FrancophonIA/ELRC3.0 huggingface dataset:
English: • Beta-haemolytic streptococci of Groups A, B, C, G: Susceptible ≤ 0.125 mg/l; Resistant > 0.125 mg/l,
Slovenian: • beta-hemolitični streptokoki skupin A, B, C, G: občutljivi ≤ 0,125 mg/l;
English: General disorders and administration site conditions infusion-related reactions
Slovenian: Splošne težave in spremembe na mestu aplikacije z infuzijo povezana reakcija
English: Infections and infestations vulvovaginal mycotic infection, urinary tract infection, fungal infection, Clostridioides (formerly Clostridium) difficile colitis, oral candidiasis
Slovenian: Infekcijske in parazitske bolezni vulvovaginalna glivična okužba, okužba sečil, glivična okužba, kolitis zaradi razrasta Clostridioides (prej Clostridium) difficile, oralna kandidiaza
English: In the major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only.
Slovenian: (ABSSSI) so bile vrste zdravljenih okužb omejene samo na celulitis/šen, abscese in okužbe ran.
English: Xydalba must be reconstituted and then further diluted prior to administration by intravenous infusion over a 30 - minute period.
Slovenian: Zdravilo Xydalba mora biti rekonstituirano in potem še razredčeno pred dajanjem intravenske infuzije, ki traja 30 minut.
English: 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.
Slovenian: V fazi 2/3 kliničnih študij je 2473 bolnikov prejelo dalbavancin z enkratnim infundiranjem 1500 mg ali infundiranjem 1000 mg, ki mu je po enem tednu sledilo še 500 mg.
English: Two-dose regimen2
Slovenian: Režim z dvema odmerkoma2
English: The prepared Xydalba solution for infusion must not be used if there are any particles or the solution is cloudy.
Slovenian: Pripravljene raztopine za infundiranje Xydalba ne smete uporabiti, če so v njej kakršni koli delci ali pa je raztopina motna.
English: Xydalba is given in a single dose of 1,500 mg or in two doses a week apart: 1,000 mg on Day 1 and 500 mg on Day 8.
Slovenian: Zdravilo Xydalba boste prejeli v enkratnem odmerku 1500 mg ali v dveh odmerkih s tednom dni razmika: 1000 mg prvi dan in 500 mg osmi dan.
English: Xydalba powder for concentrate for solution for infusion is provided in a 48 ml glass vial with a green flip off seal.
Slovenian: Xydalba prašek za koncentrat za raztopino za infundiranje je na voljo 48-ml stekleni viali z zeleno snemljivo zaporko.
English: Xydalba may cause dizziness.
Slovenian: Zdravilo Xydalba lahko povzroči omotico.
English: Rapid intravenous infusions of glycopeptide antibacterial agents can cause reactions that resemble “Red-Man Syndrome”, including flushing of the upper body, urticaria, pruritus, and/or rash.
Slovenian: Hitre intravenske infuzije glikopeptidnih protibakterijskih zdravil lahko povzročijo reakcijo, ki je podobna “sindromu rdečeličneža”, z rdečico na zgornjem delu telesa, z urtikarijo, pruritusom in/ali izpuščajem.
English: 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).
Slovenian: Skupaj 10 otrok v starosti od 12 do 16 let s trajajočimi okužbami je prejelo enkratni odmerek dalbavancina 1000 mg (telesna masa ≥ 60 kg) ali 15 mg/kg dalbavancin, če je bila telesna masa
English: Dose adjustments are not required for patients receiving regularly scheduled haemodialysis (3 times/week), and dalbavancin may be administered without regard to the timing of haemodialysis.
Slovenian: Pri bolnikih, ki redno prejemajo hemodializo (3-krat tedensko), prilagoditve odmerka niso potrebne, dalbavancin se lahko uporablja ne glede na čas hemodialize.
English: 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).
Slovenian: Pri bolnikih s kronično okvaro delovanja ledvic, katerih kreatininski očistek je < 30 ml/min in ki ne prejemajo redno hemodialize, je priporočeni odmerek dalbavancina zmanjšan na 1000 mg z enkratnim infundiranjem ali 750 mg, ki mu sledi 375 mg v naslednjem tednu (glej poglavje 5.2).
English: After dilution the solution for infusion must have a final concentration of 1 to 5 mg/ml dalbavancin
Slovenian: Razredčena raztopina za infundiranje mora imeti končno koncentracijo od 1 do 5 mg/ml dalbavancina
English: 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).
Slovenian: Priporočeni odmerek in trajanje zdravljenja pri odraslih Priporočeni odmerek dalbavancina pri odraslih bolnikih z ABSSSI je 1500 mg z enkratnim infundiranjem 1500 mg ali 1000 mg prvi teden, naslednji teden pa 500 mg (glej poglavji 5.1 in 5.2).
English: Dalbavancin was not mutagenic or clastogenic in a battery of in vitro and in vivo genotoxicity tests.
Slovenian: Dalbavancin v bateriji in vitro in in vivo genotoksičnih testov ni bil mutagen niti klastogen.
English: Estimated pharmacokinetic parameters of dalbavancin following the two-dose regimen and the single-dose regimen, respectively, are shown in Table 2 below.
Slovenian: Ocenjeni farmakokinetični parametri dalbavancina po uporabi režima z dvema odmerkoma oziroma režima z enkratnim odmerkom so prikazani v spodnji preglednici 2.
English: What Xydalba looks like and contents of the pack
Slovenian: Izgled zdravila Xydalba in vsebina pakiranja
English: Immune system disorders anaphylactoid reaction
Slovenian: Bolezni imunskega sistema anafilaktoidna reakcija
English: Sodium chloride containing solutions can cause precipitation and should NOT be used for reconstitution or dilution.
Slovenian: Raztopine, ki vsebujejo natrijev klorid, lahko povzročijo nastajanje usedlin in jih NE smete uporabljati za rekonstitucijo ali redčenje.
English: Potential for dalbavancin to affect the pharmacokinetics of other medicinal products.
Slovenian: Potencialni vpliv dalbavancina na farmakokinetiko drugih zdravil
English: No specific information is available on the treatment of overdose with dalbavancin, as dose-limiting toxicity has not been observed in clinical studies.
Slovenian: Posebnih podatkov o prevelikem odmerjanju dalbavancina ni, ker v kliničnih študijah niso opazovali toksičnih učinkov, ki bi omejevali odmerek.
English: 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).
Slovenian: 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).
English: The following adverse reactions have been identified in Phase 2/3 clinical trials with dalbavancin.
Slovenian: Seznam neželenih učinkov v preglednici (Preglednica 1) Naslednji neželeni učinki so bili zabeleženi v fazi 2/3 kliničnih preskušanj z dalbavancinom.
English: 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.
Slovenian: 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.
English: 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,
Slovenian: 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,
English: 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.
Slovenian: 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.
English: 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).
Slovenian: Xydalba za eno ali več podskupin pediatrične populacije za ABSSSI (za podatke o uporabi pri pediatrični populaciji glejte poglavji 4.2 in 5.2).
English: Respiratory, thoracic and mediastinal disorders cough bronchospasm
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj bronhospazem
English: Single-use 48 ml type I glass vial with an elastomeric stopper and a green flip off seal.
Slovenian: 48-ml steklena viala za enkratno uporabo, tipa I, z elastomernim zamaškom in z zeleno snemljivo zaporko.
English: • Change in sense of taste
Slovenian: • omotica; • spremembe pri zaznavanju okusa;
English: The reconstituted concentrate in the vial contains 20 mg /ml dalbavancin.
Slovenian: Rekonstituiran koncentrat v viali vsebuje 20 mg/ml dalbavancina.
English: 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.
Slovenian: 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
English: • Inflammation and swelling of surface veins, flushing
Slovenian: • vnetje in otekanje površinskih ven, vročinski oblivi;
English: The compatibility of reconstituted Xydalba concentrate has only been established with 50 mg/ml (5 %) glucose solution for infusion.
Slovenian: Kompatibilnost rekonstituiranega koncentrata zdravila Xydalba je bila ugotovljena le s 50 mg/ml (5 %) raztopino glukoze za infundiranje.
English: Xydalba is for single use only.
Slovenian: Zdravilo Xydalba je samo za enkratno uporabo.
English: It is not known if Xydalba passes into breast milk in humans.
Slovenian: Ni znano, ali zdravilo Xydalba prehaja v mleko doječe matere.
English: Nervous system disorders headache dysgeusia, dizziness
Slovenian: Bolezni živčevja glavobol dizgevzija, omotica
English: Dalbavancin toxicity has been evaluated after daily intravenous administration for durations of up to
Slovenian: Toksičnost dalbavancina je bila ocenjena po dnevni intravenski uporabi v obdobju do 3 mesecev na podganah in psih.
English: For dosing instructions in subjects with renal impairment refer to section 4.2.
Slovenian: Za navodila o odmerjanju pri osebah z ledvično okvaro glejte poglavje 4.2.
English: It may affect up to 1 in 100 people.
Slovenian: Občasni - pojavijo se lahko pri največ 1 od 100 bolnikov:
English: If particulate matter or discoloration is identified, the solution must be discarded.
Slovenian: Če opazite vidne delce ali obarvanje, raztopino zavrzite.
English: Skin and subcutaneous tissue disorders pruritus, urticaria, rash
Slovenian: Bolezni kože in podkožja pruritus, urtikarija, izpuščaj
English: Xydalba vials are for single-use only.
Slovenian: Viale zdravila Xydalba so le za enkratno uporabo.
English: • Difficulty sleeping
Slovenian: • težave z nespečnostjo;
English: 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).
Slovenian: Zato je pri bolnikih z drisko med ali po zdravljenju z dalbavancinom pomembno upoštevati tudi to diagnozo
English: • 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.
Slovenian: • 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;
English: Information on the efficacy and safety of dalbavancin in patients with creatinine clearance < 30 ml/min is limited.
Slovenian: Podatki o učinkovitosti in varnosti dalbavancina pri bolnikih s kreatininskim očistkom, manjšim od
English: Figure 1.
Slovenian: Preglednica 1
English: Xydalba 500 mg powder for concentrate dalbavancin intravenous use after reconstitution and dilution
Slovenian: Xydalba 500 mg prašek za koncentrat dalbavancin intravenska uporaba po rekonstituciji in redčenju
English: After reconstitution each ml contains 20 mg dalbavancin.
Slovenian: Po rekonstituiranju en ml vsebuje 20 mg dalbavancina.
English: White to off-white to pale yellow powder.
Slovenian: Bel do umazano bel do bledo rumen prašek.
English: The reconstituted concentrate must be further diluted with 50 mg/ml (5 %) glucose solution for infusion.
Slovenian: Rekonstituiran koncentrat mora biti v nadaljevanju še razredčen s 50 mg/ml (5 %) raztopino glukoze za infundiranje.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Xydalba Vsebina pakiranja in dodatne informacije
English: Efficacy has been demonstrated in clinical studies against the pathogens listed for ABSSSI that were susceptible to dalbavancin in vitro:
Slovenian: 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:
English: Dalbavancin Plasma Concentrations versus time in a typical ABSSSI patient (simulation using population pharmacokinetic model) for both the single and the two-dose regimens.
Slovenian: ABSSSI (simulacija s populacijskim farmakokinetičnim modelom) za režim enkratnega odmerka in dveh odmerkov.
English: 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.
Slovenian: 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.
English: For dosing instructions in subjects with hepatic impairment refer to section 4.2.
Slovenian: Za navodila o odmerjanju pri osebah z okvaro jeter glejte poglavje 4.2.
English: Common - may affect up to 1 in 10 people: Headache
Slovenian: Pogosti - pojavijo se lahko pri največ 1 od 10 bolnikov:
English: constipation, abdominal pain, dyspepsia, abdominal discomfort, vomiting
Slovenian: zaprtost, bolečine v trebuhu, dispepsija, neprijeten občutek v trebuhu, bruhanje
English: It may affect up to 1 in 1,000 people.
Slovenian: Redki - pojavijo se lahko pri največ 1 od 1000 bolnikov:
English: Xydalba must be reconstituted with sterile water for injections and subsequently diluted with 50 mg/ml (5 %) glucose solution for infusion.
Slovenian: Zdravilo Xydalba mora biti rekonstituirano s sterilno vodo za injekcije in nato razredčeno s 50 mg/ml
English: Pain, redness or swelling at the place where the infusion was given Feeling hot
Slovenian: • bolečina, pordelost ali otekanje na mestu infundiranja; • občutek vročine;
English: Koidu str. 20-19
Slovenian: Lorenzo Pharma OÜ Koidu str. 20-19
English: The dalbavancin plasma concentration-time following the two-dose and the single-dose regimens, respectively, are shown in Figure 1.
Slovenian: Odvisnost koncentracije dalbavancina v plazmi od časa po uporabi režima z enkratnim odmerkom oziroma dvema odmerkoma, kot je prikazano na sliki 1.
English: 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).
Slovenian: ceftazidim, ceftriakson, imipenem, meropenem, amikacin, aztreonam, ciprofloksacin, piperacilin/tazobaktam in trimetoprim/sulfametoksazol).
English: Aseptic technique must be used for reconstitution and dilution of Xydalba.
Slovenian: Navodila za rekonstitucijo in redčenje Za rekonstitucijo in redčenje zdravila Xydalba je potrebno uporabiti sterilno (aseptično) tehniko.
English: • Changes in hearing.
Slovenian: • spremembe v krvi pri drugih testih;
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before being given Xydalba:
Slovenian: Pred začetkom prejemanja zdravila Xydalba se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: How to store Xydalba
Slovenian: Kako boste prejeli zdravilo Xydalba
English: 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.
Slovenian: Kopičenja dalbavancina po večkratnem intravenskem infundiranju enkrat tedensko v obdobju do 8 tednov (1000 mg prvi dan,
English: Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
Slovenian: Ena viala praška vsebuje dalbavancinijev klorid, kar ustreza 500 mg dalbavancina.
English: 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.
Slovenian: (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.
English: Each vial contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
Slovenian: Ena viala vsebuje dalbavancinijev klorid, kar ustreza 500 mg dalbavancina.
English: Xydalba 500 mg powder for concentrate for solution for infusion
Slovenian: Xydalba 500 mg prašek za koncentrat za raztopino za infundiranje
English: Lactose monohydrate Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol (E421) laktoza monohidrat klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
English: Xydalba 500 mg powder for concentrate for solution for infusion dalbavancin
Slovenian: Xydalba 500 mg prašek za koncentrat za raztopino za infundiranje dalbavancin
English: • Abdominal pain and discomfort, indigestion, constipation
Slovenian: • kašelj; • bolečine in neugodje v predelu trebuha, prebavne motnje, zaprtje;
English: You should not breastfeed when given Xydalba.
Slovenian: Ko se zdravite z zdravilom Xydalba, ne smete dojiti.
English: 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.
Slovenian: Povprečni AUC je bil nespremenjen pri osebah z blago okvaro jeter v primerjavi z osebami z normalnim delovanjem jeter, povprečni AUC
English: Vascular disorders flushing, phlebitis
Slovenian: Žilne bolezni vročinski oblivi, flebitis
English: Being sick (vomiting)
Slovenian: • siljenje na bruhanje (navzea),
English: 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.
Slovenian: Pričakovana je majhna verjetnost interakcije dalbavancina z zdravili, ki se presnavljajo z encimi CYP,
English: No dose adjustment of dalbavancin is recommended for patients with mild hepatic impairment (Child-Pugh A).
Slovenian: Pri bolnikih z blago okvaro delovanja jeter (Child-Pugh A) prilagoditev odmerka dalbavancina ni potrebna.
English: 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.
Slovenian: In vivo farmakokinetično/farmakodinamično razmerje dalbavancina za S. aureus so raziskovali z uporabo nevtropenskega modela živalske okužbe.
English: Package leaflet: Information for the patient Xydalba 500 mg powder for concentrate for solution for infusion dalbavancin
Slovenian: Navodilo za uporabo Xydalba 500 mg prašek za koncentrat za raztopino za infundiranje dalbavancin
English: Susceptibility testing breakpoints
Slovenian: Mejne vrednosti pri preskušanju občutljivosti
English: Sodium hydroxide and/or hydrochloric acid (for pH adjustment)
Slovenian: manitol (E421), laktoza monohidrat, natrijev hidroksid in/ali klorovodikova kislina (za uravnavanje pH)
English: Genital itching (females)
Slovenian: • srbenje v predelu spolovil (ženske);
English: Tell your doctor or nurse immediately if you are concerned that you may have been given too much Xydalba.
Slovenian: 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.
English: Mannitol (E421)
Slovenian: office@angelini.bg
English: Talk to your doctor, pharmacist or nurse if you get any of the following side effects:
Slovenian: farmacevtom ali medicinsko sestro:
English: Patients with more than 1 BCC
Slovenian: bolniki z več kot 1 BCC
English: Lower 97.5% Confidence Limit
Slovenian: Nižja 97,5 % Meja zaupanja
English: Subgroups:
Slovenian: Skupaj Podskupine:
English: - allergic reaction1
Slovenian: − alergijska reakcija1
English: Allemagne / Deutschland / Duitsland / Германия / Německo / Saksamaa / Γερμανία / Njemačka / Germany / Þýskaland / Germania / Vācija / Vokietija / Németország / Il-Ġermanja / Niemcy /
Slovenian: Allemagne / Deutschland / Duitsland / Германия / Německo / Saksamaa / Γερμανία / Njemačka / Germany / Þýskaland / Germania / Vācija / Vokietija / Németország / Il-Ġermanja / Niemcy / Alemanha / Nemčija / Nemecko,
English: No experience exists with these situations.
Slovenian: Ni izkušenj pri takih stanjih.
English: However, in some cases they may persist for 1 to 2 weeks or even longer.
Slovenian: V nekaterih primerih lahko trajajo tudi en teden ali dva ali celo dlje.
English: Each side of the face/scalp was treated with one of the two products.
Slovenian: Vsako stran obraza/lasišče so zdravili z enim izmed teh dveh izdelkov.
English: All these adverse reactions were non serious.
Slovenian: Vsi ti neželeni učinki niso bili resni.
English: Positive allergy tests were reported in the study.
Slovenian: V študiji so poročali o pozitivnih testih alergije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/740/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/740/001
English: The latter causes damage of cellular components and eventually destroys the target cells.
Slovenian: Te poškodujejo sestavne dele celic in sčasoma uničijo ciljne celice.
English: Your doctor will decide which treatment option to use, depending on your lesions.
Slovenian: Vaš zdravnik bo določil, katera možnost zdravljenja bo uporabljena, odvisno od vaših lezij.