qanastek/EMEA-V3 huggingface dataset:
Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW United Kingdom
Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW Ir- Renju Unit
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GHAT - TQEGHID FIS- SUQ
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Procter & Gamble Pharmaceuticals - Germany GmbH Dr. -Otto-Röhm-Strasse 2-4 D-64331 Weiterstadt Germany
Procter & Gamble Pharmaceuticals - Germany GmbH Dr. - Otto- Röhm- Strasse 2- 4 D- 64331 Weiterstadt Il- Ġermanja
Procter & Gamble Pharmaceuticals Longjumeau Parc d’ activité de la Grande Brèche 5 rue Désir Prévost 91070 Bondoufle France
Procter & Gamble Pharmaceuticals Longjumeau Parc d’ activité de la Grande Brèche 5 rue Désir Prévost 91070 Bondoufle Franza
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GHAT- TQEGHID FIS- SUQ
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GHAT- TQEGHID FIS- SUQ
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq irid jiżgura li s- sistema ta ’ farmakoviġilanza tkun implimentata u tkun taħdem qabel ma l- prodott jibda jinbiegħ, u sakemm il- prodott li jkun inbiegħ jibqa ’ jintuża.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq jikkommetti l- obligu li jwettaq l- istudji u attivitajiet ta ’ farmakoviġilanza addizzjonali deskritti fil- pjan tal- Farmakoviġilanza.
An updated Risk Management Plan, as per the CHMP Guideline on Risk Management Systems for medicinal products for human use, should be submitted at the same time as the PSURs, within 60 days of an important (Pharmacovigilance or Risk minimisation) milestone being reached or when the results of a study become available or at the request of the Competent authority.
Pjan aġġornat dwar l- Immaniġġjar tar- Riskju skond il- Linja Gwida CHPM dwar is- Sistemi ta ’ l - Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, għandu jkun sottomess fl- istess ħin mal- PSURs, fi żmien 60 jum minn meta tintlaħaq milestone importanti (Farmakoviġilanza jew minimizzazzjoni tar- Riskju), jew meta r- riżultati ta ’ studju jsiru disponibbli jew fuq it- talba ta ’ l - awtorità Kompetenti.
OUTER CARTON (Box of 2, 8 or 24 patches)
KAXXA TA ’ BARRA (Kaxxa ta ’ 2, 8 jew 24 garżi)
Intrinsa 300 micrograms/ 24 hours transdermal patch Testosterone
Intrinsa 300 mikrogramma/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Testosterone
1 patch of 28 cm2 contains 8.4 mg of testosterone and provides 300 micrograms per 24 hours.
Garża waħda ta ’ 28 ċm2 fiha 8. 4 mg ta ’ testosterone u tipprovdi 300 mikrogramma ta ’ testosterone kull 24 siegħa.
Also contains:
Fiha ukoll:
Sorbitan oleate, 2-Ethylhexylacrylate – 1-Vinyl-2-pyrrolidone copolymer, E110, E180, copper phthalocyanine blue pigment, polyethylene, siliconised polyester.
Sorbitan oleate, 2- Ethylhexylacrylate – 1- Vinyl- 2- pyrrolidone copolymer, E110, E180, copper phthalocyanine blue pigment, polyethylene, siliconised polyester.
2 transdermal patches 8 transdermal patches 24 transdermal patches
2 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda 8 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda 24 garżi li jipprovdu mediċina li tgħaddi minn ġol- ġilda
Apply immediately upon removal from the sachet.
Applika immedjatament hekk kif tneħħi mill- qartas.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GHAT- TQEGHID FIS- SUQ
Rusham Park Technical Centre, Whitehall Lane, Egham, Surrey TW20 9NW United Kingdom
Rusham Park Technical Centre, Whitehall Lane, Egham, Surrey TW20 9NW Ir- Renju Unit
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GHAT- TQEGHID FIS- SUQ
Tuck flap here to close.
Itwi l- ġewnaħ tal- pakkett (flap) hawnhekk biex tagħlaq.
Information to appear on the inside of the flap
Informazzjoni biex tidher fuq in- naħa ta ’ ġewwa tal- ġewnaħ tal- pakkett
When to apply the patch:
Meta għandek tapplika l- garża:
The patch needs to be changed twice weekly.
Għandek tibdel l- garża darbtejn fil- ġimgħa.
Choose your two days and tick the box.
Agħżel il- jumejn li tippreferi u mmarka l- kaxxa.
Change the patch only on these two days. o Sunday + Wednesday o Monday + Thursday o Tuesday + Friday o Wednesday + Saturday o Thursday + Sunday o Friday + Monday o Saturday + Tuesday
Ibdel l - garża biss f’ dawn il- jumejn. o Il- Ħadd + l- Erbgħa o It- Tnejn + il- Ħamis o It- Tlieta + il- Ġimgħa o L- Erbgħa + is- Sibt o Il- Ħamis + il- Ħadd o Il- Ġimgħa + it- Tnejn o Is- Sibt + it- Tlieta
Continue to use for as long as your doctor prescribes.
Kompli uża l- mediċina sakemm it- tabib jibqa ’ jagħtik riċetta għaliha.
16 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Intrinsa 300 micrograms/ 24 hours transdermal patch Testosterone Transdermal use
Intrinsa 300 mikrogramma/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda Testosterone Użu minn fuq il- ġilda
1 transdermal patch
1 garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
It may harm them, even if their symptoms appear to be the same as yours.  If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.  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.
What Intrinsa is and what it is used for 2.
X’ inhu Intrinsa u għalxiex jintuża 2.
What you should consider before you use Intrinsa 3.
X’ għandek tikkunsidra qabel ma tuża Intrinsa 3.
How to use Intrinsa 4.
Kif għandek tuża Intrinsa 4.
How to store Intrinsa 6.
Kif taħżen Intrinsa 6.
WHAT INTRINSA IS AND WHAT IT IS USED FOR
X’ INHU INTRINSA U GĦALXIEX JINTUŻA
Intrinsa is a transdermal patch which constantly releases small amounts of testosterone that is absorbed through your skin into the bloodstream.
Intrinsa hi garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda li l- ħin kollu terħi ammonti żgħar ta ’ testosterone li jiġi assorbit minn ġol- ġilda tiegħek fiċ- ċirkolazzjoni tad- demm.
The testosterone in Intrinsa is the same hormone as that produced naturally in men and women.
It- testosterone f’ Intrinsa hu l- istess ormon bħal dak li hu prodott b’ mod naturali fl- irġiel u fin- nisa.
After removal of the ovaries, testosterone drops to half of the levels compared to before the operation.
Wara li l- ovarji jitneħħew, il- livell tat- testosterone jaqa ’ bin- nofs meta mqabbel mal- livelli ta ’ qabel l - operazzjoni.
Decrease in testosterone has been associated with low sexual desire, reduced sexual thoughts and reduced sexual arousal.
In- tnaqqis fit- testosterone kien assoċjat ma ’ xewqa sesswali baxxa, nuqqas ta ’ ħsibijiet sesswali u eċċitament sesswali mnaqqas.
All or any of these problems can cause personal distress or relationship difficulties.
Xi wħud, jew dawn il- problemi kollha, jistgħu jikkawżaw inkwiet personali jew diffikultajiet fir- relazzjoni.
The medical term for this condition is Hypoactive Sexual Desire Disorder, also known as HSDD.
L- isem mediku għal din il- kundizzjoni hu Hypoactive Sexual Desire Disorder, magħrufa wkoll bħala HSDD.
Intrinsa is used to treat HSDD.
Intrinsa jintuża għat- trattament ta ’ HSDD.
Intrinsa is intended for use by women up to the age of 60 years who:  have a low sexual desire which is causing distress or concern, and  have had both of their ovaries removed, and  have had their womb removed (hysterectomy), and  are receiving estrogen therapy.
Intrinsa hu intenzjonat biex jintuża minn nisa li għandhom sa 60 sena, li:  jkollhom xewqa sesswali baxxa li tkun qed tikkawża inkwiet jew problemi, u  li kellhom l- ovarji t- tnejn imneħħija, u  li kellhom l- utru mneħħi (isterektomija), u  li qed jirċievu terapija bl- estroġenu.
It may take longer than one month for you to notice an improvement.
Tista ’ ddum iktar minn xahar qabel ma tinnota xi titjib.
If you have not experienced a positive effect of Intrinsa within 3-6 months, you should inform your doctor, who will suggest that treatment be discontinued.
Jekk ma jkollokx effett pożittiv b’ Intrinsa fi żmien 3- 6 xhur, għandek tinforma lit- tabib tiegħek, li ser jissuġġerixxi li t- trattament għandu jitwaqqaf.
WHAT YOU SHOULD CONSIDER BEFORE YOU USE INTRINSA
X’ GĦANDEK TIKKUNSIDRA QABEL MA TUŻA INTRINSA
Do not use Intrinsa  if you are allergic (hypersensitive) to testosterone or any of the other ingredients of Intrinsa.  if you know that you have had in the past, currently have, or think that you might have, breast cancer or any other cancer which your doctor has described as being caused or stimulated by the female hormone estrogen, also called ‘ estrogen-dependent’ cancers.  if you have other conditions that your doctor may consider not appropriate for the use of estrogen and/ or testosterone.
Tużax Intrinsa  jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għat- testosterone jew sustanzi oħra ta ’ Intrinsa.  jekk taf li kellek fil- passat, jekk għandek, jew jekk taħseb li jista ’ jkollok, kanċer tas- sider jew kwalunkwe kanċer ieħor li t- tabib tiegħek iddeskriva li kien ikkawżat jew stimulat mill- ormon femminili, l- estroġenu, imsejħin ukoll kanċers ‘ dipendenti fuq l- estroġenu ’.
19 Take special care with Intrinsa  if you have a history of heart, liver or kidney disease.  if you are diabetic, as testosterone may lower blood glucose levels.  if you have a history of excessive adult acne, body or facial hair, hair loss, enlargement of the clitoris or voice deepening or hoarseness.
19  jekk inti għandek kundizzjonijiet oħrajn li t- tabib tiegħek jista ’ jikkunsidra li mhumiex adattati għall- użu ta ’ l- estroġenu u/ jew tat- testosterone.
If you have any of the above, tell your doctor before you start to use Intrinsa.
Jekk għandek kwalunkwe minn dawn t’ hawn fuq, għid it- tabib tiegħek qabel ma tibda tuża Intrinsa.
Your doctor will advise you on what you should do.
It - tabib tiegħek ser jagħtik parir dwar x’ għandek tagħmel.
The efficacy of Intrinsa is reduced if your estrogen therapy is of a certain type (‘ conjugated equine estrogens’).
L- effikaċja ta ’ Intrinsa titnaqqas jekk it- terapija tiegħek bl- estroġenu tkun ta ’ ċertu tip (‘ conjugated equine estrogens ’).
Therefore, you need to discuss your type of estrogen with your doctor, who could advise you which type of estrogen is suitable together with Intrinsa.
Għalhekk, jeħtieġ li tiddiskuti t- tip ta ’ estroġenu tiegħek mat- tabib tiegħek, li jista ’ jagħtik parir dwar liema tip ta ’ estroġenu hu adattat għalik flimkien ma ’ Intrinsa.
If you stop estrogen therapy you must also stop using Intrinsa.
Jekk twaqqaf it - terapija bl- estroġenu, għandek tieqaf tuża Intrinsa wkoll.
Keep in mind that estrogens should be administered for the shortest possible duration.
Ftakar li l- estroġeni għandhom jingħataw għall- inqas tul ta ’ żmien possibbli.
Use Intrinsa only as long as you experience a positive effect of the treatment.
Użu Intrinsa biss sakemm ikollok effett pożittiv tat- trattament.
There is no information on the safety of Intrinsa beyond 12 months.
M’ hemm l- ebda informazzjoni dwar is - sigurtà ta ’ Intrinsa wara iktar minn 12- il xahar.
There are limited data about the use in women above the age of 60.
Hemm informazzjoni limitata dwar l- użu f’ nisa li għandhom iktar minn 60 sena.
It is not known whether Intrinsa increases the risk of breast cancer.
Mhux magħruf jekk Intrinsa jżidx ir- riskju ta ’ kanċer tas- sider.
Your doctor will carefully monitor you with regard to breast cancer.
It- tabib tiegħek ser jimmonitorjak b’ attenzjoni fir- rigward tal- kanċer tas- sider.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Take particular care if you are taking medicines containing any of the following active substances:  blood-thinning (anticoagulant) treatment
Oqgħod attent b’ mod partikulari jekk qed tieħu mediċini li fihom kwalunkwe minn dawn is- sustanzi attivi li ġejjin:  trattament b’ mediċini li jraqqu d- demm
Children and adolescents Intrinsa is not for use in children and adolescents.
Tfal u adoloxxenti Intrinsa mhuwiex għall- użu fit- tfal u fl- adolexxenti.
Intrinsa is only indicated for women in their menopause after the ovaries and uterus have been removed.
Intrinsa hu indikat biss għal nisa li jkollhom il- menopawsa wara li l- ovarji u l- utru jkunu tneħħew.
Do not use Intrinsa if you are, or suspect that you may be pregnant or are able to become pregnant, because it may cause harm to the unborn child.
Tużax Intrinsa jekk inti tqila, jew tissuspetta li tista ’ tkun tqila jew jekk tista ’ toħroġ tqila, minħabba li dan jista ’ jikkawża ħsara lit- tarbija mhix imwielda.
Do not use Intrinsa in case of breast-feeding because it may cause harm to the child.
Tużax Intrinsa f’ każ jekk qed tredda ’, minħabba li dan jista ’ jikkawża ħsara lit- tarbija.
Driving and using machines You can drive and use machines while using Intrinsa.
Sewqan u tħaddim ta ’ magni Inti tista ’ ssuq u tuża l- magni waqt li tkun qed tuża Intrinsa.
Intrinsa should be replaced twice weekly (each 3 to 4 days).
KIF GĦANDEK TUŻA INTRINSA
The active substance is released from the patch constantly over 3 to 4 days and is absorbed through your skin.
Is- sustanza attiva tintreħa mill- garża l - ħin kollu fuq perjodu ta ’ 3 sa 4 ijiem u tiġi assorbita minn ġol- ġilda tiegħek.
Always use Intrinsa exactly as your doctor has told you.
Dejjem għandek tuża Intrinsa skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure of the instructions or if you want any more information.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju dwar l- istruzzjonijiet, jew jekk trid iktar informazzjoni.
Where to stick the patch  Stick the patch onto your lower abdomen, below your waist.
20 Fejn twaħħal il- garża  Waħħal il- garża fuq in- naħa t’ isfel taż- żaqq, taħt qaddek.
Do not stick the patch on the breasts or bottom.
Twaħħalx il- garża fuq is- sider jew fuq il- warrani.
20 Make sure that your skin at the application site is:  clean and dry (free of lotions, moisturisers, and powders)  as smooth as possible (no major creases or skin folds)  not cut or irritated (free of rashes or other skin problems)  unlikely to be rubbed by clothing excessively  preferably free from hair.  When changing your patch, stick the new patch on to a different area of the skin of your abdomen, otherwise you are more likely to cause skin irritation.
Aċċerta ruħek li l- ġilda tiegħek fis- sit ta ’ l- applikazzjoni hi:  nadifa u xotta (ħielsa minn żjut, moisturisers, u terra)  lixxa kemm jista ’ jkun (l- ebda tikmix kbir jew saffi kbar ta ’ ġilda fuq xulxin)  mhijiex maqsuma jew irritata (ħielsa minn raxx jew problemi oħrajn tal- ġilda)  ma tkunx mistennija li l- ilbies iħokk magħha b’ mod eċċessiv  preferibbilment tkun bla xagħar.  Meta tibdel il- garża tiegħek, waħħal il- garża l- ġdida fuq żona differenti tal- ġilda ta ’ żaqqek, għax inkella jkun hemm iktar ċans li tikkawża irritazzjoni tal- ġilda.
 Only one patch is to be worn at a time.
 Għandha titwaħħal garża waħda biss f’ ħin wieħed.
 If you are also using estrogen patches, make sure that the patch and the estrogen patch do not overlap.
 Jekk qed tuża garżi ta ’ l- estroġenu wkoll, aċċerta ruħek li l- garża u l- garża ta ’ l- estroġenu ma jkunux fuq xulxin.
 For at least one week after removing a patch, do not place a new patch in the same area.
 Għal mill- inqas ġimgħa li tneħħi l- garża, terġax twaħħal oħra ġdida fl- istess żona.
How to stick on the patch Step 1 Tear open the sachet.
Kif twaħħal l- garża Pass 1 Iftaħ il- qartas.
Remove the patch.
Tużax imqass, għax tista ’ tagħmel il- ħsara lill- garża aċċidentalment.
Apply the patch immediately after removing it from the sachet.
Neħħi l - garża. Waħħal il- garża immedjatament wara li tneħħiha mill- qartas.
Step 2 While holding the patch, remove half of the protective liner that covers the sticky part of the patch.
Pass 2 Waqt li tkun qed iżżomm l- garża, neħħi nofs l- inforra protettiva li tkun tiksi l- parti li twaħħal tal- garża.
Avoid touching the sticky side of the patch with your fingers.
Evita li tmiss in- naħa li teħel tal- garża b’ subgħajk.
Step 3 Apply the sticky side of the patch to the selected area onto your skin.
Pass 3 Waħħal in- naħa li teħel tal- garża fuq iż- żona magħżula fuq il- ġilda tiegħek.
Press the sticky side of the patch firmly into place for about 10 seconds.
Agħfas b’ mod sod in- naħa li teħel tal- garża fil- post għal madwar 10 sekondi.
21 Step 4 Fold back the patch and carefully remove the other half of the liner.
21 Pass 4 Itwi lura l- garża u neħħi b’ attenzjoni n- nofs l- ieħor ta ’ l- inforra.
Press the entire patch firmly against your skin with the palm of your hand for about 10 seconds.
Agħfas l- garża kollha fuq il - ġilda tiegħek bil- keffa ta ’ idejk għal madwar 10 sekondi.
Use your fingers to make sure the edges of the patch stick to the skin.
Uża s- swaba ’ tiegħek biex taċċerta ruħek li t- truf tal- garża jeħlu mal- ġilda.
If an area of the patch lifts, apply pressure to that area.
Jekk xi żona tal- garża tintrefa ’, applika pressjoni lil dik iż- żona.
How to change your patch  You will need to change your patch every 3 to 4 days, which means using two patches each week.
Kif tibdel l- garża tiegħek  Ser ikollok tibdel l- garża tiegħek kull 3 sa 4 ijiem, li jfisser li trid tuża żewġ garżi kull ġimgħa.
This will mean that you wear one patch for 3 days and the other for 4 days.
Dan ifisser li inti ser ikollok garża waħda għal 3 ijiem u l- oħra għal 4 ijiem.
Decide which two days each week you are going to change your patch, and change the patch on the same two days each week.
Iddeċiedi liema jumejn kull ġimgħa ser tibdel il- garża tiegħek, u ibdel il- garża f’ dawk il- jumejn kull ġimgħa.
For example:
Per eżempju:
If you decide to start treatment on a Monday, then you have to change your patch always on a Thursday and a Monday.
Jekk tiddeċiedi li tibda t- trattament nhar ta ’ Tnejn, allura għandek tibdel il- garża tiegħek dejjem nhar ta ’ Ħamis u nhar ta ’ Tnejn.
Sunday + Wednesday Monday + Thursday Tuesday + Friday Wednesday + Saturday Thursday + Sunday Friday + Monday Saturday + Tuesday
Il- Ħadd + l- Erbgħa It- Tnejn + il- Ħamis It- Tlieta + il- Ġimgħa L- Erbgħa + is- Sibt Il- Ħamis + il- Ħadd Il- Ġimgħa + it- Tnejn Is- Sibt + it- Tlieta
As a reminder, mark on the outer carton your chosen patch-change days.
Biex tiftakar, immarka fuq il- kaxxa tal- kartun il- jiem li tkun għażilt meta ser tibdel il- garża tiegħek.
 On the patch-change day, remove the used patch and immediately stick the new patch on to a different area of skin of your abdomen.
 Fil- jum meta tkun ser tibdel il- garża tiegħek, neħħi il- garża l- qadima u waħħal il- garża l- ġdida immedjatament fuq żona differenti tal- ġilda ta ’ żaqqek.
Continue your treatment for as long as your doctor advises.
Kompli t- trattament tiegħek sakemm igħidlek it- tabib.
 Fold the used patch in half, sticking the patch to itself, and discard it in a safe way in order to keep it away from children (e. g. in a rubbish bin).
 Itwi l- garża l- qadima min- nofs, waħħal il- garża magħha stess, u armiha b’ mod sigur biex iżżommha ’ il bogħod mit- tfal (eż. f’ kontenitur ta ’ l- iskart).
Medicines should not be disposed of via wastewater (do not flush it down the toilet).
Mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ (tifflaxxjahomx fit- tojlit).
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill- ispiżjar tiegħek dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
What about showering, bathing and exercising?
X’ għandi nagħmel meta nieħu doċċa, banju jew nagħmel eżerċizzju fiżiku?
You may shower, bath, swim and exercise as normal while wearing the patch.
Tista tieħu doċċa, banju jew tagħmel eżerċizzju fiżiku bħas- soltu meta jkollok il- garża mwaħħla.
The patch is designed to remain in place during these times.
Il - garża hi maħsuba biex tibqa ’ f’ postha matul dawn l- attivitajiet.
However, do not scrub the area where the patch has been placed too hard.
Madankollu, togħrokx ħafna ż- żona fejn tkun waħħalt il- garża.
What about sunbathing?
Nista ’ mmur nixxemmex?
Always make sure your patch is covered by clothing.
Iva, iżda dejjem aċċerta ruħek li l- garża tiegħek tkun mgħottiha bl- ilbies.
What if your patch becomes loose, lifts at the edges or falls off?
X’ jiġri jekk il- garża tiegħek tibda tinqala ’, it- truf jinqalgħu jew tinqala ’ għal kollox?
If a patch does begin to come off, you may be able to make it stick again by pressing on it firmly.
Jekk garża tibda tinqala ’, tista ’ terġa ’ twaħħalha mill- ġdid billi tagħfas fuqha b’ mod sod.
If you cannot get the patch to stick successfully, remove the loose patch and use a new patch.
Imbagħad kompli bl- iskeda regolari
Then continue with your regular schedule of patch-change days, even if this means discarding a patch after you have worn it for less than 3-4 days.
22 tiegħek tal- jiem li fihom tibdel il- garża, anki jekk dan ifisser li tarmi garża wara li tkun ilha fuqek għal inqas minn 3- 4 ijiem.
22 If you use more patches than you should If you have applied more than one patch at a time Remove all the patches sticking on to your skin and consult your doctor or pharmacist for further information on how to continue treatment with Intrinsa.
Jekk tuża iktar garżi milli suppost Jekk tkun waħħalt iktar minn garża waħda fl- istess ħin Neħħi l- garżi kollha li jkollok imwaħħlin fuq il- ġilda tiegħek u kellem lit- tabib jew l- ispiżjar tiegħek għal informazzjoni addizzjonali dwar kif tkompli t- trattament b’ Intrinsa.
Overdosing with Intrinsa is unlikely when used as directed, because once the patch is taken off testosterone is quickly removed by the body.
Mhux mistenni li jkun hemm doża eċċessiva b’ Intrinsa meta jintuża skond l- istruzzjonijiet, minħabba li, ġaladarba l- garża tinqala ’ t - testosterone jitneħħa malajr mill- ġisem.
If you forget to use a patch If you forget to change your patch Change your patch as soon as you remember, and then continue with your regular schedule of patch- change days, even if this means discarding a patch after you have worn it for less than 3-4 days.
Jekk tinsa tuża garża Jekk tinsa tibdel il- garża tiegħek Ibdel il- garża tiegħek hekk kif tiftakar, u mbagħad kompli bl- iskeda regolari tiegħek tal- jiem li fihom tibdel il- garża, anki jekk dan ifisser li tarmi garża wara li tkun ilha fuqek għal inqas minn 3- 4 ijiem.
Returning to your regular schedule will help you remember when to change your patch.
Li terġa ’ lura għall- iskeda regolari tiegħek ser jgħinek tiftakar meta għandek tibdel il- garża tiegħek.
Like all medicines, Intrinsa can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Intrinsa jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor immediately:  if you experience hair loss, enlargement of the clitoris, an increase in the amount of hair on the chin or upper lip, voice deepening or hoarseness, although these side effects may be mild.
Għid lit- tabib tiegħek immedjatament:  jekk ikollok telf ta ’ xagħar, tkabbir tal- klitoris, żieda fl- ammont ta ’ xagħar fuq l- ilħit jew fin - naħa ta ’ fuq tax- xufftejn, il- vuċi ssir ħoxna jew tinħanaq, għalkemm dawn l- effetti sekondarji jistgħu jkunu ħfief.
They are usually reversible if Intrinsa treatment is discontinued.
Dawn is- sintomi normalment huma riversibbli jekk it- trattament b’ Intrinsa jitwaqqaf.
You should self assess for increased acne, increased hair growth on your face, loss of hair, deepening of your voice or enlargement of your clitoris, which all could be signs of adverse effects of testosterone, which is the active substance in Intrinsa.
Għandek tagħmel evalwazzjoni tiegħek innifsek għal żieda fl- akne, żieda fit- tkabbir tax- xagħar f’ wiċċek, telf ta ’ xagħar, il- vuċi tiegħek issir ħoxna jew ikollok tkabbir fil- klitoris, li kollha jistgħu jkunu sinjali ta ’ effetti avversi tat- testosterone, li hi s- sustanza attiva f’ Intrinsa.
 if you notice any skin reactions at the site of application such as redness, oedema, or blistering.
 jekk tinnota kwalunkwe reazzjonijiet tal- ġilda fis- sit ta ’ applikazzjoni bħal ħmura, edema, jew infafet.
In case of severe application site reaction, the treatment should be discontinued.
F’ każ ta ’ reazzjoni severa fis- sit ta ’ l- applikazzjoni, it- trattament għandu jitwaqqaf.
Very common side effects The following side effects may occur very commonly (in more than 1 out of 10 patients). o rash/ irritation/ itching/ redness at the site of the skin where the patch is applied o increase in the amount of hair on the chin or upper lip (likely to be mild and reversible)
Effetti sekondarji komuni ħafna L- effetti sekondarji li ġejjin jistgħu jseħħu b’ mod komuni ħafna (f’ iktar minn 1 minn kull 10 pazjenti). o raxx/ irritazzjoni/ ħakk/ ħmura fiż- żona tal- ġilda fejn il- garża tkun applikata o żieda fl- ammont ta ’ xagħar fuq l- ilħit jew fin- naħa ta ’ fuq tax- xufftejn (x’ aktarx li ser tkun ħafifa u riversibbli)
Common side effects The following side effects may occur commonly (in more than 1 out of 100, but less than 1 out of 10 patients), but most of them are mild in nature and reversible. o hair loss o acne o migraine o insomnia/ inability to sleep properly o voice deepening or hoarseness o breast pain o weight gain o abdominal pain
Effetti sekondarji komuni L- effetti sekondarji li ġejjin jistgħu jseħħu b’ mod komuni (f’ iktar minn 1 minn kull 100 pazjent, iżda f’ inqas minn 1 minn kull 10 pazjenti), iżda l- biċċa l- kbira tagħhom huma ta ’ natura ħafifa u riversibbli. o telf ta ’ xagħar o akne o emigranja o nuqqas ta ’ rqad/ ma tkunx tista ’ torqod kif suppost o il- vuċi ssir ħoxna jew tinħanaq o uġigħ fis- sider o żieda fil- piż o uġigħ ta ’ żaqq
If any of the side effects become serious, or if you notice any side effects mentioned above or side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE INTRINSA
KIF TAĦŻEN INTRINSA
 Keep out of the reach and sight of children.  Do not store above 30°C.  Do not refrigerate or freeze.
 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.  Taħżinx f’ temperatura ’ l fuq minn 30°C.  Tagħmlux fil- friġġ jew fil- friża.
23 Do not use Intrinsa after the expiry date which is stated on the carton and sachet.
Tużax Intrinsa wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- qartas.
What Intrinsa contains The active substance is testosterone.
X’ fih Intrinsa Is- sustanza attiva hi testosterone.
Each patch contains 8.4 mg of testosterone, releasing 300 micrograms of testosterone over 24 hours.
Kull garża fiha 8. 4 mg ta ’ testosterone, li terħi 300 mikrogramma ta ’ testosterone fuq perjodu ta ’ 24 siegħa.
Sorbitan oleate, 2-Ethylhexylacrylate – 1-Vinyl-2-pyrrolidone co-polymer.
Sorbitan oleate, 2- Ethylhexylacrylate – 1- Vinyl- 2- pyrrolidone co- polymer.
Protective release liner:
Inforra prottettiva li tipproteġi r- reħi tal- mediċina:
What Intrinsa looks like and contents of the pack Intrinsa is a thin, clear, oval patch with PG T001 stamped on the back.
Id- dehra tal- prodott u d- daqs tal- pakkett Intrinsa hi garża rqiqa, ċara u ovali bil- kliem PG T001 stampat fuq in- naħa ta ’ wara.
The following pack sizes are available:
Id- daqsijiet tal- pakkett li ġejjin huma disponibbli:
2, 8 and 24 patches.
2, 8 u 24 garżi.
Marketing Authorisation Holder Procter & Gamble Pharmaceuticals UK Ltd.
Id- Detentur Ta ’ l- Awtorizzazzjoni għat- Tqegħid Fis- Suq Procter & Gamble Pharmaceuticals UK Ltd.
Rusham Park Technical Centre Whitehall Lane Egham, Surrey TW20 9NW United Kingdom
Rusham Park Technical Centre Whitehall Lane Egham, Surrey TW20 9NW Ir- Renju Unit
Manufacturer Procter & Gamble Pharmaceuticals – Germany GmbH Dr. -Otto-Röhm-Strasse 2-4 D-64331 Weiterstadt Germany
Manifattur Procter & Gamble Pharmaceuticals – Germany GmbH Dr. - Otto- Röhm- Strasse 2- 4 D- 64331 Weiterstadt Il- Ġermanja
This leaflet was last approved in {MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ukoll partil mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is IntronA?
X’ inhi IntronA?
IntronA is a medicine containing the active substance interferon alfa-2b.
IntronA hija mediċina li fiha s- sustanza attiva interferon alfa- 2b.
It is available as a powder and solvent to be made into a solution for injection or infusion, as a ready-to-use solution for injection and as a multidose pen for injection.
Hija disponibbli bħala trab u solvent li jridu jitħalltu f’ soluzzjoni għal injezzjoni jew infużjoni, bħala soluzzjoni lesta biex tintuża għal injezzjoni u bħala pinna b’ diversi dożi għal injezzjoni.
These contain from 1 to 50 million IU (international units) per millilitre.
Dawn fihom minn 1 sa 50 miljun IU (unitajiet internazzjonali) kull millimetru.
What is IntronA used for?
Għalxiex tintuża IntronA?
IntronA is used for the treatment of: • chronic (long-term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus) in adults, • chronic hepatitis C (a disease of the liver due to an infection by the hepatitis C virus).
IntronA tintuża għat- trattament ta ’: • epatite B kronika (fuq tul ta ’ żmien) (marda tal- fwied minħabba infezzjoni mil- vajrus ta ’ l - epatite B) fl- adulti, • epatite Ċ kronika (marda tal- fwied minħabba infezzjoni mil- vajrus ta ’ l- epatite Ċ).
In adults IntronA can be used on its own but is best used in combination with ribavirin (an antiviral medicine), and in children, it is used with ribavirin, • hairy cell leukaemia (a cancer of the white blood cells), • chronic myelogenous leukaemia (CML, another cancer of the white blood cells) in adults.
IntronA jista ’ jintuża waħdu mill- adulti imma huwa użat b’ mod ferm aħjar jekk ikkumbinat ma ribavirin (mediċina antivirali), u mit- tfal, jekk użat ma ’ ribavirin, • lewkimija biċ- ċelloli muswafa (kanċer taċ- ċelloli bojod tad- demm), • lewkimija mjeloġena kronika (CML, kanċer ieħor taċ- ċelloli bojod tad- demm) fl- adulti.
IntronA can be used in combination with cytarabine (an anticancer medicine) in the first 12 months, • multiple myeloma (a cancer of the bone marrow).
IntronA tista ’ tintuża flimkien ma ’ cytarabine (mediċina kontra l- kanċer) fl- ewwel 12 – il xahar, • mjeloma multipla (kanċer tal- mudullun).
IntronA is used to maintain anticancer effects in patients who have responded to a previous treatment with anticancer medicines, • follicular lymphoma (a cancer of the lymph tissue).
IntronA hija użata bħala terapija ta ’ manutenzjoni kontra l- kanċer fil- pazjenti li rrispondew għal trattament preċedenti ta ’ mediċini kontra l - kanċer, • limfoma follikulari (kanċer tat- tessut limfatiku).
IntronA is used as an add-on to anticancer treatments, • carcinoid tumour (a tumour of the endocrine system that produces hormones), • malignant melanoma (a type of skin cancer affecting cells called melanocytes).
IntronA hija użata bħala addizzjoni mat - trattamenti kontra l- kanċer. • tumur karċinojdu (tumur tas- sistema endokrinali li tipproduċi l- ormoni), • melanoma malinja (tip ta ’ kanċer tal- ġilda li jaffettwa ċ- ċelloli msejħa melanocytes).
IntronA is used after surgery in patients whose melanoma could come back.
IntronA hija użata wara l- kirurġija fuq pazjenti li l- melanoma tagħhom tista ’ terġa titfaċċa.
How is IntronA used?
Kif tintuża IntronA?
Treatment with IntronA should be initiated by a doctor who has experience in the management of the disease it is being used for.
Trattament b’ IntronA irid jinbeda minn tabib li għandu esperjenza fil- kura tal- marda li għaliha qed tintuża.
IntronA is generally given three times per week (every other day) but the injection can be given more frequently in some diseases (CML and melanoma).
IntronA b’ mod ġenerali huwa mogħti tlett darbiet fil- ġimgħa (ġurnata iva oħra le) imma l - injezzjoni tista ’ tingħata b’ mod iktar frekwenti fir- rigward ta ’ xi mard (CML u melanoma).
The dose and duration of treatment depend on the disease being treated and
Normalment huwa mogħti permezz ta ’ injezzjoni taħt il- ġilda (subcutaneous injection), imma fil - melanoma jista ’ jingħata wkoll permezz ta ’ infużjoni intravenuża (drip ġol vina).
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Id- doża u t- tul tat - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 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 the response of the patient, with doses ranging from 2 to 20 million IU per square metre of body surface area.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 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 trattament jiddependi fuq il- marda li qed tiġi trattata u r- reazzjoni tal- pazjent, b’ dożi li jvarjaw minn 2 sa 20 miljun IU kull metru kwadru tas- superfiċje tal- ġisem.
For more information, see the Package Leaflet.
Għal iktar informazzjoni, ara l- Fuljett ta 'Tagħrif.
IntronA has to be stored in a refrigerator (2°C-8°C).
IntronA trid tinħażen f ’ refriġerejter (2°C- 8°C).
How does IntronA work?
Kif taħdem IntronA?
The active substance in IntronA, interferon alfa-2b, belongs to the group ‘ interferons’.
Is- sustanza attiva f’ IntronA, interferon alfa- 2b, hija parti mill- grupp ta ’ interferoni.
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
L- interferoni huma sustanzi naturali prodotti mill- ġisem sabiex jgħinuh jiġġieled kontra attakki bħal infezzjonijiet ikkawżati minn vajrusijiet.
The exact way alpha interferons work in cancer and viral diseases in not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system, the body ’ s defence system, works).
Il- mod preċiż kif l- alfa interferoni jaħdmu fil- kanċer u mard virali mhuwiex kompletament mifhum, imma huwa maħsub li huma jaġixxu bħala immunomodulaturi (sustanzi li jimmodifikaw kif is- sistema immunitarja, is- sistema tad- difiża tal- ġisem, taħdem).
Alpha interferons may also block the multiplication of viruses.
L- Alfa interferoni jistgħu wkoll jimblukkaw il- multiplikazzjoni tal- vajrusijiet.
The interferon alfa-2b in IntronA is produced by a method known as ‘ recombinant DNA technology’: the interferon alfa-2b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
L ’ interferon alfa- 2a, f ’ IntronA huwa prodott permezz tal- metodu magħruf bħala ‘ teknoloġija tad - DNA rikombinanti ’: l’ interferon alfa- 2b hija magħmula minn batterju li kiseb ġene (DNA), li jagħtiha l- abbiltà li tipproduċiha.
The replacement interferon alfa-2b acts in same way as naturally produced interferon alpha.
L- interferon alfa- 2b li jistotwixxi jaġixxi bl- istess mod bħal interferon alfa li jiġi prodott b’ mod naturali.
How has IntronA been studied?
Kif ġiet studjata IntronA?
Because interferon alfa-2b has been used to treat a number of diseases in the European Union (EU) before, the company that makes IntronA supplied data from the scientific literature and from studies of its use with cytarabine in CML (745 patients) and of its use in children with chronic hepatitis B.
Minħabba li interferon alfa- 2b qabel ġie użat biex jitratta numru ta ’ mard fl- Unjoni Ewropea (EU), il - kumpanija li tagħmel IntronA forniet id- dejta mil- litteratura xjentifika, mill- istudji ta ’ l- użu tagħha ma cytarabine f’ CML (745 pazjent) u mill- użu tagħha fuq it- tfal li jbagħtu minn epatite B kronika.
The company also supplied information from a number of studies of IntronA used alone or with ribavirin for the treatment of chronic hepatitis C.
Il - kumpanija forniet ukoll informazzjoni minn numru ta ’ studji fuq IntronA użata waħedha jew ma ’ ibavirin għat- trattament ta ’ epatite Ċ kronika.
These included a total of 2,552 treatment-naïve patients (who had not been treated before) and a total of 345 patients whose disease had relapsed (returned) after previous treatment with interferon.
Dawn inkludew total ta ’ 2, 552 pazjent li ma kienux ġew ittrattati qabel (treatment- naïve) u total ta ’ 345 pazjent li l- marda tagħhom reġgħet tfaċċat (relapsed) wara trattament preċedenti b ’ interferon.
The use of IntronA in combination with ribavirin has also been studied in 118 hepatitis C treatment-naïve children aged between 3 and 16 years.
L- użu ta ’ IntronA flimkien ma ribavirin ġie studjat ukoll f ’ 118 tifel u tifla li għandhom bejn 3 u 16 – il sena, li jbagħtu mill- epatite Ċ u li ma kienux ġew trattati qabel.
The main measures of effectiveness were response rates in the hepatitis studies and survival time in the cancer studies.
Il- miżuri ewlenin ta ’ l- effettikaċja kienu r- rati ta ’ reazzjonijiet fl- istudji ta ’ l- epatite u ż- żmien ta ’ l - għajxien fl- istudji tal- kanċer.
What benefit has IntronA shown during the studies?
Liema benefiċċju wriet IntronA waqt l- istudji li ġew mwettqa?
The studies showed that IntronA is effective in the diseases for which it can be used.
L- istudji wrew li IntronA hija effettiva fil- mard li għalihom tista ’ tintuża.
In CML, more patients who received IntronA with cytarabine were still alive after 3 years than patients who only received IntronA.
F’ CML, iktar pazjenti li rċevew IntronA flimkien ma ’ cytarabine kienu għadhom ħajjin wara 3 snin milli pazjenti li rċevew biss IntronA.
IntronA was also shown to have a benefit in children with chronic hepatitis B.
Intwera wkoll li IntronA kellha benefiċċju fuq it- tfal li jbagħtu minn epatite B kronika.
IntronA, with or without ribavirin, was shown to be effective in treating hepatitis C in both treatment- naïve and relapsed adults.
Intwera wkoll li IntronA, bi u mingħajr ribavirin, kienet effettiva fit- trattament ta ’ l- epatite Ċ kemm fuq adulti li ma kienux ġew trattati u kemm fuq dawk li l- marda tagħhom reġgħet tfaċċat.
It was also effective in children, when used with ribavirin, with 46% of the children having responded to treatment at the 6-month follow up visit following 1-year treatment.
Ġiet osservata wkoll reazzjoni għat- trattament waqt il- vista ta ’ kontroll li saret sitt xhur wara sena ta ’ trattament f’ 46% tat- tfal, meta IntronA kienet użata flimkien ma ribavirin.
What is the risk associated with IntronA?
X’ inhu r- riskju assoċjat ma ’ IntronA?
The most common side effects with IntronA (generally reported in more than 1 patient in 10) are viral infections, pharyngitis (sore throat), anorexia (loss of appetite), depression, insomnia (difficulty sleeping), anxiety, emotional lability (mood swings), headache, impaired concentration, dizziness, cough, dyspnoea (difficulty breathing), nausea (feeling sick), diarrhoea, abdominal (tummy) pain, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection including inflammation, fatigue (tiredness), rigors (shaking chills), fever, flu-like symptoms, asthenia (weakness), irritability and weight loss.
L- iktar effetti sekondarji komuni ta ’ IntronA (irrapurtati f’ iktar minn 1 minn kull 10 pazjenti) huma infezzjonijiet virali, farinġite (uġiegħ fil- griżmejn), anoressja (telfa ta ’ l- aptit), depressjoni, insomnja (diffikultà fl- irqad), ansjetà, nuqqas ta ’ stabbilità fl- emozzjoni (tibdil tal- burdati), uġigħ fir- ras, ħsara fil- konċentrazzjoni, sturdament, sogħla, dispnea (diffikulta fit- teħid tan- nifs), nawsea (tħossok imdardar), dijarea, uġigħ addominali (fiż- żaqq), alopeċja (tfartis), prurite (ħakk), ġilda niexfa, raxx, mijalġja (uġigħ fil- muskoli), antralġja (uġigħ fil- ġogi), uġigħ muskuloskeletali (uġigħ fil- muskoli u l - għadam), reazzjonijiet fuq il- parti fejn tingħata l- injezzjoni inkluż infjammazzjoni, għeja kbira, rigors (tertir bil- bard), deni, sintomi simili għall dawk ta ’ l- influwenza, astenja (djgħufija), irritabilità u telf ta ’ piż.
For the full list of all side effects reported with IntronA, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrapportati b' IntronA, ara l- Fuljett ta 'Tagħrif.
IntronA should not be used in people who may be hypersensitive (allergic) to interferon alfa-2b or any of the other ingredients.
IntronA m' għandiex tintuża minn persuni li jistgħu jkunu allerġiċi għal interferon alfa- 2b jew għal xi sustanza oħra li tinstab fiha.
IntronA should not be used in: • patients with severe heart disease, • patients with severe kidney or liver disease including that caused by cancer, • patients with epilepsy or other central nervous system problems, • patients with thyroid disease unless it is controlled, • hepatitis patients with liver cirrhosis or who have recently received medicines that affect the immune system, • patients with a history of certain disorders of the immune system, or have had an organ transplant and are taking medicine that suppress immune system • children and adolescents with a history of severe mental illness, particularly severe depression, suicidal thoughts or suicide attempts.
IntronA m’ għandiex tintuża f ’: • pazjenti li jbagħtu minn mard tal- qalb serju: • pazjenti li jbagħtu minn mard tal- kliewi jew tal- fwied serju inkluż dak ikkawżat mil- kanċer, • pazjenti li jbagħtu minn epilessja jew problem oħra tas- sistema ċentrali tan- nervituri, • pazjenti li jbagħtu minn mard tat- tirojde sakemm dan ma jkunx ikkontrollat, • pazjenti bl- epatite b’ ċirrożi tal- fwied jew li riċentement ħadu mediċini li jaffettwaw is- sistema immunitorja,
For a list of all restrictions with IntronA, see the Package Leaflet.
Għal- lista sħiħa ta ’ restrizzjonijiet ta ’ IntronA, ara l- Fuljett ta ’ Tagħrif.
Why has IntronA been approved?
Għaliex ġiet approvata IntronA?
The Committee for Medicinal products for Human Use (CHMP) decided that IntronA’ s benefits are greater than its risks for the treatment of chronic hepatitis B and C, hairy cell leukaemia, CML, multiple myeloma, follicular lymphoma, carcinoid tumour and malignant melanoma.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ IntronA jisbqu r- riskji tagħha għat- trattament ta ’ epatite B u Ċ kronika, lewkimija biċ- ċelloli muswafa, CML, mjeloma multipla, limfoma follikulari, tumur karċinojdu u melanoma malinja.
The Committee recommended that IntronA be given marketing authorisation.
Għaldaqstant il - kumitat irrakkomanda li dan il- prodott jingħata l- awtorizzazzjoni għat- tqegħid fuq is- suq.
Other information about IntronA:
Informazzjoni oħra dwar IntronA:
The European Commission granted a marketing authorisation valid throughout the European Union, for IntronA to SP Europe on 9 March 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal IntronA lil SP Europe fid- 9 ta ’ Marzu 2000.
The marketing authorisation was renewed on 9 March 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet aġġornata fid- 9 ta ’ Marzu 2005.
The full EPAR for IntronA is available here.
L- EPAR sħiħ dwar IntronA jinstab hawnhekk.
This summary was last updated in 06-2007.
Dan is- sommarju kien aġġornat l- aħħar fi 06- 2007.
 1 1.
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT 1.
IntronA 1 million IU/ ml powder and solvent for solution for injection or infusion
IntronA 1 miljun IU/ ml trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni
One vial of powder contains 1 million IU of interferon alfa-2b produced in E. coli by recombinant DNA technology.
Kull kunjett ta ’ trab fih 1 miljun IU ta ’ interferon alfa- 2b mgħamul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti.
After reconstitution, 1 ml contains 1 million IU of interferon alfa-2b.
Meta jkun rikostitwit, 1 ml jkun fih 1 miljun IU ta ’ interferon alfa- 2b.
Powder and solvent for solution for injection or infusion
Trab u solvent għal soluzzjoni għall- injezzjoni jew infużjoni
White to cream coloured powder.
Trab abjad għal lewn il- krema.
Clear and colourless solvent.
Solvent ċar u bla kulur.
Chronic Hepatitis B:
Epatite B Kronika:
Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/ or fibrosis.
It- trattament ta ’ pazjenti adulti li għandhom l- epatite B kronika assoċjata ma ’ evidenza ta ’ replikazzjoni virali ta ’ l- epatite B (preżenza ta ’ HBV- DNA u HBeAg), alanine aminotransferase (ALT) elevat u infjammazzjoni u/ jew fibrożi attiva fil- fwied li tkun konfermata b' mod istoloġiku.
Chronic Hepatitis C:
Epatite Ċ Kronika:
Adult patients:
Pazjenti adulti:
IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4).
IntronA huwa ndikat għat- trattament ta ’ pazjenti adulti li għandhom l- epatite Ċ kronika u għandhom transaminases elevati mingħajr dikompensazzjoni tal- fwied u li huma pożittivi għall- HCV- RNA jew għall- anti- HCV fis- serum (ara sezzjoni 4. 4).
The best way to use IntronA in this indication is in combination with ribavirin.
L- aħjar mod kif tuża IntronA f’ din l- indikazzjoni huwa flimkien ma ’ ribavirin.
Chidren and adolescents:
Tfal u adolexxenti:
IntronA is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
IntronA huwa intenzjonat biex jintuża, f’ kors ta ’ kombinazzjoni ma ’ ribavirin, għall- kura ta ’ tfal u adolexxenti minn 3 snin ‘ l fuq, li għandhom epatite Ċ kronika, li ma ġietx ikkurata qabel, mingħajr dikumpensazzjoni tal- fwied, u li huma pożittivi għall- HCV- RNA.
The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load.
Id- deċiżjoni jekk għandhiex tingħata l- kura għandha tittieħed skond il- każ, billi jkun meqjus jekk hemmx avvanz tal- marda bħal infjammazzjoni epatika u fibrożi, kif ukoll fatturi ta ’ tbassir għar- rispons, ġenotip tal- HCV u viral load.
The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).
Il- benefiċċju mistenni mill- kura għandu jintiżen mas- sejbiet tas- sigurtà li jkunu dehru għal individwi pedjatriċi fil- provi kliniċi (ara sezzjonijiet 4. 4, 4. 8 u 5. 1).
Hairy Cell Leukaemia:
Lewkimja tal- Hairy cell: