natgillin/translations-raw huggingface dataset:
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).
16,248 µg •h/ml) in Cmax (212 µg/ml in 191 µg/ml) je bila podobna pri odmerkih 1000 mg pri otrocih (12 - 16 let) s telesno maso > 60 kg (61,9 - 105,2 kg) kot pri odmerkih 15 mg/kg pri otrocih, težkih < 60 kg (47,9 - 58,9 kg).
The following adverse reactions have been identified in Phase 2/3 clinical trials with dalbavancin.
Seznam neželenih učinkov v preglednici (Preglednica 1) Naslednji neželeni učinki so bili zabeleženi v fazi 2/3 kliničnih preskušanj z dalbavancinom.
The pharmacokinetics of dalbavancin were evaluated in 17 subjects with mild, moderate, or severe hepatic impairment and compared to 9 matched healthy subjects with normal hepatic function.
Okvara delovanja jeter Farmakokinetika dalbavancina je bila ocenjena pri 17 osebah z blago, zmerno ali hudo okvaro jeter in pri 9 osebah v kontrolni skupini z normalnim delovanjem jeter.
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,
Preiskave zvišana laktat-dehidrogenaza v krvi, zvišana alanin-aminotransferaza, zvišana aspartat-aminotransferaza, zvišana raven sečne kisline v krvi, neobičajni rezultati testa jetrne funkcije, zvišane vrednosti transaminaz, zvišane vrednosti alkalne fosfataze v krvi, povečano število krvnih ploščic, zvišana telesna temperatura,
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.
Driska zaradi bakterije Clostridioides (prej Clostridium) difficile Kolitis, povezan s protibakterijskimi zdravili, in psevdomembranski kolitis sta bila zabeležena pri uporabi skoraj vseh antibiotikov in sta lahko blaga pa vse do smrtno ogrožajoča.
The European Medicines Agency has deferred the obligation to submit the results of studies with Xydalba in one or more subsets of the paediatric population in ABSSSI (see sections 4.2 and 5.2 for information on paediatric use).
Xydalba za eno ali več podskupin pediatrične populacije za ABSSSI (za podatke o uporabi pri pediatrični populaciji glejte poglavji 4.2 in 5.2).
Respiratory, thoracic and mediastinal disorders cough bronchospasm
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj bronhospazem
Single-use 48 ml type I glass vial with an elastomeric stopper and a green flip off seal.
48-ml steklena viala za enkratno uporabo, tipa I, z elastomernim zamaškom in z zeleno snemljivo zaporko.
• Change in sense of taste
• omotica; • spremembe pri zaznavanju okusa;
The reconstituted concentrate in the vial contains 20 mg /ml dalbavancin.
Rekonstituiran koncentrat v viali vsebuje 20 mg/ml dalbavancina.
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.
Da razredčite rekonstituiran koncentrat, je treba ustrezno količino od 20 mg/ml koncentrata prenesti iz viale v intravensko vrečko ali steklenico, ki vsebuje 50 mg/ml
• Inflammation and swelling of surface veins, flushing
• vnetje in otekanje površinskih ven, vročinski oblivi;
The compatibility of reconstituted Xydalba concentrate has only been established with 50 mg/ml (5 %) glucose solution for infusion.
Kompatibilnost rekonstituiranega koncentrata zdravila Xydalba je bila ugotovljena le s 50 mg/ml (5 %) raztopino glukoze za infundiranje.
Xydalba is for single use only.
Zdravilo Xydalba je samo za enkratno uporabo.
It is not known if Xydalba passes into breast milk in humans.
Ni znano, ali zdravilo Xydalba prehaja v mleko doječe matere.
Nervous system disorders headache dysgeusia, dizziness
Bolezni živčevja glavobol dizgevzija, omotica
Dalbavancin toxicity has been evaluated after daily intravenous administration for durations of up to
Toksičnost dalbavancina je bila ocenjena po dnevni intravenski uporabi v obdobju do 3 mesecev na podganah in psih.
For dosing instructions in subjects with renal impairment refer to section 4.2.
Za navodila o odmerjanju pri osebah z ledvično okvaro glejte poglavje 4.2.
It may affect up to 1 in 100 people.
Občasni - pojavijo se lahko pri največ 1 od 100 bolnikov:
If particulate matter or discoloration is identified, the solution must be discarded.
Če opazite vidne delce ali obarvanje, raztopino zavrzite.
Skin and subcutaneous tissue disorders pruritus, urticaria, rash
Bolezni kože in podkožja pruritus, urtikarija, izpuščaj
Xydalba vials are for single-use only.
Viale zdravila Xydalba so le za enkratno uporabo.
• Difficulty sleeping
• težave z nespečnostjo;
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the treatment with dalbavancin (see section 4.8).
Zato je pri bolnikih z drisko med ali po zdravljenju z dalbavancinom pomembno upoštevati tudi to diagnozo
• Sudden swelling of your lips, face, throat or tongue; severe rash; itchiness; throat tightening; drop in blood pressure; difficulty in swallowing and /or difficulty in breathing.
• nenadno otekanje ustnic, obraza, grla ali jezika; hud izpuščaj; srbenje; stiskanje v grlu; padec krvnega tlaka; težave pri požiranju in/ali težave z dihanjem; vse to so lahko znaki preobčutljivostne reakcije in so lahko smrtno nevarni; takšno resno reakcijo so zabeležili kot redek neželeni učinek, pojavi se lahko pri največ 1 od 1.000 bolnikov;
Information on the efficacy and safety of dalbavancin in patients with creatinine clearance < 30 ml/min is limited.
Podatki o učinkovitosti in varnosti dalbavancina pri bolnikih s kreatininskim očistkom, manjšim od
Figure 1.
Preglednica 1
Xydalba 500 mg powder for concentrate dalbavancin intravenous use after reconstitution and dilution
Xydalba 500 mg prašek za koncentrat dalbavancin intravenska uporaba po rekonstituciji in redčenju
After reconstitution each ml contains 20 mg dalbavancin.
Po rekonstituiranju en ml vsebuje 20 mg dalbavancina.
White to off-white to pale yellow powder.
Bel do umazano bel do bledo rumen prašek.
The reconstituted concentrate must be further diluted with 50 mg/ml (5 %) glucose solution for infusion.
Rekonstituiran koncentrat mora biti v nadaljevanju še razredčen s 50 mg/ml (5 %) raztopino glukoze za infundiranje.
Contents of the pack and other information
Shranjevanje zdravila Xydalba Vsebina pakiranja in dodatne informacije
Efficacy has been demonstrated in clinical studies against the pathogens listed for ABSSSI that were susceptible to dalbavancin in vitro:
Klinična učinkovitost proti specifičnim patogenim organizmom Pri kliničnih študijah se je pokazala učinkovitost proti patogenim organizmom, povezanim z akutno bakterijsko okužbo kože in kožnih struktur (ABSSSI), ki so občutljivi za dalbavancin in vitro:
Dalbavancin Plasma Concentrations versus time in a typical ABSSSI patient (simulation using population pharmacokinetic model) for both the single and the two-dose regimens.
ABSSSI (simulacija s populacijskim farmakokinetičnim modelom) za režim enkratnega odmerka in dveh odmerkov.
Dalbavancin pharmacokinetics in subjects with end-stage renal disease receiving regularly scheduled renal dialysis (3 times/week) were similar to those observed in subjects with mild to moderate renal impairment, and less than 6 % of an administered dose is removed after 3 hours of haemodialysis.
Farmakokinetika dalbavancina pri osebah s končno ledvično odpovedjo, ki redno prejemajo hemodializo (3-krat/teden), je bila podobna kot pri osebah z blago do zmerno okvaro ledvic.
For dosing instructions in subjects with hepatic impairment refer to section 4.2.
Za navodila o odmerjanju pri osebah z okvaro jeter glejte poglavje 4.2.
Common - may affect up to 1 in 10 people: Headache
Pogosti - pojavijo se lahko pri največ 1 od 10 bolnikov:
constipation, abdominal pain, dyspepsia, abdominal discomfort, vomiting
zaprtost, bolečine v trebuhu, dispepsija, neprijeten občutek v trebuhu, bruhanje
It may affect up to 1 in 1,000 people.
Redki - pojavijo se lahko pri največ 1 od 1000 bolnikov:
Xydalba must be reconstituted with sterile water for injections and subsequently diluted with 50 mg/ml (5 %) glucose solution for infusion.
Zdravilo Xydalba mora biti rekonstituirano s sterilno vodo za injekcije in nato razredčeno s 50 mg/ml
Pain, redness or swelling at the place where the infusion was given Feeling hot
• bolečina, pordelost ali otekanje na mestu infundiranja; • občutek vročine;
The dalbavancin plasma concentration-time following the two-dose and the single-dose regimens, respectively, are shown in Figure 1.
Odvisnost koncentracije dalbavancina v plazmi od časa po uporabi režima z enkratnim odmerkom oziroma dvema odmerkoma, kot je prikazano na sliki 1.
In in vitro studies, no antagonism has been observed between dalbavancin and other commonly used antibiotics (i.e. cefepime, ceftazidime, ceftriaxone, imipenem, meropenem, amikacin, aztreonam, ciprofloxacin, piperacillin/tazobactam and trimethoprim/sulfamethoxazole), when tested against 12 species of Gram-negative pathogens (see section 4.5).
ceftazidim, ceftriakson, imipenem, meropenem, amikacin, aztreonam, ciprofloksacin, piperacilin/tazobaktam in trimetoprim/sulfametoksazol).
Aseptic technique must be used for reconstitution and dilution of Xydalba.
Navodila za rekonstitucijo in redčenje Za rekonstitucijo in redčenje zdravila Xydalba je potrebno uporabiti sterilno (aseptično) tehniko.
• Changes in hearing.
• spremembe v krvi pri drugih testih;
Warnings and precautions Talk to your doctor, pharmacist or nurse before being given Xydalba:
Pred začetkom prejemanja zdravila Xydalba se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
How to store Xydalba
Kako boste prejeli zdravilo Xydalba
No accumulation of dalbavancin was observed following multiple intravenous infusions administered once-weekly for up to 8 weeks (1,000 mg on Day 1, followed by up to 7 weekly 500 mg doses) in healthy adults.
Kopičenja dalbavancina po večkratnem intravenskem infundiranju enkrat tedensko v obdobju do 8 tednov (1000 mg prvi dan,
Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
Ena viala praška vsebuje dalbavancinijev klorid, kar ustreza 500 mg dalbavancina.
In dogs only, infusion reactions characterised by skin swelling and/or redness (not associated with the injection site), mucosal pallor, salivation, vomiting, sedation, and modest declines in blood pressure and increases in heart rate were observed in a dose-dependent manner.
(nevezano na mesto injiciranja), bledico sluznice, slinjenje, bruhanje, sedacijo, zaznali pa so pa tudi zmerne odklone krvnega tlaka in povišanje srčnega utripa v odvisnosti od odmerka.
Each vial contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
Ena viala vsebuje dalbavancinijev klorid, kar ustreza 500 mg dalbavancina.
Xydalba 500 mg powder for concentrate for solution for infusion
Xydalba 500 mg prašek za koncentrat za raztopino za infundiranje
Lactose monohydrate Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol (E421) laktoza monohidrat klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
Xydalba 500 mg powder for concentrate for solution for infusion dalbavancin
Xydalba 500 mg prašek za koncentrat za raztopino za infundiranje dalbavancin
• Abdominal pain and discomfort, indigestion, constipation
• kašelj; • bolečine in neugodje v predelu trebuha, prebavne motnje, zaprtje;
You should not breastfeed when given Xydalba.
Ko se zdravite z zdravilom Xydalba, ne smete dojiti.
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.
Povprečni AUC je bil nespremenjen pri osebah z blago okvaro jeter v primerjavi z osebami z normalnim delovanjem jeter, povprečni AUC
Vascular disorders flushing, phlebitis
Žilne bolezni vročinski oblivi, flebitis
Being sick (vomiting)
• siljenje na bruhanje (navzea),
The interaction potential of dalbavancin on medicinal products metabolised by CYP enzymes is expected to be low since it is neither an inhibitor nor an inducer of CYP enzymes in vitro.
Pričakovana je majhna verjetnost interakcije dalbavancina z zdravili, ki se presnavljajo z encimi CYP,
No dose adjustment of dalbavancin is recommended for patients with mild hepatic impairment (Child-Pugh A).
Pri bolnikih z blago okvaro delovanja jeter (Child-Pugh A) prilagoditev odmerka dalbavancina ni potrebna.
In vivo PK/PD relationship of dalbavancin for S. aureus was investigated using a neutropenic model of animal infection that showed that net reduction in the log10 of colony-forming units (CFU) was greatest when larger doses were given less frequently.
In vivo farmakokinetično/farmakodinamično razmerje dalbavancina za S. aureus so raziskovali z uporabo nevtropenskega modela živalske okužbe.
Package leaflet: Information for the patient Xydalba 500 mg powder for concentrate for solution for infusion dalbavancin
Navodilo za uporabo Xydalba 500 mg prašek za koncentrat za raztopino za infundiranje dalbavancin
Susceptibility testing breakpoints
Mejne vrednosti pri preskušanju občutljivosti
Sodium hydroxide and/or hydrochloric acid (for pH adjustment)
manitol (E421), laktoza monohidrat, natrijev hidroksid in/ali klorovodikova kislina (za uravnavanje pH)
Genital itching (females)
• srbenje v predelu spolovil (ženske);
Tell your doctor or nurse immediately if you are concerned that you may have been given too much Xydalba.
Če ste prejeli večji odmerek zdravila Xydalba, kot bi smeli Če menite, da ste prejeli prevelik odmerek zdravila Xydalba, to takoj povejte zdravniku ali medicinski sestri.
Talk to your doctor, pharmacist or nurse if you get any of the following side effects:
farmacevtom ali medicinsko sestro:
Patients with more than 1 BCC
bolniki z več kot 1 BCC
Lower 97.5% Confidence Limit
Nižja 97,5 % Meja zaupanja
Subgroups:
Skupaj Podskupine:
No experience exists with these situations.
Ni izkušenj pri takih stanjih.
However, in some cases they may persist for 1 to 2 weeks or even longer.
V nekaterih primerih lahko trajajo tudi en teden ali dva ali celo dlje.
Each side of the face/scalp was treated with one of the two products.
Vsako stran obraza/lasišče so zdravili z enim izmed teh dveh izdelkov.
All these adverse reactions were non serious.
Vsi ti neželeni učinki niso bili resni.
Positive allergy tests were reported in the study.
V študiji so poročali o pozitivnih testih alergije.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/740/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/740/001
The latter causes damage of cellular components and eventually destroys the target cells.
Te poškodujejo sestavne dele celic in sčasoma uničijo ciljne celice.
Your doctor will decide which treatment option to use, depending on your lesions.
Vaš zdravnik bo določil, katera možnost zdravljenja bo uporabljena, odvisno od vaših lezij.
These factors vary with lamp type.
Ti dejavniki se razlikujejo glede na vrsto svetilke.
- change of colour
− sprememba barve
* Data from post-marketing period.
* Podatki iz obdobja trženja.
Ameluz daylight photodynamic therapy is feasible all year long in southern Europe, from February to October in middle Europe, and from March to October in northern Europe.
Fotodinamično zdravljenje z zdravilom Ameluz z uporabo dnevne svetlobe je v južni Evropi mogoče vse leto, v srednji Evropi od februarja do oktobra, v severni Evropi pa od marca do oktobra.
1 This reaction also occurs before illumination.
1 Ta reakcija se pojavi tudi pred osvetlitvijo.
• In very rare cases photodynamic therapy may increase the risk of developing temporary memory loss.
• V zelo redkih primerih lahko fotodinamično zdravljenje poveča tveganje razvoja začasne izgube spomina.
Your doctor will decide how well each skin lesion has responded, and treatment may have to be repeated at this time.
Zdravnik bo presodil, kako dobro se je posamezna kožna lezija odzvala, in morda bo tokrat zdravljenje treba ponoviti.
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.
Zato se ne zdi verodostojno, da bi lahko to negativno vplivalo na trditev o enakovrednosti cilja študije ali splošnih trendov, ki so jih opazili v vseh podskupinah.
• reactions at the application site
• reakcije na mestu uporabe
Date of latest renewal: 21 November 2016
Datum prve odobritve: 14. december 2011 Datum zadnjega podaljšanja: 21. november 2016
Protection from sun light exposure for 48 hours and observation are nevertheless recommended.
Kljub temu se priporočata 48-urna zaščita pred izpostavljenostjo soncu in opazovanje.
Each lamp should be used according to the user manual.
Vsaka svetilka se mora uporabljati v skladu s priročnikom za uporabo.
In the presence of oxygen, reactive oxygen species are formed.
V prisotnosti kisika se oblikujejo reaktivne kisikove spojine.
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.
Sklepamo lahko, da je kljub premajhnim velikostim podskupin za pomembna sklepanja o posamičnih skupinah, porazdelitev obeh zdravil v vsakokratne podskupine zelo podobna.
Some reactions at the application site have been observed before the use of light.
Nekatere reakcije na mestu uporabe so opazili pred uporabo svetlobe.
- on skin areas affected by other diseases or tattoos, because this may hinder the success and assessment of the treatment.
− na dele kože, prizadete zaradi drugih bolezni, ali na tetovaže, saj lahko to ovira uspeh in oceno zdravljenja.
In 12 cases the reactions started before illumination.
V 12 primerih se je reakcija začela pred osvetlitvijo.
Protoporphyrin IX is activated by illumination with red light of a suitable wavelength and energy.
Protoporfirin IX se aktivira z osvetlitvijo z rdečo svetlobo primerne valovne dolžine in energije.
There is no need to protect healthy untreated skin.
Zaščita zdrave, nezdravljene kože ni potrebna.
Immediately after cleaning, the entire treated area is illuminated using a red light source.
Takoj po čiščenju se celotno zdravljeno območje osvetli z uporabo vira rdeče svetlobe.
Number of treatments
Število zdravljenj
Patient distribution in the subgroups was similar for both products and represents the distribution in the general population, where more than 70% of BCCs are located in the head/trunk region.
Porazdelitev bolnikov v podskupinah je bila podobna za obe zdravili in predstavlja porazdelitev v splošni populaciji, pri čemere je več kot 70 % BCC na predelu glave/trupa.
The intensity of these effects is dependent on the type of illumination used for photodynamic therapy.
Intenzivnost teh učinkov je odvisna od vrste osvetlitve, uporabljene za fotodinamično zdravljenje.
The light dose is determined by factors such as the size of the light field, the distance between lamp and skin surface, and the illumination time.
Uporabljeni odmerek svetlobe se določi na osnovi dejavnikov, kot so velikost svetlobnega polja, razdalja med svetilko in površino kože ter čas osvetljevanja.
Although the exact mechanism is not known, stress and pain associated with PDT may increase the risk to develop transient amnesia.
Čeprav natančni mehanizem ni znan, lahko stres in bolečina, povezana s fotodinamičnim zdravljenjem, povečata tveganje za razvoj prehodne amnezije.
Actinic keratoses and basal cell carcinomas do not occur in children and adolescents, except in extremely rare cases.
Aktinične keratoze in bazalnocelični karcinomi se pri otrocih in mladostnikih ne pojavljajo, razen v zelo redkih primerih.
Remaining gel will be removed after completion of light exposure.
Preostali gel bo odstranjen po zaključku osvetlitve.
A distance of at least 1 cm is to be maintained.
Nanašajte vsaj 1 cm od njih.
Special care should be taken to avoid bleeding during lesion preparation in such patients (see section 4.2).
Posebna pozornost je potrebna, da se prepreči krvavitev med pripravo lezije pri teh bolnikih (glejte poglavje 4.2).
• if you have other skin conditions caused by, or made worse by, exposure to light
• če imate druga kožna obolenja, ki jih povzroča ali poslabša izpostavljenost svetlobi
The dressing is removed after 3 hours.
Povoj odstranite po treh urah.
After 24 hours, the mean cumulative absorption (including accumulation in the dermis) through human skin was 0.2% of the administered dose.
Po 24 urah je bila povprečna skupna absorpcija (vključno s kopičenjem v povrhnjici) skozi človeško kožo 0,2 % uporabljenega odmerka.
Before PDT (%) 12 months after PDT (%)
12 mesecev po PDT (%)
Use of immunosupressants
Uporaba imunosupresivov
• if you have impaired formation of red blood pigment called porphyria
• če imate obolenje, pri katerem je okvarjeno tvorjenje rdečega krvnega pigmenta, imenovano porfirija
3 severe very thick and / or obvious AK
3 huda zelo odebeljena in/ali očitna aktinična keratoza
Actinic keratoses are certain changes in the outer layer of the skin that can lead to skin cancer.
Aktinične keratoze so določene spremembe na zunanji plasti kože, ki lahko povzročijo kožnega raka.
It is important to ensure that the correct light dose is administered.
Pomembno je, da se zagotovi uporaba pravilnega odmerka svetlobe.
Clinical description of severity grading
Klinični opis stopnje resnosti
• soybean phosphatidylcholine: If you are allergic to peanut or soya, do not use this medicine.
• sojin fosfatidilholin: če ste alergični na arašide ali sojo, ne uporabljajte tega zdravila.
The symptoms are usually of mild or moderate intensity (investigator's assessment on a 4-point scale), and last for 1 to 4 days in most cases; in some cases, however, they may persist for 1 to 2 weeks or even longer.
Simptomi so običajno blagi ali zmerni (ocena raziskovalcev na štiristopenjski lestvici) in v večini primerov trajajo od enega do štirih dni; v nekaterih primerih lahko trajajo tudi en teden ali dva oziroma celo dlje.
The percentage of patients with skin impairment before PDT and 12 months after PDT is listed in the table below.
Odstotek bolnikov s prizadetostjo kože pred PDT in ter 12 mesecev po PDT je naveden v spodnji preglednici.
This therapy is known as photodynamic therapy (PDT).
To zdravljenje se imenuje fotodinamično zdravljenje (PDT- photodynamic therapy).
Blister, dry skin, petechiae
Mehurji, suha koža, petehije
Illumination with appropriate light produces reactive oxygen-containing molecules which act against the target cells.
Osvetlitev s primerno svetlobo proizvaja reaktivne molekule kisika, ki delujejo proti ciljnim celicam.
None of the post-dose levels were increased in comparison to the naturally occuring predose levels, showing absence of a relevant systemic absorption after topical administration.
Nobena raven po odmerjanju v primerjavi z naravno prisotnimi ravnmi pred odmerjanju ni bila povečana, kar kaže na odsotnost pomembne sistemske absorpcije po topikalni uporabi.
Carcinogenicity studies have not been performed with ALA.
Študije kancerogenosti z ALA niso bile izvedene.
Ameluz is only used on the skin.
Zdravilo Ameluz se uporablja samo na koži.
After more extended time periods, treatment with Ameluz frequently results in continued improvement of skin quality parameters.
Po daljšem obdobju je rezultat zdravljenja z zdravilom Ameluz pogosto stalno izboljšanje parametrov kakovosti kože.
Illumination using a red-light lamp
Osvetlitev z uporabo svetilke z rdečo svetlobo
Mottled or irregular pigmentation
Lisasta ali nepravilna pigmentacija