natgillin/translations-raw huggingface dataset:
The treated AK field was located on the balding scalp or face with a contiguous area of about 40 cm² for both treatment groups presenting with a median number of 7 clinically typical AK lesions at baseline.
Zdravljeni AK predeli so se nahajali na neporaščenem lasišču ali obrazu s sklenjeno površino približno 40 cm² pri obeh zdravljenih skupinah, v katerih je bila mediana številka klinično značilnih AK lezij v izhodišču 7.
If not washed daily the foreskin may be more likely to show signs of tightness, swelling and wearing away of the skin and result in difficulty in pulling it back.
Če se ta postopek ne izvaja, se poveča verjetnost pojava znakov zoženja, otekline in oguljene kože, kar povzroča težave pri premikanju kožice.
Peak serum drug concentrations at the end of week 16 were observed between 9 and 12 hours and were 0.1, 0.2, and 1.6 ng/mL for the applications to face (12.5 mg, 1 single-use sachet), scalp (25 mg, 2 sachets) and hands/arms (75 mg, 6 sachets), respectively.
Najvišje koncentracije zdravila v plazmi konec 16. tedna so bile dosežene po 9 do 12 urah in so znašale 0,1 ng/mL za nanos na obraz (12,5 mg, 1 vrečka za enkratno uporabo), 0,2 ng/mL za nanos na lasišče (25 mg, 2 vrečki) in 1,6 ng/mL za nanos na dlani/roke (75 mg, 6 vrečk).
Local skin reactions are common but these reactions generally decrease in intensity during therapy or resolve after cessation of imiquimod cream therapy.
Lokalne reakcije na koži so pogoste, vendar se intenzivnost teh reakcij ponavadi med zdravljenjem zmanjša oz. reakcije po prekinitvi zdravljenja z imikvimodom izzvenijo.
In a four-month rat dermal toxicity study, significantly decreased body weight and increased spleen weight were observed at 0.5 and 2.5 mg/kg; similar effects were not seen in a four month mouse dermal study.
V štirimesečni študiji kožne toksičnosti na podganah,so pri odmerkih 0,5 in 2,5 mg/kg opazili znatno zmanjšanje telesne mase in povečanje teže vranice.
If you forget to use Aldara cream
Če ste pozabili nanesti kremo Aldara
- The active substance is imiquimod.
- Zdravilna učinkovina je imikvimod.
Marketing Authorisation Holder Meda AB
Imetnik dovoljenja za promet z zdravilom Meda AB
Local skin reactions such as erythema, erosion, excoriation, flaking and oedema are common.
Lokalne reakcije na koži, kot npr. rdečica, erozija, lupljenje, luskavost in otekline, so pogoste.
After 6 to 10 hours wash the area where Aldara cream was applied with mild soap and water.
Po 6 do 10 urah področje nanosa kreme Aldara umijte z blagim milom in vodo.
The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours.
Kremo nanašamo pred običajnim časom spanja, kjer naj ostane približno 8 ur.
Each sachet contains 250 mg cream (100 mg cream contains 5 mg imiquimod).
Vsaka vrečka vsebuje 250 mg kreme (100 mg kreme vsebuje 5 mg imikvimoda).
• Warts (condylomata acuminata) on the surface of the genitals (sexual organs) and around the anus (back passage)
• Bradavic (condylomata acuminata) na površini spolovila ali v okolici zadnjične odprtine (anusa).
A patient was counted as recurrent in these trials if at least one AK lesion was observed in the completely cleared field whereby a recurrent lesion could be a lesion which occurred at the same location as a formerly cleared lesion or a newly identified lesion anywhere in the treated AK field.
Za potrebe študije je bila ponovitev opredeljena kot vsaj ena AK lezija, zaznana na predelu s popolno odpravo lezij, pri čemer se je kot ponovljena lezija štela tako lezija, ki se je pojavila na istem mestu kot predhodno odpravljene lezije, kot tudi nova lezija, nastala kjer koli drugje na zdravljenem AK predelu.
Local skin reactions can be a sign that the drug is working as intended.
Lokalne kožne reakcije so znak delovanja zdravila.
Apply Aldara cream to the affected area and 1cm (approx. 0.5 inch) around the affected area.
Nanesite tanek sloj kreme Aldara na prizadeto področje in 1 cm okoli prizadetega področja.
Local skin reactions, such as erythema, are probably an extension of the pharmacologic effects of imiquimod cream.
Lokalne reakcije na koži, kot npr. rdečica, so verjetno posledica farmakoloških učinkov imikvimod kreme.
These adverse events are considered at least possibly causally related to treatment with imiquimod.
Za te neželene učinke se smatra, da so najmanj možno vzročno povezani z zdravljenjem z imikvimodom.
Most skin reactions were mild to moderate in severity and resolved within 2 weeks of treatment discontinuation.
Večina kožnih reakcij je bila zmernih po resnosti in je izzvenela po 2 tednih po prekinitvi zdravljenja.
Imiquimod cream therapy is not recommended until the skin has healed after any previous drug or surgical treatment.
Uporaba imikvimod kreme ni priporočljiva, dokler se koža ne zaceli po predhodnem zdravljenju ali kirurškem posegu.
Genital candidiasis
Genitalna kandidaza
Psychiatric disorders: Insomnia
Psihiatrične motnje: Nespečnost
The most frequently reported adverse event from these trials judged probably or possibly related to imiquimod cream was application site reactions (22% of imiquimod treated patients).
Najpogosteje poročani neželeni učinki v teh preskušanjih, za katere je bilo presojeno, da so verjetno oz. možno povezani z zdravljenjem z imikvimod kremo, so bile reakcije na mestu nanašanja (22 % bolnikov, zdravljenih z imikvimodom).
External genital warts, superficial basal cell carcinoma and actinic keratosis:
Zunanje genitalne bradavice, površinski karcinom bazalnih celic in aktinična keratoza:
Response of the treated tumour to imiquimod cream should be assessed 12 weeks after the end of treatment.
Odziv zdravljenega tumorja je potrebno oceniti 12 tednov po zaključku zdravljenja.
Local inflammatory reactions may be accompanied, or even preceded, by flu-like systemic signs and symptoms including malaise, pyrexia, nausea, myalgias and rigors.
Lokalne vnetne reakcije lahko spremljajo (ali jih celo prehitijo) gripi podobni sistemski znaki in simptomi, denimo, slabo počutje, pireksija, slabost, bolečine v mišicah in rigor.
Rectal disorder
Rektalne motnje
Commonly some patients (4% or less) have experienced headache, uncommonly fevers and flu like symptoms joint and muscle pains; prolapse of the womb; pain on intercourse in females; erection difficulties; increase in sweating; feeling sick; stomach and bowel symptoms; ringing in the ears; flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; loss of appetite; swollen glands; bacterial, viral and fungal infections (e.g. cold sores); vaginal infection including thrush; cough and colds with sore throat.
Pogosto se je pri nekaterih bolnikih (4 % ali manj) pojavil glavobol, občasno zvišana telesna temperatura in gripi podobni simptomi in bolečine v mišicah in sklepih; prolaps maternice; bolečine ob spolnem odnosu pri ženskah; motnje erekcije; povečano potenje; slabost; simptomi v želodcu in trebuhu; zvonjenje v ušesih; rdečica; utrujenost; omotica; migrena; mravljinčenje; nespečnost; depresija; pomanjkanje apetita; otekle žleze; bakterijske, virusne in glivične okužbe (npr. herpesna okužba v ustih); okužbe v nožnici vključno s kandidazo; kašelj in prehlad z vnetim žrelom.
The efficacy of imiquimod applied 3 times per week for one or two courses of 4 weeks, separated by a 4 week treatment-free period, was studied in two double-blind vehicle controlled clinical trials.
Učinkovitost imkvimoda trikrat tedensko za 4 tedne oz. dvakrat po 4 tedne z vmesno 4-tedensko prekinitvijo je bila raziskana v dveh dvojno slepih kliničnih preskušanjih, nadzorovanih z nosilcem.
Hardening under the skin, small open sores, a crust that forms during healing, and small bubbles under the skin may also occur.
Lahko se pojavijo tudi otrdlina pod kožo, majhne odprte ranice, kraste in drobni mehurčki pod kožo.
Regarding the primary endpoint, histological progression, overall 13 of 242 patients (5.4%) of the imiquimod group and 26 of 237 patients (11.0%) of the diclofenac group were found to have a histological progression to in situ or invasive SCC within 3 years, a difference of -5.6% (95% CI: -10.7% to -0.7%).
V zvezi s primarnim opazovanim dogodkom, ki je bil histološko napredovanje, so pri skupno 13 od 242 bolnikov (5,4 %) v skupini z imikvimodom in 26 od 237 bolnikov (11,0 %) v skupini z diklofenakom ugotovili histološko napredovanje v in situ ali invazivni SCC v obdobju 3 let, razlika -5,6 % (95 % IZ: -10,7 % do -0,7 %).
Pharyngo laryngeal pain
Faringo-laringealne bolečine
In the pivotal trials with 3 times a week dosing, the most frequently reported adverse drug reactions judged to be probably or possibly related to imiquimod cream treatment were application site reactions at the wart treatment site (33.7% of imiquimod treated patients).
V treh preskušanjih z odmerjanjem trikrat tedensko so bili najpogosteje poročani neželeni učinki, za katere je bilo presojeno, da so verjetno oz. možno povezani z zdravljenjem z imikvimod kremo, reakcije na mestu nanašanja na zdravljenem področju z bradavicami (33,7 % bolnikov, zdravljenih z imikvimodom).
If any lesions persist, treatment should be repeated for another four weeks.
Če AK v zdravljenem področju ne izginejo je potrebno zdravljenje ponoviti za nadaljnje 4 tedne.
Based on current knowledge, treating urethral, intra-vaginal, cervical, rectal or intra-anal warts is not recommended.
Na podlagi trenutnega znanja, zdravljenje bradavic v sečnici, nožnici, na materničnem vratu in rektalnih ter intraanalnih bradavic ni priporočljivo.
Interactions with systemic drugs would be limited by the minimal percutaneous absorption of imiquimod cream.
Takšne reakcije s sistemskimi zdravili so omejene zaradi minimalne absorpcije imikvimod kreme skozi kožo.
100 mg of cream contains 5 mg of imiquimod.
100 mg kreme vsebuje 5 mg imikvimoda.
Superficial basal cell carcinoma in adults:
Površinski karcinom bazalnih celic pri odraslih bolnikih:
Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5 %).
Ena vrečka vsebuje 12,5 mg imikvimoda v 250 mg kreme (5 %).
Rare reports have been received of exacerbation of autoimmune conditions.
Redko so poročali o poslabšanju avtoimunskih obolenj.
Due to its immunostimulating properties, imiquimod cream should be used with caution in patients who are receiving immunosuppressive medication (see section 4.4).
Zaradi njenih imunsko-stimulativnih lastnosti pri bolnikih, ki prejemajo imunosupresivna zdravila, imikvimod kremo uporabljamo previdno (glejte poglavje 4.4).
• Superficial basal cell carcinoma.
• Površinskega karcinoma bazalnih celic.
Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol
Krema Aldara vsebuje metilparahidroksibenzoat, propilparahidroksibenzoat, cetilalkohol, stearilalkohol in benzilalkohol
Men with warts under the foreskin should pull the foreskin back each day and wash underneath it.
Moški z bradavicami pod kožico penisa morajo vsak dan kožico potegniti nazaj in kožo pod njo umiti.
• Do not use more cream than your doctor has advised.
• Ne prekoračite priporočenega odmerka kreme.
Rarely, intense local inflammatory reactions including skin weeping or erosion can occur after only a few applications of imiquimod cream.
Redko se lahko pojavijo burne lokalne vnetne reakcije, denimo, rosenje kože ali razjede, že po nekajkratnem nanosu kreme imikvimod.
Men with warts under the foreskin should pull the foreskin back each day and wash underneath it (see section 2 “Warnings and precautions”)
Moški z bradavicami pod kožico penisa morajo vsak dan kožico potegniti nazaj in kožo pod njo umiti (glejte poglavje 2.
Patient reported adverse reactions from 2292 patients treated with imiquimod cream in placebo controlled and open clinical studies are presented below.
Spodaj so prikazani podatki o reakcijah, o katerih je poročalo 2292 bolnikov, zdravljenih z imikvimod kremo v raziskavah, nadzorovanih s placebom in v odprtih kliničnih raziskavah.
After about 8 hours, wash the area where Aldara cream was applied with mild soap and water.
Po približno 8 urah področje nanosa kreme Aldara umijte z blagim milom in vodo.
If you experience skin lesions or spots on your skin that start out as small red areas and progress to look like mini targets, possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores, stop using Aldara cream and tell your doctor immediately.
Če opazite na koži lezije, madeže, ki se razvijajo v majhne rdeče lise, ki se lahko še naprej povečujejo in ki jih lahko spremljajo znaki kot so srbenje, vročina, slabo počutje, bolečine v sklepih, motnje vida, pečenje, bolečine ali srbenje v očeh in izpuščaji v ustih, prenehajte uporabljati kremo Aldara in o tem obvestite svojega zdravnika.
• External genital and perianal warts (condylomata acuminata) in adults.
• zunanjih bradavic na spolovilu in v okolici zadnjične odprtine (condylomata acuminata) pri odraslih bolnikih
Treatment with imiquimod cream can be resumed after the skin reaction has moderated.
Zdravljenje z imikvimod kremo naj se nadaljuje, ko se reakcija umiri.
There was no evidence for serious adverse reaction caused by imiquimod in paediatric patients.
Ni dokazov o resnih neželenih učinkih imikvimoda pri otrocih.
Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday and Friday) for four weeks prior to normal sleeping hours, and left on the skin for approximately 8 hours.
Imikvimod kremo nanašamo štiri tedne in sicer trikrat tedensko (npr. v ponedeljek, sredo in petek) pred običajnim časom spanja in jo pustimo na koži za približno 8 ur.
The most frequently reported adverse events from the trials judged probably or possibly related to imiquimod cream are application site disorders, with a frequency of 28.1%.
Najpogosteje poročan neželen dogodek, za katerega je bilo presojeno, da so verjetno oz. možno povezani z zdravljenjem z imikvimod kremo, so bile spremembe na mestu nanašanja s pogostnostjo 28,1 %.
When applied topically, systemic overdosage with imiquimod cream is unlikely due to minimal percutaneous absorption.
Če imikvimod krema daje topikalno, sistemsko preveliko odmerjanje ni verjetno zaradi minimalne absorpcije skozi kožo.
Application site dermatitis
Dermatitis na mestu aplikacije
• If you are being treated for genital warts:
● Če se zdravite zaradi genitalnih bradavic:
In 157 imiquimod-treated male patients, the combined total clearance rate was 23% as compared to 5% in 161 vehicle-treated patients (95%CI for rate difference: 3% to 36%, p<0.001).
Pri 157 moških bolnikih, zdravljenih z imikvimodom, je bil delež bolnikov s popolno odstranitvijo bradavic 23 %, pri 161 bolnikih, zdravljenih z nosilcem, pa 5 % (95 % interval zaupanja razlike med očistkoma: 3 % do 36 %, p<0,001).
Do not use Aldara cream for more than 16 weeks in the treatment of each episode of warts.
Kreme Aldara ne uporabljajte dlje kot 16 tednov za zdravljenje vsake ponovitve (epizode) bradavic na spolovilu ali bradavic v okolici zadnjične odprtine.
Rub gently into the skin until the cream vanishes.
Kremo nežno vtirajte v kožo dokler ne izgine.
Imiquimod cream may weaken condoms and diaphragms, therefore concurrent use with imiquimod cream is not recommended.
Imikvimod krema lahko oslabi kondome in diafragme, zato sočasna uporaba ni priporočljiva.
● If you are being treated for actinic keratosis
• Če se zdravite zaradi aktinične keratoze
The cream should be rubbed into the treatment area until the cream vanishes.
Kremo vtiramo v področje zdravljenja, dokler se ne vpije.
External genital warts:
Zunanje genitalne bradavice:
Apart from reactions in the skin, other common effects include headache, anorexia, nausea, muscle pain, joint pain and tiredness.
Poleg reakcij na koži so bili drugi pogosti učinki glavobol, izguba apetita, slabost, bolečine v mišicah, bolečine v sklepih in utrujenost.
Apply imiquimod cream for 6 weeks, 5 times per week (example: Monday to Friday) prior to normal sleeping hours, and leave on the skin for approximately 8 hours.
Imikvimod kremo nanašamo petkrat tedensko (npr. od ponedeljka do petka) za 6 tednov pred običajnim časom spanja in jo pustimo na koži za približno 8 ur.
Face oedema
Edem obraza
(3x/wk, 4 or 8 wks) N = 252
Aktinična keratoza (3x/teden, 4 ali 8 tednov) n=252
• Actinic keratosis
• Aktinična keratoza
The excipients methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed).
Pomožni snovi metilhidroksibenzoat (E 218) in propilhidroksibenzoat (E 216), lahko povzročita preobčutljivostne reakcije (lahko zapoznele).
Imiquimod has not been evaluated for the treatment of basal cell carcinoma within 1 cm of the eyelids, nose, lips or hairline.
Uporaba imikvimoda za zdravljenje karcinomov bazalnih celic, ki se nahajajo bližje kot 1 cm od očesnih vek, nosu, ustnic in lasišča, ni raziskana.
Aldara cream has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo krema Aldara nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Imiquimod cream should be applied prior to normal sleeping hours.
Imikvimod kremo nanašamo pred spanjem.
- If you have any further questions, please ask your doctor or your pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
Do not use Aldara cream
Ne uporabljajte kreme Aldara:
In 119 imiquimod-treated female patients, the combined total clearance rate was 60% as compared to 20% in 105 vehicle-treated patients (95% CI for rate difference: 20% to 61%, p<0.001).
Pri 119 bolnicah, zdravljenih z imikvimodom, je bil delež bolnic s popolno odstranitvijo bradavic 60 %, pri 105 bolnicah, zdravljenih z nosilcem, pa 20 % (95 % interval zaupanja (IZ) razlike med očistkoma: 20 % do 61 %, p<0,001).
Minimal systemic absorption of imiquimod 5% cream across the skin of 58 patients with actinic keratosis was observed with 3 times per week dosing for 16 weeks.
Pri 58 bolnikih z aktinično keratozo, ki so nanašali kremo trikrat tedensko za 16 tednov, so opazili minimalno sistemsko absorpcijo imikvimod 5 % kreme preko kože.
EU/1/98/080/001-002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/98/080/001-002
Uncircumcised males treating warts under the foreskin should retract the foreskin and wash the area daily (see section 4.4).
Neobrezani moški, ki zdravijo bradavice pod kožico penisa, morajo vsak dan kožico potegniti nazaj in prizadeto območje umiti (glejte poglavje 4.4).
Painful skin reactions at the opening of the vagina have very rarely made it difficult for some women to pass urine.
Pri nekaterih ženskah so v zelo redkih primerih boleče kožne reakcije na področju vhoda v nožnico otežile izločanje urina.
External genital warts in adults:
Zunanje genitalne bradavice pri odraslih bolnikih:
Uncommonly some patients experience changes at the application site (bleeding, inflammation, discharge, sensitivity, swelling, small swollen areas in the skin, pins and needles, scabbing, scarring, ulceration or a feeling of warmth or discomfort), or inflammation of the lining of the nose, stuffy nose, flu or flu-like symptoms, depression, eye irritation, swelling of the eyelid, throat pain, diarrhoea, actinic keratosis, redness, swelling of the face, ulcers, pain in extremity, fever, weakness or shivering.
Občasno so se pri nekaterih bolnikih pojavile spremembe na mestu nanosa (krvavitev, vnetje, izcedek, občutljivost, oteklina, majhne otekline v koži, mravljinčenje, tvorba krast, zabrazgotinjenje, razjeda ali občutek toplote ali neugodja) ali vnetje sluznice nosu, zamašen nos, gripa in gripi podobni simptomi, depresija, draženje oči, oteklina očesne veke, bolečine v žrelu, driska, aktinična keratoza, rdečina, otekanje obraza, razjede, bolečine v udih, zvišana telesna temperatura, občutek slabosti in drgetanje.
Other local reactions such as induration, ulceration, scabbing, and vesicles have also been reported.
Poročali so tudi o drugih lokalnih reakcijah, kot npr. otrdline, ulceracije, pojavu brazgotin in mehurčkov.
An interruption of dosing should be considered if intense local inflammatory reactions occur (see section 4.4) or if infection is observed at the treatment site.
Če se pojavijo burne lokalne vnetne reakcije (glejte poglavje 4.4) ali če se na področju zdravljenja razvije okužba, je treba razmisliti o prekinitvi zdravljenja.
• Do not cover the treated area with bandages or other dressings after you have applied Aldara cream.
• Ne pokrivajte področja zdravljenja s povoji ali obvezami po nanosu kreme Aldara.
b) Tabular Listing of adverse events:
b) Navedba neželenih učinkov v preglednici:
Infections and infestations: Infection
Infekcijske in parazitske bolezni: Okužba pogosti pogosti
Imiquimod cream should be applied in a thin layer and rubbed on the clean wart area until the cream vanishes.
Imikvimod kremo nanesemo v tankem sloju na čisto področje z bradavicami in jo vtiramo dokler se krema ne vpije.
For those patients with complete clinical clearance of the treated AK field recurrence of AK lesions was evaluated.
Pri bolnikih s popolno klinično ozdravitvijo lezij na zdravljenem AK predelu so ocenili ponovitve AK lezij.
Patient reported adverse reactions from 185 patients treated with imiquimod cream in placebo controlled phase III clinical studies for superficial basal cell carcinoma are presented below.
Spodaj so prikazani podatki o reakcijah, o katerih je poročalo 185 bolnikov, zdravljenih z imikvimod kremo v kliničnih raziskavah faze III, nadzorovanih s placebom.
Very Commonly the treated skin may be slightly itchy.
Zelo pogosto lahko zdravljena koža rahlo srbi.
Imiquimod should be used with caution in patients with reduced haematologic reserve (refer to section 4.8d).
Pri bolnikih z zmanjšanimi hematološkimi vrednostmi je potrebna previdnost pri uporabi imikvimoda (glejte poglavje 4.8 d).
A single-use sachet is sufficient to cover a wart area of 20 cm
Vrečka za enkratno uporabo zadostuje za prekritje 20 cm področja z bradavicami.
Imiquimod has the potential to exacerbate inflammatory conditions of the skin.
Imikvimod krema lahko poslabša vnetja na koži.
Investigators of the placebo controlled clinical trials were required to evaluate protocol mandated clinical signs (skin reactions).
Raziskovalci so morali v nadzorovanih preskušanjih z vehiklom oceniti klinične znake (lokalne reakcije na koži), ki so bili navedeni v protokolu.
Remote site skin reactions, mainly erythema (44%), were also reported in the placebo controlled trials.
V preskušanjih nadzorovanih s placebom so poročali tudi o kožnih reakcijah na oddaljenih mestih, predvsem rdečici (44 %).
No clinical experience exists with the use of imiquimod cream in immunocompromised patients.
Z uporabo imikvimod kreme pri imunsko kompromitiranih bolnikih kliničnih izkušenj ni.
Actinic keratosis in adults
Aktinična keratoza pri odraslih bolnikih:
Imiquimod cream therapy should not be initiated in tissues where open sores or wounds exist until after the area has healed.
Z imikvimod kremo se ne sme zdraviti tkiva z odprtimi ranami, dokler se le-te ne zacelijo.
How to use Aldara cream
Kako uporabljati kremo Aldara
Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday, and Friday; or Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for 6 to 10 hours.
Imikvimod kremo nanašamo trikrat tedensko (npr. v ponedeljek, sredo in petek; ali v torek, četrtek in soboto) pred spanjem.
6.1 List of excipients isostearic acid benzyl alcohol cetyl alcohol stearyl alcohol white soft paraffin polysorbate 60 sorbitan stearate glycerol methyl hydroxybenzoate (E 218) propyl hydroxybenzoate (E 216) xanthan gum purified water.
6.1 Seznam pomožnih snovi izostearinska kislina benzilalkohol cetilalkohol stearilalkohol beli vazelin polisorbat 60 sorbitan stearat glicerol metilparahidroksibenzoat (E 218) propilparahidroksibenzoat (E 216) ksantanski gumi prečiščena voda
When clinical assessment was also included, clearance judged by this composite endpoint was noted in 75%
Če je bilo vključeno tudi klinično vrednotenje, je bila odstranitev glede na to sestavljeno končno točko dosežena pri 75 % (139/185) vseh bolnikov.
Renal and urinary disorders: Dysuria
Bolezni sečil: Dizurija