natgillin/translations-raw huggingface dataset:
As no quantifiable levels (> 5 ng/ml) of imiquimod are detected in the serum after single and multiple topical doses, no specific advice can be given on whether to use or not in lactating mothers.
Ker po enkratnem in večkratnem topičnem odmerku v serumu ni zaznavnih koncentracij imikvimoda (> 5 ng/ ml), ni mogoče podati specifičnih nasvetov o uporabi pri doječih materah.
From the undesirable effects noted in section 4.8, it is unlikely that treatment will have any effect on the ability to drive and use machines.
Na podlagi neželenih učinkov navedenih v poglavju 4. 8, ni verjetno, da bi zdravljenje kakor koli vplivalo na sposobnost vožnje in upravljanja s stroji.
a) General Description:
a) Splošen opis:
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).
Some systemic adverse reactions, including headache (3.7%), influenza-like symptoms (1.1%), and myalgia (1.5%) were also reported.
Poročali so tudi o nekaterih sistemskih neželenih učinkih, med drugim tudi o glavobolu (3, 7%), simptomih podobnih gripi (1, 1%) in mialgiji (1, 5%).
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 imikvimod.
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%.
Some systemic adverse reactions, including back pain (1.1%) and influenza-like symptoms (0.5%) were reported by imiquimod cream patients.
Bolniki, ki so prejemali imikvimod kremo, so poročali o nekaterih sistemskih neželenih reakcijah, med drugim o bolečini v križu (1, 1%) in simptomih podobnih gripi (0, 5%).
The most frequently reported adverse event
Najmanj en neželeni učinek so opazili pri 56% bolnikov, ki so prejemali imikvimod.
7 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).
Some systemic adverse reactions, including myalgia (2%) were reported by imiquimod treated patients.
Pri bolnikih, zdravljenih z imikvimodom, so poročali tudi o nekaterih sistemskih neželenih učinkih, vključno z mialgijo (2%).
Frequencies are defined as Very common (≥1/10), Common (≥1/100 to < 1/10) and Uncommon (≥1/1,000 to < 1/100).
7 Pogostnost neželenih učinkov je definirana kot zelo pogosti (≥1/ 10), pogosti (≥1/ 100, < 1/ 10), občasni (≥1/ 1. 000, < 1/ 100).
Superficial basal cell carcinoma
Infekcijske in parazitske bolezni:
(3x/ wk,16wks) N = 2292
Zunanje genitalne bradavice (3x tedensko/ 16 tednov) n = 2292
(5x/wk, 6 wks) N = 185
Površinski karcinom bazalnih celic (5x tedensko, 6 tednov) n = 185
(3x/wk, 4 or 8 wks) N = 252
Aktinična keratoza (3x/ teden, 4 ali 8 tednov) n=252
Infection Pustules Herpes simplex Genital candidiasis Vaginitis Bacterial infection Fungal infection Upper respiratory tract infection Vulvitis Rhinitis Influenza Blood and lymphatic system disorders:
Okužba Pustule Herpes simpleks Genitalna kandidaza Vaginitis Bakterijska okužba Okužba z glivami Okužba zgornjih dihal Vulvitis
Common Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon
pogosti občasni občasni občasni občasni občasni občasni občasni
Common Common
občasni občasni
Lymphadenopathy Metabolism and nutrition disorders:
Limfadenopatija Presnovne in prehranske motnje:
Anorexia Psychiatric disorders:
Anoreksija Psihiatrične motnje:
Depression Irritability Nervous system disorders:
Depresija Razdraženost Bolezni živčevja:
Headache Paraesthesia Dizziness Migraine Somnolence Eye disorders
Glavobol Parestezija Omotičnost Migrena Somnolenca Očesne bolezni
Common Uncommon Uncommon Uncommon Uncommon
pogosti občasni občasni občasni občasni
Conjunctival irritation Eyelid oedema Ear and labyrinth disorders:
Draženje veznice Edem očesne veke Ušesne bolezni, vključno z motnjami labirinta:
Tinnitus Vascular disorders:
Tinitus Žilne bolezni:
Flushing Respiratory, thoracic and mediastinal disorders:
Rdečica Bolezni dihal, prsnega koša in mediastinalnega prostora:
Pharyngitis
občasni občasni
8
8 Bolezni prebavil:
Rhinitis Nasal congestion Pharyngo laryngeal pain
Slabost Bolečine v trebuhu
Diarrhoea Vomiting Rectal disorder Rectal tenesmus Dry mouth
Driska Bruhanje Rektalne motnje Rektalni tenezem Izsušena usta
Dermatitis Folliculitis Rash erythematous Eczema Rash Sweating increased Urticaria Actinic keratosis Erythema Face oedema Skin ulcer
Dermatitis Folikulitis Eritmatozen izpuščaj Ekcem Izpuščaj Povečano potenje Urtikarija Aktinična keratoza Eritem Edem obraza Kožna razjeda
Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon
občasni občasni občasni občasni občasni občasni občasni
Myalgia Arthralgia Back pain Pain in extremity
Mialgija Artralgija Bolečine v križu Bolečine v okončinah
Dysuria
Dizurija
Reproductive system and breast disorders:
občasni občasni občasni občasni
Genital pain male Penile disorder Dyspareunia Erectile dysfunction Uterovaginal prolapse Vaginal pain Vaginitis atrophic Vulval disorder
Maternično- nožnični prolaps Bolečine v nožnici Atrofični vaginitis Spremembe vulve
Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon
občasni občasni občasni občasni
Application site pruritus Application site pain Application site burning Application site irritation Application site erythema Application site reaction
Pruritus na mestu aplikacije Bolečina na mestu aplikacije
Very common Very common Common Common
pogosti zelo pogosti pogosti pogosti
Very common Common Common Common Common
pogosti pogosti
Very common Common Common Common Common Common
pogosti pogosti
Application site bleeding Application site papules Application site paraesthesia
Krvavitev na mestu aplikacije Papule na mestu aplikacije Parestezija na mestu aplikacije
Application site rash
Izpuščaj na mestu aplikacije
Fatigue Pyrexia Influenza-like illness Pain
Utrujenost Povišana telesna temperatura Bolezen podobna gripi Bolečine
Common Uncommon Uncommon Uncommon
pogosti občasni občasni občasni
Asthenia Malaise
Astenija Slabost
Rigors Application site dermatitis
Otrplost Dermatitis na mestu aplikacije
Application site discharge Application site hyperaesthesia Application site inflammation
Izcedek na mestu aplikacije Hiperstezija na mestu
Application site oedema Application site scabbing Application site scar Application site skin breakdown
Edem na mestu aplikacije Tvorba krast na mestu
Uncommon Uncommon Uncommon
občasni občasni
Application site swelling Application site ulcer
Brazgotina na mestu aplikacije Razpokanje kože na mestu
Appli cation site vesicles Application site warmth Lethargy Discomfort Inflammation
Vezikli na mestu aplikacije Občutek toplote na mestu
c) Frequently occurring adverse events:
Pogostejši neželeni dogodki:
These protocol mandated clinical sign assessments indicate that local skin reactions including erythema (61%), erosion (30%), excoriation/flaking/scaling (23%) and oedema (14%) were common in these placebo controlled clinical trials with imiquimod cream applied three times weekly (see section 4.4).
Ta predpisana vrednotenja kliničnih znakov so pokazala, da so bile lokalne reakcije na koži, vključno z rdečico (61%), erozijo (30%), lupljenjem/ luskavostjo (23%) in oteklino (14%), pogoste v teh s placebom nadzorovanih preskušanjih, kjer je bila imikvimod krema nanešena trikrat tedensko (glejte poglavje 4. 4).
However, in some cases these reactions have been severe, requiring treatment and/or causing incapacitation.
Vendar pa so bile v nekaterih primerih te reakcije hude in so zahtevale zdravljenje in/ ali so povzročile nezmožnost.
In very rare cases, severe reactions at the urethral meatus have resulted in dysuria in women (see section 4.4).
V zelo redkih primerih so hude reakcije ob sečevodu povzročile disurijo pri ženskah (glej poglavje 4. 4).
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.
Skin infections during treatment with imiquimod have been observed.
10 Med zdravljenjem z imikvimod kremo so opazili kožne infekcije.
10 In clinical trials of imiquimod cream 3 times weekly for 4 or 8 weeks the most frequently occurring application site reactions were itching at the target site (14%) and burning at the target site (5%).
Pri kliničnih preskušanjih z imikvimod kremo 3 krat tedensko v času 4 ali 8 tednov so bile najpogosteje opažene reakcije na mestu aplikacije srbečica (14%) in pekoč občutek (5%).
Severe erythema (24%) and severe scabbing and crusting (20%) were very common.
Huda rdečica (24%) in huda luskavost ter tvorba krast (20%) so zelo pogoste.
See 4.2 an d 4.4 for information on rest periods.
Glejte poglavji 4. 2 in 4. 4 za podatke o obdobjih prekinitve.
d) Adverse events applicable to all indications:
d) Neželeni dogodki relevantni za vse indikacije:
Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod cream use.
Poročali so tudi o lokalni hipopigmentaciji in hiperpigmentaciji po uporabi imikvimod kreme.
Clinical studies investigating the use of imiquimod for the treatment of actinic keratosis have detected a 0.4% (5/1214) frequency of alopecia at the treatment site or surrounding area.
V kliničnih preskušanjih, kjer so raziskovali uporabo imikvimoda za zdravljenje aktinične keratoze, so odkrili 0, 4% (5/ 1214) pogostnost alopecije na mestu zdravljenja ali okolišnjem področju.
When applied topically, systemic overdosage with imiquimod cream is unlikely due to minimal percutaneous absorption.
Če imikvimod krema daje topično, sistemsko preveliko odmerjanje ni verjetno zaradi minimalne absorpcije skozi kožo.
Studies in rabbits reveal a dermal lethal dose of greater than 5 g/kg.
Študije na kuncih so pokazale, da je dermalni smrtni odmerek večji kot 5 g/ kg.
The most clinically serious adverse event reported following multiple oral doses of ≥ 200 mg was hypotension which resolved following oral or intravenous fluid administration.
Klinično najresnejši neželeni dogodek po večkratnih peroralnih odmerkih ≥ 200 mg je bila hipotenzija, ki je izzvenela po peroralnem in intravenskem dajanju tekočin.
5.1 Pharmacodynamic properties:
5. 1 Farmakodinamične lastnosti
ATC Code:
Kemoterapevtiki za lokalno zdravljenje, Protivirusni pripravki Oznaka ATC:
Imiquimod is an immune response modifier.
11 Imikvimod je modulator imunskega odziva.
The induction of alpha interferon and
Na živalskih modelih je imikvimod učinkovit proti virusnim okužbam in deluje protitumorsko, predvsem zaradi spodbujanja interferona alfa in drugih citokinov.
11 other cytokines following imiquimod cream application to genital wart tissue has also been demonstrated in clinical studies.
V kliničnih študijah je bilo po nanosu imikvimod kreme dokazano spodbujanje interferona alfa in drugih citokinov v tkivu z genitalnimi bradavicami.
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:
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% to 61%, p < 0.001).
20% do 61%, p < 0, 001).
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:
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% to 36%, p < 0.001).
3% do 36%, p < 0, 001).
Target tumours were histologically confirmed single primary superficial basal cell carcinomas with a minimum size of 0.5 cm2 and a maximum diameter of 2 cm.
Ciljni tumorji so bili histološko potrjeni posamezni primarni površinski karcinomi bazalnih celic, ki so obsegali najmanj 0, 5 cm2, njihov premer pa ni presegal 2 cm.
In a pooled analysis of these two studies, histological clearance was noted in 82% (152/185) of patients.
V združeni analizi teh dveh raziskavah so histološko odstranitev opazili pri 82% (152/ 185) vseh bolnikov.
When clinical assessment was also included, clearance judged by this composite endpoint was noted in 75% (139/185) of patients.
Če je bilo vključeno tudi klinično vrednotenje, je bila odstranitev glede na to sestavljeno končno točko dosežena pri 75% (139/ 185) vseh bolnikov.
These results were statistically significant (p < 0.001) by comparison with the vehicle group, 3% (6/179) and 2% (3/179) respectively.
2% (3/ 179).
Four-year data from a long-term open-label uncontrolled study indicate that an estimated 79.3% [95% CI (73.7%, 84.9%)] of all the subjects who initially received treatment became clinically clear and remained clear at 48 months.
Ocenjujejo, da so pri 79, 3% [95 -% IZ (73, 7%, 84, 9%)] bolnikov, ki so prejeli zdravilo na začetku, klinični znaki bolezni izginili in 48 mesecev ni prišlo do njihovega povratka.
Data on recurrence rates beyond 48 months are not yet available.
Podatki o povratku bolezni po več kot 48 mesecih še niso na voljo.
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.
4-8 AK lesions were treated.
Zdravljeno je bilo območje 4- 8
12 The recurrence rate for individual lesions was 5.6% (41/737).
Stopnja popolnega izginotja (imikvimod minus placeba) pri združenih preizkušanjih je bila 46, 1% (IZ 39, 0%, 53, 1%).
Corresponding recurrence rates for vehicle were 47% (8/17 patients) and 7.5% (6/80 lesions).
Stopnja ponovitve pri vehiklu je bila 47% (8/ 17 bonikov) in 7, 5% (6/ 88 lezij).
The rate of progression to squamous cell carcinoma (SCC) was reported in 1.6% (2/128 patients).
Poročali so, da je stopnja rasti skvamozno celičnega SCC pri 1, 6% (2/ 128) bolnikih.
Paediatric patients:
Otroci
These trials failed to demonstrate efficacy of imiquimod at any of the tested dosage regimens (3x/week for ≤16 weeks and 7x/week for ≤8 weeks).
Ti poskusi niso pokazali učinkovitosti imikvimoda pri nobenem od preskušanih načinov odmerjanja (3x/ teden ≤ 16 tednov, 7x/ teden ≤ 8 tednov).
Less than 0.9% of a topically applied single dose of radiolabelled imiquimod was absorbed through the skin of human subjects.
Pri ljudeh se je manj kot 0, 9% topično nanesenega odmerka radioaktivno označenega imikvimoda absorbiralo skozi kožo.
No quantifiable levels (> 5 ng/ml) of drug were detected in serum after single or multiple topical doses.
Po enkratnem in večkratnem topičnem odmerku v serumu ni bilo zaznavnih koncentracij imikvimoda (> 5 ng/ ml).
Systemic exposure (percutaneous penetration) was calculated from recovery of carbon-14 from [14C] imiquimod in urine and faeces.
Sistemska izpostavitev (s prehajanjem skozi kožo) je bila izračunana z določanjem vsebnosti ogljika- 14 [14C] iz imikvimoda v urinu in blatu.
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).
The application surface area was not controlled in the scalp and hands/ arms groups.
Površina nanašanja ni bila nadzorovana pri lasišču in dlaneh/ rokah.
Urinary recovery was less than 0.6% of the applied dose at week 16 in these patients.
Vsebnost v urinu je bila pri teh bolnikih manjša od 0, 6% nanešenega odmerka v 16. tednu.
In younger p atients aged 2-5 years absorption, based on Cmax values, was higher compared to adults.
Pri mlajših bolnikih od 2 – 5 let je bila absorbcija, na podlagi vrednosti Cmax, višja v primerjavi z odraslimi.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity and teratogenicity.
13 Neklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
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.
Podobnih učinkov niso opazili v štirimesečni študiji na koži miših.
13 A two-year mouse carcinogenicity study by dermal administration on three days a week did not induce tumours at the application site.
V dvoletni študiji rakotvornosti na miših z dermalnim nanašanjem tri dni na teden, zdravilo ni sprožilo nastanka tumorjev na mestu nanašanja.
Furthermore, tumours were not seen at any site in a 2-year oral carcinogenicity study in rats.
Poleg tega, se tumorji niso pojavili na nobenem mestu v dvoletni rakotvornost pri podganah peroralno.
Topical administration of imiquimod cream resulted in no tumour enhancement at any dose, in comparison with the vehicle cream group.
Topično nanašanje imikvimod kreme v primerjavi s skupino z nosilcem kreme v nobenem odmerku ni pospešilo tumorjev.
isostearic acid benzyl alcohol cetyl alcohol stearyl alcohol white soft paraffin polysorbate 60 sorbitan stearate glycerol methyl hydroxybenzoate (E218) propyl hydroxybenzoate (E216) xanthan gum purified water.
izostearinska kislina benzilalkohol cetilalkohol stearilalkohol beli vazelin polisorbat 60 sorbitan stearat glicerol metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) ksantanski gumi prečiščena voda
6. 2 Incompatibilities
6. 2 Inkompatibilnosti
Boxes of 12 single-use polyester/aluminium foil sachets, containing 250 mg of cream.
14 Škatlice po 12 vrečk za enkratno uporabo iz poliesterske/ aluminijske folije, vsaka vsebuje 250 mg kreme.
Date of first authorisation:
Datum pridobitve:
18/09/1998 Date of last renewal:
18/ 09/ 1998 Datum zadnjega podaljšanja dovoljenja za promet:
15 ANNEX II
15 DODATEK II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
MANUFACTURING AUTHORISATION HOLDER RESPONSI BLE FOR BATCH RELEASE
IZDELOVALEC IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
3M Health Care Limited, Derby Road, Loughborough, Leicester, LE11 5SF, United Kingdom.
3M Health Care Limited Derby Road, Loughborough, Leicester, LE11 5SF, United Kingdom.
B CONDITIONS OF THE MARKETING AUTH ORISATION
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
Medicinal product subject to medicinal prescription
Izdaja zdravila je le na recept.
17 ANNEX III
17 DODATEK III
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
19 PODATKI NA ZUNANJI OVOJNINI ALI STIČNI OZ.
Excipients: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), xanthan gum, purified water.
Pomožne snovi: izostearinska kislina, benzilalkohol, cetilalkohol, stearilalkohol, beli vazelin, polisorbat 60, sorbitan stearat, glicerol, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), ksantanski gumi, prečiščena voda.
Cream 12 sachets.
12 vrečk.
For cutaneous use
Samo za zunanjo uporabo.
Meda AB Box 906 170 09 Solna Sweden
Meda AB Box 906 170 09 Solna Švedska
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
21 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Aldara 5% cream Imiquimod For cutaneous use
Aldara 5% krema imikvimod Samo za zunanjo uporabo.
CONTENTS BY WEIGHT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
23 PACKAGE LEAFLET:
23 NAVODILO ZA UPORABO
- If you have any further questions, please ask your doctor or your pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen
please tell your doctor or pharmacist.
v tem navodilu, obvestite svojega zdravnika ali farmacevta.
2.
Kaj je krema Aldara in za kaj jo uporabljamo 2.
3.
Kaj morate vedeti, preden boste uporabili kremo Aldara 3.
4.
Kako uporabljati kremo Aldara 4.
5.
Možni neželeni učinki 5.
6.
Shranjevanje kreme Aldara 6.
WHAT IS ALDARA CREAM AND WHAT IT IS USED FOR
KAJ JE KREMA ALDARA IN ZA KAJ JO UPORABLJAMO
Actinic keratosis Actinic keratoses are rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime.
• Aktinična keratoza Aktinične keratoze so področja hrapave kože pri ljudeh, ki so bili prekomerno izpostavljeni soncu.
BEFORE YOU USE ALDARA CREAM
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI KREMO ALDARA
Do not use Aldara cream:
Ne uporabljajte kreme Aldara:
- If you are allergic to imiquimod (the active ingredient) or any of the ingredients of the cream.
- če ste preobčutljivi na imikvimod (na zdravilno učinkovino) ali katerokoli sestavino kreme Aldara.
Take special care with Aldara cream:
Bodite posebno pozorni pri uporabi kreme Aldara:
24 • If you have previously used Aldara cream or other similar preparations tell your doctor before starting this treatment. • Tell your doctor if you have problems with your immune system. • Do not use Aldara cream until the area to be treated has healed after previous drug or surgical treatment. • Avoid contact with the eyes, lips and nostrils.
Preprečite stik z očmi, ustnicami in nosnicami.
In the event of accidental contact, remove cream by rinsing with water. • Do not apply the cream internally. • Do not use more cream than your doctor has advised. • Do not cover the treated area with bandages or other dressings after you have applied Aldara cream. • If the treated site becomes too uncomfortable, wash the cream off with mild soap and water.
Krema je namenjena samo za zunanjo uporabo. o Ne prekoračite priporočenega odmerka kreme. o Ne pokrivajte področja zdravljenja s povoji ali obvezami po nanosu kreme Aldara. o Če se na področju nanosa kreme pojavi neprijeten ali pekoč občutek, kremo sperite z blagim o milom in vodo.
As soon as the problem has stopped you may restart to apply the cream. • Tell your doctor if you have an abnormal blood count.
Obvestite vašega zdravnika v kolikor imate zmanjšano število krvnih celic. o
Using other medicines:
Jemanje drugih zdravil:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.