qanastek/EMEA-V3 huggingface dataset:
Tarceva 25 mg Film-Coated Tablets Tarceva 100 mg Film-Coated Tablets Tarceva 150 mg Film-Coated Tablets Erlotinib
Tarceva 25 mg Pilloli Miksija b’ Rita Tarceva 100 mg Pilloli Miksija b’ Rita Tarceva 150 mg Pilloli Miksija b’ Rita Erlotinib
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew ill- ispiżjar tiegħek.
What Tarceva is and what it is used for 2.
X’ inhu Tarceva u għalxiex jintuża 2.
Before you take Tarceva 3.
Qabel ma tieħu Tarceva 3.
How to take Tarceva 4.
Kif għandek tieħu Tarceva 4.
How to store Tarceva 6.
Kif taħżen Tarceva 6.
WHAT IS TARCEVA AND WHAT IT IS USED FOR
X’ INHU TARCEVA U GĦALXIEX JINTUŻA
Tarceva is a medicinal product used to treat cancer by preventing the activity of a protein called epidermal growth factor receptor.
Tarceva huwa prodott mediċinali li jintuża fil- kura tal- kanċer billi jipprevjeni l- attività ta ’ protejina msejħa riċettur tal- fattur ta ’ l- iżvilupp fl- epidermidi.
This protein is known to be involved in the growth and spread of cancer cells.
Din il- protejina hija magħrufa li hi nvoluta fl - iżvilupp u tixrid taċ- ċelloli tal- kanċer.
This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage and chemotherapy has not helped to stop your disease.
Din il- mediċina tista ’ tiġi preskritta lilek jekk għandek kanċer tal- pulmun mhux taċ- ċellola żgħira fi stat avvanzat u kemjoterapija ma għinitx twaqqaf il- marda tiegħek.
This medicine can also be prescribed to you in combination with another treatment called gemcitabine if you have cancer of the pancreas at a metastatic stage.
Din il- mediċina tista ’ wkoll tiġi preskritta lilek flimkien ma ’ kura oħra msejħa gemcitabine jekk għandek kanċer tal- frixa fi stat metastatiku.
BEFORE YOU TAKE TARCEVA
QABEL MA TIEĦU TARCEVA
- if you are allergic (hypersensitive) to erlotinib or to any of the ingredients of Tarceva.
Tieħux Tarceva: jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal erlotinib jew sustanzi oħra ta ’
Take special care during treatment with Tarceva:
Oqgħod attent ħafna b’ Tarceva:
- if you are taking other medicines that may increase or decrease the amount of erlotinib in your
- jekk qed tieħu mediċini oħra li jistgħu jżidu jew inaqqsu l- ammont ta ’ erlotinib fid- demm
blood (for example antifungals like ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine or St.
tiegħek (per eżempju kura kontra l- fungu bħal ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine jew St.
John’s Wort).
John’ s Wort).
In some cases these medicines may reduce the efficacy or increase the side effects of Tarceva and your doctor may need to adjust your treatment.
F’ ċertu każijiet dawn il- mediċini jistgħu jnaqqsu l- effikaċjà jew iżidu l- effetti sekondarji ta ’ Tarceva u t- tabib tiegħek jista ’ jkollu bżonn jaġġustalek il- kura.
Your doctor might avoid treating you with these medicines while you are receiving Tarceva.
It - tabib tiegħek għandu mnejn jevita milli jikkurak b’ dawn il- mediċini sakemm qed tieħu Tarceva.
- if you take blood thinners (like warfarin or other coumarin-derivatives) because Tarceva may
- Jekk qed tieħu mediċini li jraqqu d- demm (bħal warfarina u derivati oħra ta ’ coumarin)
increase your risk of bleeding and your doctor will need to regularly monitor you with blood tests.
minħabba li Tarceva jista ’ jżid ir- riskju ta ’ fsada u t- tabib tiegħek irid jissorveljak regolarment permezz ta ’ testijiet tad- demm.
See also below “Taking other medicines”.
Ara isfel “ Meta tieħu mediċini oħra ”.
61 You should tell your doctor:
62 Trid tgħid lit- tabib tiegħek:
- if you have sudden difficulty in breathing associated with cough or fever because your doctor
- jekk għandek diffikultà f’ daqqa biex tieħu n- nifs assoċjata ma ’ sogħla jew deni, għax it- tabib
may need to treat you with other medicines and interrupt your Tarceva treatment;
tiegħek jista ’ jkollu bżonn jikkurak b’ mediċini oħra u jinterrompi l- kura tiegħek b’ Tarceva;
- if you have diarrhoea because your doctor may need to treat you with anti-diarrhoeal (for
- jekk għandek dijarea, għax it- tabib tiegħek jista ’ jkollu bżonn jikkurak b’ mediċini kontra d -
example loperamide);
dijarea (per eżempju loperamide);
- immediately, if you have severe or persistent diarrhoea, nausea, loss of appetite, or vomiting
- minnufih, jekk għandek dijarea severa jew persistenti, dardir, nuqqas ta ’ aptit, jew qed
because your doctor may need to interrupt your Tarceva treatment and may need to treat you in the hospital.
tirremetti, għax it- tabib tiegħek jista ’ jkollu bżonn jinterrompi l- kura tiegħek b’ Tarceva u jista ’ jkollu bżonn jikkurak l- isptar.
See also section 4 “Possible side effects”.
Ara wkoll sezzjoni 4 “ Effetti sekondarji li jista ’ jkollu ”.
It is not known whether Tarceva has a different effect if your liver or kidneys are not functioning normally.
Mhux magħruf jekk Tarceva ikollux effetti differenti jekk il- fwied jew il- kliewi tiegħek mhux qed jaħdmu normali.
The treatment with this medicine is not recommended if you have a severe liver disease or severe kidney disease.
Il- kura b’ din il- mediċina mhux rakkomandata jekk għandek mard sever tal- fwied jew mard sever tal- kliewi.
Your doctor must treat you with caution if you have a glucuronidation disorder like Gilbert’s syndrome.
It- tabib tiegħek għandu jikkurak b’ kawtela jekk għandek marda ta ’ glucuronidazzjoni bħas- sindromu ta ’ Gilbert.
You are advised to stop smoking if you are treated with Tarceva as smoking could decrease the amount of your medicine in the blood.
Inti avżat biex tieqaf tpejjep jekk qed tiġi kkurat b’ Tarceva għax it- tipjip jista ’ jnaqqas l- ammont tal - mediċina tiegħek fid- demm.
Taking Tarceva with food and drink:
Meta tieħu tuża Tarceva ma ’ l- ikel u max- xorb:
Do not take Tarceva with food.
Tieħux Tarceva ma ’ l- ikel.
Children and adolescents Tarceva has not been studied in patients under the age of 18 years.
Tfal u adoloxxenti Ma sarux studji b’ Tarceva f’ pazjenti taħt l- età ta ’ 18- il sena.
The treatment with this medicine is not recommended for children and adolescents.
Il- kura b’ din il- mediċina mhux rakkomandata għat- tfal u adoloxxenti.
Pregnancy and breast-feeding Avoid pregnancy while being treated with Tarceva.
Tqala u Treddigħ Evita li tinqabad tqila waqt li qed tiġi kkurata b’ Tarceva.
If you could become pregnant use adequate contraception during treatment, and for at least 2 weeks after taking the last tablet.
Jekk tista ’ tinqabad tqila uża kontraċezzjoni adegwata waqt il- kura, u għal ta ’ l- anqas ġimagħtejn wara li tieħu l- aħħar pillola.
If you become pregnant while you are being treated with Tarceva, immediately inform your doctor who will decide if the treatment should be continued.
Dan jiddeċiedi jekk il- kura għandiex titkompla.
Do not breast-feed if you are being treated with Tarceva.
Treddax jekk qed tiġi kkurata b’ Tarceva.
Tarceva has not been studied for its possible effects on the ability to drive and use machines but it is very unlikely that your treatment will affect this ability.
Ma sarux studji b’ Tarceva dwar l- effetti possibli fuq l- abilità li ssuq jew tħaddem magni, iżda mhux probabbli li l- kura tiegħek taffettwa din l- abilità.
Important information about some of the ingredients of Tarceva:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Tarceva:
Tarceva contains a sugar called lactose monohydrate.
Tarceva fih zokkor li jissejjaħ lactose monohydrate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Tarceva.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi zokkrijiet, kellem lit- tabib tiegħek qabel tieħu Tarceva.
HOW TO TAKE TARCEVA
KIF GĦANDEK TIEĦU TARCEVA
Always take Tarceva exactly as your doctor has told you.
Dejjem għandek tieħu Tarceva skond il- parir tat- tabib.
The tablet should be taken at least one hour before or two hours after the ingestion of food.
Il- pillola għandha tittieħed ta ’ l- anqas siegħa qabel jew sagħtejn wara l- ikel.
The usual dose is one tablet of Tarceva 150 mg each day if you have non-small cell lung cancer.
Id- doża tas- soltu hija ta ’ pillola waħda Tarceva 150 mg kuljum jekk għandek kanċer tal- pulmun mhux taċ- ċellola żgħira
The usual dose is one tablet of Tarceva 100 mg each day if you have metastatic pancreatic cancer.
63 Id- doża tas- soltu hija ta ’ pillola waħda Tarceva 100 mg kuljum jekk għandek kanċer metastatiku tal - frixa.
Tarceva is given in combination with gemcitabine treatment.
Tarceva jingħata flimkien ma ’ kura b’ gemcitabine.
62 Your doctor may adjust your dose in 50 mg steps.
It- tabib tiegħek jista ’ jaġġustalek id- doża tiegħek bi kwantitajiet ta ’ 50 mg kull darba.
For the different dosage regimens Tarceva is available in strengths of 25 mg, 100 mg or 150 mg.
Għal dożaġġi differenti Tarceva hija disponiblli f’ qawwiet ta ’ 25 mg, 100 mg jew 150 mg.
If you take more Tarceva than you should:
Jekk tieħu Tarceva aktar milli suppost:
Contact your doctor or pharmacist immediately.
Kellem lit- tabib jew lill- ispiżjar tiegħek minnufih.
You may have increased side effects and your doctor may interrupt your treatment.
Għandu mnejn ikollok żieda ta ’ l- effetti sekondarji u t- tabib tiegħek għandu mnejn jinterrompi l- kura tiegħek.
If you forget to take Tarceva:
Jekk tinsa tieħu Tarceva:
If you miss one or more doses of Tarceva, contact your doctor or pharmacist as soon as possible.
Jekk tinsa doża waħda jew aktar ta ’ Tarceva, kellem lit- tabib jew lill- ispiżjar tiegħek malajr kemm jista ’ jkun.
If you stop taking Tarceva:
Jekk tieqaf tieħu Tarceva:
It is important to keep taking Tarceva every day, as long as your doctor prescribes it for you.
Huwa mportanti li tibqa tieħu Tarceva kuljum, sakemm kitiblek li tieħdu t- tabib tiegħek.
Like all medicines, Tarceva can cause side effects.
Bħal kull mediċina oħra, Tarceva jista ’ jkollu effetti sekondarji.
Very common side effects (occurring in more than 1 out of 10 patients) are rash and diarrhoea as well as itching, dry skin, loss of hair, eye irritation due to conjunctivitis/keratocunjunctivitis, loss of appetite, decreased weight, nausea, vomiting, mouth irritation, stomach pain, indigestion, flatulence, tiredness, fever, rigors, difficulty in breathing, cough, infection, headache, altered skin sensation or numbness in the extremities, depression and abnormal blood tests for the liver function.
Effetti sekondarji komuni ħafna (iseħħu f’ aktar minn 1 minn kull 10 pazjenti) huma raxx u dijarea, kif ukoll ħakk, ġilda xotta, jaqa ’ x- xahar, irritazzjoni ta ’ l- għajnejn minħabba konġuntivite / keratokonġuntivite, nuqqas ta ’ aptit, tnaqqis fil- piż, nawsja, rimettar, irritazzjoni tal- ħalq, uġigħ fl - istonku, indigistjoni, gass, għeja, deni, rogħda ta ’ bard, diffikultà biex tieħu n- nifs, sogħla, infezzjoni, uġigħ ta ’ ras, sensazzjoni mibdula fil- ġilda jew tirżiħ fl- estremitajiet, dipressjoni u testijiet tad- demm tal- funzjoni tal- fwied mhux normali.
In rare cases (occurring in less than 1 out of 1000 patients), liver failure was observed.
F’ każijiet rari (li seħħew f’ inqas minn 1 kull 1000 pazjent), kienet osservata insuffiċjenza tal- fwied.
If your blood tests indicate severe changes in your liver function, your doctor may need to interrupt your treatment.
Jekk it- testijiet tad- demm tiegħek jindikaw bidliet severi fil - funzjoni tal- fwied, it- tabib tiegħek jista ’ jkollu bżonn iwaqqaf il- kura tiegħek.
Persistent and severe diarrhoea may lead to low blood potassium and kidney failure, particularly if you receive other chemotherapy treatments at the same time.
Dijarea persistenti u severa tista ’ twassal għal pottassju baxx fid- demm u falliment tal- kliewi, speċjalment jekk qed tirċievi kura ta ’ kemjoterapija oħra fl- istess waqt.
If you experience more severe or persistent diarrhoea contact your doctor immediately as your doctor may need to treat you in the hospital.
Jekk ikollok dijarea aktar severa jew persistenti kellem lit - tabib tiegħek minnufih għax it- tabib tiegħek jista ’ jkollu bżonn jikkurak l- isptar.
Common side effects (occurring in less than 1 out of 10 patients) are bleeding from the stomach or the intestines and bleeding from the nose, and eye irritation due to keratitis.
Effetti sekondarji komuni (iseħħu f’ anqas minn 1 minn kull 10 pazjenti) huma fsada mill- istonku jew l- intestini u fsada mill- imnieħer u irritazzjoni tal- għajnejn minħabba keratite.
Contact your doctor as soon as possible if you suffer from any of the above side effects.
Kellem lit- tabib malajr kemm jista ’ jkun jekk issofri minn xi effett sekondarju msemmija fuq.
In some cases your doctor may need to reduce your dose of Tarceva or interrupt treatment.
F’ xi każijiet it- tabib tiegħek jista ’ jkollu bżonn innaqqas id- doża tiegħek ta ’ Tarceva jew jinterrompi l- kura.
An uncommon serious side effect (occurring in less than 1 out of 100 patients) is a rare form of lung irritation called interstitial lung disease.
Effett sekondarju serju mhux komuni (iseħħ f’ anqas minn 1 minn kull 100 pazjenti) huwa forma rari ta ’ irritazzjoni tal- pulmun imsejjaħ marda interstizjali tal- pulmun.
This disease can also be linked to the natural progression of your medical condition and can have a fatal outcome in some cases.
Din il- marda tista ’ tkun konnessa ukoll mal- progressjoni naturali tal- kondizzjoni medika tiegħek u f’ xi każijiet jista ’ jkollha tmiem fatali.
If you develop symptoms such as sudden difficulty of breathing associated with cough or fever contact your doctor immediately as you could suffer from this disease.
Jekk tiżżviluppa sintomi bħal diffikultà f’ daqqa biex tieħu n- nifs flimkien ma ’ sogħola jew deni kellem lit- tabib tiegħek minnufih għax jista ’ jkun li qed issofri minn din il- marda.
Your doctor may decide to permanently stop your treatment with Tarceva.
It- tabib tiegħek jista ’ jiddeċiedi li jwaqqaf għal kollox il- kura tiegħek b’ Tarceva.
Hair and nail changes have been observed.
Kienu osservati bidliet fix- xagħar u fid- dwiefer.
These cases were mostly non-serious.
Ġeneralment dawn il- każijiet ma kienux serji.
They included inflammatory reactions around the fingernail (common), excess body and facial hair of a male distribution pattern (uncommon), eyelash and eyebrow changes (uncommon), and brittle and lose nails (uncommon).
Dawn kienu jinkludu reazzjonijiet infjammatorji madwar id- dwiefer ta ’ l- idejn (komuni), xagħar żejjed fil - ġisem u fil- wiċċ b’ disinn ta ’ distribuzzjoni maskili (mhux komuni), bidliet fix- xagħar ta ’ l- għajnejn u l- ħuġbejn (mhux komuni), u dwiefer fraġili u laxki (mhux komuni).
Isolated cases of ulceration of the cornea have been observed.
Kienu osservati każijiet iżolati ta ’ ulċerazzjoni tal- korneja.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
64 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 jew lill- ispiżjar tiegħek.
STORING TARCEVA
KIF TAĦŻEN TARCEVA
Do not use Tarceva after the expiry date which is stated on the blister and the carton after EXP.
Tużax Tarceva wara d- data ta ’ skadenza li tidher fuq l- istrixxa u l- kaxxa wara JIS.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jinħtieġx kondizzjonijiet speċjali ta ’ ħażna.
What Tarceva contains:
X’ fih Tarceva:
- The active substance of Tarceva is erlotinib.
- Is- sustanza attiva ta ’ Tarceva hija erlotinib.
Each film-coated tablet contains 25 mg, 100 mg
Kull pillola miksija b’ rita fiha 25 mg, 100 mg jew
or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the strength.
150 mg ta ’ erlotinib (bħala erlotinib hydrochloride), skond il- qawwa.
Tablet core: lactose monohydrate, cellulose microcrystalline, sodium starch glycolate type A, sodium laurilsulfate, magnesium stearate.
Qalba tal- pillola: lactose monohydrate, cellulose microcrystalline, sodium starch glycolate Type A, sodium laurilsulfate, magnesium stearate.
Tablet coat: hypromellose, hydroxypropyl cellulose, titanium dioxide, macrogol.
Rita tal- pillola: hypromellose, hydroxypropyl cellulose, titanium dioxide, macrogol.
Tarceva 25 mg: shellac, iron oxide yellow Tarceva 100 mg: shellac, iron oxide yellow, iron oxide black, titanium dioxide Tarceva 150 mg: shellac, iron oxide red
Tarceva 25 mg: shellac, iron oxide isfar Tarceva 100mg: shellac, iron oxide isfar, iron oxide iswed, titanium dioxide Tarceva 150 mg: shellac, iron oxide aħmar
What Tarceva looks like and contents of the pack:
Id- Dehra ta ’ Tarceva u l- kontenuti tal- pakkett:
Tarceva 25 mg is supplied as a white to yellowish, round, film-coated tablet with ‘Tarceva 25’ and logo printed in brownish yellow on one side and is available in pack sizes of 30 tablets.
Tarceva 25 mg hija pprovduta bħala pillola miksija b’ rita, tonda, ta ’ kulur abjad għal safrani b ’ ‘ Tarceva 25 ’ u logo stampati bl- isfar kannellin fuq naħa waħda u hija disponibbli f’ pakketti ta ’ 30 pillola.
Tarceva 100 mg is supplied as a white to yellowish, round, film-coated tablet with ‘Tarceva 100’ and logo printed in grey on one side and is available in pack sizes of 30 tablets.
Tarceva 100 mg hija pprovduta bħala pillola miksija b’ rita, tonda, ta ’ kulur abjad għal safrani b ’ ‘ Tarceva 100 ’ u logo stampati bil- griż fuq naħa waħda u hija disponibbli f’ pakketti ta ’ 30 pillola.
Tarceva 150 mg is supplied as a white to yellowish, round, film-coated tablet with ‘Tarceva 150’ and logo printed in brown on one side and is available in pack sizes of 30 tablets.
Tarceva 150 mg hija pprovduta bħala pillola miksija b’ rita, tonda, ta ’ kulur abjad għal safrani b ’ ‘ Tarceva 150 ’ u logo stampati bil- kannella fuq naħa waħda u hija disponibbli f’ pakketti ta ’ 30 pillola.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
65 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Malta (See United Kingdom)
Malta (Ara United Kingdom)
Suomi/Finland Roche Oy Puh/ Tel: +358 (0) 10 554 500 Sverige Roche AB Tel: +46 (0) 8 726 1200
Suomi/ Finland Roche Oy Puh/ Tel: +358 (0) 10 554 500 Sverige Roche AB Tel: +46 (0) 8 726 1200
65 This leaflet was last approved in {MM/YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ {MM/ YYYY}.
TARGRETIN EPAR summary for the public
TARGRETIN Sommarju ta ’ l- EPAR għall- pubbliku
What is Targretin?
X’ inhu Targretin?
Targretin is a medicine containing the active substance bexarotene.
Targretin hija mediċina li fiha s- sustanza attiva bexarotene.
It is available as white soft capsules (75 mg).
Hija disponibbli bħala kapsula bajda ratba (75 mg).
What is Targretin used for?
Għal x’ hiex jintuża Targretin?
Targretin is used for the treatment of the visible signs on the skin of cutaneous T-cell lymphoma (CTCL).
Targretin jintuża għat- trattament tas- sinjali viżibbli fuq il- ġilda tal- limfoma taċ- ċelloli- T tal- ġilda (CTCL).
CTCL is a rare type of lymphoma (cancer of the lymph tissue) where some white blood cells (T-cells) grow in the skin.
CTCL hija tip ta ’ limfoma (kanċer tat- tessuti limfatiċi) fejn xi ċelloli tad- demm bojod (ċelloli- T) jikbru fil- ġilda.
Targretin is used in patients who have an advanced disease and have failed to respond to at least one other treatment.
Targretin jingħata lil pazjenti li għandhom mard avvanzat u li ma rnexxielhomx jirrispondu għal ta ’ l- anqas trattament wieħed ieħor.
How is Targretin used?
Kif jintuża Targretin?
Treatment with Targretin should only be initiated and maintained by a doctor who has experience in the treatment of patients with CTCL.
Trattament b’ Targretin għandu jinbeda u jiġi sorveljat biss minn tabib li għandu esperjenza fi trattamenti ta ’ pazjenti b’ CTCL.
The dose of Targretin is based on the patient’ s body surface area in square metres (m2).
Id- doża ta ’ Targretin hija bbażata fuq il- metri kwadri (m2) ta ’ l- erja tas- superfiċje tal- pazjent.
The recommended starting dose is 300 mg/ m2/ day.
Id- doża tal- bidu rakkomandata hi ta ’ 300 mg/ m2/ kuljum.
The dose is adjusted depending on the patient ’ s response to treatment or side effects.
Id- doża hija aġġustata skond ir- reazzjoni tal- pazjent għat- trattament jew l- effetti sekondarji.
Treatment should continue as long as the patient gets a benefit from it.
It- trattament għandu jitkompla sakemm il- pazjent jibqa ’ jieħu benefiċċju minnu.
See the Summary of Product Characteristics, also part of the EPAR, for full details.
Għad- dettalji sħaħ, ara s- Sommarju tal - Karatteristiċi tal- Prodott, ukoll parti mill- EPAR.
Targretin capsules should be taken as a single dose once a day with a meal.
Il- kapsuli Targretin għandhom jittieħdu bħala doża waħda, darba kuljum ma ’ l- ikel.
How does Targretin work?
Kif jaħdem Targretin?
The active substance in Targretin, bexarotene, is an anticancer agent.
Is- sustanza attiva f’ Targretin, bexarotene, hija mediċina kontra l- kanċer.
It belongs to the group of retinoids, substances that are derived from vitamin A.
Hija tifforma parti mill grupp tar- retinojde, sustanzi li joħorġu mill- vitamina A.
The exact way bexarotene works in CTCL is not known.
Il- mod eżatt kif jaħdem bexarotene fil- CTCL għadu mhux magħruf.
How has Targretin been studied?
Kif ġie studjat Targretin?
The effectiveness of Targretin has been examined in two studies involving a total of 193 patients with CTCL who had failed on at least two previous treatments.
L- effettività ta ’ Tagretin ġiet eżaminata f’ żewġ studji li nvolvew total ta ’ 193 pazjent b’ CTCL li ma ħadmux fuqhom minn ta ’ l- anqas żewġ trattamenti preċedenti.
The studies did not include a control group (Targetin was not compared to another medicine or to placebo).
L- istudji ma inkludewx grupp ta ’ kontroll (Targretin ma tqabbilx ma ’ mediċina oħra jew ma ’ plaċebo).
Ninety-three of these patients had advanced disease that had not responded to other treatment.
Tlieta u disgħin minn dawn il - pazjenti kellhom mard avvanzat li ma rrispondiex għal trattamenti oħra.
Sixty-one patients were treated at the starting dose of 300 mg/ m2/ day.
Wieħed u sittin pazjent kienu ttrattati b’ doża tal- bidu ta ’ 300 mg/ m2/ kuljum.
(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 effectiveness was the response to treatment after 16 weeks.
(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 X’ benefiċċju wera Targretin waqt l- istudji?
Across the two studies, among the patients who received 300 mg/ m2, about half of them responded to treatment, according the doctor’ s grading.
Fuq il- medda taż- żewġ studji, fost il- pazjenti li ngħataw 300 mg/ m2, madwar nofshom irrispondew għat- trattament, skond il- klassifika tat- tabib.
The response rates according to the 5 skin scores were 36% and 27%, respectively.
Ir- rati ta ’ rispons skond il- 5 punteġġi tal- ġilda kienu 36% u 27%, rispettivament.
What is the risk associated with Targretin?
X’ inhu r- riskju assoċjat ma ’ Targretin?
The most common side effects seen with Targretin (in more than 1 patient in 10) are leucopenia (reduced white cell count), hypothyroidism (underactive thyroid gland), hyperlipaemia (high levels of fats in the blood), hypercholesterolaemia (high blood cholesterol), exfoliative dermatitis (skin peeling), pruritus (itching), rash, pain, headache and asthenia (weakness).
L- aktar reazzjonijiet sekondarji komuni li dehru b’ Targretin (f’ aktar minn pazjent 1 f’ 10) kienu lewkopinja (tnaqqis fl- għadd ta ’ ċelloli bojod), ipotirojdiżmu (glandola tat- tirojde taħdem inqas milli suppost), iperlipidimja (livelli għoljin ta ’ xaħam fid- demm), iperkolesterolemija (livell tal- kolesterol għoli fid- demm), dermatite eksfoljattiva (tqaxxir tal- ġilda), prurite (ħakk), raxx, uġigħ, uġigħ ta ’ ras u astenja (dgħjufija).
For the full list of all side effects reported with Targretin, see the Package Leaflet.
Għall- lista sħiħa ta ’ l- effetti sekondarji kollha rraportati b’ Targretin, ara l- Fuljett ta ’ Tagħrif mehmuż mal- pakkett.
Targretin should not be used in people who may be hypersensitive (allergic) to bexarotene or any of the other ingredients.
Targretin m’ għandux jintuża f’ nies li jista ’ jkollhom sensittività eċċessiva (allerġiċi) għal bexarotene jew għal xi waħda mis- sustanzi l- oħra.
Targretin should also not be used in the following situations:  women who are pregnant or breast-feeding  women who could become pregnant  anyone who has had pancreatitis (inflammation of the pancreas)  uncontrolled hypercholesterolaemia (high blood cholesterol).  uncontrolled hypertriglyceridaemia (high blood triglycerides [fat]).  hypervitaminosis A (high levels of vitamin A)  uncontrolled thyroid disease.  liver disease  where there is a body infection.
Targretin m’ għandux jintuża ukoll fis- sitwazzjonijiet li ġejjin:  nisa li huma tqal jew li qed ireddgħu  nisa li jistgħu joħorġu tqal  kull min kellu pankreatite (infjammazzjoni tal- frixa)  iperkolesterolemija mhux ikkontrollata (kolesterol għoli fid- demm).  ipertrigliċeridemija mhux ikkontrollata (trigliċeridi għoljin fid- demm[ xaħam])  ipervitaminożi A (livelli għoljin ta ’ vitamina A)  mard tat- tirojde mhux ikkontrollat  mard tal- fwied  fejn hemm infezzjoni diġa preżenti
Why has Targretin been approved?
Għaliex ġie approvat Targretin?
The Committee for Medicinal products for Human Use (CHMP) decided that Targretin’ s benefits are greater than its risks for the treatment of the skin manifestations of advanced stage cutaneous T-cell lymphoma patients refractory to at least one systemic treatment.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Targretin huma akbar mir- riskji tiegħu fit- trattament ta ’ manifestazzjonijiet ta ’ limfoma taċ- ċelloli- T fil- ġilda fi stadju avvanzat refrattorja għal ta ’ l- anqas trattament sistemiku wieħed.
They recommended that Targretin be given marketing authorisation.
Huma rrakkomandaw li Targretin jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Targretin:
Aktar tagħrif dwar Targretin:
The European Commission granted a marketing authorisation valid throughout the European Union, for Targretin on 29 March 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Targretin fid- 29 ta ’ Marzu 2001.
The marketing authorisation was renewed on 29 March 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid - 29 ta ’ Marzu 2006.
The full EPAR for Targretin is available here.
L- EPAR sħiħ dwar Targretin huwa disponibbli hawnhekk.
This summary was last updated in 03-2007.
Dan is- sommarju ġie aġġornat f’ 03- 2007.
Targretin 75 mg soft capsules
Targretin 75 mg kapsuli rotob
Each capsule contains 75 mg of bexarotene.
Kull kapsula fiha 75 mg ta ’ bexarotene.
Off-white capsule, containing a liquid suspension and imprinted with “ Targretin”.
Kapsula bajda tagħti fil- griż, li fiha suspensjoni likwida u stampata bil- kliem“ Targretin ” fuqha.
Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment.
Il- kapsuli Targretin huma indikati għall- kura ta ’ manifestazzjonijiet fil- ġilda f’ pazjenti li qegħdin fi stadju avvanzat ta ’ cutaneous T- cell lymphoma (CTCL) li mhux qed jirrispondu għal mill- anqas kura sistemika waħda.
Bexarotene therapy should only be initiated and maintained by physicians experienced in the treatment of patients with CTCL.
It- terapija b’ bexarotene trid tinbeda u titkompla biss minn tobba li għandhom esperjenza fil- kura ta ’ pazjenti bis- CTCL.
The recommended initial dose is 300 mg/ m2/ day.
Id- doża rakkomandata tal- bidu hi ta ’ 300 mg/ m2/ kuljum.
Targretin capsules should be taken as a single oral daily dose with a meal (see section 4.5).
Il- kapsuli Targretin għandhom jittieħdu bħala doża waħda orali kuljum flimkien ma ’ l- ikel (ara sezzjoni 4. 5).
Initial dose calculations according to body surface area are as follows:
Il- kalkolazzjonijiet tad- doża tal - bidu skond l- erja tas- superfiċje tal- ġisem huma kif ġej:
Initial dose level (300 mg/ m2/ day) Number of 75 mg
mg/ m2/ kuljum)
Body
Doża totali ta ’
Surface Area (m2)
tal- ġisem (m2)
Total daily dose (mg/ day)
kuljum (mg/ kuljum)
0.88 – 1.12 1.13 - 1.37 1.38 - 1.62 1.63 - 1.87 1.88 - 2.12 2.13 - 2.37 2.38 - 2.62
0. 88 – 1. 12 1. 13 - 1. 37 1. 38 - 1. 62 1. 63 - 1. 87 1. 88 - 2. 12 2. 13 - 2. 37
Dose modification guidelines: the 300 mg/ m2/ day dose level may be adjusted to 200 mg/ m2/ day then to 100 mg/ m2/ day, or temporarily suspended, if necessitated by toxicity.
Il- livell tad- doża ta ’ 300 mg/ m2/ kuljum jista ’ jkun aġġustat għal 200 mg/ m2/ kuljum u mbagħad għal 100 mg/ m2/ kuljum, jew ikun sospiż temporanjament jekk ikun meħtieġ minħabba t- tossiċità.
When toxicity is controlled, doses may be carefully readjusted upward.
Meta t- tossiċità tkun ikkontrollata, id- dożi jistgħu jerġgħu jkunu aġġustati mill- ġdid ’ il fuq b’ attenzjoni.
With appropriate clinical monitoring, individual patients may benefit from doses above 300 mg/ m2/ day.
B’ monitoraġġ kliniku adattat, il- pazjenti individwali jistgħu jibbenefikaw minn dożi ta ’ aktar minn 300 mg/ m2/ kuljum.
Doses greater than 650 mg/ m2/ day have not been evaluated in patients with CTCL.
Dożi ta ’ aktar minn 650 mg/ m2/ kuljum ma
In clinical trials, bexarotene was administered for up to 118 weeks to patients with CTCL.
Fi provi kliniċi, bexarotene ingħata sa 118- il ġimgħa lill- pazjenti bis- CTCL.
Treatment should be continued as long as the patient is deriving benefit.
Il- kura għandha titkompla sakemm il- pazjent ikun qed jibbenefika minnha.
2 Use in children and adolescents: the clinical safety and effectiveness of bexarotene in the paediatric population (below 18 years of age) have not been studied and this product should not be used in a paediatric population until further data become available.
L- użu fit- tfal u fl- adolexxenti: is- sigurtà klinika u l- effettività ta ’ bexarotene fil- popolazzjoni pedjatrika (taħt it- 18- il sena) ma kinux studjati, u dan il- prodott m’ għandux jintuża f’ pazjenti pedjatriċi sakemm aktar informazzjoni issir disponibbli.
Use in the elderly: of the total number of patients with CTCL in clinical studies, 61% were 60 years or older, while 30% were 70 years or older.
L- użu f’ pazjenti anzjani: fl- istudji kliniċi, min- numru totali ta ’ pazjenti bis- CTCL, 61% kienu ta ’ 60 sena jew aktar, filwaqt li 30% kienu ta ’ 70 sena jew aktar.
No overall differences in safety were observed between patients 70 years or older and younger patients, but greater sensitivity of some older individuals to bexarotene cannot be ruled out.
L- ebda differenzi globali fis- sigurtà ma kienu osservati bejn il- pazjenti ta ’ 70 sena jew aktar, u pazjenti iżgħar, iżda wieħed ma jistax jeskludi s- sensittività akbar għal bexarotene ta ’ xi individwi li jkunu aktar anzjani.
The standard dose should be used in the elderly.
Id- doża standard għandha tintuża fl- anzjani.
Renal insufficiency: no formal studies have been conducted in patients with renal insufficiency.
Insuffiċjenza renali: ma saru l- ebda studji formali fuq pazjenti b’ insuffiċjenza renali.
Clinical pharmacokinetic data indicate that urinary elimination of bexarotene and its metabolites is a minor excretory pathway for bexarotene.
Informazzjoni klinika farmakokinetika tindika li t- tneħħija ta ’ bexarotene fl- awrina u tal- metaboliti tiegħu, hi passaġġ sekondarju tat- tneħħija għal bexarotene.
In all evaluated patients, the estimated renal clearance of bexarotene was less than 1 ml/ minute.
Fil- pazjenti kollha li kienu evalwati, it- tneħħija renali ta ’ bexarotene kienet ta ’ inqas minn 1 ml/ minuta.
In view of the limited data, patients with renal insufficiency should be monitored carefully while on bexarotene therapy.
Minħabba li l- informazzjoni hi limitata, il- pazjenti b’ insuffiċjenza renali għandhom ikunu mmonitorati b’ attenzjoni waqt li jkunu qegħdin fuq it- terapija ta ’ bexarotene.
Known hypersensitivity to bexarotene or to any of the excipients of the product.
Sensittività eċċessiva għal bexarotene jew għal xi sustanzi mhux attivi tal- prodott.
Women of child-bearing potential without effective birth-control measures.
Nisa li jistgħu jkollhom it- tfal li mhux qed jużaw miżuri effettivi ta ’ kontraċezzjoni.
History of pancreatitis.
Storja ta ’ pankreatite.
Uncontrolled hypercholesterolaemia.
Iperkolesterolemija mhux ikkontrollata.
Uncontrolled hypertriglyceridaemia.
Ipertrigliċeridemija mhux ikkontrollata.
Hypervitaminosis A.
Ipervitaminosi A.
Uncontrolled thyroid disease.
Mard mhux ikkontrollat fit- tirojde.
Hepatic insufficiency.
Insuffiċjenza epatika.
Ongoing systemic infection.
Infezzjoni sistemika li ghadha għaddejja.
Targretin capsules should be used with caution in patients with a known hypersensitivity to retinoids.
Il- kapsuli targretin għandhom jintużaw bl- attenzjoni f’ pazjenti li hu magħruf li għandhom sensittività eċċessiva għar- retinojdi.
No clinical instances of cross-reactivity have been noted.
Ma kienu osservati l- ebda każijiet ta ’ reattività inkroċjata.
Patients receiving bexarotene should not donate blood for transfusion.
Pazjenti li jkunu qed jieħdu bexarotene, m’ għandhomx jagħtu d- demm għat- trasfużjoni.
Butylated hydroxyanisole, an ingredient in Targretin, may cause irritation to the mucous membranes, therefore the capsules must be swallowed intact and not chewed.
Butylated hydroxyanisole, sustanza f’ Targretin, tista ’ tikkawża irritazzjoni lill- membrani mukużi; għalhekk il - kapsuli jridu jinbelgħu intatti, u m’ għandekx tomgħodhom.
Lipids: hyperlipidaemia has been identified as an effect associated with the use of bexarotene in clinical studies.
Fi studji kliniċi, l- iperlipidimja kienet identifikata bħala effett marbut ma ’ l- użu ta ’ bexarotene.
Fasting blood lipid determinations (triglycerides and cholesterol) should be performed before bexarotene therapy is initiated and at weekly intervals until the lipid response to bexarotene is established, which usually occurs within two to four weeks, and then at intervals no less than monthly thereafter.
Id- determinazzjonijiet tal- lipidi fid- demm (triglycerides u kolesterol) fl- istat sajjem għandhom jitwettqu qabel ma tinbeda t- terapija b’ bexarotene, u f’ intervalli ta ’ kull ġimgħa sakemm ir- rispons tal - lipidi għal bexarotene ikun stabbilit, li normalment iseħħ fi żmien minn ġimagħtejn sa erba ’ ġimgħat, u mbagħad f’ intervalli ta ’ mhux inqas minn darba f’ xahar wara dak il- perjodu.
Fasting triglycerides should be normal or normalised with appropriate intervention prior to bexarotene therapy.
Il- livelli tat - triglycerides fl- istat sajjem għandhom ikunu normali jew normalizzati b’ intervent adattat qabel ma tinbeda t- terapija b’ bexarotene.
Every attempt should be made to maintain triglyceride levels below 4.52 mmol/ l in order to reduce the risk of clinical sequelae.
Għandu jsir kull sforz biex il- livelli tat- triglycerides jinżammu taħt 4. 52 mmol/ l biex jitnaqqas ir- riskju ta ’ kundizzjonijiet jew mard kliniku b’ konsegwenza ta ’ dan.
If fasting triglycerides are elevated or become elevated during treatment, institution of antilipaemic therapy is recommended, and if necessary, dose reductions (from 300 mg/ m2/ day of bexarotene to 200 mg/ m2/ day, and if necessary to 100 mg/ m2/ day) or treatment discontinuation.
Jekk, fl- istat sajjem, il- livelli tat- triglycerides huma għoljin jew jogħlew matul il- kura, hu rakkomandat li tinbeda terapija antilipemika, u jekk ikun meħtieġ, tnaqqis fid- doża (minn 300 mg/ m2/ kuljum ta ’ bexarotene għal 200 mg/ m2/ kuljum, u jekk meħtieġ għal 100 mg/ m2/ kuljum) jew it- twaqqif tal- kura.
Data from clinical studies indicate that bexarotene concentrations were not affected by concomitant administration of atorvastatin.
Informazzjoni minn studji kliniċi tindika li l- konċentrazzjonijiet ta ’ bexarotene ma kinux affettwati mill- għoti fl- istess ħin ta ’ atorvastatin.
However, concomitant administration of gemfibrozil resulted in substantial increases in plasma concentrations of bexarotene and therefore, concomitant administration of gemfibrozil with bexarotene is not recommended (see section 4.5).
Madankollu, l- għoti fl- istess ħin ta ’ gemfibrozil irriżulta f’ żidiet sostanzjali fil- konċentrazzjonijiet fil- plażma ta ’ bexarotene, u għalhekk, l- għoti fl- istess ħin ta ’ gemfibrozil ma ’ bexarotene mhuwiex rakkomandat (ara sezzjoni 4. 5).
Elevations of serum cholesterol should be managed according to current medical practice.
Żidiet tal- kolesterol fis- serum għandhom ikunu mmaniġġjati skond il- prattika medika kurrenti.
Pancreatitis: acute pancreatitis associated with elevations of fasting serum triglycerides has been reported in clinical studies.
3 Pankreatite: fi studji kliniċi, il- pankreatite akuta marbuta ma ’ żidiet ta ’ triglycerides fis- serum fl- istat sajjem, kienet irrappurtata.
Patients with CTCL having risk factors for pancreatitis (e. g., prior episodes of pancreatitis, uncontrolled hyperlipidaemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity) should not be treated with bexarotene, unless the potential benefit outweighs the risk.
Pazjenti bis- CTCL li jkollhom fatturi ta ’ riskju għall- pankreatite (eż. episodji ta ’ pankreatite fil- passat, iperlipidimja mhux ikkontrollata, konsum żejjed ta ’ alkoħol, dijabete mellitus mhux ikkontrollata, mard ta ’ l- apparat biljari, u li qed jieħdu mediċini li huma magħrufin li jżidu l- livelli tat- triglycerides jew li huma marbuta ma ’ tossiċità pankreatika), m’ għandhomx ikunu kkurati b’ bexarotene, ħlief jekk il- benefiċċju potenzjali jegħleb ir- riskju.
3 Liver Function Test (LFT) abnormalities:
Anormalitajiet tat- Test tal- Funzjoni tal- Fwied (Liver Function Test - LFT):
LFT elevations associated with the use of bexarotene have been reported.
Kienu rrappurtati żidiet tal- LFT marbuta ma ’ l- użu ta ’ bexarotene.
Based on data from ongoing clinical trials, elevation of LFTs resolved within one month in 80% of patients following a decrease in dose or discontinuation of therapy.
Ibbażat fuq informazzjoni mill- provi kliniċi li għadhom għaddejjin, iż- żieda ta ’ LFTs għabet fi żmien xahar fi 80% tal- pazjenti wara tnaqqis fid- doża jew it - twaqqif tat- terapija.
Baseline LFTs should be obtained, and LFTs should be carefully monitored weekly during the first month and then monthly thereafter.
L- LFTs fil- linja bażi għandhom jinkisbu, u l- LFTs għandhom ikunu mmonitorjati bl- attenzjoni kull ġimgħa matul l- ewwel xahar, u mbagħad kull xahar wara dak il- perjodu.
Consideration should be given to a suspension or discontinuation of bexarotene if test results reach greater than three times the upper limit of normal values for SGOT/ AST, SGPT/ ALT, or bilirubin.
Għandha tingħata konsiderazzjoni lis- sospensjoni jew it- twaqqif ta ’ bexarotene jekk ir- riżultati tat- test ikunu ta ’ aktar minn tliet darbiet tal- Limitu ta ’ Fuq tan- Normal għal SGOT/ AST, SGPT/ ALT, jew il- bilirubina.
Thyroid function test alterations: changes in thyroid function tests have been observed in patients receiving bexarotene, most often noted as a reversible reduction in thyroid hormone (total thyroxine [total T4]) and thyroid-stimulating hormone (TSH) levels.
Bidliet fit- test tal- funzjoni tat- tirojde: bidliet fit- testijiet tal- funzjoni tat- tirojde kienu osservati f’ pazjenti li kienu qed jirċievu bexarotene, u fil- biċċa l- kbira tagħhom kienu osservati bħala tnaqqis riversibbli fil- livelli ta ’ l- ormon tat- tirojde (total ta ’ thyroxine ta ’ T4]) u fil- livelli ta ’ l- ormon li jistimula t- tirojde (thyroid- stimulating hormone - TSH).
Baseline thyroid function tests should be obtained and then monitored at least monthly during treatment and as indicated by the emergence of symptoms consistent with hypothyroidism.
It- testijiet tal- funzjoni tat- tirojde fil- linja bażi għandhom jinkisbu u mbagħad ikunu mmonitorati mill- anqas kull xahar matul il- kura u kif indikat mill- iżvilupp ta ’ sintomi li huma konsistenti ma ’ l- ipotirojdiżmu.
Patients with symptomatic hypothyroidism on bexarotene therapy have been treated with thyroid hormone supplements with resolution of symptoms.
Pazjenti b’ ipotirojdiżmu sintomatiku li jkunu fuq terapija b’ bexarotene, kienu kkurati b’ supplimenti ta ’ l- ormon tat- tirojde, bil- fejqan tas - sintomi.
Leucopenia: leucopenia associated with bexarotene therapy has been reported in clinical studies.
Lewkopenja: lewkopenja marbuta mat- terapija b’ bexarotene kienet irrappurtata fl- istudji kliniċi.
The majority of cases resolved after dose reduction or discontinuation of treatment.
Il - maġġoranza tal- każijiet fiequ wara tnaqqis fid- doża jew it- twaqqif tal- kura.
Determination of white blood cell count with differential count should be obtained at baseline, weekly during the first month and then monthly thereafter.
Id- determinazzjoni ta ’ l - għadd taċ- ċelluli tad- demm bojod flimkien ma ’ l- għadd differenzjali għandhom jinkisbu fil- linja bażi, darba f’ ġimgħa matul l- ewwel xahar u mbagħad kull xahar wara dak il- perjodu.
Anaemia: anaemia associated with bexarotene therapy has been reported in clinical studies.
Anemija: anemija marbuta mat- terapija b’ bexarotene kienet irrappurtata fl- istudji kliniċi.
Determination of haemoglobin should be obtained at baseline, weekly during the first month and then monthly thereafter.
Id - determinazzjoni ta ’ l- emoglobina għandha tinkiseb fil- linja bażi, darba f’ ġimgħa matul l- ewwel xahar u mbagħad kull xahar wara dak il- perjodu.
Decreases of haemoglobin should be managed according to current medical practice.
It- tnaqqis ta ’ l- emoglobina għandu jkun immaniġġjat skond il- prattika medika kurrenti.
Lens opacities: following bexarotene treatment, some patients were observed to have previously undetected lens opacities or a change in pre-existing lens opacities unrelated to treatment duration or dose level of exposure.
Opaċitajiet tal- lenti: wara l- kura b’ bexarotene, kien osservat li xi pazjenti kellhom opaċitajiet tal- lenti fil- passat li ma kinux ġew innutati, jew bidla fl- opaċitajiet tal- lenti li kienu jeżistu minn qabel, li ma kinux marbuta mat- tul tal- kura jew mal- livell tad- doża ta ’ l- espożizzjoni.
Given the high prevalence and natural rate of cataract formation in the older patient population represented in the clinical studies, there was no apparent association between the incidence of lens opacity formation and bexarotene administration.
Minħabba l- prevalenza għolja u r- rata naturali tal- formazzjoni ta ’ katarretti fil- popolazzjoni tal- pazjenti aktar anzjani li kienu rrappreżentati fl- istudji kliniċi, ma kien hemm l- ebda rabta apparenti bejn l- inċidenza tal- formazzjoni ta ’ l- opaċità tal- lenti u l- għoti ta ’ bexarotene.
However, an adverse effect of long-term bexarotene treatment on lens opacity formation in humans has not been excluded.
Madankollu, ma kienx eskluż effett avvers tal- kura fit- tul ta ’ bexarotene fuq l- opaċità tal- lenti fil- bnedmin.
Any patient treated with bexarotene who experiences visual difficulties should have an appropriate ophthalmologic examination.
Kwalunkwe pazjent ikkurat b’ bexarotene li jkollu diffikultajiet fil- vista, għandu jkollu eżami oftalmoloġiku adattat.
Vitamin A supplementation: because of the relationship of bexarotene to vitamin A, patients should be advised to limit vitamin A supplements to ≤ 15,000 IU/ day to avoid potential additive toxic effects.
Supplimentazzjoni ta ’ vitamina A: minħabba r- relazzjoni ta ’ bexarotene ma ’ vitamina A, il- pazjenti għandhom jingħataw parir biex jillimitaw is- supplimenti ta ’ vitamina A għal ≤15, 000 IU/ kuljum biex jevitaw effetti tossiċi addittivi potenzjali.
Patients with diabetes mellitus: caution should be exercised when administering bexarotene in patients using insulin, agents enhancing insulin secretion (e. g. sulfonylureas), or insulin-sensitisers (e. g. thiazolidinediones).
Pazjenti li għandhom dijabete mellitus: għandha tingħata attenzjoni meta bexarotene jingħata lil pazjenti li jkunu qed jużaw l- insulina, mediċini li jtejbu t- tnixxija ta ’ l- insulina (eż. sulfonylureas), jew sensitisers ta ’ l- insulina (eż. thiazolidinediones).
Based on the known mechanism of action, bexarotene may potentially enhance the action of these agents, resulting in hypoglycaemia.
Ibbażat fuq il- mekkaniżmu magħruf ta ’ l- azzjoni, bexarotene jista ’ potenzjalment isaħħaħ l- azzjoni ta ’ dawn il- mediċini, li tirriżulta f’ ipogliċemija.
No cases of hypoglycaemia associated with the use of bexarotene as monotherapy have been reported.
Ma kienu rrappurtati l- ebda każijiet ta ’ ipogliċemija marbuta ma ’ l- użu ta bexarotene bħala monoterapija.
Photosensitivity: the use of some retinoids has been associated with photosensitivity.
L- użu ta ’ xi retinojdi kien marbut ma ’ sensittività għad- dawl.
Patients should be advised to minimise exposure to sunlight and avoid sun lamps during therapy with bexarotene, as in vitro data indicate that bexarotene may potentially have a photosensitising effect.
4 jintużaw sabiex wieħed jismar matul it- terapija b’ bexarotene, għax informazzjoni in vitro tindika li bexarotene jista ’ potenzjalment ikollu effett ta ’ fotosensittività.
Oral contraceptives: bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestive contraceptives.
Kontraċettivi orali: bexarotene jista ’ potenzjalment jikkaġuna enzimi metaboliċi u għalhekk, teoretikament inaqqas l- effikaċja tal- kontraċettivi oestroprogestative.
Thus, if treatment with bexarotene is intended in a woman of childbearing potential, a reliable, non-hormonal form of contraception is also required, because bexarotene belongs to a therapeutic class for which the human malformative risk is high.
Għaldaqstant, jekk il- kura b’ bexarotene hi intenzjonata għal mara li jista ’ jkollha t- tfal, metodu kontraċettiv affidabbli u mhux ormonali hu rakkomandat ukoll, minħabba li bexarotene jappartjeni għal klassi terapewtika li għaliha, ir- riskju ta ’ malformazzjonijiet umani hu għoli.
Effects of other substances on bexarotene: no formal studies to evaluate interactions with bexarotene have been conducted.
Effetti ta ’ sustanzi oħrajn fuq bexarotene:
On the basis of the oxidative metabolism of bexarotene by cytochrome
Ma saru l- ebda studji biex jevalwaw l- interazzjonijiet ma ’ bexarotene.
4 P450 3A4 (CYP3A4), coadministration with other CYP3A4 substrates such as ketoconazole, itraconazole, protease inhibitors, clarithromycin and erythromycin may theoretically lead to an increase in plasma bexarotene concentrations.
Fuq il- bażi tal- metaboliżmu li jossida ta ’ bexarotene minn ċitokrom P450 3A4 (CYP3A4), l- għoti flimkien ma ’ sotto- strati oħrajn ta ’ CYP3A4, bħal ketoconazole, itraconazole, inibituri tal - protease, clarithromycin u erythromycin, jista ’ teoretikament iwassal għal żieda fil- konċentrazzjonijiet fil- plażma ta ’ bexarotene.
Furthermore, co-administration with CYP3A4 inducers such as rifampicin, phenytoin, dexamethasone or phenobarbital may theoretically cause a reduction in plasma bexarotene concentrations.
Flimkien ma ’ dan, l- għoti flimkien ma ’ inducers ta ’ CYP3A4 bħal rifampicin, phenytoin, dexamethasone jew phenobarbital, jista ’ teoretikament jikkawża tnaqqis fil - konċentrazzjonijiet fil- plażma ta ’ bexarotene.