qanastek/EMEA-V3 huggingface dataset:
Imiquimod cream therapy is not recommended until the skin has healed after any previous drug or surgical treatment.
It- terapija bil- krema imiquimod mhix rakkomandata sakemm il- ġilda tkun tfieqet minn kull trattament mediċinali jew kirurġiku ta 'qabel.
The use of an occlusive dressing is not recommended with imiquimod cream therapy.
Applikazzjoni fuq gilda maqsuma jista iwassal biex jigi assorbit aktar imiquimod li jista jwassal ghal riskju akbar ta effetti mhux mixtieqa (irriferi ghal sezzjoni 4. 8 u 4. 9) L- użu tal- faxxa okklusiva mhix rakkomandata b' terapija bil- krema imiquimod.
The excipients methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetyl alcohol and stearyl alcohol may cause allergic reactions.
Is- sustanzi mhux attivi methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetyl alcohol u stearyl alcohol jistgħu jikkaġunaw reazzjonijiet allerġiċi.
Rarely, intense local inflammatory reactions including skin weeping or erosion can occur after only a few applications of imiquimod cream.
Rarement, reazzjonijiet ta 'infjammazzjoni lokali li jinkludu l- ġilda tnixxi jew it- tnawwir iseħħu wara ftit applikazzjonijiet bil- krema imiquimod.
Local inflammatory reactions may be accompanied, or even
Reazzjonijiet ta 'infjammazzjoni lokali jistgħu jkunu akkumpanjati, jew ikunu preċeduti b' sinjali u sintomi bħal ta' l- influwenza li jinkludu tħossok ma tiflaħx, deni, nawsea, majlaġji u tregħid.
An interruption of dosing should be considered.
Interruzzjoni fid- dożaġġ għandu jiġi kkonsidrat.
Imiquimod should be used with caution in patients with reduced haematologic reserve (refer to section 4.8d).
Imiquimod għandu jintuża b' kawtela f' pazjenti li għandhom riżerva mnaqqsa ematoloġika (irreferi għal sezzjoni 4. 8d).
There is limited experience in the use of imiquimod cream in the treatment of men with foreskin- associated warts.
Hemm esperjenza ristretta fl- użu tal- krema imiquimod fit- trattament ta ’ irġiel bil- felul assoċjat mal- prepuzju.
The safety database in uncircumcised men treated with imiquimod cream three times weekly and carrying out a daily foreskin hygiene routine is less than 100 patients.
Id- database tas- sigurtà, f’ irġiel mhux ċirkonċiżi, trattati bil- krema imiquimod tliet darbiet fil- ġimgħa u li jaħslu l- prepuzju kuljum bħala rutina hija ta ’ inqas minn 100 pazjent.
In other studies, in which a daily foreskin hygiene routine was not followed, there were two cases of severe phimosis and one case of stricture leading to circumcision.
Fi studji ohra, li fihom ma ġietx segwita r- rutina ta ’ iġene fir- rigward tal- prepuzju, kien hemm żewg każi ta ’ fimosi serji u każ ieħor ta ’ kontrazzjoni li wassal għal ċirkonċiżjoni.
Treatment in this patient population is therefore recommended only in men who are able or willing to follow the daily foreskin hygiene routine.
Għalhekk, it- trattament f’ din il - popolazzjoni ta ’ pazjenti huwa rakkomandat biss għal irġiel li lesti jsegwu rutina ta ’ kuljum fl- iġene tal- prepuzju.
Early signs of stricture may include local skin reactions (e.g. erosion, ulceration, oedema, induration), or increasing difficulty in retracting the foreskin.
Sinjali bikrija ta ’ kontrazzjoni jistgħu jinkludu reazzjonijiet lokali tal- ġilda (p. e. tgħawwir, ulċerazzjoni, edema, twebbis), jew diffikultajiet akbar biex tiritratta l- prepuzju.
If these symptoms occur, the treatment should be stopped immediately.
Jekk dawn is- sintomi iseħħu, it- trattament għandu jieqaf ħesrem.
Based on current knowledge, treating urethral, intra-vaginal, cervical, rectal or intra-anal warts is not recommended.
Bit- tagħrif attwali disponibbli, mhux rakomandat li felul uretrali, intra- vaġinali, ċervikali, rettali u intra- anali jiġi trattat b’ dan il- mod.
Imiquimod cream therapy should not be initiated in tissues where open sores or wounds exist until after the area has healed.
It- terapija bil - krema imiquimod m’ għandhiex tinbeda f’ tessuti fejn hemm feriti miftuħin kemm- il darba din l- erja ma tkunx fieqet.
Local skin reactions such as erythema, erosion, excoriation, flaking and oedema are common.
Reazzjonijiet tal- ġilda lokali bħalma hi eritema, tgħawwir, sliħ, sfoll u edema huma komuni.
Other local reactions such as induration, ulceration, scabbing, and vesicles have also been reported.
Reazzjonijiet lokali oħra bħalma hi ebusija, ulċerazzjoni, inkrostar, u nuffat ġew rapportati wkoll.
Should an intolerable skin reaction occur, the cream should be removed by washing the area with mild soap and water.
Jekk ikun hemm reazzjoni intollerabbli fuq il- ġilda, il- krema għandha titneħħa billi tinħasel l- erja b’ sapuna hafifa u ilma.
Treatment with imiquimod cream can be resumed after the skin reaction has moderated.
It- trattament bil- krema imiquimod jista ’ tissokta wara li r- reazzjoni fuq il- ġilda tkun immoderat.
The risk of severe local skin reactions may be increased when imiquimod is used at higher than recommended doses (see section 4.2).
Ir- riskju ta ’ reazzjonijiet lokali serji tal- ġilda jistgħu jiżdiedu meta imiquimod hu wżat f’ dożi aktar għolja minn dawk rakkomandati (ara sezzjoni 4. 2).
However, in rare cases severe local reactions that have required treatment and/or caused temporary incapacitation have been observed in patients who have used imiquimod according to the instructions.
Madankollu, f’ każijiet rari reazzjonijiet lokali qawwija li kellhom bżonn trattament u/ jew ikkawżaw inkapacità temporanja ġew osservati f’ pazjenti li wżaw imiquimod skond l- istruzzjonijiet.
Where such reactions have occurred at the urethral meatus, some women have experienced difficulty in urinating, sometimes requiring emergency catheterisation and treatment of the affected area.
Meta seħħew dawn ir- reazzjoniiet fil- meatus uretrali, xi nisa sabuha diffiċli biex jgħaddu l- urina, xi drabi wkoll ħtiegu katiterazzjoni ta ’ emerġenza u trattament fl- erja affetwata.
No clinical experience exists with imiquimod cream immediately following treatment with other cutaneously applied drugs for treatment of external genital or perianal warts.
L- ebda esperjenza klinika ma teżisti bil- krema imiquimod applikata minnufiħ wara trattament b’ mediċini kutaneji oħra applikati għat- trattament tal- felul estern jew ta ’ madwar il- parti anali.
Imiquimod cream should be washed from the skin before sexual activity.
Il - krema imiquimod għandha tinħasel minn mal- ġilda qabel kull attività sesswali.
Imiquimod cream may weaken condoms and diaphragms, therefore concurrent use with imiquimod cream is not recommended.
Il- krema imiquimod tista 'iddgħajjef il- kondoms u dijaframmi, għalhekk l- użu konġunt ma' krema imiquimod mhux rakkomandat.
Alternative forms of contraception should be considered.
Forom alternattivi oħra ta ’ kontraċezzjoni għandhom jiġu kunsidrati.
In immunocompromised patients, repeat treatment with imiquimod cream is not recommended.
F’ pazjenti immunikompromessi, trattament ripetut bil- krema imiquimod m’ huwiex rakkomandat.
While limited data have shown an increased rate of wart reduction in HIV positive patients, imiquimod cream has not been shown to be as effective in terms of wart clearance in this patient group.
Għalkemm dejta ristretta wriet rata ogħla fit- tnaqqis tal- felul f’ pazjenti li huma pożittivi bl- HIV, il- krema imiquimod ma wrietx li hi daqstant effettiva fir- rigward ta ’ tneħħija tal- felul f’ dan il- grupp ta ’ pazjenti.
Imiquimod has not been evaluated for the treatment of basal cell carcinoma within 1 cm of the eyelids, nose, lips or hairline.
Imiquimod ma ġiex evalwat għat- trattament ta 'karċinoma taċ- ċellola bażali fi spazju ta' 1ċm mill- kappell ta 'l- għajn, l- imnieħer, ix- xofftejn jew il- linja tax- xahar.
During therapy and until healed, affected skin is likely to appear noticeably different from normal skin.
Waqt it- terapija u sakemm tfiq, il- ġilda affettwata x' aktarx tidher notevolment differenti mill- ġilda normali.
Local skin reactions are common but these reactions generally decrease in intensity during therapy or resolve after cessation of imiquimod cream therapy.
Reazzjonijiet lokali tal- ġilda huma komuni imma dawn ir- reazzjonijiet jonqsu fl- intensità matul it- terapija jew jirrisolvu wara waqfien ta 'terapija bil- krema imiquimod.
There is an association between the complete clearance rate and the intensity of local skin reactions (e.g. erythema).
Hemm assoċjazzjoni bejn ir- rata ta 'tneħħija kompleta u l- intensità tar- reazzjonijiet tal- ġilda lokali (e. g. eritema).
These local skin reactions may be related to the stimulation of local immune response.
Ir - reazzjonijiet tal- ġilda lokali jistgħu jkunu relatati ma 'l- istimulazzjoni tar- rispons immunoloġiku.
If required by the patient’s discomfort or the severity of the local skin reaction, a rest period of several days may be taken.
Jekk meħtieġ minħabba l- iskumdità tal- pazjent jew minħabba is- severità tar- reazzjoni lokali tal- ġilda, jista 'jittieħed perijodu ta' serħan ta 'diversi jiem.
Treatment with imiquimod cream can be resumed after the skin reaction has moderated.
It- trattament bil- krema imiquimod jista ’ jissokta wara li r- reazzjoni fuq il- ġilda tkun immoderat.
5 The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 12 weeks after the end of treatment.
L- eżitu kliniku tat- terapija jista 'jiġi stabbilit wara r- riġenerazzjoni tal- ġilda trattata, madwar 12- il ġimgħa wara t- tmiem tat- trattament.
As data on long-term clearance rates beyond 36 months post-treatment are not currently available, other appropriate therapeutic modalities should be considered for sBCC.
Peress li dejta dwar rati ta 'tneħħija fuq perijodu ta' aktar minn 36 xhar mhumiex disponibbli attwalment, modalitajiet terapewtiċi oħra xierqa għandhom jiġu kkonsidrati għal sBCC.
No clinical experience exists with the use of imiquimod cream in immunocompromised patients.
Ma teżisti ebda esperjenza klinika dwar l- użu tal- krema imiquimod għal pazjenti immunokompromessi.
No clinical experience exists in patients with recurrent and previously treated BCCs, therefore use for previously treated tumours is not recommended.
Ma 'teżisti l- ebda esperjenza klinika għal pazjenti li għandhom BCC rikorrenti jew kienu trattati għalih qabel, għalhekk l- użu għal trattamenti ta' tumuri użati qabel mhux rakkomandat.
Data from an open label clinical trial suggest that large tumours (> 7.25 cm2) are less likely to respond to imiquimod therapy.
Dejta minn prova klinikika b' tikketta tidher tissuġerixxi li tumuri kbar (> 7. 25 ċm2) probabbli li jirrispondu inqas għal terapija b 'imiquimod.
The skin surface area treated should be protected from solar exposure.
L- erja tal- wiċċ tal- ġilda trattata għandha tiġi protetta mill- espożizzjoni tax- xemx.
Actinic keratosis
Keratosi aktinika:
Lesions clinically atypical for AK or suspicious for malignancy should be biopsied to determine appropriate treatment.
Feriti li mhumiex klinikament tipiċi bħal keratosi aktinika( AK) jew li huma suspettużi għal malinnjità għandha issirilhom bijopsija sabiex jiġi stabbilit it- trattament xieraq.
Imiquimod has not been evaluated for the treatment of actinic keratoses on the eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border.
Imiquimod ma ġiex evalwat għat- trattament ta 'keratosi aktinika fuq il- kappell ta' l- għajnejn, ġewwa fl- imnifsejn, jew widnejn, jew iż- żona tax- xoffa ġewwa l- burdura vermiljona.
There are very limited data available on the use of imiquimod for the treatment of actinic keratoses in anatomical locations other than the face and scalp.
Hemm biss dejta ristretta ħafna dwar l- użu ta 'imiquimod għat- trattament ta' keratosi aktinika f' postijiet anatomiċi barra mill- wiċċ u l- qorriegħa.
The available data on actinic keratosis on the forearms and hands do not support efficacy in this indication and therefore such use is not recommended.
Id- dejta disponibbli dwar keratosi aktinika fuq id- dirgħajn mill- minkeb sal- polz u l- idejn ma jsostnux l- effikaċja f' din l- indikazzjoni u għalhekk l- użu għal dan mhux rakkomandat.
Imiquimod is not recommended for the treatment of AK lesions with marked hyperkeratosis or hypertrophy as seen in cutaneous horns.
Imiquimod mhux rakkomandat għat- trattament ta 'feriti ta' keratosi aktinika( AK) b' iperkeratosi jew ipertropija notevoli kif jidher f' kallu kutaneju.
There is an association between the complete clearance rate and the intensity of local skin reactions (e.g. erythema).
Hemm assoċjazzjoni bejn ir- rata ta 'tneħħija kompleta u l- intensità tar- reazzjonijiet tal- ġilda lokali (e. ż. eritema).
If required by the patient’s discomfort or the intensity of the local skin reaction, a rest period of several days may be taken.
Jekk meħtieġ minħabba l- iskumdità tal- pazjent jew minħabba s- severità tar- reazzjoni lokali tal- ġilda, jista 'jittieħed perijodu ta' serħan għal diversi jiem.
The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 4-8 weeks after the end of treatment.
L- eżitu kliniku tat- terapija jista 'jiġi stabbilit wara r- riġenerazzjoni tal- ġilda trattata, madwar 4- 8 ġimgħat wara t- tmiem tat- trattament.
No data are available on re-treating actinic keratoses that have cleared after one or two courses of treatment and subsequently recur, and any such use is therefore not recommended.
L- ebda dejta ma hi disponibbli dwar it- trattament mill- ġdid ta 'keratosi aktinika li għaddiet wara kors jew tnejn ta' trattament u rikorenza sussegwenti, u għalhekk użu bħal dan mhux rakkomandat.
Data from an open-label clinical trial suggest that subjects with more than 8 AK lesions showed a decreased rate of complete clearance compared to patients with less than 8 lesions.
Dejta minn prova klinika bit- tikketta tidher tissuġerixxi li pazjenti b' aktar minn 8 leżjonijiet dovuti għal keratosi aktinika( AK) wrew tnaqqis fir- rata ta 'tneħħija kompleta meta mqabbla ma' pazjenti b' inqas minn 8 feriti.
6 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
This includes studies with immunosuppressive drugs.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott Dan jinkludi studji b' mediċini immunisuppressivi.
Interactions with systemic drugs would be limited by the minimal percutaneous absorption of imiquimod cream.
Dawn l- interazzjonijiet mal- mediċini sistemiċi jkunu limitati bl- assorbiment perkutaneju minimu tal- krema imiquimod.
Due to its immunostimulating properties, imiquimod cream should be used with caution in patients who are receiving immunosuppressive medication (see Section 4.4).
Minħabba l- karatteristiċi immunostimulanti, il- krema imiquimod għandha tintuża b' kawtela f' pazjenti li qed jirċievu mediċini immunosuppressivi (ara Sezzjoni 4. 4).
For imiquimod no clinical data on exposed pregnancies are available.
Għal imiquimod m' hemmx tagħrif kliniku fuq tqalat esposti.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see 5.3).
Studji fuq annimali m’ humiex biżżejjed rigward l- effetti fuq it- tqala jew fuq l- iżvilupp ta ’ l- embriju / fetu / jew il- ħlas jew l- żvilupp wara t - twelid (ara 5. 3).
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.
Billi m' hemmx livelli kwantitattivi (> 5 ng/ ml) rivelati ta 'imiquimod fis- sirum wara doża waħda jew multipli, l- ebda rakkomandazzjoni ma tista' tingħata dwar l- użu jew le lin- nisa li qed ireddgħu.
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.
Mill- effetti mhux mixtieqa nnotati f’ sezzjoni 4. 8, m’ huwiex probabbli li t- trattament ikollu xi effett fuq il- ħila biex issuq u tħaddem magni.
a) General Description:
a) Deskrizzjoni Ġenerali:
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).
Fil- provi pivitali b’ dożaġġ ta ’ 3 darbiet fil- ġimgha, l- aktar reazzjonijiet avversi tal- mediċina rapportati li ġew iġġudikati li probabilment jew possibilment huma relatati mal- krema imiquimod kienu reazzjonijiet fuq il- lok ta’ applikazzjoni fis- sit ta ’ trattament tal- felul (33. 7% ta 'pazjenti trattati b' imiquimod).
Some systemic adverse reactions, including headache (3.7%), influenza-like symptoms (1.1%), and myalgia (1.5%) were also reported.
Xi reazzjonijiet sistemiċi avversi, li jinkludu uġigħ ta ’ ras (3. 7%), sintomi ta 'l - influwenza (1. 1%), u milaġja (1. 5) ġew rapportati wkoll.
Patient reported adverse reactions from 2292 patients treated with imiquimod cream in placebo controlled and open clinical studies are presented below.
Reazzjonijiet avversi rapportati mill- pazjenti minn 2292 pazjenti trattati bil- krema imiquimod fi studji kontrollati bi plaċebo u studji kliniċi miftuħa huma preżentati hawn isfel.
These adverse events are considered at least possibly causally related to treatment with imiquimod.
Dawn il- każijiet avversi huma konsidrati li ta 'lanqas huma possibilment b' mod każwali relatati mat- trattament b' imiquimod.
In trials with 5 times per week dosing 58% of patients experienced at least one adverse event.
Fi provi b' doża ta ’ 5 darbiet kull ġimgħa 58% tal- pazjenti ħassew ta 'lanqas avveniment avvers wieħed.
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%.
L- aktar każijiet avversi frekwentament rapportati mill- provi li probabilment jew possibilment huma dikjarati li setgħu seħħew minħabba l- krema imiquimod huma disturbi tas- sit ta 'l- applikazzjoni, bi frekwenza ta' 28. 1%.
Some systemic adverse reactions, including back pain (1.1%) and influenza-like symptoms (0.5%) were reported by imiquimod cream patients.
Xi reazzjonijiet sistematiċi avversi, li jinkludu uġigħ fid- dahar (1. 1%) u sintomi bħal ta 'l- influwenza (0. 5%) ġew rapportati f' pazjenti li użaw il- krema imiquimod.
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.
Reazzjonijiet avversi rapportati minn pazjenti f' 185 pazjent li kienu qed jużaw il- krema imiquimod fi studji kliniċi ta 'fażi III ikkontrollati bi plaċebo għal karċinoma superfiċjali taċ- ċellola bażali huma preżentati hawn isfel.
The most frequently reported adverse event
Fil- provi pivitali b' doża li tittieħed 3 darbiet fil- ġimgħa u meħuda fuq 2 korsijiet kull wieħed ta '4 ġimgħat, 56% tal- pazjenti fuq imiquimod irraportaw ta' lanqas każ avvers wieħed.
7 from these trials judged probably or possibly related to imiquimod cream was application site reactions (22% of imiquimod treated patients).
L- aktar każ avvers f' dawn il- provi rrappurtat b' mod frekwenti li possibilment jew probabilment huwa relatat mal- krema imiquimod kien dak ta ’ reazzjonijiet fuq is- sit t' applikazzjoni (22% ta 'pazjenti trattati b' imiquimod).
Some systemic adverse reactions, including myalgia (2%) were reported by imiquimod treated patients.
Xi reazzjonijiet avversi sistematiċi, li jinkludu uġigħ fil- muskolu (2%) ġew rapportati f' pazjenti trattati b' imiquimod.
Patient reported adverse reactions from 252 patients treated with imiquimod cream in vehicle controlled phase III clinical studies for actinic keratosis are presented below.
Reazzjonijiet avversi rapportati minn pazjenti minn 252 pazjent li kienu qed jużaw il- krema imiquimod fi studji kliniċi ta 'fażi III għal keratinosi aktinika ikkontrollati permezz ta' midjum huma preżentati hawn isfel.
b) Tabular Listing of adverse events:
b) Każijiet avversi elenkati f' tabella:
Frequencies are defined as Very common (≥1/10), Common (≥1/100 to < 1/10) and Uncommon (≥1/1,000 to < 1/100).
Il- frekwenzi huma mfissra bħala Komuni ħafna (≥ 1/ 10), Komuni (≥1/ 100 sa < 1/ 10) u Mhux komuni (≥1/ 1, 000 sa < 1/ 100).
Lower frequencies from clinical trials are not reported here.
Frekwenzi aktar baxxi minn provi kliniċi m' humiex rapportati hawn.
External genital warts
Felul ġenitali fuq barra:
Superficial basal cell carcinoma
Karċinoma superfiċjali taċ -
(3x/ wk,16wks) N = 2292
(3x / ġmgħ, 16ġmgħ) N = 2292
(5x/wk, 6 wks) N = 185
ċellola bażali (5x/ ġmgħ, 6 ġmgħ) N = 185
(3x/wk, 4 or 8 wks) N = 252
(3x/ ġmgħ, 4 jew 8 ġmgħ) 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:
Infezzjoni Infafet Herpes simplex Kandidjasi ġenitali Vaġinite Infezzjoni batterika Infezzjoni fungali Infezzjoni fil- parti ta 'fuq ta' l - apparat respiratorju.
Common Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon
Komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni
Common Common
Mhux komuni Mhux komuni
Uncommon Uncommon Uncommon Uncommon
Mhux komuni Mhux komuni
Lymphadenopathy Metabolism and nutrition disorders:
Disturbi tad- demm u tas- sistema limfatika:
Anorexia Psychiatric disorders:
Disturbi fil- metaboliżmu u n - nutrizzjoni:
Insomnia
Nuqqas ta 'rqad
Depression Irritability Nervous system disorders:
Dipressjoni Irritabilità fis- sistema nervuża:
Headache Paraesthesia Dizziness Migraine Somnolence Eye disorders
Uġigħ ta 'ras Paraestesja Sturdament Migranja Ħedla
Common Uncommon Uncommon Uncommon Uncommon
Komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni
Conjunctival irritation Eyelid oedema Ear and labyrinth disorders:
Disturbi fl- għajnejn
Tinnitus Vascular disorders:
Disturbi fil- widnejn u fis- sistema labirintika:
Flushing Respiratory, thoracic and mediastinal disorders:
Disturbi vaskulari
Uncommon
Fwawar
8
Disturbi respiratorji, toraċiċi u medjastinali
Rhinitis Nasal congestion Pharyngo laryngeal pain
Farinġite Rinite Konġestjoni nażali Uġigħ farinġjo- laringeali
Nausea Abdominal pain
Tqallih Uġgħ addominali
Diarrhoea Vomiting Rectal disorder Rectal tenesmus Dry mouth
Dijarrea Remettar Disturbi tar- rektum Tenesmus tar- rektum Ħalq xott
Uncommon Uncommon Uncommon Uncommon
Mhux komuni Mhux komuni Mhux komuni Mhux komuni
Skin and subcutaneous tissue disorders:
Disturbi fil- ġilda u fit- tessuti ta 'taħt il- ġilda:
Pruritus
Prurite
Dermatitis Folliculitis Rash erythematous Eczema Rash Sweating increased Urticaria Actinic keratosis Erythema Face oedema Skin ulcer
Eritema edema tal- wiċċ Ulċera tal- ġilda
Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon
Mhux komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni
Musculoskeletal and connective tissue disorders:
Disturbi muskolu- skeletrali u tal - connective tissue
Myalgia Arthralgia Back pain Pain in extremity
Mijalġja Artralġja Uġigħ tad- dahar Uġigħ fl- estremità
Common Uncommon Uncommon
Komuni Mhux komuni Mhux komuni
Common Common Uncommon
Komuni Komuni Mhux komuni
Dysuria
Dajsurja
Genital pain male Penile disorder Dyspareunia Erectile dysfunction Uterovaginal prolapse Vaginal pain Vaginitis atrophic Vulval disorder
Uġigħ ġenitali fl- irġiel Disturb fil- pene Disparewnja Impotenza Prolassi uterovaġinali Uġigħ vaġinali Vaginite atropika Disturb vulvali
Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon
Mhux komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni Mhux komuni
General disorders and administration site conditions:
Disturbi ġenerali u kundizzjonijiet ta 'mnejn jingħata:
Application site pruritus Application site pain Application site burning Application site irritation Application site erythema Application site reaction
Prurite fis- sit ta 'l- applikazzjoni Uġgħ tas- sit ta' l- applikazzjoni Ħruq fis- sit ta 'l- applikazzjoni Irritazzjoni fis- sit t' applikazzjoni Eritema fis- sit t' applikazzjoni Reazzjoni fis- sit t' applikazzjoni
Very common Very common Common Common
Komuni ħafna Komuni ħafna Komuni Komuni
Very common Common Common Common Common
Komuni ħafna Komuni Komuni Komuni Komuni
Very common Common Common Common Common Common
Komuni ħafna Komuni Komuni Komuni Komuni Komuni
Application site bleeding Application site papules Application site paraesthesia
Fsada fis- sit t' applikazzjoni Nuffat fis- sit t' applikazzjoni Paraestesja fis- sit t' applikazzjoni Raxx fis- sit t' applikazzjoni
Common Common Common
Komuni Komuni Komuni Komuni
Fatigue Pyrexia Influenza-like illness Pain
Għejja Deni mard bħal ta 'l- influwenza Uġigħ
Common Uncommon Uncommon Uncommon
Komuni Mhux komuni Mhux komuni Mhux komuni
Asthenia Malaise
Astenja Telqa
Rigors Application site dermatitis
Sirdat Dermatite fis- sit t' applikazzjoni
Application site discharge Application site hyperaesthesia Application site inflammation
Tnixxija fis- sit t' applikazzjoni Iperestesja fis- sit t' applikazzjoni Infjammazzjoni fis- sit
Application site oedema Application site scabbing Application site scar Application site skin breakdown
Edema fis- sit t' applikazzjoni Tnixxif fis- sit t' applikazzjoni Briex fis- sit t' applikazzjoni Il- ġilda tinkiser fis- sit
Application site swelling Application site ulcer
Tinfiħ fis- sit t' applikazzjoni Ulċera fis- sit t' applikazzjoni
Appli cation site vesicles Application site warmth Lethargy Discomfort Inflammation
Infafet fis- sit t' applikazzjoni Sħana fis- sit t' applikazzjoni Letarġija Skonfort Infjammazzjoni
c) Frequently occurring adverse events:
Każijiet avversi li jseħħu ta 'spiss:
Investigators of placebo controlled trials were required to evaluate protocol mandated clinical signs (skin reactions).
Investigaturi tal- provi kontrollati bi plaċebo kienu meħtieġa li jevalwaw sinjali kliniċi obbligati bi protokoll (reazzjonijiet tal- ġilda).
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).
Dawn l- istimi tas- sinjali kliniċi obbligati bi protokoll jindikaw li r- reazzjonijiet lokali fuq il- ġilda li jinkludu eritema (61%), tnawwir (30%), sliħ/ sfoll/ qxur (23%) u edema (14%) kienu komuni f' dawn il- provi kliniċi kontrollati bi plaċebo bil- krema imiquimod applikata tliet darbiet fil- ġimgħa (ara sezzjoni 4. 4).
Local skin reactions, such as erythema, are probably an extension of the pharmacologic effects of imiquimod cream.
Reazzjonijiet tal- ġilda lokali, bħal eritema, huma probabilment estensjoni ta 'l- effetti farmakoloġiċi tal- krema imiquimod.
Remote site skin reactions, mainly erythema (44%), were also reported in the placebo controlled trials.
Reazzjonijiet tal- ġilda f' sit remot, prinċipalment eritema (44%), kienu wkoll rapportati fi provi kliniċi kontrollati bi plaċebo.
These reactions were at non-wart sites which may have been in contact with imiquimod cream.
Dawn ir- reazzjonijiet kienu siti li ma kellhomx felul li setgħu ġew f' kuntatt mal- krema imiquimod.
Most skin reactions were mild to moderate in severity and resolved within 2 weeks of treatment discontinuation.
Il- biċċa l- kbira minn dawn ir- reazzjonijiet kienu ħfief sa moderati fil- qawwa tagħhom u rrisolvew fi żmien ġimagħtejn wara l- waqfien tat- trattament.
However, in some cases these reactions have been severe, requiring treatment and/or causing incapacitation.
Madankollu, f' xi każijiet dawn ir- reazzjonijiet kienu serji, kienu jeħtieġu t- trattament u/ jew jikkawżaw inkapaċità.
In very rare cases, severe reactions at the urethral meatus have resulted in dysuria in women (see section 4.4).
F' każijiet rari ħafna, reazzjonijiet qawwija fil- meatus uretrali wassal għal disurja fin- nisa (ara sezzjoni 4. 4).
Investigators of the placebo controlled clinical trials were required to evaluate protocol mandated clinical signs (skin reactions).
Investigaturi tal- provi kliniċi kontrollati bi plaċebo kienu meħtieġa li jevalwaw sinjali kliniċi obbligati bi protokoll (reazzjonijiet tal- ġilda).
These protocol mandated clinical sign assessments indicate that severe erythema (31%) severe erosions (13%) and severe scabbing and crusting (19%) were very common in these trials with imiquimod cream applied 5 times weekly.
Dawn l- istimi tas- sinjali kliniċi obbligati bi protokoll jindikaw li eritema serja (31%), tnawwir serju (13%), u tnixxif u qxur (19%) kienu komuni ħafna f' dawn il- provi kliniċi bil- krema imiquimod applikata 5 darbiet fil- ġimgħa (ara sezzjoni 4. 4 għal aktar dettalji).
Local skin reactions, such as erythema, are probably an extension of the pharmacologic effect of imiquimod cream.
Reazzjonijiet tal- ġilda lokali, bħal eritema, huma probabilment estensjoni ta 'l- effetti farmakoloġiċi tal- krema imiquimod.
Skin infections during treatment with imiquimod have been observed.
Infezzjonijiet tal- ġilda matul it- trattament b' imiquimod ġew osservati.
While serious sequelae have not resulted, the possibility of infection in broken skin should always be considered.
Filwaqt li sequelae serja ma rriżultatx, il- possibilità ta 'infezzjoni f' ġilda maqsuma għandha dejjem tiġi kkonsidrata.
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%).
Fil- provi kliniċi bil- krema imiquimod 3 darbiet fil- ġimgħa għal 4 jew 8 ġimgħat l- aktar reazzjonijiet frekwenti li seħħew fis- sit t' applikazzjoni kienu ħakk fis- sit bersalljat (14%) u ħruq fis- sit bersalljat (5%).
Severe erythema (24%) and severe scabbing and crusting (20%) were very common.
Eritema qawwija (24%) u tnixxif u qxur (20%) kienu komuni ħafna.
See 4.2 an d 4.4 for information on rest periods.
Ara 4. 2 u 4. 4 għal informazzjoni fuq perijodi ta 'serħan.
d) Adverse events applicable to all indications:
d) Reazzjonijiet avversi applikabbli għall- indikazzjonijiet kollha:
Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod cream use.
Waslu rapporti ta 'ipopigmentazzjoni u iperpigmentazzjoni lokalizzata wara l- użu bil- krema imiquimod.
Follow-up information suggests that these skin colour changes may be permanent in some patients.
Informazzjoni sussegwenti tissuġerixxi li dawn il- bidliet fil- kulur tal- ġilda jistgħu jkunu permanenti f' xi pazjenti.
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.
Studji kliniċi li jistħarrġu l- użu ta 'imiquimod għat- trattament ta' keratosi aktinika rrivelaw frekwenza ta '0. 4% (5/ 1214) ta' alopeċja fis- sit ta 'trattament taż- żona tal- madwar.
Postmarketing reports of suspected alopecia occurring during the treatment of sBCC and EGW have been received.
Waslu rapporti ta 'wara t - tqegħid fis- suq li hemm suspett t' alopeċja waqt it- trattament ta' sBCC u EGW.
Reductions in haemoglobin, white blood cell count, absolute neutrophils and platelets have been observed in clinical trials.
Tnaqqis fl- emoglobina, fl- għadd totali ta 'ċelloli tad- demm, newtrofili u plejtlits assoluti ġew osservati fil- provi kliniċi.
These reductions are not considered to be clinically significant in patients with normal haematologic reserve.
Dan it- tnaqqis mhux ikkonsidrat li hu klinikament sinifikattiv f' riżerva ematoloġika normali.
Patients with reduced haematologic reserve have not been studied in clinical trials.
Pazjenti li għandhom riżerva ematoloġika mnaqqsa ma ġewx studjati fl- istudji kliniċi.
Reductions in haematological parameters requiring clinical intervention have been reported from postmarketing experience.
Tnaqqis fil- parametri ematoloġiċi li jinħtieġu intervent kliniku ġew rapportati fl- esperjenza wara t- tqegħid fis - suq.
There have been postmarketing reports of elevated liver enzymes.
Wara it- tqegħid fis- suq, kien hemm rapporti ta ’ livelli oghlja ta ’ enzimi tal- fwied.
Rare reports have been received of exacerbation of autoimmune conditions.
Waslu rapporti rari li kundizzjonijiet awtoimmuni ħraxu.
Rare cases of remote site dermatologic drug reactions, including erythema multiforme, have been reported from clinical trials.
Waslu rapporti minn provi kliniċi ta 'każijiet rari dwar reazzjonijiet dermatoloġiċi għal mediċina f' sit remot, li jinkludi eritema multiforme.
Serious skin reactions reported from postmarketing experience include erythema multiforme, Stevens Johnson syndrome and cutaneous lupus erythematosus.
Kien hemm rapporti ta 'reazzjonijiet serji tal- ġilda mill - esperjenza ta' wara t- tqegħid fis- suq dwar erythema multiforme, is- sindromu ta 'Stevens Johnson u lupus eritematosi kutanea.
When applied topically, systemic overdosage with imiquimod cream is unlikely due to minimal percutaneous absorption.
Meta applikat topikament, doża sistematika eċċessiva bil- krema imiquimod mhux probabbli sseħħ minħabba assorbenza perkutanea minima.
Studies in rabbits reveal a dermal lethal dose of greater than 5 g/kg.
Studji fil- fniek rrivelaw doża letali dermali ta ’ aktar minn 5g/ kg.
Persistent dermal overdosing of imiquimod cream could result in severe local skin reactions.
Dożagg dermali eċċessiv u persistenti tal- krema imiquimod tista ’ twassal ghal reazzjonijniet lokali severi tal- ġilda.
Following accidental ingestion, nausea, emesis, headache, myalgia and fever could occur after a single dose of 200 mg imiquimod which corresponds to the content of approximately 16 sachets.
Wara inġestjoni aċċidentali, jista 'jkun hemm tqallih, emesi, uġigh ta ’ ras, uġigħ tal- muskoli u deni wara doża waħdanija ta ’ 200 mg imiquimod li tikkorispondi mal- kontenut ta’ 16- il qartas.
The most clinically serious adverse event reported following multiple oral doses of ≥ 200 mg was hypotension which resolved following oral or intravenous fluid administration.
L- aktar każ kliniku avvers serju rapportat wara teħid ta ’ dożi orali ta ’ ≥ 200 mg kien ta ’ ipotensjoni li gie riżolt wara tehid ta ’ fluwidi b’ mod orali jew fil- vini.
5.1 Pharmacodynamic properties:
5. 1 Tagħrif farmakodinamiku
Chemotherapeutics for topical use, antivirals:
Kemoterapewtiċi għall- użu topiku, antivirali:
Imiquimod is an immune response modifier.
Imiquimod huwa modifikatur li jirrispondi fis- sistema immuni.
Saturable binding studies suggest a membrane receptor for imiquimod exists on responding immune cells.
Studji eżawrjenti marbuta jissuġerixxu li riċevitur fil- membrana għal imiquimod jeżisti fiċ- ċelloli immuni li jirrispodu.
Imiquimod has no direct antiviral activity.
Imiquimod m’ għandux effett antivirali dirett.
The induction of alpha interferon and
F’ annimali mudelli, imiquimod huwa effettiv kontra l- infezzjonijiet virali u jaħdem bħala aġent ewlieni kontra t- tumuri bl- indukrar ta ’ alpha interferon u ċitokini oħra.
11 other cytokines following imiquimod cream application to genital wart tissue has also been demonstrated in clinical studies.
Is- sensitizzazzjoni ta ’ alpha interferon u ċitokini oħra wara l- applikazzjoni tal- krema imiquimod għal felul li jinsab fit- tessut ġenitali ġie stabbilit fi studji kliniċi.
Increases in systemic levels of alpha interferon and other cytokines following topical application of imiquimod were demonstrated in a pharmacokinetic study.
Żidied fil- livelli sistematiċi t' alpha interferon u ċitokoni oħra wara applikazzjoni topikali ta 'imiquimod ġew murija fi studju farmakokinetiku.
The results of 3 phase III pivotal efficacy studies showed that treatment with imiquimod for sixteen weeks was significantly more effective than treatment with vehicle as measured by total clearance of treated warts.
Effikaċja klinikali Ir- riżultati ta ’ 3 studji ewlenien ta ’ fażi III fuq l- effetività urew li t- trattament bl- imiquimod għal sittax - il ġimgħa kienu sinjifikattivament aktar effettivi mit- trattament bil- vettura kif imkejjel ghat- tneħħija totali ta ’ felul itrattat.
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:
F’ 119- il pazjent mara ttrattati bl- imiquimod, ir- rata totali kkombinata ta ’ eliminazzjoni kienet ta ’ 60% meta mqabbla ma 20% f’ 105 pazjenti trattati bil- vettura (95% CI ghad- differenza tar- rata:
20% to 61%, p < 0.001).
20% sa 61%, p < 0. 001).
In those imiquimod patients who achieved total clearance of their warts, the median time to clearance was 8 weeks.
F’ dawk il- pazjenti li l- felul kollu tneħħa, iż- żmien medjan ta ’ tneħħija kienet ta ’ 8 ġimghat.
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:
F’ 157 pazjent raġel ittrattat bl- imiquimod, ir- rata totali kkombinata ta ’ tneħhija kienet ta ’ 23% meta mqabbla ma 5% f’ 161 pazjent trattat bil- vettura (95% CI ghad- differenza tar- rata:
3% to 36%, p < 0.001).
3% sa 36%, p < 0. 001).
In those imiquimod patients who achieved total clearance of their warts, the median time to clearance was 12 weeks.
F’ dawk il- pazjenti li kienu qed jużaw imiquimod li l- felul tagħhom tneħħa kollu, iż- żmien medjan ta ’ tneħħija kien ta’ 12- il ġimgha.
Clinical efficacy:
Effikaċja klinikali
The efficacy of imiquimod 5 times per week for 6 weeks was studied in two double-blind vehicle controlled clinical trials.
L- effikaċja ta 'imiquimod li jingħata 5 darbiet fil- ġimgħa għal 6 ġimgħat kien studjat f' żewġ provi kliniċi double blind kontrollati.
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.
Tumuri bersalljati kienu istoloġikament konfermati li kienu karċinomi superfiċjali ta 'ċellula bażali b' daqs minimu ta' 0. 5 ċm2 u b' dijametru massimu ta '2 ċm.
Tumours located within 1 cm of the eyes, nose, mouth, ears or hairline were excluded.
Tumuri li kienu jinsabu fi ħdan 1 ċm mill- għajnejn, l- imnieħer, il- widnejn jew l- linja tax- xagħar kienu esklużi.
In a pooled analysis of these two studies, histological clearance was noted in 82% (152/185) of patients.
F' analiżi puljata ta 'dawn l- istudji, it- tneħħija istoloġika ġiet innotata fi 82% (152/ 185) ta' pazjenti.
When clinical assessment was also included, clearance judged by this composite endpoint was noted in 75% (139/185) of patients.
Meta eżami kliniku ġie inkluż ukoll, it- tneħħija dikjarata permezz ta 'dan il- punt ta' tmiem kompost ġiet innotata f' 75% (139/ 185) ta 'pazjenti.
These results were statistically significant (p < 0.001) by comparison with the vehicle group, 3% (6/179) and 2% (3/179) respectively.
Dawn ir- riżultati kienu statistikament sinifikanti (p < 0. 001) bi tqabbil mal- vehicle group, 3% (6/ 179) u 2% (3/ 179) rispettivament.
There was a significant association between the intensity of local skin reactions (e.g. erythema) seen during the treatment period and complete clearance of the basal cell carcinoma.
Kien hemm assoċjazzjoni sinifikanti bejn l- intensità tar- reazzjonijiet lokali tal- ġilda (eż. eritema) li dehret waqt il- perijodu ta 'trattament u ta ’ tneħħija kompluta tal- karċinoma taċ- ċellola bażali.
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.
Dejta miġbura fuq erba snin minn studju mingħajr kontrolli b' tikketta li tidher tindika stima ta '79. 3% [95% CI (73. 7%, 84. 9%)] tal- pazjenti kollha li inizjalment bdew it- trattament saru klinikament ċari u baqgħu ċari wara 48 xahar.
Data on recurrence rates beyond 48 months are not yet available.
Dejta dwar rati ta 'rikorrenza lil hinn minn 48 xahar għadhom m' humiex disponibbli.
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.
L- effikaċja ta 'imiquimod applikat 3 darbiet fil- ġimgħa għal kors wieħed jew żewġ korsijiet ta' 4 ġimgħat, isseparati b' perijodu mingħajr trattament ta '4 ġimgħat, ġie studjat f' żewġ provi kliniċi double- blind vehicle controlled.
Patients had clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions on the balding scalp or face within a contiguous 25 cm2 treatment area.
Il- pazjenti kellhom leżjonijiet ta 'kertosi aktinika klinikament tipiċi, viżibbli, diskreti, li mhumiex iperkeratoniċi, li mhumiex ipertropiċi fuq il- qorriegħa li qed titfartas jew wiċċ fi ħdan 25 cm2 erja ta' trattament.
The complete clearance rate (imiquimod minus placebo) for the combined trials was 46.1% (CI 39.0%, 53.1%).
4- 8 leżjonijiet ta 'kertosi aktinika ġew trattati. Ir- rata ta' tneħħija kompluta (imiquimod nieqes il- plaċebo) għal provi kombinati kienet ta '46. 1% (CI 39. 0%, 53. 1%).
One-year data from two combined observational studies indicate a recurrence rate of 27% (35/128 patients) in those patients who became clinically clear after one or two courses of treatment.
Dejta fuq sena minn żewġ studji t' osservazzjoni kombinati jindikaw stat ta 'rikorrenza ta' 27% (35/ 128 pazjent) f' dawk il- pazjenti li saru klinikament ċari wara kors jew tnejn ta 'trattament.
12 The recurrence rate for individual lesions was 5.6% (41/737).
Ir- rata ta 'rikorrenza għal leżjonijiet individwali kienet ta' 5. 6% (41/ 737).
Corresponding recurrence rates for vehicle were 47% (8/17 patients) and 7.5% (6/80 lesions).
Rati ta 'rikorrenza korrispondenti għal vettura kienu 47% (8/ 17- il pazjent) u 7. 5% (6/ 80 leżjoni).
The rate of progression to squamous cell carcinoma (SCC) was reported in 1.6% (2/128 patients).
Ir- rata ta 'firxa għal karċinoma ta' ċellola skwamuża (SCC) ġiet rapportata f' 1. 6% (2/ 128 pazjent).
There are no data on recurrence and progression rates beyond 1 year.
Ma kienx hemm dejta fuq rati ta 'rikorrenza u progressjoni lil hinn aktar minn sena.
The approved indications genital warts, actinic keratosis and superficial basal cell carcinoma are conditions not generally seen within the paediatric population and were not studied.
Pazjenti pedjatrici L- indikazzjonijiet approvati ta ’ felul genitali, keratosi aktinika u karċinoma superfiċjali taċ- ċelluli bażali m`humiex kundizzjonijiet li wiehed normalment jara f’ popolazzjoni pedjatrika w ma gewx studjati.
Aldara Cream has been evaluated in four randomised, vehicle controlled, double-blind trials in children aged 2 to 15 years with molluscum contagiosum (imiquimod n = 576, vehicle n = 313).
Il - krema Aldara giet evalwata f`erbgha studji ikkontrollati bla ghazla, “ vehicle controlled ” “ double blind ” fuq tfal bejn is - 2- 15 il- sena bil molluskum kontagjosum (imiquimod n=576, vettura n=313).
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).
Dawn il- provi naqsu milli juru l- effikaċja ta ’ imiquimod f’ kull doża li ġiet ittestjata (3X/ fil- gimgha ghal ≤ 16 il- gimgha u 7X/ fil- gimgha ghal ≤ 8 gimghat).
Less than 0.9% of a topically applied single dose of radiolabelled imiquimod was absorbed through the skin of human subjects.
Inqas minn 0. 9% ta ’ doża wahda applikata topikament ta ’ imiquimod radjoattiv gie assorbit mill- gilda ta ’ suggetti bnedmin.
The small amount of drug 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.
L- ammont żgħir ta ’ mediċina assorbita fiċ- ċirkolazzjoni sistemika ġiet eliminata minnufiħ bir- rotot urinarji u fekali fil proporzjon medju ta ’ 3 għal 1.
No quantifiable levels (> 5 ng/ml) of drug were detected in serum after single or multiple topical doses.
L- ebda livell kwantifikabbli (> 5 ng/ ml) ta ’ farmaċewtiku ma ġie intraċċat fis- serum wara doża waħda jew dożi topiċi multipli.
Systemic exposure (percutaneous penetration) was calculated from recovery of carbon-14 from [14C] imiquimod in urine and faeces.
Espożizzjoni sistemika (penetrazzjoni perkutanea) ġiet ikkalkulata bl- irkupru ta ’ karbonju- 14 [14C] imiquimod fl- urina u l- ippurgar.
The extent of percutaneous absorption did not change significantly between the first and last doses of this study.
L- assorbiment sistematiku minimu ta 'krema ta' 5% imiquimod tul il- ġilda ta '58 pazjent b' keratosi aktinika ġiet osservata b' dożaġġ ta' 3 darbiet fil- ġimgħa għal 16- il ġimgħa. Il- firxa ta 'assorbiment perkutaneju ma nbidletx b' mod sinifikanti bejn l- ewwel u l- aħħar doża f' dan l- istudju.
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.
L- ogħla konċentrazzjonijiet tal- mediċina fis- sirum fl- aħħar ta 'ġimgħa 16 kienu osservati bejn 9 u 12- il siegħa wara u kienu 0. 1, 0. 2, u 1. 6 ng/ mL għall- applikazzjonijiet fuq il- wiċċ (12. 5 mg, qartas 1 li jintuża darba), il- qorriegħa (25 mg, 2 qratas) u l- idejn/ dirgħajn (75 mg, 6 qratas), rispettivament.
The application surface area was not controlled in the scalp and hands/ arms groups.
L- erja superfiċjali t' applikaazzjoni ma ġietx ikkontrollata fil- gruppi tal- qorriegħa u l- idejn/ dirgħajn.
Dose proportionality was not observed.
Il- proporzjonalità tad- doża ma ġietx osservata.
Urinary recovery was less than 0.6% of the applied dose at week 16 in these patients.
Half- life apparenti kienet ikkalkulata li kienet madwar 10 darbiet akbar mill- ħalf- life ta 'sagħtejn li dehret wara dożi subkutaneji fi studju preċedenti, li jissuġerixxi żamma mdewma tal- mediċina fuq il- ġilda L- irkupru awrinarju kien anqas minn 0. 6% tad- doża applikata f' ġimgħa 16 f' dawn il- pazjenti.
Paediatric patients:
Pazjenti pedjatrici
The pharmacokinetic properties of imiquimod following single and multiple topical application in paediatric patients with molluscum contagiosum (MC) have been investigated.
Il- karatteristici tal- farmakokinetika ta` “ imiquimod ” f`pazjenti pedjatrici bill- molluskum kontagjosum (MK) gew investigati.
The systemic exposure data demonstrated that the extent of absorption of imiquimod following topical application to the MC lesional skin of the paediatric patients aged 6-12 years was low and comparable to that observed in healthy adults and adults with actinic keratosis or superficial basal cell carcinoma.
Dejta fuq l - “ imiquimod ” applikat fuq il- ġilda tal- wiċċ b`lessjoni ta MK f`pazjenti pedjatriċi ta` eta ta ’ bejn 6- 12 il- sena turi li l- ammont li gie assorbit sistematikament kienu baxxi w jikkumparaw ma dawk li ġew osservati f`adulti b`saħħitom w adulti b`keratosi aktinika jew karċinoma superfiċjali taċ- ċelluli bażali.
In younger p atients aged 2-5 years absorption, based on Cmax values, was higher compared to adults.
F`pazjenti zghar ta ’ eta ’ ta ’ bejn 2- 5 snin l- ammont assorbit ibbazat fuq valuri Cmassimu, kien aktar gholi meta ikkumparat ma dak ta` adulti.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity and teratogenicity.
Dejta mhux klinika bażata fuq studji konvenzjonali ta ’ farmakoloġija sikura, mutaġeniċità u teratoġeniċità, ma wriet l- ebda periklu speċjali għal bniedem.
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.
Fi studju tossiku- dermali fil- firien mifrux fuq erba ’ xhur, tnaqqis sinjifikanti tal- piż tal- ġisem u żieda fil- piż tal- milsa ġie osservat f’ 0. 5 u 2. 5 mg/ kg; effetti bhal dawn ma ntwerewx fuq studju dermali tal- ġrieden mifrux fuq erba ’ xhur.
Local dermal irritation, especially at higher doses, was observed in both species.
Irritazzjoni dermali lokali, speċjalment f’ dożi ogħla, ġie osservat fiż - żewġ speċi.
13 A two-year mouse carcinogenicity study by dermal administration on three days a week did not induce tumours at the application site.
Studju karsinoġeniku ta ’ sentejn fuq il- ġrieden bit- teħid dermali tliet darbiet fil- ġimgha ma ’ stimulax tumuri fil- lok t’ applikazzjoni.