FrancophonIA/ELRC3.0 huggingface dataset:
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: MA (EU) number (Invented) name
Slovenian: Številka (EU)
English: Route of Administration
Slovenian: dovoljenja za promet
English: Pack size
Slovenian: Error!
English: Content (concentration)
Slovenian: (Izmišljeno)
English: This difference was not statistically significant.
Slovenian: Ta razlika ni bila statistično pomembna.
English: Therefore, these findings are considered to be incidental.
Slovenian: Iz tega razloga se ta opažanja štejejo za naključna.
English: The significance for man is unknown.
Slovenian: Pomen tega opažanja za človeka ni znan.
English: Mice were maintained for an additional 12 weeks.
Slovenian: Miši so opazovali še dodatnih 12 tednov.
English: This includes studies with immunosuppressive medicinal products.
Slovenian: To vključuje študije z imunosupresivnimi zdravili.
English: While these changes have tended to improve with time, in some patients they may be permanent.
Slovenian: Čeprav so se te spremembe s časom izboljšale, pa so lahko nekaterih bolnikih trajne.
English: • if you have previously used this medicine or other similar preparations in a different concentration.
Slovenian: - če ste že kdaj uporabljali to zdravilo ali kakšen drug podoben pripravek drugačne koncentracije.
English: There is also a possibility that existing inflammation may temporarily worsen.
Slovenian: Obstaja tudi verjetnost začasnega poslabšanja obstoječega vnetja.
English: This medicine contains 5 mg benzyl alcohol in each sachet.
Slovenian: To zdravilo vsebuje 5 mg benzil alkohola v vsaki vrečki.
English: Do not use this medicine until your doctor has shown you the right way to use it.
Slovenian: Ne uporabljajte tega zdravila, dokler vam zdravnik ne bo pokazal, kako ga pravilno uporabljamo.
English: These patients should be monitored under the close supervision of an experienced physician.
Slovenian: Te bolnike je treba spremljati pod skrbnim nadzorom izkušenega zdravnika.
English: If you go outside during the day use sunscreen and wear protective clothing and a wide-brimmed hat.
Slovenian: Če greste podnevi na prosto, uporabite sončno kremo ter nosite zaščitna oblačila in klobuk s širokimi krajci.
English: Leave Zyclara on the skin for about 8 hours.
Slovenian: Pustite zdravilo Zyclara na koži približno 8 ur.
English: Frequencies are defined as:
Slovenian: Pogostnost neželenih učinkov je definirana kot:
English: 61352 Bad Homburg Germany
Slovenian: 61352 Bad Homburg
English: It is the lead compound of the imidazoline family.
Slovenian: Je vodilna spojina družine imidazolinov.
English: - if you are allergic to imiquimod or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na imikvimod ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: These local skin reactions may be related to the stimulation of local immune response.
Slovenian: Te lokalne kožne reakcije so lahko povezane s stimulacijo lokalnega imunskega odziva.
English: Systemic reactions
Slovenian: Sistemske reakcije
English: This medicine should not be given to children below the age of 18 years because the safety and efficacy in patients below the age of 18 years have not been established.
Slovenian: Tega zdravila ne smemo dati otrokom, starim do 18 let, ker varnost in učinkovitost pri bolnikih, starih do 18 let, še nista bili dokazani.
English: Follow-up information suggests that these skin colour changes may be permanent in some patients.
Slovenian: Spremljanje podatkov nakazuje, da so lahko te spremembe barve kože pri nekaterih bolnikih trajne.
English: Management of overdose should consist of treatment of clinical symptoms.
Slovenian: Zdravljenje prevelikega odmerjanja mora vsebovati zdravljenje kliničnih simptomov.
English: This medicine stimulates your body's own immune system to produce natural substances which help fight your actinic keratosis.
Slovenian: To zdravilo spodbuja vaš imunski sistem, da proizvaja naravne snovi, ki pomagajo v boju proti aktinični keratozi.
English: These areas can be the same colour as your skin or are greyish, pink, red or brown.
Slovenian: Ta področja so lahko enake barve kot koža ali pa sivkaste, rožnate ali rjave barve.
English: White to faintly yellow cream with a uniform appearance.
Slovenian: krema Bela do bledo rumena krema z enotnim videzom.
English: He may advise you to stop applying this medicine for a few days (i.e. to have a short rest from treatment).
Slovenian: Morda vam bo priporočil, da prekinete uporabo tega zdravila za nekaj dni (t.j.
English: Fertility No clinical data are available, potential risk for human is unknown.
Slovenian: Plodnost Kliničnih podatkov ni na voljo, morebitno tveganje za ljudi je neznano.
English: Studies in animals do not indicate direct or indirect harmful effects in pregnancy.
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov med nosečnostjo.
English: Your doctor will discuss the risks and benefits of using Zyclara during pregnancy.
Slovenian: Zdravnik se bo z vami pogovoril glede tveganj in koristi uporabe zdravila Zyclara med nosečnostjo.
English: Excipients with known effects:
Slovenian: Pomožne snovi z znanim učinkom:
English: These reductions are not considered to be clinically significant in patients with normal haematologic reserve.
Slovenian: Ta zmanjšanja se ne štejejo za klinično pomembna pri bolnikih z normalnimi hematološkimi vrednostmi.
English: In some individuals a lowering of blood counts was noted (frequency not known).
Slovenian: Pri nekaterih posameznikih so opazili zmanjšanje števila krvnih celic (neznana pogostnost).
English: Hypopigmentation and hyperpigmentation
Slovenian: Hipopigmentacija in hiperpigmentacija
English: Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, antivirals, ATC Code: D06BB10
Slovenian: Farmakoterapevtska skupina: antibiotiki in kemoterapevtiki za uporabo v dermatologiji, protivirusna zdravila, oznaka ATC: D06BB10
English: Date of first authorisation: 23/08/2012 Date of latest renewal: 22/03/2017
Slovenian: Datum prve odobritve: 23.08.2012 Datum zadnjega podaljšanja: 22.03.2017
English: • if you have an abnormal blood count.
Slovenian: - če imate nenormalno krvno sliko.
English: • if you have problems with your immune system or if you take medicine to suppress your immune system (e.g. after an organ transplant).
Slovenian: - če imate težave z vašim imunskim sistemom ali če jemljete zdravila za zaviranje odziva imunskega sistema (npr. po presaditvi organa).
English: • Only use the cream externally (on the skin of face or scalp).
Slovenian: - Krema je namenjena samo za zunanjo uporabo (na koži obraza ali na lasišču).
English: What Zyclara is and what it is used for
Slovenian: Kaj je zdravilo Zyclara in za kaj ga uporabljamo
English: Zyclara should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Slovenian: Zdravilo Zyclara se lahko uporablja med nosečnostjo le če morebitna korist upravičuje morebitno tveganje za plod.
English: It is not known whether imiquimod passes into breast milk.
Slovenian: Ni znano, ali imikvimod prehaja v materino mleko.
English: The clinical outcome of therapy has to be determined after regeneration of the treated skin, approximately 8 weeks after the end of treatment and on appropriate intervals thereafter based on clinical judgment.
Slovenian: Klinični izid zdravljenja je treba oceniti po regeneraciji zdravljene kože, približno 8 tednov po končanem zdravljenju in ob primernih časovnih presledkih na osnovi klinične presoje.
English: If there is pus or another sign of skin infection (frequency not known), discuss this with your doctor.
Slovenian: Če se pojavi gnoj ali drug znak okužbe kože (neznana pogostnost), se posvetujte z zdravnikom.
English: There is an association between the complete clearance rate and the intensity of local skin reactions (e.g. erythema).
Slovenian: Obstaja povezava med stopnjo popolnega izginotja in intenzivnostjo lokalnih kožnih reakcij (npr. eritema).
English: even if their sign of illness are the same as yours.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
English: Response to treatment cannot be adequately assessed until resolution of local skin reactions.
Slovenian: Odziva na zdravljenje ni mogoče ustrezno oceniti, dokler se lokalne kožne reakcije ne umirijo.
English: Only in female mice, the incidences of hepatocellular adenomas were slightly greater than those for controls.
Slovenian: Le pri samicah je bila pojavnost hepatoceličnih adenomov nekoliko večja kot pri kontrolnih živalih.
English: Do not shower or bathe the area during this time.
Slovenian: V tem času se ne prhajte ali kopajte.
English: During this period, showering and bathing should be avoided.
Slovenian: V tem času se je treba izogibati prhanju ali kopanju.
English: Biotransformation Orally administered imiquimod is rapidly and extensively metabolised into two main metabolites.
Slovenian: Peroralno uporabljen imikvimod se hitro in obsežno presnavlja v dva glavna metabolita.
English: As imiquimod has low systemic absorption from human skin, and is not mutagenic, any risk to humans from systemic exposure is likely to be low.
Slovenian: Ker ima imikvimod pri ljudeh majhno sistemsko absorpcijo iz kože in ni mutagen, je tveganje za človeka, ki bi izviralo iz sistemske izpostavitve, verjetno nizko.
English: Meda AB Pipers väg 2A 170 73 Solna Sweden
Slovenian: Meda AB Pipers väg 2A 170 73 Solna Švedska
English: Data presented in the table below reflects: - exposure to Zyclara or vehicle in above mentioned studies (frequencies very common to uncommon and at greater frequency after vehicle).
Slovenian: Podatki, prikazani v spodnji preglednici, odražajo: - izpostavljenost zdravilu Zyclara ali vehiklu v zgoraj omenjenih študijah (pogostnosti: zelo pogosti do občasni in pogostejši po uporabi vehikla).
English: If you receive immunosuppressive medicinal products which inhibit the immune system, tell your doctor before starting the treatment.
Slovenian: Če prejemate imunosupresivna zdravila, ki zavirajo imunski sistem, se pred začetkom zdravljenja posvetujte z zdravnikom.
English: Other medicines and Zyclara
Slovenian: Druga zdravila in zdravilo Zyclara
English: There are no data available of the use of imiquimod in children and adolescents.
Slovenian: Podatkov o uporabi imikvimoda pri otrocih in mladostnikih ni na voljo.
English: Many of the side effects of this medicine are due to its local action on your skin.
Slovenian: Številni neželeni učinki tega zdravila izvirajo iz njegovega lokalnega delovanja na kožo.
English: Patients should continue treatment as prescribed.
Slovenian: Bolniki naj nadaljujejo s predpisanim načinom zdravljenja.
English: This medicine may reveal and treat actinic keratosis that have not be seen or felt before, and these may later go away.
Slovenian: To zdravilo lahko razkrije in zdravi aktinične keratoze, ki pred tem niso bile vidne ali otipljive, in ki lahko pozneje izginejo.
English: Patients with reduced haematologic reserve should be monitored under the close supervision of an experienced physician (see section 4.8).
Slovenian: Bolnike z zmanjšano hematološko rezervo je treba spremljati pod skrbnim nadzorom izkušenega zdravnika (glejte poglavje 4.8).
English: This medicine should only be used for actinic keratosis on the face or scalp if your doctor has decided that it is the most appropriate treatment for you.
Slovenian: To zdravilo se lahko uporablja samo za zdravljenje aktinične keratoze na obrazu in lasišču, če je zdravnik presodil, da je to za vas najprimernejše zdravljenje.
English: Local skin reactions
Slovenian: Lokalne kožne reakcije
English: Maximum daily dose is 2 sachets (500 mg = 2 sachets of 250 mg each).
Slovenian: Najvišji dnevni odmerek je 2 vrečici (500 mg = 2 vrečici po 250 mg vsaka).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Study treatments were given as officially recommended.
Slovenian: Zdravili v študijah sta bili uporabljeni v skladu z uradnimi priporočili.
English: Persistent topical overdosing of imiquimod cream could result in severe local skin reactions and may increase the risk for systemic reactions.
Slovenian: Vztrajno prekomerno lokalno odmerjanje imikvimod kreme lahko povzroči hude lokalne reakcije na koži in lahko poveča tveganje za sistemske reakcije.
English: The small amount of medicinal product which was absorbed into the systemic circulation was promptly excreted by both urinary and faecal routes at a mean ratio of approximately 3 to 1.
Slovenian: Majhna količina zdravila, ki se je absorbirala v sistemski obtok, je bila hitro izločena tako z urinom kot blatom s povprečnim razmerjem približno 3 proti 1.
English: - Hair loss A small number of patients have experienced hair loss at the treatment site or surrounding area.
Slovenian: - izpadanje las Pri manjšem številu bolnikov je prišlo do izpadanja las na zdravljenem predelu ali v njegovi okolici.
English: EU/1/12/783/001 14 sachets EU/1/12/783/002 28 sachets EU/1/12/783/003 56 sachets
Slovenian: EU/1/12/783/001 14 vrečic EU/1/12/783/002 28 vrečic EU/1/12/783/003 56 vrečic
English: Reductions in haematological parameters requiring clinical intervention have been reported from postmarketing experience.
Slovenian: O znižanju hematoloških parametrov, ki so zahtevali klinično intervencijo, so poročali v obdobju po prihodu zdravila na trg.
English: Actinic keratosis appears as rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime.
Slovenian: Aktinična keratoza se pojavi kot področja hrapave kože pri ljudeh, ki so bili v življenju prekomerno izpostavljeni soncu.
English: Apply this medicine to the affected area once a day just before bedtime.
Slovenian: Odmerjanje To zdravilo nanesite na prizadeti predel enkrat na dan tik pred spanjem.
English: In addition, these studies supported the use of up to two additional treatment cycles of imiquimod when the AK lesions are not completely cleared or if the AK lesions recurred after successful initial treatment with imiquimod.
Slovenian: Poleg tega so te študije podprle uporabo do dveh dodatnih ciklov zdravljenja z imikvimodom v primerih, ko lezije na zdravljenem AK predelu niso v celoti izginile ter v primerih, ko so se AK lezije po uspešnem začetnem zdravljenju z imikvimodom ponovile.
English: Imiquimod induces the release of interferon alpha (IFN-α) and other cytokines from a variety of human and animal cells (e.g. from human monocytes/macrophages and keratinocytes).
Slovenian: Imikvimod inducira sproščanje interferona alfa (IFN-α) in drugih citokinov iz različnih človeških in živalskih celic (npr. iz humanih monocitov/makrofagov in keratinocitov).
English: Skin infections during treatment with imiquimod have been observed.
Slovenian: Okužbe kože so opazili med zdravljenjem z imikvimodom.
English: The skin surface area treated should be protected from solar exposure.
Slovenian: Zdravljene predele kože je treba zaščititi pred sončno svetlobo.
English: If you use more Zyclara than you should
Slovenian: Če ste uporabili večji odmerek zdravila Zyclara, kot bi smeli
English: Imiquimod cream was evaluated in a photocarcinogenicity bioassay in albino hairless mice exposed to simulated solar ultraviolet radiation (UVR).
Slovenian: Imikvimod krema je bila ovrednotena v biološkem testu fotokarcinogenosti na neporaščenih miših albino, ki so sončnemu ultravijoličnemu sevanju (UVR).
English: Contact with eyes, lips and nostrils should be avoided as imiquimod has not been evaluated for the treatment of actinic keratosis on the eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border.
Slovenian: Preprečiti je treba stik zdravila z očmi, ustnicami in nosnicami, saj uporaba imikvimoda ni bila ovrednotena za zdravljenje aktiničnih keratoz na vekah, v nosnicah, v ušesih ali predelu ustnic znotraj meje s kožo.
English: However, only 11% (17/160) of patients in clinical trials with Zyclara required rest periods (treatment interruption) due to local adverse reactions.
Slovenian: Vendar pa je bilo treba le pri 11 % (17/160) bolnikov, ki so sodelovali v kliničnih preskušanjih zdravila Zyclara, prekiniti obdobja zdravljenja zaradi lokalnih neželenih učinkov.
English: The efficacy of Zyclara was studied in two double-blind, randomized, vehicle-controlled clinical studies.
Slovenian: Učinkovitost zdravila Zyclara so preučevali v dveh randomiziranih, dvojno slepih, z vehiklom nadzorovanih kliničnih študijah.
English: These reactions can be a sign that the medicine is working as intended.
Slovenian: Te reakcije so lahko znak, da zdravilo deluje.
English: If you notice any of these symptoms, tell your doctor.
Slovenian: Če opazite katerega od teh simptomov, o tem obvestite zdravnika.
English: Cream 14 sachets 28 sachets 56 sachets
Slovenian: 14 vrečic 28 vrečic 56 vrečic
English: 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.
Slovenian: 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; v štirimesečni študiji na koži miši podobnih učinkov niso opazili.
English: Less than 0.9% of a topically applied single dose of radiolabelled imiquimod was absorbed through the skin of human subjects.
Slovenian: Pri ljudeh se je manj kot 0,9 % lokalno nanesenega enkratnega odmerka radioaktivno označenega imikvimoda absorbiralo skozi kožo.
English: For imiquimod no clinical data on exposed pregnancies are available.
Slovenian: Za imikvimod ni na voljo kliničnih podatkov pri nosečnicah, ki so bile izpostavljene zdravilu.
English: General instructions for treatment
Slovenian: Splošna navodila za zdravljenje
English: Missed dose
Slovenian: Pozabljen odmerek
English: This medicine is prescribed for the treatment of actinic keratosis in adults.
Slovenian: To zdravilo se uporablja za zdravljenje aktinične keratoze pri odraslih.
English: Zyclara should be left on the skin for approximately 8 hours; after this time it is essential that the cream is removed by washing the area and the hands with mild soap and water.
Slovenian: Zdravilo Zyclara je treba pustiti na koži približno 8 ur; po tem obdobju moramo kremo nujno odstraniti tako, da zdravljeni predel in roke umijemo z blagim milom in vodo.
English: Contents of the pack and other information What Zyclara contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zyclara
English: Therefore, imiquimod cream should be used with caution in these patients (see section 4.5).
Slovenian: Zato je treba imikvimod kremo pri teh bolnikih uporabljati previdno (glejte poglavje 4.5).
English: The panel of induced cytokines varies with the cell's tissue origin.
Slovenian: Skupina induciranih citokinov se razlikuje glede na izvor celičnega tkiva.
English: Talk to your doctor before you stop treatment with Zyclara.
Slovenian: Posvetujte se s svojim zdravnikom preden boste prenehali zdravljenje z zdravilom Zyclara.
English: Partially-used sachets should be discarded and not reused.
Slovenian: Delno uporabljenih vrečic se ne sme ponovno uporabiti in jih je treba zavreči.
English: • If you have recently had surgery or medicinal treatment, wait until the area to be treated has healed before using this medicine.
Slovenian: - Če ste imeli pred kratkim operacijo ali ste prejemali zdravila, počakajte, da se predel, ki ga boste zdravili, popolnoma zaceli, preden boste uporabili to zdravilo.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zyclara therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Zyclara, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: A 18-month mouse carcinogenicity study by dermal administration on three days a week did not induce tumours at the application site.
Slovenian: V 18-mesečni študiji kancerogenosti na miših z dermalnim nanašanjem trikrat na teden zdravilo ni sprožilo nastanka tumorjev na mestu nanašanja.
English: While serious sequelae have not resulted, the possibility of infection in broken skin should always be considered.
Slovenian: Čeprav ni prišlo do resnih posledic, se je vedno treba zavedati možnosti okužbe razpokane/poškodovane kože.
English: Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod 5 % cream use.
Slovenian: Poročali so o lokalni hipopigmentaciji in hiperpigmentaciji po uporabi kreme imikvimod 5 %.
English: Rarely, intense local inflammatory reactions including skin weeping or erosion can occur after only a few applications of imiquimod cream.
Slovenian: Redko se intenzivne lokalne vnetne reakcije, vključno z rosenjem ali erozijo kože, lahko pojavijo po zgolj nekaj nanosih imikvimod kreme.
English: Seek medical attention right away if any of these severe side effects occur when using this medicine:
Slovenian: Nemudoma poiščite zdravniško pomoč, če se med uporabo tega zdravila pojavi kateri od naslednjih hudih neželenih učinkov:
English: What you need to know before you use Zyclara Do not use Zyclara.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Zyclara Ne uporabljajte zdravila Zyclara
English: Two open-label randomized, controlled studies investigated the long-term effects of imiquimod 5% (and not with this 3.75% product) in comparison to topical diclofenac (3% gel).
Slovenian: V dveh odprtih, randomiziranih, nadzorovanih študijah so primerjali dolgoročne učinke imikvimoda 5% (in ne s tem 3,75% zdravilom) in lokalnega diklofenaka (3% gel).
English: In animal models imiquimod is effective against viral infections and acts as an antitumour agent principally by inducing release of alpha interferon and other cytokines.
Slovenian: Na živalskih modelih imikvimod učinkovito deluje proti virusnim okužbam in deluje protitumorsko, predvsem zaradi spodbujanja interferona alfa in drugih citokinov.
English: Discard any cream remaining in a sachet after use.
Slovenian: Zavrzite kremo, ki ostane v vrečici po uporabi.
English: The most clinically serious adverse event reported following multiple oral doses of ≥ 200 mg was hypotension which resolved following oral or intravenous fluid administration.
Slovenian: Klinično najresnejši neželeni učinek, o katerem so poročali po uporabi več peroralnih odmerkov ≥ 200 mg, je bila hipotenzija, ki je po uporabi peroralnega ali intravenskega vnosa tekočin izzvenela.
English: Studies in rabbits reveal a dermal lethal imiquimod dose of greater than 5 g/kg.
Slovenian: Študije na kuncih so pokazale, da je dermalni smrtni odmerek večji od 5 g/kg.
English: A transient increase in actinic keratosis counts may be observed during treatment due to the likely effect of imiquimod to reveal and treat subclinical lesions.
Slovenian: Med zdravljenjem lahko pride do prehodnega povečanja števila aktiničnih keratoz zaradi verjetnega učinka imikvimoda na odkrivanje in zdravljenje subkliničnih lezij.
English: Furthermore, imiquimod has the potential to exacerbate inflammatory conditions of the skin.
Slovenian: Imikvimod lahko tudi poslabša vnetna stanja kože.
English: In the event of accidental contact, remove cream by rinsing with water.
Slovenian: V primeru nenamernega stika kremo odstranite s spiranjem z vodo.