qanastek/EMEA-V3 huggingface dataset:
However, the incidences of hepatocellular tumours among treated animals were greater than those for controls.
Madankollu, l- inċidenzi ta ’ tumuri epatoċellulari fl- annimali trattati kienu oghla minn dawk fil- kontrolli.
The mechanism for this is not known, but as imiquimod has low systemic absorption from human skin, and is not mutagenic, any risk to humans from systemic exposure is likely to be low.
Il- mekkaniżmu għal dan mhux magħruf, imma billi imiquimod għandu assorbiment sistemiku baxx mill- ġilda tal- bniedem, u mhuwiex mutaġeniku, kull riskju għal bniedem minn espożizzjoni sistemika x’ aktarx huwa baxx.
Furthermore, tumours were not seen at any site in a 2-year oral carcinogenicity study in rats.
Barra dan, tumuri ma dehrux f’ xi lok fi studju karsinoġeniku orali fuq il- ġrieden.
Imiquimod cream was evaluated in a photocarcinogenicity bioassay in albino hairless mice exposed to simulated solar ultraviolet radiation (UVR).
Il- krema imiquimod kienet evalwata b' bijoassaġġ ta 'fotokarsinoġeniċità fi ġriedem albino mingħajr xagħar li ġew esposti għal radjazzjoni ultravjola solari (UVR).
Animals were administered imiquimod cream three times per week and were irradiated 5 days per week for 40 weeks.
L- annimali ġew amministrati l- krema imiquimod tliet darbiet fil- ġimgħa u ġew irradjati 5 t' ijiem kull ġimgħa għal 40 ġimgħa.
Mice were maintained for an additional 12 weeks for a total of 52 weeks.
Il- ġrieden kienu miżmuma għal 12- il ġimgħa addizzjonali għal total ta '52 ġimgħa.
Tumours occurred earlier and in greater number in the group of mice administered the vehicle cream in comparison with the low UVR control group.
It- tumuri seħħew aktar kmieni u f' numri akbar fil- grupp ta 'ġrieden li ġew amministrati l- krema vettura meta mqabbel mal- grupp ta' kontroll UVR baxx.
The significance for man is unknown.
Is- sinifikat għal bniedem mhux magħruf.
Topical administration of imiquimod cream resulted in no tumour enhancement at any dose, in comparison with the vehicle cream group.
L- amministrazzjoni topika tal- krema imiquimod ma rriżultatx fi tħarrix ta 'tumuri fi kwalunkwe doża, meta mqabbel mall- grupp tal- krema vettura.
isostearic acid benzyl alcohol cetyl alcohol stearyl alcohol white soft paraffin polysorbate 60 sorbitan stearate glycerol methyl hydroxybenzoate (E218) propyl hydroxybenzoate (E216) xanthan gum purified water.
isostearic acid benzyl alcohol cetyl alcohol stearyl alcohol white soft paraffin polysorbate 60 sorbitan stearate glycerol methyl hydroxybenzoate (E218) propyl hydroxybenzoate (E216) xanthan gum ilma ppurifikat
6. 2 Incompatibilities
6. 2 Inkompatibilitajiet
Do not store above 25°C.
Taħżinx f’ temperatura ‘ lfuq minn 25°C.
Sachets should not be re-used once opened.
Il- qratas m’ għandhomx jintużaw mill- ġdid wara li jinfetħu.
Boxes of 12 single-use polyester/aluminium foil sachets, containing 250 mg of cream.
Kaxxi ta ’ 12- il qartas li kull wieħed jintuża darba biss magħmul minn fojl tal- polyester/ aluminju, li fih hemm 250 mg ta ’ krema.
6.6 Special precautions for disposal and other handling
6. 6 Struzzjonijiet għall- użu u maniggjar u għar- rimi (jekk xieraq)
No special requirements.
L- ebda ħtigijiet speċjali 7.
Meda AB Pipers väg 2A 170 73 Solna Sweden
Meda AB Pipers väg 2 170 73 Solna Żvezja
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIŻŻAZZJONI / TIĠDID TA ’ L- AWTORIŻŻAZZJONI
18/09/1998 Date of last renewal:
18/ 09/ 1998 Data ta 'l- aħħar reviżjoni:
DATE OF REVISION OF THE TEXT
DATA TA ’ META ĠIET RIVEDUTA L- KITBA ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ A.
MANUFACTURING AUTHORISATION HOLDER RESPONSI BLE FOR BATCH RELEASE
DETENTUR TA ’ AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUG TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott
3M Health Care Limited, Derby Road, Loughborough, Leicester, LE11 5SF, United Kingdom.
3M Health Care Limited, Derby Road, Loughborough, Leicester, LE11 5SF, Ir- Renju Unit.
B CONDITIONS OF THE MARKETING AUTH ORISATION
B KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Medicinal product subject to medicinal prescription
Prodott mediċinali jingħata bir- riċetta tat- tabib.
• OTHER CONDITIONS
• KUNDIZZJONIJIET OĦRA ANNESS III A.
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT EWLIENI
Aldara 5% cream imiquimod
Aldara 5% krema Imiquimod
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA (/ I) ATTIVA (/ I)
100 mg cream contains 5 mg imiquimod
Kull qartas fih 12. 5mg ta` imiquimod f`250mg krema (5%) 100 mg krema jkun fiha 5 mg imiquimod
Excipients: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), xanthan gum, purified water.
Sustanzi mhux attivi: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), xanthan gum, ilma ppurifikat
See package leaflet for further information.
Ara l- fuljett għal aktar informazzjoni.
Cream 12 sachets.
12- il qartas.
Each containing 250 mg of cream.
Kull wieħed fih 250 mg ta ’ krema.
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA 'KIF U MNEJN GHANDU JINGĦATA
For cutaneous use
Għal użu kutaneju
Keep out of the reach and sight of children
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal żgħar
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJ( A) / JIET SPEĊJALI, JEKK MEĦTIEGA
For single use only.
Sabiex jintuża darba biss.
Discard any cream remaining in a sachet after use.
Armi il- krema li tibqa 'fil- qartas wara l- użu.
EXPIRY DATE
DATA TA ’ META JISKADI 9 KONDIZZJONIJIET SPEĊJALI TA 'KIF TAĦŻEN
Exp.
JIS.
Do not store above 25°C
Taħżinx f’ temperatura ‘ l fuq minn 25°C
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TA ’ SID L- AWTORIZZAZZJONI GHALL- KUMMERĊ
Meda AB Box 906 170 09 Solna Sweden
Meda AB Box 906 170 09 Solna Żvezja
MARKETING AUTHORISATION NUMBER(S)
NUMRU (/ I) TA ’ L- AWTORIZZAZZJONI GHALL- KUMMERĊ
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA LILL- PAZJENT
INSTRUCTIONS ON USE
Mhux applikabbli
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Aldara TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- PAKKETTI Ż- ŻGĦAR EWLENIN
SACHET TEXT
KITBA FUQ IL- QARTAS
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI
Aldara 5% cream Imiquimod For cutaneous use
Aldara 5% krema imiquimod Għal użu għall- ġilda
CONTENTS BY WEIGHT
IL- KONTENUT SKOND IL- PIŻ
250 mg cream
250 mg krema
OTHER
OĦRAJN B.
PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF FULJETT TA ’ TAGĦRIF:
Aldara 5% cream Imiquimod
ALDARA 5% krema Imiquimod
- If you have any further questions, please ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not pass it on to others.
M’ għandekx tgħaddiha lil persuna oħra.
In this leaflet:
F' dan il- fuljett
2.
X’ inhu Aldara u għalxiex jintuża 2.
3.
Qabel ma tuża Aldara 3.
4.
Kif għandek tuża l- krema Aldara 4.
6.
Kif għandek taħżen il- krema Aldara 6.
WHAT IS ALDARA CREAM AND WHAT IT IS USED FOR
X’ INHU L- KREMA ALDARA U GĦALXIEX JINTUŻA
Aldara cream may be used for three different conditions.
Il- krema Aldara tista 'tintuża għal tliet kundizzjonijiet.
Your doctor may prescribe Aldara cream for the treatment of:
It- tabib tiegħek jista 'jagħtik riċetta għal Aldara għat- trattament ta':
Warts (condylomata acuminata) on the surface of the genitals (sexual organs) and around the anus (back passage)
●Felul (condylomata acuminata) fuq il- wiċċ tal- ġenitali (organi sesswali) u madwar l- anus (il- passaġġ ta 'wara)
Superficial basal cell carcinoma.
●Karċinoma superfiċjali taċ- ċellola bażali.
This is a common slow-growing form of skin cancer with a very small likelihood of spread to other parts of the body.
Din forma komuni ta 'kanċer tal- ġilda li tikber bil- mod bi probabilità żgħira li tinfirex f' partijiet oħra tal- ġisem.
It usually occurs in middle-aged and elderly people, especially those who are fair-skinned and is caused by too much sun exposure.
Ġeneralment iseħħ f' persuni ta 'mezz età u persuni anzjani, speċjalment dawk ġinġlin u tiġi kawżata minħabba espożizzjoni żejda fix- xemx.
If left untreated, basal cell carcinoma can disfigure, especially on the face – therefore early recognition and treatment are important.
Jekk ma tiġix trattata, il- karċinoma taċ- ċellola bażali tista tisfigura, speċjalment il- wiċċ – għalhekk ir- rikonoxximent bikri u t- trattament huma importanti.
Actinic keratosis Actinic keratoses are rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime.
●Keratosi aktinika Keratosi aktinika huma żoni ħorox fil- ġilda li jinsabu f' persuni li ġew esposti għal ħafna xemx matul ħajjithom.
Some are skin coloured, others are greyish, pink, red or brown.
Xi wħud huma kuluriti skond il- ġilda, oħrajn huma griżi, roża, ħomor jew kannella.
They can be flat and scaly, or raised, rough, hard and warty.
Jistgħu jkunu ċatti u bil- qxur, jew mgħollija, ħorox u bil- felul.
Aldara should only be used for flat actinic keratoses on the face and scalp in patients with a healthy immune system where your doctor has decided that Aldara is the most appropriate treatment for you.
Aldara għandha tintuża biss għal keratosi aktinika ċatta fuq il- wiċċ u l- qorriegħa f' pazjenti li għandhom sistema immuni b' saħħitha meta t- tabib tiegħek ddeċieda li Aldara hija l- aktar trattament adattat għalik.
Aldara cream helps your body´s own immune system to produce natural substances which help fight your basal cell carcinoma, actinic keratosis or the virus that has caused your warts.
Il- krema Aldara tghin lis- sistemaimmunitarja tal- gisem biex tipproduci is- sustanzi naturali li jgħinuh jiġġieled il- karċinoma ta 'ċellola bażali, il- keratosi aktinika jew il- virus li jikkaġuna l- felul tiegħek.
BEFORE YOU USE ALDARA CREAM
QABEL MA TUŻA L- KREMA ALDARA
Do not use Aldara cream:
Tużax il- krema Aldara:
- If you are allergic to imiquimod (the active ingredient) or any of the ingredients of the cream.
- Jekk inti allerġiku ghal imiquimod (is- sustanza attiva) jew xi wieħed mis- sustanzi
Take special care with Aldara cream:
Oqgħod attent ħafna bil- krema Aldara:
24 • If you have previously used Aldara cream or other similar preparations tell your doctor before starting this treatment. • Tell your doctor if you have problems with your immune system. • Do not use Aldara cream until the area to be treated has healed after previous drug or surgical treatment. • Avoid contact with the eyes, lips and nostrils.
• Jekk użajt il- krema Aldara qabel jew preparazzjonijiet oħra simili informa lit- tabib tiegħek qabel ma tibda dan it- trattament. • Informa lit- tabib tiegħek jekk għandek problemi bis- sistema immunitarja tiegħek. • Tużax il- krema Aldara sakemm l- erja li qed tiġi trattata tkun fieqet minn trattament preċedenti bil- mediċini jew kirurġiċi. • Evita l- kuntatt ma 'l- għajnejn, ix- xofftejn u l- imnifsejn.
In the event of accidental contact, remove cream by rinsing with water. • Do not apply the cream internally. • Do not use more cream than your doctor has advised. • Do not cover the treated area with bandages or other dressings after you have applied Aldara cream. • If the treated site becomes too uncomfortable, wash the cream off with mild soap and water.
F' każ ta 'kuntatt aċċidentali, neħħi l- krema billi tlaħlaħ bl- ilma. • Tapplikax il- krema fuq ġewwa. • Tużax aktar krema milli rakomandalek it- tabib tiegħek. • Tgħattiex l- erja trattata bil- faxxex jew bi preparazzjoni mediċinali oħra wara li tkun applikajt il- krema Aldara. • Jekk is- sit trattat ikun skomdu wisq, neħħi l- krema billi taħsilha sew b' sapuna ħafifa u ilma.
As soon as the problem has stopped you may restart to apply the cream. • Tell your doctor if you have an abnormal blood count.
Hekk kif il- problema tieqaf, tista 'terġa tibda' tapplika l- krema mill- ġdid. • Għid lit- tabib tiegħek jekk għandek l- għadd totali tad- demm mhux normali.
Because of the way Aldara works, there is a possibility that the cream may worsen existing inflammation in the treatment area.
Minħabba l- mod kif Aldara jaħdem, jista 'jkun hemm il- possibilità li l- krema tista' tħarrax l- infjammazzjoni eżistenti fl- erja ta 'trattament.
• If you are being treated for genital warts follow these additional precautions:
● Jekk qed tiġi kkurat għal felul ġenitali, segwi dawn l- prekawzjonijiet addizzjonali:
Men with warts under the foreskin should pull the foreskin back each day and wash underneath it.
Irġiel bil- felul taħt il- prepuzju għandhom jiġbdu l- prepuzju lura kuljum u jaħslu taħtu.
If not washed daily the foreskin may be more likely to show signs of tightness, swelling and wearing away of the skin and result in difficulty in pulling it back.
Jekk ma jinħasilx kuljum il- prepuzju aktarx juri sinjali ta 'tiġbid, tinfiħ u l- ġilda tittiekel bir- riżultat li jkun diffiċli jinġibed lura.
If these symptoms occur, stop the treatment immediately and call your doctor.
Jekk dawn is- sintomi huma preżenti, waqqaf it- trattament minnufiħ u sejjaħ it - tabib.
If you have open sores: do not start using Aldara cream until after the sores have healed.
Jekk għandek feriti miftuħin: tibdiex tuża l- krema Aldara qabel ma jitfiequ l- feriti.
If you have internal warts: do not use Aldara cream in the urethra (the hole from which urine is passed), the vagina (birth canal), the cervix (internal female organ), or anywhere inside your anus (rectum).
Tużax il- krema Aldara fl- uretra (it- toqba minn fejn tgħaddi l- awrina), il- vaġina (il- kanal tat- twelid), l- għonq ċervikali (organu intern tal- mara), jew f’ kull post ieħor anali tiegħek (rektum).
Do not use this medication for more than one course if you have problems with your immune system, either due to illness or because of the medicines you are already taking.
Tużax din il- mediċina ghal aktar minn kors wieħed jekk għandek problema bis- sistema immunitarja tiegħek, jew minħabba mard jew l- mediċini li int digà qed tieħu.
If you think this applies to you talk to your doctor.
Jekk taħseb li dan japplika għalik kellem it- tabib tiegħek.
If you are HIV positive you should inform your doctor as Aldara cream has not been shown to be as effective in HIV positive patients.
Jekk inti pożittiv ghal HIV għandek tinforma t- tabib tiegħek billi l- krema Aldara ma ntweritx li hija effettiva f’ pazjenti pożittivi bl- HIV.
If you decide to have sexual relations while you still have warts, apply Aldara cream after - not before - sexual activity.
Jekk tiddeċiedi li trid li jkollok relazzjonijiet sesswali waqt li għad għandek il- felul, applika l- krema Aldara wara – mhux qabel – l- attività sesswali.
Aldara cream may weaken condoms and diaphragms, therefore the cream should not be left on during sexual activity.
Il- krema Aldara tista ’ iddghajjef kondoms u dijaframmi, għalhekk il- krema m’ għandhiex titħalla waqt l- attività sesswali.
Remember, Aldara cream does not protect against giving HIV or other sexually transmitted diseases to someone else.
Ftakar, il- krema Aldara ma tipproteġiex kontra t- teħid tal- virus lil haddiehor.
• If you are being treated for basal cell carcinoma or actinic keratosis follow these additional precautions:
●Jekk qed tiġi trattat għal karċinoma taċ- ċellola bażali jew keratosi aktinika segwi dawn il - prekawzjonijiet addizzjonali:
Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with Aldara cream.
Tużax lampi tax- xemx jew sodod tat- tismir, u evita d- dawl tax- xemx kemm jista 'jkun waqt it - trattament bil- krema Aldara.
Wear protective clothing and wide brimmed hats when outdoors.
Ilbes ilbies protettiv u kpiepel bil- falda wiesgħa meta tkun barra.
Whilst using Aldara cream and until healed, the treatment area is likely to appear noticeably different from normal skin.
Waqt li tkun qed tuża l- krema Aldara u sakemm tfieq, l- erja ta 'trattament x' aktarx ser tidher notevolment differenti mill- ġilda normali.
Using other medicines:
Meta tuża mediċini ohra:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt xi mediċini oħra fil- passat qrib, anki jekk mhux bir- riċetta.
There are no medicines known to be incompatible with Aldara cream.
M’ hemmx mediċini magħrufa li ma jaqblux mal- krema Aldara.
25 Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
You must tell your doctor if you are pregnant or intend to become pregnant.
Għandek tgħid lit- tabib tiegħek jekk inti tqila jew beħsiebek tinqabad tqila.
Your doctor will discuss the risks and benefits of using Aldara cream during pregnancy.
It- tabib tiegħek ser jiddiskuti r- riskji u s- siwi tal- krema Aldara waqt it- tqala.
Studies in animals do not indicate direct or indirect harmful effects in pregnancy.
Studji f’ annimali ma jindikawx effetti direttament jew indirettament perikolużi fit- tqala.
Do not breast-feed your infant during treatment with Aldara cream, as it is not known whether imiquimod is secreted in human milk.
M’ għandekx tredda t- tarbija tiegħek waqt il- perijodu ta ’ trattament bil- krema Aldara, billi mhux magħruf jekk imiquimod jnixxiex fil- ħalib tal- bniedem.
Important information about some of the ingredients of Aldara cream:
Tagħrif importanti dwar xi wħud mis- sustanzi tal- krema Aldara
Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) may cause allergic reactions (possibly delayed).
Methyl hydroxybenzoate (E218) u propyl hydroxybenzoate (E216) jistgħu jikkawżaw reazzjonijiet allerġiċi (possibilment tardjati).
Cetyl and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Cetyl u stearyl alcohol jistgħu jikkaġunaw reazzjonijiet lokali tal- ġilda (eż. dermatite tal- kuntatt).
HOW TO USE ALDARA CREAM
KIF GĦANDEK TUŻA ALDARA
Always use Aldara cream exactly as your doctor has told you.
Dejjem għandek tuża l- krema Aldara skond il- parir tat- tabib.
Check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
Wash hands carefully before and after applying the cream.
Aħsel idejk sew qabel ma tapplika l- krema.
Do not cover the treated area with bandages or other dressings after you have applied Aldara cream.
Tgħattiex l- erja trattata bil- faxxex jew xi preparazzjoni mediċi oħra wara li tkun applikajt il- krema Aldara.
Open a new sachet each time you use the cream.
Iftaħ qartas ġdid kull darba li tużha l- krema.
Do not save the opened sachet for use at a later date.
Armi l- krema li tibqa fil- qartas wara l- użu. Taħżinx biex tuża ghal data aktar tard il- pakkett miftuħ.
The treatment frequency and duration differ for genital warts, basal cell carcinoma and actinic keratosis (see specific instructions for each indication).
Il- frekwenza tat- trattament u t- tul ivarja għal felul ġenitali, karċinoma taċ- ċellola bażali u keratosi aktinika (ara struzzjonijiet speċifiċi għal kull indikazzjoni).
If you are being treated for genital warts:
● Jekk qed tiġi trattat għal felul ġenitali:
Application Instructions – (Mon, Wed and Fri) 1.
Struzzjonijiet t' applikazzjoni – (It- Tnejn, L- Erbgħa u L- Ġimgħa) 1.
Dry thoroughly.
Qabel ma tidħol fis- sodda, aħsel idejk u l- erja tat- tratatment f' sapuna ħafifa u ilma. Ixxotta sew.
Open a new sachet and squeeze some cream onto your fingertip.
Iftaħ qartas ġdid u għasar ftit krema fuq tarf is- suba '.
Apply a thin layer of Aldara cream onto clean, dry wart area and rub gently into the skin until cream vanishes.
Applika saff irqiq ta 'krema Aldara f' erja nadifa u xotta u għorok bil- mod fil- ġilda sakemm il - krema tisparixxi.
After application of the cream, throw away the opened sachet and wash hands with soap and water.
Wara li tagħmel il- krema, armi l- qartas miftuħ u aħsel idejk bis- sapun u l- ilma.
Leave Aldara cream on the warts for 6 to 10 hours.
Ħalli l- krema Aldara fuq il- felul għal bejn 6 sa 10 sigħat.
Do not shower or bathe during this time.
Tieħux doċċa jew xi banju matul dan il- ħin.
After 6 to 10 hours wash the area where Aldara cream was applied with mild soap and water.
Wara 6 sa 10 sigħat aħsel l- erja fejn l- krema Aldara ġiet applikata bis- sapun ħafif u ilma.
Apply Aldara cream 3 times per week.
Applika l- krema Aldara 3 darbiet fil- ġimgħa.
For example, apply the cream on Monday, Wednesday and Friday.
Per eżempju, applika l- krema nhar ta 'Tnejn, l- Erbgħa u l - Ġimgħa.
3 square inches).
Qartas wieħed fih biżżejjed krema biex ikopri erja ta 'felul ta' 20 cm2 (madwar 3 pulzieri kwadri).
26 Men with warts under the foreskin should pull the foreskin back each day and wash underneath it (see section 2 “Take special care with Aldara cream:”)
Irġiel bil- felul taħt il- prepuzju għandhom jiġbdu lura l- prepuzju kuljum u jaħslu taħtu (ara sezzjoni 2 “ Agħti attenzjoni speċjali meta tuża l- krema Aldara: ”).
Continue to use Aldara cream as instructed until your warts have completely gone (half the females who clear will do so in 8 weeks, half the males who clear will do so in 12 weeks but in some patients warts may clear as early as 4 weeks).
Għandek tibqa ’ tuża l- krema Aldara kif indikat sakemm il- felul ikun telaq kollu (nofs in- nisa li jitnaddfu mill- felul jagħmlu dan fi żmien 8 ġimgħat, nofs l- irgiel li jitnaddfu jagħmlu dan fi 12- il ġimgħa, imma f’ xi pazjenti l- felul ikun diġà telaq fi żmien 4 ġimgħat).
Do not use Aldara cream for more than 16 weeks in the treatment of each episode of warts.
Il- krema Aldara m’ għandhiex tintuża għal aktar minn 16- il ġimgħa għal kull episodju ta ’ felul ġenitali jew ta ’ madwar il- parti anali.
If you have the impression that the effect of Aldara cream is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l- effett tal- krema Aldara huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
• If you are being treated for basal cell carcinoma:
● Jekk qed tiġi trattat għal karċinoma ta 'ċellola bażali:
Application Instructions – (Mon, Tues, Wed, Thurs and Fri) 1.
Struzzjonijiet t' applikazzjoni – (It- Tnejn, It- Tlieta, L- Erbgħa, Il- Ħamis u L- Ġimgħa) 1.
Before going to bed, wash your hands and the treatment area with mild soap and water.
Qabel ma tidħol fis- sodda, aħsel idejk u l- erja tat- trattatment f' sapun ħafif u ilma.
Dry thoroughly.
Ixxotta sew.
0.5 inch) around the affected area.
Applika l- krema Aldara fl- erja affetwata u 1ċm (madwar 0. 5 pulzieri) madwar l- erja affettwata.
Rub gently into the skin until the cream vanishes.
Għorok bil- mod fil- ġilda sakemm il- krema tisparixxi.
After application of the cream, throw away the opened sachet.
Wara li tapplika l- krema, armi l- qartas miftuħ.
Wash hands with soap and water.
Aħsel idejk bis- sapun u l- ilma.
Leave Aldara cream on the skin for about 8 hours.
Ħalli l- krema Aldara fuq il- ġilda għal madwar 8 sigħat.
After about 8 hours, wash the area where Aldara cream was applied with mild soap and water.
Wara madwar 8 sigħat, aħsel l- erja fejn kinet applikata l- krema Aldara b' sapun ħafif u l- ilma.
Apply sufficient Aldara cream to cover the treatment area and 1 cm (about ½ an inch) around the treatment area each day for 5 consecutive days each week for 6 weeks.
Applika biżżejjed krema Aldara biex tkopri l- erja ta 'trattament u 1 ċm (madwar ½ pulzier) madwar l- erja ta' trattament kuljum għal ħames ġranet konsekuttivi għal 6 ġimgħat.
For example, apply the cream from Monday to Friday.
Pereżempju, applika l - krema mit- Tnejn sal- Ġimgħa.
Do not apply the cream on Saturday and Sunday.
Tapplikax il- krema s- Sibt u l- Ħadd.
• If you are being treated for actinic keratosis
● Jekk qed tiġi trattat għal keratosi aktinika
Application Instructions – (Mon, Wed and Fri) 1.
Struzzjonijiet ta 'applikazzjoni – (It- Tnejn, L- Erbgħa u L- Ġimgħa) 1.
Before going to bed, wash your hands and the treatment area with mild soap and water.
Qabel ma tidħol fis- sodda, aħsel idejk u l- erja tat- tratatment f' sapuna ħafifa u ilma.
Apply the cream to the affected area.
Applika l- krema fl- erja affettwata.
Rub gently into the area until the cream vanishes.
Għorok bil- mod fl- erja sakemm il- krema tisparixxi.
For example, apply the cream on Monday, Wednesday and Friday.
Pereżempju, applika l- krema nhar ta 'Tnejn, l- Erbgħa u l- Ġimgħa.
4 square inches).
Qartas wieħed fih biżżejjed krema biex ikopri erja ta 'felul ta' 25 cm2 (madwar 4 pulzieri kwadri).
Continue treatment for four weeks.
Issokta bit- trattament għal erba 'ġimgħat.
Four weeks after finishing this first treatment, your doctor will assess your skin.
Erba 'ġimgħat wara li ttemm dan l- ewwel trattament, it- tabib tiegħek ser jeżamina l- ġilda tiegħek.
If the lesions have not all disappeared, a further four weeks of treatment may be necessary.
Jekk il- leżjonijiet ma sparixxawx kollha, jista 'jkun hemm bżonn ta' erba 'ġimgħat ta' trattament oħra.
If you use more Aldara cream than you should:
Jekk tużha aktar krema Aldara milli suppost ghandek:
Wash the extra away with mild soap and water.
Aħsel iżżejjed b’ sapun hafif u ilma.
When any skin reaction has gone you may then continue with your treatment.
Meta r- reazzjoni tal- ġilda tkun marret imbagħad issokta bit- trattament tiegħek.
If you accidentally swallow Aldara cream please contact your doctor.
Jekk aċċidentalment tibla l- krema Aldara, jekk jgħogbok ikkuntattja lit- tabib.
If you forget to use Aldara cream:
Jekk tinsa tuża l- krema Aldara:
Do not apply the cream more than once per day.
Jekk tonqos tapplika xi doża, applika l- krema hekk kif tiftakar u mbagħad kompli fl- iskeda regolari tiegħek. Tapplikax il- krema aktar minn darba f' ġurnata.
27 If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet dwar l- użu ta 'dan il- prodott staqsi lit- tabib jew lill- ispiżjar tiegħek.
Very common side effects (likely to occur in more than 1 in 10 patients) Common side effects (likely to occur in fewer than 1 in 10 patients) Uncommon side effects (likely to occur in fewer than 1 in 100 patients) Rare side effects (likely to occur in fewer than 1 in 1,000 patients) Very rare side effects (likely to occur in fewer than 1 in 10,000 patients).
Il frekwenza tal- effetti sekondarji jigu ikklasifikati hekk Effetti sekondarji komuni hafna (x`aktarx li jigru f`aktar minn 1 minn kull 10 pazjenti Effetti sekondarji komuni (x`aktarx li jigru f`anqas minn 1 minn kull 10 pazjenti Effetti sekondarji mhux komuni (x`aktarx li jigru f`anqas minn 1 minn kull 100 pazjent Effetti sekondarji rari (x`aktarx li jigru f`anqas minn 1 minn kull 1, 000 pazjenti Effetti sekondarji rari hafna (x`aktarx li jigru f`anqas minn 1 minn kull 10, 000 pazjenti
Like all medicines, Aldara cream can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, il- krema Aldara jista ’ jkollha effetti sekondarji oħra, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Aldara cream.
Għid lit- tabib jew spiżjar tiegħek kemm jista ’ jkun malajr jekk ma tħossokx f’ siktek waqt li qed tużha l- krema Aldara.
Some patients have experienced changes in skin colour in the area where Aldara cream was applied.
Xi pazjenti kellhom bidliet fil- kulur tal- ġilda fl- erja fejn ġiet applikata l- krema Aldara.
While these changes have tended to improve with time, in some patients they may be permanent.
Filwaqt li dawn il - bidliet kellhom tendenza li jitjiebu biż- żmien, f' xi pazjenti jistgħu jkunu permanenti.
If your skin reacts badly when using Aldara cream, stop applying the cream, wash the area with mild soap and water and contact your doctor or pharmacist.
Jekk il- ġilda tiegħek tirreaġixxi ħażin meta tuża l- krema Aldara, waqqaf l- applikazzjoni tal- krema, aħsel l- erja b' sapun ħafif u ilma u kkuntattja lit- tabib jew lill- ispiżjar tiegħek.
In some individuals a lowering of blood counts was noted.
F 'xi individwi ġie nnotat li kien hemm tnaqqis fl- għadd totali ta' ċelloli tad- demm.
A lowering of blood counts might make you more susceptible to infections, make you bruise more easily or cause fatigue.
Tnaqqis fl- għadd taċ- ċelloli tad- demm jista 'jagħmlek aktar suxxetibbli għal infezzjonijiet, iġegħelk titbenġel aktar faċilment jew tkun għajjien.
If you notice any of these symptoms, tell your doctor.
Jekk tinduna b' xi sintomi bħal dawn, għid lit- tabib tiegħek.
Serious skin reactions have been reported rarely.
Reazzjonijiet serji tal- ġilda ġew irrapportati rarament.
If you experience skin lesions or spots on your skin that start out as small red areas and progress to look like mini targets, possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores, stop using Aldara cream and tell your doctor immediately.
Jekk ikollok leżjonijiet tal- ġilda jew tebgħat fuq il- ġilda tiegħek li jibdew bħala żoni ħomor u jikbru biex jidhru bħal bersalli żgħar, possibilment b' sintomi ta 'ħakk, deni, tħossok mhux f' tiegħek, ġogi juġgħawk, problemi bil- vista, ħruq, l- għajnejn juġgħawk jew trid tħokkhom u ġrieħi fil- ħalq, tibqax tuża l- krema Aldara u għarraf lit- tabib tiegħek minnufih.
A small number of patients have experienced hair loss at the treatment site or surrounding area.
Għadd żgħir ta 'pazjenti waqgħalhom xagħarhom fil- post tat- trattament jew l- erja tal- madwar.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti kollaterali jiggrava jew jekk tinnota xi effetti oħra li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għarraf lit- tabib jew lill- ispiżjar tiegħek.
● If you are being treated for genital warts:
● Jekk qed tiġi trattat għal felul ġenitali:
Many of the undesirable effects of Aldara cream are due to its local action on your skin.
Ħafna mill- effetti mhux mixtieqa tal- krema Aldara huma dovuti għal azzjoni lokali fuq il- ġilda tiegħek.
Very common effects include redness (61% patients), wearing away of the skin (30% patients), flakiness and swelling.
Effetti komuni hafna jinkludu ħmura (61% tal- pazjenti), il- ġilda tittiekel (30% tal- pazjenti), sfoll u nefħa.
Hardening under the skin, small open sores, a crust that forms during healing, and small bubbles under the skin may also occur.
Jista 'jkun hemm ukoll twebbis taħt il- ġilda, ġrieħi miftuħin żgħar, qoxra li tifforma waqt il - fejqan u nfafet taħt il- ġilda.
You might also feel itching (32% patients), a burning sensation (26% patients) or pain in areas where you have applied Aldara cream (8% patients).
Tista 'ukoll tħoss ħakk (32% tal- pazjenti), sensazzjoni ta' ħruq (26% pazjenti) jew uġigħ f' postijiet fejn tkun applikajt il- krema Aldara (8% tal- pazjenti).
Most of these skin reactions are mild and the skin will return to normal within about 2 weeks after stopping treatment.
Ħafna minn dawn ir- reazzjonijiet tal- ġilda huma ħfief u l- ġilda terġa ’ tirritorna lura għan- normal wara ġimagħtejn litwaqqaf it- trattament.
Commonly some patients (4% or less) have experienced headache, uncommonly fevers and flu like symptoms joint and muscle pains; prolapse of the womb; pain on intercourse in females; erection difficulties; increase in sweating; feeling sick; stomach and bowel symptoms; ringing in the ears; flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; loss of appetite; swollen glands; bacterial, viral and fungal infections (e.g. cold sores); vaginal infection including thrush; cough and colds with sore throat.
Huwa komuni li xi pazjenti (4% jew inqas) kellhom uġigħ ta 'ras, deni, uġigħ tal- ġogi u l- muskoli f' sintomi bħal ta' l- influwenza; prolass tal- ġuf; uġigħ waqt l- att fin- nisa; impotenza; żieda fl- għaraq; tħossok ma tiflaħx, sintomi ta 'l- istonku u ta' l- imsaren, ċenċil fil- widnejn; għejja; sturdamenti, migranja; tingiż u labar; nuqqas ta 'rqad; dipressjoni; nuqqas t' aptit; glandoli minfuħa, infezzjonijiet batteriċi, virali u fungali (e. g. ponot); infezzjoni vaġinali li tinkludi thrush; sogħla u irjaħat fl- uġigħ fil- griżmejn.
Very rarely severe and painful reactions have occurred, particularly when more cream has been used than recommended.
Rari ħafna reazzjonijiet serji u ta 'uġigħ seħħew, partikolarment meta intużat aktar krema minn dik rakkomandata.
Painful skin reactions at the opening of the vagina have very rarely made it difficult for some women to pass urine.
Reazzjonijiet ta ’ uġigh tal- ġilda rari fil- fetħa tal- vaġina kienu għamluha diffiċli għal xi nisa li jgħaddu l- urina.
If this occurs you should seek medical help immediately.
Jekk dan iseħħ għandek tfittex l- għajnuna medika minnufiħ.
28 Many of the undesirable effects of Aldara cream are due to its local action on your skin.
Ħafna mill- effetti mhux mixtieqa tal- krema Aldara huma dovuti għal azzjoni lokali fuq il- ġilda tiegħek.
Local skin reactions can be a sign that the drug is working as intended.
Reazzjonijiet tal- ġilda lokali jistgħu jkunu sinjali li l- mediċina qed taħdem kif maħsub.
Very Commonly the treated skin may be slightly itchy.
Komunament ħafna l- ġilda trattata għandha mnejn ġġagħlek tħokk daqsxejn.
Common effects include: pins and needles, small swollen areas in the skin, pain, burning, irritation, bleeding, redness or rash.
Effetti komuni jinkludu: tingiż u labar, postijiet żgħar fil- ġilda minfuħin, uġigħ, ħruq, irritazzjoni, fsada, ħmura jew raxx.
If a skin reaction becomes too uncomfortable during treatment, speak to your doctor.
Jekk reazzjoni tal- ġilda ssir skomda żżejjed waqt it- trattament, kellem lit- tabib tiegħek.
He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).
Hu/ hi jista 'jagħtik parir biex tieqaf tapplika l- krema Aldara għal ftit jiem (i. e. għal ftit serħan mit- trattament).
If there is pus (matter) or other suggestion of infection, discuss this with your doctor.
Jekk ikun hemm pas (materja) jew infezzjoni tkun imputata, idduskuti dan mat- tabib tiegħek.
Apart from reactions in the skin, other common effects include swollen glands and back pain.
Barra minn reazzjonijiet fil- ġilda, effetti komuni oħra jinkludu glandoli minfuħinu uġigħ fid- dahar.
Uncommonly some patients experience changes at the application site (discharge, inflammation, swelling, scabbing, skin breakdown, blisters, dermatitis) or irritability, feeling sick, dry mouth, flu-like symptoms and tiredness.
Mhux komuni li xi pazjenti jħossu bidliet fis- sit t' applikazzjoni (tnixxija, infjammazzjoni, nefħa, il - ġilda tinkiser, il- ġilda tifforma skorċa hi u qiegħda tfiq, infafet, dermatite) jew irritabilità, tħossok marid, ħalq xott, sintomi bħal ta 'l- influwenza u għejja.
Very commonly the treated skin may be slightly itchy.
Komunament ħafna l- ġilda trattata għandha mnejn ġġagħlek tħokk daqsxejn.
Common effects include pain, burning, irritation or redness.
Effetti komuni jinkludu uġigħ, ħruq, irritazzjoni jew ħmura.
Apart from reactions in the skin, other common effects include headache, anorexia, nausea, muscle pain, joint pain and tiredness.
Barra minn reazzjonijiet fuq il- ġilda, effetti komuni oħra jinkludu uġigħ ta 'ras, anoreksja, tqallih, uġigħ fil - muskoli, uġigħ fil- ġogi u għejja.
Uncommonly some patients experience changes at the application site (bleeding, inflammation, discharge, sensitivity, swelling, small swollen areas in the skin, pins and needles, scabbing, scarring, ulceration or a feeling of warmth or discomfort), or inflammation of the lining of the nose, stuffy nose, flu or flu-like symptoms, depression, eye irritation, swelling of the eyelid, throat pain, diarrhoea, actinic keratosis, redness, swelling of the face, ulcers, pain in extremity, fever, weakness or shivering.
Mhux komuni li xi pazjenti jħossu bidliet fis- sit t' applikazzjoni (fsada, infjammazzjoni, tisfija, sensitività, tinfiħ, tinfiħ żgħir f' partijiet tal- ġilda, tingiż u labar, sfoll, ċikatriċ, ulċerazzjoni jew sensazzjoni ta 'sħana jew skonfort), jew infjammazzjoni tar- riti ta' l- imnieħer, imnieħer miżdud, influwenza jew sintomi bħal ta 'l- influwenza, dipressjoni, irritazzjoni ta' l- għajnejn, tinfiħ tal- kappell ta 'l- għajn, uġigħ tal- griżmejn, dijarea, keratosi aktinika, ħmura, tinfiħ tal- wiċċ, ulċeri, uġigħ fl - estrimitajiet, deni, debolezza jew tertir.
HOW TO STORE ALDARA CREAM
KIF GĦANDEK TAĦŻEN ALDARA
Do not use after the expiry date stated on the label.
M’ għandekx tuża wara d- data ta ’ skadenza mniżżla fuq it- tikketta.
Sachets should not be re -used once opened.
Il- qratas m' għandhomx jintużaw mill- ġdid la darba jkunu nfetħu.
Ask your pharmacist to dispose of medicines no longer required.
Staqsi lill- ispiżjar tiegħek dwar kif għandek tarmi mediċini li m' għandekx bżonn.
What Aldara cream contains:
X’ fih Aldara:
- The active substance is imiquimod.
- Is- sustanza attiva hi imiquimod.
Each sachet contains 250 mg cream (100 mg cream contains
Kull qartas fih 250 mg krema (100 mg krema fiha 5 mg
- The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft
- Is- sustanzi l- oħra huma isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft
paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), xanthan gum, purified water.
paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), xanthan gum, ilma purifikat.
What Aldara cream looks like and contents of the pack:
Id- dehra Aldara u l- kontenuti tal- pakkett
- Each Aldara 5% cream sachet contains 250 mg of a white to slightly yellow cream.
- Kull qartas ta 'krema Aldara ta' 5% fih 250 mg ta 'krema bajda li tkanġi daqsxejn fl- isfar.
- Each box contains 12 single-use polyester/aluminium foil sachets.
- Kull kaxxa fiha 12- il qartas f' folja tal- polyester/ aluminju li jintuża darba.
Meda AB Box 906 170 09 Solna Sweden
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ Meda AB Box 906 170 09 Solna Żvezja
MANUFACTURER:
MANIFATTUR:
3M Health Care Limited Derby Road Loughborough Leicestershire LE11 5SF, United Kingdom
3M Health Care Limited Derby Road Loughborough Leicestershire LE11 5SF, ir- Renju Unit
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 ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq.
48 Mill Street Qormi Qrm 03 Tel: +356 21 470090
48 Mill Street Záhřebská 577 / 33 Qormi 120 00 Praha 2 Qrm 03 Tel: +420 222 514 950 Tel: +356 21 470090
32
Dan il- fuljett kien approvat l- aħħar f '{XX/ SSSS}
What is Aldurazyme?
X’ inhu Aldurazyme?
Aldurazyme is a solution for infusion (drip into a vein).
Aldurazyme huwa soluzzjoni għal infużjoni (drip fil- vina).
It contains the active substance laronidase.
Fih is- sustanza attiva laronidase.
What is Aldurazyme used for?
Għal x’ hiex jintuża Aldurazyme?
Aldurazyme is used for enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; α -L-iduronidase deficiency) to treat the non-neurological symptoms of the disease (not connected with the brain or nerves).
Aldurazyme jintuża bħala terapija ta ’ sostituzzjoni ta ’ enzim f’ pazjenti b’ dijanjożi konfermata ta ’ mucopolysaccharidosis I (MPS I; defiċjenza α- L- iduronidase) biex jittratta s- sintomi mhux newroloġiċi tal- marda (mhux imqabbda mal- moħħ jew nervituri).
MPS I is a rare, inherited disease, where the level of α -L-iduronidase enzyme activity is much lower than normal.
MPS I hija marda rari u li tintiret, fejn il- livell ta ’ l- attività ta ’ l- enzim α- L- iduronidase huwa ferm inqas min- normal.
This means that certain substances (glycosaminoglycans, GAGs) are not broken down, so they build up in most of the organs in the body and damage them.
Dan ifisser li ċerti sustanzi (glycosaminoglycans, GAGs) ma jitkissrux, għalhekk jakkumulaw f’ ħafna mill- organi fil - ġisem u jagħmlulhom il- ħsara.
The non-neurological symptoms of MPS I can be an enlarged liver, stiff joints which make moving more difficult, less lung volume, heart disease and eye disease.
Is- sintomi mhux newroloġiċi ta ’ MPS I jistgħu jkunu fwied imkabbar, ġogi iebsin li jagħmlu l- movimenti aktar diffiċli, inqas volum fil- pulmun, problemi fil- qalb u mard ta ’ l- għajnejn.
Because the number of patients with MPS I is low, the disease is considered ‘ rare’, and Aldurazyme was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 14 February 2001.
Minħabba li n- numru ta ’ pazjenti b’ MPS I huwa wieħed baxx, il- marda hija meqjusa ‘ rari ’, u Aldurazyme ġie kklassifikat bħala ‘ mediċina orfni ’ (mediċina wżata f’ mard rari) fl- 14 ta ’ Frar 2001.
How is Aldurazyme used?
Kif jintuża Aldurazyme?
Aldurazyme treatment should be supervised by a doctor experienced in the management of patients with MPS I or other inherited metabolic diseases.
It- trattament b’ Aldurazyme għandu jiġi sorveljat minn tabib b’ esperjenza fil- ġestjoni ta ’ pazjenti b’ MPS I jew b’ mard metaboliku li jintiret ieħor.
Administration of Aldurazyme should be carried out in a hospital or clinic where resuscitation equipment is available, and patients may need to receive some medicines before the infusion to prevent an allergic reaction.
L- għoti ta ’ Aldurazyme għandu jsir fi sptar jew klinika fejn ikun hemm disponibbli apparat ta ’ risuxxitazzjoni, u l- pazjenti jistgħu jkunu jeħtieġu li jirċievu xi mediċini qabel l- infużjoni sabiex tkun impeduta reazzjoni allerġika.
Aldurazyme is given once every week as an intravenous infusion.
Aldurazyme jingħata darba fil- ġimgħa bħala infużjoni fil- vina.
Aldurazyme is designed for long-term use.
Aldurazyme huwa mfassal biex jintuża fuq perjodu twil.
How does Aldurazyme work?
Kif jaħdem Aldurazyme?
The active ingredient in Aldurazyme, laronidase, is a copy of the human enzyme α -L-iduronidase.
Is- sustanza attiva f’ Aldurazyme, laronidase, hija kopja ta ’ l- enzima umana α- L- iduronidase.
It is produced by a method known as ‘ recombinant DNA technology’: the enzyme is made by a cell which has received a gene (DNA) that makes it able to produce the enzyme.
Hija prodotta b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: l- enzim huwa magħmul minn ċellola li rċeviet ġene (DNA) li tagħmilha possibbli li tipproduċi l- enzim.
Laronidase replaces the enzyme missing in patients with MPS I.
Laronidase jissostitwixxi l - enzim li jkun nieqes f’ pazjenti b’ MPS I.
By supplying the missing enzyme, the symptoms of MPS I are controlled and this improves the patient ’ s quality of life.
Bl- għoti ta ’ l- enzim nieqes, is- sintomi tal- MPS I huma kkontrollati u dan itejjeb il- kwalità tal- ħajja tal- pazjent.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Aldurazyme been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Aldurazyme?
Aldurazyme has been studied in 45 patients aged five years and over with a confirmed diagnosis of MPS I.
Aldurazyme ġie studjat f’ 45 pazjent ta ’ ħames snin u akbar b’ dijanjożi konfermata ta ’ MPS I.
The study compared the effect of Aldurazyme to that of placebo (a dummy treatment).
L - istudju qabbel l- effett ta ’ Aldurazyme ma ’ dak ta ’ plaċebo (trattament finta).
The main measure of effectiveness was the lung function (forced vital capacity, FVC) and the distance the patients could walk over six minutes before and after 26 weeks of treatment, but the study continued for up to four years.
Il- miżura ewlenija ta ’ l - effikaċja kienet il- funzjoni tal- pulmun (kapaċità vitali forzata, FVC) u d- distanza li l- pazjenti setgħu jimxu fuq sitt minuti qabel u wara 26 ġimgħa tat- trattament, madankollu, l- istudju kompla sa erba ’ snin.
Aldurazyme has also been studied in 20 children below the age of five years who received Aldurazyme for a year.
Aldurazyme ġie studjat ukoll f’ 20 tifel/ tifla taħt l- età ta ’ ħames snin li rċevew Aldurazyme għal sena.
The study was looking mainly at the safety of the medicine, but it also measured its effectiveness (looking at its effect on reducing levels of GAGs in the urine and on the size of the liver).
L- istudju fittex prinċipalment is- sigurtà tal- mediċina, iżda kejjel ukoll kemm kienet effikaċi (ħares lejn l- effett tagħha fit- tnaqqis tal- livelli ta ’ GAGs fl- awrina u fuq id- daqs tal- fwied).
What benefit has Aldurazyme shown during the studies?
X’ benefiċċju wera Aldurazyme matul l- istudji?
The study showed that Aldurazyme had improved both the FVC and the walking ability of patients at 26 weeks.
L- istudju wera li Aldurazyme tejjeb kemm l- FVC kif ukoll l- abbiltà fil- mixi ta ’ pazjenti f’ 26 ġimgħa.
This effect was maintained for up to four years.
Dan l- effett inżamm sa erba ’ snin.
In children under five years of age, Aldurazyme reduced the levels of GAGs in the urine by about 60% and half of the children treated had a liver of a normal size at the end of the study.
Fi tfal taħt l- età ta ’ ħames snin, Aldurazyme naqqas il- livelli ta ’ GAGs fl- awrina b’ madwar 60% u nofs it- tfal trattati kellhom fwied ta ’ daqs normali fi tmiem l- istudju.
What is the risk associated with Aldurazyme?
X’ inhu r- riskju assoċjat ma ’ Aldurazyme?
Most of the side effects seen with Aldurazyme are reactions caused by the infusion rather than the medicine itself.
Ħafna mill- effetti sekondarji li dehru b’ Aldurazyme huma reazzjonijiet ikkawżati mill- infużjoni milli bil- mediċina nfisha.
These are generally mild to moderate in intensity and decrease with time.
Normalment, dawn huma ħfief għal moderati fl- intensità u jonqsu maż- żmien.
The most common side effects with Aldurazyme in patients over the age of five (seen in more than 1 patient in 10) are headache, nausea (feeling sick), abdominal (tummy) pain, rash, arthropathy (damage to the joints), arthralgia (joint pain), back pain, pain in the extremities (hands and feet), flushing, pyrexia (fever) and reactions at the site of the infusion.
L - aktar effetti sekondarji komuni b’ Aldurazyme f’ pazjenti li għandhom iktar minn ħames snin (li jidhru f’ aktar minn pazjent 1 minn kull 10) huma uġigħ ta ’ ras, nawsja (dardir), uġigħ addominali (ta ’ żaqq), raxx, artropatija (ħsara fil- ġogi u uġigħ fil- ġogi), uġigħ fid- dahar, uġigħ fl- estremitajiet (idejn u saqajn), ħmura u pireksja (deni) u reazzjonijiet fis- sijt ta ’ l- infużjoni.
In patients under five years of age, the very common side effects are increased blood pressure, decreased oxygen saturation (a measure of lung function), tachycardia (fast heart rate), pyrexia and chills.
F’ pazjenti taħt il- ħames snin, l - aktar effetti sekondarji komuni huma żieda fil- pressjoni tad- demm, tnaqqis fis- saturazzjoni ta ’ l - ossiġenu (kejl tal- funzjoni tal- pulmun), takikardja (rata ta ’ taħbit tal- qalb qawwija), pireksja u rogħda.
For the full list of all side effects reported with Aldurazyme, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Aldurazyme, ara l- Fuljett ta ’ Tagħrif.
Almost all patients who receive Aldurazyme develop antibodies (proteins that are produced in response to Aldurazyme).
Kważi l- pazjenti kollha li jirċievu Aldurazyme jiżviluppaw anti- korpi (proteini li huma prodotti f’ rispons għal Aldurazyme).
The effect of these on the safety and effectiveness of the medicine is not fully known.
L- effett ta ’ dawn fuq is- sigurtà u l- effikaċja tal- mediċina għadu mhux magħruf għal kollox.