Two-dose regimen2 
Dvokratna doza2
Mannitol (E421) 
office@angelini.bg
A distance of at least 1 cm is to be maintained. 
Mora se održati udaljenost od najmanje 1 cm (centimetar).
Patients with more than 1 BCC 
Bolesnici s više od 1 BCC
No experience exists with these situations. 
Nema iskustava s tim situacijama.
Subgroups: 
Ukupno Podskupine:
However, in some cases they may persist for 1 to 2 weeks or even longer. 
Međutim, u nekim slučajevima se mogu zadržati 1 do 2 tjedna ili čak duže.
It is used to treat: 
Upotrebljava se za liječenje:
In conclusion, even though subgroup sizes are too small to draw significant conclusions on individual groups, the distribution of the two products to the relevant subgroups is very similar. 
U zaključku, iako su veličine podskupina premale da bi se mogli izvući značajni zaključci za pojedinačne skupine, raspodjela ova dva lijeka u relevantnim podskupinama vrlo je slična.
- allergic reaction1 
− alergijska reakcija1
Date of latest renewal: 21 November 2016 
Datum posljednje obnove odobrenja: 21. studenog 2016.
• if you have impaired formation of red blood pigment called porphyria 
• ako imate oštećeno stvaranje crvenog krvnog pigmenta zvano porfirija
Thus, it seems not plausible that this could negatively impact the non-inferiority claim of the primary study endpoint or the general trends observed across all subgroups. 
Stoga se ne čini vjerojatnim da bi to moglo negativno utjecati na tvrdnju o neinferiornosti primarne mjere ishoda ispitivanja ili općih trendova opaženih u svim podskupinama.
All these adverse reactions were non serious. 
Nijedna od tih nuspojava nije bila ozbiljna.
Lower 97.5% Confidence Limit 
Donja granica 97,5% raspona pouzdanosti
See also section 6.6. 
Vidjeti također dio 6.6.
Risk of allergic reaction 
Rizik od alergijske reakcije
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier. 
17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
Each lamp should be used according to the user manual. 
Svaka se lampa mora koristiti u skladu s korisničkim priručnikom.
Adverse events and tolerability were comparable for both treatments. 
Štetni događaji i podnošljivost bili su usporedivi u oba liječenja.
The dressing is removed after 3 hours. 
Zavoj se uklanja nakon 3 sata.
- change of colour 
− promjena boje
Your doctor will decide how well each skin lesion has responded, and treatment may have to be repeated at this time. 
Liječnik će odlučiti koliko je dobro svaka lezija odgovorila na liječenje, koje se tada možda mora ponoviti.
The light dose delivered should be monitored if a suitable detector is available. 
Primijenjena doza svjetlosti mora se pratiti ako je dostupan odgovarajući detektor.
Ameluz transiently increases phototoxicity 
Ameluz prolazno pojačava fototoksičnost
Talk to your doctor before using Ameluz. 
Obratite se svom liječniku prije nego primijenite Ameluz.
Keep the tube tightly closed after first opening. 
Tubu čuvati čvrsto zatvorenu nakon prvog otvaranja.