qanastek/EMEA-V3 huggingface dataset:
Agenerase is used in protease inhibitor experienced HIV -1 infected adults and children above the age of 4 years.
Agenerase jintuża fl- adulti u tfal minn erbà snin ‘ il fuq, li huma infettati bl- HIV- 1 u li jkunu għamlu żmien taħt kura bl- inibituri protease.
- triazolam, oral (taken by mouth) midazolam (used to help you sleep and / or relieve
- triazolam u midazolam orali (jittieħed mill- ħalq) (jintużaw biex jgħinuk torqod u /
- bepridil (used to treat hypertension).
- bepridil (li jintuża biex jikkura l- pressjoni għolja).
- if you are currently taking any products containing St John’s wort (Hypericum perforatum) as
- jekk qed tieħu mediċini li fihom St John’ s Wort( Hypericum perforatum) għax dawn jistgħu itellfu lil Agenerase milli jaħdem kif suppost.
this may stop Agenerase from working properly (see Taking/using other medicines).
(ara ‘ Qabel ma tieħu/ tuża mediċini oħra.
Bone problems Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Problemi fl- għadam Xi pazjenti li jieħdu terapija antiretrovirali kombinata jistgħu jiżviluppaw marda ta ’ l- għadam li tissejjaħ ostejonekrożi (il- mewt tat- tessut ta ’ l- għadam minħabba nuqqas ta ’ ċirkolazzjoni għall -
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
It- tul tat- terapija antiretrovirali kombinata, l- użu ta ’ kortikosterojdi, il- konsum ta ’ alkoħol, trażżin kbir fl- immunità u indiċi tal- massa tal- ġisem aktar għoli fost oħrajn, jistgħu ikunu ftit mill - ħafna fatturi ta ’ riskju biex tiżviluppa din il- marda.
90 Treatment with Agenerase has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Il- kura b’ Agenerase ma tnaqqasx ir- riskju li wieħed ixerred l- HIV permezz ta ’ kuntatti sesswali jew permezz tad- demm.
Driving and using machines No studies on the effects of Agenerase on the ability to drive and use machines have been done.
95 Sewqan u tħaddim ta ’ magni Ma sar l- ebda studju fuq l- effett li jista jkollu Agenerase fuq min isuq, juża għodda jew iħaddem magni.
91 Because Agenerase capsules contain vitamin E, you should not take additional vitamin E supplements.
Minħabba li l- kapsuli ta ’ Agenerase fihom il- vitamina E, m’ għandekx tieħu xi vitamini oħra li fihom il- vitamina E.
Always take Agenerase exactly as your doctor has told you.
Dejjem għandek tieħu Agenerase skond il- parir tat- tabib.
- Adults and adolescents (of 12 years of age and older), (greater than 50 kg body weight): the usual
- Adulti u adoloxxenti minn 12- il sena ‘ l fuq (piż tal- ġisem aktar minn 50kg): id- doża normali ta ’
The usual dose for Agenerase capsules is 20 mg for each kg of body weight, twice a day..
Id- doża normali ta ’ kapsuli ta ’ Agenerase hija ta ’ 20 mg għal kull kilogramm ta ’ piż tal- gisem darbtejn kuljum.
Headache, feeling tired Diarrhoea, feeling sick, vomiting, flatulence Skin Rashes (red, raised or itchy) – Occasionally, the skin rash may be severe and you may have to stop taking this medicine.
• Uġigħ ta ’ ras, tħossok għajjien • Diarreja, tħossok imqalla, rimettar, gass Raxx fil- Ġilda (ħamra, mtella jew bil- ħakk - Xi drabi r- raxx fil- ġilda jistà jkun qawwi u inti jkollok bżonn twaqqaf din il- mediċina.
If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
STORING AGENERASE
KIF TAĦŻEN AGENERASE
Do not take Agenerase after the expiry date which is stated on the carton.
M’ għandekx tuża Agenerase wara d- data li jiskadi li tidher fuq il- kartuna.
Agenerase 150 mg soft capsules are supplied in a pack with two plastic bottles each containing 240 soft capsules.
Agenerase 150 mg kapsuli rotob jiġu f’ pakkett ta ’ żewġ fliexken li kull wieħed fih 240 kapsula ratba.
These soft capsules are oblong, opaque, off white to cream in colour and marked with the code GX CC2.
Dawn il- kapsuli rotob għandhom forma rettangolari, huma opaki b’ lewn abjad maħmuġ jkanġi għall - krema u stampati bl- ittri GX CC2.
Marketing Authorisation Holder
Sid l- Awtorizzazzjoni għall- kummerċ Manifattur
Glaxo Wellcome Operations Priory Street Ware Hertfordshire SG12 ODJ United Kingdom
Glaxo Group Ltd Glaxo Wellcome Operations Glaxo Wellcome House Priory Street Berkeley Avenue Ware Greenford Hertfordshire SG12 ODJ Middlesex UB6 ONN Renju Unit Renju Unit
For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holde
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtoriżżazzjoni għat- tqegħid fis- Suq.
Česká republika GlaxoSmithKline s.r.o.
98 Česká republika GlaxoSmithKline s. r. o.
Latvija GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com
99 Latvija GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv- epasts@ gsk. com
95 PACKAGE LEAFLET:
100 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Agenerase 15 mg/ml oral solution Amprenavir
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Agenerase 15 mg/ ml, soluzzjoni orali Amprenavir
The benefit of Agenerase oral solution boosted with ritonavir has not been demonstrated either in protease inhibitor naïve patients or protease inhibitor experienced patients.
Ma ġiex muri li s- soluzzjoni orali ta ’ Agenerase flimkien ma ’ ritonavir huwa ta ’ benefiċċju la f’ dawk il- pazjenti li m’ għandhomx esperjenza PI u lanqas f’ dawk li għandhom esperjenza PI.
You should take Agenerase capsules as soon as you are able to swallow them.
Hekk kif int tkun tistà tiblà għandek tibda tieħu il- kapsuli ta ’ Agenerase.
- if you are allergic (hypersensitive) to amprenavir or to any of the other ingredients in
Tieħux Agenerase - jekk inti allerġiku (tbati minn sensittivita ’ eċċessiva) għal amprenavir jew sustanzi oħra ta ’ Agenerase
- triazolam and oral (taken by mouth) midazolam (used to help you sleep and / or relieve
- flecainide u propafenone (mediċini tal- qalb)
anxiety
101
- bepridil (used to treat hypertension).
- triazolam u midazolam orali (jittieħed mill- ħalq) (jintużaw biex jgħinuk torqod u /
96
jew biex itaffu l- ansjeta ’)
- if you are currently taking any products containing St John’s wort (Hypericum perforatum) as
- bepridil (li jintuża biex jikkura l- pressjoni għolja).
this may stop Agenerase from working properly (see Taking/using other medicines).
- jekk qed tieħu mediċini li fihom St John’ s Wort( Hypericum perforatum) għax dawn jistgħu itellfu lil Agenerase milli jaħdem kif suppost (ara ‘ Qabel ma tieħu/ tuża mediċini oħra.
Because of the potential risk of toxicity from the large amount of the excipient propylene glycol, Agenerase oral solution is contraindicated in infants and children below the age of 4 years, pregnant women, patients with hepatic impairment or failure, patients with renal failure, and patients treated with disulfiram or metronidazole or preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol (see also Take special care with Agenerase).
Minħabba r- riskju ta ’ tossiċità li jeżisti kawża ta ’ l- ammont għoli ta ’ propylene glycol, li huwa sustanza mhux attiva, is- soluzzjoni orali ta ’ Agenerase hija kontra- indikata fi tfal li għandhom inqas minn 4 snin, f’ nisa tqal, f’ pazjenti li jbatu minn ħsara jew insuffiċjenza tal- fwied jew insuffiċjenza tal - kliewi, f’ dawk il- pazjenti li qed jieħdu kura permezz ta ’ disulfiram jew metronidazole jew preparazzjonijiet oħra li fihom l- alkoħol (eż. soluzzjoni orali ta ’ ritonavir) jew aktar propylene glycol (ara wkoll il- parti ta ’ dan il- fuljett imsejħa, Oqgħod attent ħafna waqt li qed tieħu Agenerase).
Take special care with Agenerase You will need to take Agenerase every day.
Oqgħod attent ħafna b’ Agenerase Inti tkun trid tieħu Agenerase kuljum.
No dosing recommendations can be made regarding the use of low dose ritonavir (normally used as an activity booster with Agenerase capsules) together with Agenerase oral solution.
M’ hemmx doża rakkomandabbli dwar l- użu ta ’ doża baxxa ta ’ ritonavir (jintuża flimkien mal- kapsuli ta ’ Agenerase għax isaħħaħ l- effett tagħhom) flimkien mas- soluzzjoni orali ta ’ Agenerase.
Therefore this combination must be avoided.
Għalhekk din it- taħlita m’ għandiex tintuża.
Agenerase oral solution should be used with caution if you have limited liver enzyme activity, kidney impairment or a genetically lower ability to metabolise alcohol (e.g.
Is- soluzzjoni orali ta ’ Agenerase għandha tintuża b’ attenzjoni jekk inti tbati min- nuqqas ta ’ attività fl - enżimi tal- fwied, jekk tbati minn ħsara fil- kliewi jew għandek nuqqas ġenetiku fil- ħila tiegħek biex timmetabolizza l- alkoħol (eż. jekk inti ta ’ nisel Asjatiku).
Asian origin) due to adverse reactions that may be related to the propylene glycol in the solution.
Dan minħabba reazzjonijiet avversi li jistgħu jinqalgħu kawża ta ’ l- ammont għoli ta ’ propylene glycol fis- soluzzjoni.
For the same reason you must not take disulfiram or other medicines that reduce alcohol metabolism (e.g. metronidazole) or preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol while you are taking Agenerase oral solution (see also Do not take Agenerase).
Minħabba l- istess raġuni m’ għandekx tieħu disulfiram jew mediċini oħra li jnaqqsu il- metaboliżmu ta ’ l- alkoħol (eż. metronidazole) u preparazzjonijiet oħra li fihom l- alkoħol (eż. soluzzjoni orali ta ’ ritonavir) jew aktar propylene glycol fl- istess waqt li qed tieħu s- soluzzjoni orali ta ’ Agenerase (ara wkoll il- parti ta ’ dan il- fuljett imsejħa Tieħux Agenerase).
Your doctor may monitor you for adverse reactions potentially related to the propylene glycol content of the Agenerase oral solution, especially when you have renal or hepatic disease.
It- tabib tiegħek jistà jpoġġik taħt osservazzjoni minħabba r- riskju ta ’ reazzjonijiet avversi kawża ta ’ l - ammont ta ’ propylene glycol li hemm fis- soluzzjoni orali ta ’ Agenerase.
It might also be necessary to reconsider the treatment with Agenerase oral solution.
F’ każi bħal dawn wieħed jistà jerġa jaħsibha jekk il- kura bis - soluzzjoni orali ta ’ Agenerase għandiex titkompla.
You should stop taking Agenerase oral solution as soon as you are able to swallow the Agenerase capsules.
Inti għandek tieqaf tieħu is- soluzzjoni orali ta ’ Agenerase hekk kif tkun tistà tibda tiblà il- kapsuli ta ’ Agenerase.
- If you have had liver disease discuss this with your doctor.
- Kellem lit- tabib tiegħek jekk inti kont tbati minn mard fil- fwied.
- Agenerase oral solution should not be used if you suffer from any liver disease.
- Is- soluzzjoni orali ta ’ Agenerase m’ għandiex tintuża jekk inti tbati minn xi forma ta ’ mard jew
- Please speak with your doctor if you have a history of liver disease.
- Kellem lit- tabib tiegħek jekk inti kont tbati minn mard fil- fwied.
Patients with chronic
Pazjenti li huma morda kroniċi
hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
bl- epatite B jew C u li jingħataw mediċini antiretrovirali ikunu f’ riskju akbar li jsofru minn
- inhibitors.
jieħdu l- inibituri protease.
You may need additional factor VIII to control
Jistà jkun li tkun tinħtieġ aktar factor VIII sabiex twaqqaf din il- fsada.
Treatment with Agenerase has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Il- kura b’ Agenerase ma tnaqqasx ir- riskju li wieħed ixerred l- HIV permezz ta ’ kuntatti sesswali jew permezz tad- demm.
Taking/using other medicines Before starting treatment with Agenerase, please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu/ tuża mediċini oħra Jekk jogħġbok għarraf lit- tabib jew spiżjar tiegħek jekk qed tieħu, jew ħadt dan l- aħħar, xi mediċini oħra, anki dawk bla riċetta.
This is very important, as taking some types of medicines at the same time as Agenerase can strengthen or weaken the effect of the medicines.
Dan huwa mportanti ħafna minħabba li meta xi mediċini jittieħdu fl - istess waqt ma ’ Agenerase dan jistà jwassal għal żieda jew nuqqas fl- effett li dawn il- mediċini jistà jkollhom.
This can sometimes lead to serious medical conditions.
Dan jistà jikkawża problemi serji.
There are some medicines that you must not take with Agenerase (please see ‘Do not take Agenerase’ for further information).
Hemm xi mediċini li ma tistax tieħu ma ’ Agenerase (jekk jogħġbok ara ‘ Tieħux Agenerase ’ għal aktar informazzjoni)
Agenerase may interact with certain other medicines.
Agenerase jistà ma jaqbilx ma ’ xi mediċini oħrajn.
The use of the following medicines, together with Agenerase, should only take place on the basis of medical advice: anaesthetics (e.g. lidocaine), antibiotics (e.g. rifabutin, clarithromycin, dapsone and erythromycin), antifungals (e.g. ketoconazole, itraconazole), antimalarials (e.g. halofantrine), anticonvulsant medicines (e.g. carbamazepine, phenytoin and phenobarbital), calcium channel blockers (e.g. amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine and verapamil), cholesterol lowering medicines (e.g. atorvastatin, lovastatin and simvastatin), erectile dysfunction medicines (e.g. sildenafil and vardenafil), non-nucleoside reverse transcriptase inhibitors (e.g. delavirdine, efavirenz and nevirapine), opioids (e.g. methadone), hormones like oestrogens and progestogens (e.g. hormonal contraceptives such as the ‘pill’), some glucocorticoids (e.g. fluticasone propionate and budesonide), tricyclic antidepressants (i.e. desipramine and nortriptyline), sedative agents (e.g. midazolam administered by injection), and others (e.g. clozapine and loratadine).
M’ għandekx tieħu l- mediċini li ġejjin flimkien ma ’ Agenerase sakemm mhux bl- ordni tat- tabib tiegħek: anestetiċi (eż lidocaine), anti- bijotiċi (eż rifabutin, clarithromycin, dapsone u erythromycin), antifungals (eż ketoconazole u itraconazole), mediċini kontra l- malarja (eż halofantrine), mediċini kontra l- konvulżjonijiet (eż carbamazepine, phenytoin u phenobarbital), calcium channel blockers (eż amlopidine, diltiazem, felopidine, israpidine, nicardipine, nifedipine, nimodipine, nisoldipine u verapamil), mediċini li jbaxxu l- kolesterol (eż atorvastatin, lovastatin u simvaststin), mediċini għal erectile dysfunction (sildenafil u vardenafil), inibituri non - nuklejosajd rivers transkriptejż (eż delavirdine, efavirenz u nevirapine), opioids (eż methadone), ormoni bħal oestrogens u progestogens (eż kontraċettivi ormonali bħal ‘ pillola ’), xi glucocorticoids (eż fluticasone propionate u budesonide), antidipressanti triċikliċi (eż desipramine u nortriptyline), sustanzi sedattivi (i. e. midazolam meta jingħata fil- vina), u oħrajn (eż clozapine u loratadine).
If you are taking certain medicines that can cause serious side effects, such as carbamazepine, phenobarbital, phenytoin, lidocaine, cyclosporine, tacrolimus, rapamycin, tricyclic antidepressants and warfarin, at the same time as you are taking Agenerase, your doctor may carry out additional blood tests to minimise any potential safety problems.
Jekk qed tieħu mediċini li jistgħu jikkawżaw effetti mhux mixtieqa li huma serji, bħal carbamazepine, phenobarbital, phenytoin, lidocaine, cyclosporine, tacrolimus, rapamycin, tricyclic antidepressants, u warfarin, fl- istess waqt ma ’ Agenerase, it- tabib tiegħek jistà jkollu bżonn jagħmel testijiet oħra tad - demm sabiex jevita xi problemi ta ’ sigurtà li jistà jkun hemm.
Due to the propylene glycol content of the oral solution you should not take disulfiram or other medicines that reduce alcohol metabolism (e.g. metronidazole) or preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol while you are taking Agenerase oral solution (see Do not take Agenerase).
Minħabba l- ammont ta ’ propylene glycol fis- soluzzjoni orali m’ għandekx tieħu disulfiram jew mediċini oħra li jnaqqsu il- metaboliżmu ta ’ l- alkoħol (eż. metronidazole) u preparazzjonijiet oħra li
If you are taking the contraceptive pill, it is recommended that you use an alternative method (e.g. a condom) to prevent pregnancy, while you are taking Agenerase.
103 fihom l- alkoħol (eż. soluzzjoni orali ta ’ ritonavir) jew aktar propylene glycol fl- istess waqt li qed tieħu s- soluzzjoni orali ta ’ Agenerase (ara il- parti ta ’ dan il- fuljett imsejħa Tieħux Agenerase).
The concomitant use of Agenerase and contraceptive pill may result in a decrease of the therapeutic effect of Agenerase.
Jekk tieħu l- pillola kontraċettiva fl- istess waqt ma ’ Agenerase jistà jkun hemm tnaqqis fl- effett terapewtiku ta ’ Agenerase.
98 Taking Agenerase with food and drink Agenerase oral solution can be taken with or without food.
Meta tieħu Agenerase ma ’ l- ikel u max- xorb Is- soluzzjoni orali ta ’ Agenerase tista ’ tittieħed ma ’ jew mingħajr ikel
Important information about ingredients of Agenerase oral solution The oral solution contains propylene glycol, which can cause adverse effects in high doses.
Tagħrif importanti dwar xi wħud mis- sustanzi tas- soluzzjoni orali ta ’ Agenerase Is- soluzzjoni orali ta ’ Agnerase fiha propylene glycol li jistà jwassal għal effetti mhux mixtieqa f’ dożi għoljin.
Propylene glycol can cause a range of adverse effects including seizures, stupor, rapid heart beat and the breakdown of red blood cells (see also Do not take Agenerase, Take special care with Agenerase).
Propylene glycol jista ’ jwassal għal sensiela ta ’ effetti avversi bħal aċċessjonijiet, stupor, qalb tħabbat ħafna u ħsara fic- celloli ħomor tad- demm (ara wkoll Tieħux Agenerase u Oqgħod attent ħafna b’ Agenerase).
This medicinal product contains 4 mg sodium per ml.
Dan il- prodott mediċinali fih 4mg ta ’ sodium kull ml.
To be taken into consideration by patients on a controlled sodium diet,
Dan għandu jiġi kkunsidrat minn pazjenti fuq dieta kkontrollata ta ’ sodju.
This medicinal product also contains 1 mg potassium per ml.
Dan il- prodott mediċinali fih ukoll 1mg ta ’ potassium kull ml.
To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet,
Dan għandu jiġi kkunsidrat minn pazjenti b’ funzjoni mnaqqsa tal- kliewi jew pazjenti fuq dieta kkontrollata ta ’ potassium.
Because Agenerase oral solution contains vitamin E, you should not take additional vitamin E supplements.
Minħabba li s- soluzzjoni orali ta ’ Agenerase fiha il- vitamina E, m’ għandekx tieħu xi vitamini oħra li fihom il- vitamina E.
HOW TO TAKE AGENERASE
KIF GHANDEK TIEĦU AGENERASE
Always take Agenerase exactly as your doctor has told you.
Dejjem għandek tieħu Agenerase skond ma jgħidlek it- tabib.
Agenerase can be taken with or without food.
Is- soluzzjoni orali ta ’ Agenerase tistà tittieħed kemm ma ’ l - ikel kif ukoll waħidha.
The dose will be calculated
- Pazjenti minn 4 snin ‘ il fuq li ma jistgħux jibilgħu kapsuli: id- doża meħtieġa tiġi maħduma mit -
according to your weight by your doctor.
tabib tiegħek skond il- piż tiegħek.
The usual dose of Agenerase oral solution is 17 mg (1.1 ml) for each kg of body weight three times a day.
Id- doża rakkomandata ta ’ soluzzjoni orali ta ’ Agenerase hija ta ’ 17 mg (1. 1 ml) kull kilogramm tliet darbiet kuljum.
You should not take more than 2800 mg per day.
M’ għandekx tieħu 2800 mg kuljum.
In some cases, your doctor may adapt the dose of Agenerase when other drugs are administered concomitantly with Agenerase.
F’ xi każi fejn ikunu qed jingħataw mediċini oħra flimkien ma ’ Agenerase, it- tabib tiegħek jistà jbiddel id- doża ta ’ Agenerase.
To derive the full benefit of Agenerase, it is very important that you take the full daily dose prescribed by your doctor.
104 Sabiex inti tgawdi mill- benefiċċji kollha ta ’ Agenerase, huwa mportanti ħafna li inti tieħu d- doża kollha hekk kif ordnat mit- tabib tiegħek.
A 20 ml measuring cup is provided, to help you measure out the correct amount of oral solution for each dose.
Fil- pakkett għandek issib tazza tal- kejl ta ’ 20 ml sabiex inti tkun tistà tkejjel eżatt l- ammont li għandek tieħu.
If you take more Agenerase than you should If you have taken more than the prescribed dose of Agenerase, you should contact your doctor or pharmacist immediately for advice.
Jekk tieħu Agenerase aktar milli suppost għandek tieħu Jekk ħadt aktar Agenerase minn kemm ordnalek it- tabib, għandek tkellem lit- tabib jew spiżjar tiegħek minnufih.
99 If you forget to take Agenerase If you forget to take a dose of Agenerase, take it as soon as you remember and then continue as before.
Wara tistà tkompli bħal qabel.
Like all medicines, Agenerase can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Agenerase jista ’ jagħmel effetti mhux mixtieqa għalkemm mhux kulħadd ikollu.
Headache, feeling tired Diarrhoea, feeling sick, vomiting, flatulence Skin Rashes (red, raised or itchy) – Occasionally, the skin rash may be svere and you may have to stop taking this medicine.
• Uġigħ ta ’ ras, tħossok għajjien • Diarreja, tħossok imqalla, rimettar, gass Raxx fil- Ġilda (ħamra, mtella jew bil- ħakk - Xi drabi r- raxx fil- ġilda jistà jkun qawwi u inti jkollok bżonn twaqqaf din il- mediċina.
Other possible effects
105 Effetti mhux mixtieqa oħrajn li jistgħu jiġru
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo
Dan it- tibdil jinkludi telf ta ’ xaħam mis- saqajn, mill- idejn u mill- wiċċ, żieda ta ’ xaħam addominali (maż- żaqq) u ma ’ organi interni oħra tal- ġisem, tkabbir tas- sider u ħotba ta ’ xaħam fuq wara tal- għonq (buffalo hump).
Do not use Agenerase after the expiry date which is stated on the bottle and carton.
M’ għandekx tuża Agenerase wara d- data li jiskadi li tidher fuq il- flixkun u l- kartuna.
Discard Agenerase oral solution 15 days after first opening the bottle.
Dak li jibqa mis - soluzzjoni orali ta ’ Agenerase 15- il ġurnata wara li jkun infetaħ il- flixkun, għandu jiġi mormi.
What Agenerase contains
X' fihAgenerase
The active substance is amprenavir The Agenerase oral solution contains 15 mg/ml of amprenavir.
Is- sustanza attiva hi amprenavir Is- soluzzjoni orali fiha 15 mg/ ml ta ’ amprenavir
The other ingredients are propylene glycol, macrogol 400 (polyethylene glycol 400), d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), acesulfame potassium, saccharin sodium, sodium chloride, artificial grape bubblegum flavour, natural peppermint flavour, menthol, citric acid anhydrous, sodium citrate dihydrate, purified water.
Sustanzi oħra jinkludu propylene glycol, macrogol 400 (polyethylene glycol 400), d- alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), acesulfame potassium, saccharin sodium, sodium chloride, togħma artifiċjali ta ’ bubblegum ta ’ l- għeneb, togħma ta ’ peppermint naturali, menthol, citric acid, anhydrous, sodium citrate dihydrate, ilma ppurifikat.
Agenerase oral solution is supplied in plastic bottles containing 240 ml of oral solution.
Is- soluzzjoni orali ta ’ Agenerase tiġi fi fliexken li fihom 240 ml ta ’ soluzzjoni orali.
It is a clear, pale yellow to yellow solution with grape, bubblegum and peppermint flavouring.
Is- soluzzjoni orali hija ta ’ lewn ċar jagħti fl- isfar u għandha togħma ta ’ għeneb, bubblegum u peppermint.
Marketing Authorisation Holder and Manufacturer
106 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Manufacturer
Sid l- Awtorizzazzjoni għall- kummerċ Manifattur
Marketing Authorisation Holder
Glaxo Group Ltd Glaxo Wellcome Operations Glaxo Wellcome House Speke Boulevard Berkeley Avenue Speke Greenford Liverpool L24 9JD Middlesex UB6 ONN Renju Unit Renju Unit jew
KG Industriestrasse 32-36 23843 Bad Oldesloe Germany
Industriestrasse 32- 36 23843 Bad Oldesloe Germany
For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
España GlaxoSmithKline, S.A.
107 España GlaxoSmithKline, S. A.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Aldara?
X’ inhi Aldara?
Aldara is a cream containing the active substance imiquimod.
Aldara hija ingwent li fih is- sustanza attiva imiquimod.
It is available as 250 mg sachets, each containing 12.5 mg imiquimod (5%).
Hija tiġi bħala qratas ta ’ 250 mg, kull wieħed ikun fih 12. 5 mg ta ’ imiquimod (5%).
What is Aldara used for?
Għal xiex tintuża Aldara?
Aldara is used in adults to treat the following skin diseases: • warts on the genitals and around the anus; • small basal cell carcinomas (slow-growing types of skin cancer); • actinic keratoses of the face and scalp (precancerous, abnormal skin growths that develop after too much exposure to sunlight), in patients whose immune system is working normally.
Aldara tintuża fl- adulti biex tikkura l- mard tal- ġilda li ġej: • Felul fuq il- ġenitali u madwar l- anus; • Karċinomi żgħar taċ- ċellola bażali (tipi ta ’ kanċer tal- ġilda li jikbru bil- mod); • Keratożi aktinika tal- wiċċ u l- qurriegħa (żviluppi mhux normali tal- ġilda li jseħħ qabel ifeġġ kanċer u li jiżviluppa wara esponiment żejjed għad- dawl tax- xemx), f’ pazjenti li s- sistema immunitarja tagħhom qed taħdem sewwa.
It is used when other treatments such as cryotherapy (freezing) cannot be used.
Hija tintuża meta kuri oħra bħalma huma krajoterapija (iffriżar) ma jistgħux jintużaw.
How is Aldara used?
Kif tintuża Aldara?
The number of times Aldara is applied and the duration of treatment depend on the condition being treated: • For genital warts, Aldara is applied three times a week for up to 16 weeks. • For small basal cell carcinomas, the cream is applied five times a week for six weeks. • For actinic keratoses, it is applied three times a week, for one or two four-week courses, with four weeks between courses.
In- numru ta ’ drabi li Aldara hija applikata u t- tul ta ’ żmien tal- kura jiddependu fuq il- kondizzjoni li qed tiġi ikkurata: • Għal felul ġenitali, Aldara hija applikata tliet darbiet fil- ġimgħa sa 16- il ġimgħa. • Għal karċinoma żgħar taċ- ċellola bażali, l- ingwent huwa applikat ħames darbiet fil- ġimgħa għal sitt ġimgħat. • Għal keratożi aktinika, huwa applikat tliet darbiet fil- ġimgħa għal ġimgħa, għal wieħed jew żewġ korsijiet ta ’ erba ’ ġimgħat, b’ erba ’ ġimgħat bejn il- korsijiet.
The cream is applied in a thin layer to the affected areas of skin before sleeping, so that it remains on the skin for a suitable length of time (about eight hours) before being washed off.
L- ingwent huwa applikat f’ saff irqiq fuq il- partijiet effettwati tal- ġilda qabel l- irqad, ħalli jibqa ’ fuq il - ġilda għal tul ta ’ żmien addatat (madwar tmien sigħat) qabel ma jitneħħa bil- ħasil.
For further information, see the Package Leaflet.
Għal aktar tagħrif, ara l- Fuljett ta ’ Tagħrif.
How does Aldara work?
Kif taħdem Aldara?
The active substance in Aldara cream, imiquimod, is an immune response modifier.
Is- sustanza attiva fl- ingwent Aldara, imiquimod, hija modifikatur tar- reazzjoni immunitarja.
This means that it uses the immune system, the body ’ s natural defences, to bring about its effect.
Dan ifisser li tuża s- sistema immunitarja, id- difiżi naturali tal- ġisem, biex toħroġ l- effett tagħha.
When imiquimod is applied to the skin, it acts locally on the immune system to trigger the release of cytokines, including interferon.
Meta imiquimod huwa applikat fuq il- ġilda, huwa jaħdem lokalment fuq is- sistema immunitarja biex iqanqal il- ħelsien ta ’ ċitokini, inklużi interferon.
These substances help to kill the viruses that cause warts or the abnormal cells in the skin that develop into skin cancer or keratoses.
Dawn is- sutanzi jgħinu biex joqtlu l- vajrusis li jikkaġunaw felul jew iċ- ċelloli annormali fil- ġilda li jiżviluppaw f’ kanċer tal- ġilda jew keratożijiet.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. euorpa. eu http: // www. emea. europa. eu
Reproduction is authorised provided the source is acknowledged.
©European Medicines Agency 2008 Reproduction is authorised provided the source is acknowledged Kif ġiet studjata Aldara?
In all studies, Aldara was compared with placebo (the same cream but without the active substance). • Aldara has been studied in 923 patients with genital warts in four main studies lasting 16 weeks.
Fl- istudji kollha, AldaraA ġiet imqabbla ma ’ plaċebo (l- istess ingwent iżda mingħajr is- sustanza attiva). • Aldara ġiet studjata f’ 923 pazjent b’ felul ġenitali f’ erba ’ studji ewlenin li damu 16- il ġimgħa.
The main measure of effectiveness was the number of patients with total clearance of treated warts. • Aldara has also been studied in 724 patients with small basal cell carcinomas in two studies where patients were treated for six weeks, and used Aldara or placebo either five times a week or every day.
Il - kejl ewlieni ta ’ l- effikaċja kien in- numru ta ’ pazjenti b’ eliminazzjoni totali tal- felul ikkurati. • Aldara ġiet ukoll studjata f’ 724 pazjent b’ karċinomi żgħar taċ- ċellola bażali f’ żewġ studji fejn il - pazjenti kienu ikkurati għal sitt ġimgħat, u użaw Aldara jew plaċebo jew ħames darbiet fil- ġimgħa jew kuljum.
The main measure of effectiveness was the number of patients with total clearance of the tumours after 12 weeks. • Aldara has also been studied in patients with actinic keratoses in two studies involving a total of 505 patients.
Il- kejl ewlieni ta ’ l- effikaċja kien in- numru ta ’ pazjenti b’ eliminazzjoni totali tat - tumuri wara 12- il ġimgħa. • Aldara ġiet ukoll studjata f’ pazjenti b’ keratożi aktinika f’ żewġ studji li involvew total ta ’ 505 pazjenti.
The main measure of effectiveness was the number of patients whose keratoses had cleared after one or two four-week courses of treatment.
Il- kejl ewliei ta ’ l- effikaċja kien in- numru ta ’ pazjenti li l- keratożi tagħhom tkun telqet wara wieħed jew żewġ korsijiet ta ’ kura ta ’ erba ’ ġimgħat tat- trattament.
What benefit has Aldara shown during the studies?
X’ benefiċċju wriet Aldara waqt l- istudji?
In all studies, Aldara was more effective than placebo. • In the treatment of genital warts, the total clearance rate across the four main studies was 15 to 52% in the Aldara-treated patients, compared with 3 to 18% in the placebo-treated patients. • When the results of the two studies in basal cell carcinoma were looked at together, total clearance was seen in 66 to 80% of Aldara-treated patients compared with 0 to 3% in the placebo group.
Fl- istudji kollha, Aldara kienet aktar effettiva minn plaċebo. • Fil- kura ta ’ felul ġenitali, ir- rata ta ’ eliminazzjoni totali fl- erba ’ studji ewlenin kienet 15 sa 52% f’ pazjenti ikkurati b’ Aldara meta mqabbla ma ’ 3 sa 18% f’ pazjenti ikkurati bil- plaċebo. • Meta saret ħarsa lejn ir- riżultati taż- żewġ studji flimkien f’ karċinoma taċ- ċellola bażali, eliminazzjoni totali dehret f’ 66 sa 80% ta ’ pazjenti ikkurati b’ Aldara meta mqabbla ma ’ 0 sa 3% fil- grupp tal- plaċebo.
There were no differences between the two dose frequencies. • In actinic keratoses, complete clearance after one or two courses of treatment was seen in 54 and 55% of Aldara-treated patients in the two studies, compared with 15 and 2% in the placebo-treated patients.
Ma kien hemm l- ebda differenza bejn il- frekwenzi taż- żewġ dożaġġi. • F’ keratożi aktinika, eliminazzjoni kompluta wara kors wieħed jew tnejn ta ’ kura dehru f’ 54 u 55% ta ’ pazjenti ikkurati b’ Aldara fiż- żewġ studji, meta mqabbla ma ’ 15 u 2% fil- pazjenti ikkurati bi plaċebo.
What is the risk associated with Aldara?
X’ inhu r- riskju assoċjat ma ’ Aldara?
The most common side effect with Aldara (seen in more that 1 patient in 10) is a reaction at the site of application of the cream (pain or itching).
L- aktar effett sekondarju komuni b’ Aldara (deher f’ aktar minn pazjent 1 f’ 10) hija reazzjoni fis- sit ta ’ l- applikazzjoni ta ’ l- ingwent (uġigħ jew ħakk).
For the full list of all side effects reported with Aldara, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ Aldara, ara l- Fuljett ta ’ Tagħrif.
Aldara should not be used in people who may be hypersensitive (allergic) to imiquimod or any of the other ingredients.
Aldara m’ għandhiex tintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal imiquimod jew kwalunkwe mis- sustanzi l- oħra.
Why has Aldara been approved?
Għaliex ġiet approvata Aldara?
The Committee for Medicinal Products for Human Use (CHMP) decided that Aldara’ s benefits are greater than its risks for the treatment of external genital and perianal warts (condylomata acuminata), small basal cell carcinomas and nonhyperkeratotic, nonhypertrophic actinic keratoses in immunocompetent adult patients when other topical treatment options are contraindicated or less appropriate.
Il- Kumitat għal Prodotti Mediċinali għal Użu tal- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ ALDARA huma akbar mir- riskji tagħha għall- kura ta ’ felul tal- ġenitali esterni u perianali (condylomata acuminata), karċinomi żgħar taċ- ċellola bażali u keratożi aktinika mhux iperkeratotika, mhux ipertrofika f’ pazjenti adulti immunokompetenti meta għażliet ta ’ kuri topikali oħra mhux indikati jew anqas addattati.
The Committee recommended that Aldara be given marketing authorisation.
Il- Kumitat irrikkmanda li Aldara tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Aldara:
Tagħrif ieħor dwar Aldara:
The European Commission granted a marketing authorisation valid throughout the European Union for Aldara on 18 September 1998.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Aldara fit- 18 ta ’ Settembru 1998.
The marketing authorisation was renewed on 18 September 2003 and on 18 September 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 18 ta ’ Settembru 2003 u fit- 18 ta ’ Settembru 2008.
The marketing authorisation holder is Meda AB.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq huwa Meda AB.
The full EPAR for Aldara is available here.
L- EPAR sħiħ għal Aldara huwa disponibbli minn hawn.
This summary was last updated in 09-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi: 09- 2008.
ANNEX 1
KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR 1.
Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5%).
Kull qartas fih 12. 5 mg ta ’ imiquimod f’ 250 mg ta 'krema (5%).
Excipients:
100mg tal- krema ghanda 5mg ta` imiquimod Sustanzi mhux attivi:
Methyl hydroxybenzoate (E218) Propyl hydroxybenzoate (E216) Cetyl alcohol Stearyl alcohol
Methyl hydroxybenzoate (E218) Propyl hydroxybenzoate (E216) Cetyl alcohol Stearyl alcohol
White to slightly yellow cream.
Krema Krema bajda li tkanġi fl- isfar.
Imiquimod cream is indicated for the topical treatment of:
Il- krema imiquimod hi indikata għat- trattament topiku ta ’:
External genital and perianal warts (condylomata acuminata) in adults.
Felul li jinsab fil- parti esterna tal- partijiet ġenitali u madwar il- parti anali (condylomata acuminata) f’ adulti.
Small superficial basal cell carcinomas (sBCCs) in adults.
Karċinomi superfiċjali żgħar taċ- ċelloli bażali (sBCCs) f' adulti.
Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.
Klinikament, keratożijiet aktiniċi (AKs) tipiċi, mhux iperkeratotiċi u mhux ipertrofiċi fuq il- wiċċ jew il- ġilda tal- qorriegħa tar- ras f’ pazjenti adulti immunokompetenti meta d- daqs jew in- numru ta ’ leżjonijiet jillimitaw l- effikaċja u/ jew l- aċċettabilità ta ’ krijoterapija u għażliet ta ’ trattamenti topiċi oħrajn huma kontrindikati jew anqas adattati.
The application frequency and duration of treatment with imiquimod cream is different for each indication.
Pożoloġija L- applikazzjoni u d- dewmien tat- trattament bil- krema imiquimod hi differenti għal kull indikazzjoni.
External genital warts in adults:
Sinjali esterni ta 'felul fl- adulti:
Monday, Wednesday, and Friday; or Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for 6 to 10 hours.
Il- krema imiquimod għandha tiġi applikata 3 darbiet fil- ġimgha (eżempju: it- Tnejn, l- Erbgħa, u l- Ġimgħa; jew it- Tlieta, il- Ħamis, u s- Sibt) qabel is- sigħat normali ta ’ l- irqad, u għandha tibqa ’ fuq il- ġilda għal bejn 6 sa 10 sigħat.
Imiquimod cream treatment should continue until the clearance of visible genital or perianal warts or for a maximum of 16 weeks per episode of warts.
It- trattament bil- krema imiquimod għandu jibqa ’ sejjer sakemm ma jidhrux aktar il- felul fil- partijiet ġenitali jew madwar il- parti anali jew għal massimu ta’ 16- il ġimgha għal kull episodju ta ’ felul.
For quantity to be applied see 4.2 Method of administration.
Ghall- kwantita li trid tigi applikata ara 4. 2 Metodu ta` amministrazzjoni
Superficial basal cell carcinoma in adults:
Karċinoma superfiċjali taċ- ċellula bażali f' adulti:
2 Apply imiquimod cream for 6 weeks, 5 times per week (example:
Applika l- krema imiquimod għal 6 ġimgħat, 5 darbiet fil- ġimgħa (eżempju:
Monday to Friday) prior to normal sleeping hours, and leave on the skin for approximately 8 hours.
Mit- Tnejn sal- Ġimgħa) qabel is- sigħat normali ta 'l- irqadt, u ħalli fuq il- ġilda għal madwar 8 sigħat.
Actinic keratosis in adults
Keratosi aktinika fl- adulti
Treatment should be initiated and monitored by a physician.
It- trattament għandu jiġi mibdi u sorveljat minn tabib.
Imiquimod cream should be applied 3 times per week (example:
Il- krema imiquimod għandha tiġi applikata 3 darbiet fil- ġimgħa (eżempju:
Monday, Wednesday and Friday) for four weeks prior to normal sleeping hours, and left on the skin for approximately 8 hours.
It- Tnejn, l- Erbgħa u l- Ġimgħa) għal 4 ġimgħat qabel is- sigħat normali ta 'l- irqadt, u mħolli fil- ġilda għal madwar 8 sigħat.
Sufficient cream should be applied to cover the treatment area.
Għandha tiġi applikata biżżejjed krema biex tkopri l- erja ta 'trattament.
After a 4-week treatment-free period, clearance of AKs should be assessed.
Wara perijodu ta '4 ġimgħat mingħajr trattament, it- tneħħija ta' AKs għanha tiġi assessjata.
If any lesions persist, treatment should be repeated for another four weeks.
Jekk jibqa 'xi feriti, it- trattament għandu jiġi ripetut għal erba' ġimgħat oħra.
The maximum recommended dose is one sachet.
Id- doża massima rakkomandata hi ta 'qartas wieħed.
The maximum recommended treatment duration is 8 weeks.
It- tul massimu ta 'żmien rakkomandat hu ta' 8 ġimgħat.
An interruption of dosing should be considered if intense local inflammatory reactions occur (see section 4.4) or if infection is observed at the treatment site.
Waqfien tad- doża għandha tiġi konsidrata jekk ikun hemm reazzjonijiet infjammatorji lokali intensi (ara sezzjoni 4. 4) jew jekk ikun hemm infezzjoni fuq is- sit tat- trattament.
In this latter case, appropriate other measures should be taken.
Fil- każ ta 'l- aħħar, għandhom jittieħdu miżuri oħra xierqa.
Each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods.
Kull perijodu ta 'trattament m' għandux jiġi estiż għal aktar minn 4 ġimgħat minħabba dożi li ma ttieħdux jew perijodi ta' serħan.
If the treated lesion(s) show an incomplete response at the follow-up examination at 4-8 weeks after the second treatment period, a different therapy should be used (see section 4.4)
Jekk il- ferita( i) trattata( i) juru rispons inkomplet fl- eżami sussegwenti wara 4- 8 ġimgħat wara t- tieni perijodu ta 'trattament, għandha tintuża terapija differenti (ara sezzjoni 4. 4)
Information applicable to all indications:
Informazzjoni applikabbli għall- indikazzjonijiet kollha:
If a dose is missed, the patient should apply the cream as soon as he/she remember and then he/she should continue with the regular schedule.
Meta tinqabez xi doża, il=pazjent ghandu japplika l- krema meta huwa/ hija tiftakar u mbagħad jkompli bl- iskeda regolari.
However the cream should not be applied more than once a day.
Madankollu il- krema maghandiex tintuza aktar minn darba kulljum.
Paediatric patients Use in the paediatric patient population is not recommended.
Mhux rakkomandat l- uzu f’ popolazzjoni ta ’ pazjenti pedjatrici.
There are no data available on the use of imiquimod in children and adolescents in the approved indications.
M’ hemmx dejta dwar l- uzu ta` “ imiquimod ” fit- tfal u fl- adoloxxenti fl- indikazzjonijiet approvati.
Aldara should not be used in children with molluscum contagiosum due to lack of efficacy in this indication (see section 5.1).
(Ara sezzjoni 5. 1)
Method of administration
Metodu ta 'amministrazzjoni
External genital warts:
Felul ġenitali fuq barra:
Imiquimod cream should be applied in a thin layer and rubbed on the clean wart area until the cream vanishes.
Il- krema imiquimod għandha tiġi applikata f’ saff irqiq u mogħrok madwar l- erja tal- felula mnaddfa sakemm il- krema tisparixxi.
Only apply to affected areas and avoid any application on internal surfaces.
Applika biss fiż- żoni affetwati u evita kull applikazzjoni fuq l- uċuħ interni.
Imiquimod cream should be applied prior to normal sleeping hours.
Il- krema imiquimod għandha tiġi applikata qabel is- sigħat normali tal- irqad.
During the 6 to 10 hour treatment period, showering or bathing should be avoided.
F’ dak il - perijodu ta ’ trattament ta ’ bejn 6 sa 10 sigħat, għandu jiġi evitat li wieħed jinħasel f’ banju jew f' doċċa.
After this period it is essential that imiquimod cream is removed with mild soap and water.
Wara dan il- perijodu huwa essenzjali li l- krema imiquimod titneħħa b’ sapuna ħafifa u ilma.
Application of an excess of cream or prolonged contact with the skin may result in a severe application site reaction (see sections 4.4, 4.8 and 4.9).
L- applikazzjoni żejda tal- krema jew għal kuntatt fit- tul jista ’ jwassal għal reazzjoni serja fil- lok t’ aplikazzjoni (ara sezzjonijiet 4. 4, 4. 8 u 4. 9).
3 inches2).
Qartas li tużah darba huwa biżżejjed biex ikopri żona ta ’ felul ta’ 20cm2 (madwar 3 pulzieri2).
Sachets should not be re-used once opened.
Il- qratas m' għandhomx jintużaw mill- ġdid la darba jkunu nfetħu.
Hands should be washed carefully before and after application of cream.
L- idejn għandhom jinħasslu sew qabel u wara l- applikazzjoni tal- krema.
Uncircumcised males treating warts under the foreskin should retract the foreskin and wash the area daily (see section 4.4).
Irġiel mhux ċirkonċiżi li qed jitrattaw il- felul taħt il- prepuzju għandhom jiġbdu lura l- prepuzju u jaħslu l- erja kuljum (ara sezzjoni 4. 4).
Superficial basal cell carcinoma:
Karċinoma superfiċjali taċ- ċellula bażali:
Before applying imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly.
Qabel ma japplikaw il- krema imiquimod, il- pazjenti għandhom jaħslu l- erja ta 'trattament b' sapun ħafif u ilma u jixxottaw sew.
Sufficient cream should be applied to cover the treatment area, including one centimetre of skin surrounding the tumour.
Għandha tiġi applikata biżżejjed krema biex tkopri l- erja ta 'trattament, li jinkludi ċentimetru ta' ġilda li ddawwar it- tumur.
The cream should be rubbed into the treatment area until 3 the cream vanishes.
Il- krema għanda tiġi mgħorka fl- erja ta 'trattament sakemm il- krema tisparixxi.
The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours.
Il- krema għandha tiġi applikata qabel is- sigħat normali ta 'l- irqadt u għandha tibqa' fuq il- ġilda għal madwar 8 sigħat.
During this period, showering and bathing should be avoided.
Matul dan il- perijodu, id- doċċi u l- banjijiet għandhom jiġu evitati.
After this period it is essential that imiquimod cream is removed with mild soap and water.
Wara dan il- perijodu huwa essenzjali li l- krema imiquimod titneħħa b’ sapun ħafif u l- ilma.
Hands should be washed carefully before and after application of cream.
L- idejn għandhom ikunu nodfa qabel u wara l- applikazzjoni tal- krema.
Response of the treated tumour to imiquimod cream should be assessed 12 weeks after the end of treatment.
Ir- rispons tat- tumur trattat għal krema imiquimod għandu jiġi assessjat 12- il ġimgħa wara tmiem it- trattament.
If the treated tumour shows an incomplete response, a different therapy should be used (see section 4.4).
Jekk it- tumur trattat juri rispons inkomplet, għandha tintuża terapija differenti (ara sezzjoni 4. 4).
A rest period of several days may be taken (see section 4.4) if the local skin reaction to imiquimod cream causes excessive discomfort to the patient, or if infection is observed at the treatment site.
Jista 'jittieħed perijodu ta' serħan ta 'diversi jiem (ara sezzjoni 4. 4) jekk ir- reazzjoni tal- ġilda għal krema imiquimod jikkaġuna skonfort eċċessiv' il- pazjent, jew jekk l- infezzjoni tiġi osservata fis- sit ta 'trattament.
Actinic keratosis:
Keratosi aktinika:
The cream should be rubbed into the treatment area until the cream vanishes.
Il- krema għanda tiġi mgħorka fl- erja ta 'trattament sakemm il- krema tisparixxi.
The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours.
Il- krema għandha tiġi applikata qabel is- sigħat normali ta 'l- irqad u għandha tibqa' fuq il- ġilda għal madwar 8 sigħat.
After this period it is essential that imiquimod cream is removed with mild soap and water.
Wara dan il- perijodu huwa essenzjali li l - krema imiquimod titneħħa b’ sapun ħafif u l- ilma.
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva ghas- sustanza attiva jew għal xi sustanzi mhux attivi.
4.4 Special warnings and special precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet speċjali għall- użu
External genital warts, superficial basal cell carcinoma and actinic keratosis:
Felul ġenitali fuq barra, karċinoma superfiċjali ta 'ċellola bażali u keratosi aktinika:
Avoid contact with the eyes, lips and nostrils.
Evita l- kuntatt ma 'l- għajnejn, ix- xofftejn u l- imnifsejn.
Imiquimod has the potential to exacerbate inflammatory conditions of the skin.
Imiquimod għandu l- potenzjal li jħarrax il- kundizzjonijiet infjammatorji tal- ġilda.
Imiquimod cream should be used with caution in patients with autoimmune conditions (refer to section 4.5).
Il- krema imiquimod għandha tintuża b' kawtela f' pazjenti li għandhom kundizzjonijiet awtoimmuni (irreferi għal sezzjoni 4. 5).
Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with a possible worsening of their autoimmune condition.
Konsiderazzjoni għandha tingħata sabiex jitwieżen is- siwi tat- trattament b' imiquimod għal dawk il- pazjenti bir- riskju assoċjat ma 'tiħżin possibbli tal- kundizzjoni awtoimmuni.
Imiquimod cream should be used with caution in organ transplant patients (refer to section 4.5).
Il- krema imiquimod għandha tintuża b' kawtela f' pazjenti li kellhom trapjant ta 'organu (irreferi għal sezzjoni 4. 5).
Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with the possibility of organ rejection or graft-versus-host disease.
Konsiderazzjoni għandha tingħata sabiex jiġi mwieżen is- siwi tat- trattament b' imiquimod għal dawn il- pazjenti bir- riskju assoċjat bil- possibilità ta 'riġettazzjoni ta' l- organu jew il- mard tal- graft kontra l- ospitu.